What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-02-03 compared with 2025-11-06 · 87 added, 78 removed, 352 unchanged (32% of the section changed)

3 unchanged sentences

We have based these forward-looking statements on our current expectations and projections about future events.

The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report, particularly including those risks identified in Part II, Item 1A “Risk Factors” and our other filings with the Securities Exchange Commission, or SEC.

We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report.

19 unchanged sentences

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, 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.

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.

1 unchanged sentence

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 for RP1 in combination with nivolumab in the same setting.

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.

10 unchanged sentences

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.

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 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.

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.

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.

2 unchanged sentences

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.

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.

5 unchanged sentences

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.

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.

8 unchanged sentences

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.

This updated data showed anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate of 23.1%) and 2-year duration of response of 61.0%.

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.

11 unchanged sentences

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 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.

We are enrolling patients in a registration-directed study, or the REVEAL 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.

1 unchanged sentence

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.

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 fourth quarter of 2025.

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.

7 unchanged sentences

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 $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.

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.

These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations.

9 unchanged sentences

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

• hire and retain additional clinical, quality control, scientific and general and administration personnel;

• hire, train and retain additional clinical, quality control, scientific and general and administration personnel;

• acquire or in-license other drugs, technologies or intellectual property rights;

3 unchanged sentences

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 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.

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.

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

69 unchanged sentences

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 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.

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 September 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 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 September 30, 2025 and 2024

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

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:

Three Months Ended

September 30,

2025 2024 Change

12 unchanged sentences

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)

Net loss $ (70,930) $ (66,340) $ (4,590)

Research and development expenses

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:

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:

Three Months Ended

September 30,

2025 2024 Change

13 unchanged sentences

Total research and development expenses $ 53,140 $ 48,004 $ 5,136

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.

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 $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.

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 $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,

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

12 unchanged sentences

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 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,

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

13 unchanged sentences

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

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 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 a $5.2 million increase in spending on RP2 as a result of increased enrollment as compared to the prior year.

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.

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.

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 $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.

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.

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 can not predict when we may generate revenue from sales of any products, if at all.

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.

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 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.

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.

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

Six Months Ended September 30,

Nine Months Ended December 31,

(Amounts in thousands)

Net cash used in operating activities $ (224,183) $ (138,519)

Net cash provided by investing activities

Net cash provided by (used in) investing activities

224,337 (16,096)

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

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

Effect of exchange rate changes on cash and cash equivalents 1,062 (125)

Net (decrease) increase in cash and cash equivalents $ (8,819) $ 39,042

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

Operating activities

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.

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.

Investing activities

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.

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.

Financing Activities

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.

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.

Funding requirements

9 unchanged sentences

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

• hire and retain additional clinical, quality control, scientific and general and administration personnel;

• hire, train and retain additional clinical, quality control, scientific and general and administration personnel;

• acquire or in-license other drugs, technologies or third-party intellectual property;

2 unchanged sentences

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 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.

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.

11 unchanged sentences

Contractual obligations and commitments

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.

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.

Collaborations

38 unchanged sentences

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.

16 unchanged sentences

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