PresentationGood morning, everyone. Thanks for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng. I'm one of the Senior Biotech Analysts here at the firm. On stage, we have CG Oncology. I will now pass the mic to their CEO, Arthur Kuan for a short presentation followed by a live audience Q&A. Arthur, welcome. The stage is yours.Arthur KuanChairman & CEO Thank you, Brian. Good morning, everyone. So at CG Oncology, we're laser-focused on one mission, and that is we're ...

Summary of CG Oncology FY Conference Call Company Overview - **Company**: CG Oncology (NasdaqGS:CGON) - **Focus**: Developing a bladder-sparing therapeutic for bladder cancer patients, specifically targeting the non-muscle invasive bladder cancer (NMIBC) segment, which includes approximately 150,000 patients per year in the U.S. [2][3] Industry Insights - **Bladder Cancer Statistics**: - Incidence: Approximately 85,000 new cases annually in the U.S. - Prevalence: Over 700,000 patients, with 75% being non-muscle invasive [2] - Recurrence rates are high, often leading to progression and metastatic disease [2] Core Strategies and Trials - **Target Market**: Focus on intermediate-risk and high-risk populations within NMIBC [2][3] - **Pivotal Trials**: - **PIVOT-006**: Expected data readout in the first half of 2026, targeting 25,000 patients in the BCG-unresponsive segment [3][4] - **BOND-003**: Phase 3 monotherapy trial already read out, currently under BLA process [3] - **CORE-008, Cohort CX**: Combination trial of Credo plus gemcitabine, with data expected in the first half of 2026 [4][5] Product Profile - **Credo**: An oncolytic immunotherapy with a dual mechanism of action, selectively killing cancer cells and triggering a potent anti-tumor immune response [7][8] - **Clinical Data**: - 75.5% complete response rate in over 110 patients with BCG-unresponsive disease [10] - 46.4% observed complete response rate at 12 months and 42% at 24 months [10] - 96.4% progression-free survival from muscle-invasive disease at 24 months [10] - 90% of patients who achieve a complete response at 12 months remain in response at 24 months [11] Competitive Positioning - **Differentiation**: Credo shows superior efficacy and safety compared to existing therapies, with no significant grade three side effects reported [12][22] - **Market Opportunity**: The intermediate-risk population represents a potential 50,000 patients per year opportunity for CG Oncology [14] Commercial Strategy - **Pre-launch Activities**: Engaging with key accounts and conducting clinical research to prepare for market entry [20][21] - **Field Force**: Plans to deploy a lean field force of 75 to cover 300 network sites that account for 70% of BCG and TURBT volume [20] - **Manufacturing Capacity**: Current capacity of 50,000 vials per year, with plans to scale up to meet anticipated demand [22] Financial Outlook - **Cash Position**: As of Q3, CG Oncology reported $680 million, providing a runway into the first half of 2028 without revenue projections [41] Pricing Strategy - **Market Pricing**: Competitors' pricing ranges from $200,000 to $690,000 per year for BCG-unresponsive disease [43] - **Pricing Considerations**: Factors include efficacy, safety, treatment length, and access for physicians and patients [43][45] Future Directions - **Regulatory Submissions**: Ongoing BLA submission for high-risk BCG-unresponsive indication, with a focus on de-risking the submission process [33][34] - **Expansion Plans**: Interest in conducting randomized trials for the BCG-exposed population, which has been underserved due to the BCG shortage [48] Conclusion - CG Oncology is positioned to make a significant impact in the bladder cancer treatment landscape with its innovative therapy, Credo, and is preparing for a strategic market entry backed by strong clinical data and a solid financial foundation [22][41]

Core Insights - CG Oncology (CGON) shares have increased nearly 32% in the past week following the announcement of earlier-than-expected top-line data from the phase III PIVOT-006 study, now anticipated in the first half of 2026 [1][8] - Over the last six months, CGON shares have surged 112.8%, significantly outperforming the industry growth of 22.9% [3] Study Details - The phase III PIVOT-006 study is assessing the efficacy of adjuvant intravesical cretostimogene grenadenorepvec against active surveillance in over 360 adult patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) post-tumor resection [2] - The primary endpoint is recurrence-free survival (RFS), with secondary endpoints including RFS at specific intervals and progression-free survival [2] Regulatory and Development Updates - CG Oncology has reported positive durability and response data from the phase III BOND-003 study for high-risk NMIBC patients unresponsive to Bacillus Calmette Guerin, with the FDA granting Fast Track and Breakthrough Therapy designations in December 2023 [6] - A rolling biologics license application submission is underway, expected to be completed in 2026 [6] - A separate phase II CORE-008 study is also evaluating the safety and effectiveness of cretostimogene in high-risk NMIBC [7] Market Context - With no FDA-approved therapies available for IR NMIBC patients post-surgery, the accelerated timeline for the phase III study and positive late-stage data have bolstered expectations for regulatory approval, enhancing investor confidence [9]

Core Insights - CG Oncology is a biopharmaceutical company focused on developing innovative cancer therapies, particularly for bladder cancer treatments [1] - The company has received a "Strong Buy" rating due to its pipeline progress and upcoming catalysts in 2026 [3] Market Performance - Morgan Stanley set a price target of $93 for CGON, indicating a potential increase of about 71.59% from its current trading price of $54.20 [2][6] - The stock has experienced a significant rise of 29.26%, with a change of $12.27, reflecting strong market interest [2] Key Developments - CG Oncology completed the rolling Biologics License Application (BLA) for cretostimogene, targeting high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [3][6] - The early completion of enrollment in the phase 3 PIVOT-006 trial for intermediate-risk NMIBC has accelerated the timeline for topline data to the first half of 2026, positioning the company for a potential first FDA approval in this segment [4][6] Financial Metrics - CGON's market capitalization is approximately $4.06 billion, with a trading volume of 6,958,295 shares on the NASDAQ exchange [5] - The stock has fluctuated between a low of $43.25 and a high of $57.40 today, with a 52-week range of $14.80 to $57.40, indicating its volatile yet promising nature [5]

Group 1 - The article discusses CG Oncology and its potential positive Phase 3 outcome that could lead to a Biologics License Application (BLA) for Cretostimogene [2] - The author, Terry Chrisomalis, has extensive experience in the biotech sector and runs the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies [2] - Biotech Analysis Central offers a library of over 600 articles, a model portfolio of small and mid-cap stocks, and various analysis tools for healthcare investors [2] Group 2 - The article does not provide any specific financial data or performance metrics related to CG Oncology or its products [1][3][4]

Market Performance - U.S. stocks showed positive movement, with the Nasdaq Composite gaining approximately 150 points on Friday [1] - The Dow increased by 0.38% to 49,453.05, while the NASDAQ rose by 0.66% to 23,635.11, and the S&P 500 climbed 0.48% to 6,954.85 [1] - European shares also experienced gains, with the eurozone's STOXX 600 up by 0.91% and other major indices like Spain's IBEX 35 and London's FTSE 100 also rising [6] - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 1.61% and China's Shanghai Composite rising 0.92% [7] Sector Performance - Utilities sector shares increased by 1.5% on Friday, while health care stocks saw a decline of 0.5% [1] Commodity Prices - Oil prices rose by 2.7% to $59.34, gold increased by 1.2% to $4,514.50, silver surged by 6.3% to $79.895, and copper rose by 2% to $5.9150 [5] Company News - Rich Sparkle Holdings Ltd shares surged 115% to $52.00 after signing a $39 million offering of 3 million ordinary shares at $13 per share [9] - Quanterix Corp shares increased by 31% to $8.54 following the appointment of a new CEO [9] - CG Oncology Inc shares rose by 24% to $52.18 after announcing an expedited timeline for clinical trial data [9] - Aquestive Therapeutics Inc shares dropped 40% to $3.72 due to FDA identified deficiencies [9] - Pacira Biosciences Inc shares fell 13% to $22.70 after reporting preliminary FY25 revenue results [9] - Beta Bionics Inc shares decreased by 31% to $21.98 following preliminary fourth-quarter financial results [9] Economic Indicators - Nonfarm payrolls increased by 50,000 in December, slightly below expectations [10] - The unemployment rate decreased to 4.4%, below expectations of 4.5% [10] - Average hourly earnings rose by 0.3%, matching forecasts [10] - Housing starts declined by 4.6% to an annualized rate of 1.246 million units [10] - Building permits fell by 0.2% to an annualized rate of 1.412 million [10] - The University of Michigan's consumer sentiment index rose to 54.0, the highest since September 2025 [2][10]

Market Performance - U.S. stocks showed positive movement, with the Nasdaq Composite gaining approximately 150 points on Friday [1] - The Dow increased by 0.38% to 49,453.05, while the NASDAQ rose by 0.66% to 23,635.11, and the S&P 500 climbed 0.48% to 6,954.85 [1] - Utilities sector shares increased by 1.5%, while health care stocks experienced a decline of 0.5% [1] Commodity Prices - Oil prices rose by 2.7% to $59.34, gold increased by 1.2% to $4,514.50, silver surged by 6.3% to $79.895, and copper rose by 2% to $5.9150 [5] European Market Trends - European shares were generally higher, with the eurozone's STOXX 600 gaining 0.91%, Spain's IBEX 35 Index rising 0.01%, London's FTSE 100 increasing by 0.85%, Germany's DAX up by 0.43%, and France's CAC 40 rising by 1.23% [6] Asian Market Trends - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 1.61%, Hong Kong's Hang Seng Index up by 0.32%, China's Shanghai Composite rising by 0.92%, while India's BSE Sensex fell by 0.72% [7] Company-Specific Movements - Rich Sparkle Holdings Ltd saw its shares increase by 115% to $52.00 after signing a $39 million offering of 3 million ordinary shares at $13 per share [9] - Quanterix Corp shares surged by 31% to $8.54 following the appointment of Everett Cunningham as President and CEO [9] - CG Oncology Inc shares rose by 24% to $52.18 after announcing an expedited timeline for clinical trial data [9] - Aquestive Therapeutics Inc shares dropped by 40% to $3.72 due to an FDA letter identifying deficiencies [9] - Pacira Biosciences Inc shares fell by 13% to $22.70 after reporting preliminary FY25 revenue results [9] - Beta Bionics Inc shares decreased by 31% to $21.98 following preliminary fourth-quarter financial results [9] Economic Indicators - Nonfarm payrolls increased by 50,000 in December, slightly below expectations of 60,000 [10] - The unemployment rate decreased from 4.5% in November to 4.4%, below expectations [10] - Average hourly earnings rose by 0.3%, matching forecasts [10] - Housing starts declined by 4.6% to an annualized rate of 1.246 million units, while building permits fell by 0.2% to an annualized rate of 1.412 million [10] - The University of Michigan's consumer sentiment index rose to 54.0 in January, the highest since September 2025 [10]

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 ...