Brainstorm Cell Therapeutics - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 was defined by regulatory and operational progress (FDA clearance to initiate the Phase 3b ENDURANCE ALS trial; Minaris CDMO LOI), offset by continued losses and constrained liquidity; no revenue recognized.
• EPS of $0.34 loss was essentially in line with one-estimate S&P Global consensus (-$0.34 actual vs -$0.33 est; revenue est $0.0 and actual $0.0), reflecting a development-stage cost profile with tighter G&A and modestly higher R&D.
• Liquidity tightened: cash, equivalents, and restricted cash fell to ~$1.03M at 6/30/25 (from ~$1.8M at 3/31/25), highlighting urgency around funding options discussed by management.
• Notable Q3-to-date events: FDA consideration of a Citizen Petition related to NurOwn and Nasdaq delisting/transition to OTCQB; both are meaningful narrative catalysts for regulatory and trading status, respectively.

What Went Well and What Went Wrong

• What Went Well

  • FDA cleared initiation of the Phase 3b ENDURANCE trial (SPA-backed design); management reiterated that successful completion of Part A is expected to support a new BLA submission.
  • Manufacturing readiness advanced via LOI with Minaris (U.S.) and ongoing collaboration with Pluri (Israel), strengthening supply-chain optionality for a multicenter U.S. trial.
  • Management emphasized confidence and engagement with clinicians/ALS community; CEO: “We reached an important milestone in Q2 with FDA clearance…designed to generate confirmatory data to support a potential BLA submission”.

• What Went Wrong

  • Liquidity remained very limited: ~$1.03M cash, equivalents, and restricted cash at 6/30/25 vs ~$1.8M at 3/31/25; management underscored the need to secure financing (including a potential $15M non-dilutive grant under review) before trial start.
  • Listing risk materialized post-quarter: BCLI was delisted from Nasdaq for minimum stockholders’ equity non-compliance; shares transitioned to OTCQB as of July 18, 2025.
  • Limited sell-side coverage: only one EPS estimate and two revenue estimates for Q2, limiting signal value of the beat/miss framework for traders [GetEstimates Q2 2025].

Transcript

Speaker 2

Thanks, and welcome to the BrainStorm Cell Therapeutics second quarter 2025 conference call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

Speaker 0

Thank you, Kelly. Good morning, everyone, and thank you for joining us this morning. Before passing it off to company management for prepared remarks, I would like to remind listeners that this conference call will contain numerous statements, descriptions, forecasts, and projections regarding BrainStorm Cell Therapeutics and its potential future business operations and performance, statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS, the sufficiency of the company's existing capital resources for continuing operations in 2025 and beyond, the safety and clinical effectiveness of the NurOwn technology platform, clinical trials of NurOwn and related clinical development programs, and the company's ability to develop strategic collaborations and partnerships to support its business planning efforts. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond BrainStorm's control, including the risks and uncertainties described from time to time in the company's SEC filings.

The company's results may differ materially from those projected on today's call, and the company undertakes no obligation to publicly update any forward-looking statements. Joining us on the call this morning will be Chaim Lebovits, President and CEO of BrainStorm, Dr. Bob Dagher, Executive Vice President and Chief Medical Officer, Haro Hartounian, Executive Vice President and Chief Operating Officer, and Alla Patlis, Interim Chief Financial Officer. I would now like to turn the call over to Mr. Lebovits. Please go ahead.

Speaker 1

Thank you, Mike. Good morning, everyone. Thank you for joining us today.