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REVTORPYK is commercially available in the United States as of September 30, 2026, following its July 14 FDA approval. The next commercial tests are access, prescribing, realized revenue and cash conversion. The PIK3CA-mutant sNDA submitted in August remains a separate regulatory process; availability for the approved population is not an expanded label.
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Commercial availability was confirmed September 30. Initial sales and prescribing remain unreported. Updated mCRPC clinical data and strategy remain guided for Q4 (Celcuity release, August 13, 2026 (8-K EX-99.1)); no exact date is given for those data or the next earnings report. The separate August 26 sNDA has no announced FDA acceptance or PDUFA date. September 30 Form 8-K · Issuer release, exhibit 99.1
Selling, general and administrative expense reached $35.0 million in the second quarter of 2026 against $7.6 million a year earlier, while revenue remained zero. The $50.0 million Pfizer milestone accrued at June 30 was triggered by July 14 approval; that filing does not update subsequent payment status, royalties in low to mid-teens percentages apply to net sales, and $776.3 million of convertible principal sits against 48.9 million shares outstanding.
REVTORPYK is FDA-approved for its specified PIK3CA wild-type population and became commercially available September 30. Randomized PFS results and the company-reported NCCN Category 1 recommendation support adoption. The August 26 supplemental filing seeks a distinct mutant indication, and June 30 liquidity of $754.0 million supports management’s operating forecast at least into 2029.
Availability does not establish prescriptions, reimbursement or net sales. Q2 operating expenses were $66.1 million and first-half operating cash use was $110.5 million before an established commercial revenue stream. Convertible principal of $776.3 million, potential share issuance, Pfizer royalties and the accrued approval milestone affect future cash and shareholder economics. The supplemental indication remains subject to separate FDA review.
Cash and short-term investments were $754.0 million at June 30, 2026, against $776.3 million of convertible principal and negative equity of $12.8 million. Q2 net loss was $78.9 million and operating cash use was $55.4 million. Management expects current resources to fund operations at least into 2029 under its plan. These are pre-launch balances; the September 30 availability announcement does not update cash or quantify sales. Q2 Form 10-Q.
Celcuity’s central transition is from an approved regimen to measurable commercial demand. The wild-type indication and mutant supplemental application have different regulatory status and different trial comparators. Uptake will depend on patient selection, administration capacity, tolerability and coverage as well as efficacy. The first full commercial quarter is Q4 2026; the key distinctions in financial reporting will be stocking versus sustained treatment and sales versus cash collection. Convertible debt and Pfizer economics remain relevant even with substantial liquidity, while first-line breast cancer and prostate development carry their own evidence requirements.
Celcuity will present updated VIKTORIA-1 results as a late-breaking rapid oral (LBA 16) on October 24 at ESMO in Madrid, plus three posters: gedatolisib with darolutamide in prostate cancer (October 23), a network meta-analysis in PIK3CA wild-type breast cancer and a VIKTORIA-2 trial-in-progress design (both October 24). Abstracts are released October 19; the results themselves are not yet public.
Celcuity’s October 2, 2026 announcement and Form 8-K report the appointment of David W. Gryska, effective October 1, following an increase in board size from eight to nine. The board determined that he is independent and appointed him to the Audit and Compensation committees. He brings former CFO experience at Incyte, Celgene and Scios; this is a board appointment, not a change in Celcuity’s chief financial officer or chief executive.
Celcuity confirms that REVTORPYK (gedatolisib) is now commercially available in the United States. This resolves the previous late-Q3 launch window; the release does not quantify shipments, prescriptions, net sales or reimbursement outcomes.
The supplemental application covers HR+/HER2- patients with locally advanced or metastatic breast cancer and a PIK3CA mutation, after at least one line of endocrine therapy. It rests on the mutant cohort of the Phase 3 VIKTORIA-1 trial: the REVTORPYK triplet with fulvestrant and palbociclib cut the risk of progression or death by 50% versus alpelisib plus fulvestrant (HR 0.50; 95% CI 0.37-0.68; p<0.0001), median PFS 11.1 versus 5.6 months; the doublet by 49% (HR 0.51; 95% CI 0.33-0.79; descriptive p=0.0013), median PFS 11.3 versus 5.6 months. ORR 49% with a 15.7-month median DOR for the triplet, 36% and 24.2 months for the doublet. The FDA has not yet communicated acceptance or a PDUFA date.
August 18 Forms 4 report August 14 compensation awards: 116,000 RSUs in total (Sullivan 80,000; Laing 20,000; Hahne 16,000), vesting 25% annually, plus 140,000 PSUs (120,000; 10,000; 10,000 respectively) subject to stock-price performance conditions. Awards are not open-market purchases or immediately issued common shares. Sullivan’s 1,450,199 directly held securities exclude separately reported trust holdings of 948,042 and 802,742.
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Celcuity’s October 2, 2026 announcement and Form 8-K report the appointment of David W. Gryska, effective October 1, following an increase in board size from eight to nine. The board determined that he is independent and appointed him to the Audit and Compensation committees. He brings former CFO experience at Incyte, Celgene and Scios; this is a board appointment, not a change in Celcuity’s chief financial officer or chief executive. Primary source
The filing describes the existing non-employee-director program as a $70,000 annual cash retainer and a $100,000 annual equity award, with pro-rated compensation for this appointment. Gryska received a pro-rated grant of 893 restricted stock units vesting at the earlier of the 2027 annual meeting or April 30, 2027. Those are compensation terms, not a capital raise, a market purchase of shares or a newly disclosed drug-development payment. Primary source
Celcuity is a Minneapolis-based biotechnology company whose entire value rests on one molecule used across several settings. Gedatolisib, now marketed as REVTORPYK, is a kinase inhibitor of all four class I PI3K isoforms (alpha, beta, delta and gamma) and of both mTOR complexes, mTORC1 and mTORC2. That breadth is the differentiating claim: approved and investigational competitors in this pathway inhibit PI3K-alpha, AKT, or mTORC1 alone or in pairs, and the company’s position is that comprehensive blockade of the PI3K/AKT/mTOR pathway, which the field abbreviates as the PAM pathway, produces a different efficacy and resistance profile.
The molecule is not native to Celcuity. It was licensed from Pfizer on April 8, 2021 under an agreement granting exclusive global development and commercialisation rights, in exchange for $5.0 million upfront, 349,406 shares of common stock, milestone payments of up to $335.0 million in aggregate, and tiered royalties on net sales in low to mid-teens percentages. Celcuity ran the Phase 3 programme, filed the NDA through the FDA’s Real-Time Oncology Review pathway in November 2025, and obtained approval in July 2026.
The development programme now runs on four tracks. VIKTORIA-1 is complete and has produced both the approval and the data package for the filed sNDA. VIKTORIA-2 is enrolling in the first-line setting, with two independent studies covering endocrine-resistant and endocrine-sensitive patients. CELC-G-201 is a Phase 1b/2 trial of gedatolisib with darolutamide in metastatic castration-resistant prostate cancer. And a subcutaneous formulation is in development, aimed at supporting indications where treatment could run for several years and where weekly intravenous administration becomes a practical constraint.
The company reported no revenue in any period through June 30, 2026. Headcount growth in the first half of 2026 was concentrated in the commercial function, which is visible in the selling, general and administrative line more than in research and development, where employee-related and consulting expense also rose.
The reading on this page rests on Celcuity converting an approved regimen into measurable commercial demand while its June 30, 2026 liquidity carries the launch. The following developments would materially change that reading.
These are observations that would weaken the interpretation, not forecasts of inevitable events.
The approved indication is specific, and its boundaries matter more than the headline. REVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for adult patients with HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after at least one line of endocrine therapy in the metastatic setting. Two features of that sentence carry commercial weight.
First, the label covers both the triplet and the doublet. A physician may add palbociclib or not, which matters because the doublet has a markedly lower neutropenia burden than the triplet, not zero risk. That flexibility lets the regimen be adapted to patient fitness without going off-label, and it provides two approved combination options within the stated indication.
PIK3CA wild-type is a specific biomarker definition. It does not mean the tumour lacks every PAM-pathway alteration. Capivasertib has a biomarker-selected indication that includes AKT1 or PTEN alterations as well as PIK3CA, so some PIK3CA wild-type patients may qualify for other targeted therapy. REVTORPYK’s label must be assessed on its own eligibility criteria.
The company reports that NCCN lists REVTORPYK with fulvestrant, with or without palbociclib, as a preferred Category 1 option in the specified second-line and subsequent-line setting. Guideline support does not guarantee payer coverage, treatment selection or commercial uptake.
Administration is intravenous, once weekly for three weeks of every four-week cycle, which is the practical constraint the subcutaneous programme is designed to relieve.
VIKTORIA-1 enrolled at more than 200 clinical sites across North America, Europe, South America and Asia-Pacific, and was built as two independent studies so that PIK3CA wild-type and mutant populations could be evaluated separately. In the wild-type study, patients were randomised 1:1:1 to gedatolisib with palbociclib and fulvestrant, gedatolisib with fulvestrant, or fulvestrant alone. The database cut-off was May 30, 2025, topline data were announced on July 28, 2025, and fuller results were presented at ESMO on October 18, 2025.
The triplet reduced the risk of progression or death by 76% against fulvestrant, a hazard ratio of 0.24 with a 95% confidence interval of 0.17 to 0.35 and p<0.0001. Median progression-free survival by blinded independent central review was 9.3 months against 2.0 months, an incremental 7.3 months. The doublet reduced that risk by 67%, a hazard ratio of 0.33 with a confidence interval of 0.24 to 0.48, and delivered 7.4 months against 2.0 months, an incremental 5.4 months.
Response data followed the same pattern. The approval press release reports an objective response rate of 32% for the triplet against 1% for fulvestrant, with median duration of response of 17.5 months; the second quarter Form 10-Q states 31% for the same comparison, a one-point difference between two company documents that both describe the wild-type cohort. The doublet produced a 28% response rate in the approval release and 28.3% in the Form 10-Q, with a 12.0-month median duration of response. Median duration of response could not be determined for fulvestrant, because a single objective response occurred in that arm.
Two subgroup readings sit behind any commercial model. Among patients enrolled in the United States and Canada, median progression-free survival was 19.3 months for the triplet (hazard ratio 0.13; 90% CI 0.07-0.29) and 14.9 months for the doublet (hazard ratio 0.35; 90% CI 0.17-0.76). At the San Antonio Breast Cancer Symposium in December 2025, the company reported 16.6 months for the triplet and 7.1 months for the doublet against 1.9 months for fulvestrant among patients in the United States, Canada, Western Europe and Asia-Pacific. Those figures come from subgroups rather than the primary analysis, and subgroup estimates in oncology trials are directional rather than definitive.
The cohort that supports the approved label. Blinded independent central review, database cut-off May 30, 2025.
HR 0.24 (95% CI 0.17-0.35), p<0.0001, an incremental 7.3 months
HR 0.33 (95% CI 0.24-0.48), p<0.0001, an incremental 5.4 months
control arm
The control arm here is fulvestrant alone. The mutant cohort below used an active comparator, so the two charts are scaled separately and the bar lengths are not comparable between them.
Source: Celcuity Form 8-K exhibit EX-99.1 of July 15, 2026 and Form 10-Q filed August 13, 2026.
The safety profile splits cleanly between the two approved regimens, and that split is the commercial argument for having both on the label.
In the wild-type cohort, Grade 3 treatment-related adverse events for the triplet, doublet and fulvestrant arms included neutropenia in 52.3%, 0% and 0.8% of patients; stomatitis in 19.2%, 12.3% and 0%; rash in 4.6%, 5.4% and 0%; and hyperglycemia in 2.3%, 2.3% and 0%. Grade 4 events were principally neutropenia, at 10.0% for the triplet and 0.8% for the doublet. The marked difference is consistent with the additional palbociclib component, but these comparisons do not prove exclusive causation; Grade 4 neutropenia also occurred in the doublet arm.
Discontinuation is where the profile reads most favourably. Treatment-related adverse events led to discontinuation of study treatment in 2.3% of triplet patients and 3.1% of doublet patients, against 0% on fulvestrant alone. In the mutant cohort, where the comparator was alpelisib plus fulvestrant, 5.2% of triplet patients and 3.8% of doublet patients discontinued gedatolisib because of an adverse event, against 19.1% who discontinued alpelisib. The company recalculated those rates using the same methodology that produced the discontinuation figure in the REVTORPYK label, which makes the comparison internally consistent rather than assembled from differently defined denominators. The June 2, 2026 release had reported a different measure for the same cohort, treatment-related adverse events leading to discontinuation of study treatment: 2.6% for the triplet, 3.8% for the doublet and 7.1% for alpelisib plus fulvestrant. The two sets of figures use different definitions and should not be mixed. Source
The hyperglycemia comparison carries the clearest mechanistic message. Grade 3 or higher hyperglycemia occurred in 2.6% of gedatolisib triplet patients and 0% of doublet patients in the mutant cohort, against 14.5% for alpelisib plus fulvestrant; Grade 3 or higher rash was 6.5% and 5.8% against 15.1%. Alpha-selective PI3K inhibition drives the metabolic toxicity that has limited that class in practice, and the comparative data suggest gedatolisib does not reproduce it at the same rate despite inhibiting the same isoform among others.
The comparison does not run one way. In the same cohort, Grade 3 or higher neutropenia was 58.8% for the gedatolisib triplet and 0% for the doublet, against 0.7% for alpelisib plus fulvestrant, and stomatitis was 16.3% and 5.8% against 5.3%. The metabolic and dermatologic burden favours gedatolisib; the haematologic and mucosal burden of the triplet does not.
One Grade 5 treatment-related event occurred in the gedatolisib triplet group of the mutant cohort, attributed to palbociclib; none occurred in the doublet group, and two occurred in the alpelisib plus fulvestrant group.
Grade 3 tables understate what a patient experiences, and the approved label carries the all-grade figures. Stomatitis occurred in 72% of patients treated with REVTORPYK plus fulvestrant and palbociclib, including Grade 3 events in 22%, and in 58% of patients on REVTORPYK plus fulvestrant, including Grade 3 events in 12%. The label directs prescribers to start a steroid-containing, alcohol-free mouthwash before treatment begins and to continue it prophylactically, and to withhold, reduce or discontinue based on severity. A mandatory supportive-care step of that kind is a practical factor in how a regimen is adopted, separate from how it performs.
Treatment duration data updated as of August 2, 2026 give an early read on persistence. With median follow-up of roughly 21 months in the wild-type cohort and 17 months in the mutant cohort, patients on the triplet had received a mean of 9.0 and 10.0 cycles respectively, and 12% and 22% were still receiving therapy. For the doublet the figures were 9.7 and 11.3 cycles, with 12% and 19% still on treatment.
REVTORPYK commercial availability confirmed on September 30 — September 30, 2026. Celcuity’s September 30 Form 8-K and accompanying release confirm commercial availability for eligible adults with HR-positive/HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, after progression on or after at least one endocrine-therapy line in the metastatic setting. The July 14 approval covers the combinations with palbociclib and fulvestrant, and with fulvestrant. The company has also launched REVTORPYK Support Services for access, insurance and financial-assistance support.
The September announcement changes the status from expected launch to commercial availability. It supplies no initial prescription count, net revenue, gross-to-net adjustment or reimbursement success rate, so it does not justify an invented sales run rate or an adjustment to the dated June cash balance. The August sNDA for PIK3CA-mutant disease is distinct: submission does not establish FDA acceptance or approval. Subsequent financial reports must show how availability converts into demand, revenue and cash. September 30 Form 8-K · Issuer release, exhibit 99.1
The expanded access programme opened in early August 2026 to provide gedatolisib to eligible patients through participating physicians before commercial supply. Access does not itself establish commercial revenue or predict uptake.
The cost of readiness is already visible. Selling, general and administrative expense rose to $35.0 million in the second quarter of 2026 from $7.6 million in the same quarter of 2025. The $27.4 million increase breaks down into $14.5 million of employee-related expense, of which $3.3 million was stock-based compensation, and $12.9 million of other costs, of which $10.8 million was pre-commercial launch spending on consulting, professional fees and infrastructure and $2.1 million other administrative expense. The company states separately that $23.4 million of the $27.4 million related to commercial headcount additions and other launch-related activities. A company that has spent at this rate before a single unit ships has removed the excuse of not being ready.
The second study within VIKTORIA-1 randomised PIK3CA-mutant patients 3:3:1 to the gedatolisib triplet, alpelisib plus fulvestrant, or the gedatolisib doublet. The database cut-off was March 9, 2026, topline results were announced on May 1, 2026, and detailed results were presented in a late-breaking oral session at the ASCO Annual Meeting on June 2, 2026.
This is the harder comparison, because the control arm is an active PI3K-alpha inhibitor rather than endocrine therapy alone. The triplet halved the risk of progression or death against alpelisib plus fulvestrant, a hazard ratio of 0.50 with a 95% confidence interval of 0.37 to 0.68 and p<0.0001, with median progression-free survival of 11.1 months against 5.6 months. The doublet produced a hazard ratio of 0.51, confidence interval 0.33 to 0.79, descriptive p=0.0013, and median progression-free survival of 11.3 months against the same 5.6-month comparator.
Response rates separated as clearly: 49% for the triplet against 26% for alpelisib plus fulvestrant, with median duration of response of 15.7 months against 7.5 months, and 36% for the doublet with a 24.2-month median duration of response. The company describes this as the first Phase 3 trial to demonstrate superiority of one PAM inhibitor over another.
Overall survival, a key secondary endpoint, was immature at the time of analysis and showed what the company characterises as promising trends for both regimens. Immature survival data support nothing on their own, and a later analysis can move in either direction.
Celcuity submitted these data in a supplemental New Drug Application announced August 26, 2026, and has described plans for subsequent submissions outside the United States. An approval in the mutant population would widen the addressable label from roughly 60% of HR+/HER2- patients to substantially all of them in the second-line setting, and would place gedatolisib in direct competition with alpelisib on the strength of a head-to-head Phase 3 result rather than cross-trial inference. The submission occurred on August 26, 2026; acceptance and a PDUFA date have not been communicated.
The cohort behind the supplemental application filed on August 26, 2026, not yet part of the approved label. Blinded independent central review, database cut-off March 9, 2026.
HR 0.51 (95% CI 0.33-0.79), descriptive p=0.0013
HR 0.50 (95% CI 0.37-0.68), p<0.0001
active comparator arm
The comparator is an approved PI3K-alpha inhibitor rather than endocrine therapy alone, which makes the absolute months here a different measurement from the wild-type chart above.
Source: Celcuity Form 8-K exhibit EX-99.1 of August 13, 2026 and Form 10-Q filed August 13, 2026.
VIKTORIA-2 is the first-line programme, and it was restructured in the second quarter of 2026 in a way that enlarges what gedatolisib could eventually cover. The trial now runs two independent studies with separate statistical analysis plans and separate primary endpoints. Study 1 evaluates gedatolisib with palbociclib and fulvestrant against ribociclib with fulvestrant in roughly 440 treatment-naive patients with endocrine-resistant disease. Study 2, added in the second quarter, evaluates gedatolisib with palbociclib and letrozole against ribociclib with letrozole in roughly 740 treatment-naive patients with endocrine-sensitive disease.
Both studies enrol the full intent-to-treat population regardless of PIK3CA status, with progression-free survival by blinded independent central review as the primary endpoint. Roughly 200 sites participate, many of them carried over from VIKTORIA-1. Topline data for Study 1 are expected by the end of 2028 and for Study 2 in 2030. Those timelines put the first-line opportunity outside any reasonable near-term horizon, and the control arms are ribociclib-based regimens that represent current standard of care rather than a weakened comparator.
In metastatic castration-resistant prostate cancer, the CELC-G-201 Phase 1b/2 trial combines gedatolisib with darolutamide. Dose finding has completed evaluation of a 240 mg dose with no adverse events leading to gedatolisib discontinuation and no dose-limiting toxicity criteria met for dose reduction; a 300 mg dose is under evaluation. Once the Phase 1/1b portion completes, the company expects to select the recommended Phase 2 dose or doses and the control arm options for the randomised portion, and to provide updated data and strategy detail during the fourth quarter of 2026.
The subcutaneous formulation programme aims to demonstrate clinical equivalence to the intravenous form. Its purpose is explicitly forward-looking: if gedatolisib moves into first-line use, treatment durations could extend beyond several years, and weekly intravenous infusion for three weeks of every four over that horizon becomes a burden on patients and infusion capacity alike. No timeline for that programme has been disclosed.
The next public data point is now dated. On October 5, 2026 Celcuity announced four presentations at the ESMO Congress 2026 in Madrid (October 23–27). The main one is LBA 16, a late-breaking rapid oral with updated results from VIKTORIA-1, Study 2, scheduled for Saturday, October 24, 10:15–11:45 CEST. Three posters complete the list: 2237P on gedatolisib plus darolutamide in metastatic castration-resistant prostate cancer (CELC-G-201, Friday, October 23); 1873P, a network meta-analysis of gedatolisib versus other regimens after CDK4/6 inhibitors in PIK3CA wild-type HR+/HER2- advanced breast cancer (October 24); and 57TiP, the trial-in-progress design of the first-line VIKTORIA-2 study (October 24), which by definition contains no efficacy data. Abstracts are released on October 19 at 00:05 CEST. Source Until then, the content of the updated results is not public, and nothing in this hub anticipates it. The prostate poster falls in the quarter for which Celcuity guided updated mCRPC data in its second-quarter report; whether it carries that update will be clear only from the abstract. Source
The 10-Q for the quarter ended June 30, 2026 was filed on August 13, 2026 and is the current financial reference for every figure below.
Cash and cash equivalents stood at $182.0 million and short-term investments at $572.0 million, for total liquidity of $754.0 million, against $387.1 million at March 31, 2026 and $441.5 million at December 31, 2025. Total assets were $828.2 million.
Operating expenses for the quarter were $66.1 million against $44.0 million a year earlier. Research and development fell to $31.1 million from $36.4 million, a 15% decrease the company attributes to a $7.0 million reduction in clinical trial costs as VIKTORIA-1 wound down and a $5.0 million reduction in licence milestone costs, partly offset by $3.8 million more in employee-related and consulting expense and $2.9 million more in manufacturing and other costs. Selling, general and administrative expense rose to $35.0 million from $7.6 million. For the first time, the commercial line exceeds the research line.
Net loss was $78.9 million, or $1.44 per share, against $45.3 million and $1.04 a year earlier. The company also presents a non-GAAP adjusted net loss of $58.7 million, or $1.07 per share, which excludes stock-based compensation, non-cash interest expense, non-cash investment items and the loss on debt extinguishment. Of the $20.2 million gap, $11.5 million is the loss on extinguishing the term loan and $6.9 million is stock-based compensation; only the first is a one-off.
Net cash used in operating activities was $55.4 million in the quarter and $110.5 million in the first half, against $36.2 million in the comparable quarter of 2025. Interest expense was $5.4 million in the quarter, of which $1.5 million was non-cash, and $11.5 million in the half, of which $3.0 million was non-cash. Common shares outstanding were 48,922,556 at June 30, 2026 and 48,931,908 as of August 6, 2026 on the 10-Q cover page. A further 6,147,787 pre-funded warrant shares, exercisable for nominal consideration, are included in the earnings-per-share computation, which is why the weighted average behind the $1.44 loss per share is 54,816,437 rather than the common-share count.
Quarterly operating cash use of roughly $55 million is historical, before launch costs reach a run rate. Liquidity of $754.0 million underlies management’s forecast into 2029. The $50.0 million Pfizer milestone accrued at June 30 and triggered July 14, and launch working capital, affect cash needs; the June filing does not establish the milestone’s subsequent payment status.
| Line | Q2 2026 | Q1 2026 | Dec 31, 2025 or FY2025 |
|---|---|---|---|
| Cash and cash equivalents | $182.0M | $145.2M | $165.7M |
| Short-term investments | $572.0M | $241.9M | $275.8M |
| Total liquidity | $754.0M | $387.1M | $441.5M |
| Research and development | $31.1M | $33.1M | $145.0M (FY25) |
| Selling, general and administrative | $35.0M | $17.4M | $27.2M (FY25) |
| Total operating expenses | $66.1M | $50.5M | n/a |
| Net loss | $78.9M | $52.8M | not shown |
| Net loss per share | $1.44 | $0.97 | $3.79 (FY25) |
| Net cash used in operations | $55.4M | $55.1M | $153.3M (FY25) |
| Total stockholders’ equity (deficit) | -$12.8M | $53.5M | $100.6M |
All figures are as reported in the Form 10-Q for the relevant period. FY2025 research and development and selling, general and administrative are as reported in the 2025 Form 10-K: in connection with the FDA approval the company reclassified expense from research and development to selling, general and administrative, $6.3 million in the first half of 2025 alone, so the FY2025 split is not on the same basis as the 2026 quarters.
Stockholders’ equity was negative $12.8 million at June 30, 2026, against positive $100.6 million at December 31, 2025. A company holding three quarters of a billion dollars in liquid assets and reporting an equity deficit looks contradictory until the liability side is read in full, and the explanation is entirely mechanical.
Total liabilities were $841.0 million, of which convertible notes accounted for $753.2 million in carrying value. Two instruments sit in that line. The 2031 notes, whose issuance completed on August 1, 2025, carry a 2.750% coupon on $201.3 million of principal and convert at $51.30 per share, a rate of 19.4932 shares per $1,000, giving 3,923,002 shares issuable at June 30, 2026 against a maximum of 5,296,053. The 2032 notes, issued on June 8, 2026, carry a 0.250% coupon on $575.0 million of principal, including full exercise of a $75.0 million over-allotment option, and convert at $124.53 per share, a rate of 8.0302 shares per $1,000, giving 4,617,361 shares issuable at June 30, 2026 against a maximum of 6,464,306.
Negative book equity does not itself establish a liquidity crisis. Both convertible series had fair values above carrying values at June 30: $655.6 million versus $557.4 million for 2032, and $422.2 million versus $195.8 million for 2031. Conversion optionality, interest rates and credit conditions can affect fair value; the filing does not isolate their contributions. The $51.30 conversion price of the 2031 notes was below the dated share price, but the potential 3,923,002 conversion shares remain subject to contractual terms.
The term loan is gone. On June 8, 2026 the company paid $137.4 million to retire all principal, interest, fees and expenses under the amended Innovatus and Oxford loan agreement, wrote off $7.3 million of unamortised discounts and recorded an $11.5 million loss on extinguishment. The statement of cash flows shows $137.0 million under repayment of note payable within $422.9 million of net financing inflows for the half; the $0.4 million difference from the payoff amount is accrued interest, which the cash-flow statement classifies elsewhere. Removing a secured, covenanted term loan and replacing it with unsecured convertible notes at a 0.250% coupon lowers cash interest cost sharply and removes the collateral constraint.
Convertible notes are one source of potential dilution; equity compensation and future financing are additional possibilities. Conversion of both series at the stated rates would add 8.5 million shares. The maximum figures of 11.8 million shares assume the conversion-rate increases that apply on a make-whole fundamental change, meaning a takeover, a de-listing or the company calling the notes, rather than a simple conversion. Measured against the roughly 55.1 million shares that include the pre-funded warrants, the maximum case is about 21%; against common shares alone it is about 24%. The company retains the right to redeem either series from August 6, 2029 if the stock trades above 130% of the conversion price on the specified schedule.
| Term | 2031 notes | 2032 notes |
|---|---|---|
| Principal | $201.3M | $575.0M |
| Coupon | 2.750% | 0.250% |
| Issued | July 2025 | June 8, 2026 |
| Maturity | 2031 | August 1, 2032 |
| Conversion price | $51.30 per share | $124.53 per share |
| Conversion rate | 19.4932 shares per $1,000 | 8.0302 shares per $1,000 |
| Shares issuable at June 30, 2026 | 3,923,002 | 4,617,361 |
| Maximum shares issuable | 5,296,053 | 6,464,306 |
| Company redemption right | From August 6, 2029, subject to a 130% price test | From August 6, 2029, subject to a 130% price test |
Gedatolisib is licensed, not owned outright, and the terms determine how much of any commercial success reaches Celcuity’s own income statement.
Under the April 8, 2021 licence agreement, Celcuity paid $5.0 million upfront and issued 349,406 shares to Pfizer, and owes milestone payments of up to $335.0 million in aggregate: up to $155.0 million tied to development events and up to $180.0 million tied to commercial events, each payable within 60 days of achievement. The development schedule includes $5.0 million on NDA filing, recorded as research and development expense in June 2025 and paid in January 2026; $50.0 million on FDA approval of an NDA; and seven further development milestones totalling $100.0 million.
The approval milestone was triggered on July 14, 2026. Because that date falls after the balance sheet date but before the financial statements were issued, the company treated the approval as evidence of a contingent obligation existing at June 30, 2026, recognising a $50.0 million accrued licence milestone as a liability and a $50.0 million intangible asset. That intangible will amortise into cost of sales beginning at commercial launch, so the first revenue quarters will carry an amortisation charge alongside whatever gross margin the product generates.
Royalties are the recurring cost. Celcuity owes Pfizer tiered royalties on REVTORPYK net sales in low to mid-teens percentages, subject to reductions for expiry of valid patent claims, amounts due under third-party licences, and generic competition. Applied to any revenue forecast, a royalty in that band plus the amortisation of a $50.0 million intangible plus the commercial infrastructure already built means the contribution margin per dollar of sales is materially below what a wholly owned asset would produce. Up to $180.0 million of commercial milestones sit ahead as well, triggered by sales thresholds the company has not disclosed individually.
Celcuity may terminate the agreement for convenience on 90 days’ notice; Pfizer may not. Either party may terminate for uncured material breach.
These are third-party market-data figures as of September 30, 2026 unless another date is stated. They describe reported holdings and trading, not the motives of individual investors.
Institutional ownership stands at 103.60% and insider ownership at 17.66%. This third-party aggregate can reflect overlapping or stale filings and securities lending; it is not an exact partition of ownership. Against 48,931,908 shares as of August 6, 2026, reported on the cover of the Form 10-Q filed August 13, the float is 40.29 million, 82.34% of the total. A float that size against a $3.89 billion market capitalisation produces price moves disproportionate to the volume behind them, and average daily volume of about 1.15 million shares means a single institutional repositioning can dominate a session. On September 30, 2,530,162 shares changed hands, more than twice the average, and the session that opened at $81.30 reached $88.68 before closing at $79.52. The session range does not establish which holders traded or why.
Short interest was reported as 28.20% of float, or 11.36 million shares, with a short ratio of 9.92 in the September 30 snapshot. It had increased from the September 4 snapshot, but aggregate data cannot show whether particular positions were retained or replaced. Directional shorts and convertible hedges are possible explanations, not identified facts about holders.
Retail sentiment on Stocktwits reads 100% bullish against 0% bearish among the messages that carry a tag, on a platform score of 74 out of 100 labelled bullish, with 2,210 watchers following the stream and message volume in the high band at 62 out of 100. The platform score has climbed steeply into the launch: the average of the twenty-two readings from August 31 is 40.0, the low was 24 on September 8, and 74 on September 30 is the highest reading of the period. Those are self-reported tags from retail traders and non-professional investors rather than analyst positions, and they describe how one-sided the conversation has become rather than anything about the company.
The September 30 consensus target of $159.64 aggregates third-party opinions with different dates and assumptions. It is not company guidance or a Merlintrader valuation.
| Metric | $CELC |
|---|---|
| Close, September 30, 2026 | $79.52, on 2,530,162 shares |
| Market capitalisation | ~$3.89B, on the filed count of 48,931,908 shares |
| Shares outstanding / float | 48.93M / 40.29M, the float 82.34% of the total |
| Shares outstanding, filed | 48,922,556 at June 30, 2026; 48,931,908 as of August 6, 2026 on the 10-Q cover page |
| Pre-funded warrant shares | 6,147,787, exercisable for nominal consideration and included in the earnings-per-share computation |
| Insider / institutional ownership | 17.66% / 103.60%, a third-party aggregate rather than an exact ownership partition |
| Short interest | 28.20% of float, 11.36 million shares, short ratio 9.92 |
| Average daily volume | About 1.15 million shares |
| Sell-side consensus target | $159.64, Finviz aggregate, September 30, 2026 |
The market-cap calculation uses common shares only; 6,147,787 pre-funded warrant shares are additional economic exposure exercisable for nominal consideration. This distinction matters when comparing basic and diluted valuations.
Celcuity had reported no product revenue through June 30, 2026, and no post-launch sales have yet been reported, so historical product-sales multiples are not available. What can be framed is the relationship between the current market capitalisation and the commercial outcome it implies.
Using the September 30 close of $79.52 and the August 6 common-share count gives approximately $3.89 billion of common equity value. An illustrative bridge adds $776.3 million of convertible principal and the $50 million accrued Pfizer milestone, then subtracts June 30 liquidity of $754 million. This mixes dated inputs and is not a current enterprise-value estimate; pre-funded warrants and eventual note conversion require separate diluted-share analysis.
The company has published the top of the funnel. It estimates roughly 37,000 patients in the United States receiving second-line treatment for HR+/HER2- advanced breast cancer, and, using wholesale acquisition cost and internal duration-of-treatment assumptions, a second-line addressable market of more than $6.0 billion a year. That is a list-price ceiling rather than a forecast: it says nothing about penetration, persistence or the gap between list and net.
The inputs below that ceiling do not exist yet. Net price per patient after gross-to-net adjustments is unknown. The share of prescriptions taking the triplet versus the doublet is unknown, and it changes both efficacy expectations and the palbociclib component of each regimen. Persistence in commercial use is unknown; trial data show a mean of 9.0 to 11.3 cycles depending on cohort and regimen as of August 2, 2026, but commercial populations are typically less fit than trial populations. Payer coverage breadth is unknown.
Commercial availability is now confirmed. Subsequent quarterly statements are where sales, receivables and operating cash use will become visible. Q4 2026 is the first full calendar quarter after availability, while the timing and outcome of FDA review of the August 26 supplemental application remain separate uncertainties. Earnings-report months discussed here are indicative expectations, not issuer-confirmed dates.
The second-line HR+/HER2- setting is where several mechanisms now converge, and gedatolisib enters it with a specific structural advantage and a specific structural disadvantage.
The approved REVTORPYK population lacks a detected PIK3CA mutation. That does not eliminate all competing targeted approaches: AKT1 or PTEN alterations can create eligibility for capivasertib even without PIK3CA mutation. The mutant-cohort comparison against alpelisib supports the separate supplemental filing, but does not establish superiority to every option in this setting.
The disadvantage is administration. REVTORPYK is given intravenously once weekly for three weeks of every four-week cycle, while alpelisib and capivasertib are oral. In a setting where patients may remain on therapy for a year or more, that schedule imposes a burden on patients and on infusion centre capacity that oral competitors do not. The subcutaneous programme exists to address exactly this, without a disclosed timeline.
Beyond the PAM pathway, oral selective estrogen receptor degraders are moving through this same line of therapy, with elacestrant already approved for ESR1-mutant disease and further candidates in late-stage development. Those agents compete for the same treatment slot but through a different mechanism, and combinations rather than head-to-head displacement are the more likely outcome. Antibody-drug conjugates are used across this and later lines and compete for the same patients through a different mechanism, and the filings take no position on relative sequencing.
Financial figures refer to June 30, 2026. Current market and retail-sentiment snapshots on this page are as of September 30, 2026; older comparisons retain their individual dates. Third-party ownership categories may overlap and are not a partition of shareholders.
Yes. The Form 8-K of September 30, 2026 states that REVTORPYK (gedatolisib) is now commercially available in the United States for eligible patients with HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after at least one line of endocrine therapy in the metastatic setting. It was approved by the FDA on July 14, 2026.
No. Commercial availability applies to the population already approved, the PIK3CA wild-type cohort. The supplemental application to extend the label to the PIK3CA-mutant population was submitted on August 26, 2026 and is a separate regulatory process, with no announced FDA acceptance and no PDUFA date.
$754.0 million of cash and short-term investments at June 30, 2026, with operations stated as funded at least into 2029. Against that sit $776.3 million of convertible principal across two series, the 2031 notes at 2.750% ($201.3 million) and the 2032 notes at 0.250% ($575.0 million).
The third-quarter 2026 report, expected in November 2026, is the first one that touches the commercial period — but availability began on September 30, the last day of the quarter, so the first full quarter of sales is the fourth, reported around March 2027.
Market data as of September 30 showed short interest of 28.20% of float, or 11.36 million shares. Directional views and convertible hedging are possible contributors, but aggregate data cannot identify their proportions or the motives of holders.
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Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases and market-data providers, and are stated with their reference dates. Data can change without notice, and figures published before a results release become outdated the moment that release is issued. Merlintrader makes no representation that the information is complete or current at the time of reading. Readers should verify every figure against the primary source before acting on it.
Celcuity is a single-asset company that has just begun its first commercial launch and had reported no product revenue through June 30, with no post-launch sales yet reported. Its shares carry the risks typical of that stage: uptake may fall short of expectations, the submitted supplemental application may face delay or an adverse FDA outcome, convertible notes may dilute existing holders on conversion, and short interest above a quarter of the float can amplify moves in both directions.
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