BRAINSTORM CELL THERAPEUTICS INC. (BCLI)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 was a financing-and-execution quarter: management reiterated readiness to initiate the Phase IIIb ALS trial under an FDA Special Protocol Assessment (SPA), with manufacturing and CRO partners in place; cash at year-end was ~$0.19M, and a ~$1.64M warrant inducement closed around April 1, 2025 .
• EPS and revenue remained negative/zero; versus S&P Global consensus, Q4 EPS missed (actual -$0.52 vs -$0.27; FY 2024 -$2.31 vs -$2.10) driven by ongoing R&D and SG&A with no product revenue; revenue was $0 and in line with consensus [GetEstimates]*.
• Annual opex fell markedly YoY: R&D declined to $4.7M (from $10.7M), G&A to $7.0M (from $10.7M), cutting the net loss to $11.6M (from $17.2M); however, liquidity tightened (cash ~$0.4M vs ~$1.5M) .
• Near-term stock reaction catalysts: IND model submission, FDA clearance to proceed, first Clinical Trial Agreement (CTA) signatures, and first-patient-in; management framed annual trial funding needs at ~$20–$30M (later clarified at ~$23M) with nondilutive grants and partnerships targeted .

What Went Well and What Went Wrong

• What Went Well

  • FDA alignment: SPA secured and CMC alignment achieved, materially de-risking the regulatory path for the Phase IIIb trial .
  • Operational readiness: CRO partnership (IQVIA) and manufacturing arrangements (Pluri; plus planned U.S. facility) established to support consistent clinical supply .
  • Cost discipline: YoY reductions in R&D ($4.7M vs $10.7M) and G&A ($7.0M vs $10.7M), narrowing net loss ($11.6M vs $17.2M); “salary reductions” and senior leadership working without remuneration highlighted .
  • Quote: “We secured a Special Protocol Assessment… We’re also aligned with the FDA on Chemistry, Manufacturing and Controls…” . “We have contracted with Pluri Inc. … and plan to bring an additional U.S.-based manufacturing center online” .

• What Went Wrong

  • Liquidity constraints: year-end cash ~$0.4M, requiring continued external financing; accounts payable rose to ~$6.1M .
  • Timing concerns: investors questioned perceived delays; management cited IND technical transfer/QA/QC work and multi-site CTA negotiations as time-consuming .
  • Estimate miss: Q4 EPS missed S&P consensus (no revenue to offset fixed costs), reflecting ongoing operating losses [GetEstimates]*.
  • Analyst concerns: skepticism around efficacy and resubmission strategy; management emphasized definitive evidence via Phase IIIb and pooling prior data in early-stage ALS .

Financial Results

Notes: Asterisks (*) denote values retrieved from S&P Global. Annual figures from FY 2024 are provided in the 8-K Exhibit 99.1.

EPS vs Estimates (S&P Global)

Notes: Values retrieved from S&P Global. Bolded commentary below on beats/misses.

Annual YoY Comparison

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Prepared remarks emphasized de-risked regulatory path: “We secured a Special Protocol Assessment… We’re also aligned with the FDA on Chemistry, Manufacturing and Controls…” .
• Emphasis on trial execution within financing realities: “We anticipate needing approximately $20 million, $30 million annually… raising this amount of cash upfront is not practical… milestones should improve valuation” .
• Manufacturing and CRO readiness: “Contracted with Pluri Inc.… planning to bring an additional U.S.-based manufacturing center online… partnered with IQVIA” .
• Cost actions and team commitment: “Senior officers are at times working without remuneration… employees have taken significant reductions in compensation” .
• Strategic path: “Refiling the BLA at this time would not… we are focused on generating robust data… designed to address specific concerns and provide the evidence necessary to support a new BLA” .

Q&A Highlights

• Macro/regulatory backdrop for cell therapy: questions on favorable shifts and nondilutive capital; management kept focus on scientific data, noted first-ever MSC approval for GVHD as positive precedent .
• Use of prior Phase III data: management expects pooling of early-stage data to support Phase IIIb/BLA strategy .
• U.S. manufacturing site: intent to have a facility ready for FDA inspection by end of trial; investor perception concerns addressed .
• Funding threshold to start trial: partners providing leeway; additional funding and nondilutive grant targeted, with aim to announce plans to enhance comfort .

Estimates Context

• Q4 EPS missed consensus: actual -$0.52 vs -$0.27 (miss of -$0.25); FY EPS -$2.31 vs -$2.10 (miss of -$0.21). Revenue was $0 and in line with consensus. Values retrieved from S&P Global [GetEstimates]*.
• Drivers: no revenue; operating losses persist despite YoY opex reductions; liquidity constraints necessitate incremental financing, with management expecting valuation uplift upon execution milestones .
• Implications: Street likely to maintain cautious stance until IND submissions and first-patient-in are achieved; raises/revisions may hinge on financing visibility and trial start timing .

Key Takeaways for Investors

• Execution catalysts dominate: IND model submission, FDA clearance to proceed, CTA signings, and first-patient-in are the key near-term stock movers .
• Funding runway remains tight: expect staged financing (warrants, licensing of noncore assets, grants, partnerships) rather than a single upfront raise of $20–$30M annually (management cited ~$23M) .
• Regulatory de-risking is real: SPA and CMC alignment mitigate protocol risk; efficacy must be demonstrated in early-stage ALS as designed .
• Manufacturing/CRO infrastructure in place: Pluri contracted and IQVIA engaged; plan for U.S. manufacturing site supports inspection and commercialization readiness if data are positive .
• Opex discipline helps, but liquidity is the constraint: YoY cost cuts narrowed losses, yet cash was ~$0.4M at year-end; continuous financing updates are critical .
• Narrative watch: any positive data updates (biomarkers, survival), grant awards, or strategic partnerships could re-rate shares; conversely, financing delays or site activation slippage would weigh .
• No financial guidance: monitor operational milestones over P&L figures; no revenue expected until approval/commercialization .

Asterisks (*) denote values retrieved from S&P Global.