Nuvectis Pharma, Inc. Reports 2024 Financial Results and Business Highlights
Nuvectis Pharma (NASDAQ: NVCT) reported its 2024 financial results and business highlights, showing progress in its clinical-stage oncology drug candidates. The company's NXP800 received Orphan Drug Designation from the FDA for ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. A Phase 1b study in platinum-resistant, ARID1a-mutated ovarian cancer continues with updated results expected in Q2 2025.
For NXP900, the Phase 1a dose escalation study is ongoing with preparations underway for Phase 1b trials starting mid-2025. The upcoming program will evaluate NXP900 as monotherapy in YES1/SRC-driven solid tumors and in combination with EGFR and ALK inhibitors for non-small cell lung cancer.
Financially, Nuvectis completed a follow-on offering in February 2025, raising $15.5 million in gross proceeds, extending cash runway into 2027. The company reported a net loss of $19.0 million for 2024, compared to $22.3 million in 2023, a $3.3 million improvement. Cash and equivalents stood at $18.5 million as of December 31, 2024, slightly down from $19.1 million at the end of 2023.
Nuvectis Pharma (NASDAQ: NVCT) ha riportato i risultati finanziari e i punti salienti aziendali per il 2024, mostrando progressi nei suoi candidati farmaci oncologici in fase clinica. Il farmaco NXP800 ha ricevuto la Designazione di Farmaco Orfano dalla FDA per i tumori ovarici, delle tube di Falloppio e peritoneali primari carenti di ARID1a. Uno studio di Fase 1b nel cancro ovarico resistente al platino e mutato per ARID1a è in corso, con risultati aggiornati attesi nel secondo trimestre del 2025.
Per NXP900, lo studio di escalation della dose di Fase 1a è in corso e sono in preparazione gli studi di Fase 1b che inizieranno a metà del 2025. Il programma imminente valuterà NXP900 come monoterapia in tumori solidi guidati da YES1/SRC e in combinazione con inibitori di EGFR e ALK per il cancro polmonare non a piccole cellule.
Dal punto di vista finanziario, Nuvectis ha completato un'offerta di follow-on a febbraio 2025, raccogliendo 15,5 milioni di dollari in proventi lordi, estendendo la liquidità fino al 2027. L'azienda ha riportato una perdita netta di 19,0 milioni di dollari per il 2024, rispetto ai 22,3 milioni di dollari del 2023, con un miglioramento di 3,3 milioni di dollari. La liquidità e gli equivalenti ammontavano a 18,5 milioni di dollari al 31 dicembre 2024, leggermente in calo rispetto ai 19,1 milioni di dollari alla fine del 2023.
Nuvectis Pharma (NASDAQ: NVCT) reportó sus resultados financieros y aspectos destacados del negocio para 2024, mostrando progresos en sus candidatos a medicamentos oncológicos en etapa clínica. El medicamento NXP800 recibió la Designación de Medicamento Huérfano de la FDA para cánceres de ovario, trompas de Falopio y peritoneo primario deficientes en ARID1a. Un estudio de Fase 1b en cáncer de ovario resistente a platino y mutado para ARID1a continúa, con resultados actualizados esperados para el segundo trimestre de 2025.
Para NXP900, el estudio de escalación de dosis de Fase 1a está en curso y se están preparando ensayos de Fase 1b que comenzarán a mediados de 2025. El programa próximo evaluará NXP900 como monoterapia en tumores sólidos impulsados por YES1/SRC y en combinación con inhibidores de EGFR y ALK para cáncer de pulmón no microcítico.
Desde el punto de vista financiero, Nuvectis completó una oferta de seguimiento en febrero de 2025, recaudando 15,5 millones de dólares en ingresos brutos, extendiendo su liquidez hasta 2027. La compañía reportó una pérdida neta de 19,0 millones de dólares para 2024, en comparación con 22,3 millones de dólares en 2023, una mejora de 3,3 millones de dólares. El efectivo y equivalentes ascendían a 18,5 millones de dólares al 31 de diciembre de 2024, ligeramente por debajo de los 19,1 millones de dólares a finales de 2023.
Nuvectis Pharma (NASDAQ: NVCT)는 2024년 재무 결과 및 비즈니스 하이라이트를 보고하며 임상 단계의 항암제 후보에서의 진전을 보여주었습니다. 회사의 NXP800은 ARID1a 결핍 난소암, 난관암 및 원발성 복막암에 대해 FDA로부터 희귀의약품 지정을 받았습니다. 백금 내성 ARID1a 변이 난소암에 대한 1b상 연구가 진행 중이며, 업데이트된 결과는 2025년 2분기에 예상됩니다.
NXP900에 대해서는 1a상 용량 증량 연구가 진행 중이며, 2025년 중반에 시작될 1b상 시험을 위한 준비가 underway입니다. 다가오는 프로그램은 YES1/SRC에 의해 유도된 고형 종양에서 NXP900을 단독 요법으로 평가하고, 비소세포 폐암에 대해 EGFR 및 ALK 억제제와의 병용 요법으로 평가할 것입니다.
재무적으로 Nuvectis는 2025년 2월에 후속 공모를 완료하여 1,550만 달러의 총 수익을 올리며 2027년까지 자금을 연장했습니다. 회사는 2024년에 1,900만 달러의 순손실을 보고했으며, 이는 2023년의 2,230만 달러에 비해 330만 달러 개선된 수치입니다. 2024년 12월 31일 기준 현금 및 현금성 자산은 1,850만 달러로, 2023년 말의 1,910만 달러에서 약간 감소했습니다.
Nuvectis Pharma (NASDAQ: NVCT) a publié ses résultats financiers et les points saillants de son activité pour 2024, montrant des progrès dans ses candidats médicaments en oncologie en phase clinique. Le médicament NXP800 a reçu la désignation de médicament orphelin par la FDA pour les cancers de l'ovaire, des trompes de Fallope et péritonéaux primaires déficients en ARID1a. Une étude de phase 1b sur le cancer de l'ovaire résistant au platine et muté pour ARID1a se poursuit, avec des résultats actualisés attendus au deuxième trimestre de 2025.
Pour NXP900, l'étude d'escalade de dose de phase 1a est en cours et les préparatifs pour les essais de phase 1b qui commenceront à la mi-2025 sont en cours. Le programme à venir évaluera NXP900 en monothérapie dans les tumeurs solides dirigées par YES1/SRC et en combinaison avec des inhibiteurs d'EGFR et d'ALK pour le cancer du poumon non à petites cellules.
Sur le plan financier, Nuvectis a complété une offre de suivi en février 2025, levant 15,5 millions de dollars de produits bruts, prolongeant ainsi sa liquidité jusqu'en 2027. L'entreprise a rapporté une perte nette de 19,0 millions de dollars pour 2024, par rapport à 22,3 millions de dollars en 2023, soit une amélioration de 3,3 millions de dollars. La trésorerie et les équivalents se sont élevés à 18,5 millions de dollars au 31 décembre 2024, légèrement en baisse par rapport à 19,1 millions de dollars à la fin de 2023.
Nuvectis Pharma (NASDAQ: NVCT) hat seine finanziellen Ergebnisse und Unternehmenshighlights für 2024 veröffentlicht und Fortschritte bei seinen klinischen Onkologie-Arzneimittelkandidaten gezeigt. Das Medikament NXP800 erhielt von der FDA die Orphan Drug Designation für ARID1a-defiziente Eierstock-, Eileiter- und primäre Peritonealkrebsarten. Eine Phase 1b-Studie bei platinresistentem, ARID1a-mutiertem Eierstockkrebs läuft weiterhin, wobei aktualisierte Ergebnisse im 2. Quartal 2025 erwartet werden.
Für NXP900 läuft die Phase 1a-Dosiserhöhungsstudie, und die Vorbereitungen für die Phase 1b-Studien, die Mitte 2025 beginnen sollen, sind im Gange. Das bevorstehende Programm wird NXP900 als Monotherapie bei YES1/SRC-gesteuerten soliden Tumoren und in Kombination mit EGFR- und ALK-Inhibitoren bei nicht-kleinzelligem Lungenkrebs bewerten.
Finanziell hat Nuvectis im Februar 2025 eine Folgeemission abgeschlossen und 15,5 Millionen Dollar brutto eingenommen, wodurch die Liquidität bis 2027 verlängert wurde. Das Unternehmen berichtete von einem Nettoverlust von 19,0 Millionen Dollar für 2024, verglichen mit 22,3 Millionen Dollar im Jahr 2023, was eine Verbesserung um 3,3 Millionen Dollar darstellt. Zum 31. Dezember 2024 betrugen die liquiden Mittel und Äquivalente 18,5 Millionen Dollar, leicht gesenkt von 19,1 Millionen Dollar Ende 2023.
- Orphan Drug Designation granted by FDA for NXP800
- Net loss decreased by $3.3 million compared to 2023
- Research and development expenses decreased by $2.5 million year-over-year
- Follow-on offering raised $15.5 million, extending cash runway into 2027
- Cash and cash equivalents decreased from $19.1M to $18.5M year-over-year
- Company still operating at a net loss of $19.0 million for 2024
Insights
Nuvectis Pharma's 2024 financial results and clinical updates highlight meaningful progress for this $169 million market cap oncology-focused biotech, with several potential catalysts on the horizon that could significantly impact valuation.
The company's lead candidate NXP800 has secured Orphan Drug Designation for ARID1a-deficient gynecological cancers – a critical regulatory milestone that provides benefits including tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity upon approval. This designation validates the program's potential in addressing a serious unmet need in treatment-resistant ovarian cancer. The ongoing Phase 1b trial employing an intermittent dosing schedule at 75mg/day represents a strategic approach to optimize the therapeutic window. The anticipated Q2 2025 data readout will be pivotal in determining whether NXP800 demonstrates the efficacy signal necessary to advance to later-stage trials.
For NXP900, Nuvectis is executing a two-pronged development strategy that maximizes shots on goal. The planned Phase 1b program targeting both YES1/SRC-driven tumors as monotherapy and combination approaches with EGFR/ALK inhibitors in non-small cell lung cancer addresses substantial market opportunities. The SRC kinase family plays a critical role in tumor progression and treatment resistance across multiple cancer types, potentially positioning NXP900 as a versatile therapeutic option if clinical data supports efficacy.
Financially, Nuvectis has demonstrated disciplined resource management with R&D expenses decreasing by $2.5 million year-over-year while advancing both clinical programs. The recent $15.5 million raise extends runway into 2027, providing approximately two years of operational cushion. With a quarterly cash burn of roughly $4-5 million (excluding non-cash expenses), the company appears adequately funded through multiple data inflection points that could drive partnership interest or valuation reassessment.
For investors, Nuvectis represents a classic biotech risk/reward proposition with nearer-term catalysts than many peers. The company's focused pipeline, extended cash runway, and multiple upcoming data readouts position it as an intriguing opportunity in the precision oncology space, though success ultimately hinges on forthcoming clinical results in highly competitive therapeutic areas.
- NXP800 Phase 1b study in patients with platinum resistant, ARID1a-mutated ovarian cancer is ongoing; Orphan Drug Designation granted by the U.S. FDA. Updated Phase 1b results anticipated in Q2 2025
- NXP900 Phase 1a dose escalation study continues to enroll, preparation for the start of the Phase 1b program is underway. Phase 1b program expected to begin in mid-2025
- Follow-on offering completed in February 2025 extends cash runway into 2027
FORT LEE, N.J., Feb. 25, 2025 (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 year ended December 31, 2024 and provided an update on recent business progress.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “In 2024, Nuvectis made important progress in the development of our two clinical-stage drug candidates, NXP800 and NXP900. NXP800 was granted Orphan Drug Designation by the U.S. FDA for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers. Enrollment is ongoing in the Phase 1b clinical trial, in which patients with platinum resistant, ARID1a-mutated ovarian cancer are currently being treated with a dose of 75mg/day, on an intermittent dosing schedule. We intend to provide an update from this study in the second quarter and plan to provide the first data from the investigator-initiated study in cholangiocarcinoma later this year.”
Mr. Bentsur continued, "For NXP900, enrollment continues in the Phase 1a dose escalation clinical trial and we are pleased with the emerging clinical profile of NXP900, based on safety, pharmacokinetics and pharmacodynamics information to date. In parallel, preparations are underway to begin the Phase 1b program in mid-year. This program is designed to evaluate NXP900 as monotherapy in YES1/SRC-driven solid tumors, and in combination with EGFR and ALK inhibitors, in patients with non-small cell lung cancer. Positive results could showcase NXP900’s potential broad applicability in these large oncology markets.
Mr. Bentsur concluded, "Our successful follow-on offering, completed this month, provided Nuvectis with
Full Year 2024 Financial Results
Cash and cash equivalents were
The Company's net loss was
Research and development expenses, including non-cash and stock-based compensation, were
General and administrative expenses, including non-cash and stock-based compensation, were
Interest income was
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 clinical-stage 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. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900’s unique mechanism of action enables it to inhibit both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.
For more information on Nuvectis, please visit our website at https://nuvectis.com/.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. 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, including preclinical and clinical safety and efficacy data generated to date for NXP800 and NXP900, 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 and data regarding the preclinical studies for NXP800 and NXP900, and the Phase 1a data for NXP800 and the NXP900 Phase 1a study data to date, as well as the clinical expectations for the ongoing NXP800 Phase 1b study in platinum-resistant, ARID1a-mutated ovarian carcinoma, including the potential ability of the 75mg/day dose intensity in the NXP800 Phase 1b study to generate satisfactory safety and efficacy results, 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 the timing for completion of the clinical trials, including the ongoing NXP800 Phase 1b study in platinum-resistant ARID1a-mutated ovarian cancer and the investigator-initiated study in cholangiocarcinoma, and statements regarding NXP900's therapeutic potential and the expected timing for the completion of the Phase 1a dose-escalation study and start of the NXP900 Phase 1b program. 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 3Q 2024 Form 10-Q and our other public filings with the U.S. 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 safe harbor 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, | |||||||||||||
| 2024 | 2023 | ||||||||||||
| Assets | |||||||||||||
| CURRENT ASSETS | |||||||||||||
| Cash and cash equivalents | $ | 18,533 | $ | 19,126 | |||||||||
| Other current assets | 74 | 59 | |||||||||||
| TOTAL CURRENT ASSETS | 18,607 | 19,185 | |||||||||||
| TOTAL ASSETS | $ | 18,607 | $ | 19,185 | |||||||||
| Liabilities and Stockholders’ Equity | |||||||||||||
| CURRENT LIABILITIES | |||||||||||||
| Accounts payables | $ | 2,498 | $ | 2,771 | |||||||||
| Accrued liabilities | 840 | 415 | |||||||||||
| Employee compensation and benefits | 5,556 | 3,798 | |||||||||||
| TOTAL CURRENT LIABILITIES | 8,894 | 6,984 | |||||||||||
| TOTAL LIABILITIES | 8,894 | 6,984 | |||||||||||
| COMMITMENTS AND CONTINGENCIES | |||||||||||||
| STOCKHOLDERS’ EQUITY | |||||||||||||
| Common Shares, | * | * | |||||||||||
| Additional paid in capital | 82,958 | 66,446 | |||||||||||
| Accumulated deficit | (73,245 | ) | (54,245 | ) | |||||||||
| TOTAL STOCKHOLDERS’ EQUITY | 9,713 | 12,201 | |||||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 18,607 | $ | 19,185 | |||||||||
| * Represent amount lower than | |||||||||||||
| 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, 2024 | December 31, 2023 | |||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | 12,918 | $ | 15,380 | ||||
| General and administrative | 6,929 | 7,517 | ||||||
| OPERATING LOSS | (19,847 | ) | (22,897 | ) | ||||
| Finance income | 847 | 637 | ||||||
| NET LOSS | $ | (19,000 | ) | $ | (22,260 | ) | ||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (19,000 | ) | $ | (22,260 | ) | ||
| BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING | $ | (1.11 | ) | $ | (1.43 | ) | ||
| Basic and diluted weighted average number of common shares outstanding | 17,113,169 | 15,556,655 | ||||||
FAQ
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