Item 1.01 Entry into a Material Definitive Agreement.

Collaboration and License Agreement

On January 8, 2023 (the "Agreement Date"), Voyager Therapeutics, Inc. (the "Company") entered into a Collaboration and License Agreement (the "Collaboration Agreement") with Neurocrine Biosciences, Inc. ("Neurocrine") for the research, development, manufacture and commercialization of gene therapy products directed to the gene that encodes glucosylceramidase beta 1 ("GBA1") for the treatment of Parkinson's disease and other diseases associated with GBA1 (the "GBA1 Program") and three new programs focused on the research, development, manufacture and commercialization of gene therapies designed to address central nervous system diseases or conditions associated with rare genetic targets (the "New Discovery Programs" and, collectively with the GBA1 Program, the "Programs").

Collaboration and License. Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any required approvals or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the "Effective Date" and such clearance, "Antitrust Clearance"), the Company and Neurocrine have agreed to collaborate on the conduct of the Programs. Under the terms of the Collaboration Agreement, subject to the rights retained by the Company thereunder, the Company has also agreed to grant to Neurocrine, as of the Effective Date, an exclusive, royalty-bearing, sublicensable, worldwide license, under certain of the Company's intellectual property rights, to research, develop, manufacture and commercialize gene therapy products (the "New Collaboration Products") arising under the Programs.

Pursuant to mutually-agreed development plans (the "Development Plans"), during the period beginning on the Effective Date and ending on the third anniversary of the Effective Date, which period may be extended upon mutual written agreement of the Company and Neurocrine (the "Discovery Period"), and as overseen by the joint steering committee that oversees the Company's ongoing collaboration with Neurocrine (the "JSC"), the Company is responsible for identifying capsids meeting target criteria, producing development candidates, and conducting other non-clinical activities regarding the New Collaboration Products. Neurocrine has agreed to be responsible for all costs incurred by the Company in conducting non-clinical development activities for each Program, in accordance with an agreed budget. If the Company breaches its development responsibilities or, in certain circumstances, upon a change of control of the Company, Neurocrine has the right, but not the obligation, to assume the conduct of the Company's activities under such Program.

The Company has the option (a "Co-Co Option") to co-develop and co-commercialize New Collaboration Products in the GBA1 Program in the U.S. upon the occurrence of a specified event (a "Co-Co Trigger Event"). Should the Company elect to exercise its Co-Co Option, the Company and Neurocrine agree to enter into a cost- and profit-sharing arrangement (a "Co-Co Agreement"), whereby the Company and Neurocrine agree to jointly develop and commercialize New Collaboration Products in the GBA1 Program ("Co-Co Products") in the U.S. and share equally in the GBA1 Program's costs, profits and losses in the U.S., with each party entitled to or responsible for 50% of profits and losses with respect to each Co-Co Product in the United States, subject to specified exceptions. The parties have agreed that the Co-Co Agreement will provide the Company the right to terminate the Co-Co Agreement for any reason upon prior written notice to Neurocrine and provide Neurocrine the right to terminate or amend the Co-Co Agreement upon a change of control of the Company under certain circumstances. In the event the Company exercises its Co-Co Option, the parties have also agreed that Neurocrine is entitled to receive (in addition to its 50% share of profits) 50% of the Company's share of profits until the Company's obligation to repay 50% of all development costs incurred by Neurocrine in connection with the GBA1 Program prior to such exercise have been paid off out of such 50% of the Company's share of profits. The Co-Co Trigger Event is the date on which the Company receives topline data from the first Phase 1 clinical trial for a product candidate being developed pursuant to the GBA1 Program.

Governance. The Company's research and development activities under the Collaboration Agreement are to be conducted pursuant to plans agreed to by the parties, on a Program-by-Program basis, and overseen by the JSC, which is composed of an equal number of representatives from each of the Company and Neurocrine. The JSC may delegate matters within its authority to subcommittees of the JSC. In addition, the Collaboration Agreement establishes working groups to handle specified matters on a subject matter-by-subject matter basis. If a working group or subcommittee cannot agree on a matter within its purview within a specified time, such matter is to be referred sequentially to the JSC and then the executive officers of the parties. If the executive officers are not able to resolve the matter, then (i) with respect to the GBA1 Program, subject to specified exceptions, (a) Neurocrine has the right to resolve such matter prior to the Company's exercise of its Co-Co Option for the GBA1 Program or in the event the Company elects not to exercise its Co-Co Option, and (b) following the exercise by the Company of its Co-Co Option for the GBA1 Program, depending on the subject of such matter, either Neurocrine, in certain instances, or the parties jointly or the JSC, in other instances, would have the right to resolve such matter, and (ii) with respect to the New Discovery Programs, subject to specified exceptions, Neurocrine has the right to decide any unresolved matters relating to a New Discovery Program that are within the JSC's authority.

Candidate Selection. Either Party may notify the JSC of any gene therapy product candidate that includes a Company capsid and a payload that is being developed under a Program (a "Collaboration Candidate") that it desires to nominate as a development candidate. In such event, the JSC shall determine whether such nominated Collaboration Candidate meets certain development criteria. There will be a maximum of four potential development candidates for which development is being performed under any Program at any given time during the Discovery Period. If a Collaboration Candidate fails to meet criteria established by the JSC and is removed from consideration to become a development candidate or is named a development candidate, then a new Collaboration Candidate may be nominated to be a potential development candidate to replace the Collaboration Candidate that has failed or succeeded such that not more than four potential development candidates per program are under consideration at any one time during the Discovery Period.

Manufacturing. The parties have agreed that the Development Plans shall specify the allocation between the Company and Neurocrine of responsibilities for the manufacturing of Collaboration Candidates associated with the applicable Program . . .

Item 2.02 Results of Operations and Financial Condition

The Company is currently completing its reports of the Company's operational and financial results for the year ended December 31, 2022. However, the Company estimates its preliminary unaudited cash and cash equivalents and marketable securities to be approximately $119.2 million as of December 31, 2022, and that its preliminary unaudited cash and cash equivalents and marketable securities as of December 31, 2022, as adjusted to give effect to subsequent receipt by the Company of the $175.0 million in upfront payments under the Collaboration Agreement described above, would be approximately $294.2 million. The Company anticipates providing further financial guidance in light of the collaboration in connection with the filing of the Company's 2022 Annual Report.

The estimated cash and cash equivalent and marketable securities amounts as of December 31, 2022 discussed above are based on preliminary and unaudited information and management's estimates as of the date of this Current Report on Form 8-K and are subject to completion of the Company's customary financial closing procedures. The receipt of the $175.0 million in upfront payments is subject to obtaining Antitrust Clearance for the collaboration with respect to the Programs and the satisfaction or waiver of customary closing conditions for the 2023 Stock Purchase Agreement as described above. The Company's independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, these amounts.

The information in Item 2.02 of this Current Report on Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 3.02 Unregistered Sales of Equity Securities

The information set forth in Item 1.01 above under the caption "2023 Stock Purchase Agreement" is incorporated herein by reference. Based in part upon the representations of Neurocrine in the 2023 Stock Purchase Agreement, the Company expects the Shares to be issued in reliance on the exemption from registration under Section 4(a)(2) of the Securities Act for a transaction by an issuer not involving any public offering within the meaning of Section 4(a)(2) and/or under Rule 506 of Regulation D promulgated under the Securities Act and corresponding provisions of state securities or "blue sky" laws.




Item 8.01 Other Events


On January 9, 2023, the Company announced an update to its Huntington's disease program. Previously, the Company had explored the potential of AAV gene therapies delivered via intraparenchymal injection to silence the expression of the Huntingtin ("HTT") gene. Huntington's disease is caused by mutations in the HTT gene. The Company has now initiated research efforts focusing on the development of a vectorized, small interfering RNA approach, to be delivered intravenously leveraging the Company's proprietary TRACER capsids, to silence both the HTT gene, on an allele-specific basis, and the MSH3 gene. The MSH3 gene encodes for an enzyme potentially involved in harmful DNA repeat expansions in the HTT gene.





Forward-Looking Statements



This Current Report on Form 8-K contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "undoubtedly," "target," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements.

For example, all statements the Company makes regarding the consummation of the collaboration with Neurocrine and the sale and issuance of Company common stock to Neurocrine, the satisfaction of closing conditions and the receipt of regulatory clearances necessary for the consummation of the collaboration and the sale and issuance of Company common stock to Neurocrine, the Company's entitlement to receive the Upfront Payment, milestone payments and royalties from Neurocrine under the Collaboration Agreement, the creation of value and the establishment of new opportunities that may arise as a result of the collaboration, the ability of the Company and Neurocrine to perform under the 2019 Collaboration Agreement and the Collaboration Agreement, including the Company's and Neurocrine's abilities to advance gene therapy product candidates under this collaboration into, and successfully initiate, enroll and complete, clinical trials, the ability of the Company and Neurocrine to perform their obligations under the Amended and Restated Investor Agreement, the ability of the Company to add new programs to its pipeline, the ability of the Company to develop its pipeline programs including its new research efforts focused on Huntington's disease, the ability of the Company to enter into new partnerships or collaborations, the ability of the Company to continue to develop the TRACER platform, the regulatory pathway of, and the timing or likelihood of its regulatory filings and approvals for, any of the Company's product candidates, the Company's preliminary unaudited cash and cash equivalent and marketable securities amounts as of December 31, 2022, and the sufficiency of the Company's cash resources are forward-looking.

All forward-looking statements are based on estimates and assumptions by the Company's management that, although the Company believes them to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that the Company expected. Such risks and uncertainties include, among others, the expectations and decisions of regulatory authorities; the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the continued development of the Company's capsid and gene therapy platforms; the availability or commercial potential of product candidates under this collaboration; the willingness and ability of the Company's collaboration partners to meet obligations under collaboration agreements with the Company; and uncertainties as to the Company's preliminary unaudited cash and cash equivalent and marketable securities amounts as of December 31, 2022, which are estimates based on preliminary and unaudited information, subject to the completion of the Company's customary financial closing procedures and have not been audited or reviewed by the Company's independent public accounting firm.

These statements are also subject to a number of material risks and uncertainties that are described in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in this Form 8-K is as of the date of this Form 8-K, and any forward-looking statement speaks only as of the date on which it was made. The Company undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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