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, 2021 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 ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited financial statements show decreased assets and increased net loss, driven by higher operating cash outflows [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a decline in total assets and stockholders' equity, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Data (in thousands) | | September 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $82,269 | $142,743 | | Total current assets | $118,577 | $171,504 | | Total assets | $142,172 | $187,817 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $26,638 | $21,143 | | Total liabilities | $34,086 | $31,694 | | Total stockholders' equity | $108,086 | $156,123 | | Total liabilities and stockholders' equity | $142,172 | $187,817 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statement of operations shows a higher net loss, primarily driven by a significant increase in research and development expenses Statement of Operations Highlights (in thousands, except per share data) | | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :--- | :--- | :--- | | Revenue from collaboration and licensing | $14,553 | $14,421 | | Research and development | ($60,434) | ($39,099) | | General and administrative | ($13,746) | ($13,413) | | Loss from operations | ($59,627) | ($38,091) | | Net loss | ($54,430) | ($31,608) | | Net loss per share — basic and diluted | ($1.66) | ($1.23) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statement indicates a substantial increase in cash used in operating activities, leading to a significant overall decrease in cash Cash Flow Summary (in thousands) | | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($52,773) | ($28,038) | | Net cash used in investing activities | ($7,440) | ($1,866) | | Net cash provided by (used in) financing activities | $175 | ($1,656) | | Net decrease in cash, cash equivalents and restricted cash | ($60,038) | ($31,560) | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage status, reliance on Gilead revenue, going concern assessment, and contractual obligations - The company is a clinical-stage biopharmaceutical firm developing immunotherapeutics based on its proprietary arenavirus platform[30](index=30&type=chunk) - The company expects existing cash to fund operations for at least 12 months, but additional funding will be required for long-term development and commercialization goals[37](index=37&type=chunk)[38](index=38&type=chunk) - All revenue is derived from a collaboration and license agreement with Gilead Sciences, Inc. for HBV and HIV programs[60](index=60&type=chunk)[79](index=79&type=chunk) - As of September 30, 2021, the company had **$10.5 million** in non-cancellable obligations under contracts with Contract Manufacturing Organizations (CMOs)[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's arenavirus platform, increased R&D expenses, and liquidity needs for future development [Overview](index=43&type=section&id=Overview) This section provides an overview of HOOKIPA's clinical-stage immunotherapy pipeline and the impact of COVID-19 on its operations - The company's oncology pipeline includes **HB-200** (Phase 1/2 for HPV16+ cancers), **HB-300** (IND filing expected Q3 2022), and **HB-700** (preclinical for KRAS mutated cancers)[152](index=152&type=chunk)[156](index=156&type=chunk) - The infectious disease pipeline includes **HB-101** (Phase 2 for CMV, enrollment complete) and a collaboration with Gilead for HBV and HIV, with HB-101 requiring a partner for further pursuit[158](index=158&type=chunk)[159](index=159&type=chunk) - The COVID-19 pandemic caused disruptions, including temporary suspension of patient enrollment for the **HB-101** Phase 2 trial and supply chain impacts[165](index=165&type=chunk)[166](index=166&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) Revenue remained stable, while a significant increase in R&D expenses, particularly for the HB-201/202 program, led to a higher net loss Results of Operations Summary (in thousands) | | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :--- | :--- | :--- | | Revenue from collaboration and licensing | $14,553 | $14,421 | | Research and development | ($60,434) | ($39,099) | | General and administrative | ($13,746) | ($13,413) | | Loss from operations | ($59,627) | ($38,091) | | Net loss | ($54,430) | ($31,608) | - The **$21.3 million** increase in R&D expenses was driven by increased direct and internal expenses, primarily due to **HB-201/202** clinical trial progress[204](index=204&type=chunk) Research and Development Expenses by Program (in thousands) | Program | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :--- | :--- | :--- | | HB-101 | $3,182 | $4,744 | | HB-201/202 | $17,915 | $7,005 | | Gilead partnered programs | $9,031 | $6,171 | | Other and earlier-stage programs | $9,335 | $6,340 | | **Total direct expenses** | **$39,463** | **$24,260** | [Liquidity and Capital Resources](index=60&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$82.7 million** in cash, expecting it to fund operations for 12 months, but anticipates needing substantial additional financing for long-term development - As of September 30, 2021, the company held **$82.7 million** in cash, cash equivalents, and restricted cash[222](index=222&type=chunk) - The company expects existing cash and cash equivalents to fund operating expenses and capital requirements for at least the next 12 months[237](index=237&type=chunk) - Net cash used in operating activities increased to **$52.8 million** from **$28.0 million** year-over-year, primarily due to a higher net loss[240](index=240&type=chunk)[243](index=243&type=chunk) Contractual Obligations as of September 30, 2021 (in thousands) | Obligation Type | Total | Less Than 1 Year | 1 - 3 Years | 4 - 5 Years | | :--- | :--- | :--- | :--- | :--- | | Lease commitments | $4,592 | $1,994 | $2,598 | $0 | | CMO commitments | $10,448 | $7,165 | $3,252 | $31 | | Debt obligations | $6,213 | $3,124 | $3,089 | $0 | | **Total** | **$21,253** | **$12,283** | **$8,939** | **$31** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=70&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks primarily from foreign currency exchange rate fluctuations, particularly the euro, and interest rate changes - The company's primary market risks are foreign currency exchange rate fluctuations, specifically the euro, and changes in interest rates on its cash and cash equivalents[257](index=257&type=chunk) [Item 4. Controls and Procedures](index=72&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2021[263](index=263&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter[264](index=264&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=73&type=section&id=Item%201.%20Legal%20Proceedings) A third party filed an opposition to European Patent No. 3218504, exclusively licensed to the company, regarding its arenavirus platform technology - A third party has opposed European Patent No. **3218504**, exclusively licensed to HOOKIPA, related to its replicating arenavirus platform technology used in product candidates like **HB-201** and **HB-202**[266](index=266&type=chunk) [Item 1A. Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported since the Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes to risk factors were reported since the Annual Report on Form 10-K filed on March 18, 2021[268](index=268&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=73&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 nine months ended September 30, 2021 - There were no unregistered sales of equity securities during the nine months ended September 30, 2021[269](index=269&type=chunk) [Item 6. Exhibits](index=74&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications and XBRL data files - The report includes standard exhibits such as CEO and CFO certifications and XBRL interactive data files[275](index=275&type=chunk)

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, 2021 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 ...

Immuno-Oncology Pipeline (HB-200 Program) - HB-200 monotherapy in L3+ head & neck cancer patients shows promising progression-free survival (PFS) data, better than 2L standard of care, and overall response rate (ORR) comparable to 2L PD1 inhibitor data[19] - In the ASCO data set (data cut-off Mar 31, 2021), out of 38 patients dosed, 18 patients were still on treatment[8] - Single dose of HB-201 or HB-202 drives robust T cell induction, with up to 8% of antigen-specific IFNg+ CD8+ T cells[10] - All patients treated with alternating HB-202/HB-201 IV showed increased CD8+ T cell levels, with an average increase of 6%, and a maximum of 40%[12] - 53% of patients had tumor regression with HB-201/HB-202 monotherapy[21] - The company plans to initiate Phase 2 studies in early 2022 for HB-200 in HPV16+ cancers, potentially registration-enabling[28] Infectious Diseases (HB-101 Program) - Approximately 20%-30% or ~25,000 solid organ transplant (SOT) recipients develop CMV disease annually worldwide[31] - In the U S, 20,000-30,000 birth defects occur annually due to CMV infection during pregnancy, representing 0.5%-1.0% of births[31] - HB-101 Phase 2 interim analysis shows that 3 doses induce 100% seroconversion at levels superior to 2 doses or placebo[38] - HB-101 Phase 2 interim analysis data in patients who obtained 3 doses shows a 48% reduction in CMV viremia, a 42% reduction in the required use of antivirals, and a 100% reduction in CMV disease[39] Financial Status - The company's cash position at the end of Q1 2021 was $128 million[2]

Supercharging Immunotherapy May 2021 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 ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents For the quarterly period ended March 31, 2021 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) Commission File Number: 001-38869 (I.R.S. Employer Identification No.) HOOKIPA PHARMA INC. Registrant's telephone number, including area code: +43 1 890 63 60 Securities registered pursuant to Section 12(b) of the Act: OR (Exact Name of Registrant as Specified in its ...

HOOKIPA Pharma Inc. (NASDAQ:HOOK) Q4 2020 Results Conference Call March 18, 2021 8:30 AM ET Company Participants Matthew Beck - Head of Investor Relations Joern Aldag - Chief Executive Officer Reinhard Kandera - Chief Financial Officer Igor Matushansky - Chief Medical Officer and Head of Global Research and Development Christine Baker - Chief Business Officer Roman Necina - Chief Technology Officer Conference Call Participants Alec Stranahan - Bank of America Securities Ingrid Gafanhão - Kempen Roy Buchanan ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K HOOKIPA PHARMA INC. (Exact name of registrant as specified in its charter) Delaware 81-5395687 (State of Other Jurisdiction of incorporation or Organization) (I.R.S. Employer Identification No.) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 350 Fifth Avenue, 72nd Floor, Suite 7240 For the fiscal year ended December 31, 2020 New York, New York (Address of principal exec ...

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, 2020 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 ...

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, 2020 OR Table of Contents UNITED STATES ☐ 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 ...