BRAINSTORM CELL THERAPEUTICS INC.
For the period ended Dec 31, 2025. Filed Mar 31, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 31, 2026
BCLI$1.14-7.3%Stored close · as of Jul 8, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-31.
0001410578-25-000545
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001104659-26-037927
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 44 previous paragraphs and 52 current paragraphs.
24 unchanged; 16 reworded; 9 added; 4 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 12 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
In February 2026, the Company entered into two separate Securities Purchase Agreements (the “Agreements”) for the issuance of securities in private placement transactions, seeking to raise aggregate gross proceeds of up to $2,000,000. Under the terms of both Agreements, investors are purchasing units consisting of Common Stock at a purchase price of $0.60 per share, or Pre-Funded Warrants at a purchase price of $0.59995 per warrant (with an exercise price of $0.00005 per share) to comply with beneficial ownership limitations. In connection with these placements, the Company is also issuing Common Warrants exercisable for a number of shares equal to 120% of the purchased units at an exercise price of $1.00 per share, subject to standard anti-dilution adjustments.
Current report
Recent Financing Activities:
Current report
On October 31, 2025, the Company entered into a securities purchase agreement (the “Vanquish Purchase Agreement”) with Vanquish Funding Group Inc., a Virgina corporation (“Vanquish”), pursuant to which the Company issued to Vanquish a promissory note (the “Note”) in the principal amount of $182,400 (including $22,400 of original issue discount) and received funds of $155,000 after combined legal fees and due diligence fees of $5,000. Upon an event of default the Note is convertible into shares of common stock of the Company (“Conversion Shares”), subject to a 4.99% beneficial ownership limitation, at a 35% discount to the lowest trading price of the Company’s common stock for the 10 trading days prior to the conversion. The Note bears interest at 12%, which interest rate increases to 22% if not timely paid. The Note matures on August 30, 2026. Under the Note, $102,144 is payable on April 30, 2026 and $25,536 is payable on each of May 30, 2026, June 30, 2026, July 30, 2026, and August 30, 2026. The Vanquish Purchase Agreement provides that, subject to further agreement between Vanquish and the Company, Vanquish may provide additional tranches of financing during the next twelve (12) months of up to $2 million in the aggregate.
Current report
On November 10, 2025, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with Labrys Fund II, L.P., a Delaware limited partnership (“Labrys”), pursuant to which the Company issued to Labrys a promissory note (the “Labrys Note”) in the principal amount of $143,750 (including $18,750 of original issue discount) and received funds of $121,500 after legal fees of $3,500. Upon an event of default, the Labrys Note is convertible into shares of common stock of the Company (“Conversion Shares”), subject to a 4.99% beneficial ownership limitation, at a 25% discount to the lowest trading price of the Company’s common stock for the 20 trading days prior to the conversion. Under the Labrys Note, $22,589 is payable on each of May 11, 2026, June 10, 2026, July 10, 2026, August 10, 2026, September 10, 2026, and October 9, 2026. On November 10, 2026, the Note matures, and all remaining principal and any accrued and unpaid interests and other fees will be due.
Current report
On December 31, 2025, January 5, 2026 and January 6, 2026, the Company entered into three separate securities purchase transactions pursuant to which it issued three promissory notes to three institutional investors, as summarized below. Each transaction was entered into in reliance upon exemptions from registration under the Securities Act of 1933, as amended.
Current report
On December 31, 2025, the Company entered into a Securities Purchase Agreement with Vanquish Funding Group Inc., under which the Company issued a note in the aggregate principal amount of $94,300 (including $12,300 original issue discount) for aggregate purchase price proceeds of $82,000, and with the agreement contemplating additional tranches of up to $2,000,000 subject to further agreement (the “Vanquish Note”). The Vanquish Note bears a one-time interest charge of 12%, matures October 30, 2026, and provides for five scheduled payments from June 30, 2026 through October 30, 2026, with a five-day grace period. The Company may prepay at specified discounts within 180 days after issuance. Five days after a material event of default, the holder may convert all or any portion of outstanding amounts into common stock at a price equal to 65% of the lowest trading price during the 10 trading days prior to conversion, subject to a 4.99% beneficial ownership limitation, customary adjustments, and specified liquidated damages for late delivery of conversion shares. The Vanquish Note includes customary covenants, events of default and related remedies, including a default payment equal to 150% of outstanding principal and accrued amounts, adjusted to 175% upon certain subsequent defaults, and is governed by Virginia law. The Vanquish Note is unsecured.
Current report
On January 5, 2026, the Company entered into a Note Purchase Agreement with Quick Capital, LLC, under which the Company issued a convertible promissory note in the principal amount of $94,875, and received aggregate proceeds, of approximately $80,000, reflecting an original issue discount of $12,500 (the “Quick Capital Note”). The Quick Capital Note bears a one-time interest charge equal to 10% of principal and matures 12 months from the issue date, with contractual monthly amortization payments beginning July 5, 2026 through January 5, 2027. Upon an event of default, the holder may convert all or a portion of the outstanding amounts into common stock at a price per-share equal to 75% of the lowest trading price during the 20 trading days preceding conversion, subject to a 4.99% beneficial ownership limitation, customary adjustments, and specified liquidated damages for conversion delays. The Quick Capital Note contains customary covenants, events of default, cross-default provisions and remedies, including a default payment equal to 150% of outstanding principal and accrued amounts upon certain events of default. The Quick Capital Note is unsecured.
Current report
On January 6, 2026, the Company entered into a Securities Purchase Agreement with Auctus Fund, LLC, under which the Company issued a convertible promissory note in the aggregate principal amount of $140,000, including a $14,000 original issue discount, for cash proceeds of $126,000 before purchaser fees and due diligence costs withheld at closing (the “Auctus Fund Note”). The Auctus Fund Note bears a one-time interest charge of 12% of principal, matures 12 months from the issue date, and provides for scheduled amortization payments beginning 60 days after closing. Beginning six months after issuance, or earlier upon an event of default, the note is convertible at a price equal to 65% of the lowest traded price during the 15 trading days prior to conversion, subject to a 4.99% beneficial ownership limitation and customary adjustments. The agreement includes piggy-back registration rights, a most favored nation provision and variable rate transaction prohibitions, and a right permitting the holder to require up to 50% of subsequent financing or other specified cash proceeds above a $500,000 threshold to be applied to repayment. The Auctus Fund Note includes customary events of default, remedies including a default amount equal to 150% of outstanding principal and accrued amounts, liquidated damages for conversion delays, and prohibitions on certain transactions. The Auctus Fund Note is unsecured.
Current report
In February 2026, the Company entered into two separate Securities Purchase Agreements (the “Agreements”) for the issuance of securities in private placement transactions, seeking to raise aggregate gross proceeds of up to $2,000,000. Under the terms of both Agreements, investors are purchasing units consisting of Common Stock at a purchase price of $0.60 per share, or Pre-Funded Warrants at a purchase price of $0.59995 per warrant (with an exercise price of $0.00005 per share) to comply with beneficial ownership limitations. In connection with these placements, the Company is also issuing Common Warrants exercisable for a number of shares equal to 120% of the purchased units at an exercise price of $1.00 per share, subject to standard anti-dilution adjustments.
Removed paragraphs (4)
Previous report
Net cash provided by investing activities for the year ended December 31, 2024 was $12,000 representing disposal of equipment.
Previous report
Recent Sales of Unregistered Securities:
Previous report
On July 17, 2023, the Company entered into a Securities Purchase Agreement with the purchaser named therein, pursuant to which the Company agreed to sell, in the Offering, an aggregate of 270,270 shares of Common Stock, together with the Common Warrants to purchase 270,270 shares of Common Stock, at a purchase price of $27.75 per share and accompanying warrants for gross proceeds to the Company of approximately $7.5 million, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company. The Offering closed on July 19, 2023. The Common Warrants are immediately exercisable, expire five years following the date of issuance and have an exercise price of $30.00 per share.
Previous report
On June 27, 2024, the Company entered into a Securities Purchase Agreement with the purchaser, pursuant to which the Company agreed to sell, (i) an aggregate of 527,918 registered shares of the Company’s common stock, (ii) the Pre-Funded Warrants to purchase up to 212,823 shares of Common Stock and (iii) unregistered warrants to purchase up to 1,111,111 shares of Common Stock, at a purchase price of $5.4 per share of Common Stock and accompanying Common Warrant, or $5.399 per Pre-Funded Warrant and accompanying Common Warrant. The Offering of the Securities yielded gross proceeds to the Company of approximately $4.0 million, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company. The Offering closed on June 28, 2024. The Warrants will be exercisable six months after the issuance date, will expire five years following the date of issuance and have an exercise price of $5.868 per share. The Pre-Funded Warrant Shares are immediately exercisable at an exercise price of $0.00005 per share and will remain exercisable until the Pre-Funded Warrants are exercised in full.
Reworded paragraphs (16)
Previous wording
For the period from inception (September 22, 2000) until December 31, 2024, we did not generate any revenues from operations. In addition, we incurred operating costs and expenses of approximately $11,623,000 during the year ended December 31, 2024.
Current wording
For the period from inception (September 22, 2000) until December 31, 2025, we did not generate any revenues from operations. In addition, we incurred operating costs and expenses of approximately $10,307,000 during the year ended December 31, 2025.
Previous wording
Our business model calls for significant investments in research and development. Our research and development expenditures, net in the year ended December 31, 2024 were $4,651,000, a decrease of $6,095,000 compared to $10,746,000 for the year ended December 31, 2023.
Current wording
Our business model calls for significant investments in research and development. Our research and development expenditures, net in the year ended December 31, 2025 were $4,175,000, a decrease of $476,000 compared to $4,651,000 for the year ended December 31, 2024.
Previous wording
This decrease is due to: (i) a decrease of $2,450,000 in connection with costs related to the Phase 3 Clinical Trials; (ii) a decrease of $2,028,000 in connection with materials and clean room facilities; (iii) a decrease of $1,476,000 for costs related to payroll expenses and costs related to stock-based compensation expenses and (iv) a decrease of $141,000 in connection with patens, depreciation and rent and other costs.
Current wording
This decrease is due to: (i) a decrease of $401,000 for costs related to clinical activities suppliers; (ii) a decrease of $196,000 in connection with materials and clean room facilities; (iii) a decrease of $38,000 for costs related to payroll expenses and (iv) a decrease of $132,000 in connection with depreciation and travel costs. This decrease was partially offset by an increase of $291,000 in stock-based compensation expenses, patens, rent and other costs.
Previous wording
General and administrative expenses for the years ended December 31, 2024 and 2023 were $7,042,000 and $10,693,000, respectively. The decrease of $3,651,000 in general and administrative expenses is mainly due to: (i) a decrease of $2,841,000 in in payroll expenses and (ii) a decrease of $844,000 in the travel costs, consultants, rent costs, depreciation and costs of our investor relations and public relations activities. This decrease was partially offset by an increase of $34,000 in stock-based compensation expenses and stock costs.
Current wording
General and administrative expenses for the years ended December 31, 2025 and 2024 were $5,778,000 and $7,042,000, respectively. The decrease of $1,264,000 in general and administrative expenses is mainly due to: (i) a decrease of $852,000 in in payroll expenses and (ii) a decrease of $1,020,000 in the travel costs, consultants, rent costs, depreciation, stock costs and costs of our investor relations and public relations activities. This decrease was partially offset by an increase of $608,000 in stock-based compensation expenses.
Previous wording
Financial expense for the year ended December 31, 2024 was $77,000 as compared to financial expenses of $447,000 for the year ended December 31, 2023 due to conversion exchange rates that was offset by financial expenses of $169 related to issuance costs of warrants that were classified as a liability in 2023.
Current wording
Financial expense for the year ended December 31, 2025 was $533,000 as compared to financial expenses of $77,000 for the year ended December 31, 2024 as a result of interest paid for loans and due to conversion exchange rates.
Previous wording
Net loss for the year ended December 31, 2024 was $11,623,000, as compared to a net loss of $17,192,000 for the year ended December 31, 2023. Net loss per share for the year ended December 31, 2024 and December 31, 2023 was $2.31 and $6.00, respectively.
Current wording
Net loss for the year ended December 31, 2025 was $10,307,000, as compared to a net loss of $11,623,000 for the year ended December 31, 2024. Net loss per share for the year ended December 31, 2025 and December 31, 2024 was $1.11 and $2.31, respectively.
Previous wording
The weighted average number of shares of Common Stock used in computing basic and diluted net loss per share for the year ended December 31, 2024 was 5,021,798 compared to 2,871,729 for the year ended December 31, 2023.
Current wording
The weighted average number of shares of Common Stock used in computing basic and diluted net loss per share for the year ended December 31, 2025 was 9,268,976 compared to 5,021,798 for the year ended December 31, 2024.
Previous wording
To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional public and private sales of its Common Stock and warrants, the exercise of warrants, the issuance of convertible promissory notes, sales of Common Stock via its August 9, 2021 ATM program and other funding transactions. While the Company has been successful in raising financing recently and in the past, there can be no assurance that it will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all.
Current wording
To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional public and private sales of its Common Stock and warrants, the exercise of warrants, the issuance of convertible promissory notes and other funding transactions. While the Company has been successful in raising financing recently and in the past, there can be no assurance that it will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. The Company’s common stock has been delisted from the Nasdaq and now trades on the OTCQB Venture Market. Accordingly, the August 9, 2021 ATM may no longer be available for use by the Company.
Previous wording
Management expects that the Company will continue to generate losses from the clinical development and regulatory activities, which will result in a negative cash flow from operating activity. The Company has completed regulatory review of the BLA for NurOwn for the treatment of ALS with the withdrawal of the BLA on November 3, 2023. The decision to withdraw the BLA was coordinated with FDA and is viewed by FDA as a withdrawal without prejudice. On November 20, 2023, we announced that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting took place on December 6, 2023. On December 7, 2023, we announced the completion of a productive meeting with the FDA to discuss NurOwn®. The primary objective of the meeting was to discuss plans for an SPA with FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. The ultimate goal of the SPA is to secure the FDA’s agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application. On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under an SPA, on the design for a Phase 3b trial of NurOwn® in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that support a future BLA in ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn®, its investigational therapy for ALS. This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a SPA agreement for its NurOwn Phase 3b trial.
Current wording
of the meeting was to discuss plans for an SPA with FDA on the overall protocol design for a planned Phase 3b registrational trial for NurOwn®. The ultimate goal of the SPA is to secure the FDA’s agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application. On February 23, 2024, we announced that we submitted the SPA request to the FDA for the planned Phase 3b clinical trial of NurOwn® for the treatment of ALS. On April 9, 2024, the Company announced that it received written agreement from the FDA, under an SPA, on the design for a Phase 3b trial of NurOwn® in ALS. The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating the Company’s adequacy in addressing objectives that support a future BLA in ALS. On June 26, 2024, the Company announced that it has reached alignment with FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn®, its investigational therapy for ALS. This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a SPA agreement for its NurOwn Phase 3b trial.
Previous wording
Since inception, the Company has financed its operations primarily through public and private sales of its Common Stock and warrants, the exercise of warrants, the issuance of convertible promissory notes, sales via the ATM programs and through various grants. At December 31, 2024 cash, cash equivalents and restricted cash amounted to $371,000.
Current wording
Since inception, the Company has financed its operations primarily through public and private sales of its Common Stock and warrants, the exercise of warrants, the issuance of convertible promissory notes, sales via the ATM programs and through various grants. At December 31, 2025 cash, cash equivalents and restricted cash amounted to $276,000.
Previous wording
Net cash used in operating activities for the year ended December 31, 2024 was $9,093,000. Cash used for operating activities was primarily attributed to cost of clinical trials, rent of clean rooms and materials for clinical trials, payroll costs, rent, outside legal fee expenses and public relations expenses.
Current wording
Net cash used in operating activities for the year ended December 31, 2025 was $6,975,000. Cash used for operating activities was primarily attributed to cost of clinical trials, rent of clean rooms and materials for clinical trials, payroll costs, rent, outside legal fee expenses and public relations expenses.
Previous wording
Net cash provided by financing activities for the year ended December 31, 2024 was $7,967,000 from sales of common stock under the August 9, 2021 ATM programs and proceeds from issuance of shares for private placement.
Current wording
Net cash provided by financing activities for the year ended December 31, 2025 was $6,880,000 from sales of common stock under the August 9, 2021 ATM programs, proceeds from short-term loans and warrants exercise.
Previous wording
On August 9, 2021, the Company entered into an Amended and Restated Distribution Agreement (the “New Distribution Agreement”) with the Agents pursuant to which the Company may sell from time to time, through the Agents, shares of Common Stock, having an aggregate offering price of up to $100,000,000 (the “August 9, 2021, ATM”). Sales under the August 9, 2021, ATM are to be made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and the Agents. In connection with the New Distribution Agreement, the Company terminated the previous Distribution Agreement and the September 25, 2020, ATM. During the twelve months ended December 31, 2024, the Company has sold 1,250,876 shares of Common Stock for gross proceeds of approximately $4,485,936 under the August 9, 2021, ATM.
Current wording
On August 9, 2021, the Company entered into an Amended and Restated Distribution Agreement (the “New Distribution Agreement”) with the Agents pursuant to which the Company may sell from time to time, through the Agents, shares of Common Stock, having an aggregate offering price of up to $100,000,000 (the “August 9, 2021, ATM”). Sales under the August 9, 2021, ATM are to be made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and the Agents. In connection with the New Distribution Agreement, the Company terminated the previous Distribution Agreement and the September 25, 2020, ATM. During the nine months ended September 30, 2025, the Company has sold 2,567,940 shares of Common Stock for gross proceeds of approximately $4,472 under the August 9, 2021, ATM.
Previous wording
On March 6, 2020, the Company entered into a new distribution agreement with Raymond James (the “Agent”), pursuant to which the Company was able to sell from time to time, through the Agent, shares of Common Stock, having an aggregate offering price of up to $50,000,000 (the “March 6, 2020, ATM”). Sales under the March 6, 2020. ATM were made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and Raymond James. Under the March 6, 2020, ATM, the Company sold an aggregate of 163,109 shares of Common Stock at an average price of $141.75 per share, raising gross proceeds of approximately $23.11 million.
Current wording
$50,000,000 (the “March 6, 2020, ATM”). Sales under the March 6, 2020. ATM were made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and Raymond James. Under the March 6, 2020, ATM, the Company sold an aggregate of 163,109 shares of Common Stock at an average price of $141.75 per share, raising gross proceeds of approximately $23.11 million.
Previous wording
On August 9, 2021, the Company entered into the New Distribution Agreement with the Agents pursuant to which the Company may sell from time to time, through the Agents, shares of Common Stock, having an aggregate offering price of up to $100,000,000 (the “August 9, 2021, ATM”). Sales under the August 9, 2021, ATM are to be made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and the Agents. In connection with the New Distribution Agreement, the Company terminated the previous Distribution Agreement and the September 25, 2020, ATM. During the twelve months ended December 31, 2024, the Company has sold 1,250,876 shares of Common Stock for gross proceeds of approximately $4,485,936 under the August 9, 2021, ATM.
Current wording
On August 9, 2021, the Company entered into the New Distribution Agreement with the Agents pursuant to which the Company may sell from time to time, through the Agents, shares of Common Stock, having an aggregate offering price of up to $100,000,000 (the “August 9, 2021, ATM”). Sales under the August 9, 2021, ATM are to be made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Exchange Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and the Agents. In connection with the New Distribution Agreement, the Company terminated the previous Distribution Agreement and the September 25, 2020, ATM. During the nine months ended September 30, 2025, the Company has sold 2,567,940 shares of Common Stock for gross proceeds of approximately $4,472 under the August 9, 2021, ATM.
Previous wording
We expect that we will continue to generate losses from the clinical development and regulatory activities, which will result in a negative cash flow from operating activity. If we are granted an SPA with the FDA, additional capital raise will be needed to conduct a Phase 3b trial in ALS, to commercialize NurOwn® for ALS, and for future trials that may be needed for other indications. The actual amount of cash that the Company will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our product candidates, along with cost to commercialize these product candidates.
Current wording
trial in ALS, to commercialize NurOwn® for ALS, and for future trials that may be needed for other indications. The actual amount of cash that the Company will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our product candidates, along with cost to commercialize these product candidates.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Management expects that the Company will continue to generate losses from the clinical development and regulatory activities, which will result in a negative cash flow from operating activity. The Company has completed regulatory review of the BLA for NurOwn for the treatment of ALS with the withdrawal of the BLA on November 3, 2023. The decision to withdraw the BLA was coordinated with FDA and is viewed by FDA as a withdrawal without prejudice. On November 20, 2023, we announced that the FDA granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting took place on December 6, 2023. On December 7, 2023, we announced the completion of a productive meeting with the FDA to discuss NurOwn®. The primary objective
Current report — wording carried from elsewhere
On March 6, 2020, the Company entered into a new distribution agreement with Raymond James (the “Agent”), pursuant to which the Company was able to sell from time to time, through the Agent, shares of Common Stock, having an aggregate offering price of up to
Current report — wording carried from elsewhere
We expect that we will continue to generate losses from the clinical development and regulatory activities, which will result in a negative cash flow from operating activity. If we are granted an SPA with the FDA, additional capital raise will be needed to conduct a Phase 3b