• Kite Pharma (Gilead) for solid tumors.
• Bluebird Bio, but focused on personalized cell therapies for solid tumors.
• The Moderna or BioNTech of personalized solid tumor cell therapy.

• AMTAGVI (lifileucel): An individualized, single-dose cell therapy approved for adult patients with advanced melanoma who have progressed after prior treatments.
• Tumor-Infiltrating Lymphocyte (TIL) Therapy Pipeline: Iovance develops a pipeline of Tumor-Infiltrating Lymphocyte (TIL) cell therapies aimed at treating various solid tumor cancers by harnessing the patient's own immune system.

• McKesson Corporation (MCK)
• AmerisourceBergen Corporation (ABC)
• Cardinal Health, Inc. (CAH)

• AmerisourceBergen (ABC)
• Kuehne+Nagel International AG (KNIN.SW)

Frederick G. Vogt, Interim CEO, President & General Counsel

Dr. Vogt joined Iovance in September 2016 as General Counsel and has served as Interim CEO and President since May 2021. With over 20 years of experience in the pharmaceutical and biopharmaceutical industries, he previously practiced law at Morgan, Lewis & Bockius, specializing in intellectual property and business law in life sciences. Prior to that, he held scientific, management, and legal roles at GlaxoSmithKline for 13 years, contributing to oncology and cardiovascular drug development.

Corleen Roche, Chief Financial Officer

Ms. Roche joined Iovance in August 2025, bringing over 30 years of experience in the biotech and life sciences industry, including executive financial leadership in publicly traded companies. She most recently served as CFO of CG Oncology and has held CFO positions at Immunome, U.S. CFO at Biogen, North America CFO at CSL Behring, and various finance roles at Sandoz, Wyeth, and Pfizer. Ms. Roche has developed and executed financial strategies for the commercial launches of several significant products, including ZARXIO, GLATOPA, and PREVNAR 13.

Igor Bilinsky, Chief Operating Officer

Dr. Bilinsky joined Iovance in March 2021 and has over 20 years of leadership experience, including roles as Chief Executive Officer, Chief Operating Officer, and Chief Business Officer in the life sciences industry. Before Iovance, he was Chief Business Officer of Oncternal Therapeutics, a publicly traded oncology company he helped build. He also served as Chief Operating Officer of AmpliPhi Biosciences and as General Manager and Senior Vice President at IGNYTA, which later became part of Roche.

Friedrich Graf Finckenstein, Chief Medical Officer

Dr. Graf Finckenstein joined Iovance in July 2019. He is a physician-scientist with decades of experience in clinical medicine, laboratory cancer research, and drug development in the biopharmaceutical industry. Prior to Iovance, he was the Global Head of Oncology Translational Medicine at Roche Pharma Research and Early Development (pRED) in Basel, Switzerland, where he led all clinical development aspects in the Oncology Discovery and Translational area.

Howard B. Johnson, Chief Business Officer

Mr. Johnson joined Iovance in August 2015 and was promoted to Chief Business Officer in March 2019. He is an entrepreneurial executive with over 30 years of experience in operations, finance, business development, investor relations, and venture capital, primarily in bioscience companies. He founded and ran a medical device company and was a founding investor and initial board member of Acorda Therapeutics. His past executive roles include President and Chief Financial Officer at Vion Pharmaceuticals, an oncology drug development company.

Key Risks to Iovance Biotherapeutics (IOVA)

Iovance Biotherapeutics' primary product is Amtagvi (lifileucel), a tumor-infiltrating lymphocyte (TIL) therapy. The company is also developing lifileucel for other indications, notably Non-Small Cell Lung Cancer (NSCLC) and cervical cancer.

Here are the addressable market sizes for their main products and services:

• Amtagvi (lifileucel) for Advanced Melanoma:
  • The initial estimated addressable patient population is 30,000 patients annually, potentially expanding to over 70,000 patients annually with an expanded label indication for all frontline advanced melanoma patients. This patient population includes both the U.S. and potentially Canada.
  • The U.S. market for melanoma therapeutics was valued at approximately USD 7.24 billion in 2024 and is projected to reach USD 11.98 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.75%.
  • Another estimate for the U.S. melanoma therapeutics market size suggests it was USD 1.92 billion in 2024 and is projected to reach around USD 5.21 billion by 2034, with a CAGR of 10.49%.
  • The global melanoma drugs market was valued at USD 9.17 billion in 2024, expected to grow to USD 10.15 billion in 2025 at a CAGR of 10.7%, and further to USD 15.27 billion in 2029 at a CAGR of 10.8%.
  • Iovance projects U.S. peak sales potential of over $1 billion for Amtagvi in melanoma.
• Lifileucel for Non-Small Cell Lung Cancer (NSCLC):
  • The addressable patient population in the U.S. alone for lifileucel in NSCLC is approximately 50,000 patients.
  • The U.S. market opportunity for Iovance in NSCLC is estimated to be about seven times larger than its current melanoma opportunity.
  • The global non-small cell lung cancer therapeutics market size was valued at USD 21.85 billion in 2024 and is anticipated to reach approximately USD 72.42 billion by 2034, with a CAGR of 12.73% from 2025 to 2034.
  • North America held the largest market share in the NSCLC therapeutics industry in 2024.
• Lifileucel for Cervical Cancer:
  • Lifileucel is also indicated for metastatic cervical cancer.
  • The global cervical cancer treatment market size was valued at approximately USD 8.65 billion in 2024, growing to USD 9.12 billion in 2025, and is projected to reach around USD 14.68 billion by 2034, expanding at a CAGR of 5.44% between 2025 and 2034.
  • The U.S. cervical cancer treatment market is projected to reach USD 4.8 billion by 2032.

Iovance Biotherapeutics (NASDAQ: IOVA) is poised for significant revenue growth over the next 2-3 years, driven by several key factors pertaining to its lead product, AMTAGVI (lifileucel), and its broader pipeline.

The primary drivers of future revenue growth include:

1. Increasing Adoption and Utilization of AMTAGVI in Advanced Melanoma: Iovance is experiencing strong and growing demand for AMTAGVI since its U.S. launch in early 2024. The company's strategy involves broadening adoption and utilization, boosting patient referrals, and expanding its network of Authorized Treatment Centers (ATCs) to include larger community practices. This ongoing commercial momentum is expected to accelerate, with management projecting U.S. peak sales for AMTAGVI in advanced melanoma to exceed $1 billion.
2. International Expansion of AMTAGVI: Beyond the U.S. market, Iovance is actively pursuing regulatory approvals for AMTAGVI in additional geographies. Regulatory applications for AMTAGVI in melanoma are currently under review in Australia, Switzerland, and the United Kingdom, with potential approvals anticipated within the next two years. Canada has already approved AMTAGVI, marking the first international market expansion. Significant international revenue is expected to begin flowing in from 2027 onward.
3. Pipeline Expansion into New Indications: A major long-term driver is the potential approval and launch of AMTAGVI (lifileucel) in new indications. The company has reported promising interim clinical data for lifileucel in previously treated non-squamous non-small cell lung cancer (NSCLC), an indication with a market opportunity estimated to be approximately seven times larger than advanced melanoma. Iovance plans to complete enrollment in its LUN-202 registrational trial for NSCLC in 2026, with a potential launch in the second half of 2027, which could represent U.S. peak sales of $10 billion.
4. Continued Growth of Proleukin Sales: Proleukin, which is used in the AMTAGVI treatment regimen and also sold globally, is expected to continue contributing to revenue growth. Iovance is also evaluating its pricing strategy for Proleukin outside the United States to further enhance future revenue.
5. Improved Manufacturing Efficiency and Gross Margins: While not a direct revenue generator, significant improvements in manufacturing capacity utilization and operational efficiency are expected to lead to higher gross margins. The centralization of manufacturing at Iovance's internal facility by early 2026 is anticipated to further enhance margins and ensure reliable supply, ultimately positively impacting the company's profitability and financial outlook.

Share Issuance

• In June 2020, Iovance Biotherapeutics adopted the 2020 Employee Stock Purchase Plan (ESPP) and reserved 500,000 shares of common stock for issuance.
• The number of shares reserved for issuance under the 2020 ESPP was increased multiple times: to 1,400,000 shares on June 6, 2023, to 1,900,000 shares on June 11, 2024, and to 2,900,000 shares on June 10, 2025.
• Stockholders approved an amendment in April 2025 to increase the number of shares authorized under the 2018 Equity Incentive Plan by 12,500,000 shares.

Outbound Investments

• Iovance acquired Proleukin in 2023, which allowed the company to begin generating revenue from its sales.

Capital Expenditures

• Iovance has consistently invested in property, plant, and equipment, with quarterly capital expenditures typically ranging from $3-6 million.
• Capital expenditures were approximately $7.5 million for the quarter ending June 2025.
• The primary focus of capital expenditures includes ongoing development efforts and expanding manufacturing capacity to support over 5,000 patients annually. The company plans to centralize manufacturing at the Iovance Cell Therapy Center (iCTC) in early 2026 to reduce external manufacturing expenses.