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Spideyboy

06/30/17 12:38 PM

#2374 RE: early_retirement2 #2373

Along with the impending start to Phase III, which from my understanding it is meant to start in 2H/2017 but no real guidance given, which is prob closer to end Q3.

BCLI exited the first quarter of 2017 with 8.3 million cash, and with a 2 million burn per quarter. With that cash good enough to get thew to end Q2/2018.

While I would expect preparations to be ready and the City of Hope staff to be well trained up by now on NurOwn manufacturing.

So even with the IIA 2 million grant, my issue still is the funding for the Phase III of the 200 patients, (expecting at least a 10 million USD cost?) thus my expectation of dilution in the near term and holding off accumulating till I see the cash come in. Also again I'd rather they did do dilution that partner with royalties, as at the current ppr of 4.16, they would just need to issue 2.4-3 million shares to get the extra money I believe they would need. If the results are good, this will sell itself and will be all over the media, share price should fly from that.

What would be your thoughts?
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early_retirement2

07/05/17 10:22 AM

#2375 RE: early_retirement2 #2373

NEWS - Clinical Update


Worldwide Clinical Trials Selected by BrainStorm as CRO for Phase 3 NurOwn Trial in ALS


HACKENSACK, N.J. and PETACH TIKVAH, Israel, July 3, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has selected Worldwide Clinical Trials ("Worldwide") as its Clinical Research Organization (CRO) for its planned Phase 3 study of NurOwn® in the treatment of amyotrophic lateral sclerosis (ALS). A study kick-off meeting is expected this month.

Logo - hi-res

"Selecting a CRO is a critical step before initiating patient enrollment into our Phase 3 study of NurOwn in the treatment of ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We see Worldwide as the ideal partner for this important clinical trial - its deep expertise and capabilities in managing pivotal Phase 3 clinical trials in more than 60 countries, particularly in the fields of ALS and neurology, will be tremendous assets to us."

With support from Worldwide, BrainStorm will proceed with conducting a randomized, double-blind, placebo-controlled multi-dose Phase 3 trial that will be conducted at multiple sites.

About Worldwide Clinical Trials:
Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world sees CROs – in the best possible way. From early phase and bioanalytical sciences through late phase and post-approval, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID) and rare diseases. We never compromise on science or safety. We're never satisfied with the status quo. We're the Cure for the Common CRO. For more information, visit Worldwide.com.

About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University . NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel . In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement
Statements in this announcement other than historical data and information 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, 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 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.

CONTACTS

Media:
Uri Yablonka
Chief Business Officer
Brainstorm Cell Therapeutics Inc.
Phone: (646) 666-3188
uri@brainstorm-cell.com

Investors:
Michael Rice
LifeSci Advisors, LLC
Phone: 646-597-6979
mrice@lifesciadvisors.com

Worldwide Contacts
Media: Sherri Stuart, Worldwide Clinical Trials, +1 610-563-8768,
sherri.stuart@worldwide.com



To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/worldwide-clinical-trials-selected-by-brainstorm-as-cro-for-phase-3-nurown-trial-in-als-300482969.html

SOURCE BrainStorm Cell Therapeutics Inc.