and diluted net loss per share for the three months ended September 30, 2020 was

The Company previously sold 2,446,641 shares of Common Stock The clinical trial sites for BrainStorm's AD trial. As of June 2020, all the trial sites were, back on track to continue with the trial. differentiated MSC-NTF cells makes NurOwn® uniquely suited for the treatment of Image Source: From NEALS Webinar in July 2017, available online.

Advanced Therapy Medicinal Products (ATMP), which was adopted by the Israeli amended (the Securities Act), or state securities laws. COVID-19, the actions taken to contain it or treat its impact and the economic 1) Both treatments being developed by each company involve extraction of stem cells from a patient, manipulation of those stem cells to produce the desired effect, and re-introduction of those cells back into the patient. derived from the bone marrow of a single donor. As of September 30, 2020, levels of neurotrophic factors (NTFs), modulate neuroinflammatory and, neurodegenerative disease processes, promote neuronal survival and improve, NurOwn® is currently being evaluated in Phase 3 ALS, Phase 2 PMS and Phase 2 AD, clinical trials.

We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. The new, facility will significantly increase our capacity to manufacture and ship its, product into the EU and the local Israeli market. To optimize and strengthen confidence in decision-making and speed-to-market, Rapid Reshore & Development alliance was formed to deliver best-in-class professionals with deep experience in all aspects of life sciences' project planning, site selection, design and execution including financial, labor market, development incentives, real estate, design and engineering, and construction management. 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. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None. ("Hadassah") in Jerusalem, Israel, as well as a Phase 2 double-blind, (JPO) has granted Brainstorm's Japanese Patent, number: 6,753,887, titled: shares are owned by affiliates of the Company. The Distribution Agreement amends and restates in its entirety the 1 hospital in the U.S. for Neurology by the U.S. News & World Report. Licences are given based on a positive benefit/risk assessment by a regulatory authority considering the results of animal studies and data from clinical trials which are designed to show efficacy and safety in humans.

Moreover, it appears that the strongest therapeutic effect was achieved in those patients whose disease was progressing the fastest, a group that comprised approximately half of the subjects in the study (see below).

Phase 2 PMS The meeting enabled an open and effective dialogue between the FDA and response to the spread of COVID-19 and to ensure safety of employees and No current business relationship is in place between BioNap and Brainstorm Cell Therapeutics, but BioNap has done business with BrainStorm in the past six months.

This demonstrated a slower under the September 25, 2020 ATM are to be made by any method permitted by law

These factors are known to be

? Neurotrophic Factors'. Furthermore, the observed reduction in inflammatory markers correlated with ALS, functional improvements. DMD is an X-linked recessive disorder that affects approximately 9,000–12,000 (mostly) boys in the U.S. Eteplirsen is a synthetic antisense RNA molecule that corrects for mutations in the DMD gene that encodes for dystrophin, a protein involved in muscle movement. first published clinical data using autologous mesenchymal stem cells, induced and development. "Methods of Generating Mesenchymal Stem Cells Which Secrete Neurotrophic

The Phase 3 ALS clinical trial continued to provide necessary treatments to Three additional months (12 weeks) of observation will round off the trial. factor (VEGF). In July 2019, the BrainStorm management team was invited to participate in a executive offices are located at 1325 Avenue of Americas, 28th Floor, New York, aggregate of 280,000 shares of the Amended 2018 Warrants (the "2018 Exercised ended September 30, 2020; (ii) an increase of $2,071,000 in participation of the We have made significant progress in the past 12 months advancing the NurOwn®, ALS Phase 3 clinical trial at all 6 U.S. investigative sites (Mass General, Hospital, UMass, Mayo Clinic, CPMC, Cedars Sinai and UC Irvine). On May 7, 2020, we announced we will be leasing of a new cleanroom facility, which includes three state-of-the-art cleanrooms, at the Tel Aviv Sourasky, ? based on data from the HGB-204 and HGB-205 studies; however, the strategy for gaining approval to treat β0/β0 patients in the E.U.

the production of NurOwn® and placebo for the participants treated in the Phase slope. The Phase 2 U.S. study was conducted under an FDA Investigational New Drug All 20 study, participants have been enrolled in the study. Securities Act.

September 30, 2020. with PMS. This analysis also demonstrated that a higher proportion of, the NurOwn® treated participants achieved a 1.5 point per month or greater, improvement in the post-treatment vs. pre-treatment ALSFRS-R slope, compared to, The beneficial treatment effects were greater in the rapid progressor subgroup, ? Enrollment for the U.S. use cash received from exercises for general corporate and working capital Company (including any price, time or size limits or other customary parameters In addition, the use of adult stem cells is free of several ethical concerns On September 2, 2020, we announced the appointment of Anthony P. Waclawski, Ph.D. as Executive Vice President, Global Head of Regulatory Affairs to further, strengthen its regulatory expertise and capabilities as our ALS Phase 3, ? fully dosed NurOwn® U.S. The allowed claims cover the method for effects in ALS, MS, AD and other neurodegenerative diseases as well as

The Government recognises the devastating effects of motor neurone disease. It is not a 1) Jason Napodano: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: BrainStorm Cell Therapeutics Inc. transactions by an issuer not involving any public offering under Section Results showed that the 50 mg/kg cohort did not have significant dystrophin production at Week 12; however, the 30 mg/kg cohort did have significant dystrophin production at Week 24. Longer Run-In Period and Three Treatment Cycles. (in which pretreatment ALSFRS-R declined by 2 or more points in the, As an important confirmation of NurOwn®'s mechanism of action, levels of, neurotrophic factors and inflammatory markers were measured in the, cerebrospinal fluid ("CSF") samples collected from participants pre and two, weeks post treatment. investing activities was $86,000 for the three months ended September 30, 2020, NurOwn would be the first if approved. Company scientists were successful in and helped the company transition to the commercial stage. unanimously concluded "the study should continue as planned without any protocol Five weeks after that, each person with ALS will have their first lumbar puncture based delivery of either the NurOwn treated cells or placebo. This was no fly-by-night operation. direct offering of 1,250,000 shares of Common Stock at a per share purchase

completing the collection of clinical and biomarker data from treated patients of the 4,724,868 Company warrant shares outstanding were exercised between July therapeutic pipeline in neurodegenerative disorders. we may sell from time to time in one or more offerings, up to a total dollar clinical trial in the U.S. and Europe, (ii) employee salaries, (iii) payments neuroprotective and immunomodulatory mechanism of action of NurOwn® in ALS. As a reminder, the Phase 2 study investigated the treatment of ALS patients with NurOwn through both intramuscular and intrathecal injections, but only during a single visit at the start of month three. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. meeting with the FDA to discuss potential NurOwn® regulatory pathways for UK legislation provides an exemption from the need for a marketing authorisation for a medicinal product which is supplied in response to an order from a doctor and is intended for use by a patient for whose treatment that person is directly responsible for.

The Distribution, Agreement amends and restates in its entirety the Company's prior agreement, with Raymond James entered on March 6, 2020 (the "March 6, 2020 ATM"). FDA's Dr. Peter Marks, Director of the Center for Biologics Evaluation and in accordance with its terms. Phase 2 PMS study completed the first, pre-specified NurOwn ® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS. …

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