Celcuity(CELC) - 2025 Q2 - Quarterly Results

Celcuity Inc. Q2 2025 Earnings Release Corporate Update and Business Highlights Celcuity reported positive Phase 3 VIKTORIA-1 data for gedatolisib, plans Q4 2025 NDA, and secured $286.5 million in financing - Announced positive topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, showing unprecedented reduction in risk of disease progression or death[3][4] - Plans to submit a New Drug Application (NDA) for gedatolisib to the FDA in the fourth quarter of 2025, based on data from the PIK3CA wild-type cohort[3][4][7] - Completed concurrent offerings of convertible notes, common stock, and warrants, raising net proceeds of $286.5 million[4][7] - A new patent was issued for gedatolisib's dosing regimen, extending U.S. patent exclusivity into 2042[4][7] Clinical Trial Updates (Gedatolisib) Gedatolisib showed significant risk reduction in VIKTORIA-1's PIK3CA wild-type cohort, with other trials progressing VIKTORIA-1 PIK3CA Wild-Type Cohort Efficacy | Regimen | Hazard Ratio (HR) vs Fulvestrant | Risk Reduction | Median PFS (months) | Incremental PFS Improvement (months) | | :--- | :--- | :--- | :--- | :--- | | Gedatolisib Triplet | 0.24 | 76% | 9.3 | 7.3 | | Gedatolisib Doublet | 0.33 | 67% | 7.4 | 5.4 | - Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial, with topline data anticipated by the end of 2025[4][7] - The first patient was dosed in the Phase 3 VIKTORIA-2 trial, evaluating gedatolisib as a first-line treatment for HR+/HER2- ABC[4][7] - Positive topline data from the Phase 1b CELC-G-201 study in metastatic castration resistant prostate cancer (mCRPC) showed a six-month radiographic progression-free survival rate of 66%[7] Corporate and Financial Strength Celcuity significantly strengthened its financial position, raising $286.5 million and securing $455 million proforma cash - Completed concurrent offerings of convertible notes, common stock, and pre-funded warrants with net proceeds of $286.5 million[4][7] - Proforma cash, cash equivalents, and short-term investments totaled $455 million as of June 30, 2025, which is expected to fund operations through 2027[4][13] Q2 2025 Financial Results Celcuity's Q2 2025 operating expenses increased to $44.0 million, leading to a $45.3 million GAAP net loss due to higher R&D Q2 2025 Financial Summary (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Operating Expenses | $44.0 million | $24.3 million | | R&D Expenses | $40.2 million | $22.5 million | | G&A Expenses | $3.8 million | $1.8 million | | GAAP Net Loss | $45.3 million | $23.7 million | | GAAP Net Loss Per Share | $1.04 | $0.62 | | Non-GAAP Adjusted Net Loss | $40.5 million | $22.2 million | | Non-GAAP Adj. Net Loss/Share | $0.93 | $0.58 | Statement of Operations Analysis Q2 2025 R&D expenses increased by $17.7 million due to employee, clinical trial, and milestone costs, while G&A rose by $2.0 million - R&D expenses increased by $17.7 million, primarily due to a $5.0 million anticipated development milestone payment, $6.6 million in employee/consulting expenses, and $6.1 million in costs for ongoing clinical trials[9] - G&A expenses increased by approximately $2.0 million, with $1.6 million related to higher employee and consulting costs[10] Balance Sheet and Cash Flow Celcuity reported $168.4 million in cash and equivalents as of June 30, 2025, with net cash used in operations at $36.2 million for Q2 - Cash, cash equivalents, and short-term investments stood at $168.4 million as of June 30, 2025[13] - Net cash used in operating activities for Q2 2025 was $36.2 million, compared to $18.1 million for Q2 2024[12] Financial Statements This section presents Celcuity's unaudited Q2 2025 financial statements, including balance sheet, statement of operations, and GAAP to non-GAAP reconciliation Condensed Balance Sheets The condensed balance sheet shows total assets of $183.6 million and total liabilities of $139.2 million as of June 30, 2025 Condensed Balance Sheet Data (in thousands) | Account | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $46,354 | $22,515 | | Investments | $122,032 | $212,589 | | Total Current Assets | $183,104 | $244,571 | | Total Assets | $183,592 | $245,123 | | Total Current Liabilities | $39,941 | $31,723 | | Total Liabilities | $139,217 | $129,504 | | Total Stockholders' Equity | $44,375 | $115,619 | Condensed Statements of Operations For Q2 2025, Celcuity reported total operating expenses of $44.0 million and a net loss of $45.3 million Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $40,222 | $22,498 | | General and administrative | $3,787 | $1,786 | | Total operating expenses | $44,009 | $24,284 | | Loss from operations | $(44,009) | $(24,284) | | Net loss | $(45,268) | $(23,722) | | Net loss per share | $(1.04) | $(0.62) | Reconciliation of GAAP to Non-GAAP Measures This section reconciles GAAP net loss to non-GAAP adjusted net loss, with Q2 2025 GAAP net loss of $45.3 million adjusted to $40.5 million non-GAAP - Management uses non-GAAP measures to exclude items like stock-based compensation and non-cash interest, believing it better enables a focus on cash used in operations[23] GAAP to Non-GAAP Reconciliation for Q2 2025 (in thousands) | Description | Amount | | :--- | :--- | | GAAP net loss | $(45,268) | | Stock-based compensation (R&D) | $1,722 | | Stock-based compensation (G&A) | $982 | | Non-cash interest expense | $789 | | Non-cash interest income | $1,286 | | Non-GAAP adjusted net loss | $(40,489) |