Biophytis Sa Stock Price, News & Analysis

Biophytis SA (BPTSY) is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. The company describes its lead product, BIO101 (20-hydroxyecdysone), as a small molecule in development across several therapeutic areas, notably muscular, respiratory, metabolic, and neuromuscular diseases. Biophytis is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. Its ordinary shares trade on Euronext Growth Paris under the symbol ALBPS, and its American Depositary Shares (ADS) trade on the OTC market under the symbol BPTSY.

Across multiple company communications, Biophytis characterizes itself as specializing in the development of treatments for conditions linked to aging, such as sarcopenia, obesity, Duchenne muscular dystrophy, COVID-19–related respiratory disease, and amyotrophic lateral sclerosis (ALS). The company positions BIO101 at the center of this strategy, advancing it through different clinical phases depending on the indication.

Core therapeutic focus and BIO101 pipeline

Biophytis reports that BIO101 (20-hydroxyecdysone) is its lead drug candidate and that it is in development for several indications:

• Muscular diseases: Biophytis states that BIO101 is in development for sarcopenia, with a Phase 3 program described as "Phase 3 ready to start." The company also cites development plans in Duchenne muscular dystrophy, where a Phase 1–2 program is described as "to be started."
• Metabolic disorders: The company highlights obesity as a key area, with a Phase 2 program for BIO101 described as "to be started" or "Phase 2 ready to start" in obesity. Biophytis emphasizes patients with obesity treated with GLP‑1 receptor agonists as a high-value subpopulation.
• Respiratory diseases: Biophytis indicates that BIO101 has been developed in COVID‑19, with a Phase 2–3 program described as completed.
• Rare neuromuscular diseases: Through a co-development agreement with AskHelpU, Biophytis states that BIO101 will be evaluated in amyotrophic lateral sclerosis (ALS), with the possibility of progressing to larger-scale clinical phases if initial results are promising.

In its communications, the company repeatedly refers to itself as a clinical-stage biotechnology company, underscoring that its programs are in clinical and preclinical development rather than commercialized stages.

Focus on muscle function, mobility, and obesity

Biophytis devotes significant attention to the intersection of obesity, muscle strength, and mobility. The company notes that many patients with obesity experience muscle strength impairment, and it highlights preclinical and early clinical findings where BIO101, alone or in combination with GLP‑1 receptor agonists, was associated with protection or improvement of muscle strength and mobility in animal models and in certain patient cohorts.

In several press releases, Biophytis presents BIO101 as being developed in combination with GLP‑1 therapies for patients with obesity, with the stated aim of reducing muscle strength loss associated with GLP‑1 treatment and improving functional mobility. The company describes this as addressing an unmet medical need related to the "quality" of weight loss, emphasizing preservation of muscle mass and mobility rather than weight reduction alone.

Sarcopenia and age-related muscle loss

Biophytis describes sarcopenia as a major public health issue and reports that it has conducted a Phase 2 clinical trial, SARA‑INT, in this indication. According to the company, SARA‑INT evaluated BIO101 in sarcopenic patients and generated data that supported a Phase 3 program described as ready to start. Biophytis also notes that results from SARA‑INT were published in the Journal of Cachexia, Sarcopenia and Muscle, which it characterizes as a key reference journal for sarcopenia research.

The company states that no therapeutic solution exists today for treating sarcopenia and that it considers itself highly advanced in this indication with BIO101. It also references plans to launch a Phase 3 SARA clinical program aimed at confirming the efficacy of BIO101 in sarcopenia.

Geographic footprint and partnerships

Biophytis reports that it is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The company’s communications highlight a partnership-oriented business model, mentioning:

• A strategic licensing agreement with Blanver related to obesity development in Latin America.
• Exclusive negotiations with a Chinese pharmaceutical company to co-develop and commercialize BIO101 in China for viral respiratory infections, sarcopenia, and obesity.
• A co-development agreement with AskHelpU in China to evaluate BIO101 in ALS.
• Public funding and agreements with clinical partners in Brazil for an obesity Phase 2 trial, as referenced in a Form 6‑K filing.

These disclosures indicate that Biophytis seeks to advance BIO101 through regional collaborations in the Americas, Europe, and Asia for its main indications.

Regulatory and clinical development milestones

Biophytis has reported several regulatory and clinical milestones for BIO101:

• FDA Investigational New Drug (IND) clearance for the OBA obesity program, which the company describes as a major milestone enabling the planned Phase 2 clinical study in obesity.
• Completion of a Phase 2–3 COVID‑19 program, as referenced in multiple company descriptions.
• Publication of SARA‑INT Phase 2 results in sarcopenia and confirmation that a Phase 3 program is ready to start.
• Ongoing preparations to initiate a Phase 2 OBA study in obesity, focusing on patients treated with GLP‑1 receptor agonists.

Through its Form 6‑K filings, Biophytis also reports on interim financial information and shareholder meetings, indicating continued reporting as a foreign private issuer under the Securities Exchange Act of 1934.

Stock listing and reporting status

Biophytis states that its ordinary shares are listed on Euronext Growth Paris under the symbol ALBPS and that its American Depositary Shares trade on the OTC market under the symbol BPTSY. The SEC filings provided are on Form 6‑K, which are current reports used by foreign private issuers to furnish information such as press releases, interim financial reports, and other material updates.

The available filings do not include forms indicating delisting or deregistration, such as Form 25 or Form 15‑12G, and the company continues to file Form 6‑K reports for corporate and financial updates.

Positioning within biotechnology and age-related diseases

Throughout its communications, Biophytis consistently describes itself as a clinical-stage biotechnology company that focuses on age-related diseases. These include conditions associated with aging populations, such as sarcopenia and obesity, as well as age-linked or chronic respiratory and neuromuscular diseases. The company emphasizes muscle function, mobility, and the impact of obesity treatments on muscle mass as central themes in its development strategy for BIO101.

FAQs about Biophytis SA (BPTSY)

• What does Biophytis SA do?
  

  Biophytis SA describes itself as a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. Its lead candidate, BIO101 (20-hydroxyecdysone), is being developed for muscular, respiratory, metabolic, and neuromuscular indications.

• What is BIO101?
  

  According to the company, BIO101 (20-hydroxyecdysone) is a small-molecule drug candidate. Biophytis reports that BIO101 is in development for sarcopenia, Duchenne muscular dystrophy, COVID‑19–related respiratory disease, obesity, and ALS, with different clinical phases depending on the indication.

• Which diseases is Biophytis targeting with BIO101?
  

  Biophytis states that BIO101 is being developed for muscular diseases such as sarcopenia and Duchenne muscular dystrophy, respiratory diseases such as COVID‑19, metabolic disorders such as obesity, and rare neuromuscular diseases such as ALS.

• How is Biophytis involved in obesity treatment?
  

  The company reports that BIO101 is being developed in obesity, including in combination with GLP‑1 receptor agonists. Biophytis highlights preclinical and early clinical data suggesting effects on muscle strength and mobility in patients with obesity and describes a planned Phase 2 OBA clinical study in this population.

• What is Biophytis doing in sarcopenia?
  

  Biophytis indicates that it has completed the SARA‑INT Phase 2 clinical trial of BIO101 in sarcopenia and that the results have been published in a specialized journal. The company describes its Phase 3 sarcopenia program as ready to start and notes that no approved therapeutic solution exists for sarcopenia.

• Where is Biophytis based?
  

  Biophytis reports that it is headquartered in Paris, France, and that it has subsidiaries in Cambridge, Massachusetts, USA, and Brazil.

• On which markets are Biophytis shares traded?
  

  The company states that its ordinary shares are listed on Euronext Growth Paris under the symbol ALBPS and that its American Depositary Shares trade on the OTC market under the symbol BPTSY.

• What partnerships has Biophytis announced?
  

  Biophytis has announced a strategic licensing agreement with Blanver, exclusive negotiations with a Chinese pharmaceutical company regarding BIO101 in China, and a co-development agreement with AskHelpU in ALS. It has also reported public funding and clinical partnerships in Brazil for an obesity Phase 2 trial.

• What regulatory milestones has Biophytis reported?
  

  The company reports receiving FDA IND clearance for its OBA obesity program, completing a Phase 2–3 COVID‑19 program, and preparing Phase 2 and Phase 3 studies for obesity and sarcopenia, respectively. These milestones are described in its press releases and Form 6‑K filings.

• Is Biophytis a commercial-stage or clinical-stage company?
  

  Biophytis repeatedly describes itself as a clinical-stage biotechnology company, indicating that its drug candidates, including BIO101, are in clinical and preclinical development rather than being marketed products.