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A clinical-stage biotech developing gedatolisib, a drug aimed at blocking cancer-driving cell signals to treat advanced breast and prostate cancer. Founded in 2012 by Brian Sullivan and Lance Laing, the company first built CELsignia, a tool that reads living tumor cells, before pivoting to drug development. Its name blends "cell" and "acuity" — a nod to the sharp, precise view the founders wanted of a tumor's inner workings.
Celcuity's net loss widened to $78.9M as commercial launch spending rose ahead of first product revenue expected in Q3.
Celcuity is no longer just a clinical-stage company — it is now preparing to launch its first drug. The net loss widened to $78.9 million, or $1.44 per share, as selling, general and administrative expenses rose 361% to $35.0 million to build a commercial team for REVTORPYK, which received FDA approval on July 14, 2026. The company holds $754.0 million in cash and expects its first product in the third quarter, but the cost of the launch has pushed the quarterly to $55.4 million.
Key takeaways
Selling, general and administrative expenses rose 361% to $35.0 million, driven by commercial headcount and pre-launch activities for REVTORPYK, the company's first approved product.
Research and development expenses fell 15% to $31.1 million, as a $7.0 million reduction in VIKTORIA-1 clinical trial costs and a $5.0 million decrease in license milestone costs more than offset higher employee expenses.
The net loss widened to $78.9 million from $45.3 million a year earlier, and included an $11.5 million non-cash from the voluntary prepayment of the Amended A&R Loan Agreement.
Section summaries
Management's Discussion and Analysis
Net loss widened to $78.9M in Q2 FY2026 as SG&A surged 361% for REVTORPYK launch prep; R&D fell 15% on lower trial costs.
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Total operating expenses rose 50% to $66.1M, driven by a $27.4M (361%) increase in SG&A, primarily for commercial headcount and pre-launch activities for REVTORPYK.
R&D expenses decreased 15% to $31.1M, mainly due to a $7.0M reduction in VIKTORIA-1 clinical trial costs and a $5.0M decrease in license milestone costs.
Net loss for Q2 FY2026 was $78.9M compared to $45.3M in Q2 FY2025, impacted by an $11.5M non-cash from the voluntary prepayment of the Amended A&R Loan Agreement.
Cash, cash equivalents, and short-term investments rose to $754.0 million as of June 30, 2026, up from $183.6 million a year earlier, following the issuance of $575.0 million in 2032 Notes.
The FDA approved REVTORPYK on July 14, 2026, and the company expects to generate its first product from sales commencing in the third quarter of 2026.
fell to zero from $105.6 million a year earlier, as the company used proceeds from the 2032 Notes to extinguish its prior term loan facility.
What changed
The VIKTORIA-1 topline data readout, flagged across multiple prior quarters as the defining binary event, was reported in Q3 FY2025 as positive, and the New Drug Application was submitted; the FDA approved REVTORPYK on July 14, 2026, resolving the central clinical and regulatory risk.
The quarterly SG&A expense run rate, flagged in Q1 FY2026 to watch for stabilization near $17.4 million, instead more than doubled to $35.0 million in Q2 FY2026 as commercial build-out accelerated into the final pre-launch quarter.
The quarterly , previously tracked against a projected runway through 2027, reached $55.4 million in Q2 FY2026; management now projects the $754.0 million cash balance will fund operations at least into 2029, reflecting the $575.0 million convertible notes offering.
The VIKTORIA-2 and CELC-G-201 pipeline trials, flagged as absent from recent quarterly discussions, remained unmentioned in this filing, suggesting the company's focus has shifted entirely to the REVTORPYK commercial launch.
What to watch
The first quarter of REVTORPYK product in Q3 FY2026, which will establish the baseline for the company's commercial trajectory and begin to offset operating expenses.
The quarterly SG&A expense run rate in Q3 FY2026, to gauge whether the $35.0 million in Q2 represents a peak launch-quarter spend or a new baseline for the commercial organization.
The quarterly relative to the $754.0 million cash balance, to confirm the newly projected runway into 2029 remains intact once product begins.
Any update on the VIKTORIA-2 and CELC-G-201 pipeline trials, whose continued absence from disclosures would indicate a full strategic pivot to commercialization of the lead asset.
increased 69% to $5.4M following the issuance of $575.0M in 2032 Notes, while interest income rose 114% to $4.2M on higher invested cash balances.
Cash, cash equivalents, and short-term investments totaled $754.0M as of June 30, 2026, which management believes is sufficient to fund operations at least into 2029.
The company expects to generate its first product from REVTORPYK sales commencing in Q3 FY2026 following FDA approval on July 14, 2026.
From time to time, we may be involved in disputes or litigation relating to claims arising out of our operations. We are not currently a party to any legal proceedings that could reasonably be expected to have a material adverse effect on our business, financial condition and re…
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From time to time, we may be involved in disputes or litigation relating to claims arising out of our operations. We are not currently a party to any legal proceedings that could reasonably be expected to have a material adverse effect on our business, financial condition and results of operations.
In addition to other information set forth in this Quarterly Report, including the important information in the section entitled “Special Note Regarding Forward-Looking Statements,” you should carefully consider the “Risk Factors” discussed in the 2025 10-K, for a discussion of…
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In addition to other information set forth in this Quarterly Report, including the important information in the section entitled “Special Note Regarding Forward-Looking Statements,” you should carefully consider the “Risk Factors” discussed in the 2025 10-K, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report. There have been no material changes to the risk factors previously disclosed in the 2025 10-K. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition and/or operating results.