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]

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, 2020 ☐ 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 charter) Delaware ...

BrainStorm Cell Therapeutics Inc. BCLI) Q1 2020 Earnings Conference Call May 7, 2020 8:00 AM ET Company Participants Sean Leous - ICR Westwicke Chaim Lebovits - President and Chief Executive Officer Preetam Shah - EVP and Chief Financial Officer Ralph Kern - President and Chief Medical Officer David Setboun - Chief Operating Officer Conference Call Participants Marcia Kaplan - Ameriprise Financial John Evans - Raymond James Operator Greetings and welcome to the BrainStorm Cell Therapeutics First Quarter 202 ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's Q1 2020 financial statements show improved equity from financing, despite increased net loss due to R&D, with going concern uncertainty noted [Interim Condensed Consolidated Balance Sheets](index=6&type=section&id=Interim%20Condensed%20Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights (in thousands USD) | Account | March 31, 2020 (Unaudited) | December 31, 2019 (Audited) | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | $12,471 | $536 | +$11,935 | | Total current assets | $15,205 | $3,360 | +$11,845 | | Total assets | $18,071 | $6,534 | +$11,537 | | **Liabilities & Equity** | | | | | Accounts payable | $4,571 | $14,677 | -$10,106 | | Total current liabilities | $8,252 | $17,654 | -$9,402 | | Total liabilities | $9,060 | $18,757 | -$9,697 | | Total stockholders' equity (deficit) | $9,011 | $(12,223) | +$21,234 | - The company's financial position improved significantly, moving from a stockholders' deficit of **$(12,223) thousand** to an equity of **$9,011 thousand**, primarily due to capital raised from financing activities[9](index=9&type=chunk) [Interim Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Statement of Comprehensive Loss (in thousands USD, except per share data) | Metric | Three months ended March 31, 2020 | Three months ended March 31, 2019 | | :--- | :--- | :--- | | Research and development, net | $5,948 | $3,456 | | General and administrative | $2,360 | $1,472 | | **Operating loss** | **$(8,308)** | **$(4,928)** | | **Net loss** | **$(8,114)** | **$(5,027)** | | Basic and diluted net loss per share | $(0.32) | $(0.24) | - The net loss increased by **61%** year-over-year, primarily driven by a **72%** increase in research and development expenses related to ongoing clinical trials[10](index=10&type=chunk) [Statements of Changes in Stockholders' Equity](index=8&type=section&id=Statements%20of%20Changes%20in%20Stockholders%27%20Equity) - Stockholders' equity increased from a deficit of **$(12,223) thousand** at the beginning of 2020 to a positive **$9,011 thousand** by March 31, 2020[13](index=13&type=chunk) - The significant improvement in equity was driven by capital raising activities, including **$19.0 million** from an at-the-market (ATM) offering and **$10.0 million** from a Registered Direct Offering during the quarter[13](index=13&type=chunk) [Interim Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows Highlights (in thousands USD) | Cash Flow Activity | Three months ended March 31, 2020 | Three months ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,029) | $(835) | | Net cash provided by (used in) investing activities | $(1,994) | $3,131 | | Net cash provided by financing activities | $28,958 | $0 | | **Increase in cash and cash equivalents** | **$11,935** | **$2,296** | - The company generated **$29.0 million** in cash from financing activities, primarily from at-the-market (ATM) and registered direct offerings, which more than offset the **$15.0 million** cash used in operations[19](index=19&type=chunk) [Notes to Interim Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Notes detail NurOwn® therapy development, Q1 2020 capital raises, going concern uncertainty, and COVID-19 impacts on trials - The company is in the clinical development stage for its NurOwn® therapy, with a Phase 3 trial for ALS and a Phase 2 trial for Progressive Multiple Sclerosis (PMS)[25](index=25&type=chunk)[27](index=27&type=chunk) - Management has concluded that substantial doubt exists about the company's ability to continue as a going concern due to recurring losses and the need for additional funding to complete clinical trials and commercialization[32](index=32&type=chunk) - In Q1 2020, the company raised approximately **$17.86 million** from its June 2019 ATM, **$1.76 million** from its new March 2020 ATM, and **$10.0 million** from a Registered Direct Offering[51](index=51&type=chunk)[53](index=53&type=chunk)[55](index=55&type=chunk) - The COVID-19 pandemic has caused delays in the enrollment pace for the Phase 2 PMS clinical trial, though the Phase 3 ALS trial continues with modifications like telephone-based non-treatment visits[85](index=85&type=chunk)[86](index=86&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses NurOwn® trials, Q1 2020 net loss increase from R&D, and improved liquidity from financing, with ongoing capital needs [Company Overview and Recent Highlights](index=24&type=section&id=Company%20Overview%20and%20Recent%20Highlights) - BrainStorm is a biotechnology company developing autologous cellular therapies, with its lead candidate NurOwn® in a Phase 3 trial for ALS and a Phase 2 trial for Progressive Multiple Sclerosis (PMS)[89](index=89&type=chunk)[91](index=91&type=chunk) - The COVID-19 pandemic has caused enrollment delays in the Phase 2 PMS trial, but the Phase 3 ALS trial remains on track for top-line data in Q4 2020[91](index=91&type=chunk)[97](index=97&type=chunk) - The company held a high-level meeting with the FDA, which confirmed the Phase 3 ALS trial is collecting relevant data and committed to working collaboratively to identify a regulatory pathway forward[100](index=100&type=chunk) - Significant financing was secured in Q1 2020, including completing a **$20 million** ATM, initiating a new **$50 million** ATM, and closing a **$10 million** registered direct offering[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) [NurOwn® Proprietary Technology and Clinical Program](index=27&type=section&id=NurOwn%C2%AE%20Proprietary%20Technology%20and%20Clinical%20Program) - NurOwn® technology induces a patient's own bone marrow-derived mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors, which may protect neurons and reduce neuroinflammation[110](index=110&type=chunk)[114](index=114&type=chunk) - The ongoing Phase 3 ALS trial has completed enrollment of **200 patients** and is a multi-dose, double-blind, placebo-controlled study designed to support a Biologic License Application (BLA). Top-line data is expected in Q4 2020[25](index=25&type=chunk)[127](index=127&type=chunk)[131](index=131&type=chunk) - The Phase 2 trial in Progressive Multiple Sclerosis (PMS) is an open-label study recruiting **20 patients** across **5 U.S. centers**. Enrollment has been delayed by COVID-19, but top-line results may still be possible in Q4 2020[139](index=139&type=chunk)[142](index=142&type=chunk) - The company has received non-dilutive funding, including a total of **$14.75 million** to date from a **$15.91 million** CIRM grant for the ALS trial and a new **$1.5 million** grant from the Israel Innovation Authority (IIA)[144](index=144&type=chunk)[145](index=145&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands USD) | Expense Category | Three months ended March 31, 2020 | Three months ended March 31, 2019 | Change | | :--- | :--- | :--- | :--- | | Research and Development Expenses, net | $5,948 | $3,456 | +$2,492 | | General and Administrative Expenses | $2,360 | $1,472 | +$888 | | **Operating Loss** | **$8,308** | **$4,928** | **+$3,380** | | **Net Loss** | **$8,114** | **$5,027** | **+$3,087** | - The increase in R&D expenses was primarily due to costs associated with the ongoing Phase 3 ALS and Phase 2 PMS clinical trials[161](index=161&type=chunk) - General and administrative expenses rose mainly due to increased payroll, stock-based compensation, and public/investor relations costs[163](index=163&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2020, the company had approximately **$14.5 million** in cash, cash equivalents, and short-term bank deposits[165](index=165&type=chunk) - Net cash used in operating activities was **$15.0 million** for the quarter, while net cash provided by financing activities was **$29.0 million**[166](index=166&type=chunk) - The company raised gross proceeds of approximately **$17.86 million** from its June 2019 ATM, **$1.76 million** from its March 2020 ATM, and **$10.0 million** from a registered direct offering during the quarter[168](index=168&type=chunk)[169](index=169&type=chunk)[171](index=171&type=chunk) - The company will require substantial additional capital to complete the commercialization of its products and has stated that if it cannot raise more funds, it may not be able to continue as a going concern[173](index=173&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section has been omitted as the company qualifies as a smaller reporting company - Information regarding market risk is omitted because the company qualifies as a smaller reporting company[179](index=179&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and CFO concluded the company's disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2020[180](index=180&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the quarter ended March 31, 2020[181](index=181&type=chunk) [PART II – OTHER INFORMATION](index=35&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would adversely affect its business, financial condition, or results of operations - As of the report date, the company is not involved in any material legal proceedings[182](index=182&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section highlights COVID-19 related risks, including delays in the Phase 2 PMS trial and potential future impacts on clinical activities and capital raising - A new risk factor has been added concerning the business disruptions caused by the COVID-19 pandemic[183](index=183&type=chunk)[185](index=185&type=chunk) - The pandemic has already caused delays in the enrollment for the Phase 2 PMS clinical trial due to restricted access to healthcare sites[187](index=187&type=chunk) - Future impacts of COVID-19 are highly uncertain and could severely affect clinical trial activities, participant enrollment, study timelines, and the company's ability to raise capital[189](index=189&type=chunk)[190](index=190&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) No material changes were made to the procedures for stockholders to recommend board nominees during the quarter ended March 31, 2020 - No material changes were made to the procedures for stockholders to recommend board nominees during the quarter[192](index=192&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists documents filed as exhibits to the Form 10-Q, including distribution and securities purchase agreements, warrants, and various certifications - The report includes several exhibits, such as the March 6, 2020 Distribution Agreement with Raymond James and the Securities Purchase Agreement with Abbhi Investments, LLC[193](index=193&type=chunk)

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q4 2019 Results Earnings Conference Call February 18, 2020 8:00 AM ET Company Participants Sean Leous - ICR Westwicke Chaim Lebovits - President and Chief Executive Officer Preetam Shah - EVP and Chief Financial Officer Ralph Kern - Chief Operating and Chief Medical Officer Arturo Araya - Chief Commercial Officer Conference Call Participants Jason Kolbert - Dawson James Operator Greetings and welcome to the BrainStorm Cell Therapeutics Fourth Quarter 2019 Earn ...

UNITED STATES Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.00005 par value BCLI NASDAQ Stock Market LLC (Nasdaq Capital Market) SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K x ANNUAL REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2019 ¨ TRANSITION REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO _________ ...