Nuvectis Pharma (NASDAQ:NVCT) said its third quarter marked a strategic shift into late-stage development following a licensing agreement with Haisco for ex-China rights to two drug candidates: ciprocopan, also known as NXP100, and NXP200.
Chairman and CEO Ron Bentsur said the agreement, completed in late June, added programs that he described as having potential in complement-mediated diseases and BRAF-mutated solid tumors. The company subsequently completed a follow-on offering that generated $150 million in gross proceeds and raised approximately $37 million through its at-the-market facility during the quarter.
Nuvectis ended the quarter with approximately $140 million in cash and said it expects that capital to fund operations into the second half of 2029.
NXP100 Regulatory and Clinical Plans
NXP100 is a once-daily oral complement Factor B inhibitor that has been approved in China for newly diagnosed paroxysmal nocturnal hemoglobinuria, or PNH. The approval was supported by a Phase III study in which NXP100 was compared with Soliris in treatment-naive patients, according to Bentsur. He said the candidate was superior on the primary endpoint and key secondary endpoints.
A second Chinese marketing application, covering PNH patients previously treated with C5 inhibitors, remains under review. Nuvectis expects Haisco to announce a decision in the first quarter of 2027. Bentsur said the study supporting that application also met its primary and key secondary endpoints.
The company is in discussions with the U.S. Food and Drug Administration regarding a U.S. development plan for PNH and expects to provide an update by the end of 2026. During the question-and-answer session, Bentsur said Nuvectis had its first formal FDA interaction in late September and that the agency had asked questions intended to compare the China-based studies with U.S. guidelines and studies conducted for Novartis’ Fabhalta.
Management said possible FDA outcomes could range from no additional trial requirement to one or two additional clinical trials. Bentsur said the company is preparing for the possibility that the FDA will request a study, potentially involving roughly 35 to 40 patients per arm in a controlled trial.
Nuvectis also plans to file at least one investigational new drug application for NXP100 by year-end for an indication outside PNH and to begin additional studies in the first half of 2027. The company is monitoring ongoing NXP100 studies in China, including a Phase III trial in IgA nephropathy, as well as trials of Novartis’ Fabhalta in additional complement-mediated diseases.
In IgA nephropathy, Bentsur pointed to a 24-week Phase II study in China that showed a statistically significant reduction in proteinuria and an approximately three-point increase in estimated glomerular filtration rate, or eGFR, in the NXP100 arm, compared with a 1.5-point decline in the placebo group. The ongoing Phase III trial in China includes 370 patients, according to comments made during the call.
NXP200 Data and U.S. Development
NXP200 is an oral, brain-penetrant “paradox-breaker” BRAF inhibitor being developed for BRAF-mutated solid tumors. In September, the drug received breakthrough designation in China for recurrent or progressive BRAF V600-mutant high-grade glioma.
At the ESMO conference in October, Haisco presented updated Phase Ib data from China. In the 20-patient high-grade glioma cohort, NXP200 produced a 40% objective response rate, including three complete responses, two of which were confirmed and one pending. In the low-grade glioma cohort, the objective response rate was 42.9%, including one confirmed complete response.
Bentsur said responses were assessed using RANO 2.0 criteria, which he characterized as the FDA regulatory standard for brain tumors. He also said the study included patients who had previously received BRAF inhibitors, with responses observed in two of three such patients.
Nuvectis expects another update from the ongoing Phase Ib study in China in the coming months, including data in colorectal cancer, melanoma, non-small cell lung cancer and papillary thyroid cancer. Management said it is particularly focused on the potential for activity among patients previously treated with BRAF inhibitors.
The company remains on track to submit a U.S. IND for NXP200 by the end of 2026, with the goal of initiating a U.S. Phase Ib study in early 2027. Bentsur said the company is also considering pursuing U.S. breakthrough designation as further data become available.
NXP900 Combination Studies Continue
Nuvectis said it is narrowing development of its legacy oncology candidate, NXP900, toward selected combination opportunities as it places greater emphasis on NXP100. Ongoing Phase Ib studies are evaluating NXP900 in combination with Tagrisso, or osimertinib, and Lorbrena, or lorlatinib.
The company also plans an investigator-initiated study combining NXP900 with the recently approved KRAS inhibitor daraxonrasib in pancreatic cancer. Nuvectis expects to provide clinical updates from the NXP900 program in the first half of 2027.
Third-Quarter Results and Upcoming Catalysts
Nuvectis reported a third-quarter net loss of $30.1 million. Excluding an upfront license payment, a one-time NXP900 milestone and non-cash stock-based compensation, adjusted net loss was $5.8 million.
Near-term milestones cited by the company include:
- An update on the U.S. regulatory path for NXP100 in PNH by year-end.
- At least one NXP100 IND filing by year-end.
- A U.S. IND filing for NXP200 by year-end.
- Potential Chinese approval for NXP100 in previously treated PNH patients during the first quarter of 2027.
- Additional NXP200 clinical data from China in early 2027.
- NXP900 clinical updates in the first half of 2027.
The company also said it has begun transferring manufacturing activities to its own contract manufacturing organization, a process it expects to occur in parallel with clinical development and not delay planned trial starts.
About Nuvectis Pharma (NASDAQ:NVCT)
Nuvectis Pharma, Inc is a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, with an emphasis on cancers that have limited therapeutic options. The company is headquartered in Fort Lee, New Jersey, and its common stock trades on the Nasdaq Capital Market under the symbol NVCT.
Nuvectis Pharma’s lead product candidate is NXP800, an orally administered small-molecule inhibitor of heat shock protein 90 (HSP90). The company is evaluating NXP800 in clinical studies for certain advanced solid tumors, including platinum-resistant ovarian cancer and cholangiocarcinoma.
