Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

Management's Discussion and Analysis of the Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this report. The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words "expect," "anticipate," "intend," "believe," "may," "plan," "seek" or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. For such forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Our business and financial performance are subject to substantial risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider the information set forth under the heading "Risk Factors" herein and in our Annual Report on Form 10-K for the year ended December 31, 2025. As used below, the words "we," "us," and "our" may refer to Nuvectis Pharma, Inc.

Overview

We are a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of complement-related conditions and oncology.

NXP100 (Complement Factor B Inhibitor)  

In June 2026, we licensed exclusive world-wide development, manufacturing and commercial rights, excluding China, to NXP100/HSK39297/ciprocopan ("NXP100") an oral, once daily, potent and selective small-molecule complement Factor B inhibitor ("CFBi") in advanced stages of development. Factor B is a key component of the complement system, a clinically validated target with an FDA approved CFBi approved in several chronic diseases including paroxysmal nocturnal hematoglobinuria ("PNH"), IgA Nephropathy ("IgAN"), and C3 glomerulonephritis (C3G). Factor B is considered potentially important in other diseases such as lupus nephritis ("LN"), myasthenia graves ("MG"), and dry age-related macular degeneration ("d-AMD"). NXP100's PK/PD profile enables a once-daily administration compared to iptacopan, the only FDA-approved factor B inhibitor, which is administered orally twice-daily, providing a potential dosing convenience advantage which is an important attribute for diseases requiring life-long therapy.

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Ciprocopan (NXP100) has received marketing approval by the National Medical Products Administration (NMPA) in China for PNH patients previously untreated with complement inhibitors (treatment naive). A marketing application for previously treated PNH is under review, and a Phase 3 study for IgAN and a Phase 2 study in LN are ongoing in China. Based on cross-trial comparisons, NXP100 demonstrated similar activity to iptacopan, with a similar safety profile.

NXP200 (BRAF Inhibitor)

In June 2026, we licensed exclusive world-wide development, manufacturing and commercial rights, excluding China, to NXP200/HSK42360 an inhibitor of the BRAF serine/threonine kinase ("BRAFi") that has the potential to be a best-in-class, brain-penetrant paradox breaker, overcoming broad-spectrum BRAF-related drug resistance and to become a treatment option for multiple solid tumor types and primary brain cancer. The paradox breaking properties of NXP200 have the potential to address key unmet needs associated with BRAF inhibition, including emerging resistance to first generation BRAFi while reducing toxicities associated with their usage. To date, NXP200 demonstrated excellent efficacy in treating low- and high-grade glioma in adult patients, and generated single agent durable responses in heavily pretreated patients with non-small cell lung cancer, colorectal, papillary thyroid and others. A phase 1b expansion study is ongoing in China.

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In October, expanded NXP200 Phase 1b data in patients with recurrent or progressive BRAF V600-mutated gliomas were presented at the 2026 ESMO Congress by our partner Haisco. As of the May 4, 2026 cutoff, 27 efficacy-evaluable patients with recurrent or progressive BRAF V600 glioma were treated with NXP200 monotherapy, including 20 patients with high-grade glioma and 7 with low-grade glioma. Treatment with NXP200 resulted in an overall response rate ("ORR") of 40.0% in the high-grade glioma cohort, including 3 complete responses ("CRs") (one preliminary CR) and 42.9%, including one confirmed CR, in the low-grade glioma cohort (responses

based on RANO 2.0 criteria). Notably, among the three patients previously treated with a BRAF inhibitor, two achieved a partial response and one had stable disease ("SD"). Deep responses (>80% tumor burden reduction) were achieved in 87.5% of responders with high-grade glioma and 66.7% of responders with low-grade glioma. 81.5% of patients achieved tumor reduction and the Disease Control Rate (ORR plus SD) was 85.2%. A phase 1b expansion study is ongoing in China.

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NXP900 (SRC/YES1 Kinase Inhibitor)

We have licensed exclusive world-wide development and commercial rights to NXP900, a SRC Family Kinase ("SFK") inhibitor that potently inhibits the c-Src ("SRC") and YES1 kinases. NXP900 was discovered at the University of Edinburgh, Scotland.

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There are two ongoing combination Phase 1b studies, and a third pending. The first trial is evaluating the safety, tolerability and preliminary efficacy of NXP900 combination with a market-leading EGFR, osimertinib, and the second is a combination study with the anaplastic lymphoma kinase ("ALK") inhibitor, lorlatinib. An investigator-sponsored trial to evaluate the combination of NXP900 plus the recently approved daraxonrasib in patients with pancreatic cancer is planned at two leading medical centers in the U.S.

Results of Operations

From our inception on July 27, 2020, through September 30, 2026, we did not generate any revenue. Since our inception through September 30, 2026, our primary activities have been focused on the development of our four drug candidates, NXP100, NXP200, NXP900, and NXP800, including the completion of in-licensing agreements for each drug candidate, IND-enabling studies, and other organizational activities such as capital raising. For NXP900, regulatory filings with the Medicines and Healthcare products Regulatory Agency ("MHRA") and FDA, preparation and execution for the Phase 1a, Phase 1b (single agent) and Phase 1b (combination study with osimertinib) clinical trials for NXP900, which commenced in September 2023, August 2025 and December 2025, 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.

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The following table summarizes our results of operations expenses for the three months ended September 30, 2026 and 2025: (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, 2026 and 2025: (in thousands)

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Research and development expenses increased by $21.6 million, or 374%, during the three months ended September 30, 2026, compared to the same period in 2025. The increase in research and development expense during the three months ended September 30, 2026, was primarily driven by a $19.8 million increase in license fees due to $20.0 million related to our license agreement with Haisco Inc, $1.8 million in license fees to the University of Edinburgh related to our fund raising milestones, partially offset by $2.0 million in milestone achievements in 2025, $1.2 million increase in employee compensation and benefits, and $0.6 million increase in clinical trial and manufacturing expenses related to the development of NXP100, NXP200 and NXP900.

The following table summarizes our general and administrative expenses for the three months ended September 30, 2026 and 2025: (in thousands)

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General and administrative expenses increased by $1.7 million, or 82%, during the three months ended September 30, 2026, compared to the same period in 2025. The increase in general and administrative expenses during the three months ended September 30, 2026, was primarily driven by the $1.2 million increase in professional and consulting services, $0.2 million increase in employee compensation and benefits and $0.3 million increase related to public company-related expenses.

As a result of the foregoing, our loss from operations for the three months ended September 30, 2026, increased $23.3 million or 298%, compared to the same period in 2025.

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The following table summarizes our results of operations expenses for the nine months ended September 30, 2026, and 2025:

(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, 2026, and 2025:

(in thousands)

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Research and development expenses increased by $23.1 million during the nine months ended September 30, 2026, compared to the same period in 2025. The increase in research and development expenses during the nine months ended September 30, 2026, was primarily driven by a $19.4 million increase in license fees, a $1.8 million increase in employee compensation and benefits, $1.0 million increase in clinical trial expenses, and a $0.9 million increase in manufacturing expenses.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2026, and 2025: (in thousands)

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General and administrative expenses increased $1.5 million during the nine months ended September 30, 2026, compared to the same period in 2025. The increase in general and administrative expenses during the nine months ended September 30, 2026, was primarily driven by the $0.9 million increase in professional and consulting services related to public company-related expenses, a $0.4 million increase in employee compensation and benefits, and a $0.2 million increase in insurance and other expenses.

As a result of the foregoing, our loss from operations for the nine months ended September 30, 2026, increased $24.5 million, compared to the same period in 2025, which was primarily driven by increases in license fees, clinical trial expenses, manufacturing, and employee compensation and benefits.

Liquidity and Capital Resources

As of September 30, 2026, we had $140.7 million of cash and cash equivalents. For the three months ended September 30, 2026 and 2025, we reported net losses of $30.1 million and $9.9 million, respectively. For the nine months ended September 30, 2026, and 2025, our net losses were $43.1 million and $19.1 million, respectively.

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).

On July 1, 2026, we completed a public offering, in which we received gross proceeds of $100.0 million, before deducting underwriting discounts and expenses and other offering expenses. On July 29, 2026, the underwriters fully exercised their option to purchase an additional 750,000 shares, for which we received additional gross proceeds of $15.0 million before deducting underwriter discounts and expenses. The offering resulted in total net proceeds of approximately $106.3 million, after deducting underwriting discounts, commissions, and estimated offering expenses payable by us.

On August 21, 2026, 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 $200.0 million. In connection with the filing of the Registration Statement, we also amended our sales agreement with Jefferies LLC. (the "Sales Agent"), pursuant to which we may issue and sell shares of our common stock for an aggregate offering price of up to $75.0 million under an at-the-market offering program (the "ATM"), which is included in the $200.0 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. We are not obligated to make any sales of shares under the ATM.

We believe that our existing cash and cash equivalents as of September 30, 2026, 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 milestone payments and sponsored research commitments associated with our license agreements for our drug candidates. In addition, we expect to incur additional costs associated with operating as a public company as we continue to grow, including increased legal, accounting, investor relations, and other expenses. 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, 2026, $36.3 million of cash was used in operating activities. This was primarily attributable to our net loss of $43.1 million, partially offset by non-cash charges of $6.0 million. The change in our operating assets and liabilities was primarily due to $1.5 million for vendor accruals and a $0.1 million payment for our directors and officers' insurance.

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 in future payments to vendor, and $0.1 million payment for our director and officer insurance.

Financing activities

During the nine months ended September 30, 2026, net cash provided by financing activities was $145.4 million, consisting primarily of net proceeds from the July 2026 public offering and the ATM Program.

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 Program.

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 NXP100 and NXP200 License Agreement, we are required to make payments to Haisco Pharmaceutical Group Co., Ltd. ("Haisco"), for the achievement of certain development, regulatory and commercial sales milestones, including an upfront payment of $20.0 million which was paid in July 2026, totaling up to approximately an additional $1.4 billion in potential milestone payments, and 9% to 14% royalties on a tiered basis on net 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 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 an additional $0.4 million in 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, 2026.

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, 2025, with the SEC on February 11, 2026.

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.