Celcuity(US:CELC)2025-11-13 22:15Drug Development and Clinical Trials - Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for p110α, p110β, p110γ, and p110δ isoforms, and mTORC1 and mTORC2 complexes, providing comprehensive inhibition of the PAM pathway[93]. - In the Phase 1b clinical trial, the overall response rate (ORR) for treatment-naïve patients with advanced breast cancer was 85%, while the ORR for patients who received prior hormonal therapy ranged from 36% to 77%[99]. - The median progression-free survival (PFS) for treatment-naïve patients receiving gedatolisib combined with palbociclib plus letrozole was 48.6 months[100]. - As of September 30, 2025, 492 patients with solid tumors have received gedatolisib across eight completed clinical trials[97]. - The VIKTORIA-1 Phase 3 trial has completed enrollment of 351 subjects for the PIK3CA wild-type cohort, with primary completion achieved in May 2025[108]. - The Phase 3 trial VIKTORIA-2 is currently enrolling patients, evaluating gedatolisib in combination with a CDK 4/6 inhibitor and fulvestrant for advanced breast cancer[91]. - The median PFS for patients with PIK3CA mutant tumors was 14.6 months, with an ORR of 48%[104]. - Topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial is expected to be available in late Q1 2026 or Q2 2026[108]. - The gedatolisib triplet demonstrated a median progression-free survival (PFS) of 9.3 months, an improvement of 7.3 months over fulvestrant, with a hazard ratio (HR) of 0.24, indicating a 76% reduction in the risk of disease progression or death[109]. - The gedatolisib doublet showed a median PFS of 7.4 months, an improvement of 5.4 months over fulvestrant, with a HR of 0.33, indicating a 67% reduction in the risk of disease progression or death[109]. - The overall response rate (ORR) for the gedatolisib triplet was 31.5%, with a median duration of response (DOR) of 17.5 months, while the ORR for the gedatolisib doublet was 28.3% with a median DOR of 12.0 months[109]. - The CELC-G-201 Phase 1b trial reported a six-month radiographic progression-free survival (rPFS) rate of 67% and a median rPFS of 9.1 months across both treatment arms[118]. Financial Performance and Expenses - The company reported a net loss of approximately $43.8 million for the three months ended September 30, 2025, compared to a net loss of $29.8 million for the same period in 2024[128]. - As of September 30, 2025, the company had an accumulated deficit of approximately $397.9 million and cash and cash equivalents of approximately $455.0 million[128]. - Research and development expenses for Q3 2025 were approximately $34.9 million, an increase of 27% compared to Q3 2024[140]. - General and administrative expenses for Q3 2025 were approximately $7.9 million, reflecting a significant increase of 221% compared to Q3 2024[143]. - Total operating expenses for Q3 2025 reached $42.8 million, a 43% increase from $30.1 million in Q3 2024[137]. - Research and development expenses for the nine months ended September 30, 2025, were approximately $107.4 million, a 52% increase from $70.7 million in the same period of 2024[141]. - Total operating expenses for the nine months ended September 30, 2025, were $123.0 million, a 60% increase compared to $76.8 million in the same period of 2024[139]. - Interest expense for Q3 2025 was $4.6 million, a 37% increase compared to $3.3 million in Q3 2024[146]. Capital and Funding Activities - The company completed an equity offering of 1,836,842 shares at $38.00 per share, raising approximately $69.7 million[123]. - The company raised approximately $481.7 million through equity securities and $194.9 million through the issuance of convertible notes since inception[150]. - The company completed an equity offering in July 2025, generating approximately $91.6 million in net proceeds for working capital and general corporate purposes[152]. - The company received net proceeds of approximately $27.8 million from the disbursement of the $30.0 million Term D Loan[166]. - The company achieved the Term D Milestone, allowing for the draw of an additional $30.0 million of indebtedness under the Term D Loan[171]. - The company is entitled to make interest-only payments for up to 48 months under the A&R Loan Agreement, with interest rates starting at 7.75% plus 2.85%[175]. - The company recognized a Final Fee of $4.5 million as additional debt principal, which will be amortized over the life of the loan[176]. Future Outlook and Risks - The company expects research and development expenses to increase as it continues to develop gedatolisib and conduct multiple clinical trials[179]. - The company believes its current cash and available borrowings will be sufficient to finance operations through 2027[180]. - The company may seek to raise additional capital through equity or convertible debt securities, which could result in dilution to stockholders[181]. - The company is facing known and unknown risks that may cause actual results to differ materially from forward-looking statements[196]. - There are uncertainties and costs associated with the development and commercialization of gedatolisib, which may impact timely regulatory approval[196]. - The company may encounter challenges in maintaining relationships with pharmaceutical partners and suppliers[196]. - Market acceptance by physicians, patients, and payors remains uncertain, affecting potential market opportunities[196]. - The company is subject to risks related to hiring and retaining qualified personnel, which could impact growth management[196]. - Changes in government regulations and tightening credit markets may affect capital access[196]. - The company has no obligation to update forward-looking statements unless required by law[197]. - As a smaller reporting company, the company is not required to provide specific market risk disclosures[198].