Celcuity Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. Celcuity is a clinical-stage oncology biotechnology company developing gedatolisib and its CELsignia diagnostic platform. It has not generated revenue and has not been profitable.
Financial results and liquidity
| Metric | Q1 2024 | Q1 2023 or prior period |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $20.6 million | $11.3 million |
| General and administrative expense | $1.8 million | $1.3 million |
| Total operating expenses | $22.5 million | $12.5 million |
| Net loss | $21.6 million | $11.9 million |
| Net loss per share, basic and diluted | $0.64 | $0.55 |
| Net cash used in operating activities | $17.1 million | $12.9 million |
There are no product sales or gross margins to report. Interest income was $2.3 million and interest expense was $1.4 million. Operating expenses increased 79%; R&D rose 83%, primarily due to VIKTORIA-1 and CELC-G-201 trial costs, as well as increased employee and consulting expense.
At March 31, 2024, cash and cash equivalents were $31.2 million and short-term investments were $146.4 million, totaling approximately $177.7 million. Current assets were $187.5 million and current liabilities were $16.7 million. Long-term debt had a carrying value of $37.6 million, comprising $35.0 million principal plus accrued PIK interest, net of issuance costs and discount. The company reported an accumulated deficit of $181.7 million.
Cash and cash equivalents increased $0.6 million during the quarter. Operating cash use was partly offset by $14.0 million from warrant exercises; investing cash flow was $3.5 million, mainly from net maturities of Treasury investments.
Business developments, outlook, and risks
- VIKTORIA-1, a Phase 3 trial of gedatolisib regimens in HR+/HER2- advanced breast cancer, was enrolling patients. CELC-G-201, a Phase 1b/2 study of gedatolisib with darolutamide in metastatic castration-resistant prostate cancer, began enrolling in Q1; the first patient was dosed in February 2024.
- Management expects R&D and G&A expenses to rise as trials and development activities expand, and anticipates sales and marketing costs if products approach commercialization.
- Management stated that cash, investments, and available Innovatus borrowing capacity are expected to fund operations and obligations through at least 2025. This estimate depends on assumptions; the company may need additional capital, which may be unavailable or dilute shareholders.
- The Innovatus agreement permits additional tranches subject to milestones, covenants, and other conditions. The March 2024 amendment extended the Term C draw deadline to June 1, 2024. Existing debt principal, including PIK interest, is scheduled for repayment in 2025–2027.
- After quarter-end, Celcuity sold 435,414 shares under its Jefferies sale agreement for $7.6 million gross, or approximately $7.4 million after disclosed commissions and offering expenses.
- Key risks include clinical-trial outcomes and costs, regulatory approval, commercialization and market acceptance, dependence on financing, competition, and execution of the companion-diagnostic strategy. Clinical-cost estimates may change as trials ramp up. The filing reported no material legal proceedings and no material changes to internal control over financial reporting.
Important facts to verify
- Trial enrollment, timelines, safety, and forthcoming efficacy results for VIKTORIA-1 and CELC-G-201.
- Cash burn, investment maturities, and whether resources remain sufficient through at least 2025 as trial expenses increase.
- Availability and terms of additional Innovatus tranches, and the debt repayment schedule including PIK interest.
- Share dilution from warrant exercises, preferred-stock conversions, pre-funded warrants, and the post-quarter Jefferies share sale. The filing reports 30.8 million common shares outstanding at quarter-end but weighted-average shares of 33.6 million; pre-funded warrant shares are included in the loss-per-share calculation.