BrainStorm Cell Therapeutics Inc (BCLI)

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BrainStorm Announces Financial Results for the Second Quarter of 2020 and Provides a Corporate Update

PR Newswire PR Newswire•August 5, 2020

- Conference Call and Webcast at 8am ET Today

- ALS Phase 3 Clinical Trial Remains on Track for Q4'20 Top-line Data Readout

- All Participants Enrolled in Phase 2 Progressive MS trial with Dosing to be Completed in Q4'20

NEW YORK, Aug. 5, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the second quarter and first half ended June 30, 2020, and provided a corporate update.

"Despite the impact of COVID-19 on healthcare access, we completed enrollment and dosing of our Phase 3 ALS clinical trial and expanded our pipeline across new indications," stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We want to recognize and thank the relentless dedication of the trial participants, their loved ones, our investigators and the team here at BrainStorm for this outstanding achievement. We expect a topline data readout by the end of November this year."

The application of NurOwn® as a platform technology in neurodegenerative disease has great potential and we are actively investing in clinical trials to evaluate the product in other conditions beyond ALS. The Phase 2 clinical trial ongoing in progressive multiple sclerosis (PMS) is expected to complete dosing by the end of 2020. In addition, we recently unveiled a clinical development program in Alzheimer's disease and are planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France. We believe that leveraging the NurOwn platform and potentially bringing much needed innovative treatment options to patients across multiple diseases will result in value creation for our various stakeholders.

Second Quarter 2020 and Recent Corporate Highlights:

Completed dosing of all patients in the ongoing NurOwn Phase 3 clinical trial in amyotrophic lateral sclerosis (ALS).
NurOwn is being investigated in a Phase 2 clinical trial in patients with progressive multiple sclerosis (PMS) which is ongoing at 5 leading U.S. MS centers. As of August 4, 2020, all 20 study participants have been enrolled in the study and dosing is expected to be completed by the end of 2020.
Announced a new clinical program focused on NurOwn as a treatment for Alzheimer's disease (AD). The Company is planning a multi-national Phase 2 clinical trial in Europe in patients with prodromal to mild AD.
The Alzheimer's disease program and Phase 2 trial were featured in a Key Opinion Leader (KOL) webinar on July 8.
Announced groundbreaking pre-clinical study of NurOwn derived exosome-based treatment for Covid-19 ARDS.
Granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency
Announced leasing of three state-of-the-art cleanrooms, at the Tel Aviv Sourasky Medical Center to increase manufacturing capability for EU and the local Israeli market
Awarded $0.5 Million by The ALS Association and IAMALS for ALS Biomarker Study
Professor Jacob Frankel appointed as Chairman of the Board of Directors
Appointed Stacy R. Lindborg Ph.D. as Executive Vice President, Head of Global Clinical Research
Appointed David Setboun as Executive Vice President and Chief Operating Officer
Presented new data highlighting NurOwn immunomodulation in Neurology Journal
Awarded $1.5 million grant for 2020 by the Israel Innovation Authority
Received non-dilutive bonus payment of $700,000 from CIRM for treating more California participants than originally proposed in our Phase 3 ALS clinical trial.
Joined the Russell 2000® and Russel 3000® Indexes
Presented at the following Investor Conferences:

Raymond James Human Health Innovations Conference
BIO Digital 2020
Cash and Liquidity as of July 31, 2020

Total available funding as of July 31, 2020, which includes cash on hand of approximately $34.7 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $37.5 million.

Financial Results for the Three Months Ended June 30, 2020

Cash, cash equivalents, and short-term bank deposits were approximately $16.2 million as of June 30, 2020, compared to $6.2 million on March 31, 2019.
Research and development expenses, net for the three months ended June 30, 2020 and 2019 were $5.69 million and $3.55 million, respectively.
- Excluding participation from IIA and CIRM under the grants and proceeds received under the hospital exemption regulatory pathway, research and development expenses decreased by $520,000 from $6.54 million in the second quarter of 2019 to $6.02 million in the second quarter of 2020.
General and administrative expenses for the three months ended June 30, 2020 and 2019 were $1.71 million and $1.30 million, respectively.
Net loss for the three months ended June 30, 2020 was $7.39 million, as compared to a net loss of $4.90 million for the three months ended June 30, 2019.
- Net loss per share for the three months ended June 30, 2020 and 2019 was $0.25 and $0.23, respectively.
Conference Call & Webcast

Wednesday, August 5, 2020 at 8am Eastern Time

From the US: 877-407-9205
International: 201-689-8054
Webcast: https://bit.ly/2DciAC9

Replays, available through August 19

From the US: 877-481-4010
International: 919-882-2331
Replay Passcode: 36017