NEW YORK & PETACH TIKVAH, Israel -- (BUSINESS WIRE) -- BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that its CEO, Dr. Adrian Harel, has issued an Annual Letter to Shareholders summarizing the company’s extremely significant developments of 2012:
Dear BrainStorm Shareholders,
2012 has been a pivotal year for BrainStorm, as the company has achieved the most significant milestones since its inception. We’ve made dramatic progress in our clinical trials, establishing the safety of NurOwn cells in a first group of ALS patients and demonstrating promising indications of clinical improvement in some patients. As a result we’ve been fast-tracked to a Phase IIa preliminary efficacy trial after only one year of testing. We’ve also made key advances in product development, and secured the largest amount of financing in any single year of operations. I am proud to share with you the major highlights of the past twelve months:
I. Clinical Trials Progress
In early June, we performed the 12th ALS patient transplantation in our Phase I/II clinical trial with NurOwn at Hadassah Medical Center in Jerusalem. In July, we submitted a positive interim safety report to the Israeli Ministry of Health (MOH) on the first 12 ALS patients in the study, demonstrating that treatment was well-tolerated and that there were promising indications of clinical improvement in some of the patients.
Just as we welcomed in 2013, the MOH approved acceleration to a Phase IIa dose-escalating trial to further evaluate the safety and preliminary efficacy of NurOwn treatment. In the Phase IIa trial, which we are launching this month, a second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be monitored for three to six months after transplantation.
In addition, preparations are well underway for a Phase II clinical trial in the USA, scheduled for 2013, pending FDA approval.
II. Advances in Product Development
In December 2012, we signed a strategic agreement with Octane Biotech of Kingston, Ontario, to jointly develop a proprietary bioreactor for production scale-up of NurOwn. The customized bioreactor will enable us to significantly increase our production capabilities by using a single clean room for multiple patients, reducing costs and time. We are very excited to be working with Octane, given their expertise in developing automated production processes for mesenchymal cell therapy technologies. The project is currently being launched.
This year we also developed an innovative method for cryopreservation, or freezing, of cells, for long-term storage, and production of repeat patient doses of NurOwn without the need for additional bone marrow aspirations. Applying this approach in a pre-clinical study, we established the safety of repeat doses of NurOwn in mice using frozen cells, an important step in the regulatory approval process for repeat dosing in ALS patients. We believe that repeat dosing is the key to the long-term clinical efficacy of NurOwn, and our proprietary cryopreservation method will enable us to do so without having to perform repeat bone marrow aspirations for each treatment.
III. Financing in Place
This year, the Company received funding from Israel’s Office of the Chief Scientist (OCS) in the amount of $530,000 for the company’s R&D and clinical program for NurOwn in ALS patients. In December, the OCS approved an annual grant to BrainStorm for 2013, for the sixth straight year. The 2013 funding in the amount of $800,000 will support our NurOwn clinical development program. In addition, we were awarded a 3-year grant by the CIIRDF (Canada-Israel Research & Development Program) to fund 50% of our budget in a CAD$1.3 million collaboration with Octane Biotech on development of a customized bioreactor.
In July, the Company completed a public offering, raising gross proceeds of approximately $5.75 million. Maxim Group LLC served as the lead placement agent for the offering and Leader Underwriters (1993) Ltd. acted as a sub-agent of the placement agent.
With cash reserves of approximately $4 million, we are ready to embark on our R&D and clinical trials program for 2013.
Having made huge strides these past 12 months, we look forward to an even more impressive year in 2013, as we forge ahead with further expansion of our clinical program to the United States, continued advances in product development, and ramping-up of our business activities towards commercialization.
I thank you for your unwavering support.
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. 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.