Analyst Conference Summary

biotechnology

conference date: November 5, 2026 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2026 (third quarter, Q3 2026)

Forward-looking statements

Overview: Strong revenue growth.

Basic data (GAAP):

Revenue was $121.5 million, up 23% sequentially from $99 million, and up 80% from $67.5 million year-earlier.

Net Income was negative $22.3 million, up sequentially from negative $47 million, and up from negative $91.3 million year-earlier.

EPS (Earnings per Share), diluted, were negative $0.05, up sequentially from negative $0.11, and up from negative $0.25 year-earlier.

Guidance:

2026 product revenue unchanged at $410 to $420 million. Cash runway to 2029.

Conference Highlights:

Frederick Vogt, Interim President and CEO said, "Third quarter revenue reached a new record of $122 million with our highest gross margin ever, driven by continued U.S. Amtagvi demand. We remain on track to achieve our full-year 2026 total revenue guidance of $410 to $420 million and recently marked the tremendous milestone of more than 1,000 commercially treated Amtagvi patients. We released our positive results for Cohorts 1 and 2 of our ongoing IOV-LUN-202 trial with a 24.6% ORR in 69 patients and excellent durability that is much greater than current standard of care. We are completing enrollment in Cohorts 1 and 2 and preparing for a supplemental Biologics License Application (sBLA) submission, while adding the new Positility and Optilism trials supported by a remarkable 59.1% ORR in biomarker-selected patients. We also recently presented best-in-class data for lifileucel in chemotherapy-refractory UPS and DDLPS in support of our Saratoga registrational trial, where our confirmed ORR has now increased to 55.6% in 9 patients with strong durability."

Commercial momentum is continued into Q3. Focus is on physician education. Moving from academic to community settings, which now are about one-third of our network. Real world response rates are convincing. U.S. ATCs are strategically located, allow for broad access. 31 day or less turnaround time. Marketing authorization in UK could be approved in Q1 2027. SAme for Switzerland. Will resubmit in EU in 2027.

Revenue consisted of $102 million from U.S. sales of Amtagvi (lifileucel) plus $20 million from global sales of Proleukin. In Q2 2026 announced real world objective response rates of 52%. The Authorized treatment center (ATC) networkgrew to more than 100 U.S., Canadian, and Australian ATCs, with at least 110 expected to be active by the end of 2026. Community ATCs now make up a third of the network; expected to increase significantly over the next several quarters.

Numerous real-world studies using commercial Amtagvi continue to highlight efficacy and safety, with objective response rates (ORRs) of 50% or greater in second-line patients. That supports earlier adoption of Amtagvi with rapid patient referrals and access. In a poster at ESMO 2026 an indirect comparison suggested that lifileucel may approximately double four-year overall survival (OS) rates compared with standard-of-care therapies in anti-PD-1-resistant advanced melanoma.

In Q3 2026 multiple investigator-sponsored clinical trials of lifileucel are enrolling in cutaneous squamous and Merkel cell carcinomas as well as other new solid tumor indications.

In Q4 2026 IOV-LUN-202 trial for previously treated metastatic non-squamous NSCLC reported a 24.6% ORR, much better than standard of care. Will submit an sBLA to the FDA in 2027. Two trials of subgroups with better responses are scheduled to begin before year-end.

In Q4 2026 IOV-SAR-201 for UPS (Undifferentiated Pleomorphic Sarcoma) and DDLPS (Dedifferentiated Liposarcoma) Phase 2 registrational trial is enrolling patients. Multiple responses have already been observed. Fast Tracked. sBLA could be in late 2028 or in 2029.

In Q4 2026 a Phase 3 trial of lifileucel plus pembrolizumab for first line advanced melanoma continued enrollment.

The Phase 2 trial of lifileucel for previously treated metastatic serous endometrial cancer using a biomarker strategy based on histology, wich reported positive results in Q1 2026, will restart after discussions with the FDA on an expedited approval pathway.

In Q4 2026 the Phase 1/2 IOV-5001 for multiple solid tumor cohorts was enrolling.

In Q4 2026 the Phase 1/2 IOV-4001 (PD-1 inactived TIL) is enrolling patients with melanoma and NSCLC.

In Q4 2026 the Phase 1 IOV-3001 is advancing through dosing cohorts.

In Q3 2026 Iovance contracted with Cell and Gene Therapy Catapult, a UK independent innovation and technology organization advancing cell and gene therapies, for an option to license a next-generation smart manufacturing platform.

Cash and investments ended at $376 million, down sequentially from $297 million.

Total expenses were $145 milllion, consisting of: cost of sales $48 million, R&D $49 million, SG&A $39 million, depreciation and amortization $9 million. Other income $2 million. Income tax $0.6 million.

Q&A selective summary:

December mainenance this year? Q4 guidance? Maintenance should no longer be an issue. We hope for q/q growth, we would be happy to beat the guidance.

Path to profitability or cash flow break even? We are on the way, but not guiding when.

Proleukin sales? It is in line with Amtagvi demand. Communicating with wholesalers to keep it supplied to hospitals.

Lung study? Should finish soon, report next year. Don't be surprised if OR is not reached at that point.

Prescibing patterns? We are focussed on opening community centers, are getting better at that. But business is still concentrated at academic centers, about 2/3rds of total.

Lung 202 FDA discussions? Productive. Should be registrational and approvable. sBLA likely in 2027.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: