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BrainStorm Issues Statement (Italian Translation Included)

NEW YORK, NY, May 28, 2019, -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, issues today the following statement: Recently, numerous organizations approached BrainStorm Cell Therapeutics informing management that an Italian patient publicly stated he has received approval for treatment of his ALS with the Company’s investigational therapy NurOwn®. We were also informed that a Go Fund Me account was established to raise money to pay for the investigational therapy NurOwn® in Israel. BrainStorm has reached out to the patient via email to inform him, that he, has not been, in direct contact with anyone from BrainStorm concerning his treatment, nor has anyone at Brainstorm ever committed, verbally or in writing, to treating him, in Israel or elsewhere. We have attempted to initiate a direct conversation with the patient and/or his family without success. While we have the greatest sympathy for the patient and his family, BrainStorm is not involved in this process. Therefore; we are issuing this statement to clarify the issue and publicly set the record straight. BrainStorm is fully focused on its pivotal Phase 3 clinical trial. The Company conducts clinical trials adhering to all regulations of the U.S. FDA and The Israeli Ministry of Health, at all times, without exception. The BCT-002 double-blind placebo-controlled phase 3 trial evaluating the efficacy and safety of repeated doses of the investigational therapy NurOwn® is actively recruiting eligible participants at all 6 U.S. sites for US and Canadian citizens only. The Israeli Ministry of Health recently approved NurOwn® treatment for 13 patients at Tel Aviv Sourasky Medical Center (Ichilov) through the Hospital Exemption pathway. The patient in question is not one of the 5 international patients currently being treated under the Hospital Exemption pathway at Ichilov. BrainStorm remains dedicated to rapidly advancing our pivotal phase 3 ALS trial and we appreciate the support and encouragement of the ALS community. Dichiarazione di BrainStorm Cell Therapeutics Recentemente, numerose organizzazioni hanno contattato BrainStorm Cell Therapeutics informando la team di gestione che un paziente italiano ha pubblicamente comunicato che ha ricevuto l’approvazione per sottoporsi al trattamento della SLA con la terapia investigazionale NurOwn® dell’azienda. Siamo stati anche informati che un conto Go Fund Me è stato creato per una raccolta fondi per pagare la terapia NurOwn® investigazionale in Israele. BrainStorm ha contattato il paziente via posta elettronica per informarlo, che lui non è mai stato direttamente in contatto con nessuno dell’azienda BrainStorm circa il ricevimento del trattamento, e che nessuno dell’azienda BrainStorm gli ha mai dato l’autorizzazione verbale o scritta, per sottoporsi al trattamento in Israele o in qualsiasi altro posto. Abbiamo provato ad iniziare una conversazione direttamente con il paziente e/o la sua famiglia senza aver avuto alcun successo. Mentre abbiamo la più grande compassione per il paziente e la sua famiglia, BrainStorm non è coinvolto in questo processo. Quindi; stiamo presentando questa dichiarazione per chiarire il fatto e sistemare la situazione per bene pubblicamente. BrainStorm è concentrata in pieno sulla nostra prova clinica essenziale in Fase 3. L’Azienda conduce le prove cliniche aderenti a tutte le regole dell’ U.S. FDA e del Ministero della Sanità Israeliana, in qualsiasi tempo, senza eccezioni. La prova clinica BCT-002 in doppio cieco, placebo controllato, in Fase 3 valuta l’efficacia e sicurezza dei dosaggi ripetitivi della terapia investigazionale NurOwn®. Il reclutamento è aperto per i partecipanti eleggibili in 6 centri degli Stati Uniti, unicamente per i cittadini statunitensi e canadesi. Il Ministero della Sanità Israeliana ha recentemente approvato il trattamento NurOwn® per 13 pazienti all’ospedale Tel Aviv Sourasky Medical Center (Ichilov) tramite l’accesso del Protocollo di Esenzione Ospedaliera. Pertanto, il paziente sopraindicato non è uno dei 5 pazienti internazionali che sta ricevendo il trattamento tramite il Protocollo di Esenzione Ospedaliera al centro Ichilov. BrainStorm rimane dedicata ad avanzare rapidamente la nostra prova clinica essenziale per la SLA in Fase 3, e apprezziamo molto il sostegno e incoraggiamento della comunità SLA. 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 (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., 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. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at Safe-Harbor Statements Statements in this announcement other than historical data and information constitute "forwardlooking 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, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forwardlooking 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: Mary Kay Turner Vice President, Patient Advocacy and Government Affairs BrainStorm Cell Therapeutics Inc. Phone: 201-488-0460 Ext. 105 Phone: Cell: 917-246-7021 Media Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839

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