On November 8, 2022 Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the third quarter of 2022 and provided an update on recent business progress (Press release, Nuvectis Pharma, NOV 8, 2022, View Source [SID1234623383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the third quarter of 2022, we continued to advance both of our pipeline products, NXP800 and NXP900, toward the next phase in their respective development programs. The NXP800 Phase 1a dose-escalation study is proceeding as planned, with the start of the Phase 1b expansion phase expected in Q1 2023. The recently reported positive preclinical data in an ARID1a-mutated gastric carcinoma model provides another possible development opportunity for NXP800, as ARID1a is mutated in approximately 20-25% of the roughly 26,000 new cases reported in the US annually," commented Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, "We believe that NXP900 is uniquely positioned to become the first SRC/YES1 kinase inhibitor for the treatment of certain solid tumors. In this regard, the recent discovery of increased sensitivity to NXP900 in cancer cells harboring alterations in the HIPPO signaling pathway is very important, as it provides additional potential criteria for patient selection. We anticipate completing the NXP900 IND-enabling studies by the end of this year and to submit an IND or an equivalent application in Q1 2023." Mr. Bentsur concluded, "We continue to operate efficiently with an expected cash runway into the second half of 2024."

Third Quarter Highlights

NXP800

•The Phase 1a dose escalation portion of the Phase 1 clinical program of NXP800 is ongoing, and the Phase 1b dose expansion study is expected to begin in Q1 2023.
•Positive preclinical data in a xenograft model of ARID1a-mutated gastric cancer provides another possible development opportunity for NXP800. According to the American Cancer Society, approximately 26,000 new cases of gastric cancer are expected in 2022, of which approximately 25% will carry an ARID1a mutation.
•Biomarker data supporting the clinical development of NXP800 were presented at the 2022 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) ("ENA") Symposium.

NXP900

•NXP900 preclinical data was presented at the 2022 ENA Symposium. The presentation provided new data on the differential activity profile of NXP900 versus dasatinib, and on the increased sensitivity to NXP900 in cancer cells harboring alterations in the HIPPO signaling pathway.

Third Quarter 2022 Financial Results

Cash, cash equivalents, and short-term investments were $23.6 million as of September 30, 2022, compared to $5.7 million as of December 31, 2021. The increase of $17.9 million was primarily a result of the Company’s initial public offering in February 2022 and the private placement in July 2022.

The Company’s net loss was $5.9 million for the three months ended September 30, 2022, compared to $4.7 million for the three months ended September 30, 2021, an increase of $1.2 million. Net loss for the third quarter of 2022 included $0.5 million in non-cash expenses and $3.4 million in one-time expenses, primarily related to milestone and fee payments in connection with the NXP800 and NXP900 license agreements.

Research and development expenses were $4.5 million for the three months ended September 30, 2022, compared to $4.2 million for the three months ended September 30, 2021, an increase of $0.4 million. The increase in research and development expenses is primarily attributed to one-time expenses related to milestone and fee payments in connection with the license agreements, and an increase in preclinical and clinical development costs. Research and development expenses for the third quarter of 2022 included $0.3 million in non-cash expenses.

General and administrative expenses were $1.4 million for the three months ended September 30, 2022, compared to $0.5 million for the three months ended September 30, 2021, an increase of $0.9 million. The increase in general and administrative expenses is primarily attributed to the 2022 initial public offering. General and administrative expenses for the third quarter of 2022 also included $0.2 million in non-cash expenses.