BrainStorm Cell Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update
Company received written agreement from the
Conference call planned for later this quarter to provide update on NurOwn program
"We recently achieved an important milestone on our Debamestrocel (NurOwn®) development program, reaching agreement with the
First Quarter 2024 and Recent Highlights
Clinical and regulatory
- In
April 2024 , BrainStorm received written agreement from theU.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). The SPA agreement validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS. BrainStorm anticipates initiating the Phase 3b study in 2024, after reviewing the protocol with investigators, securing study siteInstitutional Review Board approvals, and engaging with appropriate members of the ALS community. - In
April 2024 , Phase 3 biomarker data on NurOwn in ALS were published in Muscle and Nerve in a paper entitled "Debamestrocel multimodal effects on biomarker pathways in amyotrophic lateral sclerosis are linked to clinical outcomes". The published data show that NurOwn treatment resulted in a positive impact on important CSF biomarkers relevant to ALS compared to placebo. Significant changes in multiple ALS disease pathways support NurOwn's mechanism of action and complement the clinical effects observed in ALS. - Brainstorm's proposed design for the planned Phase 3b trial of NurOwn ALS was presented in a poster at the
MDA Clinical and Scientific Conference in March, 2024. The design is for a two-part, multicenter, Phase 3b study to assess the efficacy and safety of NurOwn in participants with ALS. The entry criteria will enroll people living with mild-to-moderate ALS. The primary endpoint will be based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).
Corporate
- In
April 2024 , promoted Dr. Bob Dagher to Executive Vice President and Chief Medical Officer.Dr. Dagher has over 20 years' of experience in clinical research and development, with a proven track record of leading successful clinical trials and fostering innovation in drug development. In addition, after four years of maintaining top executive roles, Dr. Stacy Lindborg is stepping down [or has stepped down?] from the role of Co-CEO and will remain with BrainStorm as a member of its Board of Directors. These strategic management changes are being made as the Company prepares to embark on the registrational Phase 3b trial for NurOwn®.
Upcoming Event – ALS Drug Development Summit
- BrainStorm will participate in the forthcoming 3rd Annual ALS Drug Development Summit, to take place
May 21 to 23, 2024 in Boston MA. Dr.Stacy Lindborg will deliver a presentation Promising Longer-Term Biomarker Data from NurOwn Program in ALS: Spotlight on NfL in EAP Extension Cohort. The new data to be presented suggest that patients may benefit from longer term treatment with NurOwn, as evidenced by changes in neurofilament light (NfL), an important biomarker associated with clinical outcomes in ALS. Other members of BrainStorm's team,Antonio Trejo , VP of Regulatory Affairs;Mary Kay Turner Senior Vice President, Global Patient Advocacy & Public Affairs; andKylan Morris , Senior Manager,Patient Advocacy will take part in a workshop and panel at the Summit.
Financial Results for the First Quarter Ended
- Cash, cash equivalents, and restricted cash amounted to approximately
$1.0 million , as ofMarch 31, 2024 . - Research and development expenses, net, in the first quarter ended
March 31, 2024 were approximately$1.0 million , compared to$2.9 million for the quarter endedMarch 31, 2023 . - General and administrative expenses for the first quarters ended
March 31, 2024 and 2023 were$1.5 million and$2.2 million , respectively. - Net loss for the first quarter ended
March 31, 2024 was$3.4 million as compared to a net loss of$5.1 million for the quarter endedMarch 31, 2023 . - Net loss per share for the quarter ended
March 31, 2024 andMarch 31, 2023 was$0.05 and$0.14 , respectively.
Conference Call and Webcast
BrainStorm management will host a conference call for the investment community later in the second quarter to provide update on the NurOwn program. Details on the conference call will be provided when available.
About
Notice Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the
CONTACTS
Phone: +1 646-597-6983
mwood@lifesciadvisors.com
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
(Except share data)
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2024 |
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2023 |
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Unaudited |
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Audited |
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U.S. $ in thousands |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
779 |
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$ |
1,300 |
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Other accounts receivable |
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26 |
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51 |
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Prepaid expenses and other current assets (Note 4) |
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454 |
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548 |
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Total current assets |
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$ |
1,259 |
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$ |
1,899 |
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Long-Term Assets: |
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Prepaid expenses and other long-term assets |
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$ |
20 |
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$ |
22 |
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Restricted Cash |
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182 |
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185 |
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Operating lease right of use asset (Note 5) |
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1,265 |
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1,416 |
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Property and Equipment, Net |
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622 |
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686 |
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Total Long-Term Assets |
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$ |
2,089 |
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$ |
2,309 |
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Total assets |
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$ |
3,348 |
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$ |
4,208 |
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LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
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Current Liabilities: |
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Accounts payables |
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$ |
4,690 |
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$ |
4,954 |
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Accrued expenses |
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636 |
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1,240 |
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Operating lease liability (Note 5) |
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588 |
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603 |
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Employees related liability |
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917 |
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1,003 |
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Total current liabilities |
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$ |
6,831 |
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$ |
7,800 |
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Long-Term Liabilities: |
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Operating lease liability (Note 5) |
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533 |
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672 |
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Warrants liability (Note 6) |
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1,534 |
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594 |
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Total long-term liabilities |
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$ |
2,067 |
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$ |
1,266 |
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Total liabilities |
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$ |
8,898 |
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$ |
9,066 |
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Stockholders' Deficit: |
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Stock capital: (Note 7) |
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13 |
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13 |
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Common Stock of |
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Additional paid-in-capital |
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212,967 |
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210,258 |
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(116) |
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(116) |
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Accumulated deficit |
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(218,414) |
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(215,013) |
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Total stockholders' deficit |
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$ |
(5,550) |
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$ |
(4,858) |
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Total liabilities and stockholders' deficit |
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$ |
3,348 |
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$ |
4,208 |
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The accompanying notes are an integral part of the consolidated financial statements.
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
(Except share data)
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Three months ended |
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2024 |
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2023 |
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Unaudited |
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Operating expenses: |
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Research and development, net |
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$ |
961 |
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$ |
2,924 |
General and administrative |
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1,513 |
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2,227 |
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Operating loss |
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(2,474) |
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(5,151) |
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Financial income, net |
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13 |
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92 |
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Loss on change in fair value of Warrants liability (Note 6) |
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(940) |
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— |
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Net loss |
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$ |
(3,401) |
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$ |
(5,059) |
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Basic and diluted net loss per share from continuing operations |
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$ |
(0.05) |
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$ |
(0.14) |
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Weighted average number of shares outstanding used in computing basic and diluted net loss per share |
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64,738,544 |
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36,735,435 |
The accompanying notes are an integral part of the consolidated financial statements.
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