Financial Data and Key Metrics Changes - The fourth quarter net loss was $36.7 million or $0.85 per share compared to a net loss of $18.8 million or $0.65 per share for the fourth quarter of 2023 [41] - The full year net loss for 2024 was $111.8 million or $2.83 per share compared to a net loss of $63.8 million or $2.69 per share for the same period in 2023 [41] - Non-GAAP adjusted net loss for the fourth quarter of 2024 was $32.3 million or $0.75 per share compared to $17.6 million or $0.61 per share for the fourth quarter of 2023 [42] - Research and development expenses were $33.5 million for the fourth quarter of 2024 compared to $18.1 million for the fourth quarter of 2023 [42] - The company ended the year with approximately $235.1 million of cash, cash equivalents, and short-term investments, compared to $180.6 million on December 31, 2023 [45] Business Line Data and Key Metrics Changes - The increase in R&D expenses year-over-year was primarily due to ongoing activities supporting the Victoria 1 Phase 3 trial and the Phase 1B2 prostate trial, along with the commencement of the Victoria 2 Phase 3 trial [43] - General and administrative expenses were $3 million for the fourth quarter of 2024 compared to $1.6 million for the same period in 2023 [43] Market Data and Key Metrics Changes - The company estimates that approximately 15,000 to 20,000 patients with endocrine therapy-resistant advanced breast cancer are diagnosed each year in the United States alone [35] - The potential peak revenue for the second line indication could exceed $2 billion with just 40% market penetration [31] Company Strategy and Development Direction - The company anticipates 2025 to be a transformational year, expecting to report several important clinical data readouts [11] - The strategy includes the development of an optimized PAM inhibitor that targets all class I PI3K isoforms and mTORC1 and 2 to improve the standard of care in HR-positive HER2-negative advanced breast cancer [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for gadotilisib to be well-tolerated and provide clinically meaningful benefits, which could favor its positioning in the treatment landscape [19] - The company is focused on optimizing the dose and schedule for the prostate cancer program, with preliminary data expected by the end of the second quarter of this year [37] Other Important Information - The company reported overall survival data from its Phase 1b study for treatment-naive and CDK4-6 pretreated patients, indicating promising results [39] - The company plans to initiate a real-time oncology review request soon after obtaining top-line data [54] Q&A Session Summary Question: Current status of the event rate for Victoria 1 - Management is not commenting on specifics related to achieving the ability to report top-line data at this stage [52] Question: Plans following the second quarter readout and NDA filing - The company hopes to initiate an RTOR request soon after top-line data is available, with expectations for priority review due to breakthrough status [54] Question: Extent of data planned to share in the 2Q top line - The company expects to present median PFS data for each of the three arms in the wild-type cohort and corresponding hazard ratios [60] Question: Feedback from investigators regarding the recent letter from Roche - Management refrained from commenting on Roche's situation but noted that PI3K alpha inhibitors require careful monitoring [62] Question: How closely to look at patient baseline characteristics in upcoming data - Management emphasized the importance of understanding patient populations and the relevance of hazard ratios for interpreting data [75] Question: Assumptions behind the $2 billion second line opportunity - The estimate is based on third-party data, with assumptions about patient numbers and pricing for proprietary drugs [84]

Financial Performance - Celcuity reported a net loss of approximately $111.8 million for the year ended December 31, 2024, compared to a net loss of $63.8 million for 2023[314]. - The net loss for the year ended December 31, 2024, was $111.8 million, a 75% increase from the previous year[323]. - Net cash used in operating activities was approximately $83.5 million for the year ended December 31, 2024, compared to $53.8 million in 2023[345][346]. - Net cash used in investing activities for 2024 was approximately $63.1 million, significantly higher than $5.0 million in 2023[347][348]. - Net cash provided by financing activities for 2024 was approximately $138.4 million, up from $64.9 million in 2023[349][350]. - The company raised approximately $369.0 million in net proceeds through equity securities and convertible notes from inception through December 31, 2024[330]. - As of December 31, 2024, Celcuity had cash and cash equivalents of approximately $235.1 million and an accumulated deficit of approximately $271.9 million[314]. - As of December 31, 2024, the company had cash and cash equivalents of approximately $22.5 million and short-term investments of $212.6 million[330]. - The Company believes its current cash and available borrowings will be sufficient to finance clinical development activities through 2026[342]. - The Company may seek additional capital to finance future expenditures and operations, which could result in dilution to existing shareholders[343]. Research and Development - Gedatolisib has been administered to 492 patients across eight clinical trials, with 129 patients receiving it as a single agent[299]. - In the Phase 1b clinical trial, the overall response rate (ORR) for treatment-naïve patients was 85%, while the ORR for patients who received prior hormonal therapy ranged from 36% to 77%[302]. - The median progression-free survival (PFS) for treatment-naïve patients receiving gedatolisib combined with palbociclib plus letrozole was 48.6 months[303]. - The VIKTORIA-1 Phase 3 clinical trial is fully enrolled for the PIK3CA wild-type cohort, with topline data expected in Q2 2025[311]. - The VIKTORIA-2 Phase 3 trial is set to enroll its first patient in Q2 2025, evaluating gedatolisib in combination with fulvestrant and a CDK4/6 inhibitor[312]. - The FDA approved the clinical development of gedatolisib in combination with Nubeqa® for metastatic castration-resistant prostate cancer in mid-2023[307]. - The Phase 1b/2 study CELC-G-201 is currently enrolling patients with mCRPC, with initial data expected by the end of Q2 2025[309]. - Gedatolisib's unique mechanism of action targets all Class I isoforms of PI3K and both mTOR complexes, potentially overcoming limitations of existing therapies[294]. - The Company expects to incur increased research and development expenses as it continues to develop gedatolisib and manage multiple clinical trials[341]. - The company plans to increase research and development expenses to support ongoing clinical trials, including VIKTORIA-1 and VIKTORIA-2[325]. Expenses - Research and development expenses for the year ended December 31, 2024, were approximately $104.2 million, an increase of 72% compared to 2023[324]. - General and administrative expenses for the year ended December 31, 2024, totaled $9.1 million, reflecting a 61% increase from 2023[326]. - Interest expense for the year ended December 31, 2024, was $10.3 million, up 93% compared to 2023, primarily due to increased debt[328]. - Interest income for the year ended December 31, 2024, was $11.8 million, representing a 51% increase compared to 2023[329]. - The Company anticipates future increases in general and administrative expenses due to potential commercialization of gedatolisib and expanding infrastructure[327]. - The Company anticipates increased sales and marketing expenses as it commercializes gedatolisib[341]. Debt and Financing - The company entered into an Amended and Restated Loan and Security Agreement on May 30, 2024, with a total principal amount of up to $180 million[335]. - The Company recognized a Final Fee of $4.5 million as additional debt principal on May 30, 2024[338]. - The Company issued 103,876 warrants with an exercise price of $14.84 per share, with a relative fair value of approximately $1.2 million[340].

Financial Performance - Net loss for Q4 2024 was $36.7 million, or $0.85 loss per share, compared to a net loss of $18.8 million, or $0.65 loss per share, for Q4 2023[13] - The net loss for the three months ended December 31, 2024, was $36,653,041, compared to a net loss of $18,848,472 for the same period in 2023, representing a 94.5% increase[22] - The total net loss for the twelve months ended December 31, 2024, was $111,779,105, compared to $63,779,116 for the same period in 2023, a 75.2% increase[22] - The non-GAAP adjusted net loss for the three months ended December 31, 2024, was $32,271,697, compared to $17,631,428 for the same period in 2023, indicating an increase of 83.1%[26] - The non-GAAP adjusted net loss per share for the three months ended December 31, 2024, was $0.75, compared to $0.61 for the same period in 2023, indicating a 22.9% increase[26] Operating Expenses - Total operating expenses for Q4 2024 were $36.4 million, up from $19.7 million in Q4 2023, representing an increase of 84.5%[7] - General and administrative (G&A) expenses for Q4 2024 were $3.0 million, up from $1.6 million in Q4 2023, an increase of 87.5%[11] - For the three months ended December 31, 2024, the total operating expenses were $36,430,131, a 84.8% increase from $19,729,273 in the same period of 2023[22] Research and Development - Research and development (R&D) expenses for Q4 2024 were $33.5 million, compared to $18.1 million in the prior-year period, reflecting an increase of 85.0%[8] - R&D expenses for the full year 2024 totaled $104.2 million, compared to $60.6 million in 2023, marking an increase of 72.0%[9] - Research and development expenses for the three months ended December 31, 2024, were $33,471,213, up from $18,081,194 in the same period of 2023, marking an increase of 85.1%[22] Cash and Investments - Cash, cash equivalents, and short-term investments were approximately $235.1 million at the end of Q4 2024, expected to fund clinical development activities through 2026[5] Trials and Clinical Development - The VIKTORIA-1 Phase 3 trial is fully enrolled for the PIK3CA wild-type cohort, with topline data expected in Q2 2025[6] - The Phase 1b/2 trial for metastatic castration resistant prostate cancer is on track to report preliminary data in late Q2 2025[10] - The VIKTORIA-2 Phase 3 trial is expected to enroll its first patient in Q2 2025, with approximately 200 sites planned across multiple regions[6] Liabilities and Shares - Total liabilities increased to $129.5 million as of December 31, 2024, compared to $51.5 million at the end of 2023[20] - The weighted average common shares outstanding, basic and diluted, increased to 42,873,934 for the three months ended December 31, 2024, from 28,900,075 in the same period of 2023, a rise of 48.4%[26] Interest Income and Expense - Interest expense for the three months ended December 31, 2024, was $3,275,161, compared to $1,397,247 in the same period of 2023, reflecting a 134.0% increase[22] - Interest income for the three months ended December 31, 2024, was $3,052,251, up from $2,278,048 in the same period of 2023, representing an increase of 33.9%[22]

MINNEAPOLIS, March 31, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the fourth quarter ended December 31, 2024 and other recent business developments. "We expect 2025 to be a transformational year for Celcuity as we anticipate reporting several clinical data readouts, including primary analysis for the PIK3CA wild-type cohort of the VIKTORIA-1 trial. We expect to sh ...

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor, which has differentiated pharmacokinetic properties compared to other therapies targeting PI3K or mTOR [3] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [3] - A Phase 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - A second Phase 3 clinical trial, VIKTORIA-2, is expected to begin enrolling patients in Q2 2025, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Financial Results Announcement - Celcuity will release its financial results for Q4 and full year 2024 after market close on March 31, 2025, followed by a webcast/teleconference at 4:30 p.m. Eastern Time [1]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor, which has differentiated pharmacokinetic properties compared to other therapies targeting PI3K or mTOR [3] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [3] - A Phase 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - A second Phase 3 clinical trial, VIKTORIA-2, is expected to begin enrolling patients in Q2 2025, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Financial Results Announcement - Celcuity will release its financial results for Q4 and full year 2024 after market close on March 31, 2025, followed by a webcast/teleconference at 4:30 p.m. Eastern Time [1]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [1] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor, which has a differentiated mechanism of action compared to other therapies targeting PI3K or mTOR [1] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [1] - A Phase 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [1] - A second Phase 3 clinical trial, VIKTORIA-2, is expected to begin enrolling patients in Q2 2025, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [1] Investor Engagement - Brian Sullivan, CEO and Co-founder of Celcuity, will present at investor conferences, including the TD Cowen 45th Annual Health Care Conference on March 4, 2025, and the Leerink Global Healthcare Conference 2025 on March 12, 2025 [2]

Group 1 - Celcuity is focused on developing gedatolisib, a pan-PI3K/mTOR inhibitor aimed at treating advanced breast cancer [1] - The company is currently undervalued, with its market valuation reflecting skepticism rather than its potential [1] - Gedatolisib has been designated as a Breakthrough Therapy, indicating its significance in the treatment landscape [1] Group 2 - The company operates in a high-growth sector, particularly in the field of innovative cancer therapies [1] - There is a strong belief in the potential of disruptive technologies to generate substantial returns in the investment landscape [1]

Core Insights - Celcuity Inc. announced promising overall survival data from a Phase 1b trial of gedatolisib in combination with palbociclib for patients with HR+, HER2- advanced breast cancer [1][2][3] Group 1: Clinical Trial Results - Median overall survival (OS) for treatment-naïve patients was reported at 77.3 months with a 95% confidence interval (CI) of 50.3 to 89.0 [2] - For patients previously treated with a CDK4/6 inhibitor, the median OS was 33.9 months with a 95% CI of 17.8 to 52.3 [2] - The results are favorable compared to existing first- or second-line standard-of-care regimens for the same patient population [3] Group 2: Mechanism and Development Strategy - Gedatolisib is a pan-PI3K/mTORC1/2 inhibitor that targets all Class I PI3K isoforms, potentially reducing drug resistance compared to isoform-specific inhibitors [4] - The clinical development strategy involves blocking multiple signaling pathways (ER, CDK4/6, and PAM) to enhance treatment efficacy [3] - Two Phase 3 clinical trials, VIKTORIA-1 and VIKTORIA-2, are planned to further evaluate this treatment strategy in HR+, HER2- advanced breast cancer [3][5] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on targeted therapies for solid tumors, with gedatolisib as its lead candidate [5] - The company is currently enrolling patients for the VIKTORIA-1 trial and plans to begin the VIKTORIA-2 trial in Q2 2025 [5]

Financial Data and Key Metrics Changes - The net loss for Q3 2024 was $29.8 million or $0.70 per share, compared to a net loss of $18.4 million or $0.83 per share for Q3 2023 [32] - The non-GAAP adjusted net loss was $27.6 million or $0.65 per share for Q3 2024, compared to a non-GAAP adjusted net loss of $17.3 million or $0.78 per share for Q3 2023 [33] - Cash, cash equivalents, and short-term investments at the end of Q3 2024 were approximately $264.1 million, up from $180.6 million at December 31, 2023 [36] Business Line Data and Key Metrics Changes - Research and development expenses increased to $27.6 million in Q3 2024 from $17.5 million in Q3 2023, primarily due to activities supporting the VIKTORIA-1 and VIKTORIA-2 trials [34] - General and administrative expenses rose to $2.5 million in Q3 2024 from $1.4 million in Q3 2023, driven by employee and consulting-related expenses [35] Market Data and Key Metrics Changes - The company is on track to enroll the first patient in the VIKTORIA-2 Phase III trial in Q2 2025, with site qualification activities ongoing across multiple regions [24][25] Company Strategy and Development Direction - The company aims to establish a triplet regimen that includes gedatolisib to optimize antitumor control in HR-positive, HER2-negative advanced breast cancer [19][21] - Feedback from oncologists indicates a preference for delaying chemotherapy until the benefits of endocrine therapies are exhausted, which may favor gedatolisib's positioning [16][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for gedatolisib, particularly regarding its IV administration route and its expected peak revenue potential exceeding $2 billion [23] - The company is focused on the evolving treatment landscape and believes that simultaneous blockade of key signaling pathways is essential for improving patient outcomes [19] Other Important Information - The company plans to present clinical and non-clinical data at the San Antonio Breast Cancer Symposium in December, highlighting the progress made in clinical development [30] Q&A Session Summary Question: Insights on event rate and enrollment - Management noted that the higher proportion of mutated patients affected the enrollment rate for the wild-type population, but overall enrollment is ahead of expectations [40] Question: Impact of Roche's approval on gedatolisib - Management believes that the approval of inavolisib will not significantly reduce the patient population for gedatolisib, as their target population is different [43] Question: Expectations for mPFS numbers - Management indicated a desire to see two years of median progression-free survival (mPFS) and noted that a three-month delta relative to control would be meaningful [56][59] Question: Enrollment expectations for VIKTORIA-2 - Management is optimistic about enrollment rates for VIKTORIA-2, expecting them to be at least as good as VIKTORIA-1 due to the experience gained [65]