CG Oncology, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 27 February 2026: press release. Guidance figures: 1 raised, 1 new, 2 kept. The quarter’s numbers.

Key takeaways

Q4 net loss widened year on year: Q4 net loss attributable to common stockholders was $41.3 million, or ($0.52) per share, against $31.8 million, or ($0.46) per share, a year earlier. Source
PIVOT-006 readout pulled forward: PIVOT-006, a Phase 3 trial of cretostimogene in intermediate-risk NMIBC, had its timeline accelerated in January 2026, which the company described as nearly a year ahead of schedule. Source
BOND-003 Cohort P event-free survival rates: At the December 2025 SUO meeting, BOND-003 Cohort P data showed high-grade event-free survival (HG-EFS) of 95.7%, 84.6% and 80.4% at 3, 6 and 9 months. Source
R&D spend rose on trial and headcount costs: Q4 R&D expenses were $30.0 million, up from $26.8 million, with the company citing clinical trial costs including CMC and compensation from higher headcount. Source
Cash rose to $742.2 million: Cash, cash equivalents and marketable securities were $742.2 million at December 31, 2025, up from $680.3 million at September 30, 2025. Source
Runway now into first half of 2029: Management expects existing cash to fund operations into the first half of 2029, up from the first half of 2028 stated in the prior release. Source

“In the coming months, we look forward to sharing topline data from PIVOT-006, the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC.”
Arthur Kuan, Chairman & Chief Executive Officer

Guidance

Area	Period	Figure	Against last quarter
Cash runway Source	Into 2029, from cash as of February 26, 2026	first half of 2029	Raised from first half of 2028
PIVOT-006 Phase 3 topline data Source	First half of 2026	1H’26	New
CORE-008 Cohort CX combination results Source	First half of 2026	first half 2026	Kept
BLA submission Source	2026	completion in 2026	Kept
Durability data Source	2026	durability data in 2026

What changed from last quarter

Guidance raised: Cash runway extended to the first half of 2029 from the first half of 2028. Source
New: PIVOT-006 timeline expedited in January 2026, nearly a year ahead of the schedule the company had set. Source
Guidance kept: BLA completion expected in 2026, the same timing as the prior release. Source
New: Clinical development program described as including more than 600 patients, up from more than 400 in the prior release. Source
New: Christy Rossi, former Chief Operating Officer of Blueprint Medicines, added to the board, announced November 2025. Source

Results and growth drivers

Q4 net loss widened year on year: Q4 net loss attributable to common stockholders was $41.3 million, or ($0.52) per share, against $31.8 million, or ($0.46) per share, a year earlier. Source
Full-year net loss reached $161.0 million: Full-year 2025 net loss attributable to common stockholders was $161.0 million, or ($2.08) per share, compared with $88.0 million, or ($1.41) per share, for 2024. Source
Interest income narrowed the loss gap: Net interest income was $29.9 million in 2025 against $26.6 million in 2024, narrowing the gap between the $190.8 million operating loss and the net loss. Source

Clinical programs and data

PIVOT-006 readout pulled forward: PIVOT-006, a Phase 3 trial of cretostimogene in intermediate-risk NMIBC, had its timeline accelerated in January 2026, which the company described as nearly a year ahead of schedule. Source
BOND-003 Cohort P event-free survival rates: At the December 2025 SUO meeting, BOND-003 Cohort P data showed high-grade event-free survival (HG-EFS) of 95.7%, 84.6% and 80.4% at 3, 6 and 9 months. Source
CORE-008 Cohort A complete response: CORE-008 Cohort A, in HR BCG-naive NMIBC, showed an 88% complete response (CR) rate in data reported in December 2025. Source

“With cretostimogene’s unique best-in-disease profile, we remain laser-focused on advancing a comprehensive strategy designed to support an optimized product label and ensure success across additional indications - positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients”
Arthur Kuan, Chairman & Chief Executive Officer

Product and regulatory status

Cretostimogene remains investigational: Cretostimogene is an investigational candidate; the company states its safety and efficacy have not been established by the FDA or any other health authority. Source
Expanded access program in North America: An Expanded Access Program for cretostimogene in North America covers patients unresponsive to BCG who meet program eligibility requirements. Source
Two Phase 3 trials in the program: The program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. Source

Operating costs

R&D spend rose on trial and headcount costs: Q4 R&D expenses were $30.0 million, up from $26.8 million, with the company citing clinical trial costs including CMC and compensation from higher headcount. Source
Q4 G&A rose year on year: Q4 G&A expenses were $18.0 million against $11.7 million a year earlier; the company cited personnel costs, professional fees and marketing-related costs. Source
Full-year G&A more than doubled: Full-year 2025 G&A expenses were $73.5 million, compared with $33.7 million for 2024. Source

Cash, financing and runway

Cash rose to $742.2 million: Cash, cash equivalents and marketable securities were $742.2 million at December 31, 2025, up from $680.3 million at September 30, 2025. Source
At-the-market sales lifted cash: January 2026 at-the-market sales raised about $188.0 million from 3,623,101 shares, bringing the balance to about $903.0 million as of February 26, 2026; Q4 ATM proceeds were about $98.4 million. Source
Runway now into first half of 2029: Management expects existing cash to fund operations into the first half of 2029, up from the first half of 2028 stated in the prior release. Source

Strategy and governance

Multi-cohort Phase 2 program: CORE-008 is a multi-cohort Phase 2 trial evaluating cretostimogene's safety and efficacy in high-risk NMIBC. Source
Focus on bladder-sparing backbone therapy: The company describes itself as focused on a potential backbone bladder-sparing therapeutic for patients with bladder cancer. Source
Board adds commercial launch executive: Christy Rossi, former Chief Operating Officer of Blueprint Medicines, was added to the board; the company cites her experience building commercial organizations and launching medicines. Source

Upcoming milestones

CORE-008 Cohort CX results due: First CORE-008 Cohort CX results from the cretostimogene and gemcitabine combination are expected in the coming quarter. Source
BLA completion expected in 2026: Completion of the BLA for the initial indication is expected in 2026. Source
Durability data listed for 2026: Durability data for BOND-003 Cohort C, Cohort P and CORE-008 Cohort A are listed for 2026. Source

Coming up, as management said on 27 February 2026

CORE-008 Cohort CX results coming: Management expects to share first CORE-008 Cohort CX results from the combination with gemcitabine in the coming quarter. Source
PIVOT-006 topline due first half 2026: Phase 3 topline data from PIVOT-006 are expected in the first half of 2026. Source
BLA completion expected in 2026: Completion of the BLA submission for the initial indication is expected in 2026. Source
Durability data expected in 2026: Durability data for BOND-003 Cohort C, Cohort P and CORE-008 Cohort A are listed for 2026. Source

Figures management reported

Figure	Reported
R&D expense, full year 2025 Source	$116.6 million
R&D expense, Q4 2025 Source	$30.0 million
Commercial and development revenue, 2025 Source	$3,234 thousand
PIVOT-006 Phase 3 topline data Source	Expected 1H 2026
BOND-003 Cohort P HG-EFS at 9 months Source	80.4%
CORE-008 Cohort A complete response Source	88% CR
BLA submission milestone Source	Completion expected in 2026

Earlier plans management reported on

Ahead: Management said the PIVOT-006 timeline was expedited in January 2026, nearly a year ahead of schedule. Source
Ahead: The prior release said enrollment in PIVOT-006 was completed approximately 10 months ahead of schedule.
Not stated: The prior release said more data would be shared before year-end; the February release reports Cohort P and Cohort A data presented at SUO in December 2025.
Not stated: Rolling BLA submission was initiated; the prior release expected complete submission in 2026.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

CG Oncology Reports 2025 Year End Financial Results and Provides Business Updates

PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC expected first half 2026

CORE-008 Cohort CX Phase 2 first results of combination cretostimogene with gemcitabine in high-risk (HR) NMIBC expected first half 2026

Well-positioned to deliver on key milestones with approximately $903.0 million cash, cash equivalents and marketable securities sufficient to fund operations into the first half of 2029

IRVINE, Calif., February 27, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the fourth quarter and year ended December 31, 2025, and provided business updates.

“In the coming months, we look forward to sharing topline data from PIVOT-006, the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC. We believe we have the opportunity to set the new standard in intermediate-risk NMIBC. I am extremely proud of our team for planning, enrolling and executing this important trial in record time. With cretostimogene’s unique best-in-disease profile, we remain laser-focused on advancing a comprehensive strategy designed to support an optimized product label and ensure success across additional indications - positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “We are also looking forward to sharing results from CORE-008 Cohort CX in high-risk BCG exposed from our first trial evaluating the combination of cretostimogene with gemcitabine in the coming quarter.”

Corporate Highlights

Updated timeline for Phase 3 topline data from PIVOT-006 clinical trial evaluating cretostimogene as an adjuvant therapy in intermediate-risk NMIBC. In January 2026, the Company announced an expedited timeline for PIVOT-006, nearly a year ahead of schedule underscoring the excitement for cretostimogene and the significant unmet need in intermediate-risk NMIBC. PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines including HG Ta solitary lesions ≤ 3cm.

Presented Late-Breaking Abstracts at the Society of Urologic Oncology (SUO) 26th Annual Meeting in December 2025. Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 disease in BOND-003 Cohort P. CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety.

Strengthened Board of Directors with the addition of life-science executive Christina Rossi. In November 2025, the Company announced the addition of Christy Rossi, former Chief Operating Officer of Blueprint Medicines, to its board. Christy brings robust expertise in building high-performing commercial organizations, launching new medicines, and delivering impactful programs to HCPs and most importantly to patients.

Anticipated 2026 Milestones

PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data in 1H’26

CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC): First results from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26

Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 2026

BOND-003 Cohort C (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data in 2026

Fourth Quarter and Year End Financial Highlights

Cash Position: Cash and cash equivalents and marketable securities as of December 31, 2025, were $742.2 million, compared with $680.3 million as of September 30, 2025. The December 31, 2025 cash includes net proceeds of approximately $98.4 million from a total of 2,343,967 shares sold through the Company’s at-the-market (ATM) facility in Q4 based on reverse inquiries from existing and new, high-quality funds.

In addition, net proceeds of approximately $188.0 million was raised from a total of 3,623,101 shares sold in January 2026 through the Company’s ATM facility, resulting in a cash, cash equivalents, and marketable securities balance as of February 26, 2026 of approximately $903.0 million. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations into the first half of 2029.

Research and Development (R&D) Expenses: R&D expenses were $30.0 million for the fourth quarter of 2025, as compared to $26.8 million for the prior year period. 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. For the full year 2025, R&D expenses were $116.6 million, which compares to $82.1 million for the full year 2024.

General and Administrative (G&A) Expenses: G&A expenses were $18.0 million for the fourth quarter of 2025, as compared to $11.7 million for the prior year period. 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 marketing-related costs. For the full year 2025, G&A expenses were $73.5 million, which compares to $33.7 million for the full year 2024.

Net Loss: Net loss attributable to common stockholders was $41.3 million, or ($0.52) per share, for the fourth quarter of 2025, as compared to $31.8 million, or ($0.46) per share, for the prior year period. For the full year 2025, net loss attributable to common stockholders was $161.0 million, or ($2.08) per share, as compared to $88.0 million, or ($1.41) per share, for the full year 2024.

About Cretostimogene Grenadenorepvec

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational 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

Forward-looking statements notice

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; the timing and likelihood of regulatory filings and approvals for cretostimogene; the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and that cretostimogene has a best-in-disease product profile. 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.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

	Year Ended December 31,
	2025	2024
	(unaudited)
Revenues
Commercial and development revenue	$3,234	$ -
License and collaboration revenue	806	1,139
Total revenues	4,040	1,139
Operating costs and expenses
Cost of sales	4,647	-
Research and development	116,641	82,102
General and administrative	73,526	33,703
Total operating costs and expenses	194,814	115,805
Loss from operations	(190,774)	(114,666)
Other income (expense), net:
Interest income, net	29,931	26,624
Other (expense) income, net	(152)	3
Total other income, net	29,779	26,627
Net loss and comprehensive loss	$(160,995)	$(88,039)
Net loss per share, basic and diluted	$(2.08)	$(1.41)
Weighted average shares of common stock outstanding, basic and diluted	77,303,440	62,496,725

CG Oncology, Inc.

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

	December 31,	December 31,
	2025	2024
	(unaudited)
Cash, cash equivalents, and marketable securities	$742,155	$741,998
Total assets	791,592	754,797
Total liabilities	38,990	21,420
Total stockholders' equity	752,602	733,377

Contacts
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology sarah.connors@cgoncology.com
Megan Knight
Vice President, Investor Relations, CG Oncology megan.knight@cgoncology.com
CG Oncology, Inc.