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 ...

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q2 2019 Results Earnings Conference Call August 13, 2019 8:00 AM ET Company Participants Sean Leous - ICR Westwicke Chaim Lebovits - President and Chief Executive Officer Eyal Rubin - Executive Vice President and Chief Financial Officer Ralph Kern - Chief Operating Officer and Chief Medical Officer Conference Call Participants David Bautz - Zacks Small Cap Research Jason Kolbert - Dawson James John Rice - Wells Fargo Operator Good day and welcome to BrainStorm ...

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the company's interim financial statements, notes, and management's discussion and analysis [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited interim financial statements for June 30, 2019, reveal a net loss of $9.9 million and a $4.5 million stockholders' deficit, raising going concern doubts [Interim Condensed Consolidated Balance Sheets](index=6&type=section&id=Interim%20Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $8.86 million, while liabilities surged to $13.38 million, resulting in a $4.52 million stockholders' deficit by June 30, 2019 Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2019 (Unaudited) | Dec 31, 2018 (Audited) | | :--- | :--- | :--- | | **Total Current Assets** | $5,535 | $10,270 | | **Total Assets** | $8,864 | $11,228 | | **Total Current Liabilities** | $10,543 | $6,212 | | **Total Liabilities** | $13,380 | $6,212 | | **Total Stockholders' Equity (Deficit)** | $(4,516) | $5,016 | [Interim Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported increased net losses of $4.9 million for Q2 and $9.9 million for H1 2019, primarily due to higher R&D expenses Statement of Comprehensive Loss (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development, net | $3,554 | $1,481 | $7,010 | $2,458 | | General and administrative | $1,303 | $1,606 | $2,775 | $2,936 | | **Operating Loss** | **$(4,857)** | **$(3,087)** | **$(9,785)** | **$(5,394)** | | **Net Loss** | **$(4,900)** | **$(3,091)** | **$(9,927)** | **$(5,389)** | | **Basic and diluted net loss per share** | **$(0.23)** | **$(0.16)** | **$(0.47)** | **$(0.28)** | [Interim Condensed Statements of Changes in Stockholders' Equity](index=8&type=section&id=Interim%20Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity shifted from a $5.0 million positive balance to a $4.5 million deficit by June 30, 2019, mainly due to a $9.9 million net loss Changes in Stockholders' Equity (in thousands) | Description | Amount | | :--- | :--- | | Balance as of January 1, 2019 | $5,016 | | Net loss | $(9,927) | | Stock-based compensation | $390 | | Exercise of options/warrants | $5 | | **Balance as of June 30, 2019** | **$(4,516)** | [Interim Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $4.3 million for H1 2019, while investing activities provided $4.5 million, resulting in a slight cash increase to $1.13 million Cash Flow Summary - Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,343) | $(2,071) | | Net cash provided by (used in) investing activities | $4,522 | $(10,169) | | Net cash provided by financing activities | $5 | $12,019 | | **Increase (decrease) in cash** | **$184** | **$(221)** | | **Cash at end of period** | **$1,126** | **$2,262** | [Notes to Interim Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight a 'Going Concern' warning due to recurring losses, detail a $15.9 million CIRM grant, a $20 million ATM offering, and a $3.3 million post-period warrant exercise - The company's recurring operating losses and lack of revenue raise **substantial doubt about its ability to continue as a going concern**, with management planning to raise additional funds[24](index=24&type=chunk)[26](index=26&type=chunk) - A **$15.9 million grant from CIRM** was received in July 2017 for the NurOwn® Phase 3 study, with **$12.55 million received** by June 30, 2019[45](index=45&type=chunk) - The company established a **$20 million at-the-market (ATM) offering** on June 11, 2019, though no shares were sold by June 30, 2019[52](index=52&type=chunk)[54](index=54&type=chunk) - Post-quarter, on August 2, 2019, the company generated approximately **$3.3 million in gross cash proceeds** from a warrant exercise[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses progress on NurOwn® clinical trials for ALS and MS, reports increased net losses due to R&D, and addresses ongoing liquidity challenges requiring additional capital [Company Overview and Recent Highlights](index=24&type=section&id=Company%20Overview%20and%20Recent%20Highlights) Brainstorm, a biotech company, is advancing NurOwn® for ALS (Phase 3, over 75% enrolled) and Progressive MS (Phase 2), expanding into exosomes, and generated $1 million from patient treatments in Israel - The NurOwn® Phase 3 ALS trial is **over 75% enrolled**, with completion by Q3 2019 and top-line data expected in H2 2020[91](index=91&type=chunk) - The company expanded its cellular technology platform to include **NurOwn®-derived exosomes** for CNS disorder development[93](index=93&type=chunk) - Approximately **$1 million** was generated from treating **6 ALS patients in Israel** via the Hospital Exemption pathway[94](index=94&type=chunk) [NurOwn® Technology and Clinical Programs](index=25&type=section&id=NurOwn%C2%AE%20Technology%20and%20Clinical%20Programs) NurOwn® is an autologous MSC-based technology in pivotal Phase 3 for ALS, targeting rapid progressors, and in Phase 2 for Progressive MS, with top-line data for both expected in H2 2020 - NurOwn® technology utilizes **autologous cells**, mitigating rejection risk and eliminating the need for immunosuppressive agents[101](index=101&type=chunk) - The Phase 3 ALS trial targets **rapid progressors**, a subgroup with superior Phase 2 outcomes, using an **ALSFRS-R score responder analysis** as the primary endpoint[112](index=112&type=chunk)[113](index=113&type=chunk) - A Phase 2 open-label trial for NurOwn® in **progressive Multiple Sclerosis (MS)** is recruiting **20 patients** across **5 U.S. centers**, with top-line data anticipated in H2 2020[118](index=118&type=chunk) [Funding and Intellectual Property](index=29&type=section&id=Funding%20and%20Intellectual%20Property) The company secured **$15.9 million from CIRM** (with $12.55 million received) and **$3 million from IIA** in non-dilutive funding, bolstering its IP portfolio of **14 granted patents** and **24 pending applications** - A non-refundable **$15.9 million grant from CIRM** supports the Phase 3 ALS study, with **$12.55 million received** to date[119](index=119&type=chunk) - The company received approximately **$3 million in aggregate grants** from the Israel Innovation Authority (IIA) in 2018 and 2019[120](index=120&type=chunk) - A European patent was granted in March 2019, covering the use of **Mesenchymal Stem Cells** for treating various CNS diseases, including ALS, MS, and Parkinson's[122](index=122&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The company reported a **net loss of $4.9 million** ($0.23 per share) for Q2 2019, an increase from $3.1 million in 2018, primarily due to a **$2.1 million rise in R&D expenses** Comparison of Operating Results - Three Months Ended June 30 (in thousands) | Expense Category | 2019 | 2018 | Change | | :--- | :--- | :--- | :--- | | Research and Development, net | $3,554 | $1,481 | +$2,073 | | General and Administrative | $1,303 | $1,606 | -$303 | | **Operating Loss** | **$4,857** | **$3,087** | **+$1,770** | | **Net Loss** | **$4,900** | **$3,091** | **+$1,809** | [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and equivalents totaled **$2.7 million**, with **$3.5 million cash used in operations** for the quarter, necessitating additional capital despite a **$20 million ATM program** and a **$3.3 million post-quarter warrant exercise** - Cash, cash equivalents, and short-term bank deposits totaled approximately **$2.7 million**[135](index=135&type=chunk) - Net cash used in operating activities was **$3.5 million** for Q2 2019, primarily for clinical trial costs, payroll, and rent[136](index=136&type=chunk) - An at-the-market (ATM) program allows the sale of up to **$20 million in common stock**, offering financial flexibility, with no sales in the quarter[139](index=139&type=chunk) - On August 2, 2019, the company raised approximately **$3.3 million in gross proceeds** from a warrant exercise agreement[140](index=140&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section has been omitted from the report because the company qualifies as a smaller reporting company - Market risk information is omitted as the Company qualifies as a **smaller reporting company**[144](index=144&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation conducted by management, including the CEO and CFO, the company's disclosure controls and procedures were concluded to be effective as of June 30, 2019, with no material changes to internal controls over financial reporting during the quarter - The CEO and CFO concluded that disclosure controls and procedures were **effective** as of the period end[145](index=145&type=chunk) - No material changes to internal control over financial reporting occurred during the quarter[146](index=146&type=chunk) [PART II– OTHER INFORMATION](index=34&type=section&id=PART%20II%E2%80%93%20OTHER%20INFORMATION) This section details legal proceedings, risk factors, other disclosures, and a comprehensive list of filed exhibits [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would be expected to have a material adverse effect on its business, financial condition, or results of operations - The company is not currently a party to any **material legal proceedings**[148](index=148&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors that were previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 - No material changes occurred from the risk factors previously disclosed in the **Annual Report on Form 10-K** for FY2018[149](index=149&type=chunk) [Other Information](index=34&type=section&id=Item%205.%20Other%20Information) During the quarter ended June 30, 2019, the company made no material changes to the procedures by which stockholders may recommend nominees to its Board of Directors - No material changes were made to procedures for stockholder recommendations for Board nominees[150](index=150&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the documents filed as exhibits to the Form 10-Q, which include a Distribution Agreement related to the at-the-market offering, CEO and CFO certifications as required by the Sarbanes-Oxley Act, and XBRL data files - Filed exhibits include the **ATM offering Distribution Agreement**, **Sarbanes-Oxley certifications**, and **XBRL instance documents**[151](index=151&type=chunk)

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 March 31, 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) Delaware ...

UNITED STATES 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, 2018 ¨ TRANSITION REPORT UNDER 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 20-7273918 (State or other jurisd ...