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

Rhea-AI Summary

CG Oncology (NASDAQ: CGON) reported year-end 2025 results and pipeline timing updates on Feb 27, 2026. The company holds approximately $903.0 million in cash, cash equivalents and marketable securities as of Feb 26, 2026, expected to fund operations into the first half of 2029.

Key clinical milestones include Phase 3 PIVOT-006 topline data and CORE-008 Cohort CX first combination results, both expected 1H 2026. 2025 operating metrics showed higher R&D and G&A spend and a wider net loss versus 2024.

Positive

• Cash, equivalents and marketable securities of $903.0M (as of Feb 26, 2026)
• PIVOT-006 Phase 3 topline data expected in 1H 2026
• CORE-008 Cohort CX combination results expected in 1H 2026
• R&D investment increased to $116.6M in 2025 supporting trials

Negative

• Net loss widened to $161.0M in 2025 from $88.0M in 2024
• G&A expenses doubled to $73.5M in 2025 versus $33.7M
• ATM share sales raised proceeds (~$286.4M), causing shareholder dilution

Key Figures

Cash & securities: $903.0 million Cash & securities: $742.2 million Cash & securities: $680.3 million +5 more

8 metrics

Cash & securities $903.0 million Cash, cash equivalents and marketable securities as of Feb 26, 2026

Cash & securities $742.2 million As of December 31, 2025

Cash & securities $680.3 million As of September 30, 2025

ATM proceeds Q4 2025 $98.4 million Net proceeds from 2,343,967 shares sold via ATM in Q4 2025

ATM proceeds Jan 2026 $188.0 million Net proceeds from 3,623,101 shares sold via ATM in Jan 2026

R&D expenses Q4 2025 $30.0 million Research and Development, quarter ended December 31, 2025

R&D expenses 2025 $116.6 million Full year 2025 vs $82.1 million in 2024

Net loss 2025 $161.0 million ($2.08/share) Full year 2025 vs $88.0 million ($1.41/share) in 2024

Market Reality Check

Price: $56.11 Vol: Volume 732,643 is slightl...

normal vol

$56.11 Last Close

Volume Volume 732,643 is slightly below 20-day average 799,331 ahead of the earnings release. normal

Technical Shares trade above the 200-day MA at $36.91, reflecting a sustained uptrend into results.

Peers on Argus

CGON is down 1.54% while peers show mixed moves: TARS +3.78%, CELC +2.95%, LQDA ...

CGON is down 1.54% while peers show mixed moves: TARS +3.78%, CELC +2.95%, LQDA +1.55%, FOLD -0.07%, IBRX -3.63%. This points to stock-specific trading around CGON’s update rather than a uniform biotech move.

Previous Earnings Reports

5 past events · Latest: Nov 14 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 14	Q3 2025 earnings	Positive	+8.6%	Reported Q3 results, BLA progress, and cash of <b>$680.3M</b> funding into H1 2028.
Aug 08	Q2 2025 earnings	Positive	+2.0%	Strong BOND‑003 durability data, favorable legal verdict, and cash of <b>$661.1M</b>.
May 13	Q1 2025 earnings	Neutral	-3.9%	Q1 results with promising BOND‑003 data and higher R&D and G&A expenses.
Mar 28	2024 year-end results	Positive	-1.9%	2024 progress, <b>$742.0M</b> cash, higher expenses and net loss of <b>$88.0M</b>.
Nov 12	Q3 2024 earnings	Neutral	-6.8%	Q3 2024 loss of <b>$20.4M</b> with cash of <b>$540.7M</b> and rising R&D and G&A.

Pattern Detected

Earnings updates have generally led to modest moves, with a slightly negative average reaction despite consistently strong cash runway and clinical progress.

Recent Company History

Over the last year, CG Oncology’s earnings-related updates have emphasized cretostimogene’s advancing clinical profile and a strengthening balance sheet. Prior releases highlighted BLA progress in high-risk BCG‑unresponsive NMIBC, early completion of PIVOT‑006 enrollment, and cash positions between $540.7M and $742.0M, expected to fund operations into H1 2028. Price reactions around these events were mixed, with several positive moves but also notable selloffs, suggesting investors have alternated between rewarding milestones and fading strength after good news. Today’s full‑year 2025 update continues that pattern of strong funding and clinical momentum.

Historical Comparison

-0.4% avg move · Across five prior earnings updates, CGON’s average move was -0.4%, with mixed reactions to similar c...

earnings

-0.4%

Average Historical Move earnings

Across five prior earnings updates, CGON’s average move was -0.4%, with mixed reactions to similar cash-runway and clinical-progress messages. Today’s trading fits that historically modest, often cautious pattern.

Earnings updates have tracked a steady build: growing cash from $540.7M to $742.0M, runway into H1 2028, and advancing cretostimogene toward BLA completion and pivotal readouts. The current release extends that funding horizon and clinical visibility.

Market Pulse Summary

This announcement combines full-year 2025 financials with a detailed roadmap of 2026 catalysts, incl...

Analysis

This announcement combines full-year 2025 financials with a detailed roadmap of 2026 catalysts, including Phase 3 PIVOT‑006 topline data and CORE‑008 results, plus plans to complete a BLA in high‑risk NMIBC. Cash, cash equivalents and marketable securities of $903.0M are expected to fund operations into H1 2029, offset by rising R&D and G&A expenses and a $161.0M annual net loss. Investors may watch upcoming readouts, BLA progress, and any further ATM usage as key drivers of future risk–reward.

Key Terms

bla submission, at-the-market (atm) facility, phase 3, phase 2, +4 more

8 terms

bla submission regulatory

"Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC..."

A BLA submission is a company’s formal application to the U.S. Food and Drug Administration asking for permission to market a biologic drug or therapy. Think of it like applying for a permit to sell a complex medical product: the agency reviews safety, effectiveness, and manufacturing quality before deciding. For investors, a BLA filing signals a late-stage regulatory milestone that can reduce uncertainty and, if approved, unlock revenue and change a company’s valuation, while also carrying regulatory and timing risk.

at-the-market (atm) facility financial

"shares sold through the Company’s at-the-market (ATM) facility in Q4..."

An at-the-market (ATM) facility is a program that lets a company sell newly issued shares directly into the open market at current prices through a broker, rather than selling a large block all at once. For investors, it matters because it gives the company a flexible, usually faster way to raise cash when needed, but it can slowly reduce each existing shareholder’s ownership and earnings per share as new shares are added over time—like drip-feeding new product into a crowded marketplace.

phase 3 medical

"PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 2 medical

"CORE-008 Cohort CX Phase 2 first results of combination cretostimogene..."

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

nmibc medical

"intermediate-risk NMIBC expected first half 2026..."

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.

cis medical

"HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 2026..."

Cis is a descriptor from chemistry meaning two parts of a molecule sit on the same side of a bond or ring, like two passengers sitting on the same side of a seesaw. That arrangement can change a drug’s shape, how it behaves in the body, and whether regulators approve it or competitors can patent it. Investors watch “cis” versus “trans” forms because those small structural differences can affect safety, effectiveness, manufacturing and commercial value.

high-grade event-free survival medical

"Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6%..."

High-grade event-free survival measures how long patients with an aggressive or severe form of a disease remain alive without a predefined negative outcome — such as disease progression, relapse, or treatment-related complications. For investors, it’s a key clinical metric showing whether a therapy meaningfully delays bad outcomes in the toughest cases; stronger results can increase the chances of regulatory approval, wider use, and commercial value. Think of it like the length of time a high-performance car runs trouble-free after a major repair.

complete response medical

"CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR..."

A complete response is a positive outcome in which a company’s efforts to address issues or questions fully resolve the problem, often meaning that no further action or investigation is needed. For investors, it signals that concerns have been thoroughly addressed, which can boost confidence in the company's stability or decision-making. Think of it like a doctor fully treating an illness, leaving no remaining symptoms.

AI-generated analysis. Not financial advice.

• 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., Feb. 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
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.

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. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts)
	Year Ended December 31,
	2025				2024
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
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

FAQ

When will CGON report PIVOT-006 Phase 3 topline data and what is its focus?

PIVOT-006 topline data is expected in 1H 2026, targeting adjuvant therapy in intermediate-risk NMIBC. According to the company, PIVOT-006 is the first randomized registrational trial in intermediate-risk NMIBC and includes a broad range of patient types per AUA/SUO guidelines.

What does CGON say about CORE-008 Cohort CX timing and its treatment combination (CGON)?

First results from CORE-008 Cohort CX are expected in 1H 2026, assessing cretostimogene plus gemcitabine. According to the company, this is the first trial evaluating that combination in high-risk, BCG-exposed or BCG-unresponsive NMIBC.

How much cash does CGON have and how long will it fund operations (CGON)?

CGON reports approximately $903.0 million in cash, equivalents and marketable securities as of Feb 26, 2026. According to the company, this balance is sufficient to fund operations into the first half of 2029.

How did CGON’s operating expenses and net loss change in 2025 compared to 2024?

Net loss increased to $161.0M in 2025 from $88.0M in 2024, while R&D rose to $116.6M and G&A to $73.5M. According to the company, higher clinical, CMC and personnel costs drove the increases.

What recent financing did CGON complete and how were proceeds raised (CGON)?

CGON raised net proceeds of roughly $98.4M in Q4 2025 and ~$188.0M in Jan 2026 via its ATM facility. According to the company, these ATM sales increased cash to about $903.0M as of Feb 26, 2026.