HOOKIPA Pharma Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>HOOKIPA Pharma Inc. has filed its 2023 10-K report detailing its financial performance and corporate activities for the fiscal year ending December 31, 2023.</b>

AI Summary

HOOKIPA Pharma Inc. (HOOK) filed a Annual Report (10-K) with the SEC on March 22, 2024. HOOKIPA Pharma Inc. filed its 2023 Form 10-K on March 22, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business address is in New York, NY. HOOKIPA Pharma Inc. is classified under Pharmaceutical Preparations (SIC 2834). The filing includes details on various stock issuances and capital changes throughout 2023.

Why It Matters

For investors and stakeholders tracking HOOKIPA Pharma Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of HOOKIPA Pharma's financial health, operational status, and strategic direction for the past fiscal year, crucial for investors assessing the company's current standing and future prospects. The detailed financial data and risk factors disclosed in the 10-K are essential for stakeholders to understand the company's performance, potential challenges, and investment risks.

Risk Assessment

Risk Level: medium — HOOKIPA Pharma Inc. shows moderate risk based on this filing. The company's financial performance and future viability are subject to the inherent risks of the pharmaceutical industry, including clinical trial success, regulatory approvals, and market competition, as detailed in the 10-K.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess HOOKIPA Pharma's current financial health and future growth potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (The end date of the reporting period for the 10-K.)
• 2024-03-22 — Filing Date (The date the 10-K was filed with the SEC.)
• 118 — Public Document Count (Number of documents included in the filing.)

Key Players & Entities

• HOOKIPA Pharma Inc. (company) — Filer of the 10-K report.
• 2023 (date) — Fiscal year covered by the 10-K.
• 2024-03-22 (date) — Filing date of the 10-K.
• New York, NY (location) — Business address of HOOKIPA Pharma Inc.
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations.

FAQ

Industry Context

HOOKIPA Pharma Inc. operates within the pharmaceutical preparations industry, focusing on the development of novel immunotherapies.

Regulatory Implications

As a pharmaceutical company, HOOKIPA Pharma is subject to stringent regulatory oversight from bodies like the FDA, impacting drug development, approval processes, and market access.

What Investors Should Do

1. Review HOOKIPA Pharma's detailed financial statements for the fiscal year ended December 31, 2023.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing the company.
3. Examine any disclosed information regarding collaborations, licensing agreements, or significant corporate events.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-22: 10-K Filing Date — Date HOOKIPA Pharma Inc. submitted its annual report.

Year-Over-Year Comparison

This is the initial filing analyzed for the fiscal year 2023; no prior period comparison data is available from this specific extract.

Key Financial Figures

• $0.0001 — ) On Which Registered Common Stock, $0.0001 Par Value per Share HOOK The Nasdaq
• $5.0 million — ights: In January 2023, we received a $5.0 million milestone payment under our HB-400 coll
• $10.0 million — trial. In February 2023, we received a $10.0 million milestone payment under our HB-700 coll
• $50.0 million — al trial. In June 2023, we completed a $50.0 million public offering of common stock and non
• $21.25 m — hares of common stock for approximately $21.25 million, at a price of $1.4167 per share,
• $1.4167 — oximately $21.25 million, at a price of $1.4167 per share, to Gilead under a stock purc
• $8.75 million — ns, to sell an additional approximately $8.75 million of common stock to Gilead as pro-rata p
• $117.5 million — f 2024. As of December 31, 2023, we had $117.5 million in cash, 7 Table of Contents cash

Filing Documents

• hook-20231231x10k.htm (10-K) — 2954KB
• hook-20231231xex4d3.htm (EX-4.3) — 68KB
• hook-20231231xex23d1.htm (EX-23.1) — 4KB
• hook-20231231xex31d1.htm (EX-31.1) — 17KB
• hook-20231231xex31d2.htm (EX-31.2) — 17KB
• hook-20231231xex32d1.htm (EX-32.1) — 8KB
• hook-20231231xex97d1.htm (EX-97.1) — 34KB
• hook-20231231x10k001.jpg (GRAPHIC) — 32KB
• hook-20231231x10k002.jpg (GRAPHIC) — 36KB
• hook-20231231x10k003.jpg (GRAPHIC) — 29KB
• hook-20231231x10k004.jpg (GRAPHIC) — 15KB
• hook-20231231x10k005.jpg (GRAPHIC) — 27KB
• hook-20231231x10k006.jpg (GRAPHIC) — 65KB
• hook-20231231x10k007.jpg (GRAPHIC) — 65KB
• hook-20231231x10k008.jpg (GRAPHIC) — 116KB
• hook-20231231x10k009.jpg (GRAPHIC) — 49KB
• hook-20231231x10k010.jpg (GRAPHIC) — 36KB
• hook-20231231x10k011.jpg (GRAPHIC) — 30KB
• hook-20231231x10k012.jpg (GRAPHIC) — 24KB
• hook-20231231x10k013.jpg (GRAPHIC) — 24KB
• hook-20231231x10k014.jpg (GRAPHIC) — 23KB
• hook-20231231x10k015.jpg (GRAPHIC) — 56KB
• hook-20231231x10k016.jpg (GRAPHIC) — 50KB
• hook-20231231x10k017.jpg (GRAPHIC) — 10KB
• hook-20231231x10k018.jpg (GRAPHIC) — 20KB
• hook-20231231x10k019.jpg (GRAPHIC) — 12KB
• hook-20231231x10k020.jpg (GRAPHIC) — 21KB
• hook-20231231x10k021.jpg (GRAPHIC) — 22KB
• hook-20231231x10k022.jpg (GRAPHIC) — 21KB
• hook-20231231x10k023.jpg (GRAPHIC) — 16KB
• 0001558370-24-003738.txt (&nbsp;) — 12821KB
• hook-20231231.xsd (EX-101.SCH) — 72KB
• hook-20231231_cal.xml (EX-101.CAL) — 71KB
• hook-20231231_def.xml (EX-101.DEF) — 310KB
• hook-20231231_lab.xml (EX-101.LAB) — 608KB
• hook-20231231_pre.xml (EX-101.PRE) — 460KB
• hook-20231231x10k_htm.xml (XML) — 1655KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 62 Item 1B. Unresolved Staff Comments 119 Item 1C. Cybersecurity 119 Item 2.

Properties

Properties 121 PART II Item 3.

Legal Proceedings

Legal Proceedings 121 Item 4. Mine Safety Disclosures 121 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 121 Item 6. [Reserved] 122 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 122 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 141 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 142 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 142 Item 9A.

Controls and Procedures

Controls and Procedures 142 Item 9B. Other Information 143 Item 9C. Disclosure regarding Foreign Jurisdictions that Prevent Inspections 144 PART III Item 10. Directors, Executive Officers, and Corporate Governance 145 Item 11.

Executive Compensation

Executive Compensation 145 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 145 Item 13. Certain Relationships and Related Transactions, and Director Independence 145 Item 14. Principal Accountant Fees and Services 145 PART IV Item 15. Exhibits and Financial Statement Schedules 146 Item 16. Form 10-K Summary 150

Signatures

Signatures 151 2 Table of Contents

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, including "Business" in Part I Item I and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Part II Item 7, contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements may be identified by such forward-looking terminology as "may," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue" or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding: the success, cost and timing of our product development activities and clinical trials; the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug Application and Biological Licensing Application filings for our current and future product candidates, and final U.S. Food and Drug Administration, European Commission or other foreign regulatory authority approval of our current and future product candidates; our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies; our manufacturing, commerc

Business

Item 1. Business Overview We are a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on our proprietary arenavirus platform that is designed to target and amplify T cell and immune responses to fight diseases. Our replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. We believe that our technologies can meaningfully leverage the human immune system for prophylactic and therapeutic purposes by inducing CD8+ T cell response levels previously not achieved by other immune therapy approaches. We are building a proprietary immuno-oncology pipeline utilizing our replicating technology. Our oncology portfolio targets oncoviral cancer antigens and next-generation antigens and includes two primary programs in development: HB-200 and HB-700. HB-200 is in clinical development for the treatment of Human Papillomavirus 16-positive ("HPV16+") head and neck cancers in a Phase 1/2 clinical trial. HB-700 is in preclinical development for the treatment of KRAS mutated cancers, including lung, colorectal and pancreatic cancers. We also have a third oncology program, HB-300, targeting self-antigens for the treatment of prostate cancer, which the Company paused further development in January 2024, to conserve capital and ensure pipeline success and operational efficiency. Our strategic priority is the development of our oncology portfolio, most importantly the advancement of our HB-200 program, and we expect to initiate a randomized Phase 2/3 trial in 2024. Additionally, we are developing infectious disease therapies in partnership with other companies. Our Hepatitis B ("HBV") program, HB-400, and our Human Immunodeficiency Virus ("HIV") program, HB-500, are being developed in a partnership with Gilead. 2023 Highlights In 2023, we executed on several key areas across our pipeline. The highlights include: Oncology: HB-200 in com

View Full Filing

View this 10-K filing on SEC EDGAR