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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 15, 2020

 

Brainstorm Cell Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-36641   20-7273918
(State or other jurisdiction of
incorporation) 		  (Commission File No.)   (IRS Employer Identification No.)

 

1325 Avenue of Americas, 28th Floor  
New York, NY 10019
(Address of principal executive offices) (Zip Code)

 

(201) 488-0460

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

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)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

  

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On October 15, 2020, Brainstorm Cell Therapeutics Inc. (the “Company”) issued a press release announcing its financial and operating results for the quarter ended September 30, 2020. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.

 

The Company will host a live conference call and webcast at 8:00 am ET on Thursday, October 15, 2020 to discuss third quarter 2020 financial results and business progress. A live webcast of the conference call may be accessed by visiting the Investors & Media section of the Company’s website at https://ir.brainstorm-cell.com.

 

The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

   Description
     
99.1   Press Release issued by the Company on October 15, 2020, furnished hereto.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document) 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

     
  BRAINSTORM CELL THERAPEUTICS INC.
   
     
Date: October 15, 2020 By: /s/ Chaim Lebovits
    Chaim Lebovits
  Chief Executive Officer

 

 

 

Exhibit 99.1

 

BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update

 

Pivotal Phase 3 ALS trial remains on track for top-line data readout by the end of November 2020

 

New senior executives strengthen regulatory and market access capabilities as the Company prepares to transition to a commercial organization

 

Conference Call and Webcast at 8 a.m. ET Today

 

 

NEW YORK, October 15, 2020 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2020, and provided a corporate update.

 

“The most important near-term event for BrainStorm will be the upcoming top-line data readout for the NurOwn® Phase 3 trial in ALS, expected by the end of November. A successful outcome will set us on the path to filing a Biologic License Application (BLA) for what we believe will be a valuable new treatment for ALS,” said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. “In parallel to our preparations for upcoming data read out, we are very busy planning and executing on other pre-BLA activities. On the management front, we appointed William K. White and Dr. Anthony Waclawski, adding valuable commercial and regulatory expertise to our leadership team. This expertise will be crucial as we work towards obtaining regulatory approval for NurOwn and ensuring that, if approved, it will be readily accessible to ALS patients in need of new treatment options for this devastating disease.”

 

NurOwn has an innovative mechanism of action that is broadly applicable across neurodegenerative diseases and BrainStorm continues to invest in clinical trials evaluating the product in conditions beyond ALS to maximize value creation for its various stakeholders. The company remains on track to complete dosing in its Phase 2 clinical trial in progressive multiple sclerosis (PMS) by the end of 2020. In addition, the Company recently unveiled a clinical development program in Alzheimer’s’ disease (AD) and is planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France.

 

Third Quarter 2020 and Recent Corporate Highlights:

·Completed dosing of all patients in the ongoing NurOwn Phase 3 clinical trial in ALS and plans remains on track to report top-line data by the end of November 2020.
·Announced the publication of a manuscript titled “Effects of MSC-NTF cells on T and B regulatory cell function in ALS" in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. The manuscript describes NurOwn’s immunomodulatory effects on T and B regulatory cell function, suggesting that its mechanism of action is broadly applicable in ALS, PMS and Alzheimer’s disease.
·Presented a scientific poster titled “Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS (NEALS) Meeting.

 

 

 

 

 

·A Phase 2 trial evaluating NurOwn® as a treatment for progressive multiple sclerosis (PMS) is ongoing at 5 leading U.S. multiple sclerosis centers. The Company remains on track to complete dosing by year end 2020.
·Presented progressive MS natural history data at the MSVirtual2020 meeting documenting an association between magnetic resonance imaging (MRI) measures and functional improvement in patients matched to the phase 2 NurOwn clinical trial.
·Hosted a Key Opinion Leader (KOL) webinar on the Alzheimer’s disease program and the planned European Phase 2 trial. The webinar featured presentations by two lead investigators in the trial: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at the VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital in Paris, France.
·Announced a groundbreaking pre-clinical study of a NurOwn® derived exosome-based treatment for COVID-19 acute respiratory distress syndrome (ARDS).
·Appointed Anthony Waclawski Ph.D. as Executive Vice President, Global Head of Regulatory Affairs.
·Appointed William K. White as Senior Vice President, Head of Market Access and Pricing.
·Received a non-dilutive bonus payment of $700,000 from California Institute for Regenerative Medicine (CIRM) for treating more California participants than originally proposed in the Phase 3 ALS trial.
·Announced the grant of Japanese Patent No. 6,753,887, titled: “Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors”.

 

Presented at the following Investor Conferences:

·40th Annual Canaccord Genuity Growth Conference

 

Cash and Liquidity as of October 14, 2020

 

Total available funding as of October 14, 2020, which includes cash, cash equivalents and short-term bank deposits of approximately $33.1 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $36 million.

  

Financial Results for the Three Months Ended September 30, 2020

 

·Cash and cash equivalents, and short-term bank deposits amounted to approximately $28.8 million at September 30, 2020 compared to $16.2 million at June 30, 2020.
·Research and development expenses, net for the three months ended September 30, 2020 and 2019 were $1.87 million and $4.01 million, respectively.
oExcluding participation from IIA and CIRM under the grants and proceeds received under the hospital exemption regulatory pathway, research and development expenses decreased by $1.68 million from $5.66 million in the third quarter of 2019 to $3.98 million in the third quarter of 2020.

 

 

 

 

·General and administrative expenses for the three months ended September 30, 2020 and 2019 were $2.62 million and $1.54 million, respectively.
·Net loss for the three months ended on September 30, 2020 was $4.49 million, as compared to a net loss of $5.63 million for the three months ended September 30, 2019.
oNet loss per share for the three months ended September 30, 2020 and 2019 was $0.14 and $0.25, respectively.

 

Conference Call & Webcast

Thursday, October 15, 2020 at 8 a.m. Eastern Time

From the US: 877-407-9205

International: 201-689-8054

Webcast: https://www.webcaster4.com/Webcast/Page/2354/37811

 

Replays, available through October 29, 2020

From the US: 877-481-4010

International: 919-882-2331

Replay Passcode: 37811

 

About NurOwn®

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and completed enrollment in August 2020.

 

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

 

 

 

 

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

 

Contacts
Investor Relations:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Phone: +1 646-465-1138
cdavis@lifesciadvisors.com

 

Media:
Paul Tyahla
SmithSolve
Phone: + 1.973.713.3768
Paul.tyahla@smithsolve.com

 

 

 

 

 

 

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

 

   September 30,   December 31, 
   2020   2019 
   U.S. $ in thousands 
   Unaudited   Audited 
ASSETS          
Current Assets:          
Cash and cash equivalents  $24,770   $536 
Short-term deposit (Note 4)   4,038    33 
Other accounts receivable   1,473    2,359 
Prepaid expenses and other current assets (Note 5)   56    432 
Total current assets   30,337    3,360 
           
Long-Term Assets:          
Prepaid expenses and other long-term assets   27    32 
Operating lease right of use asset (Note 6)   1,377    2,182 
Property and Equipment, Net   950    960 
Total Long-Term Assets   2,354    3,174 
           
Total assets  $32,691   $6,534 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)          
Current Liabilities:          
Accounts payable  $3,283   $14,677 
Accrued expenses   917    1,000 
Operating lease liability (Note 6)   1,216    1,263 
Other accounts payable   1,013    714 
Total current liabilities   6,429    17,654 
           
Long-Term Liabilities:          
Operating lease liability (Note 6)   284    1,103 
Total long-term liabilities   284    1,103 
           
Total liabilities  $6,713   $18,757 
           
Stockholders’ Equity (deficit):          
Stock capital: (Note 7)   12    11 
Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 31,567,592 and 23,174,228 shares at September 30, 2020 and December 31, 2019 respectively.          
Additional paid-in-capital   163,238    105,042 
Receipts on account of shares   —    — 
Accumulated deficit   (137,272)   (117,276)
Total stockholders’ equity (deficit)   25,978    (12,223)
           
Total liabilities and stockholders’ equity  $32,691   $6,534 

 

 

 

 

 

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

U.S. dollars in thousands

(Except share data)

 

   Nine months ended   Three months ended 
   September 30,   September 30, 
   2020   2019   2020   2019 
   Unaudited   Unaudited 
                 
Operating expenses:                    
                     
Research and development, net  $13,509   $11,018   $1,867   $4,008 
General and administrative   6,684    4,318    2,618    1,543 
                     
Operating loss   (20,193)   (15,336)   (4,485)   (5,551)
                     
Financial expenses (income), net   (197)   225    3    83 
                     
Net loss  $(19,996)  $(15,561)  $(4,488)  $(5,634)
                     
Basic and diluted net loss per share from continuing operations  $(0.70)  $(0.72)  $(0.14)  $(0.25)
                     
Weighted average number of shares outstanding used in computing basic and diluted net loss per share   28,695,540    21,630,007    31,154,101    22,254,993 

 

 

 

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