BrainStorm Cell Therapeutics Inc (BCLI)

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BrainStorm Announces Full Year 2020 Financial Results and Provides a Corporate Update


https://finance.yahoo.com/news/brainstorm-announces-full-2020-financial-120000929.html

- Company met with the FDA to present phase 3 data and is in ongoing discussions with the FDA to identify agreed upon regulatory pathways that may support NurOwn's future approval in ALS

- Progressive MS Phase 2 trial remains on track for top-line data readout in Q1 2021

- Conference call and webcast at 8 a.m. ET today

NEW YORK, Feb. 4, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the fiscal year ended December 31, 2020, and provided a corporate update.

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"In 2020 we achieved several important company milestones, the most significant of which was the timely completion of our pivotal Phase 3 ALS trial," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "The trial generated robust data suggesting that NurOwn® has a clinically meaningful treatment effect and the FDA is actively reviewing these data following a recent meeting with our clinical team. The unmet needs of ALS patients continue to be our greatest inspiration and foremost priority, and we will keep the market updated as we receive formal feedback from the FDA and diligently pursue next steps to advance NurOwn's development in this devastating disease."

Mr. Lebovits continued, "Beyond our lead ALS program, we continue to make progress and are poised for a catalyst rich 2021 for our NurOwn technology platform. In progressive MS, our Phase 2 top-line data are expected by the end of the first quarter, which we believe will highlight the broad applicability of NurOwn's mechanism of action (MOA). We plan to further advance our pipeline through our clinical development program in Alzheimer's disease, a highly prevalent disease with enormous societal impact and limited treatment options. These clinical programs will be complemented by the expansion of our manufacturing capabilities and advancement of our exosome-based platform technology, which has demonstrated the potential to treat COVID-19 acute respiratory distress syndrome in a recently published preclinical study. We believe that execution of these milestones will help move us toward our ultimate goal of addressing the critical unmet needs of patients with neurodegenerative diseases while simultaneously positioning the company to generate shareholder value."

Fourth Quarter 2020 and Recent Corporate Highlights:

Announced top-line results from the NurOwn® Phase 3 amyotrophic lateral sclerosis (ALS) trial. Though the trial did not meet statistical significance in the primary efficacy endpoint, pre-specified analyses suggest that NurOwn® has a clinically meaningful treatment effect, which we seek to further explore in ongoing discussions with the FDA.

Presented the NurOwn® Phase 3 results in a platform session at the 31st International Symposium on ALS/MND.

Initiated a NurOwn® Expanded Access Program for patients who completed the Phase 3 ALS trial and meet specific eligibility requirements.

Completed dosing of all patients in the ongoing Phase 2 clinical trial evaluating NurOwn® as a treatment for adults with progressive multiple sclerosis (MS). Top-line data from the trial are expected by the end of the first quarter 2021.

Announced a partnership with Catalent for NurOwn® manufacturing. The partnership is designed to support a continuous supply of NurOwn® for future clinical trials and initial commercialization.

Selected Rapid Reshore & Development (RR&D) as our partner to expedite site selection and design services for a state-of-the-art manufacturing facility for NurOwn® in the U.S.

Announced the publication of a preclinical study entitled "MSC-NTF (NurOwn®) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model," in the peer-reviewed journal Stem Cell and Research Therapy. Data from the study showed that intrathecal administration of NurOwn® derived exosomes significantly improved lung function and histology in a mouse model of acute respiratory distress syndrome (ARDS), a type of respiratory failure frequently associated with COVID-19.

Presented preclinical NurOwn® derived exosome ARDS data at the Virtual New York Stem Cell Foundation Conference.

Presented an on-demand webinar at the 2020 Cell & Gene Meeting on the Mesa.

Cash and Liquidity as of January 31, 2021

Total cash and liquidity as of January 31, 2021 was approximately $45.0 million.

Financial Results for the Year Ended December 31, 2020

Cash, cash equivalents, and short-term bank deposits were approximately $41.9 million as of December 31, 2020, compared to approximately $0.6 million on December 31, 2019.

Research and development expenses, net for year ended December 31, 2020 and 2019 were approximately $22.3 million and $17.2 million, respectively.

General and administrative expenses for the year ended December 31, 2020 and 2019 were approximately $9.4 million and $5.8 million, respectively.

Net loss for the year ended on December 31, 2020 was $31.8 million, as compared to a net loss of $23.3 million for the year ended December 31, 2019.

For further details on BrainStorm's financials, including financial results for the year ended December 31, 2020, refer to the Form 10-K filed with the SEC today.

Conference Call & Webcast

Thursday, February 4, 2021 at 8 a.m. Eastern Time
From the US: 877-407-9205
International: 201-689-8054
Webcast: https://cutt.ly/vjBvkTp

Replays, available through February 18, 2021
From the US: 877-481-4010
International: 919-882-2331
Replay Passcode: 39495