Replimune Group, Inc. Files 2024 10-K

TL;DR

<b>Replimune Group, Inc. has filed its annual 10-K report for the fiscal year ending March 31, 2024.</b>

AI Summary

Replimune Group, Inc. (REPL) filed a Annual Report (10-K) with the SEC on May 16, 2024. Filed 10-K for the fiscal year ended March 31, 2024. Company is in the Biological Products (No Diagnostic Substances) industry. Primary business address is 500 Unicorn Park, Woburn, MA 01801. Fiscal year end is March 31. SEC file number is 001-38596.

Why It Matters

For investors and stakeholders tracking Replimune Group, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Replimune's financial performance, business operations, and risk factors for the fiscal year 2024. Investors and stakeholders can use this report to assess the company's financial health, strategic direction, and potential risks in the biotechnology sector.

Risk Assessment

Risk Level: — Replimune Group, Inc. shows moderate risk based on this filing. The company operates in the highly regulated and competitive biotechnology sector, facing risks related to clinical trial success, regulatory approvals, and market adoption of its products.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand Replimune's current financial position and future outlook.

Key Numbers

• 2024-03-31 — Fiscal Year End (Conformed period of report)
• 2024-05-16 — Filing Date (Filed as of date)

Key Players & Entities

• Replimune Group, Inc. (company) — Filer name
• Woburn, MA (location) — Business address city and state
• 001-38596 (other) — SEC file number
• 2836 (other) — Standard Industrial Classification code

FAQ

Industry Context

Replimune Group operates within the biotechnology sector, specifically focusing on biological products.

Regulatory Implications

The company is subject to regulations governing biological products, including those related to research, development, manufacturing, and marketing.

What Investors Should Do

1. Analyze the financial statements for revenue, net income, and cash flow.
2. Review the risk factors section for potential challenges and uncertainties.
3. Examine management's discussion and analysis for strategic insights.

Key Dates

• 2024-03-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-05-16: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the 10-K filing for the fiscal year ended March 31, 2024, providing updated information compared to previous filings.

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 per share REPL The Nasdaq Stock Market

Filing Documents

• repl-20240331.htm (10-K) — 1750KB
• repl-20220331x10kxex43.htm (EX-4.3) — 24KB
• usreplperformancestockunit.htm (EX-10.4) — 55KB
• ukreplperformancestockunit.htm (EX-10.5) — 72KB
• repl_usnqsoinducementgrant.htm (EX-10.6) — 61KB
• replimunegroupinc-induceme.htm (EX-10.7) — 60KB
• replimune-ceosecondaremplo.htm (EX-10.33) — 109KB
• replimune_pastley-sparkexe.htm (EX-10.34) — 113KB
• rcoffinreplimuneinc-separa.htm (EX-10.35) — 100KB
• replimuneinc-consultingagr.htm (EX-10.36) — 61KB
• pespositoreplimuneinc-sepa.htm (EX-10.39) — 99KB
• replimuneinc-pespositocons.htm (EX-10.40) — 58KB
• tlewisreplimuneinc-separat.htm (EX-10.41) — 75KB
• replimuneinc-tlewisconsult.htm (EX-10.42) — 50KB
• replimune-clawbackpolicy_e.htm (EX-10.43) — 48KB
• exhibit211_replimunexsubsi.htm (EX-21.1) — 5KB
• replimunefy24consentforex2.htm (EX-23.1) — 2KB
• repl-20240331x10kxexx311.htm (EX-31.1) — 10KB
• repl-20240331x10kxex312.htm (EX-31.2) — 10KB
• repl-20240331x10kxex321.htm (EX-32.1) — 5KB
• repl-20240331x10kxex322.htm (EX-32.2) — 5KB
• repl-20240331_g1.jpg (GRAPHIC) — 124KB
• 0001737953-24-000008.txt (&nbsp;) — 9960KB
• repl-20240331.xsd (EX-101.SCH) — 66KB
• repl-20240331_cal.xml (EX-101.CAL) — 104KB
• repl-20240331_def.xml (EX-101.DEF) — 258KB
• repl-20240331_lab.xml (EX-101.LAB) — 784KB
• repl-20240331_pre.xml (EX-101.PRE) — 552KB
• repl-20240331_htm.xml (XML) — 985KB

Business

Business 1 Item 1A.

Risk factors

Risk factors 24 Item 1B. Unresolved staff comments 58

C

Item 1 C . Cybersecurity 58 Item 2.

Properties

Properties 58 Item 3.

Legal proceedings

Legal proceedings 59 Item 4. Mine safety disclosures 59 PART II 60 Item 5. Market for registrant's common equity, related stockholder matters and issuer purchases of equity securities 60 Item 6. Reserved 60 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 60 Item 7A.

Quantitative and qualitative disclosures about market risk

Quantitative and qualitative disclosures about market risk 71 Item 8.

Financial statements and supplementary data

Financial statements and supplementary data 71 Item 9 Changes in and disagreements with accountants on accounting and financial disclosures 71 Item 9A.

Controls and procedures

Controls and procedures 71 Item 9B Other Information 72 Item 9C Disclosure regarding foreign jurisdictions that prevent inspections 73 PART III 74 Item 10. Directors, executive officers and corporate governance 74 Item 11.

Executive compensation

Executive compensation 74 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 74 Item 13. Certain relationships and related transactions, and director independence 74 Item 14. Principal accountant fees and services 75 PART IV 76 Item 15. Exhibits and financial statement schedules 76 Item 16. 10-K summary 76

SIGNATURES

SIGNATURES i TABLE OF CONTENTS Special note regarding forward-looking statements This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "seeks," "approximately," "predicts," "intends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. We believe these factors include, among other things: the timing, progress, and results of preclinical studies and clinical trials for our product candidates, including the timing of initiation and completion of studies or trials and related preparatory work and the period during which the results of the trials will become available; our ability to obtain additional funding as necessary

Business

Item 1. Business Overview We are a clinical-stage biotechnology company committed to applying our leading expertise in the field of oncolytic immunotherapy to transform the lives of cancer patients through our novel oncolytic immunotherapies. Our proprietary oncolytic immunotherapy product candidates are designed and intended to maximally activate the immune system against cancer. Oncolytic immunotherapy is an emerging drug class, which we intend to establish as the second cornerstone of immune-based cancer treatments, alongside checkpoint blockade. Oncolytic immunotherapy exploits the ability of certain viruses to selectively replicate in and directly kill tumors, as well as induce a potent, patient-specific, anti-tumor immune response. Our product candidates incorporate multiple mechanisms into a practical "off-the-shelf" approach that is intended to maximize the immune response against a patient's cancer and to offer significant advantages over other approaches to inducing anti-tumor immunity, including personalized vaccine approaches. We believe that the bundling of multiple approaches for the treatment of cancer into single therapies may improve patient outcomes and simplify the development path of our product candidates. Our proprietary RPx platform is based on a novel, engineered strain of herpes simplex virus 1, or HSV-1, backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. Our RPx platform is intended to have unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor-derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Our product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile our RPx platform is expected to have the versatility to be developed