BCLI Brainstorm Cell Therapeutics Inc

 

 

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): November 14, 2024

 

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 November 14, 2024, Brainstorm Cell Therapeutics Inc. issued a press release announcing its financial results for the quarter ended September 30, 2024. The full text of the press release is being furnished as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.

 

The information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or 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 a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d): Exhibits:

 

Exhibit No.	Description
99.1	Press Release issued by Brainstorm Cell Therapeutics Inc., dated November 14, 2024.
104	Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

 

 

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: November 14, 2024	By:	/s/ Chaim Lebovits
		Chaim Lebovits
		Chief Executive Officer

 

 

 

Exhibit 99.1

 

BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update

 

Conference call planned for later in Q4 2024 to provide updates on NurOwn® program

 

NEW YORK, November 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2024 and provided a corporate update.

 

"BrainStorm’s primary focus continues to be preparing for the upcoming Phase 3b registration trial of NurOwn in ALS,” said Chaim Lebovits, President and CEO of Brainstorm. "We have carefully refined the trial design based on the learnings from our previous study, and we believe this will increase the probability of demonstrating a treatment effect. We are partnering with Pluri Inc., an established global leader in the development and manufacturing of cell-based therapeutics, to support the clinical supply needs. We have also selected a leading Clinical Research Organization and continue to work with investigators to establish multiple trial sites.  We remain committed to the ALS community as we work to advance NurOwn and deliver a therapeutic option that we believe will make a difference for patients and their families."

 

Third Quarter 2024 and Recent Highlights

 

·

In November 2024, BrainStorm entered into a Memorandum of Understanding (MOU) with Pluri Inc. (Pluri) to manufacture NurOwn® for use in the planned Phase 3b ALS trial. This MOU enables Brainstorm to begin the immediate transfer of its manufacturing technology and start producing NurOwn at Pluri’s facility while the binding definitive agreement is being finalized.

 

·

In October 2024, Brainstorm announced further details of the Phase 3b trial at the Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting.

 

	·	Up to approximately 200 participants with ALS are expected to enroll in the two-part Phase 3b trial, to receive 3 doses of either NurOwn (debamestrocel) or placebo for 24 weeks (Part-A), followed by an open label period during which all patients will receive 3 doses of NurOwn for another 24 weeks (Part B). Successful completion of Part A is expected to support a Biologic License Application (BLA).
	·	The primary efficacy endpoint will be a comparison of change in ALSFRS-R from baseline to week-24 (i.e. at the end of Part A) for NurOwn vs. placebo. Other outcome assessments will include CAFS (Clinical Assessment of Function & Survival), SVC, HHD (Hand-Held Dynamometry), survival, ALSAQ-40 questionnaire, the ZBI (Zarit Burden Interview), and disease biomarkers.
	·	The entry criteria are specifically targeting people living with ALS in the early stage of their disease. Key entry criteria will include: age 18 to 75 years old, ALS diagnosis defined by the revised El Escorial criteria as laboratory-supported probable, clinically probable, or definite, symptom onset within 24 months of screening, ≥2 points on each item of the ALSFRS-R, ALSFRS-R total score ≤45, and upright Slow Vital Capacity (SVC) ≥65% of predicted.
	·	Participants in both treatment arms will be able to receive standard of care while on study.

 

 

·

Also at the NEALS meeting, Brainstorm presented a poster “Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program” featuring the results from 10 participants (6 NurOwn, 4 placebo) from the company's prior Phase 3 clinical trial (BCT-002-US) who enrolled in an open label Expanded Access Program (EAP). The EAP spanned two 28-week periods, with a break in time between the periods. Participants received a dose of NurOwn every 8 weeks, for a maximum of 6 doses over the 2 periods.

 

	·	Promising long term survival benefits were observed in NurOwn treated patients compared to matched controls in the PRO-ACT database. The survival curves revealed a statistically significant difference in favor of NurOwn (LRT, p= 0.0379) with a median survival time of 46.6 months for the treated group compared to 41.1 months for the matched control.
	·	Consistent reductions in neurofilament light (NfL) were observed both during the randomized Phase 3 trial and in the subsequent EAP period, indicating that patients treated with NurOwn continued to see benefits from extended treatment. NfL is an important biomarker in ALS, measuring neurodegeneration and neural cell death. These data align with the understanding of NurOwn's mechanism of action.

 

Investor Conference Call and Webcast

 

BrainStorm is planning to host a conference call and webcast for the investment community later in Q4 2024 to provide further updates on the NurOwn Phase 3 program. Details will be provided in the near future.

 

Financial Results for the Third Quarter Ended September 30, 2024

 

·

Cash, cash equivalents, and restricted cash amounted to approximately $0.35 million, as of September 30, 2024.

 

·

Research and development expenses, net, in the third quarter ended September 30, 2024 were $1 million, compared to $3.3 million for the quarter ended September 30, 2023.

 

·

General and administrative expenses for the third quarter ended September 30, 2024 and 2023 were $2 million and $2.7 million, respectively.

 

·

Net loss for the third quarter ended September 30, 2024 was $2.7 million as compared to a net loss of $1.2 million for the quarter ended September 30, 2023.

 

·

Net loss per share for the third quarter ended September 30, 2024 and September 30, 2023 was $0.51 and $0.45, respectively.

 

 

About BrainStorm Cell Therapeutics Inc. 

 

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm 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 designation status 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 completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

 

Notice Regarding Forward-Looking Statements

 

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the probability of NurOwn demonstrating a treatment effect in ALS, the patient enrollment and dosing in the Phase 3b trial for NurOwn®, and the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, 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

 

Media: 
Lisa Guiterman
Phone: +1 202-330-3431
lisa.guiterman@gmail.com 

 

IR:
Michael Wood
Phone: +1 646-597-6983
mwood@lifesciadvisors.com

 

 

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

 

		September 30,				December 31,
		2024				2023
		Unaudited				Audited
		U.S. $ in thousands
ASSETS
Current Assets:
Cash and cash equivalents		$	168			$	1,300
Other accounts receivable			40				51
Prepaid expenses and other current assets (Note 4)			156				548
Total current assets		$	364			$	1,899
Long-Term Assets:
Prepaid expenses and other long-term assets		$	22			$	22
Restricted Cash			181				185
Operating lease right of use asset (Note 5)			959				1,416
Property and Equipment, Net			499				686
Total Long-Term Assets		$	1,661			$	2,309
Total assets		$	2,025			$	4,208
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities:
Accounts payables		$	4,603			$	4,954
Accrued expenses			865				1,240
Operating lease liability (Note 5)			570				603
Employees related liability			1,044				1,003
Total current liabilities		$	7,082			$	7,800
Long-Term Liabilities:
Operating lease liability (Note 5)			271				672
Warrants liability (Note 6)			729				594
Total long-term liabilities		$	1,000			$	1,266
Total liabilities		$	8,082			$	9,066
Stockholders’ Deficit:
Stock capital: (Note 7)			14				13
Common Stock of $0.00005 par value - Authorized: 250,000,000 shares at September 30, 2024 and 100,000,000 shares at December 31, 2023 respectively; Issued and outstanding: 5,309,796 and 4,032,614 shares at September 30, 2024 and December 31, 2023 respectively (*)
Additional paid-in-capital			217,708				210,258
Treasury stocks			(116	)			(116	)
Accumulated deficit			(223,663	)			(215,013	)
Total stockholders’ deficit		$	(6,057	)		$	(4,858	)
Total liabilities and stockholders’ deficit		$	2,025			$	4,208

 

* Retroactively adjusted (See Note 7). 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

 

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,
		2024				2023				2024				2023
		Unaudited								Unaudited
Operating expenses:
Research and development, net		$	2,928			$	9,048			$	1,045			$	3,330
General and administrative			5,576				7,587				2,003				2,705
Operating loss			(8,504	)			(16,635	)			(3,048	)			(6,035	)
Financial (expense) income, net			(11	)			91				(54	)			(121	)
Gain (loss) on change in fair value of Warrants liability (Note 6)			(135	)			4,930				394				4,930
Net loss		$	(8,650	)		$	(11,614	)		$	(2,708	)		$	(1,226	)
Basic and diluted net loss per share from continuing operations		$	(1.80	)		$	(4.35	)(*)		$	(0.51	)		$	(0.45	)(*)
Weighted average number of shares outstanding used in computing basic and diluted net loss per share			4,793,026				2,683,700	(*)			5,309,796				2,950,121	(*)

 

 

* Retroactively adjusted (See Note 7). 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

 

 

 

 

v3.24.3

Cover	Nov. 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 14, 2024
Entity File Number	001-36641
Entity Registrant Name	Brainstorm Cell Therapeutics Inc.
Entity Central Index Key	0001137883
Entity Tax Identification Number	20-7273918
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1325 Avenue of Americas
Entity Address, Address Line Two	28th Floor
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10019
City Area Code	201
Local Phone Number	488-0460
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.00005 par value
Trading Symbol	BCLI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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