Core Insights - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by approximately 200 points on Friday [1] Company Highlights - CG Oncology Inc (NASDAQ:CGON) saw its shares rise by 21.8% to $51.05 after announcing an expedited timeline for topline data from the Phase 3 PIVOT-006 clinical trial, now expected in the first half of 2026 [1][2] - Rich Sparkle Holdings Ltd (NASDAQ:ANPA) surged 113.6% to $51.70 following a $39 million offering of 3 million ordinary shares at $13 per share [3] - NovaBay Pharmaceuticals Inc (NYSE:NBY) increased by 34.4% to $12.81 [3] - Quanterix Corp (NASDAQ:QTRX) gained 29.3% to $8.42 after naming Everett Cunningham as President and CEO, effective January 19 [3] - MoonLake Immunotherapeutics (NASDAQ:MLTX) rose 21.7% to $17.45 after receiving FDA feedback on its clinical evidence strategy for Sonelokimab in Hidradenitis Suppurativa [3] - Enliven Therapeutics Inc (NASDAQ:ELVN) increased by 21.5% to $28.24, sharing positive initial data from its Phase 1b ENABLE trial for ELVN-001 in chronic myeloid leukemia [3] - Aeva Technologies Inc (NASDAQ:AEVA) surged 21.2% to $20.47 [3] - Loandepot Inc (NYSE:LDI) rose 20.1% to $2.93 [3] - ASP Isotopes Inc (NASDAQ:ASPI) increased by 19.7% to $7.71 [3] - Allogene Therapeutics Inc (NASDAQ:ALLO) gained 19.5% to $1.78 [3] - Opendoor Technologies Inc (NASDAQ:OPEN) rose 19.2% to $7.67 following a new housing market proposal by President Donald Trump [3] - Liquidia Corp (NASDAQ:LQDA) jumped 14% to $36.22 after announcing preliminary full-year 2025 YUTREPIA net sales [3] - Vistra Corp (NYSE:VST) gained 13.1% to $170.34 after entering into 20-year power purchase agreements for zero-carbon nuclear energy to support Meta's operations [3] - Oklo Inc (NYSE:OKLO) rose 12.6% to $109.95 after announcing an agreement with Meta for a 1.2 gigawatt power campus [3] - Applied Digital Corp (NASDAQ:APLD) surged 11.8% to $35.72, reporting strong second-quarter results and advanced talks with a new hyperscaler tenant [3] - AST SpaceMobile Inc (NASDAQ:ASTS) gained 10% to $99.65 [3] - SanDisk Corp (NASDAQ:SNDK) increased by 9.6% to $366.93 [3] - Mirion Technologies Inc (NYSE:MIR) rose 9.5% to $26.56 [3] - TTM Technologies Inc (NASDAQ:TTMI) gained 9.1% to $72.94 [3] - SoundHound AI Inc (NASDAQ:SOUN) rose 8.5% to $11.96 [3] - Kratos Defense & Security Solutions Inc (NASDAQ:KTOS) gained 8.3% to $112.64, with B. Riley Securities maintaining a Buy rating and raising the price target from $105 to $128 [3]

Core Insights - CG Oncology has announced that topline data from the Phase 3 PIVOT-006 clinical trial is now expected in the first half of 2026, nearly one year ahead of schedule due to rapid enrollment [1][2][3] - The PIVOT-006 trial is the first randomized registrational study evaluating an investigational therapy for intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) [1][3] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies for bladder cancer, aiming to improve the quality of life for patients [5] - The company is developing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy, which has been studied in over 400 patients with non-muscle invasive bladder cancer [4] Clinical Trial Details - The PIVOT-006 study involves more than 360 patients and compares adjuvant intravesical cretostimogene grenadenorepvec against surveillance following bladder tumor removal [3] - The trial encompasses a broad range of patient types according to AUA/SUO Guidelines, including high-grade Ta solitary lesions less than 3 cm [1][3] Market Potential - The IR NMIBC patient population in the U.S. is estimated to exceed 50,000, indicating a significant unmet medical need [2][4] - The rapid enrollment across over 90 sites highlights the real-world relevance of the trial and the demand for effective treatment options in this patient demographic [2][3]

Attacking Bladder Cancer for a Better Tomorrow | 1 Disclaimer and Forward -Looking Statements We caution you that this presentation contains forward -looking statements about us and our industry. All statements other than s tatements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, rese arch and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned clinical ...

Core Viewpoint - CG Oncology, Inc. is preparing to present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its focus on developing a bladder-sparing therapeutic for bladder cancer patients [1]. Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company dedicated to developing and commercializing innovative immunotherapies aimed at improving the quality of life for patients with bladder cancer [3]. - The company envisions a future where urologic cancer patients can benefit from its therapies, allowing them to live with dignity [3]. Event Details - Arthur Kuan, Chairman & CEO, and Ambaw Bellete, President & COO, will present at the conference on January 15, 2026, at 8:15 am PT / 11:15 am ET [1]. - The conference will be held at the Westin St. Francis in San Francisco, California [1]. - Interested parties can access a live audio webcast of the presentation from the company's Investor Relations section on its website, with a replay available for approximately 90 days post-event [2].

Core Insights - Biotech stocks are primarily driven by data, but share prices do not always reflect the underlying value indicated by that data [1] Company Analysis - CG Oncology, Inc. (CGON) has experienced data releases that suggest a discrepancy between its stock price and the value implied by its data [1]

Group 1: Fellowship Announcement - The Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) and CG Oncology announced the second annual CG-SUO-CTC NMIBC Research Fellowship to support clinical cancer research focused on Non-Muscle Invasive Bladder Cancer (NMIBC) [2][4] - Two applicants will each receive a grant of $50,000 to support their research projects, with applications due by February 27, 2026 [1][4] Group 2: Research and Innovation - There is a significant unmet need for treating NMIBC, and the fellowship aims to advance research and innovation in this area, improving patient care [3] - The program provides an opportunity for emerging urologists to collaborate with mentors and present their findings at prominent forums such as the American Urological Association (AUA) annual meeting [3][4] Group 3: Bladder Cancer Statistics - In 2024, more than 83,000 people are estimated to be diagnosed with bladder cancer, with NMIBC representing approximately 75% of newly diagnosed cases [5] - Bladder cancer is the sixth most common form of cancer in the United States, with men accounting for three-quarters of new diagnoses [5] Group 4: Organizations Overview - SUO-CTC is a clinical research network with over 600 members from more than 300 clinical sites in the U.S. and Canada, dedicated to advancing urology research [6] - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing bladder-sparing therapeutics for bladder cancer patients [7]

Core Insights - CG Oncology, Inc. announced promising topline data from BOND-003 Cohort P and CORE-008 Cohort A, indicating efficacy, safety, and tolerability of cretostimogene for bladder cancer treatment [1][2][3] BOND-003 Cohort P Results - The BOND-003 trial demonstrated High-Grade Event-Free Survival (HG-EFS) rates of 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months among 51 evaluable patients [4][9] - No Grade 3 or greater treatment-related adverse events (TRAEs) were reported, and no patients progressed to muscle-invasive bladder cancer (MIBC) [5][9] - The study included 56 patients across 35 clinical sites in the U.S. and Japan [6] CORE-008 Cohort A Results - CORE-008 Cohort A showed an overall Complete Response (CR) rate of 83.7% in evaluable patients, with an 88.0% CR rate for optimized administration compared to 79.2% for original administration [7][10] - The safety profile was consistent with previous trials, with no serious adverse events or treatment-related discontinuations reported [8][10] Cretostimogene Overview - Cretostimogene is an investigational oncolytic immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC), with over 400 patients involved in its clinical development [11] - The company is conducting two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [11] Company Background - CG Oncology focuses on developing and commercializing bladder-sparing therapies for bladder cancer patients, aiming to improve their quality of life [12]

Core Insights - CG Oncology has appointed Christina Rossi, an experienced life sciences executive, to its Board of Directors, while Simone Song has resigned from the Board [1][2] - The company is at a pivotal moment with the initiation of the Biologics License Application (BLA) for cretostimogene, aiming for a successful launch upon FDA approval [2] - Cretostimogene is an investigational oncolytic immunotherapy being studied in over 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC) through multiple clinical trials [4] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing a 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] Executive Background - Christina Rossi has over 25 years of experience in the pharmaceutical and biotechnology sectors, previously serving as COO of Blueprint Medicines and holding various leadership roles at Sanofi Genzyme and Biogen [3] - Rossi's expertise includes overseeing commercial launches and optimizing operations to improve patient access to therapies [3]

Core Insights - CG Oncology is presenting new data on cretostimogene, an investigational therapy for non-muscle invasive bladder cancer (NMIBC), at the Society of Urologic Oncology (SUO) 26th Annual Meeting [1][2] - The presentations include topline results from BOND-003 Cohort P and CORE-008 Cohort A, reinforcing cretostimogene's potential as a backbone immunotherapy for NMIBC patients [2][5] Late-Breaking Podium Presentations - BOND-003 Cohort P focuses on high-risk, papillary-only, BCG-unresponsive NMIBC, with results presented by Dr. Mark D. Tyson on December 5, 2025 [3] - CORE-008 Cohort A evaluates high-risk BCG-naïve NMIBC, with initial results presented by Dr. Trinity J. Bivalacqua on December 5, 2025 [4] Posters - A poster on durable 24-month outcomes from BOND-003 Cohort C will be presented by Dr. Mark D. Tyson on December 3, 2025 [4] - Another poster on CORE-008 Cohort B, assessing intravesical cretostimogene in BCG-exposed NMIBC patients, will also be presented by Dr. Trinity J. Bivalacqua on December 3, 2025 [4] - A poster discussing a patient-centric expanded access program for cretostimogene will be presented by Dr. Sarah P. Psutka on December 4, 2025 [4] About Cretostimogene Grenadenorepvec - Cretostimogene is an investigational oncolytic immunotherapy delivered intravesically, with over 400 patients studied in its clinical development program [5] - The program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC, along with a Phase 2 trial, CORE-008 [5] About CG Oncology - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing therapies for bladder cancer, aiming to improve the quality of life for patients [6]

Clinical Trial Results - Cretostimogene achieved a 24-month complete response rate of 41.8% in high-risk Non-Muscle Invasive Bladder Cancer patients, with 46 confirmed complete responses out of 110 patients [112]. - The trial reported a 75.5% complete response rate at any time, with a median duration of response of 28 months [113]. - 96.6% of patients were free from progression to muscle invasive disease at 24 months, with no Grade 3 or greater treatment-related adverse events reported [113]. - The company initiated a BLA submission for cretostimogene in the fourth quarter of 2025, having received Fast Track and Breakthrough Therapy designations from the FDA [113]. Financial Performance - The company incurred net losses of $119.7 million for the nine months ended September 30, 2025, compared to $56.2 million for the same period in 2024 [116]. - Total revenues for the nine months ended September 30, 2025, were $1.7 million, up from $683,000 in the same period in 2024, reflecting a $1.0 million increase [146]. - Commercial and development revenue for Q3 2025 was $1.5 million, a significant increase from zero in Q3 2024, attributed to the Conversion Event in July 2025 [140]. - License and collaboration revenue recognized from agreements totaled $26.3 million since inception, with no revenue expected from cretostimogene product sales in the foreseeable future [125]. Expenses and Operating Costs - Research and development expenses for Q3 2025 were $27.9 million, an increase of $8.3 million from $19.6 million in Q3 2024, driven by higher external clinical trial costs and increased personnel-related expenses [143]. - General and administrative expenses for Q3 2025 reached $23.3 million, up $14.6 million from $8.7 million in Q3 2024, primarily due to increased professional fees and compensation costs [144]. - Total operating costs and expenses for Q3 2025 were $52.8 million, compared to $28.3 million in Q3 2024, marking a $24.5 million increase [139]. - Total research and development expenses increased to $86.7 million for the nine months ended September 30, 2025, compared to $55.3 million in 2024, marking a $31.4 million increase [151]. - General and administrative expenses rose to $55.5 million for the nine months ended September 30, 2025, up from $22.0 million in 2024, reflecting a $33.5 million increase [152]. Cash and Funding - Cash, cash equivalents, and marketable securities totaled $680.3 million as of September 30, 2025, expected to fund operations into the first half of 2028 [117][119]. - Net cash used in operating activities was $96.1 million for the nine months ended September 30, 2025, compared to $58.1 million in 2024 [161]. - Net cash provided by financing activities was $54.5 million for the nine months ended September 30, 2025, compared to $404.9 million in 2024 [166]. - The company expects existing cash resources to fund operations into the first half of 2028, based on current operating plans [157]. Investment and Financial Management - The primary objective of the company's investment activities is to preserve capital while maximizing income from investments without assuming significant risk [176]. - The company seeks to limit its exposure to interest rate risk due to the short-term duration and low risk profile of its investment portfolio [176]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations for the periods covered by the Quarterly Report [177]. - The company does not currently have any off-balance sheet arrangements as defined by SEC regulations [173]. Other Financial Information - The company had an accumulated deficit of $337.7 million as of September 30, 2025, primarily due to research and development costs [116]. - Other income, net, increased to $22.4 million for the nine months ended September 30, 2025, compared to $20.4 million in 2024 [153]. - Recently issued accounting standards that may impact the company's financial position and results of operations are detailed in Note 2 of the Quarterly Report [174]. - There have been no material differences between the company's estimates of expenses and the amounts actually incurred to date [172]. - The company estimates the timing and level of effort for services performed, adjusting accruals or prepaid expenses as necessary [171].