Full Press Release Details
MINNEAPOLIS, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the third quarter ended September 30, 2025 and other recent business developments.
“We made significant clinical and regulatory progress in the third quarter,” said Brian Sullivan, CEO and co-founder of Celcuity. “At the ESMO Congress, we presented potentially practice-changing safety and efficacy results for the gedatolisib regimens from thePIK3CAwild-type cohort of our Phase 3 VIKTORIA-1 trial at a late breaking oral presentation. We remain on track to submit the New Drug Application for gedatolisib later this year based on data from thePIK3CAwild-type cohort. ThePIK3CAmutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected in late Q1 2026 or during Q2 2026.”
“There is an urgent need for more efficacious therapies than those currently available for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor. With our strengthened balance sheet, and unprecedented efficacy results in this patient population, we are well positioned to bring gedatolisib to patients should we get FDA approval.”
Third Quarter 2025 Business Highlights and Other Recent Developments
Third Quarter 2025 Financial Results
Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2025, compared to the third quarter ended September 30, 2024.
Total operating expenses were $42.8 million for the third quarter of 2025, compared to $30.1 million for the third quarter of 2024.
Research and development (“R&D”) expenses were $34.9 million for the third quarter of 2025, compared to $27.6 million for the prior-year period. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch-related activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials.
General and administrative (“G&A”) expenses were $7.9 million for the third quarter of 2025, compared to $2.5 million for the prior-year period. Of the approximately $5.4 million increase in general and administrative expenses, $4.9 million was related to increased employee and consulting expenses. Of this $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation. The remaining $0.5 million of the $5.4 million increase was primarily related to professional fees, expanding infrastructure and other administrative expenses.
Net loss for the third quarter of 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss for the third quarter of 2025 was $37.2 million, or $0.78 loss per share, compared to non-GAAP adjusted net loss of $27.6 million, or $0.65 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (“GAAP”) to non-GAAP financial measures, please see the financial tables at the end of this press release.
Net cash used in operating activities for the third quarter of 2025 was $44.8 million, compared to $20.6 million for the third quarter of 2024.
At September 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $455.0 million. We expect cash, cash equivalents, investments and drawdowns on our debt facility to fund operations through 2027.
Webcast and Conference Call Information
The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2025 financial results and provide a corporate update. 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=1736070&tp_key=9d6c00e337. A replay of the webcast will be available on the Celcuity website following the live event.
About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is 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 PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC has completed enrollment and the company has reported detailed results for thePIK3CAWT cohort, and has completed enrollment of patients for thePIK3CAmutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. A Phase 1/2 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 atClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found atwww.celcuity.com. Follow us onLinkedInandX.
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 the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the market opportunity for gedatolisib; the ability of our data to support the filing of an NDA with the FDA and the expected timing of such filing; our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib; our anticipated use of cash; and the strength of our 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 our clinical results are based on an ongoing analysis of key 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 our clinical trials; unforeseen delays in our planned NDA for gedatolisib; our ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our 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 we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
View source version of release on GlobeNewswire.com
| Celcuity Inc. | ||||||||
| Condensed Balance Sheets | ||||||||
| (in thousands) | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 74,252 | $ | 22,515 | ||||
| Investments | 380,726 | 212,589 | ||||||
| Other current assets | 20,519 | 9,467 | ||||||
| Total current assets | 475,497 | 244,571 | ||||||
| Property and equipment, net | 417 | 336 | ||||||
| Operating lease right-of-use assets | 90 | 216 | ||||||
| Total Assets | $ | 476,004 | $ | 245,123 | ||||
| Liabilities and Stockholders' Equity: | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 11,418 | $ | 9,366 | ||||
| Operating lease liabilities | 96 | 172 | ||||||
| Accrued expenses | 27,278 | 22,185 | ||||||
| Total current liabilities | 38,792 | 31,723 | ||||||
| Operating lease liabilities | – | 54 | ||||||
| Note payable, non-current | 125,166 | 97,727 | ||||||
| Convertible Debt | 195,083 | – | ||||||
| Total Liabilities | 359,041 | 129,504 | ||||||
| Total Stockholders' Equity | 116,963 | 115,619 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 476,004 | $ | 245,123 |
| Celcuity Inc. | ||||||||||||||||
| Condensed Statements of Operations | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 34,915 | $ | 27,588 | $ | 107,364 | $ | 70,732 | ||||||||
| General and administrative | 7,934 | 2,472 | 15,627 | 6,105 | ||||||||||||
| Total operating expenses | 42,849 | 30,060 | 122,991 | 76,837 | ||||||||||||
| Loss from operations | (42,849 | ) | (30,060 | ) | (122,991 | ) | (76,837 | ) | ||||||||
| Other (expense) income | ||||||||||||||||
| Interest expense | (4,595 | ) | (3,344 | ) | (10,982 | ) | (7,005 | ) | ||||||||
| Interest income | 3,640 | 3,612 | 7,904 | 8,716 | ||||||||||||
| Other (expense) income, net | (955 | ) | 268 | (3,078 | ) | 1,711 | ||||||||||
| Net loss before income taxes | (43,804 | ) | (29,792 | ) | (126,069 | ) | (75,126 | ) | ||||||||
| Income tax benefits | – | – | – | – | ||||||||||||
| Net loss | $ | (43,804 | ) | $ | (29,792 | ) | $ | (126,069 | ) | $ | (75,126 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.92 | ) | $ | (0.70 | ) | $ | (2.81 | ) | $ | (1.96 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 47,589,731 | 42,793,047 | 44,785,236 | 38,299,548 |
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, and non-cash interest income 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 Celcuity to focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share are not recognized measures under GAAP and do not have a standardized meaning prescribed by GAAP. As a result, management’s method of calculating non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other companies. Therefore, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similarly titled measures presented by other companies. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed as alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with GAAP) as an indicator of Celcuity’s performance or as a measure of liquidity and cash flows.
| Celcuity Inc. | ||||||||||||||||
| 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 | ||||||||||||||||
| (in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| GAAP net loss | $ | (43,804 | ) | $ | (29,792 | ) | $ | (126,069 | ) | $ | (75,126 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | ||||||||||||||||
| Research and development(1) | 2,057 | 1,190 | 5,285 | 3,001 | ||||||||||||
| General and administrative(2) | 4,722 | 741 | 6,642 | 1,672 | ||||||||||||
| Non-cash interest expense(3) | 1,050 | 730 | 2,639 | 1,891 | ||||||||||||
| Non-cash interest income(4) | (1,180 | ) | (474 | ) | (840 | ) | (1,113 | ) | ||||||||
| Non-GAAP adjusted net loss | $ | (37,155 | ) | $ | (27,605 | ) | $ | (112,343 | ) | $ | (69,675 | ) | ||||
| GAAP net loss per share – basic and diluted | $ | (0.92 | ) | $ | (0.70 | ) | $ | (2.81 | ) | $ | (1.96 | ) | ||||
| Adjustment to net loss: | ||||||||||||||||
| Stock -based compensation | ||||||||||||||||
| Research and development | 0.04 | 0.03 | 0.12 | 0.08 | ||||||||||||
| General and administrative | 0.10 | 0.02 | 0.15 | 0.04 | ||||||||||||
| Non-cash interest expense | 0.02 | 0.01 | 0.06 | 0.05 | ||||||||||||
| Non-cash interest income | (0.02 | ) | (0.01 | ) | (0.02 | ) | (0.03 | ) | ||||||||
| Non-GAAP adjusted net loss per share | $ | (0.78 | ) | $ | (0.65 | ) | $ | (2.50 | ) | $ | (1.82 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 47,589,731 | 42,793,047 | 44,785,236 | 38,299,548 | ||||||||||||
| (1) To reflect a non-cash charge to operating expense for Research and Development stock-based compensation.(2) To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.(3) To reflect a non-cash charge to other expense for amortization of debt issuance and discount costs and PIK interest related to the issuance of a note payable.(4) To reflect a non-cash adjustment to other income for accretion on investments. |