NEW YORK, Aug. 14, 2026 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update.
"We continue to advance and complete the preparations necessary to initiate the Phase 3b ENDURANCE study of NurOwn in ALS, supported by an FDA-agreed protocol under a Special Protocol Assessment," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "The recent appointment of Peter Pitts as Executive Chairman represents an important enhancement to our leadership. Peter is joining the Company in an active executive capacity and will help lead the regulatory, operational, partnership and capital-markets initiatives surrounding the NurOwn program. His experience as a former senior FDA official brings an additional level of regulatory insight and strategic perspective as we prepare to enter this next phase. ALS imposes an enormous burden on patients, families and caregivers, and we remain resolute in our commitment to the ALS community and to advancing what we believe will be a valuable new therapeutic option."
Recent Highlights
-- Advancing readiness for the Phase 3b ENDURANCE trial of NurOwn.
BrainStorm is completing the operational and regulatory work needed to
open ENDURANCE for enrollment. The trial is planned to enroll about 200
patients with ALS in two 24-week parts: a randomized, double-blind,
placebo-controlled portion (Part A), then an open-label extension in
which all participants receive NurOwn (Part B). The primary endpoint is
change on the ALSFRS-R scale, and Part A results are intended to support
a new BLA. ENDURANCE will be conducted under a Special Protocol
Assessment with the FDA, the first ever granted for an ALS therapeutic
candidate. For more information, refer to ClinicalTrials.gov NCT06973629.
Corporate and Leadership
-- Appointed Peter J. Pitts as Executive Chairman. In July 2026, BrainStorm
named Peter J. Pitts, a former FDA Associate Commissioner and co-founder
of the Center for Medicine in the Public Interest, as Executive Chairman
and Chief Strategic Regulatory and Policy Officer. Mr. Pitts, who joined
the Board in May 2026, will lead the Company's daily operations,
partnerships, investor engagement, and regulatory strategy, focused
primarily on advancing the Phase 3b ENDURANCE trial. Professor Jacob
Frenkel, in BrainStorm's leadership since 2007 and Board Chairman since
2020, will transition to Senior Advisor.
-- Completed private placements totaling $400,000, priced at a premium to
market. In May 2026, BrainStorm entered into private placement agreements
for gross proceeds of $400,000. Together with the $2.0 million raised in
February 2026, capital raised in first-half 2026 totals approximately
$2.4 million.
Publications
-- Published a peer-reviewed article calling for updated FDA approaches to
ALS, rare diseases, and regenerative medicine. In June 2026, BrainStorm
announced an article co-authored by Peter J. Pitts and CEO Chaim Lebovits
in the Journal of the Academy of Public Health, "Restoring Regulatory
Fairness and Reclaiming Biomedical Leadership: ALS, Rare Disease
Regulation, and the Future of Regenerative Medicine." The authors argue
that regulation should keep pace with advances in biomarkers, genomics,
artificial intelligence, and precision medicine, and that tools such as
accelerated approval, adaptive trial design, and Bayesian statistics can
improve therapy development for ALS and other rare diseases. It
highlights the Company's Special Protocol Assessment as a model of
sponsor and regulator collaboration.
Financial Results for the Second Quarter Ended June 30, 2026
-- Cash, cash equivalents, and restricted cash were approximately $0.2
million as of June 30, 2026, compared to approximately $1.03 million as
of June 30, 2025.
-- Research and development expenditures, net, for the second quarter of
2026 were approximately $1 million, compared to approximately $1.1
million for the second quarter of 2025.
-- General and administrative expenses for the second quarter of 2026 were
approximately $2.7 million, compared to approximately $1.5 million for
the second quarter of 2025.
-- Net loss for the second quarter of 2026 was approximately $3.9 million,
compared to a net loss of approximately $2.9 million for the second
quarter of 2025.
-- Net loss per share for the second quarters of 2026 and 2025 was $(0.35)
and $(0.34), respectively.
U.S. dollars in thousands
(Except share and per share amounts)
June 30, December 31,
---------- --------------
2026 2025
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Unaudited Audited
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U.S. $ in thousands
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ASSETS
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Current Assets:
Cash and cash equivalents $ 22 $ 29
Other accounts receivable 162 86
Prepaid expenses and other current assets 132 192
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Total current assets $ 316 $ 307
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Long-Term Assets:
Prepaid expenses and other long-term assets $ 27 $ 25
Restricted Cash 187 247
Right of use asset (Note 3) 106 208
Property and equipment, net 152 235
--------- ----------
Total Long-Term Assets $ 472 $ 715
========= ==========
Total assets $ 788 $ 1,022
========= ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT)
-------------------------------------------
Current Liabilities:
Accounts payable $ 7,488 $ 7,067
Accrued expenses 454 396
Short-term loans (Note 6) 1,261 967
Operating lease liability (Note 3) 113 208
Employees related liability 3,069 2,369
--------- ----------
Total current liabilities $ 12,385 $ 11,007
--------- ----------
Total liabilities $ 12,385 $ 11,007
Stockholders' Deficit:
Stock capital: (Note 4) 16 16
Common stock $0.00005 par
value; 250,000,000 shares authorized
and 11,034,775 shares issued and
outstanding
Additional paid-in-capital 231,428 227,058
Treasury stock (116) (116)
Accumulated deficit (242,925) (236,943)
--------- ----------
Total stockholders' deficit $ (11,597) $ (9,985)
========= ==========
Total liabilities and stockholders' deficit $ 788 $ 1,022
========= ==========
The accompanying notes are an integral part of the consolidated financial statements.
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
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INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
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U.S. dollars in thousands
(Except share and per share amounts)
Six months ended Three months ended
----------------------- -----------------------
June 30, June 30,
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2026 2025 2026 2025
----------- ---------- ----------- ----------
Unaudited Unaudited
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Operating
expenses:
Research and
development,
net $ 1,725 $ 2,424 $ 963 $ 1,120
General and
administrative 3,934 3,238 2,650 1,453
---------- --------- ---------- ---------
Operating loss (5,659) (5,662) (3,613) (2,573)
Financial income
(expense), net (323) (284) (242) (330)
Gain (loss) on
change in fair
value of
Warrants
liability - 179 - -
---------- --------- ---------- ---------
Net loss $ (5,982) $ (5,767) $ (3,855) $ (2,903)
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