To provide patients with therapeutic RELIEF from serious diseases with high unmet medical need.

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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 October 14, 2020, there were 24,017,658 options and 586,658,667 warrants outstanding.

On September 28, 2020, Relief announced the conclusion of its existing Share Subscription Facility (SSF) with the Company’s main shareholder GEM Global Yield LLC SCS. Relief currently has no plans to put a new SSF in place.

RLF-100™ is a synthetic Vasoactive Intestinal Peptide (VIP) that has a multimodal mechanism of action. 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; has vasodilatory and inotropic effects through the vascular system; and helps to maintain the bronchial system by upregulating the production of surfactant in the lungs, preventing cell death.

Scientific publications on RLF-100™ can be view here: https://2020.relieftherapeutics.com/pipeline.

We cannot speculate on the likelihood or timing of an FDA-approval. We anticipate top-line results from the U.S. Phase 2b/3 trial with the IV formulation of RLF-100™ in January 2021. In September, we submitted a request for an Emergency Use Authorization (EUA) with the FDA for the use of RLF-100™ in patients who are receiving intensive care and who have exhausted all approved treatments. We expect to file a New Drug Application (NDA) with the FDA for full formal approval of RLF-100™ during 2021.

The U.S. Phase 2b/3 study with the inhaled formulation of RLF-100™ is expected to start enrolling patients in October/November 2020 with top-line data expected in Q2 2021.

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.

The FDA does not have a specific timeline by which it must respond to an EUA application and so, unfortunately, we are not able to provide further clarity on the timing of an agency response. With this in mind, a response could come before or after top-line data are released from our Phase 2b/3 trial in critically ill COVID-19 patients. Top-line data are currently expected in January 2021.

Comparisons between RLF-100™ and company products recently granted EUA cannot be drawn. For one, there is no way to determine when a company filed an EUA application unless a company discloses this information, which is not common practice. We did so to provide the utmost of transparency to our investors and stakeholders. It is important to note that the receipt of an EUA by any other company would not exclude RLF-100™ from being granted EUA as well. RLF-100™ in its current trial is used as a therapeutic for the most critical patients. To our knowledge, there is no other drug currently available on the market or in late-stage clinical development that specifically focuses on this patient population.

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, we are firstly 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 Phase 2/3 trial with inhaled RLF-100™ for the treatment of moderate and severe COVID-19 related lung injury [in patients with no evidence of respiratory failure] is being run by our partner NeuroRx Inc. To our knowledge, the trial is expected to start by the end of 2020, with top-line results (based on current enrollment estimates) anticipated in Q2 2021.

Relief is currently preparing a European Phase 2b/3 study with RLF-100™ in COVID-19 patients. Based on current projections the trial should 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 trial results are positive, a New Drug Application (NDA) submission requesting marketing approval is planned for Q1 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 earlier this year in express response to the emergence of the COVID-19 pandemic. Full NDA approval could thus be granted to RLF-100™ for the US market by Q3 2021.

Regarding the EUA, if this is not granted by the time of the top-line data, we would still not be able to provide further clarity on timing as the FDA does not have a specific timeline to respond to an EUA application.

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