Nuvectis Pharma, Inc.
For the period ended Jun 30, 2025. Filed Aug 5, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 5, 2025
NVCT$20.91+17.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-06.
0001558370-25-006497
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0001558370-25-010203
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 73 previous paragraphs and 82 current paragraphs.
51 unchanged; 19 reworded; 8 added; 3 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 23 previous and 26 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
The NXP900 Phase 1a dose escalation study evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of NXP900 in patients with advanced solid tumors (all comers). In this study, a dose range of 20 to 300 mg/day was evaluated and the dose limiting toxicity dose level was not reached. The most common treatment emergent adverse events were mainly gastrointestinal-related and mild to moderate in intensity; systemic exposure to NXP900 increased with increased doses and a robust pharmacodynamic response of
Current report
approximately 90% inhibition of SRC kinase phosphorylation was elicited at doses of 150 mg/day and higher, suggesting a potentially wide therapeutic window.
Current report
The NXP900 DDI study was conducted to evaluate the potentially of NXP900 to induce the activity of Cytochrome P450 (“CYP”) enzymes, that showed that NXP900 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.
Current report
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 the Company 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.
Current report
Research and development expenses increased by $0.7 million, or 23% during the three months ended June 30, 2025, compared to the same period in 2024. The increase in research and development expense during the three months ended June 30, 2025, was primarily
Current report
driven by a $0.7 million increase in clinical expenses related to the development of NXP900 and NXP800, $0.2 million increase in employee compensation and benefits, partially offset by a $0.3 million decrease in manufacturing.
Current report
million increase in clinical expenses, $0.4 million increase in employee compensation, and $0.4 million in one-time license fees for NXP900, partially offset by a $0.2 million decrease in manufacturing expenses.
Current report
General and administrative expenses increased $1.4 million during the six months ended June 30, 2025 compared to the same period in 2024. The increase in general and administrative expenses during the six months ended June 30, 2024, was primarily driven by the $1.2 million increase in professional and consulting services related to public company related expenses including $0.4 million increase in stock-based compensation, $0.2 million increase for insurance and other expenses and $0.1 million increase in employee compensation.
Removed paragraphs (3)
Previous report
Research and Development Expenses
Previous report
Research and Development Expenses
Previous report
manufacturing related costs including $0.3 million in one-time milestone fees offset by a $0.2 million reduction in GMP manufacturing runs in the quarter.
Reworded paragraphs (19)
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 doses and dosing schedules 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. In July 2025 we announced the completion and topline results from of a clinical drug-drug interaction (DDI) study in healthy volunteers.
Previous wording
From our inception on July 27, 2020, through March 31, 2025, we did not generate any revenue. Since our inception through March 31, 2025, our main activities have been development activities for our two drug candidates, NXP800 and NXP900, including completion of the in-license agreements, IND-enabling studies and the conduct of the ongoing Phase 1 clinical trials for each drug candidate and other organizational activities including capital raising. For NXP800, we conducted IND-enabling studies, which were followed by our Clinical Trial Application and acceptance by the Medicines and Healthcare Regulatory Agency in the UK, IND application and acceptance by the FDA, and 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. For NXP900, we conducted IND-enabling studies, which were followed by our IND application and acceptance by the FDA, as well as preparations for the Phase 1a clinical trial, which commenced in September 2023.
Current wording
From our inception on July 27, 2020, through June 30, 2025, we did not generate any revenue. Since our inception through June 30, 2025,* *our main activities have been development activities for our two drug candidates, NXP900 and NXP800, including completion of the in-license agreements, IND-enabling studies and the conduct of the ongoing Phase 1 clinical trials for each drug candidate and other organizational activities including capital raising. For NXP900, we conducted IND-enabling studies, which were followed by our IND application and acceptance by the FDA, as well as the Phase 1a clinical trial, which commenced in September 2023 and the DDI study 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 Regulatory Agency in the UK, IND application and acceptance by the FDA, and 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.
Previous wording
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.
Current wording
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 and other corporate activities.
Previous wording
The following table summarizes our results of operations expenses for the three months ended March 31, 2025 and 2024:
Current wording
The following table summarizes our results of operations expenses for the three months ended June 30, 2025 and 2024: (in thousands)
Previous wording
The following table summarizes our research and development expenses for the three months ended March 31, 2025, and 2024:
Current wording
The following table summarizes our research and development expenses for the three months ended June 30, 2025 and 2024: (in thousands)
Previous 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.
Current wording
General and administrative expenses increase by $1.3 million, or 75%, during the three months ended June 30, 2025, compared to the same period in 2024. The increase in general and administrative expenses during the three months ended June 30, 2025, was primarily driven by the $1.5 million increase in professional and consulting services related to public company related expenses including a $0.4 million increase in stock-based compensation.
Previous 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.
Current wording
As a result of the foregoing, our loss from operations for the three months ended June 30, 2025, increased $1.9 million or 43%, compared to the same period in 2024.
Previous 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
Current wording
Research and development expenses increased by $1.7 million during the six months ended June 30, 2025 compared to the same period in 2024. The increase in research and development expenses during the six months ended June 30, 2025 was primarily driven by a $1.0
Previous 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.
Current wording
As of June 30, 2025, we had $26.8 million of cash and cash equivalents. For the three months ended June 30, 2025 and 2024, we reported net losses of $6.3 million and $4.4 million, respectively. For the six months ended June 30, 2025 and 2024, our net losses were $11.7 million and $8.6 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 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.
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 and six months ended June 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 June 30, 2025, 79,104 placement agent warrants were exercised, and $0.8 million, net of fees, was received.
Previous wording
any shares of our common stock. We are not obligated to make any sales of shares under the ATM. As of March 31, 2025, we have sold 2,065,829 shares of our common stock and received $18.0 million in net proceeds under the ATM.
Current wording
any shares of our common stock. We are not obligated to make any sales of shares under the ATM. As of June 30, 2025, we have sold 2,127,830 shares of our common stock and received $19.2 million in net proceeds under the ATM. Subsequent to June 30, 2025, we have sold an additional 1,579,261 shares of common stock under the ATM for aggregate total gross proceeds of approximately $12.6 million.
Previous wording
On February 6, 2025, we completed a public offering, in which we received with 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).
Current wording
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).
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 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:
Current wording
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. 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 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.
Current wording
During the six months ended June 30, 2025, $7.5 million of cash was used in operating activities. This was primarily attributable to our net loss of $11.7 million, partially offset by non-cash charges of $3.1 million. The change in our operating assets and liabilities was primarily due to $1.1 million payments to vendors, and a $0.1 million payment for our director and officer insurance.
Previous 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.
Current wording
During the six months ended June 30, 2024, $7.4 million of cash was used in operating activities. This was primarily attributable to our net loss of $8.6 million, partially offset by non-cash charges of $2.6 million. The change in our operating assets and liabilities was primarily due to $0.5 million of payments for employee compensation and benefits.
Previous 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.
Current wording
During the six months ended June 30, 2025, net cash provided by financing activities was $15.8 million, consisting primarily of net proceeds from the sale of common stock through the public offering and the ATM.
Previous 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.
Current wording
During the six months ended June 30, 2024, net cash provided by financing activities was $6.4 million, consisting of $6.4 million 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 non-cancelable 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 noncancelable 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 renewed on May 1, 2025.
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 signed on May 1, 2025.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
The following table summarizes our results of operations expenses for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table summarizes our general and administrative expenses for the six months ended June 30, 2025 and 2024: (in thousands)
Current report — wording carried from elsewhere
As a result of the foregoing, our loss from operations for the six months ended June 30, 2025, increased $3.1 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 one-time license fee for NXP900.