Iovance Biotherapeutics (IOVA) Goldman Sachs 45th Annual Global Healthcare Conference summary

AMTAGVI launch and adoption

• Strong demand observed with rapid expansion from 30 to 50 Authorized Treatment Centers (ATCs) within 90 days, with plans to reach 70 by year-end to meet geographic and patient needs.

• Month-over-month growth in patient enrollment, with over 100 patients enrolled and 60+ in screening as of the last update.

• Average time from enrollment to treatment is 8-10 weeks, with most enrolled patients proceeding to infusion.

• Inclusion in NCCN guidelines has improved reimbursement and is expected to drive broader community adoption over time.

• Hospital systems and ATCs are adapting processes, with logistical hurdles decreasing as experience grows.

Patient selection, therapy logistics, and physician experience

• High-volume centers are judicious in patient selection, focusing on fit, second-line patients with resectable lesions.

• IL-2 administration is not a significant barrier, with up to six doses well tolerated and not limiting eligibility.

• Bridging therapy use is evolving, with peer-to-peer support helping optimize patient management.

• Community physicians play a key role in referrals, with variability in referral patterns based on hospital system structure.

• Most ATCs are actively screening or treating patients, with demand reported across all centers.

Expansion plans and regulatory strategy

• EMA application is planned for the end of the current quarter, with MHRA and Canada submissions by year-end.

• Manufacturing capacity is designed to support up to 10,000 patients annually, with facilities positioned for efficient U.S. and European distribution.

• Expansion into other indications is ongoing, with non-small cell lung cancer (NSCLC) as a major focus due to high unmet need and promising early data.

• Next-gen TIL therapies, including IL-12 tethered products, aim to broaden reach and improve efficacy across cancer types.

• Financial runway extends through 2025, supporting ongoing trials and commercial activities.