Iovance Biotherapeutics (IOVA) H.C. Wainwright 28th Annual Global Investment Conference summary

Key business and financial highlights

• Achieved record Q2 revenue of nearly $100 million and a 56% margin, with a cash runway extending into mid-2028 and a clear path to profitability.

• Treated over 2,000 patients with two commercialized therapies, Amtagvi and Proleukin, establishing a global leadership position in TIL therapy.

• Centralized manufacturing hub in Philadelphia supports global clinical and commercial supply, with capacity for over 5,000 patients and strategic value for margin expansion.

• Over 250 million lives covered by payer policies, including Medicare and commercial payers, covering more than 75% of the U.S. population.

• Authorized Treatment Center network exceeds 95 locations, expected to reach 110 by year-end, ensuring over 95% of patients are within 200 miles of a center.

Clinical and pipeline developments

• TIL therapy demonstrated unprecedented durability and response rates in refractory melanoma, with five-year survival data supporting FDA, Canada, and Australia approvals.

• Second-line melanoma patients showed response rates above 50%, with operational improvements expected to further enhance outcomes.

• Frontline combination trial with pembrolizumab in advanced melanoma achieved a 30% complete response rate, with confirmatory phase III trial (TILVANCE-301) underway.

• Non-small cell lung cancer program nearing trial completion, with Fast Track designation and sBLA submission targeted for 2027.

• Soft tissue sarcoma trial showed a 50% response rate in second-line patients, now advancing as a registrational trial (SARATOGA).

Next-generation and platform expansion

• Genetically modified TIL therapy (IOV-4001) and IL-12-expressing TIL (IOV-5001) are advancing, targeting broader and more resistant tumor types.

• IOV-5001 designed to localize IL-12 activity to the tumor microenvironment, aiming to reduce systemic toxicity and expand TIL therapy to "colder" tumors.

• IOV-3001 program focuses on optimizing IL-2 for T cell growth, currently in dose-escalation trials.

• Precision medicine approaches identified a 40% response rate and 100% disease control in serous endometrial carcinoma, prompting expedited FDA engagement.

• Ongoing expansion into additional solid tumor indications, leveraging established relationships with leading surgeons and oncologists.