NEW YORK - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a developer of adult stem cell therapies for neurodegenerative diseases, has named Hartoun Hartounian Ph.D. its new Executive Vice President and Chief Operating Officer as of Monday.
Hartounian, with over three decades of biopharmaceutical industry experience, will oversee the company’s operations, focusing on the commercial readiness of its therapeutic platforms, including NurOwn® for amyotrophic lateral sclerosis (ALS).
The new COO's extensive background includes founding BioCentriq, a cell and gene therapy CDMO facility, and leading it to a $73 million acquisition in 2022. He has also been instrumental in the growth of four biotechnology companies. He has held various CEO roles, demonstrating a strong ability to achieve aggressive goals in both large and startup settings.
Hartounian holds a Ph.D. in chemical engineering and has served as faculty at the New Jersey Institute of Technology and Columbia University.
Chaim Lebovits, President and CEO of BrainStorm, expressed confidence in Hartounian’s expertise to navigate the company through the complexities of CMC and commercialization. Hartounian himself is eager to leverage his experience to advance the company’s innovative therapies, particularly as the company approaches the registrational Phase 3b study of NurOwn®.
BrainStorm Cell Therapeutics is known for its work on NurOwn®, a technology platform used to produce autologous MSC-NTF cells, which has received Orphan Drug designation from the FDA and EMA for the treatment of ALS. The company has completed a Phase 3 trial in ALS and a Phase 2 trial in progressive MS, supported by grants from the California Institute for Regenerative Medicine and the National MS Society, respectively.
This article is based on a press release statement from BrainStorm Cell Therapeutics.
In other recent news, BrainStorm Cell Therapeutics has successfully regained compliance with the Nasdaq's minimum market value requirement, addressing concerns that could have led to potential delisting.
The company has also announced the publication of Phase 3 biomarker data, indicating that their investigational cell therapy, NurOwn, may influence key biomarkers related to amyotrophic lateral sclerosis (ALS). The research revealed three biomarkers predictive of clinical outcomes in participants treated with debamestrocel: NfL, LAP/TGFb1, and Galectin-1.
In another development, the U.S. Food and Drug Administration (FDA) has proposed designing a Phase 3b trial for NurOwn® in ALS patients. This agreement, achieved through a Special Protocol Assessment (SPA), solidifies the clinical trial protocol and statistical analysis plan, aiming to bolster a future Biologics License Application (BLA).
The Phase 3b trial, Study BCT-006-US, will evaluate NurOwn's efficacy and safety in ALS patients, targeting up to 200 individuals early in their disease progression.
BrainStorm plans to start the Phase 3b study in 2024, following protocol reviews with investigators, Institutional Review Board approvals, and engagement with the ALS community. These are recent developments in the company's ongoing efforts to develop potential treatments for neurodegenerative diseases.
InvestingPro Insights
As BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) welcomes Hartounian as the new Executive Vice President and Chief Operating Officer, the company's financial health and market performance provide a backdrop to the strategic challenges and opportunities ahead. According to InvestingPro data, the company's market capitalization stands at a modest $28.04 million, reflecting its status as a smaller player in the biopharmaceutical industry. The financial metrics paint a picture of a company that is not currently profitable, with a negative P/E ratio of -1.8 for the last twelve months as of Q1 2024, and an EBITDA of -$18.5 million, despite a growth of 23.62% in the same period.
InvestingPro Tips indicate that BrainStorm Cell Therapeutics is quickly burning through cash, with short-term obligations exceeding its liquid assets. Analysts are not optimistic about the company turning a profit this year, as evidenced by the stock's significant hit over the last week and month, with a price total return of -9.68% and -29.44% respectively. Nevertheless, the stock has seen a large price uptick over the last six months, with a total return of 106.13%, suggesting some investor optimism about the company's future prospects.
Investors following BrainStorm Cell Therapeutics may want to consider these financial metrics and market performance as they assess the company's potential to navigate the commercialization of its therapies. For those looking for deeper analysis, InvestingPro offers additional insights, with a total of 11 InvestingPro Tips available for BCLI at https://www.investing.com/pro/BCLI. To access these valuable insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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