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 _____________ | --- | --- | --- | |----------------------------------|-------------------|-------------------------------------------------| ...

Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) Q2 2020 Results Conference Call August 5, 2020 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - Chief Executive Officer Ralph Kern - President and Chief Medical Officer Revital Geffen-Aricha - Vice President of Research of and Development Preetam Shah - Executive Vice President and Chief Financial Officer Conference Call Participants Jason McCarthy - Maxim Group David Bautz - Zacks Small-Cap Research Jason Kolbert - Dawson James ...

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 _________ ...

Company Overview - Brainstorm Cell Therapeutics is a clinical-stage biotechnology company focused on autologous stem cell therapies for neurodegenerative diseases like ALS and Progressive MS[6] - The company highlights large addressable markets for ALS with 30000 patients in the US and 450000 worldwide, and for Progressive MS with 500000 patients in the US and 1250000 worldwide[6] - The company also mentions potential markets in Parkinson's Disease with 1000000 US patients and Huntington's Disease with 30000 US patients[23] Clinical Trials and Development - The company's lead product, NurOwn, is being evaluated in preclinical models for various neurodegenerative diseases[25] - A Phase 3 ALS trial is fully enrolled, with topline data expected in the second half of 2020[6, 37] - A Phase 2 Progressive MS trial is actively enrolling[6] NurOwn Mechanism and Data - NurOwn increases Treg Cells, as shown in Phase 1/2a trials and in-vitro studies[34] - Phase 2 clinical trial demographics show a balanced baseline between MSC-NTF (n=36) and Placebo (n=12) groups[45] - ALSFRS-R efficacy outcomes from a Phase 2 trial show a change from post-treatment to pre-treatment slope with MSC-NTF compared to placebo[48] - CSF Neurotrophic Factors increased post-treatment in NurOwn treated patients[50] Clinical Trial Status and Regulatory - The Phase 3 ALS clinical trial completed enrollment in October 2019, with a DSMB safety review conducted at the end of October 2019[74] - The company has an agreement with the FDA on potential regulatory pathways for approval in ALS as of February 2020[74] - The Phase 2 Progressive MS clinical trial IND was granted in December 2018, with the first subjects enrolled in March 2019[77]

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2019 were $4.01 million, up from $1.97 million in Q3 2018, with a year-over-year increase of $1.59 million when excluding certain grants [17] - General and administrative expenses increased to $1.54 million in Q3 2019 from $1.26 million in Q3 2018, primarily due to higher payroll and stock-based compensation [17] - Net loss for Q3 2019 was $5.6 million or negative $0.25 per share, compared to a net loss of $3.17 million or negative $0.15 per share in Q3 2018 [18] Business Line Data and Key Metrics Changes - The Phase 3 ALS clinical trial was fully enrolled with 200 patients, and results are expected to be published in Q4 2020 [9] - The Phase 2 progressive MS trial is progressing well, with eight patients enrolled and expected readout in Q4 2020 [11] Market Data and Key Metrics Changes - The company received an additional $1.6 million from the Hospital Exemption pathway in Israel, aiding in the treatment of ALS patients [12] - The total available funding, including cash and remaining grants, amounts to approximately $5.9 million [18] Company Strategy and Development Direction - The management is engaged in strategic partnerships and collaborations, emphasizing that any agreements will prioritize patient and shareholder interests [14] - The company is focused on expanding its Investor Relations program and increasing awareness among institutional investors [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding ongoing engagement with the FDA and the ALS community, highlighting productive meetings and the potential for future collaborations [12][21] - The company is preparing for potential commercialization and has plans to ramp up manufacturing capabilities in anticipation of BLA approval [76] Other Important Information - The management team is actively exploring additional grants and funding opportunities to support ongoing clinical trials and operations [19][73] - The company is working on improving its manufacturing process to reduce costs and increase efficiency [59][77] Q&A Session Summary Question: Did BrainStorm management meet with FDA officials? - Yes, there was a productive meeting with FDA officials in September, and ongoing meetings are scheduled [21][22] Question: How does management plan to increase shareholder value? - The focus is on reaching out to institutional investors and exploring strategic partnerships while being selective in capital raising [27] Question: What is the status of the Hospital Exemption program in Israel? - The program is proceeding well, with ten patients enrolled and potential for additional approvals [29] Question: What updates are there on the Phase 2 MS trials? - Eight patients have been enrolled, and the trial is expected to complete enrollment by late spring [33] Question: Has the company submitted any data for expedited approvals? - Yes, data from the Phase 2 trial has been submitted, and fast track designation has been granted [35] Question: What is the competitive landscape for ALS treatments? - The competitive landscape is limited in later-stage programs, with BrainStorm positioned to be among the first to report results [43]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 ¨ 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) Dela ...