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Brainstorm Cell Therapeutics (BCLI)

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is also conducting an FDA-approved Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

Company profile

Ticker
BCLI
Exchange
CEO
Chaim Lebovits
Employees
Incorporated
Location
Fiscal year end
Former names
BRAINSTORM CELL THERAPEUTICS INC, GOLDEN HAND RESOURCES INC, WIZBANG TECHNOLOGIES INC
SEC CIK
Subsidiaries
BrainStorm Cell Therapeutics Ltd. • Advanced Cell Therapies Ltd. • BrainStorm Cell Therapeutics UK Ltd. • Brainstorm Cell Therapeutics Limited ...
IRS number
208133057

BCLI stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

15 Aug 22
28 Sep 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 9.01M 9.01M 9.01M 9.01M 9.01M 9.01M
Cash burn (monthly) 2.05M 1.8M 2.53M 2.05M 2.04M 1.82M
Cash used (since last report) 6.05M 5.31M 7.47M 6.04M 6.04M 5.36M
Cash remaining 2.95M 3.7M 1.53M 2.96M 2.97M 3.64M
Runway (months of cash) 1.4 2.1 0.6 1.4 1.5 2.0

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
6 Apr 22 Frenkel Jacob A Stock Option Common Stock Grant Acquire A No No 0.75 50,000 37.5K 50,000
6 Mar 22 Ralph Dr. Kern Common Stock Grant Acquire A No No 0 35,885 0 223,310
1 Feb 22 Polverino Anthony J. Common Stock Grant Acquire A No No 0 3,882 0 25,960
15 Dec 21 Irit Arbel Stock Option Common Stock Grant Acquire A No No 0.75 25,333 19K 25,333
15 Dec 21 Yablonka Uri Stock Option Common Stock Grant Acquire A No No 0.75 13,333 10K 13,333
17.5% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 49 41 +19.5%
Opened positions 11 6 +83.3%
Closed positions 3 9 -66.7%
Increased positions 6 9 -33.3%
Reduced positions 17 9 +88.9%
13F shares Current Prev Q Change
Total value 12M 16.91M -29.1%
Total shares 6.39M 6.59M -2.9%
Total puts 102.2K 193.1K -47.1%
Total calls 585.8K 325.5K +80.0%
Total put/call ratio 0.2 0.6 -70.6%
Largest owners Shares Value Change
Abbhi Investments 2.43M $0 0.0%
Vanguard 1.43M $3.94M +0.5%
BLK Blackrock 473.73K $1.31M -0.2%
Geode Capital Management 275.91K $761K -2.7%
Abner Herrman & Brock 265K $731K 0.0%
Ikarian Capital 253.43K $698K -16.7%
Raymond James & Associates 187.4K $517K -1.6%
JPM JPMorgan Chase & Co. 187.07K $516K -24.0%
Millennium Management 110K $304K -22.1%
Weaver Consulting 104.65K $289K -19.5%
Largest transactions Shares Bought/sold Change
Susquehanna International 15.32K -79.28K -83.8%
JPM JPMorgan Chase & Co. 187.07K -59.13K -24.0%
Ikarian Capital 253.43K -50.73K -16.7%
Millennium Management 110K -31.26K -22.1%
Liberty Wealth Management 30K +30K NEW
Weaver Consulting 104.65K -25.35K -19.5%
Group One Trading 24.13K -24.96K -50.8%
VIRT Virtu Financial 20.7K +20.7K NEW
Renaissance Technologies 17.1K +17.1K NEW
HighPoint Advisor 17.03K +17.03K NEW

Financial report summary

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Competition
BiogenCytokineticsMedicinovaPalisade BioAthersysLongeveron
Risks
  • Continuing concerns resulting from the pandemic of COVID-19 and the future outbreak of other highly infectious or contagious diseases, could have a material adverse impact on our business, financial condition and results of operations, including our preclinical studies and clinical trials.
  • We need to raise additional capital. If we are unable to raise additional capital in favorable terms and a timely manner, we will not be able to execute our business plan and we could be forced to restrict or cease our operations.
  • Our Company has a history of losses and we expect to incur losses for the foreseeable future.
  • We are exposed to fluctuations in currency exchange rates.
  • The dollar cost of our operations in Israel will increase to the extent increases in the rate of inflation in Israel are not offset by a devaluation of the NIS in relation to the dollar, which would harm our results of operations.
  • If our NurOwn® stem cell therapy does not demonstrate safety and efficacy sufficient to obtain regulatory approval, it may not receive regulatory approval and we will be unable to market it.
  • Our product development programs are based on novel technologies and are inherently risky.
  • If serious or unexpected adverse side effects are identified during the development of our NurOwn® stem cell therapy, we may need to abandon or limit its development.
  • We may not be able to secure and maintain research institutions to conduct our clinical trials.
  • The field of stem cell therapy is relatively new and our development efforts may not yield an effective treatment of human diseases.
  • Our NurOwn® stem cell therapy, even if approved, may not be accepted in the marketplace; therefore, we may not be able to generate significant revenue, if any.
  • Adoption of our NurOwn® stem cell therapy for the treatment of patients with ALS, PMS, AD or other neurodegenerative diseases, even if approved, may be slow or limited. If our NurOwn® stem cell therapy does not achieve broad acceptance as a treatment option for ALS, PMS, AD or other neurodegenerative diseases, our business would be negatively impact our revenue forecast.
  • Our success will depend in part on establishing and maintaining effective strategic partnerships and collaborations, which may impose restrictions on our business and subject us to additional regulation.
  • We will need to develop or acquire additional capabilities in order to commercialize our NurOwn® stem cell therapy, if approved for sale, and we may encounter unexpected costs or difficulties in doing so.
  • We expect to expand our development, regulatory, manufacturing and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We have never manufactured our NurOwn® stem cell therapy at commercial scale and there can be no assurance that it can be manufactured in compliance with regulations at a cost or in quantities necessary to make it commercially viable.
  • Lack of coordination internally among our employees and externally with physicians, hospitals and third-party suppliers and carriers, could cause manufacturing difficulties, disruptions or delays and cause us to not meet our expected clinical trial requirements or potential commercial requirements.
  • We face competition in our efforts to develop cell therapies for ALS and other neurodegenerative diseases.
  • The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.
  • There is a scarcity of experienced professionals in the field of cell therapy and we may not be able to retain key personnel or hire new key personnel needed to implement our business strategy and develop our products and businesses. If we are unable to retain or hire key personnel, we may be unable to continue to grow our business or to implement our business strategy, and our business may be materially and adversely affected.
  • Technological and medical developments or improvements in conventional therapies could render the use of stem cells and our services and planned products obsolete.
  • We may expend our limited resources to pursue our NurOwn® stem cell therapy or a specific indication for its use and fail to capitalize on stem cell therapies or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our NurOwn® stem cell therapy is based on a novel technology, which may raise development issues that we may not be able to resolve, regulatory issues that could delay or prevent approval or personnel issues that may keep us from being able to develop our treatments.
  • We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws health information privacy and security laws, and other health care laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • It is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.
  • Unintended consequences of recently adopted health reform legislation in the U.S. may adversely affect our business.
  • Ethical and other concerns surrounding the use of stem cell therapy may negatively impact the public perception of our stem cell services, thereby suppressing demand for our services.
  • We may be subject to significant product liability claims and litigation which could adversely affect our future earnings and financial condition.
  • Political, economic and military instability in Israel may impede our ability to execute our plan of operations.
  • Man-Made Problems Such as Computer Viruses or Terrorism May Disrupt Our Operations and Harm Our Operating Results
  • We are subject to a strict regulatory environment. If we fail to obtain and maintain required regulatory approvals for our potential cell therapy products, our ability to commercialize our potential cell therapy products will be severely limited.
  • Even if regulatory approvals are obtained for our stem cell therapies, we will be subject to ongoing government regulation. If we or one or more of our partners or collaborators fail to comply with applicable current and future laws and government regulations, our business and financial results could be adversely affected.
  • We are subject to environmental, health and safety laws.
  • We are subject to significant regulation with respect to manufacturing of our NurOwn® stem cell therapy.
  • Part of our business in the foreseeable future will be based on technology licensed from Ramot and if this license were to be terminated upon failure to make required royalty payments in the future, we would need to change our business strategy and we may be forced to cease our operations.
  • If Ramot is unable to obtain patents on the patent applications and technology licensed to our Israeli Subsidiary or if patents are obtained but do not provide meaningful protection, we may not be able to successfully market our proposed products.
  • We may be unable to protect our intellectual property from infringement by third parties.
  • Third parties may claim that we infringe on their intellectual property.
  • As a result of our reliance on consultants, we may not be able to protect the confidentiality of our technology, which, if disseminated, could negatively impact our plan of operations.
  • We received grants from the Israel Innovation Authority, or IIA, we are subject to on-going restrictions.
  • The price and trading volume of our stock is expected to be volatile.
  • Your percentage ownership will be diluted by future issuances of our securities.
  • ACCBT holds equity participation rights and other rights that could affect our ability to raise funds.
  • You may experience difficulties in attempting to enforce liabilities based upon U.S. federal securities laws against us and our non-U.S. resident directors and officers.
  • If we fail to implement and maintain an effective system of internal controls, we may be unable to accurately report our results of operations or prevent fraud, and investor confidence and the market price of our Common Stock may be materially and adversely affected.
  • Delaware law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely affect existing stockholders.
  • We do not expect to pay dividends in the foreseeable future, and accordingly you must rely on stock appreciation for any return on your investment.
Management Discussion
  • For the period from inception (September 22, 2000) until June 30, 2022, we did not generate any revenues from operations. In addition, we incurred operating costs and expenses of approximately $7,591,000 during the three months ended June 30, 2022, compared to $6,121,000 during the three months ended June 30, 2021. We incurred operating costs and expenses of approximately $13,066,000 during the six months ended June 30, 2022, compared to $13,050,000 during the six months ended June 30, 2021.

Content analysis

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H.S. sophomore Avg
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