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Post by morangie777 on Mar 17, 2016 17:47:17 GMT
On a related note, the recent 10K guided "Results from this trial are not expected until the middle of 2016." referring to the US ALS trial. "middle" is quite vague, so it could happen anytime from May to August, but it seems to me we are seeing a slow steady run up in anticipation of it. A validation of previous results would be great, as this is a placebo controlled trial, and that's what everyone (except of course for the placebo patients themselves) wants to see being done.
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Post by JHam on Feb 21, 2017 14:36:17 GMT
ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=irol-newsArticle&ID=2247581BrainStorm Seeking Approval To Distribute NurOwn® in Canada Signs agreement with CCRM for regulatory support of ALS treatment TORONTO, HACKENSACK, N.J. and PETACH TIKVAH, Israel, Feb. 21, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, has signed an agreement with CCRM, a Toronto-based leader in developing and commercializing regenerative medicine technologies, and cell and gene therapies, to support the market authorization request for NurOwn®. At this time, CCRM is helping Brainstorm explore the opportunity to access Health Canada's early access pathway for treatment of patients with Amyotrophic Lateral Sclerosis (ALS). If NurOwn® qualifies for Health Canada's "Notice of Compliance with Conditions" pathway, it could be authorized in Canada for distribution in early 2018. "We are pleased to partner with CCRM as we continue our efforts to develop and make NurOwn available commercially to patients with ALS as quickly as possible," says Chaim Lebovits, president and CEO of BrainStorm. "We look forward to discussing with Health Canada staff the results of our ALS clinical program to date, which we believe shows compelling evidence of safety and efficacy and may qualify for rapid review under Canada's regulatory guidelines for drugs to treat serious or life-threatening conditions." "Regulatory affairs is an essential part of the commercialization process which is why CCRM has developed in-house expertise to offer consulting to our academic and industry partners," explains Dr. Michael May, president and CEO, CCRM. "Patrick Bedford is working with BrainStorm to support its efforts to bring a treatment for ALS to patients in Canada." Patrick Bedford, manager of clinical translation and regulatory affairs, CCRM adds: "Health Canada is a world-class regulator that can use special regulatory pathways to review safety data and preliminary efficacy data to authorize promising therapies, while awaiting the completion of confirmatory efficacy studies. In fact, ALS has been specifically identified by Health Canada as a serious condition with unmet clinical needs that may qualify for a special regulatory pathway. If BrainStorm's existing clinical trial data can be found sufficient, NurOwn could be distributed to Canadians by next year." About CCRM CCRM, a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, strategic investors and entrepreneurs, CCRM aims to accelerate the translation of scientific discovery into marketable products for patients with specialized teams, funding, and infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Toronto's Medicine by Design. CCRM is hosted by the University of Toronto. Visit us at ccrm.ca 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 70 patients with ALS in two open label clinical trials and in compassionate use treatments in Israel and in a Phase 2 randomized, double-blind, placebo-controlled clinical trial in the United States. 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 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, COO Chief Operating 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 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-seeking-approval-to-distribute-nurown-in-canada-300409900.html SOURCE BrainStorm Cell Therapeutics Inc.
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Post by JHam on Feb 27, 2017 7:22:38 GMT
BCLI announced two nice additions to their BoD today. I still like this company and may buy shares again at some point, but Chaim Lebovits method of adding a sprinkle of "pumpiness" to everything turns me off (see headline below): BrainStorm Names Dr. June S. Almenoff and Arturo O. Araya to its Board of Directors as Company Prepares for Clinical and Commercial Success ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=irol-newsArticle&ID=2249471
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Post by lcd on Oct 16, 2017 14:49:52 GMT
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Post by lcd on Dec 15, 2017 16:30:01 GMT
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Post by lcd on May 7, 2018 21:37:33 GMT
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Post by lcd on May 16, 2018 19:04:23 GMT
BCLI is on quite a run this week with over 20% gains on heavy volume. I didn't listen to their earnings call on Monday, but don't see in the summary anything that would drive the price up, especially considering they are on track to run out of money before the end of the year. It looks like they are getting some coverage with target prices in the $9-11 range so there might be a rash of new traders coming in.
I find it interesting that the three Israel based companies followed by this board, BCLI, KTOV, and RDHL, are all killing it this week.
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Post by JHam on May 25, 2018 2:05:50 GMT
BCLI is on quite a run this week with over 20% gains on heavy volume. I didn't listen to their earnings call on Monday, but don't see in the summary anything that would drive the price up, especially considering they are on track to run out of money before the end of the year. It looks like they are getting some coverage with target prices in the $9-11 range so there might be a rash of new traders coming in. I find it interesting that the three Israel based companies followed by this board, BCLI, KTOV, and RDHL, are all killing it this week. Good to see this one start to rise from the dead. After all these years some of these companies that we have followed since the old Google Board days are finally well into late-stage trials (where institutions start to take notice). Move the embassy to Jerusalem and Israeli biotechs take off - go figure
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Post by JHam on Jun 8, 2018 5:46:57 GMT
Possible good entry point? ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=irol-newsArticle&ID=2353695 BrainStorm Announces Exercise of Warrants Resulting in Cash Proceeds of ~$12.3 Million at $5 ShareNEW YORK and PETACH TIKVA, Israel, June 7, 2018 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced it has entered into a Warrant Exercise Agreement with certain holders of warrants issued in the January 8, 2015 private placement. These holders have exercised warrants (for a total of 2,458,201 shares of common stock to be issued) at an amended exercise price of $5.00 per share, which generated gross cash proceeds of approximately $12.3 million. For each warrant exercised, BrainStorm has agreed to issue one new warrant to the holders to purchase unregistered shares of common stock at an exercise price of $9.00 and an expiration date of December 31, 2020. BrainStorm will file a registration statement covering the resale of the additional shares of common stock underlying the newly issued warrants. Maxim Group LLC was retained as financial advisor on behalf of BrainStorm in connection with this transaction. "Upon the closing of this warrant exercise, we have strengthened our balance sheet," stated Chaim Lebovits, BrainStorm's president and CEO. "We now have sufficient capital to not only complete our ongoing Phase 3 trial of NurOwn in ALS but also to advance the development of other promising R&D programs in our pipeline." The shares of common stock and warrants issued in this transaction have not been registered under the Securities Act of 1933, as amended (the Securities Act), or state securities laws. These shares of common stock have been registered for resale on registration statement Form S-3 No. 333-201704. The issuance of the shares of common stock and warrants is exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated under the Securities Act. The Company made this determination based on the representations that each party is an "accredited investor" within the meaning of Rule 501 of Regulation D. The Company made this determination based on the representations that each party is an "accredited investor" within the meaning of Rule 501 of Regulation D. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933.
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Post by JHam on Feb 11, 2020 11:21:08 GMT
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Post by lcd on Feb 11, 2020 12:51:54 GMT
Definitely not substantive news, but they needed a PR to keep their name out there. Pre-market up about 4.5%, but I doubt any gains hold.
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Post by lcd on Feb 13, 2020 21:30:20 GMT
As usual, I was wrong in my prediction of the stock price. BCLI is having a little moment, hitting almost $7 on relatively huge volume. They have an earnings call next week so hopefully more news positive news comes out then.
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Post by JHam on Feb 14, 2020 1:32:15 GMT
As usual, I was wrong in my prediction of the stock price. BCLI is having a little moment, hitting almost $7 on relatively huge volume. They have an earnings call next week so hopefully more news positive news comes out then. Yeah, people seemed to like what they said at the BIO CEO conference. I'm happy for those who have been holding this stock forever. (It still doesn't change the fact that the last PR was a bit fluffy)
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Post by lcd on Mar 6, 2020 20:50:41 GMT
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Post by lcd on Jul 23, 2020 12:23:34 GMT
I think I have been the only one on this board holding this stock. I bought my first shares just over 6 years ago and added more over the years. I certainly could have done better investing in something else prior to this year, but the pps has always held pretty steady (probably because the CEO owns so many shares) and I wanted to be part of it if it turns out to be a cure or significant life improvement to this horrible disease. I have no idea if this treatment works, but it has been fun to watch it run up over 300% from my purchase price. I sold about half my shares recently so I am treating the rest as "free shares" and going to ride this one out.
Does anyone else own BCLI shares?
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Post by JHam on Jul 23, 2020 15:35:58 GMT
I think I have been the only one on this board holding this stock. I bought my first shares just over 6 years ago and added more over the years. I certainly could have done better investing in something else prior to this year, but the pps has always held pretty steady (probably because the CEO owns so many shares) and I wanted to be part of it if it turns out to be a cure or significant life improvement to this horrible disease. I have no idea if this treatment works, but it has been fun to watch it run up over 300% from my purchase price. I sold about half my shares recently so I am treating the rest as "free shares" and going to ride this one out. Does anyone else own BCLI shares? I still have it on my watch list but don’t own any shares. You have to brag about that more so we can all celebrate together Congrats! I think NurOwn is theoretically sound, but the world seems to be bearish on stem cell based therapies recently. So I pretty much abandoned that space. Nice news today. I hope it works. This stock has had a great run. Good luck the rest of the way! www.globenewswire.com/news-release/2020/07/23/2066465/0/en/BrainStorm-Announces-Groundbreaking-Pre-Clinical-Study-of-NurOwn-derived-Exosome-Based-Treatment-for-COVID-19-ARDS.html
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Post by stemman on Sept 24, 2020 6:40:17 GMT
Haven't been on here for a long time (at least 4 or 5 years?). Still holding some BCLI shares bought a very long time ago. Looking forward to P3 data, then approval path, then Multiple Sclerosis trials, them possibly Alzheimer's...
Hope everyone stays careful and healthy.
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Post by lcd on Sept 24, 2020 11:43:08 GMT
Haven't been on here for a long time (at least 4 or 5 years?). Still holding some BCLI shares bought a very long time ago. Looking forward to P3 data, then approval path, then Multiple Sclerosis trials, them possibly Alzheimer's... Hope everyone stays careful and healthy. Stemman, good to have you visit back to the board, especially since you and I might be the only holders of this stock here.
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Post by stemman on Sept 26, 2020 10:01:10 GMT
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Post by stemman on Sept 28, 2020 18:08:49 GMT
www.youtube.com/watch?v=kdgfyxIyz4U - NurOwn® (autologous MSC-NTF cells) in ALS- phase 3 clinical trial update - Ralph Kern Published three days ago, but recorded on September 14 at the annual CIRM Grantee Meeting. I like this presentation a lot. There is hope for the patients suffering from this horrible illness. I also think the way Dr. Kern is presenting the data is impressive and highly professional. (Looks like he is doing it from his home.) A few points I liked most: - The advantages of the product being autologous. - The pipeline (multiple indications lined up; MS already in phase 2). - Beautiful trial design: the "48-point rating scale" across 4 domains, the end-point selection, the outcome analysis, only "fast progressors" being allowed in phase 3. (I think the latter point will make the results even more statistically significant.) Should anyone choose to watch the presentation, I am sure they will find additional notable take-away points.
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