Nuvectis Pharma, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
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.
Sep 30, 2026 · Filed Nov 4, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-04.
0001104659-26-090109
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001104659-26-122387
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 71 previous paragraphs and 73 current paragraphs.
46 unchanged; 23 reworded; 3 added; 1 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 26 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 (3)
Current report
NXP100 (Complement Factor B Inhibitor)
Current report
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
Current report
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.
Removed paragraphs (1)
Previous report
NXP100 (Factor B Inhibitor)
Reworded paragraphs (23)
Previous wording
In June 2026 we have licensed exclusive world-wide development, manufacturing and commercial rights, excluding China, to NXP100/HSK39297 an oral, once daily, potent and selective small-molecule Factor B inhibitor in advanced stages of development. Factor B is a key component of the complement system, a clinically validated target and FDA approved in several chronic diseases including paroxysmal nocturnal hematoglobinuria (“PNH”), IgA Nephropathy (“IgAN”), and C3 glomerulonephritis (C3G), and 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.
Current wording
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.
Previous wording
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 applications for previously treated PNH, and a Phase 3 study for IgAN and a Phase 2 study in LN are ongoing in China. In cross-trial comparisons, NXP100 demonstrated similar activity to iptacopan, with a similar safety profile.
Current wording
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.
Previous wording
In June 2026 we have 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, by 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.
Current wording
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.
Previous wording
The ongoing Phase 1b study is evaluating the safety, tolerability and preliminary efficacy of NXP900 combination with market-leading EGFR and a combination study with the anaplastic lymphoma kinase (“ALK”) inhibitor, lorlatonib is pending commencement.
Current wording
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.
Previous wording
Research and development expenses increased by $1.1 million, or 30%, during the three months ended June 30, 2026, compared to the same period in 2025. The increase in research and development expense during the three months ended June 30, 2026, was primarily driven by a $0.8 million increase in clinical trial and manufacturing expenses related to the development of NXP900, and a $0.3 million increase in employee compensation and benefits.
Current wording
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.
Previous wording
General and administrative expenses decreased by $0.5 million, or 16%, during the three months ended June 30, 2026, compared to the same period in 2025. The decrease in general and administrative expenses during the three months ended June 30, 2026, was primarily driven by the $0.5 million decrease in professional and consulting services related to public company-related expenses.
Current wording
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.
Previous wording
As a result of the foregoing, our loss from operations for the three months ended June 30, 2026, increased $0.7 million or 11%, compared to the same period in 2025.
Current wording
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.
Previous wording
The following table summarizes our results of operations expenses for the six months ended June 30, 2026, and 2025:
Current wording
The following table summarizes our results of operations expenses for the nine months ended September 30, 2026, and 2025:
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2026, and 2025:
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2026, and 2025:
Previous wording
Research and development expenses increased by $1.5 million during the six months ended June 30, 2026, compared to the same period in 2025. The increase in research and development expenses during the six months ended June 30, 2026, was primarily driven by a $0.8 million increase in manufacturing expenses, a $0.7 million increase in employee compensation and benefits, and a $0.5 million increase in clinical expenses.
Current wording
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.
Previous wording
The following table summarizes our general and administrative expenses for the six months ended June 30, 2026, and 2025: (in thousands)
Current wording
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2026, and 2025: (in thousands)
Previous wording
General and administrative expenses decreased $0.2 million during the six months ended June 30, 2026, compared to the same period in 2025. The decrease in general and administrative expenses during the six months ended June 30, 2026, was primarily driven by the $0.3 million decrease in professional and consulting services related to public company-related expenses, and a $0.1 million decrease in insurance and other expenses, partially offset by a $0.2 million increase in employee compensation and benefits.
Current wording
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.
Previous wording
As a result of the foregoing, our loss from operations for the six months ended June 30, 2026, increased $1.4 million, compared to the same period in 2025, which was primarily driven by increases in clinical trial expenses, manufacturing, and employee compensation and benefits.
Current wording
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.
Previous wording
As of June 30, 2026, we had $22.2 million of cash and cash equivalents. For the three months ended June 30, 2026 and 2025, we reported net losses of $7.0 million and $6.3 million, respectively. For the six months ended June 30, 2026, and 2025, our net losses were $13.1 million and $11.7 million, respectively.
Current wording
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.
Previous wording
additional 750,000 shares, for which we received additional gross proceeds of $15 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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
We believe that our existing cash and cash equivalents as of June 30, 2026, and the proceeds from our public offering completed in July 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.
Current wording
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.
Previous wording
During the six months ended June 30, 2026, $11.0 million of cash was used in operating activities. This was primarily attributable to our net loss of $13.1 million, partially offset by non-cash charges of $3.6 million. The change in our operating assets and liabilities was primarily due to $1.1 million of payments for vendors and a $0.1 million payment for our directors and officers' insurance
Current wording
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.
Previous 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 a $2.4 million increase in accounts payable to our vendors and a $0.1 million payment for our directors and officers' insurance.
Current wording
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.
Previous wording
During the six months ended June 30, 2026, net cash provided by financing activities was $1.6 million, consisting primarily of net proceeds from the ATM Program.
Current wording
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.
Previous wording
During the six months ended June 30, 2025, net cash provided by financing activities was $15.8 million, consisting of $14.0 million of net proceeds from the sale of common stock through the February 2025 public offering and the ATM Program.
Current wording
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.
Previous wording
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 $1.4 billion in potential milestone payments, and 9% to 14% royalties on a tiered basis on net sales.
Current wording
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.
Previous wording
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.
Current wording
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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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