Every material Form 8-K IOVANCE BIOTHERAPEUTICS, INC. has filed with the SEC since October 29, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Iovance furnished an updated corporate presentation on November 5, 2026, for use at healthcare conferences and with analysts and stockholders. The presentation gives full-year 2026 revenue guidance of $410 million to $420 million, and its footnote states the midpoint is $55 million, or about 15%, above the previous range of $350 million to $370 million.
Full-year 2026 revenue guidance is $410 million to $420 million, up from a previous range of $350 million to $370 million.
The presentation cites about 80% year-over-year and about 22% quarter-over-quarter revenue growth in third-quarter 2026.
Cash, cash equivalents, short-term investments and restricted cash were about $382 million as of September 30, 2026, with runway stated as well into 2029.
Margin from cost of sales, excluding depreciation and amortization, was about 60% in third-quarter 2026 and 54% year to date.
Iovance reported third quarter 2026 product revenue of $121.5 million, up about 80% from $67.5 million a year earlier, and a net loss of $22.3 million, down from $91.3 million. The company said it remains on track to meet its full-year 2026 total product revenue guidance of $410 million to $420 million.
Q3 2026 product revenue was $121.5 million, up about 22% from roughly $99 million in Q2 2026
Net loss per share was $0.05 in Q3 2026 versus $0.25 in Q3 2025
Full-year 2026 product revenue guidance of $410 million to $420 million was reaffirmed, not changed
Gross margin was about 60%, compared with 56% in Q2 2026
Iovance updated results from Cohorts 1 and 2 of its Phase 2 IOV-LUN-202 trial in previously treated non-squamous metastatic non-small-cell lung cancer, reporting a 24.6% objective response rate in 69 patients, consistent with the 25.6% previously reported. The company also introduced a retrospectively identified biomarker subgroup with a 59.1% response rate, a precision strategy that could change how the lung cancer program is developed and how the company plans its next trial.
Broader population: 24.6% objective response rate (17 of 69 patients), consistent with the 25.6% rate in 39 patients previously reported.
Retrospective biomarker subgroup (KRAS wild-type, HER2 wild-type, current or former smoker): 59.1% response rate (13 of 22 patients), including both complete responses.
POSITILITY study to begin enrollment in November 2026; supplemental Biologics License Application for non-squamous mNSCLC planned for 2027, subject to FDA discussions.
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