- REVTORPYK™ (gedatolisib) approved by the
U.S . FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer onJuly 14, 2026 ; on track for commercial launch late third quarter 2026 - NCCN® Clinical Practice Guidelines recommended REVTORPYK in combination with fulvestrant, with or without palbociclib, as a preferred Category 1 option for second-line therapy in HR+/HER2- advanced breast cancer
- The Phase 3 PIK3CA mutant cohort of the VIKTORIA-1 trial achieved its primary endpoint by doubling the likelihood of survival without disease progression or death compared to alpelisib plus fulvestrant; a supplemental New Drug Application (“sNDA”) is planned for submission in the third quarter of 2026
- The Phase 3 VIKTORIA-2 trial was expanded to include a second study evaluating gedatolisib as first-line treatment in patients with endocrine-sensitive HR+/HER2- advanced breast cancer
- Completed issuance of
$575.0 million convertible note offering, with net proceeds of$557.2 million - Management to host webcast and conference call today,
August 13, 2026 , at4:30 p.m. EDT
“Celcuity made monumental progress these past few months, achieving critical clinical and regulatory milestones related to gedatolisib. With the FDA approval of REVTORPYK, positive results from the PIK3CA MT cohort of the pivotal VIKTORIA-1 study, and a preferred Category 1 recommendation in the NCCN Guidelines®, we are well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2-, locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy,” said
Clinical Highlights
HR+/HER2- Advanced Breast Cancer
2nd
Following the unprecedented results from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, on
The build-out of the commercialization infrastructure needed to support a successful launch of REVTORPYK is complete and commercial launch activities for REVTORPYK commenced immediately after approval. Shipments of REVTORPYK are expected to begin late in the third quarter of 2026.
To make gedatolisib available to patients prior to commercial availability of REVTORPYK, last week
2nd
Gedatolisib continued to demonstrate a differentiated clinical profile across different patient populations when combined with fulvestrant, with or without palbociclib. At the 2026
Gedatolisib plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib plus fulvestrant (the “gedatolisib-doublet”) reduced the risk of disease progression or death by 49% vs. alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79; descriptive p=0.0013). Median PFS was 11.3 months with the gedatolisib-doublet versus 5.6 months with alpelisib plus fulvestrant. Gedatolisib regimens demonstrated robust and durable responses: 49% objective response rate (“ORR”) and median duration of response (“DoR”) of 15.7 months for the gedatolisib-triplet and 36% ORR and median DoR of 24.2 months for the gedatolisib-doublet.
The safety data for the gedatolisib-triplet and -doublet were consistent with previously reported data from the PIK3CA wild-type cohort of VIKTORIA-1. Analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA MT cohort were updated using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA WT cohort presented in the REVTORPYK label. For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. For patients who received alpelisib, 19.1% discontinued treatment with alpelisib due to an adverse event.
Analyses of the mean number of gedatolisib treatment cycles patients received in the PIK3CA WT and MT cohorts of the VIKTORIA-1 Phase 3 trial were also updated as of
1st
Metastatic Castration-Resistant Prostate Cancer (“mCRPC”)
Development of gedatolisib in combination with darolutamide continues to advance. In the dose finding portion of Celcuity’s Phase 1b study, evaluation of a 240 mg dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib and dose limiting toxicity criteria for dose reduction were not met. Evaluation of a 300 mg dose is ongoing. Once the Phase 1/1b portion of the study is completed,
Other Recent Developments
In
Celcuity’s advancement of a subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.
Second Quarter 2026 Financial Results
Unless otherwise stated, all comparisons are for the second quarter ended
Net loss for the second quarter of 2026 was
Total operating expenses were
Research and development (“R&D”) expenses were
Selling, general and administrative (“SG&A”) expenses were
Net cash used in operating activities for the second quarter of 2026 was
Webcast and Conference Call Information
To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865.
A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1767665&tp_key=7e57f2ab18. A replay of the webcast will be available on the
About REVTORPYK (gedatolisib)
REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Please click here for Important Safety Information and Full Prescribing Information for REVTORPYK.
About Celcuity
We are a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Our first FDA-approved product is REVTORPYKTM (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Ka, AKT or mTORC1 alone or together. Our Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing.
More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity and its products, including important safety information and full prescribing information can be found at www.celcuity.com. Follow us on LinkedIn and X.
Forward Looking Statements
This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s sNDA for gedatolisib, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for gedatolisib; the Company’s expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for gedatolisib; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
References:
1. Internal estimates using data from National Cancer Institute, SEER, 2024; Pan, H, NEJM, 2017;377:1836-46; Dowsett, M 2009; Salvo, E. M. et al. 2021
© 2026 Celcuity Inc. All rights reserved. REVTORPYK and the Celcuity logo are trademarks of Celcuity Inc.
Contacts:
Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924
Condensed Balance Sheets (in thousands) | ||||||||
2026 | 2025 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 182,049 | $ | 165,703 | ||||
| Investments | 571,995 | 275,794 | ||||||
| Prepaid clinical trial costs | 12,996 | 18,896 | ||||||
| Other current assets | 8,801 | 5,266 | ||||||
| Total current assets | 775,841 | 465,659 | ||||||
| Property and equipment, net | 611 | 499 | ||||||
| Intangible assets, net | 50,000 | — | ||||||
| Operating lease right-of-use assets | 1,107 | 51 | ||||||
| Other non-current assets | 661 | 349 | ||||||
| Total assets | $ | 828,220 | $ | 466,558 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,093 | $ | 6,407 | ||||
| Accrued clinical trial costs | 7,942 | 16,826 | ||||||
| Accrued license milestone | 50,000 | 5,000 | ||||||
| Other accrued expenses | 20,581 | 15,865 | ||||||
| Operating lease liabilities, current | 257 | 54 | ||||||
| Total current liabilities | 86,873 | 44,152 | ||||||
| Operating lease liabilities, non-current | 893 | — | ||||||
| Convertible notes | 753,235 | 195,324 | ||||||
| Note payable | — | 126,527 | ||||||
| Total liabilities | 841,001 | 366,003 | ||||||
| Total stockholders' equity (deficit) | (12,781 | ) | 100,555 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 828,220 | $ | 466,558 | ||||
Condensed Statements of Operations (unaudited) (in thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development (1) | $ | 31,077 | $ | 36,415 | $ | 64,140 | $ | 66,174 | |||||||
| Selling, general and administrative (1) | 35,041 | 7,594 | 52,485 | 13,968 | |||||||||||
| Total operating expenses | 66,118 | 44,009 | 116,625 | 80,142 | |||||||||||
| Loss from operations | (66,118 | ) | (44,009 | ) | (116,625 | ) | (80,142 | ) | |||||||
| Other (expense) income: | |||||||||||||||
| Interest expense | (5,423 | ) | (3,204 | ) | (11,508 | ) | (6,387 | ) | |||||||
| Interest income | 4,154 | 1,945 | 7,905 | 4,264 | |||||||||||
| Loss on debt extinguishment | (11,477 | ) | — | (11,477 | ) | — | |||||||||
| Other expense, net | (12,746 | ) | (1,259 | ) | (15,080 | ) | (2,123 | ) | |||||||
| Net loss before income taxes | (78,864 | ) | (45,268 | ) | (131,705 | ) | (82,265 | ) | |||||||
| Income taxes | — | — | — | — | |||||||||||
| Net loss | $ | (78,864 | ) | $ | (45,268 | ) | $ | (131,705 | ) | $ | (82,265 | ) | |||
| Net loss per share, basic and diluted | $ | (1.44 | ) | $ | (1.04 | ) | $ | (2.41 | ) | $ | (1.90 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 54,816,437 | 43,663,364 | 54,640,608 | 43,359,748 | |||||||||||
| (1 | ) | Certain prior period amounts have been reclassified from research and development expenses to selling, general and administrative expenses to conform to the current period presentation. |
Cautionary Statement Regarding Non-GAAP Financial Measures
This press release contains references to non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP financial measures are useful supplemental measures for planning, monitoring, and evaluating operational performance as they exclude stock-based compensation expense, non-cash interest expense, non-cash investment (income) expense and loss on debt extinguishment from net loss and net loss per share. Management excludes these items because they do not impact Celcuity’s cash position, which management believes better enables
Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss and GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per Share (unaudited) (in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| GAAP net loss | $ | (78,864 | ) | $ | (45,268 | ) | $ | (131,705 | ) | $ | (82,265 | ) | ||||
| Adjustments to net loss: | ||||||||||||||||
| Stock-based compensation | ||||||||||||||||
| Research and development (1), (2) | 2,240 | 1,261 | 4,352 | 2,425 | ||||||||||||
| Selling, general and administrative (1), (3) | 4,664 | 1,443 | 7,877 | 2,723 | ||||||||||||
| Non-cash interest expense (4) | 1,471 | 789 | 3,048 | 1,589 | ||||||||||||
| Non-cash investment (income) expense (5) | 332 | 1,286 | (551 | ) | 340 | |||||||||||
| Loss on debt extinguishment (6) | 11,477 | — | 11,477 | — | ||||||||||||
| Non-GAAP adjusted net loss | $ | (58,680 | ) | $ | (40,489 | ) | $ | (105,502 | ) | $ | (75,188 | ) | ||||
| GAAP net loss per share - basic and diluted | $ | (1.44 | ) | $ | (1.04 | ) | $ | (2.41 | ) | $ | (1.90 | ) | ||||
| Adjustments to net loss: | ||||||||||||||||
| Stock-based compensation | ||||||||||||||||
| Research and development (1), (2) | 0.04 | 0.03 | 0.08 | 0.06 | ||||||||||||
| Selling, general and administrative (1), (3) | 0.08 | 0.03 | 0.14 | 0.06 | ||||||||||||
| Non-cash interest expense (4) | 0.03 | 0.02 | 0.06 | 0.04 | ||||||||||||
| Non-cash investment (income) expense (5) | 0.01 | 0.03 | (0.01 | ) | 0.01 | |||||||||||
| Loss on debt extinguishment (6) | 0.21 | — | 0.21 | — | ||||||||||||
| Non-GAAP adjusted net loss per share - basic and diluted | $ | (1.07 | ) | $ | (0.93 | ) | $ | (1.93 | ) | $ | (1.73 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 54,816,437 | 43,663,364 | 54,640,608 | 43,359,748 | ||||||||||||
| (1 | ) | Certain prior period amounts have been reclassified from research and development expenses to selling, general and administrative expenses to conform to the current period presentation. |
| (2 | ) | To reflect a non-cash adjustment to operating expenses for research and development stock-based compensation. |
| (3 | ) | To reflect a non-cash adjustment to operating expenses for selling, general and administrative stock-based compensation. |
| (4 | ) | To reflect a non-cash adjustment to other (expense) income for amortization of debt issuance costs and discount and payment-in-kind interest related to the issuance of the convertible notes and note payable. |
| (5 | ) | To reflect a non-cash adjustment to other (expense) income for accretion on investments and change in accrued interest income. |
| (6 | ) | To reflect a non-cash adjustment to other (expense) income for loss on extinguishment related to the repayment of the note payable. |
