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
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Global Emerging Markets (GEM)
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.)
The reporting form can be found at this link: www.ser-ag.com
Relief shares are listed on the SIX Swiss Exchange and quoted on the U.S. OTCQB Venture
To provide patients with therapeutic RELIEF from serious diseases with high unmet medical need.
RELIEF THERAPEUTICS Holding AG was formed in 2013 by three ex-Merck (Serono division) employees.
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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.
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.
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.
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.
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.
As of January 22, 2021, there were 24,467,658 options and 0 warrants outstanding.
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.
RLF-100™ is a synthetic Vasoactive Intestinal Peptide (VIP) that has a multimodal mechanism of action:
Scientific publications on RLF-100™ can be view here: https://2020.relieftherapeutics.com/pipeline.
We cannot speculate on the likelihood or timing of FDA approvals. We anticipate top-line results from the U.S. Phase 2b/3 trial with the IV formulation of RLF-100™ in February 2021. It is possible that the FDA could grant Emergency Use Authorization (EUA) based on these results. A full New Drug Application (NDA) requesting marketing approval would also be submitted 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. Full NDA approval could be granted to RLF-100™ for the U.S. market in late 2021. 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.
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.
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.
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.
The FDA did not agree to grant EUA as applied for in September, based upon the ongoing open-label study (Expanded Access Program), but has advised that they remain committed to working with NeuroRx in the development of RLF-100™ and will promptly review the forthcoming top-line data from the Phase2b/3 randomized trial – –expected in February 2021. Until that time, available stocks of RLF-100™ will continue to be administered under the Expanded Access Protocol and individual patient requests under Right to Try laws.
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.
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.
Relief is currently preparing a European Phase 2b/3 study with RLF-100™ in COVID-19 patients. Based on current projections, the trial could commence in Q1 2021. 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.
Assuming that the top-line data are positive, the FDA could at that time consider granting EUA, which would permit the drug to be launched in Q1-Q2 2021. A New Drug Application (NDA) requesting marketing approval would then be submitted based on positive top-line results. Full NDA approval could be granted to RLF-100™ for the U.S. market in late-2021. 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.
MC Services AG
Anne Hennecke / Brittney Sojeva
Tel.: +49 (0) 211-529-252-14