Group 1 - Celcuity (NASDAQ: CELC) recently announced positive results from its phase 3 VIKTORIA-1 trial, which tested its drug gedatolisib in combination with other therapies for treating patients with PIK3CA wildtype HR+/HER2- advanced breast cancer [2] - The trial involved a triplet therapy approach, indicating a potential advancement in treatment options for this specific type of breast cancer [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] - The service is available for $49 per month, with a discounted yearly plan at $399, providing a 33.50% savings for subscribers [1]

Core Viewpoint - Celcuity Inc. has announced the pricing of its public offerings, including $175 million in convertible senior notes and approximately 1.84 million shares of common stock at $38.00 per share, aiming to raise a total of approximately $248.7 million for various corporate purposes [1][6]. Offering Details - The company is offering $175 million in 2.750% convertible senior notes due 2031, with an option for underwriters to purchase an additional $26.25 million to cover over-allotments [1][2]. - The common stock offering includes 1,836,842 shares priced at $38.00 each, with pre-funded warrants available at $37.999 per warrant [1][2]. Financial Terms - The convertible notes will accrue interest at 2.750% per year, payable semiannually, and will mature on August 1, 2031 [3]. - The initial conversion rate for the convertible notes is set at 19.4932 shares of common stock per $1,000 principal amount, equating to a conversion price of approximately $51.30 per share, representing a 35% premium over the common stock offering price [4]. Closing Timeline - The expected closing date for the convertible notes offering is August 1, 2025, while the common stock offering is anticipated to close on July 31, 2025, subject to customary closing conditions [5]. Use of Proceeds - The net proceeds from both offerings are estimated to be approximately $248.7 million, which will be used for working capital, clinical trial expenditures, and other general corporate purposes [6]. Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, with its lead candidate, gedatolisib, currently undergoing multiple clinical trials for various cancer indications [11].

CANADA - 2025/07/28: In this photo illustration, the Celcuity logo is seen displayed on a smartphone ... More screen. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images) SOPA Images/LightRocket via Getty Images Celcuity stock (NASDAQ: CELC), a clinical-stage biotechnology company, experienced an extraordinary 3x surge in a single trading session, with shares rocketing from approximately $14 to a peak of $46 before stabilizing around $37. This dramatic price movement was triggered ...

Core Viewpoint - Celcuity Inc. is conducting public offerings of $150 million in convertible senior notes and $75 million in common stock to support its oncology-focused development efforts [1][4]. Group 1: Offerings Details - The company plans to offer $150 million in convertible senior notes due in 2031 and $75 million in common stock, with options for underwriters to purchase additional amounts [1][2]. - The convertible notes will be unsecured, with interest payable semi-annually, maturing on August 1, 2031, unless converted or redeemed earlier [3]. - The net proceeds from both offerings will be used for capped call transactions, working capital, and general corporate purposes, including clinical trials and business development [4]. Group 2: Capped Call Transactions - The company expects to enter capped call transactions to mitigate potential dilution from the convertible notes, which will cover shares of common stock underlying the notes [6]. - These transactions are designed to offset cash payments exceeding the principal amount of converted notes, subject to a cap [6]. - The option counterparties may engage in derivative transactions that could influence the market price of the common stock and convertible notes [7][8]. Group 3: Management and Underwriters - Jefferies, TD Cowen, and Leerink Partners are the joint book-running managers for the offerings, with LifeSci Capital acting as lead manager for the convertible notes [9]. - The company has filed a registration statement with the SEC regarding these offerings, providing necessary documentation for potential investors [10]. Group 4: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, with its lead candidate being gedatolisib, a pan-PI3K and mTORC1/2 inhibitor [12]. - Ongoing clinical trials include VIKTORIA-1 for advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [12].

Market Performance - U.S. stocks traded mostly higher, with the Nasdaq Composite gaining over 50 points on Monday. The Dow increased by 0.07% to 44,932.70, the NASDAQ rose by 0.28% to 21,167.71, and the S&P 500 gained 0.09% to 6,394.33 [1] - Energy shares saw a rise of 0.9%, while materials stocks dipped by 1.1% on the same day [1] Commodity Prices - Oil prices increased by 2.2% to $66.57, while gold prices decreased by 0.9% to $3,306.90. Silver fell by 0.3% to $38.235, and copper dropped by 1% to $5.7285 [5] European Market Trends - European shares were lower, with the eurozone's STOXX 600 slipping by 0.19%. Spain's IBEX 35 Index fell by 0.09%, London's FTSE 100 decreased by 0.57%, Germany's DAX 40 declined by 0.89%, and France's CAC 40 fell by 0.37% [6] Asian Market Trends - Asian markets closed mixed, with Japan's Nikkei 225 falling by 1.10%, Hong Kong's Hang Seng gaining by 0.68%, China's Shanghai Composite rising by 0.12%, and India's BSE Sensex decreasing by 0.70% [7] Company-Specific Movements - CEA Industries Inc. saw its shares surge by 600% to $62.10 following a $500 million private placement announcement [9] - Celcuity Inc. shares increased by 167% to $36.80 after releasing topline results from its Phase 3 VIKTORIA-1 trial [9] - AIM ImmunoTech Inc. shares rose by 41% to $11.82 after announcing mid-year data from its Phase 2 DURIPANC trial [9] - Quhuo Limited shares dropped by 84% to $0.21 after announcing a strategic partnership with NIU World [9] - Adaptimmune Therapeutics plc shares fell by 63% to $0.1271 after agreeing to sell assets related to its cell therapy products for $55 million [9] - Sidus Space, Inc. shares decreased by 44% to $1.1200 following a $7.5 million public offering announcement [9]

Celcuity is seeing much more options activity than usual, though puts are outweighing calls nine to one as traders appear to bet on a correction. The most popular contract today is the August 25 put, with new positions being bought to open there. The treatment demonstrated a favorable safety profile in comparison to similar drugs, and the triple combo of gedatolisib, Pfizer's (PFE) Ibrance, and AstraZeneca's (AZN) endocrine therapy Faslode reduced the risk of disease progression or death by 76%. Headed for ...

Summary of Celcuity (CELC) Investor Call - July 28, 2025 Company Overview - **Company**: Celcuity (CELC) - **Focus**: Development of geditalisib for HR positive, HER2 negative advanced breast cancer Key Industry Insights - **Clinical Trial**: Phase III VICTORIA-one trial results presented - **Target Population**: Patients with HR positive, HER2 negative advanced breast cancer, specifically those with PIK3CA wild type tumors Core Findings and Results - **Progression-Free Survival (PFS)**: - **Triplet Regimen (geditalisib + fulvestrant + palbociclib)**: Median PFS of 9.3 months vs. 2 months for fulvestrant alone, with a hazard ratio of 0.24, indicating a 4.2 times higher likelihood of survival without disease progression [10][25] - **Doublet Regimen (geditalisib + fulvestrant)**: Median PFS of 7.4 months vs. 2 months for fulvestrant alone, with a hazard ratio of 0.33, indicating a 3 times higher likelihood of survival without disease progression [11][26] - **Significance**: These results are unprecedented in the treatment of this patient population, establishing new milestones in drug development [11][12] Mechanism of Action - **PAM Pathway**: Geditalisib targets the PAM pathway, which is crucial in cancer progression. The drug provides comprehensive blockade of the pathway, reducing the potential for adaptive resistance [8][19] - **Efficacy Across Mutation Status**: Preliminary data shows objective response rates over 50% in patients with or without PIK3CA mutations [20] Safety and Tolerability - **Adverse Events**: Both triplet and doublet regimens were well tolerated, with lower discontinuation rates due to treatment-related adverse events compared to previous studies [28][44] - **Overall Survival Trends**: Positive trends observed, although data is still immature due to crossover from the control arm [29][60] Market Opportunity - **Patient Population**: Estimated 34,000 patients transitioning to second-line treatment after CDK4/6 inhibitors, with approximately 60% being PIK3CA wild type [46] - **Market Size**: Projected market opportunity of $5 billion for geditalisib [46] - **Reimbursement Dynamics**: IV administered drugs like geditalisib typically face smoother reimbursement processes compared to oral drugs [46] Future Plans - **NDA Submission**: Anticipated submission for geditalisib in Q4 2025 [52] - **Upcoming Data Presentations**: Full results from the VICTORIA-one trial to be presented at major medical conferences [30][52] - **Continued Research**: Ongoing studies to explore the efficacy of geditalisib in combination with other therapies, including oral SERDs [74] Conclusion - **Strategic Positioning**: Celcuity is well-positioned to address significant unmet needs in the treatment of HR positive, HER2 negative advanced breast cancer, with geditalisib showing promising clinical results and a strong market opportunity ahead [48][49]

Core Insights - Celcuity Inc. announced positive topline results from the Phase 3 VIKTORIA-1 clinical trial for gedatolisib in combination with fulvestrant, showing significant improvements in progression-free survival (PFS) for patients with HR+/HER2- advanced breast cancer [2][5][9] Efficacy Results - The gedatolisib triplet (gedatolisib + palbociclib + fulvestrant) reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median PFS of 9.3 months versus 2.0 months, representing an incremental improvement of 7.3 months [3][6][7] - The gedatolisib doublet (gedatolisib + fulvestrant) reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months for fulvestrant, an incremental improvement of 5.4 months [4][6][7] Historical Significance - The hazard ratios for both the gedatolisib triplet and doublet are the most favorable reported in any Phase 3 trial for HR+/HER2- advanced breast cancer [7] - The incremental improvements in median PFS for both regimens are unprecedented for patients receiving at least their second line of therapy in this category [7][8] Safety Profile - Treatment discontinuation due to treatment-related adverse events for both the gedatolisib triplet and doublet was lower than observed in previous trials, indicating a favorable safety profile [6][8] - Lower rates of hyperglycemia and stomatitis were reported compared to earlier studies, suggesting better tolerability of the gedatolisib regimens [6][8] Future Developments - Full data from the VIKTORIA-1 trial will be presented at an upcoming medical conference, and Celcuity plans to submit a New Drug Application for gedatolisib to the FDA in Q4 2025 [5][9]

Core Insights - Celcuity Inc. is set to disclose topline results from the Phase 3 VIKTORIA-1 trial on July 28, 2025 [1][2] - The company focuses on developing targeted therapies for oncology, particularly for solid tumors [3] Company Overview - Celcuity is a clinical-stage biotechnology company headquartered in Minneapolis [3] - The lead therapeutic candidate is gedatolisib, a pan-PI3K and mTORC1/2 inhibitor, which targets the PAM pathway [3] - Ongoing clinical trials include VIKTORIA-1 for HR+/HER2- advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [3]

Core Insights - Celcuity Inc. has initiated the Phase 3 clinical trial VIKTORIA-2 to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant for HR+/HER2- advanced breast cancer patients who are resistant to endocrine therapy [1][2][3] Group 1: Clinical Trial Details - The VIKTORIA-2 trial is an open-label, randomized study comparing the efficacy and safety of gedatolisib combined with fulvestrant and a CDK4/6 inhibitor against the standard treatment of fulvestrant and a CDK4/6 inhibitor [3][4] - Approximately 638 subjects will be enrolled, with random assignment to either the experimental group (gedatolisib, fulvestrant, and a CDK4/6 inhibitor) or the control group (fulvestrant and a CDK4/6 inhibitor) [4] - The trial will assess primary endpoints of progression-free survival (PFS) based on RECIST 1.1 criteria, evaluated separately for PI3KCA wild type and mutant subjects [4] Group 2: Efficacy and Safety - Previous Phase 1b trial results indicated that patients receiving gedatolisib with palbociclib and letrozole had a median progression-free survival of 48.6 months and median overall survival of 77.3 months, with an objective response rate of 79% [2] - The trial aims to provide robust data to support the potential of gedatolisib as a first-line treatment option for patients with endocrine-resistant advanced breast cancer [2][3] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5][6] - The company is headquartered in Minneapolis and is also conducting other clinical trials, including VIKTORIA-1 and CELC-G-201, targeting different cancer types [5][6]