Core Insights - Celcuity reported a narrower-than-expected net loss for Q4 2025, leading to a stock price increase of over 4% [1] Financial Performance - The company did not report any revenue for Q4 or the full year 2025 [2] - Operating expenses rose to over $49 million from over $36 million in Q4 2024 [2] - The net loss under GAAP increased to $38.4 million ($0.73 per share) from $32.3 million the previous year, which was better than analysts' expectations of a $1.05 per share loss [3] Clinical Developments - Celcuity anticipates topline results from a phase 3 clinical trial of gedatolisib for advanced breast cancer, expected in Q2 [4] Cash Position - The company had cash and cash equivalents of nearly $166 million at the end of the quarter, significantly up from $22.5 million at the end of 2024, providing a solid financial foundation for future operations [6] Market Sentiment - The positive financial update and upcoming trial results contribute to a bullish outlook for the company [7]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Financial Data and Key Metrics Changes - The fourth quarter net loss was $51 million or $0.97 per share, compared to a net loss of $36.7 million or $0.85 per share for the fourth quarter of 2024 [25] - The full year net loss was $177 million or $3.79 per share, compared to $111.8 million or $2.83 per share for the same period in 2024 [25] - Non-GAAP adjusted net loss for the fourth quarter was $38.4 million or $0.73 per share, compared to $32.3 million or $0.75 per share for the fourth quarter of 2024 [26] - Non-GAAP adjusted net loss for the full year was $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share for 2024 [26] - Cash, cash equivalents, and short-term investments were $441.5 million at the end of fiscal year 2025, expected to finance operations through 2027 [30] Business Line Data and Key Metrics Changes - Research and development expenses for the fourth quarter were $37.6 million, up from $33.5 million for the prior year period [27] - R&D expenses for the full year were $145 million, compared to $104.2 million for the prior year [27] - General and administrative expenses for the fourth quarter were $11.6 million, compared to $3 million for the prior year period [28] - G&A expenses for the full year were $27.2 million, compared to $9.1 million for the prior year [28] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be more than $5 billion, with potential peak revenue of up to $2.5 billion annually [18] Company Strategy and Development Direction - The company is preparing for the potential approval and commercialization of gedatolisib, with a PDUFA goal date of July 17, 2026 [5] - The company aims to establish gedatolisib as a new standard of care therapy for patients with HR-positive, HER2-negative advanced breast cancer [5] - The company is engaging with payers and strategic accounts to ensure access to gedatolisib for oncologists and their patients [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's review of the NDA based on unprecedented efficacy data from the phase III VIKTORIA-1 clinical trial [6] - The company believes that the positive results from the PIK3CA wild-type cohort will position gedatolisib favorably in the market [14] - Management highlighted the importance of the safety profile of gedatolisib, which does not induce clinically relevant hypoglycemia [11][70] Other Important Information - The company has completed enrollment of the PIK3CA mutant cohort of the phase III VIKTORIA-1 trial and expects to announce results in the second quarter [7] - The company is also evaluating gedatolisib in combination with darolutamide for men with metastatic castration-resistant prostate cancer [15] Q&A Session Summary Question: Status update on the mutant data - Management could not comment on the database lock status [33] Question: Details on the disclosure of mutant data - Management indicated that top-line data will be provided in a press release, with details at a medical conference [34] Question: Feedback from physicians on launch segments - Management stated that the sales force will reach out generally to doctors to help them understand the benefits of gedatolisib [43] Question: Will physicians use it off-label for mutants? - Management confirmed that there have been no discussions with doctors about off-label use [44] Question: Details on the top-line release of median data - Management confirmed that the release will include a statement regarding the achievement of statistical significance [48] Question: Key gating factor for frontline endocrine-sensitive trial - The key gating factor is completing the safety run-in [58] Question: Challenges in getting patients for infusions - Management believes that efficacy is the most important factor for physicians and does not expect significant patient pushback on IV administration [61] Question: Commercial advantages of having a label across metastatic breast cancer subtypes - Management aims to simplify decision-making for physicians by providing a biomarker-agnostic alternative [66] Question: Learnings from the launch of inavolisib - Management noted that gedatolisib does not induce significant glycemic disruption, allowing broader patient treatment [70] Question: European commercial strategy for gedatolisib - Management plans to submit a supplemental NDA after initial approval and explore partnerships for launching in Europe [78]

Financial Data and Key Metrics Changes - The fourth quarter net loss was $51 million or $0.97 per share, compared to a net loss of $36.7 million or $0.85 per share for the fourth quarter of 2024 [25] - The full year net loss was $177 million or $3.79 per share, compared to $111.8 million or $2.83 per share for the same period in 2024 [25] - Non-GAAP adjusted net loss for the fourth quarter was $38.4 million or $0.73 per share, compared to $32.3 million or $0.75 per share for the fourth quarter of 2024 [26] - Non-GAAP adjusted net loss for the full year was $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share for 2024 [26] - Cash, cash equivalents, and short-term investments were $441.5 million at the end of fiscal year 2025, expected to finance operations through 2027 [30] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for the fourth quarter were $37.6 million, up from $33.5 million for the prior year [27] - R&D expenses for the full year were $145 million, compared to $104.2 million for the prior year [27] - General and administrative (G&A) expenses for the fourth quarter were $11.6 million, compared to $3 million for the prior year [28] - G&A expenses for the full year were $27.2 million, compared to $9.1 million for the prior year [28] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be more than $5 billion, with potential peak revenue of up to $2.5 billion annually [18] Company Strategy and Development Direction - The company is preparing for the potential approval and commercialization of gedatolisib, aiming to establish it as a new standard of care for HR-positive, HER2-negative advanced breast cancer [5][19] - The company has engaged extensively with payers and strategic accounts to ensure access to gedatolisib upon approval [16][90] - The company plans to conduct a supplemental NDA submission for the mutant cohort following initial approval for gedatolisib [76] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the NDA for gedatolisib, citing unprecedented efficacy data from clinical trials [6][17] - The company believes that gedatolisib's unique mechanism of action and safety profile position it well in the market [19][92] - Management highlighted the importance of efficacy as the primary factor influencing physician and patient decisions regarding treatment [62] Other Important Information - The company completed enrollment of the PIK3CA mutant cohort of the phase III VIKTORIA-1 trial and expects to announce results in the second quarter of 2026 [7] - Safety results from clinical trials indicated that gedatolisib was generally well-tolerated, with low rates of treatment-related adverse events [10][11] Q&A Session Summary Question: Status update on the mutant data - Management could not comment on the database lock status for the mutant data [33] Question: Details on the disclosure of mutant data - Management indicated that top-line data will be provided in a press release, with further details at a medical conference [34] Question: Feedback from physicians on treatment segments - Management stated that the sales force will reach out to doctors generally to explain how gedatolisib offers improvements over current alternatives [43] Question: Will physicians use gedatolisib off-label for mutants? - Management confirmed that there have been no discussions with doctors regarding off-label use [44] Question: Details on the top-line release of median data - Management stated that the release will include a statement regarding the achievement of statistical significance [48] Question: Key gating factor for frontline endocrine-sensitive trial - The key gating factor is completing the safety run-in for the trial [58] Question: Challenges in getting patients for infusions - Management believes that efficacy will be the most important factor for physicians and patients, and they do not expect significant pushback on IV administration [61] Question: Commercial advantages of having a label across metastatic breast cancer subtypes - Management aims to simplify decision-making for physicians by providing a biomarker-agnostic alternative [66] Question: Learnings from the launch of inavolisib - Management noted that gedatolisib does not induce significant glycemic disruption, allowing broader patient eligibility [70] Question: European commercial strategy for gedatolisib - Management plans to explore partnerships for launching gedatolisib in Europe while proceeding with regulatory activities [78]

Financial Data and Key Metrics Changes - The net loss for Q4 2025 was $51 million or $0.97 per share, compared to a net loss of $36.7 million or $0.85 per share for Q4 2024 [22] - The net loss for the full year 2025 was $177 million or $3.79 per share, compared to $111.8 million or $2.83 per share for 2024 [23] - Non-GAAP adjusted net loss for Q4 2025 was $38.4 million or $0.73 per share, compared to $32.3 million or $0.75 per share for Q4 2024 [24] - Non-GAAP adjusted net loss for the full year 2025 was $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share for 2024 [24] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for Q4 2025 were $37.6 million, up from $33.5 million in the prior year [25] - R&D expenses for the full year 2025 were $145 million, compared to $104.2 million for the prior year [25] - General and administrative (G&A) expenses for Q4 2025 were $11.6 million, compared to $3 million for the prior year [26] - G&A expenses for the full year 2025 were $27.2 million, compared to $9.1 million for the prior year [26] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be more than $5 billion, with potential peak revenue of up to $2.5 billion annually [17] Company Strategy and Development Direction - The company aims to establish gedatolisib as a new standard of care therapy for HR-positive, HER2-negative advanced breast cancer, with a PDUFA goal date of July 17, 2026 [4] - The company is preparing for the potential launch of gedatolisib, having built a sales force and internal systems required for commercial operations [15] - The company is engaging with payers and strategic accounts to ensure access to gedatolisib for oncologists and their patients [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the NDA for gedatolisib, citing unprecedented efficacy data from clinical trials [5] - The company believes that the positive results from the PIK3CA wild-type cohort of the VIKTORIA-1 study will support the efficacy of gedatolisib in the second-line setting [12] - Management highlighted the importance of the safety profile of gedatolisib, which does not induce significant glycemic disruption, making it suitable for a broader patient population [68] Other Important Information - Cash, cash equivalents, and short-term investments were $441.5 million at the end of fiscal year 2025, expected to finance operations through 2027 [28] Q&A Session Summary Question: Status of mutant data database lock - Management could not comment on the database lock status [31] Question: Details on the mutant data disclosure - Management indicated that top-line data will be provided in a press release, with details at a medical conference [32] Question: Feedback from physicians on launch segments - Management stated that the sales force will reach out to doctors generally to explain how gedatolisib offers improvements over current alternatives [40] Question: Will physicians use gedatolisib off-label for mutants? - Management confirmed that there have been no discussions with doctors about off-label use [41] Question: Details on the top-line release of median data - Management confirmed that the top-line release will include a statement regarding the achievement of statistical significance [46] Question: Key gating factor for frontline endocrine-sensitive trial - The key gating factor is completing the safety run-in for the trial [56] Question: Challenges in getting patients for infusions - Management believes that efficacy is the most important factor for physicians and that patient pushback on IV administration will be minimal [58] Question: Thoughts on competition from next-generation assets - Management believes that comprehensive inhibition of the PI3K pathway is necessary for optimal antitumor control, and they see limited biological potential in single-target inhibitors [90]

Core Insights - Celcuity Inc. is positioned for a transformative year in 2026, with anticipated topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study, which could enhance treatment standards for HR+/HER2- advanced breast cancer patients [2] - The FDA has accepted Celcuity's New Drug Application for gedatolisib, granting Priority Review with a PDUFA goal date of July 17, 2026 [4] Business Highlights - The Phase 3 VIKTORIA-1 study has shown promising results, with a median progression-free survival of 16.6 months for the gedatolisib triplet compared to 1.9 months for fulvestrant, indicating a significant improvement in patient outcomes [5] - The gedatolisib triplet demonstrated a median time to definitive deterioration of 23.7 months, significantly better than the 4.0 months for fulvestrant [5] - The triplet therapy was generally well tolerated, with low-grade treatment-related adverse events reported [5] Financial Results - Total operating expenses for Q4 2025 were $49.2 million, up from $36.4 million in Q4 2024, while full-year operating expenses reached $172.2 million compared to $113.3 million in 2024 [7] - Research and development expenses for Q4 2025 were $37.6 million, an increase from $33.5 million in the prior year, driven by higher employee and consulting costs [8] - The net loss for Q4 2025 was $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share, in Q4 2024 [12] Cash Position - Cash, cash equivalents, and short-term investments totaled $441.5 million at the end of 2025, expected to finance operations through 2027 [14]

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]

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]