What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-07 · 147 added, 73 removed, 283 unchanged (44% of the section changed)

Management’s discussion and analysis of financial condition and results of operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q, or this Quarterly Report, and with our audited consolidated financial statements and notes thereto for the year ended March 31, 2025, included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2025.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q, or this Quarterly Report, and with our audited consolidated financial statements and notes thereto for the year ended March 31, 2025, included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2025.

In addition to historical information, some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

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

The topline results showed the overall response rate, or ORR, was 33.6% by modified RECIST 1.1 criteria, the primary endpoint as defined in the protocol, and 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA.

Responses from baseline were highly durable with 85% of responses lasting more than 12 months.

The median duration of response from baseline was 27.6 months and the median duration of response from treatment initiation was 21.6 months.

As reported in the Journal of Clinical Oncology, July 8, 2025 (https://doi.org/10.1200/JCO-25-01346), 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.

In November 2024, we announced submission of a biologics license application, or BLA, to 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 to RP1 in combination with nivolumab in the same setting.

In November 2024, we announced submission of a biologics license application, or BLA, to 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.

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

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

We plan to interact with the FDA in an attempt to find a path forward, including potentially pursuing a Type A meeting with the FDA, for the timely accelerated approval of RP1 in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen.

If we are unable to reach a timely and mutually agreeable path forward with the FDA with respect to the scope, design, implementation and timing for the potential approval for RP1 in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen, we might not be able to continue the development of RP1 for this indication, if at all, and it may require us to implement a restructuring plan and review the priorities across the RPx portfolio.

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 plan to interact 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 over 100 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.

We continue to enroll patients in the I-3 trial.

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.

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.

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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.

Enrollment remains open in this cohort.

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 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 are planning on closing 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 will 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 enrolling 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.

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.

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

We continue to enroll patients into the ARTACUS trial.

More recently, Dr.

Migden presented updated data from the ARTACUS trial at the Society for Melanoma Research 22nd International Congress in October 2025.

We continue to enroll patients into the ARTACUS trial and 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.

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

We have initiated and are enrolling patients in a registration-directed study, or the REVEAL study, of RP2 in mUM patients who are immune checkpoints inhibitor-naive.

The REVEAL study is a randomized, phase 2/3 open label study to investigate the efficacy and safety of RP2 in combination with nivolunab vs.

ipilimumab in combination with nivolunab in immune checkpoint inhibitor naive adult patients with metastatic uveal melanoma.

We have initiated and are enrolling patients in a registration-directed study, or the REVEAL study, of RP2 in mUM patients who are immune checkpoints 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.

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.

We anticipate releasing preliminary HCC data in the first half of 2026.

The protocol is currently being amended to include RP2 as monotherapy and we plan to release preliminary HCC data by the end of 2026.

We are also planning to open a cohort in our RP2 study to enroll patients with biliary tract cancer, or BTC, and dose RP2 in combination with durvalumab.

This cohort is expected to enroll the first patient in the second half of 2025.

This cohort is expected to enroll the first patient 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.

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

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 a public entity in June 2024, and $41.9 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 a public entity in June 2024, and 2,313,997 shares of common stock through our at-the-market facilities.

Our net losses were $86.7 million and $53.8 million for the three months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $1,035.3 million.

Since our initial public offering, or IPO, on July 20, 2018, we have raised an aggregate of approximately $1,101.8 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 $41.9 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 2,313,997 shares of common stock through our at-the-market facilities.

Our net losses were $83.1 million and $53.1 million for the three months ended September 30, 2025 and 2024, respectively, and $169.8 million and $106.8 million for the six months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $1,118.4 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.

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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 June 30, 2025, we had cash and cash equivalents and short-term investments of $403.3 million.

Based on our current operating plan including the commercialization of RP1 in the near term, w e believe that our existing cash and cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements through at least 12 months from the issuance of the consolidated financial statements included in this Quarterly Report.

As of September 30, 2025, we had cash and cash equivalents and short-term investments of $323.6 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 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.

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

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Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

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.

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Selling, general and administrative expenses

Selling, general and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, corporate, commercial and business development and administrative

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.

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Interest expense on finance lease liability consists of amortization of finance charges under our financing lease.

Other income (expense)

Other income (expense) consists primarily of realized and unrealized foreign currency transaction gains and losses.

Other (expense) income

Other (expense) income consists primarily of realized and unrealized foreign currency transaction gains and losses.

The Company’s tax provision and the resulting effective tax rate for interim periods is determined based upon its estimated annual effective tax rate (“AETR”), adjusted for the effect of discrete items arising in that quarter.

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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 months ended June 30, 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.

For the three and six months ended September 30, 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 June 30, 2025 and March 31, 2025, the Company has recorded a full valuation allowance against its net deferred tax assets.

As a result, as of September 30, 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 June 30, 2025 and 2024

The following chart summarizes our results of operations for the three months ended June 30, 2025 and 2024:

Comparison of the three months ended September 30, 2025 and 2024

The following chart summarizes our results of operations for the three months ended September 30, 2025 and 2024:

Three Months Ended

September 30,

2025 2024 Change

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Interest expense on debt obligations (1,488) (1,438) (50)

Other income (expense) 591 406 185

Other (expense) income, net (876) 2,028 (2,904)

Total other income (expense), net 1,191 5,861 (4,670)

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Research and development expenses

Research and development expenses for the three months ended June 30, 2025 were $57.8 million, compared to $43.0 million for the three months ended June 30, 2024.

The following table summarizes our research and development expenses for the three months ended June 30, 2025 and 2024:

Research and development expenses for the three months ended September 30, 2025 were $57.9 million, compared to $43.4 million for the three months ended September 30, 2024.

The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:

Three Months Ended

September 30,

2025 2024 Change

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Total research and development expenses $ 57,877 $ 43,448 $ 14,429

The overall increase of $14.9 million in total research and development expenses was driven by an increase of approximately $9.6 million in our unallocated expenses which is comprised of a $5.5 million increase in personnel related costs, as well as a $4.1 million increase in other costs primarily attributable to increased medical affairs and consulting costs.

The increase of $5.2 million in direct research costs is primarily driven by an increase of $4.0 million in costs related to the IGNYTE-3 confirmatory study, which ramped up activity in the second half of fiscal 2025.

In addition, the increase of $1.8 million in spending on RP2 is primarily attributable to an increase of approximately $1.6 million in costs related to the REVEAL study which began enrollment in the prior fiscal year.

The overall increase of $14.4 million in total research and development expenses was driven by an increase of approximately $9.2 million in direct research costs, which includes an increase of $6.3 million in RP1 costs consisting primarily of $4.8 million in costs related to the IGNYTE-3 confirmatory study, which ramped up activity and enrollment in this current fiscal year.

The increase in RP1 also 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 to the increases in RP1, there was an increase of $3.4 million in spending on RP2 as a result of increased enrollment as compared to the same quarter prior year.

The increase in spend of $5.3 million in our unallocated expenses is comprised of a $5.8 million increase in personnel related costs as a result of higher headcount year over year, slightly offset by a $0.6 million decrease in other costs.

The increase in personnel related costs during the quarter was driven by the additional headcount that the Company hired in preparation for the potential launch of RP1 in advanced melanoma.

Selling, general and administrative expenses

Selling, general and administrative expenses were $32.6 million for the three months ended June 30, 2025, compared to $14.4 million for the three months ended June 30, 2024.

The increase of $18.2 million is primarily the result of an increase of $9.0 million in sales and marketing costs as the Company prepares for its first potential commercial launch of RP1.

In addition, there is an increase of $7.2 million in personnel related costs, including an increase of $8.4 million in payroll and fringe benefits, slightly offset by a $1.2 million decrease in stock-based compensation expense.

The increase in personnel related costs during the quarter was driven by continued hiring in our selling, general and administrative functions, focusing on additional pre-launch planning and continued building of the Company's commercial infrastructure.

Selling, general and administrative expenses were $26.4 million for the three months ended September 30, 2025, compared to $15.5 million for the three months ended September 30, 2024.

The increase of $10.9 million is primarily the result of an increase of $9.5 million in sales and marketing costs, driven by personnel costs, as the Company continues preparation for its first potential commercial launch of RP1.

Personnel related costs increased by approximately $7.2 million, including an increase of $7.9 million in payroll and fringe benefits, offset slightly by a decrease of $0.6 million in stock-based compensation expense.

The increase in personnel related costs during the quarter was driven by continued focus on additional pre-launch planning and continued building of the Company's commercial infrastructure.

Total other income (expense), net

Other income (expense), net was $3.7 million for the three months ended June 30, 2025, compared to income of $3.6 million for the three months ended June 30, 2024.

Total other income (expense), net is relatively consistent year over year, with a net change of $0.1 million.

The change is primarily attributable to a decrease in expense of $0.2 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.

This was somewhat offset by an increase in interest expense on debt obligations.

Income tax provision

During the three months ended June 30, 2025 and 2024, the Company did not record an income tax provision for the three months ended June 30, 2025 or 2024 as a result of a forecasted United States and United Kingdom losses for the respective years.

Other income (expense), net was $1.2 million for the three months ended September 30, 2025, compared to income of $5.9 million for the three months ended September 30, 2024.

The net change of $4.7 million is primarily attributable to an increase in expense of $2.9 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.

In addition, there was a decrease in investment income of $1.7 million as a result of a lower investment balance year over year.

Comparison of the six months ended September 30, 2025 and 2024

The following chart summarizes our results of operations for the six months ended September 30, 2025 and 2024:

Six Months Ended

September 30,

2025 2024 Change

(Amounts in thousands)

Operating expenses:

Research and development $ 115,721 $ 86,420 $ 29,301

Selling, general and administrative 58,994 $ 29,863 29,131

Total operating expenses 174,715 116,283 58,432

Loss from operations (174,715) (116,283) (58,432)

Other income (expense):

Research and development incentives 797 846 (49)

Investment income 8,411 10,106 (1,695)

Interest expense on finance lease liability (1,039) (1,065) 26

Interest expense on debt obligations (2,963) (2,864) (99)

Other (expense) income, net (284) 2,433 (2,717)

Total other income (expense), net 4,922 9,456 (4,534)

Net loss $ (169,793) $ (106,827) $ (62,966)

Research and development expenses

Research and development expenses for the six months ended September 30, 2025 were $115.7 million, compared to $86.4 million for the six months ended September 30, 2024.

The following table summarizes our research and development expenses for the six months ended September 30, 2025 and 2024:

Six Months Ended September 30,

2025 2024 Change

Direct research and development expenses by program

RP1 program costs by study:

IGNYTE 6,014 7,604 (1,590)

ARTACUS 3,235 3,423 (188)

CERPASS 2,640 3,962 (1,322)

IGNYTE-3 11,335 2,534 8,801

Other RP1 study costs 9,963 5,487 4,476

Total RP1 costs 33,187 23,010 10,177

RP2 9,128 3,913 5,215

RP3 1,437 2,422 (985)

Unallocated research and development expenses:

Personnel related (including stock-based compensation) 53,966 42,603 11,363

Other 18,003 14,472 3,531

Total research and development expenses $ 115,721 $ 86,420 $ 29,301

The total increase of $29.3 million in research and development expenses was attributable to an increase of $14.9 million in unallocated expenses, as well as an increase of $14.4 million in our direct research and development costs.

The increase in unallocated expenses includes $11.4 million in personnel-related costs and $3.5 million in other costs.

The increase in personnel-related costs is primarily attributable to a $10.6 million increase in payroll and fringe benefits as well as a $0.8 million increase in stock-based compensation expense.

The increase in personnel-related costs 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 consulting costs, medical affairs and facility costs.

The increase of approximately $14.4 million in our direct research and development costs primarily relates to an increase of $10.2 million in RP1 as a result of an increase of $8.8 million in spending related to the confirmatory study, which ramped up activity and enrollment in this current fiscal year, as well as $4.5 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 a $5.2 million increase in spending on RP2 as a result of increased enrollment as compared to the prior year.

Selling, general and administrative expenses

Selling, general and administrative expenses were $59.0 million for the six months ended September 30, 2025, compared to $29.9 million for the six months ended September 30, 2024.

The increase of approximately $29.1 million in sales, general and administrative costs is driven by an increase of $14.6 million in personnel-related costs, as well as $10.6 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.

Total other income (expense), net

Other income (expense), net was $4.9 million for the six months ended September 30, 2025, compared to income of $9.5 million for the six months ended September 30, 2024.

The net change of $4.5 million is primarily attributable to an increase in expense of $2.7 million in the current year 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 a decrease in investment income of $1.7 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.

Liquidity and capital resources

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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, 2025, we had received net proceeds of $1,101.8 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 June 30, 2025, we had cash and cash equivalents and short-term investments of $403.3 million.

Through September 30, 2025, we had received net proceeds of $1,101.8 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 September 30, 2025, we had cash and cash equivalents and short-term investments of $323.6 million.

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

Three Months Ended June 30,

Six Months Ended September 30,

(Amounts in thousands)

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149,217 30,224

Net cash (used in) provided by financing activities (158) 96,637

Net cash provided by (used in) financing activities 166 96,598

Effect of exchange rate changes on cash and cash equivalents 26 26

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Operating activities

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.

During the three months ended June 30, 2024, net cash used in operating activities was $49.2 million, primarily resulting from our net loss of $53.8 million partially offset by non-cash charges of $7.4 million, which primarily consist of stock-based compensation expense of $9.5 million, somewhat offset by net amortization of premiums and discounts on short-term investments of $2.8 million, and an increase in cash of $2.8 million related to changes in our operating assets and liabilities.

Changes in our operating assets and liabilities for the three months ended June 30, 2024 consisted primarily of a $3.2 million decrease in accrued expenses and other current liabilities, a $1.8 million increase in prepaid expenses and other current assets, a $1.6 million decrease in accounts payable, and a $0.4 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 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.

During the six months ended September 30, 2024, net cash used in operating activities was $87.8 million, primarily resulting from our net loss of $106.8 million partially offset by non-cash charges of $12.9 million, which primarily consist of stock-based compensation expense of $18.1 million, somewhat offset by net amortization of premiums and discounts on short-term investments of $5.2 million, and an increase in cash of $6.1 million related to changes in our operating assets and liabilities.

Changes in our operating assets and liabilities for the six months ended September 30, 2024 consisted primarily of a $5.8 million increase in accounts payable, a $2.8 million decrease in accrued expenses and other current liabilities, a $2.2 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 $1.2 million change in operating and financing right-of-use assets and lease liabilities.

Investing activities

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.

During the three months ended June 30, 2024, net cash provided by investing activities was $29.8 million, consisting of $136.9 million in proceeds from sales and maturities of short-term investments, partially offset by $105.5 million in purchases of available for sale securities, and $1.7 million in purchases of property, plant and equipment and capitalized software.

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.

During the six months ended September 30, 2024, net cash provided by investing activities was $30.2 million, consisting of $228.9 million in proceeds from sales and maturities of short-term investments, partially offset by $194.9 million in purchases of available for sale securities, and $3.8 million in purchases of property, plant and equipment and capitalized software.

Financing Activities

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.

During the three months ended June 30, 2024, net cash provided by financing activities was $96.6 million, consisting primarily of $96.7 million from the sale of securities from the Company's private investment in a public entity in June 2024.

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.

During the six months ended September 30, 2024, net cash provided by financing activities was $96.6 million, consisting primarily of $96.7 million in proceeds from the Company's private investment in a public entity in June 2024.

Funding requirements

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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 June 30, 2025, we had cash and cash equivalents and short-term investments of $403.3 million.

Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments as of June 30, 2025, will enable us to fund operations into the fourth quarter of 2026 which includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

As of September 30, 2025, we had cash and cash equivalents and short-term investments of $323.6 million.

Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments as of September 30, 2025, will enable us to fund operations late into the fourth quarter of 2026 which 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, including the assumption that the development of RP1 will remain viable, and we could utilize our available capital resources sooner than we expect.

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Contractual obligations and commitments

During the three months ended June 30, 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 September 30, 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.

Collaborations

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Critical accounting policies and estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States.

The preparation of our 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 consolidated financial statements.

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States.

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.

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Our actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in greater detail in Note 2 to our consolidated financial statements appearing elsewhere in this Quarterly Report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

While our significant accounting policies are described in greater detail in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our condensed consolidated financial statements.

Accrued research and development expenses

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.

As part of the process of preparing our condensed consolidated financial statements, we are required to estimate our accrued research and development expenses.

This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs.

of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met;

The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met;

however, some require advanced payments.

We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time.

We make estimates of our accrued expenses as of each balance sheet date in the condensed consolidated financial statements based on facts and circumstances known to us at that time.

Examples of estimated accrued research and development expenses include fees paid to:

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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 consolidated financial statements appearing elsewhere in this Quarterly Report for more information.

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.

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Recently issued accounting pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements appearing elsewhere in this Quarterly Report.

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

Quantitative and Qualitative Disclosures about Market Risks.

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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