The U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted Priority Review with a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, for gedatolisib in HR+/HER2-/PIK3CA wild-type (“WT”) advanced breast cancer (“ABC”)Results from PIK3CA WT cohort of Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2- ABC published in Journal of Clinical OncologyTopline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected ...

Core Insights - Celcuity Inc. will release its financial results for Q4 and full year 2025 on March 25, 2026, after market close, followed by a webcast/teleconference at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update [1] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [3] - Celcuity has completed enrollment for the Phase 3 clinical trial VIKTORIA-1, which evaluates gedatolisib in combination with fulvestrant, with or without palbociclib, for HR+/HER2- advanced breast cancer [3] - The ongoing Phase 3 clinical trial VIKTORIA-2 is assessing gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for endocrine resistant HR+/HER2- advanced breast cancer [3] - A Phase 1/2 clinical trial, CELC-G-201, is also ongoing, evaluating gedatolisib in combination with darolutamide for metastatic castration resistant prostate cancer [3]

Core Insights - Deerfield Management Company disclosed a significant purchase of Celcuity shares, acquiring 980,470 shares valued at approximately $80.60 million in the fourth quarter of 2026 [1][2] - The total value of Deerfield's position in Celcuity reached $170.95 million at the end of the quarter, reflecting an increase of $134.72 million from the previous quarter, driven by both new purchases and share price appreciation [2] Company Overview - Celcuity Inc. is a biotechnology firm focused on precision oncology, utilizing its CELsignia platform and a pipeline of targeted therapeutics to identify specific cellular drivers of cancer for personalized treatment [5] - The company has a market capitalization of $5.3 billion and reported a net income of -$162.72 million over the trailing twelve months [4] Product and Pipeline - Celcuity's lead drug candidate, Gedatolisib, targets the PI3K and mTOR signaling pathways, which are crucial for cancer growth, by blocking multiple components simultaneously [9] - The FDA has accepted Celcuity's new drug application for Gedatolisib in hormone receptor positive, HER2 negative advanced breast cancer, granting it priority review with a decision date set for July 17, 2026 [10] Market Performance - Celcuity's shares have surged over 1,040% in the past year, significantly outperforming the S&P 500's gain of approximately 19% during the same period [7] - The company is expected to release its upcoming quarterly report soon, and as of September 30, it reported having around $455 million in cash and short-term investments, sufficient to fund operations through the next year [11]

Group 1 - The company aims to develop a platform to isolate and quantify the activity of live patient tumor cells to identify patients responsive to targeted therapies [1] - The company has been working in the PI3K space and has identified gedatolisib, a pan-PI3K/mTOR inhibitor, which began development in 2021 [2] - The company has completed one Phase III study and is preparing to report another in the second-line setting for breast cancer, along with a first-line study and an early phase study in prostate cancer [2]

Summary of Celcuity Conference Call Company Overview - **Company**: Celcuity (NasdaqCM:CELC) - **Focus**: Development of a platform to isolate and quantify the activity of live patient tumor cells to identify responsive patients for targeted therapies, particularly in the PI3K space with the drug gedatolisib, a pan-PI3K/mTOR inhibitor [7][8] Key Points and Arguments Clinical Development - **Phase 3 Studies**: Completed one phase three study and has another upcoming report in the second line study for breast cancer, along with a first line study in progress [7][8] - **Efficacy of Gedatolisib**: - Demonstrated unprecedented efficacy in the second line setting with a median progression-free survival (PFS) of 9.3 months compared to 2 months for fulvestrant, with a hazard ratio of 0.24 [34] - Early phase data showed a median PFS of 14.5 months in a cohort of patients with PIK3CA mutations, indicating potential for significant clinical relevance [36][37] - **Targeting the PAM Pathway**: Gedatolisib is believed to effectively target the PAM pathway, which has been suboptimally targeted by other drugs, leading to modest efficacy in a subset of patients [14][15] Market Landscape - **Current Treatments**: The current standard of care for HR-positive breast cancer patients is yielding limited results, with existing therapies like fulvestrant and AI not showing significant improvements [25][26] - **Impact of Competitors**: Recent failures of other oral SERDs in clinical trials provide clarity on treatment regimens and highlight the potential for gedatolisib to fill the gap in treatment efficacy [27][28] Future Studies and Expectations - **Upcoming Data**: Expected to report data on the mutant population by the end of the current quarter or next quarter, with a focus on achieving statistically significant results [36][37] - **Frontline Study**: A phase 3 study targeting HR-positive, treatment-naive patients is in progress, with a safety run-in evaluating gedatolisib combined with ribociclib [55][57] Commercial Strategy - **Sales Force Preparation**: The company is preparing to build a sales force, targeting around 90 representatives, to effectively reach healthcare providers [63][64] - **Market Access**: The intravenous formulation of gedatolisib is expected to facilitate easier reimbursement pathways compared to oral drugs, enhancing market access [67] International Expansion - **Regulatory Strategy**: Plans to submit a Marketing Authorization Application (MAA) in Europe following the mutation data submission to the FDA, with a focus on major markets including the EU and Japan [81][82] Additional Insights - **Prostate Cancer Program**: Gedatolisib is also being evaluated in combination with darolutamide for prostate cancer, showing promising early results [70][71] - **Potential for Other Tumor Types**: There is interest in exploring gedatolisib's efficacy in endometrial cancer, although the landscape is complicated by the use of PD-1 drugs [74] Intellectual Property - **Patent Exclusivity**: The company expects patent term exclusivity through 2042 based on dosing patents, which are critical for optimizing treatment outcomes [76][77] This summary encapsulates the key points discussed during the Celcuity conference call, highlighting the company's strategic direction, clinical developments, and market positioning.

Core Insights - Celcuity Inc. announced significant efficacy results from the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, showing a 76% reduction in disease progression or death with the gedatolisib triplet compared to fulvestrant [1][5] - The trial focused on patients with hormone receptor positive, HER2 negative, PIK3CA wild-type advanced breast cancer who had previously progressed on CDK4/6 inhibitors and aromatase inhibitors [1][2] Efficacy Results - In the PIK3CA wild-type cohort, the median progression-free survival (PFS) for the gedatolisib triplet was 9.3 months, compared to 2.0 months for fulvestrant, representing a 7.3-month improvement (HR=0.24; p<0.0001) [3] - The objective response rate (ORR) for the gedatolisib triplet was 31.5%, while the ORR for fulvestrant was only 1% [3] - For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months for fulvestrant, an improvement of 5.4 months (HR=0.33; p<0.0001) [3] Safety Profile - The gedatolisib triplet and doublet were generally well tolerated, with low-grade treatment-related adverse events (TRAEs) [4] - Common grade 3 TRAEs included neutropenia (52.3% for triplet, 0% for doublet, 0.8% for fulvestrant) and stomatitis (19.2% for triplet, 12.3% for doublet, 0% for fulvestrant) [4] - TRAEs led to treatment discontinuation in 2.3% of patients in the gedatolisib triplet group and 3.1% in the gedatolisib doublet group, with no discontinuations in the fulvestrant group [4] Regulatory Status - The U.S. FDA has granted Priority Review for Celcuity's New Drug Application for gedatolisib, with a Prescription Drug User Fee Act goal date set for July 17, 2026 [5] Background on Breast Cancer - Breast cancer is the second most common cancer globally, with over two million cases diagnosed in 2022 [6] - HR+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases, and therapies targeting the PI3K/AKT/mTOR pathway are crucial for treatment [6][7] About Gedatolisib - Gedatolisib is a multi-target PAM inhibitor that comprehensively blocks the PI3K/AKT/mTOR pathway, differentiating it from single-target inhibitors [9][10] - It has shown comparable potency in both PIK3CA-mutant and wild-type breast tumor cells in early clinical data [9]

Core Insights - Celcuity is a clinical stage company focused on developing drugs targeting the PAM pathway, specifically the PI3K/AKT/mTOR pathway, which is crucial in oncology [1] Group 1: Clinical Trials - The company has three ongoing trials, including a Phase III trial evaluating GEDA in combination with palbociclib and fulvestrant for women who have progressed on prior CDK therapy [1] - A first-line study is being conducted with the same drug combination for treatment-naive women with endocrine-resistant metastatic breast cancer [2] - A third study is in an earlier phase, investigating the drug combination with an androgen receptor inhibitor in men with castration-resistant prostate cancer [2]

Company Overview - Celcuity is a clinical-stage biotechnology company focused on precision oncology, utilizing its proprietary CELsignia platform to identify abnormal cellular signaling in cancer cells and guide targeted therapy development [6] - The company's pipeline includes innovative diagnostic and therapeutic candidates, with a strategic emphasis on addressing unmet needs in breast and ovarian cancer [6] - As of February 17, 2026, Celcuity shares were priced at $107.32, with a market capitalization of $4.97 billion and a net income of ($162.72 million) [4][8] Recent Developments - On February 17, 2026, Boxer Capital Management, LLC disclosed a purchase of 135,000 shares of Celcuity, valued at an estimated $11.10 million based on quarterly average pricing [1][2] - This acquisition increased Boxer Capital's stake in Celcuity to represent 4.9% of the fund's 13F reportable assets, with the reported value of the position rising to $22.44 million, up $18.00 million from the prior quarter [2][3] - Celcuity shares have experienced a significant one-year price change of 741.1%, outperforming the S&P 500 by 721.3 percentage points [3] Competitive Position - Celcuity develops molecularly targeted therapies for cancer, including the CELsignia diagnostic platform and the investigational drug Gedatolisib for breast cancer treatment [8] - The company’s competitive advantage lies in its integrated approach to diagnostics and therapeutics, supported by partnerships such as its license agreement with Pfizer for Gedatolisib [9]

Summary of Celcuity's Fireside Chat at TD Cowen's 46th Annual Healthcare Conference Company Overview - **Company**: Celcuity - **Focus**: Clinical-stage biotechnology company developing drugs targeting the PAM pathway, specifically the PI3K/AKT/mTOR pathway, which is crucial in oncology [3][3]. Key Trials and Developments - **Ongoing Trials**: - **Phase 3 Trial**: Evaluating Gedatolisib in combination with palbociclib and fulvestrant for women who have progressed on prior CDK therapy [3][3]. - **First-Line Study**: Same drug combination for treatment-naive women with endocrine-resistant metastatic breast cancer [3][3]. - **Earlier Phase Study**: Investigating Gedatolisib with an androgen receptor inhibitor in men with castration-resistant prostate cancer [3][3]. Regulatory Insights - **RTOR Designation**: Celcuity received Real-Time Oncology Review (RTOR) designation, which allows for early submission of data to the FDA, potentially shortening approval timelines for supplemental NDAs [11][11]. - **PDUFA Date**: The priority review is expected to conclude six months after the NDA acceptance, with expectations aligned with historical outcomes for similar drugs [12][12]. Launch Preparation - **Commercial Strategy**: A comprehensive launch plan has been in place for two years, focusing on building a commercial team and infrastructure across various departments [21][21][22][22]. - **Sales Force**: The hiring of sales representatives is expected to begin in the second quarter, aligning with the anticipated launch of Gedatolisib [22][22]. Market Segmentation and Patient Focus - **Target Patient Population**: The primary focus will be on PIK3CA wild type patients, constituting approximately 60% of the market. Data on mutant cohorts will be available prior to the launch, which could enhance market positioning [28][28]. - **Market Dynamics**: Celcuity anticipates a competitive landscape, particularly in the 20% of the market with ESR1 mutations, but believes it holds a significant advantage in the remaining 80% [78][78]. Efficacy and Safety Profile - **Efficacy Expectations**: The company aims for a median progression-free survival (PFS) of at least 10 months, which is statistically significant compared to existing treatments [43][43][45][45]. - **Safety Profile**: Gedatolisib shows a favorable safety profile with low rates of hyperglycemia (less than 10% overall, 2% grade three), contrasting sharply with competitors like alpelisib, which has an 80% hyperglycemia rate [64][64][66][66]. Financial Projections - **Revenue Potential**: Celcuity estimates a potential peak revenue exceeding $10 billion from Gedatolisib in breast cancer treatment, highlighting the significant market opportunity [95][95]. Conclusion - **Underappreciated Aspects**: The size of the patient population eligible for treatment and the potential impact of an effective drug targeting critical disease drivers are seen as key factors that could reshape investor perceptions [96][96].

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