Core Viewpoint - BrainStorm Cell Therapeutics Inc. is advancing its NurOwn® program for ALS, focusing on a Phase 3b registration trial, with updates expected in Q4 2024 [1][6]. Company Updates - The company has refined the Phase 3b trial design based on previous study learnings to enhance the likelihood of demonstrating treatment efficacy [2]. - A Memorandum of Understanding (MOU) was signed with Pluri Inc. for the manufacturing of NurOwn® for the upcoming trial [3]. - The Phase 3b trial is expected to enroll approximately 200 ALS participants, with a two-part structure involving both placebo and NurOwn treatments [4]. Clinical Trial Details - The trial will consist of a 24-week Part A with three doses of either NurOwn or placebo, followed by a 24-week open-label Part B where all participants will receive NurOwn [4]. - Primary efficacy will be measured using the ALSFRS-R score, with additional assessments including survival rates and various clinical measures [4]. Financial Performance - As of September 30, 2024, the company reported cash and cash equivalents of approximately $0.35 million, a decrease from $1.3 million year-over-year [7]. - Research and development expenses for Q3 2024 were $1 million, down from $3.3 million in Q3 2023, while general and administrative expenses decreased to $2 million from $2.7 million [7]. - The net loss for Q3 2024 was $2.7 million, compared to a net loss of $1.2 million in the same quarter of 2023 [7]. Long-Term Benefits and Biomarkers - Promising long-term survival benefits were observed in patients treated with NurOwn, with a median survival time of 46.6 months compared to 41.1 months for matched controls [5]. - Consistent reductions in neurofilament light (NfL) levels were noted, indicating ongoing benefits from extended treatment, which aligns with the understanding of NurOwn's mechanism of action [5].

Core Insights - BrainStorm Cell Therapeutics Inc. presented promising data on NurOwn® at the 2024 NEALS Meeting, indicating potential long-term benefits for ALS patients from extended treatment with debamestrocel [1][3] Group 1: NurOwn and ALS Treatment - The Expanded Access Program (EAP) for NurOwn involved 10 ALS participants, with 9 out of 10 remaining alive at the last visit, showing a median survival time of 46.6 months for the debamestrocel group compared to 41.1 months for the matched control [2][3] - A significant reduction in neurofilament light (NfL), a biomarker for neurodegeneration, was observed in participants who received debamestrocel, while those on placebo showed a 37% worsening in NfL levels [2][3] Group 2: Upcoming Phase 3b Trial - The upcoming Phase 3b trial aims to enroll approximately 200 ALS participants, with a two-part design involving 3 doses of either debamestrocel or placebo over 24 weeks, followed by an open-label period [4][6] - Key entry criteria for the trial include ages 18 to 75, ALS diagnosis within 24 months of screening, and specific ALSFRS-R scores [4][6] Group 3: Efficacy and Regulatory Aspects - The primary efficacy endpoint will compare changes in ALSFRS-R scores from baseline to week 24 between the debamestrocel and placebo groups [4] - The company has secured a Special Protocol Assessment (SPA) agreement with the FDA, which reduces regulatory risks associated with the trial [6] Group 4: NurOwn Technology Overview - NurOwn technology utilizes autologous MSC-NTF cells, which are designed to secrete neurotrophic factors targeting neurodegenerative diseases, with a focus on ALS [7][9] - The clinical program has provided insights into ALS pathology and treatment, including pharmacogenomic analysis of clinical outcomes [8]

Company Overview - BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for neurodegenerative diseases, specifically targeting amyotrophic lateral sclerosis (ALS) through its NurOwn® technology platform [5] - The company has received Orphan Drug designation status from the U.S. FDA and the European Medicines Agency for the treatment of ALS [5] Upcoming Events - BrainStorm will participate in the 2024 Maxim Healthcare Virtual Summit from October 15 to 17, where CEO Chaim Lebovits will discuss the planned Phase 3b clinical trial for NurOwn® [1][2] - The Fireside Chat is scheduled for October 15 at 9:30 a.m. ET, providing an opportunity to engage with the investment community [1] Clinical Development - The NurOwn® technology platform involves harvesting MSC-NTF cells from ALS patients, which are then manufactured to secrete neurotrophic factors targeting neurodegenerative diseases [3] - The clinical program has provided insights into ALS pathology, disease progression, and treatment, including a comprehensive analysis of biomarkers and genetic data [4] Research and Funding - BrainStorm has completed a Phase 3 trial for ALS, supported by grants from the California Institute for Regenerative Medicine and the ALS Association [5] - The company has also conducted a Phase 2 open-label multicenter trial for progressive multiple sclerosis, backed by the National MS Society [5]

NEW YORK, Sept. 24, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the acceptance of two abstracts featuring NurOwn® (MSC-NTF or Debamestrocel) at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting, to take place October 21 - 24, in-person in Clearwater, Florida and virtually."We look forward to sharing the latest update on NurOwn at this year's NEALS meeting. ...

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q2 2024 Earnings Conference Call August 14, 2024 8:30 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and CEO Alla Patlis - Interim Chief Financial Officer Haro Hartounian - Chief Operating Officer Bob Dagher - Chief Medical Officer Conference Call Participants Joanne Lee - Maxim Group David Bautz - Zacks Small-Cap Research Christopher Nicholson - ACF Equity Research Operator Greetings, and welcome to the Brainstorm Cell T ...

Clinical Trials and Regulatory Status - NurOwn® has completed Phase 3 ALS and Phase 2 PMS clinical trials, with positive top-line data announced on March 24, 2021, for PMS[95]. - The FDA granted a Special Protocol Assessment (SPA) agreement for the Phase 3b trial of NurOwn® in ALS on April 9, 2024, validating the clinical trial protocol[101]. - The Advisory Committee voted on September 27, 2023, with 17 voting no, one voting yes, and one abstention, indicating that NurOwn® did not demonstrate substantial evidence of effectiveness for mild to moderate ALS[95]. - The BLA for NurOwn® was withdrawn on November 3, 2023, in coordination with the FDA, viewed as a withdrawal without prejudice[95]. - The Phase 3 clinical trial of NurOwn® did not achieve statistically significant results, with 32.6% of participants meeting the primary endpoint compared to 27.7% for placebo (p=0.453)[125]. - In a pre-specified subgroup with ALSFRS-R baseline scores of 35 or greater, NurOwn® showed a 34.6% responder rate versus 15.6% for placebo (p=0.305) and an average change of -1.56 on NurOwn® compared to -3.65 on placebo (p=0.050)[126]. - The Phase 2 trial demonstrated a slower rate of disease progression in ALS patients, with significant improvements in ALSFRS-R and FVC[116]. - NurOwn® treatment resulted in statistically significant increases in neurotrophic factors and reductions in inflammatory markers in cerebrospinal fluid samples[120]. - The Phase 3 trial enrolled a broad set of participants, including those with advanced ALS, which may have impacted the sensitivity of the ALSFRS-R[129]. - The company is actively exploring next steps for NurOwn®, including publication of emerging clinical data and development of a protocol for an additional clinical study[95]. - The FDA invited the company for an expedited meeting to discuss the regulatory path forward for NurOwn® in ALS on October 18, 2023[112]. - The company plans to submit a SPA request for a Phase 3b clinical trial for NurOwn® to discuss protocol design with the FDA[112]. - A meeting with the FDA on December 6, 2023, focused on discussing the regulatory path forward for NurOwn® and plans for a Special Protocol Assessment (SPA) for a Phase 3b trial[134]. - The company received written agreement from the FDA on April 9, 2024, under a SPA for the design of the Phase 3b trial of NurOwn® in ALS, validating the clinical trial protocol[134]. Financial Performance and Funding - The company incurred operating costs of approximately $2,982,000 for the three months ended June 30, 2024, a decrease of 45.1% compared to $5,449,000 for the same period in 2023[185]. - Research and development expenditures, net for the three months ended June 30, 2024 were $922,000, a decrease of 67.1% compared to $2,794,000 for the same period in 2023[187]. - The net loss for the three months ended June 30, 2024 was $2,541,000, compared to a net loss of $5,329,000 for the same period in 2023, representing a reduction of 52.3%[191]. - The company had cash, cash equivalents, and restricted cash amounting to $3,648,000 as of June 30, 2024[197]. - Net cash used in operating activities for the six months ended June 30, 2024 was $4,746,000, primarily attributed to clinical trial costs and payroll expenses[197]. - The company received $6,909,000 from financing activities for the six months ended June 30, 2024, primarily from sales of common stock under the ATM program[197]. - The company anticipates needing to raise substantial additional financing in the future to fund operations, including potential debt and equity offerings[210]. - The Company sold an aggregate of 2,446,641 shares of Common Stock at an average price of $9.45 per share, raising gross proceeds of approximately $23.11 million under the March 6, 2020 ATM[201]. - The Company entered into a Securities Purchase Agreement on July 17, 2023, agreeing to sell 4,054,055 shares of Common Stock at a purchase price of $1.85 per share, yielding gross proceeds of approximately $7.5 million[205]. - On June 27, 2024, the Company agreed to sell 7,918,764 registered shares of Common Stock and pre-funded warrants, yielding gross proceeds of approximately $4.0 million[207]. Legal and Compliance Issues - The company is involved in ongoing litigation, including a putative securities class action complaint alleging violations related to NurOwn® for the treatment of ALS[220]. - The company is facing multiple derivative action complaints alleging breach of fiduciary duty and unjust enrichment against certain officers and directors, with claims related to the internal controls and FDA submissions for NurOwn® for ALS treatment[221]. - The company received a letter from Nasdaq on November 1, 2023, indicating non-compliance with the $1.00 minimum bid price requirement, with a compliance period until April 29, 2024[226]. - Nasdaq determined to delist the company's common stock on May 1, 2024, due to continued non-compliance with the bid price requirement[226]. - The company submitted a hearing request to Nasdaq on May 2, 2024, and was granted a temporary exception to regain compliance by October 21, 2024[227]. - The company received a notice on July 18, 2024, indicating it did not maintain the minimum market value of listed securities of $35 million, with a compliance period until January 14, 2025[228]. - Failure to regain compliance with either the bid price or market value requirements could lead to delisting from Nasdaq, negatively impacting trading and liquidity[229]. - The company is subject to securities class action litigation and other stockholder litigation, which could result in substantial costs and divert management's attention[230]. Company Operations and Workforce - The company currently employs 29 employees in the United States and Israel, with a focus on recruiting and retaining talent to support its objectives[99]. - The company has a GMP manufacturing center in Tel Aviv, enhancing its capacity to manufacture and ship NurOwn® into the EU and local Israeli markets[99]. - The company has developed a validated cryopreservation process for MSC, allowing multiple doses of NurOwn® from a single bone marrow harvest, enhancing manufacturing efficiency[135]. - As of November 1, 2023, the company optimized its manufacturing capabilities by leasing a GMP-certified cleanroom manufacturing center, significantly enhancing production capacity for NurOwn®[138]. - The company has improved the efficiency of NurOwn® production and its stability, allowing centralized manufacturing and distribution to clinical trial sites[183]. Research and Development - The company presented new biomarker data suggesting that ALS patients may benefit from longer-term treatment with NurOwn® at the 3rd Annual ALS Drug Development Summit in May 2024[103]. - The NurOwn® technology has received Fast Track designation and Orphan Drug status from the FDA and EMA for ALS, indicating its potential significance in treating this condition[98]. - The FDA granted Fast Track designation and Orphan Drug Status for NurOwn® in ALS, providing potential for extended exclusivity[112]. - The company is considering advancing NurOwn® as a treatment option for Alzheimer's Disease, focusing on its capability to target multiple biological pathways[161]. - The company received a total of $15,912,390 in grant funding from the California Institute for Regenerative Medicine (CIRM) for the Phase 3 study of NurOwn® for ALS[162]. - The company holds 27 granted patents and 23 patent applications worldwide, protecting its proprietary technologies and products[164]. - The company announced the European grant for NurOwn® and the acceptance of applications for exosomes derived from MSC-NTF cells in Australia and Israel[171]. - The Phase 2 PMS clinical trial compared clinical efficacy outcomes with a matched clinical cohort from the CLIMB Study, demonstrating significant improvements in various measures of function and cognition[156]. - In the Phase 2 study for Progressive Multiple Sclerosis (PMS), 80% of the 20 enrolled patients completed the study, with no deaths or serious adverse events reported[155]. - Key findings from the PMS trial included a 10% mean improvement in the timed 25-foot walk (T25FW) and a 4.8% improvement in the 9-hole peg test (9-HPT) for NurOwn® treated patients[158].

Exhibit 99.1 BrainStorm Cell Therapeutics Announces Second Quarter 2024 Financial Results and Provides Corporate Update Company reached alignment with the U.S. FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its planned Phase 3b clinical trial for NurOwn® in ALS SPA in place for Phase 3b NurOwn® trial in ALS Enhanced leadership team with appointment of Hartoun Hartounian Ph.D. as EVP and Chief Operating Officer, and promotion of Dr. Bob Dagher to EVP and Chief Medical Officer Conference c ...

- Company reached alignment with the U.S. FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its planned Phase 3b clinical trial for NurOwn® in ALS- SPA in place for Phase 3b NurOwn® trial in ALS- Enhanced leadership team with appointment of  Hartoun Hartounian Ph.D. as EVP and Chief Operating Officer, and promotion of Dr. Bob Dagher to EVP and Chief Medical Officer- Conference call and webcast at 8.30am ET todayNEW YORK, Aug. 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDA ...

Core Viewpoint - BrainStorm Cell Therapeutics Inc. will hold a conference call on August 14, 2024, to update shareholders on Q2 financial results and provide a corporate update [1] Group 1: Conference Call Details - The conference call is scheduled for 8:30 a.m. Eastern Time on August 14, 2024 [1] - Participants can submit questions in advance until 5:00 p.m. Eastern Time on August 12, 2024 [1] - The call can be accessed via toll-free and international numbers, with a specific access code provided [2] Group 2: Company Overview - BrainStorm Cell Therapeutics is focused on developing autologous adult stem cell therapeutics for neurodegenerative diseases [3] - The company holds rights to the NurOwn® technology platform for producing autologous MSC-NTF cells through an exclusive licensing agreement [3] Group 3: Clinical Development - Autologous MSC-NTF cells have received Orphan Drug designation from the FDA and EMA for treating amyotrophic lateral sclerosis (ALS) [4] - A Phase 3 trial for ALS has been completed, investigating the safety and efficacy of repeat-administration of autologous MSC-NTF cells [4] - The company has also completed a Phase 2 open-label multicenter trial for progressive multiple sclerosis (MS) [4]

ACF Equity Research FROM ACF EQUITY RESEARCH HEALTHCARE TEAMLONDON, July 24, 2024 /PRNewswire/ -- NASDAQ: BCLIREAD ACF EQUITY RESEARCH'S UPDATE NOTE HERE READ ACF EQUITY RESEARCH'S RELATED THEMATIC RESEARCH NOTE ON REGENERATIVE MEDICINE – NEURODEGENERATIVE DISEASE STEM CELLS & ALS/MND/LOU GEHRIG'S HEREUPDATE NOTE: BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) develops NurOwn® stem cell therapy for Neurodegenerative diseases (NDDs) – BCLI's first target is ALS (MND/Lou Gehrig's). Since initiation – PIIIb ...