CG Oncology Reports Third Quarter 2024 Financial Results and Provides Business Updates
CG Oncology reported Q3 2024 financial results with a net loss of $20.4 million ($0.30 per share), compared to $17.5 million ($4.00 per share) in Q3 2023. Cash position stood at $540.7 million as of September 30, 2024. R&D expenses increased to $19.6 million from $11.7 million year-over-year, while G&A expenses rose to $8.7 million from $2.3 million. The company's late-breaking abstract on Phase 3 BOND-003 trial results for cretostimogene monotherapy in BCG-Unresponsive NMIBC was accepted at the SUO 25th Annual Meeting. Current cash reserves are expected to fund operations through 2027.
CG Oncology ha riportato i risultati finanziari del terzo trimestre del 2024 con una perdita netta di 20,4 milioni di dollari (0,30 dollari per azione), rispetto ai 17,5 milioni di dollari (4,00 dollari per azione) nel terzo trimestre del 2023. La posizione di liquidità si è attestata a 540,7 milioni di dollari al 30 settembre 2024. Le spese per ricerca e sviluppo sono aumentate a 19,6 milioni di dollari da 11,7 milioni di dollari anno su anno, mentre le spese generali e amministrative sono salite a 8,7 milioni di dollari da 2,3 milioni di dollari. L'abstract dell'azienda sui risultati del trial di fase 3 BOND-003 per la monoterapia con cretostimogene in NMIBC non responsivo a BCG è stato accettato al 25° Congresso annuale SUO. Le attuali riserve di liquidità dovrebbero finanziare le operazioni fino al 2027.
CG Oncology informó sobre los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 20,4 millones de dólares (0,30 dólares por acción), en comparación con 17,5 millones de dólares (4,00 dólares por acción) en el tercer trimestre de 2023. La posición de efectivo se situó en 540,7 millones de dólares al 30 de septiembre de 2024. Los gastos de I+D aumentaron a 19,6 millones de dólares desde 11,7 millones de dólares interanualmente, mientras que los gastos generales y administrativos subieron a 8,7 millones de dólares desde 2,3 millones de dólares. El artículo de última hora de la compañía sobre los resultados del ensayo de fase 3 BOND-003 para la monoterapia con cretostimogén en NMIBC no responsivo a BCG fue aceptado en la 25ª Reunión Anual de SUO. Se espera que las reservas de efectivo actuales financien las operaciones hasta 2027.
CG Oncology는 2024년 3분기 재무 결과를 발표했으며, 순손실은 2040만 달러 (주당 0.30 달러)로, 2023년 3분기의 1750만 달러 (주당 4.00 달러)에 비해 증가했습니다. 2024년 9월 30일 기준 현금 보유액은 5억 4070만 달러로 보고되었습니다. 연구개발 비용은 전년 대비 1170만 달러에서 1960만 달러로 증가했으며, 일반 및 관리 비용은 230만 달러에서 870만 달러로 증가했습니다. 회사의 BCG 비반응성 NMIBC에서의 크레토스티모겐 단일 요법에 대한 3상 BOND-003 시험 결과에 대한 최종 발표는 SUO 제25차 연례 회의에서 수락되었습니다. 현재의 현금 보유액은 2027년까지 운영 자금을 지원할 것으로 예상됩니다.
CG Oncology a annoncé les résultats financiers du troisième trimestre 2024, avec une perte nette de 20,4 millions de dollars (0,30 dollar par action), par rapport à 17,5 millions de dollars (4,00 dollars par action) au troisième trimestre 2023. La position de trésorerie s'élevait à 540,7 millions de dollars au 30 septembre 2024. Les dépenses de R&D ont augmenté à 19,6 millions de dollars contre 11,7 millions de dollars d'une année à l'autre, tandis que les dépenses générales et administratives ont augmenté à 8,7 millions de dollars contre 2,3 millions de dollars. L'abstract de dernière minute de l'entreprise sur les résultats de l'essai de phase 3 BOND-003 pour la monothérapie au créto-stimogène dans le NMIBC non réactif au BCG a été accepté lors de la 25e Réunion Annuelle de la SUO. Les réserves de trésorerie actuelles devraient financer les opérations jusqu'en 2027.
CG Oncology hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit einem Nettoverlust von 20,4 Millionen Dollar (0,30 Dollar pro Aktie), im Vergleich zu 17,5 Millionen Dollar (4,00 Dollar pro Aktie) im dritten Quartal 2023. Die Liquiditätslage belief sich zum 30. September 2024 auf 540,7 Millionen Dollar. Die F&E-Ausgaben stiegen im Jahresvergleich auf 19,6 Millionen Dollar von 11,7 Millionen Dollar, während die allgemeinen Verwaltungsaufwendungen auf 8,7 Millionen Dollar von 2,3 Millionen Dollar anstiegen. Das kurzfristige Abstract des Unternehmens zu den Ergebnissen der Phase-3-Studie BOND-003 zur Monotherapie mit Cretostimogen bei BCG-unempfindlichem NMIBC wurde beim 25. Jahresmeeting der SUO angenommen. Die aktuellen Barreserven sollen die Betriebskosten bis 2027 finanzieren.
- Strong cash position of $540.7 million sufficient to fund operations through 2027
- Phase 3 BOND-003 trial results acceptance for presentation at SUO Annual Meeting
- Reported sustained and durable complete response in bladder cancer patients with strong safety profile
- Net loss increased to $20.4 million in Q3 2024 from $17.5 million in Q3 2023
- R&D expenses increased 67.5% year-over-year to $19.6 million
- G&A expenses significantly increased to $8.7 million from $2.3 million year-over-year
Insights
The Q3 financial results reveal a solid cash position of
G&A expenses saw a significant jump to
The acceptance of BOND-003 trial results as a late-breaking abstract at SUO signals potential significance in the clinical data for cretostimogene in BCG-unresponsive NMIBC. Previous data presented at AUA and ASCO demonstrated promising durability of response and safety profile, key differentiators in the NMIBC treatment landscape where options are
The company's positioning of cretostimogene as a "backbone bladder-sparing therapy" suggests confidence in its potential to become a standard treatment option. The continued investment in clinical development and manufacturing indicates progression toward potential commercialization, though regulatory approval remains a critical milestone.
- Late-Breaking Abstract on Results of Phase 3 BOND-003 Trial of Cretostimogene Monotherapy in BCG-Unresponsive NMIBC Accepted at the Society of Urologic Oncology (SUO) 25th Annual Meeting -
IRVINE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the third quarter ended September 30, 2024, and provided business updates.
“This quarter, we’ve continued to make significant advancements across our pipeline to bring forward a potential backbone bladder-sparing therapy for patients with Non-Muscle Invasive Bladder Cancer (NMIBC),” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “As we reported earlier this year at the AUA and ASCO annual meetings, cretostimogene has the ability to induce a sustained and durable complete response in bladder cancer patients with a strong safety and tolerability profile. We believe that cretostimogene’s unique product profile differentiates it from current and investigational NMIBC treatments, and we look forward to sharing updated results from our BOND-003 registrational study at SUO.”
Third Quarter 2024 Financial Highlights
- Cash Position: Cash and cash equivalents and marketable securities as of September 30, 2024, were
$540.7 million , compared with$552.9 million as of June 30, 2024. Based on current operating plans, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through 2027. - Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2024 were
$19.6 million compared with$11.7 million for the three months ended September 30, 2023. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount. - General and Administrative (G&A) Expenses: G&A expenses for the three months ended September 30, 2024 were
$8.7 million compared with$2.3 million for the three months ended September 30, 2023. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount, an increase in professional and consultant fees related to legal, accounting and consulting fees, and an increase in insurance and marketing-related costs. - Net Loss: Net loss attributable to common stockholders was
$20.4 million , or ($0.30) per share, for the three months ended September 30, 2024, compared to$17.5 million , or ($4.00) per share, for the three months ended September 30, 2023.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in patients with intermediate-risk NMIBC. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer. Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; and the timing and likelihood of regulatory filings and approvals for cretostimogene. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts
Media
Sarah Connors
VP, Communications and Patient Advocacy
(508) 654-2277
sarah.connors@cgoncology.com
Investor Relations
Chau Cheng
VP, Investor Relations
(949) 342-8939
chau.cheng@cgoncology.com
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