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Replimune Group, Inc.

For the period ended Sep 30, 2026. Filed Oct 28, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Oct 28, 2026

REPL$21.62+8.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-14.

0001628280-26-057099

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-10-28.

0001628280-26-067722

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 169 previous paragraphs and 172 current paragraphs.

131 unchanged; 31 reworded; 8 added; 5 removed; 2 previous and 2 current paragraphs rearranged.

Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (8)

Current report

Since commercial launch in early October 2026, multiple payer policies have published, from both major national and regional payers, that cover TUDRIQEV to label, including retreatment if clinically appropriate. These payer policies represent a majority of commercially covered lives. In addition, Medicare coverage has been established and TUDRIQEV has been listed in the NCCN Clinical Practice Guidelines in Oncology as a category 2A recommendation. We have also submitted for a permanent J-code, which we anticipate having in place in the first half of 2027.

Current report

Comparison of the six months ended September 30, 2026 and 2025

Current report

Research and development expenses for the six months ended September 30, 2026 were $83.6 million, compared to $115.7 million for the six months ended September 30, 2025. The following table summarizes our research and development expenses for the six months ended September 30, 2026 and 2025:

Current report

Direct research costs decreased by approximately $6.1 million overall which was a result of a decrease of $14.4 million in total RP1 costs specifically as a result of a decrease in total RP1 costs relating to the IGNYTE, ARTACUS and CERPASS studies, specifically as a result of the completion of the IGNYTE advanced melanoma cohort and completion of enrollment in and the wind down of the CERPASS and ARTACUS studies. Within the RP1 program, the IGNYTE-3 confirmatory study continues to enroll patients and has an increase in study costs of $3.4 million as compared to the prior year. Furthermore, there was a $9.1 million increase in spending on RP2 primarily as a result of increased enrollment in the REVEAL study as compared to the prior year.

Current report

Selling, general and administrative expenses were $40.9 million for the six months ended September 30, 2026, compared to $59.0 million for the six months ended September 30, 2025. The decrease of approximately $18.1 million in sales, general and administrative costs is driven by a decrease of $11.5 million in sales and marketing costs related to promotional materials, market access and insights and analytics. Sales and marketing costs were put on hold after the Company received a complete response letter in April 2026 from the FDA and did not resume until late in the second quarter of this fiscal year. In addition, there was a decrease of approximately $7.0 million in personnel-related costs as a result of the Company restructuring in April 2026.

Current report

Other (expense) income, net was $2.4 million for the six months ended September 30, 2026, compared to income of $4.9 million for the six months ended September 30, 2025. The net change of $7.3 million is primarily attributable to a decrease in investment income of $4.6 million as a result of the cash and investment balance being lower throughout the year as compared to the prior year due to normal cash burn. Additionally, there was an increase in expense on debt of $2.1 million as a result of a higher debt balance as compared to the prior year.

Current report

During the six months ended September 30, 2026, net cash provided by financing activities was $161.3 million, relating primarily to $141.0 million in proceeds as a result of the Company's offering of common stock and pre-funded warrants in August 2026, as well as $15.0 million in proceeds from long-term debt from the initial draw down on tranche 4 in September 2026. Financing activities also included approximately $5.8 million in proceeds from the exercise of stock options, somewhat offset by principal payments of the Company's financing lease obligation.
Removed paragraphs (5)

Previous report

In November 2024, we announced submission of our first Biologics License Application, or BLA, to the U.S. Food and Drug Administration, or the FDA, for TUDRIQEV in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen, and that the FDA had granted Breakthrough Therapy designation for TUDRIQEV in combination with nivolumab in the same setting. In July 2025, we received the first of two CRLs on our BLA for TUDRIQEV in combination with nivolumab for advanced melanoma patients, with the second CRL being issued by the FDA in April 2026. Ultimately, however, at a July 30, 2026 meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the "Advisory Committee"), the Advisory Committee voted 10 to 3 on the question: “Are the efficacy results from IGNYTE evaluable and clinically meaningful?” Following this meeting, on August 6, 2026, the FDA granted accelerated approval of TUDRIQEV in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.
Reworded paragraphs (31)

Previous wording

Our leading clinical trial of RP1 is referred to as the IGNYTE trial, which is a multi-cohort clinical trial being conducted in collaboration with Bristol Myers Squibb Company, or BMS, under which BMS has granted us a non-exclusive, royalty-free license to, and is supplying at no cost, its anti-PD-1 therapy, nivolumab, for use in combination with RP1.

Current wording

Our leading clinical trial of RP1 was referred to as the IGNYTE trial, which was a multi-cohort clinical trial being conducted in collaboration with Bristol Myers Squibb Company, or BMS, under which BMS has granted us a non-exclusive, royalty-free license to, and is supplying at no cost, its anti-PD-1 therapy, nivolumab, for use in combination with RP1.

Previous wording

The leading tumor specific cohort in the IGNYTE trial is our registration directed Phase 2 expansion cohort in anti-PD-1 failed cutaneous melanoma. The anti-PD-1 failed melanoma cohort from the IGNYTE trial includes 140 patients who received RP1 in combination with nivolumab. On August 6, 2026, we announced the FDA granted accelerated approval to TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial(s). The IGNYTE trial enrolled 140 patients with 91 patients with at least one non-injected lesion included in the efficacy-evaluable population. In this population, TUDRIQEV plus nivolumab achieved an objective response rate (ORR) of 24.2%, with a median duration of response of 14.1 months. Treatment was well tolerated with mostly mild-to-moderate adverse events. The patient population included patients with Stage 4 disease (80%), prior anti-PD-1 adjuvant treatment (13%), PD-L1 negative status (54%), lung (45%) and liver lesions (24%). TUDRIQEV in combination with nivolumab was generally well tolerated, with adverse events predominantly mild to moderate in severity. The most common (incidence ≥ 10%) adverse reactions in patients treated with TUDRIQEV combined with nivolumab were nausea, diarrhea, vomiting, constipation, decreased appetite, abdominal pain, fatigue, pyrexia, chills, injection site reaction, influenza-like illness, infections, musculoskeletal pain, arthralgia, headache, dizziness, cough, dyspnea, rash, edema, pruritus and hemorrhage. Most treatment-related adverse reactions were grade 1 and 2 and transient. There were no grade 4 or 5 common adverse events. See additional Important Safety Information. The IGNYTE study data were published in the Journal of Clinical Oncology in July 2025.

Current wording

The IGNYTE trial enrolled 140 patients with 91 patients with at least one non-injected lesion included in the efficacy-evaluable population. In this population, TUDRIQEV plus nivolumab achieved an objective response rate (ORR) of 24.2%, with a median duration of response of 14.1 months. Treatment was well tolerated with mostly mild-to-moderate adverse events. The patient population included patients with Stage 4 disease (80%), prior anti-PD-1 adjuvant treatment (13%), PD-L1 negative status (54%), lung (45%) and liver lesions (24%). TUDRIQEV in combination with nivolumab was generally well tolerated, with adverse events predominantly mild to moderate in severity. The most common (incidence ≥ 10%) adverse reactions in patients treated with TUDRIQEV combined with nivolumab were nausea, diarrhea, vomiting, constipation, decreased appetite, abdominal pain, fatigue, pyrexia, chills, injection site reaction, influenza-like illness, infections, musculoskeletal pain, arthralgia, headache, dizziness, cough, dyspnea, rash, edema, pruritus and hemorrhage. Most treatment-related adverse reactions were grade 1 and 2 and transient. There were no grade 4 or 5 common adverse events. The IGNYTE study data were published in the Journal of Clinical Oncology in July 2025.

Previous wording

In August 2024, we announced the dosing of the first patient in the IGNYTE-3 trial, or the I-3 trial, a 2-arm randomized Phase 3 clinical trial with physician's choice of treatment as a comparator arm in anti-PD-1 failed melanoma patients. Overall survival is the primary endpoint, and the trial is expected to randomize approximately 400 patients. We continue to enroll patients in the I-3 trial. The I-3 trial is an FDA postmarketing requirement and is intended to serve as the required accelerated approval confirmatory study. In addition to the I-3 trial, we must also complete a pediatric study of TUDRIQEV in combination with nivolumab in pediatric patients 12 years of age and older and are required to fulfill certain other postmarketing commitments set out in FDA’s TUDRIQEV approval letter. We continue to enroll patients in the I-3 trial.

Current wording

In August 2024, we announced the dosing of the first patient in the IGNYTE-3 trial, or the I-3 trial, a 2-arm randomized Phase 3 clinical trial with physician's choice of treatment as a comparator arm in anti-PD-1 failed melanoma patients. Overall survival is the primary endpoint, and the trial is expected to randomize approximately 400 patients. We continue to enroll patients in the I-3 trial. The I-3 trial is an FDA postmarketing requirement and is intended to serve as the required accelerated approval confirmatory study. In addition to the I-3 trial, we must also complete a pediatric study of TUDRIQEV in combination with nivolumab in pediatric patients 12 years of age and older and are required to fulfill certain other postmarketing commitments set out in FDA’s TUDRIQEV approval letter.

Previous wording

In addition to our development of TUDRIQEV for melanoma, we also are studying the product for other indications. In our non-melanoma skin cancer, or NMSC, cohort of the IGNYTE trial, we provided a data update in December 2023 from the first 30 patients with at least 6 months of follow up including patients with cutaneous squamous cell carcinoma, or CSCC, Merkel cell carcinoma, or MCC, basal cell carcinoma, or BCC, and angiosarcoma in this cohort. The data showed that treatment with TUDRIQEV in combination with nivolumab led to an ORR of 30% which is consistent with data from the anti-PD-1 failed melanoma cohort with approximately one-third of patients responding and 60% demonstrating clinical benefit. The combination of TUDRIQEV and nivolumab was well tolerated in this patient population with a safety profile consistent with the overall experience seen with this treatment regimen to date. We provided updated data from the NMSC cohort during our June 2025 Investor Day event and in October 2025 at the European Society for Medical Oncology, or ESMO, conference. Responses to TUDRIQEV plus nivolumab occurred across the NMSC tumor types enrolled, with confirmed responses seen in patients with both anti–PD-1 naïve and anti-PD-1 failed disease, as well as both in locally advanced and metastatic disease. The ORR by NMSC tumor type for anti-PD-1 naïve patients was 100.0% (n=4) in MCC, 33.3% (n=3) in BCC, 66.7% (n=6) in angiosarcoma, and 56.3% (n=16) in CSCC. The ORR by NMSC tumor type for anti-PD-1 failed patients was 26.3% (n=19) in MCC, 30.0% (n=10) in BCC, 37.5% (n=8) in angiosarcoma, and 15.2% (n=33) in CSCC. We closed enrollment in the NMSC tumor type cohorts in the fourth quarter of 2025.

Current wording

In addition to our development of TUDRIQEV for melanoma, we also are studying the product for other indications. In our non-melanoma skin cancer, or NMSC, cohort of the IGNYTE trial, we provided a data update in December 2023 from the first 30 patients with at least 6 months of follow up including patients with cutaneous squamous cell carcinoma, or CSCC, Merkel cell carcinoma, or MCC, basal cell carcinoma, or BCC, and angiosarcoma in this cohort. The data showed that treatment with RP1 in combination with nivolumab led to an ORR of 30% which is consistent with data from the anti-PD-1 failed melanoma cohort with approximately one-third of patients responding and 60% demonstrating clinical benefit. The combination of RP1 and nivolumab was well tolerated in this patient population with a safety profile consistent with the overall experience seen with this treatment regimen to date. We provided updated data from the NMSC cohort during our June 2025 Investor Day event and in October 2025 at the European Society for Medical Oncology, or ESMO, conference. Responses to RP1 plus nivolumab occurred across the NMSC tumor types enrolled, with confirmed responses seen in patients with both anti–PD-1 naïve and anti-PD-1 failed disease, as well as both in locally advanced and metastatic disease. The ORR by NMSC tumor type for anti-PD-1 naïve patients was 100.0% (n=4) in MCC, 33.3% (n=3) in BCC, 66.7% (n=6) in angiosarcoma, and 56.3% (n=16) in CSCC. The ORR by NMSC tumor type for anti-PD-1 failed patients was 26.3% (n=19) in MCC, 30.0% (n=10) in BCC, 37.5% (n=8) in angiosarcoma, and 15.2% (n=33) in CSCC. We closed enrollment in the NMSC tumor type cohorts in the fourth quarter of 2025.

Previous wording

We had been furthering development of TUDRIQEV through enrollment in a Phase 1b/2 clinical trial of single agent TUDRIQEV in solid organ transplant recipients with skin cancers, including CSCC, which we referred to as the ARTACUS trial. The ARTACUS trial enrolled 69 patients to assess the safety and efficacy of TUDRIQEV in liver, kidney, heart, lung, and hematopoietic cell transplant patients with skin cancers. Most recently, Dr. Michael R. Migden presented updated data from the ARTACUS trial at the Society for Melanoma Research 22nd International Congress in October 2025. This updated data showed anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate of 23.1%) and 2-year duration of response of

Current wording

We had been furthering development of RP1 through enrollment in a Phase 1b/2 clinical trial of single agent RP1 in solid organ transplant recipients with skin cancers, including CSCC, which we referred to as the ARTACUS trial. The ARTACUS trial enrolled 69 patients to assess the safety and efficacy of RP1 in liver, kidney, heart, lung, and hematopoietic cell transplant patients with skin cancers. Most recently, Dr. Michael R. Migden presented updated data from the ARTACUS trial at the Society for Melanoma Research 22nd International Congress in October 2025. This updated data showed anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate of 23.1%) and 2-year duration of response of 61.0%. Furthermore, the data showed that RP1 monotherapy continued to be well tolerated and the safety profile continued to be similar to that observed in non-immunocompromised patients with advanced skin cancers, and, importantly, no implant rejections were attributed to the RP1 treatment. We have closed enrollment in the ARTACUS trial and are planning a publication submission in 2026.

Previous wording

Our previous clinical trial of TUDRIQEV in patients with CSCC, which we referred to as the CERPASS trial, is fully closed and we are planning for a study report to be available in 2026.

Current wording

Our previous clinical trial of RP1 in patients with CSCC, which we referred to as the CERPASS trial, is fully closed and we are planning for a study report to be available in 2026.

Previous wording

Leading the development of the RP2 product candidate is our REVEAL study. The REVEAL study is enrolling patients in a registration-directed study of RP2 in mUM patients who are immune checkpoint inhibitor-naïve. The REVEAL study is a randomized, Phase 2/3 open label study expected to enroll approximately 280 patients to investigate the efficacy and safety of RP2 in combination with nivolumab vs. ipilimumab in combination with nivolumab in immune checkpoint inhibitor naïve adult patients with metastatic uveal melanoma. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. In January 2026 we announced the Phase 2/3 transition is expected to occur in the first quarter of 2027.

Current wording

Leading the development of the RP2 product candidate is our REVEAL study. The REVEAL study is enrolling patients in a registration-directed study of RP2 in mUM patients who are immune checkpoint inhibitor-naïve. The REVEAL study is a randomized, Phase 2/3 open label study expected to enroll approximately 280 patients to investigate the efficacy and safety of RP2 in combination with nivolumab vs. ipilimumab in combination with nivolumab in immune checkpoint inhibitor naïve adult patients with metastatic uveal melanoma. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. The Phase 2/3 transition is expected to occur in the first quarter of 2027.

Previous wording

We continue our signal finding trial of RP2 in combination with atezolizumab and bevacizumab in the second-line (2L) setting of patients with hepatocellular carcinoma, or HCC, in collaboration with Roche. The protocol has been amended to include RP2 as monotherapy and we plan to release preliminary HCC data by the end of 2026. We have also opened a cohort in our RP2 study to investigate the potential to address biliary tract cancer, or BTC, through the dosing of RP2 in combination with durvalumab. We are currently evaluating these signal finding studies.

Current wording

We continue our signal seeking trial of RP2 in combination with atezolizumab and bevacizumab in the second-line (2L) setting of patients with hepatocellular carcinoma, or HCC, in collaboration with Roche. We have also opened a cohort in our RP2 study to investigate the potential to address biliary tract cancer, or BTC, through the dosing of RP2 in combination with durvalumab. We are currently evaluating these studies and we expect to share preliminary findings in the first quarter of 2027.

Previous wording

Since our inception, we have devoted substantially all of our resources to developing our proprietary RPx platform, building our intellectual property portfolio, conducting research and development of our product candidates, business planning, raising capital and providing general and administrative support for our operations. To date, we have incurred significant operating losses and we have financed our operations primarily with proceeds from the sale of equity securities and to a lesser extent, proceeds from borrowing under secured loan facilities. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of TUDRIQEV and our other product candidates. As of June 30, 2026, we do not have any products approved for sale and have not generated any revenue from product sales.

Current wording

Since our inception, we have devoted substantially all of our resources to developing our proprietary RPx platform, building our intellectual property portfolio, conducting research and development of our product candidates, business planning, raising capital and providing general and administrative support for our operations. To date, we have incurred significant operating losses and we have financed our operations primarily with proceeds from the sale of equity securities and to a lesser extent, proceeds from borrowing under secured loan facilities. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of TUDRIQEV and our other product candidates. As of September 30, 2026, TUDRIQEV is our only approved product, and we have not yet generated any revenue from product sales.

Previous wording

Since our initial public offering, or IPO, on July 20, 2018, we have raised an aggregate of approximately $1,132.9 million in net proceeds to fund our operations, of which $101.2 million was from our IPO, $862.0 million was from four separate follow-on offerings, or the Public Offerings, that we closed in November 2019, June 2020, October 2020, December 2022, and November 2024, respectively, $96.7 million was from our private investment in public equity offering in June 2024, and $73.0 million was from at-the-market offerings.

Current wording

Since our initial public offering, or IPO, on July 20, 2018 through September 30, 2026, we have raised an aggregate of approximately $1,273.9 million in net proceeds to fund our operations, of which $101.2 million was from our IPO, $1,003.0 million was from six separate follow-on offerings, or the Public Offerings, that we closed in November 2019, June 2020, October 2020, December 2022, November 2024, and August 2026, respectively, $96.7 million was from our private investment in public equity offering in June 2024, and $73.0 million was from at-the-market offerings.

Previous wording

Our net losses were $69.8 million and $86.7 million for the three months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $1,332.3 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

Current wording

Our net losses were $57.1 million and $83.1 million for the three months ended September 30, 2026 and 2025, and $126.9 million and $169.8 million for the six months ended September 30, 2026 and 2025, respectively. The reduced costs for the three and six months ended September 30, 2026 are, in part, a result of the Company restructuring that was announced in April 2026. These costs included, but are not limited to, personnel costs including stock-based compensation, professional fees and recruitment. As of September 30, 2026, we had an accumulated deficit of $1,389.4 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations.

Previous wording

As of June 30, 2026, we had cash and cash equivalents and short-term investments of $195.3 million. Based on our current operating plan including the commercialization of TUDRIQEV in the near term, we believe that our existing cash and cash equivalents and short-term investments, including the $141.0 million of net proceeds from the issuance of our common stock in August 2026, will be sufficient to fund operating expenses and capital expenditure requirements for greater than twelve months from the issuance of these condensed consolidated financial statements included in this quarterly report.

Current wording

We expect that our cash and cash equivalents of $307.8 million as of September 30, 2026 will be sufficient to fund our operations and capital expenditure requirements for greater than twelve months from the issuance of these condensed consolidated financial statements, including the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

Previous wording

To date, we have not generated any revenue from product sales as we previously did not have any approved products prior to the approval of TUDRIQEV in August 2026. We can not be certain we will generate any revenue from the sale of TUDRIQEV or other potential products in the future. If our development efforts for any of our other product candidates that we may develop in the future are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from those collaborations or license agreements.

Current wording

Prior to the commercialization of TUDRIQEV in early October 2026, we have not generated any revenue from product sales. We can not be certain of the revenue from the sale of TUDRIQEV or other potential products in the future. If our development efforts for any of our other product candidates that we may develop in the future are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from those collaborations or license agreements.

Previous wording

Research and development expenses for the three months ended June 30, 2026 were $49.3 million, compared to $57.8 million for the three months ended June 30, 2025. The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025:

Current wording

Research and development expenses for the three months ended September 30, 2026 were $34.4 million, compared to $57.9 million for the three months ended September 30, 2025. The following table summarizes our research and development expenses for the three months ended September 30, 2026 and 2025:

Previous wording

The overall decrease of $8.6 million in total research and development expenses was driven by a decrease in unallocated expenses of approximately $7.6 million, which included a decrease of $3.8 million in personnel related costs and a decrease of $3.8 million in other costs. Personnel related costs, including stock compensation, were down as a result of the

Current wording

The overall decrease of $23.5 million in total research and development expenses was driven by a decrease in unallocated expenses of approximately $18.4 million, which included a decrease of $14.0 million in personnel related costs and a decrease of $4.4 million in other costs. Personnel related costs, including stock compensation, were down as a result of the Company restructuring which was announced in April 2026. The Company also had lower costs relating to medical affairs, professional fees and recruitment of approximately $4.6 million as compared to the same quarter in the prior year. These decreases are somewhat offset by an increase of approximately $1.4 million in consulting costs. In addition, the Company began capitalizing inventory during the quarter which includes an allocation of manufacturing costs that otherwise would have been included in personnel and other expenses.

Previous wording

Direct research costs decreased by approximately $1.0 million overall which was a result of a decrease of $5.3 million in total TUDRIQEV costs relating to the IGNYTE, ARTACUS and CERPASS studies, specifically as a result of the completion of enrollment in the IGNYTE advanced melanoma cohort and declining enrollment and the wind down of the CERPASS and ARTACUS studies. These TUDRIQEV cost decreases were somewhat offset by an increase of $3.1 million related to the IGNYTE-3 confirmatory study, which continued to progress in first quarter of fiscal 2027. In addition, RP2 direct spending increased by approximately $5.0 million versus the same quarter of the prior year related to the REVEAL study, as the Company continued to ramp up enrollment and expanded this trial outside of the United States.

Current wording

Direct research costs decreased by approximately $5.1 million overall which was a result of a decrease of $9.0 million in total RP1 costs specifically as a result of a decrease in total RP1 costs relating to the IGNYTE, ARTACUS and CERPASS studies, specifically as a result of the completion of the IGNYTE advanced melanoma cohort and completion of enrollment and the wind down of the CERPASS and ARTACUS studies. The decreases in RP1 spending were somewhat offset by RP2 direct spending which increased by approximately $4.2 million versus the same quarter of the prior year related to the REVEAL study, as the Company continued to ramp up enrollment and expanded this trial outside of the United States.

Previous wording

Selling, general and administrative expenses were $19.0 million for the three months ended June 30, 2026, compared to $32.6 million for the three months ended June 30, 2025. The decrease of $13.6 million is primarily the result of a decrease of $10.2 million in external sales and marketing costs and a decrease of $3.4 million in personnel related costs in the sales and marketing and G&A functions. These decreases are the result of the Company restructuring which occurred during the first quarter of fiscal 2027, and included a reduction of workforce by approximately 55%, impacting the entirety of the Company's commercial team.

Current wording

Selling, general and administrative expenses were $21.9 million for the three months ended September 30, 2026, compared to $26.4 million for the three months ended September 30, 2025. The decrease of $4.5 million is primarily the result of a decrease of $3.6 million in personnel related costs in the sales and marketing and G&A functions as well as a decrease of $1.4 million in external sales and marketing costs. These decreases are the result of the Company restructuring which occurred during the first quarter of fiscal 2027, and included a reduction of workforce by approximately 55%, impacting the entirety of the Company's commercial team, and rehiring did not begin to ramp back up until later in the second quarter after receiving approval from the FDA.

Previous wording

Other expense was $1.5 million for the three months ended June 30, 2026, compared to income of $3.7 million for the three months ended June 30, 2025. The net change of $5.2 million is primarily attributable to a decrease in investment income of $2.8 million as a result of a lower investment balance year over year. In addition, there was an increase in expense of $1.3 million in the current quarter compared to the prior year due to exchange rate fluctuations related to the changes in foreign exchange rates of the British Pound Sterling to the United States Dollar, specifically on intercompany and other non-functional currency transactions, as well as an increase in expense on debt of $1.1 million as a result of a higher debt balance as compared to the same quarter in the prior year.

Current wording

Other expense was $0.8 million for the three months ended September 30, 2026, compared to income of $1.2 million for the three months ended September 30, 2025. The net change of $2.0 million is primarily attributable to a decrease in investment income of $1.8 million as a result of a lower investment balance year over year. In addition, there was an increase in expense on debt of $1.0 million as a result of a higher debt balance as compared to the same quarter in the prior year, as well as a decrease in expense of $0.9 million in the current quarter compared to the prior year due to exchange rate fluctuations related to the changes in foreign exchange rates of the British Pound Sterling to the United States Dollar, specifically on intercompany and other non-functional currency transactions.

Previous wording

Company restructuring which was announced in April 2026. The decrease in other costs is driven by a decrease in consulting costs and medical affairs spending.

Current wording

The total decrease of $32.1 million in research and development expenses was primarily attributable to a decrease of $26.0 million in unallocated expenses, which includes a decrease of $17.7 million in personnel-related costs and $8.2 million in other costs. Personnel-related costs, including payroll, fringe benefits and stock-based compensation, were down as a result of the Company restructuring which was announced in April 2026. The decrease in other costs is driven primarily by lower costs relating to medical affairs, professional fees and recruitment of approximately $6.0 million as compared to the prior year. Also, as noted above, the Company began capitalizing inventory during the second quarter of this fiscal year which includes an allocation of manufacturing costs that otherwise would have been included in personnel and other expenses.

Previous wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Until we are able to generate sufficient revenue from TUDRIQEV and our other product candidates that we develop, which may never occur, we anticipate that we will continue to incur significant operating losses and negative cash flows from our operations.

Current wording

Since our inception and prior to the commercialization of TUDRIQEV in early October 2026, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Until we are able to generate sufficient revenue from TUDRIQEV or any of our other product candidates that we develop, which may never occur, we anticipate that we will continue to incur significant operating losses and negative cash flows from our operations.

Previous wording

To date, we have financed our operations primarily with proceeds from the sale of equity securities and, to a lesser extent, proceeds from borrowing under a secured loan facility. Through June 30, 2026, we had received net proceeds of $1,132.9 million through the sale of shares of common stock and pre-funded warrants exercisable for common stock in public offerings, a private placement transaction, and at-the-market offerings, as well as our incurrence of debt under the Hercules Loan Agreement. As of June 30, 2026, we had cash and cash equivalents and short-term investments of $195.3 million.

Current wording

To date, we have financed our operations primarily with proceeds from the sale of equity securities and, to a lesser extent, proceeds from borrowing under a secured loan facility. Through September 30, 2026, we had received net proceeds of $1,273.9 million through the sale of shares of common stock and pre-funded warrants exercisable for common stock in public offerings, a private placement transaction, and at-the-market offerings, as well as our incurrence of debt under the Hercules Loan Agreement. As of September 30, 2026, we had cash and cash equivalents and short-term investments of $307.8 million.

Previous wording

During the three months ended June 30, 2026, net cash used in operating activities was $75.7 million, primarily resulting from our net loss of $69.8 million partially offset by non-cash charges of $9.5 million, which primarily consist of stock-based compensation expense of $7.7 million and depreciation and amortization of $1.8 million, and a decrease in cash of $15.5 million related to changes in our operating assets and liabilities. Changes in our operating assets and liabilities for the three months ended June 30, 2026 consisted primarily of a $2.3 million decrease in accounts payable, a $17.4 million decrease in accrued expenses and other current liabilities, and a $1.3 million decrease in research and development incentives receivable from the United Kingdom government due to the timing and amount of our qualifying expenditures.

Current wording

During the six months ended September 30, 2026, net cash used in operating activities was $123.4 million, primarily resulting from our net loss of $126.9 million partially offset by non-cash charges of $23.1 million, which primarily consist of stock-based compensation expense of $18.2 million and depreciation and amortization of $3.3 million, and a decrease in cash of $19.7 million related to changes in our operating assets and liabilities. Changes in our operating assets and liabilities for the six months ended September 30, 2026 consisted primarily of a $12.1 million decrease in accrued expenses and other current liabilities, and a $9.9 million increase in inventory related to the commercial launch of TUDRIQEV, partially offset by a $2.3 million decrease in prepaid and other expenses and a $1.1 million decrease in research and development incentives receivable.

Previous wording

During the three months ended June 30, 2025, net cash used in operating activities was $77.0 million, primarily resulting from our net loss of $86.7 million partially offset by non-cash charges of $10.1 million, which primarily consist of stock-based compensation expense of $8.8 million and depreciation and amortization of $1.7 million, somewhat offset by net amortization of premiums and discounts on short-term investments of $1.3 million, and a decrease in cash of $0.4 million related to changes in our operating assets and liabilities. Changes in our operating assets and liabilities for the three months ended June 30, 2025 consisted primarily of a $5.5 million decrease in accrued expenses and other current liabilities, offset by a $3.8 million increase in accounts payable, and a $1.6 million decrease in research and development incentives receivable from the United Kingdom government due to the timing and amount of our qualifying expenditures.

Current wording

During the six months ended September 30, 2025, net cash used in operating activities was $158.2 million, primarily resulting from our net loss of $169.8 million partially offset by non-cash charges of $18.9 million, which primarily consist of stock-based compensation expense of $17.1 million and depreciation and amortization of $3.3 million, somewhat offset by net amortization of premiums and discounts on short-term investments of $2.1 million, and a decrease in cash of $7.3 million related to changes in our operating assets and liabilities. Changes in our operating assets and liabilities for the six months ended September 30, 2025 consisted primarily of a $5.2 million decrease in accounts payable, a $2.8 million decrease in accrued expenses and other current liabilities, and a $1.3 million decrease in research and development incentives receivable from the United Kingdom government due to the timing and amount of our qualifying expenditures.

Previous wording

During the three months ended June 30, 2026, net cash provided by investing activities was $50.0 million, consisting of $59.9 million in proceeds from sales and maturities of short-term investments, partially offset by $9.9 million in purchases of available for sale securities.

Current wording

During the six months ended September 30, 2026, net cash provided by investing activities was $59.8 million, consisting of $69.6 million in proceeds from sales and maturities of short-term investments, partially offset by $9.9 million in purchases of available for sale securities.

Previous wording

During the three months ended June 30, 2025, net cash provided by investing activities was $65.0 million, consisting of $105.4 million in proceeds from sales and maturities of short-term investments, partially offset by $37.6 million in purchases of available for sale securities and $2.7 million in purchases of property, plant and equipment and capitalized software.

Current wording

During the six months ended September 30, 2025, net cash provided by investing activities was $149.2 million, consisting of $200.7 million in proceeds from sales and maturities of short-term investments, partially offset by $47.4 million in purchases of available for sale securities and $4.1 million in purchases of property, plant and equipment and capitalized software.

Previous wording

During the three months ended June 30, 2026, net cash provided by financing activities was $0.8 million, relating to approximately $1.0 million in proceeds from the exercise of stock options, somewhat offset by principal payments of the Company's financing lease obligation.

Current wording

During the six months ended September 30, 2025, net cash provided by financing activities was $0.2 million, relating to proceeds from the exercise of stock options and pre funded warrants, somewhat offset by principal payments of the Company's financing lease obligation.

Previous wording

As of June 30, 2026, we had cash and cash equivalents and short-term investments of $195.3 million. Based on its current operating plan, the Company expects that its cash and cash equivalents and short-term investments will be sufficient to fund its operations for greater than twelve months from the issuance of these condensed consolidated financial statements, which includes the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

Current wording

As of September 30, 2026, we had cash and cash equivalents of $307.8 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations and capital expenditure requirements for greater than twelve months from the issuance of these condensed consolidated financial statements, including the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

Previous wording

During the three months ended June 30, 2026, there were no material changes to our contractual obligations and commitments from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended March 31, 2026, which was filed with the SEC on June 29, 2026.

Current wording

During the six months ended September 30, 2026, the Company closed the Fourth Amendment to the Loan Agreement with Hercules. There were no other material changes to our contractual obligations and commitments from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended March 31, 2026, which was filed with the SEC on June 29, 2026.

Previous wording

In February 2018, we entered into a Clinical Trial Collaboration and Supply Agreement with BMS. Pursuant to the agreement, BMS is providing to us, at no cost, nivolumab, its anti-PD-1 therapy, for use in combination with RP1 in our ongoing Phase 1/2 clinical trial. Under the agreement, we will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon protocol. BMS granted us a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use nivolumab in the clinical trial and has agreed to supply nivolumab, at no cost to us, for use in the clinical trial. Both parties will own the study data produced in the clinical trial, other than study data related solely to nivolumab, which will belong solely to BMS, or study data related solely to RP1, which will belong solely to us. In January 2020, this agreement was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.

Current wording

In February 2018, we entered into a Clinical Trial Collaboration and Supply Agreement with BMS. Pursuant to the agreement, BMS provided to us, at no cost, nivolumab, its anti-PD-1 therapy, for use in combination with RP1 in our IGNYTE Phase 1/2 clinical trials. Under the agreement, we will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon protocol. BMS granted us a non-exclusive, non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use nivolumab in the clinical trial and has agreed to supply nivolumab, at no cost to us, for use in the IGNYTE Phase 1/2 clinical trials. Both parties will own the study data produced in the clinical trial, other than study data related solely to nivolumab, which will belong solely to BMS, or study data related solely to RP1, which will belong solely to us. In January 2020, this agreement was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma. The Company is not using BMS supplied nivolumab in the conduct of the IGNYTE-3 clinical trial.

Previous wording

In April 2019, we entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to which BMS will provide, at no cost to us, nivolumab for use in our Phase 1 clinical trial of RP2 in combination with nivolumab.

Current wording

In April 2019, we entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to which BMS will provide, at no cost to us, nivolumab for use in our Phase 1 clinical trial of RP2 in combination with nivolumab. The Company is using BMS supplied nivolumab in the conduct of the REVEAL clinical trial.

Previous wording

We issue stock-based awards to employees, directors, consultants and non-employees in the form of stock options and restricted stock units. We measure such stock-based awards in accordance with ASC 718, Compensation — Stock Compensation, which requires all stock-based awards to be recognized in the consolidated statements of operations and comprehensive loss based on their fair value on the date of the grant and the related compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. We have, to date, only issued stock-based awards with service-based vesting conditions and record the expense for these awards using the straight-line method. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and our expected dividend yield. See Note 10 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report for more information. Forfeitures are accounted for as they occur. The fair value of each stock-based award is estimated on the date of grant based on the fair value of our common stock on that same date.

Current wording

We issue stock-based awards to employees, directors, consultants and non-employees in the form of stock options and restricted stock units. We measure such stock-based awards in accordance with ASC 718, Compensation — Stock Compensation, which requires all stock-based awards to be recognized in the consolidated statements of operations and comprehensive loss based on their fair value on the date of the grant and the related compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. To date, we have issued stock-based awards with service-based vesting conditions, as well as perforance-based stock units with milestone vesting conditions. The expense for these awards is recorded using the straight-line method. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and our expected dividend yield. See Note 11 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report for more information. Forfeitures are accounted for as they occur. The fair value of each stock-based award is estimated on the date of grant based on the fair value of our common stock on that same date.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

The leading tumor specific cohort in the IGNYTE trial was our registration directed Phase 2 expansion cohort in anti-PD-1 failed cutaneous melanoma. The anti-PD-1 failed melanoma cohort from the IGNYTE trial included 140 patients who received RP1 in combination with nivolumab. On August 6, 2026, we announced the FDA granted accelerated approval to TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial(s). Since approval, we have engaged with more than 70 percent of our 200 predefined priority accounts to establish workflows and enable efficient adoption and handling of TUDRIQEV. Since becoming commercially available in early October 2026, about 20 melanoma institutions have placed TUDRIQEV on formulary and, as of October 23, 2026 over 15 institutions have written one or more prescriptions and have started treating patients with TUDRIQEV. We have also established a patient support program, ReplimuneConnect Plus, providing a comprehensive range of support services for enrolled TUDRIQEV patients.

Current report — wording carried from elsewhere

The following chart summarizes our results of operations for the six months ended September 30, 2026 and 2025:
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

61.0%. Furthermore, the data showed that TUDRIQEV monotherapy continued to be well tolerated and the safety profile continued to be similar to that observed in non-immunocompromised patients with advanced skin cancers, and, importantly, no implant rejections were attributed to the TUDRIQEV treatment. We have closed enrollment in the ARTACUS trial and are planning a publication of the data in 2026.

Previous report — wording carried elsewhere

During the three months ended June 30, 2025, net cash used in financing activities was $0.2 million, relating to principal payments of the Company's financing lease obligation.