0001137883 false 0001137883 2020-10-22 2020-10-22 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 27, 2020 (October 22, 2020)

 

Brainstorm Cell Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-36641   20-7273918
(State or other jurisdiction of incorporation)   (Commission File No.)   (IRS Employer Identification No.)

 

1325 Avenue of Americas, 28th Floor  
New York, NY 10019
(Address of principal executive offices) (Zip Code)

 

(201) 488-0460

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, $0.00005 par value BCLI

NASDAQ Stock Market LLC

(Nasdaq Capital Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

  

 

 

  

Item 1.01 Entry into a Material Definitive Agreement.

 

On October 22, 2020, Brainstorm Cell Therapeutics Inc. (the “Company”) entered into a binding proposal (the “Agreement”) with Catalent Houston, LLC, a subsidiary of Catalent, Inc. (“Catalent”) pursuant to which the Company will contract Catalent to begin initial technology transfer work for its own NurOwn® program, raw materials storage and GMP Preparation.

 

The Agreement calls for an initial non-refundable $1 million payment from the Company to Catalent, which the Company paid, along with additional payments to be made upon an agreed upon schedule upon the completion of certain aspects of the partnership, totaling initially, up to approximately $4.2 million.

 

The Agreement is terminable by the Company for three (3) months from the execution date of the Agreement, in the event that (i) any ongoing clinical trials relating to the Company’s NurOwn® program fail to achieve their primary endpoints, or (ii) the U.S. Food and Drug Administration places a hold on any of the Company’s clinical trials relating to the NurOwn® program. Upon the event of termination by the Company, the Company shall pay Catalent for (1) all fees related to services and activities performed prior to the effective date of such termination, and (2) all costs and expenses incurred, and all non-cancellable commitments made, in the performance of such services and activities, including (A) any costs incurred to wind down and cease any ongoing services and (B) the costs for any sample/materials, reference materials, equipment, and supplies purchased by Catalent for their work under the Agreement.

 

The Company and Catalent are working on material documentation, which, pursuant to the terms of the Agreement, will include an implementation strategy for the technology transfer, estimated costs, as well as project timelines. 

The above summary of the Agreement does not purport to be complete and is qualified in its entirety to the full text of the Agreement and additional material documentation to be entered into between the Company and Catalent, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2020.

 

Item 8.01 Other Events.

 

On October 22, 2020, the Company and Catalent jointly issued a press release announcing the Agreement and partnership with Catalent. A copy of the press release is attached hereto as Exhibits 99.1 and is incorporated herein by reference.

 

On October 26, 2020, the Company also issued a joint press release with Rapid Reshore & Development (“RR&D”), a three-firm services alliance consisting of EwingCole, Facility Logix and Biggins, Lacy, Shapiro & Company, announcing that that the Company has selected RR&D as its partner to expedite site selection and design services for a state-of-the-art manufacturing facility for its NurOwn® program in the United States. A copy of the press release is attached hereto as Exhibits 99.2 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No. Description
99.1 Joint Press Release issued by Brainstorm Cell Therapeutics Inc. and Catalent, Inc. on October 22, 2020
99.2 Joint Press Release issued by Brainstorm Cell Therapeutics Inc. and Rapid Reshore & Development, Inc. on October 26, 2020
104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 

 

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

     
  BRAINSTORM CELL THERAPEUTICS INC.
     
Date: October 27, 2020 By: /s/ Chaim Lebovits
    Chaim Lebovits
  Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

Catalent_CMYK
   
   
press_release  

 

Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn®

 

SOMERSET, N.J. and New York – October 22, 2020 — Catalent (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and BrainStorm Cell Therapeutics Inc (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced an agreement for the manufacture of NurOwn®, BrainStorm’s autologous cellular therapy being investigated for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease or motor neuron disease.

 

NurOwn induces mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote the survival of neurons and neuroprotection. The therapy has received Fast Track status from the U.S. FDA for ALS and has also been granted Orphan Drug Status for ALS by both the FDA and the European Medicines Agency. BrainStorm is currently completing a 200-patient, double-blind, placebo-controlled, repeat-dosing NurOwn Phase 3 study in the U.S.

 

As part of its commitment, Catalent will undertake the transfer of the manufacturing process to, and provide future CGMP clinical supply of NurOwn from, its new, 32,000 square-foot cell therapy manufacturing facility in Houston, Texas. On completion of the clinical trials and in anticipation of potential approval of NurOwn, the companies will look to extend the partnership to include commercial supply from the Houston facility.

 

“We are proud to have a partner in Catalent whose excellence in manufacturing quality therapies will support commercial supply of NurOwn,” said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. “We know that ALS patients are in urgent need of a new treatment option. If NurOwn is successful in the current clinical trials, this agreement will be integral to ensuring rapid access for patients.”

 

 

 

Catalent_CMYK 

 

Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy, said, “Our experience in cell therapy development, and the manufacturing capabilities that our newly constructed, state-of-the-art facility in Houston offers, position us to best support BrainStorm, with its leading therapeutic candidate for ALS treatment. We look forward to partnering with BrainStorm and providing our stem cell manufacturing expertise as we work to optimize production and streamline the product’s path towards commercial launch.”

 

About Catalent Cell & Gene Therapy

 

With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

 

About Catalent

 

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

 

More products. Better treatments. Reliably supplied.™

 

About NurOwn®

 

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

 

  2

 

 Catalent_CMYK

 

About BrainStorm Cell Therapeutics Inc.

 

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 status designation 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 fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a 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 enrollment in August 2020. 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, including statements regarding future clinical trial enrollment and data, 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, 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. 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.

 

  3

 

 

Catalent_CMYK 

 

 

 

Media Contacts:

 

Catalent   BrainStorm Cell Therapeutics

Chris Halling

+44 (0)7580 041073

chris.halling@catalent.com

Richard Kerns

+44 (0) 161 728 5880

richard@nepr.agency

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

 

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

 

 

  4

Exhibit 99.2

 

Media Contact:

Zachary DeRitis

Communications Specialist

215-409-4249

zdertis@rapidreshore.com

 

 

 

Rapid Reshore & Development and BrainStorm Cell Therapeutics Announce Agreement to Advance Construction of BrainStorm’s U.S. Manufacturing Facility

 

RR&D to lead site selection and design

 

Site analyses to begin immediately

 

Philadelphia, PA. and New York - October 26, 2020 - Rapid Reshore & Development (RR&D), an alliance of three specialized firms, and BrainStorm Cell Therapeutics, Inc (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced that BrainStorm has selected RR&D as its partner to expedite site selection and design services for a state-of-the-art manufacturing facility for NurOwn® (autologous MSC-NTF) in the U.S.

 

BrainStorm is investigating NurOwn as a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). BrainStorm’s most advanced clinical program for NurOwn is in ALS, which is currently being evaluated in a pivotal Phase 3 clinical trial.

 

BrainStorm seeks to locate, design and construct a new commercial manufacturing facility in the U.S. to prepare for potential commercialization. RR&D, a three-firm services alliance consisting of EwingCole, Facility Logix and Biggins, Lacy, Shapiro & Company, will identify the location and develop the design of BrainStorm’s new commercial manufacturing facility.

 

“We’re thrilled to be working with BrainStorm on this project and to have the opportunity to deliver this critical work to our region,” said EwingCole CEO, Jared Loos, PE, AIA. “We embrace the spirit of creating potentially life-changing technology and we will do everything we can to move the project forward in an efficient and yet responsible manner.”

 

BrainStorm intends to use the facility primarily for cell therapy production. RR&D will provide custom, streamlined project management, site selection analysis and design/construction management services throughout the project’s lifecycle.

 

Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics commented, “Our decision to partner with RR&D was driven by the strong capabilities of the individual partners and their holistic approach to planning, site selection and design services. The expansion of BrainStorm’s manufacturing capabilities is a key part of our broader corporate strategy to prepare for potential regulatory approvals of NurOwn and becoming a commercial organization. This new partnership follows our recently announced agreement with Catalent Pharma Solutions to manufacture NurOwn at a scale large enough to meet potential commercial needs at the time of launch. The dedicated, state-of-the-art manufacturing facility developed by RR&D will provide us with important long-term autonomy and strategic flexibility, including the capacity to supply NurOwn for additional disease indications beyond ALS. Together these two partnerships will help ensure that BrainStorm has the manufacturing capacity to meet the needs of patients today and well into the future.

 

Site selection analyses will begin immediately with the goal of identifying locations that offer a cost-effective solution for BrainStorm’s new manufacturing facility. At the same time, the design team will begin developing a conceptual design of the manufacturing facility, based upon input from BrainStorm’s process, engineering, and scientific staff, by defining the main steps of the production process and Current Good Manufacturing Practices (cGMP) requirements. The approximately 50,000 square-foot building will contain manufacturing suites, complementary support and infrastructure, and the ability to expand the facility to 100,000 square feet to anticipate future programmatic needs.

 

 

 

 

Media Contact:

Zachary DeRitis

Communications Specialist

215-409-4249

zdertis@rapidreshore.com

 

 

 

About BrainStorm Cell Therapeutics Inc.

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 status designation 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 fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a 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 enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

 

About Rapid Reshore & Development:

Rapid Reshore & Development is an alliance of expert firms providing confidence and support throughout the life sciences industry, representing an evolution from transaction-driven service models to a holistic focus on client needs, integrating an interdisciplinary team customized for a variety of individual projects. 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. For additional information, visit: www.rapidreshore.com

 

# # #

 

Safe-Harbor Statement 

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, 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, 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. 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.

 

 

 

 

Media Contact:

Zachary DeRitis

Communications Specialist

215-409-4249

zdertis@rapidreshore.com

 

 

 

 

 

CONTACTS 

 

Brainstorm: Rapid Reshore & Development (RR&D):
Investor Relations: Media Contact:
Corey Davis, Ph.D. Zachary DeRitis
LifeSci Advisors, LLC Communications Specialist
Phone: +1 646-465-1138 215-409-4249
cdavis@lifesciadvisors.com zdertis@rapidreshore.com
Media:  
Paul Tyahla  
SmithSolve  
Phone: + 1.973.713.3768  
Paul.tyahla@smithsolve.com   

 

 

 

 

 

 

 

 

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