BrainStorm Cell Therapeutics’ ALS Treatment Fails to Win FDA Approval

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BRAINSTORM ($NASDAQ:BCLI): BrainStorm Cell Therapeutics is a biotech company that focuses on cellular therapies. The company announced Thursday that the FDA did not accept its New Biologics License Application for NurOwn as a treatment for amyotrophic lateral sclerosis, a rare neurological disease. The FDA issued a so-called refusal to file letter, which means that the regulator has indicated that BrainStorm could request a Type A meeting to discuss its contents. “The company intends to request a Type A meeting and looks forward to continued discussions with the FDA,” Chief Executive Chaim Lebovits said in a statement.

BrainStorm is hopeful that it can convince the FDA to change its decision and that NurOwn will eventually be approved as a treatment for ALS. The company will continue to work with the FDA in order to make this happen.

Stock Price

The FDA’s rejection of BrainStorm Cell Therapeutics’ ALS treatment came as a blow to the company and its shareholders. On Thursday, BrainStorm Cell Therapeutics’ stock opened at $1.2 and closed at $1.7, a 42.2% plunge from its previous closing price of $2.9. The FDA’s decision means that the company will have to go back to the drawing board if it wants to bring its treatment to market. This is a major setback for BrainStorm Cell Therapeutics and its shareholders.

VI Analysis

The company’s fundamentals reflect its long term potential. The company is classified as ‘elephant’ according to VI Star Chart. The company has a low health score of 3/10 with regard to its cashflows and debt, which means it is less likely to pay off debt and fund future operations.

However, the company is strong in asset, and weak in dividend, growth, profitability. Such company may be interesting for investors who are looking for a company with long term potential and strong asset base.

VI Peers

The competition in the cell therapy market is heating up as more and more companies are vying for a piece of the pie. Among the major players are Brainstorm Cell Therapeutics Inc, TCR2 Therapeutics Inc, Adicet Bio Inc, and Iovance Biotherapeutics Inc. All of these companies are working on cutting-edge cell therapies that have the potential to change the way we treat diseases.

– TCR2 Therapeutics Inc ($NASDAQ:TCRR)

TCR2 Therapeutics Inc is a clinical-stage immuno-oncology company, which focuses on the development of novel T cell therapies for the treatment of cancer. The company has a market cap of $54.51M and a ROE of -24.78%. TCR2 is developing two novel T cell therapies, which are designed to target different types of cancer. The first therapy, which is in clinical trials, targets solid tumors, while the second therapy is in preclinical development and targets blood cancers.

– Adicet Bio Inc ($NASDAQ:ACET)

Adicet Bio Inc is a clinical-stage biopharmaceutical company focused on the development of immune cell therapies for cancer and other diseases. The company’s most advanced product candidate is a T cell therapy for solid tumors, which is currently in a Phase 1/2 clinical trial. The company has a market cap of $871.6M as of 2022 and a Return on Equity of -11.39%.

– Iovance Biotherapeutics Inc ($NASDAQ:IOVA)

Iovance Biotherapeutics Inc is a late-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products based on tumor-infiltrating lymphocyte (TIL) technology.

The company’s lead product candidate, lifileucel, is a TIL therapy that is in Phase III clinical trials for the treatment of metastatic melanoma and recurrent or metastatic squamous cell carcinoma of the head and neck. Iovance is also evaluating lifileucel in a Phase II clinical trial for the treatment of cervical cancer.

Iovance has a market cap of 1.19B as of 2022. The company’s Return on Equity is -56.45%.

Summary

Investing in BrainStorm Cell Therapeutics is a risky proposition. The company’s primary product, NurOwn, is currently in clinical trials for the treatment of ALS, and the FDA has not yet approved it. The company’s stock price is highly volatile and could drop significantly if NurOwn fails to win FDA approval. However, if NurOwn is approved, BrainStorm Cell Therapeutics could see a significant increase in its stock price.