BrainStorm Cell Therapeutics Inc (BCLI)

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BrainStorm Cell Therapeutics Announces First Quarter 2022 Financial Results and Provides a Corporate Update

https://finance.yahoo.com/news/brainstorm-cell-therapeutics-announces-first-110500315.html

BrainStorm continues to gain insights and perspectives from leading ALS experts as it seeks the optimal path forward to provide broad patient access to NurOwn®

Strengthened executive team in preparation for anticipated growth and corporate development, with the appointment of Netta Blondheim-Shraga, PhD, as VP of Research & Development and Antal Pearl-Lendner, Avd, as Chief Legal Counsel

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

NEW YORK, May 16, 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 first quarter ended March 31, 2022 and provided a corporate update.

"We remain firmly committed to addressing the urgent needs of ALS patients by working expeditiously towards our goal of enabling broad access to NurOwn®," said Chaim Lebovits, Chief Executive Officer. "Our efforts here are bolstered by peer-reviewed Phase 3 data that provide evidence of NurOwn's greater treatment effects for ALS patients with less advanced disease, and by our ongoing interactions with the broader physician and patient community. These have allowed us to gain valuable perspective from the world's most prominent thought leaders as we seek NurOwn's optimal path forward. Looking ahead, we will continue to leverage expert feedback as we work with the regulatory authorities to enable NurOwn's advancement. We believe our strong clinical and biomarker data and highly talented leadership team has us poised for sustained success."

First Quarter 2022 and Recent Highlights

Biomarker analyses from NurOwn's Phase 3 trial in ALS were presented by James 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, in an abstract at the American Academy of Neurology 2022 Virtual Congress. These results demonstrated significant changes across multiple cerebrospinal fluid biomarkers following NurOwn treatment, with the strongest effects observed in biomarkers related to neuroprotection and neuroinflammation.

Presented a prospective genetic analyses from NurOwn's Phase 3 ALS trial suggesting that NurOwn treatment may influence disease progression in patients carrying the ALS UNC13A risk allele. The presentation was featured in a late-breaking oral session at the 2022 Muscular Dystrophy and Association (Clinical & Scientific Conference) and delivered by Merit E. Cudkowicz, MD, MSc, Chief of Neurology at Massachusetts General Hospital, Julieanne Dorn Professor of Neurology at Harvard Medical School, and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

Presented preclinical data demonstrating greater macrophage immunomodulation of NurOwn-derived exosomes (Exo MSC-NTF) compared to naïve mesenchymal stem cell-derived exosomes (Exo MSC) against acute lung injury at the International Society of Cell & Gene Therapy (ISCT) 2022 Meeting. The presentation was delivered by Dr. Kim Thacker, Senior Vice President, Medical Affairs and Clinical Innovation, BrainStorm Cell Therapeutics.

Announced upcoming presentations at the ALS Drug Development Summit (May 25, 2022) and the ISEV 2022 Annual Meeting (May 26, 2022). The ALS Drug Development Summit presentation by Ralph Kern MD MHSc, President and Chief Medical Officer Brainstorm Cell Therapeutics, will focus on the use of cerebrospinal fluid biomarkers to interrogate multiple neuroinflammatory, neurodegenerative and neuroprotection pathways in NurOwn's Phase 3 ALS trial and how this information may be leveraged to confirm ALS target engagement and improve therapeutic outcomes. The ISEV presentation features the results of a preclinical study examining the advantages of Exo MSC-NTF over Exo MSC in models of acute lung injury and will be presented by Haggai Kaspi PhD, Brainstorm R&D.

Strengthened the Company's executive team in preparation for anticipated growth and corporate development, with the appointments of Netta Blondheim-Shraga, PhD, as VP of Research & Development and Antal Pearl-Lendner, Adv, as Chief Legal Counsel.

Granted a new Brazilian patent covering methods of manufacturing NurOwn titled - A method of generating cells which secrete Brain Derived Neurotrophic Factor (BDNF), Glial Derived Neurotrophic Factor (GDNF), Hepatocyte Growth Factor (HGF) And Vascular Endothelial Growth Factor (VEGF), wherein said cells do not Secrete Nerve Growth Factor (NGF).

Presented a corporate and Phase 3 ALS clinical overview at the 12th Annual California ALS Research Summit on January 27, 2022 by Ralph Kern MD MHSc, President and Chief Medical Officer Brainstorm Cell Therapeutics.

Financial Results for the First Quarter Ended March 31, 2022

Cash, cash equivalents, and short-term bank deposits were approximately $18.4 million as of March 31, 2022, compared to $22.1 million as of December 31, 2021.

Research and development expenses for the three months ended March 31, 2022, and 2021 were approximately $2.6 million and $4.3 million, respectively.

General and administrative expenses for the three months ended March 31, 2022, and 2021 were approximately $2.9 million and $2.6 million, respectively.

Net loss for the three months ended March 31, 2022, was approximately $5.4 million, as compared to a net loss of approximately $6.7 million for the three months ended March 31, 2021.

Net loss per share for the three months ended March 31, 2022, and 2021 was $0.15 and $0.19 respectively.

Conference Call and Webcast

May 16, 2022, at 8:00 a.m. Eastern Time

Participant Numbers:

Toll Free:

888-506-0062

International:

973-528-0011

Entry Code:

476792

Webcast URL:

https://www.webcaster4.com/Webcast/Page/2354/45459

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Toll Free:

877-481-4010

International:

919-882-2331

Replay Passcode:

45459