Celcuity (CELC) Q4 FY25 earnings call: guidance and Q&A

Will the database lock for the mutant data be in place, and how will the readout be disclosed?

Management declined to comment on the database lock status. They reiterated that top-line data will be released via a press release, followed by full results at an upcoming medical conference.

“Well, as I indicated, we'll provide top line data in a press release, and then we will provide details at an upcoming medical conference.”

asked by Maurice Raycroft · answered by Brian Sullivan

What feedback is being heard from physicians regarding which patient segments might be treated immediately upon wild-type approval, and how is this influencing launch cadence planning?

Management stated they will not be targeting or narrow-casting their approach. They believe gedatolisib offers an improved option for all patients and their sales force will broadly educate doctors on its benefits.

“As we launch, we aren't going to be targeting or narrow casting our approach to doctors or patient segments. We believe gedatolisib regimens offer an opportunity to get the best option relative to what's available today.”

asked by Tara Bancroft · answered by Brian Sullivan

Will the top-line press release for the mutant data include specific PFS numbers and risk reduction, or just a statement on statistical significance?

Management confirmed the top-line release will primarily state the achievement of statistical significance, without detailed PFS numbers or risk reduction, to adhere to embargo requirements for a subsequent medical conference presentation.

“It will be the latter. I mean we're mindful of embargo requirements to -- that we need to adhere to in order to be in a position to have a podium presentation at one of these medical conferences.”

asked by Stephen Willey · answered by Brian Sullivan

How high can the dose be pushed in the prostate cancer trial, and what efficacy metrics are prioritized for dose nomination?

Management noted the 180mg dose showed good safety, leading to exploration of higher doses using standard methodology. They balance tolerability with potential dose response and expect a data look by end of 2026/early 2027. While not explicitly stating efficacy metrics, the context implies a focus on improved response at higher doses.

“But to the extent that we believe there's a dose response that would lead to improved response at higher doses, we want to explore where that might take us. And so we would expect to have some look at that data by the end of this year, sometime early next year.”

asked by Stephen Willey · answered by Brian Sullivan

Are there potential challenges in patient adoption due to gedatolisib's IV administration, and how does the company plan to address them?

Management stated that market research shows efficacy is the most important factor for physicians and patients. IV administration is a negative factor in meaningfully less than 10% of responses. They believe patients with metastatic breast cancer prioritize the best available treatment, and the IV route will not significantly restrict physician preference.

“And one thing that's very clear when we review the results of that research is that, a, the efficacy is clearly the most important factor for them as they're evaluating the regimen; and b, the IV administration shows up as a negative factor in meaningfully less than 10% of the responses we have in this research.”

asked by Gil Blum · answered by Brian Sullivan

What learnings from the inavolisib launch for PIK3CA mutant endocrine therapy resistant setting are supportive of gedatolisib's positioning?

Management highlighted that inavolisib's usage is limited by metabolic health restrictions (e.g., HbAC1 levels) and extensive glucose monitoring requirements, impacting clinical uptake. Gedatolisib, in contrast, does not induce significant glycemic disruption, allowing for a broader patient population without such restrictions, demonstrating its unique safety profile.

“So from a learning standpoint for us, I mean, it essentially highlights just how unique a drug geda is, a, we're addressing this pathway. But more importantly or rather very importantly, we're not inducing the levels of glycemic system disruption that can lead to hypoglycemia that requires significant management or any management at all actually.”

asked by Oliver McCammon · answered by Brian Sullivan

What feedback has been received from payers during early pre-launch discussions, and how has this influenced thoughts on potential pricing?

Management reported very positive reception from payers regarding the data shared. Payers are collaborative in ensuring access to therapies. No specific details on pricing were disclosed, but the feedback was described as pleasing and supportive of early patient access.

“I guess just the overall reception to information that we've shared with payers and strategic accounts, which we're able to do on a safe harbor basis since they're not health care providers has been very, very positive.”

asked by Chase Knickerbocker · answered by Brian Sullivan

What are Celcuity's thoughts on potential future competition from mutant selective PI3K alpha inhibitors?

Management believes there is a biological limit to the benefit single-target inhibitors like PI3K-alpha inhibitors can induce. They argue that gedatolisib's comprehensive inhibition of all Class I PI3K isoforms and mTORC1/2 is necessary for optimal antitumor control, suggesting that the mutant-selective approach will be 'obsoleted' if gedatolisib's data continues to be strong.

“But ultimately, I think there's going to be a limited biological potential to induce an optimal outcome for efficacy. And I think the results to date for geda certainly, we think, demonstrate the value and importance of providing comprehensive inhibition of this pathway as opposed to selective inhibition of this pathway.”

asked by Chase Knickerbocker · answered by Brian Sullivan