Celcuity Q2 2026 Earnings Report

Celcuity EPS Results

• Actual EPS: -$1.44
• Consensus EPS: -$1.16
• Beat/Miss: Missed by -$0.28
• One Year Ago EPS: N/A

Celcuity Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $4.42 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Celcuity Announcement Details

• Quarter: Q2 2026
• Date: 8/13/2026
• Time: After Market Closes
• Conference Call Date: Thursday, August 13, 2026
• Conference Call Time: 4:30PM ET

Celcuity (NASDAQ:CELC) is a clinical-stage biotechnology company specializing in precision oncology diagnostics. The company develops and commercializes predictive biomarker assays designed to identify which patients are most likely to benefit from targeted cancer therapies. By integrating functional profiling of tumor cells with molecular analyses, Celcuity seeks to optimize treatment selection and improve outcomes for patients with solid tumors.

Celcuity’s proprietary platform evaluates tumor cell sensitivity to various therapeutic agents using ex vivo assays that measure DNA damage response and other critical pathways. These assays are intended to serve as companion diagnostics, guiding the use of therapies such as PARP inhibitors and other targeted molecules in oncology. In addition to its core diagnostic offerings, Celcuity collaborates with pharmaceutical companies to co-develop new companion tests alongside emerging drug candidates, aiming to streamline clinical development and regulatory approval.

Headquartered in Malvern, Pennsylvania, Celcuity was founded in the mid-2000s by a team of scientists and clinicians with extensive experience in cancer biology and diagnostic innovation. The company’s operations are primarily focused on the North American market, where it provides testing services through its CAP-accredited and CLIA-registered laboratory. Celcuity’s leadership team brings together expertise in biopharma partnerships, clinical diagnostics, and regulatory affairs to advance its pipeline of precision oncology solutions.

Celcuity Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: REVTORPYK was FDA-approved for HR-positive, HER2-negative advanced breast cancer without detected PIK3CA mutations, and both its doublet and triplet regimens received preferred Category 1 recommendations in the NCCN guidelines.
• Positive Sentiment: In the PIK3CA-mutant VIKTORIA-1 cohort, gedatolisib-based regimens significantly improved median progression-free survival to approximately 11 months versus 5.6 months for alpelisib plus fulvestrant, while treatment discontinuation due to adverse events was lower for gedatolisib. Celcuity plans to submit an sNDA in the third quarter of 2026.
• Positive Sentiment: Celcuity remains confident that commercial shipments will begin in late Q3 2026. The company has completed its commercial infrastructure, deployed 88 oncology sales specialists, begun an expanded-access program, and estimates a U.S. addressable market exceeding $6 billion annually.
• Positive Sentiment: The VIKTORIA-2 first-line breast cancer program has been expanded to include endocrine-sensitive patients, potentially broadening gedatolisib’s use across most newly diagnosed advanced HR-positive, HER2-negative patients. Celcuity also expects to provide additional prostate cancer data in Q4 2026.
• Negative Sentiment: Second-quarter net loss widened to $78.9 million from $45.3 million year over year, while selling, general and administrative expenses rose sharply due to launch preparation. The company ended June with $754 million in cash and investments and expects funding into 2029, helped by a $575 million convertible-note offering.

Presentation

[Operator]

I would now like to turn the conference over to Jodi Sievers, corporate communications and investor relations at Celcuity. Please go ahead.

[Jodi Sievers, Corporate Communications and Investor Relations at Celcuity]

Thank you, Ludy, and good afternoon to everyone. Thank you for joining us today to review Celcuity's second quarter 2026 financial results and business update. Earlier today, Celcuity released financial results for the quarter ended June 30, 2026. The press release can be found on the investors section of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-founder, Vicky Hahne, Chief Financial Officer, as well as Igor Gorbatchevsky, Chief Medical Officer, and Eldon Mayer, Chief Commercial Officer, who will be available during Q&A. As we begin, I would like to remind listeners that our comments today will 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 and results may differ materially from those projected in the forward-looking statements.

[Jodi Sievers, Corporate Communications and Investor Relations at Celcuity]

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 will also refer to non-GAAP financial measures. These non-GAAP financial 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 the GAAP measures in today's press release. With that, I would like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead, Brian.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Thank you, Jodi, and good afternoon, everyone. Thank you for joining our second quarter 2026 operating and financial update conference call. Celcuity continues to make monumental progress advancing clinical development of gedatolisib for patients with HR-positive, HER2-negative advanced breast cancer. With the FDA approval of REVTORPYK, positive results from the PIK3CA mutant cohort of our pivotal VIKTORIA-1 study, and a preferred Category 1 recommendation in the NCCN guidelines, we are well-positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR-positive, HER2-negative advanced breast cancer. We remain on track to begin shipping REVTORPYK late in the third quarter of 2026, and we look forward to making this important therapy available to patients with advanced breast cancer.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Based on the positive data from the PIK3CA mutant cohort of the phase III VIKTORIA-1 study, we plan to submit a supplemental NDA, or sNDA, in the third quarter of 2026. Additionally, our VIKTORIA-2 study was expanded to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, positioning gedatolisib regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status. In sum, we've had an eventful past few months. I'd first like to review in a bit more depth the status of our clinical development programs, and then provide an update on the commercial launch of REVTORPYK.

[Brian Sullivan, CEO and Co-founder at Celcuity]

On July 14th, a few days before our PDUFA date, we received notice from the FDA that REVTORPYK in combination with fulvestrant, with or without palbociclib, was approved for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. A little over 2 weeks later, NCCN updated their guidelines for HR-positive, HER2-negative breast cancer treatment, recommending both the REVTORPYK triplet and doublet regimens as preferred Category 1 regimens for second-line or subsequent treatment for tumors without a PIK3CA mutation. We're very encouraged by the panel's rapid review and recommendation. In June, we presented positive efficacy and safety results from the PIK3CA mutant cohort of the VIKTORIA-1 phase III trial at the ASCO annual meeting.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Primary efficacy analysis of the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS, progression-free survival, compared to alpelisib, a PI3K alpha inhibitor, and fulvestrant. Median PFS was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant, with a hazard ratio of 0.5. The secondary endpoint comparing the gedatolisib doublet versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Median PFS was 11.3 months with the gedatolisib doublet versus 5.6 months with alpelisib plus fulvestrant, with a hazard ratio of 0.51. The safety data for the gedatolisib triplet and doublet were consistent with previously reported data from the wild type cohort of VIKTORIA-1.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Now we've since updated the analyses of the treatment discontinuation rate due to an adverse event for gedatolisib and alpelisib in the PIK3CA mutant cohort using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA wild type cohort presented in the REVTORPYK label. For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. For patients who received alpelisib 19% discontinued treatment with alpelisib due to an adverse event. Now, we believe the lower gedatolisib treatment discontinuation rate for the mutant cohort than was reported in the wild-type cohort reflects the fact that the discontinuation rate was higher early in the overall VIKTORIA-1 study and then fell as physicians gained experience.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Since a much higher 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. Thus, we believe the treatment discontinuation rate for gedatolisib reported for the mutant cohort, roughly 4%-5%, best represents what we expect to see in a real-world setting. We also updated analyses of the mean number of gedatolisib treatment cycles patients received in the wild-type and mutant cohorts of VIKTORIA-1 as of August 2, 2026, and this analysis had a median follow-up period of approximately 21 months for the wild-type cohort and 17 months for the mutant cohort. For patients treated with the gedatolisib triplet in the wild-type cohort, the mean number of treatment cycles for gedatolisib was 9.0, and 16 of these patients, representing 12% of those dosed, are still receiving gedatolisib.

[Brian Sullivan, CEO and Co-founder at Celcuity]

For those treated with the gedatolisib triplet in the mutant cohort, the mean number of treatment cycles for gedatolisib was 10.0. Thirty-four of these patients, representing 22% of those dosed, are still receiving gedatolisib. For patients treated with the gedatolisib doublet in the wild-type cohort, the mean number of treatment cycles for gedatolisib was 9.7, and 15 of these patients, representing 12% of those dosed, were still receiving gedatolisib. For patients treated with the gedatolisib doublet in the PIK3CA mutant cohort, the mean number of treatment cycles for patients receiving gedatolisib was 11.3, and 10 of these patients, representing 19% of those dosed, are still receiving gedatolisib.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Now, analyses of mean treatment cycles for REVTORPYK in the VIKTORIA-1 trial are particularly relevant for assessing the commercial potential of REVTORPYK, since they incorporate the effect that patients who remain on REVTORPYK for extended periods of time have on the likely usage expected in the real world. The median duration of treatment metric truncates this effect and thus underestimates drug usage for a patient population. We expect to provide further updates to results from both the wild-type and mutant cohorts of VIKTORIA-1 at medical conferences later in the year.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Now, with the FDA approval of our NDA in hand and positive data from the mutant cohort, we expect to submit the data from the mutant cohort to the FDA as an sNDA in the third quarter of 2026, and we expect to submit VIKTORIA-1 phase III data for both the wild-type and mutant cohorts to global regulatory authorities following the sNDA submission. Now, the gedatolisib regimens have demonstrated the potential to improve the standard of care in the second-line setting, regardless of the PIK3CA status of a patient's tumor. We believe 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 phase III VIKTORIA-2 trial we have underway to advance development of gedatolisib in the first-line setting for patients with advanced breast cancer.

[Brian Sullivan, CEO and Co-founder at Celcuity]

In May, we announced that we were expanding the VIKTORIA-2 trial to include a second study, Study 2, evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in patients with treatment-naive, endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer. These are women whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. Endocrine-sensitive patients represent approximately two-thirds of the women in the U.S. newly diagnosed with advanced breast cancer each year, and current standard of care therapies for these patients provide median progression-free survival of approximately 25 months. Study 1 of the VIKTORIA-2 trial, which was already ongoing, is evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with treatment-naive, endocrine-resistant, HR-positive, HER2-negative advanced breast cancer.

[Brian Sullivan, CEO and Co-founder at Celcuity]

These are patients whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. Results from the phase I-B clinical trial that we ran several years ago provided strong evidence that the PAM pathway is an important disease driver in treatment-naive patients with advanced breast cancer. In this early phase I 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. Ribociclib plus letrozole are the therapy that we're using as the control in our VIKTORIA-2 trial for endocrine-sensitive patients. The objective response rate was 79%, which again compares favorably to historical data of 53% in the first-line setting for ribociclib plus letrozole.

[Brian Sullivan, CEO and Co-founder at Celcuity]

In light of the positive results for the PIK3CA wild-type and mutant cohorts of VIKTORIA-1 and the promising preliminary data for gedatolisib triplet as first-line treatment, we're optimistic about the results of both our first-line studies. Successful development in this 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. 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 for gedatolisib regimens that may result and duration of treatment periods greater than several years. Now let's turn to our phase I-B/II trial. That's evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer.

[Brian Sullivan, CEO and Co-founder at Celcuity]

In the dose-finding portion of the phase I-B study, evaluation of a 240 milligram dose of gedatolisib was completed. No adverse events led to treatment discontinuation of gedatolisib, and dose-limiting toxicity criteria for dose reduction were not met. This allowed us to begin evaluation of a 300 milligram dose, which is ongoing. Once the dose-finding portion of the study is completed, we expect to select two potential recommended phase II dose levels and control arm options for the randomized phase II portion of the study. We expect to provide updated clinical data and additional visibility into our development strategy for prostate cancer during the fourth quarter of 2026. Now I'd like to discuss our launch plans and the commercial opportunity for REVTORPYK. We began laying the groundwork for a potential gedatolisib launch over 24 months ago.

[Brian Sullivan, CEO and Co-founder at Celcuity]

During this period, we've engaged over 1,000 key opinion leaders and community breast cancer experts, over 250 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 has already driven awareness of the PAM pathway, with metrics tracking well ahead of industry benchmarks. CME and third-party peer-to-peer programs and regional events have further increased levels of awareness about the unmet need in the second-line setting. The build-out of the commercialization infrastructure needed to support successful launch of gedatolisib is now complete, and commercial launch activities for gedatolisib 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 gedatolisib order sets within the electronic health record systems of their accounts, and in-servicing infusion centers and pharmacies.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Our strategic accounts, payer reimbursement, medical science liaison, and KOL-focused teams are following through on the groundwork they laid prior to gedatolisib approval. Payer and strategic account pathway dossiers have been submitted, and formal efforts to get included on formularies and pathways are in process. All of these efforts are designed to offer patients and providers with rapid access and seamless support. Shipments of gedatolisib are expected to begin late in the third quarter of 2026. Wholesale acquisition cost, or WAC, of gedatolisib, which has been reported to the Drug Pricing Compendium, will be $10,000 per vial or $30,000 per cycle of treatment once gedatolisib is commercially available. To enable treating physicians to obtain gedatolisib on behalf of their eligible patients prior to commercial availability of gedatolisib, Celcuity opened an expanded access program last week, and shipments to these physicians have begun.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Based on analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer. Assuming an average of roughly 10 cycles of treatment for gedatolisib per patient at the WAC price, we estimate the total addressable market for gedatolisib in the wild-type and mutant setting combined is potentially over $6 billion annually. That concludes my remarks. I'd now like to hand the call over to Vicky to review our finances.

[Vicky Hahne, CFO at Celcuity]

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter of 2026. Our second quarter net loss was $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million, or $1.04 per share for the prior year period. Our non-GAAP adjusted net loss was $58.7 million, or $1.07 per share for the second quarter of 2026, compared to non-GAAP adjusted net loss of $40.5 million or $0.93 per share for the prior year period. Research and development expenses were $31.1 million for the second quarter of 2026, compared to $36.4 million for the prior year period. The $5.3 million decrease was primarily due to a $7 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 phase III clinical trial.

[Vicky Hahne, CFO at Celcuity]

The remaining decrease was primarily due to a $5 million decrease in licensed milestone costs, partially offset by a $3.8 million increase in employee-related and consulting expense and $2.9 million increase in manufacturing and other costs. Selling, general and administrative expenses were $35 million for the second quarter of 2026, compared to $7.6 million for the prior year period. The $27.4 million increase was primarily due to a $14.5 million increase in employee-related expenses, largely driven by the hiring of additional personnel within our commercial function to support the anticipated launch of REVTORPYK. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees, and expanding infrastructure costs, and a $2.1 million increase in other administrative expenses.

[Vicky Hahne, CFO at Celcuity]

In aggregate, $23.4 million of the $27.4 million selling, general and administrative increase related to commercial headcount additions and other launch-related activities. Net cash used in operating activities for the second quarter of 2026 was $55.4 million, compared to $36.2 million for the prior year period. The additional cash used in operating activities quarter-over-quarter of $19.2 million was primarily due to non-GAAP adjusted net loss of $18.2 million and working capital adjustments of $1 million. Cash, cash equivalents, and short-term investments were $754 million as of June 30th, 2026, compared to $441.5 million as of December 31st, 2025. The $312.5 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 $557.2 million.

[Vicky Hahne, CFO at Celcuity]

The proceeds were offset by a $137 million repayment of our term loan and $110.5 million cash used in operating activities. Additional cash provided by financing activities of $2.8 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases. We expect cash equivalents, and investments to finance our operations at least into 2029. I will now hand the call back to Jodi.

[Jodi Sievers, Corporate Communications and Investor Relations at Celcuity]

Operator, could you please open the call for questions?

[Operator]

Thank you. Ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press star followed by the number 1 on your telephone keypad. To withdraw your question, please press star followed by the number 2. One moment please for your first question. Your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead.

[Tara Bancroft, Analyst at TD Cowen]

Hi. Thanks so much for taking the question. I guess what I'd really like to understand is more of what underscores your confidence in the late Q3 shipments. Like for instance, are you initially launching with the existing clinical supply? If so, how long would that last you? How long is the process for setup with the backup manufacturing, and what does that entail? I know that sounds like a lot of questions, but I'm just getting at the same thing of your level of confidence in supplying the launch without delay.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure. As I explained a couple weeks ago, we want to have confidence that our review process with the FDA will proceed according to what we expect to occur, that there are no surprises. We're very confident about being able to ship beginning at the end of this quarter. Nothing's changed.

[Tara Bancroft, Analyst at TD Cowen]

Okay, great. I guess, just as a follow-up, as part of that review process, do you need an inspection?

[Brian Sullivan, CEO and Co-founder at Celcuity]

Well, the FDA can do whatever they want, but typically-

[Tara Bancroft, Analyst at TD Cowen]

Yeah

[Brian Sullivan, CEO and Co-founder at Celcuity]

if you are with a manufacturer that has met requirements, they do not necessarily require that. Again, you do not want to really be in the position of projecting what the FDA does or will not do. But we believe the validation data that we have is very consistent with the validation from our first site. So we would anticipate that the review process will be straightforward.

[Tara Bancroft, Analyst at TD Cowen]

Okay, great. Thanks so much.

[Brian Sullivan, CEO and Co-founder at Celcuity]

You are welcome.

[Operator]

Your next question comes from the line of Maury Raycroft with Jefferies. Please go ahead.

[Maury Raycroft, Analyst at Jefferies]

Hi. Congrats on the progress, and thanks for taking my questions. I'll follow up on Tara's questions. Just wondering if you can clarify if you've submitted that validation work, the necessary information to FDA yet, or what are the rate-limiting steps remaining there? Do you need FDA to provide any type of sign-off before you can launch with product from that site?

[Brian Sullivan, CEO and Co-founder at Celcuity]

Well, two things. We submitted the data almost immediately after we got the approval. We had validation, the package of information required to get the FDA to review and for approval the use of that site. That's been begun. You can't ship from that new site until you have received the go-ahead from the FDA. That's the limitation on getting access to material from that second site. Again, as we've indicated, we want visibility on the review process for that site. Again, we're confident about our ability to ship in the third quarter, late third quarter.

[Maury Raycroft, Analyst at Jefferies]

Got it. Okay. Maybe one other question just on the expanded access program. Wondering how many sites or doctors are participating in it, and do you have some patients enrolled already? Will you provide quarterly updates on where you're at with enrollment there? Is that something that could-

[Brian Sullivan, CEO and Co-founder at Celcuity]

Hopefully we're not providing quarterly updates, right? Because it'll go away. Yes, we just got the program started last week. I mean, essentially had to get approval, submit to the FDA as well as get IRB approval, central IRB approval. That occurred last week, and we've already begun shipping drug to sites where physicians are treating patients.

[Maury Raycroft, Analyst at Jefferies]

Got it. Presumably, once you have drug launched, then those patients will convert over to commercial drug then?

[Brian Sullivan, CEO and Co-founder at Celcuity]

Exactly. That was reflected in the protocol.

[Maury Raycroft, Analyst at Jefferies]

Got it. Okay. Thanks for taking my questions.

[Brian Sullivan, CEO and Co-founder at Celcuity]

You're welcome.

[Operator]

The next question comes from the line of Brad Canino with Guggenheim. Please go ahead.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Hey, Brad.

[Brad Canino, Analyst at Guggenheim]

Thanks for the update, especially around the prostate cancer progress. It's good to hear. I am actually wondering about a different cancer setting, because I know one of your competitors in the space is doing a lot of work in endometrioid cancer, and I am wondering how you think about that as an opportunity for gedatolisib. I know there is probably some old data that Pfizer conducted, probably not the right regimen and treatment line and setting, et cetera. How do you think about bringing that into the development portfolio, if that is an opportunity for you guys? Thank you.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure. There is certainly a strong rationale for us to consider that, and we will be updating folks on our development plans as we get further into the year. But until then, I can simply say that some preliminary data that was generated previously was indicating that even as monotherapy, gedatolisib can induce an objective response, and the underlying drivers of the disease include the role of the PIK3CA pathway, and for a certain significant cohort, the endometrioid patient population, the hormonal pathway is also involved. So there is certainly a strong rationale for us to consider developing in that setting.

[Brad Canino, Analyst at Guggenheim]

Right. In prostate specifically, too, I am tracking this somewhat from afar, and I am hearing KOLs have a pretty intense conversation around capivasertib and its potential role there as the first inaugural pathway inhibitor on the PAM pathway to go after that. What do you think, as you have the conversations with those same investigators and KOLs, we can actually learn from the capivasertib data and it as a foreshadow of the opportunity for something like gedatolisib, and what should we keep in mind that could be different as you approach it? Thank you.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure. capivasertib, as you know, is approved in breast cancer to treat patients who have a PIK3CA mutation. Its efficacy was comparable to the efficacy for alpelisib in its phase III study in a similar setting as what we were just studying. gedatolisib, as we announced recently, showed double the activity relative to alpelisib, which we think is a reasonable proxy for what capivasertib is capable of doing. We think the fact that capivasertib got an approval for the PTEN loss population, essentially that is the most relevant mutation of the PAM pathway in prostate cancer. That drug is limited to that roughly 40% of patients with PTEN loss. But we think it augurs well for us. They are evaluating, rather they got an approval in patients who are at an earlier stage than the patients we are evaluating. They were evaluating hormone-sensitive prostate patients.

[Brian Sullivan, CEO and Co-founder at Celcuity]

We are evaluating castration-resistant patients. But the fact they got over the line with a positive study in a mutant cohort, similar to what they did in breast cancer, we think is translatable to what we may be able to do. We have encouraging data. We will be updating that data later this year. We believe that they demonstrate that this pathway, the PAM pathway, plays a role as a driver and that when combined with an androgen receptor inhibitor, you can induce an improvement in outcomes relative to androgen receptor alone. That is ultimately our hypothesis. We are going to be evaluating that in a different setting. But it certainly provides another demonstration of the importance of this pathway in this disease.

[Brad Canino, Analyst at Guggenheim]

Great. Thanks, Brian.

[Brian Sullivan, CEO and Co-founder at Celcuity]

You are welcome.

[Operator]

Your next question comes from the line of Eva Fortea-Verdejo with Wells Fargo. Please go ahead.

[Eva Fortea-Verdejo, Analyst at Wells Fargo]

Hi, team. Congrats on the progress, and thanks for taking our question. A quick one from us on the EAP. Can you provide more color on how long do you expect it will take to transition the patients from the EAP to commercial following the launch in late Q3? Thanks.

[Brian Sullivan, CEO and Co-founder at Celcuity]

I do not want to get committed to a particular timeline. Certainly we have to be very sensitive to the needs of the patient and make sure that there is no risk of interruption in supply. Again, it could be very site-specific, patient-specific, depending on their insurance situation and other factors that may be relevant. But the intent is certainly to transition those patients to commercial supply. That is embedded within the protocol and is well understood by the participating investigators.

[Brian Sullivan, CEO and Co-founder at Celcuity]

That is a very standard approach. Again, we would expect that transition to occur. It may occur in that 2-week gap from day 15 to the next cycle of treatment, in effect day 29. Again, the overall goal is to make sure that there is no disruption to the patient's access to the therapy, and we will essentially accommodate whatever might be required to ensure that that transition occurs smoothly.

[Eva Fortea-Verdejo, Analyst at Wells Fargo]

Got it. Very helpful. Thanks.

[Operator]

Your next question comes from the line of Andrew Berens with Leerink Partners. Please go ahead.

[Isabelle Lin, Analyst at Leerink Partners]

Hi, this is Isabelle on for Andy. Thanks for taking our question. We were wondering if you could give more color on the expected gross net. Thanks.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure. We've done an analysis that we think is fairly robust, actually very robust, that kind of identifies the various components of the discounts, and they don't involve discounts that reflect discounting of the drug per se, but they reflect channel differences that are just a function of the makeup of those channels. But for our drug, we expect the gross to net percentage to be about 80%. The discounts involved from WAC will be about 20%. Based on data we've seen for oral therapies, that gross to net discount can be about 30%. We think we'll be able to capture a higher percentage of the WAC than the corresponding oral therapies in this category are able to capture.

[Operator]

All right. Thank you. Your next question comes from the line of Oliver McCammon with LifeSci Capital. Please go ahead.

[Oliver McCammon, Analyst at LifeSci Capital]

Hi. Thanks for taking my questions. Maybe just a broader question on the commercialization and your work engaging physicians. Curious what proportion of community oncology practices, as you think about associated infusion centers as well as geography, you think would be amenable to IV therapy in this setting? And then relatedly, do you think there are any learnings to take from what we hear is fairly common use of IV administered in HER2, even in second line? Thanks again.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure. Well, we think nearly every community practice has access to infusion centers because some of the most important therapies used to treat breast cancer are infused therapies, and HER2 is one. You mentioned pembrolizumab and TNBC is another. Herceptin and PERJETA, which are two anti-HER2 antibodies, are also standard of care treatments in advanced breast cancer, HER2-positive breast cancer. And then all the chemotherapies, or many of the chemotherapies that are prescribed are infused. So, the practice of medicine treating breast cancer patients requires access to infusion centers. So we don't think there's going to be any barrier to a community oncologist prescribing gedatolisib and ensuring their patient can get infused. These docs represent the community treaters, treat about 80% of phys-

[Operator]

Excuse me, ladies and gentlemen, please continue to stand by. Your conference will resume momentarily. Thank you. Ladies and gentlemen, we will now resume our conference. We do apologize for the technical difficulties. Brian, please go ahead.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Well, thank you. I hope you all heard the last answer to my question. Operator, if there's additional questions, happy to answer those.

[Operator]

Oliver, do you still have any additional questions? All right. Thank you. Your next question comes from the line of Kalpit Patel with Wolfe Research. Please go ahead.

[Kalpit Patel, Analyst at Wolfe Research]

Yeah. Hey, good afternoon, and thanks for taking my question. Just one from us on the prostate cancer program. Can you give us a little more granularity on what to expect in the fourth quarter? Is it just PSA response data, or are we going to see rPFS data as well? What would success look like to you in that area? Thank you.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure. We expect to provide additional data. It could include PSA50 data as well as updated progression-free survival data and looking at different subgroups of patients, as well as data from the 240-milligram dose as well. The data with 300-milligram dose may not be mature enough to present. It will be data that hasn't been presented before that we think will hopefully shed some good light on the program itself.

[Kalpit Patel, Analyst at Wolfe Research]

Okay, and any color on what would be encouraging in your view for rPFS?

[Brian Sullivan, CEO and Co-founder at Celcuity]

Well, I think the standard of care today, or rather, I would say, there's two components to that answer. Current patients in the second-line setting who've progressed on, let's say, prior abiraterone can expect to receive 5 to 6 months median PFS. Similarly, if they are treated with docetaxel instead of hormonal therapy. The minimum bar to beat would be 3 to 4 months better than those options. PLUVICTO's out there as an option as well. They're offering patients north of 10 months. Our expectation would be that we would need at least to be comparable to PLUVICTO. We think there'd be advantages to use of our drug versus their drug in that setting, and certainly, we would hope to be superior to that.

[Brian Sullivan, CEO and Co-founder at Celcuity]

But that if we're able to demonstrate typical 3 to 4-month superiority relative to what would be an add-on therapy with gedatolisib versus a switched androgen receptor inhibitor, or at least comparable efficacy to PLUVICTO that we could potentially play an important role in that treatment. Of course, we know there's some other data that could be coming down the pike, and that'll be very relevant to any assessment that we make.

[Kalpit Patel, Analyst at Wolfe Research]

Okay. That's super helpful. Thank you.

[Brian Sullivan, CEO and Co-founder at Celcuity]

You're welcome.

[Operator]

Your next question comes from the line of Gil Blum with Needham & Company. Please go ahead.

[Jonathan Nudler, Analyst at Needham & Company]

Hi, guys. This is Jonathan on for Gil. Just a quick question about the secondary manufacturing site. For the supplemental filing, what is the timeline that you guys are expecting for hearing back from the FDA? Is it similar to an sNDA timeline?

[Brian Sullivan, CEO and Co-founder at Celcuity]

Not an sNDA. There's multiple processes and steps along the way, but it can involve a review as brief as 2 months or 4 months. Again, if there's issues, which again, we don't expect to occur, it can take longer. There's a standard process, a 4-month review process. It can be shorter. Again, you're interacting with the agency during that process, and you'll gain an understanding from that initial feedback what, if any, issues they may have or considerations they may be wanting us to address. That's what we think we'll find out relatively early in the process.

[Jonathan Nudler, Analyst at Needham & Company]

Just a quick follow-up. If this supplemental filing was approved, what percent of supply would you expect would be coming from the second site at full capacity or-

[Brian Sullivan, CEO and Co-founder at Celcuity]

That is a very tactical. It will be appropriate. We will be using inventory from both sites and managing inventory accordingly. It is important to keep both sites going. You want to create a rhythm for them. You are always going to be balancing mix of product between those two sites.

[Jonathan Nudler, Analyst at Needham & Company]

Awesome. Yep. Thanks again, and congrats again on all the progress.

[Brian Sullivan, CEO and Co-founder at Celcuity]

You are welcome.

[Operator]

Your next question comes from the line of Stephen Willey with Stifel. Please go ahead.

[Stephen Willey, Managing Director at Stifel]

Yeah, good afternoon. Thanks for taking the questions. Just curious where you are in terms of preparing a publication of the mutant data.

[Stephen Willey, Managing Director at Stifel]

And whether you believe a compendia listing for use in these patients could be achieved before formal label expansion. And was also just wondering how you are thinking about communicating launch progress to The Street, and what metrics you think you might be providing to us over the next quarters. Thanks.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure. Regarding the article, we have submitted an article to a journal, and that process is variable in time. It can take 3 months. It can take 6 months. We would hope to have it be on the shorter range of that timeline, but it is not 100% in our control, obviously. But that process is well underway. As far as mutant usage, we cannot promote mutant usage. But we would have the opportunity potentially to, and it is up to the NCCN panels to have the NCCN make a recommendation based on published data. They cannot make recommendations just based on, for instance, a presentation given at a major medical conference, say. They need to see data from a peer-reviewed journal before they would consider making changes to their recommendations. But if they made recommendations, those are widely followed by payers.

[Brian Sullivan, CEO and Co-founder at Celcuity]

And if the recommendations are appropriate what the payers require, then physicians would be in a position to prescribe the medicine and their patients to get reimbursed for it. But again, not something we can certainly drive or really discuss at all in the clinical context. But those are variables that could be present in the marketplace. And as far as progress, we will be reporting sales, obviously, as we go. We do not have the granularity of data that you have with oral therapies. We ship to a site, buy and bill, but we do not get a prescriber name on that therapy. And so we do not get as much visibility. There is not a name on the prescription, for instance. So we do not get as much visibility as, let us say, an oral medication gets.

[Brian Sullivan, CEO and Co-founder at Celcuity]

So the granularity of data won't be as high as people might be used to for oral therapies. We will be doing survey data that will give us a view on probably 40%-50% of patients treated. But there'll be a lag in that. That'll be 2-3 months lag. So it won't be current or necessarily representative. It'll provide us important information to help manage the business. But it won't be a real-time evaluation. We internally will be certainly tracking and be able to intuit based on our analyses where the drug is going, who's at the locations, and be able to do analysis like that. But we won't have sufficient specificity to, for instance, identify how many docs prescribing and how many re-prescribed it, how many patients on therapy. We'll simply have, in real time setting, the actual number of vials shipped to sites.

[Brian Sullivan, CEO and Co-founder at Celcuity]

And we expect that to represent demand. There really won't be inventorying of this drug. Our distributor, our 3PL, will be delivering this drug overnight in a great majority of cases. And some of the larger sites, depending on their overall approach, may maintain some stock based on the number of patients they have on the drug. So there could be, in certain facilities, a little bit of loading, but we wouldn't expect that to represent, let's say, more than a cycle of treatment. We think that would be unlikely.

[Stephen Willey, Managing Director at Stifel]

All right. That's very helpful. Thank you.

[Brian Sullivan, CEO and Co-founder at Celcuity]

You're welcome.

[Operator]

Your next question comes from the line of Silvan Turkcan with Citizens. Please go ahead.

[Joshua Werman, Analyst at Citizens]

Hey, this is Josh on for Silvan. Thanks for taking the question. You mentioned plans to submit the sNDA for the mutant population in 3Q. Could you maybe just walk us through some of the potential regulatory timelines, maybe submission to filing and then potential for a more rapid review period?

[Brian Sullivan, CEO and Co-founder at Celcuity]

Sure.

[Joshua Werman, Analyst at Citizens]

Thanks.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Yep, sure. Because it's an sNDA, while they will need to accept the sNDA, the clock starts for the review when the final submission is made. From the time we complete our submission to whatever the prescribed PDUFA date is, would be the expected review cycle. If it's a priority review, it would be 6 months from submission. If it's a regular review, it would be 10 months from submission.

[Joshua Werman, Analyst at Citizens]

Great. Thank you.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Welcome.

[Operator]

I am showing no further questions at this time. I would like to turn it back to our CEO, Brian Sullivan, for closing remarks.

[Brian Sullivan, CEO and Co-founder at Celcuity]

Well, thank you for participating in our call today, for your ongoing support, and look forward to seeing you potentially at conferences over the next few months. Take care.

[Operator]

Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.

Participants

Executives

• Jodi Sievers, Corporate Communications and Investor Relations
• Brian Sullivan, CEO and Co-founder
• Vicky Hahne, CFO

Analysts

• Tara Bancroft, Analyst at TD Cowen
• Maury Raycroft, Analyst at Jefferies
• Brad Canino, Analyst at Guggenheim
• Eva Fortea-Verdejo, Analyst at Wells Fargo
• Isabelle Lin, Analyst at Leerink Partners
• Oliver McCammon, Analyst at LifeSci Capital
• Kalpit Patel, Analyst at Wolfe Research
• Jonathan Nudler, Analyst at Needham & Company
• Stephen Willey, Managing Director at Stifel
• Joshua Werman, Analyst at Citizens