Celcuity (CELC) Q2 2026 Earnings Call Transcript

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DATE

Thursday, Aug. 13, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer and Cofounder - Brian F. Sullivan
• Chief Financial Officer - Vicky Hahne
• Chief Medical Officer - Igor Gorbachevsky
• Chief Commercial Officer - Eldon C. Mayer
• Corporate Communications and Investor Relations - Jodi Sievers

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TAKEAWAYS

• Net Loss -- $78.9 million, or $1.44 per share, compared to a net loss of $45.3 million in the prior year period.
• Non-GAAP Adjusted Net Loss -- $58.7 million, or $1.07 per share, reflecting adjustments for stock-based compensation and non-cash interest expense.
• Cash and Cash Equivalents -- $754 million as of June 30, 2026, which management expects will fund operations at least into 2029.
• Convertible Senior Note Offering -- $575 million in gross proceeds, completed in June 2026 to strengthen the capital structure.
• Net Proceeds from Convertible Notes -- $557.2 million, after accounting for underwriting discounts and estimated offering expenses.
• Selling, General, and Administrative Expenses -- $35 million, representing a $27.4 million increase primarily due to the hiring of commercial personnel for the launch of Revtopik.
• Research and Development Expenses -- $31.1 million, a decrease of $5.3 million reflecting lower clinical trial costs for the VICTORIA-1 Phase 3 study.
• Revtopik Wholesale Acquisition Cost -- $10,000 per vial or $30,000 per cycle of treatment, as reported to the drug pricing compendia.
• Estimated Gross to Net Percentage -- Approximately 80%, representing channel-related discounts of roughly 20% from the list price.
• Total Addressable Market (TAM) -- Over $6 billion annually, assuming 37,000 patients in the second-line setting and roughly 10 treatment cycles per patient.
• VIKTORIA-1 Median PFS (Triplet) -- 11.1 months for the gedatolisib triplet versus 5.6 months for alpelisib plus fulvestrant in the mutant cohort.
• VIKTORIA-1 Hazard Ratio (Triplet) -- 0.5, representing a 50% reduction in the risk of disease progression or death.
• VIKTORIA-1 Median PFS (Doublet) -- 11.3 months, showing a hazard ratio of 0.51 compared to the control group.
• Treatment Discontinuation Rates (Mutant) -- 5.2% for the gedatolisib triplet and 3.8% for the doublet, compared to 19% for alpelisib.
• Mean Treatment Cycles (Wild-Type Triplet) -- 9.0 cycles as of Aug. 2, 2026, based on a median follow-up period of approximately 21 months.
• Mean Treatment Cycles (Mutant Triplet) -- 10.0 cycles as of Aug. 2, 2026, with 22% of dosed patients still receiving therapy.
• Objective Response Rate (First-Line Phase 1b) -- 79% for gedatolisib plus palbociclib and letrozole, compared to a historical benchmark of 53%.
• Median PFS (First-Line Phase 1b) -- 48.6 months for the gedatolisib triplet, compared to historical data of approximately 25 months for ribociclib plus letrozole.
• Commercial Sales Specialist Headcount -- 80 oncology specialists with an average of 24 years of industry experience are currently supporting launch activities.
• Prostate Cancer Trial Dosage Evaluation -- Completion of the 240 mg gedatolisib dose evaluation, with evaluation of a 300 mg dose currently ongoing.
• Repayment of Term Loan -- $137 million, utilizing a portion of the net proceeds from the convertible note offering.
• VIKTORIA-1 Objective Response Rate (Mutant Triplet) -- 49%, with a median duration of response reported at 15.7 months.

SUMMARY

Management reported the U.S. Food and Drug Administration approval of Revtopik for patients with hormone receptor positive, human epidermal growth factor 2 receptor negative advanced breast cancer. The company stated that pivotal Phase 3 data from the VIKTORIA-1 mutant cohort demonstrated a significant reduction in the risk of disease progression, which will support a supplemental New Drug Application in the third quarter of 2026. Management indicated that the expansion of the VIKTORIA-2 trial into treatment-naive patients aims to position gedatolisib as a first-line treatment option regardless of mutation status. The company recently completed a convertible note offering to provide a multiyear cash runway into 2029 for commercial launch activities and continued clinical pipeline advancement.

• Management confirmed that the build-out of the commercial infrastructure, including 80 oncology sales specialists, is complete.
• CEO Sullivan stated, "we believe the treatment discontinuation rate for gedatolisib reported for the mutant cohort roughly 4% to 5% best represents what we expect to see in a real world setting."
• The company launched an Expanded Access Program last week to provide gedatolisib to patients prior to the commercial availability of Revtopik.
• Management reported that validation data for a second manufacturing site was submitted to the FDA immediately following the initial approval of Revtopik.
• CEO Sullivan stated, "we believe the results from the VICTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K, AKT, mTOR, or PAM pathway."
• Celcuity is developing a subcutaneous formulation of gedatolisib with the goal of demonstrating clinical equivalence to the current intravenous version.

INDUSTRY GLOSSARY

• ABC: Advanced breast cancer, encompassing locally advanced or metastatic stages of the disease.
• Gedatolisib: A potent, pan-PI3K and mTORC1/2 inhibitor designed to blockade the PAM pathway.
• HR+/HER2-: Breast cancer that is hormone receptor positive but does not overexpress the human epidermal growth factor 2 receptor.
• NCCN: National Comprehensive Cancer Network, an alliance of cancer centers that establishes clinical practice guidelines in oncology.
• PAM Pathway: The PI3K, AKT, and mTOR signaling pathway, which is frequently overactive in several cancer types.
• PFS: Progression-free survival, a metric measuring the time during and after treatment that a patient lives with the disease without it worsening.
• PIK3CA: A gene that can mutate to drive overactivity in the PAM pathway, often associated with breast cancer progression.
• sNDA: Supplemental New Drug Application, a request to the FDA to modify an existing approved drug label.
• WACC: Wholesale Acquisition Cost, the standard list price for a pharmaceutical product sold to wholesalers or direct purchasers.

Full Conference Call Transcript

Operator: Good afternoon, ladies and gentlemen. Welcome to Security second Quarter 26 Financial Results Conference Call and Webcast. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the 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: Thank you, Ludi, and good afternoon to everyone. Thank you for joining us today to read Celcuity's second quarter 26 financial results and business update. Earlier today, Cellcuity released financial results for the quarter ended 06/30/2026. The press release can be found on the Investors section of Celcuity's website Joining me on the call today are Brian F. Sullivan, Celcuity's Chief executive officer and cofounder Vicky Hahne, chief financial officer as well as Igor Gorbachevsky, chief medical officer; and Eldon C. 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. 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, 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 and with the And with that, I would like to turn the call over to Brian F. Sullivan, CEO of Cellcuity.

Operator: Please go ahead, Brian.

Brian F. Sullivan: Thank you, Jodi, and good afternoon, everyone. Thank you for joining our second quarter 26 operating and financial update conference call. Celcuity continues to make monumental progress. Advancing clinical development of gedatolisib for patients with HR positive, HER 2 negative advanced breast cancer. With the FDA approval of Revtopik, 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 each year by HR positive, HER 2 negative advanced breast cancer.

We remain on track to begin shipping Revtopik late in the third quarter of 26 we look forward to making this important therapy available to patients with advanced breast cancer. Based on the positive data from the PIK3CA mutant cohort of the phase 3 VICTORIA-1 study, we plan to submit a supplemental NDA or sNDA in the third quarter of 26. Additionally, our VICTORIA-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 have had an eventful past few months.

I would 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 Revtopik. On July 14, a few days before our PDUFA date, we received notice from the FDA that Revtopik in combination with filvestrant 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 1 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 Revtopik triplet and doublet regimens as preferred category 1 regimens for second line or subsequent treatment for tumors without a PIK3CA mutation. We are 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 VICTORIA-1 phase 3 trial at the ASCO annual meeting. 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 second end 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 and fulvestrant. Median PFS was 11.3 months with a gadothelosib doublet, versus 5.6 months with opalifib 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 Victoria 1.

Now we have 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 with a PIK3CA wild type cohort presented in the Reptarpic label. Patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8% of patients discontinued gedatolisib due to an adverse event, respectively. 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 that the discontinuation rate was higher early in the overall VICTORIA-1 study. And then fell as physicians gained experience. 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. And thus we believe the treatment discontinuation rate for gedatolisib reported for the mutant cohort roughly 4% to 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 Victoria 1 as of August 2nd 26. 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. For those treated with the gedatolisib triplet in the mutant cohort, the mean number of treatment cycles for gedatolisib was 10.0.

34 percent, 34 of these patients, representing 22 percent 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. In 15 of these patients, representing 12% of those dosed, were still receiving gedatolisib. And 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. In 10 of these patients representing 19% of those dosed. Are still receiving gedatolisib.

Now analyses of mean treatment cycles for Revtopik in the VICTORIA-1 trial are particularly relevant for assessing the commercial potential of Revtopik since they incorporate the effect that patients who remain on Revtopik 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 VICTORIA-1 at medical conferences later in the year.

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 VICTORIA-1 Phase 3 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. 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 augur well for the phase 3 VICTORIA-2 trial we have underway to advance development of gedatolisib in the first line setting for patients with advanced breast cancer. In May, we announced that we were expanding the VICTORIA-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. And 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 2-thirds of the women in the US 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 VICTORIA-2 trial which was already ongoing, is evaluating gedatolisib in combination with fulvestrant In patients with treatment naive endocrine resistant HR positive, HER2 negative advanced breast cancer. And these are patients whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy.

Now results from the Phase 1b clinical trial that we ran several years ago provided strong evidence the PAM pathway is an important disease driver in treatment naive patients with advanced breast cancer. In this 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. Ribociclib plus letrozole are the therapy that we are using as the control in our Victoria 2 trial 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. In light of the positive results for the PIK3CA wild type and mutant cohorts in VICTORIA-1, and the promising preliminary data. For gedatolisib triplet as first line treatment, we are 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 thousand women each year who are diagnosed with late stage HR positive, HER2 negative advanced breast cancer in The US. Irrespective of their endocrine sensitivity or PIK3CA status.

Our advancement of subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gadatholicit. Subcutaneous formulation is aimed at supporting potential future indications for gadgets elusive regimens that may result in a duration of treatment periods greater than several years. And now let's turn to our Phase 1b/2 trial, that is evaluating gedatolisib in combination with darolutamide. In men with metastatic castration resistant breast prostate cancer. In the dose finding portion of the Phase 1b 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.

And this allowed us to begin evaluation of a 300 milligram dose, which is ongoing. The dose finding portion of the study is completed, we expect to select to select 2 potential recommended phase 2 dose levels and control arm options for the randomized phase 2 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 26. Now I would like to discuss our launch plans and the commercial opportunity for Revtopik. We began laying the groundwork for a potential gedatolisib launch over 24 months ago.

And during this period, we have engaged over 1 thousand 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. Now the build out of the commercialization infrastructure needed to support successful launch of Revtopik is now complete. And commercial launch activities for Reftapik commenced immediately after approval.

Our 80 oncology sales specialists, who have an average of 24 years of industry experience are calling on physicians, and supporting installation of Revtopik order sets within the electronic health record systems of their accounts, and in servicing infusion centers and pharmacies. Our strategic accounts, payer reimbursement, medical liaison, and KOL focused teams are following through on the groundwork they laid prior to Revetorpic 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 Revtopic are expected to begin late in the third quarter of 26.

Now wholesale acquisition cost or WACC of Reptarpic which has been reported to the drug pricing compendia, will be $10 thousand per vial or $30 thousand per cycle of treatment. Once Revtopik is commercially available, to enable treating physicians to obtain gedatolisib on behalf of their eligible patients prior to commercial availability of Revtopik, Celcuity opened an expanded access program last week. And shipments to these physicians have begun. Based on analysis of published epidemiological data, we estimate there are 37 thousand patients in The US receiving second line treatment for HR positive HER 2 negative advanced breast cancer.

Assuming an average of roughly 10 cycles of treatment, for Revtopik per patient at the WACC price, we estimate the total addressable market for Revtopik in the wild type and mutant setting combined is potentially over $6 billion annually. And that concludes my remarks. I would now like to hand the call over to Vicky, to review our finances.

Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I will provide a brief overview of our financial results for the second quarter of 26. 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 26 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 26. 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 VICTORIA-1 phase 3 clinical trial. The remaining decrease was primarily due to a $5 million decrease in license 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 26. 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 Reptorpic. 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. 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 26 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 06/30/2026, compared to $441.5 million as of 12/31/2025. 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 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, cash equivalents, and investments to finance our operations at least into 2029. I will now hand the call back to Jodi.

Jodi Sievers: Operator, could you please open the call for questions?

Operator: Thank you. And ladies and gentlemen, we will now begin the 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. 1 moment, for your first question. And your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead.

Tara Bancroft: So I guess what I would 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? And if so, how long would that last you? And, you know, 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 am just getting at the same thing of your level of confidence supplying the launch without delay.

Brian F. Sullivan: Sure. As I explained, you know, last, couple weeks ago, I mean Mhmm. You know, 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. And we are very confident about being able to ship beginning at the end of this quarter. So nothing's changed.

Tara Bancroft: Okay. Brent. And I guess just as a follow-up, as part of that review process, do you need an inspection?

Brian F. Sullivan: Well, the FDA can do whatever they want. But, typically Yeah. If you are with a manufacturer that has met requirements, They do not necessarily require that. It would again, you do not want to really be in the position of projecting what the FDA, you know, does or will not do. But we believe the validation data that we have is very consistent with the validation from our first site. And so we would anticipate that the review process will be straightforward.

Tara Bancroft: Okay. Great. Thanks so much. You are welcome.

Operator: And your next question comes from the line of Maury Raycroft with Jefferies. Please go ahead.

Maury Raycroft: Hi. Congrats on the progress. Thanks for taking my questions. I will follow-up on Tara's questions. Just wondering if you can clarify if you submitted that validation work, the necessary information to FDA yet. Or what are the rate limiting steps remaining there. And do you need FDA to provide any type of sign off before you can launch with products in that site?

Brian F. Sullivan: Well, 2 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 for the use of that site. So that is begun. And you cannot ship from that new site until you have received the go ahead from the FDA. that is the limitation on getting access to material from that second site. But again, as we have indicated, we want visibility on the review process for that site. And, again, we are confident about our ability to ship on the third quarter. Late third quarter.

Maury Raycroft: Got it. Okay. Maybe 1 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? And will you provide quarterly updates, on where you are at with enrollment there?

Brian F. Sullivan: I guess, is that something that could Hopefully, we are not providing quarterly updates. Right? Because Yeah. It will go away. But yes. We just, you know, got the program started last week. I mean, essentially, had to get you know, approval, you know, submit to the FDA as well as get IRB approval central IRB approval. So that occurred last week, and we have already begun shipping drug to physician or to sites where physicians are treating patients. Got it.

Maury Raycroft: And then presumably, once you have drug launched, then those patients would convert over to commercial drug then.

Brian F. Sullivan: Exactly. And that was reflected in the protocol. Got it.

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

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

Brian F. Sullivan: Hey, Bradley.

Brad Canino: Thanks for the update, especially around the prostate cancer progress. it is good to hear I am actually wondering about a different cancer center because I know 1 of your competitors in the space is doing a lot of work in endometrial 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, etcetera. So how do you think about bringing that into the development portfolio if that is an opportunity for you guys? Thank you.

Brian F. Sullivan: Sure. there is certainly a strong rationale for us to consider that, and, you know, we will be updating folks on our, excuse me, 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, GEDA can induce a objective response. And you know, 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. Right.

Brad Canino: And then 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 how it has a foreshadow of the opportunity for something like gedotolitinib? And what should we keep in mind that could be different for gedatolisib as you approach it? Thank you.

Brian F. Sullivan: Sure. So 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 3 study. In a similar setting as what we were just studying and gedatolisib as we, you know, announced recently. Showed double the activity relative to alpelisib, which we think is a reasonable proxy for what capivasertib is capable of doing. And so 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. And so, that drug is limited to that roughly 40% of patients with 10 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 are evaluating hormone sensitive prostate patients. You know, we are evaluating castration resistant patients. But the fact they got off the line with a positive study in a mutant cohort similar to what they did in breast cancer, we think it is translatable to what we may be able to do. We have encouraging data. We will be updating that data later this year. And we believe, you know, 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. And that is ultimately our hypothesis. We are we are going to be evaluating that in a different setting. But it certainly provides another demonstration of the importance of the pathway in this disease. Okay. Thanks, Brian. You are welcome.

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

Eva Fortea-Verdejo: Hi, team. Congrats on the progress, and thanks for taking our question. A quick 1 from us on the EAP. Can you provide more color on how long do you expect it will take to transition the patient from the EAP to commercial following the launch in late Q3?

Brian F. Sullivan: You know, I do not wanna get committed to a particular timeline. I mean, certainly, we have to be very sensitive to the needs of the patient and make sure that, you know, there is no risk of interruption in supply. And so you know, again, it could be very site specific, patient specific you know, 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. The participating investigators. So, and that is a very standard approach. But again, we would expect that transition to occur.

You know, it may occur in that 2 week gap from day 15 to the next cycle of treatment, you know, in effect day 29. But 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 transition occurs smoothly.

Eva Fortea-Verdejo: Got it. Very helpful. Thanks.

Operator: And your next question comes from the line of Andrew Berens with Leerink Partners. Please go ahead.

Analyst: Hi. This is Isabelle on for Andy. Thanks for taking our question. Wondering if you could give more color on the expected gross to net. Thanks.

Brian F. Sullivan: Sure. So we have done an analysis that we think is fairly robust, actually very robust, that kind of identifies the various components of the discounts. And they do not involve discounts to, you know, they do not reflect discounting of the drug per se, but they reflect channel differences that just a function of, you know, the makeup of those channels. But for our drug, we expect a gross to net percentage to be about 80%, the discounts involved From WACC will be about 20%. And based on data we have seen for oral therapies, you know, that gross to net discount can be about 30%.

So, you know, so we think we will be able to capture a higher percentage of the WACC than the corresponding oral therapies in this category. Are able to capture.

Analyst: All right. Thank you.

Operator: And your next question comes from the line of Oliver McCammon with LifeSci Capital. Please go ahead.

Oliver McCammon: Maybe just a broader question on the commercialization and your work engaging physicians. But 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 HER 2 even in second line? Thanks again.

Brian F. Sullivan: Sure. Well, we think nearly every community practice has access to infusion centers because some of the most important therapies in breast cancer used to treat breast cancer are infused therapies. and HER2 was 1 you mentioned, pembrolizumab and TNBC is another. Perceptin or and Perjeta, which are 2 anti HER 2 antibodies. Are also standard of care treatments in advanced breast cancer, HER 2 positive breast cancer. And then all the chemotherapies or many of the chemotherapies that are prescribed are infused. And so, you know, the practice of medicine treating breast cancer patients requires access. To infusion centers.

So we do not think there is gonna be any barrier to a community oncologist prescribing gedatolisib and ensuring their patient can get infused. And these docs represent the community treaters, treat about 80% of Excuse me.

Operator: Ladies and gentlemen, please continue to stand by. Your conference will resume momentarily. Thank you. Ladies and gentlemen, we will now resume our conference with the technical difficulties. Brian, please go ahead.

Brian F. Sullivan: Well, thank you. I hope, you all heard the last answer to my question. Operator, if there is an additional questions, I am happy to answer those.

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

Kalpit Patel: Yeah. Hey. Good afternoon, and thanks for taking my question. Just 1 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 gonna see RPFS data as well? And then what would success look like to you in that area? Thank you.

Brian F. Sullivan: Sure. So we expect to provide additional data that could include PSA 50 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 from the 300 milligram dose may not be mature enough to present. But it will be data that has not been presented before that we think will hopefully shed some good light on the program itself.

Kalpit Patel: Okay. And any color on what would be encouraging in your view? For RPFS?

Brian F. Sullivan: Well, I think the standard of care today, or rather, I would say, there are kind of 2 components to that answer. Current patients in the second line setting who have progressed on, let's say, prior abiturone, can expect to receive 5 to 6 months median PFS. Similarly, if they are treated with docetaxel as instead of a hormonal therapy. So the minimum bar to beat would be, you know, 3 to 4 months better than those options. Pluvicto's out there as an option as well. They are offering patients, you know, north of 10 months. And so our expectation would be that we would need at least to be comparable to Pluvicto.

We think there would be advantages to use of our drug versus their drug. In that setting, and certainly, would hope to be superior to that. But if we are able to demonstrate you know, typical 3 to 4 month superiority relative to you know, what would be an add on therapy with gedatolisib versus a switched androgen receptor inhibitor. At least comparable efficacy to Pluvicto that we could potentially play an important role in that treatment. Of course, you know, we know there is some other data that could be coming down the pike and that will be very relevant, to any assessment, that we make.

Kalpit Patel: Okay. that is super helpful. Thank you. You are welcome.

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

Analyst: Hi, guys. This is Jonathan on for Gil. A quick question about the secondary manufacturing site.

Brian F. Sullivan: 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? it is not an sNDA. There are multiple processes and steps along the way, but you know, it can involve a review as brief as 2 months or, you know, or 4 months. And, again, if there is issues, which, again, we do not expect to occur, you know, it can take longer. And so, you know, there is a standard process of 4-month review process. It can be shorter.

And but, again, you are interacting with the agency during that process, and you will gain an understanding from that initial feedback, you know, what, if any, issues know, they may have or considerations they may be wanting us to address. But that is that is what we think we will find out. Relatively early in the process.

Analyst: And 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? You know, that is that is a very tactical. It will be appropriate. We will be using you know, inventory from both sites and, you know, managing. Inventory accordingly. it is important to keep both sites going. it is just you wanna create a rhythm for them. And so you are you are always gonna be balancing. Mix of product yeah, between those 2 sites. Again, and congrats again on all the progress. You are welcome.

Operator: And your next question comes from the line of Stephen Willey with Stifel. Please go ahead.

Analyst: Yes. Good afternoon. Thanks for taking the questions. Just curious where you are in terms of preparing a publication of the mutant data and whether you believe the compendia listing for use of these patients could be achieved before formal label expansion. And then it was also just wondering how you are thinking about communicating launch progress to the street and metrics you think you might be providing to us over the next few quarters? Thanks.

Brian F. Sullivan: Sure. Regarding the article, we have we have submitted an article to journal. And that process is variable in time. It can, you know, take you know, 3 months. It can take 6 months. We would hope to have it be on the shorter range of that timeline, but it is 100% in our control, obviously. But that process is well underway. As far as mutant usage, I mean, we cannot promote the mutant usage. But we would have the opportunity potentially to-- 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 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 and if the recommendations are appropriate, what the payers require, then the physicians would be in a position to prescribe the medicine and their patients to get reimbursed for it. But, again, they are not something we can certainly drive or really discuss at all in the clinical context. But those are variables that, you know, could be present in the marketplace. And as far as progress, we will be reporting sales, obviously.

As we go. You know, we do not have the granularity of data that you have with oral therapies. You know, we have-- 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's say, an oral medication gets. So the granularity of data will not 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% to 50% of patients treated, but there will be a lag in that. That will be 2 to 3 months. Lag. So it will not be current or necessarily representative. It will provide us important information to help manage the business. But it will not be a real time evaluation. We internally will be certainly tracking and be able to intuit based on our analyses, you know, where the drug is going, who is at the locations, and be able to do analysis like that.

But we will not have the sufficient specificity to, for instance, identify, you know, how many docs prescribed it, how many re prescribed it, how many patients on therapy. You know, we will we will simply have in real time setting. Actual number of vials, shipped to, sites. And we expect that to represent demand. You know, there really will not be inventorying of this drug. Our distributor, our 3PL, will be delivering this drug overnight in a great majority of cases. And so we do not expect and some of the larger sites, depending on their overall approach, you know, may we will provide-- 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 would not expect that to represent you know, let's say more than a cycle of treatment. We think that would be unlikely. Alright. that is very helpful. Thank you. You are welcome.

Operator: And your next question comes from the line of Silvan Tuerkcan with Citizens. Please go ahead.

Josh Boen: Hey. This is Josh on for Silvan. Thanks for taking the question. Yeah. So you mentioned plans to submit the sNDA for the mutant population in March. Could you maybe just walk us through some of the potential regulatory timelines maybe submission to filing and then potential for a priority review period?

Brian F. Sullivan: Sure. Yeah. Sure. No. Because it is an sNDA, while they will need to accept the sNDA, the clock starts for the review. When the final submission is made. And so, from the time we complete our submission to whatever the prescribed PDUFA date is would be the expected review cycle. If it is a priority review, it would be 6 months from submission. If it is a regular review, it would be 10 months, from submission.

Josh Boen: Great. Thank you. You are welcome.

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

Brian F. Sullivan: 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.

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