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REPL on Nasdaq

Replimune Group, Inc.

In its 2026 annual report the company says: “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.”6 It is headquartered in Woburn, United States.2 Its shares trade on Nasdaq under the symbol REPL.2

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Last updated Oct 21, 2026.

Overview

-$313.9MNet income, fiscal 20263

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  • TickerREPL on Nasdaq2
  • IndustryBiological Products, (No Diagnostic Substances)2
  • HeadquartersWoburn, United States2
  • Incorporated inDE4
  • Business address500 Unicorn Park, Woburn, Ma 018014
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation2
  • LEI549300AY704NEIRC4K642
  • StatusActive2
  • LEI statusIssued and current2
  • Registered addressc/o THE CORPORATION TRUST COMPANY, CORPORATION TRUST CENTER, 1209 ORANGE ST, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 64670822

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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.6 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2026

-188.9%Return on equity3
0.50×Debt to equity3

Financial statements

Operating income7891011123-$319.9M in 2026+934% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$30.9M-$30.9M20192020: -$56.2M-$56.2M2020+82%2021: -$80.0M-$80.0M2021+42%2022: -$118.3M-$118.3M2022+48%2023: -$177.1M-$177.1M2023+50%2024: -$234.8M-$234.8M2024+33%2025: -$261.6M-$261.6M2025+11%2026: -$319.9M-$319.9M2026+22%
Net income7891011123-$313.9M in 2026+918% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$30.8M-$30.8M20192020: -$52.6M-$52.6M2020+71%2021: -$80.9M-$80.9M2021+54%2022: -$118.0M-$118.0M2022+46%2023: -$174.3M-$174.3M2023+48%2024: -$215.8M-$215.8M2024+24%2025: -$247.3M-$247.3M2025+15%2026: -$313.9M-$313.9M2026+27%

Every line of the income statement as filed: the last 2 fiscal years, latest first.3

Period ending2026-03-312025-03-31
Research and development$221.2M$189.4M
Selling, general and administrative$98.7M$72.2M
Total operating expenses$319.9M$261.6M
Loss from operations-$319.9M-$261.6M
Research and development incentives$1.6M$1.8M
Investment income$13.6M$21.1M
Interest expense on finance lease liability-$2.1M-$2.1M
Interest expense on debt obligations-$6.8M-$5.8M
Other expense-$942.0K-$202.0K
Total other income, net$5.4M$14.8M
Loss before income taxes-$314.5M-$246.8M
Income tax (benefit) provision-$551.0K$468.0K
Net loss-$313.9M-$247.3M
Net loss per common share, basic (in dollars per share)-$3.38-$3.07
Net loss per common share, diluted (in dollars per share)-$3.38-$3.07
Weighted average common shares outstanding, basic (in shares)92.8M shares80.6M shares
Weighted average common shares outstanding, diluted (in shares)92.8M shares80.6M shares

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Corporate structure

Replimune Group, Inc. sits at the top of its group. 4 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Replimune Group, Inc.

  • Replimune Group, Inc. Woburn, Massachusetts, United States
    • Replimune (Ireland) Limited Subsidiary · Ireland
    • Replimune Limited Subsidiary · United Kingdom
    • Replimune Securities Corporation Subsidiary · Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Replimune Group, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$29.7M3 Mar 31, 2026$27.1M3 Mar 31, 2025+9.5%
Accumulated depreciation$16.7M3 Mar 31, 2026$13.4M3 Mar 31, 2025+24.9%
Property and equipment, net$13.0M3 Mar 31, 2026$13.7M3 Mar 31, 2025−5.6%
Finance-lease assets$32.4M3 Mar 31, 2026$34.8M3 Mar 31, 2025−7.0%
Operating-lease assets (leased space)$3.3M3 Mar 31, 2026$4.0M3 Mar 31, 2025−18.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$209.0M3 Mar 31, 2026$111.1M3 Mar 31, 2025+88.1%
Marketable securities, current$59.9M3 Mar 31, 2026$372.7M3 Mar 31, 2025−83.9%

Properties, in its own words

Our corporate headquarters is located in Woburn, Massachusetts, where we occupy approximately 18,712 square feet pursuant to a lease expiring in 2029, with an option to extend by an additional five years. We also lease an approximately 12,000 square-foot facility in Oxfordshire, United Kingdom, containing research and development, laboratory and office space. This lease expires in April 2031 and we have the right to terminate it in April 2026. In October 2021 and March 2023, the Company entered into additional agreements to lease approximately 2,951 and 2,058 square feet, respectively, of research and development, office and laboratory space in Abingdon, Oxfordshire, United Kingdom. These lease agreements are both for five years and expire in October 2026 and March 2028, respectively, with no right to renewal.

In June 2018, we entered into an agreement to lease approximately 63,000 square feet of office, manufacturing and laboratory space in Framingham, Massachusetts. Pursuant to the lease agreement, the lease term commenced in December 2018 and the rent commenced in August 2019. The initial lease term is ten years from the rent commencement date and includes two optional five-year extensions.

The rest of Item 2

We believe that our current facilities are suitable and adequate to meet our current and planned needs. Our leases can be renewed, and we believe that suitable alternative spaces will be available as needed in the future, on commercially reasonable terms. We do not own any real property.

Item 2 of the 10-K filed Jun 29, 2026.6

Leadership

Who has led Replimune Group, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Robert Coffin2019
  2. Philip Astley-Sparke2020–2023
  3. Sushil Patel2024–now

Chair

  1. Philip Astley-Sparke2018–2024

President

  1. Robert Coffin2018–2023

Chief financial officer

  1. Jean M. Franchi2019–2023
  2. Emily Luisa Hill2023–now

Chief operating officer

  1. Colin Love2018–2024
20202025
Board members and other officers (30)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Replimune (Ireland) Limited Ireland5
  • Replimune Limited United Kingdom5
  • Replimune Securities Corporation Massachusetts5
  • Replimune, Inc. Delaware5

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Sep 16, 20268-K Bylaws or fiscal year changed; Shareholder vote49
  2. Aug 14, 20268-K Results of operations50
  3. Aug 11, 20268-K Other events51
  4. Aug 10, 20268-K Other events52
  5. Aug 7, 20268-K Other events53
  6. Jul 31, 20268-K Other events54
  7. Jul 30, 20268-K Regulation FD disclosure55
  8. Jun 29, 20268-K Results of operations56
  9. Jun 26, 20268-K Regulation FD disclosure57
  10. May 29, 20268-K Regulation FD disclosure58
  11. Apr 13, 20268-K Regulation FD disclosure; Other events59
  12. Feb 3, 20268-K Entered a material agreement; Results of operations; New debt or obligation60
  13. Apr 3, 2024New chief executive Sushil Patel becomes CEO16
  14. Apr 2, 2020New chief executive Philip Astley-Sparke becomes CEO17
  15. Sep 25, 2019New chief executive Robert Coffin becomes CEO18
  16. Jul 5, 2017Founded Replimune Group, Inc. is founded2

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.90) a share, on Nov 6, 2025.61

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results50
  2. Jun 29, 2026Reported quarterly or annual results56
  3. Feb 3, 2026Reported quarterly or annual results60
  4. Nov 6, 2025Reported quarterly or annual results62
  5. Aug 7, 2025Reported quarterly or annual results63
  6. May 22, 2025Reported quarterly or annual results64
  7. Feb 12, 2025Reported quarterly or annual results65
  8. Nov 12, 2024Reported quarterly or annual results66

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

358 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 66 major events, 161 insider forms, 49 large holders, 62 other. The latest 20:

  1. Sep 16, 20268-K EDGAR
  2. Aug 24, 20264 OWNERSHIP DOCUMENT EDGAR
  3. Aug 19, 20264 OWNERSHIP DOCUMENT EDGAR
  4. Aug 14, 202610-Q EDGAR
  5. Aug 14, 2026S-3ASR EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 20268-K EDGAR
  8. Aug 12, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Aug 12, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Aug 12, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Aug 12, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Aug 11, 20264 EDGAR
  13. Aug 11, 2026SCHEDULE 13D/A EDGAR
  14. Aug 11, 20268-K/A EDGAR
  15. Aug 10, 20268-K EDGAR
  16. Aug 10, 2026424B5 EDGAR
  17. Aug 10, 2026SCHEDULE 13G EDGAR
  18. Aug 7, 20268-K EDGAR
  19. Aug 7, 2026SCHEDULE 13G EDGAR
  20. Aug 6, 2026SCHEDULE 13G/A EDGAR

The 358 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

80 open-market trades by officers, directors and large owners since October 2021: 0 buys and 80 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 17, 2026Hill Emily LuisaChief Financial OfficerSale9,256$14.28$132.2KForm 4
Aug 10, 2026Patel SushilChief Executive OfficerSale39,341$12.97$510.3KForm 4
Aug 10, 2026Hill Emily LuisaChief Financial OfficerSale11,448$12.97$148.5KForm 4
Aug 10, 2026Xynos KonstantinosChief Medical OfficerSale11,447$12.97$148.5KForm 4
Aug 10, 2026Schwendenman AndrewChief Accounting OfficerSale7,632$12.97$99.0KForm 4
Jun 1, 2026Sarchi ChristopherChief Commercial OfficerSale12,000$9.24$110.9KForm 4
May 18, 2026Xynos KonstantinosChief Medical OfficerSale14,023$5.08$71.2KForm 4
May 18, 2026Schwendenman AndrewChief Accounting OfficerSale7,894$5.08$40.1KForm 4
May 18, 2026Sarchi ChristopherChief Commercial OfficerSale8,626$5.08$43.8KForm 4
May 18, 2026Astley-Sparke PhilipDirectorSale17,657$5.08$89.7KForm 4
May 18, 2026Patel SushilChief Executive OfficerSale37,324$5.08$189.6KForm 4
May 18, 2026Hill Emily LuisaChief Financial OfficerSale7,812$5.08$39.7KForm 4
Apr 2, 2026Sarchi ChristopherChief Commercial OfficerSale6,500$8.01$52.1KForm 4
Dec 9, 2025Dhingra KapilDirectorSale3,169$10.40$33.0KForm 4
Dec 2, 2025Patel SushilChief Executive OfficerSale10,000$11.13$111.3KForm 4
Nov 17, 2025Sarchi ChristopherChief Commercial OfficerSale5,208$9.10$47.4KForm 4
Nov 17, 2025Xynos KonstantinosChief Medical OfficerSale7,248$9.10$66.0KForm 4
Aug 15, 2025Hill Emily LuisaChief Financial OfficerSale9,154$5.37$49.2KForm 4
May 20, 2025Astley-Sparke PhilipDirectorSale32,279$8.06$260.2KForm 4
May 20, 2025Xynos KonstantinosChief Medical OfficerSale7,952$8.06$64.1KForm 4

All 80 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2026Sushil Patel Chief Executive Officer$700.0K$5.8M83
2026Konstantinos Xynos Chief Medical Officer60$536.0K$2.1M83
2026Emily Hill Chief Financial Officer46$532.0K$2.1M83
2025Sushil Patel Chief Executive Officer$600.0K$3.7M83
2025Konstantinos Xynos Chief Medical Officer60$516.5K$1.6M83
2025Emily Hill Chief Financial Officer46$516.5K$1.6M83

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Baker Bros. Advisors LP11,045,336$122.3M0.6%No change
BlackRock, Inc.8,958,535$99.2M0.0%+2,719,296
Rtw Investments, LP7,411,581$82.0M0.7%+54,665
Ridgeback Capital Investments L.P.7,310,656$80.9M100.0%New
Goldman Sachs Group Inc4,541,018$50.3M0.0%+2,263,742
State Street Corp4,440,144$49.2M0.0%+657,907
Montanova Capital, LLC4,389,836$48.6M1.0%+168,000
Boxer Capital Management, LLC3,983,000$44.1M3.3%+2,808,000
Vanguard Capital Management LLC2,896,004$32.1M0.0%+136,884
Fcpm III Services B.v.2,808,368$31.1M4.1%No change
Aqr Capital Management LLC2,566,241$28.4M0.0%+2,310,746
Logos Global Management LP2,500,000$27.7M1.2%New
Jane Street Group, LLC2,322,545$25.7M0.0%+1,894,400
Erste Asset Management GmbH2,120,000$23.7M0.2%No change
Geode Capital Management, LLC2,035,187$22.5M0.0%+233,662
D. E. Shaw & Co., Inc.1,789,964$19.8M0.0%−546,564
Opaleye Management Inc.1,384,993$15.3M1.4%New
Toronto Dominion Bank1,275,000$14.1M0.0%−316,030
UBS Group AG1,128,276$12.5M0.0%+547,066
Artisan Partners Limited Partnership973,496$10.8M0.0%New
Fmr LLC929,375$10.3M0.0%−1,116,115
Millennium Management LLC821,958$9.1M0.0%+521,125
Citadel Advisors LLC784,233$8.7M0.0%+385,504
Caption Management, LLC783,873$8.7M0.3%+332,051
Invesco Ltd.724,244$8.0M0.0%+533,319

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Replimune Group, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARReplimune Group, Inc.1
  • CIK0001737953
  • Employer ID (EIN)82-20825536
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsMarch 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address500 Unicorn Park, Woburn, MA 018011
  • Phone(781) 222-96001
  • Shares outstanding94,219,634 as of Aug 11, 202615
  • Public float$234.5M as of Sep 30, 20256
  • AuditorPricewaterhouseCoopers LLP, Florham Park, New Jersey PCAOB ID 238; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceMay 3, 20181
  • Filings650 in all: 4 (281), 8-K (110), SC 13G/A (37), 3 (32), 10-Q (25), SC 13G (14), S-8 (13), 424B5 (12)1
    All 42 form types

    UPLOAD (12), CORRESP (11), SCHEDULE 13G/A (11), 144 (9), 10-K (8), DEF 14A (8), EFFECT (7), DEFA14A (6), S-3 (6), SCHEDULE 13G (6), SC 13D/A (5), ARS (4), 8-K/A (3), S-1/A (3), CT ORDER (2), DRS/A (2), DRSLTR (2), FWP (2), PRE 14A (2), S-3/A (2), S-3ASR (2), 10-K/A (1), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), POS AM (1), POSASR (1), PRER14A (1), S-1 (1), SC 13D (1), SCHEDULE 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Jun 29, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Jul 29, 2026
    Latest 8-K (8-K) Sep 16, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareREPLNasdaq

From the cover page of the 10-K filed Jun 29, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Replimune Group, Inc. names in Item 1A of its 10-K filed Jun 29, 2026: 59 risks under these headings, as written.6

  • Risks related to product development
  • Our product candidates are in various stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We cannot be certain that we will be able to successfully develop our product candidates or obtain regulatory approval for our product candidates, including following the CRLs we received for our BLA of RP1 in combination with nivolumab for the treatment of advanced melanoma. We have never generated any revenue from product sales and may never be profitable.
  • We will not be able to commercialize our product candidates if our preclinical studies do not produce successful results and/or our clinical trials do not demonstrate the safety and efficacy of our product candidates.
  • Topline data may not accurately reflect the complete results of a particular study or trial.
  • We anticipate that our product candidates will be used in combination with third-party drugs, some of which are still in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs.
  • An underlying problem with our proprietary RPx platform would adversely affect our business and may require us to discontinue development of product candidates based on the same or similar therapeutic approaches.
  • If we fail to develop additional product candidates, our commercial opportunity could be limited.
  • Risks related to regulatory approval
  • Even if our development efforts are successful, we may not obtain regulatory approval for any of our product candidates in the United States or other jurisdictions, which would prevent us from commercializing our product candidates. Even if we obtain regulatory approval for our product candidates, any such approval may be subject to limitations, including with respect to the approved indications or patient populations, which could impair our ability to successfully commercialize our product candidates.
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates as expected, and our ability to generate revenue may be materially impaired.
  • The FDA or a comparable foreign regulatory authority may determine that our product candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization.
  • Our product candidates may be subject to review by an FDA advisory committee, and an unfavorable recommendation could adversely affect our business.
The other 49 risks
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • Regulatory approval by the FDA or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval has been granted, and we may be subject to substantial fines, penalties, injunctions, or other enforcement actions, including criminal actions, if we are determined to be promoting the use of our products for unapproved or “off label” uses, resulting in damage to our reputation and business.
  • Even if our product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense and limit how we manufacture and market our products.
  • We conduct clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Obtaining and maintaining marketing approval for our product candidates in one jurisdiction would not mean that we will be successful in obtaining marketing approval of that product candidate in other jurisdictions, which could prevent us from marketing our products internationally.
  • Risks related to commercialization
  • If we are unable to successfully commercialize RP1 or any of our other product candidates for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed.
  • We face significant competition from other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If their product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or eliminated.
  • If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market and sell our product candidates, if they are approved, the revenues that we generate may be limited and we may never become profitable.
  • As we continue to evolve from a company primarily involved in research and development to a company also expected to be involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully.
  • Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.
  • If our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales may be limited, and we may never become profitable.
  • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which government authorities and health insurers establish adequate reimbursement levels and pricing policies.
  • The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.
  • Negative developments in the field of immuno-oncology could damage public perception of our product candidates and negatively affect our business.
  • Risks related to our financial position and need for additional capital
  • We are a clinical stage biopharmaceutical company with a very limited operating history. We have incurred net losses since our inception and anticipate that we will continue to incur substantial and increasing net losses in the foreseeable future. We may never achieve or sustain profitability.
  • Our ability to generate revenue from product sales and become profitable will depend significantly on our success in achieving a number of goals.
  • We will require additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Risks related to intellectual property
  • If we are unable to obtain, maintain and protect our intellectual property rights for our technology and product candidates, or if our intellectual property rights are inadequate, our competitive position could be harmed.
  • Third parties may in the future initiate legal proceedings alleging that we are infringing their intellectual property rights, and we may become involved in lawsuits or other administrative procedures to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse effect on the success of our business.
  • Risks related to manufacturing and our reliance on third parties
  • We have agreements with third party collaborators, and in the future may have agreements with other companies, to obtain the supply of co-delivery therapies for the development of our product candidates. If our relationships with these third party collaborators, or any future collaborator or supplier are not successful, we may be delayed or unable to complete the development of our product candidates.
  • Our collaboration agreements with any future partners may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
  • We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third parties do not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements, we may be unable to obtain regulatory approval for our product candidates or any other product candidates that we may develop in the future.
  • If the manufacturers upon which we rely fail to produce our raw materials, process consumables or product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues.
  • Operating and maintaining our own manufacturing facility may result in unanticipated delays or expenses and we may not experience the anticipated operating efficiencies we intended.
  • Risks related to legal and compliance matters
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization of any approved products and/or our product candidates.
  • We are subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and other anticorruption laws, as well as import and export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, financial condition, results of operations, stock price and prospects.
  • If we fail to comply with federal and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.
  • We are subject to new legislation, regulatory proposals and healthcare payor initiatives that may increase our costs of compliance, and adversely affect our ability to market our products, obtain collaborators, and raise capital.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, CMOs, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business.
  • We are subject to stringent and changing obligations related to privacy, data protection, security, operational resilience, and AI. Our actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation (including from business partners and/or affected individuals) and/or adverse publicity and could negatively affect our operating results and business.
  • Risks related to our operations
  • We will need to expand the size of our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
  • Our future success depends on our ability to retain our key employees and consultants, and to attract and motivate highly qualified personnel.
  • If we fail to establish and maintain proper and effective internal control over financial reporting our ability to produce accurate and timely financial statements could be impaired.
  • Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or access to our systems.
  • Risks related to our common stock and general risks
  • An active trading market for our common stock may not be sustained.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • We have broad discretion in how we use our cash, cash equivalents and investments, and may not use these resources effectively, which could affect our results of operations and cause our stock price to decline.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • Unfavorable market and economic conditions may have serious adverse consequences on our business, financial condition, results of operations, stock price and prospects.
  • Exchange rate fluctuations may materially affect our results of operations and financial conditions.
  • Unfavorable global economic conditions and geopolitical events could adversely affect our business, financial condition or results of operations.
  • The increasing focus on environmental sustainability and social initiatives could increase our costs, harm our reputation and adversely impact our financial results.
  • The Hercules Loan and Security Agreement contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay any outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.

Legal proceedings

On July 24, 2025, a class action complaint alleging violations of the federal securities laws was filed against the Company and its directors and certain officers in the United States District Court for the District of Massachusetts, or the District of Massachusetts. The complaint, captioned Jboor v. Replimune Group, Inc. et al., Case No. 1:25-cv-12085-JEK, was filed shortly after the Company announced it received a complete response letter from the FDA for its RP1 BLA for the treatment of advanced melanoma on July 22, 2025 and the subsequent decline in the trading price of the Company's common stock. The Court has appointed a lead plaintiff, or the Lead Plaintiff. On January 13, 2026, the Lead Plaintiff filed an amended complaint. The Company and the other defendants deny any wrongdoing and continue to vigorously defend this action.

Following the class action complaint, three shareholders filed separate derivative actions on behalf of the Company in the District of Massachusetts captioned Chea v. Patel et al., Case No. 1:25-cv-12316-JEK, Wright v. Patel et al., Case No. 1:25-cv-12401-WGY, and Vochten v. Patel et al., Case No. 1:25-cv-12484-JEK. The plaintiffs allege substantially similar facts as the class action complaint and assert that the Company’s directors and officers breached their fiduciary duties. The parties have consolidated the derivative actions and agreed to a stay pending further developments in the class action.

On September 10, 2025, the Company received a letter from a shareholder demanding that the Company's board of directors take action to address alleged wrongdoing by certain directors and officers. The demand letter alleged substantially similar facts as the class action and derivative action complaints. The board of directors determined to defer action on the demand pending further developments in the class action.

The opening of Item 3, Legal Proceedings.6

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