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Thursday, October 21, 2021

Everybody is Talking About RLF-100 (Aviptadil); Relief Therapeutics Holding AG (OTCMKTS: RLFTF)

Relief Therapeutics Holding AG (OTCMKTS: RLFTF) is on a powerful rise up the charts and emerging as the darling of small caps as its coronavirus therapeutic RLF-100 (Aviptadil) gains serious traction. RLF-100 (Aviptadil) is believed to be the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while at the same time preventing synthesis of cytokines in the lung. It is a patented formulation of Aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA fast track designation, FDA emergency use IND authorization, and an expanded access protocol.

Relief just completed a capital raise of CHF 17,949,600 which puts the Company’s cash position at approximately CHF 48,000,000 ($52.2 million USD) which will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (IV) in COVID-19 acute respiratory distress syndrome (NCT04311697) and the RLF-100 (inhaled) trial for the treatment of non-acute lung injury in COVID-19 (NCT04360096) as well as to run a phase 3 study in Europe. Relief and its partner, NeuroRx anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020. The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks. RLF-100 is starting to get noticed by mainstream press including articles in Reuters, NyTimes and Fox News. According to the Reuters article “Relief Therapeutics sees 60-70% chance of COVID-19 drug approval” Relief Therapeutics’ chairman said he was optimistic its RLF-100 (Aviptadil) drug will win approval for treating COVID-19 patients in a matter of months.”

Relief Therapeutics and NeuroRx Announce Final Manufacturing Validation of RLF-100 for Phase 2b/3 Clinical Trial in Patients with COVID-19 Associated Acute Respiratory Distress Syndrome | Relief TherapeuticsRelief Therapeutics Holding AG (OTCMKTS: RLFTF) is a Swiss-based publicly-traded drug development company with a vision of becoming a dominant player in the lucrative biotech and pharmaceutical space. Relief strongly believes that only by effectively treating patients will its investors realize significant return on investment. The Company’s areas of interest cover a broad range of indications from niche (orphan indications) up to larger markets. Relief experimental drugs are primarily of natural origin and have been already tested or used safely in the clinical setting thereby minimizing risks and maximizing efficacious potential. Relief focuses on late stage clinical assets and strives to reduce development times and costs to quickly reach high quality decision-enabling results.

RLF-100™ is in FDA-approved phase 2b/3 clinical trials for the treatment of critical COVID-19 in the US. A readout by the study’s Data Monitoring Committee is expected within the next month. European trials with RLF-100TM are in preparation and are scheduled to start in Q1 2021. Relief and its partner, NeuroRx anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020. The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks. RLF-100 is the first COVID-19 therapeutic to demonstrate the ability to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while preventing synthesis of cytokines in the lung. Since July 2020, severe COVID-19 patients have been treated with RLF-100 under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19. According to a recent Reuters article: “Relief Therapeutics sees 60-70% chance of COVID-19 drug approval” Relief Therapeutics’ chairman said he was optimistic its RLF-100 (Aviptadil) drug will win approval for treating COVID-19 patients in a matter of months.”

Relief has been busy in recent weeks; they finalized their partnership agreement with NeuroRx for the commercialization of RLF-100™(Aviptadil) 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. As part of their agreement, Relief and NeuroRx intend to pursue the issuance of trademarks on RLF-100. NeuroRx shall prosecute such trademarks in the U.S., Canada and Israel, while Relief shall prosecute trademarks in all other territories.

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Last week NeuroRx submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100™ Aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments. The submission is based on a case-control study that compared patients who were treated with RLF-100™ (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff.  Patients treated with RLF-100™ demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement.  Hypotension was seen in two Aviptadil patients and was successfully managed with pressors.  Diarrhea was seen in 4/21 Aviptadil-treated patients and 3/30 control patients.  The results have been submitted to a peer-reviewed journal.

Relief also has completed a capital increase pursuant to a drawdown of its Share Subscription Facility (SSF) with the Company’s main shareholder GEM Global Yield Fund LLC SCS (“GEM”). Funds raised amount to CHF 17,949,600. The available cash on the balance sheet of the Company, after receipt of the funds, will be approximately CHF 48,000,000 ($52.2 million USD) and will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (IV) in COVID-19 acute respiratory distress syndrome (NCT04311697) and the RLF-100 (inhaled) trial for the treatment of non-acute lung injury in COVID-19 (NCT04360096) as well as to run a phase 3 study in Europe. Relief believes that with the conclusion of this raise, its capital resources will be sufficient to support its planned operations through 2022, without taking into account potential revenues generated from sales of RLF-100. Execution of the SSF, together with the latest exercises of stock options, brings the total amount of shares outstanding to 2,580,068,581.

Relief and its partner NeuroRx have established supply chain agreements and ordered sufficient drug substance (RLF-100TM) to prepare to treat 1 million patients with COVID-19. The partners contracted with Nephron Pharmaceuticals, Inc., Bachem Americas, as well as a leading nationwide pharmaceutical logistics partner in order to ensure overnight commercial supply to US hospitals, should RLF-100™ continue to succeed in clinical trials.

Dr. Raghuram (Ram) Selvaraju, Chairman of the Board of Relief commented: “In normal circumstances, it would be prudent to wait until all the data are in before initiating commercial scale-up. However, in an environment where more than 40,000 Americans are contracting COVID-19 daily and 800 are dying each day, there is not a moment to lose in ensuring that sufficient quantities of RLF-100™ will be available, should the clinical trials succeed in proving safety and efficacy.  We are living in unprecedented times, which call for flexibility and innovative thinking, in and outside the clinic. Therefore, we have taken the necessary steps to match the rapid clinical development of RLF-100TM by establishing a supply chain capable of scaling up to meet the urgent medical needs of critical COVID-19 patients.”

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Relief is on a powerful rise up the charts in recent months emerging as the darling of small caps as its coronavirus therapeutic RLF-100 (Aviptadil) gains serious traction. Relief just completed a capital raise of CHF 17,949,600 which puts the Company’s cash position at approximately CHF 48,000,000 ($52.2 million USD) which will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (IV) in COVID-19 acute respiratory distress syndrome (NCT04311697) and the RLF-100 (inhaled) trial for the treatment of non-acute lung injury in COVID-19 (NCT04360096) as well as to run a phase 3 study in Europe. Relief and its partner, NeuroRx anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020. The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks. RLF-100 is starting to get noticed by mainstream press including articles in Reuters, NyTimes and Fox News. According to the Reuters article “Relief Therapeutics sees 60-70% chance of COVID-19 drug approval” Relief Therapeutics’ chairman said he was optimistic its RLF-100 (Aviptadil) drug will win approval for treating COVID-19 patients in a matter of months.” Relief stock took off in the last week of July after the FDA granted expanded access protocol for treatment of Respiratory Failure in COVID-19 with RLF-100. Aviptadil is the first coronavirus therapeutic to demonstrate the ability to block replication of the virus in human lung cells and monocytes, while at the same time preventing synthesis of cytokines in the lungs. Microcapdaily covers Relief on the regular and first reported on the Company on August 3 as Relief was running northbound off its $0.05 base. We will be updating on Relief on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with Relief.

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Disclosure: we hold no position in Relief either long or short and we have not been compensated for this article.

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