SANA BIOTECHNOLOGY, INC. : conclusion of a material definitive agreement, other events, financial statements and exhibits (Form 8-K)

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Item 1.01 Conclusion of a Material Definitive Agreement.

At October 15, 2021 (the “Effective Date”), Sana Biotechnology, Inc. (the “Company”) has entered into an option and license agreement (the “Agreement”) with Beam Therapeutics Inc. (“Beam”), pursuant to which Beam has granted the Company a non-exclusive license to use nuclease Beam’s exclusive CRISPR Cas12b. editing technology, for a specified number of gene editing targets, to research, develop and commercialize modified cell therapy products (each, a “licensed product”) which (i) are directed to certain antigenic targets, with respect to the Company’s allogeneic T cells programs, or (ii) include certain types of human cells, with respect to the programs derived from the Company’s stem cells. The Company is authorized to use the CRISPR Cas12b system to modify or introduce, ex vivo, selected genetic sequences relating to the Licensed Products. The Agreement excludes any basic editing rights using the CRISPR Cas12b system.

In accordance with the Agreement, the Company has the option (the “Option”), for a period of one year from the Effective Date, to select additional antigenic targets, with respect to the programs. of the Company’s allogeneic T cells, or human cell types, with with respect to the Company’s stem cell-derived programs, in each case, upon payment by the Company of an option payment of $ 10 million by antigen target or cell type. In addition, the Company may, for a period of three years from the Effective Date, (i) elect to replace an antigen target, with respect to the allogeneic T cell programs of the Company, or human cell type, with respect to the Company’s stem cells – derivative programs (the “Replacement Right”) previously selected by the Company and (ii) select new gene editing targets, or replace gene editing targets previously selected by the Company, with respect to any Licensed Product (the “Genetic Nomination Right”). In each case, the rights of the Company with regard to its exercise of the Option, the Replacement Right or the Genetic Nomination Right are subject to certain limitations.

In accordance with the Agreement, the Company will make an upfront payment of
$ 50 million shine. In addition, with respect to each Licensed Product, the Company will be obligated to pay Beam up to $ 65 million in the specified development and trade milestone payments.

The Company will also be required to pay Beam an aggregate royalty, including any royalty owed by Beam to its licensor, licensed product by licensed product and country by country, in the low to medium range. , subject to reduction in certain circumstances, on the net sales of each licensed product until (i) the expiration of certain patents covering that licensed product in the applicable country, (ii) the date on which any applicable regulatory exclusivity, including orphan drug, new chemical entity, data or pediatric exclusivity, with respect to this licensed product expires in that country, or (iii) the 10th anniversary of the first commercial sale of this licensed product in this country. country. The Company cannot determine when the Company’s potential royalty payment obligations to Beam would expire because the Company has not yet developed any products licensed under the Agreement, and the Company therefore cannot not yet identify the date of the first commercial sale or expiration. any applicable patent covering or period of regulatory exclusivity relating to such Licensed Products.

Unless terminated early by either party, the Agreement will expire licensed product by licensed product and country by country upon expiration of the Company’s payment obligations with respect to each licensed product under the Agreement. The Company may terminate the Agreement in its entirety or on a target antigen per antigen target basis (with respect to Licensed Products applicable to the Company’s allogeneic T cell programs), on a cell-type basis by cell type (with respect to Licensed Products applicable to the Company’s stem cell-derived programs), or on a licensed product by licensed product basis, in each case upon (i) written notice 90 days, if such notice is provided prior to the first commercial sale of a licensed product, or (ii) 180 days written notice, if such notice is provided after the first commercial sale of a licensed product . Either party may terminate the Agreement with written notice for the other party’s material breach if that breaching party fails to timely remedy the breach with respect to the country in which that breach. material violation relates. Beam may terminate the Agreement in its entirety if the Company or its affiliates or sub-licensees initiates legal action disputing the validity, patentability, enforceability or scope of any of the patent rights licensed to the Company. Company under the Agreement. Either party may also terminate the Agreement in its entirety in the event of an insolvency involving the other party.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, of which the Company intends to file an attached copy of its Quarterly Report on Form 10-Q for his fiscal quarter ended September 30, 2021.

Item 8.01 Other Events.


At October 19, 2021 the Company issued a press release announcing the agreement with Beam, described above in section 1.01 of this current report on Form 8-K. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial statements and supporting documents.




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(d) Exhibits


See the Attachment Index below, which is incorporated by reference herein.

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