By David Bautz, PhD
READ THE FULL BCLI RESEARCH REPORT
Topline Data from Phase 3 ALS Trial Before End of November 2020
BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). A total of 200 patients were randomized 1:1 to receive NurOwn or placebo in the randomized, double blind, placebo controlled, multi-dose trial. Cells were extracted once from each patient prior to treatment, with all administrations of NurOwn derived from the same extraction of cells due to a cryopreservation process the company developed for long-term storage of mesenchymal stem cells (MSC). Just as with the companys prior studies, there was a 3-month run-in period prior to the first treatment with two additional NurOwn treatments occurring two and four months following the first treatment. The company is focusing the trial on faster-progressing ALS patients since those patients demonstrated superior outcomes in the Phase 2 trial of NurOwn. The primary outcome of the trial is the ALSFRS-R score responder analysis and we now anticipate topline results before the end of November 2020.
Update on Phase 2 Progressive Multiple Sclerosis Trial
BrainStorm is currently conducting a Phase 2 clinical trial of NurOwn in patients with progressive multiple sclerosis (MS) (NCT03799718). The trial is an open label, single arm study that is enrolling patients with progressive MS with Expanded Disability Status Scale (EDSS) scores of 3.0 6.5. The primary endpoint of the study is the safety and tolerability of three doses of NurOwn with secondary endpoints examining the timed 25-foot walking speed or 9-hole peg test (both validated MS clinical outcome assessments) along with paired cerebrospinal fluid (CSF) and blood biomarker analysis. The National Multiple Sclerosis Society awarded the company a $0.5 million grant to help fund the study.
The trial is now fully enrolled and we anticipate dosing to be completed for all patients by the end of 2020. While the company had previously considered performing an interim analysis, since topline data would be available soon after an interim analysis could be performed the company has decided against performing an interim analysis and will instead report topline data for all 20 patients when it becomes available.
NurOwn Derived Exosomes Show Promise in Preclinical ARDS Study
On July 23, 2020, BrainStorm announced the successful completion of the first milestone in developing an exosome-based platform for the treatment of severe acute respiratory distress syndrome (ARDS) caused by COVID-19. Exosomes are small vesicles (30-150 nm) that are secreted by all cell types. Exosomes from mesenchymal stem cells (MSCs), from which NurOwn is derived, can penetrate into deep tissues and deliver various bioactive molecules. In addition, they can be delivered both intravenously or intratracheally.
BrainStorm conducted a preclinical study of MSC-derived exosomes in a mouse model of lipopolysaccharide (LPS)-induced ARDS. Treatment with intratracheally administered exosomes resulted in a statistically significant improvement in various lung functions, including functional lung recovery and decreased lung damage, as judged by the lung disease severity score (P=0.03). In addition, they led to a reduction in a number of pro-inflammatory cytokines. Lastly, exosomes derived from MSC-NTF cells were superior to exosomes derived from nave MSC from the same donor.
We anticipate the results being submitted to a peer reviewed journal for publication and the company is currently deciding whether to initiate a clinical trial program in COVID-19 patients with ARDS.
On August 5, 2020, BrainStorm announced financial results for the second quarter of 2020. As anticipated, the company did not report any revenues during the second quarter of 2020. Net R&D expenses for the second quarter of 2020 were $5.7 million, compared to $3.6 million for the second quarter of 2019. The increase was primarily due to an increase in payroll and stock-based compensation and a decrease in support from the Israel Innovation Authority (IIA) and California Institute for Regenerative Medicine (CIRM) along with a decrease in costs related to the Phase 3 and Phase 2 clinical trials. Excluding participation from the IIA and CIRM, R&D expenses were $6.0 million in the second quarter of 2020, compared to $6.5 million in the second quarter of 2019. G&A expenses for the second quarter of 2020 were $1.7 million, compared to $1.3 million in the second quarter of 2019. The increase was primarily due to increased payroll and stock-based compensation.
The company exited the second quarter of 2020 with approximately $16.2 million in cash, cash equivalents, and short-term investments. Subsequent to the end of the quarter, the company raised gross proceeds of approximately $13.7 million from the $50 million ATM facility entered into in March 2020 through the sale of 945,082 shares at an average price of $14.48 per share. In addition, the company raised gross proceeds of approximately $6.3 million from the exercise of warrants. We estimate that the company currently has approximately $35 million in cash, cash equivalents, and short-term investments.
As of July 31, 2020, the company had approximately 31.5 million shares outstanding and, when factoring in warrants and stock options, a fully diluted share count of approximately 37.0 million.
The countdown is on to the topline data release for the Phase 3 ALS trial, with those results expected before the end of November 2020. Even with the great run the stock has had since its recent lows in March 2020, we continue to view the shares as undervalued as we currently forecast peak sales for NurOwn of >$1 billion in ALS, >$500 million in MS, and >$2 billion in Alzheimers disease. We recently made a slight change to our model, in which we decreased the discount rate from 17% to 13%, and combined with the recent financing activity has resulted in an increase to our valuation to $33 per share.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCHtoreceive our articles and reports emailed directly to you each morning. Please visit ourwebsitefor additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks provides and Zacks receives quarterly payments totaling a maximum fee of $40,000 annually for these services. Full Disclaimer HERE.
Go here to read the rest:
- Global Animal Stem Cell Therapy Market Research Report by Size, Data, Developments, Global Demand, In-Depth Analysis and Forecast 2020 to 2025 |... - November 27th, 2020
- Stem Cell Therapy Market Size, Growth, Demand, Opportunities & Forecast To 2025 - Cheshire Media - November 27th, 2020
- Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in... - November 27th, 2020
- Scientists Reveal a New Drug That Directs Stem Cells To Desired Sites - Science Times - November 27th, 2020
- Global Stem Cells Market is estimated to account for US$ 18289.9 Mn by end of 2027, Says Coherent Market Insights (CMI) - Business Wire - November 27th, 2020
- Stem Cell Therapy Market To Observe Exponential Growth By 2020-2027 | Reports Globe - Cheshire Media - November 27th, 2020
- Ash 2020 cell therapy preview the battle for recognition - Vantage - November 27th, 2020
- Animal Stem Cell Therapy Market 2020 to Flourish with an Impressive CAGR of XX% in the year 2026, Market Size & Growth with Complete Business... - November 27th, 2020
- Adipose Tissue-derived Stem Cell Therapy Market: Worldwide Industry to Boost in the Period of 2020-2025 - Express Journal - October 19th, 2020
- Global Stem Cell Therapy Market 2020: Trends, and Opportunity Analysis, Top Manufacturers And Forecast to 2027 - PRnews Leader - October 19th, 2020
- Stem Cell Therapy Market Research Report Forecast to 2029 (Includes Business Impact of COVID-19) - Eurowire - October 19th, 2020
- Global Adipose Tissue-derived Stem Cell Therapy Market 2020 Demand, Business Growing Strategies, Industry Segmentation and Forecast 2025 -... - October 19th, 2020
- Stem Cell Therapy Market Trends, Opportunities, New Technologies and Developments, Competitor analysis and Market Sizing from 2020 to 2026 - PRnews... - October 19th, 2020
- Global Adipose Derived Stem Cell Therapy Market 2020 Demand, Business Growing Strategies, Industry Segmentation and Forecast 2025 - TechnoWeekly - October 19th, 2020
- Notch Therapeutics Strengthens Leadership Team with Appointment of Kamran Alam as CFO and Gregory Block as SVP, Corporate Development - PRNewswire - October 19th, 2020
- Stem Cell Therapy Market To Observe Exponential Growth By 2020-2027 | Verified Market Research - Stock Market Vista - October 19th, 2020
- Stem Cell Therapy Market 2020 growth factors, latest trend and regional analysis of leading players by 2025 - News by Decresearch - October 19th, 2020
- Cell Therapy Market Size, Share, Market Research and Industry Forecast Report, 2020-2027 (Includes Business Impact of COVID-19) - Eurowire - October 19th, 2020
- Autologous Cell Therapy Market is Anticipated to Expand at a CAGR of 18.1% from 2019 to 2027 - Eurowire - October 19th, 2020
- Cell Therapy Market Trend,COVID-19 Impact,Current Industry Figures With Demand By Countries And Future Growth - PRnews Leader - October 19th, 2020
- Gamida Cell and Be The Match BioTherapies Expand Strategic Collaboration - BioSpace - October 19th, 2020
- Cell Therapy Manufacturing Market to be Worth USD 8 billion by 2030, predicts Roots Analysis - The Think Curiouser - October 19th, 2020
- Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome... - October 19th, 2020
- UofL-born company secures an additional $115 million to advance cell therapy - uoflnews.com - October 19th, 2020
- Global and United States Cancer Stem Cell Therapy Market Leading Players Expected to Witness the Highest Growth 2025 | AVIVA BioSciences, AdnaGen,... - October 19th, 2020
- Can Stem Cell Therapy Repair Damaged Knees? - September 2nd, 2020
- Vor Biopharma and Metagenomi to Collaborate on Engineered Hematopoietic Stem-Cell Therapies - Business Wire - September 2nd, 2020
- COVID-19 cell therapy drives Mesoblast to seek manufacturing muscle - BioPharma-Reporter.com - September 2nd, 2020
- New Report Begins a New Era of Stem Cell Science and Medicine: Stem Cell Biotechnology Company Asymmetrex Tells How It Counts Therapeutic Tissue Stem... - September 2nd, 2020
- Optimized Freezing Solutions for Clinical Application of Cell Therapy Products - Technology Networks - September 2nd, 2020
- Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players - PRNewswire - September 2nd, 2020
- Cartesian Therapeutics Initiates Clinical Trial of First RNA-Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID-19 - PRNewswire - September 2nd, 2020
- New Comprehensive Report on Stem Cell Therapy Market to Witness an Outstanding Growth during 2020 2025 with Top Players Like Chiesi Pharmaceuticals,... - September 2nd, 2020
- CAR T-Cell Optimization Starts in Production, Extends to Therapy - Genetic Engineering & Biotechnology News - September 2nd, 2020
- Ruxolitinib May Be Another Option for Children With Steroid Refractory aGVHD - AJMC.com Managed Markets Network - September 2nd, 2020
- Growing Focus on R&D Likely to Accelerate the Growth of the Stem Cell Therapy Market - The News Brok - September 2nd, 2020
- Oldest male polar bear on record humanely euthanized at Point Defiance Zoo - MyNorthwest.com - September 2nd, 2020
- FDA Approves First Maintenance Therapy for AML - Medscape - September 2nd, 2020
- Elixirgen Therapeutics planning to begin Phase I/II Clinical Trials of its COVID-19 Vaccine Candidate EXG-5003 at Fujita Health University -... - September 2nd, 2020
- Hill Highlights the Potential of Selinexor as a Less Intensive Option for DLBCL - OncLive - September 2nd, 2020
- Global Rheumatoid Arthritis Stem Cell Therapy Market Dynamics, Forecast, Analysis and Supply Demand 2018 to 2028 - Scientect - September 2nd, 2020
- Growing at an annualized rate of over 20%, the cell therapy manufacturing market is estimated to reach close to USD 10 Billion by 2030, claims Roots... - September 2nd, 2020
- Strategic Analysis to Understand the Competitive Outlook of Cell Therapy Manufacturing Market - The News Brok - September 2nd, 2020
- In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Canine Stem Cell Therapy Coronavirus Impact Editon of Key Players VETSTEM... - August 10th, 2020
- Tevogen Bio Announces Partnership With Preeminent Scientist Professor Neal Flomenberg, MD, to Investigate Proprietary T-Cell Therapy for Treatment of... - August 10th, 2020
- Marker Therapeutics Reports Second Quarter 2020 Operating and Financial Results - PRNewswire - August 10th, 2020
- University of Minnesota expands clinical investigation of engineered iPSC-derived natural killer cells, opening U.S. clinical trial for the treatment... - August 10th, 2020
- Clinical study using mesenchymal stem cells for the treatment of patients with severe COVID-19 - DocWire News - August 10th, 2020
- UPDATED: After a 4-year sojourn, struggling microbiome pioneer Seres claims a breakout PhIII comeback. And shares respond in frenzied spike -... - August 10th, 2020
- New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 - PharmiWeb.com - August 10th, 2020
- Covid-19 roundup: CureVac beefs up its unicorn IPO dreams as billionaire owner takes this Covid-19 mRNA player on a forced march to Nasdaq; Kodak's... - August 10th, 2020
- Coronavirus Drug and Treatment Tracker - The New York Times - August 10th, 2020
- Nearly 70K donated so far towards Wistaston boy's 120K lifesaving treatment - Cheshire Live - August 10th, 2020
- Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments - Cambridge Independent - August 9th, 2020
- Three Years After Stem Cell Trial for Heart Failure was Abandoned New Evidence Shows it Works - Diagnostic and Interventional Cardiology - August 9th, 2020
- Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook,... - August 9th, 2020
- IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment... - August 9th, 2020
- Strathmore man with MS calls for more Canadian treatment alternatives - CTV Toronto - August 9th, 2020
- Wave of New Therapies Improve Outcomes for Patients with Multiple Myeloma - Dana-Farber Cancer Institute - August 9th, 2020
- Adipose Derived Stem Cell Therapy Market: Technological Advancement & Growth Analysis with Forecast to 2026 - Chelanpress - August 9th, 2020
- ASCO Expert on the Possible Benchmark Analysis of Autologous Transplantation in B-Cell Lymphomas - Cancer Network - August 9th, 2020
- Cell Therapy Market: Study Navigating the Future Growth Outlook | Osiris Therapeutics, NuVasive, Vericel Corporation - Chelanpress - August 9th, 2020
- Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Chelanpress - August 9th, 2020
- Personalized Cell Therapies Market to Show Incredible Growth by 2025 - Owned - August 9th, 2020
- Nerve Repair and Regeneration Market worth $9.7 billion by 2025 - Exclusive Report by MarketsandMarkets - PRNewswire - August 9th, 2020
- High-throughput 3D screening for differentiation of hPSC-derived cell therapy candidates - Science Advances - August 9th, 2020
- Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth - GlobeNewswire - August 9th, 2020
- Contract Manufacturing Services market for stem cells is expected to be worth over USD 2.5 billion by 2030, claims Roots Analysis - Market Research... - August 9th, 2020
- In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Cancer Stem Cell Market Report 2020 Key Players Thermo Fisher Scientific Inc.,... - August 9th, 2020
- Tafasitamab Combination Approved for Adults With R/R DLBCL - AJMC.com Managed Markets Network - August 8th, 2020
- Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 - PRNewswire - August 8th, 2020
- Trending News on Targeted Oncology, Week of August 7, 2020 - Targeted Oncology - August 8th, 2020
- Find Out Why Bioreactor Market is thriving worldwide by top key players like mergency Response USA, Buddi US, LLC, Connect America - Owned - August 8th, 2020
- New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 - GlobeNewswire - August 8th, 2020
- Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth - marketscreener.com - August 8th, 2020
- Impact of COVID-19 Outbreak on Canine Stem Cell Therapy Market Expected to Secure Notable Revenue Share During 2020-2026 - Research Newspaper - August 8th, 2020
- Calidi Biotherapeutics in San Diego receives FDA Approval for COVID-19 Treatment clinical trial - - KUSI - August 7th, 2020
- Edited Transcript of BLCM.OQ earnings conference call or presentation 6-Aug-20 9:00pm GMT - Yahoo Finance - August 7th, 2020
- NICE Amends Guidance on Haematopoietic Stem Cell Transplantation During the Pandemic - Medscape - August 6th, 2020
- AlloVir raises $276M IPO to run broad cell therapy program - FierceBiotech - August 6th, 2020