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 under the symbol RLFTF

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

3'246'727'248

Authorized capital (in units)
1’250’000’000
Conditional capital (in units)
375’215’608

    

Share details (U.S. OTCQB)
Ticker symbol

RLFTF

Auditor

Mazars

Principal shareholders

Global Emerging Markets (GEM)
Relief founders

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

      Financial Calendar

      • Annual Report

        April 15, 2021
      • Annual General Meeting

        June 18, 2021
      • Interim Financial Statement

        By September 2021

        Shareholder FAQ

        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://2020.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 and 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. While Relief has plans to expand the management team in order to pursue additional M&A and in-licensing opportunities such as the recently announced Acer Therapeutics letter of intent, we are currently focused on building the right team to see RLF-100™ through clinical development. In parallel, we are setting up a team of experts to competently handle all commercial aspects associated with a potential approval, ensuring our therapy reaches patients in need.

         

        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 stock part of a benchmark index?

        Relief stock is included, amongst others, in the Swiss Exchange Swiss Performance Index.

        With effect of November 30, 2020 Relief stock will also be included in the MSCI Global Small Cap Index.

        How many stock options and warrants are outstanding?

        As of January 22, 2021, there were 24,467,658 options and 0 warrants outstanding.

        What is the remaining size and duration of the SSF program 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. 

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

         

        RLF-100™

        What is RLF-100™’s mode-of-action?

        RLF-100™ is a synthetic Vasoactive Intestinal Peptide (VIP) that has a multimodal mechanism of action:

        1. It binds to Type 2 alveolar cells (found in the lungs), resulting in a significant modulation of the immune cell response (macrophages, CD4-T cells and tolerogenic dendritic cells) mediated by activation of the VPAC1 and VPAc2 receptors. RLF-100™ thus plays an anti-inflammatory and immunomodulatory role vis-à-vis the immune cells,
        2. has vasodilatory and inotropic effects through the vascular system, and
        3. helps to maintain the bronchial system by upregulating the production of surfactant in the lungs, preventing cell death.
        When do you expect FDA-approvals for either the intravenous or inhaled formulations?

        We cannot speculate on the likelihood or timing of FDA approvals. It is possible that the FDA could grant Emergency Use Authorization (EUA) based on final 60-day results. A full New Drug Application (NDA) requesting marketing approval could also be submitted at a later time, based on positive 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, 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 our partner, NeuroRx, Inc. in February 2021. We cannot speculate on the timing or likelihood of an FDA approval.

        What is the nature of your partnership with NeuroRx?

        On September 21, 2020, Relief and NeuroRx announced the completion of their partnership agreement for the commercialization of RLF-100™ worldwide. The two organizations have 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. They have agreed that NeuroRx will lead commercialization in the United States, Canada, and Israel, while Relief will lead 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.

        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 RoW (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.

        Are there any other compounds next to RLF-100™ in your pipeline that are already in the clinic?

        On January 25, 2021, Relief Therapeutics and Acer Therapeutics signed an option agreement for exclusivity to negotiate a collaboration and license agreement for the worldwide development and commercialization of ACER-001 for the Treatment of Urea Cycle Disorders and Maple Syrup Urine Disease.

        Relief continues to seek partnerships with companies who have late-stage clinical assets that can be rapidly advanced in order to bring new therapeutic options to the market as quickly as possible.

        How did the FDA respond to the Emergency Use Authorization (EUA) application filed at the end of September?

        The FDA did not agree to grant EUA as applied for in September, based upon the ongoing open-label study (Expanded Access Program), but advised at the time that they remained committed to working with NeuroRx in the development of RLF-100™. NeuroRx has indicated that based on 60-day data findings, it plans to apply immediately to the FDA for EUA and to subsequently submit a NDA.

        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. 

        When will RLF-100™ be available in Europe?

        Relief is currently preparing a European Phase 2b/3 study with RLF-100™ in COVID-19 patients. However, it is our hope that should positive results be obtained in the U.S. trial, this could expedite the clinical assessment of RLF-100™ in Europe.  For this reason, a European trial would not commence until the U.S. data have been fully analyzed.

        How long will it take the FDA to approve RLF-100™ after top-line data are available?

        NeuroRx has indicated it anticipates submitting a request for EUA in the population of critically ill patients who are on high flow nasal oxygen who have exhausted all currently approved treatments, should the trends seen in the day 60 data support this.

        Assuming that the 60-day data are positive, the FDA could at that time consider granting EUA, which would permit the drug to be launched in Q2 2021. A full New Drug Application (NDA) requesting marketing approval could be submitted at a later time, based on positive 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, 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 six months compared to ten 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 earlier this year in express response to the emergence of the COVID-19 pandemic.

         

        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 release. If ACER-001 is approved, its taste-masked properties 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 approvals for ACER-001 in Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD)?

        A pre-NDA meeting with the FDA for ACER-001 for the treatment of UCDs is scheduled to occur in the second quarter of 2021. Provided no additional data are requested by the FDA during the pre-NDA meeting and ongoing development activities are successfully completed, an NDA is planned to be submitted by Acer Therapeutics for ACER-001 in UCDs in mid-2021. We cannot speculate on the timing or likelihood of approval.

        However, according to the 505(b)(2) pathway promulgated by the FDA under which ACER-001 would be submitted for approval, the statutory review period would be 10 months. Accordingly, if the NDA for ACER-001 is submitted in mid-2021, regulatory approval for the U.S. market could occur during the first half of 2022.

        Clinical studies evaluating ACER-001 in MSUD are expected to begin in late 2021. Based on positive data, an NDA for ACER-001 in the treatment of MSUD to the FDA would subsequently be submitted. At this time, we cannot speculate on the timing or likelihood of success.

        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.

        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..

        Investor Contact

        For investor inquires contact:

        MC Services AG
        Anne Hennecke / Brittney Sojeva
        Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
        Tel.: +49 (0) 211-529-252-14