การประชุมแถลงผลประกอบการไตรมาส 3 ปี 2026 ของ Celcuity (CELC): การเปิดตัว Gedatolisib และเงินสด 642.7 ล้านดอลลาร์

ประเด็นสำคัญ

• Celcuity เริ่มจัดส่งยา gedatolisib เชิงพาณิชย์เมื่อวันที่ 30 กันยายน 2026 สำหรับผู้ป่วยโรคมะเร็งเต้านมระยะลุกลามชนิด HR-positive, HER2-negative ที่ตรวจไม่พบการกลายพันธุ์ของยีน PIK3CA และมีคุณสมบัติตามเกณฑ์ ทั้งนี้ บริษัทไม่มีการรับรู้รายได้จากผลิตภัณฑ์ในไตรมาส 3 เนื่องจากมีการส่งมอบหลังจากสิ้นสุดไตรมาส
• การเข้าถึงในช่วงเริ่มต้นเปิดตัวเป็นไปอย่างกว้างขวาง โดย 78% ของลูกค้าระดับยุทธศาสตร์ชั้นนำ 36 รายได้สั่งซื้อผลิตภัณฑ์แล้ว ขณะที่ 91% ของผู้ถือกรมธรรม์ประกันสุขภาพเชิงพาณิชย์และเมดิแคร์ (Medicare) ในสหรัฐฯ อยู่ในแผนประกันที่ให้ความคุ้มครอง นอกจากนี้ การรักษาดังกล่าวยังได้รับการบรรจุเข้าสู่แนวทางการรักษาของผู้ให้บริการรายใหญ่ 3 ใน 4 แห่งภายในเวลา 30 วัน
• ผลขาดทุนสุทธิในไตรมาส 3 ขยายตัวแตะ 73.3 ล้านดอลลาร์ หรือ 1.33 ดอลลาร์ต่อหุ้น จาก 43.8 ล้านดอลลาร์ หรือ 0.92 ดอลลาร์ต่อหุ้นในปีก่อนหน้า โดยการขยายงานเชิงพาณิชย์เป็นปัจจัยหลักที่ผลักดันให้ค่าใช้จ่ายในการดำเนินงานเพิ่มขึ้น
• เงินสด รายการเทียบเท่าเงินสด และเงินลงทุนระยะสั้นมีมูลค่ารวม 642.7 ล้านดอลลาร์ ณ วันที่ 30 กันยายน 2026 โดยฝ่ายบริหารคาดว่าเงินทุนที่มีอยู่จะสามารถรองรับการดำเนินงานได้จนถึงปี 2029
• ข้อมูลที่อัปเดตจากการศึกษา VICTORIA-1 แสดงให้เห็นว่าค่ามัธยฐานของการรอดชีวิตโดยโรคสงบ (PFS) อยู่ที่ 21.5 เดือนสำหรับการใช้ยา gedatolisib สูตร 3 ตัว (triplet) และ 11.5 เดือนสำหรับสูตร 2 ตัว (doublet) ในกลุ่มผู้ป่วยที่ไม่มีการแพร่กระจายไปที่ตับ เทียบกับ 9.1 เดือนสำหรับยา alpelisib ร่วมกับ fulvestrant
• Celcuity ได้ยื่นคำขออนุมัติยาใหม่ส่วนต่อขยาย (sNDA) สำหรับกลุ่มผู้ป่วยที่มีการกลายพันธุ์ของยีน PIK3CA ในระหว่างไตรมาส 3 โดยฝ่ายบริหารคาดว่าจะทราบข้อมูลอัตราการรอดชีวิตโดยรวม (OS) จากการศึกษา VICTORIA-1 ในช่วงครึ่งแรกของปี 2027 ทั้งนี้ขึ้นอยู่กับกรอบเวลาที่อิงตามจำนวนเหตุการณ์ที่เกิดขึ้น (event-driven timeline)

ข้อมูลทางการเงินที่สำคัญ

การเสนอขายหุ้นกู้แปลงสภาพสร้างรายรับรวม 575 ล้านดอลลาร์ และรายรับสุทธิ 557 ล้านดอลลาร์ ทั้งนี้ ในระหว่างปี 2026 Celcuity ยังได้ใช้เงิน 172.7 ล้านดอลลาร์สำหรับการดำเนินงาน ชำระคืนเงินกู้ระยะยาว (term loan) จำนวน 137 ล้านดอลลาร์ และจ่ายเงินตามเงื่อนไขความสำเร็จในการได้รับการอนุมัติจาก FDA (milestone payment) จำนวน 50 ล้านดอลลาร์ให้แก่ Pfizer

ผลการดำเนินงานทางธุรกิจและการปฏิบัติการ

Celcuity ก้าวเข้าสู่ระยะเชิงพาณิชย์ในระหว่างไตรมาสนี้ โดยแพทย์ในสหรัฐฯ สามารถใช้ยา gedatolisib ร่วมกับ fulvestrant ทั้งในรูปแบบที่ใช้ร่วมกับ palbociclib หรือไม่ใช้ร่วมด้วย สำหรับผู้ป่วยโรคมะเร็งเต้านมระยะลุกลามชนิด HR-positive, HER2-negative ที่มีคุณสมบัติตามเกณฑ์ และตรวจไม่พบการกลายพันธุ์ของยีน PIK3CA หลังจากที่โรคดำเนินลุกลามต่อไปหลังการรักษาด้วยฮอร์โมน (endocrine therapy)

การเปิดตัวดังกล่าวเข้าถึงเครือข่ายการรักษาเป็นสัดส่วนจำนวนมาก โดยสถานพยาบาลมากกว่า 3,400 แห่งได้ติดต่อประสานงานโดยตรงกับผู้เชี่ยวชาญด้านการขายยาโรคมะเร็งของ Celcuity ซึ่งคิดเป็นสถานพยาบาลที่ทำการรักษาผู้ป่วยมะเร็งเต้านมในสัดส่วน 82% นอกจากนี้ ผู้ให้บริการทางการแพทย์มากกว่า 1,100 รายได้เข้าร่วมโครงการให้ความรู้ และบริษัทได้ส่งผู้เชี่ยวชาญด้านการขายยาโรคมะเร็งลงพื้นที่ปฏิบัติงานจำนวน 88 คน

ฝ่ายบริหารระบุว่าผู้ป่วยที่มีคุณสมบัติตามเกณฑ์เกือบทั้งหมดสามารถเข้าถึงยาได้ผ่านความคุ้มครองของผู้จ่ายเงิน (payer coverage) และแนวทางการรักษาของผู้ให้บริการ โดย gedatolisib ได้รับคำแนะนำระดับพึงประสงค์ Category 1 จาก NCCN สำหรับทั้งสูตรยา 3 ตัวและสูตรยา 2 ตัวในฐานะทางเลือกการรักษาระดับที่สอง (second-line) ภายในสองสัปดาห์หลังได้รับการอนุมัติ

ต้นทุนการจัดซื้อระดับค้าส่ง (WAC) อยู่ที่ 10,000 ดอลลาร์ต่อขวด หรือ 30,000 ดอลลาร์ต่อรอบการรักษา 28 วัน จากการประเมินผู้ป่วยที่รับการรักษาระดับที่สองในสหรัฐฯ จำนวน 37,000 ราย รอบการรักษาเฉลี่ย 10 รอบ และรายรับสุทธิคิดเป็น 80% ของ WAC ฝ่ายบริหารจึงประมาณการตลาดรวมที่สามารถเข้าถึงได้ต่อปีไว้ที่ราว 9 พันล้านดอลลาร์ ครอบคลุมทั้งผู้ป่วยกลุ่มยีน PIK3CA แบบดั้งเดิม (wild-type) และกลุ่มที่มีการกลายพันธุ์

คาดว่าคำสั่งซื้อส่วนใหญ่จะดำเนินการผ่านผู้จัดจำหน่ายเฉพาะทางภายใต้โมเดลซื้อแล้วเรียกเก็บเงิน (buy-and-bill) โดยจะจัดส่งผลิตภัณฑ์ไปยังสถานพยาบาลโดยตรง ทั้งนี้ ฝ่ายบริหารระบุว่าคำสั่งซื้อน่าจะเชื่อมโยงกับผู้ป่วยแต่ละรายโดยตรงมากกว่าการสต็อกสินค้าคงคลัง

การพัฒนาทางคลินิก

ผลการศึกษา VICTORIA-1 ฉบับอัปเดตที่นำเสนอในการประชุม ESMO ประกอบด้วย:

• ค่ามัธยฐาน PFS อยู่ที่ 21.5 เดือนสำหรับ gedatolisib สูตร 3 ตัว และ 11.5 เดือนสำหรับสูตร 2 ตัวในผู้ป่วยที่ไม่มีการแพร่กระจายไปที่ตับ เทียบกับ 9.1 เดือนสำหรับ alpelisib ร่วมกับ fulvestrant
• อัตราส่วนอันตราย (Hazard ratio) อยู่ที่ 0.46 สำหรับสูตร 3 ตัว และ 0.71 สำหรับสูตร 2 ตัว ในผู้ป่วยที่ไม่มีการแพร่กระจายไปที่ตับ
• อัตราการตอบสนองโดยรวม (ORR) อยู่ที่ 59% สำหรับสูตร 3 ตัว และ 43% สำหรับสูตร 2 ตัว เทียบกับ 33% สำหรับกลุ่มยาเปรียบเทียบ
• ค่ามัธยฐานของระยะเวลาการตอบสนอง (DOR) อยู่ที่ 19.4 เดือนสำหรับสูตร 3 ตัว และ 27.8 เดือนสำหรับสูตร 2 ตัว เทียบกับ 7.5 เดือนสำหรับกลุ่มยาเปรียบเทียบ
• อัตราการหยุดการรักษาเนื่องจากเหตุการณ์ไม่พึงประสงค์อยู่ที่ 5% สำหรับสูตร 3 ตัว และ 4% สำหรับสูตร 2 ตัว เทียบกับ 19% สำหรับ alpelisib ร่วมกับ fulvestrant

นอกจากนี้ Celcuity ยังอยู่ระหว่างการประเมินยา gedatolisib ในโครงการ VICTORIA-2 สำหรับการรักษาระดับแรก (first-line) โดยฝ่ายบริหารได้อ้างถึงข้อมูลการทดลองทางคลินิกระยะที่ 1 ซึ่งแสดงค่ามัธยฐาน PFS ที่ 48.6 เดือน และอัตราการตอบสนองโดยรวม 79% สำหรับการใช้ gedatolisib ร่วมกับ palbociclib และ letrozole ทั้งนี้ บริษัทประเมินตลาดรวมที่สามารถเข้าถึงได้ต่อปีสำหรับการรักษาระดับแรกไว้ที่มากกว่า 1 หมื่นล้านดอลลาร์

สำหรับมะเร็งต่อมลูกหมากระยะแพร่กระจายที่ดื้อต่อการรักษาด้วยการลดฮอร์โมน (mCRPC) การใช้ gedatolisib ร่วมกับ darolutamide ให้ค่ามัธยฐานของการรอดชีวิตโดยโรคสงบจากการประเมินทางรังสีวิทยา (rPFS) อยู่ที่ 15.7 เดือนในผู้ป่วยที่เคยได้รับการรักษาด้วย abiraterone มาก่อน และ 9.1 เดือนในผู้ป่วยที่เคยได้รับ enzalutamide มาก่อน โดยคาดว่าการศึกษาระยะที่ 2 แบบสุ่มตัวอย่างจะเริ่มขึ้นในช่วงครึ่งแรกของปี 2027

แนวทางคาดการณ์ของฝ่ายบริหาร

• Celcuity คาดว่าเงินสด รายการเทียบเท่าเงินสด และเงินลงทุนจะสามารถสนับสนุนเงินทุนในการดำเนินงานได้จนถึงปี 2029
• ฝ่ายบริหารวางแผนที่จะเปิดเผยข้อมูลอัปเดตยอดขายเบื้องต้นของไตรมาส 4 ในช่วงกลางเดือนมกราคม 2027
• คาดว่าจะได้รับรหัสเบิกจ่ายถาวร (permanent J-code) ในวันที่ 1 มกราคม 2027 และเริ่มมีผลบังคับใช้ในวันที่ 1 เมษายน 2027
• โรงงานผลิตแห่งที่สองคาดว่าจะได้รับการอนุมัติในช่วงกลางปี 2027 โดยฝ่ายบริหารระบุว่ากำลังการผลิตในปัจจุบันสามารถรองรับอุปสงค์ตามแผนหรือสูงกว่าแผนได้
• คาดว่าจะทราบข้อมูลอัตราการรอดชีวิตโดยรวมจากการศึกษา VICTORIA-1 ในช่วงครึ่งแรกของปี 2027 แม้ว่ากรอบเวลายังคงขึ้นอยู่กับจำนวนเหตุการณ์ที่เกิดขึ้นก็ตาม
• บริษัทคาดว่าจะยื่นข้อมูลจากการศึกษา VICTORIA-1 สำหรับทั้งกลุ่มผู้ป่วยที่มีประเภทยีน PIK3CA แบบดั้งเดิมและกลุ่มที่มีการกลายพันธุ์ ให้แก่หน่วยงานกำกับดูแลทั่วโลกในช่วงปลายปี 2026 หรือต้นปี 2027
• การพัฒนายา gedatolisib รูปแบบฉีดใต้ผิวหนังยังคงเป็นไปตามกำหนดการ แต่ฝ่ายบริหารคาดว่าการเปิดเผยความคืบหน้าจะยังคงเป็นในเชิงคุณภาพต่อไปในอนาคตอันใกล้

ความเสี่ยงและประเด็นที่ต้องจับตา

โมเดลการจัดจำหน่ายแบบซื้อแล้วเรียกเก็บเงิน (buy-and-bill) ทำให้ Celcuity มีข้อจำกัดในการเข้าถึงข้อมูลในระดับผู้สั่งจ่ายยาและระดับผู้ป่วย ดังนั้น การรายงานผลการเปิดตัวในอนาคตจะมุ่งเน้นไปที่ยอดขาย จำนวนขวดยาที่จัดส่ง และตัวชี้วัดการเข้าถึงตลาด แทนที่จะเป็นข้อมูลใบสั่งยาโดยละเอียด

สถานพยาบาลชุมชนบางแห่งอาจชะลอการเริ่มใช้ยาออกไปจนกว่ารหัส J-code ถาวรจะมีผลบังคับใช้ เนื่องจากความกังวลเรื่องการเบิกจ่ายและกระแสเงินสด ซึ่ง Celcuity กำลังให้การสนับสนุนด้านการเบิกจ่ายและขยายระยะเวลาการชำระเงินเพื่อลดอุปสรรคดังกล่าว

การระบุข้อบ่งใช้บนฉลากยาสำหรับกลุ่มที่มีการกลายพันธุ์ของยีน PIK3CA ยังคงมีความไม่แน่นอน โดยฝ่ายบริหารตั้งข้อสังเกตว่าการออกแบบทางสถิติมีความแตกต่างจากกลุ่มยีนแบบดั้งเดิม ส่งผลให้ความเป็นไปได้ในการอนุมัติฉลากยาจาก FDA สำหรับสูตรยา 3 ตัวและสูตรยา 2 ตัวนั้นมีความซับซ้อนและตรงไปตรงมาน้อยกว่า

การวิเคราะห์อัตราการรอดชีวิตโดยรวมขึ้นอยู่กับจำนวนเหตุการณ์ที่เกิดขึ้น และการเปลี่ยนกลุ่มการรักษา (crossover) จากกลุ่มควบคุมที่ใช้ยา fulvestrant ในกลุ่มยีนแบบดั้งเดิมอาจส่งผลกระทบต่อผลลัพธ์ โดยฝ่ายบริหารระบุว่าผลลัพธ์ OS ที่เป็นบวกอาจมีนัยสำคัญ แต่ไม่ได้มองว่าเป็นสิ่งจำเป็นในการสนับสนุนการนำยามาใช้ในปัจจุบัน

ประเด็นสำคัญจากช่วงถาม-ตอบกับนักวิเคราะห์

ฝ่ายบริหารระบุว่ามีแพทย์ผู้สั่งจ่ายยาในช่วงเริ่มต้นเพียงส่วนน้อยเท่านั้นที่เคยมีประสบการณ์การใช้ gedatolisib มาก่อนผ่านการศึกษา VICTORIA-1 หรือโครงการขยายการเข้าถึงยา (expanded access program) ซึ่งบ่งชี้ว่าการนำยาไปใช้มีความครอบคลุมกว้างขวางกว่าเครือข่ายทางคลินิกเดิม ทั้งนี้ โครงการขยายการเข้าถึงยานั้นรับผู้ป่วยเข้าร่วมเพียงไม่กี่ราย เนื่องจากเปิดให้เข้าร่วมเป็นเวลาเพียงประมาณหกสัปดาห์ก่อนการจำหน่ายเชิงพาณิชย์

ลูกค้าระดับยุทธศาสตร์ชั้นนำที่เหลือซึ่งยังไม่ได้สั่งซื้อนั้น ส่วนใหญ่อยู่ระหว่างการดำเนินการตามกระบวนการของสถาบัน เช่น การเชื่อมโยงชุดคำสั่งซื้อทางอิเล็กทรอนิกส์ โดยฝ่ายบริหารไม่ได้ระบุว่าความสนใจของแพทย์เป็นอุปสรรคหลัก

ข้อมูลสะท้อนกลับเบื้องต้นจากภาคสนามระบุว่า โดยทั่วไปแพทย์นิยมใช้สูตรยา 3 ตัวสำหรับผู้ป่วยส่วนใหญ่ โดยฝ่ายบริหารระบุว่าข้อมูลกลุ่มย่อยจากการประชุม ESMO ซึ่งรวมถึงความแตกต่างของค่า PFS ที่ 10 เดือนระหว่างสูตร 3 ตัวและสูตร 2 ตัวในผู้ป่วยที่ไม่มีการแพร่กระจายไปที่ตับ เป็นปัจจัยที่ช่วยตอกย้ำความนิยมดังกล่าว

ความคิดเห็นเบื้องต้นจากผู้ป่วยและแพทย์ได้รับการระบุว่าเป็นไปในเชิงบวก โดยไม่พบปัญหาด้านความปลอดภัยที่ไม่คาดคิด ขณะที่ทีมงานภาคสนามของ Celcuity กำลังเน้นย้ำถึงความพร้อมของน้ำยาบ้วนปากเดกซาเมทาโซน (dexamethasone) และแนวทางการจัดการภาวะปากอักเสบ (stomatitis)

ฝ่ายบริหารยังคงประมาณการอัตราส่วนการรับรู้รายได้สุทธิจากยอดขายรวม (gross-to-net realization) ไว้ที่ประมาณ 80% พร้อมระบุว่าสัดส่วน 30% ถึง 40% อาจเป็นเกณฑ์มาตรฐานของอุตสาหกรรมสำหรับสัดส่วนธุรกิจที่เกี่ยวข้องกับโรงพยาบาลในโครงการ 340B ขณะเดียวกันก็ชี้แจงว่ายังเร็วเกินไปที่จะระบุสัดส่วนที่แท้จริงของ Celcuity

บทถอดเสียงการแถลงผลประกอบการฉบับเต็ม

บทถอดเสียงฉบับเต็มของการประชุมทางโทรศัพท์ผลประกอบการ

คำชี้แจงจากฝ่ายบริหาร

Operator

Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for an operator. call is being recorded on Thursday, November 5th, 2026. And I would now like to turn the conference over to Jody Seavers. Please go ahead.

Jodi Sievers

Thank you, Marissa, and good afternoon, everyone. Thank you for joining us to review Celcuity's third quarter, 2026 financial results and business update. Earlier today, Celcuity, Inc. released financial results for the quarter ended September 30th, 2026. The press release can be found on the investor section of Salcuity's website. Joining me on the call today are Brian Sullivan, Salcuity's Chief Executive Officer and Co-Founder, Vicki Hahn, our Chief Financial Officer, as well as Igor Gorbachevsky, our Chief Medical Officer, and Eldon Mayer, our Chief Commercial Officer, who will both be available for questions during Q&A. Before we begin, I would like to remind listeners that our comments today include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC.

Actual events or results may differ materially projected in the forward-looking statement. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we also refer to non-GAAP financial measures These non-GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance, Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table, Reconciling the Non-GAAP Financial Measures to GAAP Measures, in today's press release. And with that, I would like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead, Brian.

Brian Sullivan

Thank you, Jody, and good afternoon, everyone. Thank you for joining our third quarter of 2026 operating and financial update conference call. 2026 has been a transformative year for Cellcuity as we transition to a commercial stage company. RaptorPIC is now available to US physicians to prescribe for use in combination with fulvestrant with or without palbociclib for the treatment of HR positive, HER2 negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression of on or after treatment with at least one line of endocrine therapy in the metastatic setting. The unprecedented efficacy results and favorable safety profile reported from the PIK3CA wild-type cohort of the Victoria 1 study provide physicians with a compelling rationale to utilize a gedatolisib regimen to address a significant unmet need for the tens of thousands of patients affected each year by advanced breast cancer. And we're pleased to report and provide our first update on the results of the foundational work our commercial and medical teams have been performing for the past two years to prepare for the commercial launch of RaptorPIC. Our launch is off to a great start and results today are all very encouraging. To provide insight into the effectiveness of our field teams launch activities, particularly since the drug became commercial available on September 30th, we can share the following key metrics.

Since Revuforj became commercially available on September 30th, 78% of the top 36 strategic accounts have ordered Revuforj. These accounts treat roughly 50% of the total addressable patient population. Over 3,400 sites, many of which are affiliated with one of the top 36 strategic accounts, have directly engaged with Salcuity Oncology Sales Specialists. These sites treat 82% of breast cancer patients. Over 1,100 healthcare providers have attended RevTropiq educational programs. Our market access and medical affairs teams have also been very effective. Their efforts have resulted in obtaining early and broad payer coverage and inclusion in major provider pathways so that nearly all eligible patients now, nearly all eligible patients are now have access to RevTropiq.

Within two weeks of approval, we obtained a preferred category one recommendation in the NCCN guidelines for the RevTropiq triplet and doublet as a second line treatment option for HR positive HER2 negative patients. advanced breast cancer patients lacking a PIK3CA mutation. With this NCCN recommendation and the direct engagement of our team, and it has had with nearly all U.S. payers over the past 18 months. Ninety-one percent of U.S. commercial and Medicare lives are in health care plans that cover Revtropic. Now given the complexity of managing care for cancer patients, most healthcare providers adhere to treatment guidelines, most commonly referred to as treatment pathways, that provide guidance and recommendations for the physician to work within a specific healthcare system or network. Inclusion in these pathways eliminates a critical potential barrier to physician utilization of a medicine. take, in some cases, up to 12 months. Our team, though, was able to get RevTripPic incorporated in three of the four largest healthcare provider pathways within just 30 days of becoming commercially available. And these results reflect the groundwork we've been laying for the past 24 months.

During this period, we've engaged over 1,000 key opinion leaders and community breast cancer experts, key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at PAMPathway.com drove awareness of the PAMPathway with metrics that tracked well ahead of industry benchmarks. CME and third party peer to peer programs and regional events have further increased levels of awareness about the importance of comprehensive PAM inhibition and the unmet need in the second line setting. With the build out of the commercialization infrastructure needed to support the successful launch of RevTribPIC completed, commercial launch activities for RevTribPIC commenced immediately after approval. Our 88 oncology sales specialists who have an average of 24 years of industry experience are calling on physicians, supporting installation of RevTribPIC 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 RevTribPIC approval. All of these efforts are designed to offer patients and providers with rapid access and seamless support. to enable treating physicians to obtain gedatolisib on behalf of their eligible patients after we received FDA approval and prior to commercial availability of Revtripit.

So, Purity opened an expanded access program in mid-August. And now, nearly all of the patients enrolled in this program have been transitioned to commercial product. Shipments of Revtripit, which began on September 30th, at a wholesale acquisition cost of 10 $10,000 per vial or $30,000 per 28-day cycle of treatment. Published epidemiological data estimates there are 37,000 patients in the U.S. receiving second-line treatment for HR-positive HER2-negative advanced breast cancer, and that based on the data from the Victoria 1 trial, patients treated with the geda plus fulvestrant regimen in this setting will remain on therapy for an average of 10 treatment cycles. Assuming... Net receipt of 80% of our $30,000 WAC price per cycle. We estimate the total addressable market for Revterpic in the second line setting, including both PIC3CA wild type and mutant patients, is approximately $9 billion annually. Most healthcare providers will order Revtropik through specialty distributors using buy and bill reimbursement.

Revtropik is then drop shipped directly to the treatment location, which is typical for infused therapies, rather than through specialty pharmacies. By selling the product through this channel, we do not obtain access to granular information, such as the number of doctors prescribing. of the number of patients receiving Revtropik. As a result, when we report sales results beginning next year, the data we will be able to provide will be limited to metrics such as gross and net sales, vials shipped, and market access-related metrics. We expect to provide a flash report on fourth-quarter sales in mid-January. and we look forward to providing further updates next year. I'd like now to turn to an update on the status of our clinical development programs and recently reported data. Based on the positive data from the PIK3CA mutant cohort of the phase three Victoria 1 study, we submitted a supplemental NDA to the FDA in third quarter of 2026. And we expect to submit Victoria 1 phase three data for both the wild type and mutant cohorts to global regulatory authorities later this year or early next year.

In October, updated results from the phase three Victoria one study were presented in a late breaking rapid oral presentation at ESMO. These results included median PFS of 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib plus fulvestrant in patients who had no liver metastases. The hazard ratio for the gedatolisib triplet and doublet versus the alpelisib doublet 0.46 and 0.71 respectively. And this is a particularly important result since patients lacking liver mets represent approximately 70% of all patients treated in the setting according to real-world analyses. Now, results for patients with liver mets were also very favorable and consistent with the primary PFS analysis. For the getotelicib triplet and doublet versus the opalypsib doublet, the hazard ratio was 0.47 and 0.38, respectively. The objective response rate for patients with evaluable disease, updated to include both confirmed and unconfirmed responders, was 59% and 43% for the gedatolisib triplet and doublet, respectively, versus 33% for the palbociclib doublet.

And for these patients, the median duration of response for the gedatolisib triplet and doublet was 19.4 and 27.8 months, respectively, versus 7.5 months for alpelisib plus fulvestrant. The discontinuation rate for gadotilisib due to adverse events is 5% and 4%, with the gadotilisib triplet and doublet, respectively, compared to 19% for opalipsib plus fulvestrin. the gadatolisib treatment discontinuation rate for the mutant cohort was lower than was reported for the wild-type cohort. The higher discontinuation rate for the wild-type cohort versus the mutant cohort largely reflects the activity in one region early in the study that enrolled a significant proportion of patients in the first six months. Discontinuations fell in this region as physicians gained experience. Since a much larger proportion of wild-type patients were enrolled during this period than mutant patients, the impact of this initial higher discontinuation rate early in the study fell disproportionately on the wild-type cohort. The mutant cohort, which enrolled more slowly initially and over a longer period of time than the wild-type cohort, we did not see disparity in discontinuation discontinuation rates across regions. Thus, we believe the treatment discontinuation rate for garetoslisib reported for the mutant cohort was four to five percent.

Best represents what we expect to see in a real world setting. And consistent with the data from the PIK3CA wild type cohort, the stomatitis events observed occurred primarily in the first cycle and were transient. By the second cycle of treatment, less than 3% of patients had grade 3 stomatitis, and all grade 3 events improved within one to two weeks. Discontinuations due to stomatitis for the gedatolisib triplet doublet were minimal, 1% and 0% respectively. Additionally, at ESMO, Dr. Sarah Telaney, Chief of the Division of Breast Oncology at the Dana-Farber Cancer Institute, presented a comparative analysis of data for the gadotelicid regimens from the PIK3CA wild-type cohort of Victoria 1 and other regimens evaluated in patients with HR-positive, HER2-negative advanced breast cancer. Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR-positive her2-negative breast cancer who had prior CDK4-6 exposure and had PIK3CA wild-type tumors. And this analysis found that the gadotelicid triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and a progression-free survival rate at six months relative to all of the non-gadotelicid regimens evaluated.

Of note, the analysis found that patients treated with the gadotelicid triplet and doublet were two times more likely and 1.5% more likely to have a gadotelicid triplet 1.5 times more likely respectively, a statistically significant level to survive without disease progression or death compared to fulvestrant plus abemaciclib. We expect to provide further updates to results from both the mutant and wild type cohorts of Victoria 1 at the upcoming San Antonio Breast Cancer Symposium later this year. Gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second line setting regardless of the PIK3CA status of a patient's tumor. And we believe the results from the VICTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K-AKT-MTOR or PAM pathway. Additionally, these results augur well for the Phase III Victoria II trial we have underway to advance development of gedatolisib for two different HR-positive HER2-negative advanced breast cancer populations in the first-line setting. Results from our Phase 1B clinical trial provided strong evidence that the PAM pathway is an important disease driver in treatment-naive patients with advanced breast cancer. In the early phase one study, we evaluated gedatolisib plus palbociclib and letrozole as first-line treatment in 41 patients with endocrine-sensitive, HR-positive, HER2-negative advanced breast Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib plus letrozole, the therapy we are using as the control in a Victoria 2 trial.

The objective response rate was 79% for getaflicid plus palbociclib, which again compares favorably to historical data of 53% for ribociclib plus letrozole. In light of the positive results for the PIK3CA wild type and mutant cohorts in Victoria 1 and the promising preliminary data for a gedatolisib triplet as first-line treatment, we're optimistic about the results of both the first-line studies. And successful development in the first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed. diagnosed with late stage HR positive, HER2 negative advanced breast cancer in the US, irrespective of their endocrine sensitivity or PIK3CA status. The total addressable market for gettalizib in the first line setting is well over $10 billion annually. Our advancement of a subcutaneous gettalizib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gettalizib. It aims to support potential future indications of gettalizib regimens that may result in duration of treatment periods greater than several years. like now to turn to our phase 1b2 clinical trial that's evaluating getalizib in combination with darolutamide in men with metastatic castration resistant prostate cancer so Curoty presented updated data from the study during a poster session that last month's ESMO Congress 2026 key results included Median progression-free survival, or RPFS, was 15.7 months, and the six-month RPFS rate was 82.2% in patients with prior exposure to abiraterone. median RPFS was 9.1 months, and the six-month RPFS rate was 62.5% in patients with prior exposure to enzalutamide. sets of results compare favorably to published data for patients with these with either a novel hormonal therapy or docetaxel in this setting. Now, the difference in results between patients with prior exposure to abiraterone versus enzalotamide was expected and reflects differences in the mechanism of action of these two drugs.

For patients who had more than 50% decreases from baseline PSA, we observed them consistently across all dose levels. The PSA response rates were 36%, 47%, and 67% at the 120, 180, and 240 milligram dose levels, respectively, in patients with prior exposure to either abiraterone or enzalotamide. Abiraterone or Enzalutamide. Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels of 120, 180, and 240 mg with only one dose limiting toxicity, which was grade 3 rash. No grade 4 or 5 treatment-related adverse events or TRAEs, and no TRAEs leading to this continuation of GETA or death. Grade 3 TRAEs occurred in 20% of patients with only rash and pruritus occurring in more than one patient. A randomized phase two study to determine the recommended phase three dose level of gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer is expected to begin in the first half of 2027 after completion of the phase one B part of this study. Now with programs in both breast cancer and prostate cancer, reflecting the important role of the PAM pathway in these diseases, Celcuity is well positioned to build an important pharmaceutical company over the next few years. concludes my remarks.

I would like now to hand the call over to Vicki, our CFO, to review our finances.

Unknown Speaker

Thank you, Brian, and good afternoon everyone. I'll provide a brief overview of our financial results for the third quarter of 2026. Our third quarter net loss was 73.3 million, or $1.33 per share, compared to a net loss of 43.8 million, or $0.92 per share, for the prior year period. Our non-GAAP adjusted net loss was 66.8 million or $1.21 per share for the third quarter of 2026, compared to non-GAAP adjusted net loss of 37.2 million or $0.78 per share for the prior year period. Shipments of Rytelo commenced on September 30, 2026. We recognized revenue when control of Rytelo transferred to the treatment location, which generally occurs upon delivery, because no product was received at the treatment location until the treatment was completed. until after September 30th, 2026, we did not recognize any product revenue during the third quarter of 2026. Total operating expenses were 77.3 million for the third quarter of 2026, compared to 42.8 million for the prior year period.

Research and development expenses were 37.5 million for the third quarter of 2026 compared to 30.4 million for the prior year period. The 7.1 million increase was primarily due to a 5.3 million increase in employee-related and consulting expenses. and 2.1 million increase in manufacturing and other costs. These increases were partially offset by a 0.3 million decrease in clinical trial costs. Selling, general, and administrative expenses were 39.8 million for the third quarter of 2026 compared to 12.4 million for the prior year period. The 27.4 million increase was primarily due to a 14.4 million increase in employee-related expenses, primarily driven by the hiring of additional personnel within our commercial function to support the commercialization of RevTorpec. The remaining 13 million increase was primarily due to 11.1 million increase in costs to support the commercialization of REVTORPIC, including consulting expenses, expanding infrastructure costs, and a 1.9 million increase in other administrative expenses. In the aggregate, 25.3 million of the 27.4 million selling general and administrative increase related to commercial headcount additions and other activities to support the commercialization of RevTorpec.

Net cash used in operating activities for the third quarter of 2026 was 66.2 million, compared to 44.8 million for the prior year period. The additional cash used in operating activities quarter over quarter 21.4 million was primarily due to non-GAAP adjusted net loss of 29.7 million, partially offset by working capital changes of 8.3 million. In addition, we made a $50 million payment to Pfizer, which was triggered by receipt of the FDA approval for gedatolisib per our exclusive global license agreement for gedatolisib. This payment was classified as investing activity on the condensed statement of cash flows during the third quarter of 2026. Cash equivalents and short-term investments were 642.7 million at the end of the third quarter compared to 441.5 million as of December 31, 2025. The 201.2 million increase was primarily driven by the convertible note offering completed in June 2026. This resulted in gross proceeds of 575 million and net proceeds of 557 million.

The proceeds were partially offset by 172.7 million of cash used in operating activities. repayment of 137 million term loan and the $50 million payment to Pfizer for the license milestone payment. Additional cash provided by investing and financing activities of 3.9 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases. We expect cash, cash equivalents, and investments to finance our operations through 2029. I will now hand the call back to Jody.

Jodi Sievers

Thank you, Vicki. Marissa, could you please open the call for questions?.

Operator

Absolutely. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star, followed by one on your touchtone phone. You will hear a prompt that your hand has been raised. And should you wish to remove your hand from the queue, please press star, followed by two. Just a moment for your first question. Your first question comes from Maury Raycroft with Jefferies. Please go ahead.

Unknown Speaker

Hi, congrats on the early progress and thanks for taking my questions. I was going to ask for your initial prescribers, can you say what proportion of these prescribers had prior experience with the drug through the EAP or your clinical programs and how broad is adoption beyond those physicians?.

Brian Sullivan

I would say a very small percentage of the doctors prescribing were those who had participated in the Victoria One study or who had prescribed medicine with EAP. We had significant participation by those prescribers, but they did not comprise a significant proportion of the total. Yes, significant participation by those. based on our analysis of the number of vials. But we don't see specific data by doctor. So again, we can only estimate what we think the impact of their involvement in the initial uptake was.

Unknown Speaker

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

Brian Sullivan

I would say it was a handful. And again, I think as I've indicated earlier, the program became active mid-August and with the idea that it was going to become irrelevant or no longer available. by the end of the third quarter or roughly six weeks. And so that essentially led many physicians to indicate that the kind of work to get approval from their IRB was not going to yield their ability to enroll a patient in the EAP program before our drug became commercially available. them. And so while some doctors did take advantage of it, you know, the short timeframe when the program was believed to be relevant, you know, really disincentivized most doctors to participate in the program. But it did allow those who had either, you know, the ability because of their systems flexibility or willingness to do the work upfront to participate. And that was one of the goals was to, you know, for those who institutionally or personally were able to over this short period of time, take advantage of the program, and that was a good outcome.

Unknown Speaker

Got it. Okay. And then I'll ask one more question and then hop back in the queue. Just wondering if you can clarify if the second manufacturing site is fully operational, and is there any perspective you can share on inventory and whether there are any gatings.

Brian Sullivan

to maintaining a steady supply of the drug? Yes, I would just say that we have sufficient production to handle are planned or higher than planned demand from the field. And we indicated that we don't expect the second site to be operational, to be, approved until sometime middle of 2027.

Operator

been consistent with what we've stated previously. Got it. Okay. Thanks for taking my questions. You're welcome. Your next question comes from Anupam Rama with JP Morgan. Please go ahead.

ช่วงถาม-ตอบ

Anupam Rama

Hey guys, thanks so much for taking the question and congrats on the progress here. I know in the press release you talked about 78% of your top sort of 36 priority accounts have ordered the REVAuto pic. Can you give us a little bit more color on the balance of the centers and kind of what are the gating factors for that? them to kind of get their first order in. Thanks so much.

Brian Sullivan

I would say the primary gating factor, I mean, to be frank, to put that in context, we've spoken with some people and these accounts can be the ones that can take several months to get on. And so to get 78% in the first month is quite significant. But for those that didn't place an order, it was less about their lack of interest in doing so. and more to do with, you know, essentially the specific organizational requirements, whether it's getting the order set fully embedded in their systems. Some of these institutions have, you know, are complex organizations or other organizations kind of again more bureaucratic implementations to make the drug available. So we don't anticipate that there are any true barriers other than just getting them institutionally prepared to prescribe, have their doctors prescribe the medicine. Great. Thanks so much for taking our question.

Operator

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

Tara Bancroft

Hi, good afternoon. So obviously your team has had a lot of touch points with the treating community. So I'm curious to hear from those experiences, what your updated thoughts or expectations are for seeing any potential for a bolus at all, either this quarter in wild type or in in mutant patients once approval is reached there. And if you're so far seeing or expecting any off-label use in the mutant segment prior to that approval, or if you think physicians will wait for the formal label. Thanks so much.

Brian Sullivan

I kind of know what you're getting at with the bolus, but again, these are sick patients and they're not stacked up, ready to go. And so I would say that the demand almost completely reflects patients who require a new treatment option, whether that's in the second or third line setting. great bulk just based anecdotally on feedback we've received from reps and information they report back to us that the bulk of the patients receiving the medicine are in the second line setting, which is as we would expect. But of course, there's a lot of patients in the third line setting who don't have great treatment options, and so doctors are taking advantage of the availability of Rezurock to treat them. As far as mutants, usage in patients who have PIK3CA mutations. We've certainly heard physicians have an interest. They're very excited about the data. They would like to use it.

And obviously we're not approved to treat those patients. And so our Salesforce does not engage in those discussions. as you'd expect and to the extent that the physicians make the decision based on the data that has been reported, you know, that they have that, that have the ability, and then they'll have to work through reimbursement for the patient. But other than that, I can't really comment on, you know, prescribing behavior with that population.

Operator

Okay, great. Yes, understood. That's very helpful. Thank you. You're welcome. Your next question comes from Michael Schmidt with Guggenheim. Please go ahead.

Unknown Speaker

Oh, hey, good afternoon. Thanks for taking my question. Yes, just a few more questions if you could share sort of anecdotes in terms of how you're seeing the drug use early on in terms of, you know, the types of patients that are going on to therapy relative to the Victoria 1 study and, you know, any insights on usage in either 1, you know, mutant versus wild-type patients and perhaps split between the triplet and the doublet.

Brian Sullivan

Sure. We haven't really gotten much visibility on usage with, of according to ESR1 status, to be frank. So I really don't have anything to add offer there. But regarding the usage of the triplet versus the doublet, that is something that our oncology sales specialists have discussed with the doctors that are looking for input and help in sorting through the data to make that decision. And again, this is anecdotal, but we see a pretty consistent pattern based on the self-reporting that we obtained from our OSS's, that the triplet is the preferred regimen by most of the doctors for most of the patients that they treat. And that's consistent with the surveys we've done over the course of the past year with docs where we present the data and ask for their decision about which therapy they would select first. And over time, you know, we would expect that pattern to hold. But it's early, and again, we don't get precise data, and it's primarily anecdotal, but so far consistent with what our expectations were.

Okay, great. And how should investors think about sort of the launch trajectory, perhaps over the next 12 months relative to some of the recent breast cancer launches? When you think about, you know, unique dynamics around JCODE, for example, do you expect that to be a significant bolus for uptake next year? Well, again, because we're an infused drug, we have to work on a temporary J-code. Because we were approved after the halfway point of the year, our J-code won't become active until April 1st. We'll receive the J-code itself January 1st, but it's not active. A lot of community sites, for instance, are the ones that can be particularly affected by J-code or weary of prescribing drugs that don't have a permanent J-code. because of the reimbursement risk in their view. But we have not found that to be a huge obstacle at this point, certainly some. We expected that. We have a reimbursement specialist that in our Rezzayo Support Service group that has been effective helping community sites, for instance, navigate some of the challenges. or concerns that some of these sites have about reimbursement. We also have a program that is offering these sites extended payment terms so that they're not at risk of essentially going upside down from a cashflow standpoint with, with getting solicited with ReftroPik.

And so while it will be an obstacle for, for a certain number of accounts, we bake that into the plan, but it's not an immovable object. Certainly that friction will be removed when the J code comes, but it's not – it's.

Operator

an all-encompassing barrier in general. Okay, thank you. Your next question comes from Gil Blum with Needham. Please go ahead.

Gil Blum

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

Brian Sullivan

We have, that's actually one of the requirements that we've asked our reps to follow through on. that A, once they learn that a doctor or that an order has been placed to a specific site, typically know early on at least, it'll be easy for them to know which doctor it was. They're expected to follow up with the doctor to make sure the site is ready, has what they need, dexamethasone mouth rinse is available at that site or that pharmacy for the patient before the they come in and then also to follow up with us with either the doctor or an appropriate individual at the site the treating center to see how the patient experienced the infusion and get up. And so far, based on those types of conversations, which should be happening every day across the country, the feedback has been very positive. Patients are having a very good experience, nothing anomalous. And I think our group has done a very good job of edging out the relevant healthcare providers to help them understand what to expect from an adverse event standpoint, to make sure that the guidelines that we've put in place for the of Stomatitis Management been put in place. So there's been no surprises, which is important. either for the providers or for the patients. And so I would say, almost universally, from the feedback we've received to date, the patient experience and the doctor's perspective on the patient's experience has been very positive.

Thank you. Very helpful.

Operator

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

Unknown Speaker

Daniel Brander on for Lee Wacek. Thank you for taking our question and congrats on the update. We were wondering if you could comment on the potential future implications of last night's update on 340B or Rytelo's launch right now, but then also as you expanded to the mutant population. Thank you.

Brian Sullivan

Well, since our drug got approval prior to this program becoming effective, we're grandfathered in to the current discounts offered to the 340Bs, so we do not expect... this new program to affect our reimbursement rate for those hospitals. And so essentially what we've communicated to date regarding our gross to net estimate is consistent. that that program was in place, but we were able to avoid it. impacting us by getting our approval in time to get the appropriate paperwork filed so that we would be grandfathered into the current system or the system that preceded this one.

Operator

Thank you. Your next question comes from Andrew Behrens with Leerink Partners. Please go ahead.

Unknown Speaker

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

Brian Sullivan

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

And so all of those components of the program are factored into our timelines and we're on track with the program overall.

Operator

Got it. Thank you. Cool. Your next question comes from Stephen Willie with Stifel. Please go ahead.

Stephen Willey

Yes, good afternoon. Thanks for taking the questions. Maybe just to follow up on the last question. Should we expect any kind of quantitative disclosure around progress being made on the sub-Q formulation, say over like the next 12 months or so, or will the process be done? progress updates here kind of continue to be mostly qualitative in nature.

Brian Sullivan

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

Stephen Willey

And then maybe just, can you say if the study two data updates that were presented at ESMO, were those included in the sNDA submission? And I guess just any updated thoughts on how it a mutant label might read with respect to either both or one of the regimen, thanks.

Brian Sullivan

We're in the middle of providing additional data to the agencies. This is part of the normal review cycle. And so we provided a variety of analyses, additional analyses, including some of the data that you saw in the ESMO presentation. As far as the label, again, I don't want to speculate. It's less straightforward than the the wild type because the wild type had two primary endpoints with alpha assigned. The doublet was a secondary endpoint but with no alpha assigned, so that makes it a little uh, less, um, uh, obvious, I guess, exactly, uh, how the agency will stand. And, again, we, we've discussed that, uh, because of the nature of the expectations the agency has for powering studies to support an indication on the label.

But those are the type of discussions we'll be having with the agency and we'll see what we see.

Operator

All right, thanks for taking the questions. You're welcome. Your next question comes from Sylvain Turcan with Citizens. Please go ahead.

Silvan Tuerkcan

Hey, good afternoon, congrats on the quarter and thanks for taking my question and I may be a little rusty on my CMS rules. I just want to follow up on that. You know, that change in the rule. How exactly does it work that you're grandfathered in into the current discounts? Just do you have qualifying pathways? pass-through status, or how does that work? And how much roughly do you expect utilization to be through the 340B? be hospitals? And then a second question is how much inventory do you think sites will build in the near term? And do you have any visibility into how many.

Brian Sullivan

weeks that could be thank you but okay so we don't expect sites to really build much inventory we drop ship within essentially next day to the sites and so it's quick turnaround time. There's no reason, most sites I think will conclude there's no reason to build inventory. So any orders that we're getting in our view are linked to a a particular patient and not putting drug on the shelf. As far as the 340B, again, I can say what I said before, but what I said before is what's the case. So we won't be exposed to this, new rules and so as far as the percentage of 340B, It can vary depending on the indication. I think other companies have reported 30 to 40% of business can be 340B. You know, we're early in the process.

I don't want to make a number up, but, you know, that's a useful benchmark to consider. And we have an assumption in our estimate along that range that allowed us to estimate that we think the gross to net will be 80%. 20% discount. Great. Thank you for taking my question.

Operator

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

Unknown Speaker

Hi, thanks for taking my questions. I'm just curious if you can remind us on the timeline to mature overall survival data from Victoria one, the process for potentially adding these data to the FDA label in the future, and then any early feedback you're hearing on how meaningful OS could be for the launch curve. Thanks again.

Brian Sullivan

So, as far as the OS data, we've indicated previously that we expect that sometime in the first half of 27. So again, it's event driven and we follow the trends. But the events and OS analysis can be be a little bit more unpredictable than in progression so you know we have to have we're using a fairly wide time band uh for that estimate as far as the label uh you know it would only really get incorporated in the label if it's positive So, again, until we see the data, we won't know. As far as, you know, the impact it can have, I mean, certainly if it's positive, it would be impactful because, best I know, and again, to the best of my knowledge, there has been no second-line indication showing, at least with an endocrine backbone therapy, positive. a favorable OS advantage over the control. And so certainly if we achieve that, that would be helpful, but I don't, and important for the patients, But I don't think there's an expectation, at least as we've discussed IMerge and the results with doctors, an expectation that that's required for them to, you know, make a decision on use of imetelstat, you know, essentially. progression-free survival has really been the data that's been used and then subgroup analyses to help better understand treatment effects for particularly important clinical populations. if we were to achieve it, it would be a big deal. We've also indicated that because our study one, you know, the PIC3CA wild type cohort, allowed patients to cross over from the fulvestrant arm without control, that creates a confounding effect. And so while we showed a favorable trend and we were encouraged by that in the interim analysis, whenever you have crossover, you just have to expect that there's going to be confounding.

And so, again, we don't wanna create any expectations of anything, we'll see it when we see it. But I don't think it's, the OS is not a positive result. You know, I don't think that will have any impact on the launch. Very helpful. Thank you.

Operator

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

Kalpit Patel

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

Brian Sullivan

Thank you. Sure, thanks for the questions. So regarding the NCCN guidelines for mutant patients, If that's dependent on publication being available, they will only consider a publication or rather for an additional expansion of the recommendations based on the peer review journal article. We expect to have that available this quarter. We would then submit, to the NCCN asking for a recommendation. And the timing of that is difficult to project because it's somewhat dependent on their, Meeting schedule, since this won't be linked to a label, you know, it's not clear to us whether they would call an ad hoc meeting as they did for, you know, the wild type indication. But it's not unreasonable to expect that prior to an approval decision by the FDA that NCCN would incorporate some recommendation in their guidelines. Okay, and regarding the average time.

So we think it's quite quick. Again, this is all anecdotal. This is all self-reported from our reps. Our reps are very intimately involved, particularly in these early, and the average... Oh, okay. And regarding the average... patients, you know, because they've been working to essentially ride shotgun on the process with the patient. But we think it's fairly quick. I mean, based on experience that when doctors identify a patient, they want to put them on therapy as soon as they can. There's not a wait and see approach.

So we're receiving demand that we think is real time reflection of a patient requiring treatment and the intention of giving them that treatment as soon as it's available.

Kalpit Patel

Okay. And if I can squeeze in a follow-up here, do you have any granularity on how many sites have actually ordered? I know you gave the number for the strategic accounts.

Brian Sullivan

So we'll be providing those types of updates. Yes, no, I appreciate the question. We'll be providing those types of updates. when we provide an overview in January of the full quarter. Okay, thank you. You're welcome. Your next question comes from Sylvain Turcan with Citizens. Please go ahead.

Silvan Tuerkcan

Thanks so much for taking my follow up. I just want to know if you have any takeaways from ESMO from your doctors, maybe that you engage there with, given the presentation that you had from Victoria breaking out these different patient populations in terms of if they understand how wide you cast your net in terms of patients that you're enrolling in.

Brian Sullivan

versus some of these maybe mutant selective trials that are ongoing. Do you have any feedback Sure. Is the patient appreciated? No, it's, sure. No, we've had conversations with, since we've had our approval obviously with a broader group of doctors. But I would say there's a general understanding or recognition that we enrolled a patient population with significant disease burden that wasn't necessarily representative of the typical patient that they'll see. And really, I think the most telling statistic relates to the presence of, You know, 70% of patients typically don't have liver mets, and liver mets are probably one of the most important factors that correlate to worse prognosis and lower liver disease. less favorable treatment effect on an absolute basis. And so in our case, we had over 50% or 50% or so of patients in the mutant setting, as well as the wild type that had liver mets.

So essentially that can act as a depressant in your absolute number. It doesn't affect the hazard ratio as it turns out when you look at the subgroups and you see the hazard ratio are comparable across subgroups, depending on the treatment burden, or rather disease burden. But the data that we presented, roughly 21 and a half months median PFS for the no liver mets was really important for two reasons, as I indicated in my remarks. It's essentially representative of roughly 70% of patients. And so that was really a fantastic It also highlighted and was clarifying for many docs in understanding the contribution of Palbociclib because certainly, the intent to treat PFS was very similar of the doublet and triplet, and so somewhat confounding. And at the same time, OS trend was more favorable in the triplet than in the doublet. But again, interim analysis of immature people were reluctant to draw too many conclusions about that.

But in this case, with the triplet versus the doublet, showed a 10-month advantage. relative to the doublet, which is obviously very meaningful clinically. And so that really, I think, clarifies for many doctors a question they've had. What should I start with? Should I start with the doublet or the triplet? And the feedback, I think, was fairly consistent that this really – motivates them, indicates to them that it makes sense to start with a triplet. And again, that's what we're seeing in the wild type cohort so far, anecdotally recorded. But with the data at ESMO, it filled in some blanks that led most of the physicians we spoke to, I think almost every one, to prioritize use of the triplet for patients unless there are other factors that may warrant avoidance of neutropenia, for instance. Thank you, Brian. Thanks for the details. You're welcome.

Operator

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

Brian Sullivan

Thank you everyone for your interest in Cellcuity. We look forward to reporting back in January timeframe. Take care. Thank you, everyone, for your participation.

Operator

This concludes today's webcast and conference call. You may now disconnect.

This live transcript is auto-generated without human intervention or review.

[Call has ended.]

This live transcript is auto-generated without human intervention or review.