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 ...

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 ...

[PART I: FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201%20Financial%20Statements) The company's unaudited statements show a decreased cash balance, increased net loss, and a growing accumulated deficit [Unaudited Condensed Balance Sheets](index=3&type=section&id=Unaudited%20Condensed%20Balance%20Sheets) Total assets and stockholders' equity declined due to a reduction in cash and an increase in the accumulated deficit Condensed Balance Sheet (USD in thousands) | | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,468 | $19,993 | | TOTAL CURRENT ASSETS | $16,208 | $20,405 | | **TOTAL ASSETS** | **$16,208** | **$20,405** | | **Liabilities and Stockholders' Equity** | | | | TOTAL CURRENT LIABILITIES | $3,934 | $6,186 | | **TOTAL LIABILITIES** | **$3,934** | **$6,186** | | Accumulated deficit | $(36,034) | $(31,985) | | **TOTAL STOCKHOLDERS' EQUITY** | **$12,274** | **$14,219** | [Unaudited Condensed Statements of Operations](index=4&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations) The company's net loss widened year-over-year, driven by increased research and general administrative expenses Condensed Statements of Operations (USD in thousands) | | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $2,367 | $1,805 | | General and administrative | $1,734 | $1,140 | | **OPERATING LOSS** | **$(4,101)** | **$(2,945)** | | **NET LOSS** | **$(4,049)** | **$(2,943)** | | BASIC AND DILUTED NET LOSS PER COMMON STOCK | $(0.27) | $(0.32) | | Basic and diluted weighted average number of common stock outstanding | 14,724,249 | 9,159,139 | [Unaudited Condensed Statements of Cash Flows](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations increased while financing cash flows decreased, resulting in a net cash reduction Condensed Statements of Cash Flows (USD in thousands) | | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,777) | $(3,076) | | Net cash provided by financing activities | $252 | $14,027 | | **(DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS** | **$(4,525)** | **$10,951** | | CASH AND CASH EQUIVALENTS AT END OF PERIOD | $15,468 | $16,693 | [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail the company's financial position, reliance on equity financing, and share-based compensation activities - The company is a biopharmaceutical firm focused on oncology and has incurred net operating losses since inception, with an **accumulated deficit of $36 million** as of March 31, 2023[21](index=21&type=chunk)[22](index=22&type=chunk) - Management believes existing **cash of $15.5 million is sufficient to fund planned operations for at least 12 months**, but additional capital will be needed to complete clinical trials[23](index=23&type=chunk)[24](index=24&type=chunk) - In Q1 2023, the company granted **585,499 Restricted Stock Awards (RSAs) and 34,500 stock options**, with total unrecognized compensation cost of **$4.6 million and $0.7 million**, respectively[50](index=50&type=chunk)[51](index=51&type=chunk) - Subsequent to the quarter end, an investor exercised 34,000 Preferred Investment Options, generating **gross proceeds of approximately $0.3 million**[62](index=62&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its oncology pipeline progress, rising operating losses, and capital resource strategy [Overview and Pipeline](index=17&type=section&id=Overview%20and%20Pipeline) The company is advancing its oncology pipeline with NXP800 in a Phase 1b study and NXP900 pending IND submission - NXP800 (HSF1-Pathway Inhibitor): The **Phase 1b portion of the clinical study was initiated in April 2023** to evaluate safety and anti-tumor activity in patients with platinum-resistant, ARID1a-mutated ovarian carcinoma[68](index=68&type=chunk) - The FDA granted **Fast Track Designation** status to the NXP800 development program in December 2022[69](index=69&type=chunk) - NXP900 (SRC/YES1 Kinase Inhibitor): The company has completed IND enabling preclinical studies and the **IND for NXP900 is currently pending**[73](index=73&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) The operating loss increased to $4.1 million in Q1 2023, driven by higher R&D and G&A employee compensation Comparison of Operating Expenses (USD in thousands) | | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and Development | $2,367 | $1,805 | $562 | | General and Administrative | $1,734 | $1,140 | $594 | | **OPERATING LOSS** | **$(4,101)** | **$(2,945)** | **$(1,156)** | - The increase in R&D expenses was primarily driven by a **$0.9 million increase in employee compensation and benefits**, including $0.4 million in stock-based compensation, and a $0.2 million increase in clinical expenses[81](index=81&type=chunk) - The increase in G&A expenses was primarily driven by a **$0.3 million increase in employee compensation** (including $0.2 million in stock compensation) and a $0.2 million increase in professional and consulting fees[82](index=82&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) With $15.5 million in cash, the company has sufficient funds for 12 months and has filed a $150 million shelf registration - As of March 31, 2023, the company had **$15.5 million in cash and cash equivalents** and an **accumulated deficit of $36 million**[84](index=84&type=chunk) - The company believes its existing cash will **fund operating expenses and capital expenditures for at least the next 12 months** from the financial statement issuance date[87](index=87&type=chunk) - On March 17, 2023, the company filed a shelf registration statement on Form S-3 to offer and sell up to **$150.0 million of securities**, which includes an at-the-market (ATM) offering program for up to $40.0 million[88](index=88&type=chunk) [Contractual Obligations and Other Commitments](index=25&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) The company faces significant future milestone payments for its licensed drug candidates NXP800 and NXP900 - Under the NXP800 License Agreement, the company is obligated to pay ICR up to **$22.0 million in pre-approval milestones** and up to an additional **$178 million in sales milestones**[101](index=101&type=chunk) - Under the NXP900 License Agreement, the company is obligated to pay UoE up to **$45.5 million in pre-approval milestones** and up to **$279.6 million in sales milestones**[102](index=102&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing market risk disclosures - The company is a **"smaller reporting company"** and is therefore not required to provide quantitative and qualitative disclosures about market risk[110](index=110&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - Based on an evaluation as of March 31, 2023, the company's principal executive officer and principal financial officer concluded that **disclosure controls and procedures were effective**[112](index=112&type=chunk) - **No changes in internal controls over financial reporting** occurred during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[113](index=113&type=chunk) [PART II: OTHER INFORMATION](index=29&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=29&type=section&id=Item%201%20Legal%20Proceedings) The company reports no involvement in any material legal proceedings or claims as of the report date - As of the date of this report, the company was **not a party to any material legal matters or claims**[116](index=116&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's Form 10-K - There have been **no material changes to the risk factors** previously disclosed in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022[117](index=117&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details the use of proceeds from its 2022 IPO and private placement for pipeline development - The company sold 3,200,000 shares of common stock in its IPO on February 8, 2022, for **aggregate net proceeds of approximately $13.1 million**[119](index=119&type=chunk) - In a private placement closed on July 29, 2022, the company sold shares and pre-funded warrants for **aggregate net proceeds of approximately $14.3 million**[120](index=120&type=chunk) - Net proceeds from these offerings are intended to **fund Phase 1/2 development of NXP800**, preclinical and clinical development of NXP800 and NXP900, and for other general corporate purposes[121](index=121&type=chunk) [Item 3. Defaults Upon Senior Securities](index=29&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities during the period - **None**[123](index=123&type=chunk) [Item 4. Mine Safety Disclosures](index=29&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - **Not applicable**[124](index=124&type=chunk) [Item 5. Other Information](index=29&type=section&id=Item%205%20Other%20Information) The company reports no other material information for the period - **None**[125](index=125&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including agreements and officer certifications - Exhibits filed include an **At the Market Offering Agreement** with H.C. Wainwright & Co., LLC, and various **officer certifications**[126](index=126&type=chunk) [Signatures](index=32&type=section&id=Signatures) - The report was duly signed on **May 10, 2023**, by **Ron Bentsur**, Chairman, Chief Executive Officer and President, and **Michael J Carson**, Vice President of Finance[128](index=128&type=chunk)[129](index=129&type=chunk)

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].

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 ...

| --- | --- | --- | |-------------------------------|-------|-------| | | | | | 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 ...

Financial Position - As of June 30, 2022, Nuvectis Pharma had cash and cash equivalents of $13.6 million, a significant increase from $5.7 million as of December 31, 2021, representing a 137% growth[10]. - Total stockholders' equity increased to $11.5 million as of June 30, 2022, compared to a deficit of $11 million as of December 31, 2021[10]. - The company incurred an accumulated deficit of $19.4 million as of June 30, 2022, up from $12.9 million at the end of 2021[24]. - The company’s total current assets increased to $14.2 million as of June 30, 2022, compared to $5.8 million as of December 31, 2021, reflecting a 143% increase[10]. - As of June 30, 2022, the company had 331,580 RSUs outstanding with an intrinsic value of $3.714 million[62]. - As of June 30, 2022, the company was obligated to pay up to $23.0 million in milestone payments related to the NXP800 License Agreement, with additional potential payments of up to $178 million for regulatory and commercial sales milestones[113]. - Under the NXP900 License Agreement, the company is required to make payments of up to $46.0 million in milestone payments, including $0.5 million on the first anniversary of the agreement, and up to $279.5 million in regulatory and commercial sales milestones[114]. Revenue and Losses - The company reported a net loss of $3.6 million for the three months ended June 30, 2022, compared to a net loss of $5.9 million for the same period in 2021, indicating a 40% improvement in losses[13]. - The net loss attributable to common stockholders for the six months ended June 30, 2022, was $6.512 million, with a basic net loss per share of $0.59[67]. - The net loss for the six months ended June 30, 2022, increased by $0.6 million or 9% to $6.5 million compared to $6.0 million in the same period in 2021[97]. - The company has not generated any revenue since its inception on July 27, 2020, and has focused on organizational and capital raising activities[84]. Expenses - Research and development expenses for the three months ended June 30, 2022, were $2.5 million, down 41% from $4.2 million in the same period of 2021[13]. - General and administrative expenses decreased by $0.6 million or 37% to $1.1 million for the three months ended June 30, 2022, compared to $1.7 million in the same period in 2021[92]. - For the six months ended June 30, 2022, research and development expenses increased by $0.1 million or 2% to $4.3 million compared to $4.2 million in the same period in 2021[95]. - General and administrative expenses increased by $0.5 million or 29% to $2.2 million for the six months ended June 30, 2022, compared to $1.7 million in the same period in 2021[96]. - The company anticipates significant increases in expenses related to ongoing activities, particularly for clinical trials and operating as a public company[102]. Capital Raising Activities - Nuvectis Pharma completed an initial public offering on February 8, 2022, selling 3,200,000 shares at $5.00 per share, resulting in net proceeds of $12.6 million[27]. - The company raised approximately $14.2 million in net proceeds from a private placement completed on July 29, 2022[25]. - The company completed a private placement on July 27, 2022, raising approximately $15.9 million through the issuance of 1,015,598 shares at $8.25 per share[72]. - For the six months ended June 30, 2022, net cash provided by financing activities was $13.4 million, primarily from the sale of common stock, offset by $2.6 million in commissions and deferred offering costs[110]. Stock and Equity - The weighted average number of common shares outstanding increased significantly to 12,717,794 as of June 30, 2022, from 4,155,661 in the same period of 2021[13]. - As of June 30, 2022, the Company had 12,717,794 common shares issued and paid, with a total authorized common stock of 60,000,000[52]. - The Company granted 128,000 fully vested warrants with an exercise price of $6.25 per share, valued at approximately $458,000, as part of the IPO[55]. - The Company has reserved a total of 1,500,000 common stock for issuance under the 2021 Global Equity Incentive Plan[57]. - As of June 30, 2022, there was $0.6 million of unrecognized stock-based compensation expense related to unvested stock options expected to be recognized over a weighted-average period of 2.22 years[59]. - The Company recognized $0.1 million of research and development support expense during the three and six months ended June 30, 2022[45]. Clinical Development - The Phase 1 clinical trial for NXP800 was initiated in December 2021, with the FDA clearing the IND application in June 2022[79]. - NXP900, a preclinical-stage drug candidate, demonstrated potent inhibition of SRC and YES1 kinases and substantial growth inhibition in animal models[81]. - The company plans to submit an IND for NXP900 in early 2023[82]. - The Company has agreed to provide an additional $865,000 in research and development support to the Institute of Cancer Research over the next 18 months for the NXP800 Program[45]. Accounting and Compliance - The Company’s financial statements are prepared in accordance with U.S. GAAP and are stated in U.S. dollars[33]. - The company has no contingent liabilities as of June 30, 2022, and December 31, 2021[50]. - The Company’s common stock has no preemptive rights, conversion rights, or other subscription rights[53]. - There have been no significant changes to critical accounting policies and estimates compared to the previous fiscal year[119]. - The company has not issued any unregistered securities during the reporting period[129]. - As of June 30, 2022, the company's disclosure controls and procedures were deemed effective by management[124]. - The company does not currently have any off-balance sheet arrangements[117].

Financial Position - As of March 31, 2022, Nuvectis Pharma had cash and cash equivalents of $16.7 million, a significant increase from $5.7 million as of December 31, 2021, representing a 191% increase[10] - Total current assets increased to $17.618 million as of March 31, 2022, compared to $5.833 million as of December 31, 2021, marking a 202% increase[10] - The company had an accumulated deficit of $15.843 million as of March 31, 2022, up from $12.900 million at the end of 2021[10] - Nuvectis Pharma's total liabilities as of March 31, 2022, were $3.059 million, unchanged from December 31, 2021[10] - As of March 31, 2022, the company reported a net cash used in operating activities of $3.0 million, primarily due to a net loss of $2.9 million[98] - Net cash provided by financing activities for the three months ended March 31, 2022, was $14.0 million, mainly from the sale of common stock[100] Losses and Expenses - The company reported a net loss of $2.943 million for the three months ended March 31, 2022, compared to a net loss of $23, indicating a substantial increase in losses[13] - Research and development expenses for the first quarter of 2022 were $1.805 million, while general and administrative expenses were $1.140 million, reflecting a shift in operational focus[13] - The company reported a net loss attributable to common stockholders of $2.943 million for the three months ended March 31, 2022, resulting in a basic and diluted net loss per share of $0.32, compared to a loss of $23,000 and less than $0.01 per share for the same period in 2021[64] - The company expects substantial increases in research and development and general administrative expenses as it advances its product candidates and builds its infrastructure[87] - The company anticipates incurring additional costs associated with operating as a public company following the IPO[91] Initial Public Offering (IPO) - Nuvectis Pharma completed an initial public offering on February 8, 2022, selling 3,200,000 shares at $5.00 per share, resulting in net proceeds of $12.6 million[28] - The company completed its initial public offering (IPO) on February 8, 2022, raising gross proceeds of $16.0 million, with net proceeds of $12.6 million[90] - Nuvectis Pharma's shares began trading on NASDAQ under the symbol "NVCT" in February 2022, marking a significant milestone for the company[28] Stock and Equity - The company converted 5,012,280 shares of Series A redeemable convertible preferred stock into common stock on a 1:1 basis, enhancing its equity structure[28] - As of March 31, 2022, the company had 12,717,794 shares of common stock issued and paid, an increase from 4,505,514 shares as of December 31, 2021[50] - The company has a total of 408,486 common stock reserved for issuance under the 2021 Global Equity Incentive Plan, which was increased to 1,500,000 shares in February 2022[57] Research and Development - The company plans to raise additional capital to fund clinical trials and product development, indicating ongoing financial needs[27] - The company plans to clinically investigate NXP800 in Ovarian Clear Cell Carcinoma and endometrioid ovarian carcinoma, with a focus on the ARID1a mutation as a potential biomarker[74] - NXP900, a preclinical-stage drug candidate, is designed to inhibit SRC and YES1 kinases, with plans to submit an IND or equivalent submission in early 2023[78] - The company has committed to provide up to an additional $500,000 in research and development support to the Institute of Cancer Research in London over the next 18 months[43] Compensation and Bonuses - The company awarded bonuses totaling $431,250 related to the completion of the IPO, with additional salary increases for key executives[69] - The company expects to recognize $0.3 million of unrecognized stock-based compensation expense related to unvested stock options over a weighted-average period of 2.25 years[59] - The company granted 29,000 restricted stock units (RSUs) during the three months ended March 31, 2022, with an expected total unrecognized compensation cost of $0.2 million to be recognized over a weighted average period of 2.63 years[61] - The company granted 128,000 fully vested warrants to HC Wainwright & Co. with an estimated value of approximately $458,000, recognized as a reduction from gross proceeds of the IPO[55] Legal and Regulatory - There are no material legal proceedings currently involving the company that would adversely impact its financial position[117] - The company has not experienced any significant changes in critical accounting policies compared to previous disclosures[109] - The company has no long-term leases and operates under a one-year rental agreement for its office space[105] Management - Ron Bentsur serves as the Chairman, Chief Executive Officer, and President of Nuvectis Pharma, Inc.[131] - Michael J Carson is the Vice President of Finance and serves as the Principal Financial and Accounting Officer[131]

Part I [Business](index=7&type=section&id=Item%201.%20Business) Nuvectis Pharma is a clinical-stage biopharmaceutical company developing precision oncology medicines, with lead candidates NXP800 and NXP900, relying on third-party manufacturing and a small team - The company is a **biopharmaceutical entity** specializing in the development of **innovative precision medicines** for treating significant unmet medical needs in oncology[24](index=24&type=chunk) - The company's strategy includes establishing a **leadership position in HSF1 pathway inhibition**, advancing **NXP800 and NXP900 through clinical development**, maximizing their therapeutic potential, and expanding the oncology pipeline through business development[51](index=51&type=chunk) - Nuvectis relies entirely on **third-party manufacturers (CMOs)** for its product candidates, including a **single-source manufacturer** for both the NXP800 drug substance and drug product[71](index=71&type=chunk) - As of March 22, 2022, the company had **8 full-time employees** and relies on expert consultants and vendors for various business functions[89](index=89&type=chunk) Product Pipeline Overview | Product Candidate | Target Pathway | Development Stage | Initial Indications | | :--- | :--- | :--- | :--- | | **NXP800** | HSF1 Pathway Inhibitor | Phase 1a (initiated Dec 2021) | Ovarian Clear Cell Carcinoma (OCCC), Endometrioid Ovarian Carcinoma with ARID1a mutations | | **NXP900** | SRC/YES1 Kinase Inhibitor | Preclinical (IND-enabling studies started Q4 2021) | Solid Tumors with SRC/YES1 overactivation | License Agreement Financial Terms (in millions) | Agreement | Upfront Payment | Pre-Approval Milestones (Max) | Commercial Milestones (Max) | Royalties | | :--- | :--- | :--- | :--- | :--- | | **NXP800 (CRT)** | $3.5M (paid) | ~$26.5M | $178M | Mid-single digit to 10% | | **NXP900 (UoE)** | $3.5M (paid) | ~$49.5M | $279.5M | Mid-single digit to 8% | [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from its limited operating history, accumulated losses, dependence on lead product NXP800, need for future capital, reliance on third parties, and intellectual property challenges - The company has a **limited operating history**, has incurred losses since inception, and has an **accumulated deficit of $12.9 million** as of December 31, 2021 It has **not generated any revenue** and expects to incur continued losses[93](index=93&type=chunk)[96](index=96&type=chunk) - Nuvectis is **substantially dependent on the success of its lead product candidate, NXP800**, which only commenced its first Phase 1 clinical trial in December 2021 Its second candidate, NXP900, is in the preclinical stage[19](index=19&type=chunk)[109](index=109&type=chunk) - The company will require **substantial additional funding** to finance operations Raising capital may cause dilution or require relinquishing rights Failure to raise capital could force delays or elimination of development programs[101](index=101&type=chunk) - Nuvectis **relies on third parties** for critical functions, including **single-source CMOs** for manufacturing NXP800 and CROs for conducting clinical trials This reliance introduces risks of delays, quality issues, and lack of control[201](index=201&type=chunk)[207](index=207&type=chunk) - The company's success depends on **maintaining its in-licensed patent protection** for NXP800 and NXP900 The patent for **NXP800's composition of matter expires in October 2034**, and for **NXP900 in April 2036**, subject to potential extensions[170](index=170&type=chunk)[175](index=175&type=chunk)[179](index=179&type=chunk) - As of March 22, 2022, principal stockholders and management beneficially owned approximately **66.8% of the company's voting stock**, allowing them to exert **significant influence** over stockholder matters[233](index=233&type=chunk) [Unresolved Staff Comments](index=45&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - None[241](index=241&type=chunk) [Properties](index=45&type=section&id=Item%202.%20Properties) The company leases its principal executive offices in Fort Lee, NJ, under a one-year agreement, deeming its current facilities adequate - The company leases its principal executive offices in Fort Lee, NJ, under a one-year agreement that commenced on **May 3, 2021**[242](index=242&type=chunk) [Legal Proceedings](index=45&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, Nuvectis Pharma was not a party to any material legal proceedings or claims - The company was not a party to any **material legal matters or claims** as of the date of this report[243](index=243&type=chunk) [Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[244](index=244&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=45&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Nuvectis's common stock began trading on NASDAQ in February 2022 after its IPO, with the company raising $15.3 million in 2021 and $13.6 million from the IPO, while retaining earnings for growth - The company's common stock is listed on the NASDAQ Capital Market under the symbol '**NVCT**', with trading commencing on **February 4, 2022**[245](index=245&type=chunk) - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future, intending to retain earnings for **business development**[250](index=250&type=chunk) - In June and July 2021, the company sold **128,520 shares of Series A Preferred Stock** for total proceeds of approximately **$15.3 million** in a private placement[252](index=252&type=chunk) - Following its IPO on **February 8, 2022**, the company sold **3,200,000 shares of common stock at $5.00 per share**, generating aggregate net proceeds of approximately **$13.6 million**[253](index=253&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For the year ended December 31, 2021, Nuvectis reported a **net loss of $12.9 million** with no revenue, driven by R&D and G&A expenses, but subsequent IPO proceeds of **$13.6 million** are expected to fund operations for at least the next 12 months - R&D expenses in 2021 were primarily driven by one-time upfront payments totaling **$7.0 million** for the exclusive license agreements for NXP800 and NXP900[260](index=260&type=chunk) - Management believes that proceeds from the IPO will fund operating expenses and capital expenditures for at least the **next 12 months** from the financial statement issuance date[268](index=268&type=chunk) - The company has significant future contingent payment obligations under its license agreements, including up to **$201 million** in milestones for NXP800 and up to **$329 million** for NXP900, plus royalties[278](index=278&type=chunk)[279](index=279&type=chunk) Results of Operations (in millions) | | For the year ended Dec 31, 2021 | For the period from Jul 27, 2020 to Dec 31, 2020 | | :--- | :--- | :--- | | **Revenue** | $0 | $0 | | **Research and Development** | $9.6 | $0 | | **General and Administrative** | $3.3 | $0.01 | | **Operating Loss** | ($12.9) | ($0.01) | Liquidity and Capital Resources | Metric | As of Dec 31, 2021 | | :--- | :--- | | **Cash and cash equivalents** | $5.7 million | | **2021 Capital Raise (Preferred Stock)** | $15.3 million | | **Feb 2022 IPO (Net Proceeds)** | $13.6 million | [Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This disclosure is not applicable as the company is a smaller reporting company - The company is a **smaller reporting company**, and therefore this disclosure is not applicable[291](index=291&type=chunk) [Financial Statements and Supplementary Data](index=54&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the company's audited financial statements and supplementary data, located starting at page F-1 of the Annual Report - The required financial statements and notes are located starting at **page F-1** of the Annual Report[292](index=292&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=54&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[293](index=293&type=chunk) [Controls and Procedures](index=54&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of December 31, 2021, with no management report or auditor attestation on internal control over financial reporting required for newly public companies - Management concluded that as of **December 31, 2021**, the company's disclosure controls and procedures were **effective**[294](index=294&type=chunk) - The annual report does not include a management assessment or auditor attestation on internal control over financial reporting, as permitted for **newly public companies**[295](index=295&type=chunk)[296](index=296&type=chunk) [Other Information](index=54&type=section&id=Item%209B.%20Other%20Information) The company reports no other information - None[297](index=297&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=55&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's governance is led by Ron Bentsur, with a four-member board including three independent directors, and established Audit and Compensation Committees, while a majority of independent directors recommend nominees - The executive team includes **Ron Bentsur** (Chairman, CEO & President), **Enrique Poradosu** (EVP, Chief Scientific & Business Officer), and **Shay Shemesh** (EVP, Chief Development & Operations Officer)[303](index=303&type=chunk) - The Board of Directors has determined that **Kenneth Hoberman, Matthew Kaplan, and James Oliviero** are independent directors[316](index=316&type=chunk) - The Audit Committee consists of the three independent directors, with **James Oliviero** serving as chair and designated **audit committee financial expert**[323](index=323&type=chunk) - The Compensation Committee consists of the three independent directors, with **Kenneth Hoberman** serving as chair[325](index=325&type=chunk) [Executive Compensation](index=61&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for 2021 primarily involved stock awards, with post-IPO 2022 salaries set at **$575,000** for the CEO and **$400,000** for other NEOs, alongside equity awards and director retainers - Effective **February 4, 2022**, CEO Ron Bentsur's annual base salary is **$575,000** with a **75% target bonus**, while other NEOs have base salaries of **$400,000** with a **50% target bonus**[334](index=334&type=chunk)[335](index=335&type=chunk)[342](index=342&type=chunk)[344](index=344&type=chunk) - Executive officers were granted restricted stock awards that vest upon the one-year anniversary of a qualifying financing event in **July 2021**, and are eligible for fully vested shares if the company's 30-day average market capitalization reaches **$350 million** or higher[337](index=337&type=chunk)[345](index=345&type=chunk)[353](index=353&type=chunk) - Non-employee directors receive an annual cash retainer of **$40,000**, plus committee fees, and an initial option grant of **29,250 options**, with subsequent annual option grants valued at approximately **$150,000**[366](index=366&type=chunk) 2021 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Stock Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | Ron Bentsur, Chairman & CEO | 2021 | -- | 384,018 | 384,018 | | Enrique Poradosu, Chief Scientific & Business Officer | 2021 | 27,083 | 192,056 | 219,139 | | Shay Shemesh, Chief Development and Operations Officer | 2021 | 27,083 | 192,056 | 219,139 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=66&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 17, 2022, executive officers and directors collectively owned approximately **40.08%** of the company's common stock, indicating significant insider influence Security Ownership of Major Holders (as of March 17, 2022) | Name of Beneficial Owner | Percentage of Shares Beneficially Owned | | :--- | :--- | | **5% and Greater Stockholders:** | | | Pontifax VI LP | 10.85% | | Charles Mosseri Marlio | 9.95% | | Thomas P. Peters 2012 Family Trust | 5.94% | | **Named Executive Officers and Directors:** | | | Ron Bentsur (CEO) | 21.42% | | Enrique Poradosu (CSO) | 9.04% | | Shay Shemesh (CDO) | 8.89% | | **All executive officers and directors as a group (7 persons)** | **40.08%** | [Certain Relationships and Related Transactions, and Director Independence](index=68&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has not engaged in material related party transactions since inception, and its board has adopted a review policy for such transactions, with three of its four directors deemed independent - The company has not been involved in any related party transaction where the amount involved exceeded **$120,000** or **1%** of the average of its total assets[378](index=378&type=chunk) - The board of directors has adopted a written policy for reviewing and approving related person transactions[378](index=378&type=chunk) - The board has determined that directors **Kenneth Hoberman, Matthew Kaplan, and James Oliviero** are independent[379](index=379&type=chunk) [Principal Accountant Fees and Services](index=69&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The company's principal accountant, Kesselman & Kesselman (PwC), billed **$195,000** and **$200,000** for audit services in 2021 and 2020 respectively, with no other fees for audit-related, tax, or other services Accountant Fees (in thousands) | Fee Category | 2021 | 2020 | | :--- | :--- | :--- | | Audit Fees | $195 | $200 | | Audit-Related Fees | $0 | $0 | | Tax Fees | $0 | $0 | | All Other Fees | $0 | $0 | Part IV [Exhibits and Financial Statement Schedules](index=70&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the exhibits filed as part of the report and indicates that the financial statements begin on page F-1 - This section lists the exhibits filed as part of the report and indicates that the financial statements begin on **page F-2**[388](index=388&type=chunk) [Form 10-K Summary](index=71&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has elected not to provide a summary of the Form 10-K - The Company has elected not to provide summary information[557](index=557&type=chunk) Financial Statements [Financial Statements and Notes](index=71&type=section&id=Financial%20Statements%20and%20Notes) The audited financial statements for 2021 show a **$12.9 million net loss** and **$5.7 million cash**, with a subsequent **$13.6 million IPO** providing sufficient capital for over 12 months of operations - The company's R&D expenses for 2021 included **$7.1 million** in license fees for its drug candidates[470](index=470&type=chunk) - Subsequent to the reporting period, on **February 8, 2022**, the company completed its IPO, selling **3,200,000 shares of common stock** and receiving net proceeds of **$13.6 million**[553](index=553&type=chunk) - Management believes that cash on hand as of **December 31, 2021**, along with the net proceeds from the IPO, is sufficient to fund planned operations for **more than 12 months** from the issuance date of the financial statements[423](index=423&type=chunk) Balance Sheet Highlights (as of Dec 31, 2021, in thousands) | | Amount | | :--- | :--- | | Cash and cash equivalents | $5,742 | | Total Assets | $6,657 | | Total Liabilities | $2,419 | | Accumulated Deficit | ($12,900) | | Total Stockholders' Deficit | ($11,008) | Statement of Operations Highlights (Year ended Dec 31, 2021, in thousands) | | Amount | | :--- | :--- | | Research and Development | $9,545 | | General and Administrative | $3,349 | | Operating Loss | ($12,894) | | Net Loss | ($12,890) | | Basic and Diluted Net Loss Per Share | $3.02 |