Celcuity Inc. (CELC) Business Model Canvas

Celcuity Inc. (CELC): Business Model Canvas [Dec-2025 Updated]

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You're looking at Celcuity Inc. (CELC) right now, and honestly, it's the classic biotech pivot point: a clinical-stage company that just dropped its New Drug Application in November 2025, betting everything on gedatolisib. As an analyst who's seen this movie a few times, the key question is how they bridge the gap from burning $\mathbf{\$34.9 \text{ million}}$ on R\&D in Q3 2025 to capturing those projected peak sales north of $\mathbf{\$2 \text{ billion}}$, especially with a $\mathbf{\$455.0 \text{ million}}$ war chest in the bank. This Business Model Canvas lays out the precise partnerships, the high-touch customer engagement with oncologists, and the critical CELsignia diagnostic platform that must fire perfectly for this transition to work. Dive in below to see the full mechanics of their path to commercialization; it's a defintely high-stakes play.

Celcuity Inc. (CELC) - Canvas Business Model: Key Partnerships

You're looking at the structure that underpins Celcuity Inc.'s path to commercialization, which is heavily reliant on external entities for capital, drug rights, and trial execution. Here's the breakdown of those critical relationships as of late 2025.

Pfizer Inc. for gedatolisib development and commercialization

The foundation of Celcuity Inc.'s therapeutic asset rests on the deal struck with Pfizer Inc. Celcuity Inc. holds the exclusive worldwide license to develop and commercialize gedatolisib. This partnership is structured with significant contingent payments.

The initial cost to acquire these rights in 2021 involved a payment of $5 million in cash and $5 million of Celcuity Inc.'s common stock. For future success, Pfizer Inc. is eligible to receive up to $330 million in development and sales-based milestone payments, plus tiered royalties on potential sales. Also, Pfizer Inc. provided Ibrance (palbociclib) for use in Celcuity Inc.'s Phase 3 clinical trial at no cost to Celcuity Inc.

Financial Component Amount Context
Upfront Cash Payment to Pfizer Inc. $5 million Initial license fee paid in 2021.
Upfront Equity Payment to Pfizer Inc. $5 million Initial license fee paid in 2021 (in common stock).
Maximum Milestone/Royalty Potential to Pfizer Inc. Up to $330 million Development and sales-based milestones plus royalties.
Cost of Ibrance (palbociclib) for Phase 3 Trial $0 Provided by Pfizer Inc. at no cost to Celcuity Inc.

Contract Research Organizations (CROs) for global clinical trial execution

Executing the pivotal VIKTORIA-1 and the subsequent VIKTORIA-2 Phase 3 trials requires extensive support from CROs. The financial commitment to these external research activities is evident in the operating expenses.

For the first quarter of 2025, Research and Development (R&D) expenses totaled $32.2 million. A portion of this, specifically $5.7 million in Q1 2025, was primarily related to activities supporting ongoing clinical trials, which heavily involves CROs. Key trial timelines managed through this network included:

  • VIKTORIA-1 PIK3CA wild-type cohort primary completion date expected in June 2025.
  • VIKTORIA-1 PIK3CA mutant cohort topline data readout anticipated in the fourth quarter of 2025.
  • VIKTORIA-2 Phase 3 trial on track to dose first patient in the second quarter of 2025.

Academic and community oncology centers for clinical trial site management

The commercialization strategy for gedatolisib is explicitly data-driven, targeting where patients are treated. Market research suggests that 80% of patients are treated in community settings, which dictates the focus for site engagement.

Celcuity Inc. is leveraging specific academic partnerships for ongoing and planned studies. For instance, a clinical trial collaboration was initiated with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in a different indication (endometrial cancer). Furthermore, the company is preparing for an accelerated New Drug Application (NDA) filing via the FDA's Real-Time Oncology Review (RTOR) program, suggesting readiness to work closely with regulatory and clinical sites upon approval.

Financial institutions for the $500 million term loan facility

To ensure capital availability through anticipated milestones, Celcuity Inc. upsized its senior secured credit facility. This facility was amended with an affiliate of Innovatus Capital Partners, LLC and Oxford Finance LLC and its affiliates.

The total term loan facility size was increased to $500 million. This structure is composed of $350 million in committed capital and up to $150 million available at the mutual discretion of Celcuity Inc. and the lenders. At the closing of the amendment, an initial funding of $30 million was received, bringing the total term loan outstanding to $130 million.

The facility has specific tranches tied to drug success, including $100 million available upon FDA approval of gedatolisib in second-line wild-type advanced breast cancer patients, and $120 million linked to commercial revenue milestones. This financing is projected to support current clinical development program activities through 2027.

Finance: draft 13-week cash view by Friday.

Celcuity Inc. (CELC) - Canvas Business Model: Key Activities

You're managing the final push for a potential blockbuster drug, so the key activities right now are all about execution: clinical data readout, regulatory submission, and getting the launch team ready. Here's the breakdown of what Celcuity Inc. is driving hard on as of late 2025.

Advancing Phase 3 clinical trials (VIKTORIA-1, VIKTORIA-2) for gedatolisib

The core activity centers on the data from the Phase 3 VIKTORIA-1 trial, which has already provided pivotal efficacy results for the PIK3CA wild-type cohort. The PIK3CA mutant cohort is now fully enrolled, but topline data isn't expected until late Q1 2026 or during Q2 2026. Meanwhile, the VIKTORIA-2 trial, looking at gedatolisib in the first-line setting for HR+/HER2- advanced breast cancer, is actively enrolling patients.

The efficacy data from the PIK3CA wild-type cohort of VIKTORIA-1 is substantial:

Regimen Comparison Risk Reduction (HR) Median Progression-Free Survival (PFS) Incremental PFS Improvement Objective Response Rate (ORR)
Gedatolisib Triplet vs. Fulvestrant 76% (HR=0.24) 9.3 months vs. 2.0 months 7.3 months 31.5% vs. 1%
Gedatolisib Doublet vs. Fulvestrant 67% (HR=0.33) 7.4 months vs. 2.0 months 5.4 months 28.3%

The median Duration of Response (DOR) for the gedatolisib triplet was 17.5 months in this cohort. This trial work is definitely expensive, as seen in the R&D spend.

Completing New Drug Application (NDA) submission to the FDA

Celcuity Inc. announced the completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for gedatolisib on November 17, 2025. This submission targets the treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), advanced breast cancer (ABC) patients whose tumors are PIK3CA wild-type. The filing was made under the FDA's Real-Time Oncology Review (RTOR) program, aiming for a shorter review period.

Research and development (R&D) of the proprietary CELsignia diagnostic platform

The R&D function is heavily supporting both the ongoing clinical trials and the impending commercial readiness. For the third quarter of 2025, Research and development (R&D) expenses totaled $34.9 million, an increase from $27.6 million in the third quarter of 2024. Of the approximately $7.3 million increase in Q3 2025 R&D expenses, $1.7 million was primarily related to activities supporting ongoing clinical trials. The CELsignia platform itself is the core technology that identifies patients who can benefit from the targeted therapy.

Key financial metrics related to operating expenses for Q3 2025 include:

  • Total operating expenses: $42.8 million.
  • Net cash used in operating activities: $44.8 million.
  • Cash, cash equivalents, and short-term investments on hand (as of September 30, 2025): $455.0 million.
  • Management expects current funding to support operations through 2027.

Building a commercial infrastructure and sales force for product launch

Celcuity Inc. is actively laying groundwork for commercialization, which involves building the organization, processes, and systems internally, and defining the sales structure. This includes hiring experienced personnel for first-launch roles. The company is focusing its market targeting on high-patient-volume doctors in community and academic centers.

The opportunity size driving this build-out is significant:

  • Estimated addressable market potential for a standard of care second-line therapy in this patient population: roughly $5 billion.
  • Estimated patient pool moving to second-line treatment after progressing on a CDK4/6 inhibitor: 34,000 patients.
  • Estimated percentage of that pool that is PIK3CA wild type: roughly 60%.

General and administrative (G&A) expenses reflected this build-up, rising to $7.9 million in Q3 2025 from $2.5 million in Q3 2024, with $5.6 million of the total R&D increase being related to increased employee and consulting expenses, including commercial headcount additions.

Celcuity Inc. (CELC) - Canvas Business Model: Key Resources

You're looking at the core assets Celcuity Inc. (CELC) is banking its future on. For a clinical-stage biotech, Key Resources are less about physical plant and more about proprietary science and the capital to see it through. Here's the breakdown of what truly matters for Celcuity Inc. right now, as of late 2025.

Gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor.

Gedatolisib is the centerpiece, the lead therapeutic candidate. It's designed to comprehensively blockade the PI3K/AKT/mTOR ("PAM") pathway, which is a major oncogenic pathway in solid tumors. What sets it apart, in theory, is its mechanism, which is differentiated from other therapies targeting only PI3Kα, AKT, or mTORC1 individually. The company is focused on advancing this drug through its Phase 3 VIKTORIA-1 clinical trial, with topline data for the PIK3CA mutant cohort expected in the fourth quarter of 2025, though other reports suggest early to mid-2026.

The drug's profile is supported by a growing body of intellectual property, which is a critical resource in this industry.

  • Measures ex vivo cell signal transduction activity in live tumor cells.
  • Targets the PI3K/AKT/mTOR pathway comprehensively.
  • Differentiated mechanism from single-target inhibitors.

Strong cash position of approximately $455.0 million as of Q3 2025.

This is your near-term lifeline. You need to know the burn rate to understand the runway. For the third quarter of 2025, Celcuity Inc. reported a net loss of \$43.8 million. Total operating expenses for that quarter were \$42.8 million, reflecting the high cost of advancing a Phase 3 program like the one for gedatolisib. However, the balance sheet strength is the key takeaway here. As of September 30, 2025, the company held approximately \$455.0 million in cash, cash equivalents, and short-term investments. Here's the quick math: management projects this substantial cushion will fund operations through 2027. That buys them significant time to reach potential commercialization milestones without immediate dilution pressure, which is a huge advantage for a company at this stage.

Intellectual property, including a patent extending gedatolisib exclusivity to 2042.

The IP portfolio is what protects that future revenue stream you're valuing. The recent issuance of U.S. Patent No. 12,350,276, covering the clinical dosing regimen for gedatolisib in ER+/HER2- breast cancer patients, is a major asset, extending U.S. patent exclusivity into 2042. This is a significant extension over the composition of matter patent expiration, which is expected around December 2034. The overall worldwide portfolio is quite extensive, showing a sustained effort to build a protective moat around the asset.

The intellectual property strength can be summarized like this:

IP Asset Category Count/Date Significance
U.S. Patent Exclusivity Extension (Dosing Regimen) Extends to 2042 Secures a longer commercial runway in the U.S.
Total Granted U.S. Gedatolisib Patents 13 Core U.S. protection
Total Granted Foreign Gedatolisib Patents 290 Global market protection breadth
Composition of Matter Expiration (Expected) Dec 2034 Baseline protection for the molecule itself

Proprietary CELsignia multi-omic diagnostic platform.

The CELsignia platform is the companion diagnostic resource, designed to expand the patient population for targeted therapies like gedatolisib. It measures ex vivo cell signal transduction activity in live tumor cells from individual patients. This is key because it aims to identify a cancer sub-type driven by a hyperactive signaling pathway that molecular-based (genetic) analyses might miss. The company's first diagnostic, the CELsignia Multi-Pathway Signaling Test, measures dynamic HER2, c-Met, and PI3K-node involved signaling activity in HER2-negative breast cancer patients. This diagnostic capability is a resource that directly supports the commercial viability of gedatolisib by identifying patients expected to respond, even if they lack a corresponding genomic biomarker.

Finance: draft 13-week cash view by Friday.

Celcuity Inc. (CELC) - Canvas Business Model: Value Propositions

You're looking at the core reasons why investors and clinicians are paying close attention to Celcuity Inc. as it moves toward a potential commercial launch. The value proposition centers on delivering a superior, targeted therapy for advanced breast cancer patients who have exhausted current options.

Potential to be a New Standard-of-Care for HR+/HER2- Advanced Breast Cancer

The data from the PIK3CA wild-type (WT) cohort of the Phase 3 VIKTORIA-1 trial suggests a significant shift in treatment efficacy for patients with HR+/HER2- advanced breast cancer (ABC) who have progressed after CDK4/6 inhibitor therapy. The hazard ratios reported are described as more favorable than have ever been reported by any Phase 3 trial for this patient group receiving at least their second line of an endocrine therapy-based regimen. This positions the therapy as a potential breakthrough option.

The company is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) based on this data during the fourth quarter of 2025. Furthermore, Celcuity Inc. reported a market capitalization of approximately $4.7 billion as of late 2025, reflecting strong investor belief in this potential standard-of-care shift, with the stock price increasing by 707.05% over the past year. The expected wholesale acquisition cost (WAC) pricing strategy is anticipated to be around $25,000.

Differentiated Mechanism of Action that Comprehensively Blocks the PI3K/AKT/mTOR (PAM) Pathway

The investigational drug, gedatolisib, is an inhibitor designed to target the entire PI3K/AKT/mTOR signaling cascade. This comprehensive blockade is the mechanism that differentiates it from therapies targeting only a single point in the pathway. The company's focus on this pathway inhibition is central to its therapeutic hypothesis.

Improved Progression-Free Survival (PFS) Demonstrated in the VIKTORIA-1 Trial

The clinical results from the PIK3CA WT cohort of the VIKTORIA-1 trial provide concrete, compelling numbers supporting the value proposition. Here's the quick math on the median Progression-Free Survival (PFS) improvements versus the control arm (fulvestrant):

Regimen Comparison Median PFS (Months) Incremental Improvement (Months) Risk Reduction (HR) Objective Response Rate (ORR)
Gedatolisib Triplet vs. Fulvestrant 9.3 vs. 2.0 7.3 76% (HR=0.24) 31.5% vs. 1%
Gedatolisib Doublet vs. Fulvestrant 7.4 vs. 2.0 5.4 67% (HR=0.33) 28.3%

Also, the median Duration of Response (DOR) for the triplet reached 17.5 months. The company is also awaiting topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial, expected in late Q1 2026 or during Q2 2026, which could broaden the addressable market.

Personalized Medicine Approach Using the CELsignia Platform to Identify Responders

Celcuity Inc. employs the CELsignia platform as its personalized medicine tool. This platform is designed to identify which patients are most likely to benefit from the targeted therapy, which is key to maximizing efficacy and minimizing unnecessary exposure to treatment. The platform's ability to stratify patients based on molecular characteristics is a core component of the value delivered to both prescribers and patients, ensuring the right drug reaches the right person.

  • CELsignia platform identifies patient populations for targeted therapy.
  • Aims to improve clinical trial success rates.
  • Supports the precision medicine strategy for gedatolisib.

To support these clinical efforts and commercial preparations, Celcuity Inc. reported $455.0 million in cash, cash equivalents, and short-term investments as of September 30, 2025, which management expects will fund operations through 2027. The Q3 2025 net cash used in operating activities was $44.8 million, a significant increase from $20.6 million in Q3 2024, driven by R&D expenses of $34.9 million for the quarter.

Celcuity Inc. (CELC) - Canvas Business Model: Customer Relationships

The Customer Relationships strategy for Celcuity Inc. centers on establishing deep, scientific credibility with prescribers, driven by the data supporting gedatolisib, as the company prepares for its commercial launch following regulatory milestones.

High-touch, specialized engagement with key opinion leaders (KOLs) and oncologists.

Celcuity Inc.'s commercialization strategy is explicitly data-driven, targeting the high-prescribing doctors in community and academic settings. This requires direct, high-touch engagement to translate complex clinical data into prescribing behavior. The company has executive leadership with deep oncology commercial experience, such as the Chief Business Officer who previously led Global Marketing and Commercial Development for the Pfizer Oncology Business Unit.

Direct medical affairs and scientific liaison support for clinical data dissemination.

Dissemination of clinical findings is a primary focus, evidenced by the acceptance of an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), running December 9-12, 2025, which includes updated subgroup efficacy analyses and safety data from the Phase 3 VIKTORIA-1 trial. The company is preparing for a commercial stage transition, which is reflected in rising internal costs.

The investment in commercial readiness is visible in the financial reporting:

  • General and administrative (G&A) expenses rose to $7.9 million in the third quarter of 2025, up from $2.5 million in the third quarter of 2024.
  • This G&A increase was driven by $4.9 million in higher employee and consulting expenses, which included commercial headcount additions.

The focus is on communicating the efficacy of the gedatolisib-triplet regimen, which reduced the risk of disease progression or death by 76% compared to fulvestrant in the PIK3CA wild-type cohort of the VIKTORIA-1 trial.

Regulatory body (FDA, EMA) management for accelerated review programs (RTOR).

Managing the relationship with regulatory bodies is critical for an accelerated path to market access. Celcuity Inc. completed the submission of its New Drug Application (NDA) for gedatolisib to the U.S. Food and Drug Administration (FDA) on November 17, 2025, under the Real-Time Oncology Review (RTOR) program. This submission builds on prior designations, including Breakthrough Therapy and Fast Track status. The company also has international engagement plans underway.

Here's a look at the key regulatory and data milestones driving customer engagement:

Regulatory/Data Event Date/Status (Late 2025) Associated Indication/Program
NDA Submission to FDA November 17, 2025 HR+/HER2- Advanced Breast Cancer (PIK3CA wild-type cohort) under RTOR
Prior Designations Granted Breakthrough Therapy and Fast Track
European Submission Plan Underway MAA (Marketing Authorisation Application)
Japanese Engagement Underway Alignment with Health Authority on submission requirements
Key Data Presentation December 9-12, 2025 Oral presentation at SABCS with updated efficacy/safety data

Patient support programs for access and adherence post-commercialization.

While specific patient support program statistics aren't detailed, the focus is on ensuring access given the potential market size and pricing context. The addressable market potential for a standard of care second-line therapy in the target patient population is estimated to be roughly $5 billion. For pricing context, recent novel therapeutics in this space are noted to be around $25,000, with potential discounts factored in. Celcuity Inc. expects to generate significant revenue by 2027, which implies the necessary infrastructure, including patient access support, is being built now, as evidenced by the rising G&A spend.

Celcuity Inc. (CELC) - Canvas Business Model: Channels

You're preparing to launch a novel oncology therapy, gedatolisib, and the channels you use to reach oncologists and deliver the drug are critical. As of late 2025, Celcuity Inc. is in a pre-commercialization phase, meaning the channels are heavily weighted toward clinical data dissemination and organizational build-out, rather than established sales volume.

Direct sales force targeting high-volume oncologists in the U.S.

Celcuity Inc. is actively preparing for the commercial launch of gedatolisib, contingent on the expected New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. The commercial strategy is explicitly data-driven, focusing on high-prescribing doctors in community and academic settings. As of the third quarter of 2025 earnings call, the company had completed the hiring of most commercial roles, with the exception of the field sales force. Investment in this area is visible in the operating expenses; Research and Development (R&D) expenses in Q3 2025 included approximately $3.2 million related to commercial headcount additions and other launch-related activities. The target market size informs the scale of this future channel: the estimated Total Addressable Market (TAM) for gedatolisib in the second-line setting is $5 billion to $6 billion, with projected peak revenues between $2.5 billion and $3 billion.

Specialty pharmaceutical distributors and pharmacies for drug delivery.

While Celcuity Inc. is a clinical-stage company with no commercialized product as of the end of Q3 2025, the infrastructure for drug delivery is being established in parallel with regulatory progress. The company is building the internal systems required to operate as a commercial-stage entity. The primary financial metric reflecting this pre-launch investment is the increase in General and Administrative (G&A) expenses, which reached $7.9 million in Q3 2025, up from $2.5 million in Q3 2024, supporting the expansion of infrastructure necessary for future distribution.

Clinical trial sites for data generation and physician awareness.

Clinical trial sites serve as the primary channel for generating the data that will underpin all future commercial efforts. Celcuity Inc. is actively running multiple trials to support gedatolisib across different indications. The company completed enrollment for the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial, with topline data anticipated in late Q1 2026 or during Q2 2026. Furthermore, the Phase 3 VIKTORIA-2 trial, evaluating gedatolisib as a first-line treatment for HR+/HER2- advanced breast cancer, is currently enrolling patients. The Phase 1/2 trial, CELC-G-201, evaluating gedatolisib in metastatic castration resistant prostate cancer, is also ongoing. The R&D expenses driving these channels totaled $34.9 million in Q3 2025.

Investor relations and medical conferences for data presentation.

Medical conferences are crucial channels for communicating clinical efficacy to the prescribing community. Celcuity Inc. presented detailed efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial at the 2025 European Society for Medical Oncology (ESMO) Congress. For investor awareness and capital planning, the company participated in the Stifel 2025 Healthcare Conference in November 2025 and was scheduled to present at the 8th Annual Evercore Healthcare Conference in December 2025. These activities support the company's financial runway, which management projected, as of September 30, 2025, to fund operations through 2027, supported by $455.0 million in cash, cash equivalents, and short-term investments.

Here's a quick look at the key activity metrics across the clinical and awareness channels as of late 2025:

Channel Activity Focus Key Trial/Event Status/Date Associated Financial Metric (Q3 2025)
Data Generation (Pivotal) VIKTORIA-1 (PIK3CA Mutant Cohort) Enrollment Complete; Data expected Q1/Q2 2026 R&D Expense: $34.9 million
Data Generation (First-Line) VIKTORIA-2 Currently Enrolling Patients Total Operating Expenses: $42.8 million
Data Presentation (Medical) 2025 ESMO Congress Presentation Complete (October 2025) Net Loss: $43.8 million
Data Presentation (Investor) Stifel 2025 Healthcare Conference Fireside Chat on November 11, 2025 Cash on Hand: $455.0 million
Commercial Preparation Field Sales Force Build-out Most Hires Complete (Excluding Field Sales) Commercial Headcount Addition Cost (in R&D): $3.2 million

Celcuity Inc. (CELC) - Canvas Business Model: Customer Segments

You're looking at the specific groups Celcuity Inc. (CELC) is targeting with gedatolisib, which is key to understanding their commercial focus right now, especially with the NDA submission complete for their lead indication.

The primary customer segments are defined by the specific cancer types their investigational drug, gedatolisib, is designed to treat, and the healthcare professionals who prescribe those treatments. This focus is highly specialized, targeting areas with significant unmet medical need.

Oncologists and hematologists treating solid tumors represent the core prescribers. Celcuity Inc. (CELC) needs to capture the attention of these specialists to drive adoption of gedatolisib upon potential approval. The market size for these providers is substantial, though Celcuity Inc. (CELC) is focusing its commercial efforts on high-prescribing doctors in community and academic settings, where market research indicates 80% of patients are treated.

Provider Segment Detail Metric Value (Late 2025 Context)
Total US Oncologists (Active Practice) Count 25,419
Total US Oncologists (January 2025) Count 27,475
Hematology/Oncology Specialization (Approx.) Percentage of Total Oncologists 43%
US Population Aged 55+ Living in Counties with Oncologists Percentage 89%
US Population Aged 55+ in Counties with At-Risk Coverage Percentage 68%

The patient populations targeted are highly specific, reflecting the indications being pursued in late-stage clinical trials.

  • Patients with HR+/HER2- advanced breast cancer (ABC) who have progressed on a CDK4/6 inhibitor. This segment was the basis for the NDA submission completed in November 2025.
  • Patients with HR+/HER2- ABC receiving first-line treatment, being evaluated in the ongoing Phase 3 VIKTORIA-2 trial.
  • Patients with metastatic castration-resistant prostate cancer (mCRPC) receiving combination therapy in the ongoing Phase 1/2 CELC-G-201 trial.

The clinical data for the HR+/HER2- ABC segment shows compelling differentiation. For the second-line setting (VIKTORIA-1 PIK3CA wild-type cohort), the gedatolisib triplet regimen demonstrated an unprecedented median progression-free survival (PFS) of 9.3 months versus 2.0 months for fulvestrant alone, an incremental gain of 7.3 months. This translated to a risk reduction of progression or death by 76% (HR of 0.24).

For the mCRPC segment, preliminary data from the Phase 1b portion of the CELC-G-201 study showed a 66% six-month radiographic progression-free survival rate as of the May 30, 2025 data cut-off. Honestly, seeing no discontinuations due to treatment-related adverse events in that early data is a strong signal.

The overall market opportunity is large, with the HR+/HER2- ABC market valued at $10 billion globally in 2025, and the U.S. alone having 211,000 annual incident cases of HR+/HER2- breast cancer.

Pharmaceutical companies for diagnostic platform collaborations represent a strategic customer segment, though the search results focus more on drug development partnerships rather than diagnostic platform collaborations specifically. However, the company's financial strength suggests readiness for commercial scale. Celcuity Inc. (CELC) expects its cash reserves and term loan facility to sustain operations through 2027, with pro-forma cash, cash equivalents, and short-term investments of $455 million as of the end of Q2 2025. Plus, the intellectual property provides patent exclusivity extending into 2042.

You should track the market cap, which was reported at $4.27B following the November 17, 2025 NDA announcement, as an indicator of the perceived value of this customer base.

Celcuity Inc. (CELC) - Canvas Business Model: Cost Structure

You're looking at the cost side of a clinical-stage biotech, which means the structure is dominated by the science, not sales. Honestly, for Celcuity Inc., the costs reflect the intense investment required to advance gedatolisib toward potential commercialization.

The primary cost drivers for Celcuity Inc. as of late 2025 are overwhelmingly centered on research and development, followed closely by the necessary build-out of administrative functions to support a future commercial ramp-up. Net cash used in operating activities for the third quarter of 2025 was $44.8 million, a significant increase from $20.6 million in the prior-year period, showing the acceleration of spending.

Here's a look at the key operational expenditures for the third quarter ended September 30, 2025:

Cost Category Q3 2025 Amount (Millions USD) Comparison Context
Research and Development (R&D) Expenses $34.9 Total operating expenses were $42.8 million for the quarter.
General and Administrative (G&A) Expenses $7.9 Up from $2.5 million in Q3 2024, driven by commercial launch preparation.
Total Operating Expenses $42.8 Net loss for the quarter was $43.8 million.

The increase in R&D expenses to $34.9 million from $27.6 million in Q3 2024 was largely due to increased employee and consulting expenses, with $3.2 million specifically tied to commercial headcount additions and launch activities. This shows the blending of late-stage clinical costs with early commercial preparation costs.

The G&A rise to $7.9 million from $2.5 million in the prior-year period reflects the infrastructure build needed for a potential launch. Of that increase, $4.0 million was related to non-cash, stock-based compensation, but $0.5 million was for professional fees and expanding infrastructure.

You're defintely seeing costs associated with two major areas:

  • Clinical trial operational costs, including activities supporting ongoing trials, which accounted for a $1.7 million increase in R&D expenses.
  • Manufacturing scale-up activities, which are implicitly included in the overall R&D and general corporate spending funded by recent capital raises.

Financing the operations involves debt service costs. Celcuity Inc. secured significant capital in July 2025 through new debt, which impacts future interest expense. The structure includes:

  • $150 million in 2.750% convertible senior notes due August 1, 2031.
  • Interest on these new notes is set to accrue at 2.750% per year, payable semi-annually starting February 2026.
  • The company also has a term loan facility, and drawdowns on this facility, along with cash, are expected to fund operations through 2027.

It's important to note that Celcuity Inc. management excludes non-cash interest expense when calculating non-GAAP adjusted net loss, as they state these items do not impact the company's cash position. Finance: draft 13-week cash view by Friday.

Celcuity Inc. (CELC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Celcuity Inc. (CELC) as of late 2025, and honestly, it's a classic pre-commercial biotech profile: almost entirely future-facing.

Current product revenue is near-zero, which is the reality when you are awaiting final regulatory decisions on your lead asset. For the third quarter of 2025, Celcuity Inc. reported revenue at approximately $0.15 million.

The core of the financial story for Celcuity Inc. rests on the successful commercialization of gedatolisib post-FDA approval. The potential scale here is substantial, driving most current valuation discussions.

Here's a look at the projected revenue potential from the key product:

Revenue Source Projection/Metric Source Data/Context
Gedatolisib Peak Sales (Estimate 1) $2.5 billion to $3 billion Projected peak revenues for the second-line setting
Gedatolisib Peak Sales (Estimate 2) Exceeding $5 billion Analyst estimate for peak annual sales by 2030, assuming market share expansion
Addressable Market (Second-Line) $5 billion to $6 billion Total addressable market estimate for the target setting
Prior Peak Revenue Potential $2 billion Earlier management projection for the second-line indication

The partnership with Pfizer Inc. introduces another layer of potential, though the search results primarily detail payments flowing from Celcuity Inc. to Pfizer based on development and sales achievements. Still, these represent contingent financial obligations tied directly to the asset's success.

The potential milestone payments related to the gedatolisib agreement are structured as follows:

  • Pfizer is eligible to receive up to $330 million in development and sales-based milestone payments.
  • Pfizer is also eligible for tiered royalties on potential sales.
  • Celcuity Inc. paid Pfizer an upfront fee of $5 million in cash and $5 million in common stock upon licensing.

As for other revenue streams, they remain minimal or non-existent as of late 2025, consistent with a company focused on late-stage clinical development.

  • Trailing Twelve Months (TTM) Revenue: $0.
  • Revenue from diagnostic services or research collaborations is effectively zero, as the business model is centered on the drug candidate.

Finance: draft 13-week cash view by Friday.


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