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)

4'400'230'156

Authorized capital (in units)
656'497'092
Conditional capital (in units)
1'684'874'275
Auditor
Mazars
Principal shareholders
Global Emerging Markets (GEM) Relief founders

    

Share details (U.S. OTCQB)
Ticker symbol

RLFTF

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 

Analyst Coverage

    Articles of Association

      U.S. ADR Program

        Financial Calendar

        • Annual Report

          April 15, 2021
        • Annual General Meeting

          June 18, 2021
        • Interim Financial Statement

          September 24, 2021

          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. Our management team works collectively to execute all duties traditionally assigned to a CEO. In 2020 and early 2021, Relief added senior executives with extensive experience in finance, commercialization, medical, clinical development and manufacturing, and we plan to continue to add expertise by hiring personnel and consultants in an effort to match the Company’s pace of development.

           

          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 OTCQB Venture Market under the symbol RLFTF.
          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, amongst others, in the Swiss Exchange Swiss Performance Index and in the MSCI Global Small Cap Index. Effective 20 September 2021, Relief will also be part of the SXI Life Sciences and SXI Bio+Medtech indices.
          How many stock options and warrants are outstanding?
          As of March 31, 2021, there were 22,063,846 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 March 31, 2021, 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. According to NeuroRx, across all patients and sites, RLF-100™ IV met the primary endpoint for successful recovery from respiratory failure at days 28 and 60 and also demonstrated a meaningful benefit in survival after controlling for ventilation status and treatment site. On the basis of these findings, in May 2021, NRx Pharmaceuticals, Inc. (now the parent of NeuroRx) submitted an application to the FDA for Emergency Use Authorization (EUA). NeuroRx subsequently plans to submit a New Drug Application (NDA) to the FDA based on these top-line results and including full chemistry, manufacturing and controls (CMC) data as well as additional information on the profile of the drug from other previously conducted clinical and preclinical studies. The FDA granted RLF-100™ Fast Track designation in June 2020, which, among other things, makes RLF-100™ eligible for Priority Review if relevant criteria are met. Priority Review designation means the FDA’s goal is to take action on an application within 6 months compared to 10 months under standard review. It would be reasonable to expect Priority Review for applications filed under the Coronavirus Treatment Acceleration Program (CTAP). RLF-100™ is part of this program, which was promulgated by the FDA in 2020 in express response to the emergence of the COVID-19 pandemic.

          The U.S. phase 2/3 study with the inhaled formulation of RLF-100™ was initiated by NeuroRx, Inc. in February 2021. According to clinicaltrials.gov, study completion is estimated in December 2021.

          Can you explain your partnership with NeuroRx?
          On September 21, 2020, Relief and NeuroRx announced the completion of their partnership agreement for the development and commercialization of RLF-100™ worldwide. 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.
          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. In part to further build the IP portfolio, Relief and AdVita Lifescience GmbH signed a binding term sheet in January 2021 for Relief to acquire all shares of AdVita. Relief will gain access to all AdVita assets including future pending IP rights that may cover RLF-100 inhaled formulation specifications for the potential application of inhaled aviptadil in the treatment of lung diseases such as ARDS and pulmonary sarcoidosis.

          Has an Emergency Use Authorization (EUA) application been filed with the FDA based on top-line data from the IV trial?

          In March 2021, NeuroRx reported top-line 60-day results from the phase 2b/3 clinical trial in critical COVID-19 patients with respiratory failure. According to NeuroRx, across all patients and sites, RLF-100 IV met the primary endpoint for successful recovery from respiratory failure at days 28 and 60 and also demonstrated a meaningful benefit in survival after controlling for ventilation status and treatment site. On the basis of these findings, in May 2021, NRx submitted an application to the FDA for EUA. Relief cannot speculate on the timing of a decision by the FDA but will report this information when known.

          What is the status of the U.S. inhaled trial with RLF-100™?
          The U.S. Phase 2/3 trial with inhaled RLF-100™ for the treatment of severe COVID-19 is being conducted by our partner NeuroRx Inc. and was initiated by them in partnership with UCI Health of the University of California, Irvine in February 2021. According to clinicaltrials.gov, study completion is estimated in September 2021.
          When will RLF-100™ be available in Europe?

          Relief is currently preparing a European phase 2b/3 study with RLF-100™ in COVID-19-induced acute respiratory distress syndrome (“ARDS”) patients. Once the EUA application is submitted and the FDA makes a decision, Relief will decide on the best path forward for the development of RLF-100 IV in Europe and other territories. It is our hope that, should the FDA grant EUA for RLF-100™, this could expedite the clinical assessment of RLF-100™ in Europe. For this reason, a European trial with RLF-100™ IV would not commence until a decision on EUA has been announced.

          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 study, Inhaled Aviptadil for the Prevention of COVID-19 Related ARDS (NCT045363505), is a randomized, double-blind, placebo-controlled phase 2 investigator-sponsored trial being conducted at several clinical sites in Switzerland. It is estimated that the study will take approximately 6-12 months to complete, depending on the progression of the ongoing COVID-19 pandemic.

          Is RLF-100™ being evaluated in other clinical trials?

          Additional clinical trials evaluating RLF-100™ are underway or planned. 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 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, 2021. While there can be no assurance, should the FDA approve the NDA, we believe that ACER-001 could be available commercially in the U.S. during 2022.
          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