On March 22, 2022 Nuvectis Pharma, Inc (NASDAQ: NVCT), ("Nuvectis" or the "Company") is a biopharmaceutical company focused on the development of precision medicines for serious conditions of unmet medical need in oncology reported its financial results for the fiscal year 2021 and provided an update on recent business progress (Press release, Nuvectis Pharma, MAR 22, 2022, View Source [SID1234610596]).
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"We founded Nuvectis with the goal of becoming a leading biopharmaceutical company focused on the development of innovative treatments for people suffering from serious conditions in oncology for which the prognosis is poor and there are very limited treatment options, and we believe that we are on our way to achieving that," said Ron Bentsur, Chairman and Chief Executive Officer. Mr. Bentsur continued, "2021 was a very exciting year for Nuvectis," "In 2021, we completed two exclusive world-wide licensing deals to develop and commercialize our first two drug candidates, and with our recently completed initial public offering, we are now poised to continue to advance our pipeline.
Mr. Bentsur added, "We are particularly pleased with the recent commencement of the Phase 1 study for NXP800, our potentially first-in-class Heat Shock Factor 1 ("HSF1") pathway inhibitor, and with the progress of NXP900, our selective Proto-oncogene c-Src ("SRC") SRC/YES1 kinase inhibitor. 2022 is expected to be another exciting year for Nuvectis as we look forward to reporting additional data during the year. Importantly, we remain cash prudent, effectively managing our cash position with an emphasis towards value creation activities."
2021 and Recent Highlights
NXP800
We commenced a Phase 1 study for NXP800, an HSF1 pathway inhibitor, which will have two parts: a dose-escalation Phase 1a, initiated in December 2021, which will be followed by an expansion Phase 1b. In the Phase 1a, the safety and tolerability of NXP800 will be evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In the Phase 1b, the safety and preliminary anti-tumor activity of NXP800 will be evaluated in biomarker-selected patients, initially in ovarian clear cell carcinoma and ovarian endometrioid carcinoma, two unmet medical needs.
NXP900
We began Investigational New Drug ("IND")-enabling studies for NXP900, a novel selective SRC/YES1 inhibitor, in the fourth quarter of 2021. To date, several in-vivo preclinical studies have been conducted with NXP900 in triple negative breast cancer with promising results. Nuvectis is currently conducting in vivo studies with NXP900 in various other tumor types to potentially identify additional cancers of focus for future clinical trials. Nuvectis intends to complete the IND-enabling studies for NXP900 in 2022.
Initial Public Offering on Nasdaq Capital Market
We completed our initial public offering ("IPO") in February 2022, raising $16M in gross proceeds.
Full Year 2021 Financial Results
Cash, cash equivalents and short-term investments were $5.7 million as of December 31, 2021, compared to zero as of December 31, 2020. This does not include the $16.0 million in gross proceeds from the Company’s IPO, completed in February 2022.
Research and development expenses were $9.6 million for the year ended December 31, 2021, including $0.9 million of non-cash equity-based compensation expense and $7.0 million of one-time upfront payments made in connection with our world-wide license agreements for NXP800 and NXP900.
General and administrative expenses were $3.3 million for the year ended December 31, 2021, including $1.0 million of non-cash equity-based compensation expense.
The Company’s net loss was $12.9 million for the year ended December 31, 2021, which included $1.9 million of non-cash equity-based compensation expense and the $7.0 million of one-time upfront payments made in connection with our world-wide license agreements for NXP800 and NXP900.
Management Changes
We are pleased to announce that Michael Carson, who recently joined Nuvectis as Vice President of Finance, is replacing Uri Ben-Or who served as our Interim Chief Financial Officer. Mr. Carson comes to Nuvectis with comprehensive experience in finance, accounting and audit at companies including Abbott Laboratories, Neuronetics, Smiths Medical, and most recently as the Vice President of Finance at Xylocor Therapeutics. Prior to entering private industry, Mr. Carson worked for public accounting firms Deloitte and Crowe in their assurance practices. He is a licensed Certified Public Accountant and holds degrees in Mechanical Engineering and Accounting from Lafayette College. "I believe Michael’s expertise in the life sciences industry, including recent small-company experiences, makes him an ideal fit to help us deliver long-term value to our shareholders", said Mr. Bentsur. "Additionally, I want to thank Uri for his service to the company over the last several months, which included the IPO process.