On August 7, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported second quarter and first half 2025 financial results and corporate updates (Press release, Iovance Biotherapeutics, AUG 7, 2025, View Source [SID1234654986]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "In the first half of 2025, we continued to drive U.S. adoption for Amtagvi in advanced melanoma, surpassing more than 100 patients treated within a single quarter. Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients. We expect our first ex-U.S. regulatory approval imminently and remain on track to provide updates on our clinical programs."
Second Quarter and First Half 2025 Financial Results, Corporate Guidance and Updates
Product Revenue and Guidance
Second Quarter 2025 Total Product Revenue: Iovance recognized total product revenue of $60.0 million from Amtagvi and Proleukin during the second quarter ended June 30, 2025. Year-over-year product revenue increased by 93% compared to $31.1 million in the second quarter of 2024. The U.S. FDA approved Amtagvi (lifileucel) on February 16, 2024, as the first treatment option for patients with advanced (unresectable or metastatic) melanoma after anti-PD-1 and targeted therapy.
2Q25 Amtagvi Revenue: Product revenue from U.S. Amtagvi sales was $54.1 million, representing 102 commercial patients treated. Infusion growth was a direct result of increased field activities in existing ATCs and contributions from new ATCs treating patients.
2Q25 Proleukin Revenue: Product revenue also included $5.9 million in Proleukin sales, reflecting restocking orders from two major U.S. wholesalers to keep pace with increasing Amtagvi utilization. Strong growth in Proleukin revenue in the second half of 2025 is expected to align with Amtagvi demand and year-end restocking patterns at U.S. distributors. In addition to the Amtagvi treatment regimen, Proleukin revenue is recognized from other commercial, clinical, manufacturing, and research sales.
Full Year 2025 Total Product Revenue Guidance: Iovance is reiterating total product revenue guidance within the range of $250 to $300 million in the first full calendar year of Amtagvi sales. The forecast continues to track in line with current and expected ATC growth trajectories, including large community practices and community referral activities. Proleukin sales are also expected to accelerate in the second half of 2025 from restocking at U.S. distributors, ex-U.S. demand, and sales growth for clinical and manufacturing uses. Iovance expects continued growth in total product revenue for the full year 2026 and beyond. Gross margins are expected to increase through near-term optimization of manufacturing capacity utilization over the next several years.
Amtagvi (Lifileucel) Monotherapy U.S. Launch Highlights in Advanced Melanoma
Real-World Retrospective Study for Commercial Amtagvi
The physician-assessed objective response rate (ORR) was 48.8% (20 out of 41 evaluable patients treated with commercial Amtagvi).
ORR was higher with earlier Amtagvi monotherapy:
60.9% (14/23) in third-line or earlier patients
33.3% (6/18) in patients following three or more prior lines of therapy
Iovance plans to present detailed data at an upcoming medical meeting in 2025.
Authorized Treatment Centers (ATCs)
The Amtagvi treatment network includes more than 80 U.S. ATCs across 35 states and 95% of addressable patients live within 200 miles of an ATC.
New ATCs continue to be onboarded as the network expands beyond top academic centers.
U.S. community referral activities are accelerating to drive earlier treatment with Amtagvi.
Iovance has entered into a specialty pharmacy agreement with Biologics by McKesson, a key offering within InspiroGene, McKesson’s suite of CGT commercialization solutions. This new access channel, added in direct response to requests from large community practices, will be another option for providers to acquire Amtagvi, alongside the traditional direct purchase channel.
Commercial Manufacturing
Manufacturing turnaround time has improved to 33 days from inbound to return shipment to ATCs.
The overall commercial manufacturing experience remains consistent with prior clinical experience.
Launch Expansion into New Markets
Amtagvi has the opportunity to address more than 30,000 patients globally with previously treated advanced melanoma.1 Iovance is gaining momentum to address adult patients with previously treated advanced melanoma in new markets.
Health Canada is expected to approve Amtagvi monotherapy in the coming weeks as the first T cell therapy for a solid tumor cancer and first treatment option in Canada for previously treated advanced melanoma. Iovance is preparing for a commercial launch in Canada over the next few months.
Iovance recently withdrew a marketing authorization application (MAA) from the European Medicines Agency (EMA) following interactions with EMA’s Committee for Medicinal Products for Human Use. A new strategy is in development to make Amtagvi and TIL therapy broadly accessible to patients in the EU.
Iovance expects Amtagvi approval in three additional markets:
Review in the United Kingdom is on track for potential approval and launch in the first half of 2026.
Australia’s Therapeutic Goods Administration granted Priority Review with a decision anticipated in early 2026.
Swiss Medic recommended Priority Review ahead of the Swiss regulatory submission planned in the fourth quarter of 2025.
Recent Iovance TIL Cell Therapy Pipeline Highlights
Lifileucel Franchise in Solid Tumors: Priority Programs
Combination Therapy in Frontline Advanced Melanoma: The registrational TILVANCE-301 trial continues with strong momentum to support U.S. approval of Amtagvi in combination with pembrolizumab in frontline advanced melanoma, and full approval in post-anti-PD-1 melanoma. The trial was designed with FDA and EMA input to show the contribution of components for Amtagvi in combination with pembrolizumab compared to pembrolizumab alone.
Lifileucel Monotherapy in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC): Iovance remains on track to share additional data in the second half of 2025 from the IOV-LUN-202 registrational Phase 2 trial to support a potential U.S. accelerated approval of lifileucel monotherapy in post-anti-PD-1 NSCLC in 2027. The FDA previously provided positive regulatory feedback on the IOV-LUN-202 clinical trial design and proposed potency assay matrix to support registration. The single-arm IOV-LUN-202 trial is investigating lifileucel monotherapy in a defined patient population with limited options after approved standard of care. This trial design aligns with FDA guidance for single-arm trials to support accelerated approvals in conditions with unmet medical need.
Lifileucel Monotherapy in Endometrial Cancer: Iovance is actively enrolling in the IOV-END-201 Phase 2 trial for advanced endometrial cancer, a significant unmet medical need. The trial is investigating lifileucel after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status, with initial results on track for the second half of 2025.
Next Generation TIL Pipeline
PD-1 Inactivated TIL Cell Therapy (IOV-4001): Results are anticipated in the second half of 2025 from the Phase 2 efficacy portion of the IOV-GM1-201 trial in previously treated advanced melanoma.
Next Generation Interleukin-2 (IL-2) for TIL Treatment Regimen (IOV-3001): Patient enrollment continues in a Phase 1/2 clinical trial, IOV-IL2-101, to investigate IOV-3001, a second-generation, modified IL-2 analog for use in the TIL therapy treatment regimen. Preclinical studies of IOV-3001 demonstrated the potential for improved safety, convenience of less frequent dosing and strong effector T cell expansion.
Next Generation, Cytokine-Tethered TIL Therapy (IOV-5001): IND-enabling studies are proceeding for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL cell therapy, in support of an IND in early 2026 for clinical development for multiple indications.
Publications and Presentations
The Journal of Clinical Oncology published the final five-year analysis from the Phase 2 C-144-01 clinical trial evaluating one-time lifileucel monotherapy, which represents unprecedented durability and duration of follow-up in previously treated advanced melanoma patients. The ORR was 31.4% and nearly one third of responders (31.3%) had ongoing responses. Median duration of response (mDOR) was 36.5 months, median overall survival (OS) was 13.9 months and five-year OS was 19.7%. These data were simultaneously presented at the ASCO (Free ASCO Whitepaper) 2025 annual meeting.
Cancer Communications published a peer-reviewed letter about C-144-01 patients with previously treated advanced mucosal melanoma. Following one-time lifileucel monotherapy in this difficult to treat subgroup, ORR was 50% and mDOR was not reached at a median follow up of 35.7 months.
Corporate Updates
Business Optimization: Iovance is implementing a strategic restructuring to optimize business performance, resulting in more than $100 million in annual cost savings starting in the fourth quarter of 2025 and extending cash runway into the fourth quarter of 2026. No significant changes to the pipeline are expected, and all registrational and early-phase programs remain on track. Net cash burn for the next four quarters through the second quarter of 2026 is expected to be less than $245 million, excluding one-time charges associated with the strategic restructuring. The restructuring includes a workforce reduction of approximately 19% in the third quarter of 2025. Iovance will continue to optimize and refine its cost structure through operational excellence initiatives over the next two to three quarters.
Cash Position: As of June 30, 2025, Iovance had cash, cash equivalents, investments, and restricted cash of approximately $307.1 million. The current cash position and anticipated product revenue, including cost savings from the strategic restructuring, are expected to be sufficient to fund current and planned operations into the fourth quarter of 2026.
New Leadership Appointments: Iovance recently appointed Corleen Roche as Chief Financial Officer and Marc R. Theoret, M.D. as Senior Vice President, Regulatory Strategy.
Intellectual Property: Iovance currently owns approximately 280 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide exclusivity through at least 2042. This patent portfolio covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity for Amtagvi into 2038 and additional patent rights, including methods of treating melanoma and compositions and methods for potency assays, expected to provide exclusivity into 2039 and 2042, respectively. Iovance also owns an industry-leading patent portfolio covering TIL products produced with genetic engineering, using core biopsies and peripheral blood as starting material, and using combinations of TIL products with checkpoint inhibitors, as well as Iovance’s proprietary IovanceCares system. More information on Iovance’s patent portfolio is available on the Intellectual Property page on www.iovance.com.
Second Quarter and First Half 2025 Financial Results
Net loss for the second quarter of 2025 was $111.7 million, or $0.33 per share, compared to a net loss of $97.1 million, or $0.34 per share, for the second quarter of 2024. Net loss for the first half of 2025 was $227.8 million, or $0.69 per share, compared to a net loss of $210.1 million, or $0.76 per share, for the first half of 2024.
Revenue consists of product revenue from Amtagvi and Proleukin. Revenue was $60.0 million for the second quarter of 2025, a 22% increase from $49.3 million in the first quarter of 2025 and a 93% increase over revenue of $31.1 million in the second quarter of 2024. Product revenue was $54.1 million for Amtagvi and $5.9 million for Proleukin in the second quarter of 2025 compared to $12.8 million for Amtagvi and $18.3 million for Proleukin in the second quarter of 2024.
Revenue was $109.3 million for the first half of 2025, an increase of 243% over revenue of $31.8 million in the prior year six-month period. Product revenue from Amtagvi and Proleukin was $97.7 million and $11.6 million, respectively, in the first half of 2025 compared to $12.8 million and $19.0 million, respectively, in the first half of 2024.
The increase in revenue in the second quarter and first half 2025 over the prior year periods was primarily attributable to the U.S. launch and product revenue growth from Amtagvi.
Cost of sales includes inventory, overhead and related cash and non-cash expenses that are directly associated with sales of Amtagvi and Proleukin, as well as manufacturing costs for Amtagvi.
Cost of sales was $56.7 million for the second quarter 2025, including $19.0 million for period costs associated with patient drop off and manufacturing success rates, $5.9 million for non-cash amortization expense for intangible assets and fair value mark up of inventory, $2.1 million for non-cash stock-based compensation, and $1.2 million in royalties payable on product sales. Cost of sales was $31.4 million in the second quarter of 2024. Cost of sales was $106.4 million for the first half of 2025 compared to $38.6 million in the first half of 2024.
The increase in cost of sales in the second quarter and first half of 2025 over the prior year periods was associated with the initiation and growth of product sales, certain costs associated with patient drop-off and manufacturing success rates, and related cash and non-cash expenses tied to the U.S. launch of Amtagvi that began during the first quarter of 2024.
Research and development expenses were $79.4 million for the second quarter of 2025, an increase of 28% compared to $62.1 million for the second quarter of 2024. Research and development expenses were $156.2 million for the first half of 2025, an increase of 10% compared to $141.9 million for the first half of 2024.
The increases in research and development expenses in the second quarter and first half of 2025 over the prior year periods were primarily attributable to higher headcount and related costs, offset by reductions in stock-based compensation, and clinical trial costs resulting from continued enrollment in existing trials and the resumption of the LUN-202 study. The increases for the first half of 2025 were offset by the transition of Amtagvi to commercial manufacturing.
Selling, general and administrative expenses were $37.7 million for the second quarter of 2025, a decrease of 5% compared to $39.6 million for the second quarter of 2024. The decrease in selling, general and administrative expenses in the second quarter of 2025 compared to the prior year period was primarily attributable to a decrease in stock-based compensation, partially offset by increases in headcount and related costs to support the growth in the overall business and related corporate infrastructure and costs related to the marketing and advertising of Amtagvi.
Selling, general and administrative expenses were $81.6 million for the first half of 2025, an increase of 15% compared to $71.0 million for the first half of 2024. The increase in selling, general and administrative expenses in the first half of 2025 compared to the prior year period was primarily attributable to increases in headcount and related costs, offset by reductions in stock-based compensation, to support the growth in the overall business and related corporate infrastructure, as well as costs incurred to support the distribution and commercialization of Amtagvi and Proleukin.
For additional information, please see the Company’s Selected Consolidated Balance Sheets and Statements of Operations below.
Webcast and Conference Call
Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 4:30 p.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.