CG Oncology(CGON) - 2025 Q2 - Quarterly Results

Introduction CG Oncology announced Q2 2025 financial results and business updates, highlighting positive BOND-003 data, CORE-008 new cohort initiation, and a favorable ANI Pharmaceuticals lawsuit outcome Q2 2025 Overview CG Oncology announced Q2 2025 financial results and business updates, including positive BOND-003 data, CORE-008 new cohort, and a favorable ANI Pharmaceuticals lawsuit outcome - CG Oncology announced Q2 2025 financial results and business updates, highlighting positive BOND-003 clinical trial data, the initiation of a new CORE-008 cohort, and a favorable verdict in the lawsuit against ANI Pharmaceuticals[1] CEO Commentary CEO Arthur Kuan emphasized cretostimogene's durability and tolerability in BOND-003, confirming the company's focus on advancing the therapy with a planned BLA submission in Q4 - The CEO highlighted cretostimogene's "best-in-class disease durability and tolerability" in the Phase 3 BOND-003 Cohort C trial, with plans to submit a BLA in Q4 for HR NMIBC patients unresponsive to BCG[2] - The positive outcome of the ANI lawsuit allows the company to remain focused on delivering innovative therapies[2] Corporate Highlights The company presented positive clinical data for BOND-003 Cohort C and P at AUA, and initiated the CORE-008 Cohort CX trial, expanding cretostimogene's indications Clinical Development Updates The company presented positive clinical data for BOND-003 Cohort C and P at AUA, and initiated the CORE-008 Cohort CX trial, expanding cretostimogene's indications BOND-003 Trial Data BOND-003 Cohort C showed a 75.5% complete response rate at 24 months, with 97.3% of patients free from muscle-invasive disease progression; Cohort P also showed a 90.5% high-grade recurrence-free survival rate - "Best-in-class disease durability and tolerability" data for BOND-003 Cohort C was presented at the AUA annual meeting[4] BOND-003 Cohort C Key Data | Metric | Data | As of Date | | :--- | :--- | :--- | | Anytime Complete Response Rate (CR) | 75.5% | March 14, 2025 | | Confirmed CRs at 24 months | 34 patients | March 14, 2025 | | 12-month CR Rate (K-M estimate) | 50.7% | N/A | | 24-month CR Rate (K-M estimate) | 42.3% | N/A | | Median Duration of Response | 28 months (ongoing) | N/A | | Rate of no progression to muscle-invasive disease at 24 months | 97.3% | N/A | - BOND-003 Cohort P (patients with Ta/T1 papillary disease) showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months among 24 patients[4] CORE-008 Trial Initiation The company initiated the CORE-008 Cohort CX clinical trial to evaluate cretostimogene combined with gemcitabine for high-risk BCG-exposed NMIBC patients - Initiated the CORE-008 Cohort CX clinical trial to evaluate cretostimogene in combination with gemcitabine for high-risk BCG-exposed NMIBC patients[4] Legal and Operational Updates A Delaware Superior Court jury unanimously ruled in favor of CG Oncology, absolving them from paying future royalties or other payments to ANI Pharmaceuticals for cretostimogene sales - A Delaware Superior Court jury unanimously ruled in favor of CG Oncology, absolving them from paying a 5% royalty or other payments to ANI Pharmaceuticals for future sales of cretostimogene[4] Anticipated Upcoming Milestones CG Oncology announced key clinical development and regulatory milestones for upcoming quarters, including PIVOT-006 enrollment completion, BLA submission, and top-line data releases for multiple trials Upcoming Milestones Details CG Oncology announced key clinical development and regulatory milestones for upcoming quarters, including PIVOT-006 enrollment completion, BLA submission, and top-line data releases for multiple trials - PIVOT-006 (Intermediate-risk NMIBC): Phase 3 enrollment expected to complete in Q3 2025[7] - BLA Submission: Expected in Q4 2025 for cretostimogene monotherapy in HR BCG-unresponsive NMIBC[7] - BOND-003 Cohort P: Phase 3 top-line data expected in Q4 2025[7] - CORE-008 Cohort A: Phase 2 top-line data expected in Q4 2025[7] - CORE-008 Cohort CX: Phase 2 top-line data expected in H1 2026[7] Second Quarter 2025 Financial Highlights CG Oncology's Q2 2025 financial highlights include a cash position of $661.1 million, a decrease from Q1, but sufficient to fund operations until H1 2028 Cash Position As of June 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $661.1 million, down from $688.4 million on March 31, 2025, but projected to support operations until H1 2028 Cash, Cash Equivalents, and Marketable Securities | Date | Amount (Millions USD) | Change (QoQ) | | :--- | :--- | :--- | | June 30, 2025 | 661.1 | -27.3 | | March 31, 2025 | 688.4 | N/A | - The company expects its existing cash, cash equivalents, and marketable securities to be sufficient to fund operations until H1 2028[7] Operating Expenses In Q2 2025, the company's R&D and G&A expenses significantly increased year-over-year, primarily due to higher clinical trial expenditures, personnel costs, and legal fees Research and Development (R&D) Expenses Q2 2025 R&D expenses were $31.3 million, a 69.2% increase from $18.5 million in the prior year, mainly due to increased clinical trial expenditures and personnel costs Research and Development Expenses (YoY) | Period | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 31.3 | 18.5 | +69.2% | - The increase in R&D expenses was primarily due to increased clinical trial expenditures and personnel costs[7] General and Administrative (G&A) Expenses Q2 2025 G&A expenses were $17.4 million, a 132% increase from $7.5 million in the prior year, mainly due to higher personnel-related and legal fees General and Administrative Expenses (YoY) | Period | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change | | :--- | :--- | :--- | :--- | | G&A Expenses | 17.4 | 7.5 | +132% | - The increase in G&A expenses was primarily attributable to higher personnel-related costs (including increased employee compensation) and legal fees[7] Net Loss and Earnings Per Share (EPS) Q2 2025 net loss was $41.4 million, or $0.54 per share, a significant increase from the $18.9 million net loss and $0.28 loss per share in the prior year Net Loss and Earnings Per Share (YoY) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Net Loss (Millions USD) | 41.4 | 18.9 | +119% | | Net Loss Per Share (USD) | (0.54) | (0.28) | +93% | About Cretostimogene Grenadenorepvec Cretostimogene is an investigational intravesical oncolytic immunotherapy studied in over 400 NMIBC patients across two Phase III and one Phase II clinical trials, with a North American expanded access program initiated Cretostimogene Product Overview Cretostimogene is an investigational intravesical oncolytic immunotherapy studied in over 400 NMIBC patients across two Phase III and one Phase II clinical trials, with a North American expanded access program initiated - Cretostimogene is an investigational intravesical oncolytic immunotherapy studied in over 400 NMIBC patients[8] - The drug's clinical development program includes two Phase 3 clinical trials (BOND-003 and PIVOT-006) and one Phase 2 trial (CORE-008)[8] - An expanded access program has been initiated in North America for patients unresponsive to BCG[8] About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing potential bladder cancer therapies, aiming to improve the lives of urologic cancer patients through innovative immunotherapies Company Profile CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing potential bladder cancer therapies, aiming to improve the lives of urologic cancer patients through innovative immunotherapies - CG Oncology is a late-stage clinical biopharmaceutical company, focused on developing and commercializing potential bladder cancer therapies[9] - The company's vision is to enable urologic cancer patients to benefit from its innovative immunotherapies, living with dignity and improved quality of life[9] Forward-Looking Statements This press release contains forward-looking statements regarding future expectations, financial condition, clinical trial timelines, regulatory approvals, and potential therapeutic benefits of cretostimogene, subject to inherent business risks and uncertainties Disclaimer and Risks This press release contains forward-looking statements regarding future expectations, financial condition, clinical trial timelines, regulatory approvals, and potential therapeutic benefits of cretostimogene, subject to inherent business risks and uncertainties - This press release contains forward-looking statements regarding the company's cash flow, future operating results, clinical trial timelines, regulatory approvals, and cretostimogene's therapeutic benefits[10] - Actual results may differ from forward-looking statements due to risks such as clinical trial delays, insufficient capital resources, reliance on third parties, and unexpected side effects[11] - Investors are cautioned not to place undue reliance on these statements, and the company undertakes no obligation to update them[11] Financial Statements In Q2 2025, the company reported zero license and collaboration revenue, significantly increased operating expenses, leading to an expanded net loss of $41.4 million Condensed Consolidated Statements of Operations and Comprehensive Loss In Q2 2025, the company reported zero license and collaboration revenue, significantly increased operating expenses, leading to an expanded net loss of $41.4 million Condensed Consolidated Statements of Operations and Comprehensive Loss (Q2 2025 vs Q2 2024) | Metric (Thousands USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | License and collaboration revenue | — | 111 | 52 | 640 | | Research and development expenses | 31,331 | 18,470 | 58,799 | 35,680 | | General and administrative expenses | 17,410 | 7,494 | 32,198 | 13,282 | | Total operating expenses | 48,741 | 25,964 | 90,997 | 48,962 | | Operating loss | (48,741) | (25,853) | (90,945) | (48,322) | | Interest income, net | 7,319 | 6,943 | 15,066 | 12,487 | | Net loss and comprehensive loss | (41,426) | (18,902) | (75,878) | (35,836) | | Net loss per share (basic and diluted) | (0.54) | (0.28) | (1.00) | (0.63) | | Weighted-average common shares outstanding | 76,226,829 | 66,649,443 | 76,207,333 | 56,857,104 | Consolidated Balance Sheet Data As of June 30, 2025, the company reported $661.1 million in cash, cash equivalents, and marketable securities, total assets of $701.4 million, total liabilities of $31.1 million, and total stockholders' equity of $670.4 million Consolidated Balance Sheet Data (As of June 30, 2025 vs December 31, 2024) | Metric (Thousands USD) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | 661,052 | 741,998 | | Total assets | 701,445 | 754,797 | | Total liabilities | 31,087 | 21,420 | | Total stockholders' equity | 670,358 | 733,377 | Contacts Contact information for CG Oncology's media and investor relations is provided Media and Investor Relations Contact information for CG Oncology's media and investor relations is provided - Media Contact: Sarah Connors, Vice President, Communications & Patient Advocacy[12] - Investor Relations Contact: Megan Knight, Vice President, Investor Relations[12]