STOKE THERAPEUTICS, INC. : conclusion of an important definitive agreement, results of operations and financial situation, disclosure of FD regulations, other events, financial statements and exhibits (form 8-K)

Article 1.01. The conclusion of an important definitive agreement.

At January 9, 2022, Stoke Therapeutics, Inc., a Delaware (the “Company”) has entered into a licensing and collaboration agreement (the “Agreement” with Acadia Pharmaceuticals Inc. (“Acadia”) for the discovery, development and commercialization of novel RNA-based drugs for the treatment of severe and rare genetic neurodevelopmental disease of the central nervous system (“CNS”). The agreement focuses on targets SYNGAP1, MECP2 (Rett syndrome) and an undisclosed neurodevelopmental target of mutual interest. each target, the parties will collaborate to identify potential treatments for further development and commercialization as licensed products. With respect to SYNGAP1, the parties have agreed to co-develop and co-market licensed products for this purpose. worldwide, and as part of this, the Company has granted to Acadia worldwide co-exclusive licenses (with the Company) for these licensed products. relates to MECP2 and the neurodevelopmental target, the Company has granted Acadia worldwide exclusive licenses to develop and market licensed products for these targets.

Under the terms of the Agreement, Acadia will make an upfront payment to the Company in the amount of $ 60,000,000. Acadia will fund research to identify potential licensed products for MECP2 and the neurodevelopmental target, and the parties will also fund research to identify potential licensed products for SYNGAP1. The Company is eligible to receive up to $ 907,500,000 potential total milestone payments based on the achievement of certain development milestone events, regulatory, first commercial sales, and sales across programs for the three targets, assuming each milestone has been met within least once. With respect to products licensed for MECP2 and the Neurodevelopmental Target, the Company is also eligible to receive royalties tiered at mid-digit to mid-teens percentages on future net sales by Acadia of licensed products. in the world. Royalties payable under the Agreement are subject to standard royalty reductions. For SYNGAP1 licensed products that the parties co-develop and co-market, the Company will be responsible for 50% of the development and commercialization costs and will receive 50% of the profits from global commercialization.

With regard to each SYNGAP1 licensed product co-developed or co-marketed, the agreement will remain in force, except for early termination, until the parties have agreed to definitively abandon the development and marketing of this product under Licence. With respect to products licensed for MECP2 and the neurodevelopmental target, the agreement will remain in effect, unless terminated early, until the expiration, country by country and licensed product by licensed product, of the license term. applicable, at that time, the license for that licensed product will become fully released, royalty-free, perpetual and irrevocable in that country.

The Agreement also contains customary termination provisions by Acadia for convenience and by either party for cause, including in the event of serious breach (subject to remedy). The Company has standard reversion rights in connection with certain early termination events.

The foregoing description of the terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed with the Security and Trade Commission as an attachment to the Company’s Quarterly Report on Form 10-Q for the quarter ending March 30, 2022.

Article 2.02. Operating results and financial position

At January 10, 2022, the Company intends to present certain preliminary financial and operational information within the framework of a presentation (the “Presentation”) to the JP Morgan Healthcare Conference, including the fact that the Company expects to report that it has cash, cash equivalents, marketable securities and cash subject to restrictions of approximately $ 220.4 million, and approximately 36.9 million common shares outstanding, as of December 31, 2021.

The audited financial statements of the Company for the year ended
December 31, 2021, are not yet available. Accordingly, the preliminary financial information included in the Presentation is an estimate subject to the completion of the Company’s financial close procedures and any adjustments that may result from the completion of the audit of the Company’s financial statements. Preliminary financial information may differ materially from actual results which will be reflected in the Company’s audited financial statements when completed and made public.

The information in this Section 2.02 will not be considered “filed” for the purposes of Section 18 of the Securities Exchange Act of 1924, as amended (the “Exchange Act”), or otherwise subject to the requirements of this section, nor will it be deemed to be incorporated by reference in any other filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as expressly provided by specific reference in a such deposit.

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Item 7.01. Regulation FD.


Presentation

The Company provides the Presentation, a complete copy of which is attached hereto as Exhibit 99.1.

Press release

At January 10, 2022, the Company and Acadia issued a joint press release announcing their entry into the Agreement. A copy of the press release is attached hereto as Exhibit 99.2.

The information provided with this report, including Exhibits 99.1 and 99.2, will not be considered “filed” for the purposes of section 18 of the Exchange Act, or otherwise subject to the obligations of this section, nor will it be deemed to be “filed” for the purposes of section 18 of the Exchange Act. incorporated by reference in any other filing under the Exchange Act or the Securities Act, unless expressly indicated by specific reference in such filing.


Item 8.01 Other Events


The Company has also indicated that its cash, cash equivalents, marketable securities and restricted cash, including the upfront payment payable by Acadia under the agreement, are expected to fund operations through the second half of 2024.

Caution regarding forward-looking statements

This report contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the receipt of upfront payments; receiving potential milestone payments as part of the SYNGAP1 collaboration; receipt of potential milestones and royalty payments under the MECP2 program and the third program; the ability to develop new treatments for neurodevelopmental diseases; expectations regarding the proposed transaction with Acadia; and the cash, cash equivalents, marketable securities and restricted cash expected of the Company as of December 31, 2021. Statements including words such as “believe”, “will”, “will”, “continue”, “expect”, “may” or “in progress” and statements in the future are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions which, if they do not fully materialize or prove to be incorrect, could cause the Company’s results to differ materially from those expressed or implied by these statements. forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the actual activities or results of the company to differ materially from those expressed in any forward-looking statement, including risks and uncertainties relating to the ability of the company to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and meet development goals , the ability of the Company to protect intellectual property and the other risks and uncertainties described under the heading “Risk Factors” in the documents that the Company files from time to time with the Security and Trade Commission. These forward-looking statements speak only as of the date of this press release, and the Company assumes no obligation to revise or update any forward-looking statements to reflect events or circumstances subsequent to the date hereof.

Item 9.01 Financial statements and supporting documents.


(d) Exhibits



Exhibit
Number       Description

99.1           Presentation, dated as of January 2022

99.2           Joint Press Release, dated as of January 10, 2022.

104          Cover Page Interactive Data File (the cover page XBRL tags are
             embedded within the inline XBRL document).

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