What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-14 compared with 2026-02-03 · 128 added, 198 removed, 241 unchanged (57% of the section changed)

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We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

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 intended to maximally activate the immune system against cancer.

Oncolytic immunotherapy is an emerging drug class, which we intend to establish as the second cornerstone of immune-based cancer treatments, alongside checkpoint blockade.

We are a commercial-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 and product candidates are designed and intended to maximally activate the immune system against cancer.

Oncolytic immunotherapy is an emerging drug class.

Oncolytic immunotherapy exploits the ability of certain viruses to selectively replicate in and directly kill tumors, as well as induce a potent, patient-specific, anti-tumor immune response.

Our product candidates incorporate multiple mechanisms of action into a practical “off-the-shelf” approach that is intended to maximize the immune response against a patient’s cancer and to offer significant advantages over other approaches to inducing anti-tumor immunity, including personalized vaccine approaches.

We believe that the bundling of multiple approaches for the treatment of cancer into single therapies will increase clinical efficacy and simplify the development path of our product candidates, while also improving patient outcomes.

Our proprietary RPx platform is based on a novel, engineered strain of herpes simplex virus 1, or HSV-1, backbone with added payloads intended to maximize immunogenic cell death and induce a systemic anti-tumor immune response.

The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor-derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response.

Our product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, and with an attractive safety profile, the RPx platform is expected to have the versatility to be developed alone or combined with a variety of other treatment options.

We currently have three RPx product candidates in our development pipeline, RP1 (vusolimogene oderparepvec), our lead product candidate, RP2 and RP3.

Our product and product candidates incorporate multiple mechanisms into a practical “off-the-shelf” approach that is intended to maximize the immune response against a patient’s cancer and to offer significant advantages over other approaches to inducing anti-tumor immunity.

Our proprietary RPx platform is based on a novel, engineered strain of herpes simplex virus 1, or HSV-1, backbone with payloads added that are intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response.

The RPx platform is intended to have unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor-derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.

Our product and product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile, the RPx platform is expected to have the versatility to be developed alone or combined with a variety of other treatment options.

In addition to TUDRIQEV, we currently have two further RPx product candidates in our development pipeline, RP2 (sturlimgene erparepvec) and RP3.

Although our fiscal year ends March 31st, our programs and program updates are reported on a calendar year basis.

We are conducting a number of clinical trials of RP1, both as a monotherapy and in combination with anti-PD-1 therapy, with a focus on establishing a major skin cancer franchise, assuming approval of our product candidates by the U.S.

Food and Drug Administration, or the FDA, and similar applicable foreign regulatory agencies.

We have been conducting a number of clinical trials of RP1, both as a monotherapy and in combination with anti-PD-1 therapy, with the goal of establishing a major skin cancer treatment franchise.

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.

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The anti-PD-1 failed melanoma cohort from the IGNYTE trial includes 140 patients who received RP1 in combination with nivolumab.

The primary analysis by independent central review was triggered once all patients had been followed for at least 12 months.

As reported in the Journal of Clinical Oncology 43(33):p 3589-3599, of the 140 patients enrolled, 48.6% had stage IVM1b/c/d disease, 65.7% had primary anti–PD-1 resistance, 56.4% were PD-L1 negative, and 46.4% received prior anti–PD-1 and anti–cytotoxic T-lymphocyte antigen-4, or anti-CTLA-4, therapy.

The confirmed ORR was 32.9% (15.0% complete response) and the responses occurred with similar frequency, depth, duration, and kinetics for injected and non-injected lesions, including visceral lesions.

The median duration of response was 33.7 months and overall survival rates at 1 and 2 years were 75.3% and 63.3%, respectively.

RP1 combined with nivolumab continues to be well-tolerated, with mainly Grade 1-2 "on target" side effects, observed.

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.

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 RP1 (vusolimogene oderparepvec) 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 has granted Breakthrough Therapy designation for RP1 in combination with nivolumab in the same setting.

The submission was made under the accelerated approval pathway.

The FDA accepted our BLA and granted priority review with a Prescription Drug User Fee Act, or PDUFA, goal date of July 22, 2025.

On July 21, 2025 the FDA issued a complete response letter, or CRL, for the RP1 BLA for the treatment of advanced melanoma.

The FDA stated in the CRL that it was unable to approve the application in its present form and that the IGNYTE trial was not considered to be an adequate and well-controlled clinical investigation that provided substantial evidence of effectiveness, including contribution of components.

Furthermore, the FDA said the trial could not be adequately interpreted due to the heterogeneity of the patient population.

On September 2, 2025 we announced a type A meeting with the FDA had been scheduled to discuss the CRL following our submission of a briefing book addressing the points raised in the CRL, highlighting prior agreements related to the patient population, criteria for PD-1 resistance, and use of literature to support contribution of components.

The briefing book also included an additional analysis of data from the BLA and addressed comments about the phase 3 confirmatory trial design raised by the FDA in the CRL.

On September 18, 2025 we announced that, following the type A meeting with the FDA to discuss the CRL, which was conducted on September 16, 2025, we were evaluating feedback received during the meeting to determine our next steps and that, at that time, a path forward under the accelerated approval pathway had not been determined.

Following the evaluation of FDA feedback and minutes from the type A meeting, we resubmitted the BLA on October 9, 2025.

On October 20, 2025 we announced that the FDA had accepted the resubmission of the BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.

The resubmission included additional information, data and analyses that will be part of the BLA review.

The FDA indicated that the resubmission is considered to be a complete response to the CRL and set a PDUFA date of April 10, 2026 based on a Class II resubmission timeline.

We are interacting with the FDA during the review of the resubmitted BLA and, if approved, intend to bring RP1 to adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen who otherwise have limited treatment options.

Without an approval of RP1 from this resubmitted BLA we might not be able to continue the development of RP1 for this indication, if at all, and we may be required to implement a restructuring plan and review our priorities across the RPx portfolio.

In August 2024, we announced the dosing of the first patient in the IGNYTE-3 trial, or the I-3 trial, a confirmatory study design concept consisting of 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.

With approximately 80 sites planned globally and an expectation to enroll 400 patients, the I-3 trial will assess RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment.

In the type A meeting minutes following the CRL, the FDA stated a control arm of nivolumab in combination with relatlimab (Opdualag TM ) may be an acceptable comparator for the I-3 randomized controlled trial.

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.

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.

We are also planning for an interim overall survival, or OS, analysis in the second half of 2027.

On October 19, 2025 we announced data from a new ad hoc analysis from the IGNYTE phase 2 cohort of RP1 plus nivolumab, which was released at the European Society for Medical Oncology (ESMO) Congress 2025 held in Berlin.

This ad hoc analysis focused on acral melanoma data from patients in the IGNYTE anti-PD-1 failed melanoma cohort and showed treatment with RP1 combined with nivolumab resulted in an objective response rate of 44% (8/18) with a median duration of response of 11.9 months.

The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events, similar to those of the full IGNYTE patient population previously reported.

Acral melanoma is a rare and aggressive type of cutaneous melanoma (2-3% of all melanoma cases) that frequently occurs on the palms of the hands, soles of the feet, and nailbeds, and often has poor outcomes with many patients presenting with in-transit metastases.

Acral melanoma does not

typically respond well to available therapies, such as immune checkpoint inhibitors.

Following progression on first-line therapy, aside from targeted therapy for a subset of patients with BRAF mutation-positive tumors, few viable treatment options exist for these patients.

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.

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 in our June 2025 Investor Day and in October 2025 at ESMO.

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 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 have closed enrollment in this cohort in the fourth quarter of 2025.

Furthering development of RP1, we have open for enrollment a Phase 1b/2 clinical trial of single agent RP1 in solid organ transplant recipients with skin cancers, including CSCC, which we refer to as the ARTACUS trial.

We believe that the ARTACUS trial may be potentially registrational (in its own right or, subject to discussion with regulatory authorities, following enrollment of additional patients, including as a potential label expansion after an initial approval of RP1 in a different indication).

We are currently planning to enroll up to 65 patients in the ARTACUS trial to assess the safety and efficacy of RP1 in liver, kidney, heart, lung, and hematopoietic cell transplant patients with skin cancers.

In November 2023 we presented initial data from the ARTACUS trial of RP1 monotherapy in solid organ transplant recipients with skin cancers at the Society for Immunotherapy of Cancer’s, or SITC, 38th Annual Meeting.

The data included 23 evaluable patients with CSCC (n=20) and MCC (n=3), demonstrating an ORR of 34.5% and a complete response, or CR, of 21%.

RP1 monotherapy was well tolerated in these patients and the safety profile was similar to that observed in our other RP1 clinical trials in patients who are not immune suppressed.

No immune-mediated adverse events or evidence of allograft rejection were observed to result from RP1.

This data was also presented during oral presentation at the American Association of Cancer Research 2024 Annual Meeting in April 2024.

More recently, Dr.

We closed enrollment in the NMSC tumor type cohorts in the fourth quarter of 2025.

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.

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

RP1 monotherapy continues to be well tolerated, and the safety profile continues to be similar to that observed in non-immunocompromised patients with advanced skin cancers.

We are planning a publication of the ARTACUS data in 2026.

As previously reported, our clinical trial of RP1 in patients with CSCC, which we refer to as the CERPASS trial, continues as planned to follow patients that were dosed in the trial.

We are also developing or are continuing to develop additional product candidates, RP2 and RP3, that have been further engineered to enhance anti-tumor immune responses and are intended to address additional tumor types, including traditionally less immune responsive tumor types.

In addition to the expression of GALV-GP R(-) and human GM-CSF as in RP1, RP2 has been engineered to express an antibody-like molecule intended to block the activity of CTLA-4, a protein that inhibits the full activation of an immune response, including to tumors.

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.

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.

We are also developing or are continuing to develop product candidates, RP2 and RP3, that have been further engineered to enhance anti-tumor immune responses and are intended to address additional tumor types, including traditionally less immune responsive tumor types.

In addition to the expression of GALV-GP R(-) and human GM-CSF as in TUDRIQEV, RP2 has been engineered to express an antibody-like molecule intended to block the activity of CTLA-4, a protein that inhibits the full activation of an immune response, including to tumors.

RP3 has been engineered with the intent to further stimulate an anti-tumor immune response through activation of immune co-stimulatory pathways through the additional expression of the ligands for CD40 and 4-1BBL, as well as anti-CTLA-4 and GALV-GP R(-), but without the expression of GM-CSF.

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one of the responding patients was treated with RP2 monotherapy and four of the responding patients were treated with RP2 combined with nivolumab), including responses in patients with liver, lung, and bone metastases.

The median DOR at the data cutoff was 11.47 months (range of 2.78 to 21.22 with responses ongoing).

The median duration of response (DOR) at the data cutoff was 11.47 months (range of 2.78 to 21.22 with responses ongoing).

Nearly all patients (15 of 17, 88.2%) in the study had progressed on or after immunotherapy with 12 of 17 patients (70.6%) having previously received both anti-PD-1 and anti-CTLA-4 therapies, including four of the responding patients.

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The most common grade 1 or 2 treatment related adverse events, or TRAEs, overall in both cohorts were pyrexia, chills, fatigue, hypotension and pruritis.

Six patients had grade 3 TRAEs,

including two cases of hypotension.

Six patients had grade 3 TRAEs, including two cases of hypotension.

There were no grade 4 or 5 TRAEs.

In June 2024, we presented that the disease control rate for this cohort of mUM patients was 58.8%.

We are enrolling patients in a registration-directed study, or the REVEAL study, of RP2 in mUM patients who are immune checkpoint inhibitor-naïve.

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.

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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 expansion of the REVEAL trial outside the United States with roughly 50 sites engaged and the Phase 2/3 transition is expected in the first quarter of 2027.

We continue our signal finding trial of RP2 in combination with atezolizumab and bevacizumab in the 2L setting of patients with hepatocellular carcinoma, or HCC, in collaboration with Roche.

This Phase 2 clinical trial is currently open and enrollment is underway.

In January 2026 we announced the Phase 2/3 transition is expected to occur in the first quarter of 2027.

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 enroll patients with biliary tract cancer, or BTC, and dose RP2 in combination with durvalumab.

This cohort enrolled the first patients in the fourth quarter of 2025.

RP1, RP2 and RP3 are administered by direct injection into solid tumors, guided either visually or by ultrasound, computerized tomography or other imaging methods.

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.

TUDRIQEV, RP2 and RP3 are administered by direct injection into solid tumors, guided either visually or by ultrasound, computerized tomography or other imaging methods.

We believe that direct injection maximizes virus-mediated tumor cell death, provides the most efficient delivery of virus-encoded immune activating proteins into the tumor with the goal of activating systemic immunity, and limits the systemic toxicities that could be associated with intravenous administration.

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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 one or more of our product candidates.

We do not have any products approved for sale and have not generated any revenue from product sales.

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, w e do not have any products approved for sale and have not generated any revenue from product sales.

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.

We sold 7,407,936 shares of common stock in our IPO, an aggregate of 28,968,857 shares of our common stock and pre-funded warrants to purchase 13,330,422 shares of common stock in the Public Offerings, 5,668,937 shares of our common stock and pre-funded warrants to purchase 5,669,578 shares of common stock through our private investment in public equity in June 2024, and 3,393,520 shares of common stock through our at-the-market facilities.

Our net losses were $70.9 million and $66.3 million for the three months ended December 31, 2025 and 2024, respectively, and $240.7 million and $173.2 million for the nine months ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had an accumulated deficit of $1,189.3 million.

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.

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We expect to continue to incur costs and expenses in the future and our expenses may increase if and as we:

• seek to successfully commence and achieve commercial sales of TUDRIQEV;

• seek to successfully complete one or more confirmatory trials of TUDRIQEV, including our ongoing IGNYTE-3 clinical trial;

• seek to obtain adequate coverage and reimbursement for TUDRIQEV

• continue to conduct our current and future clinical trials;

• further preclinical development of our platform;

• operate our in-house manufacturing facility;

• seek to manufacture and maintain sufficient commercial supply of TUDRIQEV, or clinical supply of our product candidates, from our in-house manufacturing facility;

• seek to identify and develop additional product candidates;

• seek marketing approvals for any of our product candidates that successfully complete clinical trials, if any;

• seek marketing approvals for any of our product and product candidates that successfully complete clinical trials, if any;

• establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

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If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As of December 31, 2025, we had cash and cash equivalents and short-term investments of $269.1 million.

Based on our current operating plan including the commercialization of RP1 in the near term, we believe that our existing cash and cash equivalents and short-term investments, in addition to the additional draw down of debt from the third amendment of the loan agreement with Hercules and the cash raised from our ATM during the subsequent event period, will enable us to fund our operating expenses and capital expenditure requirements through at least 12 months from the issuance of the condensed consolidated financial statements included in this Quarterly Report.

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.

See “—Liquidity and capital resources” and “Risk factors—Risks related to our financial position and need for additional capital.”

Components of our results of operations

To date, we have not generated any revenue from product sales as we do not have any approved products and we can not be certain we will generate any revenue from the sale of products in the future.

If our development efforts for RP1 or any 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.

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.

Operating expenses

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Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our product candidates, and include:

• expenses incurred under agreements with third parties, including clinical research organizations, or CROs, that conduct research, preclinical activities and clinical trials on our behalf as well as contract manufacturing organizations, or CMOs, that manufacture raw materials and supplies for our product candidates and their manufacturing, packaging and labeling;

• expenses incurred under agreements with third parties, including clinical research organizations, or CROs, that conduct research, preclinical activities and clinical trials on our behalf as well as contract manufacturing organizations, or CMOs, that manufacture raw materials and supplies for our product and product candidates and their manufacturing, packaging and labeling;

• salaries, benefits and other related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

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• the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials;

• costs related to compliance with regulatory requirements in connection with the development of our product candidates;

• costs related to compliance with regulatory requirements in connection with the development of our product and product candidates;

• facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

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We expect that our research and development expenses will continue to increase for the foreseeable future as we continue enrollment in, and the initiation of, additional clinical trials, as well as the continued discovery and development of additional product candidates.

However, if we determine that the continued development of RP1 is not viable, our outlook and plans may be uncertain and the impact on our research and development expenses will also be uncertain.

However, if we determine that the commercialization of TUDRIQEV is not viable, our outlook and plans may be uncertain and the impact on our research and development expenses will also be uncertain.

At this time the ability to fund and successfully develop, and commercialize, if approved, our product candidates is highly uncertain.

This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following:

• to what extent we are able to reach a mutually agreeable path forward with the FDA with respect to the scope, design, implementation and timing of an approval for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen the scope, rate of progress, expense and results of our ongoing clinical trials, as well as future clinical trials or other product candidates and other research and development activities that we may conduct;

• the extent to which we are able to reach a mutually agreeable path forward with the FDA with respect to the scope, design, implementation and timing of an approval for our product candidates and other research and development activities that we may conduct;

• the number and scope of preclinical and clinical programs we decide to pursue;

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A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.

For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, to modify the clinical design of any of our clinical trials as contemplated in the CRL or otherwise, if we experience significant trial delays due to patient enrollment or other reasons, we could be required to expend significant additional financial resources and time on the completion of clinical development.

For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant trial delays due to patient enrollment or other reasons, we could be required to expend significant additional financial resources and time on the completion of clinical development.

We may never succeed in obtaining regulatory approval for any of our product candidates.

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Selling, general and administrative expenses also include professional fees for legal, patent, accounting, auditing, tax and consulting services, pre-commercial planning, travel expenses, and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

We expect that our selling, general and administrative expenses will continue to increase in the future as we increase our selling, general and administrative headcount to support our continued research and development and pre-launch activities to prepare for potential commercialization of our product candidates.

We expect our selling, general and administrative expenses to continue to increase in the future as we increase our selling, general and administrative headcount to support our continued operations and pre-launch and launch activities for the commercialization of TUDRIQEV.

We also expect to continue to incur increased expenses, including accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements;

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and investor and public relations costs.

If we determine that the continued development of RP1 is not viable, we expect that our selling, general and administrative expenses will decrease but to what extent we are uncertain.

If we are unable to successfully commercialize TUDRIQEV, we expect that our selling, general and administrative expenses will decrease but to what extent we are uncertain.

Other income (expense), net

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In each quarter, the Company updates its estimate of the annual effective tax rate, and if the estimated annual tax rate changes, a cumulative adjustment is made in that quarter.

For the three and nine months ended December 31, 2025 and 2024, the Company excluded the United States and the United Kingdom from the calculation of the AETR as the Company anticipates an ordinary loss in this jurisdiction for which no tax benefit can be recognized.

The Company has evaluated the positive and negative evidence bearing upon its ability to realize its deferred tax assets both in the United States and United Kingdom, which primarily consist of net operating loss carryforwards.

The Company has considered its history of cumulative net losses, estimated future taxable income and prudent and feasible tax planning strategies and has concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets.

As a result, as of December 31, 2025 and March 31, 2025, the Company has recorded a full valuation allowance against its net deferred tax assets.

Results of operations

Comparison of the three months ended December 31, 2025 and 2024

The following chart summarizes our results of operations for the three months ended December 31, 2025 and 2024:

Comparison of the three months ended June 30, 2026 and 2025

The following chart summarizes our results of operations for the three months ended June 30, 2026 and 2025:

Three Months Ended

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Other (expense) income, net (688) 591 (1,279)

Total other income (expense), net 627 254 373

Loss before income taxes $ (71,241) $ (65,765) $ (5,476)

Income tax (benefit) provision $ (311) $ 575 $ (886)

Total other (expense) income, net (1,519) 3,729 (5,248)

Net loss $ (69,766) $ (86,693) $ 16,927

Research and development expenses

Research and development expenses for the three months ended December 31, 2025 were $53.1 million, compared to $48.0 million for the three months ended December 31, 2024.

The following table summarizes our research and development expenses for the three months ended December 31, 2025 and 2024:

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:

Three Months Ended

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Total research and development expenses $ 49,277 $ 57,843 $ (8,566)

The overall increase of $5.1 million in total research and development expenses was driven by an increase of approximately $6.3 million in direct research costs, which includes an increase of $3.6 million in RP1 costs, as well as an increase of $3.3 million in spending on RP2.

The increase in RP1 includes $3.6 million of other study costs including lab and operating supplies to support the Company's anticipated commercial and clinical demand.

In addition, there was an increase of $1.8 million in costs related to the IGNYTE-3 confirmatory study, which ramped up activity and enrollment in this current fiscal year.

These increases are somewhat offset by a decrease of approximately $1.2 million in the IGNYTE study as a result of the completion of enrollment in the IGNYTE advanced melanoma cohort during the year.

In addition to the increases in RP1,

there was an increase of $3.3 million in spending on RP2 as a result of increased enrollment in the REVEAL study as compared to the same quarter in the prior year.

Selling, general and administrative expenses

Selling, general and administrative expenses were $18.7 million for the three months ended December 31, 2025, compared to $18.0 million for the three months ended December 31, 2024.

The increase of $0.7 million is primarily the result of the $3.8 million in personnel related costs in the sales and marketing and G&A functions as the Company continues to prepare for its first potential commercial launch of RP1, that included pre-launch planning and continued building of the Company's commercial infrastructure.

The increase in personnel related costs is partially offset by a decrease of $3.4 million in external sales and marketing costs, as spending in this area decreased during this quarter while the Company worked with the FDA regarding the resubmission of the BLA for RP1.

Total other income (expense), net

Other income (expense), net was $0.6 million for the three months ended December 31, 2025, compared to income of $0.3 million for the three months ended December 31, 2024.

The net change of $0.4 million is primarily attributable to a decrease in expense of $2.7 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.

The decrease in expense was partially offset by a decrease in investment income of $2.3 million as a result of a lower investment balance year over year.

Comparison of the nine months ended December 31, 2025 and 2024

The following chart summarizes our results of operations for the nine months ended December 31, 2025 and 2024:

Nine Months Ended

2025 2024 Change

(Amounts in thousands)

Operating expenses:

Research and development $ 168,860 $ 135,472 $ 33,388

Selling, general and administrative 77,721 $ 46,827 30,894

Total operating expenses 246,581 182,299 64,282

Loss from operations (246,581) (182,299) (64,282)

Other income (expense):

Research and development incentives 1,138 1,222 (84)

Investment income 11,256 15,243 (3,987)

Interest expense on finance lease liability (1,553) (1,594) 41

Interest expense on debt obligations (4,429) (4,314) (115)

Other (expense) income, net (865) (850) (15)

Total other income (expense), net 5,547 9,707 (4,160)

Loss before income taxes $ (241,034) $ (172,592) $ (68,442)

Income tax (benefit) provision $ (311) $ 575 $ (886)

Net loss $ (240,723) $ (173,167) $ (67,556)

Research and development expenses

Research and development expenses for the nine months ended December 31, 2025 were $168.9 million, compared to $135.5 million for the nine months ended December 31, 2024.

The following table summarizes our research and development expenses for the nine months ended December 31, 2025 and 2024:

Nine Months Ended December 31,

2025 2024 Change

Direct research and development expenses by program

RP1 program costs by study:

IGNYTE 8,073 10,831 (2,758)

ARTACUS 4,898 5,211 (313)

CERPASS 3,653 5,573 (1,920)

IGNYTE-3 15,554 4,909 10,645

Other RP1 study costs 15,162 7,075 8,087

Total RP1 costs 47,340 33,599 13,741

RP2 16,857 8,322 8,535

RP3 2,262 3,856 (1,594)

Unallocated research and development expenses:

Personnel related (including stock-based compensation) 77,645 67,712 9,933

Other 24,756 21,983 2,773

Total research and development expenses $ 168,860 $ 135,472 $ 33,388

The total increase of $33.4 million in research and development expenses was attributable to an increase of $20.7 million in our direct research and development costs, as well as an increase of $12.7 million in unallocated expenses.

The increase of approximately $20.7 million in our direct research and development costs primarily relates to an increase of $13.7 million in RP1 as a result of an increase of $10.6 million in spending related to the confirmatory study, which ramped up activity and enrollment in this current fiscal year, as well as $8.1 million in other RP1 study costs, specifically operating and lab supplies, and facility costs.

These increases were slightly offset by decreases in the IGNYTE and CERPASS studies as a result of the completion of enrollment in the IGNYTE advanced melanoma cohort and declining enrollment and the wind down of the CERPASS study.

In addition to the increases in RP1, there was an $8.5 million increase in spending on RP2 as a result of increased enrollment as compared to the prior year.

The increase in unallocated expenses includes $9.9 million in personnel-related costs and $2.8 million in other costs.

The increase in personnel-related costs is primarily attributable to a $12.3 million increase in payroll and fringe benefits which largely reflected the increase in personnel in our research and development functions year over year as we expanded the development plan in multiple indications.

The increase in other costs is driven primarily by an increase in medical affairs and facility costs.

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

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.

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.

Selling, general and administrative expenses

Selling, general and administrative expenses were $77.7 million for the nine months ended December 31, 2025, compared to $46.8 million for the nine months ended December 31, 2024.

The increase of approximately $30.9 million in sales, general and administrative costs is driven by an increase of $18.4 million in personnel-related costs, as well as $7.7 million in sales and marketing costs related to promotional materials, market access and insights and analytics, as the Company prepares for a potential commercial launch of RP1.

In addition, the year over year increase includes approximately $2.9 million in professional fees and consulting costs.

Total other income (expense), net

Other income (expense), net was $5.5 million for the nine months ended December 31, 2025, compared to income of $9.7 million for the nine months ended December 31, 2024.

The net change of $4.2 million is primarily attributable to a decrease in investment income of $4.0 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.

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.

Total other (expense) income, net

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.

Liquidity and capital resources

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.

We have not yet commercialized any of our product candidates, which are

in various phases of preclinical and clinical development, and we cannot predict when we may generate revenue from sales of any products, if at all.

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.

Sources of liquidity

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 December 31, 2025, we had received net proceeds of $1,112.1 million through the sale of shares of common stock and pre-funded warrants exercisable for common stock in public offerings, a private investment in a public entity, and at-the-market offerings, as well as net $42.8 million from our incurrence of debt under the term loan agreement with Hercules.

As of December 31, 2025, we had cash and cash equivalents and short-term investments of $269.1 million.

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.

The following table summarizes our cash flows for each of the periods presented:

Nine Months Ended December 31,

Three Months Ended June 30,

(Amounts in thousands)

Net cash used in operating activities $ (75,728) $ (77,016)

Net cash provided by (used in) investing activities

Net cash provided by investing activities

49,993 65,048

Net cash provided by financing activities 10,617 252,528

Net cash provided by (used in) financing activities 800 (158)

Effect of exchange rate changes on cash and cash equivalents 1,270 (1,616)

Net increase in cash and cash equivalents $ 11,833 $ 97,788

Net decrease in cash and cash equivalents $ (23,665) $ (13,742)

Operating activities

During the nine months ended December 31, 2025, net cash used in operating activities was $224.2 million, primarily resulting from our net loss of $240.7 million partially offset by non-cash charges of $27.3 million, which primarily consist of stock-based compensation expense of $24.1 million and depreciation and amortization of $5.0 million, somewhat offset by net amortization of premiums and discounts on short-term investments of $2.2 million, and a decrease in cash of $10.7 million related to changes in our operating assets and liabilities.

Changes in our operating assets and liabilities for the nine months ended December 31, 2025 consisted primarily of a $5.9 million decrease in accounts payable, a $4.7 million decrease in accrued expenses and other current liabilities, and a $0.9 million decrease in research and development incentives receivable from the United Kingdom government due to the timing and amount of our qualifying expenditures.

During the nine months ended December 31, 2024, net cash used in operating activities was $138.5 million, primarily resulting from our net loss of $173.2 million partially offset by non-cash charges of $26.7 million, which primarily consist of stock-based compensation expense of $26.8 million, somewhat offset by net amortization of premiums and discounts on short-term investments of $7.0 million, and an increase in cash of $7.9 million related to changes in our operating assets and liabilities.

Changes in our operating assets and liabilities for the nine months ended December 31, 2024 consisted primarily of a $4.7 million increase in accounts payable, a $2.5 million increase in accrued expenses and other current liabilities, a $1.9 million decrease in research and development incentives receivable from the United Kingdom government due to the timing and amount of our qualifying expenditures, and a net $1.8 million change in operating and financing right-of-use assets and lease liabilities.

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.

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.

Investing activities

During the nine months ended December 31, 2025, net cash provided by investing activities was $224.3 million, consisting of $302.5 million in proceeds from sales and maturities of short-term investments, partially offset by $73.9 million in purchases of available for sale securities and $4.2 million in purchases of property, plant and equipment and capitalized software.

During the nine months ended December 31, 2024, net cash used in investing activities was $16.1 million, consisting of $332.0 million in purchases of available for sale securities and $5.6 million in purchases of property, plant and equipment and capitalized software, partially offset by $321.4 million in proceeds from sales and maturities of short-term investments.

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.

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.

Financing Activities

During the nine months ended December 31, 2025, net cash provided by financing activities was $10.6 million, relating primarily to $10.4 million from the issuance of common stock through ATM sales, as well as approximately $0.8 million in proceeds from the exercise of stock options and pre-funded warrants, somewhat offset by principal payments of the Company's financing lease obligation.

During the nine months ended December 31, 2024, net cash provided by financing activities was $252.5 million, consisting primarily of $252.7 million in proceeds from the Company's private investment in a public entity in June 2024 as well as the Company's November 2024 public offering.

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.

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.

Funding requirements

Our plan of operation is to continue implementing our business strategy, continue research and development of RP1 and our other product candidates and continue to expand our research pipeline and our internal research and development capabilities.

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our product candidates and if and as we:

• conduct our current and future clinical trials with RP1, RP2 and RP3;

• further preclinical development of our RPx platform;

• operate, qualify and maintain our in-house manufacturing facility and qualify and maintain our product candidates made therein for use in our clinical trials;

Our plan of operation is to continue implementing our business strategy, commence and achieve commercial sales of TUDRIQEV, and continue research and development of our product candidates and continue to expand our research pipeline and our internal research and development capabilities.

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the commercialization of TUDRIQEV and the preclinical activities and clinical trials of our product candidates and if and as we:

• seek to successfully commence and achieve commercial sales of TUDRIQEV;

• seek to complete one or more confirmatory trials of TUDRIQEV, including our ongoing IGNYTE-3 clinical trial, as well as our other post marketing requirements and commitments;

• seek to obtain adequate coverage and reimbursement for TUDRIQEV

• conduct our current and future clinical trials with RP2 and RP3;

• further preclinical development of any of our product candidates from our RPx platform;

• operate, qualify and maintain our in-house manufacturing facility and qualify and maintain our product and product candidates made therein for use in our clinical trials;

• seek to identify and develop additional product candidates;

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• establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

• until our planned manufacturing facility is fully validated, continued limited manufacturing by third parties for clinical development.

• seek to manufacture and maintain sufficient commercial supply of TUDRIQEV, or clinical supply of our product candidates, from our in-house manufacturing facility;

• maintain, expand, protect and defend our intellectual property portfolio;

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• add operational, financial and management information systems and personnel, including personnel to support our research and development programs, any future commercialization efforts and operations as a public company.

Following discussions with the FDA related to the CRL, we may determine that the continued development of RP1 is not viable.

If we determine that the continued development of RP1 is not viable, our outlook and plans may be uncertain and the impact on our research and development expenses will also be uncertain.

As of December 31, 2025, we had cash and cash equivalents and short-term investments of $269.1 million.

Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments as of December 31, 2025, in addition to the additional draw down of debt from the third amendment to the loan agreement with Hercules and the cash raised from our ATM during the subsequent event period, will enable us to fund operations late into the first quarter of calendar 2027.

This includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Because of the numerous risks and uncertainties associated with the development of RP1 and other product candidates and programs, and because the extent to which we may enter into collaborations with third parties for development of our product candidates is unknown, we are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates.

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.

Because of the numerous risks and uncertainties associated with the commercialization of TUDRIQEV and the development of our other product candidates and programs, and because the extent to which we may enter into collaborations with third parties for development of our product candidates is unknown, we are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates.

Our future capital requirements will depend on many factors, including those described in this section and above under “—Operating expenses—Research and development expenses.”

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Contractual obligations and commitments

During the nine months ended December 31, 2025, 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, 2025, which was filed with the SEC on May 22, 2025.

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.

Collaborations

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The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements.

We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the

results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

We evaluate our estimates and assumptions on an ongoing basis.

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There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense.

Payments under some of these contracts depend on

factors such as the successful enrollment of patients and the completion of clinical trial milestones.

Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones.

In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis