NEW YORK and VIENNA, Austria, April 24, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the Company has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers. HOOKIPA's HB-700 program is designed to treat KR ...

Human Papilloma Virus (HPV-16) luismmolina/iStock via Getty Images On Friday April 19th, shares of Hookipa Pharma (NASDAQ:HOOK) closed at $0.733/s with a valuation ~$72.53M. To be clear, this company is a High Risk/High Reward play and as such, is probably not a suitable investment for most investor’s portfolios. Typically, I would build a 2% position at most in my portfolio for this type of early clinical development target when I am interested. However, in this particular situation, I have increased my ...

NEW YORK and VIENNA, Austria, April 16, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the Compensation Committee of the Company's Board of Directors approved the grant of non-statutory options to Mark Winderlich, who was appointed Chief Development Officer of the Company effective April 1, 2024, to purchase an aggregate of 250,000 shares of the Company's Common ...

HOOKIPA announces alignment with FDA on pivotal trial design and protocol for HB-200 in combination with pembrolizumabHB-200 program receives Priority Medicines (PRIME) designation from EMA NEW YORK and VIENNA, Austria, April 10, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, HOOKIPA or the Company))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that members of HOOKIPA's Executive Team will host an investor call summarizing ...

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 81-5395687 (State of Other Jurisdiction of incorporation or Organization) (I.R.S. Employer Identification No.) 350 Fifth Avenue, 72nd Floor, Suite 7240 New York, New York (Addres ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for the nine months ended September 30, 2023, showing a net loss of **$56.8 million** and **$107.7 million** in cash. [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2023, shows total assets decreased to **$164.0 million**, while liabilities slightly increased and equity decreased due to net loss. Condensed Consolidated Balance Sheet Highlights (in thousands) | | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $ 107,676 | $ 112,488 | | Total current assets | $ 139,471 | $ 147,196 | | Total assets | $ 164,010 | $ 170,454 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $ 40,576 | $ 35,632 | | Total liabilities | $ 68,959 | $ 67,937 | | Total stockholders' equity | $ 95,051 | $ 102,517 | | Total liabilities and stockholders' equity | $ 164,010 | $ 170,454 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2023, revenue increased to **$12.7 million**, but net loss widened to **$56.8 million** due to higher R&D expenses. Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue from collaboration and licensing | $ 6,867 | $ 2,230 | $ 12,722 | $ 6,421 | | Research and development | (24,625) | (18,286) | (65,262) | (51,053) | | General and administrative | (4,912) | (4,937) | (14,259) | (14,935) | | Loss from operations | (22,670) | (20,993) | (66,799) | (59,567) | | Net loss | (19,066) | (18,280) | (56,762) | (52,604) | | Net loss per share — basic and diluted | $ (0.17) | $ (0.25) | $ (0.64) | $ (0.83) | [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity) Stockholders' equity decreased to **$95.1 million** due to a **$56.8 million** net loss, partially offset by **$46.3 million** from a June 2023 public offering. - On June 5, 2023, the company closed a public offering of common stock and Series A-2 convertible preferred stock, raising net proceeds of **$46.2 million** after deducting underwriting discounts and offering expenses[117](index=117&type=chunk) - In May 2023, stockholders converted an aggregate of **1,327 shares** of Series A and **5,000 shares** of Series A-1 convertible preferred stock into a total of **6,327,000 shares** of common stock[128](index=128&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$46.3 million**, while financing activities provided **$44.4 million**, resulting in a **$5.6 million** net cash decrease. Summary of Cash Flows (in thousands) | | Nine months ended September 30, 2023 | Nine months ended September 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $ (46,300) | $ (33,134) | | Net cash used in investing activities | $ (3,737) | $ (4,418) | | Net cash provided by financing activities | $ 44,421 | $ 72,467 | [Notes to Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes explain accounting policies, revenue sources from Gilead (**$5.1 million**) and Roche (**$7.6 million**), and confirm sufficient cash for 12 months. - The company expects its cash and cash equivalents will be sufficient to fund its operating expenses, capital expenditure requirements and debt service payments through at least **12 months** from the issuance date of the financial statements[44](index=44&type=chunk) - For the nine months ended September 30, 2023, the company recognized **$5.1 million** in revenue from its collaboration with Gilead and **$7.6 million** from its collaboration with Roche[220](index=220&type=chunk) - As of September 30, 2023, the company had total non-cancellable obligations under contracts with contract manufacturing organizations (CMOs) of **$9.3 million**[149](index=149&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=51&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial results, liquidity, and capital resources, highlighting increased revenue and R&D expenses, with sufficient cash for 12 months. [Overview](index=51&type=section&id=Overview) HOOKIPA, a clinical-stage biopharmaceutical company, develops immunotherapeutics with oncology and infectious disease programs, funded by equity and collaborations. - Preliminary data from the Phase 2 trial of HB-200 in combination with pembrolizumab for 1st line HPV16+ head and neck cancer showed a **42% objective response rate** and **74% disease control rate**[167](index=167&type=chunk) - The collaboration with Roche for HB-700 and a second program could yield up to approximately **$930 million** in future milestone payments plus royalties, with a **$10.0 million** milestone achieved in Q1 2023[171](index=171&type=chunk) - The collaboration with Gilead for HBV and HIV programs has potential for significant milestone payments and royalties, with Gilead funding the HIV program through a Phase 1b clinical trial[173](index=173&type=chunk) [Results of Operations](index=65&type=section&id=Results%20of%20Operations) Revenue increased by **$6.3 million** and R&D expenses rose by **$14.2 million** for the nine months ended September 30, 2023, leading to a higher net loss. Comparison of Results for the Nine Months Ended September 30 (in thousands) | | 2023 | 2022 | Change ($) | | :--- | :--- | :--- | :--- | | Revenue from collaboration and licensing | $ 12,722 | $ 6,421 | +$6,301 | | Research and development | (65,262) | (51,053) | +$14,209 | | General and administrative | (14,259) | (14,935) | -$676 | | Loss from operations | (66,799) | (59,567) | +$7,232 | | Net loss | (56,762) | (52,604) | +$4,158 | - The **$14.2 million** increase in R&D expenses for the nine months ended Sep 30, 2023, was primarily driven by higher clinical study expenses for the HB-200 program and increased spending for Gilead and Roche partnered programs[224](index=224&type=chunk) [Liquidity and Capital Resources](index=71&type=section&id=Liquidity%20and%20Capital%20Resources) The company had **$108.1 million** in cash as of September 30, 2023, which is expected to fund operations for at least 12 months, with future funding needs anticipated. - As of September 30, 2023, the company had cash, cash equivalents, and restricted cash of **$108.1 million**[235](index=235&type=chunk) - The company believes its existing cash and cash equivalents will enable it to fund operating expenses and capital expenditure requirements for at least the next **12 months**[251](index=251&type=chunk) - Net cash used in operating activities for the nine months ended Sep 30, 2023 was **$46.3 million**, compared to **$33.1 million** for the same period in 2022[253](index=253&type=chunk)[254](index=254&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=81&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks primarily from foreign currency exchange rate fluctuations (USD vs. Euro) and interest rate changes, though interest rate exposure is not material. - The company's primary market risks are foreign currency exchange rate fluctuations, specifically between the U.S. dollar and the euro, due to its Austrian subsidiary[267](index=267&type=chunk) - The company is also exposed to interest rate risk, but does not believe it has material exposure to changes in the fair value of its investment portfolio due to the nature of its cash and cash equivalent holdings[268](index=268&type=chunk) [Controls and Procedures](index=81&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were effective as of September 30, 2023, with no material changes to internal control over financial reporting. - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2023[274](index=274&type=chunk) - There were no changes in internal control over financial reporting during the third quarter of 2023 that have materially affected, or are reasonably likely to materially affect, internal controls[275](index=275&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=83&type=section&id=Item%201.%20Legal%20Proceedings) The company reports a favorable outcome in a patent proceeding, with European Patent No. 3218504 maintained as granted. - A third-party opposition to European Patent No. 3218504, which is exclusively licensed to the company and covers its replicating arenavirus platform, was dismissed by the European Patent Office (EPO), and the patent was maintained as granted[277](index=277&type=chunk) [Risk Factors](index=83&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors were reported compared to the Annual Report on Form 10-K for 2022. - There have been no material changes to the Company's risk factors as disclosed in its Annual Report on Form 10-K for the year ended December 31, 2022[279](index=279&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period. - None reported for the period[280](index=280&type=chunk) [Other Information](index=85&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements during the third quarter of 2023. - During the three months ended September 30, 2023, none of the Company's directors or officers adopted, terminated or modified a Rule 10b5-1 trading arrangement[284](index=284&type=chunk) [Exhibits](index=86&type=section&id=Item%206.%20Exhibits) This section lists various corporate governance documents, certifications, and Inline XBRL data files filed as exhibits with the Form 10-Q. - The report includes a list of filed exhibits, such as the Certificate of Incorporation, Bylaws, officer certifications (302 and 906), and XBRL interactive data files[286](index=286&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, 2023 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 May 2023 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 ...

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 March 31, 2023 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 Char ...

HOOKIPA Pharma Inc. (NASDAQ:HOOK) Q4 2022 Results Conference Call March 15, 2023 8:30 AM ET Company Participants Matthew Beck - Executive Director, Investor Relations Joern Aldag - Chief Executive Officer Reinhard Kandera - Chief Financial Officer Katia Schlienger - Chief Medical Officer Conference Call Participants Alec Stranahan - Bank of America Arthur He - H. C. Wainwright Asthika Goonewardene - Truist Securities Roy Buchanan - JMP Securities Suzanne van Voorthuizen - Kempen Operator Good morning and th ...