Nuvectis Pharma, Inc. Reports Third Quarter 2024 Financial Results and Business Highlights
Nuvectis Pharma reported Q3 2024 financial results and business updates. Cash position was $17.2M as of September 30, 2024, down from $19.1M in December 2023. Net loss decreased to $4.2M from $5.9M year-over-year. R&D expenses reduced to $2.8M from $4.5M, while G&A expenses decreased to $1.5M from $1.7M. The company expects clinical data update from NXP800 Phase 1b study this month, with the drug receiving Orphan Drug Designation for ARID1a-deficient cancers. NXP900 Phase 1a study completed 4 escalation cohorts with no dose-limiting toxicities.
Nuvectis Pharma ha riportato i risultati finanziari e gli aggiornamenti aziendali del terzo trimestre del 2024. La posizione di cassa era di 17,2 milioni di dollari al 30 settembre 2024, in calo rispetto ai 19,1 milioni di dollari di dicembre 2023. La perdita netta è diminuita a 4,2 milioni di dollari dai 5,9 milioni di dollari dell'anno precedente. Le spese per ricerca e sviluppo sono diminuite a 2,8 milioni di dollari dai 4,5 milioni, mentre le spese generali e amministrative sono diminuite a 1,5 milioni di dollari dai 1,7 milioni. L'azienda si aspetta un aggiornamento dei dati clinici dallo studio NXP800 Fase 1b questo mese, con il farmaco che ha ricevuto la designazione di farmaco orfano per i tumori carenti di ARID1a. Lo studio NXP900 Fase 1a ha completato 4 coorti di escalation senza tossicità limitanti alla dose.
Nuvectis Pharma informó sobre los resultados financieros y las actualizaciones comerciales del tercer trimestre de 2024. La posición de efectivo era de 17,2 millones de dólares al 30 de septiembre de 2024, en comparación con 19,1 millones de dólares en diciembre de 2023. La pérdida neta disminuyó a 4,2 millones de dólares desde 5,9 millones de dólares en el año anterior. Los gastos de I+D se redujeron a 2,8 millones de dólares desde 4,5 millones, mientras que los gastos generales y administrativos disminuyeron a 1,5 millones de dólares desde 1,7 millones. La compañía espera una actualización de datos clínicos del estudio NXP800 Fase 1b este mes, con el fármaco recibiendo la designación de medicamento huérfano para cánceres deficientes en ARID1a. El estudio NXP900 Fase 1a completó 4 cohortes de escalación sin toxicidades limitantes de dosis.
뉴벡티스 제약(Nuvectis Pharma)은 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 2024년 9월 30일 기준 현금 잔고는 1720만 달러로, 2023년 12월 1910만 달러에서 감소했습니다. 순손실은 지난해 590만 달러에서 420만 달러로 감소했습니다. R&D 비용은 450만 달러에서 280만 달러로 감소했으며, 관리비용은 170만 달러에서 150만 달러로 줄어들었습니다. 회사는 이번 달 NXP800 1b상 연구의 임상 데이터 업데이트를 기대하고 있으며, 이 약물은 ARID1a 결핍 암에 대한 고아약 지정이 확보되었습니다. NXP900 1a상 연구는 용량 제한 독성이 없는 4개의 용량 증량 코호트를 완료했습니다.
Nuvectis Pharma a publié ses résultats financiers et ses mises à jour commerciales pour le troisième trimestre 2024. La position de trésorerie était de 17,2 millions de dollars au 30 septembre 2024, en baisse par rapport à 19,1 millions de dollars en décembre 2023. La perte nette a diminué à 4,2 millions de dollars contre 5,9 millions de dollars l'année précédente. Les dépenses en R&D ont été réduites à 2,8 millions de dollars contre 4,5 millions, tandis que les dépenses générales et administratives ont diminué à 1,5 million de dollars contre 1,7 million. L'entreprise s'attend à une mise à jour des données cliniques de l'étude NXP800 Phase 1b ce mois-ci, le médicament ayant reçu la désignation de médicament orphelin pour les cancers déficients en ARID1a. L'étude NXP900 Phase 1a a complété 4 cohortes d'escalade sans toxicités limitantes de dose.
Nuvectis Pharma hat die finanziellen Ergebnisse und Geschäftsinformationen für das dritte Quartal 2024 veröffentlicht. Die Liquiditätslage betrug am 30. September 2024 17,2 Millionen USD, ein Rückgang von 19,1 Millionen USD im Dezember 2023. Der Nettoverlust verringerte sich von 5,9 Millionen USD auf 4,2 Millionen USD im Jahresvergleich. Die F&E-Ausgaben sanken von 4,5 Millionen USD auf 2,8 Millionen USD, während die allgemeinen und Verwaltungskosten von 1,7 Millionen USD auf 1,5 Millionen USD zurückgingen. Das Unternehmen erwartet in diesem Monat ein Update zu den klinischen Daten der NXP800 Phase 1b-Studie, wobei das Medikament die Orphan Drug Designation für ARID1a-defiziente Krebsarten erhalten hat. Die NXP900 Phase 1a-Studie hat 4 Eskalationskohorten ohne dosislimitierende Toxizitäten abgeschlossen.
- Net loss decreased by 28.8% YoY to $4.2M
- R&D expenses reduced by 37.8% YoY to $2.8M
- Cash runway extended into 2026
- NXP800 received Orphan Drug Designation
- NXP900 showed no dose-limiting toxicities in Phase 1a
- Cash position decreased by $1.9M since December 2023
- Ongoing share dilution through ATM facility utilization
Insights
The Q3 results show a
Notable is the
The clinical progress shows promising developments for both pipeline candidates. NXP800's upcoming Phase 1b data in platinum-resistant, ARID1a-mutated ovarian cancer represents a significant catalyst. The new Orphan Drug Designation for ARID1a-deficient cancers strengthens the regulatory position and market potential.
NXP900's Phase 1a progress is encouraging, with no dose-limiting toxicities across four cohorts - a positive safety signal. The strategic focus on non-small cell lung cancer combinations to address resistance mechanisms represents a well-considered development approach targeting a substantial market opportunity. Both programs are hitting important development milestones with clean safety profiles thus far.
- Clinical data update from the NXP800 Phase 1b study expected this month; NXP800 granted Orphan Drug Designation for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers
- NXP900 Phase 1a dose escalation study progressing as planned, 4 escalation cohorts completed with no DLTs, dose escalation continues
FORT LEE, N.J., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported its financial results for the third quarter of 2024 and provided an update on recent business progress.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “In the third quarter we continued to advance the development programs of NXP800 and NXP900. For NXP800, we anticipate the upcoming clinical data update from the Phase 1b study in platinum-resistant, ARID1a-mutated ovarian cancer this month. In addition, we obtained a second Orphan Drug Designation for NXP800 from the FDA, for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.” Mr. Bentsur continued, “For NXP900, we have cleared 4 cohorts in the dose escalation Phase 1 study so far with no reports of dose limiting toxicities, and the dose escalation continues. In parallel, we are solidifying our plans for the next stage of development with both single agent and combination approaches to unlock the full therapeutic potential of NXP900, especially in non-small cell lung cancer in combination with currently approved targeted therapies to overcome acquired resistance to such therapies”. Mr. Bentsur concluded, “Finally, we continue to be responsible and efficient with our financial resources and believe that our current cash position will allow us to meet important milestones for both clinical programs and provide working capital well into 2026.”
Third Quarter 2024 Financial Results
Cash, cash equivalents, and short-term investments were
The Company's net loss was
Research and development expenses were
General and administrative expenses were
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. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma and ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action in that it inhibits 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.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the potential benefits of the Orphan Drug Designation granted to NXP800, the preclinical and the Phase 1a data generated to date for NXP800 and the clinical expectations for the NXP800 Phase 1b study, including the pending clinical update from the ongoing Phase 1b in platinum-resistant, ARID1a-mutated ovarian carcinoma, statements regarding NXP800's mechanism of action and its 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. 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 2Q 2024 Form 10-Q and our other public filings with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the 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
Media Relations Contact
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
| NUVECTIS PHARMA, INC. CONDENSED BALANCE SHEETS (USD in thousands, except per share and share amounts) (unaudited) | |||||||||||||||
| September 30, | December 31, | ||||||||||||||
| 2024 | 2023 | ||||||||||||||
| Assets | |||||||||||||||
| CURRENT ASSETS | |||||||||||||||
| Cash and cash equivalents | $ | 17,169 | $ | 19,126 | |||||||||||
| Other current assets | 138 | 59 | |||||||||||||
| TOTAL CURRENT ASSETS | 17,307 | 19,185 | |||||||||||||
| TOTAL ASSETS | $ | 17,307 | $ | 19,185 | |||||||||||
| Liabilities and Stockholders’ Equity | |||||||||||||||
| CURRENT LIABILITIES | |||||||||||||||
| Accounts payables | $ | 2,261 | $ | 2,771 | |||||||||||
| Accrued liabilities | 282 | 415 | |||||||||||||
| Employee compensation and benefits | 3,773 | 3,798 | |||||||||||||
| TOTAL CURRENT LIABILITIES | 6,316 | 6,984 | |||||||||||||
| TOTAL LIABILITIES | 6,316 | 6,984 | |||||||||||||
| COMMITMENTS AND CONTINGENCIES | |||||||||||||||
| STOCKHOLDERS’ EQUITY | |||||||||||||||
| Common Shares, | * | * | |||||||||||||
| Additional paid in capital | 77,988 | 66,446 | |||||||||||||
| Accumulated deficit | (66,997 | ) | (54,245 | ) | |||||||||||
| TOTAL STOCKHOLDERS’ EQUITY | 10,991 | 12,201 | |||||||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 17,307 | $ | 19,185 | |||||||||||
| * Represents an amount lower than | |||||||||||||||
| NUVECTIS PHARMA, INC. CONDENSED STATEMENTS OF OPERATIONS (USD in thousands, except per share and share amounts) (unaudited) | |||||||||||||||
| Three Months Ended September 30 | Nine Months Ended September 30 | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| OPERATING EXPENSES: | |||||||||||||||
| Research and development | $ | 2,819 | $ | 4,486 | $ | 8,422 | $ | 11,115 | |||||||
| General and administrative | 1,540 | 1,672 | 4,976 | 4,916 | |||||||||||
| OPERATING LOSS | (4,359 | ) | (6,158 | ) | (13,398 | ) | (16,031 | ) | |||||||
| Finance income | 206 | 277 | 646 | 393 | |||||||||||
| NET LOSS | $ | (4,153 | ) | $ | (5,881 | ) | $ | (12,752 | ) | $ | (15,638 | ) | |||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (4,153 | ) | $ | (5,881 | ) | $ | (12,752 | ) | $ | (15,638 | ) | |||
| BASIC AND DILUTED NET LOSS PER COMMON STOCK OUTSTANDING | $ | (0.24 | ) | $ | (0.37 | ) | $ | (0.75 | ) | $ | (1.02 | ) | |||
| Basic and diluted weighted average number of common stock outstanding | 17,230,559 | 16,104,446 | 16,898,040 | 15,341,685 | |||||||||||
FAQ
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