Newsletter

Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug Application for ACER-001 to Treat Urea Cycle Disorders

Year ordering: 2021
Media Contact:

 

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Acer Therapeutics Inc.
Jim DeNike
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+1 844-902-6100

Investor relations:

RELIEF THERAPEUTICS Holding SA:

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics:
Hans Vitzthum
LifeSci Advisors
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 617-430-7578

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether Relief will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, (iv) whether RLF-100 (aviptadil) will receive emergency use authorization in the United States, (v) whether RLF-100 (aviptadil) will ever be submitted for authorization in Europe, (vi) whether Relief’s ongoing disputes with its U.S. collaboration partner for RLF-100 (aviptadil) can be resolved amicably, and (vii) those other risks, uncertainties and factors described in Relief’s annual and periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 211006_Relief_ACER001 NDA accept
Attachment (PDF): 20211006_ad_hoc_Relief_ACER-001-NDA-Acceptance.pdf

Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug Application for ACER-001 to Treat Urea Cycle Disorders

FDA sets PDUFA target action date of June 5, 2022

NEWTON, MA and GENEVA, SWITZERLAND – October 6, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders (UCDs). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022.

Acer’s 505(b)(2) NDA is supported by results from two previously announced bioequivalence (BE) trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to the reference listed drug, BUPHENYL® (sodium phenylbutyrate).

"With FDA commencing a substantive review of our NDA, ACER-001 is one step closer to potentially providing an alternative treatment option for patients with UCDs," said Chris Schelling, Chief Executive Officer and Founder of Acer. "We look forward to working with the FDA during their review of our application. In addition, we continue to collaborate with our partners to ensure we are well positioned to support a successful commercial launch of ACER-001, subject to FDA approval.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “Our collaboration with Acer is thriving and we are pleased with the progress they have made in advancing ACER-001. In parallel with Acer’s activities, we continue to execute on our global commercial strategy for ACER-001 which includes our intended submission of a Marketing Authorization Application (MAA) for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for the indications under investigation.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the stomach. Acer is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs, a commercial infrastructure in selected European countries and an internal, R&D capability, which Relief hopes to leverage for both internal pipeline products as well as for third party product development on a fee for service basis.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit
www.relieftherapeutics.com. Follow Relief on LinkedIn.

References

1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

 

Acer Therapeutics and Relief Therapeutics Announce Issuance of U.S. Patent 11,154,521 Covering ACER-001 Formulation

Year ordering: 2021
Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics Inc.
Jim DeNike
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 844-902-6100

Investor relations:

RELIEF THERAPEUTICS Holding SA:

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Acer Therapeutics:
Hans Vitzthum
LifeSci Advisors
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1 617-430-7578

Disclaimer:

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief Forward-Looking Statements

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 or at all, (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patients in Europe with UCDs will be approved, and (iv) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s annual and periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 211026_ACER001 patent issuance
Attachment (PDF): 20211026_ad_hoc_Relief_acer-001_patent_issuance.pdf

Acer Therapeutics and Relief Therapeutics Announce Issuance of U.S. Patent 11,154,521 Covering ACER-001 Formulation

Key ACER-001 formulation composition of matter patent strengthens proprietary position in U.S. until 2036

NEWTON, MA and GENEVA, SWITZERLAND – October 26, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new U.S. patent to Acer for certain claims related to ACER-001 (sodium phenylbutyrate). Patent 11,154,521 covers pharmaceutical composition claims related to ACER-001’s taste-masked, multi-particulate dosage formulation for oral administration. The newly issued patent has an expiration date in 2036.

“We are extremely pleased that our ACER-001 formulation patent has been issued, adding key protection to our growing intellectual property portfolio for ACER-001 as we continue to advance its development to potentially treat patients with Urea Cycle Disorders (UCDs), Maple Syrup Urine Disease (MSUD) and other possible indications,” said Jeff Davis, Chief Business Officer at Acer. “This patent issuance is an important step in our pursuit of possible ACER-001 commercialization, and we intend to submit it for listing by the U.S. Food and Drug Administration (FDA) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, should ACER-001 receive marketing approval.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “In parallel to the patent application efforts in the U.S., Acer and Relief are pursuing similar claims in the European Patent Office to cover ACER-001 as we continue to execute on our plan to submit a Marketing Authorization Application for ACER-001 for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that this product candidate will receive regulatory authority approval for marketing in any territory or become commercially available for the indications under investigation.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit
www.relieftherapeutics.com. Follow Relief on LinkedIn.

References
1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S. FDA for ACER-001 for Treatment of Urea Cycle Disorders

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the ongoing clinical trials of Relief’s lead compound, RLF-100™ (aviptadil) in advanced clinical development to treat respiratory deficiency due to COVID-19, will be successful. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 8.9.21 Relief and Acer announce submission of NDA
Attachment (PDF): 210809_Relief_Acer-001_NDA_Submission.pdf

Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S. FDA for ACER-001 for Treatment of Urea Cycle Disorders

NEWTON, MA and GENEVA, SWITZERLAND – August 9, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, and RELIEF THERAPEUTICS Holding AG  (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs).  ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

Based on standard FDA review timelines, Acer expects to receive notification from FDA on the potential acceptance of the NDA for filing within 60 days of submission and subsequent substantive review.

The 505(b)(2) NDA submission is supported by results from two previously announced bioequivalence (BE) trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to BUPHENYL® (sodium phenylbutyrate). Acer has also received an Agreement Letter from FDA in response to the Company’s initial Pediatric Study Plan (iPSP) which outlines an agreed upon approach that addresses the needs of pediatric patients with UCDs.

“The submission of our NDA for ACER-001 marks an important step toward bringing this potential alternative treatment option to patients with UCDs,” said Chris Schelling, Chief Executive Officer and Founder of Acer. “We look forward to working with the FDA through the review process and will continue advancing our preparations for a potential launch of ACER-001, while also assisting Relief toward regulatory submissions in Europe.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief Therapeutics, added, “We are excited about the progress made to date in support of a potential regulatory approval of ACER-001 for UCDs in the U.S. With the NDA now submitted, we will continue our efforts to back ACER-001’s development in Europe by targeting submission of a Marketing Authorization Application (MAA) for the treatment of UCDs in Europe by the end of 2021.”

ACER-001 is an investigational product candidate which has not been approved by FDA or the European Medicines Agency (EMA). There is no guarantee that this product candidate will be accepted for substantive review, or if accepted, receive regulatory authority approval in any territory, or become commercially available for the indications under investigation.

ABOUT UCDS

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms (1,2). The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication (3).

ABOUT ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste in the mouth while quickly dissolving in the low pH of the stomach. ACER-001’s taste-masked formulation is aimed to improve the palatability of sodium phenylbutyrate. Acer is also being developed for Maple Syrup Urine Disease (MSUD) and has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is an investigational product candidate which has not been approved by FDA or the European Medicines Agency (EMA).

ABOUT ACER THERAPEUTICS INC.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for development and commercialization of ACER-001. For more information, visit www.acertx.com.

ABOUT RELIEF THERAPEUTICS HOLDING AG

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

REFERENCESREFERENCES

1.Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.

2.Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).

3.Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

ACER FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Acer Therapeutics Receives Notice of Allowance of Key U.S. Patent Application Covering ACER-001 Formulation

Year ordering: 2021
Media Contact:

 

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Acer Therapeutics Inc.
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Rx Communications Group
Michael Miller
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, (iv) whether RLF-100 (aviptadil) will receive emergency use authorization in the United States, (v) whether RLF-100 (aviptadil) will ever be submitted for authorization in Europe, (vi) whether RELIEF THERAPEUTICS Holding SA’s ongoing disputes with its U.S. collaboration partner for RLF-100 (aviptadil) can be resolved amicably, and (vii) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s annual and periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 211007_Relief_ACER001 Notice of Allowance
Attachment (PDF): 20211007_ad_hoc_Relief__ACER-001_ip-notice-allowance.pdf

Acer Therapeutics Receives Notice of Allowance of Key U.S. Patent Application Covering ACER-001 Formulation

Notice of allowance of ACER-001 formulation composition of matter patent application strengthens proprietary position in U.S. until 2036

NEWTON, MA and GENEVA, SWITZERLAND – October 7, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Acer’s patent application No. 17/196,416 for certain claims related to ACER-001 (sodium phenylbutyrate). The allowed patent claims in the application titled, “Palatable Compositions Including Sodium Phenylbutyrate and Uses Thereof,” include pharmaceutical composition claims covering ACER-001’s taste-masked, multi-particulate dosage formulation for oral administration.

The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. Acer’s patent is expected to be issued in the fourth quarter of 2021 and expire in 2036. If it receives marketing approval for ACER-001, Acer intends to submit the patent for listing by the U.S. Food and Drug Administration (FDA) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

“We are extremely pleased to have received this Notice of Allowance from the USPTO for our proprietary formulation of ACER-001 as we continue to advance its development to potentially treat patients with Urea Cycle Disorders (UCDs), Maple Syrup Urine Disease (MSUD) and other possible indications,” said Jeff Davis, Chief Business Officer at Acer. “This Notice marks another important milestone in our pursuit of possible ACER-001 commercialization while we prepare to bring this treatment to UCDs patients, subject to FDA’s approval of our ACER-001 New Drug Application.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “In parallel to the patent application efforts in the U.S., Acer and Relief are pursuing similar claims in the European Patent Office to cover ACER-001 as we continue to execute on our plan to submit a Marketing Authorization Application for ACER-001 for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that this product candidate will receive regulatory authority approval for marketing in any territory or become commercially available for the indications under investigation.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs, a commercial infrastructure in selected European countries and an internal R&D capability, which Relief hopes to leverage for both internal pipeline products as well as for third party product development on a fee for service basis.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit
www.relieftherapeutics.com. Follow Relief on LinkedIn.

References
1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief and AdVita Close Definitive Agreement for Relief to Acquire All Outstanding Shares of AdVita

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its business. There can be no assurance that Relief will successfully develop the inhaled formulation of aviptadil for any indication nor that aviptadil will ultimately be approved for marketing in any country. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 20210728_Relief and Advita Closing
Attachment (PDF): 210728_ad_hoc_Relief_AdVita_Closing.pdf

Relief and AdVita Close Definitive Agreement for Relief to Acquire All Outstanding Shares of AdVita

Acquisition Expands Scope of Development of Inhaled Formulation of Aviptadil

Geneva, Switzerland, July 28, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that it has closed a definitive agreement to acquire all outstanding shares of AdVita Lifescience GmbH ("AdVita"), a Germany-based, privately held pharmaceutical company developing effective products and strategies to improve the treatment and diagnosis of rare lung diseases.

With the acquisition, Relief has gained additional pending intellectual property rights that may cover RLF-100TM inhaled formulation specifications and the potential application of inhaled aviptadil for the treatment of lung diseases such as acute respiratory distress syndrome (ARDS), pulmonary sarcoidosis and checkpoint inhibitor-induced pneumonitis (CIP).

Under the terms of the agreement, Relief paid AdVita shareholders a total of 135,741,063 Relief common shares, representing EUR 25 million in value based on a 60-day Volume-Weighted Average Price (VWAP) of Relief’s common stock, to acquire all outstanding shares of AdVita. In addition, Relief will pay milestone payments of up to EUR 20 million in cash, contingent to achievement of certain regulatory milestones related to AdVita’s development programs.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, said: "We are pleased to close this acquisition, which brings to Relief additional intellectual property concerning inhaled formulations of aviptadil.  In addition, the AdVita team has strong expertise with aviptadil that has already been extremely helpful as we advance our plans for the development of the inhaled formulation of RLF-100™ for the prevention of COVID-19-related ARDS, as well as other potential lung diseases."

Wolfgang Hoppe, Chief Executive Officer of AdVita, commented: "We are delighted to join the Relief team and are excited about working together to develop inhaled aviptadil with the goal of bringing it to patients with respiratory diseases where there is a need for better treatment options."

In April, Relief and AdVita initiated an investigator-sponsored phase 2 trial with inhaled aviptadil for the prevention of COVID-19-related acute respiratory distress syndrome. The study, “Inhaled aviptadil for the Prevention of COVID-19 Related ARDS” (NCT 04536350), is a randomized, double-blind, placebo-controlled phase 2 trial being conducted at major clinical sites in Switzerland.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Announces Issuance of Shares from Authorized Capital as Approved by 2021 Annual General Meeting

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Capital Increase
Attachment (PDF): 210722_ad_hoc_PR_share_capital_issuance_ENG.pdf

Relief Announces Issuance of Shares from Authorized Capital as Approved by 2021 Annual General Meeting

  • Shares being used in part for payments related to AdVita and APR acquisitions
  • Acquisitions are part of Relief’s transformation into a fully integrated diversified commercial-stage pharmaceutical company

Geneva, Switzerland, July 22, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the Company will, on or around July 27, 2021, issue 1,000,000,000 additional registered shares out of the authorized share capital approved by the Annual General Meeting on June 18, 2021. The new shares are fully subscribed at par value by the Company’s wholly owned subsidiary, Relief Therapeutics International SA, and will be listed on the SIX Swiss Exchange on or around July 28, 2021. Some of the shares will be used for contractually agreed payments to the respective sellers of AdVita Lifescience GmbH (“AdVita”) and APR Applied Pharma Research SA (“APR”): approximately 140,000,000 shares and 206,786,784 shares, respectively. The remaining new shares will be held as treasury shares for possible future financing transactions, acquisitions, general corporate purposes, and the settlement of possible future contingent milestone payments to the APR and AdVita sellers. The APR sellers are generally subject to a 75-day lock-up period and a subsequent leak-out schedule.

Jack Weinstein, CFO and Treasurer of Relief, said: “During the course of 2021, we have taken several important steps to transform Relief into a multi-product, revenue-generating company. One critical component of that was the recently closed acquisition of APR, which brings us a diverse pipeline, including market-stage products, and provides a commercial springboard for future Relief product launches. We also are strengthening our intellectual property position with our lead candidate, RLF-100™ (aviptadil), through the planned acquisition of AdVita. We are also actively continuing to look for other opportunities as we build our business.”

The associated listing prospectus will be listed on the SIX Prospectus Office’s website and will be made available upon request once it has been approved by the SIX Swiss Exchange, which is expected on or around July 27, 2021.

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Announces Receipt of U.S. FDA Orphan Drug Designation for the use of RLF-100 (aviptadil) in the Treatment of Sarcoidosis

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 8.3.21 Relief Therapeutics Sarcoidosis PR - FINAL
Attachment (PDF): 8.3.21_Relief_Therapeutics_Sarcoidosis_PR_-_FINAL.pdf

Relief Announces Receipt of U.S. FDA Orphan Drug Designation for the use of RLF-100 (aviptadil) in the Treatment of Sarcoidosis

Geneva, Switzerland, August 3, 2021 –RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the "Company"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that, via its newly acquired subsidiary, AdVita Lifescience GmbH, the Company has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for RLF-100 (aviptadil), an inhaled formulation in development for the treatment of sarcoidosis. RLF-100 is a synthetic form of vasoactive intestinal peptide. In open label exploratory clinical experience in sarcoidosis patients, RLF-100 has been shown to be well tolerated and safe, and to produce favorable immunoregulatory effects in the lungs that have been associated with symptom relief in a significant proportion of the patients.

“Receipt of our third Orphan Drug Designation is another important milestone for the Company, as it underscores the potential strength of our pipeline and the high need for better treatments for rare diseases such as sarcoidosis,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Directors of Relief. “The timing of this newest Orphan Drug Designation comes on the heels of our just closed acquisition of AdVita Lifescience GmbH and supplements those we have for our drug candidates for EB and PKU, which we added to our pipeline through our recent acquisition of APR Applied Pharma Research SA, consistent with our strategy to become a fully integrated diversified commercial-stage pharmaceutical company.”

Orphan Drug Designation is granted for products that are intended to treat life-threatening or chronically debilitating conditions affecting less than 200,000 patients in the U.S. and no more than five in 10,000 persons in the European Union. Further criteria include the potential of the product to provide significant patient benefit over available treatment, or to fill an unmet medical need where no treatment exists.

Orphan Drug Designation confers numerous benefits to the development of new products, including clinical protocol assistance and, upon marketing authorization, assures marketing exclusivity for a period of up to seven years in the U.S. and up to ten years in the EU once the medicine is on the market.

About Sarcoidosis

Sarcoidosis is a rare disease in which the inflammatory process involves the alveoli (air sacs), small bronchi, and small blood vessels. As the disease progresses, small lumps, or granulomas, appear in the affected tissues which tend to remain inflamed and become scarred (fibrotic). Granulomas are structured masses composed of activated immune cells (macrophages, lymphocytes, mast cells and fibroblasts). Many sarcoidosis patients are left with permanent lung damage as they undergo a chronic course where complications such as pulmonary fibrosis are common and irreversible. Currently there are about 140,000 sarcoidosis patients in the U.S.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and is quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Provides Corporate Update and Outlines Plans to Advance its Diversified Portfolio of Pipeline Candidates, Including RLF-100™ (Aviptadil)

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
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Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA can obtain approval to market RLF-100™ (aviptadil) and the effect on its efforts in that regard of the pending lawsuit against NeuroRx and its CEO, (ii) whether ACER-001 will be approved for commercialization in the U.S. and successfully commercialized if approved, (iii) whether PKU GOLIKE® can be successfully marketed in the U.S., (iv) whether RELIEF THERAPEUTICS Holding SA has sufficient cash resources to fund its operations into late 2023 and whether RELIEF THERAPEUTICS Holding SA can become cash flow positive by 2024, (v) whether RELIEF THERAPEUTICS Holding SA will be able to transition its ADR program from a Level 1 program to a Level 2 or a Level 3 program and up list its ADRs to the NASDAQ Stock Market, and (vi) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief corporate update
Attachment (PDF): 20211111_ad_hoc_Relief_Corporate_Update.pdf

Relief Provides Corporate Update and Outlines Plans to Advance its Diversified Portfolio of Pipeline Candidates, Including RLF-100™ (Aviptadil)

Geneva, Switzerland, November 11, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today provided a corporate update detailing, among other matters, its ongoing clinical development and regulatory activities, as well as its plans to accelerate the maturation of its pipeline.

RLF-100™

Relief remains committed to the development of RLF-100™ (aviptadil) for the treatment of respiratory complications of COVID-19 infection. A clinical program remains under way in Europe for inhalation-based administration, while the ACTIVE-3b/TESICO study sponsored by the U.S. National Institutes of Health (“NIH”) assessing the intravenous formulation and the I-SPY trial sponsored by Quantum Leap testing the inhaled formulation also remain ongoing. Further, the parent company of Relief’s U.S. collaboration partner has publicly reported that they are continuing to conduct an investigational study of inhaled aviptadil in the U.S. as well. In addition, Relief continues to pursue aviptadil for the treatment of pulmonary sarcoidosis, and authorization to commence a phase 2 randomized, double-blinded, placebo-controlled clinical trial in this indication was recently granted by the German medical regulatory authorities. In August 2021, Relief announced the receipt of U.S. Orphan Drug Designation for the use of aviptadil in treatment of sarcoidosis. Relief also intends to explore the clinical utility of aviptadil in acute respiratory distress syndrome (“ARDS”) unrelated to COVID-19 infection, as well as in other pulmonary disorders, including chronic beryllium disease (“berylliosis”) and checkpoint inhibitor-induced pneumonitis (“CIP”), in which AdVita has filed pending patent claims. Finally, Relief is also working to optimize the formulation of aviptadil.

As previously reported, in October 2021 Relief filed a lawsuit against NeuroRx, Inc. ("NeuroRx") and its Chief Executive Officer, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx relating to the development and commercialization of RLF-100™ (aviptadil). The complaint alleges, among other breaches of the Collaboration Agreement, that NeuroRx has failed to provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating IV RLF-100™ (aviptadil) for the treatment of acute respiratory failure due to COVID-19 (which data and information are required to be provided to Relief by NeuroRx under the Collaboration Agreement) and has failed to allow Relief to have input into NeuroRx's U.S. development program. Without doubt, Relief was disappointed that Emergency Use Authorization for aviptadil in the United States was denied. However, this decision by FDA does not affect Relief's commitment to the further development of this drug.

U.S. Commercial Initiatives

Relief is focused on establishing its U.S. commercial operations and initiating market rollout of its lead commercial product, PKU GOLIKE®, for the treatment of phenylketonuria (“PKU”). PKU GOLIKE® is a novel, proprietary next-generation prolonged-release amino acid mix for use as a mainstay of PKU therapy and is available in multiple formulations, including the innovative new PKU GOLIKE® KRUNCH™ tablets. Relief, through its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), currently markets this product in Europe. The initiative to market this product in the U.S. will be led by Relief's Head of U.S. Commercial Operations, Anthony M. Kim, who has a lengthy track record of successful commercialization of drugs aimed at rare and specialty disease indications in the U.S. market. Mr. Kim will be responsible for spearheading the creation of Relief’s U.S. commercial infrastructure and helping to optimize the introduction of the GOLIKE® product line.

Relief is also working closely with its collaboration partner Acer Therapeutics on the preparations for a potential launch of ACER-001, a proprietary, taste-masked formulation of sodium phenylbutyrate for the treatment of Urea Cycle Disorders (“UCDs”). ACER-001 is the subject of a New Drug Application (“NDA”) that has been accepted for review by the United States Food and Drug Administration (“FDA”) with a Prescription Drug User Fee Act (PDUFA) approval decision action date of June 5, 2022. Additionally, Relief is preparing to submit a Marketing Authorization Application (“MAA”) for ACER-001 to European and U.K. regulatory agencies, which is expected to be filed during the first half of 2022. Moreover, Relief intends to assess ACER-001 in a clinical program for Maple Syrup Urine Disease (“MSUD”) during 2022. Relief and Acer also continue to explore strategic options to advance the optimization of ACER-001’s commercial value in territories beyond the U.S., U.K. and Europe.

Other Initiatives

Relief intends to advance APR-TD011, a novel, proprietary, spray-based formulation of a hypotonic acid-oxidizing solution with established wound healing and anti-microbial properties, for epidermolysis bullosa (“EB”), a billion-dollar annual target market according to Knowledge Sourcing Intelligence. Relief believes that APR-TD011 could prove a transformative solution for EB patients, who suffer from debilitating pain due to large, chronic, constantly blistering skin wounds. APR-TD011 also inhibits the NF-kB pro-inflammatory pathway and by inactivating matrix metalloproteases, known to mediate wound inflammation. Relief believes that APR-TD011 could improve the quality of life of EB patients by accelerating wound healing and reducing the itching and pain linked to infections and inflammation.

Relief also possesses an array of other assets. These include SENTINOX, a novel nasal spray solution for upper airway infections with viral pathogens including the SARS-CoV-2 virus, the causal agent of COVID-19; Nexodyn AOS, an acid-oxidizing solution for treatment of chronic wounds (including foot ulcers); and the PHYSIOMIMIC platform-enabled amino acid-based product candidates for an array of rare metabolic disorders. Positive interim clinical data showing accelerated clearance of upper airway viral infection was recently reported for SENTINOX in a randomized, placebo-controlled clinical trial. SENTINOX was certified in Europe on February 16, 2021 as a Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1).

Capital Resources

Relief currently has CHF45 million in cash, and, based on current financial current projections and available cash, expects that it has sufficient resources to fund operations into late 2023, assuming timely approval of ACER-001. Relief also expects that with a successful launch of ACER-001 and the potential expansion of its GOLIKE® franchise into the United States, Relief could achieve positive operating cash flow status during 2024. This could also be positively affected if Relief is successful in obtaining an approval to market RLF-100™.

Finally, in early November, Relief took the first step to establish a Level 1 American Depositary Receipt (ADR) program in the United States by filing a registration statement on Form F-6 with the U.S. Securities and Exchange Commission. It is expected that Relief's ADRs will begin trading in the over-the-counter (OTC) market at some point after its registration statement becomes effective. Relief's ADR program will complement its existing primary listing on the SIX Swiss Exchange. JPMorgan Chase Bank, N.A. has been appointed as the depositary bank for the Level 1 ADR program. This filing is the first step in a process through which Relief hopes to transition its ADR program from a Level 1 ADR program to a Level 2 or a Level 3 ADR program, with the ultimate goal of listing its ADRs on the NASDAQ Stock Market during the first half of 2022.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports Half-Year 2021 Results and Provides Corporate Update

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide RELIEF THERAPEUTICS Holding SA with the data from its phase 2b/3 trial needed to seek approval of RLF-100 in the EU and UK, (ii) whether the phase 2 trial evaluating inhaled aviptadil for the treatment of sarcoidosis will be successful, (iii) whether RLF-100 will be granted EUA in the United States, (iv) whether the pending disputes between Relief and its U.S. collaboration partner can be resolved, (v) whether inhaled aviptadil will ever be approved by the EU and/or the U.S. for the treatment of sarcoidosis or for any other indications, or (vi) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Half Year 2021 Results
Attachment (PDF): 210924_ad_hoc_Relief_Half_Yr_Release.pdf

Relief Reports Half-Year 2021 Results and Provides Corporate Update

Geneva, Switzerland, September 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today reported its results for the half-year ended June 30, 2021 and provided a corporate update.

“While we await the FDA’s decision on the Emergency Use Authorization (EUA) for IV RLF-100 (aviptadil), filed by our collaboration partner NeuroRx, Inc. (NeuroRx), we have successfully transformed Relief into a fully-integrated, multi-product, revenue-generating biopharmaceutical company,” stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “A critical component of our success so far this year was the acquisition of APR Applied Pharma Research SA (APR), which expanded and diversified our specialty drug pipeline, added a number of key commercialized products, including the PKU GOLIKE® family of products for the treatment of phenylketonuria (PKU), provided a European based commercial infrastructure that we hope to leverage for future product launches, including ACER-001, and offers an internal R&D capability that we plan to use for the development our own products as well as for third-party products on a fee for service basis.”

Dr. Selvaraju continued, “Through our collaboration with Acer Therapeutics, we recently filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for ACER-001, a proprietary powder formulation of sodium phenylbutyrate (NaPB), designed to be both taste-masked and immediate release, for the treatment of urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). We look forward to the potential acceptance of the filing for regulatory review, which we expect to receive next month.”

“Also important was our recent acquisition of AdVita Lifescience GmbH (AdVita), from which we gained key pending intellectual property that may cover an improved inhaled formulation of RLF-100 (aviptadil), in development for a number of lung diseases, including acute respiratory distress syndrome (ARDS), and checkpoint inhibitor-induced pneumonitis (CIP). In parallel, IV RLF-100 continues to be evaluated as a treatment for severely ill COVID-19 patients, while the inhaled formulation is being tested in two clinical trials, one for patients with critical COVID-19 and another for moderate and severe COVID-19 patients. As we look ahead, and with a firm financial footing in place, we will maintain our commitment to pursuing additional strategic opportunities, both in-license and acquisition related, in order to aggressively expand and diversify our business.”

Clinical Development Highlights:
RLF-100 (aviptadil), IV

  • In March 2021, Relief’s collaboration partner, NeuroRx, Inc. (NeuroRx) announced top-line 60-day results for the phase 2b/3 trial of RLF-100™ for the treatment of patients with critical COVID-19 respiratory failure. These findings formed the basis for NeuroRx’s Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA).
  • In April 2021, NeuroRx announced that RLF-100 had been selected for inclusion in TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), an international, phase 3, multicenter clinical trial being sponsored by the U.S. National Institutes of Health (NIH).
  • In June 2021, NRx Pharmaceuticals Inc. (NRx), the parent company of NeuroRx, announced that NeuroRx had submitted its EUA application to the FDA for the use of RLF-100 in the treatment of critically ill COVID-19 in patients with respiratory failure. NeuroRx also reported that it plans to submit a New Drug Application (NDA) to the FDA.
  • In June 2021, NRx announced additional positive results from the RLF-100 U.S. Expanded Access Protocol (EAP). These EAP data were then submitted to the FDA and were characterized by NRx as “real world” evidence in support of the findings from the phase 2b/3 trial.
  • In July 2021, NRx reported that it identified a statistically significant effect of RLF-100 in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. The data was collected as part of the ongoing U.S. phase 2b/3 trial and NeuroRx reported that it had submitted these findings to the FDA as a supplement to the pending EUA application.
  • In July 2021, NRx announced the successful validation of the commercial formulation of RLF-100 for IV use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions.
  • In July 2021, NRx announced that the Nation of Georgia's Prime Minister and Minister of Health had issued an EUA for RLF-100.
  • In August 2021, NRx provided a safety update on RLF-100 which is being tested in the ACTIV-3 Critical Care phase 3 study sponsored by the NIH, designed to evaluate RLF-100 and remdesivir in critical COVID-19 patients, as a monotherapy and in combination against placebo. They reported that the study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment.
  • In August 2021, NRx reported a new analysis showing that patients with acute respiratory failure due to Critical COVID-19 who were treated with aviptadil demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. NRx noted that this analysis appears to support its plan to submit an application for Breakthrough Therapy Designation to the FDA and that, if granted, could confer Priority Review to the aviptadil NDA, when submitted.

RLF-100 (aviptadil), Inhaled

  • In January 2021, a clinical trial participation agreement for the inclusion of an inhaled formulation of RLF-100 into the I-SPY COVID-19 clinical trial was signed between NeuroRx and Quantum Leap Healthcare Collaborative™ (Quantum Leap) of San Francisco.
  • In January 2021, Relief and the former shareholders of AdVita signed a binding term sheet for Relief to acquire all shares of AdVita, giving Relief access to all of AdVita’s assets including further pending IP rights that may cover RLF-100 inhaled formulation specifications for its potential application in the treatment of lung diseases such as ARDS, pulmonary sarcoidosis and CIP.
  • In April 2021, Relief and AdVita announced the initiation of an investigator-sponsored, randomized, double-blind, placebo-controlled phase 2 trial evaluating the inhaled formulation of RLF-100 for the prevention of COVID-19-related ARDS.
  • In July 2021, NeuroRx and Quantum Leap began treating patients with inhaled RLF-100 in the I-SPY COVID-19 Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients.
  • In July 2021, Relief and the former shareholders of AdVita closed a definitive agreement for Relief to acquire all shares of AdVita, under which Relief paid the AdVita shareholders EUR 25 million in Relief common shares.
  • In August 2021, Relief received Orphan Drug Designation (ODD) from the FDA for inhaled RLF-100, for the treatment of sarcoidosis, adding to existing ODD designations for APR-OD031 for phenylketonuria (PKU) and APR-TD011 for epidermolysis bullosa (EB).
  • In September 2021, AdVita received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.

ACER-001

  • In March 2021, Relief signed a Collaboration and License Agreement with Acer Therapeutics, Inc. (Acer) for the worldwide development and commercialization of ACER-001 for the treatment of Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease.
  • In May 2021, Acer announced the outcome of its Type B pre-NDA meeting with the FDA for ACER-001, for the treatment of UCDs. Based on the FDA’s feedback, both Relief and Acer noted that the proposed data package would likely be sufficient to support a Q3 2021 NDA submission under the Section 505(b)(2) regulatory pathway.
  • Subsequently, in August 2021, Relief and Acer announced the submission of the NDA to the FDA for ACER-001 for UCDs. Relief anticipates submitting a Marketing Authorization Application for approval of ACER-001 for UCDs in the European Union before the end of 2021. Pending a positive decision by regulators, management believes that ACER-001 could be launched in both the U.S. and Europe during 2022.

APR Applied Pharma Research SA

  • In May 2021, Relief and the former shareholders of APR signed a binding term sheet for Relief to acquire all of the outstanding shares of APR, a privately held Swiss pharmaceutical company with over 25 years' experience in identifying, developing and commercializing known molecules engineered with drug delivery systems in niche and rase diseases on a global basis. The transaction closed in June 2021.
  • In May 2021, APR initiated a pivotal clinical trial with its novel nasal spray, Sentinox, a Class III medical device, in patients with mild COVID-19.
  • In September 2021, APR expanded its PKU GOLIKE® product line with the launch, in Germany and Italy, of PKU GOLIKE® KRUNCH, giving patients a convenient chewable tablet for on-the-go dietary management of phenylketonuria, a rare, recessive metabolic genetic disorder affecting approximately 350,000 people, globally. Management hopes to announce its plans to market PKU GOLIKE® in the U.S. before year end 2021.

Management and Board Additions

  • As part of the acquisition of APR, Paolo Galfetti, Chief Executive Officer of APR, has also assumed the position of President, Relief Europe, with overall responsibility for Relief’s activities in the EU and UK.
  • The Board of Directors was expanded with the appointment of Patrice Jean, Ph.D., joining Raghuram (Ram) Selvaraju, MBA, Ph.D. (Relief’s Chairman of the Board), Tom Plitz, Ph.D. and Paolo Galfetti to round out Relief’s relevant life sciences Board level expertise.
  • Taneli Jouhikainen, M.D. was appointed to the newly created position of Chief Operating Officer.

Financial Highlights for the Six Months Ended June 30, 2021

  • The operating loss amounted to CHF 14.5 million with operating expenses of CHF 15.4 million and a one-time gain of CHF 0.9 million following a third-party debt write-off.
  • The period is marked by a significant growth in operating and administrative expenses. Service expenses of CHF 8.3 million (HY2020: CHF 2.9 million) were mainly driven by development activities for RLF-100 and ACER-001. Personnel expenses increased to CHF 3.4 million (HY2020: CHF 0.2 million) as the conduct and oversight of development and administrative projects required additional skilled professionals. Legal and administrative services reached CHF 3.2 million (HY2020: CHF 0.4 million), reflecting the company's need of legal and professional services in relation to its business activities, including the acquisition of APR and AdVita.
  • Cash used in operating activities has ramped up to CHF 17.7 million from CHF 3.2 million over the same period last year.
  • Net loss for the period was CHF 14.7 million (HY2020: CHF 8.3 million profit)
  • Relief acquired APR in exchange for CHF 21.5 million in cash and CHF 45 million in Relief shares. The sellers are also entitled to receive contingent milestone payments of up to CHF 35 million in a combination of cash and Relief shares upon completion of pre-agreed milestones. APR was consolidated in the balance sheet of the group on June 30, 2021, and will contribute to the group's income statement in the second semester 2021.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief noted: “Relief remains well funded and, based on current programs, we believe we have sufficient reserves to support multiple clinical programs through key value inflection points. Since the beginning of the year to June 30, we bolstered our balance sheet with CHF 30 million in equity financings. We have also been able to take advantage of the flexibility provided by our additional share listing, giving the company, as of September 24, an available cash position of CHF 40 million.”

Post Reporting Period

  • On July 26, 2021, Relief announced that it had entered into a definitive agreement with two U.S. institutional investors to purchase in a private placement an aggregate of 71,428,572 shares of Relief common stock at a purchase price of CHF 0.21 per share, raising aggregate gross proceeds of CHF 15 million.
  • On July 27, 2021, the company issued and listed an additional 1 billion common shares. Relief used a total of 413,956,419 shares comprising 135,741,063, 206,786,784 and 71,428,572 shares, respectively, to meet its obligations to the AdVita sellers, the APR sellers and the provision of shares for the CHF 15 million private placement. The remaining shares can be used to support Relief’s current and future business development activities, and to provide additional working capital.
  • On July 27, 2021, Relief acquired AdVita in exchange of EUR 25 million in Relief shares and possible future contingent payments of EUR 20 million payable in cash.
    Further details are available in Relief’s Half Year 2021 Report, which is available for download at https://relieftherapeutics.com/investor-relations

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports Regulatory Clearance in Germany to Commence a Multicenter, Double-blind, Randomized Phase 2 Clinical Trial to Evaluate Inhaled Aviptadil for the Treatment of Sarcoidosis

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the phase 2 trial evaluating inhaled aviptadil for the treatment of sarcoidosis will be successful, (ii) whether inhaled aviptadil will ever be approved by the EU and/or the U.S. for the treatment of sarcoidosis or for any other indications, or (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Sarcoidosis_Germany
Attachment (PDF): 210902_Relief_Sarcoidosis_Phase_2_Trial_PR_-_FINAL.pdf

Relief Reports Regulatory Clearance in Germany to Commence a Multicenter, Double-blind, Randomized Phase 2 Clinical Trial to Evaluate Inhaled Aviptadil for the Treatment of Sarcoidosis

Geneva, Switzerland, September 2, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its recently acquired German subsidiary, AdVita Lifescience GmbH (“AdVita”), has received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.
Following a proof-of-concept trial in 20 sarcoidosis patients which demonstrated the suppression of inflammatory mechanisms of the lung in combination with amelioration of dry cough and exertional dyspnea, AdVita received clearance by the German medical regulatory authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) to conduct a randomized, double-blind, multicenter clinical trial in sarcoidosis patients.
Raghuram Selvaraju, Chairman of the Board of Relief, commented, “Receiving regulatory clearance to begin a phase 2 clinical trial of inhaled aviptadil marks another clinical milestone for Relief and our subsidiary, AdVita. Aviptadil is believed to be the only known experimental drug that could potentially suppress sarcoidosis-associated cough, one of the major symptoms reducing quality of life in this patient population. We look forward to initiating this trial and to further exploring the clinical utility of aviptadil across multiple pulmonary indications.”

ABOUT SARCOIDOSIS

Sarcoidosis is a rare disease in which the inflammatory process involves the alveoli (air sacs), small bronchi, and small blood vessels. As sarcoidosis progresses, small lumps, or granulomas, appear in the affected tissues which tend to remain inflamed and become scarred (fibrotic). Granulomas are structured masses composed of activated immunological cells (macrophages, lymphocytes, mast cells and fibroblasts). Many Sarcoidosis patients are left with permanent lung damage as they undergo a chronic course where complications such as pulmonary fibrosis are common and irreversible. Sarcoidosis affects up to about 100,000 people in the European Union, and a similar or higher amount in the U.S.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, brings to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a Favorable, New Safety Report for Aviptadil in the National Institutes of Health Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Foot notes:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx ACTIV3b new safety
Attachment (PDF): 20211103_ad_hoc_Relief_NRX_Favorable_Safety_Report.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a Favorable, New Safety Report for Aviptadil in the National Institutes of Health Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Geneva, Switzerland, November 3, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a press release announcing a new safety update on aviptadil, which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. According to the press release, in its third scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of more than 300 patients and recommended continued enrollment to target 640 patients. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a New Finding from the ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19  

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether Relief can resolve its ongoing dispute with NRx without litigation, (iii) whether aviptadil will ever be approved in the U.S., UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iv) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx_ADRS
Attachment (PDF): 210831_Relief_NRx_ADRS.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a New Finding from the ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19

Geneva, Switzerland, August 31, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. According to the press release, the new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. This latest analysis also appears to support NRx's plan to submit an application for Breakthrough Therapy Designation to the U.S. Food and Drug Administration for this indication. Relief believes that, if granted, this could confer Priority Review to the aviptadil New Drug Application, when submitted. The related NRx press release can be accessed through the following link.

ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether aviptadil will ever be approved in the UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iii) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 210819 Relief ACTIV-3 PR
Attachment (PDF): 210819_Relief_ACTIV-3_PR_FINAL.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19

Geneva, Switzerland, August 19, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) provided a safety update on ZYESAMI™ (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health (NIH). The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and is quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced a Second Favorable Safety Report for ZYESAMI™ (RLF-100TM/aviptadil) in the NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RLF-100TM (aviptadil) will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, (ii) whether RELIEF THERAPEUTICS Holding SA can satisfactorily resolve its ongoing disputes with NeuroRx without litigation, (iii) whether RELIEF THERAPEUTICS Holding SA will prevail in any litigation action with NeuroRx over the terms of the Collaboration Agreement, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx ACTIV3b safety
Attachment (PDF): 210930_ad_hoc_Relief_NRX_ACTIV-3b_2nd_Safety.pdf

Relief Reports that its U.S. Collaboration Partner has Announced a Second Favorable Safety Report for ZYESAMI™ (RLF-100TM/aviptadil) in the NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Geneva, Switzerland, September 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release providing a safety update on ZYESAMI™ (RLF-100TM/aviptadil) which is being tested in the ACTIV-3b/TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) phase three study sponsored by the National Institutes of Health (NIH). According to the press release, in its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 231 patients and recommended continued enrollment. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Emergency Use Authorization of Aviptadil in Nation of Georgia

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: 20210728_Relief reports Collaboration partner Announced Emergency Use Authorization of Aviptadil in Nation of Georgia
Attachment (PDF): 270728_ad_hoc_Relief_confirms_RLF100_EUA_Nation_of_Georgia.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Emergency Use Authorization of Aviptadil in Nation of Georgia

Geneva, Switzerland, July 28, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) reported in a press release yesterday that the Nation of Georgia's Prime Minister and Minister of Health have issued an Emergency Use Authorization for intravenous aviptadil for the treatment of critical COVID-19.

NRx also reported that the first doses of aviptadil will arrive in the Nation of Georgia within 24 hours, and discussions are underway with the Ministry of Health to provide access to ZYESAMI™ to Georgians suffering with Critical COVID-19.

The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMITM (RLF-100TM/aviptadil)

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will be determined by regulatory authorities to be safe and effective as a treatment for highly comorbid patients with COVID-19, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 and (iii) those risks discussed in RELIEF THERAPEUTICS Holding AG's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Comorbid Survival
Attachment (PDF): 210928_ad_hoc_Relief_NRX_Comorbid_Survival.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMITM (RLF-100TM/aviptadil)

Geneva, Switzerland, September 28, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI™ (RLF-100 ™/aviptadil). According to NRx’s press release, in highly comorbid COVID-19 patients, ZYESAMI™ provided a threefold, statistically significant increase in the likelihood of survival at one year, consistent, according to NRx, with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI™ (RLF-100 ™/aviptadil). The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced it has Received a U.S. Food and Drug Administration Review of Aviptadil Manufacturing Information

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx_Manufacturing
Attachment (PDF): 20211112_ad_hoc_Relief_NRX_FDA_Review_Manufacturing_Info.pdf

Relief Reports that its U.S. Collaboration Partner has Announced it has Received a U.S. Food and Drug Administration Review of Aviptadil Manufacturing Information

Geneva, Switzerland, November 12, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a press release announcing receipt of the U.S. Food and Drug Administration’s (FDA) response to NRx’s October 8, 2021 submission of updated manufacturing information for aviptadil. According to the press release, the FDA review allows for high volume production of aviptadil. The press release also reports that the shelf life of aviptadil has been extended from 62 days to 150 days. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Progress on Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx WW Commercial Dev
Attachment (PDF): 20211013_ad_hoc_Relief_NRX_WW_Commercial_Scale_Development_of_ZYESAMI.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Progress on Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)

Geneva, Switzerland, October 13, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing they have submitted a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) to the U.S. Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. According to the press release, NRx has also received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced Successful Commercial Formulation for Aviptadil

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Stability Aviptadil
Attachment (PDF): 210723_ad_hoc_Relief_stability_data_aviptadil_EN.pdf

Relief Reports that its U.S. Collaboration Partner has Announced Successful Commercial Formulation for Aviptadil

Geneva, Switzerland, July 23, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release reporting that it has validated a commercial formulation of aviptadil for intravenous use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions. NRx also reported in its press release that it had achieved a 30-to-50-fold increase in its manufactured lot size of aviptadil. The related NRx press release can be accessed through the following link.

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: “We are pleased that our collaboration partner has reported that it has developed a formulation of aviptadil that it reports is suitable for commercial distribution. Despite the increase in the number of people being fully vaccinated against COVID-19, with emerging variants and disparities in vaccination rates, there remains a major need for effective therapeutic options for patients with respiratory failure. We are excited about the potential that aviptadil holds in helping critical COVID-19 patients and are hopeful that the drug candidate will soon be available to those who remain in need of better treatments.”

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced that the Journal of Infectious Diseases and Treatment has Published Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx Aviptadil Data Publication
Attachment (PDF): 20211015_ad_hoc_Relief_NRX_Publication_of_Data_on_Aviptadil.pdf

Relief Reports that its U.S. Collaboration Partner has Announced that the Journal of Infectious Diseases and Treatment has Published Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure

Geneva, Switzerland, October 15, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a press release announcing that the peer-reviewed Journal of Infectious Diseases and Treatment has published positive trial data from a prospective, open label, administratively controlled trial of aviptadil in high comorbidity patients suffering from critical COVID-19 with respiratory failure. According to the press release, the study reported 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment at the Houston Methodist Hospital (P<.0001). The press release also reports that a similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure (P<.0001). The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Announced the U.S. Food and Drug Administration has Denied Breakthrough Designation for Aviptadil

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx BTD denial
Attachment (PDF): 20211124_ad_hoc_Relief_NRx_BTD_Denial.pdf

Relief Reports that its U.S. Collaboration Partner has Announced the U.S. Food and Drug Administration has Denied Breakthrough Designation for Aviptadil

Geneva, Switzerland, November 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a CEO Update announcing that the U.S. Food and Drug Administration (“FDA”) has denied Breakthrough Therapy Designation (“BTD”) for aviptadil. NRx noted that BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with the sponsor. Additionally, according to the CEO Update, the FDA has already granted priority and rolling review as part of the Fast Track Designation awarded in July 2020. Therefore, the denial does not impede NRx’s ability to seek drug approval, although it does identify areas where NRx needs to seek better scientific alignment with the FDA. The related NRx CEO Update can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Cytokine Storm
Attachment (PDF): 210720__ad_hoc_PR_confirm_RLF100_cytokine_storm_data_EN.pdf

Relief Reports that its U.S. Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19

Geneva, Switzerland, July 20, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) reported in a press release yesterday that it has identified a statistically significant effect of aviptadil in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. They reported that the cytokine data were collected as part of the U.S. phase 2b/3 trial of aviptadil compared to placebo in critically ill patients with COVID-19 respiratory failure.
NRx also reported that it has submitted these findings to the U.S. Food and Drug Administration (FDA) as a supplement to its pending application for Emergency Use Authorization (EUA) and is submitting a biomarker letter of intent to the FDA as part of the FDA biomarker program, authorized under the 21st Century Cures Act.
NRx also reported that it continues to respond to FDA information requests for additional data in support of the currently pending EUA application for aviptadil in treating critically ill patients with COVID-19.
The related NRx press release can be accessed through the following link.

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.

Follow us on LinkedIn.

Relief Reports that its U.S. Collaboration Partner’s Emergency Use Authorization Request for ZYESAMI®/RLF-100™ (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure was Declined by the U.S. Food & Drug Administration

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Aviptadil EUA Denial
Attachment (PDF): 20211105_ad_hoc_Relief_EUA_Denial.pdf

Relief Reports that its U.S. Collaboration Partner’s Emergency Use Authorization Request for ZYESAMI®/RLF-100™ (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure was Declined by the U.S. Food & Drug Administration

Geneva, Switzerland, November 5, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing that it was declined Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the use of IV aviptadil for the treatment of acute respiratory failure due to critical COVID-19. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics and InveniAI Sign a Strategic Collaboration Agreement to Identify New Product Development Opportunities using Artificial Intelligence

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor relations:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether InveniAI will bring to RELIEF THERAPEUTICS Holding SA drug candidates that can be successfully developed by RELIEF THERAPEUTICS Holding SA, (ii) whether RELIEF THERAPEUTICS Holding SA will successfully develop and ultimately market any drug candidate identified by InveniAI, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_IveniAI
Attachment (PDF): 20211124_ad_hoc_Relief_InveniAI.pdf

Relief Therapeutics and InveniAI Sign a Strategic Collaboration Agreement to Identify New Product Development Opportunities using Artificial Intelligence

Geneva, Switzerland, November 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), announced today that it has signed a collaboration agreement (the “Collaboration”) with InveniAI LLC (“InveniAI”), a U.S. based company that has pioneered the application of artificial intelligence and machine learning across biopharma and other industries, in order to identify promising drug candidates to treat rare and specialty diseases.

Under the terms of the Collaboration, InveniAI will use its proprietary platform for the identification of potential pharmaceutical product opportunities using its Pharma Big Data Innovation Lab (“Platform”), consisting of (i) its proprietary AlphaMeld® platform, a cloud-based Artificial Intelligence (“AI”) platform that utilizes proprietary machine learning and deep learning based neural networks to identify product opportunities in therapeutic areas, (ii) its cross-functional teams at its Integrated Center of Excellence, and (iii) domain expertise, to generate novel pharmaceutical opportunities and the related development pathway for the development of such concepts.
In the Collaboration, it is expected that InveniAI will utilize its Platform to navigate the volume of data for all regulatory agency approved drugs and their associated active ingredients (Active Pharmaceutical Ingredient (“API”)) to identify potential rare and specialty disease indications for development and commercialization by Relief (“Product Concepts”). InveniAI will seek to prioritize top Product Concepts, associated diseases, scientific packages and evidence to support the potential drug development opportunities by Relief. Relief anticipates InveniAI’s Platform will complement its wholly owned subsidiary APR Applied Pharma Research SA’s existing capabilities in research and development and drug reformulation. Based on product leads developed by InveniAI, Relief hopes to develop proprietary versions of existing drugs, and to protect those drugs with long-lived intellectual property and defensible patent claims.

Under the terms of the Collaboration, Relief will pay InveniAI an initial up-front fee, success milestones and commercialization royalties for the full development program. Additional financial details were not disclosed.

“We believe that the addition of InveniAI’s AI-powered capabilities will meaningfully complement our existing drug development efforts. AI is becoming an increasingly important tool in identifying and screening new drug projects and Relief intends to fully leverage this promising technology,” stated Raghuram (Ram) Selvaraju, Chairman of Relief. “In partnering with InveniAI, we are accessing decades’ worth of expertise which has already led to successful drug re-innovation (e.g., vilazodone for treatment of depression and dexmedetomidine for treatment of agitation) and a proven platform that has been the basis of multiple partnerships with established companies. We believe that our work with InveniAI could generate multiple promising additions to our pipeline that may represent capital-efficient, cost-effective and risk-mitigated approaches to product development. In focusing on the optimization of existing approved APIs, we hope to ensure well-established clinical safety and tolerability for the product concepts identified at inception, giving us a running start in pursuing development of novel uses for these drugs. In our view, this approach will enable us to rapidly and efficiently execute innovation that brings relief to patients suffering from severe and debilitating conditions.”

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces CHF 15 Million Private Placement

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner’s application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Private Placement
Attachment (PDF): 20210726_ad_hoc_Relief_PIPE_Final.pdf

Relief Therapeutics Announces CHF 15 Million Private Placement

Geneva, Switzerland, July 26, 2021 –RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that it has entered into a definitive agreement with two U.S. institutional investors to purchase in a private placement an aggregate of 71,428,572 shares of Relief common stock at a purchase price of CHF 0.21 per share. The aggregate gross proceeds from the private placement are expected to be approximately CHF 15 million, before deducting the placement agent fees and offering expenses payable by Relief. The private placement offering is expected to close on or about July 28, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Relief plans to use the net proceeds from the private placement to acquire additional assets to expand and diversify its drug pipeline, meet its obligations to pay potential milestone payments and for general corporate purposes.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, said: “This financing provides us with significant additional flexibility to both meet our potential future milestone payments for Acer Therapeutics Inc., APR Applied Pharma Research SA and AdVita Lifescience GmbH, while also expanding our ability to grow our pipeline. Chief among our priorities is moving ahead with our plan to further the development of RLF-100TM worldwide, as vaccine acceptance issues and new COVID-19 variants make the need for an effective therapy as great as ever.”

The private placement shares will be trading on the SIX Swiss Exchange and ranking pari passu (carrying the same rights) with Relief’s existing shares, and will be delivered from Relief’s treasury shares that were issued out of its authorized share capital under exclusion of the existing shareholders’ pre-emptive rights.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisition of APR Applied Pharma Research SA brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Announces Filing of Lawsuit Against its U.S. Collaboration Partner, NeuroRx, Inc. and its CEO, Dr. Jonathan Javitt, for RLF-100™ (Aviptadil)

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including: (i) whether Relief's lawsuit will be successful, (ii) whether RLF-100™ (aviptadil) will ever be approved for commercialization in the United States or Europe, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_complaint filing
Attachment (PDF): 20211007_ad_hoc_Relief_Filing_Complaint.pdf

Relief Therapeutics Announces Filing of Lawsuit Against its U.S. Collaboration Partner, NeuroRx, Inc. and its CEO, Dr. Jonathan Javitt, for RLF-100™ (Aviptadil)

• Lawsuit alleges multiple breaches of Collaboration Agreement

Geneva, Switzerland, October 7, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that it has filed a lawsuit against NeuroRx, Inc. and its Chief Executive Officer, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx relating to the development and commercialization of RLF-100™ (aviptadil). The complaint was filed in the Supreme Court of the State of New York in Manhattan.

The complaint alleges that the defendants are in breach of numerous provisions of the Collaboration Agreement, including without limitation (i) by failing to provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating IV RLF-100™ (aviptadil) for the treatment of acute respiratory failure due to COVID-19, which data and information are required to be provided to Relief by NeuroRx under the Collaboration Agreement and which data and information are required for Relief to seek approval to commercialize the product in Europe, (ii) by failing to allow Relief, despite multiple requests, to conduct a forensic audit of NeuroRx's books and records to determine how the funds that Relief provided to NeuroRx were actually used, (iii) by entering into multiple agreements relating to the development of the product subject to the collaboration without Relief's consent, as required under the Collaboration Agreement, (iv) by engaging in commercialization efforts in territories outside the purview of NeuroRx's territory under the Collaboration Agreement, and (v) by developing additional COVID-19 treatments in violation of the exclusivity provisions of the Collaboration Agreement. The suit also alleges, among other matters, breaches of the covenant of good faith and fair dealing and tortious interference with prospective economic advantage. The Complaint, among other remedies, seeks damages, an order compelling defendants to comply with multiple provisions of the Collaboration Agreement, and a declaration directing NeuroRx to deliver the entire data set from the Phase 2b/3 clinical trial of intravenously-administering aviptadil to Relief.

"We are disappointed that NeuroRx has continued to refuse to ameliorate their breaches of the Collaboration Agreement," stated Jack Weinstein, Chief Financial Officer and Treasurer of Relief. "While we continue to hope to settle these matters with NeuroRx, we are compelled to bring this action to preserve our rights under the Collaboration Agreement and to allow us to continue to develop RLF-100™ (aviptadil) in a timely manner for the treatment of acute respiratory failure due to COVID-19 in our territories."

ABOUT RELIEF THERAPEUTICS


Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. On October 4, 2021, Acer's NDA for ACER-001 was accepted for filing by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

 

Relief Therapeutics Announces Transitions in Commercial Organization to Implement Next Phase of Corporate Development

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Rx Communications Group

Michael Miller
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_A Kim appointment
Attachment (PDF): 20211109_ad_hoc_Relief_Anthony_Kim.pdf

Relief Therapeutics Announces Transitions in Commercial Organization to Implement Next Phase of Corporate Development

• Anthony M. Kim Appointed Senior Vice President and Head of U.S. Commercial Operations – Seasoned Biotech Executive Brings Vast U.S. Commercial Launch Experience to Relief
• European and United Kingdom Commercial Operations Transitioned to Paolo Galfetti, President of Relief Europe
• Chris Stijnen to Depart Relief

Geneva, Switzerland, November 9, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, announced today the appointment, effective December 1, 2021, of Anthony M. Kim as Senior Vice President and Head of U.S. Commercial Operations. The company also reported that Chris Stijnen, Chief Commercial Officer since 2020, will be leaving to pursue other opportunities effective November 30, 2021. His duties regarding EU and UK commercial operations will be assumed by Paolo Galfetti, President of Relief Europe, and the commercial team at Relief’s subsidiary, APR Applied Pharma Research SA (“APR”).

“Our collaboration with Acer Therapeutics and strategic acquisitions of APR and AdVita Lifescience GmbH, all completed in 2021, have allowed us to significantly expand our intellectual property position and pipeline, while bringing, in-house, a number of already marketed products, such as APR’s flagship PKU GOLIKE®, for the treatment of phenylketonuria,” stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “Anthony’s appointment is a direct acknowledgement of our growing corporate needs, our commitment to our-long term growth, and our plans to expand availability of our product candidates in the U.S. including PKU GOLIKE®. Anthony will also be a key part of Relief’s plan to optimize the commercial success of ACER-001 in collaboration with our partner Acer Therapeutics. As a proven commercial leader with extensive launch experience gained during his tenures at Novocure, Alexion Pharmaceuticals, Inc. and Genentech, Anthony is an invaluable addition and we are delighted to welcome him to the Relief team.”

Dr. Selvaraju added, “I would also like to acknowledge Chris Stijnen’s extensive contributions during his time with the company. His efforts over the past year have been instrumental in helping to drive our strategy and identify key opportunities for growth. We wish him all the best in his future endeavors.”

“I am excited and honored to be joining Relief, and to help further their mission of developing innovative therapies for areas of great unmet medical need,” stated Mr. Kim. “I share the company’s vision for improving the lives of patients living with acute and rare medical conditions. I look forward to building Relief’s presence in the U.S., and to living the values of the organization with integrity, sensitivity, and humility each day.”

Prior to joining Relief, for the past three years, Mr. Kim was Vice President, Global Commercial Development at Novocure, where he led a 21-person team in the planning and U.S. marketing execution for that company’s Optune® and Optune Lua™, FDA-approved, therapeutic devices that deliver alternating electrical fields to treat patients with Glioblastoma Multiforme and Mesothelioma.

From 2017 to 2018, he was Executive Director of Marketing at Ignyta (subsequently acquired by Roche), during which time he led the development of the commercial launch plan for entrectinib, an oral, oncologic agent in pan-tumor clinical trials for patients with neurotrophic tyrosine receptor kinase (NTRK) and ROS1 fusion-positive disease. From 2012 to 2017, Mr. Kim held positions of increasing responsibility at Alexion Pharmaceuticals, Inc., most recently serving as Director, Head of U.S. Marketing, Hypophosphatasia, where he managed the U.S. marketing efforts for the launch of Strensiq, a novel, first-in-class enzyme replacement therapy for the treatment of hypophosphatasia, a rare inherited metabolic bone disorder. Earlier, from 2004 to 2012, Mr. Kim held various positions at Genentech, including Product Manager, Herceptin Marketing and Divisional Sales Manager, Rituxan Hematology.

Mr. Kim received his Bachelor of Arts Degree from Harvard University and a Master of Business Administration from The Wharton School.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Comments on Certain Statements Made by NRx Pharmaceuticals in its Registration Statement on Form S-1 Filed on September 3, 2021

Year ordering: 2021
Media Contact:

 

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
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CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether Relief can satisfactorily resolve its ongoing disputes with NeuroRx without litigation, (ii) whether Relief will prevail in any litigation action with NeuroRx over the terms of the Collaboration Agreement, (iii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding AG's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_NRx_S1_response
Attachment (PDF): 210907_Relief_S1_response_PR.pdf

 

Relief Therapeutics Comments on Certain Statements Made by NRx Pharmaceuticals in its Registration Statement on Form S-1 Filed on September 3, 2021

Geneva, Switzerland, September 07, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), commented today on statements made by NRx Pharmaceuticals, Inc. ("NRx"), the parent corporation of Relief's collaboration partner for RLF-100™ (aviptadil) in the United States, NeuroRx, Inc. ("NeuroRx"), in NRx's Registration Statement on Form S-1 filed on September 3, 2021 (the "Registration Statement"). In the Registration Statement, NRx makes several assertions that Relief believes require a public comment so that the marketplace has relevant information about the pending disputes between Relief and NeuroRx. Among other issues in dispute, based on currently available information, are the following:

  1. The Registration Statement includes numerous statements of purported fact setting forth NeuroRx's version of the history of the relationship between the companies that led to the signing of the Binding Collaboration Agreement, dated September 18, 2020 (the "Collaboration Agreement"). While Relief believes that many of the statements made by NRx in the Registration Statement on this topic are false or misleading, Relief does not believe that it is necessary to lay out that historical record in public reporting, since it has no application to the current and ongoing relationship between the parties. Relief notes that the Collaboration Agreement expressly states that it "supersedes any and all prior understandings or agreements, whether written or oral, and there are no promises, agreements, condition, undertakings, warranties or representations (whether oral or written, express or implied) between them other than as [herein set forth]." Therefore, the history of what discussions led up to the parties' entry into the Collaboration Agreement has no application to the parties' rights and responsibilities presently in force and effect.

  2. In the Registration Statement, NRx accuses Relief of misleading them and Relief's public shareholders about the stability of the formulation of aviptadil that Relief brought to the parties' collaboration. Relief reiterates, once again, that in its opinion, there is no truth to these allegations, and that NeuroRx was expressly tasked with developing a stable formulation of aviptadil under the Collaboration Agreement. Further, Relief reiterates, once again, that it never guaranteed that it already had an 18-month shelf stable product, and no such statements are made in the Collaboration Agreement, which contains the entire agreement between the parties. Finally, Relief once again reiterates its belief that the version of aviptadil that was and is being used by NeuroRx in its clinical trials is the drug version covered by the Collaboration Agreement.

  3. NRx continues to state in the Registration Statement that Relief has not paid certain amounts due to NeuroRx relating to the collaboration. While the amount allegedly owed by Relief to NeuroRx according to the Registration Statement has grown exponentially when compared to the amounts stated in NRx's earlier public filings, Relief reports, once again, that not only has it met all of its financial obligations under the Collaboration Agreement, but that it has not received invoices documenting amounts anywhere close to the amounts that NeuroRx claims are allegedly due. Relief continues to have no idea of how the amount allegedly owed that is set forth in the Registration Statement is calculated and has demanded that it be allowed to perform a forensic audit on NeuroRx's books and records to determine the accuracy of the financial information provided to Relief (which NeuroRx has, to date, refused to allow).

  4. In the Registration Statement, NRx states that Relief has "declined" to fund certain expenses relating to the development of the formulation of aviptadil and NeuroRx's clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, for some months, Relief has repeatedly requested information that is reasonably necessary to make a decision on whether or not to fund these expenses. Until sufficient information is provided so that Relief can make the decision whether or not to fund these expenses, the Collaboration Agreement does not allow NeuroRx to bring in another source to directly fund these expenses.

  5. NeuroRx continues to refuse, despite repeated demands by Relief requesting this information, to share with Relief the full clinical trial data set, including details on the statistical analysis performed, from its recently completed phase 2b/3 trial, which data and information is required to be provided to Relief by NeuroRx under the Collaboration Agreement. To date, Relief has only received a high-level summary of the clinical study report and has not been provided with, among other information, access to the 53,909 individual case reports, the raw data from the clinical trial, or the data on the multiple statistical analyses performed. NeuroRx has likewise refused to share with Relief any of the correspondence between NeuroRx and the FDA. Further, NeuroRx has refused to allow NeuroRx's contract partners dealing with issues relating to the development of aviptadil to share information with Relief that it requires to develop RLF-100™ (aviptadil) in its territories (including the European Union and the United Kingdom). The failure of NeuroRx to provide this information is seriously impairing Relief's ability to develop and execute a clinical and regulatory strategy for RLF-100™ (aviptadil) in its territories.

  6. Relief reminds NeuroRx that under Section 5.1 of the Collaboration Agreement, neither party may engage in any development activities for any drug or related product or treatment intended to be used to treat, combat, ameliorate, prevent or mitigate the effects of COVID-19 that can or may reasonably be expected to compete against or reduce sales (or other monetization) of aviptadil.

  7. Relief believes that it has satisfied all of its obligations under the Collaboration Agreement and that as a result, all revenue/profit splits set forth in the Collaboration Agreement remain in full force and effect.
    Relief intends to continue to seek an amicable resolution of its pending disputes with NeuroRx relating to the Collaboration Agreement. However, if such disputes are not resolved to Relief's satisfaction, Relief intends to take all actions necessary to enforce its rights under the Collaboration Agreement. While there can be no assurance, Relief believes that it will prevail in any such legal action to enforce its rights under the Collaboration Agreement.

ABOUT RELIEF THERAPEUTICS HOLDING AG

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol "RLF" and quoted in the U.S. on OTCQB under the symbol "RLFTF." For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.

Relief Therapeutics Launches Level 1 ADR Program in the United States

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Investor relations:

Rx Communications Group

Michael Miller
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether a market will develop for Relief's ADRs, (ii) whether, if Relief's ADRs are traded in the U.S., they will become eligible to be listed on the NASDAQ Stock Market, and the timing of any such listing, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_ADR Level 1 launch
Attachment (PDF): 20211118_ad_hoc_Relief_ADR_Level_1_Launch.pdf

Relief Therapeutics Launches Level 1 ADR Program in the United States

Geneva, Switzerland, November 18, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), announced today that its Form F-6 registration statement has become effective, and that Relief has launched its Level 1 American Depositary Receipt ("ADR") program in the United States (“U.S.”). It is expected that Relief's ADRs will begin trading on the over-the-counter ("OTC") market today, November 18, 2021, under the trading symbol ("RLFTY"). Relief's ADR program will complement its existing primary listing of ordinary shares on the SIX Swiss Exchange ("SIX"). J.P. Morgan has been appointed as the depositary bank for the Level 1 ADR program.

An ADR is a negotiable receipt, resembling a stock certificate, that is issued by a U.S. depositary bank appointed by a company to evidence one or more American Depositary Shares ("ADSs"). In the case of Relief's ADRs, each ADS will represent one hundred and fifty (150) of Relief's ordinary shares. ADRs allow U.S. investors to buy shares in foreign companies without the need for cross-border or cross-currency transactions. They are priced in U.S. dollars and can be traded like shares of U.S.-based companies listed on the OTC market.

Under the program, the owners and holders of ADSs will have the same rights to dividends and distributions and voting powers as the holders of Relief's ordinary shares subject, however, to enforcement procedures provided in the deposit agreement entered into by and among Relief, J.P. Morgan, as the depositary, and the owners and holders of ADSs.

The establishment of the program by Relief is not a new offering of securities, and the ADRs will be based on the Relief ordinary shares currently in issue. Therefore, Relief will receive no proceeds from the establishment of the program. However, Relief's goal is to take the necessary steps in the future to transition from a Level 1 ADR program to a Level 2 or a Level 3 ADR program, with the ultimate goal of listing its ADRs on the Nasdaq Stock Market during the first half of 2022. There can be no assurance that Relief will be successful in those efforts.

Instructions for converting Relief ordinary shares into ADRs are posted on Relief's website at https://www.relieftherapeutics.com/investor-relations or CLICK HERE.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide ("VIP"), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Provides Update on Regulatory Interactions in the United Kingdom and European Union Relating to Lead Drug Candidate, RLF-100 (Aviptadil)

Year ordering: 2021
Media Contact:

 

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether aviptadil will ever be approved in the UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iii) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_MHRA
Attachment (PDF): 210913_Relief_MHRA_Regulatory_Guidance.pdf

Relief Therapeutics Provides Update on Regulatory Interactions in the United Kingdom and European Union Relating to Lead Drug Candidate, RLF-100 (Aviptadil)

Geneva, Switzerland, September 13, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that it has received scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) relating to its lead investigational drug, RLF-100(TM) (aviptadil), for the treatment of respiratory deficiency due to severe COVID-19. The guidance, which was provided in the context of a recent meeting that Relief held with the MHRA, included advice on the appropriate pathway for submission of an application for conditional marketing approval (CMA)  for the intravenous formulation of RLF-100, subject to provision of all data from the U.S. Phase 2b/3 study conducted by Relief’s collaboration partner, NeuroRx, Inc. ("NeuroRx") According to the MHRA, a CMA through rolling review or expedited review process would be an appropriate pathway to ensure speedy access to beneficial treatments for patients infected with COVID-19. A rolling review allows the MHRA to start review of various sections of a submission as they are completed by Relief and provided to the MHRA.

Relief also reported today that it has held discussions with the European Medicines Agency (EMA) pertaining to the regulatory path forward for RLF-100 in the European Union.  Relief has informed EMA that it will proceed with further dialogue with the MHRA once it has compiled critical information related to the study conduct, clinical data and the drug product.

Relief also reported that, to date, NeuroRx has not provided it with all of the data from its U.S. Phase 2b/3 study evaluating intravenously administered aviptadil for the treatment of respiratory failure in critically ill patients with COVID-19. There can be no assurance that NeuroRx will provide the required information.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

1 In the interest of public health, a CMA may be granted for medicines on less comprehensive clinical data than normally required, where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required. Medicines for human use are eligible if they are intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. This includes orphan medicines. Its use is also intended for a public health emergency (e.g., a pandemic).

Relief Therapeutics Reports that Collaboration Partner, NRx Pharmaceuticals, and Quantum Leap Announce Treatment of Severely Ill COVID-19 Patients with Aviptadil in the I-SPY COVID Trial

Year ordering: 2021
Media Contact:

MC Services AG
Anne Hennecke 
Tel.: +49 (0) 211-529-252-22
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RELIEF THERAPEUTICS Holding AG:
Jack Weinstein
Chief Financial Officer and Treasurer
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Disclaimer:

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding the timing or results of the I-SPY trial nor that NRx's application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_ISPY
Attachment (PDF): 20210713_ad_hoc_PR_confirm_RLF100_ISPY_first_patient_treated_EN.pdf

Relief Therapeutics Reports that Collaboration Partner, NRx Pharmaceuticals, and Quantum Leap Announce Treatment of Severely Ill COVID-19 Patients with Aviptadil in the I-SPY COVID Trial

Geneva, Switzerland, July 13, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”) and Quantum Leap Healthcare Collaborative™ (“Quantum Leap”) have announced that they have begun treating patients with inhaled aviptadil in the I-SPY COVID Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients. The related NRx/Quantum Leap press release can be accessed through the following link.

###

 

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Reports Two Publications of Positive Data on Nexodyn® AOS for Hard-to-Heal Ulcers

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

RELIEF THERAPEUTICS Holding SA

Jack Weinstein
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Investor relations:

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Nexodyn publication
Attachment (PDF): 20211020_ad_hoc_Relief_Nexodyn_publication.pdf

Relief Therapeutics Reports Two Publications of Positive Data on Nexodyn® AOS for Hard-to-Heal Ulcers

A Prospective Series on Wound Bed Preparation with Nexodyn® AOS and Standard of Care and a 32-Week Follow-Up Study Published in the Peer Reviewed Journal of Wound Care

Geneva, Switzerland, October 20, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported two papers published in the peer reviewed Journal of Wound Care, concluding that the company’s Nexodyn® acid-oxidizing solution (AOS), developed with APR’s proprietary Tehclo® technology, may represent a valuable therapeutic addition to standard of care (SOC) for the management of hard-to-heal ulcers requiring long periods of treatment. The data also confirmed the safety of Nexodyn® AOS.

Conducted by Elia Ricci, M.D., Director of the Difficult Wound Healing Unit, St. Luca Clinic, Department of Surgery A, Pecetto Torinese (TO), Piedmont, Italy, the prospective case series evaluated the clinical impact of Nexodyn® AOS in addition to SOC. Between February 2015 and February 2017, a total of 60 patients with hard-to-heal ulcers of various etiologies took part in the study. Patients were treated for 70 days with Nexodyn® AOS and the usual SOC wound dressings. The follow-up study, also conducted by Dr. Ricci, included a subset of 31 patients (51.7%) whose wounds had not fully healed by day 70, who opted to continue with treatment for another 22 weeks (for a total treatment time of 32 weeks).

By day 70, 68.3% of wounds had healed or improved, and a significant mean wound size reduction of 21% from baseline was observed (p<0.001), despite a mean baseline wound duration of 20.6 months. 90% of patients were able to control signs of infection with a significant reduction versus baseline. Additionally, Bates–Jensen and wound bed preparation (WBP) scores improved with a significant increase of patients with 100% granulation tissue, and pain scores fell significantly over time. Overall, use of Nexodyn® AOS plus SOC allow a decreased number of dressing changes. In the follow-up study, by week 32, 35.5% (n=11) of wounds healed completely and 83.9% showed improvement. Additionally, all wounds were free of infection and colonization, the WBP score improved (100% A1–A2 at T196), and pain scores fell. This follow-up evaluation, coupled with the primary study, suggests that Nexodyn® AOS may represent a valuable and safe therapeutic option in addition to SOC for the management of hard-to-heal ulcers for long periods of treatment.

“The publication of additional data provides further evidence of the effectiveness of Nexodyn® AOS, developed with our proprietary, globally patented Tehclo® nanotechnology platform, in addition to SOC – in particular, its ability to reactivate the healing process in hard-to-heal lesions,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “Also of note, the study showed that Nexodyn® AOS, with its antimicrobial properties, can create an optimal microenvironment, reducing the bioburden, modulating inflammation by inactivating matrix metalloproteinases and increasing oxygenation. Additionally, clinical benefit was observed even in wounds with less favorable initial conditions, such as a large area and/or depth or long duration, adding further evidence that Nexodyn® AOS is an important treatment for hard-to-treat wounds.”

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “These results reinforce the importance of Nexodyn® AOS as a critical wound healing treatment and provide additional real-world evidence to support our belief that an adaptation of Nexodyn® AOS may also become an effective therapeutic option for wound healing in patients suffering from epidermolysis bullosa (EB).”

About Nexodyn® Acid-Oxidizing Solution (AOS)

Nexodyn® Acid-Oxidizing Solution (AOS) is a Tehclo®-based product proven to restart wound healing in stalled wounds by creating the ideal microenvironment to sustain the physiological healing process. A wealth of evidence and real-world experience consistently show accelerated closure with reduced infection rates and less wound-associated pain.

Nexodyn® AOS is a solution with three main features: highly pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), acidic pH (2.5 – 3.0) and high Reduction-Oxidation Potential (ORP 1.000 – 1.200 mV). The product is a sprayable solution with ancillary antimicrobial properties intended for use in the debridement, irrigation, cleansing and moistening of acute and chronic wounds (e.g., diabetic foot ulcers, pressure ulcers, and vascular ulcers), post-surgical wounds, burns and other lesions. The product is certified in the European Union as a Class III medical device.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics Takes First Step to Create an ADR Program in the United States by filing a Form F-6 Registration Statement with the U.S. Securities and Exchange Commission

Year ordering: 2021
Media Contact:

Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Contact:

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Jack Weinstein
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Rx Communications Group

Michael Miller
Tel:+1-917-633-6086
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether Relief's registration statement on Form F-6 will ever become effective, (ii) whether a market will develop for Relief's ADRs, (iii) whether, if Relief's ADRs are traded in the U.S., they will become eligible to be listed on the NASDAQ Stock Market, and the timing of any such listing, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_ADR program
Attachment (PDF): F-6_Filing_Press_Release_November_3J_2021_FINAL.pdf

Relief Therapeutics Takes First Step to Create an ADR Program in the United States by filing a Form F-6 Registration Statement with the U.S. Securities and Exchange Commission

Geneva, Switzerland, November 3, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), announced today that it has taken the first steps to establish a Level 1 American Depositary Receipt (ADR) program in the United States by filing a registration statement on Form F-6 with the U.S. Securities and Exchange Commission. It is expected that Relief's ADRs will begin trading in the over-the-counter (OTC) market at some point after its registration statement becomes effective, and Relief intends to issue a press release and announce the ticker symbol for its ADRs closer to the program's effective date. Relief's ADR program will complement its existing primary listing on the SIX Swiss Exchange ("SIX"). JPMorgan Chase Bank, N.A. ("JPMorgan") has been appointed as the depositary bank for the Level 1 ADR program.

An ADR is a negotiable receipt, resembling a stock certificate that is issued by a United States depositary bank appointed by a company to evidence one or more American Depositary Shares ("ADSs"). In the case of Relief's ADRs, each ADS will represent one hundred and fifty (150) of Relief's ordinary shares. ADRs allow U.S. investors to buy shares in foreign companies without the need for cross-border or cross-currency transactions. They are priced in US dollars and can be traded like shares of U.S.-based companies in the OTC market.

Under the program, the owners and holders of ADSs will be entitled to dividends and distributions and have voting powers with respect to Relief's ordinary shares represented by their ADSs subject, however, to the provisions and enforcement procedures provided in the deposit agreement to be entered into by and among Relief, JPMorgan as the depository, and all holders and beneficial owners from time to time of ADRs issued thereunder.

The establishment of the program by Relief is not an offering of new Relief ordinary shares, and the ADSs will be based on the Relief ordinary shares currently in issue. Therefore, Relief will receive no proceeds from the establishment of the program. However, Relief's goal is to take the necessary steps in the future to transition its ADR program from a Level 1 ADR program to a Level 2 or a Level 3 ADR program, with the ultimate goal of listing its ADRs on the NASDAQ Stock Market during the first half of 2022. There can be no assurance that Relief will be successful in those efforts.

This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States or any other jurisdiction, nor shall there be any offer or sale of securities in the United States or any other jurisdiction in which such offer, solicitation, or sale would be unlawful unless registered and/or qualified under applicable securities laws. This document does not constitute a prospectus according to art. 35 of the Swiss Financial Services Act dated 15 June 2018, as amended ("FinSA"), or art. 27 et seqq. of the SIX Swiss Exchange Listing Rules. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Relief in or into Switzerland within the meaning of FinSA. Further, the ADRs have not been registered under the Securities Act of 1933, as amended (the "Act"), and no public offering of securities shall be made in the United States except by means of a prospectus meeting made available by Relief that contains detailed information about Relief and its management, as well as financial statements meeting the requirements of the Act.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Launches PKU GOLIKE® KRUNCH in Germany and Italy

Year ordering: 2021
Media Contact:

 

MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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Contact:

CONTACT:

RELIEF THERAPEUTICS Holding AG
Jack Weinstein
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Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether APR can successfully market PKU GOLIKE® KRUNCH in Germany, Italy and other European countries, (ii) whether PKU GOLIKE® KRUNCH will ever be approved as a prescription product for PKU, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding AG's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Golike Krunch Launch
Attachment (PDF): 210909_Relief_Golike_Krunch_Launch_PR.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Launches PKU GOLIKE® KRUNCH in Germany and Italy

APR Expands PKU GOLIKE® Product Line with More Convenient, Chewable Tablet Option

Geneva, Switzerland, September 9, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), has launched, through its affiliates in Germany and Italy, PKU GOLIKE® KRUNCH, a convenient chewable tablet for the dietary management of phenylketonuria (“PKU”), a rare, recessive metabolic genetic disorder affecting approximately 350,000 people globally.

“With PKU GOLIKE® KRUNCH, we are directly addressing a critical patient need with a much more flexible and convenient option for the management of PKU. In particular, PKU GOLIKE® KRUNCH gives patients a ready to chew tablet allowing for ‘on-the-go’ administration of protein substitute. This new option is intended to substantially improve adherence to therapy, which is extremely difficult to maintain for these patients, leading to better outcome and quality of life,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “As important, PKU GOLIKE® KRUNCH is the result of how flexible is our patented Physiomimic Technology™, which allows to develop effective prolonged release, taste and odor masked products. We are pleased to begin sales in Germany and Italy, two key markets within the European Union, and in the coming months we plan to expand the distribution of PKU GOLIKE® KRUNCH to additional countries in Europe.”

The PKU GOLIKE® family of products are food for special medical purposes (“FSMP”) consisting of a phenylalanine-free amino acid mix in granules. Engineered with the APR’s Physiomimic Technology™, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a better physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

“This newest launch by APR is a testament to the strength and adaptability of the Physiomimic Technology and is a key addition to our growing line of marketed products,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. “Moving forward, we plan to expand our existing commercial infrastructure and refine marketing activities to accelerate the future growth of this product line. It is also important to note that, since PKU GOLIKE® has been granted Orphan Drug Designation, we intend to assess the pursuit of PKU GOLIKE® as a prescription product for PKU in the U.S., where the majority of patients have no access to reimbursed medical foods.”

ABOUT PHENYLKETONURIA OR PKU

PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal of Wound Care, Indicating That Nexodyn® AOS Is a Highly Effective Treatment to Support Wound Healing of Hard-to-Heal Leg Ulcers

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_APR Strohal study
Attachment (PDF): 20210930_ad_hoc_Relief_APR_Strohal_Study_Nexodyn.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal of Wound Care, Indicating That Nexodyn® AOS Is a Highly Effective Treatment to Support Wound Healing of Hard-to-Heal Leg Ulcers

As an Active Cleanser, Nexodyn® AOS Shows Superior Wound Healing Performance Compared to Standard of Care

Geneva, Switzerland, September 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported data published in the peer reviewed Journal of Wound Care, indicating that the company’s Nexodyn® acid-oxidizing solution (AOS), developed with APR’s proprietary Tehclo® technology, was found to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers. The data also confirmed the safety and tolerability of Nexodyn®.

Conducted by Robert Strohal, M.D., Professor and Department Head, Department of Dermatology, Federal Academic Teaching Hospital of Feldkirch, Austria, and colleagues, the open-label, randomized controlled MACAN study was conducted at two centers is Austria. A total of 50 patients were enrolled, with either infected or non-infected hard-to-heal leg ulcers of different etiology. Patients were treated for six weeks either with Nexodyn® AOS or standard of care (SOC) wound dressings.

In the patient group treated with Nexodyn® AOS, wounds exhibited a faster and more pronounced wound size reduction compared with wounds in the SOC group. Additionally, compared to SOC, the treatment group showed a markedly greater percentage of complete healing of hard-to-heal ulcers by the end of the study period (32% versus 8%, respectively). Furthermore, Nexodyn® demonstrated its ability to significantly reduce the wound pH (p<0.0001) and thus promote a faster healing process. In all patients with infected leg ulcers, local infection was overcome more rapidly with Nexodyn® AOS treatment. Overall, the efficacy of Nexodyn® AOS was found to be not only non-inferior but superior to SOC wound dressings.

“The publication of the MACAN study reconfirms the effectiveness of Nexodyn® AOS, developed with our proprietary, globally patented Tehclo® nanotechnology platform, versus SOC, providing further evidence of its unique ability to significantly reduce healing time, protect from risk of infection and reduce clinical signs of local infection,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “Importantly, the study showed that Nexodyn® AOS, with its antimicrobial properties, is able to control infection as a stand-alone treatment and that the reduction of the pH in the wound bed is directly associated with wound healing. Additionally, by restoring the prerequisites of the physiological healing process, use of Nexodyn® AOS can meaningfully help to reinitiate chronic wound closure. The published results show that Nexodyn® AOS is not only non-inferior, but is, in fact, superior to wound dressing standard of care, clearly establishing Nexodyn® AOS, as an important treatment for chronic hard-to-treat wounds.”

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “The marked improvement in wound healing reported in the MACAN study also bodes well for APR-TD011, developed with the same Tehclo® platform as Nexodyn® AOS, which is designed as a complete treatment for epidermolysis bullosa (EB) patients to prevent or reduce skin lesion infections and inflammation through modulation of the wound microenvironment to support a faster physiological wound healing. APR TD-011 was granted Orphan Drug Designation and may become an important treatment option for the estimated 250,000 EB patients worldwide.”

About Nexodyn® Acid-Oxidizing Solution (AOS)

Nexodyn® Acid-Oxidizing Solution (AOS) is a Tehclo®-based product proven to restart wound healing in stalled wounds by creating the ideal microenvironment to sustain the physiological healing process.
A wealth of evidence and real-world experience consistently show accelerated closure with reduced infection rates and less wound-associated pain.

Nexodyn® AOS is a solution with three main features: highly pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), acidic pH (2.5 – 3.0) and high Reduction-Oxidation Potential (ORP 1.000 – 1.200 mV). The product is a sprayable solution with ancillary antimicrobial properties intended for use in the debridement, irrigation, cleansing and moistening of acute and chronic wounds (e.g., diabetic foot ulcers, pressure ulcers, and vascular ulcers), post-surgical wounds, burns and other lesions. The product is certified in the European Union as a Class III medical device.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal, Nutrients, Indicating Additional Potential Benefits of Its Physiomimic™ Technology

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact:

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether aviptadil will ever be approved in the UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iii) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_APR publication PKU
Attachment (PDF): 210921_ad_hoc_Relief_APR_Publication_on_PKU.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal, Nutrients, Indicating Additional Potential Benefits of Its Physiomimic™ Technology

Data In Healthy Volunteers Suggests That APR’s Controlled Release Amino Acid Mix, PKU GOLIKE®, May Be Key To Reducing Catabolic Events In Patients With Phenylketonuria (“PKU”), Improving Utilization Of Amino Acids And Quality Of Life

Geneva, Switzerland, September 21, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported data published in the peer reviewed journal, Nutrients, indicating additional potential benefits of the company’s Physiomimic™ Technology to the management of patients suffering from phenylketonuria (“PKU”).

The paper, entitled, “Nitrogen Balance after the Administration of a Prolonged-Release Protein Substitute for Phenylketonuria as a Single Dose in Healthy Volunteers,” provides a further evaluation of published data from APR’s previously reported, randomized, controlled, single-dose crossover trial in healthy volunteers which showed that a prolonged-release amino acid (AA) mixture, formulated with Physiomimic Technology, significantly slowed down the release and reduced the peak plasma concentrations of essential AAs compared with a free AA mixture. Authors of the current paper, including Anita MacDonald, Ph.D. and Ania C. Muntau, M.D, renowned experts in the field of metabolic diseases, concluded that the controlled release amino acid mix (PKU GOLIKE®), given its ability to prolong the release of AAs, appears to be key to reducing catabolic events in patients with PKU, resulting in a more efficient utilization of AAs for protein synthesis and, therefore, an improved quality of life.

“The paper’s conclusions reaffirm our belief as to the benefits of our patented Physiomimic Technology, the distinct advantages of our PKU GOLIKE® family of products, and the potential additional advantages conferred by the product’s unique ability to prolong the release of AAs,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “The Physiomimic Technology allows for a formulation of AAs which we believe leads to a physiological absorption profile more closely resembling the absorption profile of natural proteins. Based on the results published in the paper, we plan to explore additional clinical assessments to support the benefits of AAs physiological absorption associated with PKU GOLIKE and the patented pharmaceutical Physiomimic Technology behind it.”

“The strong clinical results are a testament to the potential benefits of PKU GOLIKE® as compared to non-prolonged release AA supplementation,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. “PKU GOLIKE® has been granted Orphan Drug Designation in the U.S. and further clinical studies on the benefits of the Physiomimic Technology will help as we pursue PKU GOLIKE® as a prescription product. In the meantime, we will focus on the commercial expansion and refinement of marketing activities to facilitate the growth of this product line in Europe.”

About PKU GOLIKE
The PKU GOLIKE family of products are food for special medical purposes (FSMP) consisting of a phenylalanine-free amino acid mix in granules. Engineered with the Company’s patented Physiomimic Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a better physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

About Phenylketonuria or PKU
PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Positive Interim Data from Its Clinical Trial of Novel Nasal Spray Sentinox in SARS-CoV-2 Infected Patients

Year ordering: 2021
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This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the final results from the study will be as positive as the interim data, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Attachment Name: Relief_Sentinox interim data
Attachment (PDF): 20211027_ad_hoc_Relief_APR_Sentinox_Interim_Results.pdf

Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Positive Interim Data from Its Clinical Trial of Novel Nasal Spray Sentinox in SARS-CoV-2 Infected Patients

Results Confirm the Safety and Tolerability of Sentinox and Suggest It Could Be Effective in Reducing Time to Negativization in SARS-CoV-2 Infected Patients

Geneva, Switzerland, October 27, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 infected patients, confirming its safety and tolerability. Relief also reported that data from the study suggest that Sentinox could be effective in reducing the SARS-CoV-2 viral load at the level of the nasal mucosa.

The post-market, confirmatory, interventional, randomized, placebo controlled clinical study is expected to enroll a total of 57 patients. The study is designed to assess the efficacy and safety of Sentinox spray in reducing viral load in the upper respiratory airways of recently infected SARS-CoV-2 individuals and is being conducted by the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa, Italy and coordinated by Prof. Giancarlo Icardi as lead investigator.

The interim analysis, based on 30 patients who have completed the study -- 10 patients for each treatment group (0.5 ml into each nostril, 3x/day, 5x/day or control group, for five days) -- showed that all patients treated with Sentinox tested negative for SARS-CoV-2 by the end of the study period (Day 21). By contrast, one out of 10 patients in the control group was still positive by Day 21. All subjects using Sentinox 3 times a day had already tested negative by visit number 7 (V7; Day 10) vs. 70% of subjects in the control group over the same study period. At visit 4, 5 and 6, a trend in favor of the 3 times a day treated group vs. control group was observed (10% of patients using Sentinox tested negative at V4 vs 0% of patients in the control arm; 40% of patients using Sentinox tested negative vs 20% in the control arm at V5; 70% of patients using Sentinox tested negative vs 40% at V6). For the purpose of this study, subjects are considered negative when their COVID-19 test becomes negative and remains negative throughout the study period.

Prof. Giancarlo Icardi, head of the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa and lead investigator, commented, “The interim analysis results are encouraging. Indeed, the preliminary efficacy data suggest that using Sentinox, in addition to standard of care, could accelerate the time to a negative SARS-CoV-2 test result, thereby allowing patients to resume their normal daily activities sooner. By lowering the viral load in the nasal mucosa, the use of Sentinox could help reduce the transmissibility of the virus and, consequentially, its spread. Moreover, it is possible that, by including a larger number of patients and clinical parameters, Sentinox will prove to be a helpful tool for improving clinical outcomes in patients with mild COVID-19 in addition to standard of care. In general, we expect that the positive data obtained so far will be confirmed by the end of the study.”

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “These positive preliminary results serve to further illustrate the versatility of APR’s proprietary, globally patented Tehclo® nanotechnology platform. We are very encouraged by the data and remain committed to proactively progressing this program with the hope that we can eventually bring Sentinox to market as an important, additional, protective option for the treatment and spread of COVID-19.”

About Sentinox

Sentinox is an acid-oxidizing solution (AOS) containing hypochlorous acid at 0.005%, certified in Europe on February 16, 2021 as Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1). The device is intended for irrigation, cleansing and moistening of the nasal cavities and is indicated for (i) reducing the risk of infections caused by bacteria and viruses, including SARS-CoV-2, by lowering the nasal microbial load, (ii) symptomatic nasal care and (iii) nasal care in case of minor lesions/alterations of the nasal mucosa.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.