Nuvectis Pharma Inc.

05/05/2026 | Press release | Distributed by Public on 05/05/2026 07:03

Quarterly Report for Quarter Ending March 31, 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 serious conditions of unmet medical need in oncology.

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.

SRC is aberrantly activated in many cancer types, including solid tumor cancers such as breast, colon, prostate, pancreatic and ovarian cancers, while remaining predominantly inactive in non-cancerous cells. Increased SRC activity is generally associated with late-stage cancers with metastatic potential and resistance to therapies and correlates with poor clinical prognosis. To date, no kinase inhibitor has been approved for the treatment of SRC-active solid tumor malignancies.

YES1 is a nonreceptor tyrosine kinase that belongs to the SRC family of kinases and controls multiple cancer signaling pathways. YES1 is gene-amplified and overexpressed in many tumor types, where it promotes cell proliferation, survival, and invasiveness. In addition, YES1 directly phosphorylates and activates the yes-associated protein 1 ("YAP1"), the main effector of the Hippo pathway, which has been identified as a promoter of drug resistance, cancer progression, and metastasis in several cancer types, including squamous cell, mesothelioma and papillary kidney cancers.

In vivo, treatment with NXP900 inhibited primary and metastatic tumor growth in xenograft models of breast, esophageal, lung, head and neck cancers and medulloblastoma, and demonstrated on-target pharmacodynamic effects. Moreover, publications in the scientific literature outlined opportunities to potentially reverse resistance to osimertinib (active ingredient of Tagrisso®) in non-small cell lung cancer ("NSCLC") and enzalutamide (active ingredient of Xtandi®) in metastatic, castration resistant prostate cancer, in combination with these agents, validating the potential importance of NXP900's key targets, YES1 and SRC kinases, in these disease settings. Studies published by Nuvectis and academic collaborators confirmed the ability of NXP900 to synergize with and restore sensitivity to epidermal growth factor receptor ("EGFR") and anaplastic lymphoma kinase ("ALK") inhibitors in NSCLC models with acquired resistance to these inhibitors. In May 2023, the U.S. Food and Drug Administration (the "FDA") cleared our IND for NXP900, which includes the Phase 1 clinical trial protocol.

The Phase 1 study was initiated in September 2023 and is comprised of two parts: dose-escalation (Phase 1a), to be followed by an expansion phase (Phase 1b). The results of the Phase 1a study support once-daily oral dosing of NXP900. In August 2025, we announced the initiation of the Phase 1b expansion portion of the study. The ongoing Phase 1b study will evaluate the safety, tolerability and preliminary efficacy of NXP900 both as a single agent targeting specific tumor types and in combination with market-leading epidermal growth factor receptor ("EGFR") and anaplastic lymphoma kinase ("ALK") inhibitors.

Results of Operations

From our inception on July 27, 2020, through March 31, 2026, we did not generate any revenue. Since our inception through March 31, 2026, our main activities have been organizational management,capital raising and the completion of the in-license agreements for, NXP800 and NXP900, regulatory filings with the Medicines and Healthcare products Regulatory Agency ("MHRA") and FDA, preparation and execution for the Phase 1a and Phase 1b clinical trial for NXP800, which commenced in December 2021 and May 2023, respectively, and 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.

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 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 increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidates is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts necessary to complete the preclinical and clinical development of any of our product candidates. We may never succeed in obtaining 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 relating to patent and corporate matters; professional fees paid for accounting, auditing, consulting, and tax services; 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 increase our headcount to support our continued research and development activities.

The following table summarizes our results of operations expenses for the three months ended March 31, 2026 and 2025:

(in thousands)

Three Months Ended March 31,

​ ​ ​

2026

​ ​ ​

2025

​ ​ ​

Change

OPERATING EXPENSES:

Research and development

$

4,106

$

3,680

$

426

General and administrative

2,154

1,888

266

OPERATING LOSS

(6,260)

(5,568)

(692)

Finance income

210

236

(26)

NET LOSS

$

(6,050)

$

(5,332)

$

(718)

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended March 31, 2026, and 2025:

(in thousands)

​ ​ ​

For the three months ended March 31,

​ ​ ​

Increase/

​ ​ ​

2026

​ ​ ​

2025

​ ​ ​

(Decrease)

Employee compensation and benefits

$

2,065

$

1,717

$

348

Clinical expenses

1,212

1,036

176

Manufacturing

829

476

353

License fee

-

438

(438)

Professional services and other

-

13

(13)

Total research and development expenses

$

4,106

$

3,680

$

426

Research and development expenses increased by $0.4 million during the three months ended March 31, 2026 compared to the same period in 2025. The increase in research and development expenses during the three months ended March 31, 2026 was primarily driven by a $0.4 million increase in manufacturing-related costs, $0.3 million increase in employee compensation and benefits, and $0.2 million increase in clinical trial expenses, offset by a $0.4 million reduction in license fees.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the three months ended March 31, 2026, and 2025: (in thousands)

For the three months ended March 31,

​ ​ ​

Increase/

​ ​ ​

2026

2025

​ ​ ​

(Decrease)

Professional and consulting services

$

1,157

$

957

$

200

Employee compensation and benefits

601

502

99

Insurance and other

396

429

(33)

Total general and administrative expenses

$

2,154

$

1,888

$

266

General and administrative expenses increased $0.3 million during the three months ended March 31, 2026 compared to the same period in 2025. The increase in general and administrative expenses during the three months ended March 31, 2026, was primarily driven by the $0.2 million increase in professional and consulting services related to public company related expenses, and $0.1 million increase in employee compensation.

As a result of the foregoing, our loss from operations for the three months ended March 31, 2026, increased $0.7 million, compared to the same period in 2025, which was primarily driven by employee compensation, clinical trial expenses, and manufacturing expenses.

Liquidity and Capital Resources

As of March 31, 2026, we had $25.1 million of cash and cash equivalents. For the three months ended March 31, 2026 and 2025, we reported net losses of $6.1 million and $5.3 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, along with deducting other offering expenses (for net proceeds of $14.0 million).

On February 13, 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 $150.0 million. In connection with the filing of the Registration Statement, we also amended our sales agreement with Leerink Partners 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 $60.0 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. We are not obligated to make any sales of shares under the ATM.

We believe that the proceeds from our ATM 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 wrong, and we could exhaust our available capital resources sooner than we expect. Our future viability in the long term is dependent on our ability to raise additional capital to finance our operations.

We expect our expenses to increase substantially 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 agreement for NXP900. 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:

advance development of our clinical and preclinical programs;
manufacture, or procure the manufacturing of, our preclinical and clinical drug material and develop processes for late stage and commercial manufacturing;
seek regulatory approvals for any current or future product candidates that successfully complete clinical trials;
achieve milestones in accordance with our license agreements;
establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any current or future product candidates for which we may obtain marketing approval;
hire additional clinical, quality control and scientific personnel;
expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;
obtain, maintain, expand and protect our intellectual property portfolio; and
acquire additional product candidates.

We anticipate that we will require additional capital as we seek regulatory approval of our product candidate 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:

the scope, progress and costs of researching and developing our current or future product candidates, including the timing and safety, tolerability and efficacy results from our preclinical and clinical trials;
the costs, timing and outcome of regulatory review of our current or future product candidates;
the costs, timing and ability to manufacture our current or future product candidates to supply our preclinical development efforts and our clinical trials;
the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our current or future product candidates for which we receive marketing approval;
the costs of manufacturing commercial-grade products and necessary inventory to support commercial launch;
the ability to receive additional non-dilutive funding, including grants from organizations and foundations;
the revenue, if any, received from commercial sale of our products, should any of our current or future product candidates receive marketing approval;
the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual property rights and defending intellectual property-related claims;
our ability to establish and maintain collaborations on favorable terms, if at all; and
the extent to which we acquire or in-license other product candidates and technologies.

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)

For the three months ended March 31,

​ ​ ​

2026

​ ​ ​

2025

Net cash used in operating activities

$

(6,511)

$

(4,174)

Net cash used in investing activities

-

-

Net cash provided by financing activities

$

7

$

15,505

Operating Activities

During the three months ended March 31, 2026, $6.5 million of cash was used in operating activities. This was primarily attributable to our net loss of $6.1 million, partially offset by non-cash charges of $1.9 million. The change in our operating assets and liabilities was primarily due to $1.7 million payments to vendors, $0.5 million payments to employees,and $0.2 million payment for our director and officer insurance.

During the three months ended March 31, 2025, $4.2 million of cash was used in operating activities. This was primarily attributable to our net loss of $5.3 million, partially offset by non-cash charges of $1.4 million. The change in our operating assets and liabilities was primarily due to a $0.5 million increase in accounts payables to vendors, $0.5 million payments to vendorsemployees, and a $0.2 million payment for our director and officer insurance.

Financing activities

During the three months ended March 31, 2026, net cash provided by financing activities was $7 thousand, consisting primarily of net proceeds from the sale of common stock through the ATM.

During the three months ended March 31, 2025, net cash provided by financing activities was $29.1 million, consisting primarily of net proceeds from the sale of common stock through the public offering and the ATM.

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 non-cancelable 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 based 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.

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 renewed on May 1, 2026.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, 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 on various other assumptions that we believe to be 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.

Nuvectis Pharma Inc. published this content on May 05, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on May 05, 2026 at 13:06 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]