Mondobiotech Holding AG (Basel) - RLFTF stock

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OTC Symbol: RLFTF | OTC Tier: OTCQB | Related ticker symbols: SW:RLF

Introduction

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.

Origin

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. The company went public in 2016 after a reverse merger with THERAMetrics Holding AG.

Registration Statement

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.

Company Operations

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.

Subsidiaries

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.

Pipeline

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.

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.

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.

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. Eton Pharmaceuticals acquired the rights to U.S. distribution with an initial payment of $2.2 million plus a potential $2.0 million based on milestones, and royalties on net sales.

Legal Issues

Lawsuits

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.