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.

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.

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.

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.

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:

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.

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. 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.

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 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.

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. 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.

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 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.

Scientific publications on ACER-001 can be view here: https://2020.relieftherapeutics.com/pipeline.

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.

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.

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