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

Rhea-AI Summary

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced its Q1 2024 financial results and provided a corporate update. The company achieved a key milestone by securing a Special Protocol Assessment (SPA) from the U.S. FDA for its Phase 3b trial of NurOwn for ALS. This SPA validates the clinical trial protocol and statistical analysis, supporting a future Biologics License Application (BLA). Q1 2024 saw research and development expenses decrease to $1.0 million from $2.9 million in Q1 2023, while general and administrative expenses dropped to $1.5 million from $2.2 million. Net loss reduced from $5.1 million in Q1 2023 to $3.4 million. The company has $1.0 million in cash, cash equivalents, and restricted cash as of March 31, 2024. Additionally, BrainStorm will participate in the ALS Drug Development Summit, and management changes include promoting Dr. Bob Dagher to Executive VP and CMO, and Dr. Stacy Lindborg stepping down as Co-CEO but remaining on the Board of Directors.

Positive

• Secured a Special Protocol Assessment (SPA) from the U.S. FDA for the Phase 3b trial of NurOwn.
• Decreased net loss to $3.4 million in Q1 2024 from $5.1 million in Q1 2023.
• Reduced research and development expenses to $1.0 million in Q1 2024 from $2.9 million in Q1 2023.
• Reduced general and administrative expenses to $1.5 million in Q1 2024 from $2.2 million in Q1 2023.
• Management changes with experienced personnel: Dr. Bob Dagher promoted to Executive VP and CMO.

Negative

• Cash, cash equivalents, and restricted cash amounted to only $1.0 million as of March 31, 2024.
• Net loss remains significant at $3.4 million despite improvements.
• Dependency on the successful initiation and outcomes of the Phase 3b trial for regulatory approval.

Insights

Financial Analyst

BrainStorm Cell Therapeutics' first quarter 2024 financial results raise several important points for retail investors to consider. The $1.0 million in cash and equivalents on hand is relatively low, suggesting a potentially tight financial position. This could mean the company might need to seek additional funding soon, which could dilute existing shares. However, the decrease in net loss from $5.1 million in Q1 2023 to $3.4 million in Q1 2024 indicates improved cost management. This is further supported by lower R&D and G&A expenses.

From a valuation perspective, the reduction in net loss per share from $0.14 to $0.05 is a positive sign, potentially reflecting operational efficiencies and better financial discipline. Investors should monitor if this trend continues in subsequent quarters.

In summary, while the financial health appears to be improving, the low cash reserves highlight a potential risk that could impact stock performance if new funding is required.

Medical Research Analyst

The agreement with the FDA on a Special Protocol Assessment (SPA) for the Phase 3b trial of NurOwn is a significant development. This agreement de-risks the regulatory pathway, thereby increasing the likelihood of successful trial outcomes and eventual approval. It validates the trial design and statistical methods, indicating that the planned study will meet the FDA's requirements for a future Biologics License Application (BLA).

Published data on biomarker pathways in the journal 'Muscle and Nerve' also support the efficacy of NurOwn. These biomarkers provide a measurable way to track the drug's impact on ALS, which could lead to more definitive clinical outcomes.

Investors should note that while these developments are positive, the actual clinical trial and its results will be the ultimate determinant of NurOwn's future. The SPA agreement is promising, but success is not guaranteed until clinical efficacy and safety are definitively proven.

Market Research Analyst

BrainStorm's progress with NurOwn in ALS, particularly the SPA agreement, positions it positively within the neurodegenerative disease treatment market. This market is highly competitive and regulated and alignment with the FDA's standards is a important step forward. NurOwn's potential to impact multiple ALS pathways distinguishes it from other treatments, making it an attractive candidate for both patients and investors.

However, the company's financial constraints could affect its market position. If funding becomes constrained, it might limit the scope and speed of future developments. Furthermore, the upcoming presentation at the ALS Drug Development Summit could provide additional data that may influence investor sentiment.

While the strategic emphasis on collaboration with the ALS community and advocacy groups is positive, the company's ultimate market success will heavily depend on the Phase 3b trial outcomes and subsequent regulatory approvals.

Company received written agreement from the U.S. FDA under a Special Protocol Assessment (SPA) on the design for a Phase 3b trial of NurOwn®

Conference call planned for later this quarter to provide update on NurOwn program

NEW YORK, May 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 First Quarter ended March 31, 2024 and provided a corporate update.

"We recently achieved an important milestone on our Debamestrocel (NurOwn®) development program, reaching agreement with the US FDA on a Special Protocol Assessment for our planned Phase 3b trial of NurOwn. The SPA covers the design and planned analysis of the trial in order to adequately address the objectives necessary to support a regulatory submission," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We believe that the SPA will substantially derisk the regulatory aspects of our program.  This moves us closer to initiating the trial and ensures our approach aligns with the FDA's current views, standards, and guidelines.  We are committed to collaborating closely with the ALS community and are grateful for the continued support and collaboration of patients, caregivers, and advocacy groups as we work to bring this potentially valuable new treatment to those affected by this devastating disease."

First Quarter 2024 and Recent Highlights

Clinical and regulatory

•  In April 2024, BrainStorm received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). The SPA agreement validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS. BrainStorm anticipates initiating the Phase 3b study in 2024, after reviewing the protocol with investigators, securing study site Institutional Review Board approvals, and engaging with appropriate members of the ALS community.
• In April 2024, Phase 3 biomarker data on NurOwn in ALS were published in Muscle and Nerve in a paper entitled "Debamestrocel multimodal effects on biomarker pathways in amyotrophic lateral sclerosis are linked to clinical outcomes".  The published data show that NurOwn treatment resulted in a positive impact on important CSF biomarkers relevant to ALS compared to placebo. Significant changes in multiple ALS disease pathways support NurOwn's mechanism of action and complement the clinical effects observed in ALS.
• Brainstorm's proposed design for the planned Phase 3b trial of NurOwn ALS was presented in a poster at the MDA Clinical and Scientific Conference in March, 2024. The design is for a two-part, multicenter, Phase 3b study to assess the efficacy and safety of NurOwn in participants with ALS.  The entry criteria will enroll people living with mild-to-moderate ALS. The primary endpoint will be based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).

Corporate

• In April 2024, promoted Dr. Bob Dagher to Executive Vice President and Chief Medical Officer. Dr. Dagher has over 20 years' of experience in clinical research and development, with a proven track record of leading successful clinical trials and fostering innovation in drug development. In addition, after four years of maintaining top executive roles, Dr. Stacy Lindborg is stepping down [or has stepped down?] from the role of Co-CEO and will remain with BrainStorm as a member of its Board of Directors. These strategic management changes are being made as the Company prepares to embark on the registrational Phase 3b trial for NurOwn®.

Upcoming Event – ALS Drug Development Summit

• BrainStorm will participate in the forthcoming 3rd Annual ALS Drug Development Summit, to take place May 21 to 23, 2024 in Boston MA.  Dr. Stacy Lindborg will deliver a presentation Promising Longer-Term Biomarker Data from NurOwn Program in ALS: Spotlight on NfL in EAP Extension Cohort. The new data to be presented suggest that patients may benefit from longer term treatment with NurOwn, as evidenced by changes in neurofilament light (NfL), an important biomarker associated with clinical outcomes in ALS. Other members of BrainStorm's team, Antonio Trejo, VP of Regulatory Affairs; Mary Kay Turner Senior Vice President, Global Patient Advocacy & Public Affairs; and Kylan Morris, Senior Manager, Patient Advocacy will take part in a workshop and panel at the Summit.

Financial Results for the First Quarter Ended March 31, 2024

• Cash, cash equivalents, and restricted cash amounted to approximately $1.0 million, as of March 31, 2024.
• Research and development expenses, net, in the first quarter ended March 31, 2024 were approximately $1.0 million, compared to $2.9 million for the quarter ended March 31, 2023.
• General and administrative expenses for the first quarters ended March 31, 2024 and 2023 were $1.5 million and $2.2 million, respectively.
• Net loss for the first quarter ended March 31, 2024 was $3.4 million as compared to a net loss of $5.1 million for the quarter ended March 31, 2023.
• Net loss per share for the quarter ended March 31, 2024 and March 31, 2023 was $0.05 and $0.14, respectively.

Conference Call and Webcast

BrainStorm management will host a conference call for the investment community later in the second quarter to provide update on the NurOwn program.  Details on the conference call will be provided when available.    

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 U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, 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

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)
							March 31,				December 31,
							2024				2023
							Unaudited				Audited
							U.S. $ in thousands
ASSETS
Current Assets:
Cash and cash equivalents							$	779			$	1,300
Other accounts receivable								26				51
Prepaid expenses and other current assets (Note 4)								454				548
Total current assets							$	1,259			$	1,899
Long-Term Assets:
Prepaid expenses and other long-term assets							$	20			$	22
Restricted Cash								182				185
Operating lease right of use asset (Note 5)								1,265				1,416
Property and Equipment, Net								622				686
Total Long-Term Assets							$	2,089			$	2,309
Total assets							$	3,348			$	4,208
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current Liabilities:
Accounts payables							$	4,690			$	4,954
Accrued expenses								636				1,240
Operating lease liability (Note 5)								588				603
Employees related liability								917				1,003
Total current liabilities							$	6,831			$	7,800
Long-Term Liabilities:
Operating lease liability (Note 5)								533				672
Warrants liability (Note 6)								1,534				594
Total long-term liabilities							$	2,067			$	1,266
Total liabilities							$	8,898			$	9,066
Stockholders' Deficit:
Stock capital: (Note 7)								13				13
Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at March 31, 2024 and December 31, 2023 respectively; Issued and outstanding: 68,447,193 and 60,489,208 shares at March 31, 2024 and December 31, 2023 respectively.
Additional paid-in-capital								212,967				210,258
Treasury stocks								(116)				(116)
Accumulated deficit								(218,414)				(215,013)
Total stockholders' deficit							$	(5,550)			$	(4,858)
Total liabilities and stockholders' deficit							$	3,348			$	4,208

 

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)
			Three months ended
			March 31,
			2024			2023
			Unaudited
Operating expenses:
Research and development, net			$	961		$	2,924
General and administrative				1,513			2,227
Operating loss				(2,474)			(5,151)
Financial income, net				13			92
Loss on change in fair value of Warrants liability (Note 6)				(940)			—
Net loss			$	(3,401)		$	(5,059)
Basic and diluted net loss per share from continuing operations			$	(0.05)		$	(0.14)
Weighted average number of shares outstanding used in computing basic and diluted net loss per share				64,738,544			36,735,435

 

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

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SOURCE BrainStorm Cell Therapeutics Inc.

FAQ

What financial results did BrainStorm Cell Therapeutics report for Q1 2024?

BrainStorm reported a net loss of $3.4 million, reduced from $5.1 million in Q1 2023, with $1.0 million in cash and cash equivalents.

What is the significance of the Special Protocol Assessment (SPA) secured by BrainStorm?

The SPA from the U.S. FDA validates the design and planned analysis for the Phase 3b trial of NurOwn, supporting future regulatory submissions.

What were BrainStorm's research and development expenses for Q1 2024?

Research and development expenses were approximately $1.0 million, down from $2.9 million in Q1 2023.

What changes were made to BrainStorm's management team in April 2024?

Dr. Bob Dagher was promoted to Executive VP and CMO, and Dr. Stacy Lindborg stepped down as Co-CEO but remains on the Board of Directors.

What are BrainStorm's plans for the Phase 3b trial of NurOwn in 2024?

BrainStorm plans to initiate the Phase 3b trial after securing approvals and engaging with the ALS community, based on the SPA agreement with the FDA.