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].
Celcuity(CELC) - 2025 Q1 - Quarterly Report