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EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Annual Results
Relief Reports 2020 Financial Results and Provides Business Update
Geneva, Switzerland, April 15, 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat COVID-19 induced lung injury, today announced its 2020 financial results for the year ended December 31, 2020 and provided a business update.
"The past year has been an incredibly productive and rewarding one for all of us at Relief," said Raghuram (Ram) Selvaraju, Chairman of the Board. "We have had an opportunity to make a true difference in fighting the ongoing COVID-19 pandemic with the development of RLF-100(TM) to treat critically ill patients. With the goal of bringing this potential treatment to patients as expeditiously as possible, we entered into important partnerships and made key hires, adding executives to our team who have strong expertise in important areas such as clinical development, regulatory and commercialization."
He continued: "Critical for the future growth of our Company, we also have taken a very important first step to broaden our development pipeline. We entered into a collaboration and license agreement for ACER-001, a compound in late-stage development for orphan diseases where patients are in need of better treatment options. We plan to continue to advance the development of our current programs and further grow our pipeline in the year ahead. I am excited about Relief's future as we work to provide patients with therapeutic relief in serious diseases with high unmet medical need."
Recent Key Development and Corporate Highlights:
Clinical Development Highlights (RLF-100)
Post reporting period
Jack Weinstein, Chief Financial Officer and Treasurer of Relief, commented: "Relief is not the same company it was a month ago, let alone a year ago. Through exercising flexible financing tools, which allows the Company to support ongoing clinical development of RLF-100, ACER-001 and its pipeline expansion strategy, we have developed a cash runway that will see us well into 2022. I remain excited about meeting the challenges of growing a biopharmaceutical company with a very bright future."
Outlook for 2021:
Relief expects to make continued progress with its development programs and in advancing its business in the months ahead.
Looking first to RLF-100 (IV), as our partner NeuroRx executes plans to file for EUA for the treatment of critically ill patients with COVID-19, followed by an NDA, Relief is preparing for clinical assessment and potential commercialization in Europe and other territories. Once Relief has received and analyzed the full data set from the U.S. phase 2b/3 trial, the Company will decide on the best path forward for the development of RLF-100 in Europe and other territories.
Turning to RLF-100 (inhaled), the acquisition of AdVita is expected to close in Q2 2021. Additionally, Relief is hopeful that its partner NeuroRx will have results from the ongoing U.S. phase 2b/3 trial evaluating inhaled RLF-100 in H2 2021.
Our second late-stage program in collaboration with Acer Therapeutics for ACER-001 is expected to progress quickly in 2021. A pre-NDA meeting is scheduled to occur between Acer and the FDA in Q2 2021 to discuss the results of the clinical study of ACER-001 in UCDs. Provided no additional data are requested by FDA during the meeting and ongoing development activities are successfully completed, Acer expects to submit a 505(b)(2) NDA for ACER-001 for the treatment of UCDs in mid-2021, with a potential regulatory decision in H1 2022. Relief plans to initiate discussions with European regulatory authorities regarding ACER-001 in UCDs in Q3 2021. Clinical studies in MSUD could start later in 2021.
Relief plans to continue its strategy to aggressively pursue opportunities to expand its pipeline with attractive late-stage clinical assets that would drive the evolution of the Company into a mature, diversified biopharmaceutical company.
Adding expertise by hiring personnel and consultants will continue in an effort to match the Company's pace of development.
Throughout 2021 Relief will continue to evaluate and take steps to facilitate interest from institutional investors. In addition, the Company expects to "up list" to a major U.S. stock exchange in the coming months.
Relief's 2020 Annual Report is available for download at https://relieftherapeutics.com/investor-relations.
ABOUT RELIEF THERAPEUTICS HOLDING AG
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
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RELIEF THERAPEUTICS Holdings AG
Avenue de Sécheron 15
SIX Swiss Exchange
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