Celcuity (CELC) Q1 FY26 earnings call: the analyst Q&A

Inquired about the nature of questions/interactions with the FDA and whether a draft label has been submitted or if labeling discussions are ongoing ahead of the PDUFA date.

Management stated they would not provide details on FDA interactions but confirmed nothing suggests they are off track for the July 17 PDUFA decision.

“there's nothing about the interactions to date that suggests that we will be off track for the PDUFA decision by July 17.”

asked by Maurice Raycroft · answered by Brian Sullivan

Asked about preclinical data, PK/PD comparability, dosing frequency, timeline to clinic, and potential bridging efforts with VIKTORIA-2.

Management outlined the development steps (optimization, manufacturing, PK studies, clinical equivalence studies) and stated the goal is to have the subcu form available around the same time as approval for the endocrine-sensitive population. They did not provide specific preclinical data details.

“the goal is to have a subcu form available basically along the same time line that we would expect to get an approval or hope to get an approval for the endocrine-sensitive population.”

asked by Maurice Raycroft · answered by Brian Sullivan

Inquired about analogs for IV to subcu small molecule conversions, the regulatory process, and whether PK/Cmax would change, potentially impacting mucositis.

Management stated the FDA requires demonstrating clinical equivalence for new formulations with different routes, and if equivalence is shown for one indication, it applies to others. They declined to speculate on mucositis impact but acknowledged Cmax is a factor.

“the FDA's position is that if you demonstrate equivalence in one indication that, that data will then in that approval will allow that new formulation to be used for any other indications that may exist.”

asked by Andrew Berens · answered by Brian Sullivan

Asked how longer-term OS data influenced the sizing of VIKTORIA-2 Study 2, given its importance in the frontline endocrine-sensitive setting, and about preliminary powering assumptions for OS or PFS.

Management explained that OS is a tie-breaker when PFS is similar, but if gedatolisib shows superior PFS to ribociclib with no OS decrement, it would satisfy regulatory and clinical expectations. They emphasized the need for a clinically meaningful incremental PFS benefit.

“if we achieve PFS and show no decrement in OS, we'll essentially satisfied certainly the regulatory requirements, and we think we'll satisfy the clinical expectations for a drug.”

asked by Stephen Willey · answered by Brian Sullivan

Asked for updated thoughts on competitive positioning versus other PIK3 inhibitors and how the subcutaneous formulation might evolve this.

Management highlighted that the gedatolisib doublet was statistically and clinically superior to a single-target PIK3CA approved drug, validating their multi-target inhibition approach. They believe single-target inhibitors have limited biological potential and cannot offer comparable efficacy.

“multi-target inhibition of this pathway is required to optimize antitumor control and that single target inhibitors are going to be limited.”

asked by Eva Fortea · answered by Brian Sullivan

Inquired about Celcuity's strategy for interacting with doctors at ASCO, planned events, messaging for the wild-type population, and progress on payer feedback discussions.

Management stated they will have a large team at ASCO to engage with doctors and view it as a "great staging ground" for a potential summer launch. They have been engaging with payers for almost a year, receiving encouraging feedback, and are well-positioned for reimbursement discussions post-approval.

“we view it as a great staging ground to lay the groundwork for what we hope is a future launch over the summer.”

asked by Silvan Tuerkcan · answered by Brian Sullivan