Celcuity targets $5B addressable market as gedatolisib posts unprecedented PFS gains and patent extends to 2042

Earnings Call Insights: Celcuity Inc. (CELC) Q2 2025

MANAGEMENT VIEW

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Brian F. Sullivan, CEO, announced several milestones, including positive top line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, initiation of dosing in the VIKTORIA-2 trial, encouraging results from two early-phase studies, and extension of patent exclusivity for gedatolisib into 2042.

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Sullivan emphasized, "The first and most importantly, of course, was the positive top line data we reported from the PIK3CA wild-type cohort of our Phase III VIKTORIA-1 clinical trial...The reported hazard ratios and improvements in median PFS are unprecedented in HR-positive, HER2-negative advanced breast cancer."

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The CEO highlighted that the company raised approximately $287 million through public offerings, positioning Celcuity to prepare for a potential launch of gedatolisib upon FDA approval next year.

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Vicky Hahne, CFO, stated, "Our second quarter net loss was $45.3 million or $1.04 per share compared to $23.7 million net loss or $0.62 per share for the second quarter of 2024...We ended the quarter with approximately $168.4 million of cash, cash equivalents and short-term investments. However, on a pro forma basis...cash, cash equivalents and short-term investments as of the end of Q2 2025 was approximately $455 million."

OUTLOOK

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The company plans to submit a new drug application to the FDA in Q4 2025 for gedatolisib based on data from the PIK3CA wild-type cohort.

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Full data from this cohort will be presented later in the year, with top line data from the PIK3CA mutation cohort expected by year-end 2025.

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Management projects the addressable market potential for a standard of care second-line therapy in this patient population is roughly $5 billion.

FINANCIAL RESULTS

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The second quarter net loss was $45.3 million or $1.04 per share, and the non-GAAP adjusted net loss was $40.5 million or $0.93 per share.

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Research and development expenses rose to $40.2 million, with a $17.7 million increase driven by higher employee and consulting expenses, increased R&D costs, and an anticipated $5 million milestone payment to Pfizer.

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General and administrative expenses increased to $3.8 million, attributed mostly to employee and consulting costs.

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Net cash used in operating activities was $36.2 million, ending the quarter with $168.4 million in cash. Including Q3 financing, cash and equivalents were $455 million, and management expects access to an additional $160 million through existing arrangements.

Q&A

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Mohamad Amin Makarem, Jefferies: Asked about subgroup analysis in the upcoming full data presentation and benchmarks for PIK3CA mutant success. Sullivan responded that initial presentations will focus on primary analyses, with subgroup data at later meetings. For the mutant cohort, Sullivan said, "If we have a positive study, we'll also be reporting clinically meaningful results."

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Frances Dovell, TD Cowen: Inquired about detailed safety data. Sullivan replied, "We were really only at this stage able to provide a general summary of what we saw, but the additional detail will be forthcoming."

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Eason Lee, Leerink Partners: Asked about PFS analysis methods and regulatory expectations. Sullivan explained the use of BICR due to the open-label structure and noted, "All the sensitivity analyses are indicating that our data is very robust, and we're very comfortable and confident about the package that we expect to submit to the FDA."

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Stephen Douglas Willey, Stifel: Questioned launch-readiness and infrastructure. Sullivan outlined that the commercial team build-out began last year, and expansion is ongoing in preparation for launch, emphasizing the experience of new hires.

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Gil Joseph Blum, Needham & Company: Asked about physician options with both doublet and triplet regimens. Sullivan indicated that both regimens allow broader patient access and that future subgroup results will guide clinical decisions.

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Chase Richard Knickerbocker, Craig-Hallum: Probed competitive landscape and manufacturing. Sullivan addressed competition and highlighted confidence in the CMC package, stating, "We're very confident just based on the robustness of the package that we've built and the data that we've generated that we should satisfy the FDA's requirements."

SENTIMENT ANALYSIS

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Analysts asked detailed questions about clinical data presentation, regulatory expectations, safety, and commercial infrastructure, showing an inquisitive but neutral to slightly positive tone.

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Management displayed confidence and clarity in both prepared remarks and responses, using strong language such as "we are very comfortable and confident about the package that we expect to submit to the FDA."

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Compared to the previous quarter, analysts maintained a similar tone, while management's confidence increased due to positive trial data and strengthened financial position.

QUARTER-OVER-QUARTER COMPARISON

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The current quarter featured the announcement of unprecedented PFS gains and hazard ratios for gedatolisib, while the prior quarter focused on upcoming data readouts and operational progress.

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Guidance language shifted from anticipation to specific plans for regulatory submission and commercial launch preparation.

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Analysts' questions moved from trial timelines and data expectations to practical details of product launch, market positioning, and competitive differentiation.

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Management's tone became more assertive, supported by new clinical and financial milestones.

RISKS AND CONCERNS

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Management acknowledged the need for detailed subgroup and safety data, with plans to release more information at conferences later in the year.

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Analysts raised questions about competitive landscape, infrastructure investment, and benchmarks for clinical success.

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Management emphasized a strong balance sheet and robust planning for commercial rollout as mitigation strategies.

FINAL TAKEAWAY

Celcuity highlighted multiple significant milestones this quarter, including positive Phase III trial outcomes for gedatolisib, issuance of a new dosing regimen patent extending exclusivity to 2042, and a strengthened balance sheet with over $450 million pro forma cash. Management is preparing for a Q4 2025 FDA submission, and the addressable market for gedatolisib is projected at $5 billion. With robust clinical data, favorable safety profile, and broad launch preparations underway, the company is positioned to advance gedatolisib as a new standard of care for a large, underserved breast cancer population.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/celc/earnings/transcripts]

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