Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38869 HOOKIPA PHARMA INC. (Exact name of registrant as specified in its charter) Delaware 81-5395687 (State of Other Jurisdiction of incorporation or Organizat ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________. Commission File Number: 001-38869 HOOKIPA PHARMA INC. (Exact Name of Registrant as Specified in its ...

Supercharging Immunotherapy September 2022 Disclaimer This presentation and other related material 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 success, cost and timing of HOOKIPA's product development activities and clinical trials; (ii) the timing, scope or likelihood of regulatory filings and approvals, including ti ...

HB-200 Program in HPV16+ Cancers - HOOKIPA's HB-200 program is targeting HPV16+ cancers, addressing a large unmet medical need with 105,000 expected patient incidence in 2030[9, 10] - Phase 1 data shows 56% of patients experienced target lesion shrinkage with HB-200, and 80% disease control rate (DCR) in the 2-vector RP2D group, which is competitive compared to earlier line CPIs[20, 24] - Alternating 2-vector therapy (HB-202/HB-201) drives up to 10x higher E7/E6-specific T cell induction and amplification than 1-vector therapy[13] - 32% of patients treated with HB-202/HB-201 break the 5% threshold of tumor-specific systemic CD8+ T cells[15] - Phase 1 tolerability profile of HB-200 shows that any treatment related adverse events occurred in 63% of patients receiving HB-201 and 75% of patients receiving HB-202, with grade ≥3 events in 9% of patients[17] Pipeline Expansion - HB-300 IND in prostate cancer was cleared by the FDA in July 2022, with First Patient In (FPI) expected in Q1 2023[48, 40] - HB-700 is targeting KRAS mutant tumors, addressing sizeable clinical cancer populations[6, 37] Infectious Diseases Collaboration - Gilead is on track to file an IND for HBV in 2022, with Hookipa eligible for $190 million in development and commercialization milestones and high-single digit to mid-teen % royalties[43, 44] - HOOKIPA will progress the HIV program through a Phase 1b study with an IND in 2023, funded by $54 million from Gilead, and is eligible for $240 million in development + commercialization milestones and mid-single digit to low double-digit % royalties[43] Financial Status - As of June 30, 2022, HOOKIPA had $118 million in cash plus a Gilead equity commitment of $30 million[48]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________. Commission File Number: 001-38869 HOOKIPA PHARMA INC. (Exact Name of Registrant as Specified in its Chart ...

Supercharging Immunotherapy June 2022 Disclaimer This presentation and other related material 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 success, cost and timing of HOOKIPA's product development activities and clinical trials; (ii) the timing, scope or likelihood of regulatory filings and approvals, including timing ...

Supercharging Immunotherapy May 2022 Disclaimer This presentation and other related material 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 success, cost and timing of HOOKIPA's product development activities and clinical trials; (ii) the timing, scope or likelihood of regulatory filings and approvals, including timing o ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) In Q1 2022, the company reported a net loss, while cash and equivalents significantly increased due to financing activities and a Gilead payment [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary (as of March 31, 2022 vs. December 31, 2021) | Metric (in thousands) | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $ 140,825 | $ 65,921 | | Total current assets | $ 171,079 | $ 102,135 | | Total assets | $ 195,711 | $ 126,045 | | **Liabilities & Equity** | | | | Total current liabilities | $ 31,228 | $ 27,654 | | Total liabilities | $ 47,782 | $ 36,453 | | Total stockholders' equity | $ 147,929 | $ 89,592 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (Three Months Ended March 31) | Metric (in thousands, except per share) | 2022 | 2021 | | :--- | :--- | :--- | | Revenue from collaboration and licensing | $ 1,445 | $ 5,301 | | Research and development | $ (16,620) | $ (20,164) | | General and administrative | $ (4,972) | $ (4,309) | | Loss from operations | $ (20,147) | $ (19,172) | | Net loss | $ (17,968) | $ (17,238) | | Net loss per share — basic and diluted | $ (0.40) | $ (0.53) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Three Months Ended March 31) | Activity (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $ 1,733 | $ (14,397) | | Net cash used in investing activities | $ (1,828) | $ (330) | | Net cash provided by financing activities | $ 75,293 | $ 101 | - Financing activities in Q1 2022 were primarily driven by **$29.6 million** from the issuance of convertible preferred stock and **$45.7 million** from the issuance of common stock, net of costs[26](index=26&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biopharmaceutical company developing immunotherapeutics based on its proprietary arenavirus platform[28](index=28&type=chunk) - The company expects its current cash and cash equivalents to be sufficient to fund operating expenses, capital expenditures, and debt service payments for at least **12 months** from the report's filing date (May 16, 2022)[35](index=35&type=chunk) - In February 2022, the company signed an Amended and Restated Collaboration Agreement with Gilead for its HIV program, receiving a **$15.0 million** program initiation fee[76](index=76&type=chunk)[77](index=77&type=chunk) - In March 2022, the company closed a public offering of common stock and Series A-1 convertible preferred stock, raising net proceeds of **$70.2 million**[99](index=99&type=chunk) - In February 2022, Gilead purchased **1,666,666** unregistered shares of the company's common stock for **$5.0 million**, as part of a stock purchase agreement for up to **$35.0 million**[98](index=98&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2022 revenue and R&D expense changes driven by collaboration and program costs, noting significant liquidity improvement from recent financing activities [Overview](index=42&type=section&id=Overview) - The company is focusing its proprietary immuno-oncology pipeline on three main programs: **HB-200** for HPV16+ cancers, **HB-300** for prostate cancer, and **HB-700** for KRAS mutated cancers[138](index=138&type=chunk) - The **HB-101** (CMV vaccine) program will only be advanced further if a collaboration partner is secured, allowing for a greater strategic focus on immuno-oncology[141](index=141&type=chunk) - The COVID-19 pandemic caused disruptions, including temporary suspension of patient enrollment for the **HB-101** trial and impacts on the supply chain, leading to a temporary focus on the core **HB-200** program[150](index=150&type=chunk)[152](index=152&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) - Revenue decreased by **$3.9 million** in Q1 2022 compared to Q1 2021, primarily due to lower cost reimbursements under the Gilead collaboration agreement[178](index=178&type=chunk) Research and Development Expenses by Program (in thousands) | Program | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | HB-200 program | $ 7,413 | $ 9,754 | | HB-300 program | $ 2,767 | $ 1,250 | | Gilead partnered programs | $ 1,733 | $ 4,820 | | Other and earlier-stage programs | $ 4,089 | $ 3,643 | | **Total R&D Expenses** | **$ 16,620** | **$ 20,164** | - The decrease in R&D expenses was mainly driven by lower manufacturing costs for the **HB-200** and Gilead programs, and lower clinical study expenses for the **HB-101** program following the completion of patient enrollment[182](index=182&type=chunk) - General and administrative expenses increased by **$0.7 million**, primarily due to a **$0.7 million** increase in professional and consulting fees and a **$0.2 million** increase in personnel-related expenses[184](index=184&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2022, the company had cash, cash equivalents, and restricted cash of **$141.8 million**[192](index=192&type=chunk) - The company believes its existing cash will be sufficient to fund operating expenses and capital expenditure requirements for at least the next **12 months**[208](index=208&type=chunk) - As of March 31, 2022, the company had total non-cancellable obligations of **$8.1 million** under contracts with contract manufacturing organizations (CMOs)[195](index=195&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=66&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from foreign currency exchange rate fluctuations, particularly the euro, and interest rate changes on cash and equivalents - The company is subject to risk from foreign currency exchange rate fluctuations, specifically with respect to the euro, and changes in interest rates on its cash and cash equivalents[226](index=226&type=chunk) [Controls and Procedures](index=66&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting during the quarter - Management, including the Principal Executive Officer and Principal Financial Officer, concluded that the company's disclosure controls and procedures were effective as of March 31, 2022[231](index=231&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[232](index=232&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=68&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a pending patent opposition proceeding concerning European Patent No. 3218504, which covers its replicating arenavirus platform technology - A third party has opposed European Patent No. **3218504**, exclusively licensed to the company and related to its replicating arenavirus platform technology, used for product candidates like **HB-201** and **HB-202**[234](index=234&type=chunk) [Risk Factors](index=68&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors, though future inflationary pressures could negatively impact the business - There have been no material changes from the risk factors disclosed in the Annual Report on Form 10-K filed on March 24, 2022[236](index=236&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=70&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the three months ended March 31, 2022 - There were no unregistered sales of equity securities by the company during the three months ended March 31, 2022[238](index=238&type=chunk) [Defaults Upon Senior Securities](index=70&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[239](index=239&type=chunk) [Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[240](index=240&type=chunk) [Other Information](index=70&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - None[241](index=241&type=chunk) [Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including agreements with Gilead and officer certifications - The exhibits filed with the report include the amended collaboration agreement with Gilead, the stock purchase agreement with Gilead, and officer certifications[243](index=243&type=chunk)[244](index=244&type=chunk)

HOOKIPA Pharma Inc. (NASDAQ:HOOK) Q4 2021 Earnings Conference Call March 24, 2022 8:30 AM ET Company Participants Matthew Beck - Executive Director, Investor Relations Joern Aldag - Chief Executive Officer Reinhard Kandera - Chief Financial Officer Igor Matushansky - Chief Medical Officer & Global Head of Research Development Conference Call Participants Andrew Berens - SVB Leerink RK - H.C. Wainwright Roy Buchanan - JMP Securities Operator Good day, and thank you for standing by. Welcome to the HOOKIPA Fou ...

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