Nuvectis Pharma(NVCT)

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Nuvectis Pharma, Inc. Reports First Quarter 2024 Financial Results and Business Highlights
Newsfilter· 2024-05-07 12:00
Encouraging preliminary data announced from the NXP800 Phase 1b study in platinum resistant, ARID1a-mutated ovarian cancer, a program granted Fast Track Designation by the US FDAData presented at the 2024 AACR demonstrate NXP900's robust activity in non-small cell cancer cell linesSeveral clinical data updates expected in 2H 2024 FORT LEE, N.J., May 07, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ:NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the develo ...
Nuvectis Pharma(NVCT) - 2023 Q4 - Annual Report
2024-03-05 22:20
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to . Commission File Number 001-41264 NUVECTIS PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 86-2405608 (State or Other Juris ...
Nuvectis Pharma(NVCT) - 2023 Q4 - Annual Results
2024-03-05 13:17
Exhibit 99.1 Nuvectis Pharma, Inc. Reports Fiscal Year 2023 Financial Results and Business Highlights 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 $ ...
Nuvectis Pharma(NVCT) - 2023 Q3 - Quarterly Report
2023-11-08 12:45
Table of Contents 315603 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to . Commission File Number 001-41264 NUVECTIS PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 86-2405608 (Stat ...
Nuvectis Pharma(NVCT) - 2023 Q2 - Quarterly Report
2023-08-09 20:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to . Commission File Number 001-41264 NUVECTIS PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 86-2405608 (State or Other J ...
Nuvectis Pharma(NVCT) - 2023 Q1 - Quarterly Report
2023-05-10 20:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to . Commission File Number 001-41264 NUVECTIS PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 86-2405608 (State or Other ...
Nuvectis Pharma(NVCT) - 2022 Q4 - Annual Report
2023-03-08 22:31
Financial Performance and Funding - The company has incurred an accumulated deficit of $32.0 million since inception through December 31, 2022, primarily due to $13.4 million in research and development expenses, $9.3 million in general and administrative expenses, and upfront payments totaling $9.3 million for licensing agreements [110]. - The company has not generated any revenue from product sales to date and anticipates continuing to incur significant losses for the foreseeable future [110]. - The company expects expenses to increase significantly as it continues to identify new product candidates and initiate clinical trials, requiring substantial additional funding [115]. - The company may need to relinquish valuable rights to its technologies or future revenue streams if it raises additional funds through collaborations or strategic alliances [116]. - The company may seek additional capital through various means, which could dilute existing stockholders and restrict operations [262]. Product Development and Clinical Trials - The lead product candidate, NXP800, started its Phase 1 clinical trial in December 2021, while the second candidate, NXP900, has completed IND-enabling studies with an IND submission pending [111]. - The company’s ability to generate revenue will depend on timely completion of preclinical studies and clinical trials, successful IND submissions, and obtaining necessary marketing approvals [111]. - The company may face significant delays or challenges in obtaining regulatory approvals or commercializing its product candidates due to various factors, including the COVID-19 pandemic [114]. - The company is early in its development efforts and is substantially dependent on the success of its lead product candidate, NXP800, for future revenue generation [128]. - Clinical trials are expensive and time-consuming, with outcomes that are inherently uncertain, leading to a high risk of failure [137]. - Difficulty in patient enrollment may delay clinical trials, particularly due to competition with other trials and specific disease focus [144]. - The company currently lacks a marketing and sales organization, which may hinder its ability to generate product revenue if approved [155]. - The company must demonstrate safety and efficacy through lengthy preclinical and clinical studies before obtaining regulatory approvals for its product candidates [149]. - Drug-related side effects could lead to trial suspensions or terminations, affecting the company's ability to complete clinical trials [150]. Regulatory and Compliance Challenges - The company has received approval for its CTA and IND for NXP800, but future submissions may face delays or issues that could impact timelines [154]. - The approval process for regulatory authorities like the FDA typically takes many years and is unpredictable, impacting the commercialization timeline [165]. - Company has not obtained regulatory approval for any drug candidate in any jurisdiction, which poses a significant risk to future revenue generation [161]. - Regulatory approval in one jurisdiction does not guarantee approval in others, potentially limiting market access and revenue opportunities [167]. - The insurance coverage and reimbursement status for newly approved products remains uncertain, which could adversely affect the company's ability to generate revenue [178]. - Cost containment trends in the U.S. healthcare industry may lead to lower prices for medications, impacting profitability [183]. - Legislative measures aimed at controlling drug prices could create downward pressure on reimbursement rates, affecting market acceptance [186]. - The company may face significant penalties for non-compliance with regulatory requirements, impacting financial stability [175]. - Changes in government regulations and policies could adversely affect the commercial success of the company's products [185]. - The company is subject to numerous healthcare laws and regulations, including the federal Anti-Kickback Statute and the False Claims Act, which could constrain its business arrangements [192]. Intellectual Property and Competitive Landscape - The company holds licenses for intellectual property rights related to its lead product candidates, NXP800 and NXP900, which are crucial for maintaining competitive advantage [198]. - The statutory expiration for issued U.S. patents covering NXP800 is October 2034, while NXP900 patents are set to expire in April 2036 [204][207]. - The company may face challenges in maintaining patent protection, which is essential for preventing competitors from commercializing similar products [208]. - The issuance of patents does not guarantee exclusivity, and challenges to patent validity could limit the company's ability to protect its technology [212]. - If the company does not obtain patent term extensions for its product candidates, it may face increased competition after patent expiration [228]. - The company’s ability to protect its trademarks and trade names is crucial for building name recognition and could be adversely affected if not adequately protected [229]. - The company may face challenges in protecting its intellectual property, which could adversely affect its competitive position and business prospects [220]. Operational and Management Risks - The company relies on third-party manufacturers for the production of NXP800 and NXP900, increasing the risk of supply issues and potential delays in development [237]. - The company depends on a single CMO for manufacturing NXP800 and NXP900, which poses risks if these relationships cannot be maintained [237]. - The company anticipates relying on third parties for clinical trials, which could lead to delays if these parties do not meet their obligations [230]. - The company may be subject to claims regarding the inventorship or ownership of its intellectual property, potentially requiring substantial legal expenditures [225]. - The company faces risks related to the timely manufacturing of its product candidates by third-party manufacturers, which may affect clinical and commercial needs [243]. - The company may experience difficulties in managing growth as it expands its organization and hires new employees [246]. - The company is subject to significant legal, accounting, and compliance costs as a public entity, which were not incurred as a private company [247]. Market and Economic Conditions - The company’s operations could be adversely affected by global economic and political conditions, including inflation and financial market volatility [259]. - The company may face delisting from NASDAQ if it fails to meet continuing listing requirements, which could negatively impact stock price and liquidity [265]. - As an emerging growth company, the company benefits from reduced reporting requirements, which may affect the attractiveness of its common stock to investors [266]. - The company has opted to take advantage of certain reduced reporting obligations, potentially leading to a less active trading market for its common stock [269]. - Provisions in the company's certificate of incorporation and bylaws may deter unsolicited takeovers, potentially depressing stock price [270]. - Delaware law restricts business combinations with interested stockholders for three years, which may limit investor willingness to pay for shares [271]. - The company is classified as a smaller reporting company, and certain market risk disclosures are not applicable [333].
Nuvectis Pharma(NVCT) - 2022 Q3 - Quarterly Report
2022-11-08 13:18
Fort Lee, NJ 07024 07024 (Address of Principal Executive Offices) (Zip Code) (201) 614-3150 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECUR ...
Nuvectis Pharma (NVCT) Investor Presentation - Slideshow
2022-09-29 18:29
| --- | --- | --- | |-------------------------------|-------|-------| | | | | | Innovative Precision Medicine | | | (NASDAQ: NVCT) Forward Looking Statements Nuvectis Pharma, Inc. 2 Certain statements in this presentation constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Statements other than those of historical fact, as well as those statements identified by words such as "anticipa ...
Nuvectis Pharma(NVCT) - 2022 Q2 - Quarterly Report
2022-08-10 17:33
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to . Commission File Number 001-41264 NUVECTIS PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 86-2405608 (State or Other J ...