Core Viewpoint - CG Oncology, Inc. has successfully closed a public offering of 9,200,000 shares of common stock, raising gross proceeds of $238.0 million, aimed at advancing its bladder cancer therapeutic development [1]. Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [5]. Offering Details - The public offering consisted of 9,200,000 shares, with 8,500,000 shares offered by CG Oncology and 700,000 shares by an existing stockholder, priced at $28.00 per share [1]. - The underwriters exercised their option to purchase an additional 1,200,000 shares in full [1]. - The gross proceeds from the offering, before deductions, amounted to $238.0 million [1]. Underwriters - The offering was managed by Morgan Stanley & Co. LLC, Goldman Sachs & Co. LLC, TD Cowen, and Stifel, Nicolaus & Company, Incorporated as joint book-running managers, with LifeSci Capital LLC as the lead manager [2]. Regulatory Compliance - A registration statement for the offering was filed with the Securities and Exchange Commission and declared effective on December 12, 2024 [3]. - A prospectus detailing the terms of the offering is available on the SEC's website [3].

Core Viewpoint - CG Oncology, Inc. has successfully closed a public offering of 9,200,000 shares of common stock, raising gross proceeds of $238.0 million before expenses, aimed at advancing its bladder cancer therapeutic development [1]. Group 1: Offering Details - The public offering consisted of 9,200,000 shares, with 8,500,000 shares offered by CG Oncology and 700,000 shares by an existing stockholder [1]. - The offering price was set at $28.00 per share, which included the full exercise of the underwriters' option to purchase an additional 1,200,000 shares [1]. - The gross proceeds to CG Oncology from the offering, before deducting underwriting discounts and commissions, amounted to $238.0 million [1]. Group 2: Underwriters and Management - Morgan Stanley & Co. LLC, Goldman Sachs & Co. LLC, TD Cowen, and Stifel, Nicolaus & Company acted as joint book-running managers for the offering [2]. - LifeSci Capital LLC served as the lead manager for the offering [2]. Group 3: Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [5]. - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [5].

Group 1 - CG Oncology, Inc. (NASDAQ: CGON) reported positive results from its phase 3 BOND-003 study for the oncolytic immunotherapy candidate Cretostimogene, targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [2] - The study's results indicate a significant advancement in treatment options for patients with NMIBC who do not respond to BCG therapy [2] - The Biotech Analysis Central service offers extensive resources for investors, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2]

Core Viewpoint - CG Oncology, Inc. has announced a public offering of 8,000,000 shares of common stock priced at $28.00 per share, aiming to raise approximately $204.4 million in gross proceeds before expenses [1]. Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [5]. Offering Details - The offering consists of 7,300,000 shares offered by CG Oncology and 700,000 shares by an existing stockholder, with the offering expected to close on December 16, 2024, subject to customary closing conditions [1]. - The underwriters have a 30-day option to purchase an additional 1,200,000 shares at the public offering price [1]. - The registration statement for the offering was filed with the Securities and Exchange Commission and declared effective on December 12, 2024 [3]. Underwriters - Morgan Stanley & Co. LLC, Goldman Sachs & Co. LLC, TD Cowen, and Stifel, Nicolaus & Company are acting as joint book-running managers for the offering, with LifeSci Capital LLC as the lead manager [2].

Company Overview - CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [5]. Proposed Offering - CG Oncology has filed a registration statement on Form S-1 with the SEC for a proposed underwritten public offering of 7,300,000 shares of its common stock [1]. - An existing stockholder intends to offer and sell 700,000 shares of CG Oncology's common stock in the proposed offering [1]. - The company will not receive proceeds from the sale of shares by the selling stockholder [1]. - CG Oncology plans to grant underwriters a 30-day option to purchase up to an additional 1,200,000 shares at the public offering price, less underwriting discounts and commissions [1]. - The public offering price has not yet been determined, and the offering is subject to market and other conditions [1]. Underwriters - Morgan Stanley & Co. LLC, Goldman Sachs & Co. LLC, TD Cowen, and Stifel, Nicolaus & Company are acting as joint book-running managers for the offering [2]. - LifeSci Capital LLC is serving as the lead manager for the offering [2]. Registration Statement - A registration statement relating to these securities has been filed with the SEC but has not yet become effective [3]. - The proposed offering will be made only by means of a prospectus, which will be available from the underwriters when ready [3].

Financial Performance - For the nine months ended September 30, 2024, CG Oncology reported a net loss of $56.2 million, compared to a net loss of $32.1 million for the same period in 2023, resulting in an accumulated deficit of $186.2 million as of September 30, 2024[77]. - Net loss for the three months ended September 30, 2024, was $20.4 million, compared to a net loss of $11.8 million in 2023, an increase of $8.6 million or 72.9%[97]. - Net loss for the nine months ended September 30, 2024, was $56.2 million, compared to a net loss of $32.1 million in 2023, an increase of $24.1 million or 75.1%[103]. - Other income for the nine months ended September 30, 2024, was $20.4 million, up from $4.0 million in the same period of 2023, primarily due to interest income from marketable securities[108]. Revenue Generation - The company has recognized a total of $25.7 million in research and collaboration revenue since inception, with no revenue generated from product sales[88]. - Research and collaboration revenue increased to $43,000 for the three months ended September 30, 2024, compared to $9,000 for the same period in 2023, representing a growth of 377.8%[98]. - The company has recognized $25.7 million in research and collaboration revenue through license and collaboration agreements as of September 30, 2024[109]. Cash and Funding - As of September 30, 2024, CG Oncology had cash, cash equivalents, and marketable securities totaling $540.7 million, which is expected to fund operations through 2027[80]. - The company estimates that its existing cash and marketable securities will be sufficient to fund projected operating expenses through 2027, although this is based on assumptions that may change[112]. - The company has no committed sources of capital and may need to finance operations through equity offerings or debt financings, which could dilute existing ownership interests[113]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $58.1 million, compared to $31.0 million for the same period in 2023[116][117]. - Net cash used in investing activities was $311.7 million for the nine months ended September 30, 2024, compared to $136.7 million in 2023, primarily due to purchases of marketable securities[118][119]. - Net cash provided by financing activities was $404.9 million for the nine months ended September 30, 2024, compared to a net cash outflow of $89.9 million in 2023[120][121]. Expenses - Research and development (R&D) expenses rose to $19.6 million for the three months ended September 30, 2024, up from $11.7 million in 2023, an increase of $7.9 million or 67.3%[100]. - R&D expenses for the nine months ended September 30, 2024, totaled $55.3 million, up from $29.4 million in 2023, an increase of $25.9 million or 88.1%[106]. - General and administrative expenses increased to $8.7 million for the three months ended September 30, 2024, compared to $2.3 million in 2023, reflecting a rise of $6.4 million or 276.6%[101]. - General and administrative expenses for the nine months ended September 30, 2024, were $22.0 million, compared to $6.9 million in 2023, reflecting an increase of $15.1 million or 218.5%[107]. - Total operating expenses for the three months ended September 30, 2024, were $28.3 million, up from $14.1 million in 2023, marking an increase of $14.3 million or 101.7%[97]. - Total operating expenses for the nine months ended September 30, 2024, reached $77.3 million, up from $36.3 million in 2023, an increase of $41.0 million or 113.0%[103]. Clinical Development - The company completed enrollment for the BOND-003 Phase 3 clinical trial and reported interim data in May 2024, with plans to submit a Biologics License Application (BLA) to the FDA if successful[75]. - CG Oncology initiated an expanded access program for cretostimogene in June 2024, with the first patient dosed and ongoing enrollment[75]. - Research and development expenses are expected to continue to increase significantly as the company advances its clinical trials and seeks regulatory approval for cretostimogene[77]. - The company expects to incur significant operating losses and expenses as it advances the clinical development of cretostimogene and other product candidates[109]. Collaborations - CG Oncology has entered into collaboration agreements with Lepu and Kissei, with potential milestone payments totaling up to $60 million and $100 million, respectively, along with royalties on net sales[85][87]. - The company relies on third parties for the manufacture and distribution of cretostimogene, which allows it to focus resources on product development[82]. Accounting Policies - There have been no material changes to the company's critical accounting policies and estimates from those described in the 2023 Annual Report[123].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation)(Commission File Number) (IRS Employer Identification No.) 400 Spectrum Center Drive Suite 2040 Irvine, California 92618 (Address of Principal Executive Offices) (Zip Code) 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 FORM 8-K CURRENT REPORT Pursuant ...

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 _____________________ | --- | --- | |--------------------------------------- ...