Voyager Therapeutics Files 8-K on Material Agreement & Equity Sales

TL;DR

**Voyager Therapeutics just reported a new material agreement and unregistered equity sales, watch for impact on financials.**

AI Summary

Voyager Therapeutics, Inc. filed an 8-K on January 2, 2024, reporting an event on December 28, 2023, related to an entry into a material definitive agreement, results of operations, and unregistered sales of equity securities. This filing indicates potential new financial activities or strategic partnerships that could impact the company's future revenue streams or operational costs. For investors, this matters because material agreements and equity sales can significantly alter the company's financial health and ownership structure, potentially affecting stock valuation.

Why It Matters

This filing signals new financial or strategic developments, which could lead to changes in the company's financial outlook and stock performance. Unregistered equity sales can dilute existing shareholder value.

Risk Assessment

Risk Level: medium — The filing mentions a material definitive agreement and unregistered sales of equity securities, which could introduce both opportunities and risks depending on the specifics not detailed in this summary.

Analyst Insight

Investors should seek further details on the 'Material Definitive Agreement' and 'Unregistered Sales of Equity Securities' to understand their financial implications and potential dilution before making investment decisions.

Key Players & Entities

• Voyager Therapeutics, Inc. (company) — the registrant filing the 8-K
• December 28, 2023 (date) — date of the earliest event reported
• January 2, 2024 (date) — date the 8-K was filed

FAQ

Key Financial Figures

• $0.001 — ge on which registered Common Stock, $0.001 par value VYGR Nasdaq Global Select
• $80 million — e Company an initial upfront payment of $80 million and to purchase 2,145,002 shares of com
• $20 million — gregate purchase price of approximately $20 million (collectively, the "Upfront Payment") p
• $200 million — stone payments of up to an aggregate of $200 million for the SMA Program and up to an aggreg
• $225 million — e SMA Program and up to an aggregate of $225 million for the HD Program, in each case for th
• $400 million — stone payments of up to an aggregate of $400 million for the SMA Program and up to an aggreg
• $375 million — e SMA Program and up to an aggregate of $375 million for the HD Program and (b) tiered, esca
• $9.324 — of the Shares to Novartis at a price of $9.324 per share, for an aggregate purchase pr
• $230.7 million — rketable securities to be approximately $230.7 million as of December 31, 2023, and that its p
• $100.0 million — ticipated receipt by the Company of the $100.0 million in aggregate upfront payments under the
• $330.7 million — described above, would be approximately $330.7 million. The Company expects its cash and cash
• $8 million — cash runway, the assumed achievement of $8 million of milestones under the Company's colla

Filing Documents

• tm241304d1_8k.htm (8-K) — 55KB
• 0001104659-24-000084.txt ( ) — 232KB
• vygr-20231228.xsd (EX-101.SCH) — 3KB
• vygr-20231228_lab.xml (EX-101.LAB) — 33KB
• vygr-20231228_pre.xml (EX-101.PRE) — 22KB
• tm241304d1_8k_htm.xml (XML) — 3KB

01 Entry into a Material Definitive Agreement

Item 1.01 Entry into a Material Definitive Agreement License and Collaboration Agreement On December 28, 2023 (the "Effective Date"), Voyager Therapeutics, Inc. (the "Company") entered into a License and Collaboration Agreement (the "Collaboration Agreement") with Novartis Pharma AG ("Novartis") to (a) provide rights to Novartis with respect to certain proprietary adeno-associated virus ("AAV") capsids discovered by the Company (the "Voyager Capsids") for use in the research, development, and commercialization by Novartis of AAV gene therapy products and product candidates, comprising such Voyager Capsids and payloads intended for the treatment of spinal muscular atrophy (the "SMA Program") and (b) collaborate to develop AAV gene therapy products and product candidates intended for the treatment of Huntington's disease (the "HD Program"), in each case, leveraging Voyager Capsids and other intellectual property controlled by the Company. SMA Program and HD Program Licenses. Under the terms of the Collaboration Agreement, the Company has agreed to grant to Novartis and its affiliates: a non-exclusive, non-transferable, non-sublicensable (except in limited circumstances for contractors), worldwide, royalty-free right and license under any patents or know-how controlled by the Company and related to the Voyager Capsids to evaluate the same for use in the development of a product or product candidate under the SMA Program (a "SMA Program Product") comprising such a Voyager Capsid and a payload selected by Novartis during the period beginning on the Effective Date and ending on the third anniversary of the Effective Date; an exclusive (even as to the Company), sublicensable, non-transferable, worldwide, royalty-bearing right and license under any patents or know-how controlled by the Company and relating to the selected Voyager Capsids to exploit the same as incorporated into an SMA Program Product for all human and veterinary diagnostic, prophylactic and therapeu

02 Results of Operations and Financial Condition

Item 2.02 Results of Operations and Financial Condition The Company is currently completing its reports of its operational and financial results for the year ended December 31, 2023. However, the Company estimates its preliminary unaudited cash and cash equivalents and marketable securities to be approximately $230.7 million as of December 31, 2023, and that its preliminary unaudited cash and cash equivalents and marketable securities as of December 31, 2023, as adjusted to give effect to anticipated receipt by the Company of the $100.0 million in aggregate upfront payments under the Collaboration Agreement and the Stock Purchase Agreement described above, would be approximately $330.7 million. The Company expects its cash and cash equivalents and marketable securities as of December 31, 2023, as adjusted to give effect to the anticipated $100.0 million in aggregate upfront payments from Novartis, along with amounts expected to be received as reimbursement for development costs under the Company's collaborations with Neurocrine Biosciences, Inc. ("Neurocrine") and Novartis, to be sufficient to meet the Company's planned operating expenses and capital expenditure requirements into mid-2026. The estimated cash and cash equivalent and marketable securities amounts as of December 31, 2023, 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 $100.0 million in upfront payments is subject to the satisfaction or waiver of customary closing conditions for the 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 deeme

02 Unregistered Sales of Equity Securities

Item 3.02 Unregistered Sales of Equity Securities The information set forth in Item 1.01 above under the caption "Stock Purchase Agreement" is incorporated herein by reference. Based in part upon the representations of Novartis in the 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.

01 Other Events

Item 8.01 Other Events Update on VY-TAU01 for the Treatment of Alzheimer's Disease The Company plans to submit an IND application for VY-TAU01, its anti-tau antibody product candidate for the treatment of Alzheimer's disease, to the U.S. Food and Drug Administration (the "FDA") in the first half of 2024. The planned Phase 1 clinical trial is designed to assess the safety of VY-TAU01 in a multi-arm dose escalation study, with a single ascending dose arm expected to be conducted in healthy subjects to be initiated in 2024 and a multiple ascending dose arm expected to be conducted in subjects with mild cognitive impairment or early Alzheimer's disease to be initiated in 2025. In connection with the planned trial, the Company also anticipates evaluating positron emission topography scans of subjects from the multiple ascending dose arm for an indication of biological activity of VY-TAU01 in the second half of 2026. Update on SOD1 Silencing Gene Therapy for the Treatment of SOD1 ALS The Company plans to submit an IND application to the FDA in mid-2025 for its gene therapy product candidate designed to deliver a vectorized, highly potent small interfering RNA construct for the treatment of superoxide dismutase 1-mutated amyotrophic lateral sclerosis ("SOD1 ALS") and to initiate a Phase 1 clinical trial in subjects with SOD1 ALS for the program as soon as possible thereafter. The Company expects to evaluate the safety and biological activity of its SOD1 ALS product candidate in this Phase 1 trial. Update on Other Programs The Company is actively advancing additional wholly-owned programs for the treatment of Alzheimer's disease and is party to collaboration or licensing arrangements with Neurocrine; Novartis; Alexion, AstraZeneca Rare Disease; and Sangamo Therapeutics, Inc. In addition to the IND applications described above, the Company expects that its collaborative partners and licensees will submit at least two additional IND applications for other partnered

Forward-Looking Statements

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 Novartis and the sale and issuance of the Shares to Novartis, the satisfaction of closing conditions necessary for the consummation of the collaboration and the sale and issuance of the Shares to Novartis, the Company's entitlement to receive the Upfront Payment, milestone payments and royalties from Novartis 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 Novartis to perform under the Collaboration Agreement, including the Company's and Novartis'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 Novartis to perform their obligations under the Investor Agreement, the ability of the Company to add new programs to its pipeline, the ability of the Company to develop its pipeline programs, the timing, initiation, and design of the Company's preclinical studies and clinical trials, the ability of the Company to enter into new partnerships or collaborations, the regulatory pathway of, and the timing or likelihood of its and its collaboration partners' or licensors' regulatory filings and approvals for, any of the Company's product candidates, the Company's preliminary unaudited cash and cash equiva

SIGNATURES

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. VOYAGER THERAPEUTICS, INC. Date: January 2, 2024 By: /s/ Alfred Sandrock, M.D., Ph.D. Alfred Sandrock, M.D., Ph.D. Chief Executive Officer, President, and Director (Principal Executive Officer)

View Full Filing

View this 8-K filing on SEC EDGAR