On March 7, 2023 Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage 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 fiscal year 2022 and provided an update on recent business progress (Press release, Nuvectis Pharma, MAR 7, 2023, View Source [SID1234628251]).
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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented: "2022 was a very busy year for Nuvectis with significant progress made on both development programs. For NXP800, we continued to advance the Phase 1a dose escalation study in patients with various advanced solid tumors, and in December we announced that the Food and Drug Administration ("FDA") granted Fast Track Designation status to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma. Moreover, we recently announced that the European Network of Gynecological Oncology Trial Groups ("ENGOT") and the GOG Foundation, Inc. ("GOG-F"), the world’s premier gynecology oncology clinical trials consortia, will lead the upcoming Phase 1b clinical trial in ARID1a-mutated ovarian carcinoma, a disease comprised mostly of clear cell and endometrioid histologies. Lastly, the discovery and optimization work performed at the Institute of Cancer Research ("ICR") was showcased in the prestigious New Drugs on the Horizon session of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), and additional in-vivo preclinical data was generated that provides further potential development opportunities for NXP800."
Mr. Bentsur continued: "For NXP900, we are very pleased with the progress made toward submission of an IND and commencement of the Phase 1 clinical trial, expected in 1H2023. NXP900’s unique mechanism of action translated into substantial single-agent activity in several in-vivo xenograft models. Additionally, publications in the scientific literature outlined opportunities to potentially reverse resistance to osimertinib (Tagrisso) in non-small cell lung cancer and enzalutamide (Xtandi) in metastatic, castration resistant prostate cancer, in combination with these agents, highlighting the importance of NXP900 key targets, YES1 and SRC kinases, in these disease settings
Mr. Bentsur concluded, "On the corporate front, we completed the initial public offering in February 2022 and a private placement in July 2022, providing us with sufficient working capital to continue the momentum for both programs into the second half of 2024. As we continue to make significant progress with NXP800 and NXP900, our exciting precision medicine drug candidates, we believe that 2023 is shaping up to be a potentially transformational year for Nuvectis
Full Year 2022 Financial Results
Cash, cash equivalents, and short-term investments were $20.0 million as of December 31, 2022, compared to $5.7 million as of December 31, 2021. The increase of $14.3 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 $19.1 million for the year ended December 31, 2022, compared to $12.9 million for the year ended December 31, 2021, an increase of $6.2 million. Net loss for the 2022 fiscal year included $1.7 million in non-cash expenses and $6.1 million in one-time expenses, primarily related to milestone, fee payments and one-time development costs in connection with NXP800 and NXP900.
Research and development expenses were $13.2 million for the year ended December 31, 2022, compared to $9.5 million for the year ended December 31, 2021, an increase of $3.7 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 2022 fiscal year included $0.9 million in non-cash expenses.
General and administrative expenses were $ 6.0 million for the year ended December 31, 2022, compared to $3.3 million for the year ended December 31, 2021, an increase of $2.7 million. The increase in general and administrative expenses is primarily attributed to costs associated with operating as a public company following our 2022 initial public offering. General and administrative expenses for the 2022 fiscal year also included $0.8 million in non-cash expenses.