Nuvectis Pharma, Inc.

Previous wording

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 which 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 the mutations in ARID1a can be detected using a commercially available next generation sequencing-based in vitro diagnostic tests, which are routinely utilized in the clinic for cancer patients.

Current wording

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 which 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 the 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.

Previous wording

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 the development program of NXP800 for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma.

Current wording

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.

Previous wording

In August 2024, we announced that the FDA granted Orphan Drug Designation to NXP800 for the treatment of patients with ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.

Current wording

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.

Previous wording

SRC is aberrantly activated in many cancer types, including solid tumors such as breast, colon, prostate, pancreatic and ovarian, while remaining predominantly inactive in non-cancerous cells. Increased SRC activity is generally associated with late-stage cancers, metastatic potential and resistance to therapy, and correlates with poor clinical prognosis. YES1 gene amplification has been reported to be implicated in several tumors including lung, head and neck, bladder and esophageal cancers. In addition, YES1 directly phosphorylates and activatesthe Yes-associated protein (“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.

Current wording

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.

Previous wording

In May 2023, the FDA cleared our IND for NXP900, which includes the Phase 1 clinical trial protocol.

Current wording

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 FDA cleared our IND for NXP900, which includes the Phase 1 clinical trial protocol.

Previous wording

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). In the ongoing Phase 1a, the safety, tolerability and pharmacokinetic properties of NXP900 in patients with advanced solid tumors are being assessed to identify a dose and dosing schedule for Phase 1b.

Current wording

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). In the ongoing Phase 1a, the safety, tolerability and pharmacokinetic properties of NXP900 in patients with advanced solid tumors are being assessed to identify doses and dosing schedules for Phase 1b.

Previous wording

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

Current wording

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 that will be necessary to complete the preclinical and clinical development of any of our product candidates and we may never succeed in obtaining regulatory approval for any of our product candidates.

Previous wording

The following table summarizes our results of operations expenses for the three months ended September 30, 2024 and 2023: (in thousands)

Current wording

The following table summarizes our results of operations expenses for the three months ended March 31, 2025 and 2024:

Previous wording

The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023: (in thousands)

Current wording

The following table summarizes our research and development expenses for the three months ended March 31, 2025, and 2024:

Previous wording

Research and development expenses decreased by $2.7 million during the nine months ended September 30, 2024 compared to the same period in 2023. The decrease in research and development expenses during the nine months ended September 30, 2024 was primarily driven by a $1.7 million decrease in manufacturing related costs, $1.0 million decrease in one-time licensing fees for NXP900, and $0.4 million decrease in clinical trial expenses, partially offset by a $0.5 million increase in employee compensation including $0.4 million increase related to employee stock compensation.

Current wording

Research and development expenses increased by $1.0 million during the three months ended March 31, 2025 compared to the same period in 2024. The increase in research and development expenses during the three months ended March 31, 2025 was primarily driven by a $0.4 million increase in one-time licensing fees for NXP900, $0.3 million increase in clinical trial expenses, $0.2 million increase in employee compensation including a $0.1 million increase related to employee stock compensation, and a $0.1 million increase in

Previous wording

General and administrative expenses decrease by $0.1 million, or 8%, during the three months ended September 30, 2024, compared to the same period in 2023. The decrease in general and administrative expenses during the three months ended September 30, 2024, was primarily driven by the $0.1 million decrease in professional and consulting services related to public company related expenses.

Current wording

General and administrative expenses increased $0.2 million during the three months ended March 31, 2025 compared to the same period in 2024. The increase in general and administrative expenses during the three months ended March 31, 2025, was primarily driven by the $0.1 million increase in professional and consulting services related to public company related expenses, and $0.1 million increase in one-time other expenses.

Previous wording

As a result of the foregoing, our loss from operations for the nine months ended September 30, 2024, decreased $2.9 million, compared to the same period in 2023, which was primarily driven by employee compensation and benefits, clinical trial expenses, manufacturing expenses, and an increase in finance income of $0.3 million.

Current wording

As a result of the foregoing, our loss from operations for the three months ended March 31, 2025, increased $1.2 million, compared to the same period in 2024, which was primarily driven by licensing fees, clinical trial expenses, and manufacturing expenses.

Previous wording

As of September 30, 2024, we had $17.2 million of cash and cash equivalents. For the three months ended September 30, 2024 and 2023, we reported net losses of $4.2 million and $5.9 million, respectively. For the nine months ended September 30, 2024 and 2023, our net losses were $12.8 million and $15.6 million, respectively.

Current wording

As of March 31, 2025, we had $29.9 million of cash and cash equivalents. For the three months ended March 31, 2025 and 2024, we reported net losses of $5.3 million and $4.2 million, respectively.

Previous wording

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, 2024, 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, 2024, 79,104 placement agent warrants were exercised, and $0.8 million, net of fees, was received.

Current wording

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 months ended March 31, 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 March 31, 2025, 79,104 placement agent warrants were exercised, and $0.8 million, net of fees, was received.

Previous wording

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 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. We are not obligated to make any sales of shares under the ATM. As of September 30, 2024, we have sold 1,337,654 shares of our common stock and received $12.9 million in net proceeds under the ATM.

Current wording

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 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

Previous wording

We believe that the proceeds from our IPO, private placement and ATM 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.

Current wording

We believe that the proceeds from our IPO, private placement, 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.

Previous wording

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 agreements for NXP800 and NXP900. In addition, we expect to incur increasing costs associated with operating as a public

Current wording

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 agreements for NXP800 and NXP900. In addition, we expect to incur increasing 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:

Previous wording

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 payments to vendors, and $0.1 million payment for our director and officer insurance.

Current wording

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 $0.5 million payments to vendors, and $0.2 million payment for our director and officer insurance.

Previous wording

During the nine months ended September 30, 2023, $12.1 million of cash was used in operating activities. This was primarily attributable to our net loss of $15.6 million, partially offset by non-cash charges of $3.5 million. The change in our operating assets and liabilities was primarily due to $0.5 million of payments for employee compensation and benefits.

Current wording

During the three months ended March 31, 2024, $4.4 million of cash was used in operating activities. This was primarily attributable to our net loss of $4.2 million, partially offset by non-cash stock-based compensation charges of $1.3 million. The change in our operating assets and liabilities was primarily due to$1.0 million in payments to vendors, $0.3 million payment of employee compensation and benefits, $0.3 million payment forour director and officer insurance, and $0.5 million payments related to public company operations.

Previous wording

During the nine months ended September 30, 2023, net cash provided by financing activities was $14.2 million, consisting primarily of $10.3 million in net proceeds from the exercise of warrants associated with our private placement along with $4.2 million of net proceeds from the sale of common stock through the ATM, offset by $0.4 million of deferred offering costs paid.

Current wording

During the three months ended March 31, 2025, net cash provided by financing activities was $15.5 million, consisting primarily of net proceeds from the sale of common stock through the public offering and the ATM.

Previous wording

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

Current wording

During the three months ended March 31, 2024, net cash provided by financing activities was $4.7 million, consisting primarily of net proceeds from the sale of common stock through the ATM.

Previous wording

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.

Current wording

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.

Previous wording

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, 2024.

Current wording

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, 2025.

Previous wording

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 with the SEC on March 5, 2024.

Current wording

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.