Celcuity (CELC) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 5, 2026

CALL PARTICIPANTS

• Chief Executive Officer and Co-Founder - Brian F. Sullivan
• Chief Financial Officer - Vicky Hahne
• Chief Commercial Officer - Eldon C. Mayer

TAKEAWAYS

• Strategic Account Orders -- 78% of the top 36 strategic accounts, representing approximately 50% of the total addressable patient population, ordered Revtopik since its commercial availability on Sept. 30.
• Sales Specialist Engagement -- Over 3,400 sites, which treat 82% of breast cancer patients, have directly engaged with the company's oncology sales specialists.
• HCP Education Attendance -- Over 1,100 health care providers attended Revtopik educational programs as part of the initial launch phase.
• Payer Coverage -- 91% of U.S. commercial and Medicare lives are in health care plans that cover Revtopik, reflecting the impact of broad engagement with payers over the last 18 months.
• Provider Pathway Inclusion -- Revtopik was incorporated in three of the four largest health care provider pathways within 30 days of becoming commercially available.
• Wholesale Acquisition Cost -- $10,000 per vial or $30,000 per 28-day cycle of treatment, with management estimating that patients will remain on therapy for an average of 10 cycles.
• Addressable Market (Second Line) -- $9 billion annually, based on approximately 37,000 U.S. patients receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer.
• Revenue -- $0, because no product reached treatment locations before the quarter ended on Sept. 30, though shipments to specialty distributors commenced on that date.
• Net Loss -- $73.3 million, or $1.33 per share, compared to a net loss of $43.8 million, or $0.92 per share, for the prior year period.
• Non-GAAP Adjusted Net Loss -- $66.8 million, or $1.21 per share, compared to $37.2 million, or $0.78 per share, for the prior year period.
• Total Operating Expenses -- $77.3 million, representing an increase from $42.8 million in the prior year period due to commercialization activities.
• SG&A Expenses -- $39.8 million, including $25.3 million in costs related to commercial headcount additions and launch infrastructure for Revtopik.
• R&D Expenses -- $37.5 million, reflecting a $7.1 million increase due to higher employee-related expenses and manufacturing costs.
• Cash and Investments -- $642.7 million as of Sept. 30, 2026, which the company expects to fund operations through 2029.
• PFS (No Liver Metastases) -- 21.5 months with the gedatolisib triplet and 11.5 months with the doublet, compared to 9.1 months for the alpelisib doublet in the VIKTORIA-1 study.
• ORR (Mutant Cohort) -- 59% for the gedatolisib triplet and 43% for the doublet, compared to 33% for the alpelisib and fulvestrant control group.
• Gedatolisib Discontinuation Rate -- 4% to 5% in the mutant cohort, which management indicates is more representative of real-world settings than the higher initial rate in the wild-type cohort.
• mCRPC rPFS -- 15.7 months for patients with prior abiraterone exposure and 9.1 months for those with prior enzalutamide exposure in the Phase 1b/2 prostate cancer trial.
• Addressable Market (First Line) -- Over $10 billion annually, targeting approximately 90,000 women diagnosed each year in the U.S. with late-stage HR-positive, HER2-negative breast cancer.
• License Milestone Payment -- $50 million paid to Pfizer during the third quarter, triggered by the FDA approval of Revtopik.
• Expanded Access Program -- A handful of patients enrolled in the program that opened in mid-August have transitioned to the commercial product.

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RISKS

• Sullivan stated, "A lot of, you know, community sites, for instance, are the ones that can be particularly affected by J-code and are leery of prescribing drugs that do not have a permanent J-code because of reimbursement risk in their view," noting the code will not be active until April 1, 2027.
• Sullivan warned that patient crossover in the PIK3CA wild-type cohort "creates a confounding effect" for the analysis of overall survival data.

SUMMARY

Celcuity Inc. (NASDAQ:CELC) reported the commercial launch of Revtopik, which began shipping on Sept. 30, following FDA approval for the treatment of HR-positive, HER2-negative metastatic breast cancer. Management reported that the product has secured a preferred Category 1 NCCN recommendation and wide payer coverage within its first month of availability. Strategic efforts are currently focused on advancing clinical trials for first-line advanced breast cancer and metastatic castration-resistant prostate cancer, while also developing a subcutaneous formulation of gedatolisib. Financial results for the period reflected substantial investments in commercial infrastructure and the fulfillment of a $50 million milestone obligation to Pfizer.

• CEO Sullivan stated, "the triplet is the preferred regimen by most of the doctors for most of the patients that they treat," based on early surveys and anecdotal feedback from the field.
• Management reported that 91% of U.S. commercial and Medicare lives are covered by health plans that have already incorporated Revtopik into their formularies.
• The company indicated that the second manufacturing site for Revtopik is not expected to receive regulatory approval until the middle of 2027.
• Management reported that three of the four largest health care provider pathways incorporated Revtopik into their treatment recommendations within 30 days of launch.
• A randomized Phase 2 study to determine the recommended Phase 3 dose for gedatolisib in combination with darolutamide is scheduled to begin in the first half of 2027.
• CEO Sullivan noted that most health care providers will order Revtopik through specialty distributors using buy and bill reimbursement, with product drop-shipped directly to treatment locations.

INDUSTRY GLOSSARY

• Gedatolisib: A pan-PI3K and mTOR inhibitor, marketed under the brand name Revtopik.
• mCRPC: Metastatic castration-resistant prostate cancer, a stage of prostate cancer that has spread and no longer responds to hormone-lowering treatments.
• NCCN: National Comprehensive Cancer Network, an alliance of cancer centers that publishes clinical practice guidelines.
• PAM pathway: The PI3K/AKT/mTOR signaling pathway, which is often dysregulated in cancer cells.
• PIK3CA: A gene that provides instructions for making a protein involved in cell signaling; mutations in this gene are common in breast cancer.
• rPFS: Radiographic progression-free survival, a measure of the time from treatment start until a tumor's growth is visible on imaging.

Full Conference Call Transcript

Operator: Good afternoon, ladies and gentlemen, and welcome to the Celcuity third Quarter 2026 Financial Results Call and webcast. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press 0 for an operator. This call is being recorded on Thursday, 11/05/2026 And I would now like to turn the conference over to Jodi Sievers. Please go ahead.

Jodi Sievers: Thank you, Marissa, and good afternoon, everyone. Thank you for joining us to review Celcuity's Third quarter 2026 financial results and business update. Earlier today, Celcuity, Inc. Released financial results for the quarter ended September 30, 2026. The press release can be found on the Investors section of Celcuity's website. Joining me on the call today are Brian F. Sullivan, Celcuity's Chief Executive Officer and Co Founder Vicky Hahne, our Chief Financial Officer as well as Igor our chief medical officer and Eldon C. Mayer, our chief commercial officer, who will both be available for questions during Q&A. Before we begin, I would like to remind listeners that our comments today include some forward-looking statements.

These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in forward-looking statements. Such forward-looking statements and they involve known and unknown risks. Uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we also refer to non GAAP financial measures. These non GAAP measures are used by management to make strategic decisions forecast future results, and evaluate the company's current performance.

Management believes the presentation of these non GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non GAAP financial measures to GAAP to non-GAAP measures in today's press release. And with that, I would like to turn the call over to Brian F. Sullivan, CEO of Celcuity.

Operator: Please go ahead, Brian.

Brian F. Sullivan: Thank you, Jodi, and good afternoon, everyone. Thank you for joining our third quarter 2026 operating and financial update conference call. 2026 has been a transformative year for Celcuity as we transition to a commercial stage company. Revtopik is now available to U. S. Physicians to prescribe for use in combination with fulvestrant with or without palbociclib for the treatment of HR positive, HER2 negative, locally advanced or metastatic breast cancer, without a PIK3CA mutation detected following progression on or after treatment with at least 1 line of endocrine therapy in the metastatic setting.

The unprecedented efficacy results and favorable safety profile reported from the PIK3CA wild type cohort of the VIKTORIA-1 study provide physicians with a compelling rationale to utilize a gedatolisib regimen to address a significant unmet need for the tens of thousands of patients affected each year by advanced breast cancer. And we are pleased to report and provide our first update on the results of the foundational work our commercial and medical teams have been performing for the past 2 years to prepare for the commercial launch of Revtopik. Our launch is off to a great start, and results to date are all very encouraging.

To provide insight into the effectiveness of our field teams' launch activities, particularly since the drug became commercially available on September 30. We can share the following key metrics. Since Revtopik became commercially available on September 30, 78% of the top 36 strategic accounts have ordered Revtopik. These accounts treat roughly 50% of the total addressable patient population. Over 3.4 thousand sites, many of which are affiliated with 1 of the top 36 strategic accounts, have directly engaged with Celcuity Oncology sales specialists. These sites treat 82 percent of breast cancer patients. Over 1.1 thousand health care providers have attended Revtopik educational programs. Our market access and medical affairs teams have also been very effective.

Their efforts have resulted in obtaining early and broad payer coverage and inclusion in major provider pathways so that nearly all eligible patients now have access to Revtopik. Within 2 weeks of approval, we obtained a preferred category 1 recommendation in the NCCN guidelines for the Revtopik triplet and doublet as a second line treatment option for HR positive HER2 negative, advanced breast cancer patients lacking a PIK3CA mutation. With this NCCN recommendation and the direct engagement of our team has had with nearly all U. S. Payers over the past 18 months, 91% of U. S. Commercial and Medicare lives are in health care plans that cover Revtopik.

Given the complexity of managing care for cancer patients, most health care providers adhere to treatment guidelines, commonly referred to as treatment pathways, that provide guidance and recommendations for the physicians who work within a specific health care system or network. Inclusion in these pathways eliminates a critical potential barrier to physician utilization of a medicine. And this process can take, in some cases, up to 12 months. Our team, though, was able to get Revtopik Incorporated in 3 of the 4 largest health care provider pathways within just 30 days of becoming commercially available. And these results reflect the groundwork we have been laying for the past 24 months.

During this period, we have engaged over 1 thousand key opinion leaders and community breast cancer experts, key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at pampathway.com drove awareness of the PAM pathway with metrics that tracked well ahead of industry benchmarks. CME and third party peer to peer programs and regional events have further increased levels of awareness about the importance of comprehensive pan inhibition and the unmet need in the second line setting. With the build out of the commercialization infrastructure needed to support the successful launch of Revtopik completed, commercial launch activities for Revtopik commenced immediately after approval.

Our 88 oncology sales specialists, who have an average of 24 years of industry experience are calling on physicians, supporting installation of Revtopik order sets within the electronic health record systems of their accounts, and in servicing infusion centers and pharmacies. Our strategic accounts payer reimbursement, medical science liaison and KOL focused teams are following through on the groundwork they laid prior to Revtopik approval. All of these efforts are designed to offer patients and providers with rapid access and seamless support. To enable treating physicians to obtain gedatolisib on behalf of their eligible patients after we received FDA approval and prior to commercial availability of Revtopik.

Celcuity opened an expanded access program in mid-August, and now nearly all of the patients enrolled in this program have been transitioned to commercial product. Shipments of Revtopik, which began on September 30, at a wholesale acquisition cost of $10 thousand per vial or $30 thousand per 28 day cycle of treatment. Published epidemiological data estimates there are 37 thousand patients in the US receiving second-line treatment for HER2 positive HR positive HER 2 negative advanced breast cancer. That based on the data from the VIKTORIA-1 trial, patients treated with the gedatolisib regimen in the setting will remain on therapy for an average of 10 treatment cycles.

Assuming net receipt of 80% of our $30 thousand WAC price per cycle, we estimate the total addressable market for Revtopik. In the second line setting. Including both PIK3CA wild type and mutant patients. Is approximately $9 billion annually. Most healthcare providers will order Revtopik through specialty distributors, using buy and bill reimbursement. RetroPic is then drop shipped directly to the treatment location, which is typical for infused therapies. Rather than through specialty pharmacies. By selling the product through this channel, we do not obtain access to granular information as to the number of doctors prescribing or the number of patients receiving Revtopik.

As a result, when we report sales results beginning next year, the data we will be able to provide will be limited to metrics such as gross and net sales, vials shipped, and market access related metrics. We expect to provide a flash report on fourth quarter sales in mid January. And we look forward to providing further updates next year. I would like now to turn to an update on the status of our clinical development programs and recently reported data. Based on the positive data from the PIK3CA mutant cohort of the Chase III VIKTORIA-1 study, we submitted a supplemental NDA to the FDA in the third quarter of 2026.

We expect to submit VIKTORIA-1 Chase III data for both the wild type and mutant cohorts to global regulatory authorities later this year or early next year. In October, updated results from the Chase III VIKTORIA-1 study were presented in a late breaking rapid oral presentation at ESMO. And key results included median PFS of 21.5 months with a gedatolisib triplet and 11.5 months with a gedatolisib doublet. Versus 9.1 months with alpelisib plus fulvestrant. In patients who had no liver metastases. The hazard ratio for the gedatolisib triplet and doublet versus alpelisib and fulvestrant Was 0.46 and 0.71, respectively.

And this is a particularly important result since patients lacking liver mets represent approximately 70% of all patients treated in the setting according to real world analyses. Our results for patients with liver mets were also very favorable. And consistent with the primary PFS analysis. But again, with the gedatolisib triplet and doublet versus the alpolipsib doublet The hazard ratio was 0.47 and 0.38, respectively. The objective response rate for patients with evaluable disease, updated to include both confirmed and unconfirmed responders was 59% and 43% for the gedatolisib triplet and doublet, respectively. Versus 33 percent for the alpelisib doublet.

And for these patients, median duration of response for the gedatolisib triplet and doublet was 19.4 and 27.8 months, respectively, versus 7.5 months for alpelisib plus fulvestrant. The discontinuation rate for gedatolisib due to adverse events was 5% and 4%, with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib plus fulvestrant. The gedatolisib has a treatment discontinuation rate for the mutant cohort was lower than was reported for the wild type cohort. The higher discontinuation rate for the wild type cohort versus the mutant cohort largely reflects the activity in 1 region early in the study that enrolled a significant proportion of patients in the first 6 months. Discontinuations fell in this region, as physicians gained experience.

Since a much larger proportion of wild type patients were enrolled during this period than mutant patients, the impact of this initial higher discontinuation rate early in the study fell disproportionately on the wild type cohort. The mutant cohort, which enrolled more slowly initially and over a longer period of time than the wild type cohort, we did not see this disparity and discontinuation rates across regions. Thus, we believe the treatment discontinuation rate for gedatolisib reported for the mutant cohort which was 4% to 5%. best represents what we expect to see in a real world setting.

Consistent with the data from the PIK3CA wild type cohort, the stomatitis events observed occurred primarily in the first cycle and were transient. By the second cycle of treatment, less than 3% of patients had grade 3 stomatitis, and all grade 3 events improved within 1 to 2 weeks. Discontinuations due to stomatitis for the gedatolisib triplet doublet were minimal, 1% and 0% respectively. Additionally, at ESMO, doctor Tara Talaney, chief of the division of breast oncology at the Dana-Farber Cancer Institute, presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR positive HER2 negative advanced breast cancer.

8 studies were included in this network meta analysis comparing progression free survival outcomes in randomized controlled trials with systemic treatments evaluated among patients with HR-positive, HER2-negative breast cancer who had prior CDK4/6 exposure. And had PIK3CA wild type tumors. And this analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS, or progression free survival rate at 6 months relative to all of the non gedatolisib regimens evaluated. Of note, the analysis found that patients treated with the gedatolisib triplet and doublet were 2x more likely and 1.5x more likely, respectively, at a statistically significant level. To survive without disease progression or death compared to elacestrant plus abemaciclib.

We expect to provide further updates to results from both the mutant and wild type cohorts in VIKTORIA-1 at the upcoming San Antonio Breast Cancer Symposium later this year. The gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second line setting regardless of PIK3CA status of a patient's tumor. And we believe that the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR or PAM pathway. Additionally, these results augur well for the Chase III VICTORIA II trial we have underway to advance development of gedatolisib for 2 different HR positive HER2 negative advanced breast cancer populations in the first line setting.

Results from our Chase 1b clinical trial provided strong evidence that the PAM pathway is an important disease driver in treatment naive patients with advanced breast cancer. In the early Phase 1 study, we evaluated gedatolisib plus palbociclib and letrozole, as first line treatment in 41 patients with endocrine sensitive HR positive HER2 negative advanced breast cancer. Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib plus letrozole. The therapy we are using as the control in our VIKTORIA-2 trial. The objective response rate was 79%, for the gedatolisib triplet again compares favorably to historical data of 53% for ribociclib plus Letrozole.

In light of the positive results for the PIK3CA wild-type and mutant cohorts in VIKTORIA-1 and the promising preliminary data for a gedatolisib triplet as first line treatment, we are optimistic about the results of both the first line studies. Successful development in the first line setting would offer the potential to advance the standard of care for the approximately 90 thousand women each year who are diagnosed with late stage HR-positive, HER2-negative advanced breast cancer. In The US, irrespective of their endocrine sensitivity or PIK3CA status. The total addressable market for gedatolisib in the first line setting is well over $10 billion annually.

Our advancement of a subcutaneous gedatolisib formulation is ongoing, and with the goal of demonstrating clinical equivalence to the current intravenous formulation. A subcutaneous formulation is aimed to support potential future indications of gedatolisib regimens that may result in duration of treatment periods greater than several years. I would like now to turn to our Phase 1b/2 clinical trial that is evaluating gedatolisib in combination with darolutamide in men with metastatic castration resistant prostate cancer. Celcuity presented updated data from the study during a poster session at last month's ESMO Congress 2026. Key results included median progression free survival, or RPFS, was 15.7 months and 6 months RPFS rate was 82.2% in patients with prior exposure to abiraterone.

Median PFS was 9.1 months, and the 6 month RPFS rate 62.5% in patients with prior exposure to enzalutamide. Both sets of results compare favorably to published data for patients treated with either a novel hormonal therapy or docetaxel in this setting. Now the difference in results between patients with prior exposure to abiraterone versus enzalutamide was expected and reflects differences in the mechanism of action of these 2 drugs. For patients who had more than 50% decreases from baseline PSA, we observed them consistently across all dose levels. PSA response rates were 36 percent, 47 percent, and 67% of the 120, 180, and 42 milligram dose levels, respectively. In patients with prior exposure to either abiraterone or enzalutamide.

Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels of 120, 180, and 240 mgs, With only 1 dose limiting toxicity, which was Grade 3 rash, no Grade 4 or 5 treatment related adverse events. Or TRAEs, and no TRAEs leading to discontinuation of gedatolisib Or death. Grade 3 TRAEs occurred in 20 percent of patients with only rash and pruritus occurring in more than 1 patient. A randomized phase 2 study to determine the recommended Phase 3 dose level of gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer. Expected to begin in the first half of 2027 after completion of the Phase 1b part of this study.

Now with programs in both breast cancer and prostate cancer, reflecting the important role of the pan pathway in these diseases, Celcuity is well positioned to build an important pharmaceutical company over the next few years. And that concludes my remarks. I would like now to hand the call over to Vicky, our CFO, to review our finances.

Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I will provide a brief overview of our financial results for the third quarter of 2026. Our third quarter net loss was $73.3 million or $1.33 per share compared to a net loss of $43.8 million or $0.92 per share for the prior year period. Our non GAAP adjusted net loss was $66.8 million or $1.21 per share for the third quarter of 2026 compared to non-GAAP adjusted net loss of $37.2 million or $0.78 per share for the prior year period.

Operator: Shipments of Revtopik commenced on September 30, 2026.

Vicky Hahne: We recognized revenue when control of Revtopik transfers to the treatment location, which generally occurs upon delivery. Because no product was received at the treatment location, until after September 30, 2026, we did not recognize any product revenue during the third quarter of 2026. Total operating expenses were $77.3 million for the third quarter of 2026 compared to $42.8 million for the prior year period. Research and development expenses were $37.5 million for the third quarter of 26 compared to $30.4 million for the prior year period. The $7.1 million increase was primarily due to a $5.3 million increase in employee related and consulting expenses and a $2.1 million increase in manufacturing and other costs.

These increases were partially offset by a $300 thousand decrease in clinical trial costs. Selling, general, and administrative expenses were $39.8 million for the third quarter of 2026 compared to $12.4 million for the prior year period. The $27.4 million increase was primarily due to a $14.4 million increase in employee related expenses primarily driven by the hiring of additional personnel within our commercial team to support the commercialization of Revtopik. The remaining $13 million increase was primarily due to an $11.1 million increase in costs to support the commercialization of Revtopik including consulting expenses, expanding infrastructure costs, and a $1.9 million increase in other administrative expenses.

In the aggregate, $25.3 million of the $27.4 million selling, general, and administrative increase related to commercial headcount additions and other activities to support the commercialization of Revtopik. Net cash used in operating activities for the third quarter of 2026 was $66.2 million compared to $44.8 million for the prior year period. The additional cash used in operating activities quarter over quarter of $21.4 million was primarily due to non GAAP adjusted net loss of $29.7 million partially offset by working capital changes of $8.3 million. In addition, we made a $50 million payment to Pfizer, which was triggered by receipt of the FDA approval for Revtopik per our exclusive global license agreement for gedatolisib.

This payment was classified as investing activity on the condensed statement of cash flows during the third quarter of 2026. Cash, cash equivalents and short term investments were $642.7 million at the end of the third quarter compared to $441.5 million as of December 31, 2025. The $201.2 million increase was primarily driven by the convertible note offering completed in June 2026. This resulted in gross proceeds of $575 million and net proceeds of $557 million. The proceeds were partially offset by $172.7 million of cash used in operating activities the repayment of a $137 million term loan, and the $50 million payment to Pfizer for the, license milestone payment.

Additional cash provided by investing and financing activities of $3.9 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases. We expect cash, cash equivalents, and investments to finance our operations through 2029. I will now hand the call back to Jodi.

Jodi Sievers: Thank you, Vicky. Marissa, could you please open the call for questions?

Operator: Absolutely. Ladies and gentlemen, we will now begin the question and answer session. Will hear a prompt that your hand has been raised. And should you wish to remove your hand from the queue, please press star followed by 2. Just a moment for your first question. Your first question comes from Maury Raycroft with Jefferies. Please go ahead.

Maury Raycroft: Congrats on the early progress, and thanks for taking my questions. I was going to ask for your initial prescribers. Can you say what proportion of these prescribers had prior experience with the drug through the EAP or your clinical programs? And how broad is adoption beyond those physicians?

Brian F. Sullivan: I would say a very small percentage of the doctors prescribing were those who had participated in the VIKTORIA-1 study or who had prescribed the medicine via the EAP. We had significant frustration by those prescribers, but they did not comprise a significant proportion of the total. Based on our analysis of the number of vials. We do not see specific data by doctor. So, you know, again, we can only estimate what we think the impact of their involvement in the initial uptake was.

Maury Raycroft: Got it. Okay. And then And for the number of patients who enrolled in the EAP can you say if that is a handful or a meaningful number, or are you sharing any more specifics on that?

Brian F. Sullivan: I would say it was a handful. And, again, I think as I have indicated earlier, the program became active mid August. And with the idea that it was going to become irrelevant. Or no longer available by the end of the third quarter or roughly 6 weeks. And so that essentially led many physicians to indicate that the kind of work needed to get approval from their IRB was not going to yield their ability to enroll a patient in the EAP program before our drug became commercially available. And so while some doctors did take advantage of it, the short time frame when the program was believed to be relevant.

Really disincented most doctors to participate in the program. But did allow those who had either the ability because of their systems flexibility or willingness to do the work upfront. To participate. And that was 1 of the goals is to. For those who institutionally or personally were able to, over this short period of time, take advantage of the program and that was a good outcome.

Maury Raycroft: Got it. Okay. And then I will ask 1 more question and then hop back in the queue. Just wondering if you can clarify if the second manufacturing site is fully operational. And is there any perspective you can share on inventory and whether there are any gating factors to maintaining a steady supply of the drug?

Brian F. Sullivan: Yeah. I would just say that we have sufficient production to handle our planned or higher than planned demand from the field. And we have we have indicated that we do not expect the second site to be approved until sometime in the middle of 2027. And that is been consistent with what we have said stated previously.

Maury Raycroft: Got it. Thanks for taking my questions. You are welcome.

Operator: Your next question comes from Anupam Rama with JPMorgan. Please go ahead.

Analyst: Hey, guys. Thanks so much for taking the question, and congrats on the progress here. I know in the press release, you talked about 78% of your top sort of 36 priority accounts have ordered Revtopik. Can you give us a little bit more color on the balance of the centers and kind of what are the gating factors for them to kind of get their first order in? Thanks so much.

Brian F. Sullivan: I would say the primary gating factor. I mean, to be frank, to put that in context, we have spoken with some people, and these accounts can be the ones that can take several months to get on. And so to get 78% in the first month is quite significant. But for those that did not place an order, where it was less about their lack of interest in doing so and more to do with, essentially, the specific organizational requirements, whether it is getting the order set fully embedded in their systems. Some of these institutions have you know, are complex organizations. Or other kind of, again, more bureaucratic implementations to make the drug available.

So we do not anticipate that there are any true barriers other than just getting them institutionally prepared to have their doctors prescribe the medicine.

Analyst: Great. Thanks so much for taking our question.

Operator: Your next question comes from Tara Bancroft with TD Cowen.

Tara Bancroft: Hi. Good afternoon. So obviously, your team has had a lot of touch points with the treating community. So I am curious to hear from those experienced what your updated thoughts or expectations are for seeing any potential for a bolus at all, either this quarter in wild type or in mutant patients once approval is reached there. And if you are so far seeing or expecting any off label use in the mutant segment, prior to that approval, or if you think physicians will wait for the formal label. Thanks so much.

Brian F. Sullivan: You know, I know I kind of know what you are getting at with the bolus, but again these are sick patients and they are not stacked up, ready to go. And so I would say that the demand almost completely reflects patients who require a new treatment option, whether that is in the second or third line setting. We know great bulk just based anecdotally on feedback we received from reps and information they report back to us. That the bulk of the patients receiving the medicine are in the second line setting. Which is as we would expect.

But of course, there is a lot of patients in the third line setting who do not have great treatment options, and so doctors are taking advantage of the availability of Revtopik to treat them. As far as mutant usage in patients who have PIK3CA mutations. We have certainly heard physicians have an interest. They are very excited about the data. They would like to use it. And obviously, we are not approved to treat those patients. And so our sales force is not engaged in those discussions. As you would expect.

And to the extent that the physicians make the decision based on the data that has been reported, they have that ability, and then they will have to work through reimbursement for the patient. But other than that, I cannot really comment on, you know, prescribing behavior with that population.

Tara Bancroft: Okay. Okay. Understood. Very helpful. Thank you. Welcome.

Operator: Your next question comes from Michael Schmidt with Guggenheim. Please go ahead.

Analyst: Hey, good afternoon. Thanks for taking my question. Just a few more questions, if you could share sort of anecdotes in terms of how you are seeing the drug use early on in terms of you know, the types of patients that are going on to therapy relative to the VIKTORIA-1 study and, you know, any insights on usage in ESR1-mutant versus wild-type patients and perhaps split between the triplet and the doublet?

Brian F. Sullivan: Sure. We do not. We have not really gotten much visibility on usage according to ESR1 status, to be frank. So I really do not have anything to offer there. But regarding the usage of the triplet versus the doublet, that is something that, you know, our oncology sales specialists have discussed with the doctors that are looking for input and help in sorting through the data to make that decision. And again, this is anecdotal. But we see a pretty consistent pattern based on the self reporting that we obtained from our OSSs. That the triplet is the preferred regimen by most of the doctors for most of the patients that they treat.

And that is consistent with the surveys we have done over the course of the past year. With docs where we present the data and ask for their decision about which therapy they would select first. And over time, we would expect that pattern to hold. But it is it is early. And, again, we do not get precise data, and it is primarily anecdotal, but so far consistent with what our expectations were. Okay, great. And how should investors think about sort of the launch trajectory perhaps over the next 12 months relative to some of the recent breast cancer launches when we think about you know, unique dynamics around J code, for example.

You expect that to be a sequencing and a bolus for uptake next year? Well, you know, again, because we are an infused drug, we have to work on a temporary J code because we were approved, you know, after the halfway point of the year, you know, our J code will not become active until, you know, April 1. We will receive the J-code itself January 1, but it is not active. A lot of, you know, community sites, for instance, are the ones that can be particularly affected by J-code and are leery of prescribing drugs that do not have a permanent J-code because of reimbursement risk in their view.

But we have not found that to be a huge obstacle at this point, certainly some. We expected that. We have a reimbursement specialist in our respiratory support service group that has been effective in helping community sites, for instance, navigate some of the challenges of. Or concerns that some of these sites have about reimbursement. We also have a program that is offering these sites extended payment terms. So that they are not at risk of essentially going upside down from a cash flow standpoint with gedatolisib with Revtopik.

And so while it will be an obstacle for certain number of accounts, and we have we have baked that into the plan, But it is not an immovable object, and so, you know, we think certainly, that friction will be removed when the J-code comes, but it is it is not an all encompassing barrier in general.

Analyst: Okay. Thank you.

Operator: Your next question comes from Gil Blum with Needham. Please go ahead.

Gil Blum: Good afternoon, everyone, and thanks for taking our question. Really, on a similar topic as everyone else. Have you gotten any early feedback from your early prescribers? And you know, their experiences with the drug and how it affected their patients? Thank you.

Brian F. Sullivan: We have. that is actually 1 of the, requirements that we have asked our reps to follow through on. A, you know, once they learn that a doctor or that an order has been placed to a specific site, Typically, early on at least, it will be easy for them to know which doctor it was. They are expected to follow-up with the doctor to make sure the site is ready. Has what they need. Dexamethasone mouth rinse is available at that site or that pharmacy for the patient before they come in. And then also to follow-up with either the doctor or an appropriate individual at the site.

The treating center, to see how the patient experienced the infusion of gedatolisib. And so far, you know, based on, you know, those types of conversations, which should be. Which are happening every day, you know, across the country. The feedback has been very positive. Patients are having a very good experience nothing anomalous. And I think our group has done a very good job of educating the relevant health care providers to help them understand what to expect from an adverse event standpoint. To make sure that the guidelines that we have put in place for stomatitis management have been put in place.

So there have been no surprises which is important, either for the providers or for the patients. And so I would say almost universally, from the feedback we have received to date, the patient experience and the doctor's perspective on the patient's experiences has been very positive.

Gil Blum: Thank you. Very helpful.

Operator: Your next question comes from Chase Knickerbocker with Cantor. Please go ahead.

Analyst: Hey. Good afternoon. This is Daniel on for Chase Knickerbocker Congrats on the update. We were wondering if you could comment on the potential future implications of last night's update on 340B for Revtopik's launch right now, but then also as you expand into the mutant population. Thank you.

Brian F. Sullivan: Well, since our drug got approval prior to this program becoming effective, we are grandfathered in to the current discounts. Offered to the 340B. So we do not expect this new program to affect our reimbursement rate for those hospitals. And so essentially, we have communicated to date regarding our gross to net estimate is consistent. We knew that program was in place, and. But we, were able to avoid it impacting us by getting our approval in time to get the appropriate paperwork filed so that we would be grandfathered into the current system or the system that preceded this 1. Thank you.

Operator: Your next question comes from Andrew Berens with Leerink Partners. Please go ahead.

Andrew Berens: Hi, guys. This is Amanda on for Andrew Berens. Maybe 1 quick question from us. What is the latest progress on the subcutaneous formulation and how that program is going? Thank you.

Brian F. Sullivan: Sure. it is going well. I mean, as I think discussed previously, there is a lot of different steps in this development of this new formulation. And so far, we are on track. To the plan that we have. We have got a number of milestones that we have identified that we need to meet in order to keep the program on track, and so far, so good. So again, you know, it is it is a lot of internal work, a lot of chemistry and other formulation work. And then work to, you know, essentially isolate and quantify you know, the general PK profile of different formulations, different approaches.

And, you know, there is a lot of work to do to assess stability of different formulations. So there is a lot of variables you are optimizing. And some of them, you know, can take meaningful period of time. there is also, you know, significant complexity, which is the case always when you are developing a new formulation. You know, to transfer from essentially lab scale to larger scale. And so all of those components of the program are factored into our time lines. And we are on track with the program overall.

Andrew Berens: Got it. Thank you.

Operator: Your next question comes from Stephen Willey with Stifel. Please go ahead.

Stephen Willey: Yes. Good afternoon. Thanks for taking the question. Maybe just a follow-up on the last question. Should we expect any kind of quantitative disclosure around progress being made on the sub q formulation, say, over, like, the next 12 months or so? Or will the progress updates here kinda continue to be mostly qualitative in nature?

Brian F. Sullivan: I think for the foreseeable future, they will be qualitative. And we some development projects and. At development projects is really kind of too many moving pieces to provide play by play because it is hard to interpret. Externally. But, again, we are confident about the development. We are on track with it. Some major milestones have been achieved that we expected to achieve, but it is nice to get them in the bag. So know, again, so far so good.

Stephen Willey: And then maybe just can you say if the VIKTORIA-2 data updates that were presented at ESMO, were those included in the sNDA submission? And I guess just any updated thoughts on how a mutant label might read with respect to, either both or 1 of the regimen. Thanks.

Brian F. Sullivan: So, we are in the middle of providing additional data to the agencies. This is part the normal review cycle. And so we provided a variety of analyses, additional analyses, including some of the data that you saw in the ESMO presentation. As far as the label, again, I do not want to speculate. it is less straightforward than the wild type because, you know, the wild type had 2 primary endpoints with alpha assigned. You know, the doublet was a secondary endpoint but with no alpha assigned. So that makes it less obvious, I guess, exactly how the agency will stand and again, we.

We have discussed that, because of the nature of, you know, the expectations the agency has for powering studies to support an indication on the label. But those are the type of discussions we will be having with the agency. And we will see what we see.

Stephen Willey: Alright for taking my questions. You are welcome.

Operator: Hey, good afternoon. Congrats on the Your next question comes from Sylvain Turcan with Citizens.

Silvan Tuerkcan: quarter and thanks for taking my question. Welcome. I may be a little brushed on my CMS rules. I just want to follow up on that. That change in the rule. How exactly is it work that you are grandfathered in into the current discount? Just. Did you have qualifying pass through status, or how does that work? And much roughly do you expect utilization to be through the 340B hospitals then the second question is how much inventory do you think sites will build in the near term? And do you have any visibility into how many weeks that could be? Thank you.

Brian F. Sullivan: But Okay. So we do not expect sites to really build much inventory. We drop-ship within, you know, essentially next day to the sites. And so it is very quick turnaround time. there is no reason most sites, I think, will conclude there is no reason to build inventory. So any orders that we are getting, you know, in our view, are linked to a particular patient and not you know, putting drug on the shelf. As far as the 340B, again, I am. I can only say what I said before, which is the case. So, you know, we will not be exposed to these new rules.

And so as far as the percentage of 340B, it can vary depending on the indication. I think other companies have reported 30% to 40% of business can be 340B. You know, we are early in the process. I do not want to make a number up. But, you know, that is a useful benchmark to consider. And we have. We have an assumption in our estimate along that range that allowed us to estimate that we think the gross to net will be 80%, a 20% discount.

Silvan Tuerkcan: Great. Thank you for taking my question. You are welcome.

Operator: Your next question comes from Oliver McCammon with LifeSci Capital. Please go ahead.

Oliver McCammon: Hi, thanks for taking my questions. I am just curious if you can remind us on the time line to mature overall survival data from VIKTORIA-1 the process for potentially adding these data to the FDA label in the future, And then any early feedback you are hearing on how meaningful OS could be for the launch curve? Thanks again.

Brian F. Sullivan: So as far as the OS data, we have indicated previously that we expect that sometime in the first half of 2027. And so you know, again, it is event driven, and you know, we follow the trends but, you know, the events and OS analysis can be a little bit more unpredictable than in progression. So, you know, we have to have we are using a fairly wide time band, for that estimate. As far as the label, it would only really get incorporated in the label if it is positive. So, again, until we see the data, we will not know.

As far as you know, the impact it can have, I mean, certainly, if it is positive, it would be impactful because as best I know. And, again, to the best of my knowledge, there has been no second line indication showing, at least with an endocrine backbone therapy. A favorable OS advantage over the control. And so certainly, if we achieve that, that would be helpful, but I do not. And important for the patients. But I do not think there is an expectation, at least as we have discussed gedatolisib and the results with doctors, an expectation that is required for them to make a decision on use of gedatolisib, essentially.

Progression free survival has really been the data that is been used and then subgroup analyses to help better understand, you know, treatment effects you know, first particularly important clinical populations. And but certainly if we were to achieve it, it would be a big deal. We have also indicated that because our study, you know, the PIK3CA wild type cohort, allowed patients to cross over from the fulvestrant arm to learn control. That creates a confounding effect. And so while we showed a favorable trend and we are encouraged by that in the interim analysis, Whenever you have crossover, you just have to expect that there is gonna be confounding.

And so, you know, again, we do not wanna create any expectations that of anything. We will see it when we see it. But I do not think it is if OS is not a positive result. I do not think that will have any impact on the launch.

Oliver McCammon: Very helpful. Thank you.

Operator: Your next question comes from Kalpit Patel with Wolfe Research. Please go ahead.

Kalpit Patel: Yeah. Good afternoon, and thanks for taking the question. A couple from us. Last time, I think, Brian, you mentioned that the NCCN guidelines could potentially include the mutant population before that approval happens. I am just curious if you have any latest thoughts on that, and whether that timing could be, before year end. And then second question, from your early experience, you have so far? Do you have a good sense on what is the average time for a new patient to actually starting on drug might be, or is it too early to comment on that? Thank you.

Brian F. Sullivan: Sure. Thanks for the questions. So regarding the NCCN guidelines for mutant patients, that is dependent on publication being available. They will only consider a publication or rather for an additional expansion of the recommendations based on peer reviewed journal article. We expect to have that available this quarter. We would then, you know, submit to the NCCN asking for a recommendation. And the timing of that is difficult to project because it is somewhat dependent on their meeting schedule since this will not be linked to a label. You know, it is not clear to us whether they would call an ad hoc meeting as they did for you know, the wild type indication.

But it is not unreasonable to expect that prior to an approval decision by the FDA, that NCCN would incorporate some recommendation in their guidelines.

Kalpit Patel: Okay.

Brian F. Sullivan: And the average. Okay. And regarding the average time. So that is we think it is quite quick. Again, this is all anecdotal. This is all self reported from our reps, who are very intimately involved. Particularly in these early patients, you know, because they have been working to essentially ride shotgun on the process with the patient. But we think it is fairly quick. I mean, based on experience when doctors identify a patient, want to put them on therapy as soon as they can. there is not a kind of a wait and see approach.

So we are receiving demand that we think is real time reflection of a patient requiring treatment and of the intention of giving them that treatment as soon as it is available.

Kalpit Patel: Okay. And if I can squeeze in a follow-up here. Do you have any granularity on how many sites have actually ordered? I know you gave the number for the strategic accounts, but any.

Brian F. Sullivan: So we will we will be providing those types of updates. Yeah. No. I appreciate the question. We will be providing those types of updates. When we provide an overview in January. Of the full quarter.

Kalpit Patel: Okay. Thank you. You are welcome.

Operator: Your next question comes from Sylvain Turcan with Citizens. Please go ahead.

Silvan Tuerkcan: Hey, thanks so much for taking my follow-up. I just wanted to know if you have any takeaways from ESMO from your doctors, maybe that you engage there with given the presentation that you had from Victoria breaking out these different patient populations in terms of if they understand how wide you cast your net in terms of patients that you enrolled versus, you know, some of these maybe mutant selective trials that are ongoing? Do you have any feedback on patient? I appreciate it.

Brian F. Sullivan: Sure. No. We. We have had conversations with since we have had our approval with, obviously, a broader group of doctors. But I would say there is a general understanding or recognition that we enrolled a patient population with significant disease burden that was not necessarily representative of the typical patient that they will see. And really, I think the most telling statistic relates to the presence of liver mets. You know, 70% of patients typically do not have liver mets, and liver mets are probably 1 of the most important factors that correlate to worse prognosis and less favorable treatment effect. On an absolute basis.

And so in our case, we had over 50% or 50% or so of patients in the mutant setting as well as the wild type that had liver mets. So essentially, that can act as a depressant in your absolute number. It does not affect the hazard ratio, as it turns when you look at the subgroups, and you see the hazard ratios are comparable across subgroups depending on, you the treatment burden. Or rather disease burden. But the data that we presented roughly 21.5-month median PFS for the no liver mets, was really important for 2 reasons, as I indicated in my remarks. it is essentially representative of roughly 70% of patients and so that is.

That was, you know, really a fantastic result. It also highlighted and was clarifying for many docs in understanding the contribution of palbociclib. Because certainly, the intent to treat PFS was very similar for the doublet and triplet. And so somewhat confounding and the same time, OS trend was more favorable in the triplet than in the doublet, but, again, interim analysis of immature people are reluctant to draw too many conclusions about that. But in this case, with the triplet versus the doublet, it showed a 10-month advantage relative to the doublet. Which is obviously very meaningful clinically. And so that is really I think, clarifies for many doctors a question they have had. What should I start with?

Should I start with the doublet or the triplet? And the feedback I think, was fairly consistent that this really motivates them, indicates to them that it makes sense to start with a triplet. And, again, that is what we are seeing in the wild-type cohort so far, anecdotally. But with the data at ESMO, it kind of filled in some blanks that led most of the physicians we spoke to think, almost everyone to prioritize use of the triplet for patients unless there are other factors that may warrant avoidance of neutropenia, for instance. Great. Thank you, Brian.

Silvan Tuerkcan: Thanks for the details. You are welcome.

Operator: There are no further questions at this time. I would like to turn the call back over to Brian F. Sullivan for closing remarks.

Brian F. Sullivan: Thank you, everyone, for your interest in Celcuity. We look forward to reporting back in January time frame. Take care.

Operator: Thank you everyone for your participation. This concludes today's conference call. You may now disconnect.

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