Summary of the Oncology Innovation Summit - CellCuity Fireside Chat Company Overview - **Company**: CellCuity - **Focus**: Development of a platform to quantify signaling pathway activity in live tumor cells, specifically targeting the PI3K AKT mTOR pathway, referred to as the PAM pathway, which is a significant oncogenic pathway and represents a large untapped drug development opportunity in solid tumors [4][5] Key Assets and Studies - **Lead Asset**: Gadotelisib, a pan-PI3K inhibitor - **Ongoing Studies**: - Phase 3 study in second-line patients with ER-positive, HER2-negative advanced breast cancer, data expected in Q3 for wild type cohort and Q4 2025 for PIK3CA mutant cohort [5][6] - Phase 3 study for first-line HR-positive, HER2-negative advanced breast cancer, enrollment expected to begin this quarter [6] - Phase 1b study in prostate cancer for metastatic castration-resistant prostate cancer, top-line data expected later this month [6] Differentiation in the Market - **Mechanism of Action**: Unlike other inhibitors that target single components of the PAM pathway, CellCuity's approach addresses multiple targets, which is crucial due to feedback loops that can lead to adaptive resistance [9][10] - **Potency**: Gadotelisib is reported to be 300 times more potent than other approved single-target PAM inhibitors and is the only drug effective in both tumor cells with and without PIK3CA mutations [11][12] Clinical Expectations and Comparisons - **Hazard Ratio (HR)**: A hazard ratio of 0.5 or below is considered compelling for the upcoming phase 3 wild type data [20] - **Comparative Studies**: Previous studies have shown HRs ranging from 0.59 to 0.68, with no study reporting an HR below 0.5 in similar patient populations [20][21] - **Phase 1b Data**: In the phase 1b study, 60% of patients had an objective response, with 49% progression-free at 12 months, indicating favorable results compared to existing therapies [38][39] Safety Profile - **Adverse Events**: Gadotelisib has shown a lower incidence of hypoglycemia compared to other drugs in the class, with a discontinuation rate of 4% in early studies versus over 26% for other drugs [48][49] - **Patient Tolerance**: Preliminary data suggests good tolerance among patients, with no discontinuations due to adverse events related to hypoglycemia [48][49] Market Opportunity and Administration - **Efficacy vs. Safety**: The primary factors influencing physician decisions will be efficacy and safety, with convenience being a secondary consideration [51] - **Infused vs. Oral Drugs**: Infused drugs are more common in oncology, and while oral drugs offer convenience, they can lead to compliance issues due to side effects [54][55] - **Financial Considerations**: Infused drugs may have less cumbersome reimbursement processes compared to oral drugs, which can expose patients to high co-pays [54][55] Conclusion - The upcoming data in Q3 and Q4 is highly anticipated, with expectations for significant insights into the efficacy and safety of CellCuity's lead asset, gadotelisib, in treating advanced breast cancer and prostate cancer [56]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [2] - The company's lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [2] - Celcuity is headquartered in Minneapolis and provides further information on its website [2] 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 [2] - A Phase 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [2] - Another Phase 3 clinical trial, VIKTORIA-2, is recruiting patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [2] Investor Engagement - Brian Sullivan, CEO and Co-founder of Celcuity, will present at investor conferences and be available for one-on-one meetings [1] - Live webcasts of the presentations will be accessible on the company's website, with replays available shortly after the events [1] - Upcoming events include a fireside chat at the TD Cowen: 6th Annual Oncology Innovation Summit on May 28, 2025, and at the Jefferies Global Healthcare Conference on June 5, 2025 [3]

Clinical Trials and Development - Gedatolisib is currently being evaluated in multiple clinical trials, including the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer, with the first patient dosed in December 2022[69]. - The VIKTORIA-1 trial aims to enroll 351 subjects with PIK3CA WT tumors, with topline data expected in Q3 2025, while enrollment for PIK3CA MT tumors is ongoing[70]. - The company has initiated a Phase 1b/2 trial (CELC-G-201) for gedatolisib in combination with darolutamide for patients with metastatic castration-resistant prostate cancer, with the first patient dosed in February 2024[71]. - Site activation for the VIKTORIA-2 Phase 3 trial is underway, with the first patient expected to be dosed in Q2 2025[76]. - The company initiated the VIKTORIA-1 Phase 3 clinical trial in 2022 and plans to report topline data in the fourth quarter of 2025[81]. - The company has initiated a second Phase 3 clinical trial, VIKTORIA-2, with the first patient dosing planned for the second quarter of 2025[82]. Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of approximately $37.0 million, compared to a net loss of $21.6 million for the same period in 2024, representing a 71% increase in losses[89]. - Research and development expenses for the three months ended March 31, 2025, were approximately $32.2 million, an increase of $11.6 million or 56% compared to the same period in 2024[90]. - General and administrative expenses for the three months ended March 31, 2025, were approximately $3.9 million, reflecting an increase of $2.1 million or 112% compared to the same period in 2024[92]. - Interest expense for the three months ended March 31, 2025, was $3.2 million, an increase of $1.8 million or 127% compared to the same period in 2024[94]. - Net cash used in operating activities was approximately $35.9 million for the three months ended March 31, 2025, compared to $17.1 million for the same period in 2024[110][111]. - Net cash provided by investing activities was approximately $24.3 million for the three months ended March 31, 2025, compared to $3.5 million for the same period in 2024[112][113]. - Net cash provided by financing activities was approximately $5.6 million for the three months ended March 31, 2025, primarily from the exercise of 695,650 common stock warrants at an exercise price of $8.05[114]. - The company raised an aggregate of approximately $374.6 million of net proceeds through sales of its securities from inception through March 31, 2025[96]. - The company has an accumulated deficit of approximately $308.9 million as of March 31, 2025[79]. Revenue Potential and Market Position - The company estimates peak revenue potential for gedatolisib in the second-line indication could exceed $2 billion with 40% market penetration if FDA approval is obtained for both PIK3CA WT and MT populations[75]. - Gedatolisib's unique mechanism of action allows for comprehensive inhibition of the PI3K/AKT/mTOR pathway, potentially overcoming resistance seen with isoform-specific inhibitors[60]. - The company has exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer, enhancing its competitive position in the market[59]. Safety and Efficacy - Gedatolisib has shown a high overall response rate (ORR) of 85% in treatment-naïve patients and 63% in all evaluable patients in the Phase 1b clinical trial[66]. - The median progression-free survival (PFS) for treatment-naïve patients receiving gedatolisib combined with palbociclib plus letrozole was 48.6 months[67]. - Gedatolisib's safety profile is favorable, with only 7% of patients experiencing Grade 3 or 4 hyperglycemia in clinical trials, compared to 39% for an FDA-approved oral PI3K inhibitor[63]. Future Expectations and Risks - The company expects research and development expenses to increase as it continues to develop gedatolisib and conduct multiple clinical trials[106]. - The company believes its current cash, cash equivalents, and short-term investments will be sufficient to finance clinical development activities through 2026[107]. - The company may seek to raise additional capital through various means, which could result in dilution to existing shareholders[108]. - The company anticipates increased costs associated with being a public company and plans to raise capital to fund its operations and expansion[120]. - The company faces known and unknown risks that may materially affect its results, including challenges in developing and commercializing gedatolisib[121]. - There are uncertainties and costs associated with clinical studies and the complexity of demonstrating safety and efficacy for regulatory approval[121]. - The company may encounter difficulties in managing growth, such as hiring and retaining qualified personnel[121]. - Changes in government regulations and tightening credit markets could impact the company's access to capital[121]. - The company has no obligation to update forward-looking statements unless required by law[122]. - As a smaller reporting company, the company is not required to provide disclosures about market risk[123].

Financial Data and Key Metrics Changes - The company's net loss for Q1 2025 was $37 million, or $0.86 per share, compared to a net loss of $21.6 million, or $0.64 per share for Q1 2024 [20] - Non-GAAP adjusted net loss was $34.7 million, or $0.81 per share for Q1 2025, compared to a non-GAAP adjusted net loss of $19.9 million, or $0.59 per share for Q1 2024 [20] - Research and development expenses increased to $32.2 million for Q1 2025 from $20.6 million in Q1 2024, with a significant portion attributed to clinical trial activities [20][21] - General and administrative expenses rose to $3.9 million for Q1 2025 from $1.8 million in Q1 2024 [21] - Net cash used in operating activities was $35.9 million for Q1 2025, compared to $17.1 million for Q1 2024 [22] - The company ended the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments [22] Business Line Data and Key Metrics Changes - The company is focused on three clinical programs, with significant revenue potential if regulatory approvals are obtained [7][8] - The Phase III VICTORIA-one trial is designed to evaluate gadotelisib in combination with fulvestrant for advanced breast cancer patients [9] - The VICTORIA-two trial is a global Phase III study evaluating gadotelisib as a first-line treatment for HR positive, HER2 negative advanced breast cancer [15][16] - The Phase 1B2 trial is assessing gadotelisib in combination with darolutamide for metastatic castration-resistant prostate cancer [17] Market Data and Key Metrics Changes - The company estimates that nearly 200,000 late-stage cancer patients globally would be eligible for treatment with gadotelisib if approved [8] - The peak revenue potential for the second-line indication of gadotelisib could exceed $2 billion with just 40% market penetration [15] Company Strategy and Development Direction - The company aims to transition to a commercial stage company following potential FDA approvals for its clinical programs [10] - The focus is on developing effective therapies for advanced breast cancer patients resistant to endocrine therapy, addressing a significant unmet need in the market [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical data readouts, with top-line data expected from the VICTORIA-one trial in Q3 2025 [7][10] - The company recognizes the importance of demonstrating clinically meaningful results in terms of progression-free survival (PFS) to gain market acceptance [12][14] Other Important Information - The company is collaborating with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gadotelisib in endometrial cancer [18] - The company expects its current cash reserves to fund clinical development activities through 2026 [22] Q&A Session Summary Question: Timing for VICTORIA-one data readout - Management expects to lock the database in June and report results in Q3 2025, with no anticipated delays [27][28][30] Question: Impact of SERNA6 on second-line setting - Management believes SERNA6 will not affect their patient population as it pertains to first-line CDK4/6 patients [36][37] Question: Minimum HR for wild type update - Management indicated that an incremental three months in PFS would be considered clinically meaningful, but specifics will not be disclosed until data is available [39][40] Question: Change in timing for wild type readout - Management clarified that variability in event distribution among trial arms influenced the timing, but they remain confident in the Q4 timeline for the PIK3CA mutant population [43][44] Question: Prior proof of concept data for prostate cancer - Management discussed the encouraging non-clinical data supporting the efficacy of gadotelisib compared to single-node inhibitors [47][49]

Financial Data and Key Metrics Changes - The company's net loss for Q1 2025 was $37 million, or $0.86 per share, compared to a net loss of $21.6 million, or $0.64 per share for Q1 2024 [21] - Non-GAAP adjusted net loss was $34.7 million, or $0.81 per share for Q1 2025, compared to a non-GAAP adjusted net loss of $19.9 million, or $0.59 per share for Q1 2024 [21] - Research and development expenses increased to $32.2 million in Q1 2025 from $20.6 million in Q1 2024, with a significant portion attributed to clinical trial activities [21][22] Business Line Data and Key Metrics Changes - The company is focused on three clinical programs, with expectations for significant revenue generation if regulatory approvals are achieved [6][7] - The VICTORIA-one trial is designed to evaluate gadotelisib in combination with fulvestrant, targeting patients with hormone receptor positive HER2 negative advanced breast cancer [8][10] - The VICTORIA-two trial is a global phase three study evaluating gadotelisib as a first-line treatment for similar patient populations [15][17] Market Data and Key Metrics Changes - The company estimates that nearly 200,000 late-stage cancer patients globally would be eligible for treatment with gadotelisib if approved [7] - The peak revenue potential for the second-line indication could exceed $2 billion with just 40% market penetration [15] Company Strategy and Development Direction - The company aims to transition to a commercial stage company following potential FDA approvals for its clinical programs [9][10] - There is a focus on addressing the significant unmet need for effective therapies in advanced breast cancer, particularly for patients resistant to endocrine therapy [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving key clinical milestones, including data readouts from ongoing trials in 2025 [6][9] - The company recognizes the importance of demonstrating clinically meaningful results in terms of progression-free survival (PFS) to gain acceptance among oncologists [12][14] Other Important Information - The company ended the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments, expected to fund clinical development activities through 2026 [22][23] - The company is collaborating with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gadotelisib in endometrial cancer [19] Q&A Session Summary Question: Timing for data readout from VICTORIA-one trial - Management indicated that the primary completion date is expected in June, with data available in Q3 2025, and typically, the time from locking the database to reporting data is no more than three months [27][30] Question: Impact of SERNA6 on second-line treatment - Management believes SERNA6 will not affect their trial as it pertains to first-line CDK4/6 patients, and they expect physicians to continue treatment with gadotelisib if data is favorable [36][38] Question: Minimum hazard ratio for wild type update - Management stated that an incremental three months in PFS would be considered clinically meaningful, but they are not providing specific projections at this time [39][40] Question: Change in timing for wild type readout - Management clarified that the timing change is due to the complexity of the three-arm trial, but they are confident about the Q4 timeline for the PIK3CA mutant population [44][46] Question: Prior proof of concept data for prostate cancer - Management discussed the encouraging data for gadotelisib in prostate cancer and indicated that the update will focus on primary analysis and safety data, with further data to be reported at a medical meeting [48][52]

Financial Performance - Net loss for Q1 2025 was $37.0 million, or $0.86 loss per share, compared to a net loss of $21.6 million, or $0.64 loss per share in Q1 2024[11]. - Non-GAAP adjusted net loss for Q1 2025 was $34.7 million, or $0.81 loss per share, compared to $19.9 million, or $0.59 loss per share in Q1 2024[11][23]. - GAAP net loss for Q1 2025 was $36.997 million, compared to a loss of $21.612 million in Q1 2024, representing a 71.2% increase in losses year-over-year[25]. - Non-GAAP adjusted net loss for Q1 2025 was $34.699 million, up from $19.904 million in Q1 2024, indicating a 74.5% increase in adjusted losses[25]. - GAAP net loss per share for Q1 2025 was $0.86, compared to $0.64 per share in Q1 2024, reflecting a 34.4% increase in loss per share[25]. - Non-GAAP adjusted net loss per share for Q1 2025 was $0.81, compared to $0.59 per share in Q1 2024, showing a 37.3% increase in adjusted loss per share[25]. Operating Expenses - Total operating expenses for Q1 2025 were $36.1 million, up from $22.5 million in Q1 2024, representing a 60% increase[8]. - Research and development expenses increased to $32.2 million in Q1 2025 from $20.6 million in Q1 2024, a rise of approximately 56%[9]. - Net cash used in operating activities for Q1 2025 was $35.9 million, compared to $17.1 million in Q1 2024[13]. Assets and Cash Position - Cash, cash equivalents, and investments totaled approximately $206 million as of March 31, 2025, expected to fund clinical development through 2026[5][13]. - Total current assets decreased to $217.6 million as of March 31, 2025, from $244.6 million at the end of 2024[19]. Clinical Trials - The topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 trial is anticipated in Q3 2025, with the primary completion date projected for June 2025[5][6]. - Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial, with topline data expected in Q4 2025[5][6]. - The VIKTORIA-2 Phase 3 trial is on track to dose its first patient in Q2 2025[5][6]. Shareholder Information - Weighted average common shares outstanding increased to 43,052,757 in Q1 2025 from 33,612,054 in Q1 2024, a growth of 28.0%[25].

Core Insights - Celcuity Inc. reported financial results for Q1 2025, highlighting progress in its clinical pipeline and upcoming data readouts [1][2] Business Highlights - The company anticipates topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 trial in Q3 2025 and for the PIK3CA mutant cohort in Q4 2025 [2][5] - A clinical trial collaboration is being initiated with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with other therapies for endometrial cancer [5][6] Financial Results - Total operating expenses for Q1 2025 were $36.1 million, up from $22.5 million in Q1 2024 [7] - Research and development expenses increased to $32.2 million from $20.6 million year-over-year, with a significant portion attributed to employee and consulting costs [8] - General and administrative expenses rose to $3.9 million from $1.8 million, driven by increased employee and consulting expenses [9] Net Loss - The net loss for Q1 2025 was $37.0 million, or $0.86 loss per share, compared to a net loss of $21.6 million, or $0.64 loss per share, in Q1 2024 [10] - Non-GAAP adjusted net loss for Q1 2025 was $34.7 million, or $0.81 loss per share, compared to $19.9 million, or $0.59 loss per share, in the prior year [10][21] Cash Position - As of March 31, 2025, the company reported approximately $206 million in cash, cash equivalents, and investments, expected to fund clinical development activities through 2026 [11]

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 mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [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] - Another Phase 3 clinical trial, VIKTORIA-2, is recruiting patients to evaluate 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 the first quarter of 2025 after the market closes on May 14, 2025 [1] - Management will host a webcast/teleconference on the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update [1]

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].