Adaptimmune Therapeutics (ADAP) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Company overview and recent milestones

• Achieved first FDA approval for Tecelra, an engineered T cell therapy for solid tumors.

• Employs about 500 staff across Philadelphia, Boston, and the UK, with significant R&D and manufacturing presence.

• Commercial launch of Tecelra began immediately after approval, with biomarker tests available nationwide.

• Six authorized treatment centers are operational, with plans to expand to at least ten by year-end and thirty next year.

• Ended Q2 with $250 million in cash, supporting ongoing operations and pipeline development.

Pipeline and product differentiation

• Pipeline includes lete-cel (expected approval in 2026), a phase II/III ovarian cancer program, and preclinical PRAME and CD70 assets.

• TCR therapies can target both cell surface and intracellular proteins, unlike CAR-Ts, broadening potential indications.

• Lete-cel targets NY-ESO-1 and expands reach to MRCLS, complementing afami-cel’s MAGE-A4 target.

• Advanced programs include ADP-600 (PRAME TCR) and ADP-520 (CD70), both moving toward IND filings.

• No current plans to pursue autoimmune indications, maintaining focus on solid tumors.

Commercial and clinical execution

• Tecelra launch supported by nationwide biomarker testing and a patient navigation program (Adaptimmune Assist).

• Key launch metrics: number of authorized treatment centers and apheresis patients, with dosing expected late in the year.

• FDA accelerated approval for Tecelra based on SPEARHEAD-1; confirmatory evidence from a second cohort already enrolled.

• No REMS required due to favorable safety profile compared to CAR-Ts.

• Lete-cel regulatory pathway mirrors Tecelra, with data transfer and application preparation underway.