BrainStorm Cell Therapeutics Inc (BCLI)

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BrainStorm Cell Therapeutics Announces Full Year 2021 Financial Results and Provides a Corporate Update

https://finance.yahoo.com/news/brainstorm-cell-therapeutics-announces-full-110500773.html

BrainStorm continues to collect and leverage expert feedback as it pursues the optimal path forward to provide broad access to NurOwn® for patients with ALS

Announced the peer reviewed publication of the full analysis of the NurOwn Phase 3 trial in ALS showing greater treatment effects in participants with less advanced disease

Extended treatment period for NurOwn's Expanded Access Protocol authorized by the United States Food and Drug Administration

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, March 28, 2022 /PRNewswire/ -- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the financial results for the fiscal year ended December 31, 2021 and provided a corporate update.

"We began 2022 with strong momentum and Phase 3 data showing that NurOwn® appears to deliver meaningful clinical benefits to ALS patients with less advanced disease," said Chaim Lebovits, Chief Executive Officer. "These data have been validated through a manuscript reviewed and accepted by a prestigious peer-reviewed journal and feedback from key opinion leaders at numerous medical conferences. The insights gained from these interactions are invaluable as we pursue the optimal path forward to provide broad access to NurOwn for patients with ALS. We also took important steps to increase our manufacturing capacity and made key additions to our leadership team in preparation for anticipated growth and success. Looking ahead, we believe we are well positioned to execute on our clinical, regulatory, and corporate goals as we pursue NurOwn's continued advancement in ALS and progressive multiple sclerosis (PMS)."

Fourth Quarter 2021 and Recent Highlights

Full results from NurOwn's Phase 3 trial in ALS published in Muscle and Nerve. Although previously announced results showed the trial did not reach statistical significance on the primary or secondary endpoints, pre-specified and post hoc analyses featured in the publication show a treatment effect with NurOwn across both primary and secondary efficacy outcomes in patients with less advanced disease. Additionally, the publication links these clinical results to biomarker changes and confirmed treatment safety.

Analyses leveraging the validated ENCALS prediction model and the primary endpoint from NurOwn's Phase 3 trial in ALS presented at the 4th Annual ALS ONE Research Symposium. We showed that in participants with less advanced disease (i.e., those predicted to have long to very long survival) there were more responders with NurOwn compared to placebo (33% vs. 14%). The presentation was delivered by Jonathan S. Katz, MD, a co-principal investigator on the trial and Chair of the Neurology Department and Director of the Forbes Norris ALS Clinic at the California Pacific Medical Center.

In Q1 2022, presented genetic analyses from the NurOwn Phase 3 trial in ALS suggesting that NurOwn treatment may influence disease progression in patients who possess the UNC13A risk allele. The presentation was delivered in a late-breaking oral session at the 2022 MDA Clinical & Scientific Conference by Merit E. Cudkowicz, MD, MSc, Chief of Neurology at Massachusetts General Hospital, Julieanne Dorn Professor of Neurology at Harvard Medical School, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

Presented biomarker data from NurOwn's Phase 3 trial in ALS at the 32nd International Symposium on ALS/MND and at the 2021 Northeast Amyotrophic Lateral Sclerosis Consortium®. Collectively, these data show significant NurOwn-driven changes across a range of neural biomarkers and suggest the NurOwn's biological activity of NurOwn observed across multiple disease pathways could prove important to impacting the progression of ALS. They also provide an increased understanding of NurOwn's mechanism of action in ALS and additional evidence linking this mechanism of action to NurOwn's potential impact on ALS disease progression. The presentations were delivered by two principal investigators from the NurOwn Phase 3 trial: Robert H. Brown Jr., MD, Director of the Program in Neurotherapeutics at the University of Massachusetts Medical School, and James D. Berry, MD, MPH, Winthrop Family Scholar in ALS Sciences, Director of the Massachusetts General Hospital multidisciplinary ALS clinic and Chief of the Division of ALS and Motor Neuron Diseases.

Received authorization from the United States Food and Drug Administration (FDA) for an extension of the dosing period in NurOwn's Expanded Access Protocol (EAP). The Agency recommended that BrainStorm submit the protocol amendment that led to this authorization, which provides patients who completed the EAP with the opportunity to receive up to three additional doses of NurOwn.

Presented Phase 2 clinical trial data of NurOwn in progressive multiple sclerosis (MS) showing general tolerability, preliminary evidence of efficacy, a reduction in neuroinflammatory biomarkers in the cerebrospinal fluid (CSF), and an increase in neuroprotective biomarkers in the CSF at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The presentation was delivered by Jeffrey Cohen, MD, Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS and Principal Investigator in the NurOwn MS Phase 2 trial.

Finalized the technology transfer for NurOwn manufacturing at Catalent's world-class, 32,000 square-foot, cell-therapy facility in Houston, Texas.

Granted a new patent in Brazil covering methods of manufacturing NurOwn.

Delivered a presentation at the 2021 Cell & Gene Meeting on the Mesa highlighting the expansion of BrainStorm's technology portfolio to include autologous and allogeneic product candidates covering multiple neurological diseases.

Presented positive preclinical results at the NYSCF 2021 VIRTUAL Meeting. These results suggest that intrathecal administration of small extracellular vesicles (sEVs) isolated from mesenchymal stem cells that were induced to secrete increased levels of regenerative and immunoregulatory factors based on the NurOwn technology platform may have therapeutic potential in acute lung-related pathologies (e.g., acute respiratory distress syndrome).

Appointed Kim Thacker, MD, as Senior VP, Medical Affairs and Clinical Innovation and Sidney A. Spector, MD, PhD, as Senior VP, Global Strategy and Medical Affairs. Drs. Thacker and Spector are working together to create a formal global medical affairs function as the Company prepares for anticipated growth.

Expanded the responsibilities of Stacy Lindborg, PhD, with a promotion to the new position of Chief Development Officer.

Appointed Menghis Bairu, MD, to the Company's Board of Directors.

Presented a corporate and clinical overview at the 12th Annual California ALS Research Summit.