Clinical Trials and Drug Development - Celcuity's lead therapeutic candidate, gedatolisib, is a pan-PI3K/mTOR inhibitor currently in clinical trials for multiple solid tumor indications, including HR+, HER2- advanced breast cancer and metastatic castration resistant prostate cancer (mCRPC) [62] - As of September 30, 2024, 492 patients with solid tumors have received gedatolisib across eight completed clinical trials, with 129 treated as a single agent and 363 in combination with other anti-cancer agents [67] - In the Phase 1b clinical trial for HR+/HER2- metastatic breast cancer, the median progression-free survival (mPFS) was 48.6 months, and the overall response rate (ORR) was 79% for treatment-naïve patients [69] - The VIKTORIA-1 clinical trial is fully enrolled for the PIK3CA wild-type cohort, with topline data expected in late Q1 2025 or Q2 2025, and for the PIK3CA mutant cohort in the second half of 2025 [72] - The Phase 1b/2 study evaluating gedatolisib combined with darolutamide for mCRPC is ongoing, with preliminary data expected in Q2 2025 [82] - The VIKTORIA-2 Phase 3 clinical trial is set to enroll its first patient in Q2 2025, evaluating gedatolisib combined with fulvestrant and a CDK4/6 inhibitor [77] - The company plans to initiate a Phase 3 clinical trial, VIKTORIA-2, to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant for advanced breast cancer [87] - The company is currently conducting a Phase 3 clinical trial (VIKTORIA-1) and a Phase 1b/2 study for gedatolisib, with plans for a Phase 3 trial (VIKTORIA-2) in the future [130] Financial Performance - For the three months ended September 30, 2024, the company reported a net loss of approximately $29.8 million, compared to a net loss of $18.4 million for the same period in 2023, representing a 62% increase in net loss [85] - Research and development expenses for the three months ended September 30, 2024, were approximately $27.6 million, an increase of 58% compared to $17.5 million in the same period in 2023 [96] - The company has an accumulated deficit of approximately $235.2 million as of September 30, 2024 [85] - General and administrative expenses for the three months ended September 30, 2024, were approximately $2.5 million, reflecting a 75% increase from $1.4 million in the same period in 2023 [99] - Interest expense for the three months ended September 30, 2024, was $3.3 million, an increase of 144% compared to $1.4 million in the same period in 2023 [101] - Interest income for the three months ended September 30, 2024, was $3.6 million, representing a 94% increase compared to $1.9 million in the same period in 2023 [103] - Research and development expenses for the nine months ended September 30, 2024, were approximately $70.7 million, an increase of 66% compared to $42.5 million in the same period in 2023 [97] - Net cash used in operating activities was approximately $55.7 million for the nine months ended September 30, 2024, primarily due to a net loss of approximately $75.1 million [121] - Net cash used in investing activities was approximately $100.6 million for the nine months ended September 30, 2024, mainly for net purchases of short-term investments [123] - Net cash provided by financing activities was approximately $138.2 million for the nine months ended September 30, 2024, primarily from incremental debt financing and an equity offering [125] Capital and Funding - The Company raised approximately $50.0 million through a private placement of pre-funded warrants on October 20, 2023 [106] - The Company sold 1,034,500 shares of common stock at $14.50 per share on December 1, 2023, generating gross proceeds of $15.0 million [107] - The Company raised approximately $60.0 million from an equity offering of 3,871,000 shares at $15.50 per share on May 30, 2024, resulting in net proceeds of approximately $56.3 million [108] - The Company entered into a loan agreement for up to $180 million, with $100 million funded on May 30, 2024, including $61.7 million of new borrowings [110] - The Company recognized a Final Fee of $4.5 million as additional debt principal under the loan agreement, to be amortized over the life of the loan [113] - The Company anticipates that its current cash and available borrowings will be sufficient to finance operations through 2026 [117] - The Company may seek additional capital to finance future expenditures and operations, which could result in dilution to existing shareholders [118] Strategic Plans and Future Outlook - If gedatolisib receives FDA approval for both PIK3CA wild-type and mutant populations, the peak revenue potential for the second-line indication could exceed $2 billion [72] - Gedatolisib has shown a favorable safety profile, with only 7% of patients experiencing Grade 3 or 4 hyperglycemia in clinical trials, compared to 39% for an FDA-approved oral p110-α specific inhibitor [66] - The company has exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer, Inc. [63] - The company expects to incur increased research and development expenses as it continues to develop gedatolisib and manage clinical trials [116] - The company anticipates revenue growth and is exploring business development activities, including collaborations with pharmaceutical companies [130] - The company has sufficient cash on hand to fund research and development expenses, capital expenditures, and general corporate expenses [130] Compliance and Legal Matters - There were no changes in internal control over financial reporting during the three months ended September 30, 2024 [136] - The company is not currently involved in any legal proceedings that could materially affect its business or financial condition [137]
Celcuity(CELC) - 2024 Q3 - Quarterly Report