Celcuity Inc. (CELC) Q1 2026 Financial Results Summary
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Celcuity Inc. (CELC) Q1 2026 Financial Results Summary
Celcuity Inc. (Nasdaq: CELC) released its financial results for the first quarter of 2026 on May 14, 2026. The report included various business updates highlighting significant progress in its clinical trials and financial performance.
Key Financial Highlights for Q1 2026
- Net Loss: Reported at $52.8 million or $0.97 per share, an increase from a net loss of $37.0 million or $0.86 per share in the same quarter the previous year. This reflects a 43% increase in net loss year-over-year.
- Non-GAAP Adjusted Net Loss: $46.8 million or $0.86 per share, compared to $34.7 million or $0.81 per share for Q1 2025. This represents a 35% increase in adjusted net loss year-over-year.
- Total Operating Expenses: Amounted to $50.5 million, up from $36.1 million in Q1 2025, reflecting a 40% increase.
- Research and Development (R&D) Expenses: Totaled $33.1 million, compared to $29.8 million the previous year, marking a 11% increase.
- Selling, General and Administrative (SG&A) Expenses: Reported at $17.4 million, up from $6.3 million in Q1 2025, resulting in a significant 175% increase.
- Net Cash Used in Operating Activities: For Q1 2026 was $55.1 million, compared to $35.9 million in Q1 2025, an increase of 53%.
- Cash Position: Cash, cash equivalents, and short-term investments totaled $387.1 million at the end of Q1 2026, indicating the company has sufficient liquidity to operate through 2027.
Clinical and Corporate Updates
- VIKTORIA Clinical Trials: Phase 3 VIKTORIA-1 trial successfully achieved its primary endpoint, showing meaningful improvement in progression-free survival for the PIK3CA mutant cohort. Detailed data is scheduled to be presented at the 2026 ASCO Annual Meeting. The Phase 3 VIKTORIA-2 trial has been expanded, including a second study to evaluate gedatolisib as a first-line treatment in patients with endocrine-sensitive HR+/HER2- advanced breast cancer.
- Patent Application: A patent application for a subcutaneous formulation of gedatolisib has been submitted, aimed at providing patients an injectable alternative to the current intravenous formulation.
- FDA Submission: Celcuity intends to submit data from the VIKTORIA trials to the FDA for a supplemental New Drug Application in Q3 2026, following the priority review of the existing New Drug Application for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer.
Notes on Performance
- Increase in Operating Expenses: The rise in R&D expenses was attributed to higher employee-related and consulting expenses, alongside an increase in manufacturing and other costs, partially offset by reduced clinical trial costs.
- Significant Growth in SG&A: The sharp increase in SG&A expenses was primarily due to escalated costs associated with headcount additions for commercial activities and enhanced professional fees.
Dividend and Share Repurchase Information
Celcuity did not declare a quarterly dividend for this period, nor was there any mention of a share repurchase program.
These findings indicate a strong commitment to advancing clinical development while navigating increased operating challenges, as reflected by the growing expenditures amid a larger than expected net loss.
Note: All amounts in the following tables are in thousands, except share and per share amounts.
| Three Months Ended | March 31, 2026 | |
|---|---|---|
| Operating expenses: | ||
| Research and development | $33,063 | |
| Selling, general and administrative | $17,444 | |
| Total operating expenses | $50,507 | |
| Loss from operations | $(50,507) | |
| Other (expense) income: | ||
| Interest expense | $(6,085) | |
| Interest income | $3,751 | |
| Other (expense) income, net | $(2,334) | |
| Net loss before income taxes | $(52,841) | |
| Income taxes | $— | |
| Net loss | $(52,841) | |
| Net loss per share, basic and diluted | $(0.97) | |
| Weighted average common shares outstanding, basic and diluted | 54,462,826 |
| March 31, 2026 | December 31, 2025 | |
|---|---|---|
| Assets | -unaudited | |
| Current assets: | ||
| Cash and cash equivalents | $145,191 | $165,703 |
| Investments | $241,873 | $275,794 |
| Other current assets | $21,865 | $24,162 |
| Total current assets | $408,929 | $465,659 |
| Property and equipment, net | $619 | $499 |
| Operating lease right-of-use | $13 | $51 |
| Other non-current assets | $603 | $349 |
| Total assets | $410,164 | $466,558 |
| Liabilities and stockholders’ equity | ||
| Current liabilities: | ||
| Accounts payable | $10,454 | $6,407 |
| Accrued expenses | $22,744 | $37,691 |
| Operating lease liabilities, current | $13 | $54 |
| Total current liabilities | $33,211 | $44,152 |
| Convertible notes | $195,566 | $195,324 |
| Note payable | $127,862 | $126,527 |
| Total liabilities | $356,639 | $366,003 |
| Total stockholders’ equity | $53,525 | $100,555 |
| Total liabilities and stockholders’ equity | $410,164 | $466,558 |
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