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FDA priority review and trial data highlight Celcuity (NASDAQ: CELC)

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(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Celcuity Inc. reported fourth quarter and full year 2025 results alongside major regulatory and clinical milestones for its lead drug candidate, gedatolisib.

The FDA accepted Celcuity’s New Drug Application for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer, granted Priority Review, and set a PDUFA goal date of July 17, 2026. Published Phase 3 VIKTORIA-1 cohort data showed the gedatolisib triplet improved median time to definitive deterioration in patient-reported well-being to 23.7 months versus 4.0 months on fulvestrant, with a hazard ratio of 0.39.

Total operating expenses rose to $49.2 million in the fourth quarter and $172.2 million for 2025, driving a GAAP net loss of $51.0 million for the quarter and $177.0 million for the year. Non-GAAP adjusted net loss was $38.4 million for the quarter and $150.8 million for 2025. Cash, cash equivalents and short-term investments were $441.5 million at year-end 2025, which the company expects will fund operations through 2027.

Positive

  • FDA Priority Review and defined PDUFA date: The FDA accepted Celcuity’s NDA for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer, granted Priority Review, and set a PDUFA goal date of July 17, 2026.
  • Strong Phase 3 clinical results: VIKTORIA-1 PIK3CA WT cohort data showed the gedatolisib triplet improved median time to definitive deterioration to 23.7 months versus 4.0 months on fulvestrant, with a hazard ratio of 0.39, alongside favorable progression and response metrics.
  • Extended cash runway: Cash, cash equivalents and short-term investments of $441.5 million at December 31, 2025 are expected to finance operations through 2027, supporting ongoing development and potential launch preparation without an immediate need for external capital.

Negative

  • Significantly higher operating expenses and losses: Total operating expenses rose to $172.2 million in 2025 from $113.3 million in 2024, driving a wider GAAP net loss of $177.0 million versus $111.8 million a year earlier.
  • Elevated cash burn and leverage: Net cash used in operating activities increased to $153.3 million in 2025 from $83.5 million in 2024, while the balance sheet now includes $195.3 million of convertible debt and a $126.5 million note payable.

Insights

Priority FDA review and strong Phase 3 data elevate gedatolisib’s outlook.

Celcuity secured FDA acceptance and Priority Review of its NDA for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer, with a PDUFA goal date of July 17, 2026. This formalizes the regulatory path and timeline toward a potential first approval.

Phase 3 VIKTORIA-1 PIK3CA WT cohort results look robust: the gedatolisib triplet improved median time to definitive deterioration in EQ-5D-5L well-being measures to 23.7 months versus 4.0 months on fulvestrant, with a hazard ratio of 0.39. Reported gains in progression-free survival, duration of response, and objective response rate versus control further position gedatolisib as a differentiated PAM-pathway inhibitor.

The program still depends on full FDA review and forthcoming topline data from the PIK3CA mutant cohort expected in Q2 2026. Those results, together with the agency’s action around the July 17, 2026 PDUFA date, will be key inflection points for assessing long-term commercial potential.

Rising losses are significant but partly offset by a stronger cash position.

Operating expenses increased to $49.2M in Q4 2025 and $172.2M for 2025, reflecting higher R&D and commercialization build-out. GAAP net loss widened to $51.0M in Q4 and $177.0M for the year, with non-GAAP adjusted net loss at $150.8M.

The balance sheet shows $441.5M in cash, cash equivalents and short-term investments at year-end 2025, alongside $195.3M of convertible debt and a $126.5M note payable. Management expects this cash to fund operations through 2027, which provides a multi-year runway despite higher cash burn of $153.3M in 2025.

Overall, the filing combines heavier spending and larger losses with improved liquidity and a clearer regulatory timeline. Actual financial impact will hinge on regulatory outcomes and the pace of any future commercial ramp disclosed in subsequent periods.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 25, 2026

 

Celcuity Inc.

(Exact name of Registrant as Specified in its Charter)

 

Delaware   001-38207   82-2863566

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

16305 36th Avenue North; Suite 100

Minneapolis, Minnesota 55446

(Address of Principal Executive Offices and Zip Code)

 

(763) 392-0767

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, $0.001 par value per share   CELC   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

Item 2.02 Results of Operations and Financial Condition.

 

On March 25, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the fourth quarter and fiscal year ended December 31, 2025. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

 

The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1 Press release dated March 25, 2026
   
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 25, 2026

  CELCUITY INC.
   
  By /s/ Brian F. Sullivan
    Brian F. Sullivan
    Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

 

  The U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted Priority Review with a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, for gedatolisib in HR+/HER2-/PIK3CA wild-type (“WT”) advanced breast cancer (“ABC”)
  Results from PIK3CA WT cohort of Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2- ABC published in Journal of Clinical Oncology
  Topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected to be released in the second quarter of 2026
  Management to host webcast and conference call today, March 25, 2026, at 4:30 p.m. EDT

 

MINNEAPOLIS, March 25, 2026 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the fourth quarter and full year ended December 31, 2025, and other recent business developments.

 

“We expect this year to be a transformative one for Celcuity. We plan to release topline results from the PIK3CA mutant cohort of our Phase 3 VIKTORIA-1 study in the second quarter of 2026, which, if positive, could potentially advance the standard-of-care second line therapy for a significant number of patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and co-founder of Celcuity. “Additionally, our efforts remain on track to launch gedatolisib commercially in anticipation of its potential FDA approval in the third quarter of 2026.”

 

Fourth Quarter 2025 Business Highlights and Other Recent Developments

 

  In December 2025, updated efficacy and safety results from the Phase 3 VIKTORIA-1 PIK3CA WT cohort were presented at the 2025 San Antonio Breast Cancer Symposium including patient sub-group analyses, safety analyses and patient reported outcomes for well-being measures.

 

  For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median progression free survival (“PFS”) was 16.6 months with the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) versus 1.9 months for fulvestrant (HR=0.14; 95% CI: 0.08-0.28; p<0.0001).

 

 
 

 

  The gedatolisib triplet delayed time to definitive deterioration versus fulvestrant according to patient reported outcomes for well-being measures that included mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (the EQ-5D-5L score). The median time to definitive deterioration was 23.7 months (HR=0.39; 95% CI: 0.25-0.67; p = 0.0003) for patients treated with the gedatolisib triplet versus 4.0 months for fulvestrant. Additionally, for the first 8 cycles of treatment, the patients’ assessment of their well-being remained stable relative to their assessment prior to starting treatment with gedatolisib.
  As reported earlier, the gedatolisib triplet was generally well tolerated in the trial with mostly low-grade treatment-related adverse events (“TRAEs”). The most common Grade 3+ TRAEs for the gedatolisib triplet and fulvestrant included neutropenia (62.3% and 0.8% of patients, respectively); stomatitis (19.2% and 0%); rash (4.6% and 0%); and hyperglycemia (2.3% and 0%). No patients experienced Grade 4 hyperglycemia. TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group and 0% in the fulvestrant group.

 

  In January 2026, the FDA accepted for filing Celcuity’s NDA for gedatolisib in HR+/HER2- PIK3CA WT ABC. The FDA granted Priority Review and assigned a PDUFA goal date of July 17, 2026.
     
  In March 2026, efficacy and safety results from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib were published in the Journal of Clinical Oncology. The cohort consisted of patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed while on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
     
  As reported previously, the results from the VIKTORIA-1 Phase 3 PIK3CA WT cohort, established several new milestones in the history of drug development for HR+/HER2- ABC:

 

  The hazard ratio for the gedatolisib triplet is more favorable than has ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.
  The 7.3-months incremental improvements in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of endocrine therapy-based regimen.
  Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR (“PAM”) pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.
  Median duration of response (“DOR”) of 17.5 months and incremental objective response rate (“ORR”) improvement of 31% relative to control for the gedatolisib triplet is the highest reported for an endocrine therapy-based regimen in second line HR+/HER2- ABC.

 

Fourth Quarter and Full Year 2025 Financial Results

 

Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2025, compared to the fourth quarter and full year ended December 31, 2024.

 

 
 

 

Total operating expenses were $49.2 million for the fourth quarter of 2025, compared to $36.4 million for the fourth quarter of 2024. Operating expenses for the full year 2025 were $172.2 million, compared to $113.3 million for the full year 2024.

 

Research and development (“R&D”) expenses were $37.6 million for the fourth quarter of 2025, compared to $33.5 million for the prior-year period. Of the $4.1 million increase in R&D expenses, $8.6 million was related to increased employee and consulting expenses, of which $5.3 million related to commercial headcount additions and other launch-related activities. These amounts were partially offset by a $4.5 million decrease primarily related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial.

 

R&D expenses for the full year 2025 were $145.0 million, compared to $104.2 million for the prior year. Of the $40.8 million increase in R&D expenses, $26.7 million was related to increased employee and consulting expenses, of which $13.1 million related to commercial headcount additions and other launch-related activities. The remaining $14.1 million increase was primarily related to activities supporting our ongoing clinical trials, a development milestone payment under the license agreement with Pfizer, and other commercial launch-related activities.

 

General and administrative (“G&A”) expenses were $11.6 million for the fourth quarter of 2025, compared to $3.0 million for the prior year period. Of the $8.6 million increase, $6.9 million was related to increased employee-related and consulting expenses, of which $5.4 million related to non-cash stock-based compensation. The remaining $1.7 million increase was primarily related to professional fees, expanding infrastructure costs, and other administrative expenses.

 

G&A expenses for the full year 2025 were $27.2 million, compared to $9.1 million for the prior year. Of the $18.1 million increase in G&A expenses, $14.9 million was related to increased employee-related and consulting expenses, of which $10.4 million related to non-cash stock-based compensation. The remaining $3.2 million increase was primarily related to professional fees, expanding infrastructure costs, and other administrative expenses.

 

Net loss for the fourth quarter of 2025 was $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share, for the fourth quarter of 2024. Net loss for the full year 2025 was $177.0 million, or $3.79 per share, compared to a net loss of $111.8 million, or $2.83 per share, in 2024. Non-GAAP adjusted net loss for the fourth quarter of 2025 was $38.4 million, or $0.73 per share, compared to non-GAAP adjusted net loss of $32.3 million, or $0.75 per share, for the fourth quarter of 2024. Non-GAAP adjusted net loss for the full year 2025 was $150.8 million, or $3.22 per share, compared to non-GAAP adjusted net loss of $101.9 million, or $2.58 per share, for 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 fourth quarter of 2025 was $36.4 million, compared to $27.8 million for the fourth quarter of 2024. Net cash used in operating activities for the full year 2025 was $153.3 million, compared to $83.5 million for the full year 2024. Cash, cash equivalents and short-term investments were $441.5 million at the end of fiscal year 2025 and are expected to finance our operations through 2027.

 

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 the weblink below. A replay of the webcast will be available on the Celcuity website following the live event. https://viavid.webcasts.com/starthere.jsp?ei=1751140&tp_key=9ff20687c4.

 

About Celcuity

 

Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the 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 PI3K/AKT/mTOR (“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- advanced breast cancer (“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- ABC, is ongoing. 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 at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity 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 the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the status and timing of the FDA’s review of our New Drug Application for gedatolisib, including the PDUFA goal date assigned by the FDA; the market opportunity for gedatolisib; 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 or the FDA’s review of our 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, 2025, 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.

 

Contacts:

 

Celcuity Inc.

Brian Sullivan, bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

(763) 392-0123

Jodi Sievers, jsievers@celcuity.com

(415) 494-9924

 

 
 

 

Celcuity Inc.

Balance Sheets

(in thousands)

 

   December 31, 2025   December 31, 2024 
Assets          
Current assets:          
Cash and cash equivalents  $165,703   $22,515 
Investments   275,794    212,589 
Other current assets   24,162    9,467 
Total current assets   465,659    244,571 
Property and equipment, net   499    336 
Operating lease right-of-use assets   51    216 
Other non-current assets   349     
Total assets  $466,558   $245,123 
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable  $6,407   $9,366 
Accrued expenses   37,691    22,185 
Operating lease liabilities, current   54    172 
Total current liabilities   44,152    31,723 
Operating lease liabilities, non-current       54 
Convertible debt   195,324     
Note payable, non-current   126,527    97,727 
Total liabilities   366,003    129,504 
Total stockholders’ equity   100,555    115,619 
Total liabilities and stockholders’ equity  $466,558   $245,123 

 

 
 

 

Celcuity Inc.

Statements of Operations

(in thousands, except share and per share amounts)

 

   Three Months Ended December 31,    Year Ended December 31, 
   2025   2024   2025   2024 
   (unaudited)         
Operating expenses:                    
Research and development  $37,631   $33,471   $144,995   $104,203 
General and administrative   11,570    2,959    27,197    9,064 
Total operating expenses   49,201    36,430    172,192    113,267 
Loss from operations   (49,201)   (36,430)   (172,192)   (113,267)
                     
Other (expense) income:                    
Interest expense   (6,166)   (3,275)   (17,148)   (10,280)
Interest income   4,394    3,052    12,298    11,768 
Other (expense) income, net   (1,772)   (223)   (4,850)   1,488 
Net loss before income taxes   (50,973)   (36,653)   (177,042)   (111,779)
Income taxes                
Net loss  $(50,973)  $(36,653)  $(177,042)  $(111,779)
                     
Net loss per share, basic and diluted  $(0.97)  $(0.85)  $(3.79)  $(2.83)
                     
Weighted average common shares outstanding, basic and diluted   52,539,744    42,873,934    46,757,691    39,449,393 

 

 
 

 

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 Ended December 31,   Year Ended December 31, 
   2025   2024   2025   2024 
GAAP net loss  $(50,973)  $(36,653)  $(177,042)  $(111,779)
Adjustments to net loss:                    
Stock-based compensation                    
Research and development (1)   3,124    1,404    8,409    4,405 
General and administrative (2)   6,332    911    12,974    2,583 
Non-cash interest expense (3)   1,602    803    4,241    2,695 
Non-cash interest income (4)   1,470    1,263    630    150 
Non-GAAP adjusted net loss  $(38,445)  $(32,272)  $(150,788)  $(101,946)
                     
GAAP net loss per share - basic and diluted  $(0.97)  $(0.85)  $(3.79)  $(2.83)
Adjustments to net loss:                    
Stock-based compensation                    
Research and development   0.06    0.03    0.18    0.11 
General and administrative   0.12    0.02    0.29    0.07 
Non-cash interest expense   0.03    0.02    0.09    0.07 
Non-cash interest income   0.03    0.03    0.01     
Non-GAAP adjusted net loss per share - basic and diluted  $(0.73)  $(0.75)  $(3.22)  $(2.58)
                     
Weighted average common shares outstanding, basic and diluted   52,539,744    42,873,934    46,757,691    39,449,393 

 

(1) To reflect a non-cash charge to operating expenses for research and development stock-based compensation.

 

(2) To reflect a non-cash charge to operating expenses for general and administrative stock-based compensation.

 

(3) To reflect a non-cash charge to other expense for amortization of debt issuance costs and discount and payment-in-kind interest related to the issuance of a note payable.

 

(4) To reflect a non-cash adjustment to other income for accretion on investments and change in accrued interest income.

 

 

FAQ

What did Celcuity (CELC) report for its 2025 net loss and operating expenses?

Celcuity reported a 2025 GAAP net loss of $177.0 million, compared to $111.8 million in 2024. Total operating expenses rose to $172.2 million from $113.3 million, driven mainly by higher R&D, commercialization activities, and increased general and administrative costs.

What is the status of Celcuity’s FDA New Drug Application for gedatolisib?

The FDA has accepted Celcuity’s NDA for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer and granted Priority Review. The agency assigned a PDUFA goal date of July 17, 2026, defining the target timeline for a regulatory decision.

How strong were the VIKTORIA-1 Phase 3 results for gedatolisib reported by Celcuity?

In the PIK3CA wild-type cohort of VIKTORIA-1, the gedatolisib triplet improved median time to definitive deterioration in EQ-5D-5L well-being scores to 23.7 months versus 4.0 months on fulvestrant, with a hazard ratio of 0.39, indicating a substantial benefit.

What cash runway does Celcuity (CELC) expect after its 2025 results?

Celcuity ended 2025 with $441.5 million in cash, cash equivalents and short-term investments. Management states this balance is expected to finance operations through 2027, even as net cash used in operating activities reached $153.3 million in 2025.

How did Celcuity’s non-GAAP adjusted net loss change in 2025?

Non-GAAP adjusted net loss, which excludes stock-based compensation and certain non-cash interest items, was $150.8 million in 2025 compared to $101.9 million in 2024. On a per-share basis, non-GAAP adjusted net loss increased to $3.22 from $2.58.

What clinical milestones does Celcuity anticipate in 2026 for gedatolisib?

Celcuity plans to release topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study in the second quarter of 2026. The company also anticipates a potential FDA decision around the July 17, 2026 PDUFA date for its NDA.

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Biotechnology
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United States
MINNEAPOLIS