TAYSHA GENE THERAPIES, INC. : Entering into a Material Definitive Agreement, Unrecorded Sale of Equity Securities, Other Events, Financial Statements and Exhibits (Form 8-K)

Section 1.01 Entering into a Material Definitive Agreement.

Option contract

On October 21, 2022 (the “Effective Date”), Taysha Gene Therapies, Inc. (the “Company”) has entered into an option agreement (the “Option Agreement”) with
Audentes Therapeutics, Inc. (d/b/a Astellas Gene Therapy) (“Astellas”).

Giant Axonal Neuropathy TSHA-120

Pursuant to the Option Agreement, the Company has granted Astellas an exclusive option to obtain an exclusive, worldwide, royalty and milestone (A) right and license to research, develop, manufacture, cause to be manufactured, use, sell, offer for sale, have sold, imported, exported and otherwise exploited (collectively, “operate”) the Product known, on the Effective Date, as TSHA-120 (the “Product 120 GAN”) and all related rescue products for use in the treatment of Giant Axonal Neuropathy (“GAN”) or any other gene therapy product intended for use in the treatment of GAN that is controlled by the Company or any of its affiliates or in respect of which the Company or any of its affiliates controls the intellectual property rights covering the Operation thereof (“GAN Product”) and (B) under any intellectual property right controlled by the Company or any of its affiliates with respect to this Exploitation (the “GAN Option”). Subject to certain extensions, the GAN Option is exercisable from the Effective Date until a specified period following Astellas’ receipt of (i) the official minutes of the End of Phase 2 meeting of type B between the company and the US Food and Drug Administration (“FDA”) in response to the Company’s meeting request sent to the FDA on September 19, 2022 for the 120 GAN Product (the “Type B End of Phase 2 Meeting”), (ii) all written comments from the FDA regarding the Type B End of Phase 2 Meeting, and (iii) all documents d information sent by the Company to the FDA as part of the end of phase 2 type B meeting.

Rett Syndrome TSHA-102

Under the Option Agreement, the Company has also granted Astellas an exclusive option to obtain an exclusive, worldwide, royalty and Milestone (A) right and license to exploit any Rett Product (as defined below), and (B) under any intellectual property rights the proprietary rights controlled by the Company or any of its affiliates in such Exploitation (the “Rett Option” and, together with the ‘GAN Option, each an “Option”). Subject to certain extensions, the Rett Option is exercisable from the Effective Date until a specified period following Astellas’ receipt of (1) certain clinical data from the pediatric female trial and (2 ) certain specified data regarding TSHA-102 (such period, the “Rett Option Period”) relating to (i) the product known, as of the Effective Date, as TSHA-102 and any related rescue product for use in the treatment of Rett syndrome (“Rett”), and (ii) any other gene therapy product for use in the treatment of Rett that is controlled by the Company or the any of its affiliates or in respect of which the Company or any of its affiliates controls the intellectual property rights covering the Exploitation thereof (“Rett Product”).

The parties have agreed that, if Astellas exercises an option, the parties will, for a specified period, negotiate a license agreement in good faith on the terms and conditions set forth in the option agreement, including payments by Astellas of an upfront payment to be determined, certain milestone payments to be determined and certain royalties to be determined on net sales of GAN Products and/or Rett Products, as applicable.

Change of control

During the Rett Option Period, the Company has agreed not to (A) solicit or encourage any inquiries, offers or proposals for, or which could reasonably be expected to lead to , a Change of Control (as defined in the Option Agreement), or (B) otherwise initiate a process for a potential Change of Control, in each case, without prior notice to Astellas and providing Astellas with the opportunity to submit an offer or proposal to the Company for a transaction that would result in a change of control. If Astellas fails or refuses to submit such an offer within a specified time after receipt of such notice, the Company shall have the option of soliciting offers from third parties for a change of control transaction. If Astellas makes an offer to the Company for a transaction which would result in a change of control, the Company and Astellas will attempt to negotiate in good faith the potential terms and conditions of such potential transaction which would result in a change of control for a specified period, which period may be shortened or extended by mutual agreement.

In consideration for the rights granted to Astellas under the Option Agreement, Astellas will pay the Company a one-time payment in the amount of
$20.0 million (the “Initial Payment”) within 30 days of receipt of an invoice for such payment, which invoice will be issued by the Company from the Effective Date. Astellas or one of its affiliates shall have the right, at its discretion and upon written notice to the Company, to offset the amount of the Initial Payment (in whole or in part, until the full amount of the Initial Payment has been cleared) against (a) any payment due to the Company or any of its affiliates (or any third party on behalf of the Company) under or in connection with any license agreement entered into with respect to any product GAN or Rett product, including any initial payment, milestone payment or royalties due to the Company or any of its affiliates (or any third party on behalf of the Company) under or in connection with such agreement license or

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(b) any amount owed to the Company or any of its affiliates in connection with a change of control transaction with Astellas or any of its affiliates. In consideration for the rights granted to Astellas under the Option Agreement, the Company and Astellas have also entered into the Securities Purchase Agreement (as defined below).

The foregoing description of the Option Agreement does not purport to be complete and is qualified in its entirety by reference to this Agreement, a copy of which will be filed as an attachment to an amendment to this current report on Form 8-K. .

Securities purchase agreement

On October 21, 2022the Company has entered into a securities purchase agreement (the “Securities Purchase Agreement”) with Astellas, pursuant to which the Company has agreed to issue and sell to Astellas under a private placement (the “Private Placement”) an aggregate of 7,266,342 shares (the “Shares”) of common stock, par value $0.00001 per share (the “Common Shares”) of the Company, for aggregate gross proceeds of approximately $30.0 million. The Securities Purchase Agreement contains customary representations, warranties and covenants of the Company, customary closing conditions, indemnification obligations of the Company, other obligations of the parties and termination provisions.

The private placement closed on October 24, 2022 (the “Closing Date”). The Company expects the net proceeds from the private placement to be used to fund the ongoing clinical, regulatory and manufacturing development of TSHA-102 and TSHA-120, TSHA-120 pre-commercialization activities and the fund rolling. . .

Item 3.02 Unrecorded Sales of Equity securities.

The description presented above under item 1.01 is incorporated herein by reference. The offer and sale of the Shares by the Company pursuant to the Private Placement has been made on the basis of an exemption from registration under section 4(a)(2) of the Securities Act .

Section 8.01 Other Events.

On October 24, 2022, the Company issued a press release announcing the private placement and the conclusion of the option agreement. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

On October 25, 2022, the company has provided the following clinical program updates. Regarding TSHA-120 for the treatment of GAN, the company’s Type B end-of-Phase 2 meeting with the FDA is scheduled for December 13, 2022and the Company expects to provide a regulatory update following receipt of the formal minutes of the meeting, expected in mid-January 2023. With respect to TSHA-102 for the treatment of Rett syndrome, the Company previously announced that it planned to report preliminary Phase 1/2 data for TSHA-102 in Rett syndrome in adult patients with ‘by the end of the year 2022, which it planned to publish consisting of security data. The Company now expects to publish preliminary clinical data on the safety and efficacy of the entire first cohort of adult patients during the first half of 2023. The Company also plans to initiate a female pediatric clinical trial during the first half of 2023.

Forward-looking statements

This Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the expected closing date of the Private Placement, the anticipated proceeds of the Private Placement and its use, and the Company intends to file a registration statement to record the resale of the Shares. The words “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, ” predict”, “project”, “target”, “should”, “should” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements due to various important factors, including risks relating to the Company’s inability, or the inability of Astellas, to satisfy the closing conditions for the private placement; risks relating to the closing of the private placement; and the risks described under “Risk Factors” in the company’s annual report on Form 10-K for the year ended December 31, 2021 filed with the Security and Exchange Commission on March 31, 2022as updated by the Company’s subsequent filings with the Security and Exchange Commission. All forward-looking statements contained in this Form 8-K speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Item 9.01 Financial statements and supporting documents.


(d) Exhibits

Exhibit
  No.        Description

99.1           Press Release of the Company, dated October 24, 2022.

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

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