Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

announced the initiation of Phase 1b expansion portion of the study. The ongoing Phase 1b will evaluate NXP900 as both a single agent targeting specific tumor types and in combination with market-leading EGFR and ALK inhibitors.

In July 2025, in advance of exploring combinations of NXP900 with EGFR and ALK inhibitors, we announced the completion and topline results from our clinical drug-drug interaction (DDI) study in healthy volunteers. The NXP900 DDI study was conducted to evaluate the potential of NXP900 to induce the activity of Cytochrome P450 ("CYP") enzymes, which showed that NXP900's effect on the enzyme CYP3A is classified as a weak inhibitor according to the International Council for Harmonization ("ICH") M12. Key safety results from the DDI study included 1) no serious or severe adverse events were reported in this study, 2) diarrhea and non-infection related increases in white blood cell counts were the most common adverse events reported, all mild to moderate in intensity.

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NXP800 (GCN2 Kinase Activator) 

We have licensed exclusive worldwide development and commercial rights to NXP800, an oral, small molecule discovered at the Institute of Cancer Research ("ICR") in London, England.

In preclinical studies, treatment with NXP800 inhibited tumor growth in xenograft models of human ovarian, endometrial, and gastric cancers, in which a genetic mutation in the AT-rich interactive domain-containing protein 1A ("ARID1a") gene was present, potentially rendering ARID1a as a biomarker for treatment sensitivity, thereby offering a potential strategy for patient enrichment. Based on this work, we have begun to clinically investigate NXP800 in platinum-resistant ARID1a-mutated ovarian carcinoma, a type of cancer that is primarily comprised of two histologies, ovarian clear cell carcinoma ("OCCC") and ovarian endometrioid carcinoma ("OEC"). We are investigating the utility of ARID1a deficiency as a patient selection marker in additional tumor types. The genetic screening for mutations in ARID1a can be detected using commercially available next-generation sequencing-based in vitro diagnostic tests, which are routinely utilized in the clinic for cancer patients.

In December 2021, the Phase 1 study was initiated in the United Kingdom, comprising two parts: a dose-escalation phase (Phase 1a) followed by an expansion phase (Phase 1b). In the Phase 1a, the safety, tolerability and pharmacokinetic properties of NXP800 were evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for Phase 1b. The Phase 1b portion of the study, initiated in the second quarter of 2023, is evaluating the safety and preliminary anti-tumor activity of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancer.

In June 2022, the Investigational New Drug ("IND") application for NXP800 was cleared by the U.S. Food and Drug Administration ("FDA"), including the Phase 1 clinical trial protocol.

In December 2022, we announced that the FDA granted Fast Track Designation status to NXP800 for the treatment of patients with platinum-resistant, ARID1a-mutated ovarian carcinoma. In August 2023, we announced that the FDA granted Orphan Drug Designation to NXP800 for the treatment of patients with cholangiocarcinoma. In August 2024, we announced that the FDA granted Orphan Drug Designation to NXP800 for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.

In July 2025, we announced a final clinical data update from the NXP800 Phase 1b study in ovarian cancer. Further development of NXP800 in ovarian cancer will not be pursued. In the coming months, we will evaluate the feasibility of development opportunities for NXP800 in other cancer types, where patients' performance status and other characteristics may allow treatment with NXP800 to be more impactful.

Results of Operations

From our inception on July 27, 2020, through September 30, 2025, we did not generate any revenue. Since our inception through September 30, 2025, our primary activities have been focused on the development of our two drug candidates, NXP900 and NXP800, including the completion of in-licensing agreements, IND-enabling studies, and the ongoing Phase 1 clinical trials for each drug candidate, as well as other organizational activities such as capital raising. For NXP900, we conducted IND-enabling studies, which were followed by our IND application and subsequent acceptance by the FDA. Additionally, the Phase 1a clinical trial commenced in September 2023, the Phase 1b trial commenced in August 2025, and a DDI study was conducted this year. For NXP800, we conducted IND-enabling studies, which were followed by our Clinical Trial Application and acceptance by the Medicines and Healthcare Products Regulatory Agency in the UK, the IND application and acceptance by the FDA, and the Clinical Trial

Application and acceptance by the Spanish Agency of Medicines and Medical Devices in Spain. The Phase 1a and Phase 1b clinical trials for NXP800 commenced in December 2021 and April 2023, respectively.

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Research and Development Expenses

Research and development expenses include costs directly attributable to the conduct of research and development programs, including licensing fees, cost of salaries, share-based compensation expenses, payroll taxes, and other employee benefits, subcontractors, and materials and services used for research and development activities, including clinical trials, manufacturing costs, and professional services. All costs associated with research and development are expensed as incurred.

Product candidates in later stages of clinical development typically incur higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. We anticipate that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and beyond. The successful development of our product candidates is highly uncertain. At this time, we cannot accurately estimate or determine the nature, timing, or costs of the efforts required to complete the preclinical and clinical development of any of our product candidates. We may also fail to obtain regulatory approval for any of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, for our personnel in executive, finance and accounting, and other administrative functions. General and administrative expenses also include legal fees related to patent and corporate matters, as well as professional fees paid for accounting, auditing, consulting, and tax services. These expenses also cover insurance costs, investor relations activities, travel expenses, and facility costs not otherwise included in research and development expenses.

We anticipate that our general and administrative expenses will increase in the future as we expand our headcount to support ongoing research and development, as well as other corporate activities.

The following table summarizes our results of operations expenses for the three months ended September 30, 2025 and 2024: (in thousands)

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Research and Development Expenses

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

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Research and development expenses increased by $3.0 million, or 105% during the three months ended September 30, 2025, compared to the same period in 2024. The increase in research and development expense during the three months ended September 30, 2025, was primarily driven by a one-time $2.0 million increase in license fees associated with the NXP900 milestone achievement, a $0.7 million increase in clinical expenses related to the development of NXP900 and NXP800, and a $0.2 million increase in employee compensation and benefits.

The following table summarizes our general and administrative expenses for the three months ended September 30, 2025 and 2024: (in thousands)

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General and administrative expenses increased by $0.5 million, or 31%, during the three months ended September 30, 2025, compared to the same period in 2024. The increase in general and administrative expenses during the three months ended September 30, 2025, was primarily driven by the $0.4 million increase in professional and consulting services related to public company-related expenses and $0.1 million in employee compensation.

As a result of the foregoing, our loss from operations for the three months ended September 30, 2025, increased $3.3 million or 80%, compared to the same period in 2024.

The following table summarizes our results of operations expenses for the nine months ended September 30, 2025, and 2024:

(in thousands)

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Research and Development Expenses

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

(in thousands)

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Research and development expenses increased by $4.6 million during the nine months ended September 30, 2025, compared to the same period in 2024. The increase in research and development expenses during the nine months ended September 30, 2025, was primarily driven by a $2.4 million increase in one-time license fees for NXP900, $1.7 million increase in clinical expenses, and $0.6 million increase in employee compensation, and partially offset by a $0.1 million decrease in manufacturing expenses.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2025, and 2024: (in thousands)

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General and administrative expenses increased $1.9 million during the nine months ended September 30, 2025, compared to the same period in 2024. The increase in general and administrative expenses during the nine months ended September 30, 2024, was primarily driven by the $1.5 million increase in professional and consulting services related to public company-related expenses, $0.2 million increase in insurance and other expenses, and $0.2 million increase in employee compensation.

As a result of the foregoing, our loss from operations for the nine months ended September 30, 2025, increased $6.4 million, compared to the same period in 2024, which was primarily driven by increased employee compensation and benefits, professional and consulting services, clinical trial expenses, and a one-time license fee for NXP900.

Liquidity and Capital Resources

As of September 30, 2025, we had $35.4 million of cash and cash equivalents. For the three months ended September 30, 2025 and 2024, we reported net losses of $7.5 million and $4.2 million, respectively. For the nine months ended September 30, 2025, and 2024, our net losses were $19.1 million and $12.8 million, respectively.

On February 4, 2022, we announced the pricing of our initial public offering of common stock (the "IPO") of 3,200,000 shares of common stock for a price of $5.00 per share, less certain underwriting discounts and commissions. Under the UoE license agreement, we are required to pay UoE 2.5% of the gross amount of each of our future fund raisings up to a cumulative total of $3.0 million. Pursuant to the IPO, we paid UoE $0.4 million associated with this fundraising.

The IPO closed on February 8, 2022, with gross proceeds of $16.0 million, before deducting underwriting discounts and expenses (for net proceeds of $12.6 million).

In addition, on July 29, 2022, we completed the July 2022 Private Placement in which we received gross proceeds of $15.9 million before deducting fees and expenses (for net proceeds of $14.2 million), excluding payments required by our license agreements. As part of this transaction, we issued Preferred Investment Options, which became exercisable on January 23, 2023, and are exercisable through January 29, 2026, at an exercise price of $9.65 per share, subject to certain adjustments as defined in the securities purchase agreement. As of December 31, 2023, 1,001,091 Preferred Investment Options were exercised for $8.9 million, net of fees. For the three and nine months ended September 30, 2025, zero Preferred Investment Options were exercised, and $0.0 million, net of fees, was received. In addition, as part of the July 2022 Private Placement, we issued warrants to the placement agent to purchase up to 115,481 shares of common stock. The placement agent warrants are in substantially the same form as the Preferred Investment Options, except that the exercise price is $10.31. As of September 30, 2025, 79,104 placement agent warrants were exercised, and $0.8 million, net of fees, was received.

On March 17, 2023, we filed a shelf registration statement on Form S-3 (the "Registration Statement"). Pursuant to the Registration Statement, we may offer and sell securities having an aggregate public offering price of up to $150.0 million. In connection with the

filing of the Registration Statement, we also entered into a at-the-market sales agreement with H. C. Wainwright & Co. (the "Sales Agent"), pursuant to which we may issue and sell shares of our common stock for an aggregate offering price of up to $40.0 million under an at-the-market offering program (the "ATM"), which is included in the $150.0 million of securities that may be offered pursuant to the Registration Statement. Pursuant to the ATM, we will pay the Sales Agent a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of our common stock. On April 30, 2025, we terminated our sales agreement with the Sales Agent. On May 9, 2025, we entered into a new sales agreement with Leerink Partners, the sales agent, pursuant to which we may issue and sell shares of our common stock for an aggregate offering price of up to $60.0 million under an at-the-market offering program (the " 2025 ATM"), which is included in the $150.0 million of securities that may be offered pursuant to the Registration Statement. Pursuant to the 2025 ATM, we will pay the Sales Agent a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of our common stock. We are not obligated to make any sales of shares under either ATM program. As of September 30, 2025, we have sold 13,835,139 shares of our common stock and received $32.3 million in net proceeds under the ATM programs.

On February 6, 2025, we completed a public offering, in which we received gross proceeds of $15.5 million, before deducting underwriting discounts and expenses and other offering expenses (for net proceeds of $14.0 million).

We believe that the proceeds from our IPO, private placement, ATM Program, and public offering will enable us to fund our operating expenses and capital expenditures through at least the next 12 months from the issuance of our financial statements. We have based this estimate on assumptions that may prove to be incorrect, and we could exhaust our available capital resources sooner than expected. Our long-term viability is dependent on our ability to raise additional capital to finance our operations.

We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the clinical trials of our current or future product candidates, including payments of milestones and sponsored research commitments associated with our license agreements for NXP900 and NXP800. Additionally, we anticipate incurring increasing costs associated with operating as a public company as we continue to grow, including higher expenses for legal, accounting, investor relations, and other services. The timing and amount of our operating expenditures will depend largely on our ability to:

We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for our current or future product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Because of the numerous risks and uncertainties associated with research, development, and commercialization of our product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of public or private equity offerings, debt financings, governmental funding, collaborations, strategic partnerships and alliances, or marketing, distribution, or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. In addition, debt financing would result in fixed payment obligations.

If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, 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 other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Cash Flows

The following table provides information regarding our cash flows for the periods presented: (in thousands)

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Operating Activities

During the nine months ended September 30, 2025, $12.0 million of cash was used in operating activities. This was primarily attributable to our net loss of $19.1 million, partially offset by non-cash charges of $4.6 million. The change in our operating assets and liabilities was primarily due to $3.1 million payments to vendors, and a $0.1 million payment for our director and officer insurance.

During the nine months ended September 30, 2024, $9.8 million of cash was used in operating activities. This was primarily attributable to our net loss of $12.8 million, partially offset by non-cash charges of $3.7 million. The change in our operating assets and liabilities was primarily due to $0.6 million of payments for vendors and $0.1 million payment for our directors and officer insurance.

Financing activities

During the nine months ended September 30, 2025, net cash provided by financing activities was $28.9 million, consisting primarily of net proceeds from the sale of common stock through the February 2025 public offering and the ATM Programs.

During the nine months ended September 30, 2024, net cash provided by financing activities was $7.8 million, consisting of $7.8 million of net proceeds from the sale of common stock through the ATM Programs.

Contractual Obligations and Other Commitments

We enter into contracts in the normal course of business with clinical research organizations, contract manufacturing organizations, and other third parties for clinical trials, preclinical research studies, and testing and manufacturing services. These contracts are cancelable by us upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. The amount and timing of such payments are not known.

We have also entered into license and collaboration agreements with third parties, which are in the normal course of business. We have not included future payments under these agreements since obligations under these agreements are contingent upon future events such as our achievement of specified development, regulatory, and commercial milestones, or royalties on net product sales.

Pursuant to the NXP900 License Agreement, we are required to make payments to the UoE for certain development and regulatory milestones, including up to $45.0 million related to pre-approval milestones, up to $279.6 million (in addition to the $45.0 million) in regulatory and commercial sales milestones, mid-single digit to 8% royalties on a tiered basis on net sales and 2.5% of the gross amount of each of our future fund raising up to a cumulative total of $3.0 million, unless development ceases. Additionally, we will provide UoE with up to an additional $754,000 in research and development support.

Pursuant to the NXP800 License Agreement, we are required to make payments to the ICR for certain development and regulatory milestones, including up to $22.0 million related to pre-approval milestones, up to $178 million (in addition to the $22.0 million) in regulatory and commercial sales milestones, and mid-single digit to 10% royalties on a tiered basis on net sales, unless development ceases. Additionally, we originally agreed to provide the ICR with up to an additional $0.5 million in research and development. On March 31, 2022, we agreed to provide the ICR with $0.4 million of additional research and development support ($0.9 million total). In July 2025, we announced a final clinical data update from the NXP800 Phase 1b study in ovarian cancer. Further development of NXP800 in ovarian cancer will not be pursued and in the coming months we will evaluate the feasibility of development opportunities

for NXP800 in other cancer types in which the patients' performance status and other characteristics may allow treatment with NXP800 to be more impactful.

We do not currently have any long-term leases. We rent our office space in Fort Lee, New Jersey, based on a one-year agreement signed on May 1, 2025.

Off-Balance Sheet Arrangements

We did not have any off-balance sheet arrangements during the periods presented, and we do not currently have any, as defined in the rules and regulations of the SEC.

Critical Accounting Policies and Significant Judgments and Estimates

Our condensed financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q are prepared in accordance with U.S. generally accepted accounting principles. The preparation of condensed financial statements also requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs, expenses, and related disclosures. We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances. Actual results could differ significantly from the estimates made by management. To the extent that there are differences between our estimates and actual results, our future financial statement presentation, financial condition, results of operations, and cash flows will be affected.

There have been no significant changes to our critical accounting policies and estimates as compared to those described in "Note 2 - Summary of Significant Accounting Policies" to our audited financial statements set forth in our Annual Report on Form 10-K filed for the fiscal year ended December 31, 2024, with the SEC on February 25, 2025.

Recently Issued Accounting Pronouncements

See Note 2 to our condensed financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements.

Emerging Growth Company and Smaller Reporting Company Status

The Jumpstart Our Business Startups Act of 2012 permits an "emerging growth company" such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to not "opt out" of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to "opt out" of such extended transition period or (ii) no longer qualify as an emerging growth company.

We are also a "smaller reporting company" meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of our initial public offering is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We will continue to be a smaller reporting company for as long as either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.