Celcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update
Celcuity Inc. (CELC) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Celcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update REVTORPYK became commercially available on September 30th for the treatment of patients with HR+/HER2- PIK3CA wild-type locally advanced or metastatic breast cancer 91% of U.S. c
How this was made
The 30-second read
Why it matters
The approval unlocks revenue potential and validates the company's pipeline, likely prompting a share price increase.
Market read
First‑report FDA approval and commercial launch for a niche oncology drug; high relevance for biotech traders.
What to watch
Potential competition from other PI3K inhibitors and the need for real‑world uptake data.
Celcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update
REVTORPYK launched commercially on September 30 with early account ordering, payor coverage and provider-pathway inclusion, but the quarter contained no recognized product revenue and operating losses, operating expenses and operating cash use increased materially from the prior-year period.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Q3 2026 product revenueGAAP | No product revenue recognized | – | – |
| Q3 2026 research and development expensesGAAP | $37.52M | – | $7.1 million increase |
| Q3 2026 selling, general and administrative expensesGAAP | $39.8M | – | $27.4 million increase |
| Q3 2026 total operating expensesGAAP | $77.32M | – | – |
| Q3 2026 loss from operationsGAAP | −$77.32M | – | – |
| Q3 2026 interest expenseGAAP | −$2.69M | – | – |
| Q3 2026 interest incomeGAAP | $6.67M | – | – |
| Q3 2026 other expense, netGAAP | −$955K | – | – |
| Q3 2026 net loss before income taxesGAAP | −$73.34M | – | – |
| Q3 2026 net lossGAAP | −$73.34M | – | – |
| Q3 2026 net loss per share, basic and dilutedGAAP | $(1.33) | – | – |
| Q3 2026 weighted average common shares outstanding, basic and dilutedGAAP | 55,143,356 | – | – |
| Q3 2026 adjusted net lossnon-GAAP | −$66.85M | – | – |
| Q3 2026 adjusted net loss per share, basic and dilutednon-GAAP | $(1.21) | – | – |
| Q3 2026 research and development stock-based compensation adjustmentnon-GAAP | $3.04M | – | – |
| Q3 2026 selling, general and administrative stock-based compensation adjustmentnon-GAAP | $6.98M | – | – |
| Q3 2026 non-cash interest expense adjustmentnon-GAAP | −$62K | – | – |
| Q3 2026 non-cash investment income adjustmentnon-GAAP | −$3.47M | – | – |
| Nine months 2026 research and development expensesGAAP | $101.7M | – | – |
| Nine months 2026 selling, general and administrative expensesGAAP | $92.28M | – | – |
| Nine months 2026 total operating expensesGAAP | $193.9M | – | – |
| Nine months 2026 loss from operationsGAAP | −$193.9M | – | – |
| Nine months 2026 interest expenseGAAP | −$14.20M | – | – |
| Nine months 2026 interest incomeGAAP | $14.58M | – | – |
| Nine months 2026 loss on debt extinguishmentGAAP | −$11.48M | – | – |
| Nine months 2026 other expense, netGAAP | −$11.10M | – | – |
| Nine months 2026 net loss before income taxesGAAP | −$205.0M | – | – |
| Nine months 2026 net lossGAAP | −$205.0M | – | – |
| Nine months 2026 net loss per share, basic and dilutedGAAP | $(3.74) | – | – |
| Nine months 2026 weighted average common shares outstanding, basic and dilutedGAAP | 54,810,032 | – | – |
| Nine months 2026 adjusted net lossnon-GAAP | −$172.3M | – | – |
| Nine months 2026 adjusted net loss per share, basic and dilutednon-GAAP | $(3.14) | – | – |
| Nine months 2026 research and development stock-based compensation adjustmentnon-GAAP | $7.39M | – | – |
| Nine months 2026 selling, general and administrative stock-based compensation adjustmentnon-GAAP | $14.86M | – | – |
| Nine months 2026 non-cash interest expense adjustmentnon-GAAP | $2.99M | – | – |
| Nine months 2026 non-cash investment income adjustmentnon-GAAP | −$4.02M | – | – |
| Nine months 2026 loss on debt extinguishment adjustmentnon-GAAP | $11.48M | – | – |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
Through 2029 outlook
- NoteCelcuity expects that its current cash, cash equivalents and short-term investments will finance its operations through 2029.
What drove it
- REVTORPYK became commercially available on September 30, 2026, and shipments commenced on September 30, 2026.
- 78% of the top 36 strategic accounts, representing ~50% of the total addressable patient population, have ordered REVTORPYK.
- 91% of U.S. commercial and Medicare lives are in health plans that cover REVTORPYK, and REVTORPYK has been incorporated in 3 of the 4 largest health care provider pathways.
- Over 3,400 sites have directly engaged with Celcuity oncology sales specialists, and these sites treat 82% of breast cancer patients.
- Over 1,100 health care providers have attended REVTORPYK educational programs.
- The $7.1 million increase in R&D expenses was primarily due to a $5.3 million increase in employee-related and consulting expenses and a $2.1 million increase in manufacturing and other costs, partially offset by a $0.3 million decrease in clinical trial costs.
- The $27.4 million increase in SG&A expenses was primarily driven by commercial headcount, commercialization-support costs and other administrative expenses; $25.3 million of the increase related to commercial headcount additions and other commercialization activities.
Concerns
- No product revenue was recognized in the third quarter because no product was received by healthcare providers or pharmacies until after September 30, 2026.
- Q3 net loss was $(73,337) (in thousands), compared with $(43,804) (in thousands) in the prior-year period.
- Q3 total operating expenses were $77,319 (in thousands), compared with $42,849 (in thousands) in the prior-year period.
- Q3 net cash used in operating activities was $66.2 million, compared to $44.8 million for the prior-year period.
- Convertible notes were $753,958 (in thousands) at September 30, 2026, and total stockholders' equity (deficit) was $(74,039) (in thousands).
- The FDA review of the supplemental New Drug Application for gedatolisib, commercialization and market acceptance of REVTORPYK, and clinical-trial timing remain identified risks.
What to watch
- Product revenue recognition following September 30, 2026 shipments of REVTORPYK.
- Ordering and treatment adoption across strategic accounts, payor coverage and provider pathways.
- FDA review of the supplemental New Drug Application submitted in the third quarter of 2026 for the PIK3CA mutant cohort.
- Submission of VIKTORIA-1 Phase 3 data for both cohorts to global regulatory authorities later this year or early next year.
- Ongoing enrollment in the Phase 3 VIKTORIA-2 trial.
- Expected initiation in the first half of 2027 of the randomized Phase 2 mCRPC study of gedatolisib with darolutamide.
- Operating cash use and execution against the stated cash runway through 2029.
Balance sheet and cash flow
- Cash, cash equivalents and short-term investments were $642.7 million at the end of the third quarter of 2026.
- Cash and cash equivalents were $178,165 (in thousands) at September 30, 2026, compared with $165,703 (in thousands) at December 31, 2025.
- Investments were $464,538 (in thousands) at September 30, 2026, compared with $275,794 (in thousands) at December 31, 2025.
- Inventory was $1,476 (in thousands) at September 30, 2026, compared with — at December 31, 2025.
- Total assets were $726,869 (in thousands) at September 30, 2026, compared with $466,558 (in thousands) at December 31, 2025.
- Convertible notes were $753,958 (in thousands) at September 30, 2026, compared with $195,324 (in thousands) at December 31, 2025.
- Note payable was — at September 30, 2026, compared with $126,527 (in thousands) at December 31, 2025.
- Total liabilities were $800,908 (in thousands) at September 30, 2026, compared with $366,003 (in thousands) at December 31, 2025.
- Total stockholders' equity (deficit) was $(74,039) (in thousands) at September 30, 2026, compared with $100,555 (in thousands) at December 31, 2025.
- Net cash used in operating activities for the third quarter of 2026 was $66.2 million, compared to $44.8 million for the prior year period.
- Celcuity made a $50.0 million payment to Pfizer triggered by receipt of FDA approval for REVTORPYK per its exclusive global license agreement for gedatolisib.
Analysis
Celcuity entered commercial execution for REVTORPYK at the end of the quarter. The product became commercially available and shipments commenced on September 30, 2026, but the company recognized no product revenue because healthcare providers and pharmacies did not receive product until after quarter end. Early launch indicators were constructive: 78% of the top 36 strategic accounts had ordered REVTORPYK, 91% of U.S. commercial and Medicare lives were in plans covering the product, and the therapy was incorporated in 3 of the 4 largest health care provider pathways.
The income statement reflects the pre-revenue investment phase. Q3 GAAP net loss was $(73,337) (in thousands), versus $(43,804) (in thousands) in the prior-year period, while non-GAAP adjusted net loss was $(66,848) (in thousands), versus $(37,155) (in thousands). Total operating expenses were $77,319 (in thousands), compared with $42,849 (in thousands). R&D expense increased to $37,519 (in thousands), with the stated increase led by employee-related and consulting expenses and manufacturing and other costs.
Commercial build-out was the principal expense driver. SG&A rose to $39,800 (in thousands) from $12,424 (in thousands), with $25.3 million of the stated increase tied to commercial headcount additions and other activities supporting REVTORPYK commercialization. Net cash used in operating activities was $66.2 million, compared with $44.8 million in the prior-year quarter, and the company also made a $50.0 million Pfizer payment triggered by FDA approval.
Liquidity was reported at $642.7 million of cash, cash equivalents and short-term investments at quarter end, and management expects current liquidity to finance operations through 2029. The balance sheet also reported $753,958 (in thousands) of convertible notes and total stockholders' equity (deficit) of $(74,039) (in thousands). Key execution milestones are initial revenue recognition after the launch, FDA review of the submitted PIK3CA mutant-cohort sNDA, global regulatory submissions, continuing VIKTORIA-2 enrollment and the expected first-half 2027 start of the randomized Phase 2 mCRPC study.
Management, verbatim
Our commercial and medical affairs teams have laid the foundation for a strong launch over the past few years, and their efforts are paying off. Physicians are enthusiastic and eager to treat their patients with REVTORPYK, and we are pleased with their interest in getting eligible patients on treatment in the initial weeks since we launched.
Brian Sullivan, CEO and co-founder of Celcuity
We estimate over 90% of commercial and Medicare lives are in health plans that cover REVTORPYK. The unprecedented efficacy results from the wild-type cohort of the pivotal VIKTORIA-1 study, and the preferred Category 1 recommendation in the NCCN Guidelines, provide physicians with a compelling value proposition to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, PIK3CA wild-type advanced breast cancer.
Brian Sullivan, CEO and co-founder of Celcuity
Not in the filing
stated, not guessed- Numerical total revenue for Q3 2026 and Q3 2025 was not reported. The company stated only that it did not recognize any product revenue during Q3 2026.
- Segment revenue, segment profit and segment comparisons were not reported.
- Gross profit, gross margin and gross-margin comparisons were not reported.
- Free cash flow was not reported.
- A numerical income-tax rate was not reported.
- Prior-quarter financial comparisons were not reported.
- Share repurchases, dividends and other capital-return activity were not reported.
- Detailed terms, interest rates and maturities for convertible notes were not reported.
- Forward revenue, gross-margin, operating-expense and tax-rate guidance were not provided.
- A prior outlook section was not provided.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure is checked against the filing text, and a metric the filing does not print, or whose value, prior period and change do not add up, is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
Celcuity filed a Form 8‑K announcing FDA approval of its gedatolisib‑based therapy REVTORPYK and providing Q3 2026 financial results.
Ticker impact
SEC 8‑K reports FDA approval and commercial launch of REVTORPYK for HR+/HER2‑ advanced breast cancer, plus Q3 financial results.
upward pressure as market prices in the FDA approval and commercial rollout.
First disclosure of FDA approval and commercial availability; biotech stocks typically rally on such news.
Market effects
Strengthens the HR+/HER2‑ breast cancer therapeutic segment and may boost peer biotech valuations.
U.S. biotech sector could see modest gains as investors rotate into newly approved oncology assets.
Limited to biotech/healthcare investors; no broad market effect.
Counterpoint
If pricing or payer coverage proves weaker than expected, the rally could be muted.
Key entities
- companyCelcuity Inc.
Biotech firm developing targeted oncology therapies.
