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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): August 14, 2023
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
August 14, 2023, Brainstorm Cell Therapeutics Inc. (the “Company”) issued a press release announcing its financial and operating
results for the quarter ended June 30, 2023. 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 August 14, 2023 to discuss its second quarter 2023 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.
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: August 14, 2023 |
By: |
/s/ Chaim Lebovits |
| |
|
Chaim Lebovits |
| |
President and Chief Executive Officer |
Exhibit 99.1
BrainStorm Cell Therapeutics Announces Second
Quarter 2023 Financial Results and Provides Corporate Update
FDA advisory committee (ADCOM) meeting to discuss
NurOwn® for Amyotrophic Lateral Sclerosis (ALS) scheduled for September 27, 2023
BrainStorm's Biologics License Application (BLA)
for NurOwn has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023
Company prepares for ADCOM date presentation and
builds resources for FDA review and decision
Conference call and webcast at 8:00 a.m. Eastern
Time today
NEW YORK, Aug. 14, 2023 /PRNewswire/ -- BrainStorm Cell
Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced
financial results for the second quarter ended June 30, 2023 and provided a corporate update.
BrainStorm's immediate priorities are to prepare for the upcoming
ADCOM meeting to review the BLA for NurOwn®, scheduled for September 27, and complete preparations for commercial launch. The
Company's senior team is working with expert consultants to ensure it will deliver a compelling presentation to the ADCOM and is prepared
to address the questions that the FDA and members of the committee might raise.
"We appreciate the FDA's guidance and input throughout the review
process, which will be instrumental in making a policy decision that meets the needs of those living with ALS," said Chaim Lebovits,
President and Chief Executive Officer of BrainStorm. "In parallel with the regulatory work, we are preparing the company for success,
with the goal of making NurOwn available to patients, if approved in December. As part of this initiative, we have been making important
additions to our talented team throughout the year and recently added Dr. Kirk Taylor as our EVP, Chief Medical Officer, Dr. Bob Dagher
as EVP, Chief Development Officer, as well as Nir Naor as Board Member."
Dr. Stacy Lindborg, Co-Chief Executive Officer of BrainStorm commented,
"We look forward to discussing NurOwn's full dataset at the forthcoming ADCOM meeting. Our clinical program has generated complex
results, and the ADCOM meeting will provide us with the opportunity for a thoughtful discussion with scientists, ALS experts, FDA reviewers,
advocates, and patients. We have full confidence in the data we have compiled, and believe that a comprehensive analysis of our
results strongly supports NurOwn's clinically meaningful effectiveness. In addition, we continue to share our data with the ALS
community at scientific meetings and recently delivered an important presentation at the 2023 ALS and Related Motor Neuron Diseases
Gordon Research Conference. The data from this new analysis showed that treatment with NurOwn significantly elevated markers
of neuroprotection and lowered markers of neuroinflammation and neurodegeneration, including neurofilament light (NfL). Reductions in
plasma NfL are believed to be a predictor of clinical benefit in ALS."
Second Quarter 2023 and Recent Highlights
Clinical and regulatory
| · | The
U.S. Food and Drug Administration (FDA) notified BrainStorm that a meeting of the Cellular,
Tissue and Gene Therapies Advisory Committee to review the BLA for NurOwn® has been scheduled
for September 27, 2023. In addition, BrainStorm's BLA for NurOwn has been assigned
a PDUFA action date targeted to occur by December 8, 2023. |
| · | In
July 2023, new biomarker data from the Phase 3 trial of NurOwn were presented at
the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference. These
data show that treatment with NurOwn significantly elevated markers of neuroprotection and
lowered markers of neuroinflammation and neurodegeneration, including NfL over time compared
to placebo in all trial participants. It is believed that reductions in plasma NfL are reasonably
likely to predict clinical benefit in ALS. |
Corporate
| · | In
July 2023, BrainStorm closed a registered direct offering with a single institutional investor
raising gross proceeds, before deducting the placement agent's fees and other offering expenses,
of approximately $7.5 million. |
| · | In
July 2023, BrainStorm appointed Dr. Bob Dagher as Executive Vice President and Chief
Development Officer. Dr. Dagher will be responsible for the portfolio strategy and advancement
of clinical development plans towards regulatory approval, including the expansion of NurOwn
into new diseases and the translation of pre-clinical research into first-in-human trials.
He will serve on BrainStorm's executive leadership team reporting to Dr. Lindborg. |
| · | In
June 2023, BrainStorm appointed Nir Naor, CPA, CFA, MBA (IMD), LL.M, as Board
Member, chairman of its Audit Committee and member of its Governance, Nomination and
Compensation Committee. Mr. Naor replaced Mr. Malcolm Taub, who retired from the same roles
after 14 years of service on BrainStorm's Board of Directors. |
| · | In
April 2023, BrainStorm appointed Dr. Kirk Taylor as Executive Vice President and
Chief Medical Officer, continuing a targeted capability build that was launched with
the promotion of Dr. Lindborg to Co-CEO in January 2023. The capability build is being implemented
to hire and bring expertise inside BrainStorm in preparation for anticipated growth. |
Financial Results for the Quarter Ended June 30, 2023
Cash, cash equivalents, and short-term bank deposits were approximately
$.75 million as of June 30, 2023, compared to $3.0 million as of December 31, 2022. In July 2023, subsequent to the end of the quarter,
BrainStorm raised gross proceeds of approximately $7.5 million in a registered direct offering.
Research and development expenses for the three months ended June
30, 2023 and 2022 were approximately $2.8 million and $5.1 million, respectively.
General and administrative expenses for the three months ended June
30, 2023 and 2022 were approximately $2.7 million and $2.5 million, respectively.
Net loss for the three months ended June 30, 2023 was approximately
$5.3 million, as compared to a net loss of approximately $7.0 million for the three months ended June 30, 2022.
Net loss per share for the three months ended June 30, 2023 and 2022
was $0.13 and $0.19, respectively.
Conference Call and Webcast, 8:00 a.m. Eastern Time Today
| Participant
Numbers: |
| Toll
Free: |
888-506-0062 |
| International: |
973-528-0011 |
| Participant
Access Code: |
569863 |
| |
|
| Webcast
URL: |
https://rb.gy/hblmt |
Those interested in listening to the conference call live via the
internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's website
at https://shorturl.at/eko26 and clicking on the conference call link.
Those that wish to listen to the replay of the conference call can
do so by dialing the numbers below. The replay will be available until August 28, 2023.
| Replay
Numbers: |
| Toll
Free: |
877-481-4010
|
| International: |
919-882-2331 |
| Replay
Passcode: |
48916 |
About NurOwn®
The NurOwn® technology platform (autologous MSC-NTF cells) represents
a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells
are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors
to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS, which is under FDA review.
BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have
been published in peer-reviewed journals.
The Phase 3 pivotal trial of NurOwn did not reach statistical significance
on the primary or secondary endpoints, likely due to a "floor effect," which confounds measurement of disease progression in
patients with more advanced disease. A thorough analysis of NurOwn Phase 3 data shows evidence of clinically meaningful effectiveness
in ALS participants who have not progressed to advanced levels of disease progression. In a pre-specified group of participants with
an ALSFRS-R score ³35, there was a larger treatment effect across all endpoints with NurOwn compared to placebo, which aligned with
historical trials and the study power assumptions and resulted in a statistically significant difference on a key endpoint (change from
baseline in ALSFRS-R). Additionally, a post-hoc sensitivity analysis of patients across threshold of >26 through ≥35 on the
ALSFRS-R highlighted that NurOwn-treated patients retain, on average, two points of function more compared to placebo–clinically
meaningful preservation and important for quality of life for a person living with ALS and their loved ones.
NurOwn's clinical program also included most robust cerebrospinal
fluid (CSF) biomarker study ever done in ALS, strong and consistent biomarker data, which are predictive of clinical response in the
trial, span pathways that are important to ALS (neuroinflammation, neurodegeneration, neuroprotection), and align with NurOwn's mechanism
of action. Biomarker data in all trial participants showed consistent biological patterns of NurOwn reducing markers of inflammation
and neurodegeneration and increasing neuroprotective markers relative to placebo. Biomarker patterns were consistent across all NurOwn-participants,
including in those with Advanced ALS disease where clinical scales, such as the ALS Functional Rating Scale, have demonstrated measurement
challenges. Three CSF biomarkers were predictive of clinical outcomes in NurOwn-treated participants–NfL, galectin-1, latency associated
peptide of TGF-beta1 (LAP or TGF-b).
The NurOwn clinical program has generated valuable insights into the
pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset
through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in
depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing
a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic
analysis of clinical outcome, offering great promise for the development of future treatments for ALS.
BrainStorm previously announced the FDA's intention to hold an ADCOM
meeting to review NurOwn for the treatment of ALS. BrainStorm filed a BLA for NurOwn on September 9, 2022, and received a Refusal
to File (RTF) letter from FDA on November 8, 2022. Following a Type A meeting and subsequent discussions with the FDA BrainStorm
requested that CBER utilize the FDA's "File Over Protest" procedure, which offers the shortest amount of time to complete the
regulatory process. The BLA was filed over protest, allowing completion of the regulatory process in the shortest time possible, and
active review resumed on February 7, 2023.
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 pivotal 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). 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 the upcoming 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
Investor Relations:
John Mullaly
LifeSci Advisors, LLC
Phone: +1 617-429-3548
jmullaly@lifesciadvisors.com
Media:
Lisa Guiterman
Phone: +1 202-330-3431
lisa.guiterman@gmail.com
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share data)
| | |
June 30, | | |
December 31, | |
| | |
2023 | | |
2022 | |
| | |
Unaudited | | |
Audited | |
| | |
U.S. $ in thousands | |
| ASSETS | |
| | | |
| | |
| | |
| | | |
| | |
| Current Assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 546 | | |
$ | 772 | |
| Short-term deposit (Note 4) | |
| 202 | | |
| 2,211 | |
| Other accounts receivable | |
| 93 | | |
| 91 | |
| Prepaid expenses and other current assets (Note 5) | |
| 372 | | |
| 32 | |
| Total current assets | |
| 1,213 | | |
| 3,106 | |
| | |
| | | |
| | |
| Long-Term Assets: | |
| | | |
| | |
| Prepaid expenses and other long-term assets | |
| 22 | | |
| 23 | |
| Operating lease right of use asset (Note 6) | |
| 3,713 | | |
| 4,389 | |
| Property and Equipment, Net | |
| 799 | | |
| 933 | |
| Total Long-Term Assets | |
| 4,534 | | |
| 5,345 | |
| Total assets | |
$ | 5,747 | | |
$ | 8,451 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |
| | | |
| | |
| | |
| | | |
| | |
| Current Liabilities: | |
| | | |
| | |
| Accounts payables | |
$ | 5,190 | | |
$ | 6,224 | |
| Accrued expenses | |
| 90 | | |
| 84 | |
| Operating lease liability (Note 6) | |
| 1,354 | | |
| 1,427 | |
| Other accounts payables | |
| 1,057 | | |
| 1,065 | |
| Total current liabilities | |
| 7,691 | | |
| 8,800 | |
| | |
| | | |
| | |
| Long-Term Liabilities: | |
| | | |
| | |
| Operating lease liability (Note 6) | |
| 1,938 | | |
| 2,666 | |
| Total long-term liabilities | |
| 1,938 | | |
| 2,666 | |
| Total liabilities | |
$ | 9,629 | | |
$ | 11,466 | |
| | |
| | | |
| | |
| Stockholders' Equity: | |
| | | |
| | |
| Stock capital: (Note 7) | |
| 12 | | |
| 12 | |
Common Stock of $0.00005 par value - Authorized: 100,000,000 shares June 30, 2023
and December 31, 2022 respectively; Issued and outstanding: 40,926,745 and
36,694,078 shares at June 30, 2023 and December 31, 2022 respectively. | |
| | | |
| | |
| Additional paid-in-capital | |
| 204,431 | | |
| 194,910 | |
| Treasury stocks | |
| (116 | ) | |
| (116 | ) |
| Accumulated deficit | |
| (208,209 | ) | |
| (197,821 | ) |
| Total stockholders' equity (deficit) | |
| (3,882 | ) | |
| (3,015 | ) |
| Total liabilities and stockholders' equity (deficit) | |
$ | 5,747 | | |
$ | 8,451 | |
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)
| | |
Six months ended | | |
Three months ended | |
| | |
June 30, | | |
June 30, | |
| | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| | |
| | |
| | |
| | |
| |
| | |
Unaudited | | |
Unaudited | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development, net (Note 8) | |
$ | 5,718 | | |
$ | 7,729 | | |
$ | 2,794 | | |
$ | 5,113 | |
| General and administrative | |
| 4,882 | | |
| 5,337 | | |
| 2,655 | | |
| 2,478 | |
| Operating loss | |
| (10,600 | ) | |
| (13,066 | ) | |
| (5,449 | ) | |
| (7,591 | ) |
| Financial expenses (income), net | |
| (212 | ) | |
| (665 | ) | |
| (120 | ) | |
| 550 | |
| Net loss | |
$ | (10,388 | ) | |
$ | (12,401 | ) | |
$ | (5,329 | ) | |
$ | (7,041 | ) |
| Basic and diluted net loss per share from continuing operations | |
$ | (0.27 | ) | |
$ | (0.34 | ) | |
$ | (0.13 | ) | |
$ | (0.19 | ) |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | |
| 38,224,230 | | |
| 36,461,667 | | |
| 39,696,665 | | |
| 36,486,180 | |
The accompanying notes are an integral part of the consolidated financial statements.
Logo - https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg
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