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NASDAQ: IOVA IOVANCE BIOTHERAPEUTICS, INC. 8-K

Iovance Q2 revenue of ~$99M beats guidance by >10%, cash runway extends into 2H 2028

Filed August 6, 2026 · Period ending August 6, 2026 · ~1 min read

5 key changes 3 high relevance 2 sections

Key Changes

  • high

    Exhibit 99.1 view on EDGAR →
  • high

    Exhibit 99.1 view on EDGAR →
  • high

    Lifileucel in nonsquamous mNSCLC showed 25.6% ORR (n=39) with median duration of response not reached at 25.4 months follow-up; FDA granted Fast Track Designation, targeting 2H 2027 launch in a market ~7x U.S. melanoma.

    Exhibit 99.1 view on EDGAR →
  • medium

    Phase 2 SARATOGA registrational trial for lifileucel in advanced soft tissue sarcomas commenced in Q2 2026 with FDA Fast Track Designation; earlier data showed 50% ORR.

    Exhibit 99.1 view on EDGAR →
  • medium

    Authorized treatment center network expanded to >95 locations as of August 5, 2026, with ~66% of addressable patients within 200 miles of an ATC.

    Exhibit 99.1 view on EDGAR →

Summary

Iovance disclosed updated corporate presentation materials showing Q2 2026 revenue of approximately $99 million, beating its prior guidance by more than 10% and representing roughly 66% year-over-year quarterly growth.

The company achieved a gross margin from cost of sales of approximately 56% (excluding depreciation and amortization) and reported cash, cash equivalents, short-term investments, and restricted cash of approximately $304 million as of June 30, 2026, providing runway into the second half of 2028.

The revenue beat and margin improvement signal accelerating commercial traction for Amtagvi in advanced melanoma and manufacturing efficiency gains as the company scales. Beyond the melanoma franchise, Iovance provided clinical updates on pipeline expansion. Lifileucel in nonsquamous metastatic non-small cell lung cancer showed a 25.6% objective response rate (n=39) with median duration of response not reached at 25.4 months median follow-up, and the FDA granted Fast Track Designation for second-line nonsquamous mNSCLC. The company targets a potential launch in the second half of 2027 in a market approximately $304M seven times the size of U.S. melanoma. The Phase 2 SARATOGA registrational trial for lifileucel in advanced soft tissue sarcomas commenced in Q2 2026 with FDA Fast Track Designation and earlier data showing a 50% objective response rate. The authorized treatment center network expanded to more than 95 locations as of August 5, 2026, with approximately 66% of addressable patients within 200 miles of an ATC, supporting geographic access as the company scales commercially and prepares for potential label expansions.

Section-by-Section Diff

Event · Item 8.01 — Other Events

~75 words

Iovance updated its corporate presentation for use at healthcare conferences and with analysts and investors.

1 Added
Show 1 minor / wording change
Added Corporate presentation update low

Added in current filing · verify on EDGAR →

On August 6, 2026, Iovance Biotherapeutics, Inc. (the “Company”) updated its corporate presentation that it uses for presentations at healthcare conferences and to analysts, current stockholders, and others.

The company refreshed its standard corporate presentation materials used for investor and analyst communications. This is a routine disclosure of updated marketing materials rather than a substantive business event.

Event · Exhibit 99.1

Iovance disclosed Q2 2026 revenue of ~$99M (>10% above guidance), ~56% gross margin, and ~$304M cash runway into 2H 2028.

2 Added
Added Authorized treatment center expansion medium

Added in current filing · view on EDGAR →

>95 Treatment Centers as of 08/05/26* ... *Includes centers in final stages of readiness or soon to be authorized.

Iovance disclosed that as of August 5, 2026, it has more than 95 authorized treatment centers (ATCs) in North America, including centers in final stages of readiness or soon to be authorized. The company states that approximately 66% of addressable patients are within 200 miles of an ATC, supporting geographic access for Amtagvi.

Added Sarcoma registrational trial and Fast Track Designation medium

Added in current filing · view on EDGAR → · paraphrased

FDA Fast Track Designation in Rare, High Grade, Aggressive RefractoryUPS & DDLPS with Very HighUnmet Need

50% ORR via RECIST v1.1

Phase 2 SARATOGA registrational trial commenced in 2Q 2026

Iovance disclosed that the Phase 2 SARATOGA registrational trial for lifileucel in advanced soft tissue sarcomas (undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma) commenced in Q2 2026. The FDA granted Fast Track Designation for this indication. Earlier data showed a 50% objective response rate via RECIST v1.1. The company plans to explore expedited pathways for registration.

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Figures/quotes linked to EDGAR · Narrative written by AI · Aug 7, 2026 · How we verify