Iovance Biotherapeutics Q3 and YTD 2024 Financial Results and Updates

Iovance Biotherapeutics, Inc., a commercial biotechnology company, has shared its financial results and corporate updates for the third quarter and year-to-date 2024. The company is focused on developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients. Iovance has reported significant demand for its product Amtagvi™ (Lifileucel), leading to substantial revenue growth.

Frederick Vogt, Interim President and CEO of Iovance, emphasized the successful U.S. launch of Amtagvi for treating advanced melanoma in patients previously treated. There has been a robust demand for Amtagvi and Proleukin® as Iovance expands its network of authorized treatment centers (ATCs) and reaches out to community oncologists. This has resulted in a higher volume of patient referrals and is expected to drive growth in the coming years. Iovance is pursuing additional regulatory approvals to expand its commercial footprint beyond the U.S. into markets with a high prevalence of advanced melanoma.

For the third quarter of 2024, Iovance recognized $58.6 million in total product revenue from sales of Amtagvi and Proleukin. Of this, $42.1 million came from U.S. Amtagvi sales, reflecting strong demand and adoption since its launch in the second quarter of 2024. Proleukin revenue contributed $16.5 million, being used in the Amtagvi treatment regimen and other settings. By the end of Q3 2024, Iovance had recognized $90.4 million in total product revenue since Amtagvi's U.S. launch on February 20, 2024.

Amtagvi has been infused into 146 patients since April 2024, with a total of 25 patients infused in Q2, 82 in Q3, and 39 in Q4. Amtagvi and Proleukin have generated year-to-date revenues of $54.9 million and $35.5 million, respectively. Iovance is reaffirming its revenue guidance for FY24 and FY25, expecting total product revenue to be between $160-$165 million for 2024 and $450-$475 million for 2025.

As of September 30, 2024, Iovance had cash, cash equivalents, investments, and restricted cash totaling $403.8 million. This is expected to be sufficient to fund current and planned operations, including manufacturing expansion, into early 2026.

Amtagvi was approved by the U.S. FDA in February 2024 as the first treatment option for advanced melanoma after anti-PD-1 and targeted therapy. Onboarding at 56 U.S. ATCs across 29 states is complete, with 70 ATCs expected by the end of 2024. Manufacturing turnaround times are on target, with ongoing efforts to reduce them further. Approximately 70% of Amtagvi patients are covered by private payers, with policies covering over 250 million lives adding Amtagvi.

Iovance is actively pursuing international regulatory approvals for lifileucel to treat advanced melanoma. Marketing authorization applications have been validated and accepted for review by European regulatory authorities. Approval in the UK is expected in the first half of 2025, with approvals in the EU and Canada anticipated in the second half of 2025. Additional regulatory submissions are planned for 2025 and 2026 in markets with significant populations of advanced melanoma patients.

Iovance's TIL cell therapy pipeline shows promising advancements. Updated clinical data for lifileucel in frontline advanced melanoma was presented at ASCO 2024, demonstrating high response rates and a differentiated safety profile. Enrollment in the TILVANCE-301 trial, which supports accelerated and full U.S. approvals of Amtagvi in combination with pembrolizumab, continues globally.

For non-small cell lung cancer (NSCLC), enrollment in the IOV-LUN-202 Phase 2 trial is accelerating. The FDA has provided positive feedback on the proposed potency matrix and trial design for lifileucel in NSCLC. Data from this trial is expected to support potential accelerated U.S. approval in 2027.

In endometrial cancer, Iovance has commenced patient enrollment in the IOV-END-201 Phase 2 trial. Research and development efforts also include next-generation TIL pipelines, such as gene-edited cell therapies and modified interleukin-2 analogs.

Iovance plans to expand its manufacturing capacity to treat thousands of patients annually. The Iovance Cell Therapy Center (iCTC) is undergoing expansion to supply TIL cell therapies to more than 5,000 patients annually. Iovance also aims to address more than 10,000 patients annually through a developing manufacturing network.

Overall, Iovance Biotherapeutics is well-positioned to remain a global leader in TIL cell therapy, with ongoing innovation and expansion efforts set to address critical unmet needs in cancer treatment.