CG Oncology Reports Third Quarter 2026 Financial Results and Provides Business Updates

Expected clinical readouts and application completion approach as quarterly research spending rises and losses widen.

Rhea-AI Summary

CG Oncology (NASDAQ: CGON) reported a wider third-quarter net loss as research and development spending increased from the prior-year period. Net loss was $56.9 million, or $0.64 per share, versus $43.8 million, or $0.57 per share. Revenue declined to $1.604 million from $1.666 million. Research and development expenses rose to $39.2 million, while general and administrative expenses fell to $23.0 million.

The company anticipates PIVOT-006 Phase 3 topline data in November 2026, 12-month data from CORE-008 Cohort CX and BOND-003 Cohort P in December, and completion of its initial cretostimogene biologics license application in Q4 2026. The application targets BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary disease. Cash and securities totaled $984.5 million at September 30, down from $1.0 billion at June 30; the company expects funding to last through 2029.

10 points · 0 major

MixediHow this balance works

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0 major · 14 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.CG Oncology expects $984.5 million in cash and securities to fund operations through 2029.
• Moderate point. Forward-looking: it has not happened yet and may not happen.PIVOT-006 Phase 3 topline data are anticipated in November 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CORE-008 Cohort CX 12-month data are anticipated in December 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.BOND-003 Cohort P 12-month data are anticipated in December 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Initial cretostimogene biologics license application completion is anticipated in Q4 2026.

5 minor points

• Minor pointThird-quarter general and administrative expenses decreased to $22.963 million from $23.334 million a year earlier.
• Minor pointNine-month revenue increased to $3.844 million from $1.718 million a year earlier.
• Minor pointCash and securities increased to $984.458 million from $742.155 million at December 31, 2025.
• Minor pointTotal assets increased to $1,046.670 million from $791.592 million at December 31, 2025.
• Minor pointStockholders' equity increased to $990.966 million from $752.602 million at December 31, 2025.

Negative

• Moderate pointThird-quarter net loss widened to $56.9 million, or $0.64 per share, from $43.8 million, or $0.57.
• Moderate pointThird-quarter research and development expenses rose to $39.221 million from $27.884 million a year earlier.
• Moderate pointThird-quarter operating loss widened to $63.249 million from $51.129 million a year earlier.
• Minor pointThird-quarter revenue decreased to $1.604 million from $1.666 million a year earlier.
• Minor pointThird-quarter cost of sales increased to $2.669 million from $1.577 million a year earlier.

9 minor points

• Minor pointThird-quarter net interest income declined to $6.423 million from $7.421 million a year earlier.
• Minor pointCash and securities declined to $984.5 million at September 30, 2026, from $1.0 billion at June 30.
• Minor pointNine-month net loss widened to $196.149 million, or $2.25 per share, from $119.686 million, or $1.57.
• Minor pointNine-month research and development expenses rose to $137.608 million from $86.683 million a year earlier.
• Minor pointNine-month general and administrative expenses increased to $72.719 million from $55.532 million a year earlier.
• Minor pointNine-month cost of sales increased to $9.556 million from $1.577 million a year earlier.
• Minor pointNine-month operating loss widened to $216.039 million from $142.074 million a year earlier.
• Minor pointNine-month net interest income declined to $20.040 million from $22.487 million a year earlier.
• Minor pointTotal liabilities increased to $55.704 million from $38.990 million at December 31, 2025.

Key Figures

Cash and runway: $984.5 million; through 2029 R&D expenses: $39.2 million vs. $27.9 million G&A expenses: $23.0 million vs. $23.3 million +5 more

Cash and runway

$984.5 million; through 2029

As of September 30, 2026; company stated funds were sufficient for operations through 2029

R&D expenses

$39.2 million vs. $27.9 million

Third quarter 2026 vs. prior-year period

G&A expenses

$23.0 million vs. $23.3 million

Third quarter 2026 vs. prior-year period

Net loss

$56.9 million vs. $43.8 million

Third quarter 2026 vs. prior-year period

Net loss per share

$(0.64) vs. $(0.57)

Third quarter 2026 vs. prior-year period

PIVOT-006 topline data

November 2026

Phase 3 trial

12-month cohort data

December 2026

CORE-008 Cohort CX and BOND-003 Cohort P

BLA completion

Q4 2026

Initial indication of BCG-unresponsive NMIBC with CIS, with or without papillary disease

Previous Earnings Reports

1 past event · Latest: Aug 06

Same Type 1 event

1. Aug 06

   Quarterly earnings

   24h Move

   +3.4%

   Prior-quarter report showed a $79.1 million net loss and expected funding operations through 2029.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

nmibc, oncolytic immunotherapy, intravesically delivered, expanded access program, +1 more

5 terms

nmibc medical

"BOND-003 for BCG-unresponsive NMIBC"

A common form of bladder cancer that stays confined to the bladder’s inner lining or the layer just below it and has not grown into the deeper muscle wall. It matters to investors because it often requires repeated procedures, ongoing surveillance and long-term treatments, creating a sizable and stable market for diagnostics, drugs and medical devices; think of it like a surface-level problem that needs frequent check-ups and follow-up care rather than a one-time fix.

oncolytic immunotherapy medical

"an investigational, intravesically delivered oncolytic immunotherapy"

A type of cancer treatment that uses specially engineered viruses to infect and destroy tumor cells while also stimulating the patient’s immune system to recognize and attack cancer elsewhere—think of the virus as a guided seed that both blows up weeds and trains a gardening robot to find the rest. For investors, progress or setbacks in trials and approvals can sharply change a company’s value because outcomes tend to be binary (successful approval or failure) and can open large, high-value markets if effective.

intravesically delivered medical

"an investigational, intravesically delivered oncolytic immunotherapy"

Delivered directly into the urinary bladder through a catheter or similar instillation method so the active drug or therapy makes local contact with the bladder lining (urothelium). This route is used to concentrate treatment at the bladder while limiting systemic exposure; it requires access to the bladder (usually via urethral catheterization) and generally produces local rather than primarily systemic effects.

expanded access program regulatory

"initiated an Expanded Access Program for cretostimogene in North America"

A program that allows patients with serious or life‑threatening conditions to receive an experimental drug or therapy before it is fully approved by regulators, when they cannot join clinical trials. Investors care because expanded access can change a treatment’s market perception, create early real‑world safety or demand signals, and affect regulatory timelines and potential revenue — like a pre‑order system that also reveals how the product performs outside controlled testing.

breakthrough therapy designation regulatory

"received FDA Fast Track and Breakthrough Therapy designations"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk and high-grade Ta NMIBC anticipated November 2026
• BOND-003 Cohort P and CORE-008 Cohort CX 12-month data anticipated December 2026
• BLA completion for BCG-unresponsive NMIBC anticipated Q4 2026
• Well-positioned to deliver on key milestones with approximately $984.5 million of cash, cash equivalents and marketable securities sufficient to fund operations through 2029
  
  

DALLAS, Nov. 06, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the third quarter ended September 30, 2026, and provided business updates.

“We are entering an eventful period for CG Oncology as we look forward to sharing PIVOT-006 topline data this month. As a reminder, PIVOT-006 is the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC. Additionally, we expect to have 12-month data from both CORE-008 Cohort CX and BOND-003 Cohort P in December, which further strengthens the growing body of evidence for cretostimogene across the NMIBC landscape and supports our goal to address the broadest number of patients. We remain confident in cretostimogene’s potential to become a backbone therapy for patients and to create long-term value for shareholders,” stated Arthur Kuan, Chairman, President & Chief Executive Officer at CG Oncology.

Corporate Highlights

• Strengthened Executive Leadership Team with the addition of life-science executive Isabel Kalofonos as Chief Commercial Officer
  • In October, the Company appointed Isabel Kalofonos as Chief Commercial Officer. Ms. Kalofonos brings more than 20 years of experience driving successful launches including PALSONIFY^TM (paltusotine) and ELAHERE® (mirvetuximab soravtansine) through strong commercial execution, helping bring innovative therapies to patients at scale across the biotechnology and pharmaceutical industries.

Anticipated 2026 Milestones

• PIVOT-006 (intermediate-risk and high-grade Ta ≤ 3cm NMIBC): Phase 3 topline data November 2026
• CORE-008 Cohort CX (BCG-exposed HR and BCG-unresponsive NMIBC) 12-month data December 2026
• BOND-003 Cohort P (BCG-unresponsive papillary only NMIBC) 12-month data December 2026
• Completion of BLA submission in initial indication of BCG-unresponsive NMIBC with CIS with or without papillary disease Q4 2026
  
  

Third Quarter Financial Highlights

• Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2026 were $984.5 million, compared with $1.0 billion as of June 30, 2026.  The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029.
  
• Research and Development (R&D) Expenses: R&D expenses were $39.2 million for the third quarter of 2026, as compared to $27.9 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.
  
• General and Administrative (G&A) Expenses: G&A expenses were $23.0 million for the third quarter of 2026, as compared to $23.3 million for the prior year period. The decrease was primarily due to a decrease in professional and consultant fees, partially offset by an increase in personnel-related expenses, including compensation costs from increased headcount, and an increase in other general G&A expenses.
  
• Net Loss: Net loss was $56.9 million, or $(0.64) per share, for the third quarter of 2026, as compared to a net loss of $43.8 million, or $(0.57) per share, for the prior year period.
  
  

About Cretostimogene Grenadenorepvec

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 700 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk and high-grade Ta ≤ 3cm NMIBC. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC. CG Oncology also has a multi-cohort trial, CORE-008, evaluating the safety and efficacy of cretostimogene in BCG-exposed HR and BCG-unresponsive 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

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; our future results of operations and financial position; the timing, progress, conduct and completion of our ongoing and planned clinical trials and preclinical studies of cretostimogene; the timing, availability, announcement, presentation and results of clinical data, including topline data from PIVOT-006 and 12-month data from BOND-003 Cohort P and CORE-008 Cohort CX; anticipated milestones in our development pipeline; the timing, completion, acceptance, review and outcome of regulatory filings and submissions for cretostimogene, including the anticipated completion of our BLA submission for BCG-unresponsive NMIBC; the timing or likelihood of regulatory approvals and the scope of any approved indication or product label; the potential safety, efficacy, therapeutic benefits, clinical utility, commercial potential and market opportunity of cretostimogene for patients with BCG-unresponsive, BCG-exposed, intermediate-risk and high-grade Ta NMIBC; and the potential for cretostimogene to address a broad range of NMIBC patients or become a backbone therapy. 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: topline, preliminary, interim or 12-month clinical-trial results may not be complete, may differ from final results, may not be confirmed upon full analysis of the data, and may not predict future or longer-term results; data from one trial, patient population, cohort or time point may not be predictive of results from other trials, populations, cohorts or time points; potential delays in the commencement, enrollment, conduct or completion of clinical trials, including the BOND-003, PIVOT-006 and CORE-008 trials; potential delays in the completion, submission, acceptance or review of our BLA, and the possibility that the FDA may not approve cretostimogene on the anticipated timeline, for the anticipated indication or label, or at all; we may use our capital resources sooner than expected, and our existing capital resources may be insufficient to achieve our anticipated milestones or fund operations for the period anticipated; our cash-runway estimates are based on assumptions regarding our current operating plans, expenses and capital requirements that may prove to be incorrect or may change; our dependence on third parties in connection with manufacturing, shipping, clinical and preclinical testing activities; results from earlier clinical trials and preclinical studies may not be predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene may limit or prevent its development, regulatory approval or commercialization; we may be unable to successfully develop, obtain approval for, manufacture or commercialize cretostimogene; 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
Vice President, Communications and Patient Advocacy, CG Oncology
sarah.connors@cgoncology.com

Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
megan.knight@cgoncology.com

CG ONCOLOGY, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
			2026				2025				2026				2025
Revenues
Commercial and development revenue		$	1,604			$	1,508			$	3,820			$	1,508
License and collaboration revenue			—				158				24				210
Total revenues			1,604				1,666				3,844				1,718
Operating costs and expenses
Cost of sales			2,669				1,577				9,556				1,577
Research and development			39,221				27,884				137,608				86,683
General and administrative			22,963				23,334				72,719				55,532
Total operating costs and expenses			64,853				52,795				219,883				143,792
Loss from operations			(63,249	)			(51,129	)			(216,039	)			(142,074	)
Other income (expense), net
Interest income, net			6,423				7,421				20,040				22,487
Other (expense) income, net			(65	)			(100	)			(150	)			(99	)
Total other income, net			6,358				7,321				19,890				22,388
Net loss and comprehensive loss		$	(56,891	)		$	(43,808	)		$	(196,149	)		$	(119,686	)
Net loss per share, basic and diluted		$	(0.64	)		$	(0.57	)		$	(2.25	)		$	(1.57	)
Weighted average shares of common stock outstanding, basic and diluted			88,871,135				76,729,726				87,212,504				76,383,376

CG ONCOLOGY, INC. Consolidated Balance Sheet Data (In thousands)
	September 30, 2026			December 31, 2025
	(unaudited)
Cash, cash equivalents, and marketable securities	$	984,458		$	742,155
Total assets		1,046,670			791,592
Total liabilities		55,704			38,990
Total stockholders' equity		990,966			752,602

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does CG Oncology expect its next cretostimogene clinical data?

CG Oncology anticipates PIVOT-006 Phase 3 topline data in November 2026 and 12-month data from CORE-008 Cohort CX and BOND-003 Cohort P in December 2026. PIVOT-006 evaluates intermediate-risk and high-grade Ta non-muscle invasive bladder cancer with tumors ≤3 cm.

How long does CG Oncology expect its cash to fund operations?

CG Oncology expects its $984.5 million of cash, cash equivalents and marketable securities at September 30, 2026, to fund operations through 2029.

Why did CG Oncology's third-quarter 2026 research and development expenses increase?

Research and development expenses increased primarily because of higher clinical trial expenses, including CMC costs, and higher compensation costs from increased headcount. Expenses totaled $39.2 million, compared with $27.9 million in the prior-year quarter.