Celcuity(CELC) - 2024 Q4 - Annual Report

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$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$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$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].