Celcuity Q3 2026 Earnings Call Transcript

Celcuity (NASDAQ:CELC) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Celcuity Inc. reported a net loss of $73.3 million for Q3 2026, with no revenue recognized due to the timing of shipments for their newly launched drug, Retropic.

The company successfully launched Retropic, achieving early adoption by 78% of top strategic accounts, with significant market access and payer coverage secured.

Clinical updates highlight strong efficacy data for Retropic in breast cancer, with ongoing trials and future potential in prostate cancer, and a subcutaneous formulation under development.

Financially, operating expenses increased due to commercialization efforts, but cash reserves were bolstered by a convertible note offering, ensuring operational funding through 2029.

Management expressed optimism about Retropic’s market potential and strategic positioning, highlighting positive physician feedback and a robust commercialization infrastructure.

Full 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 star zero for an operator. This call is being recorded on Thursday, November 5, 2026, and I would now like to turn the conference over to Jody Severs.

Please go ahead.

Jody Severs (Investor Relations)

Thank you, Marisa, and good afternoon, everyone. Thank you for joining us to review Celcuity third quarter 2026 financial results and business updates. Earlier today, Celcuity Inc. released financial results for the quarter ended September 30, 2026. The press release can be found on the Investor section of Celcuity’s website. Joining me on the call today are Brian Sullivan, Celcuity’s chief executive officer and co-founder; Vicky Hahne, our chief financial officer; as well as Igor Gorbachevsky, our chief medical officer; and Eldon Mayer, our chief commercial officer, who will both be available 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 the forward-looking statements. Such forward-looking statements and their implications 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 measures in today’s press release, and with that I would like to turn the call over to Brian Sullivan, CEO of Celcuity.

Please go ahead, Brian.

Brian Sullivan (Chief Executive Officer)

Thank you, Jody, 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. Retropic 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 on or after treatment with at least one 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 VICTORIA 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’re 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 two years to prepare for the commercial launch of Retropic.

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 team’s launch activities, particularly since the drug became commercially available on September 30, we can share the following key metrics. Since Retropic became commercially available on September 30, 78% of the top 36 strategic accounts have ordered Retropic. These accounts treat roughly 50% of the total addressable patient population. Over 3,400 sites, many of which are affiliated with one of the top 36 strategic accounts, have directly engaged with Celcuity oncology sales specialists.

These sites treat 82% of breast cancer patients. Over 1,100 health care providers have attended Retropic 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 Retropic within two weeks of approval. We obtained a preferred Category 1 recommendation in the NCCN guidelines for the Retropic 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 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 Retropic. Given the complexity of managing care for cancer patients, most healthcare providers adhere to treatment guidelines, most commonly referred to as treatment pathways, that provide guidance and recommendations for the physicians who work within a specific healthcare 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 was able to get Retropic incorporated in three of the four largest healthcare provider pathways within just 30 days of becoming commercially available, and these results reflect the groundwork we’ve been laying for the past 24 months. During this period we’ve engaged over 1,000 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 PAM inhibition and the unmet need in the second-line setting. With the buildout of the commercialization infrastructure needed to support the successful launch of Retropic completed, commercial launch activities for Retropic 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 Retropic 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 Retropic approval. All of these efforts are designed to offer patients and providers 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 Retropic, 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 Retropic, which began on September 30, are at a wholesale acquisition cost of $10,000 per vial, or $30,000 per 28-day cycle of treatment.

Published epidemiological data estimates there are 37,000 patients in the U.S. receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer and that, based on the data from the VICTORIA 1 trial, patients treated with a gedatolisib regimen in this setting will remain on therapy for an average of 10 treatment cycles. Assuming net receipt of 80% of our $30,000 WAC price per cycle, we estimate the total addressable market for Retropic in the second-line setting, including both PIK3CA wild-type and mutant patients, is approximately $9 billion annually.

Most healthcare providers will order Retropic 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 such as the number of doctors prescribing or the number of patients receiving Retropic. 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’d 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 Phase 3 VICTORIA 1 study, we submitted a supplemental NDA to the FDA in third quarter of 2026, and we expect to submit VICTORIA 1 Phase 3 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 Phase 3 VICTORIA 1 study were presented in a late-breaking rapid oral presentation at ESMO.

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 the alpelisib doublet 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.

Results for patients with liver mets were also very favorable and consistent with the primary PFS analysis, where for the gedatolisib triplet and doublet versus the alpelisib 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% for the alpelisib doublet, and for these patients, the 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 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 one region early in the study that enrolled a significant proportion of patients in the first six 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, did not see disparity in 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. And 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 one to two weeks.

Discontinuations due to stomatitis for the gedatolisib triplet and doublet were minimal, 1% and 0%, respectively. Additionally, at ESMO, Dr. Sarah Tulaney, 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 VICTORIA 1 and other regimens evaluated in patients with HR-positive, HER2-negative advanced breast cancer. Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of 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 and a progression-free survival rate at six months relative to all of the non-gedatolisib regimens evaluated.

Of note, the analysis found that patients treated with a gedatolisib triplet and doublet were 2 times more likely and 1.5 times more likely, respectively, at a statistically significant level, to survive without disease progression or death compared to fulvestrant plus abemaciclib. We expect to provide further updates to results from both the mutant and wild-type cohorts in VICTORIA 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 the PIK3CA status of a patient’s tumor, and we believe the results from the VICTORIA 1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR, or PAM, pathway. Additionally, these results all bodes well for the Phase 3 VICTORIA 2 trial we have underway to advance development of gedatolisib for two different HR-positive, HER2-negative advanced breast cancer populations in the first-line setting. Results from our Phase 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 VICTORIA 2 trial. The objective response rate was 79% for the gedatolisib triplet, which 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 VICTORIA 1 and the promising preliminary data for a gedatolisib triplet as first-line treatment, we’re optimistic about the results of both the first-line studies, and successful development in the first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR-positive, HER2-negative advanced breast cancer in the U.S., 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 with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. 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’d like now to turn to our Phase 1/2 clinical trial that’s evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. Celcuity presented updated data from this study during a poster session at last month’s ESMO Congress 2026. Key results included median rPFS was 15.7 months and 6-month rPFS rate was 82.2% in patients with prior exposure to abiraterone; median PFS was 9.1 months and the 6-month rPFS rate was 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. 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 two 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%, 47%, and 67% at the 120, 180, and 240 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 milligrams, with only one 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% of patients, with only rash and pruritus occurring in more than one 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 is 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 PAM 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 Vicki, our CFO, to review our finances.

Vicky Hahne (Chief Financial Officer)

Thank you, Brian, and good afternoon, everyone. I’ll 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.

Shipments of Revtorpic commenced on September 30, 2026. We recognized revenue when control of Revtorpic transferred 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 2026, 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 $0.3 million 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 function to support the commercialization of Revtorpic. The remaining $13 million increase was primarily due to an $11.1 million increase in costs to support the commercialization of Revtorpic, 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 Revtorpic. 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 Revtorpic 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 the $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 Jody.

Jody Severs (Investor Relations)

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. Should you have a question, please press star followed by one on your touchtone phone. You 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 two. Just a moment for your first question. Your first question comes from Mauri Raycroft with Jefferies. Please go ahead.

Mauri Raycroft (Analyst)

Hi. 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 Sullivan (Chief Executive Officer)

I would say a very small percentage of the doctors prescribing were those who had participated in the VICTORIA-1 study or who had prescribed medicine with EAP. Got it. We had significant participation by those prescribers, but they did not comprise a significant proportion of the total based on our analysis of the number of vials, but we don’t 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.

Mauri Raycroft (Analyst)

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

Brian Sullivan (Chief Executive Officer)

I would say it was a handful. And again, I think, as I’ve indicated earlier, the program became active mid-August with the idea that it was going to become irrelevant or no longer available by the end of the third quarter, or roughly six weeks. And so that essentially led many physicians to indicate that the work to get approval from their IRB was not going to yield their ability to enroll the patients in the EAP program before our drug became commercially available.

And so while some doctors did take advantage of it, the short timeframe when the program was believed to be relevant really disincented most doctors to participate in the program. But it did allow those who had either the ability, because of their systems flexibility or willingness to do the work up front to participate. And that was one of the goals, is to, you know, for those who institutionally or personally were able to, over this short period of time, take advantage of the program, then that was a good outcome.

Mauri Raycroft (Analyst)

Got it. Okay. And then I’ll ask one 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 Sullivan (Chief Executive Officer)

Yeah, I would just say that we have sufficient production to handle our planned or higher-than-planned demand from the field. And we indicated that we don’t expect the second site to be approved to operate until sometime middle of 2027. And that’s been consistent with what we’ve stated previously.

Mauri Raycroft (Analyst)

Got it. Okay. Thanks for taking more questions.

Brian Sullivan (Chief Executive Officer)

You’re welcome.

OPERATOR

Your next question comes from Anupam Rama with JP Morgan. Please go ahead.

Anupam Rama (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 the Revtorpic. 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 Sullivan (Chief Executive Officer)

I would say the primary gating factor, I mean, to be frank, to put that in context, we’ve 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 didn’t place an order, it was less about their lack of interest in doing so and more to do with essentially the specific organizational requirements, whether it’s getting the order set fully embedded in their systems.

Some of these institutions are complex organizations, or other, kind of again, more bureaucratic implementations to make the drug available. So we don’t anticipate that there are any true barriers other than just getting them institutionally prepared to have their doctors prescribe the medicine.

Anupam Rama (Analyst)

Great. Thanks so much for taking our question.

OPERATOR

Your next question comes from Tara Bancroft with TD Cowan. Please go ahead.

Tara Bancroft (Analyst)

Hi, good afternoon. So obviously your team has had a lot of touch points with the treating community. So I’m curious to hear from those experiences 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’re 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 Sullivan (Chief Executive Officer)

I kind of know what you’re getting at with the bolus, but again, these are sick patients and they’re not stacked up ready to go. So I would say that the demand almost completely reflects patients who require a new treatment option, whether that’s in the second- or third-line setting. We know, 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’s a lot of patients in the third-line setting who don’t have great treatment options, and so doctors are taking advantage of the availability of Revtorpic to treat them. As far as usage in patients who have PIK3C mutations, we’ve certainly heard physicians have an interest, they’re very excited about the data, they would like to use it. And, you know, obviously we’re not approved to treat those patients, and so our salesforce does not engage in those discussions, as you’d expect. And to the extent that the physicians make the decision based on the data that has been reported, you know, they have the ability and then they’ll have to work through reimbursement for the patient.

But other than that, I can’t really comment on prescribing behavior with that population.

Tara Bancroft (Analyst)

Okay, great. Yes, understood. That’s very helpful. Thank you.

Brian Sullivan (Chief Executive Officer)

You’re welcome.

OPERATOR

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

Michael Schmidt (Analyst)

Oh, hey, good afternoon. Thanks for taking my question. Yeah, just a few more questions, if you could share sort of anecdotes in terms of how you’re seeing the drug use early on, in terms of the types of patients that are going on to therapy relative to the VIKTORIA-1 study and any insights on usage in ESR1 mutant versus wild-type patients, and perhaps split between the triplet and the doublet? 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, do you expect that to be a significant bonus for uptake next year?

Brian Sullivan (Chief Executive Officer)

Sure. We haven’t really gotten much visibility on usage according to ESR1 status, to be frank, so I really don’t have anything to offer there. But regarding the usage of the triplet versus the doublet, that is something that 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’s consistent with the surveys we’ve 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’s early and, again, we don’t get precise data and it’s primarily unauditable, but so far consistent with what our expectations were. Well, you know, again, because of our infused drug, we have to work on a temporary J-code because we were approved after the halfway point of the year. Our J-code won’t become active until April 1st. We’ll receive the J-code itself January 1st, but it’s not active. A lot of community sites, for instance, are the ones that can be particularly affected by J-codes or wary of prescribing drugs that don’t have a permanent J-code because of the 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 reimbursement specialists in our support services group that have been effective in helping community sites, for instance, navigate some of the challenges and 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’re not at risk of essentially going upside down from a cash flow standpoint with gedatolisib.

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

OPERATOR

Your next question comes from Gail Bloom with Needham. Please go ahead.

Gail Bloom (Analyst)

Good afternoon everyone, and thanks for taking our question—really kind of on a similar topic as everyone else. Have you gotten any early feedback from your early prescribers and their experiences with the drug and how it affected their patients? Thank you.

Brian Sullivan (Chief Executive Officer)

We have. That’s actually one of the requirements that we’ve asked our reps to follow through on—that once they learn that a doctor, or that an order, has been placed to a specific site, they’ll typically know early on, at least, it’ll be easy for them to know which doctor it was. They’re 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 and gedatolisib. And so far, based on those types of conversations, which are happening every day 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 healthcare providers to help them understand what to expect from an adverse event standpoint, to make sure that the guidelines that we’ve 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’ve received to date, the patient experience and the doctor’s perspective on the patient’s experience has been very positive.

Gail Bloom (Analyst)

Thank you. Very helpful.

OPERATOR

Your next question comes from Lee Watsek with Cantor. Please go ahead.

Daniel Brunder (Analyst)

Hey, good afternoon, this is Daniel Brunder on for Lee Watsek. Thank you for taking our question and congrats on the update. We were wondering if you could comment on the potential future implications of last night’s update on 340B for the launch right now, but then also as you expand into the mutant population. Thank you.

Brian Sullivan (Chief Executive Officer)

Well, since our drug got approval prior to this program becoming effective, we are grandfathered into 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 what we’ve communicated to date regarding our gross-to-net estimate is consistent. We knew that that program was in place and that 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 one.

Daniel Brunder (Analyst)

Thank you.

OPERATOR

Your next question comes from Andrew Behrens with Learning Partners. Please go ahead.

Amanda (Analyst)

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

Brian Sullivan (Chief Executive Officer)

Sure. It’s going well. I mean, as I think discussed previously, there’s a lot of different steps in this development of this new formulation, and so far we’re on track to the plan that we have. We’ve got a number of milestones that we’ve identified that we need to meet in order to keep the program on track, and so far, so good. So, again, you know, it’s a lot of internal work, a lot of chemistry and other formulation work, and then work to essentially isolate and quantify, you know, the general PK profile of different formulations, different approaches. And, you know, there’s a lot of work to do to assess stability of different formulations. So there’s a lot of variables you’re optimizing, and some of them can take meaningful period of time. There’s also significant complexity, which is the case always when you’re 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 timelines, and we’re on track with the program overall.

Amanda (Analyst)

Got it. Thank you.

OPERATOR

Your next question comes from Steven Willie with Stifel. Please go ahead.

Steven Willie (Analyst at Stifel)

Yeah, good afternoon. Thanks for taking the question. Maybe just to 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 kind of continue to be mostly qualitative in nature?

Brian Sullivan (Chief Executive Officer)

I think for the foreseeable future they’ll be qualitative. It’s a development project, and a development project has really too many moving pieces to provide play-by-play because it’s hard to interpret externally. But again, we’re confident about the development. We’re on track with it. Some major milestones have been achieved that we expected to achieve, but it’s nice to get them in the bag. So again, so far so good.

Steven Willie (Analyst at Stifel)

And then maybe just can you say if the Study 2 data updates that were presented at a time, 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 one of the regimens? Thanks.

Brian Sullivan (Chief Executive Officer)

So we’re in the middle of providing additional data to the agencies. This is part of the normal review cycle, and so we’ve 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 don’t want to speculate. It’s less straightforward than the wild-type because the wild-type had two primary endpoints with alpha assigned. 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’ve discussed that because of the nature of the expectations the agency has for powering studies to support an indication on the label. But those are the types of discussions we’ll be having with the agency, and we’ll see what we see.

Steven Willie (Analyst at Stifel)

All right. Thanks for taking the questions.

Brian Sullivan (Chief Executive Officer)

You’re welcome.

OPERATOR

Your next question comes from Sylvan Turkan with Citizens. Please go ahead.

Sylvan Turkan (Analyst)

Hey, good afternoon. Congrats on the quarter and thanks for taking my question. And I may be a little rusty on my CMS rules. I just want to follow up on that change in the rule—how exactly does it work that you’re grandfathered into the current discount? Do you have qualifying pass-through status or how does that work, and how much roughly do you expect utilization to be through the 340B hospitals? And then a 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 Sullivan (Chief Executive Officer)

Right. Okay. So we don’t expect sites to really build much inventory. We drop-ship within essentially next day to the sites, and so it’s a very quick turnaround time. There’s no reason—most sites, I think, will conclude there’s no reason—to build inventory. So any orders that we’re getting, in our view, are linked to a particular patient and not putting drug on the shelf. As far as the 340B, again, I can say what I said before, but what I said before is what’s the case—so we won’t be exposed to these new rules. And 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.

We’re early in the process. I don’t want to make a number up, but that’s a useful benchmark to consider. And 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%—20% discount.

Sylvan Turkan (Analyst)

Great. Thank you for taking my question.

Brian Sullivan (Chief Executive Officer)

You’re welcome.

OPERATOR

Your next question comes from Oliver McKemon with LifeSci Capital. Please go ahead.

Oliver McKemon (Analyst at LifeSci Capital)

Hi, thanks for taking my questions. I’m just curious if you can remind us on the timeline 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’re hearing on how meaningful OS could be for the launch curve. Thanks again.

Brian Sullivan (Chief Executive Officer)

So as far as the OS data, We’ve indicated previously that we expected sometime 1H27. And so again, it’s event-driven and we follow the trends, but the events and OS analyses can be a little bit more unpredictable than in progression. So, you know, we have to have—we’re using—a fairly wide time band for that estimate. As far as the label, you know, it would only really get incorporated in the label if it’s positive. So again, until we see the data, we won’t know as far as, you know, the impact it can have.

I mean, certainly if it’s positive it would be impactful because, 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 and important for the patients, but I don’t think there’s an expectation—at least as we’ve discussed gedatolisib and the results with doctors—an expectation that that’s required for them to, you know, make a decision on use of gedatolisib.

You know, essentially progression-free survival has really been the data that’s been used and then subgroup analyses to help better understand, you know, treatment effects for particularly important clinical populations. But certainly if we were to achieve it, it would be a big deal. We’ve also indicated that because our Study 1, you know, the PIK3CA wild-type cohort allowed patients to cross over from the fulvestrant arm to the control, that creates a confounding effect. And so while we showed a favorable trend and we’re encouraged by that in the interim analysis, whenever you have crossover, you just have to expect that there’s going to be confounding. And so, you know, again, we don’t want to create any expectations of anything.

We’ll see it when we see it, but if the OS is not a positive result, I don’t think that will have any impact on the launch.

Oliver McKemon (Analyst at LifeSci Capital)

Very helpful, thank you.

OPERATOR

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

Kalpit Patel (Analyst)

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

Thank you.

Brian Sullivan (Chief Executive Officer)

Sure. Thanks for the questions. So regarding the NCCN guidelines for mutant patients, that’s dependent on publication being available. They will only consider an additional expansion of the recommendations based on the peer-reviewed journal article. We expect to have that available this quarter. We would then submit to the NCCN asking for a recommendation, and the timing of that is difficult to project because it’s somewhat dependent on their meeting schedule since this won’t be linked to a label.

You know, it’s not clear to us whether they would call an ad hoc meeting as they did for, you know, the wild-type indication. But it’s not unreasonable to expect that, prior to an approval decision by the FDA, the NCCN would incorporate some recommendation in their guidelines. Okay. And regarding the average time—so we think it’s quite quick. Again, this is all anecdotal, this is all self-reported from our reps. Our reps are very intimately involved, particularly in these early patients, because they’ve been working to essentially ride shotgun on the process with the patient. But we think it’s fairly quick, I mean, based on experience, that when doctors identify a patient, they want to put them on therapy as soon as they can.

There’s not a kind of a wait-and-see approach. So we’re receiving demand that we think is a real-time reflection of a patient requiring treatment and the intention of giving them that treatment as soon as it’s available.

Kalpit Patel (Analyst)

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 balance, but—

Brian Sullivan (Chief Executive Officer)

Yeah, no, I appreciate the question. We’ll be providing those types of updates when we provide an overview in January of the full quarter.

Kalpit Patel (Analyst)

Okay, thank you.

Brian Sullivan (Chief Executive Officer)

Very welcome.

OPERATOR

Your next question comes from Sylvan Turkan with Citizens. Please go ahead.

Sylvan Turkan (Analyst)

Thanks so much for taking my follow up. I just want to know if you have any takeaways from ESMO from your doctors, maybe that you engaged 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 enroll versus, you know, some of these maybe mutant-selective trials that are ongoing. Do you have any feedback on—

Brian Sullivan (Chief Executive Officer)

Sure. We’ve had conversations since we’ve had our approval, obviously, with a broader group of doctors. But I would say there’s a general understanding or recognition that we enrolled a patient population with significant disease burden that wasn’t necessarily representative of the typical patient that they’ll see. And really, I think the most telling statistic relates to the presence of liver mets. You know, 70% of patients typically don’t have liver mets, and liver mets are probably one 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 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 doesn’t affect the hazard ratio. As it turns out, when you look at the subgroups, you see the hazard ratios are comparable across subgroups depending on their disease burden. But the data that we presented—roughly 21 and a half months median PFS for the no liver mets—was really important for two reasons.

As I indicated in my remarks, it’s essentially representative of roughly 70% of patients. And so that was 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 at the same time, OS trend was more favorable in the triplet than in the doublet. But again, interim analysis, so immature—people are reluctant to draw too many conclusions about that.

But in this case, with the triplet versus the doublet, we showed a 10-month advantage relative to the doublet, which is obviously very meaningful clinically. And so that really, I think, clarifies for many doctors a question they’ve 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 the triplet.

And again, that’s what we’re seeing in the wild-type cohort so far, anecdotally recorded. But with the data at ESMO, it kind of filled in some blanks that led most of the physicians we spoke to—I think almost everyone—to prioritize use of the triplet for patients, unless there are other factors that may warrant avoidance of neutropenia, for instance.

Sylvan Turkan (Analyst)

Great. Thank you, Brian. Thanks for the detail.

Brian Sullivan (Chief Executive Officer)

You’re welcome.

OPERATOR

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

Brian Sullivan (Chief Executive Officer)

Thank you everyone for your interest in Celcuity. We look forward to reporting back in the January timeframe. Take care.

OPERATOR

Thank you everyone for your participation. This concludes today’s webcast and conference call. You may now disconnect.

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