Replimune Group, Inc. · NASDAQ:REPL

Replimune — JP Morgan Healthcare Conference 2024

34 slides from Replimune's conference presentation, Jan 8, 2024

  1. Slide 1: Igniting a Systemic Immune Response to Cancer

    Safe harbor Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements

  2. Slide 2: Safe harbor

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 2 Safe harbor Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securiti

  3. Slide 3: Replimune; Industry Leader in Oncolytic Immunotherapy

    © 2022 Replimune Group Inc. 3 3 • RP1 – activity across multiple skin cancers supports broad skin cancer strategy • 140 patient registrational IGNYTE study in anti-PD1 failed melanoma • ~ 1 in 3 patients demonstrating durable response • 100% of responses >6 months with median DOR >24 months • BLA fi

  4. Slide 4: Oncolytic immunotherapy - mechanism of action

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 4 Oncolytic immunotherapy - mechanism of action Injected tumor Distant tumors Bommareddy PK et al AJCD. 2016 Healthy tissue Tumor tissue Oncolytic immunotherapy Intact host antiviral response: Normal tissue remains undamaged Dysregulated host an

  5. Slide 5: RPx positioning: Platform designed to address a range of tumor types

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 5 RPx positioning: Platform designed to address a range of tumor types with an optimal balance of potency & tolerability Payloads GALV-GP R-, GM-CSF GALV-GP R-, anti-CTLA-4, GM-CSF Target Immunologically responsive tumor types, including anti-PD

  6. Slide 6: Agenda: RP1: Establishing a major skin cancer franchise

    © 2022 Replimune Group Inc. 6 AGENDA © 2023 Replimune Group Inc. RP1: Establishing a major skin cancer franchise

  7. Slide 7: IGNYTE RP1 + nivolumab in anti-PD1 failed melanoma registrational study data

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 7 IGNYTE RP1 + nivolumab in anti-PD1 failed melanoma registrational study data Consistent ORR benefit across all subgroups Includes 1 patient with a unconfirmed PR (uPR). There are 5 patients still on study with the opportunity for response. Res

  8. Slide 8: Depth of response

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 8 Depth of response n=156 Maximum change in target lesions; patients with at least one follow up assessment Patients with at least one post baseline assessment – target lesion response for each patient Key Takeaways • Target tumor reduction is s

  9. Slide 9: Duration of response

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 9 Duration of response (time from baseline to end of response for responders) Probability (%) Key Takeaway Responses are highly durable, with median DOR >24 months >6 months >12 months >18 months >24 months 100% 90.5% 84.7% 79.7% All patients ha

  10. Slide 10: Promising OS is seen across disease subsets

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 10 Promising OS is seen across disease subsets, including those with the greatest unmet need Stage IIIb/IIIc/IVM1a vs Stage IV M1b/c/d Prior anti-CTLA-4+anti-PD1 vs prior anti-PD1 alone All patients have at least 6 months follow up, median follo

  11. Slide 11: Patient 4401-2021: Prior Tafinlar/Mekinist, Keytruda

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 11 Patient 4401-2021: Prior Tafinlar/Mekinist, Keytruda Prior BRAF/MEK as well as progressed on anti-PD1 Stage IVM1c 12JAN2021/Baseline 15FEB2022/Day 368 12JAN2021/Baseline 15FEB2022/Day 368 Data snapshot date: 3 Nov 2022 Injected Un-injected

  12. Slide 12: Patient 1121-2011: Prior Opdivo and Keytruda

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 12 Patient 1121-2011: Prior Opdivo (adjuvant) and Keytruda (first line for metastatic disease), Stage IVM1c 29 JUL 2021 / Screening 20 APRIL 2022 Injected Un-injected

  13. Slide 13: Patient 1121-2011 Cont'd

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 13 22 Jul 2021/ Baseline 22 Sep 2021/ Day 57 29 Dec 2021/ Day 155 Injected Un-injected Patient 1121-2011 Cont’d: Prior Opdivo (adjuvant) and Keytruda (first line for metastatic disease), Stage IVM1c

  14. Slide 14: IGNYTE - Regulatory summary/next steps

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 14 IGNYTE - Regulatory summary/next steps IGNYTE IGNYTE FDA Type C meeting on anti-PD1 failed melanoma • The FDA acknowledged that the IGNYTE population is one of unmet need • The FDA agreed with a 2-arm randomized trial design in anti-PD1 faile

  15. Slide 15: CSCC disease characteristics and typical patient presentation

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 15 CSCC disease characteristics and typical patient presentation • Second most common skin cancer with ≈700,000 patients annually in the U.S.1 • Approximately 7,000-15,000 US deaths annually1-3 • 80% of patients die from locoregional progression

  16. Slide 16: CERPASS registration-directed Ph2 study in CSCC

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 16 CERPASS registration-directed Ph2 study in CSCC Key Eligibility Criteria: • Locally-advanced/metastatic CSCC • ECOG PS 0 or 1 • No active autoimmune disease • No prior treatment with a PD-1/PD-L1 inhibitor • No untreated brain metastases 57 w

  17. Slide 17: Confirmed ORR & CRR (ITT population)

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 17 Confirmed ORR & CRR (ITT population) Key Takeaways • While ORR was similar between the arms, the number of patients who achieved a CRR was substantially increased with RP1+cemiplimab (P=0.04) • In LA CSCC, there was a more than doubling of th

  18. Slide 18: Five of the most visually impactful CRs with RP1+cemiplimab

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 18 Five of the most visually impactful CRs with RP1+cemiplimab Baseline 81 weeks 4805-0002 Baseline 81 weeks 1140-0002 Baseline 63 weeks 3311-0002 Baseline 63 weeks 3002-0008 Baseline 54 weeks 1141-0009

  19. Slide 19: Duration of response (immature data)

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 19 Duration of response (immature data) Time from baseline to end of response for responders All responding patients Key Takeaway Duration of response was improved with RP1+cemiplimab as compared to cemiplimab alone (HR 0.45 immature data). Whil

  20. Slide 20: CERPASS - next steps

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 20 CERPASS - next steps CERPASS • CERPASS missed its primary endpoints while demonstrating treatment effects suggesting clinical benefit • CR rate • Duration of response • All time-based endpoints are immature (DOR, PFS and OS) and will be follo

  21. Slide 21: Additional unmet needs in CSCC/NMSC

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 21 Additional unmet needs in CSCC/NMSC ARTACUS STUDY • Treatment of high risk immune compromised populations who develop skin cancers • Anti-PD1 use can lead to loss of graft • RP1 monotherapy; 35% ORR (N=23) IGNYTE anti-PD1 failed NMSC • No FDA

  22. Slide 22: Agenda: RP1 Commercial Opportunity

    AGENDA © 2023 Replimune Group Inc. RP1 Commercial Opportunity

  23. Slide 23: Significant opportunity to establish a broad skin cancer franchise

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 23 Significant opportunity to establish a broad skin cancer franchise built upon strong foundation in melanoma Future growth driver ~11K patients2 ~13K patients1 Ability to improve the SOC either as combo or as monotherapy Address high unmet nee

  24. Slide 24: Commercial scale in-house manufacturing established

    © 2023 Replimune Group Inc. 24 Investment in manufacturing to support full commercialization • 63,000 square foot state-of-the-art facility for GMP manufacturing • RP1-2 technology transfer from CMO successfully completed • RP1 released to clinic post comparability analysis • RP1 BLA consistency lot

  25. Slide 25: Agenda: RP2 update

    © 2022 Replimune Group Inc. 25 AGENDA © 2023 Replimune Group Inc. RP2 update

  26. Slide 26: RP2 leverages Replimune's platform to express anti-CTLA-4

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 26 RP2 leverages Replimune’s platform to express anti-CTLA-4 • Anti-CTLA-4 prevents immune blockade at the APC / T cell interface § Anti-CTLA-4 is clinically validated; Ipilimumab, tremelimumab • RP2 has shown durable mono-therapy responses in m

  27. Slide 27: Mucoepidermoid carcinoma patient featured in BBC news

    © 2022 Replimune Group Inc. Confiden'al 272 7 "It’s a true miracle, there is no other word to describe it. I’ve been able to work as a builder again and spend time with my family, there’s nothing I can’t do.” “My final lifeline” Mucoepidermoid carcinoma pa.ent featured in BBC news Prior carbopla+n/p

  28. Slide 28: Patient 4401-0029: Chordoma

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 28 Patient 4401-0029: Chordoma Prior imatinib - ongoing PR at over 8 months (RP2 monotherapy) Pt 4401-0029 - ongoing PR • Left gluteal muscle injected • Liver & >50 small lung lesions also disappeared during treatment Screening 3 months 6 months

  29. Slide 29: Patient 4401-0029: Chordoma

    © 2022 Replimune Group Inc. Confiden'al 292 9 Pa.ent 4401-0029: Chordoma Prior ima+nib - ongoing PR at over 8 months (RP2 monotherapy) Pt 4401-0029 - ongoing PR • Left gluteal muscle lesion injected • Liver & >50 small lung lesions also disappeared during treatment Injected Un-injected Baseline 3 mo

  30. Slide 30: RP2 in uveal melanoma

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 30 RP2 in uveal melanoma 1Carvajal RD et al. Br J Ophthalmol 2017; 2Nathan P et al. N Engl J Med. 2021;385(13):1196-1206; 3PelsterMS et al. J Clin Oncol. 2021;39(6):599-607; 4Lukzky J et al SMR 2022; * Versus investigator’s choice, pembrolizumab

  31. Slide 31: RP2 Uveal melanoma: Duration of response

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 31 RP2 Uveal melanoma: Duration of response Durable responses in small initial dataset, both monotherapy RP2 and RP2 + nivo .. 0 60 120 180 240 300 360 420 480 540 600 660 720 780 840 900 960 1020 1080 Duration of Study (Days) 4401-0007 4402-001

  32. Slide 32: Uveal melanoma patient featured in ITV news

    © 2022 Replimune Group Inc. Confiden'al 323 2 Screening 19 months Pt 201-4403-0017 – ongoing PR • Liver metastases • PaNent has ongoing PR at 19 months Uveal melanoma patient featured in ITV news Prior nivolumab+ ipilimumab – PR (RP2+nivolumab) "This trial has given me hope in the treatment, the tri

  33. Slide 33: Summary: RP1 in skin cancer, mid-stage pipeline, strong cash position

    ©© 2022 Replimune Group Inc. 2023 Replimune Group Inc. 33 RP1 in skin cancer Mid-stage pipeline Strong cash position • Strong balance sheet; $466m (1) as of 31 December 2023 • Cash Runway into H2 2026 • Initial snapshot of data from all 156 anti-PD1 failed melanoma patients demonstrate that RP1+nivo

  34. Slide 34: Mission, vision and thank you

    MISSION To enable tumor directed oncolytic immunotherapy (TDOI) to become a cornerstone in the treatment of cancer VISION To deliver transformational results for patients across cancers using tumor directed oncolytic immunotherapy to induce a powerful and durable systemic anti-tumor immune response

Replimune Group — JP Morgan Healthcare Conference 2024 on 6ix