GENEVA, SWITZERLAND / ACCESSWIRE / September 15, 2020 / RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), a biopharmaceutical company with its lead compound RLF-100 (aviptadil) in advanced clinical development to treat severe COVID-19 patients, today announced its results for the half year ended June 30, 2020.
Operative Highlights Year to Date 2020:
RLF-100:
- US Phase IIb/III trial in severe COVID-19-induced Acute Respiratory Distress Syndrome ("ARDS") initiated; in July 2020, Data Safety Monitoring Board interim safety/futility analysis of 30 patients recommended study continue as planned. In August 2020, promising results reported from the first 21 patients treated with RLF-100 under FDA Expanded Access Protocol authorization. Topline results expected in early-4th quarter 2020.
- US Food and Drug Administration ("FDA") granted Emergency Use Investigational New Drug ("IND") authorization and Expanded Access Protocol authorization granted for treatment of respiratory failure in COVID-19.
- Fast track designation granted by FDA for acute lung injury/ARDS associated with COVID-19.
- FDA IND granted to test inhaled formulation in patients with moderate and severe COVID-19 to prevent progression to respiratory failure.
Corporate:
- Dr. Gilles Della Corte appointed Chief Medical Officer.
- Virtuoso Sarl, a strategic and tactical operational and trial delivery services firm, hired as Clinical Trials Manager to set up and run RLF-100 clinical trials in Europe.
- Relief successfully upgraded from US OTC Pink to OTCQB, meeting all qualifications.
- In July and August, the Company raised CHF 31,266,000 via its Share Subscription Facility.
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, commented: "With the onset of COVID-19, the Relief team immediately recognized that, based on its multimodal mechanism of action, RLF-100 has a high potential to become a life-saving treatment for severe COVID-19 patients with acute lung injury. We rapidly started clinical development in the US, and I am excited about the strong progress already made in the past few months to advance this important program. The Company is fully financed to successfully complete the two US COVID-19 trials underway and is now preparing for European trials with RLF-100."
Financial Highlights for the six months ended June 30, 2020:
- Cash and cash equivalents at June 30, 2020: TCHF 1,668. Relief subsequently raised funds from the Share Subscription Facility bringing the available cash balance to approximately TCHF 32,000 as of August 31, 2020.
- EBITDA for the six months ended June 30,2020 were a loss of TCHF 1,250 vs. a loss of TCHF 532 for the six months ended June 30, 2019.
- Profit/loss for the six months ended June 30,2020 were a gain of TCHF 8,251 vs. a loss of TCHF 556 for the six months ended June 30, 2019. The profit for the six months ended June 30, 2020 included a reversal of impairment losses on intangible assets of TCHF 11,200 as described below.
- Relief received funding through two loans executed in March and April 2020 with its main shareholder GEM for a total amount of TCHF 737.
- On April 1, 2020, Share Exchange Agreement concluded related to the sale of Relief Therapeutics SA between Sonnet Holdings and the Company. Sonnet Holdings paid to the Company shares of its common stock that converted into 757,933 shares of listed Sonnet Holdings common stock.
- During Q2 2020, the Group sold a total of 550,000 shares of Sonnet Holdings in various tranches at an average price of CHF 5.47 per share resulting in proceeds of TCHF 3,006.
- Reversal of RLF-100 impairment due to significant change in development plans in Q1 2020 resulted in a reversal of the impairment losses recognized in previous financial periods of TCHF 11,200.
Subsequent Events:
- In August, Relief raised TCHF 31,266 from drawdowns of its Share Subscription Facility. The Company believes it now has sufficient funds to finance its short-term operations, including completion of the two US Phase IIb/III clinical trials with RLF-100 in COVID-19 patients. Management will continue to pursue options to fund operations for the longer term.
- All outstanding debt due to GEM in the amount of TCHF 1,723 was converted into equity.
Further details are available in Relief's Half Year 2020 Report, which is available for download at https://relieftherapeutics.com/key-information/.
About Relief
Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100 (aviptadil), synthetic vasoactive intestinal peptide (VIP), is being investigated in two placebo-controlled US Phase IIb/III clinical trials in respiratory deficiency due to COVID-19. RLF-100 is believed to be 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 also 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.
Relief holds orphan drug designations from the U.S. FDA and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a U.S. patent (US8178489 formulation for aviptadil) for RLF-100 and proprietary manufacturing processes for its synthesis.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.
CONTACT
RELIEF THERAPEUTICS Holding SA
Raghuram (Ram) Selvaraju
Chairman of the Board
Mail: [email protected]
FOR MEDIA INQUIRES:
MC Services AG
Anne Hennecke / Brittney Sojeva
Mail: [email protected]
Tel.: +49 (0) 211-529-252-14
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
SOURCE: Relief Therapeutics Holdings AG via EQS Newswire