BrainStorm Cell Therapeutics Announces Full Year 2023 Financial Results and Provides Corporate Update
Conference call planned for early
"Brainstorm's priority for 2024 is to move forward with a confirmatory Phase 3b trial for NurOwn that will potentially support a new Biologics License Application," said
Fourth Quarter 2023 and Recent Highlights
Clinical and regulatory
- In
February 2024 , Brainstorm submitted a Special Protocol Assessment (SPA) request to theU.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn. An SPA agreement would indicate concurrence by FDA with the adequacy and acceptability of the overall protocol design for a planned Phase 3b study, intended to support a future marketing application. The request is currently under review, and the Company is expecting to have a response from theUS FDA very soon as we approach the 45-day SPA review cycle - 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, earlier in the disease. - In
December 2023 , company management attended an in-person meeting with the FDA to discuss the regulatory path forward for NurOwn in ALS, including plans for an SPA prior to commencing the planned Phase 3b confirmatory trial. - In
November 2023 , Bob Dagher, MD, Executive Vice President and Chief Development Officer at BrainStorm, delivered a presentation titled, "NurOwn for ALS: Biomarker exploration of NurOwn multimodal mechanism of action on neuroinflammation, neuroprotection and neurodegeneration" at the 6th Annual ALS Research Symposium hosted by ALS ONE. - In
October 2023 , Brainstorm withdrew its Biological License Application (BLA) for NurOwn in ALS. This action was coordinated with FDA and was viewed by the Agency as a withdrawal without prejudice. This decision was made following theU.S. FDA's Cellular, Tissue and Gene Therapies Advisory Committee meeting that took place inSeptember 2023 . The Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.
Corporate
- In
October 2023 , Brainstorm announced a strategic realignment to enable accelerated development of NurOwn for the treatment of ALS. The company reduced and refocusing resources by streamlining clean room operations and undertook a targeted reduction in headcount of approximately 30 percent.
Financial Results for the Year Ended
- Cash, cash equivalents, and restricted cash amounted to
$1.45 million , as ofDecember 31, 2023 , compared to cash, cash equivalents, and short-term deposits of$3 million as ofDecember 31, 2022 . - Research and development expenses for the twelve months ended
December 31, 2023 , and 2022 were approximately$10.8 million and$14 million , respectively. - General and administrative expenses for the twelve months ended
December 31, 2023 , and 2022 were approximately$10.7 million and$10.9 million , respectively. - Net loss for the year ended
December 31, 2023 was$17.2 million as compared to a net loss of$24.3 million for the year endedDecember 31, 2022 . - Net loss per share for the year ended
December 31, 2023 andDecember 31, 2022 was$0.40 and$0.66 , respectively.
Conference Call and Webcast
BrainStorm management will host a conference call for the investment community in early
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
Media:
Phone: +1 202-330-3431
lisa.guiterman@gmail.com
IR:
Phone: +1 646-597-6983
mwood@lifesciadvisors.com
BRAINSTORM CELL THERAPEUTICS INC. |
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CONSOLIDATED BALANCE SHEETS |
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(Except share data) |
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2023 |
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2022 |
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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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$ |
1,300 |
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$ |
772 |
Short-term deposit (Note 8) |
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- |
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2,211 |
Other accounts receivable |
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51 |
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91 |
Prepaid expenses and other current assets (Note 4) |
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548 |
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32 |
Total current assets |
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$ |
1,899 |
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$ |
3,106 |
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Long-Term Assets: |
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Prepaid expenses and other long-term assets |
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$ |
22 |
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$ |
23 |
Restricted Cash |
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185 |
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- |
Operating lease right of use asset (Note 5) |
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1,416 |
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4,389 |
Property and Equipment, Net (Note 6) |
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686 |
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933 |
Total Long-Term Assets |
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$ |
2,309 |
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$ |
5,345 |
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Total assets |
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$ |
4,208 |
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$ |
8,451 |
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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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$ |
4,954 |
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$ |
6,224 |
Accrued expenses |
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1,240 |
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84 |
Operating lease liability (Note 5) |
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603 |
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1,427 |
Employees related liability |
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1,003 |
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1,065 |
Total current liabilities |
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$ |
7,800 |
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$ |
8,800 |
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Long-Term Liabilities: |
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Operating lease liability (Note 5) |
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672 |
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2,666 |
Warrants liability (Note 6) |
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594 |
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- |
Total long-term liabilities |
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$ |
1,266 |
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$ |
2,666 |
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Total liabilities |
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$ |
9,066 |
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$ |
11,466 |
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Stockholders' Equity (deficit): |
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Stock capital: (Note 9) |
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13 |
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12 |
Common Stock of |
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Additional paid-in-capital |
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210,258 |
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194,910 |
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(116) |
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(116) |
Accumulated deficit |
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(215,013) |
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(197,821) |
Total stockholders' equity (deficit) |
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$ |
(4,858) |
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$ |
(3,015) |
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Total liabilities and stockholders' equity (deficit) |
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$ |
4,208 |
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$ |
8,451 |
The accompanying notes are an integral part of the consolidated financial statements.
BRAINSTORM CELL THERAPEUTICS INC. |
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CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
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(Except share data) |
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Year ended |
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2023 |
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2022 |
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Operating expenses: |
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Research and development, net (Note 12) |
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$ |
10,746 |
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$ |
13,956 |
General and administrative |
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10,693 |
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10,866 |
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Operating loss |
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(21,439) |
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(24,822) |
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Financial income (expense), net |
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(447) |
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545 |
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Gain on change in fair value of Warrants liability (Note 9) |
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4,694 |
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- |
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Net loss |
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$ |
(17,192) |
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$ |
(24,277) |
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Basic and diluted net loss per share |
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$ |
(0.40) |
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$ |
(0.66) |
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Weighted average number of shares outstanding used in |
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43,075,938 |
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36,509,060 |
The accompanying notes are an integral part of the consolidated financial statements.
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