Celcuity (CELC) 2026 年第二季法說會：REVTORPYK 預計於第三季末上市

重點摘要

• Celcuity 公布 2026 財年第二季淨虧損為 7,890 萬美元，或每股虧損 1.44 美元；相較之下，去年同期淨虧損為 4,530 萬美元，或每股虧損 1.04 美元。
• 該公司預計將於 2026 年第三季末開始 REVTORPYK 的商業化出貨。其批發採購成本將為每瓶 10,000 美元，或每個治療週期 30,000 美元。
• REVTORPYK 已獲得 FDA 批准，用於治療轉移性階段接受至少一種內分泌療法後疾病進展且未檢測出 PIK3CA 基因突變的 HR+/HER2- 局部晚期或轉移性乳癌患者。
• 在具 PIK3CA 突變的 VIKTORIA-1 試驗隊列中，gedatolisib 三聯療法的無疾病進展生存期中位數為 11.1 個月，雙聯療法為 11.3 個月，而 alpelisib 聯合 fulvestrant 則為 5.6 個月。
• 截至 2026 年 6 月 30 日，現金、現金等價物及短期投資達 7.54 億美元。管理層預計可用資金將可支持營運至少延續至 2029 年。
• Celcuity 計劃於 2026 年第三季提交針對 PIK3CA 突變人群的補充新藥申請（sNDA）。管理層表示，優先審查在提交後需時 6 個月，而標準審查則需時 10 個月。

核心財務數據

2026 年 6 月的可轉換公司債發行產生了 5.75 億美元的總收益及 5.572 億美元的淨收益。Celcuity 使用 1.37 億美元償還定期貸款，並報告 2026 年上半年營運現金支出為 1.105 億美元。

在營業與管理費用（SG&A）增加的 2,740 萬美元中，有 2,340 萬美元與商業化團隊增員及其他 REVTORPYK 上市活動相關。

業務與營運表現

REVTORPYK 獲批與上市

FDA 批准 REVTORPYK 聯合 fulvestrant（無論是否搭配 palbociclib），用於未檢測出 PIK3CA 突變的合適 HR+/HER2- 晚期乳癌患者。管理層指出，NCCN 隨後將該三聯與雙聯療法列為二線或後續治療的首選方案。

Celcuity 已完成其商業化基礎設施建置。其外勤團隊包含 88 名腫瘤銷售專家，平均具備 24 年的業界經驗。該公司已接觸超過 1,000 名關鍵意見領袖與社區乳癌專家，以及 250 多個關鍵客戶。

擴大供藥計畫已在商業出貨前啟動，且已開始向參與醫師出貨。計畫目標是在產品上市後，讓患者順利轉移至商業化供應，且不中斷治療。

管理層預計總收入至淨收入的比率約為 WAC 的 80%，意味著管道折讓約為 20%。Celcuity 估計美國有 37,000 名 HR+/HER2- 晚期乳癌患者接受二線治療。基於每位患者約 10 個治療週期，該公司估計在 PIK3CA 野生型與突變型領域的潛在年度總可服務市場（TAM）合計超過 60 億美元。

VIKTORIA-1 臨床結果

在 PIK3CA 突變隊列中，gedatolisib 三聯療法的無疾病進展生存期中位數達 11.1 個月，而 alpelisib 聯合 fulvestrant 為 5.6 個月，風險比為 0.50。gedatolisib 雙聯療法的無疾病進展生存期中位數為 11.3 個月，風險比為 0.51。

因不良事件導致 gedatolisib 停藥的比例在三聯療法中為 5.2%，在雙聯療法中為 3.8%，相較之下 alpelisib 的停藥率為 19%。管理層表示，隨著醫師在試驗期間對 gedatolisib 更加熟悉，突變隊列中約 4% 至 5% 的停藥率可能更能代表預期的真實世界情況。

截至 2026 年 8 月 2 日，在野生型與突變型的三聯及雙聯隊列中，gedatolisib 的平均治療週期介於 9.0 至 11.3 個月之間。這些群組中有 12% 至 22% 的患者仍持續接受治療。

第一線乳癌藥物開發

Celcuity 擴大了三期 VIKTORIA-2 計畫，以評估初治、對內分泌敏感的患者。研究 2 正在測試 gedatolisib 聯合 palbociclib 與 letrozole，而研究 1 則繼續評估 gedatolisib 聯合 palbociclib 與 fulvestrant 在抗內分泌患者中的效果。

管理層引用了早期針對 41 名內分泌敏感患者的 Ib 期研究，該研究顯示無疾病進展生存期中位數達 48.6 個月，客觀緩解率為 79%。相比之下，ribociclib 聯合 letrozole 的歷史數據分別約為 25 個月及 53%。

皮下注射型 gedatolisib 劑型的開發也在持續進行中，目標是證明其與靜脈注射劑型具有臨床等效性。

攝護腺癌計畫

在 gedatolisib 聯合 darolutamide 治療轉移性去勢抵抗性攝護腺癌的 Ib/II 期試驗中，240 毫克劑量未產生導致 gedatolisib 停藥的不良事件，且未達到減量劑量限制性毒性標準。300 毫克劑量的評估正在進行中。

Celcuity 預計將於 2026 年第四季公布更多臨床數據以及關於其攝護腺癌開發策略的詳細資訊。可能揭露的內容包括 PSA50 緩解率、最新無疾病進展生存期、亞組分析及額外 240 毫克劑量的數據。

管理層指引

• REVTORPYK 的商業化出貨預計將於 2026 年第三季末開始。
• 針對 PIK3CA 突變的 sNDA 提交計劃於 2026 年第三季進行。
• 基於野生型與突變型 VIKTORIA-1 隊列的全球監管申請預計將在 sNDA 提交後進行。
• VIKTORIA-1 的最新結果預計將於 2026 年晚些時候的醫學會議上發表。
• 最新的攝護腺癌數據與開發計劃預計將於 2026 年第四季公布。
• 現金與投資預計將可支持營運資金需求至少延續至 2029 年。

風險與觀察重點

• 來自 Celcuity 第二製造廠區的商業化供應需要 FDA 授權。該公司在 REVTORPYK 獲批後不久即提交了驗證資料包，對第三季末出貨保持信心，但管理層指出，若出現問題，審查可能需要 2 至 4 個月或更長時間。
• 將擴大供藥計畫的患者轉移至商業化供應的時間點，可能因治療地點、患者保險及其他情況而有所不同。
• PIK3CA 突變適應症仍有待 FDA 審查。在當前標籤下，Celcuity 無法推廣用於該人群。
• 涵蓋該臨床數據的期刊論文已提交，但管理層表示，發表時間可能在 3 至 6 個月之間，且並非完全由公司掌握。
• 由於 REVTORPYK 採用「買後請款」（Buy-and-bill）分銷模式，上市即時能見度將受到限制。Celcuity 預計將追蹤出貨瓶數，而患者層面的調查數據可能涵蓋 40% 至 50% 的受治患者，且存在 2 至 3 個月的滯後。

分析師問答亮點

• 製造與上市準備：管理層表示，第二廠區的驗證資料包已提交給 FDA。在收到授權之前，該廠區的產品無法出貨，但 Celcuity 仍維持在第三季末上市的預期。
• 擴大供藥過渡：透過擴大供藥計畫接收 REVTORPYK 的患者，預計將在產品上市後轉移至商業化供應。時間將妥善管理，以避免治療中斷。
• 總收入至淨收入假設：Celcuity 預計將保留約 80% 的 WAC，其中約 20% 為管道相關折讓。
• 輸液管道取得：管理層預計靜脈注射給藥不會造成重大障礙，因為社區腫瘤診所通常均可使用輸液中心。管理層表示，社區醫療機構占患者治療量的約 80%。
• 突變人群取得管道：管理層表示，NCCN 的推薦將需要經過同行審查並發表的數據。若獲得採納，此類推薦會被付費方廣泛遵循，儘管 Celcuity 在標籤擴展之前無法推廣用於突變人群。
• 攝護腺癌基準：管理層表示，具臨床意義的結果需要比目前針對特定二線治療選項所引用的 5 至 6 個月無疾病進展生存期中位數超出 3 至 4 個月，或者展現出至少與 Pluvicto 所引用的 10 多個月相當的療效。

法說會完整逐字稿

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完整財報電話會議逐字稿

管理層陳述

Operator

Good afternoon, ladies and gentlemen. Welcome to Celcuity Second Quarter 2026 Financial Results Conference Call and Webcast. [Operator Instructions] 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, 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. 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. And with that, I would like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead, Brian.

Brian Sullivan

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+/HER2- 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're well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR+/HER2- advanced breast cancer. We remain on track to begin shipping REVTORPYK later in the third quarter of 2026, and 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 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. On July 14, 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+/HER2- 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+/HER2- breast cancer treatment, recommending both the REVTORPYK triplet and doublet regimens as preferred category 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. 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. Now we've since updated the analysis 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 that 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. Since a much higher proportion of wild-type patients were enrolled during this period in the 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 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. For those treated with the gedatolisib triplet in the mutant cohort, the mean number of treatment cycles for gedatolisib was 10.0, 34 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. 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, and 10 of these patients representing 19% of those dosed are still receiving gedatolisib.

Now analysis 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.

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 '26. 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 the patient's tumor. And 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.

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 androrine-sensitive HR+/HER2- advanced breast cancer. And these are women whose cancer relapse 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 2/3 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+/HER2- 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 Ib 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+/HER2- 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 is 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. 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+/HER2- 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.

And now let's turn to our Phase Ib/II trial that's evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. In the dose-finding portion of the Phase Ib 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. Once the dose-finding portion of the study is completed, we expect to select 2 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. And 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.

Now the build-out of the commercialization infrastructure needed to support the successful launch of REVTORPYK is now complete and commercial launch activities for REVTORPYK commenced immediately after approval. Our 88 oncology sales specialists who have an average of 24 years of industry experience are calling on physicians and supporting installation of REVTORPYK order sets within the electronic health record systems of their accounts and in servicing infusion centers and pharmacies. Our strategic accounts, payer reimbursement, medical science liaison and KOL-focused teams are following through on the groundwork they laid prior to REVTORPYK 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 REVTORPYK are expected to begin late in the third quarter of 2026. Now wholesale acquisition cost or WAC of REVTORPYK, which has been reported to the drug pricing compendia will be $10,000 per vial or $30,000 per cycle of treatment once REVTORPYK is commercially available. To enable treating physicians to obtain gedatolisib on behalf of their eligible patients prior to commercial availability of REVTORPYK, Celcuity opened an expanded access program last week and shipments to these physicians have begun. And based on analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. receiving second-line treatment for HR+/HER2- advanced breast cancer.

Assuming an average of roughly 10 cycles of treatment for REVTORPYK per patient at the WAC price, we estimate the total addressable market for REVTORPYK in the wild-type and mutant setting combined is potentially over $6 billion annually.

And that concludes my remarks. I'd now like to hand the call over to Vicky to review our financials.

Vicky Hahne

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. 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 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. 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 30, 2026, compared to $441.5 million as of December 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 $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

[Operator Instructions]

And your first question comes from the line of Tara Bancroft with TD Cowen.

分析師問答

Tara Bancroft

So 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? And if so, how long would that last you? And how long is the process for setup with the backup manufacturing? And what does that entail? I know that, 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

Sure. As I explained last -- a couple of weeks ago, I mean, 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're very confident about being able to ship beginning at the end of this quarter. So nothing's changed.

Tara Bancroft

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

Brian Sullivan

Well, the FDA can do whatever they want. But typically, if you are with a manufacturer that has met requirements, they don't necessarily require that. It would again, you don't want to really be in a position of projecting what the FDA does or won't 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.

Operator

And your next question comes from the line of Maury Raycroft with Jefferies.

Maurice Raycroft

Congrats on the progress. I'll 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 product from that site?

Brian 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, the use of that site. So that's begun. And 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. But again, as we've indicated, we want visibility on the review process for that site. And again, we're confident about our ability to ship in the third quarter -- late third quarter.

Maurice Raycroft

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? And will you provide quarterly updates on where you're at with enrollment there? I guess, is that something that could be.

Brian Sullivan

Hopefully, we're not providing quarterly updates, right, because it will go away. But 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. So that occurred last week, and we've already begun shipping drug to sites where physicians are treating patients.

Maurice Raycroft

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

Brian Sullivan

Exactly. And that was reflected in the protocol.

Operator

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

Bradley Canino

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

Brian Sullivan

Sure. There's certainly a strong rationale for us to consider that, and we'll 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 get 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's certainly a strong rationale for us to consider developing in that setting.

Bradley Canino

And then in prostate specifically, too, I'm tracking this kind of somewhat from a far, and I'm 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 has a foreshadow of the opportunity or something like gedatolisib? And what should we keep in mind that could be different for -- as you approach it?

Brian Sullivan

Sure. So capi, 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. And gedatolisib, as we announced recently, showed double the activity relative to alpelisib, which we think is a reasonable proxy for what capi is capable of doing. And so we think the fact that capi got an approval for the P10 loss population essentially that's the most relevant mutation of the PAM pathway in prostate cancer. And so that drug is limited to roughly 40% of patients with P10 loss.

But we think it augurs well for us. They're evaluating or rather they got an approval in patients who are at an earlier stage than the patients we're evaluating. They're evaluating hormone-sensitive, prostate patients. We're evaluating castration-resistant patients. But the fact they got out of 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'll be updating that data later this year. And 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. And that's ultimately our hypothesis. We're going to be evaluating that in a different setting. But it certainly provides another demonstration of the importance of this pathway in this disease.

Operator

Your next question comes from the line of Eva Fortea with Wells Fargo.

Eva Fortea-Verdejo

Congrats on the progress. 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 patient from the EAP to commercial following the launch in late Q3?

Brian Sullivan

I don't want to get committed to a particular time line. I mean, certainly, we have to be very sensitive to the needs of the patient and make sure that there's no risk of an interruption in supply. And so 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's embedded within the protocol and is well understood by the participating investigators. And that's a very standard approach.

But 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. But again, the overall goal is to make sure that there's no disruption to the patient's access to the therapy, and we'll essentially accommodate whatever might be required to ensure that, that transition occurs smoothly.

Operator

And your next question comes from the line of Andrew Berens with Leerink Partners.

Unknown Analyst

This is Isabel on for Andy. We're wondering if you could give more color on the expected gross to net.

Brian Sullivan

Sure. So 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 to -- 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%. And based on data we've seen for oral therapies, that the gross to net discount can be about 30%. So 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

And your next question comes from the line of Oliver McCammon with LifeSci Capital.

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, do 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?

Brian 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 is one you mentioned, pembrolizumab and TNBC is another, Herceptin and Perjeta, which are 2 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. And 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 barriers or community oncologists prescribing gedatolisib and ensuring the patient can get infused. And these docs represent the community treaters, treat about 80% of physicians --

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Operator

[Operator Instructions]

Brian, please go ahead.

Brian Sullivan

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? Your next question comes from the line of Kalpit Patel with Wolfe Research.

Kalpit Patel

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? And then what would be a success look like to you in that area?

Brian Sullivan

Sure. So we expect to provide additional data and 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 with 300-milligram dose may not be mature enough to present. But -- so 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

And any color on what would be encouraging in your view for rPFS?

Brian Sullivan

Well, I think the standard of care today or rather, I would say, there's kind of 2 components to that answer. Current patients in the second-line setting who've progressed on, let's say, prior abterone can expect to receive 5 to 6 months median PFS. Similarly, if they are treated with docetaxel instead of hormonal therapy. So the minimum bar to beat would be 3 to 4 months better than those options. Pluvicto is out there as an option as well, offering patients north of 10 months. And so our expectation would be that we would need at least to be comparable to Pluvicto, we think there'll be advantages to use of our drug versus their drug in that setting. And certainly, we would hope to be superior to that.

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

Operator

Your next question comes from the line of Gil Blum with Needham.

Unknown Analyst

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

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. And again, if there's issues, which, again, we don't expect to occur, it can take longer. And so there's a standard process of 4-month review process. It can be shorter. And -- but 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. But that's what we think we'll find out relatively early in the process.

Unknown 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?

Brian Sullivan

That's very tactical. It will be appropriate. We'll be using inventory from both and managing inventory accordingly. It's important to keep both sites going. It's just you want to create a rhythm for them. And so you're always going to be balancing mix of product between those 2 sites.

Operator

And your next question comes from the line of Stephen Willey with Stifel.

Stephen Willey

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

Brian Sullivan

Sure. Regarding the article, we have submitted an article to a journal. And that process is variable in time. It can take 3 months, can take 6 months. We would hope to have it be on the shorter range of that timeline, but it's not 100% in our control, obviously. But that process is well underway. As far as mutant usage, I mean, we can't promote mutant usage, but we would have the opportunity potentially to -- and it's up to the NCCN panels to have the NCCN make a recommendation based on published data. They can't make recommendations just based on, for instance, 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 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'll be reporting sales, obviously, as we go. We don't have the granularity of data that you have with oral therapies. We have -- we ship to a site buy and bill, but we don't get a prescriber name on that therapy. And so we don't get as much visibility. There's not a name on a prescription, for instance. So we don't get as much visibility as, let's say, an oral medication gets.

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% to 50% of patients treated, but there'll be a lag in that. That will be 2 to 3 months lag. So it won't be current or necessarily representative. It will provide us important information to help manage the business, but it won't be real-time evaluation. We internally will be certainly tracking and be able to intuit based on our analysis. 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 represcribed it, how many patients on therapy. We'll simply have in real-time setting the actual number of vials shipped to sites.

And we expect that to represent demand. There really won't be inventorying of this drug. Our distributor of 3PL will be delivering this drug overnight in the great majority of cases. And so we don't expect -- 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, and we think that would be unlikely.

Operator

And your next question comes from the line of Silvan Tuerkcan with Citizens.

Josh Boen

This is Josh on for Silvan. Yes, so 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

Yes, sure. No, 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. And so 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.

Operator

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

Brian Sullivan

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.