Celcuity Inc. (CELC): Results of Operations and Financial Condition
Celcuity Inc. (CELC) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update • REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer on July 14, 2026; on
How this was made
The 30-second read
Why it matters
The most tradable elements are the FDA approval date, NCCN Category 1 positioning, expected shipment timing late Q3 2026, and quantified VIKTORIA-1 PIK3CA mutant cohort outcomes that underpin an sNDA planned for Q3 2026.
Market read
Traders can update models for CELC based on FDA approval, NCCN Category 1 recommendation, and commercialization timeline, plus quantified Phase 3 efficacy and safety discontinuation rates.
What to watch
The text emphasizes shipment start and planned sNDA, but does not provide revenue guidance, launch economics, or detailed financial metrics in the excerpt, which could temper near-term expectations.
Celcuity reported a second-quarter net loss of $78.9 million while advancing toward a late-third-quarter 2026 REVTORPYK launch following FDA approval.
FDA approval, launch readiness, positive VIKTORIA-1 PIK3CA mutant-cohort data and a strengthened cash position were offset by a wider net loss, materially higher SG&A spending and increased operating cash use.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total operating expensesGAAP | $66.1 million | – | – |
| Research and development expensesGAAP | $31.1 million | – | – |
| Selling, general and administrative expensesGAAP | $35.0 million | – | – |
| Loss from operationsGAAP | $ (66,118 ) (in thousands) | – | – |
| Interest expenseGAAP | $ (5,423 ) (in thousands) | – | – |
| Interest incomeGAAP | $4,154 (in thousands) | – | – |
| Loss on debt extinguishmentGAAP | $ (11,477 ) (in thousands) | – | – |
| Other expense, netGAAP | $ (12,746 ) (in thousands) | – | – |
| Net lossGAAP | $78.9 million | – | – |
| Net loss per shareGAAP | $1.44 per share | – | – |
| Non-GAAP adjusted net lossnon-GAAP | $58.7 million | – | – |
| Non-GAAP adjusted net loss per sharenon-GAAP | $1.07 per share | – | – |
| Weighted average common shares outstanding, basic and dilutedGAAP | 54,816,437 | – | – |
| Net cash used in operating activitiesGAAP | $55.4 million | – | – |
| Cash, cash equivalents and short-term investmentsGAAP | $754.0 million | – | – |
Third quarter of 2026 and other future periods outlook
- NoteShipments of REVTORPYK are expected to begin late in the third quarter of 2026.
- NoteCelcuity intends to submit these data to the FDA in the third quarter as an sNDA.
- NoteCelcuity expects to provide further updates to results from both the PIK3CA MT and WT cohorts of VIKTORIA-1 at medical conferences in the fourth quarter.
- NoteThe company expects to provide updated clinical data and additional visibility into its mCRPC development strategy during the fourth quarter of 2026.
- NoteWe expect that our current cash, cash equivalents and short-term investments will finance our operations at least into 2029.
Capital returns
- Completed issuance of $575.0 million convertible note offering, with net proceeds of $557.2 million.
- The Company utilized $137.0 million of the net proceeds to prepay term loan debt.
What drove it
- REVTORPYK was approved by the U.S. FDA on July 14, 2026 for HR+/HER2- PIK3CA wild-type locally advanced or metastatic breast cancer following progression on or after endocrine therapy.
- REVTORPYK in combination with fulvestrant, with or without palbociclib, was recommended in NCCN Clinical Practice Guidelines as a preferred Category 1 second-line and/or subsequent-line therapy.
- In the VIKTORIA-1 PIK3CA mutant cohort, the gedatolisib-triplet reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant, while the gedatolisib-doublet reduced the risk by 49%.
- SG&A increased primarily because of commercial hiring and pre-commercial launch activities for REVTORPYK.
- R&D expense declined primarily because of lower VIKTORIA-1 clinical trial costs and lower license milestone costs.
Concerns
- Net loss increased to $78.9 million from $45.3 million in the prior-year period.
- Net cash used in operating activities increased to $55.4 million from $36.2 million in the prior-year period.
- SG&A expenses increased to $35.0 million from $7.6 million, including commercial headcount additions and other launch-related activities.
- The second-quarter loss included $11.5 million of loss on debt extinguishment associated with repayment of the note payable.
- The company identified risks related to sNDA timing and review, maintaining regulatory approvals, market acceptance of REVTORPYK, competitive therapies and access to capital.
What to watch
- The start of REVTORPYK shipments expected late in the third quarter of 2026.
- The planned third-quarter 2026 sNDA submission for the VIKTORIA-1 PIK3CA mutant cohort.
- Further VIKTORIA-1 PIK3CA mutant-type and wild-type cohort updates expected at medical conferences in the fourth quarter.
- Updated clinical data and additional visibility into the mCRPC development strategy expected during the fourth quarter of 2026.
- Progress in the expanded VIKTORIA-2 trial, including Study 2 in treatment-naïve endocrine-sensitive HR+/HER2- advanced breast cancer.
Balance sheet and cash flow
- Cash and cash equivalents were $182,049 (in thousands) at June 30, 2026.
- Investments were $571,995 (in thousands) at June 30, 2026.
- Total assets were $828,220 (in thousands) at June 30, 2026.
- Convertible notes were $753,235 (in thousands) at June 30, 2026.
- Total liabilities were $841,001 (in thousands) at June 30, 2026.
- Total stockholders' equity (deficit) was $(12,781) (in thousands) at June 30, 2026.
- Net cash used in operating activities for the second quarter of 2026 was $55.4 million, compared to $36.2 million for the prior year period.
Analysis
Celcuity's second quarter was defined by regulatory and clinical progress rather than reported commercial performance. REVTORPYK received FDA approval on July 14, 2026, commercialization infrastructure was described as complete, and shipments are expected to begin late in the third quarter of 2026. The filing did not report revenue, so the financial results remain centered on pre-launch spending, development activity and funding capacity.
The VIKTORIA-1 PIK3CA mutant cohort provides the principal clinical catalyst in the release. The gedatolisib-triplet reduced the risk of disease progression or death by 50% versus alpelisib plus fulvestrant, with median progression-free survival of 11.1 months versus 5.6 months. The gedatolisib-doublet reduced the risk by 49%, with median progression-free survival of 11.3 months versus 5.6 months. Management plans an sNDA submission in the third quarter of 2026 and expects further VIKTORIA-1 updates in the fourth quarter.
Operating costs reflect the transition from development to commercial launch. Total operating expenses were $66.1 million versus $44.0 million, as SG&A rose to $35.0 million from $7.6 million. The company attributed $23.4 million of the SG&A increase to commercial headcount additions and other launch-related activities. R&D declined to $31.1 million from $36.4 million, driven by lower VIKTORIA-1 trial costs and license milestone costs, partially offset by higher employee-related, consulting, manufacturing and other costs.
Losses and cash use increased. GAAP net loss was $78.9 million, or $1.44 per share, compared with $45.3 million, or $1.04 per share. Non-GAAP adjusted net loss was $58.7 million, or $1.07 per share, compared with $40.5 million, or $0.93 per share. The GAAP result included $11.5 million of loss on debt extinguishment. Net cash used in operating activities was $55.4 million compared with $36.2 million, highlighting the cash demands of launch preparation and continued clinical development.
Financing materially expanded liquidity. The company completed a $575.0 million convertible note offering with $557.2 million of net proceeds and used $137.0 million to prepay term loan debt. Cash, cash equivalents and short-term investments were $754.0 million at quarter end, and management stated that current liquidity is expected to finance operations at least into 2029. The main near-term execution points are late-third-quarter product shipments, the PIK3CA mutant-cohort sNDA submission and fourth-quarter clinical and mCRPC strategy updates.
Management, verbatim
We are on track to begin shipping REVTORPYK late in the third quarter of 2026, and we look forward to making this important therapy available to patients with locally advanced or metastatic breast cancer.
Brian Sullivan, CEO and co-founder of Celcuity
Based on the positive data from the PIK3CAmutant cohort of the Phase 3 VIKTORIA-1 study, we plan to submit an sNDA to FDA in the third quarter of 2026.
Brian Sullivan, CEO and co-founder of Celcuity
Not in the filing
stated, not guessed- Total revenue
- Prior-year total revenue
- Prior-quarter total revenue
- Revenue growth
- Revenue by segment
- Gross profit
- Gross margin
- Operating income
- Prior-quarter operating expenses
- Prior-quarter R&D expenses
- Prior-quarter SG&A expenses
- Prior-quarter net loss
- Prior-quarter GAAP net loss per share
- Prior-quarter non-GAAP adjusted net loss
- Prior-quarter non-GAAP adjusted net loss per share
- Free cash flow
- Capital expenditures
- Dividends
- Share repurchases
- Financial revenue guidance
- Gross-margin guidance
- Operating-expense guidance
- Tax-rate guidance
- Previous-quarter outlook for comparison
AlphaAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; 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
This is an SEC 8-K (Item 2.02) with an exhibit announcing Q2 2026 financial results and major clinical and regulatory updates for gedatolisib (REVTORPYK).
Ticker impact
Celcuity reports Q2 2026 results and says FDA approved REVTORPYK on July 14, 2026, with shipments expected late Q3 2026.
Bullish bias with potential volatility around the planned sNDA submission in Q3 2026 and ongoing label/data updates.
The filing is a primary disclosure (8-K with exhibit) containing FDA approval status, NCCN Category 1 recommendation, shipment timing, and quantified VIKTORIA-1 PIK3CA MT efficacy and safety discontinuation rates.
Market effects
Supports sentiment for targeted oncology and pan-PI3K/mTOR pathway assets, potentially improving read-through for similar breast cancer programs.
Limited direct regional spillover; primarily US biotech sentiment tied to FDA and NCCN updates.
Moderate, as VIKTORIA-1 is global and sNDA/other-regulator submissions are planned, but the immediate catalyst is US commercialization.
Counterpoint
Approval and positive endpoints may already be partially priced; investors may focus on commercial execution risks and the timeline to sNDA acceptance.
Key entities
- companyCelcuity Inc.
Nasdaq-listed biotech developing and commercializing targeted therapies; subject of the 8-K.
- productREVTORPYK (gedatolisib)
Pan-PI3K, mTORC1/2 inhibitor approved by the FDA for HR+/HER2- PIK3CA wild-type advanced breast cancer.
- clinical_trialVIKTORIA-1
Phase 3 program; PIK3CA mutant cohort achieved primary endpoint and supports planned sNDA submission.
- clinical_trialVIKTORIA-2
Phase 3 trial expanded to evaluate gedatolisib as first-line in endocrine-sensitive HR+/HER2+ advanced breast cancer.
- financingConvertible note offering
Company completed a $575.0 million convertible note offering with $557.2 million net proceeds.
