Iovance Biotherapeutics Q2 and H1 2024 Financial Results and Updates
Iovance Biotherapeutics, Inc., a commercial biotech firm, shared its financial performance and updates for the second quarter and first half of 2024. The company is focused on pioneering polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer treatment. Frederick Vogt, Interim President and CEO of Iovance, highlighted the successful FDA approval and U.S. commercial launch of Amtagvi™ (lifileucel) for advanced melanoma, noting strong demand and increasing utilization among authorized treatment centers (ATCs).
Financial Performance and Guidance
For the second quarter of 2024, Iovance reported total product revenue of $31.1 million, driven by the initial launch of Amtagvi on February 20, 2024. Amtagvi alone accounted for $12.8 million in revenue for the quarter, with Proleukin® contributing $18.3 million. The company anticipates substantial quarter-over-quarter revenue growth, expecting third-quarter revenue to be between $53 and $55 million. For the full year 2024, Iovance projects total product revenue of $160 to $165 million and $450 to $475 million for 2025. The firm had a cash position of $449.6 million as of July 24, 2024, expected to sustain operations through early 2026.
Amtagvi U.S. Launch and Market Expansion
The FDA approved Amtagvi on February 16, 2024, making it the first T cell therapy for advanced melanoma after anti-PD-1 and targeted therapy. More than 50 U.S. ATCs across 29 states have completed onboarding, covering over 90% of addressable patients within 200 miles of a center. The manufacturing turnaround time has been about 34 days, aligning with initial launch expectations. Amtagvi has also secured a favorable position in the National Comprehensive Cancer Network® guidelines for cutaneous melanoma treatment. Approximately 75% of Amtagvi patients are covered by private payers, with policies covering over 225 million lives incorporating Amtagvi within the first five months post-launch.
Global Market and Indications Expansion
Amtagvi aims to reach more than 20,000 patients with advanced melanoma in the U.S. and global markets, with regulatory submissions planned for the European Medicines Agency and other regions including the UK, Canada, and Australia. If approved, Amtagvi will be the first therapy in its class available across European Union member states. Iovance plans to submit regulatory dossiers in additional countries in 2024 and 2025.
TIL Therapy Pipeline Highlights
Iovance continues to advance its TIL cell therapy pipeline. In frontline advanced melanoma, updated clinical data from the IOV-COM-202 trial demonstrated significant efficacy and safety, supporting the Phase 3 TILVANCE-301 trial. This trial will explore lifileucel in combination with pembrolizumab, with global site activation and patient enrollment progressing well.
In non-small cell lung cancer (NSCLC), the IOV-LUN-202 Phase 2 trial is accelerating enrollment across the U.S., Canada, and Europe. The FDA has provided positive regulatory feedback on the trial design, and Iovance aims to complete enrollment and report topline data in 2025, targeting a supplemental biologics license application in 2026.
For advanced endometrial cancer, the IOV-END-201 trial, launched in the second quarter of 2024, will investigate lifileucel for patients who have progressed after standard treatments. Iovance sees this as a significant opportunity to address unmet medical needs in the post-anti-PD-1 treatment setting.
Next-Generation TIL Pipeline and Manufacturing
The company is also working on next-generation TIL therapies, including PD-1 inactivated TIL cell therapy (IOV-4001) and a second-generation IL-2 analog (IOV-3001). Expansion plans for the Iovance Cell Therapy Center (iCTC) are underway to increase capacity to treat over 5,000 patients annually, with a long-term goal of addressing more than 10,000 patients per year.
Corporate Updates
Iovance holds over 210 granted or allowed patents and recently renewed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. This partnership aims to develop enhanced tumor reactive TIL products for various cancers over the next five years.
Financial Results
Iovance reported a net loss of $97.1 million for the second quarter of 2024, an improvement from the $106.5 million loss in the same period of 2023. Revenue for the second quarter was $31.1 million, up significantly from $0.2 million in the prior year, mainly due to the U.S. launch of Amtagvi and Proleukin sales. Cost of sales was $31.4 million, primarily due to commercial manufacturing costs for Amtagvi.
Research and development expenses decreased to $62.1 million, while selling, general, and administrative expenses rose to $39.6 million, reflecting increased headcount and costs to support commercialization efforts.
In summary, Iovance is making significant strides in commercializing Amtagvi and expanding its TIL therapy pipeline, positioning itself as a leader in innovative cancer treatments.
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