Newsletter

Key Stock Information

Relief shares are listed on the SIX Swiss Exchange under the valor symbol RLF and quoted on the U.S. OTCQB Venture Market under the symbol RLFTF

Share details (SIX)
Valor symbol
RLF
Valor number
10019113
Regulatory standard
International Reporting Standard
Trading currency
CHF
Nominal share value
CHF 0,01
Registered Share capital (in units)

4'413'334'617

Authorized capital (in units)

2’200’000’000

Conditional capital (in units)
1'671'769'814
Auditor
Mazars
Principal shareholders
Global Emerging Markets (GEM) Relief founders

    

Share details (U.S. OTCQB)
Ticker symbol

RLFTF

Trading currency

USD

    

Share details (U.S. ADR OTCQB)
Ticker symbol

RLFTY

Trading currency

USD

Disclosure of Shareholdings

Shareholders who hold shares in a company incorporated in Switzerland whose equity securities are listed in Switzerland have the duty to disclose if they reach, exceed or fall below certain thresholds (3, 5, 10, 15, 20, 25, 33 1/3, 50, 66 2/3 % of voting rights).

Please inform us in case of exceedance or shortfall of the threshold by post or e-mail (This email address is being protected from spambots. You need JavaScript enabled to view it.) with the official term, “Disclosure of Shareholdings.”

The reporting form can be found at this link:  www.ser-ag.com 

SEC FILINGS

For all SEC filings, please click here.

Analyst Coverage

    Articles of Association

      U.S. ADR Program

        Financial Calendar

        • Annual Report

          March 31, 2022
        • Annual General Meeting

          May 31, 2022
        • Half-Year Report

          September 15, 2022

          Shareholder FAQS

          Relief shares are listed on the SIX Swiss Exchange and quoted on the U.S. OTCQB Venture

          Company

          What is the Company's mission?
          To provide patients with therapeutic RELIEF from serious diseases with high unmet medical need.
          When was Relief founded?
          RELIEF THERAPEUTICS Holding AG was formed in 2013 by three ex-Merck (Serono division) employees.
          How can I receive the latest corporate news releases? Where are the archived releases located?
          To receive our latest news releases, please register for our corporate newsletter. Once registered, you will receive all corporate news as soon as they are published. Archived press releases can be found here: https://relieftherapeutics.com/archive-press.
          How can I view documents Relief has filed with the SIX swiss exchange?

          To view all documents filed with the SIX Swiss Exchange, please visit the “Notices Market Participants” section of ser-ag.com aand select RELIEF THERAPEUTICS Holding AG in the Issuer filter.

          When does Relief publish its financial results?

          We publish our half year and annual results in compliance with SIX requirements. Typically, this occurs in April and September of each fiscal year, respectively.

          When will Relief appoint a CEO?

          Relief’s management team strategy is to maintain a lean internal structure and a series of collaborations with relevant worldwide experts. The management team works collectively to execute all duties traditionally assigned to a CEO. Since 2020, Relief has added senior executives with extensive experience in finance, commercialization, medical affairs, clinical development and manufacturing. The company plans to continue to add expertise by hiring personnel and consultants in an effort to match its pace of development. Relief is planning to name a CEO in the fourth quarter of 2022.

           

          Stock

          How is Relief’s stock traded?

          Our shares are listed on the SIX Swiss Exchange under the symbol RLF and are quoted in the U.S. on the OTCQB Market under the symbol RLFTF. Additionally, the Company has a level 1 U.S. ADR traded on the OTCQB under the symbol RLFTY.

          When did Relief go public?
          Relief was formed from a reverse merger with THERAMetrics Holding AG in 2016. THERAMetrics Holding AG (then mondoBIOTECHHolding AG) was listed on the SIX since 2009. Following the business combination, Relief took over the SIX listing.
          Is Relief's stock part of a benchmark index?

          Relief's stock is included, among others, in the Swiss Exchange Swiss Performance Index, the MSCI Global Small Cap Index, as well as the SXI Life Sciences and SXI Bio+Medtech indices.

          How many stock options and warrants are outstanding?

          As of May 1, 2022, there were 66,963,197 options and 0 warrants outstanding.

          What is the SSF agreement with GEM?

          On January 21, 2021, Relief announced the implementation of a new Share Subscription Facility ("SSF") in the amount of up to CHF 50 million with the Company’s main shareholder, GEM Global Yield LLC SCS.

          Under the terms of the SSF, Relief has the right to periodically, during a timeframe of up to three years, issue and sell shares to GEM. Under the facility, GEM undertakes to subscribe to or acquire ordinary registered RELIEF THERAPEUTICS Holding AG shares upon Relief's exercise of a draw down notice. In accordance with the customary terms of the SSF agreement, Relief will control the timing and maximum amount of any draw down, and retains the right, not the obligation, to draw down on the full commitment amount.

          As of July 18, 2022, no funds have been drawn down from the current SSF agreement.

          Does Relief pay dividends?
          The Company is not currently generating revenue; no dividends are being paid.

           

          RLF-100®

          When do you expect FDA-approvals for either the intravenous or inhaled formulations?

          We cannot speculate on the likelihood or timing of FDA approvals. In March 2021, Relief’s partner, NeuroRx, reported top-line 60-day results from the phase 2b/3 clinical trial in critical COVID-19 patients with respiratory failure. On the basis of these findings, in May 2021, NRx Pharmaceuticals, Inc. (NRx) (now the parent of NeuroRx) submitted an application to the FDA for Emergency Use Authorization (EUA), which was subsequently declined in November 2021. In January 2022, NRx announced that it had submitted an application to the FDA seeking EUA for the use of aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial, which was subsequently denied in July 2022. 

          The U.S. phase 2/3 study with the inhaled formulation of RLF-100® was initiated by NeuroRx, Inc. in February 2021. In March 2022, NRx announced the study was paused. 

          Can you explain your partnership with NeuroRx?

          On September 21, 2020, Relief and NeuroRx announced the completion of their worldwide partnership agreement for the development and commercialization of RLF-100®. The two companies agreed to share all profits from sales of RLF-100® for all indications related to COVID-19 and potentially other respiratory indications on a global basis. Under the terms of the agreement, NeuroRx will lead development and commercialization in the United States, Canada, and Israel, while Relief will lead development and commercialization in Europe and the rest of the world. Profits from sales will be allocated to Relief and NeuroRx on a 50/50 basis in the U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories. Since its conclusion, the binding collaboration agreement has not been changed or adapted.

          On April 5, 2022, Relief reported that it has entered into a stipulation to stay the proceedings in its pending litigation with NeuroRx, Inc. and Jonathan Javitt to allow the parties to attempt to seek to mediate their dispute. The parties had previously begun mediating their dispute and have made progress in said mediation. Under the stipulation, which has been approved by the court, the mediation has been stayed for 90 days to allow the parties to focus on these mediation efforts. The stipulation also extends the standstill period for additional periods of time under certain circumstances.

          There can be no assurance that the parties will be able to successfully mediate their dispute or that the standstill will be extended.

          What is your IP position for RLF-100™?

          Relief holds a patent covering potential formulations of RLF-100® in the United States valid until at least July 2029, with extension opportunities up to five years, as well as in the EU and Rest of World (Great Britain, Germany, Turkey, Spain, Switzerland, Netherlands, Denmark, Ireland, Austria, PRC and Mexico) valid until at least 2026, excluding extension opportunities comparable to the U.S. The acquisition of AdVita Lifescience GmbH in July 2021, enabled us to strengthen our intellectual property position with pending intellectual property rights that cover an improved formulation of the inhaled version of RLF-100® (aviptadil) and its potential application for the treatment of acute respiratory distress syndrome (“ARDS”) unrelated to COVID-19 infection, as well as in other pulmonary disorders, including sarcoidosis, berylliosis and checkpoint inhibitor-induced pneumonitis, for which AdVita has already filed pending patent claims. 

          When will RLF-100™ be available in Europe?

          In April 2021, Relief announced the initiation of a phase 2 trial evaluating the inhaled formulation of RLF-100® for the prevention of COVID-19-related ARDS (the Leuppi study) (NCT04536350), which is a randomized, double-blind, placebo-controlled phase 2 investigator-sponsored trial being conducted at several clinical sites in Switzerland. The trial is at an advanced stage of recruitment and is slated to report top-line data later this year (subject to enrollment of eligible patients).

          Is RLF-100® being evaluated in clinical trials for other indications?

          Aviptadil remains a molecule with a well-established mechanism of action and widely documented clinical evidence of biological activity, as well as a favorable human safety and tolerability profile established across two decades of clinical evaluation. As such, Relief believes that the drug merits continued assessment across an array of pulmonary conditions, regardless of whether the drug is ever approved for the treatment of COVID-19. Relief intends to initiate a clinical trial of RLF-100® in early 2023 in patients with pulmonary sarcoidosis, a chronic, rare and debilitating pulmonary disease for which there are no treatments approved and for which Relief has received Orphan Drug designation from the FDA. Relief plans to explore RLF-100® in checkpoint inhibitor-induced pneumonitis (CIP), an indication in which Relief’s wholly owned subsidiary, AdVita LifeScience GmbH, obtained method-of-use patent protection for aviptadil in February 2022. Additionally, Relief intends to conduct European proof-of-concept clinical development of RLF-100® in the treatment of chronic berylliosis, an orphan lung disease for which there are no treatments approved, and that is characterized by severe inflammation of the lungs, coughing and increasing breathlessness (dyspnea). Please see the Pipeline-RLF-100® (aviptadil) section of the website for details.

          How do I contact Relief with additional questions?
          For more information, please contact: This email address is being protected from spambots. You need JavaScript enabled to view it..

           

          ACER-001

          What is ACER-001?

          ACER-001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB). The formulation is designed to be both taste-masked and immediate release. ACER-001 is being developed using a microencapsulation process for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD). ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach to avoid a bitter taste while still allowing for rapid systemic absorption. ACER-001’s taste-masked formulation is designed to improve the palatability of NaPB and could make it a compelling alternative to existing NaPB-based treatments, as the unpleasant taste associated with NaPB is cited as a major impediment to patient compliance with those treatments.

          When do you expect FDA approval for ACER-001?

          A pre-NDA meeting between Acer and the FDA was completed in the second quarter of 2021. In August 2021, Relief and Acer announced the submission of the NDA to the FDA under the 505(b)(2) pathway for ACER-001 in UCDs. In October 2021, the FDA accepted the NDA for the treatment of patients with UCDs and assigned a PDUFA target action date of June 5, 2022. In June 2022, Acer was issued a Complete  Response Letter (CRL) regarding the NDA for ACER-001 for UCD. The CRL stated that the FDA could not approve the NDA for ACER-001 for UCD in its current form due to an incomplete inspection of Acer’s third-party contract packaging manufacturer. The FDA did not cite any other approvability issues in the CRL related to the NDA. In mid-July 2022, Acer resubmitted its NDA for ACER-001 for the treatment of UCD FDA, which was subsequently accepted for review by the FDA in late July 2022. The FDA designated the NDA as a Class 2 resubmission and set a PDUFA target action date of January 15, 2023.

          What is the nature of your partnership with Acer Therapeutics?

          On March 22, 2021, Relief and Acer announced the signing of a Collaboration and License Agreement for the worldwide development and commercialization of ACER-001. Under the terms of the agreement, Acer will receive approximately $10 million in cash upon signing (originally $14 million, which was offset by cancellation of the $4.0 million outstanding balance of the prior loan from Relief to Acer following the signing of an exclusivity Option Agreement in January 2021 and a small amount of accrued interest). In addition, Relief has agreed to pay up to $20 million in U.S. development and commercial launch costs for the Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD) indications. Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer’s territories 60:40 in favor of Relief. In addition, Relief has licensed the rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all net sales and other revenues received in Relief’s territories. Acer may also receive a total of $6 million in development milestone payments following the first European (EU) marketing approvals for UCDs and MSUD.

          Investor Contact

          For investor inquiries contact:

          Rx Communication Group
          Michael Miller
          Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
          Tel.: 917.633.6086