Nuvectis Pharma(NVCT)

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Nuvectis Pharma(NVCT) - 2024 Q2 - Quarterly Report
2024-08-06 13:20
Financial Performance - For the three months ended June 30, 2024, the operating loss was $4,643,000, compared to an operating loss of $5,772,000 for the same period in 2023, representing a 19.6% improvement[13]. - The net loss for the three months ended June 30, 2024, was $4,428,000, compared to a net loss of $5,708,000 for the same period in 2023, indicating a 22.4% reduction in losses[13]. - The company reported a net loss of $8.6 million for the six months ended June 30, 2024, compared to a net loss of $9.8 million for the same period in 2023, representing a 12% improvement[21]. - The net loss for the six months ended June 30, 2024, was $8,599,000, a 12% improvement from a net loss of $9,757,000 for the same period in 2023[21]. - The basic net loss attributable to common stockholders for the three months ended June 30, 2024, was $4.4 million, resulting in a basic net loss per share of $0.26[48]. - Basic net loss per common share for the three months ended June 30, 2024, was $0.26, a decrease from $0.38 in the same period of 2023, indicating a 31.6% reduction in loss per share[48]. - The basic net loss per share for the six months ended June 30, 2024, was $0.51, down from $0.65 in the same period of 2023, showing a 21.5% improvement[48]. - The company recognized a total net loss of $8.599 million for the six months ended June 30, 2024, compared to $9.757 million for the same period in 2023, reflecting a 11.9% reduction[48]. Expenses and Liabilities - Research and development expenses for the six months ended June 30, 2024, were $5,603,000, down from $6,629,000 in the same period of 2023, a decrease of 15.4%[13]. - For the three months ended June 30, 2024, the company recognized $0.5 million in general and administrative expenses and $0.7 million in research and development expenses[46]. - Research and development expenses for the three months ended June 30, 2024, were $2,943,000, a decrease of 31% compared to $4,262,000 for the same period in 2023[13]. - Total current liabilities were $5,770,000, a decrease from $6,984,000 as of December 31, 2023, reflecting a 17.4% reduction[13]. - The total stockholders' equity as of June 30, 2024, was $12,528,000, a decrease from $20,332,000 as of June 30, 2023, indicating a decline of 38%[19]. Capital and Funding - The company will require substantial additional capital to finance its operations and achieve its goals[6]. - The company will need to raise additional capital to complete clinical trials for its product candidates, with no assurance of securing sufficient financing[25]. - The company raised approximately $6.6 million through the sale of 749,338 common shares under its At-the-Market Program during the six months ended June 30, 2024, at an average selling price of $8.78 per share[24]. - The company sold 246,691 common shares under its At-the-Market Program for gross proceeds of approximately $1.7 million during the three months ended June 30, 2024[23]. - As of June 30, 2024, approximately $28.1 million of securities remain available under the At-the-Market Program[40]. - The company has not generated any revenue to date and expects to incur continued losses for the foreseeable future[6]. Workforce and Operations - The company currently has 13 full-time employees and plans to grow its workforce to support its operations[9]. - The company has incurred net operating losses since its inception, highlighting the need for strategic financial planning[23]. - The company has a limited operating history and has only initiated a limited number of clinical trials, which may affect investor evaluation of its business[5]. - The company is dependent on the success of its product candidates, NXP800 and NXP900, for future revenue generation[7]. - The company is dependent on the success of its product candidates, NXP800 and NXP900, which are currently in clinical trials[7]. Stock Options and Awards - As of June 30, 2024, the company had 348,281 stock options outstanding with a weighted average exercise price of $4.59 and an intrinsic value of $606,000[41]. - The company granted 580,527 restricted stock awards (RSAs) during the six months ended June 30, 2024, with a weighted average grant fair value of $8.09[42]. - Total unrecognized compensation cost related to RSAs as of June 30, 2024, was $4.5 million, expected to be recognized over a weighted average period of 1.34 years[43]. - The total share compensation expense for the three months ended June 30, 2024, was $1.2 million, up from $1.0 million in the same period of 2023, marking a 20% increase[46]. - The company excluded 1,588,313 unvested RSAs from the diluted net loss per common share calculation for June 2024, compared to 1,093,613 for June 2023, indicating a significant increase in potentially dilutive securities[50]. Cash Flow and Financial Position - Cash and cash equivalents decreased to $18.1 million as of June 30, 2024, down from $24.6 million at the end of the same period in 2023[21]. - The company has not generated positive cash flows from operations and relies primarily on the issuance and sale of common stock to fund operations[23]. - Management believes that existing cash and cash equivalents will fund planned operations for at least 12 months following the issuance date of the financial statements[24]. - The company experienced a net cash used in operating activities of $7,378,000 for the six months ended June 30, 2024, compared to $8,860,000 for the same period in 2023, showing a 17% reduction[21].
Nuvectis Pharma(NVCT) - 2024 Q2 - Quarterly Results
2024-08-06 12:51
Financial Performance - Cash and cash equivalents decreased to $18.1 million as of June 30, 2024, down from $19.5 million as of March 31, 2024, a decrease of $1.4 million[3] - The net loss for Q2 2024 was $4.4 million, a decrease of $1.4 million compared to a net loss of $5.8 million in Q2 2023[3] - Research and development expenses were $2.9 million for Q2 2024, down from $4.3 million in Q2 2023, representing a decrease of approximately 32.6%[3] - General and administrative expenses increased to $1.7 million in Q2 2024 from $1.5 million in Q2 2023, an increase of approximately 13.3%[4] - Interest income rose to $0.2 million in Q2 2024, compared to $0.1 million in Q2 2023, an increase of 100%[4] Clinical Trials and Developments - The Phase 1b clinical trial for NXP800 is ongoing with patient enrollment at approximately 15 clinical sites in the U.S. and U.K.[2] - The company plans to provide updates on the NXP800 and NXP900 trials by the end of 2024 and during the fall of 2024, respectively[2] - NXP800 has received Fast Track Designation from the FDA for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma[5] Liabilities and Equity - Total current liabilities were $5.77 million as of June 30, 2024, down from $6.98 million as of March 31, 2024[7] - Total stockholders' equity increased to $12.53 million as of June 30, 2024, compared to $12.20 million as of December 31, 2023[9]
Nuvectis Pharma, Inc. Reports Second Quarter 2024 Financial Results and Business Highlights
GlobeNewswire News Room· 2024-08-06 12:28
FORT LEE, N.J., Aug. 06, 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 second quarter 2024 and provided an update on recent business progress. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "During the second quart ...
Wall Street Analysts See a 229.34% Upside in Nuvectis Pharma (NVCT): Can the Stock Really Move This High?
zacks.com· 2024-05-24 14:56
Group 1 - Nuvectis Pharma, Inc. (NVCT) closed at $6.68, with a 2.6% gain over the past four weeks, and has a mean price target of $22, indicating a 229.3% upside potential [1] - The mean estimate includes three short-term price targets with a standard deviation of $2.65, where the lowest estimate of $20 suggests a 199.4% increase, and the highest estimate of $25 indicates a 274.3% increase [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price movements [10][11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 15.3% over the last 30 days, with two estimates moving higher and no negative revisions [11] - NVCT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [12] - While the consensus price target may not be a reliable indicator of the stock's potential gain, it does suggest a positive direction for price movement [12]
Nuvectis Pharma, Inc. to Present at the H.C. Wainwright BioConnect Investor Conference
Newsfilter· 2024-05-16 12:30
Fort Lee, NJ, May 16, 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 announced that Ron Bentsur, Chairman and Chief Executive Officer, will present at the H.C. Wainwright 2nd BioConnect Investor Conference at the NASDAQ world headquarters in New York City. Event H.C. Wainwright 2nd ...
Nuvectis Pharma(NVCT) - 2024 Q1 - Quarterly Report
2024-05-07 20:30
```markdown [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) Q1 2024 unaudited financials show a net loss of $4.2 million, increased cash to $19.5 million, and an accumulated deficit of $58.4 million [Unaudited Condensed Balance Sheets](index=3&type=section&id=Unaudited%20Condensed%20Balance%20Sheets) As of March 31, 2024, total assets were $19.7 million, liabilities decreased, and shareholders' equity increased to $14.0 million Condensed Balance Sheet Data (USD in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $19,464 | $19,126 | | TOTAL ASSETS | $19,714 | $19,185 | | **Liabilities & Equity** | | | | TOTAL LIABILITIES | $5,692 | $6,984 | | TOTAL SHAREHOLDERS' EQUITY | $14,022 | $12,201 | | TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $19,714 | $19,185 | [Unaudited Condensed Statements of Operations](index=4&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations) Q1 2024 net loss was $4.17 million, slightly higher than Q1 2023, driven by increased research and development expenses Condensed Statement of Operations (USD in thousands) | Account | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Research and development | $2,660 | $2,367 | | General and administrative | $1,736 | $1,734 | | **OPERATING LOSS** | **$(4,396)** | **$(4,101)** | | Finance income | $225 | $52 | | **NET LOSS** | **$(4,171)** | **$(4,049)** | | **BASIC AND DILUTED NET LOSS PER SHARE** | **$(0.25)** | **$(0.27)** | [Unaudited Condensed Statements of Changes in Stockholders' Equity](index=5&type=section&id=Unaudited%20Condensed%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Shareholders' equity increased to $14.0 million in Q1 2024, primarily due to ATM proceeds, partially offset by the net loss - Shareholders' equity increased by **$1.8 million** in Q1 2024[19](index=19&type=chunk) - The increase was primarily due to net proceeds of **$4.7 million** from the At-the-Market offering, which was offset by the quarterly net loss of **$4.2 million**[19](index=19&type=chunk) [Unaudited Condensed Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) Q1 2024 net cash increased by $0.3 million to $19.5 million, primarily from financing activities offsetting operating cash use Condensed Statement of Cash Flows (USD in thousands) | Activity | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,358) | $(4,777) | | Net cash provided by financing activities | $4,696 | $252 | | **INCREASE/(DECREASE) IN CASH** | **$338** | **$(4,525)** | | Cash and cash equivalents at end of period | $19,464 | $15,468 | [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Key notes cover the accumulated deficit, cash sufficiency, ATM proceeds, and significant unaccrued contingent payment obligations - The company has an accumulated deficit of **$58.4 million** as of March 31, 2024, but management believes existing cash of **$19.5 million** is sufficient to fund planned operations for at least the next **12 months**[27](index=27&type=chunk)[29](index=29&type=chunk) - In Q1 2024, the company sold 502,647 common shares under its ATM Program, generating net proceeds of approximately **$4.7 million**[28](index=28&type=chunk)[48](index=48&type=chunk) - Potential future milestone and royalty payments under license agreements with CRT Pioneer Fund and the University of Edinburgh have not been accrued due to uncertainty[42](index=42&type=chunk)[44](index=44&type=chunk) - As of March 31, 2024, there was **$5.4 million** of total unrecognized compensation cost related to RSAs, expected to be recognized over a weighted average period of **1.32 years**[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses oncology drug candidates NXP800 and NXP900, Q1 2024 net loss of $4.2 million, $19.5 million cash, and future capital needs [Overview](index=15&type=section&id=Overview) Nuvectis develops precision oncology medicines, with lead candidate NXP800 in Phase 1b for ovarian carcinoma and NXP900 in Phase 1a for solid tumors - NXP800 is in a **Phase 1b** study for platinum-resistant, ARID1a-mutated ovarian carcinoma and has received FDA **Fast Track Designation**[69](index=69&type=chunk)[70](index=70&type=chunk) - NXP900 is a SRC/YES1 kinase inhibitor for which a **Phase 1a** study in patients with advanced solid tumors was initiated in September 2023[72](index=72&type=chunk)[74](index=74&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Q1 2024 operating loss was $4.4 million, driven by increased research and development expenses, resulting in a $4.2 million net loss Comparison of Operating Expenses (USD in thousands) | Expense Category | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $2,660 | $2,367 | $293 | | General and administrative | $1,736 | $1,734 | $2 | | **OPERATING LOSS** | **$(4,396)** | **$(4,101)** | **$(295)** | - The increase in R&D expenses was primarily driven by a **$0.2 million** increase in employee compensation, including share-based compensation and benefits[82](index=82&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, the company had $19.5 million in cash, sufficient for 12 months, but substantial additional capital will be required - The company had **$19.5 million** in cash and cash equivalents as of March 31, 2024[85](index=85&type=chunk) - Management believes current cash will fund operating expenses and capital expenditures through at least the next **12 months** from the financial statement issuance date[90](index=90&type=chunk) - As of March 31, 2024, the company has sold shares for **$9.8 million** in net proceeds under its ATM program, with approximately **$29.9 million** remaining available for sale[89](index=89&type=chunk)[49](index=49&type=chunk) [Contractual Obligations and Other Commitments](index=24&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) The company has significant contingent milestone and royalty payment obligations under its NXP800 and NXP900 license agreements - NXP800 License Agreement: Potential payments include up to **$22.0 million** in pre-approval milestones, up to **$178 million** in commercial milestones, and tiered royalties[104](index=104&type=chunk) - NXP900 License Agreement: Potential payments include up to **$45.0 million** in pre-approval milestones, up to **$279.6 million** in commercial milestones, tiered royalties, and **2.5%** of gross future fundraising up to **$3.0 million**[105](index=105&type=chunk)[106](index=106&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=20&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a **smaller reporting company**, Nuvectis is not required to provide market risk disclosures - As a "**smaller reporting company**," Nuvectis is not required to provide quantitative and qualitative disclosures about market risks[112](index=112&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were **effective** as of March 31, 2024, with **no material changes** to internal controls - Based on an evaluation as of March 31, 2024, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were **effective**[114](index=114&type=chunk) - There were **no changes** in internal controls over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal control[115](index=115&type=chunk) [PART II - OTHER INFORMATION](index=22&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company was **not a party to any material legal matters or claims** as of the report date - The company was **not a party to any material legal matters or claims** as of the date of the report[118](index=118&type=chunk) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) **No material changes** to risk factors were reported compared to the Annual Report on Form 10-K for fiscal year 2023 - **No material changes** to risk factors were reported compared to the Annual Report on Form 10-K for the year ended December 31, 2023[119](index=119&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) **No unregistered securities** were issued, and the use of proceeds from prior offerings for drug development and general corporate purposes remains **unchanged** - **No unregistered securities** were issued during the reporting period[120](index=120&type=chunk) - The intended use of proceeds from offerings is to fund Phase 1 development of NXP800 and NXP900 and for general corporate purposes, with **no material change** in this plan[123](index=123&type=chunk)[124](index=124&type=chunk) [Item 3. Defaults Upon Senior Securities](index=22&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) **No defaults** upon senior securities were reported [Item 4. Mine Safety Disclosures](index=22&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations [Item 5. Other Information](index=22&type=section&id=Item%205.%20Other%20Information) No other material information was reported [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) The report includes required exhibits such as **CEO and CFO certifications** and **Inline XBRL financial statements** - Filed exhibits include **CEO and CFO certifications** and **Inline XBRL financial data**[128](index=128&type=chunk) ```
Nuvectis Pharma(NVCT) - 2024 Q1 - Quarterly Results
2024-05-07 13:13
Financial Performance - Nuvectis reported a net loss of $4.2 million for Q1 2024, an increase of $0.2 million compared to a net loss of $4.0 million in Q1 2023[5] - Cash and cash equivalents increased to $19.5 million as of March 31, 2024, up from $19.1 million as of December 31, 2023, reflecting a $0.4 million increase[4] - Research and development expenses rose to $2.7 million in Q1 2024, compared to $2.4 million in Q1 2023, marking an increase of $0.3 million[6] - Interest income increased to $0.2 million in Q1 2024, compared to $0.1 million in Q1 2023[7] - The accumulated deficit as of March 31, 2024, was $58.4 million, up from $54.2 million as of December 31, 2023[12] Assets and Liabilities - Total current assets as of March 31, 2024, were $19.7 million, compared to $19.2 million as of December 31, 2023[12] - Total liabilities decreased to $5.7 million as of March 31, 2024, down from $7.0 million as of December 31, 2023[12] Clinical Developments - NXP800 Phase 1b study in platinum resistant, ARID1a-mutated ovarian cancer showed encouraging preliminary data, with the program granted Fast Track Designation by the US FDA[3] - NXP900's Phase 1a dose-escalation study is ongoing, with new preclinical data presented at the 2024 AACR conference demonstrating its potential in reversing resistance to EGFR and ALK targeted agents[2] - The company expects several clinical data updates in the second half of 2024, indicating a potentially transformational year ahead[2]
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 $ ...