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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
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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 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.

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

Year ordering: 2021
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MC Services AG
Anne Hennecke 
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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
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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 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
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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, 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 Reports Half-Year 2021 Results and Provides Corporate Update

Year ordering: 2021
Media Contact:

MEDIA/INVESTOR INQUIRIES: 

Rx Communications Group
Michael Miller
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CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
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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 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
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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 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 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
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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 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
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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 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 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
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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, 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 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
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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 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.

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

Year ordering: 2021
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MEDIA/INVESTOR INQUIRIES: 
Rx Communications Group
Michael Miller
Tel:+1-917-633-6086
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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.
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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
This email address is being protected from spambots. You need JavaScript enabled to view it.

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 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’ 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:

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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, 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.