“While many companies have been greatly hindered by the COVID-19 pandemic, Brainstorm, due to the incredible strength of our clinical trial participants, the amazing teams at our
First Quarter 2020 and Recent Corporate Highlights:
April 3: Awarded $1.5 MillionNon-Dilutive Grant for 2020 by the Israel Innovation Authority April 1: Appoints David Setboun as COO; Dr. Ralph Kernpromoted to President March 31: Appoints distinguished economist Dr. Jacob Frenkelas chairman of the board; appoints Mr. Sankesh Abbhi, a seasoned executive and entrepreneur in life sciences as new board member March 16: Announced receipt of $2.2 millionfrom CIRM for meeting prespecified milestones March 6: Raised gross proceeds of $10 millionfinancing from Abbhi Investments, LLCin a registered direct offering March 6: Enters common stock ATM distribution agreement for up to $50 millionwith Raymond James February 11: Announced that the Company and FDA agreed to potential NurOwn® regulatory pathway for approval in ALS and committed to work collaboratively, including opportunities to expedite statistical review of data from the Phase 3 trial.
Scientific and Company Presentations:
February 17- Presentation at Noble Capital Markets’ Sixteenth Annual Investor Conference February 11- Presentation at BIO CEO & Investor Conference January 24- Podium presentation at the 10th Annual California ALS Research Summit January 12- Presentation and participation at the Rare & Orphan Diseases Panelat the 3rd Annual Neuroscience Innovation Forum
Financial Results for the Three Months Ended
- Cash, cash equivalents, and short-term bank deposits were approximately
$14.5 millionat March 31, 2020, compared to $6.2 millionat March 31, 2019.
- Research and development expenses, net, for the three months ended
March 31, 2020were $5.95 million, compared to $3.46 million, net for the three months ended March 31, 2019.
- Excluding participation from IIA and CIRM under the grants and proceeds received under the Hospital Exemption regulatory pathway, research and development expenses increased by
$1.94 millionfrom $5.20 millionin the first quarter of 2019 to $7.14 millionin the first quarter of 2020
- General and administrative expenses for the three months ended
March 31, 2020were $2.36 million, compared to $1.47 millionin the three months ended March 31, 2019.
- Net loss for the three months ended
March 31, 2020was $8.1 million, or ( $0.32) per share, as compared to a net loss of $5.03 million, or ( $0.24) per share for the three months ended March 31, 2019.
For further details on BrainStorm’s financials, including financial results for the three months ended
Conference Call and Webcast:
A teleconference replay of the conference call will be available for 14 days on the “Investors & Media” page of BrainStorm’s website:
|Teleconference Replay Expiration:||Thursday, May 21, 2020|
NurOwn® (autologous MSC-NTF) cells represent 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. Autologous MSC-NTF cells can 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. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received
Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking 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, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; 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.
Chief Business Officer
BrainStorm Cell Therapeutics Inc.
Chief Financial Officer
Phone: + 1.862.397.1860
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
(Except share data)
|2 0 2 0||2 0 1 9|
|Cash and cash equivalents||$||12,471||$||536|
|Short-term deposit (Note 4)||2,020||33|
|Other accounts receivable||435||2,359|
|Prepaid expenses and other current assets (Note 5)||279||432|
|Total current assets||15,205||3,360|
|Prepaid expenses and other long-term assets||31||32|
|Operating lease right of use asset (Note 6)||1,917||2,182|
|Property and Equipment, Net||918||960|
|Total Long-Term Assets||2,866||3,174|
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Operating lease liability (Note 6)||1,208||1,263|
|Other accounts payable||1,170||714|
|Total current liabilities||8,252||17,654|
|Operating lease liability (Note 6)||808||1,103|
|Total long-term liabilities||808||1,103|
|Stockholders' Equity (deficit):|
|Stock capital: (Note 7)||12||11|
|Common Stock of
March 31, 2020 and
28,423,837 and 23,174,228 shares at
|Receipts on account of shares||-||-|
|Total stockholders' equity (deficit)||9,011||(12,223)|
|Total liabilities and stockholders' equity||$||18,071||$||6,534|
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
(Except share data)
|Three months ended|
|2 0 2 0||2 0 1 9|
|Research and development, net||$||5,948||$||3,456|
|General and administrative||2,360||1,472|
|Financial expenses (income), net||(194)||99|
|Basic and diluted net loss per share from continuing operations||$||(0.32)||$||(0.24)|
|Weighted average number of shares outstanding used in computing basic and diluted net loss per share||28,423,837||20,917,329|
Source: BrainStorm Cell Therapeutics Inc.