CG Oncology, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>CG Oncology, Inc. has filed its 2023 annual report, detailing its financial and operational status.</b>

AI Summary

CG Oncology, Inc. (CGON) filed a Annual Report (10-K) with the SEC on March 26, 2024. CG Oncology, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Delaware and has its principal executive offices in Irvine, California. CGON is traded on The Nasdaq Global Select Market. The company is classified as a non-accelerated filer and an emerging growth company. CG Oncology, Inc. has submitted all required reports for the preceding 12 months and has been subject to filing requirements for the past 90 days.

Why It Matters

For investors and stakeholders tracking CG Oncology, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of CG Oncology's business, financial condition, and risk factors for the fiscal year 2023, crucial for investors to assess the company's performance and outlook. As an emerging growth company and a non-accelerated filer, CG Oncology's reporting may differ from larger, more established companies, impacting how investors interpret its disclosures.

Risk Assessment

Risk Level: low — CG Oncology, Inc. shows low risk based on this filing. The filing is a standard 10-K annual report, which typically contains routine disclosures and does not indicate any immediate or significant new risks.

Analyst Insight

Investors should review the full 10-K filing for detailed financial statements, risk factors, and management's discussion and analysis to form an informed investment decision.

Key Numbers

• 20231231 — Fiscal Year End (Reported fiscal year end)
• 20240326 — Filing Date (Date the 10-K was filed)
• 001-41925 — Commission File Number (SEC Commission File Number)
• CGON — Trading Symbol (Stock ticker symbol)

Key Players & Entities

• CG Oncology, Inc. (company) — Filer name
• CGON (company) — Trading Symbol
• Nasdaq Global Select Market (company) — Exchange where securities are registered
• Delaware (company) — State of incorporation
• Irvine, CA (company) — Principal executive offices location
• 20231231 (dollar_amount) — Fiscal year end
• 001-41925 (dollar_amount) — Commission File Number
• 37-1611499 (dollar_amount) — IRS Employer Identification No.

FAQ

Industry Context

CG Oncology, Inc. operates in the biotechnology sector, focusing on the development of novel cancer therapies.

Regulatory Implications

The filing is made under the Securities Exchange Act of 1934, requiring annual reports from public companies.

What Investors Should Do

1. Review the full 10-K for detailed financial performance and operational highlights.
2. Analyze the risk factors section for potential challenges and uncertainties.
3. Assess management's discussion and analysis for strategic insights and future outlook.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-26: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the initial 10-K filing for CG Oncology, Inc. as a public company, covering the fiscal year ended December 31, 2023.

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share CGON The Nasdaq
• $1.5 b — tes of the registrant was approximately $1.5 billion, based on the closing price of th
• $37.26 — k on the Nasdaq Global Select Market of $37.26 per share. The registrant has elected t

Filing Documents

• cgon_10k_2023_1231.htm (10-K) — 2665KB
• ck0001991792-ex4_3.htm (EX-4.3) — 30KB
• ck0001991792-ex23_1.htm (EX-23.1) — 9KB
• ck0001991792-ex31_1.htm (EX-31.1) — 13KB
• ck0001991792-ex31_2.htm (EX-31.2) — 12KB
• ck0001991792-ex32_1.htm (EX-32.1) — 9KB
• ck0001991792-ex32_2.htm (EX-32.2) — 9KB
• img12121904_0.jpg (GRAPHIC) — 703KB
• img12121904_1.jpg (GRAPHIC) — 603KB
• img12121904_2.jpg (GRAPHIC) — 553KB
• img12121904_3.jpg (GRAPHIC) — 874KB
• img12121904_4.jpg (GRAPHIC) — 827KB
• img12121904_5.jpg (GRAPHIC) — 400KB
• img12121904_6.jpg (GRAPHIC) — 1035KB
• img12121904_7.jpg (GRAPHIC) — 594KB
• img12121904_8.jpg (GRAPHIC) — 188KB
• img12121904_9.jpg (GRAPHIC) — 730KB
• img12121904_10.jpg (GRAPHIC) — 1411KB
• img12121904_11.jpg (GRAPHIC) — 836KB
• 0000950170-24-036143.txt (&nbsp;) — 14343KB

Business

Business 2 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 89 Item 1C. Cybersecurity 89 Item 2.

Properties

Properties 90 Item 3.

Legal Proceedings

Legal Proceedings 90 Item 4. Mine Safety Disclosures 90 PART II Item 5. Market for Registrant&#x2019;s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 91 Item 6. [Reserved] 92 Item 7. Management&#x2019;s Discussion and Analysis of Financial Condition and Results of Operations 93 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 104 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 105 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 105 Item 9A.

Controls and Procedures

Controls and Procedures 105 Item 9B. Other Information 105 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 106 PART III Item 10. Directors, Executive Officers and Corporate Governance 107 Item 11.

Executive Compensation

Executive Compensation 114 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 122 Item 13. Certain Relationships and Related Transactions, and Director Independence 124 Item 14. Principal Accounting Fees and Services 129 PART IV Item 15. Exhibits, Financial Statement Schedules 130 Item 16. Form 10-K Summary 130 i

FORWARD-LOOKING STATEMENTS AND MARKET DATA

FORWARD-LOOKING STATEMENTS AND MARKET DATA This Annual Report on Form 10-K (Annual Report) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene and any future product candidates, the timing and likelihood of regulatory filings and approvals for cretostimogene and any future product candidates, our ability to commercialize cretostimogene and any future product candidates, if approved, the pricing and reimbursement of cretostimogene and any future product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and potential to enter into any future strategic arrangements, the timing and likelihood of success, plans and objectives of management for future operations, and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. This Annual Report also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assu

Bu siness

Item 1. Bu siness. Overview We are a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. Our product candidate, cretostimogene, is initially in clinical development for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy, the current standard-of-care for high-risk NMIBC. There is significant unmet need for treatments in these patients given the limitations of currently approved therapies and patient reluctance to undergo radical cystectomy, or the complete removal of the bladder. We are evaluating the safety and efficacy of cretostimogene as monotherapy in BOND-003, our ongoing Phase 3 clinical trial in high-risk BCG-unresponsive NMIBC patients. We have completed enrollment for this trial, reported interim data in November 2023 and expect to report topline data by the end of 2024. If successful, we believe that this trial could serve as the basis for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA). We are also evaluating the use of cretostimogene when administered to this same patient population in combination with FDA-approved pembrolizumab in CORE-001, our ongoing Phase 2 clinical trial. Moreover, we intend to assess the safety and efficacy of cretostimogene in treating a range of other bladder cancer indications as an alternative to BCG therapy and in patients who are not categorized as BCG-unresponsive, including our second Phase 3 clinical trial, PIVOT-006, evaluating adjuvant cretostimogene in intermediate-risk NMIBC patients following transurethral resection of the bladder tumor (TURBT). We believe cretostimogene, if approved, has the potential to serve as first-line therapy, thereby alleviating the current need to prioritize treatment recipients and ration administration of BCG given its

View Full Filing

View this 10-K filing on SEC EDGAR