BRAINSTORM CELL THERAPEUTICS INC
For the period ended Mar 31, 2024. Filed May 14, 2024.
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Mar 31, 2024 · Filed May 14, 2024
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Notes to Interim Condensed Consolidated Financial Statements
NOTE 1 - GENERAL
| A. | The Company was incorporated in the State of Delaware on November 15, 2006, and previously was incorporated in the State of Washington. In October 2004, the Company formed its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd. (“BCT”) in Israel, which currently conducts all the research and development activities of the Company. BCT formed wholly-owned subsidiaries Brainstorm Cell Therapeutics UK Ltd., in the United Kingdom on February 19, 2013 (currently inactive), Advanced Cell Therapies Ltd. in Israel on June 21, 2018 and Brainstorm Cell Therapeutics Limited in Ireland on October 1, 2019. |
The Company’s common stock, $0.00005 par value per share (the “Common Stock”) is publicly traded on the Nasdaq Capital Market under the symbol “BCLI”.
| B. | The Company, through BCT, holds rights to commercialize certain stem cell technology developed by Ramot of Tel Aviv University Ltd. (“Ramot”), (see Note 3). Using this technology, the Company has been developing novel adult stem cell therapies for debilitating neurodegenerative disorders such as ALS, also known as Lou Gherig Disease, PMS and Parkinson’s disease. The Company developed a proprietary process, called NurOwn®, for the propagation of Mesenchymal Stem Cells and their differentiation into neurotrophic factor secreting cells. These cells are then transplanted at or near the site of damage, offering the hope of more effectively treating neurodegenerative diseases. The process is currently autologous, or self-transplanted. |
| C. | Since its inception, the Company has devoted substantially all its efforts to research and development. The Company is still in its development and clinical stage and has not yet generated revenues. The Company has incurred operating losses since its inception and expects to continue to incur operating losses for the near-term. As of March 31, 2024, the Company had an accumulated deficit of approximately $218,000. The extent of the Company’s future operating losses and the timing of becoming profitable are uncertain. |
| D. | The Company’s primary sources of cash have been proceeds from the issuance and sale of its Common Stock and warrants, the exercise of warrants, sales of Common Stock via its at-the-market (“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. The Company has not yet commercialized any of its product candidates. Even if the Company commercializes one or more of its product candidates, it may not become profitable in the near-term. The Company’s ability to achieve profitability depends on several factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership. |
Such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Management’s plan includes raising funds from outside potential investors via its ATM program and other potential funds as mentioned. However, as mentioned above, there is no assurance such funding will be available to the Company or that it will be obtained on terms favorable to the Company or will provide the Company with sufficient funds to meet its objectives. These interim condensed financial statements do not include any adjustments relating to the recoverability and classification of assets, carrying amounts or the amount and classification of liabilities that may be required should the Company be unable to continue as a going concern.
NOTE 2 - BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
| A. | Unaudited Interim Financial Statements |
The accompanying unaudited interim condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of U.S. Securities and Exchange Commission Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included (consisting only of normal recurring adjustments except as otherwise discussed). For further information, reference is made to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Operating results for the three and nine months ended March 31, 2024, are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.
| B. | Significant Accounting Policies |
The significant accounting policies followed in the preparation of these unaudited interim condensed consolidated financial statements are identical to those applied in the preparation of the latest annual financial statements.
| C. | Recent Accounting Standards |
Management does not believe that any recently issued, but not yet effective, accounting standards, if currently adopted, would have a material effect on the Company’s condensed financial statements.
| D. | Use of estimates |
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
NOTE 3 - RESEARCH AND LICENSE AGREEMENT
In 2004, the Company entered into a Research and License Agreement, as amended and restated, with Ramot (the “License Agreement”). Pursuant to the remuneration terms of the License Agreement, the Company has agreed to pay Ramot royalties on Net Sales of the Licensed Product as follows:
| a) | So long as the making, producing, manufacturing, using, marketing, selling, importing or exporting (collectively, the “Commercialization”) of such Licensed Product is covered by a Valid Claim or is covered by Orphan Drug Status, the Company shall pay Ramot a royalty of 5% of the Net Sales received by the Company and resulting from such Commercialization; and |
| b) | In the event the Commercialization of the Licensed Product is neither covered by a Valid Claim nor by Orphan Drug status, the Company shall pay Ramot a royalty of 3% of the Net Sales received by the Company resulting from such Commercialization. This royalty shall be paid from the First Commercial Sale of the Licensed Product and for a period of fifteen (15) years thereafter. |
Capitalized terms set forth above which are not defined shall have the meanings attributed to them under the License Agreement.
NOTE 4 - PREPAID EXPENSES
As of March 31, 2024, the prepaid expenses mostly included director’s insurance of $285, whereas, as of December 31, 2023, the prepaid expenses mostly included director’s insurance of $428.
NOTE 5 - LEASES
As of March 31, 2024, and December 31, 2023, total right-of-use assets was approximately $1,265 and $1,416 and the operating lease liabilities for remaining long term lease was approximately $1,121 and $1,275, respectively. In the quarter ended March 31, 2024 and in the year ended December 31, 2023, the Company recognized approximately $164 and $1,467, respectively, in total lease costs. Variable lease costs for these periods were immaterial.
Supplemental cash flow and total lease cost information was as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended · · Three Months Ended | ||||||
| · · March 31, · · March 31, | ||||||
| · 2024 · 2023 | ||||||
| Cash payments for operating leases | | | 166 | | 386 | |
| Operating lease expense | | | 165 | | 40 | |
| Finance lease expense (income) | | | (1) | | | 118 |
As of March 31, 2024, the Company’s operating leases had a weighted average remaining lease term of 2.13 years and a weighted average discount rate of 8.62%. Future lease payments under operating leases as of March 31, 2024 were as follows:
| | | | |
|---|---|---|---|
| · Operating | |||
| · · Leases | |||
| 2024 | | 452 | |
| 2025 | | 568 | |
| 2026 | | | 186 |
| Total future lease payments | | 1,206 | |
| Less imputed interest | | (85) | |
| Total lease liability balance | | | 1,121 |
NOTE 6 - WARRANTS LIABILITY
In July 2023, the Company issued 4,054,055 shares of common stock and 4,054,055 private placement warrants (“July 2023 warrants”) to purchase shares of common stock. The gross proceeds from this transaction were approximately $7.5 million. The Common Warrants contain provisions regarding settlement in the event of a fundamental transaction that calculate the fair value of the warrants using a prespecified volatility assumption that was not consistent with the input used to value the warrants at issuance which causes the warrants to be classified as liabilities. The Common Warrants will be measured at fair value at inception and in subsequent reporting periods with changes in fair value recognized as financial income or expense as change in fair value of warrant liabilities in the period of change in the condensed consolidated statements of comprehensive loss. July 2023 warrants are classified as Level 3 financial instruments in the fair value hierarchy (refer to Note 8,Fair Value Measurement). As of March 31, 2024, the July 2023 warrants were outstanding with fair values of $1,534. The fair value of the warrant liability for the three – month period ended March 31, 2024 increased by $940. The change has been recognized as gain on change in fair value of derivatives in the Company’s Consolidated Statements of Comprehensive Loss.
NOTE 7 – STOCK CAPITAL
The rights of Common Stock are as follows:
Holders of the Common Stock have the right to receive notice to participate and vote in general meetings of the Company, the right to a share in the excess of assets upon liquidation of the Company and the right to receive dividends, if declared.
The Common Stock is publicly traded on The Nasdaq Capital Market under the symbol “BCLI”.
Private placements and public offerings:
At-the-market (ATM) Offering:
On August 9, 2021, the Company entered into an Amended and Restated Distribution Agreement (the “New Distribution Agreement”) with the Agents (as defined in the New Distribution Agreement) pursuant to which the Company may sell from time to time, through the Agents, shares of Common Stock (the “Shares”), 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 quarter ended March 31, 2024, the Company has sold 7,957,985 shares of Common Stock for gross proceeds of approximately $2,626,846 under the August 9, 2021, ATM.
Securities Purchase Agreement:
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 a public offering (the “Offering”), an aggregate of 4,054,055 shares of Common Stock, together with accompanying warrants (the “Common Warrants”) to purchase 4,054,055 shares of Common Stock, at a purchase price of $1.85 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 $2.00 per share. Please refer to Note 6.
Capital Raised Since Inception:
Since its inception through March 31, 2024, the Company has raised approximately $174 million gross in cash in consideration for issuances of Common Stock and warrants in private placements and public offerings as well as proceeds from warrants exercises.
Stock Plans:
During the three months ended March 31, 2024, the Company had outstanding awards for stock options under four stockholder approved plans: (i) the 2004 Global Stock Option Plan and the Israeli Appendix thereto (the “2004 Global Plan”) (ii) the 2005 U.S. Stock Option and Incentive Plan (the “2005 U.S. Plan,” and together with the 2004 Global Plan, the “Prior Plans”); (iii) the 2014 Global Share Option Plan and the Israeli Appendix thereto (which applies solely to participants who are residents of Israel) (the “2014 Global Plan”); and (iv) the 2014 Stock Incentive Plan (the “2014 U.S. Plan” and together with the 2014 Global Plan, the “2014 Plans”).
The 2004 Global Plan and 2005 U.S. Plan expired on November 25, 2014 and March 28, 2015, respectively. Grants that were made under the Prior Plans remain outstanding pursuant to their terms. The 2014 Plans were approved by the stockholders on August 14, 2014 (at which time the Company ceased to issue awards under each of the 2005 U.S. Plan and 2004 Global Plan) and amended on June 21, 2016 and November 29, 2018. Unless otherwise stated, option grants prior to August 14, 2014 were made pursuant to the Company’s Prior Plans, and grants issued on or after August 14, 2014 were made pursuant to the Company’s 2014 Plans, and expire on the tenth anniversary of the grant date.
Stock Plans (Cont.):
The 2014 Plans have a shared pool of 5,600,000 shares of Common Stock available for issuance. As of March 31, 2024,528,313 shares were available for future issuances under the 2014 Plans. The exercise price of the options granted under the 2014 Plans may not be less than the nominal value of the shares into which such options are exercised. Any options under the 2014 Plans that are canceled or forfeited before expiration become available for future grants. The Governance, Nominating and Compensation Committee (the “GNC Committee”) of the Board of Directors of the Company (the “Board”) administers the Company’s stock incentive compensation and equity-based plans.
Share-based compensation to employees and to directors:
Under the 2014 Plans, the Company may award stock options to certain employees, officers, directors, and/or service providers. The stock options vest in accordance with such conditions and restrictions determined by the GNC Committee.
Stock options:
These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with the Company through a specified period. Stock options awarded are valued based upon the Black-Scholes option pricing model and the Company recognizes this value as stock compensation expense over the periods in which the options vest. Use of the Black Scholes option-pricing model requires that the Company make certain assumptions, including expected volatility, risk-free interest rate, expected dividend yield, and the expected life of the options. The Company granted 0 stock options during the three months ended March 31, 2024.
A summary of the Company’s option activity related to options to employees and directors, and related information as of March 31, 2024, is as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| · · For the Three months ended | ||||
| · · March 31, 2024 | ||||
| · · Weighted | ||||
| · · · · average · · Aggregate | ||||
| · · Amount of · · exercise · · intrinsic | ||||
| · · options * · · price · · value | ||||
| · · · · $ · · $ | ||||
| Outstanding at December 31, 2023 | 1,605,783 | | 3.2671 | — |
| Granted | — | | — | — |
| Forfeited | (128,400) | | 10.5868 | — |
| Outstanding at March 31, 2024 | 1,477,383 | | 2.6310 | — |
| Exercisable at March 31, 2024 | 1,092,383 | | 2.6216 | — |
- Represents Employee Stock Options only (not including RSUs).
The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the fair market value of the Company’s shares on March 31, 2024, multiplied by the number of in-the-money options on those dates) that would have been received by the option holders had all option holders exercised their options on those dates.
As of March 31, 2024, there was $362 of total unrecognized compensation cost related to non-vested options under the Plan. The cost is expected to be recognized over a weighted average period of 1.86 years. Compensation expense recorded by the Company in respect of its stock-based employees and directors compensation awards in accordance with ASC 718-10 for the three months ended March 31, 2024 amounted to $80. For the three months ended March 31, 2023 the Company recorded compensation income amounted to $7.
Restricted Stock:
The Company awards stock and restricted stock to certain employees, officers, directors, and/or service providers. The restricted stock vests in accordance with such conditions and restrictions determined by the GNC Committee. These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with the Company through a specified restricted period. The purchase price (if any) of shares of restricted stock is determined by the GNC Committee. If the performance goals and other restrictions are not attained, the grantee will automatically forfeit their unvested awards of restricted stock to the Company. Compensation expense for restricted stock is based on fair market value at the grant date.
| · · · · · · | |||
|---|---|---|---|
| | | | Weighted Average |
| · · · · · · Remaining | |||
| · · Number of Shares · · Weighted Average · · Contractual | |||
| · · of Restricted · · Grant Date Fair · · Term | |||
| · · Stock · · Value · · (Years) | |||
| Nonvested as of December 31, 2023 | 304,896 | 2.86 | 1.32 |
| Granted | — | — | — |
| Vested | — | — | — |
| Forfeited | 17,341 | 1.73 | — |
| Nonvested as of March 31, 2024 | 287,555 | 2.82 | 1.11 |
Compensation expense recorded by the Company in respect of its stock and restricted stock awards to certain employees, officers, directors, and/or service providers for the three months ended March 31, 2024 and March 31, 2023 amounted to $90 and $11, respectively.
As of March 31, 2023, there was $289 of total unrecognized compensation cost related to non-vested restricted stock under the Plan. The cost is expected to be recognized over a weighted average period of 1.67 years.
Total Stock-Based Compensation Expense
The total stock-based compensation expense, related to shares, options and warrants granted to employees, directors and service providers was comprised, at each period, as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three months ended | ||||||
| · · March 31, | ||||||
| · 2024 · 2023 | ||||||
| Research and development | | $103 | | $(49) | ||
| General and administrative | | | 67 | | | 53 |
| Total stock-based compensation expense | | $170 | | $4 | ||
NOTE 8 – FAIR VALUE MEASUREMENT
The Company’s financial instruments consist of cash and cash equivalents, accounts payable and warrants.
Accounting standards establish a hierarchy, which prioritizes the inputs to valuation techniques used to measure fair value into three levels. The fair value hierarchy gives the highest priority to quoted market prices (unadjusted) in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Accounting standards require financial assets and liabilities to be classified based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and the exercise of this judgment may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels.
The carrying value of cash and cash equivalents, restricted cash, accounts receivable, contract assets, contract liabilities and accounts payable are considered to be representative of their fair value due to the short maturity of these instruments.
Warrants Liabilities
The July 2023 warrants are classified as Level 3 financial instruments. The Company estimated the fair value of the July 2023 warrants using the Black-Scholes model at inception and on subsequent valuation dates. This model incorporates inputs such as the stock price of the Company, risk-free interest rate, volatility, and time to expiration. The volatility involves unobservable inputs classified as Level 3 of the fair value hierarchy. The assumptions used to determine the fair value of the July 2023 warrants are as follows:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · March 31, 2024 · December 31,2023 | |||||
| Time to expiration | | 4.31 years | | 4.56 years | |
| Common stock price | | $0.56 | | $0.27 | |
| Risk-free interest rate | | 4.28 | | 3.88 | |
| Volatility | | 123% | 116% | ||
NOTE 9 – SUBSEQUENT EVENTS
| A. | On April 10, 2024, the Company received a notification letter from the Listing Qualifications Department of Nasdaq, indicating that the Company has regained compliance with the minimum market value of listed securities requirement set forth under Nasdaq Listing Rule 5550(b)(2). |
According to the Notification Letter on Compliance, Nasdaq’s staff has determined that for the 11 consecutive business days from March 22, 2024 through April 9, 2024 the Company’s market value of listed securities was $35,000,000 or greater, and the Company thus regained compliance with the Rule.
| B. | On February 14, 2024, February 15, 2024, March 21, 2024, and April 12, 2024 four purported shareholders of the Company filed derivative action complaints against the Company as nominal defendant and certain of its officers, current and former directors, and members of its scientific advisory board, captioned Porteous v. Lebovits, et al., Case No. 1:24-cv-01095; Andrev v. Lebovits, et al., Case No. 1:24-cv-1101; and Holtzman v. Lebovits, et al., Case No. 1:24-cv-02139, and Hamby v. Lebovits, et al., Case No. 1:24-cv-02811 (the “Derivative Complaints”) in the United States District Court for the Southern District of New York (the “Derivative Actions”). On April 25, 2024, the Court consolidated the Derivative Actions into a consolidated action captioned In Re Brainstorm Cell Therapeutics, Inc. Derivative Litigation, Case No. 1:24-cv-01095-DEH (the “Consolidated Derivative Action”), and appointed Co-Lead Counsel. All substantive deadlines in the Consolidated Derivative Action are currently stayed. Plaintiffs have not yet filed a consolidated complaint; thehe Derivative Actions, brought on behalf of the Company, each assert state law claims for breach of fiduciary duty and unjust enrichment against the individual defendants. The complaints in Holtzman and Hamby also assert state law claims against the individual defendants for abuse of control, gross mismanagement, corporate waste, a claim against the individual defendants for violations of Section 14(a) of the Securities and Exchange Act of 1934, as amended, and a claim against two officer defendants for contribution under Sections 10(b) and 21D of the Exchange Act. The Derivative Complaints allege that the individual defendants breached their fiduciary duties and duties under the Exchange Act in connection with the Company’s internal controls relating to, as with the allegations in the Securities Complaint, NurOwn® for the treatment of ALS, the Company’s submissions to and communications with the FDA in support of the approval of NurOwn® for the treatment of ALS, and the prospects of future approval of NurOwn® by the FDA their actions or omissions could not have been a good faith exercise of prudent business. The Derivative Actions seek among other things, monetary damages and disgorgement of performance-based compensation granted in connection with an allegedly inflated stock price between August 15, 2022 and September 27, 2023, as well as attorneys’ fees and costs. |
The Company intends to vigorously defend against the lawsuits.
| C. | On April 16, 2024, the Company announced the promotion of Dr. Bob Dagher to Executive Vice President and Chief Medical Officer. In addition, after four years of maintaining top executive roles, Dr. Stacy Lindborg stepping down from the role of Co-Chief Executive Officer and will remain with the Company as a member of its Board. These strategic management changes are being made as the Company prepares to embark on a registrational Phase 3b trial for NurOwn®, its investigational cell therapy treatment for ALS. |
| D. | On November 1, 2023, the Company received a notice in the form of a letter from the Listing Qualifications department of Nasdaq, notifying the Company that the Company was not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Minimum Bid Price Requirement”). The Notice also indicated that the Company would have 180 calendar days from the date of the Notice, or until April 29, 2024, to regain compliance with the Minimum Bid Price Requirement pursuant to Nasdaq Listing Rule 5810(c)(3)(A). |
NOTE 9 – SUBSEQUENT EVENTS (Cont.):
On May 1, 2024, the Company received a staff determination letter (“Staff Letter”) from the Staff of Nasdaq indicating that the Company had not regained compliance with the Minimum Bid Price Requirement by April 29, 2024. On May 2, 2024, the Company submitted a hearing request to the Nasdaq Hearings Panel (the “Panel”) to appeal the Staff’s determination. On the same day, the Company received a letter from Nasdaq notifying the Company that, among other things, (i) the Panel hearing has been scheduled, (ii) the hearing request submitted by the Company has stayed the suspension of the Company’s securities and the filing of the Form 25-NSE pending a final written decision by the Panel, and (iii) the Panel is providing the Company with the option to participate in an expedited review process. The Company intends to participate in the expedited review process provided by the Panel.
| E. | From April 1, 2024 through May 13, 2024, the Company has raised aggregate gross proceeds of approximately $187 under the ATM Distribution Agreement. |
In accordance with ASC 855 “Subsequent Events” the Company evaluated subsequent events through the date the condensed consolidated financial statements were issued. The Company concluded that no other subsequent events have occurred that would require recognition or disclosure in the condensed consolidated financial statements.
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