Nuvectis Pharma, Inc. Reports Fiscal Year 2023 Financial Results and Business Highlights
Nuvectis Pharma, Inc. provided an update on its two clinical-stage drug candidates, NXP800 and NXP900, with multiple clinical data readouts expected in 2024. The company reported a decrease in cash and cash equivalents, a net loss increase of $2.2 million, and higher research and development expenses in the fiscal year 2023.
Positive
Nuvectis Pharma reported progress on its clinical-stage drug candidates, NXP800 and NXP900.
Multiple clinical data readouts are anticipated in 2024 for NXP800 and NXP900.
The company's cash and cash equivalents decreased to $19.1 million in 2023.
Nuvectis Pharma's net loss increased by $2.2 million in the fiscal year 2023.
Research and development expenses rose to $15.4 million in 2023.
Negative
Net loss for the fiscal year 2023 included $4.7 million in non-cash stock-based compensation and $2.3 million in one-time non-recurring expenses.
General and administrative expenses increased to $7.5 million in 2023.
Interest income grew to $0.6 million in 2023.
The financial results of Nuvectis Pharma, Inc. indicate a modest decrease in cash and cash equivalents over the fiscal year 2023, which could be seen as a controlled burn rate in the context of biopharmaceutical development. The increase in net loss is notable, yet not uncommon for clinical-stage companies that are investing heavily in research and development (R&D). The reported rise in R&D expenses aligns with the company's progression of clinical trials, which is a critical phase for potential product validation and future revenue streams. The uptick in general and administrative expenses suggests an expansion of operational capabilities, possibly in preparation for the commercialization phase should their drug candidates succeed in clinical trials. The interest income growth, although minor, reflects a better cash management or favorable interest rates.
Investors should consider the implications of the increased net loss against the backdrop of the company's clinical advancements. The non-cash stock-based compensation is a typical remuneration strategy in the biotech industry, allowing the company to conserve cash while incentivizing employees. However, it's essential to monitor the dilutive effect of such compensation on existing shareholders. One-time non-recurring expenses might also be an investment for future gains, but they require scrutiny to ensure they are not indicative of a pattern of unexpected costs.
From a medical research perspective, the progress of NXP800 and NXP900 is significant. The Fast Track Designation for NXP800 by the FDA implies a potential for expedited review, which could lead to quicker market access and a competitive advantage. The preliminary data update expected for NXP800 is a critical inflection point that could impact the company's valuation and strategic partnerships. The Orphan Drug Designation for the treatment of cholangiocarcinoma also highlights the unmet medical need in this area and could provide market exclusivity benefits upon approval.
The initiation of multiple clinical trials, including the Phase 1b study in platinum-resistant ARID1a-mutated ovarian cancer and the Phase 1a dose escalation for NXP900, suggests a robust pipeline with diversified targets. The preclinical data demonstrating potency in ARID1A-mutated endometrial carcinoma expands the potential indications for NXP800, which could be a strategic move to increase the addressable market. The collaboration with the Mayo Clinic for the investigator-sponsored trial in cholangiocarcinoma not only adds credibility but also shares the financial burden of R&D.
ARID1a-mutated ovarian cancer represents a challenging treatment landscape where platinum resistance is a major hurdle. The development of NXP800, which targets this specific mutation, could represent a significant advancement in personalized medicine for patients with limited options. The Fast Track Designation by the FDA acknowledges the urgency of this need. Similarly, cholangiocarcinoma is a rare and aggressive cancer type where new treatments are desperately needed. The Orphan Drug Designation for NXP800 in this indication emphasizes the therapeutic potential and the importance of developing treatments for rare diseases.
The initiation of the NXP900 Phase 1a dose escalation trial is also a promising development. The ability to combine this drug with existing therapies could lead to enhanced treatment protocols. The focus on precision medicine, as demonstrated by Nuvectis Pharma's pipeline, aligns with current trends in oncology to provide more targeted and effective treatments with potentially fewer side effects compared to conventional chemotherapy.
03/05/2024 - 08:00 AM
NXP800 preliminary data update expected this month from the Phase 1b study in platinum resistant, ARID1a mutated ovarian cancer, a program that has been granted Fast Track Designation by the FDA NXP800 Investigator-sponsored clinical trial in cholangiocarcinoma initiated with the Mayo Clinic NXP800 granted Orphan Drug Designation for the treatment of cholangiocarcinoma NXP900 Phase 1a dose escalation initiated Multiple clinical data readouts expected in 2024 FORT LEE, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- 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, today reported its financial results for the fiscal year 2023 and provided an update on recent business progress.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "2023 was an eventful year for Nuvectis as we continued to make important strides with our two clinical-stage drug candidates, NXP800 and NXP900. For NXP800, we initiated the Phase 1b in platinum resistant ARID1a-mutated ovarian carcinoma and an investigator-sponsored clinical trial in cholangiocarcinoma in collaboration with the Mayo Clinic. Additional preclinical data presented during the year demonstrated the potency of NXP800 in ARID1A-mutated endometrial carcinoma, providing another potential development path for NXP800 within the gynecology-oncology space." Mr. Bentsur continued, "For NXP900, we initiated the Phase 1a dose escalation clinical trial and presented additional preclinical data that demonstrated the potential of NXP900 as a single agent and in combination with certain market-leading therapies."
Mr. Bentsur added, "We expect several catalysts in 2024 for NXP800 and NXP900, starting with the preliminary clinical data update later this month from the NXP800 Phase 1b study in platinum resistant ARID1a-mutated ovarian cancer. We also expect to provide updates from all our clinical trials throughout the year."
Mr. Bentsur concluded, "We remain cash efficient and highly focused on our mission of developing important precision medicines for the treatment of serious conditions of unmet medical need in oncology."
Full Year 2023 Financial Results
Cash, and cash equivalents were $19.1 million as of December 31, 2023, compared to $20.0 million as of December 31, 2022. The decrease of $0.9 million was a result of the Company's continued operations, offset primarily by the exercise of warrants issued in our 2022 PIPE transaction.
The Company's net loss was $22.3 million for the year ended December 31, 2023, compared to $19.1 million for the year ended December 31, 2022, an increase in net loss of $2.2 million . Net loss for the 2023 fiscal year included $4.7 million in non-cash stock-based compensation and $2.3 million in one-time non-recurring expenses.
Research and development expenses, including non-cash stock-based compensation and one-time non-recurring expenses, were $15.4 million for the year ended December 31, 2023, compared to $13.2 million for the year ended December 31, 2022, an increase of $2.2 million .
General and administrative expenses, including non-cash stock-based compensation and one-time non-recurring expenses, were $7.5 million for the year ended December 31, 2023, compared to $6.0 million for the year ended December 31, 2022, an increase of $1.5 million .
Interest income was $0.6 million for the year ended December 31, 2023, compared to $0.1 million for the year ended December 31, 2022, an increase of $0.5 million .
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor currently undergoing a Phase 1a dose escalation study.
Forward Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the conclusions and interpretation of preclinical data generated to date for NXP800 and NXP900, the Phase 1a data generated for NXP800 and the timing and clinical expectations for the NXP800 Phase 1b study, including statements regarding NXP800's potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma, cholangiocarcinoma and potentially other cancer indications, and timing of and expectations for the Phase 1a study for NXP900. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in our 2022 Form 10-K filed with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safeharbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Company Contact:
Ron Bentsur
Chairman, Chief Executive Officer and President
201-614-3151
rbentsur@nuvectis.com
Media Relations Contact:
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
NUVECTIS PHARMA, INC. BALANCE SHEETS (USD in thousands, except per share and share amounts) December 31, 2023 2022 Assets CURRENT ASSETS: Cash and cash equivalents 19,126 19,993 Other current assets 59 412 TOTAL CURRENT ASSETS 19,185 20,405 TOTAL ASSETS 19,185 20,405 Liabilities and Stockholders' Equity CURRENT LIABILITIES Accounts payables 2,771 2,910 Payable offering costs — 450 Accrued liabilities 415 445 Employee compensation and benefits 3,798 2,381 TOTAL CURRENT LIABILITIES 6,984 6,186 TOTAL LIABILITIES 6,984 6,186 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY: Common Stock, $0.00 001 par value – 60,000,000 shares authorized as of December 31, 2023, and December 31, 2022, respectively, 17,418,886, and 15,190,720 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively * * Additional paid in capital 66,446 46,204 Accumulated deficit (54,245 ) (31,985 ) TOTAL STOCKHOLDERS' EQUITY 12,201 14,219 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY 19,185 20,405
NUVECTIS PHARMA, INC. STATEMENT OF OPERATIONS (USD in thousands, except per share and share amounts) For the year ended For the year ended December 31, 2023 December 31, 2022 OPERATING EXPENSES: Research and development 15,380 13,227 General and administrative 7,517 6,007 OPERATING LOSS (22,897 ) (19,234 ) Finance income 637 149 NET LOSS (22,260 ) (19,085 ) NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS (22,260 ) (19,085 ) BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING (1.43 ) (1.51 ) Basic and diluted weighted average number of common shares outstanding 15,556,655 12,657,651
What are the two clinical-stage drug candidates mentioned in the press release by Nuvectis Pharma, Inc.?
The two clinical-stage drug candidates are NXP800 and NXP900.
What is the ticker symbol for Nuvectis Pharma, Inc.?
The ticker symbol for Nuvectis Pharma, Inc. is NVCT.
What was the cash and cash equivalents amount as of December 31, 2023?
The cash and cash equivalents were $19.1 million as of December 31, 2023.
What was the net loss for the year ended December 31, 2023?
The net loss was $22.3 million for the year ended December 31, 2023.
What were the research and development expenses for the year ended December 31, 2023?
Research and development expenses were $15.4 million for the year ended December 31, 2023.
