BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics (OTCQB: BCLI), a developer of adult stem cell therapeutics, reported Q2 2025 financial results and significant developments for its NurOwn庐 therapy. The company received FDA clearance for a Phase 3b trial (ENDURANCE) designed to support a potential BLA submission, planning to enroll approximately 200 participants.
Key highlights include promising survival data from the NurOwn Expanded Access Program, showing 100% of participants surviving beyond 5 years from ALS symptom onset, with a median survival of 6.8 years. The company signed an LOI with Minaris Advanced Therapies for manufacturing support and presented breakthrough pharmacogenomic data at ISCT 2025.
Financial results show cash position of $1.03 million, with a quarterly net loss of $2.9 million ($0.34 per share), compared to $2.54 million ($0.60 per share) in Q2 2024.
BrainStorm Cell Therapeutics (OTCQB: BCLI), sviluppatore di terapie con cellule staminali adulte, ha comunicato i risultati finanziari del secondo trimestre 2025 e sviluppi significativi per la sua terapia NurOwn庐. L'azienda ha ricevuto l'approvazione della FDA per uno studio di Fase 3b (ENDURANCE) progettato per supportare una potenziale domanda BLA, pianificando di arruolare circa 200 partecipanti.
I punti salienti includono dati di sopravvivenza promettenti dal Programma di Accesso Espanso NurOwn, che mostrano il 100% dei partecipanti vivi oltre i 5 anni dall'esordio dei sintomi della SLA, con una sopravvivenza mediana di 6,8 anni. L'azienda ha firmato una LOI con Minaris Advanced Therapies per il supporto alla produzione e ha presentato dati farmacogenomici innovativi all'ISCT 2025.
I risultati finanziari mostrano una posizione di cassa di $1.03 million, con una perdita netta trimestrale di $2.9 million ($0.34 per azione), rispetto a $2.54 million ($0.60 per azione) nel secondo trimestre 2024.
BrainStorm Cell Therapeutics (OTCQB: BCLI), desarrolladora de terapias con c茅lulas madre adultas, inform贸 los resultados financieros del segundo trimestre de 2025 y avances importantes de su terapia NurOwn庐. La compa帽铆a obtuvo la autorizaci贸n de la FDA para un ensayo de Fase 3b (ENDURANCE) dise帽ado para respaldar una posible solicitud BLA, y planea inscribir aproximadamente 200 participantes.
Entre los puntos destacados figuran datos de supervivencia prometedores del Programa de Acceso Ampliado de NurOwn, que muestran que el 100% de los participantes sobrevivieron m谩s de 5 a帽os desde el inicio de los s铆ntomas de la ELA, con una mediana de supervivencia de 6,8 a帽os. La compa帽铆a firm贸 una LOI con Minaris Advanced Therapies para apoyo en manufactura y present贸 datos farmacogen贸micos novedosos en ISCT 2025.
Los resultados financieros muestran una posici贸n de efectivo de $1.03 million, con una p茅rdida neta trimestral de $2.9 million ($0.34 por acci贸n), frente a $2.54 million ($0.60 por acci贸n) en el segundo trimestre de 2024.
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BrainStorm Cell Therapeutics (OTCQB: BCLI), d茅veloppeur de th茅rapies 脿 base de cellules souches adultes, a publi茅 ses r茅sultats financiers du 2e trimestre 2025 et des avanc茅es significatives concernant sa th茅rapie NurOwn庐. La soci茅t茅 a obtenu l'autorisation de la FDA pour un essai de phase 3b (ENDURANCE) destin茅 脿 茅tayer une 茅ventuelle soumission de BLA, pr茅voyant d'inclure environ 200 participants.
Les points cl茅s incluent des donn茅es de survie prometteuses issues du programme d'acc猫s 茅largi NurOwn, montrant que 100 % des participants ont surv茅cu plus de 5 ans apr猫s l'apparition des sympt么mes de la SLA, avec une survie m茅diane de 6,8 ans. La soci茅t茅 a sign茅 une LOI avec Minaris Advanced Therapies pour le soutien 脿 la fabrication et a pr茅sent茅 des donn茅es pharmacog茅nomiques majeures 脿 l'ISCT 2025.
Les r茅sultats financiers indiquent une position de tr茅sorerie de $1.03 million, avec une perte nette trimestrielle de $2.9 million (0,34 $ par action), contre $2.54 million (0,60 $ par action) au 2e trimestre 2024.
BrainStorm Cell Therapeutics (OTCQB: BCLI), ein Entwickler von Therapien mit adulten Stammzellen, meldete die Finanzergebnisse f眉r das 2. Quartal 2025 und bedeutende Entwicklungen f眉r seine NurOwn庐-Therapie. Das Unternehmen erhielt die FDA-Freigabe f眉r eine Phase-3b-Studie (ENDURANCE), die eine m枚gliche BLA-Einreichung unterst眉tzen soll; geplant ist die Einschreibung von etwa 200 Teilnehmern.
Zu den wichtigsten Punkten geh枚ren vielversprechende 脺berlebensdaten aus dem NurOwn Expanded Access Program, die zeigen, dass 100 % der Teilnehmer mehr als 5 Jahre nach Ausbruch der ALS-Symptome 眉berlebten, mit einer medianen 脺berlebenszeit von 6,8 Jahren. Das Unternehmen unterzeichnete eine LOI mit Minaris Advanced Therapies zur Unterst眉tzung bei der Herstellung und pr盲sentierte bahnbrechende pharmakogenomische Daten auf der ISCT 2025.
Die Finanzergebnisse weisen eine Barmittelposition von $1.03 million aus, mit einem quartalsweisen Nettoverlust von $2.9 million ($0.34 je Aktie), verglichen mit $2.54 million ($0.60 je Aktie) im 2. Quartal 2024.
- FDA clearance received for Phase 3b ENDURANCE trial of NurOwn
- 100% survival rate beyond 5 years in Expanded Access Program vs typical 10% survival rate
- Manufacturing partnership secured with Minaris Advanced Therapies
- Reduced net loss per share from $0.60 in Q2 2024 to $0.34 in Q2 2025
- General and administrative expenses decreased from $2.1M to $1.4M year-over-year
- Low cash position of only $1.03 million raises funding concerns
- Net loss increased to $2.9M from $2.54M year-over-year
- R&D expenses increased by 22% to $1.1M compared to Q2 2024
Conference call and webcast scheduled for 8:30 a.m. Eastern Time Today, Thursday, August 14, 2025
"BrainStorm remains focused on executing our clinical development plan for NurOwn庐. We reached an important milestone in Q2 with FDA clearance to initiate our Phase 3b trial, designed to generate confirmatory data to support a potential BLA submission," said Chaim Lebovits, President and CEO. "We are also advancing key operational activities, including discussions with clinical sites as well as ongoing engagement with our selected CDMO partners to ensure readiness for clinical drug supply. We are encouraged by the ongoing interest and support from clinicians and the ALS community, and we remain confident that, if approved, NurOwn has the potential to make a meaningful difference for patients and their families."
Mr. Lebovits continued, "We support the FDA's consideration of the Citizen Petition, which may provide a fresh opportunity for an objective evaluation of the scientific evidence. We continue to stand behind the integrity and rigor of our data and will continue to engage with clinicians and the ALS community."
Recent Highlights
NurOwn (MSC-NTF)听for ALS
- FDA has cleared the company to initiate the Phase听3b听clinical trial of NurOwn庐 The Phase听3b听trial, known as ENDURANCE, is expected to enroll approximately 200 participants at leading academic medical centers and will consist of a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension in which all participants will receive NurOwn. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R).听Successful completion of the double blind portion of the study (Part A) is expected to generate the clinical data needed to support a new BLA submission. Details of the trial, including a list of anticipated participating clinical sites, are available on ClinicalTrials.gov ID听.
- A Citizens Petition submitted to the FDA by听ALS Community requesting a new review of the NurOwn data The company acknowledges that the FDA's consideration of the petition provides a new opportunity to reaffirm NurOwn's potential as a therapy for听ALS. BrainStorm was not involved in drafting or submitting this petition or its contents.
- New survival data from听NurOwn Expanded Access Program show that
100% of participants (10/10) in the EAP survived more than 5 years from the onset of ALS symptoms, compared to published estimates indicating that approximately10% of individuals with ALS would survive beyond 5 years. The single death in the cohort occurred following elective euthanasia. The median survival observed in the EAP cohort was 6.8 years (range: 6 to 7 years) from symptom onset.听Although the EAP cohort included participants earlier in their disease course, these results are encouraging and support further study. - Manufacturing Partnership with听Minaris BrainStorm has signed a Letter of Intent (LOI) , a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn for the upcoming Phase 3b clinical trial.
- NurOwn庐 data selected as Breakthrough Science for Presentation at ISCT 2025 Meeting The new pharmacogenomic data were delivered in an oral presentation at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, in
New Orleans . The data highlight the impact of the UNC13A genotype on clinical outcomes for ALS patients treated with NurOwn. The presentation was featured in the ISCT public announcement regarding the meeting, which indicated that the data were "carefully reviewed and selected by the ISCT 2025 Planning Faculty, to explore the latest breakthroughs in the clinical translation of Mesenchymal Stem/Stromal Cells and how they will shape the future of cell therapies."
Financial Results for the Second quarter Ended June 30, 2025
- Cash, cash equivalents, and restricted cash were approximately
$1.03 million - Research and development expenditures, net, for the quarter ended June 30, 2025 were
$1.1 million $0.9 million - General and administrative expenses for the quarter ended June 30, 2025 were approximately
$1.4 million $2.1 million - Net loss for the quarter ended June 30, 2025, was approximately
$2.9 million $2.5 .4 million - Net loss per share for the three months ended June 30, 2025, and 2024 was
$0.34 $0.60
Conference Call and Webcast
Participant Numbers:
Toll Free | 877-545-0320听听听听听听听听听听听听听听听听听听听听听 |
International | 973-528-0002 |
Participant Access Code | 601260 |
Webcast |
|
The replay of the conference call can be accessed by dialing the numbers below and will be available until August 28.
Replay Numbers:
Toll Free | 877-481-4010听听听听听听听听听听听听听听听听听听听 |
International | 919-882-2331 |
Reply Passcode | 52831 |
听听听听听 听
The听NurOwn庐 technology platform (autologous MSC-NTF cells) represents 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 are designed to 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.
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BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn庐 platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.听听听听听听听听听听听
NurOwn庐 is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the
Notice Regarding Forward-Looking Statements听
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the
CONTACTS
Investors:
Michael Wood
Phone: +1 646-597-6983
[email protected]
Media:
Uri Yablonka, Chief Business Officer
Phone: +1 917-284-2911
[email protected]
BRAINSTORM CELL THERAPEUTICS听INC. AND SUBSIDIARIES | ||||||
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(Except share data) | ||||||
June 30, | December 31, | |||||
2025 | 2024 | |||||
Unaudited | Audited | |||||
U.S.听$听in听thousands | ||||||
ASSETS | ||||||
Current Assets: | ||||||
Cash and cash equivalents | $ | 824 | $ | 187 | ||
Other accounts receivable | 106 | 63 | ||||
Prepaid expenses and other current assets | 585 | 135 | ||||
Total current assets | $ | 1,515 | $ | 385 | ||
Long-Term Assets: | ||||||
Prepaid expenses and other long-term assets | $ | 24 | $ | 22 | ||
Restricted Cash | 201 | 184 | ||||
Operating lease right of use asset (Note 3) | 495 | 807 | ||||
Property and Equipment, Net | 331 | 434 | ||||
Total Long-Term Assets | $ | 1,051 | $ | 1,447 | ||
Total assets | $ | 2,566 | $ | 1,832 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||
Current Liabilities: | ||||||
Accounts payables | $ | 5,997 | $ | 6,080 | ||
Accrued expenses | 367 | 619 | ||||
Short-term loans (Note 7) | 101 | 300 | ||||
Operating lease liability (Note 3) | 381 | 549 | ||||
Employees related liability | 1,682 | 1,430 | ||||
Total current liabilities | $ | 8,528 | $ | 8,978 | ||
Long-Term Liabilities: | ||||||
Operating lease liability (Note 3) | 95 | 171 | ||||
Warrants liability (Note 4) | - | 447 | ||||
Total long-term liabilities | $ | 95 | $ | 618 | ||
Total liabilities | $ | 8,623 | $ | 9,596 | ||
Stockholders' Deficit: | ||||||
Stock capital: (Note 5) | 16 | 14 | ||||
Common Stock of | ||||||
Additional paid-in-capital | 226,446 | 218,974 | ||||
Treasury stocks | (116) | (116) | ||||
Accumulated deficit | (232,403) | (226,636) | ||||
Total stockholders' deficit | $ | (6,057) | $ | (7,764) | ||
Total liabilities and stockholders' deficit | $ | 2,566 | $ | 1,832 | ||
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BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES | ||||||||||||
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) | ||||||||||||
(Except share data) | ||||||||||||
Six months ended | Three months ended | |||||||||||
June听30,听 | June听30,听 | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
Unaudited | Unaudited | |||||||||||
Operating expenses: | ||||||||||||
Research and | $ | 2,424 | $ | 1,883 | $ | 1,120 | $ | 922 | ||||
General and administrative | 3,238 | 3,573 | 1,453 | 2,060 | ||||||||
Operating loss | (5,662) | (5,456) | (2,573) | (2,982) | ||||||||
Financial income (expense), | (284) | 43 | (330) | 30 | ||||||||
Gain (loss) on change in | 179 | 529 | - | (411) | ||||||||
Net loss | $ | (5,767) | $ | (5,942) | $ | (2,903) | $ | (2,541) | ||||
Basic and diluted net loss | $ | (0.77) | $ | (1.35) | $ | (0.34) | $ | (0.60) | ||||
Weighted average number | 7,487,495 | 4,531,801 | 8,620,400 | 4,747,699 | ||||||||
Logo - https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg
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FAQ
What are the key findings from BrainStorm's (BCLI) NurOwn Expanded Access Program for ALS?
What is the design of BCLI's new Phase 3b ENDURANCE trial for NurOwn?
What is BrainStorm's (BCLI) current financial position as of Q2 2025?
What manufacturing partnership did BCLI secure for NurOwn production?
What is the primary endpoint for BrainStorm's Phase 3b NurOwn trial?
