Celcuity（CELC）2026年第2四半期決算説明会：REVTORPYKのローンチを第3四半期後半に予定

要点

• セルキュイティ（Celcuity）が発表した2026年第2四半期決算は、純損失が7,890万ドル（1株当たり1.44ドル）となり、前年同期の4,530万ドル（1株当たり1.04ドル）から拡大しました。
• 同社は2026年第3四半期後半にREVTORPYKの商用出荷を開始する予定です。卸売購入価格（WAC）は1バイアル当たり10,000ドル、1治療サイクル当たり30,000ドルとなります。
• REVTORPYKは、転移性疾患において少なくとも1つの内分泌療法後に進行した、PIK3CA変異が検出されないHR+/HER2-局所進行または転移性乳がんを対象としてFDAの承認を取得しました。
• PIK3CA変異を有するVIKTORIA-1コホートにおいて、無増悪生存期間（PFS）の中央値は、アルペリシブとフルベストラントの併用療法の5.6カ月に対し、ゲダトリシブ3剤併用療法で11.1カ月、2剤併用療法で11.3カ月でした。
• 2026年6月30日時点の現金、現金同等物および短期投資は7億5,400万ドルに達しました。経営陣は、手元資金により少なくとも2029年まで事業運営を継続できると見込んでいます。
• セルキュイティは2026年第3四半期にPIK3CA変異患者群に対するsNDA（適応拡大申請）を提出する計画です。経営陣によると、優先審査の場合は申請から6カ月、通常審査の場合は10カ月を要する見通しです。

主要財務データ

2026年6月の転換社債発行による手取総額は5億7,500万ドル、手取純額は5億5,720万ドルでした。セルキュイティは1億3,700万ドルをタームローンの返済に充て、2026年上半期に1億1,050万ドルの営業キャッシュアウトを計上しました。

販売管理費の増額分2,740万ドルのうち、2,340万ドルは商用化に伴う人員増員およびその他のREVTORPYK発売関連活動に関するものでした。

事業および業績の状況

REVTORPYKの承認と発売

FDAは、PIK3CA変異が検出されない対象となるHR+/HER2-進行乳がん患者を対象に、パルボシクリブ併用または非併用のフルベストラントとの併用療法としてREVTORPYKを承認しました。経営陣によると、全米総合がんネットワーク（NCCN）はその後、3剤併用療法および2剤併用療法を2次治療以降の推奨レジメン（Preferred Regimen）に指定しました。

セルキュイティは商用インフラの構築を完了しました。現場体制には、業界で平均24年の経験を持つ88名のがん領域専門営業担当者が含まれます。同社は1,000名以上の主要意見指導者（KOL）や地域の乳がん専門家、および250以上の主要顧客と連携しています。

商用利用の開始に先立ち拡大アクセスプログラム（EAP）が開始され、参加医師への出荷が始まりました。患者は治療を中断することなく、発売後に商用供給へと移行することが予定されています。

経営陣は、売上総額に対する純売上高の比率がWAC（卸売購入価格）の約80%になると予想しており、これは約20%の割引を意味します。セルキュイティの試算によると、米国では37,000人の患者がHR+/HER2-進行乳がんの2次治療を受けています。患者1人当たり約10回の治療サイクルに基づき、同社はPIK3CA野生型と変異型を合わせた潜在的な獲得可能な最大市場（TAM）が年間60億ドルを超えると推計しています。

VIKTORIA-1臨床試験結果

PIK3CA変異コホートにおいて、ゲダトリシブ3剤併用療法は無増悪生存期間（PFS）の中央値が11.1カ月となり、アルペリシブとフルベストラント併用療法の5.6カ月に対してハザード比0.50を達成しました。ゲダトリシブ2剤併用療法はPFS中央値11.3カ月、ハザード比0.51を示しました。

有害事象によるゲダトリシブの投与中止率は、3剤併用で5.2%、2剤併用で3.8%であり、アルペリシブの中止率19%と比較して低い割合でした。経営陣は、治験中に医師がゲダトリシブの扱いに慣れたことから、変異コホートにおける約4%〜5%という中止率が実際の臨床現場での経験をより適切に反映している可能性があると説明しました。

2026年8月2日時点において、野生型および変異型の3剤併用・2剤併用コホート全体でのゲダトリシブ平均治療サイクル数は9.0〜11.3サイクルの範囲でした。これらの群における患者の12%〜22%が治療を継続していました。

1次治療乳がん開発

セルキュイティは、未治療の内分泌療法感受性患者を評価するため、第III相VIKTORIA-2プログラムを拡大しました。「Study 2」ではゲダトリシブとパルボシクリブおよびレトロゾールとの併用を検証しており、「Study 1」では内分泌療法抵抗性患者を対象にゲダトリシブとパルボシクリブおよびフルベストラントとの併用評価を継続しています。

経営陣は、内分泌療法感受性患者41人を対象とした以前の第Ib相試験で、無増悪生存期間中央値が48.6カ月、客観的奏効率が79%であったことに言及しました。これらの結果は、リボシクリブとレトロゾール併用療法の過去データ（それぞれ約25カ月および53%）と比較されています。

静脈内投与製剤に対する臨床的同等性を実証することを目的として、ゲダトリシブ皮下注射製剤の開発も進められています。

前立腺がんプログラム

転移性去勢抵抗性前立腺がんを対象としたゲダトリシブとダロルタミドの併用第Ib/II相試験において、240ミリグラム用量ではゲダトリシブの投与中止に至る有害事象は発生せず、用量減量を伴う用量制限毒性（DLT）基準にも該当しませんでした。現在、300ミリグラム用量の評価が進められています。

セルキュイティは2026年第4四半期に追加の臨床データおよび前立腺がん開発戦略のより詳しい詳細を発表する予定です。開示予定の内容には、PSA50奏効、最新の無増悪生存期間、サブグループ解析、および240ミリグラム用量の追加データが含まれます。

経営陣の見通し

• REVTORPYKの商用出荷は2026年第3四半期後半に開始される予定です。
• PIK3CA変異患者群に関するsNDA提出は2026年第3四半期に予定されています。
• 野生型および変異型VIKTORIA-1コホートに基づく世界各国の規制当局への申請は、sNDA提出後に予定されています。
• VIKTORIA-1の最新結果は2026年後半の学会で発表される見込みです。
• 前立腺がんの最新データおよび開発計画は2026年第4四半期に発表される見込みです。
• 手元資金および投資資産により、少なくとも2029年までの事業運営が賄われる見通しです。

リスクと注目点

• セルキュイティの第2製造拠点からの商用供給にはFDAの承認が必要です。同社はREVTORPYKの承認直後にバリデーションパッケージを提出しており、第3四半期後半の出荷に自信を示していますが、経営陣は審査に2〜4カ月、問題が発生した場合はさらに長期間かかる可能性があると指摘しました。
• 拡大アクセスプログラムの患者が商用供給へ移行するタイミングは、治療施設、患者の保険、その他の事情により異なる場合があります。
• PIK3CA変異に対する適応症は引き続きFDAの審査対象となっています。セルキュイティは、現在の添付文書（ラベル）の下で同患者群への使用をプロモーションすることはできません。
• 臨床データをカバーする論文が学術誌に投稿されていますが、経営陣は掲載のタイミングが3〜6カ月程度かかる可能性があり、自社で完全にコントロールできるものではないと述べました。
• REVTORPYKはバイ・アンド・ビル（buy-and-bill：医療機関が先行購入して請求する方式）流通モデルを採用しているため、発売初期のリアルタイムな状況把握は限られます。セルキュイティが出荷バイアル数を追跡する一方で、患者レベルの調査データは2〜3カ月のタイムラグを伴って治療患者の40%〜50%をカバーするにとどまる見込みです。

アナリスト質疑応答の要点

• 製造および発売準備状況：経営陣によると、第2拠点のバリデーションパッケージはFDAに提出済みです。承認を受けるまで同拠点からの製品出荷はできませんが、セルキュイティは第3四半期後半の発売見通しを維持しています。
• 拡大アクセスからの移行：拡大アクセスプログラムを通じてREVTORPYK投与を受けている患者は、発売後に商用供給へ移行する予定です。治療の中断を避けるよう時期が調整されます。
• 控除前後の売上想定：セルキュイティはWAC（卸売購入価格）の約80%を確保し、販売チャネル関連の割引が約20%になると見込んでいます。
• 点滴投与へのアクセス：地域の腫瘍診療所は一般に点滴センターを利用できるため、経営陣は静脈投与が重大な障壁になるとは予想していません。経営陣によると、地域の医療機関が患者治療の約80%を占めています。
• 変異患者群へのアクセス：経営陣は、NCCN（全米総合がんネットワーク）の推奨を得るには査読付き論文の公表が必要になると述べました。採択されれば保険支払い機関（ペイヤー）に広く従われますが、セルキュイティは適応拡大前に対象患者群へのプロモーションを行うことはできません。
• 前立腺がんのベンチマーク：経営陣は、臨床的に意味のある結果とするには、一部の2次治療の選択肢で挙げられている現在の無増悪生存期間中央値（5〜6カ月）を3〜4カ月上回るか、あるいはプルビクト（Pluvicto）で提示されている10カ月超と同等以上の有効性を示す必要があると述べました。

決算説明会（トランスクリプト）全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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 --

[Music]

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.