CG Oncology Q3 2026 net loss widens to $56.9M
CG Oncology anticipates trial data in November and December 2026 and completion of a BLA submission in Q4 2026.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
CG Oncology, Inc. reported third-quarter 2026 revenue of $1.604 million and a net loss of $56.891 million, compared with $1.666 million in revenue and a $43.808 million net loss in the third quarter of 2025. Net loss per share was $(0.64), compared with $(0.57). Research and development expense was $39.221 million versus $27.884 million, while general and administrative expense was $22.963 million versus $23.334 million.
Cash, cash equivalents and marketable securities were $984.458 million as of September 30, 2026, which CG Oncology said is expected to fund operations through 2029. The company anticipates November 2026 topline data from its Phase 3 PIVOT-006 trial and December 2026 12-month data from BOND-003 Cohort P and CORE-008 Cohort CX. Completion of a BLA submission for BCG-unresponsive NMIBC is anticipated in Q4 2026.
CG Oncology appointed Isabel Kalofonos Chief Commercial Officer in October. Cretostimogene remains investigational, and its safety and efficacy have not been established by the FDA or another health authority.
1 point · 0 major0 major · 1 point
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.Cash, cash equivalents and marketable securities of $984.458 million are expected to fund operations through 2029.
Negative
- Moderate pointQuarterly net loss reached $56.891 million, versus $43.808 million in Q3 2025.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Revenue: $1.604 million
Net loss: $56.891 million
Net loss per share, basic and diluted: $(0.64) per share
+4 more
7 metrics
Revenue
$1.604 million
Three months ended September 30, 2026
Net loss
$56.891 million
Three months ended September 30, 2026
Net loss per share, basic and diluted
$(0.64) per share
Three months ended September 30, 2026
Research and development expense
$39.221 million
Three months ended September 30, 2026
General and administrative expense
$22.963 million
Three months ended September 30, 2026
Cash, cash equivalents and marketable securities
$984.458 million
As of September 30, 2026
Weighted average shares of common stock outstanding, basic and diluted
88,871,135 shares
Three months ended September 30, 2026
Key Terms
Non-Muscle Invasive Bladder Cancer (NMIBC), intravesically delivered oncolytic immunotherapy, BLA submission, BCG-unresponsive NMIBC, +1 more
5 terms
Non-Muscle Invasive Bladder Cancer (NMIBC) medical
"Non-Muscle Invasive Bladder Cancer (NMIBC)"
Non-muscle invasive bladder cancer (NMIBC) is a form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it as a superficial patch on wallpaper rather than a stain that has soaked through the wall. It matters to investors because NMIBC often requires repeated treatments and monitoring, drives demand for outpatient therapies and diagnostics, and creates a sizable, ongoing market for drugs, devices, and procedures due to high recurrence and long-term care costs.
intravesically delivered oncolytic immunotherapy medical
"intravesically delivered oncolytic immunotherapy"
BLA submission regulatory
"anticipated completion of our BLA submission"
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.
BCG-unresponsive NMIBC medical
"initial indication of BCG-unresponsive NMIBC"
BCG-unresponsive NMIBC is a form of early-stage bladder cancer that has not responded to standard treatment with bacillus Calmette-Guérin (BCG), a common immune-stimulating therapy used for tumors that have not invaded the bladder muscle. For investors, it matters because these patients represent an unmet medical need and a defined group for clinical trials and regulatory paths; developing an effective therapy for them can open a clear market opportunity, similar to fixing a problem that existing tools can’t solve.
Expanded Access Program regulatory
"initiated an Expanded Access Program for cretostimogene"
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.
Earnings Snapshot
Revenue: $1.604 million · Guidance included
Third quarter of 2026
Revenue
$1.604 million
Compared with $1.666 million in the third quarter of 2025
Research and development expense
$39.221 million
Compared with $27.884 million in the third quarter of 2025
General and administrative expense
$22.963 million
Compared with $23.334 million in the third quarter of 2025
Net loss
$56.891 million
Compared with $43.808 million in the third quarter of 2025
Net loss per share, basic and diluted
$(0.64) per share
Compared with $(0.57) per share in the third quarter of 2025
Guidance
CG Oncology said its cash, cash equivalents and marketable securities as of September 30, 2026 are expected to fund operations through 2029.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were CGON's third-quarter 2026 results?
CG Oncology reported $1.604 million in revenue and a $56.891 million net loss for the third quarter of 2026. In the third quarter of 2025, revenue was $1.666 million and net loss was $43.808 million.
How long is CGON's cash runway?
CG Oncology reported $984.458 million in cash, cash equivalents and marketable securities as of September 30, 2026, and said this balance is expected to fund operations through 2029.
What cretostimogene milestones does CGON anticipate in 2026?
CG Oncology anticipates November topline data from PIVOT-006, a Phase 3 trial in intermediate-risk and high-grade Ta NMIBC. It also anticipates December 12-month data for BOND-003 Cohort P in BCG-unresponsive papillary-only NMIBC and CORE-008 Cohort CX in BCG-exposed HR and BCG-unresponsive NMIBC, plus BLA submission completion in Q4.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________________
FORM 8-K
_____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 06, 2026
_____________________
(Exact name of Registrant as Specified in Its Charter)
_____________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (949 ) 409-3700
N/A
(Former Name or Former Address, if Changed Since Last Report)
_____________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 6, 2026, CG Oncology, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press release, dated November 6, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CG Oncology, Inc. | |||||
| Date: November 6, 2026 | By: /s/ Josh Patterson | ||||
| Name: Josh Patterson | |||||
| Title: General Counsel and Chief Compliance Officer | |||||
Exhibit 99.1
CG Oncology Reports Third Quarter 2026 Financial Results and Provides Business Updates
•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, Texas, November 6, 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 PALSONIFYTM (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.
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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
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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
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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 | |||||||||
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