Mondobiotech Holding AG (Basel) - RLFTF stock
OTC Symbol: RLFTF | OTC Tier: OTCQB | Related ticker symbols: SW:RLF
Introduction[edit]
Relief Therapeutics Holding AG (OTC:RLFTF, SW:RLF), is a biopharmaceutical company based in Switzerland. The company is engaged in the discovery and development of top products for the treatment of unique and abandoned diseases. It provides patients with therapeutic relief from serious diseases with high unmet medical needs and develops treatments for respiratory infections. The firm focuses on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical use and either initial human activity with efficacy data or a strong scientific rationale. The company offers its services in Switzerland, the rest of Europe, South America, and internationally. Relief has RLF-100 (aviptadil) as its leading compound. RLF-100 is a synthetic human vasoactive intestinal peptide (VIP) with a multifaceted mode of action in respiratory indications. The product is used for pulmonary sarcoidosis as well. Relief shares are quoted on the U.S. OTCQB Venture Market under the symbol RLFTF.[1]
Origin[edit]
RELIEF THERAPEUTICS Holding AG was founded by three ex-Merck employees (Serono division) in 2014. The three had a goal to develop atexakin alfal. Atexakin alfal is a human recombinant version of interleukin-6, employed in the treatment of peripheral neuropathy.[2] The company went public in 2016 after a reverse merger with THERAMetrics Holding AG. [3]
Company Operations[edit]
The company conducts research and develops product candidates using known peptides and other immune-modulated materials for the treatment of rare and neglected diseases. Its stream of products is tailored to counter numerous indications including Chronic Beryllium Disease, Acute Respiratory Distress Syndrome, Methicillin-Resistant, Pulmonary Arterial Hypertension, and Idiopathic Pulmonary Fibrosis, among others. Mondobiotech operates through project and development services segments.
The project segment licenses out different stages of development projects related to the company for the treatment of rare diseases. The company’s development services provide further clinical development services specifically on request to partners in close connection with the licensing-out agreement.[4]
Subsidiaries[edit]
Relief therapeutics has a thread of subsidiaries including APR Applied Pharma Research S.A., Siena Biotech S.p.A., AdVita Lifescience GmbH, THERAMetrics Discovery AG, Interferon Medical Use SA, Mondobiotech Ag, and others. Acquired in June 2021, APR Applied Pharma Research S.A. commands more than 25 years of experience in discovering, developing, and commercializing manufactured known molecules. The company also boasts an extreme knowledge of the global drug delivery system. The acquisition not only opened doors to Relief’s clinical-stage programs and commercial products but also availed commercial infrastructure for its future product launches.[5]
Pipeline[edit]
RLF-100 is the company’s lead compound. Since the spring of COVID-19, the company has channeled a significant chunk of resources into developing a version of RLF-100 used for the treatment of COVID-19-induced severe lung injury and pulmonary sarcoidosis. The company is also conducting operations on clinical RLF-100, still in the incubation stage, for other indications in acute and chronic lung diseases.[6]
The company has rights to develop and commercialize ACER-001, a proprietary powder formulation of sodium phenylbutyrate (NaPB). The product is designed for the treatment of Maple Syrup Urine Disease and Urea Cycle Disorders, two rare and sapping diseases. It is also used to cure various inborn errors of metabolism.[7]
The firm’s acquisition of APR Applied Pharma Research S.A. increased its product portfolio with the addition of commercial Golike, for the treatment of phenylketonuria (PKU), and APR TD-011 for the treatment of epidermolysis bullosa (EB). APR TD-011 is a clinical-stage development with forecasted positive upside in the industry.[6]
Critical News[edit]
On June 28, 2022, Acer Therapeutics Inc. and Relief made public the U.S. Food and Drug Administration’s (FDA) acceptance for review of Acer’s resubmitted New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs). FDA’s Prescription Drug User Fee Act (PDUFA) target for the drug is scheduled for January 15, 2023.[8]
The company, on July 21, 2022, released a press statement to notify the public that the U.S. Securities and Exchange Commission (SEC) had declared effective its Registration Statement on Form 20-F. The effectiveness of the registration statement makes the firm a reporting company under the Securities Exchange Act of 1934, as amended. Relief kicked off the move with the aim of listing its ADRs on the NASDAQ Stock Market. The company also expressed its intention to file its application for the listing process in the forthcoming weeks.[9]
Management Team[edit]
The company’s management team[10] ensures an organized internal structure and maintains a chain of collaboration with contract research organizations, contract manufacturers, external distributors, contract sales forces, national clinical networks, and relevant international experts.
- Jack Weinstein, Chief Financial Officer, and Treasurer
-
- holds an MBA from Harvard University
- over 40 years of executive management expertise in investment banking and consulting in the biopharmaceutical and life sciences industries
- extensive experience in corporate finance, business development as well as FDA regulatory and intellectual property strategies
- previously extensive experience in corporate finance, business development as well as FDA regulatory and intellectual property strategies
- Anthony Kim, Senior Vice President and Head of U.S. Commercial Operations
-
- Joined Relief team in November 2021
- holds a B.A. from Harvard University and an MBA from The Wharton School
- a highly-experienced pharmaceutical executive with a successful track record
- former Vice President, Global Commercial Development at Novocure
- Paolo Galfetti, President, Relief Europe
-
- over 20 years of management experience in the pharmaceutical sector
- joined APR Applied Pharma Research SA in 1995 as head of licensing and business development and was appointed CEO in 2002
- he is a Chartered Financial Analyst (CFA) and has a bachelor’s degree in economics from the Commercial University Bocconi, Milan
- Nermeen Varawalla, MD, Ph.D., Chief Medical Officer
-
- over 30 years of international experience in clinical development, regulatory matters, and medical affairs within the pharmaceutical sector
- previously Chief Medical Officer and Head of Clinical Development for Atlantic Healthcare plc
- received both her MBBS, Bachelor of Medicine and Surgery, and MD degree from the University of Mumbai; her Ph.D. and the designation as a Rhodes Research Fellow from the University of Oxford and her MBA from INSEAD.
- Raghuram (Ram) Selvaraju, Ph.D., M.B.A., Chairman of the Board
-
- holds an M.B.A. from the Cornell University
- earned his Ph.D. in cellular immunology and molecular neuroscience and an M.S. in molecular biology from the University of Geneva
- a Managing Director of Equity Research at H.C. Wainwright
- over 15 years of experience on Wall Street
- held Senior Research positions at MLV & Co., Aegis Capital, Hapoalim Securities U.S.A., and Rodman & Renshaw LLC before joining Relief
Legal Issues[edit]
Lawsuits[edit]
On January 12, 2021, Relief reported that NeuroRx, Inc., its collaboration partner for aviptadil, had slapped the company with a lawsuit in the Supreme Court of the State of New York. NeuroRx sued Relief for breach of the collaboration agreement between the parties. NeuroRx filed for cancellation of the collaboration agreement and defamation. Relief, however, made it clear that the underlying agreement was still in force, and that it was NeuroRx and not Relief, that was in breach of the agreement.[11]
Company Environmental, Social, and Governance (ESG)[edit]
Relief has a documented vision and values that guide its operations in each environment[12]. Key highlights include:
- customers’ orders must be swiftly and accurately serviced
- employees’ must be treated with dignity, their merits recognized, given job security, adequately compensated, and provided with clean working environments
- the company must be responsible to the communities in which it operates and the world community by supporting good works and charities and advancing its fair spoil in taxes
- the company is also obligated to generate significant profits for shareholders
- ↑ Cnbc.com/quotes/RLFTF -CNBC News. Retrieved 7/28/2022
- ↑ Relief Therapeutic/Company - Relief Holdings Website.
- ↑ When did Relief go public? Relief Therapeutics Investor Relations. Retrieved on 8/14/2022.
- ↑ Mondobiotech Holding AG – Financial and Strategic Analysis and Review, Page 4. – yumpu.com. Retrieved 7/29/2022.
- ↑ The APR acquisition is transforming Relief into a fully integrated and diversified biopharmaceutical business - Realtherapeutics/apr
- ↑ 6.0 6.1 About the company – Real Therapeutic Holdings official website.
- ↑ Pipeline - Real Therapeutic Holdings official website.
- ↑ Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Review of NDA Resubmission for ACER-001 for Treatment of UCDs – Yahoo Finance. Retrieved on 7/30/2021
- ↑ Relief Therapeutics Announces Effectiveness of Registration Statement on Form 20-F - Markets.FinancialContent. Retreaved 7/30/2021
- ↑ Relief Management Team - Real Therapeutic Holdings official website
- ↑ Relief Comments on Lawsuit Filed Against It by NeuroRx – Releaf Newsblog. Accessed 7/30/2022
- ↑ Relief Therapeutics Code of Business Conduct and Ethics, Page 3 and 4 – company website. Retrieved 7/30/2022
