HOOKIPA Pharma Terminates Key Agreement, Signals Impairments

TL;DR

**HOOKIPA Pharma just terminated a major agreement and flagged impairments, watch out for financial hits.**

AI Summary

HOOKIPA Pharma Inc. filed an 8-K on January 29, 2024, reporting an event on January 25, 2024, related to the termination of a material definitive agreement. This filing also indicates information regarding results of operations, financial condition, costs associated with exit or disposal activities, and material impairments. This matters to investors because the termination of a key agreement and potential impairments could signal significant changes in the company's strategic direction or financial health, potentially impacting future revenue and profitability.

Why It Matters

The termination of a material agreement and potential impairments could negatively impact HOOKIPA Pharma's future revenue streams and financial stability, making the stock a riskier investment.

Risk Assessment

Risk Level: high — The termination of a material definitive agreement, coupled with potential impairments and exit costs, indicates significant operational and financial uncertainty for the company.

Analyst Insight

A smart investor would closely monitor HOOKIPA Pharma's upcoming financial disclosures for specifics on the terminated agreement, the extent of impairments, and any revised strategic plans before making investment decisions.

Key Players & Entities

• HOOKIPA Pharma Inc. (company) — the registrant filing the 8-K
• January 25, 2024 (date) — date of the earliest event reported
• January 29, 2024 (date) — date the 8-K was filed
• 001-38869 (other) — Commission File Number

Forward-Looking Statements

• HOOKIPA Pharma Inc. will likely provide more details on the terminated agreement and financial impacts in its next quarterly report. (HOOKIPA Pharma Inc.) — high confidence, target: Q1 2024 Earnings Report
• The company's stock price may experience volatility as investors react to the news of the terminated agreement and potential impairments. (HOOKIPA Pharma Inc. stock) — medium confidence, target: Near-term

FAQ

Key Financial Figures

• $0.0001 — nge on which registered Common stock, $0.0001 HOOK The Nasdaq Global Select Market
• $117.5 million — ts and restricted cash of approximately $117.5 million as of December 31, 2023. This informati
• $1.5 million — is expected to result in approximately $1.5 million in severance, restructuring and related
• $10 million — of "assets under construction" between $10 million and $13 million from the discontinuatio
• $13 million — r construction" between $10 million and $13 million from the discontinuation of the GMP fac
• $20 million — ollaboration Agreement of approximately $20 million in connection with the termination by R

Filing Documents

• tm244291d1_8k.htm (8-K) — 37KB
• tm244291d1_ex99-1.htm (EX-99.1) — 25KB
• tm244291d1_ex99-1img001.jpg (GRAPHIC) — 6KB
• 0001104659-24-007471.txt ( ) — 253KB
• hook-20240125.xsd (EX-101.SCH) — 3KB
• hook-20240125_lab.xml (EX-101.LAB) — 33KB
• hook-20240125_pre.xml (EX-101.PRE) — 22KB
• tm244291d1_8k_htm.xml (XML) — 4KB

02Termination of a Material Definitive

Item 1.02Termination of a Material Definitive Agreement. On January 25, 2024, HOOKIPA Pharma Inc. ("HOOKIPA") received written notice (the "Notice") from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (collectively referred to as "Roche") of their decision to terminate the Research Collaboration and License Agreement (the "Collaboration Agreement") among Roche and Hookipa Biotech GmbH ("HOOKIPA GmbH," and together with HOOKIPA, the "Company"), a wholly-owned subsidiary of HOOKIPA, dated October 18, 2022. Roche's decision to terminate the Collaboration Agreement was made according to Roche's right to terminate without cause, acknowledging that, to date, HOOKIPA met all go-forward criteria under the Collaboration Agreement. The Collaboration Agreement was entered into to (i) grant Roche an exclusive license to research, develop, manufacture and commercialize the Company's pre-clinical HB-700 cancer program, an arenaviral immunotherapeutic for KRAS-mutated cancers, and (ii) grant Roche an option right to exclusively license for research, development manufacturing and commercialization, a second, novel arenaviral immunotherapeutic program targeting undisclosed cancer antigens. Pursuant to the terms of the Collaboration Agreement and the Notice, the Collaboration Agreement will be terminated on April 25, 2024. The Company remains eligible for a final milestone payment associated with an IND submission. Effective April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and will have full collaboration and licensing rights for the HB-700 program. After the termination of the Collaboration Agreement, and except as disclosed above, there is no other material relationship between the Company and Roche.

02Results

Item 2.02Results of Operations and Financial Condition. On January 29, 2024, HOOKIPA issued a press release which contained information regarding its preliminary, unaudited estimate of cash and cash equivalents and restricted cash of approximately $117.5 million as of December 31, 2023. This information is preliminary and unaudited. Accordingly, undue reliance should not be placed on such preliminary numbers. The Company expects to report its audited cash, cash equivalents and marketable securities, as well as other information necessary for a complete understanding of its financial position, in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023. The information in this Item 2.02 is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended (the "Securities Act"), if such subsequent filing specifically references the information furnished pursuant to Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K.

05Costs

Item 2.05Costs Associated with Exit or Disposal Activities. On January 29, 2024, HOOKIPA announced its decision to prioritize clinical development of HB-200 for the treatment of HPV16+ head and neck cancers and Gilead-partnered programs in infectious disease and to pause development activities related to HB-300 and most of its preclinical research activities. In connection with this strategic refocus, on January 22, 2024, HOOKIPA's board of directors approved a plan to reduce the Company's workforce by 55 full-time employees, or approximately 30% of the Company's then-current employee base and to rebalance the Company's cost structure in alignment with the new prioritization of R&D programs (together, the "Reduction Plan"), and the Company notified affected employees on January 29, 2024. HOOKIPA expects to implement and substantially complete the Reduction Plan during the first quarter of 2024. In connection with the Reduction Plan, the affected employees will be provided severance benefits, including cash severance payments. Each affected employee's eligibility for these severance benefits is contingent upon such employee's entering into an effective separation agreement, which includes a general release of claims against the Company. The workforce reduction is expected to result in approximately $1.5 million in severance, restructuring and related costs. HOOKIPA expects a non-cash impairment of "assets under construction" between $10 million and $13 million from the discontinuation of the GMP facility project as part of the Reduction Plan. The Company expects to recognize deferred upfront and milestone payments under the Collaboration Agreement of approximately $20 million in connection with the termination by Roche. The estimated charges that the Company expects to incur in connection with this Reduction Plan are subject to a number of assumptions, and actual results may differ materially from these estimates. The Company may also incur additional costs not cu

06Material Impairments

Item 2.06Material Impairments. To the extent applicable, the information contained in Item 2.05 above is incorporated into this Item 2.06 by reference.

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On January 29, 2024, the Company issued a press release announcing updates on the Company's business priorities and oncology partnership programs. A copy of the press release is furnished hereto as Exhibit 99.1. The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise the Exchange Act, except as expressly set forth by specific reference in such filing.

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K and other related materials may contain a number of "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding HOOKIPA's expectation about any or all of the following: (i) the timing and consequences regarding the termination of the Collaboration Agreement, (ii) the extent, timing and plan of, and the costs and estimated cash expenditures from, the Reduction Plan, and (iii) expected cash and cash equivalents as of December 31, 2023. Forward-looking "would" or similar expressions and the negative of those terms. HOOKIPA has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its business, financial condition and results of operations. Although HOOKIPA believes that such statements are based on reasonable assumptions, forward-looking HOOKIPA's control, you should not rely on these forward-looking statements as predictions of future events. These risks and uncertainties include, among others: outcomes of HOOKIPA's planned clinical trials and studies may not be favorable; that one or more of HOOKIPA's product candidate programs will not proceed as planned for technical, scientific or commercial reasons; availability and timing of results from preclinical studies and clinical trials; uncertainty about regulatory approval to conduct clinical trials or to market a products; uncertainties regarding intellection property protection; and those risk

01. Exhibits

Item 9.01. Exhibits. (d) Exhibits 99.1 Press Release issued by HOOKIPA Pharma Inc. on January 29, 2024, furnished herewith. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

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. HOOKIPA Pharma Inc. Date: January 29, 2024 By: /s/ Joern Aldag Joern Aldag Chief Executive Officer (Principal Executive Officer)

View Full Filing

View this 8-K filing on SEC EDGAR