What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2026-06-29 compared with 2025-05-22 · 57 added, 61 removed, 254 unchanged (32% of the section changed)

7 unchanged sentences

Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Annual Report on Form 10-K, they may not be predictive of results or developments in future periods.

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

circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

We are a clinical-stage biotechnology company committed to applying our leading expertise in the field of oncolytic immunotherapy to transform the lives of cancer patients through our novel oncolytic immunotherapies.

2 unchanged sentences

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

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

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

Since our inception, we have devoted substantially all of our resources to developing our proprietary RPx platform, building our intellectual property portfolio, conducting research and development of our product candidates, business planning, raising capital and providing selling, general and administrative support for our operations.

To date, we have incurred significant operating losses and we have financed our operations primarily with proceeds from the sale of equity securities and to a lesser extent the proceeds from the issuance of debt securities.

To date, we have incurred significant operating losses and we have financed our operations primarily with proceeds from the sale of equity securities and to a lesser extent, proceeds from borrowing under secured loan facilities.

Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates.

7 unchanged sentences

We expect to continue to incur costs in connection with our ongoing development activities, including further advancement of any preclinical activities and clinical trials of our product candidates across our platform, and if and as we:

• conduct our current and future clinical trials;

• continue to conduct our current and future clinical trials;

• further preclinical development of our platform;

3 unchanged sentences

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

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

• maintain, expand and protect our intellectual property portfolio;

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

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

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

4 unchanged sentences

As of March 31, 2026, we had cash and cash equivalents and short-term investments of $268.9 million.

Based on our current operating plan, 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 consolidated financial statements included in this Annual Report on Form 10-K.

Based on our current operating plan, 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 into the first calendar quarter of 2027, which includes scale up for 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 utilize our available capital resources sooner than we expect.

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

3 unchanged sentences

Operating expenses

Our expenses since inception have consisted solely of research and development costs and general and administrative costs.

Research and development expenses

10 unchanged sentences

Direct research and development costs, consisting of costs, such as fees paid to consultants, contractors, CMOs and CROs in connection with our preclinical and clinical development activities, are tracked by study.

Additional costs, consisting primarily of our initial manufacturing costs, including materials, supplies, depreciation and facility costs, are allocated at a program level, based upon manufacturing runs, as the drug product can be utilized across multiple studies for any particular program.

Additional costs to label, package and distribute the drug product is then directly allocated to the specific studies when

incurred, as that drug product has then been assigned to a particular study.

Additional costs, consisting

primarily of our initial manufacturing costs, including materials, supplies, depreciation and facility costs, are allocated at a program level, based upon manufacturing runs, as the drug product can be utilized across multiple studies for any particular program.

Additional costs to label, package and distribute the drug product is then directly allocated to the specific studies when incurred, as that drug product has then been assigned to a particular study.

In the event our additional future or ongoing study costs become meaningful to investors, we will present those costs by study.

2 unchanged sentences

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 and initiate additional clinical trials and continue to discover and develop additional product candidates.

The successful development and commercialization of our product candidates is highly uncertain.

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.

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

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

• the scope, rate of progress, expense and results of our ongoing clinical trials, as well as future clinical trials or other product candidates and other research and development activities that we may conduct;

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

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

3 unchanged sentences

• the successful completion of clinical trials with safety, tolerability, and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;

• the receipt of regulatory approvals from applicable regulatory authorities, if any, and our ability to maintain approval of any of our product candidates;

• the receipt of regulatory approvals from applicable regulatory authorities;

• our success in operating our manufacturing facility, or securing manufacturing supply through relationships with third parties;

1 unchanged sentence

• our ability to maintain, expand and protect our rights in our intellectual property portfolio;

• the commercialization of our product candidates, if and when approved;

• the commercialization of our product candidates, if and when approved and the timing of such approval;

• the acceptance of our product candidates, if approved, by patients, the medical community, and third-party payors;

2 unchanged sentences

• competition with other products;

• significant and changing government regulation and regulatory guidance.

• significant and changing government regulation and regulatory guidance and the views and implementation of such regulation and guidance from the leadership of the applicable regulatory agency.

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

4 unchanged sentences

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

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

If the FDA provides an accelerated approval of our BLA for RP1 plus nivolumab for the treatment of advanced melanoma, we expect that our selling, general and administrative expenses will continue to increase in the future as we increase our selling, general and administrative headcount to support our continued operations and pre-launch activities to prepare for potential commercialization of our product candidates.

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

1 unchanged sentence

and investor and public relations costs.

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

Other income (expense), net

5 unchanged sentences

Interest expense on finance lease liability

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

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

Interest expense on debt obligations

2 unchanged sentences

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

During the year ended March 31, 2025 and 2024, the Company recorded an income tax provision of $0.5 million and $0.4 million, respectively, related to U.S.

current taxes primarily due to the transfer pricing arrangement between the U.S.

and the U.K., as well as unfavorable adjustments related to stock compensation, resulting in U.S.

taxable income partially reduced by certain tax attributes and U.S.

tax partially reduced by certain credits and U.S.

tax partially reduced by certain credits.

During the years ended March 31, 2026 and 2025, the Company recorded an income tax benefit of $0.6 million and a provision of $0.5 million, respectively.

Results of operations

41 unchanged sentences

Total research and development expenses $ 221,184 $ 189,447 $ 31,737 17 %

The total increase of $14.5 million in research and development expenses was driven by an increase of $26.0 million in unallocated expenses, partially offset by a decrease of $11.5 million in our direct research and development costs.

The increase in unallocated expenses includes $14.8 million in other costs and $11.2 million in personnel-related costs.

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

The increase in personnel-related costs largely reflected the hiring of additional personnel in our research and development functions, most specifically within the manufacturing departments, as we prepared and scaled operations for commercial launch.

The decrease of approximately $11.5 million in our direct research and development costs primarily relates to a decrease of $8.2 million related to RP3 as a result of the deprioritization of development efforts on this product candidate, which began in

the second half of the prior fiscal year, as well as a decrease of $4.6 million in RP1 costs as a result of declining enrollment and the wind down of the CERPASS study and completion of enrollment in the IGNYTE advanced melanoma cohort.

These decreases are slightly offset by an increase of approximately $1.3 million in RP2 costs as the Company began to ramp up costs for the MUM study, specifically with spending related to set up costs and Clinical Research Organization ("CRO") costs.

In addition, in the prior year, the company incurred costs related to manufacturing batches for RP1, as well as significant costs related to the CERPASS trial in the areas of CROs, investigators and imaging costs in preparation of the primary data release, which did not recur in the current year.

The total increase of $31.7 million in research and development expenses was driven by an increase of $24.5 million in our direct research and development costs, as well as an increase of $7.2 million in unallocated expenses.

The increase of approximately $24.5 million in our direct research and development costs was driven by an increase of $13.9 million in spending on RP2 study costs during the year, primarily related to the REVEAL study, as the Company continued to ramp up enrollment and expanded this trial outside of the United States.

In addition, RP1 costs increased by $12.9 million as a result of costs related to the IGNYTE-3 confirmatory study as well as an increase of $7.7 million in other RP1 study costs, specifically operating and lab supplies, and facility costs.

These increases were partially 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.

The increase in unallocated expenses includes an increase of $9.8 million in personnel-related costs, which is primarily related to an increase of $11.6 million 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 decrease in other costs is driven by a year over year decrease in consulting costs.

Selling, general and administrative expenses

Selling, general and administrative expenses were $98.7 million for the year ended March 31, 2026, compared to $72.2 million for the year ended March 31, 2025.

The increase of $12.4 million in sales, general and administrative costs is driven primarily by an increase of $9.3 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, there is a year over year increase of $4.3 million in personnel related costs, comprised of an increase of $7.1 million in payroll and fringe benefits offset by a stock-based compensation decrease of $2.8 million.

The increase of $26.6 million in sales, general and administrative costs is driven primarily by an increase of $20.3 million in personnel related costs, comprised of an increase of $21.4 million in payroll and fringe benefits slightly offset by a stock-based compensation decrease of $1.1 million.

The increase in personnel related costs was driven by the continued hiring of additional personnel within our selling, general and administrative functions, specifically focusing on planning for a potential commercial launch.

4 unchanged sentences

the prior year.

In addition, there is a $1.0 million increase in expense due to the changes in foreign exchange rates of the Great British Pound to United States Dollar.

Income tax provision

Income tax provision for the year ended March 31, 2025 was $0.5 million compared to $0.4 million for the year ended March 31, 2024.

The income tax provision for the current year is attributable to U.S.

current taxes primarily due to the transfer pricing arrangement between the U.S.

and the U.K., as well as unfavorable adjustments related to stock compensation, resulting in U.S.

taxable income partially reduced by certain prior year available net operating losses and U.S.

tax partially reduced by certain credits.

The income tax benefit for the year ended March 31, 2026 was $0.6 million compared to an income tax provision of $0.5 million for the year ended March 31, 2025.

Liquidity and capital resources

1 unchanged sentence

Until we are able to generate sufficient revenue from RP1 and our other product candidates that we develop, if at all, we anticipate that we will continue to incur significant operating losses and negative cash flows from our operations.

Based on its current operating plan, the Company expects to continue to generate operating losses for the foreseeable future and that its existing cash, cash equivalents and short-term investments will be sufficient to fund its operating expenses and capital expenditure requirements only into the first calendar quarter of 2027, which is less than one year from the date these consolidated financial statements are issued.

The Company does not have any committed source of additional funding and will be required to obtain additional financing to fund its operations beyond that date.

These conditions raise substantial doubt about the Company's ability to continue as a going concern.

The Company is collaborating with the FDA regarding a path forward for RP1 and, if the BLA is approved, the Company will determine the best source of capital, which may be raising additional capital through public or private equity offerings (including under our at-the-market facilities), although there can be no guarantee that the Company will be able to raise such capital on acceptable terms, or at all.

If the BLA is not approved, the Company will likely need to (i) execute a considerable restructuring and workforce reduction to reduce our cash burn, (ii) reconsider our product development efforts and strategies and (iii) pursue collaborations, strategic alliances, licensing arrangements, business combination, merger or acquisition, or other strategic business development activities to continue operations.

In either scenario, our plans are subject to risks and uncertainties, including factors outside our control.

Accordingly, we have not been able to conclude that these plans are probable of being effectively implemented and, as such, they do not alleviate the substantial doubt about our ability to continue as a going concern.

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 March 31, 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 placement transaction, and at-the-market offerings, as well as our incurrence of debt under the Hercules Loan Agreement.

Through March 31, 2026, we had received net proceeds of $1,132.9

million through the sale of shares of common stock and pre-funded warrants exercisable for common stock in public offerings, a private placement transaction, and at-the-market offerings, as well as our incurrence of debt under the Hercules Loan Agreement.

As of March 31, 2026, we had cash and cash equivalents and short-term investments of $268.9 million.

3 unchanged sentences

Net cash used in operating activities $ (280,344) $ (192,250)

Net cash (used in) provided by investing activities

(23,796) 97,201

Net cash provided by (used in) investing activities 310,843 (23,796)

Net cash provided by financing activities 66,294 252,396

Effect of exchange rate changes on cash and cash equivalents 1,112 315

Net increase (decrease) in cash and cash equivalents $ 36,665 $ (72,069)

Net increase in cash and cash equivalents $ 97,905 $ 36,665

Operating activities

During the year ended March 31, 2026, net cash used in operating activities was $280.3 million, primarily resulting from our net loss of $313.9 million, which was partially offset by non-cash charges of $37.4 million, consisting primarily of stock-based compensation expense of $32.3 million, depreciation and amortization expense of $3.3 million and a net $3.2 million change in operating and finance right-of-use assets and lease liabilities, somewhat offset by $2.5 million related to the net amortization of premiums and discounts on short-term investments and a decrease in cash of $3.8 million related to changes in our operating assets and liabilities.

Changes in our operating assets and liabilities for the year ended March 31, 2026 consisted primarily of a $4.9 million decrease in accounts payable and a $2.2 million increase in accrued expenses and other current liabilities.

During the year ended March 31, 2025, net cash used in operating activities was $192.3 million, primarily resulting from our net loss of $247.3 million, which was partially offset by non-cash charges of $31.0 million, consisting primarily of stock-based compensation expense of $35.0 million and depreciation expense of $3.5 million, somewhat offset by $8.9 million related to the net amortization of premiums and discounts on short-term investments.

Additionally, there was an increase in cash of $24.1 million related to changes in our operating assets and liabilities.

Changes in our operating assets and liabilities for the year ended March 31, 2025 consisted primarily of a $11.7 million increase in accrued expenses and other current liabilities, a $9.9 million increase in accounts payable, and a net $2.4 million change in operating and financing right-of-use assets and lease liabilities.

During the year ended March 31, 2024, net cash used in operating activities was $185.5 million, primarily resulting from our net loss of $215.8 million, which was partially offset by non-cash charges of $24.8 million, consisting primarily of stock-based compensation expense of $34.1 million offset by $12.3 million related to the net amortization of premiums and discounts on short-term investments.

Additionally, there was an increase in cash of $5.5 million related to changes in our operating assets and liabilities.

Changes in our operating assets and liabilities for the year ended March 31, 2024 consisted primarily of a $9.2 million increase in accrued expenses and other current liabilities, a $2.8 million decrease in accounts payable, and a net $2.4 million change in operating and financing right-of-use assets and lease liabilities.

Investing activities

During the year ended March 31, 2026, net cash provided by investing activities was $310.8 million, consisting of $393.0 million in proceeds from sales and maturities of short-term investments, somewhat offset by $77.9 million in purchases of available for sale securities and $4.2 million in purchases of property, plant and equipment.

During the year ended March 31, 2025, net cash used in investing activities was $23.8 million, consisting of $403.6 million in purchases of available for sale securities and $6.7 million in purchases of property, plant and equipment, partially offset by $386.5 million in proceeds from sales and maturities of short-term investments.

During the year ended March 31, 2024, net cash provided by investing activities was $97.2 million, consisting of $592.4 million in proceeds from sales and maturities of short-term investments, partially offset by $489.5 million in purchases of available for sale securities and $5.7 million in purchases of property, plant and equipment.

Financing Activities

During the year ended March 31, 2026, net cash provided by financing activities was $66.3 million, consisting primarily of $35.0 million in proceeds from the incurrence of debt under the loan agreement with Hercules, as well as $31.1 million in proceeds from the issuance of common stock through sales under our at-the-market facility.

During the year ended March 31, 2025, net cash provided by financing activities was $252.4 million, consisting primarily of $252.7 million in proceeds from the Company's private placement transaction in June 2024 as well as the Company's November 2024 public offering.

During the year ended March 31, 2024, net cash provided by financing activities was $16.3 million, consisting primarily of $15.0 million in proceeds from the incurrence of debt under the Hercules Loan Agreement, as well as approximately $1.8 million in proceeds from the exercise of stock options.

Funding requirements

12 unchanged sentences

As of March 31, 2026, we had cash and cash equivalents and short-term investments of $268.9 million and $83.3 million in long term debt.

Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments as of March 31, 2025, will enable us to fund operations into the calendar fourth quarter of 2026 which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments as of March 31, 2026, will enable us to fund operations into the first calendar quarter of 2027 which includes scale up for 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 utilize our available capital resources sooner than we expect.

10 unchanged sentences

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technology, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings or collaborations, strategic alliances or licensing arrangements with third parties when needed, we may be required to delay, limit, reduce and/or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

If we are unable to raise additional funds through equity or debt financings or collaborations, strategic alliances or licensing arrangements with third parties when needed, we may be required

to delay, limit, reduce and/or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Contractual obligations and commitments

We have entered into arrangements that contractually obligate us to make payments that will affect our liquidity and cash flows in future periods.

Our contractual obligations include those related to our operating and financing leases, long-term debt,

as well as costs associated with contracts entered into in the normal course of business with CROs, CMOs and other third parties for clinical trials and preclinical research studies and testing.

Our contractual obligations include those related to our operating and finance leases, long-term debt, as well as costs associated with contracts entered into in the normal course of business with CROs, CMOs and other third parties for clinical trials and preclinical research studies and testing.

Lease Commitments

4 unchanged sentences

Borrowings under the term loan agreement are repayable in monthly interest-only payments through September 2027, and the agreement has a maturity date of October 2027.

Our remaining commitments, based on our current draws, are due through October 2027, and include principal and interest payments of $58.3 million, and an additional fee upon maturity of the loan of $2.2 million.

A balloon payment, inclusive of accrued interest and principal, are due on the maturity date of October 1, 2027.

Our remaining commitments, based on our current draws, are due on October 2027, and include principal and interest payments of $84.2 million, and an additional fee upon maturity of the loan of $4.0 million.

See Note 7, Long term debt , of the "Notes to Consolidated Financial Statements" contained in Part II, Item 8 of this Annual Report on Form 10-K for further discussion of the Hercules term loan.

20 unchanged sentences

Roche has continued to supply its currently approved drugs, atezolizumab and bevacizumab for the 2L cohort in HCC but is not sharing costs following our re-prioritization.

Under the terms of the initial agreement we retained the responsibility of operating the

clinical trials as well as retaining all the rights to the development and commercialization of our product candidates.

Under the terms of the initial agreement we retained the responsibility of operating the clinical trials as well as retaining all the rights to the development and commercialization of our product candidates.

The agreement may be terminated by either party upon sixty days prior written notice to the other party.

28 unchanged sentences

We issue stock-based awards to employees, directors, consultants and non-employees in the form of stock options, restricted stock units, or RSUs, and performance-based restricted stock units, or PSUs.

We measure such stock-based awards in accordance with ASC 718, Compensation — Stock Compensation , which requires all stock-based awards to be recognized in the consolidated statements of operations and comprehensive loss based on their fair value on the date of the grant and the related compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of

the respective award.

We have, to date, issued stock-based awards with service-based and performance-based vesting conditions.

8 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-K

Item 7. Management’s Discussion and Analysis