Brainstorm Cell Therapeutics Inc.

What they do

The company develops autologous bone marrow-derived mesenchymal stem cells (MSCs) cultured to secrete high levels of neurotrophic factors under its NurOwn platform. NurOwn has completed a Phase 3 ALS trial and a Phase 2 PMS trial, and a Phase 3b ALS trial (ENDURANCE) is planned under an FDA Special Protocol Assessment. The company has generated no revenues from operations since inception in 2000.

Revenue drivers

• NurOwn for ALS — Lead program; no product revenue. A BLA was filed in September 2022, received a refusal-to-file, was re-filed over protest, and was withdrawn on November 3, 2023 after an FDA advisory committee voted 17-1 (one abstention) that NurOwn lacked substantial evidence of effectiveness in mild to moderate ALS.
• NurOwn for progressive MS (PMS) — Phase 2 trial of three repeated intrathecal administrations completed, with positive top-line data announced March 24, 2021; no revenue and no disclosed commercialization timeline.
• NurOwn for Alzheimer's disease (AD) — Clinical program announced June 24, 2020; no revenue and no revenue-generating milestone disclosed in the filings.
• Financing activities — The company funds operations through public and private equity sales, warrant exercises and convertible notes; first-half 2026 capital raised totaled approximately $2.4 million ($2.0 million in February 2026 and $400,000 in May 2026).

Recent performance

For the second quarter ended June 30, 2026, BrainStorm reported a net loss of approximately $3.9 million, versus approximately $2.9 million in Q2 2025, with net loss per share of $(0.35) versus $(0.34). R&D expenses, net, were approximately $1 million in Q2 2026 versus approximately $1.1 million a year earlier, while G&A expenses rose to approximately $2.7 million from approximately $1.5 million. Cash, cash equivalents and restricted cash were approximately $0.2 million at June 30, 2026, compared to approximately $1.03 million at June 30, 2025; the latest balance sheet shows total assets of $788,000, total liabilities of $12.4 million and shareholder equity of negative $11.6 million. Full-year 2025 net loss was $10.3 million, an improvement from $11.6 million in 2024, and operating cash flow improved to negative $7.0 million in 2025 from negative $9.1 million in 2024.

Strategy

Management is completing operational and regulatory preparations to open the Phase 3b ENDURANCE trial of NurOwn in ALS, planned to enroll about 200 patients in two 24-week parts: a randomized, double-blind, placebo-controlled Part A and an open-label extension Part B in which all participants receive NurOwn. The primary endpoint is change on the ALSFRS-R scale, and Part A results are intended to support a new BLA. ENDURANCE is being conducted under a Special Protocol Assessment with the FDA, which the company describes as the first ever granted for an ALS therapeutic candidate. The company is also funding itself through private placements and has added executive leadership, appointing Peter J. Pitts as Executive Chairman and Chief Strategic Regulatory and Policy Officer in July 2026.

Risks

• Going-concern liquidity — Cash, cash equivalents and restricted cash were approximately $0.2 million at June 30, 2026 against total liabilities of $12.4 million and negative shareholder equity of $11.6 million, and management states additional funding will be required.
• Prior BLA failure — The FDA advisory committee voted 17-1 with one abstention that NurOwn did not demonstrate substantial evidence of effectiveness in mild to moderate ALS, and the BLA was withdrawn on November 3, 2023.
• No commercial product or revenue — The company has generated no revenue from operations since inception in 2000 and states it has never manufactured NurOwn at commercial scale.
• Exchange and financing access — The common stock has been delisted from Nasdaq and now trades on the OTCQB Venture Market, and the company states its August 9, 2021 ATM may no longer be available for use.

Outlook

The company says it is completing the operational and regulatory work needed to open ENDURANCE for enrollment and expects to start the Phase 3b ALS trial under the FDA-agreed Special Protocol Assessment. Management expects the company to continue generating losses from clinical development and regulatory activities, producing negative cash flow. No timeline, cost estimate or financing commitment for the trial is specified in the provided materials, and the company says there can be no assurance it can raise capital on acceptable terms or at all.