Iovance Biotherapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total product revenue reached ~$122 million, an ~80% year-over-year increase from ~$67 million in Q3 2025 and a ~22% sequential increase from ~$99 million in Q2 2026.
• U.S. Amtagvi revenue was ~$102 million, up ~77% year-over-year and ~12% sequentially.
• Global Proleukin revenue was ~$20 million in Q3 2026.
• Gross margin increased to ~60% in Q3 2026, compared to 56% in Q2 2026, driven by higher sales volume and cost optimization.
• Research and Development (R&D) expenses decreased ~16% compared to Q2 2026, marking the fifth consecutive quarter of improvement.
• Net loss for the three months ended September 30, 2026, was $22.271 million, compared to $91.253 million in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $148.631 million, compared to $319.074 million in the same period in 2025.
• Cash, cash equivalents, and short-term investments were $376.320 million as of September 30, 2026, compared to $296.980 million as of December 31, 2025.
• Total assets were $991.214 million as of September 30, 2026, compared to $913.170 million as of December 31, 2025.
• Stockholders' equity was $812.662 million as of September 30, 2026, compared to $698.583 million as of December 31, 2025.

Guidance and Future Outlook:

• The company remains on track to achieve full-year 2026 total product revenue guidance of $410 to $420 million.
• Improvements in gross margin are expected to continue, excluding occasional one-time items.
• Cash on hand is expected to fund operations well into 2029.

Business Segments and Product Lines:

• Amtagvi (lifileucel): More than 1,000 patients have been commercially treated. The authorized treatment center (ATC) network has grown to over 100 centers in the U.S., Canada, and Australia, with at least 110 expected to be active by the end of 2026. Community ATCs represent one-third of the network.
• Manufacturing: The turnaround time for the majority of Amtagvi lots is 30 days or less using the FDA-approved centralized commercial manufacturing process.
• Pipeline Trials:
  • IOV-LUN-202: Achieved a 24.6% Objective Response Rate (ORR) in 69 patients with non-squamous metastatic non-small-cell lung cancer (mNSCLC). Enrollment in Cohorts 1 and 2 is completing, with a supplemental Biologics License Application (sBLA) planned for 2027.
  • POSITILITY: A first-in-class biomarker-enriched cohort trial has begun enrollment with a target of 80 patients, following a 59.1% ORR in a biomarker-selected subgroup.
  • OPTILISM: A frontline trial in biomarker-enriched non-squamous mNSCLC is planned to initiate in 2027.
  • SARATOGA (IOV-SAR-201): A registrational trial in undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS) is actively enrolling. The confirmed ORR increased to 55.6% in 9 patients.
  • TILVANCE-301: A Phase 3 trial of lifileucel and pembrolizumab in frontline advanced melanoma is enrolling at over 80 sites globally.
  • ENDURANCE (IOV-END-201): Enrollment for metastatic serous endometrial cancer is restarting following positive initial data.
• Next-Generation Pipeline:
  • POTENTIL (IOV-GE1-201): Phase 1/2 trial enrolling for IOV-5001 (second-generation IL-12 tethered TIL) in metastatic colorectal cancer, triple-negative breast cancer, and other solid tumors.
  • IOV-GM1-201: Phase 1/2 trial for IOV-4001 (PD-1 inactivated TIL) in metastatic melanoma and mNSCLC.
  • IOV-IL2-101: Phase 1 safety cohort advancing for IOV-3001 (modified IL-2 analog).
  • Investigator-Sponsored Trials (ISTs): New ISTs in clear cell renal cell carcinoma (ccRCC), cutaneous squamous cell carcinoma (CSCC), and Merkel cell carcinoma (MCC) are active or accelerating.

Market and Competitive Landscape:

• Melanoma: An indirect comparison presented at ESMO 2026 suggested lifileucel may approximately double four-year overall survival rates compared to standard-of-care therapies in anti-PD-1-resistant advanced melanoma.
• mNSCLC: The U.S. market opportunity in the biomarker-selected cohort for frontline and second-line non-squamous mNSCLC is estimated to be about ten times that of advanced melanoma.
• Sarcoma: The U.S. market opportunity in UPS and DDLPS is approximately the same size as the current second-line metastatic melanoma opportunity for Amtagvi.
• Global Expansion: Marketing Authorization Applications (MAAs) for Amtagvi in the UK and Switzerland are undergoing review with potential approvals expected in Q1 2027. An MAA for Brazil is planned for 2027, with an EMEA resubmission also targeted for 2027.

Risks and Challenges:

• The press release notes standard forward-looking statement risks including the ability to successfully commercialize products, ATC network expansion, market acceptance, pricing/reimbursement, manufacturing capacity, and regulatory approval timelines.
• Specific risks include the potential for clinical trial delays, failure to meet endpoints, and the possibility that clinical data may not support regulatory approval.

Management Commentary and Tone:

• Frederick Vogt, Ph.D., J.D., Interim CEO and President, stated that third-quarter revenue reached a new record with the highest gross margin ever, driven by continued U.S. Amtagvi demand.
• Management highlighted the milestone of over 1,000 commercially treated Amtagvi patients and described the clinical data as "best-in-class" with durability much greater than the current standard of care.
• The tone reflects confidence in achieving full-year guidance and executing on multiple registrational trials.

Other Key Points:

• Patent Portfolio: Iovance owns or licenses more than 400 granted or allowed U.S. and international patents, with over 1,000 additional applications filed, providing exclusivity through at least 2042.
• Strategic Agreement: Iovance entered a contract research agreement with Cell and Gene Therapy Catapult (UK) with an option to license a next-generation smart manufacturing platform.
• Regulatory Designations: The FDA granted Fast Track Designation (FTD) for lifileucel in mNSCLC, UPS, and DDLPS.
• Webcast: Management hosted a conference call and live audio webcast on November 5, 2026, at 8:30 a.m. ET.