Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021. ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number 001-36641 BRAINSTORM CELL THERAPEUTICS INC. (Exact name of registrant as specified i ...

Financial Data and Key Metrics Changes - Research and development expenses for Q2 2021 were $3.59 million, down from $5.69 million in Q2 2020, a decrease of approximately $2.1 million year-over-year [18] - General and administrative expenses increased to $2.52 million in Q2 2021 from $1.71 million in Q2 2020, an increase of approximately $816,000 [19] - Net loss for Q2 2021 was $6.27 million or $0.17 per share, compared to a net loss of $7.39 million or $0.25 per share in Q2 2020 [19] - Cash and cash equivalents were approximately $35 million as of June 30, 2021, down from approximately $40 million on March 31, 2021 [19] Business Line Data and Key Metrics Changes - The company is advancing its NurOwn treatment for ALS and progressive MS, with significant developments in both areas [12][16] - The phase 2 study for progressive MS showed safety and consistent changes across all functional measures, with several participants meeting criteria for clinical improvement [15] Market Data and Key Metrics Changes - The company received GMP approval from the Israeli Ministry of Health for its manufacturing facility, which more than doubles its capacity to supply NurOwn to ALS patients in Israel and Europe [16] Company Strategy and Development Direction - The company aims to secure approval for NurOwn in ALS and is exploring opportunities for its use in other neurodegenerative diseases [38] - The company is focused on gathering data from its expanded access program to support its regulatory strategy [24] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgency to provide effective treatments for ALS patients and the need for collaboration with government and advocacy groups [8][10] - The company is closely monitoring regulatory developments and is prepared to adapt its strategy accordingly [28] Other Important Information - The company has received strong support from ALS and MS advocacy organizations for its clinical programs [15][31] - A series of patents have been granted or allowed in various territories, strengthening the company's intellectual property position [17] Q&A Session Summary Question: What was the consensus regarding BLA submission based on discussions with ALS experts? - Management remains confident in the effectiveness and safety of NurOwn and is prioritizing the publication of phase 2 data in a peer-reviewed journal [23] Question: Will there be a clinical trial in Europe before NurOwn is accessible to patients? - The company is evaluating regulatory strategies for access outside the U.S. and will provide details once finalized [26] Question: When is the expected BLA submission and timeframe for peer review? - The timeline for the review process is not in the company's control, but they are working to expedite publication [28] Question: Is the hospital exemption program still active in Israel? - The hospital exemption program is not ongoing, but discussions with the Israeli Ministry regarding different regulatory paths are in progress [49] Question: What is the company's cash position and debt status? - The company has approximately $35 million in cash and no debt on its balance sheet [36] Question: Are there plans for future clinical trials? - The company is focused on gaining approval for NurOwn for ALS and exploring indications with a high probability of success [38] Question: Is the company evaluating partnering opportunities? - The company is receiving interest from partners and is in discussions regarding various parts of its pipeline [40]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021. ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number 001-36641 BRAINSTORM CELL THERAPEUTICS INC. (Exact name of registrant as specified in its ...

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q1 2021 Earnings Conference Call April 26, 2021 8:00 AM ET Company Participants Michael Wood - IR, LifeSci Advisors Chaim Lebovits - President and CEO Dr. Stacy Lindborg - EVP and Head, Global Clinical Research Dr. Ralph Kern - President and Chief Medical Officer Dr. Preetam Shah - EVP and CFO Dr. David Setboun - EVP and COO Conference Call Participants David Bautz - Zacks Small Cap Research Operator Greetings. Welcome to BrainStorm Cell Therapeutics’ First Qu ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021. ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number 001-36641 BRAINSTORM CELL THERAPEUTICS INC. (Exact name of registrant as specified in it ...

Financial Data and Key Metrics Changes - Research and Development (R&D) expenses for the year ended December 31, 2020, were $22.3 million, an increase from $17.2 million in 2019, primarily due to increased expenses related to materials, consultants, and payroll [18][19][20] - General and administrative expenses rose to approximately $9.4 million in 2020 from $5.8 million in 2019, driven by higher payroll and stock-based compensation [21] - The net loss for the year ended December 31, 2020, was $31.8 million, or $1.07 per share, compared to a net loss of $23.3 million, or $1.06 per share, in 2019 [21] - Cash and cash equivalents were approximately $42 million at December 31, 2020, compared to approximately $0.6 million at the end of 2019 [21][22] Business Line Data and Key Metrics Changes - The company is focused on the development of NurOwn for ALS, with ongoing discussions with the FDA regarding regulatory approval [7][9] - An expanded access program for ALS patients who completed the Phase III trial has been initiated, reflecting the promise of NurOwn's clinical data [10][44] - The company is also progressing in its clinical program for progressive MS, with top-line data anticipated by the end of Q1 2021 [14][46] Market Data and Key Metrics Changes - The company is actively engaging with the ALS community and regulatory bodies, which has increased confidence and support for NurOwn [8][9] - The ALS phase III trial demonstrated a clinically meaningful slowing of disease progression, which is critical for future regulatory discussions [11][12] Company Strategy and Development Direction - The primary focus is on obtaining regulatory approval for NurOwn in ALS, with a commitment to making it available to patients [6][7] - The company is also exploring the development of NurOwn as a treatment for Alzheimer's disease, targeting multiple biological pathways [15][16] - There is an ongoing assessment of the potential for NurOwn-derived exosomes to treat COVID-19 related ARDS, with discussions for development opportunities [17][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy of NurOwn and emphasized the importance of ongoing dialogue with the FDA [8][39] - The company is committed to addressing unmet medical needs in neurodegenerative diseases and is optimistic about the future of its clinical programs [14][15] Other Important Information - The company has raised approximately $21.8 million through the sale of common stock as part of an amended ATM distribution agreement [22] - The expanded access program for ALS patients is set to begin dosing shortly, with specific eligibility criteria in place [44] Q&A Session Summary Question: If NurOwn is granted FDA approval, will it be authorized for a specific subset of patients or all ALS patients? - Management cannot speculate on approval conditions but believes investigators support broad access for all patients [24][25] Question: Will additional trials be needed for the subgroup with clinically meaningful results from the phase III trial? - New analyses have been presented to the FDA, and management is in active dialogue regarding regulatory pathways [26][28] Question: Can you explain the high percentage of patients under 25 at baseline in the phase III trial? - The entry criteria were based on screening scores, and the trial included a broader set of patients compared to other studies [29][30] Question: What caused the high placebo effect observed in the phase III trial? - The placebo effect could stem from various factors, including patient randomization and disease severity [30][31] Question: What biomarkers were evaluated in the phase III trial, and how do they correlate with treatment response? - The trial collected extensive biomarker data, which correlates with clinical responses and supports NurOwn's mechanism of action [32][34] Question: When will the BLA for NurOwn be submitted to the FDA? - The BLA has not yet been submitted, and management is in ongoing discussions with the FDA regarding the regulatory path [35][39] Question: What is the status of the expanded access program for NurOwn? - The program was developed in partnership with the FDA and will initially treat less severely affected ALS patients [43][44] Question: What are the expectations for the progressive MS study's top-line data? - Top-line data is expected by the end of the current quarter, focusing on safety, efficacy, and biomarker assessments [46][47] Question: Has the Phase III Alzheimer's trial begun in Europe? - The trial is in the final steps of initiation, with no patients yet dosed [48] Question: Will the company conduct a clinical trial for the COVID-19 ARDS program? - The company is reviewing the unmet need and considering various partnerships based on promising preclinical results [52]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ⌧ ANNUAL REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2020 ¨ TRANSITION REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | FOR THE TRANS ...

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q3 2020 Earnings Conference Call October 15, 2020 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors, LLC Chaim Lebovits - President and Chief Executive Officer Ralph Kern - President and Chief Medical Officer Stacy Lindborg - Executive Vice President and Head of Global Clinical Research Preetam Shah - Executive Vice President and Chief Financial Officer David Setboun - Executive Vice President and Chief Operating Officer Anthony Waclawski - Execu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ | --- | --- | --- | |----------------------------------|-------------------|-------------------------------------------------| ...

Financial Data and Key Metrics Changes - The company reported a net loss of $7.4 million or $0.25 per share for Q2 2020, compared to a net loss of $4.9 million or $0.23 per share for Q2 2019, indicating an increase in losses year-over-year [22][23] - Cash and cash equivalents were approximately $16.2 million as of June 30, 2020, up from approximately $2.7 million as of June 30, 2019, reflecting a significant improvement in liquidity [22][23] - As of July 31, 2020, total available funding was approximately $37.5 million, including cash on hand of approximately $34.7 million and remaining non-dilutive funding from various grants [23] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2020 were $5.69 million, up from $3.55 million in Q2 2019, primarily due to increased materials, payroll, and stock-based compensation costs [21] - General and administrative expenses increased to $1.71 million in Q2 2020 from $1.3 million in Q2 2019, driven by higher payroll and stock-based compensation [22] Market Data and Key Metrics Changes - The company is actively exploring opportunities to expedite the review process with the FDA for its ALS treatment, indicating a proactive approach to market entry [14][27] - The ALS Association and IMALS awarded the company a combined grant of $500,000 to fund an ALS biomarker study, which will enhance understanding of treatment responses [14] Company Strategy and Development Direction - The company aims to expedite the submission of a Biologic License Application (BLA) with the FDA following the top-line data readout expected by the end of November 2020 [14][26] - The company is focusing on expanding its clinical pipeline to include treatments for Alzheimer’s disease and progressive MS, with plans to initiate trials in Europe [15][16][38] - The company is also developing an innovative exosome-based platform technology for treating severe COVID-19, indicating diversification in its research focus [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s strong financial position, with no debt and a record cash balance, which positions the company well for future growth [7][23] - The management team emphasized the importance of their mission to develop treatments for neurodegenerative diseases, especially during the COVID-19 pandemic [8][9] - The company is committed to addressing the urgent needs of the ALS community and is in close contact with the FDA to expedite the review process [27] Other Important Information - The company has made key additions to its senior management team, enhancing its operational capabilities [9][10] - The Phase III pivotal trial for ALS has enrolled approximately 200 participants, and all scheduled doses have been administered [12][13] Q&A Session Summary Question: Timeline for ALS Phase III data readouts and BLA submission - Management confirmed that the Phase III trial readout is expected in Q4 2020, with top-line data anticipated by the end of November [26][27] Question: Manufacturing plans if FDA approves neuron - The company is actively working with potential partners for commercial manufacturing and has streamlined its manufacturing process [28][29] Question: Update on Phase II progressive MS trial - The Phase II progressive MS trial is fully enrolled with 20 patients, and the company plans to focus on full data analysis rather than interim analysis [32][34] Question: Plans for sales force in the U.S. or Europe - The company is considering both internal and external options for a sales force and is prepared to provide treatments upon approval [65][66] Question: Guidance on earnings - Management highlighted the strong financial position with approximately $35 million cash on hand, indicating confidence in navigating the upcoming quarters [70]