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Celcuity Inc.

CELC
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Business Summary

Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications. The company's primary therapeutic candidate is gedatolisib, a kinase inhibitor that targets the phosphatidylinositol 3-kinase (PI3K), serine/threonine-protein kinase protein kinase B (AKT), and mechanistic target of rapamycin (mTOR) pathway. Gedatolisib comprehensively inhibits the PI3K/AKT/mTOR (PAM) pathway by binding to all class I PI3K isoforms and both mTORC1 and mTORC2 complexes, differentiating its mechanism of action and pharmacokinetic properties from other approved or investigational therapies that target only specific components of this pathway. The company believes this comprehensive inhibition helps overcome adaptive resistance mechanisms seen with single-component inhibitors.

The core business model of Celcuity Inc. is centered on the research, development, and eventual commercialization of gedatolisib. The company currently generates no revenue and has incurred significant operating losses since its inception in 2012. Revenue generation is entirely dependent on successfully completing clinical trials, obtaining regulatory approvals, and commercializing gedatolisib. The company's primary customer segments, if gedatolisib is approved, would be cancer patients, with treatments primarily administered by medical, surgical, or radiation oncologists and their multidisciplinary teams.

Celcuity's lead product candidate, gedatolisib, is currently being evaluated in multiple clinical trials. The Phase 3 VIKTORIA-1 clinical trial, which has completed enrollment of 754 subjects across nearly 200 clinical sites , is evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) who have progressed after prior CDK4/6 therapy. Detailed results for cohort 1 (PIK3CA wild-type (WT) tumors) were reported in the third and fourth quarters of 2025, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS). The gedatolisib triplet (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median PFS of 9.3 months versus 2.0 months , an incremental improvement of 7.3 months . The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk by 67% , with a median PFS of 7.4 months versus 2.0 months , an incremental improvement of 5.4 months . The objective response rate (ORR) for the triplet was 31% and for the doublet was 28.3% , compared to 1% for fulvestrant. Updated results for patients in the U.S., Canada, Western Europe, and Asia Pacific showed a median PFS of 16.6 months for the triplet and 7.1 months for the doublet versus 1.9 months for fulvestrant.

Another ongoing Phase 3 clinical trial, VIKTORIA-2, initiated in July 2025, is evaluating gedatolisib in combination with a CDK4/6 inhibitor (ribociclib or palbociclib) and fulvestrant as first-line treatment for patients with HR+/HER2- endocrine treatment-resistant ABC. This trial expects to randomize approximately 638 subjects across approximately 200 clinical sites . Additionally, a Phase 1b/2 clinical trial, CELC-G-201, is evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Initial preliminary data from the Phase 1 portion of CELC-G-201, based on an August 15, 2025 data cut-off, showed a six-month radiographic PFS rate of 67% and a median rPFS of 9.1 months for both arms combined. For the 120 mg gedatolisib arm, the six-month rPFS rate was 74% and median rPFS was 9.5 months . For the 180 mg gedatolisib arm, the six-month rPFS rate was 61% and median rPFS was 7.4 months .

For the fiscal year ended December 31, 2025, Celcuity reported a net loss of $177.0 million , compared to a net loss of $111.8 million for the year ended December 31, 2024. The company has not generated any revenue to date. Total operating expenses for 2025 were $172.2 million , up from $113.3 million in 2024. Research and development expenses increased to $145.0 million in 2025 from $104.2 million in 2024, representing a 39% increase. General and administrative expenses were $27.2 million in 2025, a 200% increase from $9.1 million in 2024. Loss from operations was $172.2 million in 2025, compared to $113.3 million in 2024. Interest expense increased to $17.1 million in 2025 from $10.3 million in 2024, a 67% increase. Interest income was $12.3 million in 2025, a 5% increase from $11.8 million in 2024. Diluted EPS was $(3.79) in 2025, compared to $(2.83) in 2024. As of December 31, 2025, cash and cash equivalents were $165.7 million , and short-term investments were $275.8 million , totaling $441.5 million . Total debt, including convertible debt and non-current note payable, was $321.8 million ($195.3 million convertible debt and $126.5 million note payable). The accumulated deficit as of December 31, 2025, was $448.9 million .

The increase in research and development expenses in 2025 was primarily due to a $26.7 million increase in employee-related and consulting expenses, with $13.1 million specifically for commercial headcount additions and launch activities. Other increases included $6.0 million for ongoing clinical trials, a $5.0 million development milestone payment to Pfizer, and $3.1 million in other commercial launch activities. General and administrative expenses rose due to a $14.9 million increase in employee-related and consulting expenses, including $10.4 million in non-cash stock-based compensation, and a $3.2 million increase in professional fees and infrastructure costs. The rise in interest expense was attributed to the incremental $61.7 million funding of the Term C Loan in May 2024, the issuance of $201.3 million aggregate principal amount of Notes in July 2025, and the $30.0 million disbursement of the Term D Loan in September 2025.

During the reported period, Celcuity achieved several significant operational developments. In August 2025, the FDA granted the company's request to submit its New Drug Application (NDA) for gedatolisib under the Real-Time Oncology Review (RTOR) program, based on data from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial. The first NDA pre-submission was made in September 2025, and the final NDA submission was completed in November 2025. On January 16, 2026, the FDA accepted the NDA and granted it Priority Review, with a target user fee goal date of July 17, 2026 . The company also dosed the first patient in the Phase 3 VIKTORIA-2 clinical trial in July 2025 and reported initial preliminary data for the Phase 1 portion of the CELC-G-201 trial in the fourth quarter of 2025. In January 2026, a $5.0 million milestone payment was made to Pfizer following FDA acceptance of the NDA submission.

Business Outlook

Celcuity Inc. anticipates generating revenue from sales of gedatolisib commencing in the second half of 2026, assuming regulatory approvals are obtained. The FDA has accepted the company's NDA for gedatolisib in HR+/HER2- PIK3CA WT ABC, granted it Priority Review, and set a PDUFA goal date of July 17, 2026 .

A major growth area for Celcuity is the commercialization of gedatolisib for HR+/HER2- ABC patients who have progressed after CDK4/6 inhibitor therapy, particularly the PIK3CA WT population. The company estimates the total addressable market for gedatolisib in the second-line setting to be more than $5.0 billion , with a potential to generate peak revenue of up to $2.5 billion annually if FDA approval is secured for both PIK3CA WT and PIK3CA MT populations. The ongoing Phase 3 VIKTORIA-1 clinical trial, with topline data for the PIK3CA MT cohort expected in the second quarter of 2026, is critical for expanding this market opportunity.

Another significant growth vector is the development of gedatolisib as a first-line treatment for HR+/HER2- endocrine treatment-resistant ABC through the ongoing Phase 3 VIKTORIA-2 clinical trial. This multi-center, international trial, which dosed its first patient in July 2025, is expected to randomize approximately 638 subjects across approximately 200 clinical sites in North America, Europe, and Asia-Pacific. The safety run-in portion of VIKTORIA-2 was completed in the first quarter of 2026, and an update on the final Phase 3 study design is expected in the second quarter of 2026.

The company is also pursuing the development of gedatolisib for metastatic castration-resistant prostate cancer (mCRPC) through the CELC-G-201 Phase 1b/2 clinical trial. This trial, which dosed its first patient in February 2024, aims to determine the recommended Phase 2 dose (RP2D) and assess radiographic PFS at six months. The clinical trial protocol was amended in June 2025 to explore additional doses in the Phase 1b portion, with up to six patients planned for enrollment in each of three arms. Upon RP2D determination, up to an additional 40 patients will be randomly assigned to up to four Phase 1b cohorts, followed by enrolling up to 18 additional subjects in the Phase 2 dose expansion study to reach a total of approximately 30 subjects treated with the RP2D.

Operationally, Celcuity anticipates that its research and development and general and administrative expenses will continue to increase in future periods. This is driven by ongoing clinical trials for gedatolisib (VIKTORIA-1, VIKTORIA-2, and CELC-G-201), other studies, and business development activities. Sales and marketing expenses are also expected to scale significantly as the company prepares for and executes the commercial launch of gedatolisib, following potential FDA approval. The company has begun hiring employees in preparation for the anticipated commercial launch.

Regarding capital allocation, Celcuity expects to continue increasing its research and development expenses for the foreseeable future. The company plans to use its current cash, cash equivalents, and short-term investments, along with available borrowings under the Amended A&R Loan Agreement, to fund research and development, clinical trial costs, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses. The company believes its current capital resources will be sufficient to finance operations through 2027. Future capital may be raised through equity offerings, debt financings, or collaborations, which could result in dilution to stockholders or restrictive covenants.

Risk Factors

Celcuity faces material risks including its limited operating history and the uncertainty of generating revenue or profit from its sole drug candidate, gedatolisib, which may never successfully complete clinical development, obtain regulatory approval, or be commercialized due to factors like insufficient efficacy, unacceptable side effects, or supply chain interruptions. The company's reliance on third parties for early development data, clinical trials, manufacturing, and distribution exposes it to risks of non-compliance, delays, or increased costs. Significant competition from larger pharmaceutical companies with greater resources could limit market acceptance and pricing power. The company's substantial indebtedness of $338.8 million as of December 31, 2025, including $201.3 million in convertible notes and $130.0 million in secured indebtedness, could restrict cash flow and limit access to additional financing, with an additional $220.0 million in incremental Term Loans available upon certain milestones. Cybersecurity threats, including those enhanced by AI, pose risks to sensitive information, clinical trial data, and business operations, potentially leading to delays, regulatory actions, litigation, and financial losses, with no assurance that current safeguards or insurance coverage will be adequate. Evolving U.S. and global data privacy regulations, such as the UK/EU GDPR, could result in increased compliance costs, liabilities, and significant fines of up to €20 million or 4% of annual global revenue (or £17 million/€20 million or 4% of global turnover for UK GDPR), potentially delaying product development and affecting revenue generation. Changes in U.S. or international trade policies, including new tariffs or import/export regulations, could increase costs for API and finished drug products, materially affecting financial condition. Public health matters, such as pandemics, could disrupt clinical trials, divert healthcare resources, and delay regulatory reviews. Furthermore, the FDA's Fast Track, Breakthrough Therapy, RTOR, and Priority Review designations do not guarantee faster development or approval, and the FDA may not approve the NDA by the July 17, 2026 PDUFA target goal date.

Management Priorities

Management's tone is cautiously optimistic, emphasizing the significant progress made in the clinical development of gedatolisib and its potential to become a new standard of care. They highlight the positive Phase 3 VIKTORIA-1 clinical trial results for the PIK3CA WT cohort, which demonstrated statistically significant and clinically meaningful improvements in PFS, with the gedatolisib triplet reducing the risk of disease progression or death by 76% and the doublet by 67% compared to fulvestrant. The FDA's acceptance of the NDA for gedatolisib in HR+/HER2- PIK3CA WT ABC under the Real-Time Oncology Review program and the subsequent Priority Review designation, with a PDUFA goal date of July 17, 2026 , are presented as key milestones accelerating the path to potential commercialization. Strategic priorities include the successful completion of the ongoing VIKTORIA-1 (PIK3CA MT cohort, with topline data expected in Q2 2026), VIKTORIA-2, and CELC-G-201 clinical trials, securing regulatory approval for gedatolisib, and building out the necessary commercial infrastructure for its anticipated launch in the second half of 2026. Management also acknowledges the need for additional capital to fund future operations and growth initiatives, despite believing current resources are sufficient through 2027.

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Clinical Development
  2. [2] Item 1, Business — Clinical Development
  3. [3] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  4. [4] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  5. [5] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  6. [6] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  7. [7] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  8. [8] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  9. [9] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  10. [10] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  11. [11] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  12. [12] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  13. [13] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  14. [14] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  15. [15] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  16. [16] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  17. [17] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-2)
  18. [18] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-2)
  19. [19] Item 1, Business — Phase 1b/2 mCRPC Clinical Trial (CELC-G-201)
  20. [20] Item 1, Business — Phase 1b/2 mCRPC Clinical Trial (CELC-G-201)
  21. [21] Item 1, Business — Phase 1b/2 mCRPC Clinical Trial (CELC-G-201)
  22. [22] Item 1, Business — Phase 1b/2 mCRPC Clinical Trial (CELC-G-201)
  23. [23] Item 1, Business — Phase 1b/2 mCRPC Clinical Trial (CELC-G-201)
  24. [24] Item 1, Business — Phase 1b/2 mCRPC Clinical Trial (CELC-G-201)
  25. [25] Item 7, MD&A — Results of Operations
  26. [26] Item 7, MD&A — Results of Operations
  27. [27] Item 7, MD&A — Results of Operations
  28. [28] Item 7, MD&A — Results of Operations
  29. [29] Item 7, MD&A — Research and Development
  30. [30] Item 7, MD&A — Research and Development
  31. [31] Item 7, MD&A — Research and Development
  32. [32] Item 7, MD&A — General and Administrative
  33. [33] Item 7, MD&A — General and Administrative
  34. [34] Item 7, MD&A — General and Administrative
  35. [35] Item 7, MD&A — Results of Operations
  36. [36] Item 7, MD&A — Results of Operations
  37. [37] Item 7, MD&A — Interest Expense
  38. [38] Item 7, MD&A — Interest Expense
  39. [39] Item 7, MD&A — Interest Expense
  40. [40] Item 7, MD&A — Interest Income
  41. [41] Item 7, MD&A — Interest Income
  42. [42] Item 7, MD&A — Interest Income
  43. [43] Item 8, Statements of Operations
  44. [44] Item 8, Statements of Operations
  45. [45] Item 8, Balance Sheets
  46. [46] Item 8, Balance Sheets
  47. [47] Item 1, Organization and Liquidity — Liquidity
  48. [48] Item 8, Balance Sheets (sum of Convertible debt and Note payable, non-current)
  49. [49] Item 8, Balance Sheets
  50. [50] Item 8, Balance Sheets
  51. [51] Item 7, MD&A — Results of Operations
  52. [52] Item 7, MD&A — Research and Development
  53. [53] Item 7, MD&A — Research and Development
  54. [54] Item 7, MD&A — Research and Development
  55. [55] Item 7, MD&A — Research and Development
  56. [56] Item 7, MD&A — Research and Development
  57. [57] Item 7, MD&A — General and Administrative
  58. [58] Item 7, MD&A — General and Administrative
  59. [59] Item 7, MD&A — General and Administrative
  60. [60] Item 7, MD&A — Interest Expense
  61. [61] Item 7, MD&A — Interest Expense
  62. [62] Item 7, MD&A — Interest Expense
  63. [63] Item 1, Business — Overview
  64. [64] Item 11, License Agreement
  65. [65] Item 1, Business — Overview
  66. [66] Item 1, Business — Market Opportunity
  67. [67] Item 1, Business — Market Opportunity
  68. [68] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-2)
  69. [69] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-2)
  70. [70] Item 1A, Risk Factors — Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our debt obligations.
  71. [71] Item 1A, Risk Factors — Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our debt obligations.
  72. [72] Item 1A, Risk Factors — Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our debt obligations.
  73. [73] Item 1A, Risk Factors — Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our debt obligations.
  74. [74] Item 1A, Risk Factors — Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  75. [75] Item 1A, Risk Factors — Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  76. [76] Item 1A, Risk Factors — Breakthrough Therapy Designation, Fast Track Designation, NDA submission via RTOR, and being awarded Priority Review from the FDA may not actually lead to a faster development or regulatory review or approval process.
  77. [77] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  78. [78] Item 1, Business — Phase 3 HR+/HER2- ABC Clinical Trial (VIKTORIA-1)
  79. [79] Item 1, Business — Overview

Analysis on 5/22/2026