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NEWS - Presentation
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BrainStorm CEO to Present at the Sachs Associates 2nd Annual Neuroscience Biopartnering and Investment Forum
HACKENSACK, N.J. and PETACH TIKVAH, Israel, March 22, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that Chaim Lebovits, Chief Executive Officer, will provide an update on new developments and a corporate overview at Sachs Associates 2nd Annual Neuroscience Biopartnering and Investment Forum, being held on March 27th at the New York Academy of Sciences.
Neuroscience Biopartnering and Investment Forum Presentation Details
Date:
Monday, March 27
Time:
2:20pm Eastern Time
Location:
New York Academy of Sciences, 7 World Trade Center
About the Annual Neuroscience BioPartnering & Investment Forum
The 2nd Annual Neuroscience BioPartnering & Investment Forum to take place on 27th of March at the New York Academy of Sciences. It will focus on key areas of neurodegenerative diseases and pain management with a mix of specialist panels and company presentations. The event is targeted at buy and sell side analysts from investment banks and funds and partnering executives from pharma. For more information, refer to http://www.sachsforum.com/2nbpi-about.html
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.
CONTACTS
Media:
Uri Yablonka
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-ceo-to-present-at-the-sachs-associates-2nd-annual-neuroscience-biopartnering-and-investment-forum-300427336.html
SOURCE BrainStorm Cell Therapeutics Inc.
Spideboy,
As always, you provide good insight. I apologize for not responding sooner as I'm sure it kept you up at night....haha, jk.
My day job has been very busy lately and haven't had a chance to response or look at any specifics in regards to BCLI company position and possible deals, etc.
Without researching beyond your post, what I do know about China is they're one of the leading countries in stem cell research (which you probably already know). I think Israel is in the top 10 so that's good and US is slowly coming around. On a side note, I think South Korea is the top stem cell research country.. I'll have to do research on that. With that said, a potential partnership will benefit BCLI however, with the recent hire of Dr. Kern, I'd like to see BCLI operate without partnerships who may want to chip away about potential profits. I think Dr. Kern's background will benefit BCLI on a global scale as he is familiar with global distribution solutions which they can provide patient care. Like you said, foreign policies can be an obstacle but I believe BCLI will work with countries who favor stem cell research/treatment first and others later. For instance, the potential to treat Canadian citizens since their regs aren't as strict as FDA. I think by BCLI focusing on those countries who like stem cell treatment, this will allow them to gain a strategic advantage over competition especially since their trying to treat ALS.
As for raising additional cash, I agree with you in there needs to be another way to do it. I think management has done a good job so far with raising capital without hurting shareholders. the only issue I had with them was the RS, I was down over 40% but held through so they could up list to NASDAQ (as I mentioned before). Recently, I was up over 60% (just under $7,000) total so, I sold all my shares to lock in those gains and at the moment, I'm buying again. I believe in this company and what they're doing. I removed my emotions to make the money that I did and now, I'm taking a smaller stake.
Overall, I like the companies potential. I've mentioned this before and as long as they don't get loans or other companies involved to help fund Phase 3 or other areas, i think that's ideal. they can do what they want with raising capital through stock offerings because in the short term, the stock may take a hit but long term investors will see the potential and hold.
NEWS:
BrainStorm Announces MOU with Tel Aviv Sourasky Medical Center to Make NurOwn® Available to Patients as a Hospital Exemption Product
Tel Aviv Sourasky Medical Center (Ichilov) Is Also Expected to be a Treatment Center in Planned Phase 3 Trial of NurOwn In ALS
HACKENSACK, N.J. and PETACH TIKVAH, Israel, March 1, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that is has signed a Memorandum of Understanding (MOU) with The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Sourasky Medical Center (Ichilov Hospital) to explore the possibility of making NurOwn® available to Amyotrophic Lateral Sclerosis (ALS) patients under the provisions of Hospital Exemption regulation. The MOU also covers the participation of Tel Aviv Sourasky Medical Center in the planned Phase 3 trial that will investigate NurOwn in ALS.
The MOU sets forth the basic terms under which Brainstorm and Tel Aviv Sourasky Medical Center would work together to submit an application to the Israeli Ministry of Health that will allow patient access to NurOwn and is subject to a definitive agreement. The agreement is expected to be formalized in the first half of 2017.
"We are pleased to be working with Tel Aviv Sourasky Medical Center and look forward to putting a definitive agreement in place," said Chaim Lebovits, President and CEO of BrainStorm. "We believe that NurOwn meets the requirements to be a Hospital Exempt product and, if our application is successful, we could potentially make the product available to patients prior to obtaining formal licensure."
"Tel Aviv Sourasky Medical Center and BrainStorm have a joint interest in developing a path to bring advanced therapies to patients," said Professor Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We hope our combined efforts will leverage BrainStorm's technology to provide a new and innovative treatment option for our ALS patients."
About Hospital Exemption
The Israeli Ministry of Health (MoH) has recently adopted a policy that was developed in Europe in regards to advanced medical therapies, under which a Hospital Exemption (HE) Regulation was put in place. The new MoH guidelines, which are similar to the HE rules applied in the European Union, require Brainstorm Cell Therapeutics to partner with a local medical center in order to apply for HE.
About Tel Aviv Sourasky Medical Center
Tel Aviv Sourasky Medical Center (Ichilov) is the second largest and one of the most progressive full-service healthcare treatment and research institutions in Israel. The Medical Center draws patients from throughout the world for specialty care and routine procedures, designed specifically for the needs of international patients. Medical Center physicians integrate their clinical care with research on a daily basis. The Medical Center is the leading hospital in Israel in the number of research projects conducted. Each year, hundreds of research studies, both basic science and clinical, are conducted within the Medical Center's walls, in search of new medical understanding and to develop new diagnostic and treatment modalities. For more information, refer to http://www.tasmc.org.il/sites/en/About/Pages/About.aspx.
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 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-announces-mou-with-tel-aviv-sourasky-medical-center-to-make-nurown-available-to-patients-as-a-hospital-exemption-product-300415879.html
SOURCE BrainStorm Cell Therapeutics Inc.
I agree, commercializing will be great for this company as other stem cell companies have accomplished this. I was reading an article the other day about one stem cell company that commercialized their products and have gain consistent revenues. Brainstorm still has a lot of work to do but they're moving in the right direction.
sudnwealth - welcome! if you look back at my previous post, you'll see we do have concerns about the company's finances moving forward but they seem to not be. lots of good things to come and I too an long. finally paying off after several years of being invested but I think there's more to come.
this board has a good mix of posters, rational and with good thought behind each post. I haven't seen spam posters or those that try to manipulate investors to sell shares.
good luck!
NEWS - Not huge news but rather putting more important pieces in position for additional future success.
BrainStorm Names Dr. June S. Almenoff and Arturo O. Araya to its Board of Directors as Company Prepares for Clinical and Commercial Success
HACKENSACK, N.J. and PETACH TIKVAH, Israel, Feb. 27, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today the appointments of June S. Almenoff, M.D., Ph.D., FACP, and Arturo O. Araya, M.A., M.B.A. to its Board of Directors.
"Dr. Almenoff and Mr. Araya are talented and successful pharmaceutical executives whose appointments come at an exciting time for our company," said Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics. "Their experience as industry leaders, their expertise in disease management and their guidance as members of our board will be invaluable as we prepare to launch a Phase 3 clinical study of NurOwn® adult stem cells for the treatment of amyotrophic lateral sclerosis (ALS)."
Dr. June Almenoff is an accomplished executive with 20 years of experience in the pharmaceutical industry. She recently served as President and CMO of Furiex Pharmaceuticals, which was acquired by Actavis plc (now Allergan) for ~$1.2B. Furiex developed eluxadoline (VIBERZI®), which was recently approved in both the US and EU. Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK) for 12 years, where she held various positions of increasing responsibility. She was a Vice-President in the Clinical Safety organization, chaired a PhRMA-FDA working group and worked in the area of scientific licensing. Dr. Almenoff also led the development of pioneering systems for minimizing risk in drug development, which have been widely adapted by industry and regulators.
Dr. Almenoff is currently an independent biopharma consultant and Board Director. She is Executive Chair of RDD Pharma and a Director of Tigenix NV (Nasdaq: TIG), and Ohr Pharmaceutical (Nasdaq: OHRP). She serves on the advisory boards of several private companies and the investment advisory board of the Harrington Discovery Institute.
Dr. Almenoff graduated from the M.D. Ph.D. program at the Icahn School of Medicine at Mount Sinai. She completed her medical training at Stanford University Medical Center and served on the faculty of Duke University School of Medicine.
"I'm delighted to be joining the Board of Brainstorm," said Dr. Almenoff. "The Company's innovative work shows promise toward helping ALS patients with this devastating disease."
Arturo Araya, M.A., M.B.A, was formerly the Vice President and Head of Global Commercial for Novartis' Cell and Gene Therapies Unit, where he led a cross-functional team to globally commercialize a portfolio of cell and gene therapies. In his prior role as Global Brand Leader for CTL019, a CAR-T therapy, he was responsible for developing early launch plans, including worldwide and multiple indication forecasts and resource modeling. He has lead the Oncology Unit for Novartis in seven countries. Prior to his tenure at Novartis, Mr. Araya was with Bristol-Myers Squibb Company, most recently as Associate Director of Marketing Intelligence, Business Development & Licensing. He earned an M.B.A. from the University of Michigan, and an M.A. and B.S. in Engineering from the University of Connecticut.
"It is an honor to be part of the Board of Brainstorm," said Mr. Araya. "The technology being developed at the Company has the potential to help ALS patients in great need of new treatment options."
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.
VIBERZI® is a registered trademarks of Allergan Holdings Unlimited Company.
CONTACTS
Media:
Uri Yablonka
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-names-dr-june-s-almenoff-and-arturo-o-araya-to-its-board-of-directors-as-company-prepares-for-clinical-and-commercial-success-300413763.html
SOURCE BrainStorm Cell Therapeutics Inc.
Minding - thanks! so far so good but it did take some time to get here.. this is clip from my response to Spideboy.
"I've been a shareholder for about 4 years now when this company was on the OTC and purchases shares around $0.50 and held through their RS which was necessary for them to upgrade to the NASDAQ. it was a loss I was willing to take knowing they were going to a creditable market. I bought most of shares last year as it traded between $2-$2.50.. I have a total of 4,500 shares at a cost basis of $2.72 share. Right now, my returns are looking pretty good. I could sell everything and lock in those gains and buy back in but I'd rather hold (at the moment)."
Spideyboy - I appreciate your insight and additional details about funding of Phase III. I agree with you in that there's an issue with finding the funding necessary to support Phase III and these potential agreements with City of Hope and CCRM. Hopefully the company is looking at the strategic advantage it could have as you explained. I like to think they're several steps ahead of us as they should be.
I'm still learning the biotech sector as this company is my first small cap to invest in. I've been a shareholder for about 4 years now when this company was on the OTC and purchases shares around $0.50 and held through their RS which was necessary for them to upgrade to the NASDAQ. it was a loss I was willing to take knowing they were going to a creditable market. I bought most of shares last year as it traded between $2-$2.50.. I have a total of 4,500 shares at a cost basis of $2.72 share. Right now, my returns are looking pretty good. I could sell everything and lock in those gains and buy back in but I'd rather hold (at the moment). Sorry I'm going off on a tangent but as I learn the biotech sector, I appreciate investors like yourself who provide helpful insight.
good luck to you and your current investments!
I'm excited to see this finally getting the attention it deserves. I'm long for this company as they continue to make great progress.
Could you post a level 2 when you have a moment, I can't see mine at work.
Thanks in advance!
NEWS - http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=RssLanding&cat=news&id=2247581
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 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, 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.
NEWS - http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=RssLanding&cat=news&id=2246543
City of Hope to Manufacture NurOwn® for Brainstorm's Phase 3 ALS Clinical Trial
HACKENSACK, N.J. and PETACH TIKVA, Israel and DUARTE, Calif., Feb. 16, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it plans to contract with City of Hope's Center for Biomedicine and Genetics to produce clinical supplies of NurOwn® adult stem cells for the company's planned randomized, double-blind, multi-dose Phase 3 clinical study in patients with Amyotrophic Lateral Sclerosis (ALS). City of Hope is expected to support all U.S. medical centers that will be participating in the Phase 3 trial.
"City of Hope is committed to the advancement of cellular therapy research and the treatment of serious diseases that lack effective therapies," said Dr. Joseph Gold, manufacturing director of City of Hope's biological and cellular GMP manufacturing facility, the Center for Biomedicine and Genetics. "We are pleased to support BrainStorm's ALS clinical research program."
"City of Hope's cell product manufacturing team has extensive experience in the areas of cGMP manufacturing and regenerative medicine," said Chaim Lebovits, president and CEO of BrainStorm. "This collaboration will ensure that we can provide high-quality clinical supplies of our product to patients who participate in our Phase 3 ALS clinical program. We look forward to finalizing our agreement with City of Hope in the near future."
About City of Hope
City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 47 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world. City of Hope is located in Duarte, California, just northeast of Los Angeles, with community clinics throughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation, diabetes and numerous breakthrough cancer drugs based on technology developed at the institution. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.
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 over 30 patients with ALS in clinical trials conducted in Israel, and is currently being studied in a 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 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, 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/city-of-hope-to-manufacture-nurown-for-brainstorms-phase-3-als-clinical-trial-300408623.html
SOURCE BrainStorm Cell Therapeutics Inc.
Presentation today:
http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=RssLanding&cat=news&id=2243212
BIO CEO & Investor Conference Presentation Details
Date:
Monday, February 13
Time:
1:00pm Eastern Time
Location:
Louis XVI Ballroom
Webcast:
http://www.veracast.com/webcasts/bio/ceoinvestor2017/01118554128.cfm
Nice price moment the past 5 days.. looks like the company is getting some much deserved attention.
hopefully we'll get news soon about Phase III funding and see an uptrend after the next investor conference.
Presentation News - http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=RssLanding&cat=news&id=2243212
The CEO is presenting at another investor conference next week.. Maybe we'll see another uptick in share price.
someone may know something.. just saw a sudden increase in volume and topped out at $3.06 (I believe).
Spideyboy - I just read your posts and I agree. I think some investors who aren't familiar with the process and the news gave them additional insight. Although, the cryopreservation process may not be a new process, I think the important points to take away from that PR is from the second paragraph (regardless of someone's knowledge of the company) :
"The validation involved a comparison of NurOwn® (MSC-NTF cells) derived from fresh mesenchymal stem cells (MSC) to those derived from cryopreserved MSC. Company scientists were successful in showing that the MSC can be stored in the vapor phase of liquid nitrogen for prolonged periods of time while maintaining their characteristics. The cryopreserved MSC are capable of differentiating into NurOwn®, similar to the NurOwn® derived from fresh MSC of the same patient/donor, prior to cryopreservation. This will allow the Company to provide repeated doses of autologous NurOwn® from a single bone marrow aspirate in its upcoming multidose clinical trial. Cryopreservation will avoid the need for patients to undergo repeated bone marrow aspirations. "
You bring up a good point about how viable the cells are after being thawed. Maybe you could follow up with the company and see if they would comment on that? Another good point is cash to support Phase III. To be honest, I was hoping we would have heard more about this by now. During the conference call in December, the CEO wasn't concerned about Phase III funding which lead me to believe they had a plan or serious investors willing to fund it...However, fast forward to present we know the CEO attended two large conference to discuss their progress. Anyone who listened on the conference call heard the CEO say he wouldn't go on the road to promote the company but he's done two conference already. But I will say, since he's presented at these conferences, the stock has slowly moved up... seems to be working for now. I think Phase III funding is one of their largest obstacles and yes, the stock may take a hit short-term but I believe long-term we'll be rewarded.
Here's a good read which compares BCLI with other companies, make sure you read the disclosure info at the bottom.
http://jutiagroup.com/20170116-time-to-go-long-on-brainstorm-cell-therapeutics/
definitely looking good..
thanks for the ARTH info on the other board.
thanks Minding, much appreciated!
Minding - I understand your position as I felt the same with BCLI.. I was thinking about selling it multiple times and taking the loses but held through all the changes and happy I did. I hope that the biotech companies you're invested in keep moving in the right direction and you're able to capitalize on those gains.
thanks for the ARTH recommendation. I never heard of them and I've been doing my research on them and it seems they're right on the cusp of something great. I don't know much about the path to approval for those types of devices but like you said, I presume it's much easier and less resistant.
I might jump in for a small position as they've done well over the past year. would be up around 300% if you go in last February or early March. Still looks like they could move over $1 if their device is approved.
Minding - you are correct to say, nothing is certain until FDA approval. I completely agree with you so, thanks for the reality check.. I guess im anxious about the phase 3 trial and getting ahead of myself. im very cautious about biotech stocks because of their volatility and lack of money for R&D, trials, etc. smaller biotech companies are even more risky but I feel BCLI has been going about their trials and busy the right way. I guess that's where I get excited about what the future holds....but I will take a reality check and remind myself that nothing is certain until they receive official approval.
thanks for the info about the potential market cap. if the company stock were to trade at $18/share, I'd be sitting on about $60,000 in profit... all speculation at this point but I was able to buy on the dips bringing my average to $2.65/share. if I wanted to, I could "day trade" this stock for gains, then take another large position in a dip. chances are I'd be able to purchase a position lower than my $2.65 average. guess that's the beauty of this stock, i have plenty of options on how to make gains off it.
good luck to you and your current biotech stocks. any stock(s) in particular your excited about?
Minding - you're right, I probably shouldn't play down the Phase 3 process by saying they'll get approval without any issues. But I do strongly believe it'll be approved....yes might be a long process but I think in the end, it'll be ok.
I do wonder what the stock price would be if they did get approval.
nice trading today, up almost 9%. maybe their presentation today turned some heads.
Spideyboy - interesting piece of information and thanks for pointing that out. I went back to BCLI's website and read the news. here is it for anyone who wants to review it.
http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=RssLanding&cat=news&id=2234205
in my opinion, I feel it contradicts what Chaim Lebovits said during their year end conference call. I remember that distinctly because I was surprised the company wasn't going to raise capital or seek it in other areas to fund Phase 3. my initial impression was that Chaim was already in discussion with investor(s) or other means to fund Phase 3 without adding debt. I was very pleased to hear that from them. however, this latest news about the company attending this biotech conference does raise a little concern for the short term. Maybe an investor backed out since the year end call and the company is looking for others? or maybe dilutive capital is their backup plan? idk, we can speculate all we want but I personally feel, it's nothing to get worked up about. my position is that I'm here for the long term so if they have to dilute stock to fund some of their Phase 3, so be it. I'll just buy more stock. why im not too concerned is because of the company's product and their results. I strongly feel this will get FDA approval in the future because it benefits ALS patients now. Their phase 3 trial with 150(+/-) patients who they're looking to enroll will have positive results as phase 2 did.
I would be more concerned if their product was bad and they have to go back to the drawing board and their saving grace was to attend investor conferences.. since this is isn't the case, I wouldn't worry to much about it. yes, funding phase 3 is a concern of mine but I feel they have the means and haven't discussed it yet.
of course all of this is my opinion.
Minding - you're welcome and it's my pleasure to provide the information. I enjoy being a moderator for this site and company because I feel this is a hidden gem.... the company has no debt for starters and doesn't need to dilute for capital. in addition to that, the therapy is proven and is getting huge attention within the ALS community. as I've stated before, if I make a huge profit on this, I plan to donate most of my gains to ALS research. I'd really like to donate it back to this company as they make significant progress in ALS and in other areas.
in my opinion - this company is a game changer and there's a huge upside over the next several years. I think the stock price will range between $2.40-2.80's over the next month or so unless there is really good news released, then we'll break through $3. I plan to add more to my pile as well. currently I have 3500 shares at an average price $2.72 and if it dips into $2.50's, i'll buy more. the stock won't be too exciting as they go through the phase 3 process but as the CEO stated, they don't plan to raise capital for phase 3 which means, they're very confident that they'll have plenty of money for phase 3. I really like the CEO, he's no BS, straight to the point, and very transparent. look for more detailed news about phase 3 plans and second indicator being used for MS study.
good luck to you!
yes - they have a strong second indicator for MS which they'll release in the first half of 2017. this info was from the conference call.
my personal onion, I believe they'll release news as the company has it available. I personally feel they'll be something in the next couple months jan-feb. with an update phase 3 plans. regardless, all the news will be good in my opinion.
**INFO**
You can listen to the conference call from December 19th if you haven't already. Just sign up and you'll be able to listen in and hear the Q/A session. I highly recommend you do so if you're curious about the company's 2016 progress and plans for 2017.
Webcast:
http://public.viavid.com/index.php?id=122186
yes very good news and conference call they hosted last week. I forgot my notes I took because I wanted to post them to this site. regardless, all great news and looking forward to 2017 and the beginning of their Phase 3 trial.
I hope, going to load the boat when that opportunity comes.
yea good stuff all around. im going to wait for a pull back and buy one last chunk on shares before I just ride the wave. this will be a good one. I think it'll get more momentum after the company investor meeting December 19th.
good luck!
I know, it's great news for patients and I hate to say this, investors too. I feel bad knowing I could be sitting on a great investment at the expense of ALS patients. I plan to donate towards additional research if I do make something from this.
I held through the company's reverse split and left me down over 25% but I kept buying large chunks as the stock kept going down. I knew their product was the real deal so, now I'm about even. I like how the company is getting the word out within the industry and not spending money on silly marketing attempts. they're presenting at major conference to doctors who have experience to back up their results.
overall, great stuff and looking forward 2017.
PS: there's an investors meeting December 19, here's the link for details. you should listen in. http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=irol-newsArticle&ID=2227741
i know.. this gem is waaaay under the radar. I'm sitting on 2500 shares. here's the latest news today, big news!
In-Depth Analyses Presented at International Symposium on ALS/MND Suggest Strong Biological Effect for NurOwn®; Evidence of Halting of Disease Progression
HACKENSACK, N.J. and PETACH TIKVAH, Israel, Dec. 14, 2016 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that new data from the Company's Phase 2 study of NurOwn® in ALS were presented by lead investigator Dr. James Berry at the 27th International Symposium on ALS/MND in Dublin, Ireland.
In the Phase 2 trial, levels of neurotrophic factors and inflammatory markers were measured in cerebral-spinal fluid (CSF) samples collected from patients. In the samples of those patients treated with NurOwn, a statistically significant increase in levels of neurotrophic factors VEGF, HGF and LIF was observed from pre- to post-transplantation. There was also a statistically significant reduction in inflammatory markers (MCP-1 and SDF-1) over this period, in patients treated with NurOwn® and this was not observed in the placebo group.
Dr. Berry also presented the pre-specified responder analyses from the Phase 2 trial which examined percentage improvements in post treatment of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope compared to pre-treatment slope. These analyses showed that, in the NurOwn® treated group, a greater number of patients achieved the high threshold of 100% improvement in the post-treatment vs. pre-treatment slope, compared with the placebo group. The definition of these responders is that their disease symptoms were essentially halted for the period of the treatment effect or they achieved a positive improvement on their ALSFRS-R score. Moreover, in the pre-specified subgroup that was defined in order to exclude subjects whose disease was progressing slowly, this effect was even more pronounced.
"This Phase 2 trial demonstrated clinical meaningful improvements in disease symptoms as measured by the well-established ALSFRS-R scale", stated Dr. James Berry, Unit Chief of the Mass. General ALS Multidisciplinary Clinic. "Importantly, there is evidence that NurOwn® may be halting disease progression or improving symptoms in some patients. The CSF biomarker profiles were also encouraging. The significant increases in neurotrophic factors and decrease in inflammatory markers observed in the treated group post-transplant provide a biological mechanism supporting the observed clinical effect."
The Phase 2 trial was a randomized, double-blind, placebo-controlled multi-center study designed to evaluate the safety and efficacy of NurOwn® in 48 ALS patients. It was conducted at three sites in the U.S: Massachusetts General Hospital, UMass Medical School and the Mayo Clinic. Patients were randomized to receive NurOwn cells administered via combined intramuscular and intrathecal injection (n= 36), or placebo (n=12). The primary objective of the study was safety and tolerability. The pre-specified efficacy analyses were: change in the ALSFRS-R slope, change in Slow Vital Capacity (SVC) and muscle strength, responder analysis (the percentage of subjects who improved post-treatment compared with pre-treatment), and a subgroup analysis excluding slowly progressing patients who are less likely to have a detectable benefit from NurOwn.
Dr. Berry's presentation is posted on the "Events and Presentations" page of the Brainstorm company website (www.brainstorm-cell.com).
About the International Symposium on ALS/MND
The MND Association organizes the International Symposium on ALS/MND. This International Symposium is the largest medical and scientific conference on Motor Neuron Disease, also known as Amyotrophic Lateral Sclerosis. It is the premier event in the MND research calendar, attracting over 800 delegates, representing the energy and dynamism of the global MND research community. For more information, refer to http://www.mndassociation.org/research/international-symposium/
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, COO
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/in-depth-analyses-presented-at-international-symposium-on-alsmnd-suggest-strong-biological-effect-for-nurown-evidence-of-halting-of-disease-progression-300378116.html
SOURCE BrainStorm Cell Therapeutics Inc.
INVESTOR CALL UPDATE:
http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=RssLanding&cat=news&id=2227741
BrainStorm to Host Year End Call with Investors to Discuss Important Corporate Developments Company Explores Regulatory Commercial Pathways for NurOwn®
Conference Call and Live Webcast on December 19 at 8:30 am Eastern Time
HACKENSACK, N.J. and PETACH TIKVAH, Israel, Dec. 6, 2016 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that it will hold a conference call on December 19 at 8:30 am Eastern Time. Mr. Chaim Lebovits, BrainStorm's President and Chief Executive Officer, will provide an update to shareholders to discuss ongoing progress with NurOwn® in the treatment of amyotropic lateral sclerosis (ALS). Mr. Lebovits will lay out plans for 2017, including a discussion on a planned registration trial as well as a new pathway that may potentially provide patients with access to NurOwn.
The call will be conducted in English. Callers may participate in the conference call by dialing:
USA:
888-389-5987
Canada:
719-325-2425
Israel:
1 80 924 5905
Conference ID:
3566333
Webcast:
http://public.viavid.com/index.php?id=122186
correction - they haven't been totally silent. they released 2nd and 3rd quarter results, presented at a couple conferences, and they were granted a patent for their stem cell technology.
the patent is by far the most important news. as for early access program and phase 3 plans, it's been silent.
unfortunately, it's been pretty silent from the company since the Phase 2 results. I go to their website at least once a week hoping to see something new but nothing yet. management said they would be meeting with patients to go over results and meet with FDA. they plan to move forward with phase 3 study but there hasn't been anything released to the public with a plan moving forward.
I speculate when they have phase 3 plans, they might comment on the early access program. I'm surprised at how silent it's been. phase 2 results were great but I think a lot investors might be confused with the results or just holding to invest.
good information from everyone who replied. those are decent runs too especially if you bought at the low end. without doing any technical research, looks like a good time to buy at these levels.
thanks!
if there was no dilution, where do you think the stock price would be? just curious to see what people think. I have no clue. thinking about jumping in for a small position.
Patent News
multiple websites have the same info. here's one of them;
http://www.prnewswire.com/news-releases/brainstorm-granted-united-states-patent-for-its-stem-cell-technology-300353380.html
BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) announced that it has been granted United States Patent No. 9,474,787 titled "Mesenchymal Stem Cells for the Treatment of CNS Diseases."
The allowed claims cover mesenchymal stem cells that secrete neurotrophic factors, including brain-derived neurotrophic factor (BDNF) and glial derived neurotrophic factor (GDNF), as well as a pharmaceutical compositions comprising these factors.
"We are pleased that the US Patent Office continues to recognize the innovative nature of NurOwn®, our proprietary, differentiated mesenchymal stem cells, for use as a pharmaceutical," commented BrainStorm's CEO Chaim Lebovits. "This patent, along with the previously granted patents and patent applications, is part of our strategy to aggressively establish a broad portfolio of intellectual property to protect all of our commercially important discoveries."
This patent is the result of Brainstorm's ongoing joint development of NurOwn® together with the Tel Aviv University, and reflects the collaboration between the company and the laboratory of Prof. Dani Offen, the company's chief scientist.
sounds good! i'll probably do the same.
good luck with your future options trading!
@lakingsphan0427 - I'd like to get into options trading.. glad you're doing well on this one!
do you know a good website or service that is good for beginners?
what makes you think there's a breakout coming?