What changed in this filing

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Item 1A. Risk Factors

2026-02-03 compared with 2025-11-06 · 21 added, 20 removed, 970 unchanged (4% of the section changed)

19 unchanged sentences

• our compliance with domestic and foreign laws, rules and regulations and the consequences in the event that we fail to comply with such laws, rules and regulations;

• our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

• our ability to retain the continued service of our key professionals and to identify, hire, train and retain additional qualified professionals;

• our competitive position, and developments and projections relating to our competitors and our industry;

• the potential increased costs associated with tariffs imposed or threatened by the new U.S.

• the potential increased costs associated with tariffs imposed or threatened by the current U.S.

administration on pharmaceuticals and pharmaceutical ingredients where there is no available exception;

62 unchanged sentences

• there may be events outside of our control, including, with respect to the budget, staffing, and funding of the U.S.

Federal government, the FDA’s ability to hire and retain key personnel, the FDA’s ability to accept user fees, and other regulatory and policy changes.

Federal government, the FDA’s ability to hire, train and retain key personnel, the FDA’s ability to accept user fees, and other regulatory and policy changes.

Disruptions at the FDA may slow the time to approval of a new drug or may otherwise impact our ability to obtain guidance from and interact with the agency.

224 unchanged sentences

Early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in developing or acquiring technologies complementary to, or necessary for, our programs.

These third parties compete with us in recruiting, training and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in developing or acquiring technologies complementary to, or necessary for, our programs.

If we are unable to successfully compete with these companies our business, financial condition, results of operations, stock price and prospects may be materially harmed.

118 unchanged sentences

We are not profitable and have incurred losses in each period since our inception.

For the three months ended September 30, 2025 and 2024, we reported a net loss of $83.1 million and $53.1 million, respectively.

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

For the three months ended December 31, 2025 and 2024, we reported a net loss of $70.9 million and $66.3 million, respectively.

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

We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek marketing approvals for RP1, our other product candidates and any additional product candidates we may develop.

15 unchanged sentences

• obtaining, maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how;

• attracting, hiring, and retaining qualified personnel.

• attracting, training, hiring, and retaining qualified personnel.

Even if our product candidates or any future product candidates that we develop are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any such product candidate.

5 unchanged sentences

Our operations have consumed substantial amounts of cash since inception.

At September 30, 2025, our cash and cash equivalents and short-term investments were $323.6 million.

At December 31, 2025, our cash and cash equivalents and short-term investments were $269.1 million.

We expect to continue to spend substantial amounts to continue the clinical and preclinical development of RP1 and our other product candidates.

15 unchanged sentences

Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements.

Based on our current operating plan, we expect that our existing cash and 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.

Based on our current operating plan, we expect that our existing cash and 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 this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

19 unchanged sentences

Further, the examination process may require us to narrow the claims for our pending patent applications, which may limit the scope of patent protection that may be obtained if these applications issue.

The scope of a patent may also be interpreted or reinterpreted after issuance.

The scope of a patent may also be interpreted or reinterpreted

after issuance.

The rights that may be granted under our future issued patents may not provide us with the proprietary protection or competitive advantages we are seeking.

In addition, defending against challenges in respect of the inventorship, scope,

validity or enforceability of our patents may be expensive, time consuming, difficult and in some cases may not be possible.

In addition, defending against challenges in respect of the inventorship, scope, validity or enforceability of our patents may be expensive, time consuming, difficult and in some cases may not be possible.

Although we enter into nondisclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, consultants, collaborators, and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.

266 unchanged sentences

or requiring us to increase our personal data processing capabilities and infrastructure in foreign jurisdictions at significant expense.

See Part I, Item 1C, Cybersecurity , in this Annual Report on Form 10-K for more information regarding our cybersecurity risk management, strategy, and governance.

See Part I, Item 1C, Cybersecurity , in the Annual Report on Form 10-K for more information regarding our cybersecurity risk management, strategy, and governance.

Risks related to our operations

8 unchanged sentences

Our future success depends on our ability to retain our key employees and consultants, and to attract and motivate highly qualified personnel.

Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract, motivate and retain highly qualified managerial, scientific and medical personnel.

Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract, motivate, train and retain highly qualified managerial, scientific and medical personnel.

We are highly dependent on our executive leadership team, as well as our other scientific, manufacturing, quality and medical personnel.

102 unchanged sentences

• potential unforeseen business disruptions that increase our costs or expenses;

• natural disasters, public health crises, political and economic crises, negative global climate patterns, or other catastrophic events, the possibility of an economic recession, international hostilities and trade disruptions, including, but not limited to those resulting from the recent U.S.

presidential election, ongoing military conflicts, acts of terrorism, governmental restrictions and sanctions, inflation, global supply chain disruptions, trade relationships and military and political alliances;

presidential administration, ongoing military conflicts, acts of terrorism, governmental restrictions and sanctions, inflation, global supply chain disruptions, trade relationships and military and political alliances;

• future accounting pronouncements or changes in our accounting policies;

24 unchanged sentences

Any sales of securities by these stockholders could have a material adverse effect on the market price of our common stock.

We may sell up to $100.0 million of shares of our common stock in “at-the-market” offerings pursuant to a Sales Agreement entered into on August 3, 2023, as amended, with Leerink Partners LLC, or the 2023 Sales Agreement.

We may sell shares of our common stock in “at-the-market” offerings pursuant to a Sales Agreement entered into on August 3, 2023, as amended, with Leerink Partners LLC, or the 2023 Sales Agreement.

The sale of a substantial number of shares of our common stock pursuant to the 2023 Sales Agreement, or anticipation of such sales, could cause the trading price of our common stock to decline or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise desire.

42 unchanged sentences

Sanctions imposed by the United States and other countries in response to such conflicts may also adversely impact our clinical trials, the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

A weak or declining economy or political disruption, including any international trade disputes, economic instability, changes in tax laws and regulations and additional tariffs, including based on the recent U.S.

presidential election, export controls, and increased interest rates could disrupt or otherwise adversely impact our operations and those of third parties upon which we rely.

presidential administration, export controls, and increased interest rates could disrupt or otherwise adversely impact our operations and those of third parties upon which we rely.

Although we do not currently operate in Russia, Ukraine, Israel or China, those conflicts may impact, and if any of those conflicts broaden it may further impact, the markets, countries or territories in which we do operate or intend to operate, which could have a negative impact on our ability to achieve our objectives or timelines.

8 unchanged sentences

The Hercules Loan and Security Agreement contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay any outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.

On October 6, 2022 we and certain of our subsidiaries entered into a Loan and Security Agreement, or the Hercules Loan Agreement with Hercules Capital, Inc., or Hercules, in its capacity as administrative agent and collateral agent and as a lender, which such agreement was subsequently amended in June 2023 and December 2023.

The Hercules Loan Agreement contains certain affirmative and negative covenants that could prevent us from taking certain actions without the consent of our lenders.

13 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 1A. Risk Factors