wildpixel Fresh from its large, $380mn IPO in January, CG Oncology (NASDAQ:CGON) achieved high success after its bladder cancer molecule cretostimogene grenadenorepvec demonstrated a 75.2% complete response at any time in 105 patients. The study was a phase 3 monotherapy study in NMIBC or high-risk non-muscle invasive bladder cancer that's unresponsive to Bacillus Calmette Guerin. This data, presented on May 3, was quickly followed on May 24 by data from a phase 2 study of the same molecule, this time in co ...

– Final positive safety and efficacy findings from CORE-001 study of Cretostimogene Grenadenorepvec in combination with Pembrolizumab in BCG-Unresponsive NMIBC simultaneously published online by Nature Medicine and featured at ASCO 2024 – – Announced 54% complete response (CR) rate in the intention-to-treat population at 24-month landmark and meets primary endpoint in the CORE-001 study – – Demonstrated 75.2% CR rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer in Cretostimogene Monothe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Securities registered pursuant to Section 12(b) of the Act: FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ | --- | --- | |--------------------------------------- ...

Financial Results Announcement - CG Oncology, Inc. announced its financial results for the quarter ended June 30, 2024 [6] - The press release detailing the financial results was issued on August 8, 2024 [6] - The press release is attached as Exhibit 99.1 and incorporated by reference [6] Regulatory and Compliance Information - The information in the Form 8-K, including Exhibit 99.1, is not deemed "filed" for purposes of Section 18 of the Securities Exchange Act [7] - The report was filed pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 [5] - The report was signed by Josh Patterson, General Counsel and Chief Compliance Officer of CG Oncology, Inc. [10] Company Classification and Market Information - CG Oncology, Inc. is classified as an emerging growth company [6] - CG Oncology, Inc. is registered on the Nasdaq Global Select Market under the trading symbol CGON [4] Company Contact Information - The company's principal executive offices are located at 400 Spectrum Center Drive, Suite 2040, Irvine, California 92618 [2] - The company's telephone number is (949) 409-3700 [5]

th 11 elect E i = ad pl 101 Com 01 11 -1 F Ti A LEAST Property TE p nt 1 lar ----------- i P in The Property action t r H 2017 th n 1000 Phone 34 and live y ckly E in wildpixel Maybe different isn't always better, but it can be just as good. CG Oncology (NASDAQ:CGON) is different from the biotechs I normally prefer to look at, as the company doesn't really have a platform or a pipeline beyond its lead candidate cretostimogene grenadenorepvec, an oncolytic adenovirus targeted at non-muscle invasive bladder c ...

[Filing Information](index=1&type=section&id=Filing%20Information) This section details the administrative and legal information pertinent to the company's SEC filing [Registrant Details](index=1&type=section&id=Registrant%20Details) This section provides the core identification details for CG Oncology, Inc. as filed with the SEC, including its incorporation state, commission file number, and principal executive offices - CG Oncology, Inc. is incorporated in Delaware with its principal executive offices located at 400 Spectrum Center Drive, Suite 2040, Irvine, CA 92618[1](index=1&type=chunk) [Securities and Status](index=1&type=section&id=Securities%20and%20Status) This section outlines the company's registered securities and its status as an emerging growth company, which impacts certain reporting requirements | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :--------------------------------------- | | Common Stock, par value $0.0001 per share | CGON | The Nasdaq Global Select Market | - The registrant, CG Oncology, Inc., is an emerging growth company[3](index=3&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This section reports the company's financial performance and condition for the specified period [Quarterly Financial Results Announcement](index=2&type=section&id=Quarterly%20Financial%20Results%20Announcement) CG Oncology, Inc. announced its financial results for the quarter ended March 31, 2024, via a press release, which is attached as Exhibit 99.1. The information in this report, including the exhibit, is not considered 'filed' for certain legal purposes - On May 9, 2024, CG Oncology, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2024[4](index=4&type=chunk) - The press release (Exhibit 99.1) is incorporated by reference but the information in this Form 8-K, including Exhibit 99.1, is not deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934[4](index=4&type=chunk)[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists all financial statements and supplementary exhibits included in the filing [Exhibits Filed](index=2&type=section&id=Exhibits%20Filed) This section lists the documents officially filed as exhibits to this Form 8-K, primarily the press release detailing the financial results and the interactive data file | Exhibit No. | Description | | :------------ | :-------------------------------- | | 99.1 | Press Release Dated May 9, 2024 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [SIGNATURES](index=3&type=section&id=SIGNATURES) This section provides official authorization and signatory details for the filed report [Authorization and Signatory](index=3&type=section&id=Authorization%20and%20Signatory) This section confirms the official authorization and signing of the Form 8-K by a duly authorized officer of CG Oncology, Inc - The report was signed on behalf of CG Oncology, Inc. by Corleen Roche, Chief Financial Officer, on May 9, 2024[7](index=7&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk)

WASHINGTON, DC 20549 FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-41925 CG Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) Delawa ...

Summary of CG Oncology Conference Call - May 03, 2024 Company Overview - **Company**: CG Oncology - **Product**: Credo Simogene (an investigational oncolytic immunotherapy) - **Indication**: Treatment of high-risk BCG unresponsive non-muscle invasive bladder cancer (NMIBC) Key Points and Arguments Clinical Trial Results - **BOND-three Trial**: Phase III registrational study evaluating Credo Simogene - **Complete Response (CR) Rate**: - 75.2% CR at any time for 105 evaluable patients, maintaining from 75.7% in December 2023 [6][23] - 79 complete responders reported, the highest number in this indication [23] - **Durability of Response**: - 83% of patients maintained CR for over 12 months [24] - 54% of initial non-responders converted to CR after a second induction [13][43] - **Safety Profile**: - No Grade 3 or higher adverse events reported [14][25] - 94.5% of patients completed all protocol-mandated treatments [25] Mechanism of Action - **Dual Mechanism**: Designed to replicate in and kill cancer cells while inducing antitumor immunity [8] - **Oncolytic Immunotherapy**: Mechanism supports the observed efficacy and safety [26] Comparisons with Other Therapies - **Efficacy Comparison**: - Credo Simogene's 75.2% CR rate compares favorably to: - 62% for combination therapy with MEO3 and BCG - 51% for Nadopiragine - 41% for Pembrolizumab [16] - **Safety Comparison**: - No Grade 3 or higher treatment-related adverse events, positioning Credo Simogene as a potentially safer option [14][16] Regulatory Designations - **FDA Designations**: Fast Track and Breakthrough Therapy designations granted for Credo Simogene [18] Trial Amendments and Future Studies - **New Cohorts**: Introduction of a treatment extension phase for complete responders and a new high-grade papillary cohort (Cohort P) [19] - **Expanded Access Program**: Designed to enhance geographic and ethnic diversity in patient data collection [20] Market Insights - **Target Patient Population**: - The prevalence of high-risk patients is estimated to be at least twice the incidence population [77] - **Therapeutic Landscape**: - Patients typically receive 2 to 4 lines of therapy after BCG treatment [79] Manufacturing and Logistics - **Manufacturing Process**: No changes to the robust process used in the Phase III trial, ensuring a lower risk profile for commercial launch [51] - **Cold Storage and Shipping**: Credo Simogene will be shipped in a just-in-time manner at -50 degrees Celsius, with a preparation time of 10 minutes [53][54] Additional Important Points - **Patient Demographics**: Most patients were white, male, and of Medicare age, with a median age of 73 [12] - **Physician Feedback**: High enthusiasm from urologists regarding the results, particularly appreciating the simplified installation process [29][32] - **Reinduction Acceptance**: Reinduction is a common practice in BCG therapy, and the results from Credo Simogene support this approach [42][45] This summary encapsulates the critical insights and data presented during the CG Oncology conference call, highlighting the efficacy, safety, and future potential of Credo Simogene in treating high-risk NMIBC.

[PART I](index=4&type=section&id=PART%20I) [Item 1. Business](index=4&type=section&id=Item%201.%20Business%2E) CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing cretostimogene, an oncolytic immunotherapy, for bladder cancer - CG Oncology is a late-stage clinical biopharmaceutical company developing cretostimogene for bladder cancer, with a primary focus on **high-risk Non-Muscle Invasive Bladder Cancer (NMIBC)** unresponsive to Bacillus Calmette Guerin (BCG) therapy[16](index=16&type=chunk) - The company's pipeline includes **BOND-003 (Phase 3 monotherapy)** for high-risk BCG-unresponsive NMIBC (topline data expected by end of 2024), **CORE-001 (Phase 2 combination)** with pembrolizumab, and **PIVOT-006 (Phase 3 adjuvant)** for intermediate-risk NMIBC[16](index=16&type=chunk)[18](index=18&type=chunk) - Cretostimogene has received **fast track designation** from the FDA for the treatment of BCG-unresponsive, high-risk NMIBC patients with carcinoma in-situ with or without Ta or T1 papillary tumors to improve complete response (CR)[17](index=17&type=chunk) Cretostimogene Interim Clinical Trial Results (Selected) | Trial | Patient Population | CR at Any Time | Maintained CR at 6 Months | Safety Highlights | | :---- | :----------------- | :------------- | :------------------------ | :---------------- | | BOND-003 (Phase 3 Monotherapy) | High-risk BCG-unresponsive NMIBC | 75.7% (50/66 evaluable) | 74.4% (32/43 evaluable responders) | Generally well-tolerated, mostly Grade 1/2 AEs, no Grade 3+ TRAEs, no discontinuations due to TRAEs | | CORE-001 (Phase 2 Combination with Pembrolizumab) | High-risk BCG-unresponsive NMIBC | 85% (29/34 evaluable) | 82% (27/33 evaluable patients) | Generally well-tolerated, one Grade 2 SAE related to cretostimogene, two Grade 3 SAEs related to pembrolizumab | - The company's strategy includes completing **BOND-003 for FDA approval**, **expanding cretostimogene monotherapy** across NMIBC indications (intermediate-risk, BCG-exposed/naïve), continuing combination therapy evaluations, **building in-house commercial capabilities** for the U.S., and leveraging CMC expertise for scalable manufacturing[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) - The global bladder cancer treatment market is forecast to be approximately **$9.9 billion by 2028**, with NMIBC accounting for **~75% of newly diagnosed patients**. High-risk NMIBC patients (**40% of NMIBC**) face an elevated risk of progression to more aggressive MIBC[21](index=21&type=chunk)[31](index=31&type=chunk)[33](index=33&type=chunk)[36](index=36&type=chunk) - Current high-risk NMIBC treatment with BCG therapy has limitations, including a **50% recurrence rate** and a chronic global shortage of BCG. Radical cystectomy, the standard of care for BCG-unresponsive patients, is often avoided due to significant patient burden, morbidity, and mortality[23](index=23&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - Cretostimogene is an **engineered oncolytic immunotherapy** designed to **selectively replicate in Rb gene pathway-defective cancer cells** and activate an anti-tumor immune response, with intravesical administration similar to BCG therapy[57](index=57&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk) - The company has license and collaboration agreements with **Kissei Pharmaceutical Co., Ltd.** for development and commercialization in the Kissei Territory (Japan and other Asian countries) and with **Lepu Biotech Co., Ltd.** for the Lepu Territory (mainland China, Hong Kong, Macau)[101](index=101&type=chunk)[102](index=102&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) Key Financial Terms of License and Collaboration Agreements | Agreement | Upfront Payment | Potential Milestone Payments | Royalty on Net Sales (to CG Oncology) | | :---------- | :-------------- | :--------------------------- | :----------------------------------- | | Kissei License Agreement | $10.0 million | Up to $100.0 million | Mid-twenties percentage in Kissei Territory | | Lepu License Agreement | $4.5 million | Up to $60.0 million | High single-digit percentage in Lepu Territory | - The company relies on patent, trade secret, and trademark protection for cretostimogene, with method-of-use patents expected to expire between **2036 and 2038**. As a biological product, cretostimogene may qualify for **12-year reference product exclusivity** under the BPCIA[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - The U.S. biologics development process involves extensive regulation from preclinical testing through BLA approval and post-marketing requirements, with expedited programs like **Fast Track** and **Breakthrough Therapy** available but not guaranteeing faster approval[116](index=116&type=chunk)[117](index=117&type=chunk)[123](index=123&type=chunk)[127](index=127&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk)[138](index=138&type=chunk) - The company is subject to various healthcare laws and regulations, including anti-kickback, fraud and abuse, and data privacy laws, as well as healthcare reform legislation like the **ACA** and **IRA**, which could impact coverage, reimbursement, and pricing[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) - As of December 31, 2023, the company had **61 full-time employees**, with **44 engaged in research and development activities**, and focuses on attracting and retaining highly qualified personnel[158](index=158&type=chunk)[159](index=159&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors%2E) The company faces substantial risks due to its limited operating history, significant accumulated losses, and dependence on the single product candidate, cretostimogene - The company has a limited operating history, has incurred significant operating losses since inception (**$48.6 million in 2023**, **$35.4 million in 2022**), and expects to incur substantial losses for the foreseeable future, with an accumulated deficit of **$129.9 million** as of December 31, 2023[167](index=167&type=chunk)[168](index=168&type=chunk) - The company is entirely dependent on the success of cretostimogene, its only product candidate, and will require substantial additional capital to finance operations beyond **2027**, with potential for dilution or relinquishing rights if unable to secure funding on acceptable terms[170](index=170&type=chunk)[171](index=171&type=chunk)[177](index=177&type=chunk) - Clinical and preclinical drug development is **lengthy, expensive, and uncertain**, with prior results not necessarily predictive of future outcomes. Cretostimogene's novel oncolytic immunotherapy approach presents additional challenges in regulatory approval[179](index=179&type=chunk)[180](index=180&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk) - Use of cretostimogene or future product candidates could be associated with **adverse side effects**, potentially delaying or precluding regulatory approval, limiting commercial profile, or causing clinical trial suspensions[199](index=199&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - The company relies heavily on third parties for conducting clinical trials (**CROs**) and manufacturing cretostimogene, increasing risks related to performance, regulatory compliance, supply chain, and potential disclosure of trade secrets[233](index=233&type=chunk)[237](index=237&type=chunk)[243](index=243&type=chunk) - Commercial success is **uncertain**, depending on market acceptance, coverage, and **adequate reimbursement** from third-party payors, which are increasingly challenging prices and implementing cost-containment measures[256](index=256&type=chunk)[259](index=259&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk)[264](index=264&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk) - The biopharmaceutical industry is **highly competitive**, with numerous companies developing treatments for NMIBC, many having significantly greater financial and operational resources[267](index=267&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk) - The company's ability to obtain, maintain, and enforce patent and other intellectual property protection is **critical but uncertain**, facing risks of invalidation, infringement claims, and challenges from changes in patent laws[321](index=321&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk)[325](index=325&type=chunk)[329](index=329&type=chunk)[335](index=335&type=chunk)[337](index=337&type=chunk)[352](index=352&type=chunk) - Ownership of common stock carries risks including potential **price volatility**, **significant influence** by executive officers and principal stockholders, **no anticipated dividends**, and **potential dilution** from future stock sales[370](index=370&type=chunk)[373](index=373&type=chunk)[374](index=374&type=chunk)[375](index=375&type=chunk) - The company is subject to various U.S. federal, state, and foreign healthcare laws and regulations (e.g., **Anti-Kickback Statute**, **False Claims Act**, **HIPAA**, **ACA**, **IRA**), with non-compliance potentially leading to significant penalties and adverse business impacts[287](index=287&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk)[290](index=290&type=chunk)[291](index=291&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk)[295](index=295&type=chunk)[296](index=296&type=chunk) [Item 1B. Unresolved Staff Comments](index=94&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments%2E) The company has no unresolved staff comments from the SEC - There are **no unresolved staff comments**[403](index=403&type=chunk) [Item 1C. Cybersecurity](index=94&type=section&id=Item%201C.%20Cybersecurity%2E) The company has implemented a cybersecurity risk management program based on the NIST Cybersecurity Framework, integrated into its overall enterprise risk management - The company's cybersecurity risk management program is based on the **National Institute of Standards and Technology Cybersecurity Framework (NIST CSF)** principles: Identify, Protect, Detect, Respond, and Recover[403](index=403&type=chunk) - The program is **integrated into the overall enterprise risk management**, including assessments, a dedicated security team, use of external service providers, employee training, and an incident response process[404](index=404&type=chunk)[405](index=405&type=chunk) - The Board of Directors, through its **Audit Committee**, oversees cybersecurity and other information technology risks, receiving periodic reports from management[406](index=406&type=chunk)[407](index=407&type=chunk)[408](index=408&type=chunk) - Management, including the Director of Information Technology with **35 years of risk management experience**, is responsible for assessing and managing material cybersecurity threats[409](index=409&type=chunk)[410](index=410&type=chunk) - **No risks from known cybersecurity threats** have materially affected or are reasonably likely to materially affect the company's operations, business strategy, results of operations, or financial condition to date[405](index=405&type=chunk) [Item 2. Properties](index=95&type=section&id=Item%202.%20Properties%2E) The company's principal executive offices are located in Irvine, California, with an additional office in Emeryville, California - The principal executive offices are in Irvine, California (**1,249 square feet**, lease until **August 2026**)[411](index=411&type=chunk) - Additional office space is leased in Emeryville, California (lease until **August 2025**)[411](index=411&type=chunk) - The company believes existing facilities are **adequate and suitable** additional space will be available as needed[411](index=411&type=chunk) [Item 3. Legal Proceedings](index=95&type=section&id=Item%203.%20Legal%20Proceedings%2E) A specific complaint was filed in March 2024 by ANI Pharmaceuticals, Inc., seeking a 5% royalty on cretostimogene net sales, which the company disputes - On **March 4, 2024**, ANI Pharmaceuticals, Inc. filed a complaint seeking a declaratory judgment that an assignment and technology transfer agreement obligates the company to pay a **5% royalty** on cretostimogene net sales[413](index=413&type=chunk) - The company **disputes** these allegations and intends to **vigorously defend** the matter[413](index=413&type=chunk) - Litigation, regardless of outcome, can **adversely impact** the company due to defense and settlement costs, diversion of management resources, and other factors[412](index=412&type=chunk) [Item 4. Mine Safety Disclosures](index=95&type=section&id=Item%204.%20Mine%20Safety%20Disclosures%2E) This item is not applicable to the company - This item is **not applicable**[414](index=414&type=chunk) [PART II](index=96&type=section&id=PART%20II) [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=96&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities%2E) The company's common stock began trading on the Nasdaq Global Select Market in January 2024 following its initial public offering (IPO), with 66.6 million shares outstanding as of January 31, 2024 - The company's common stock (**CGON**) began trading on the Nasdaq Global Select Market on **January 25, 2024**, at an initial public offering (IPO) price of **$19.00 per share**[417](index=417&type=chunk) - As of **January 31, 2024**, there were **66,636,192 shares** of common stock outstanding, held by approximately **111 holders of record**[418](index=418&type=chunk) - The company has **never declared or paid any cash dividends** on its capital stock and intends to retain future earnings for business development[419](index=419&type=chunk) Equity Issuances and Proceeds (in $) | Event | Date | Shares Issued | Price Per Share | Gross Proceeds | | :---- | :--- | :------------ | :-------------- | :------------- | | Series F Preferred Stock Issuance | July 2023 | 81,587,937 | $1.2872 | 105,000,000 | | IPO (Common Stock) | Jan 2024 | 23,000,000 | $19.00 | 437,000,000 | | IPO Net Proceeds | Jan 2024 | N/A | N/A | 400,400,000 | - In 2023, options to purchase **3,346,939 shares** of common stock were granted with a weighted average exercise price of **$5.78**[425](index=425&type=chunk) - The net proceeds from the IPO are held in cash, cash equivalents, and marketable securities, with **no material change** in the planned use of proceeds[429](index=429&type=chunk) [Item 6. [Reserved]](index=97&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=98&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%2E) The company is a late-stage clinical biopharmaceutical company focused on cretostimogene for bladder cancer, having incurred significant operating losses and negative cash flows since inception - The company has incurred significant operating losses and negative cash flows from operations since its inception, with net losses of **$48.6 million in 2023** and **$35.4 million in 2022**, leading to an accumulated deficit of **$129.9 million** as of December 31, 2023[435](index=435&type=chunk) - The company's operations have been primarily funded by proceeds from redeemable convertible preferred stock sales (**$307.9 million gross proceeds** through Dec 31, 2023) and term debt (repaid in 2023)[436](index=436&type=chunk)[464](index=464&type=chunk) Key Financial Highlights (in thousands) | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | Change (2023 vs 2022) | | :-------------------------------- | :---------------------- | :---------------------- | :-------------------- | | Research and collaboration revenue | $204 | $191 | +$13 | | Research and development expenses | $45,752 | $29,029 | +$16,723 | | General and administrative expenses | $9,901 | $6,408 | +$3,493 | | Total operating expenses | $55,653 | $35,437 | +$20,216 | | Loss from operations | $(55,449) | $(35,246) | $(20,203) | | Total other income (expense), net | $6,842 | $(197) | +$7,039 | | Net loss and comprehensive loss | $(48,607) | $(35,443) | $(13,164) | | Net cash used in operating activities | $(45,679) | $(29,804) | $(15,875) | | Net cash used in investing activities | $(121,195) | $(55,352) | $(65,843) | | Net cash provided by financing activities | $86,997 | $119,692 | $(32,695) | | Cash, cash equivalents and marketable securities (period end) | $187,700 | $143,481 | +$44,219 | - As of December 31, 2023, cash, cash equivalents, and marketable securities totaled **$187.7 million**. Following the January 2024 IPO, the company received **$400.4 million in net proceeds**, which are estimated to fund operations through **2027**[437](index=437&type=chunk)[438](index=438&type=chunk)[441](index=441&type=chunk)[463](index=463&type=chunk)[468](index=468&type=chunk) - Research and development expenses increased by **$16.7 million in 2023**, primarily due to higher clinical trial expenses (**CRO fees, CMC**) and increased R&D headcount[459](index=459&type=chunk) - General and administrative expenses increased by **$3.5 million in 2023**, driven by increased personnel-related expenses, professional consulting fees (legal, accounting), and facilities/travel/marketing costs[460](index=460&type=chunk) - The company **relies on third parties** for the manufacture, packaging, labeling, storage, and distribution of cretostimogene, aiming for an efficient infrastructure without internal manufacturing facilities[440](index=440&type=chunk) - Future funding requirements are expected to **increase substantially** due to ongoing clinical development, potential commercialization, and public company operating costs, necessitating **additional financing** through equity, debt, or collaborations[439](index=439&type=chunk)[466](index=466&type=chunk)[467](index=467&type=chunk)[469](index=469&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=110&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk%2E) The company's primary market risk exposure is interest rate sensitivity on its cash, cash equivalents, and marketable securities, though the short-term nature of these instruments is expected to limit material impact - The primary market risk exposure is **interest rate sensitivity** on cash, cash equivalents, and marketable securities, which consist of short-term U.S. government securities and money market funds[492](index=492&type=chunk)[493](index=493&type=chunk) - Due to the **short-term nature** of its investment portfolio, a sudden change in market interest rates is not expected to have a material impact on financial condition or results of operations[492](index=492&type=chunk)[493](index=493&type=chunk) - The company is **not currently exposed to significant foreign currency exchange risk**, as all employees and operations are in the U.S. and expenses are primarily denominated in USD[494](index=494&type=chunk) - Inflation has **not had a material effect** on the company's business, financial condition, or results of operations to date, though it could increase labor and R&D costs in the future[495](index=495&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=111&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data%2E) This section refers to the company's consolidated financial statements and the report of its independent registered public accounting firm, which are included elsewhere in the Annual Report - The consolidated financial statements and the report of the independent registered public accounting firm are included in this Annual Report on Form 10-K starting on page F-1[497](index=497&type=chunk) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=111&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure%2E) There have been no changes in or disagreements with the company's accountants on accounting or financial disclosure matters - There are **no changes in or disagreements** with accountants on accounting and financial disclosure[498](index=498&type=chunk) [Item 9A. Controls and Procedures](index=111&type=section&id=Item%209A.%20Controls%20and%20Procedures%2E) Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2023 - Management, with the participation of the principal executive officer and principal financial officer, concluded that disclosure controls and procedures were **effective at the reasonable assurance level** as of December 31, 2023[499](index=499&type=chunk)[500](index=500&type=chunk) - The Annual Report does not include a management's assessment or an attestation report from the registered public accounting firm regarding internal control over financial reporting, due to transition periods and exemptions for **newly public** and **emerging growth companies** under SEC rules and the JOBS Act[501](index=501&type=chunk)[502](index=502&type=chunk) - There have been **no changes** in internal control over financial reporting during the year ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[502](index=502&type=chunk) [Item 9B. Other Information](index=111&type=section&id=Item%209B.%20Other%20Information%2E) No officers or directors adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended December 31, 2023 - **None** of the company's officers or directors adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended December 31, 2023[503](index=503&type=chunk)[504](index=504&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=112&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections%2E) This item is not applicable to the company - This item is **not applicable**[505](index=505&type=chunk) [PART III](index=113&type=section&id=PART%20III) [Item 10. Directors, Executive Officers and Corporate Governance](index=113&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance%2E) This section outlines the company's executive officers and board of directors, including their bios and independence status, and details the board's risk oversight - The executive officers as of **March 25, 2024**, include Arthur Kuan (Chairman & CEO), Ambaw Bellete (President & COO), Corleen Roche (CFO & Secretary), and Vijay Kasturi, M.D. (CMO)[508](index=508&type=chunk)[509](index=509&type=chunk)[511](index=511&type=chunk)[512](index=512&type=chunk)[513](index=513&type=chunk)[514](index=514&type=chunk)[515](index=515&type=chunk) - The board of directors consists of **seven members**, with all directors except Mr. Kuan determined to be **independent** according to Nasdaq listing requirements[524](index=524&type=chunk)[525](index=525&type=chunk) - The board is divided into **three classes** with staggered **three-year terms**, which may delay changes in control or management[526](index=526&type=chunk) - The board leadership structure includes Arthur Kuan as Chairman and CEO, and Leonard Post, Ph.D., as the **lead independent director**, to ensure independent oversight of management[527](index=527&type=chunk)[528](index=528&type=chunk) - The board oversees risk management through its **Audit, Compensation, and Nominating and Corporate Governance committees**, which regularly discuss major risk exposures with management[530](index=530&type=chunk)[531](index=531&type=chunk)[532](index=532&type=chunk) - All members of the Audit, Compensation, and Nominating and Corporate Governance committees are **independent directors**, with specific financial expertise on the Audit Committee[534](index=534&type=chunk)[536](index=536&type=chunk)[537](index=537&type=chunk) - The company maintains an insider trading compliance policy that prohibits officers, directors, and employees from **pledging stock as collateral** or engaging in **hedging transactions**[541](index=541&type=chunk) - A written **code of business conduct and ethics** applies to all directors, officers, and employees, available on the company's website[545](index=545&type=chunk)[546](index=546&type=chunk) [Item 11. Executive Compensation](index=121&type=section&id=Item%2011.%20Executive%20Compensation%2E) This section details the compensation for the company's named executive officers (NEOs) for 2023, including base salaries, performance-based cash bonuses, and equity-based incentive awards - The named executive officers (NEOs) for **2023** were Arthur Kuan (Chairman & CEO), Ambaw Bellete (President & COO), and Vijay Kasturi, M.D. (CMO). Corleen Roche joined as CFO in **January 2024**[547](index=547&type=chunk) 2023 Summary Compensation Table for Named Executive Officers (in $) | Name | Year | Salary | Bonus | Option Awards | Non-Equity Incentive Plan Compensation | All Other Compensation | Total | | :--- | :--- | :----- | :---- | :------------ | :------------------------------------- | :--------------------- | :---- | | Arthur Kuan | 2023 | 449,000 | — | 3,293,022 | 189,000 | 2,974 | 3,933,996 | | Arthur Kuan | 2022 | 394,000 | — | 694,269 | 140,000 | 1,130 | 1,229,399 | | Ambaw Bellete | 2023 | 322,000 | 189,500 | 1,967,465 | 179,740 | 369,970 | 3,028,675 | | Vijay Kasturi, M.D. | 2023 | 152,000 | 56,000 | 2,144,844 | 87,448 | 4,240 | 2,444,532 | - Effective **January 1, 2024**, NEOs' annual base salaries increased (Kuan to **$625k**, Bellete to **$495k**, Kasturi to **$465k**, Roche to **$450k**). Target annual bonuses also increased post-IPO (Kuan to **55%**, Bellete to **45%** of base salary)[557](index=557&type=chunk)[574](index=574&type=chunk) - Equity-based incentive awards, primarily stock options, are granted with exercise prices no less than fair market value and generally vest over **four years**, with some **performance-based vesting** tied to clinical, operational, or regulatory milestones[559](index=559&type=chunk)[560](index=560&type=chunk)[561](index=561&type=chunk)[562](index=562&type=chunk)[563](index=563&type=chunk)[564](index=564&type=chunk)[565](index=565&type=chunk) - Non-employee directors receive an annual cash retainer of **$36,000** (with additional retainers for chairs/lead independent director and committee members) and equity compensation, including initial and annual option grants[587](index=587&type=chunk)[594](index=594&type=chunk)[595](index=595&type=chunk) - The company has adopted a compensation recovery (**clawback**) policy compliant with Nasdaq Listing Rules and provides indemnification agreements and D&O liability insurance for its directors and officers[586](index=586&type=chunk)[597](index=597&type=chunk)[598](index=598&type=chunk)[599](index=599&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=130&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters%2E) This section details the beneficial ownership of the company's common stock by its executive officers, directors, and significant stockholders (5% or more) as of March 25, 2024 Beneficial Ownership of Common Stock as of March 25, 2024 | Name of Beneficial Owner | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | | :--------------------------------------- | :---------------------------------- | :-------------------------------------- | | Entities affiliated with ORI Capital | 4,941,368 | 7.4% | | Decheng Capital Global Life Sciences Fund IV, L.P. | 5,358,812 | 8.0% | | Entities affiliated with Longitude Venture Partners | 4,662,281 | 7.0% | | Kissei Pharmaceutical Co., Ltd. | 3,543,533 | 5.3% | | Entities affiliated with Foresite Capital | 3,595,203 | 5.4% | | TCG Crossover Fund I, L.P. | 3,570,206 | 5.4% | | Arthur Kuan | 308,508 | * | | Ambaw Bellete | 26,218 | * | | Vijay Kasturi | 3,609 | * | | James J. Mulé, IPh.D. | 61,794 | * | | Leonard Post, Ph.D. | 139,009 | * | | Simone Song | 5,555,296 | 8.3% | | All executive officers and directors as a group (10 persons) | 1,155,066 | 1.8% | - As of **March 25, 2024**, executive officers, directors, and greater than **5% stockholders** collectively own approximately **39.5%** of the outstanding common stock, giving them significant influence over matters submitted to stockholders for approval[373](index=373&type=chunk)[606](index=606&type=chunk) Equity Compensation Plan Information as of December 31, 2023 (adjusted for reverse stock split) | Plan Category | Number of securities to be issued upon the exercise of outstanding options, warrants and rights | Weighted average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance under equity compensation plans | | :------------------------------------------ | :------------------------------------------------------------------------ | :----------------------------------------------------------------------- | :------------------------------------------------------------------------------------------ | | Equity compensation plans approved by security holders | 5,532,871 | $4.12 | 124,136 | | Equity compensation plans not approved by security holders | — | — | — | | Total | 5,532,871 | $4.12 | 124,136 | - The **2024 Incentive Award Plan** and **2024 Employee Stock Purchase Program** became effective at the time of the initial public offering, replacing the 2015 and 2022 Plans for new grants[607](index=607&type=chunk)[799](index=799&type=chunk)[800](index=800&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=133&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence%2E) This section details transactions and relationships involving the company's directors, executive officers, and significant stockholders, including preferred stock financings and consulting agreements Redeemable Convertible Preferred Stock Financings (Shares Acquired by Affiliates) | Participant | Series E Redeemable Convertible Preferred Stock | Series F Redeemable Convertible Preferred Stock | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | | Entities affiliated with ORI Capital | 37,474,236 | — | | Decheng Capital Global Life Sciences Fund IV, L.P. | 21,547,685 | 4,402,320 | | Entities affiliated with Foresite Capital | — | 23,306,401 | | Entities affiliated with Longitude Venture Partners | 21,547,685 | 4,402,320 | | TCG Crossover Fund I, L.P. | — | 23,306,401 | - In **October 2023**, Abundant Supply Global Limited (affiliated with ORI Capital) sold **27,190,800 Series C preferred shares** to other major stockholders, including Decheng Capital Global, TCG Crossover Fund I, Longitude Prime Fund, and entities affiliated with Foresite Capital[616](index=616&type=chunk) - Consulting agreements were in place with Danforth Advisors (for interim CFO services, Stephen DiPalma) and Lion Healthcare Strategies (for corporate/strategic consulting, Ambaw Bellete), with payments totaling **$372,824** and **$357,908** respectively in 2023[624](index=624&type=chunk)[625](index=625&type=chunk) - Major stockholders, including Foresite Capital, TCG Crossover, Decheng Capital Global, Longitude Capital, and Simone Hong Fang, participated in the company's **January 2024 IPO**, purchasing shares at the initial public offering price[626](index=626&type=chunk) - The Investors' Rights Agreement, Voting Agreement, and Right of Refusal and Co-Sale Agreement terminated upon the closing of the IPO, though **registration rights** under the Investors' Rights Agreement continue for **five years**[620](index=620&type=chunk)[621](index=621&type=chunk)[623](index=623&type=chunk) - The board of directors adopted a written **related person transaction policy**, effective upon the IPO, requiring audit committee review and approval for transactions exceeding **$120,000** or **one percent of average total assets**[629](index=629&type=chunk) [Item 14. Principal Accounting Fees and Services](index=137&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services%2E) This section details the audit fees paid to Ernst & Young LLP, the company's independent registered public accounting firm, for the fiscal years 2023 and 2022 Principal Accounting Fees and Services (in $) | Fee Category | Fiscal Year Ended December 31, 2023 | Fiscal Year Ended December 31, 2022 | | :----------- | :---------------------------------- | :---------------------------------- | | Audit Fees | $1,481,000 | $265,000 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | — | — | | Total Fees | $1,481,000 | $265,000 | - **Audit Fees** include services for the audit of financial statements and the issuance of consents and comfort letters related to registration statements, including the IPO[631](index=631&type=chunk) - The Audit Committee has a policy requiring **pre-approval** for all audit and permissible non-audit services provided by the independent registered public accounting firm[632](index=632&type=chunk) [PART IV](index=138&type=section&id=PART%20IV) [Item 15. Exhibits, Financial Statement Schedules](index=138&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules%2E) This section indicates that the company's financial statements are included in Part II, Item 8 of the Annual Report, with all financial statement schedules omitted - The financial statements of CG Oncology, Inc. are included in **Part II, Item 8** of this Annual Report[634](index=634&type=chunk) - All financial statement schedules are **omitted** because they are not applicable or the required information is shown in the financial statements or notes thereto[635](index=635&type=chunk) - A list of exhibits is set forth on the **Exhibit Index** immediately preceding the signature page of this Annual Report[636](index=636&type=chunk) [Item 16. Form 10-K Summary](index=138&type=section&id=Item%2016.%20Form%2010-K%20Summary%2E) This item indicates that no Form 10-K Summary is provided - **No Form 10-K Summary** is provided[637](index=637&type=chunk)