IOVANCE BIOTHERAPEUTICS, INC.
IOVA evidence brief
What we can confirm
- BioSniper Score:
- 9.3 / 10
- Market Cap:
- $4.01B
- Lead Asset:
- amtagvi (Approved)
What it means
What to watch
Prepared research question
What matters most for IOVA—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · IOVA
Iovance Biotherapeutics is a commercial-stage biotechnology company focused on tumor-infiltrating lymphocyte (TIL) therapies, with its approved product Amtagvi for advanced melanoma and a pipeline extending into lung, sarcoma, and endometrial cancers.
Key risk: Cash flow uncertainty
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Market Cap
$4.01B
Cash Runway
—
Lead Asset
amtagvi (Approved)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 5 pipeline candidates · 14 clinical trials for IOVANCE BIOTHERAPEUTICS, INC..
Iovance Biotherapeutics is a commercial-stage biotechnology company focused on tumor-infiltrating lymphocyte (TIL) therapies, with its approved product Amtagvi for advanced melanoma and a pipeline extending into lung, sarcoma, and endometrial cancers.
- Cash & equivalents of $110.8M as of 2026-06-30 [sec]
- Total revenue of $99.3M and net income of -$47.3M as of 2026-06-30 [sec]
- Amtagvi approved in Canada (August 2025) and under review in the UK, Australia, Switzerland, and EU [sec_mda · as of 2026-08-06]
- Real-world retrospective study for commercial Amtagvi showed physician-assessed ORR of ~44% [sec · filed 2026-04-28]
- Two ongoing registrational trials: frontline advanced melanoma (TILVANCE-301) and previously treated NSCLC (IOV-LUN-202) [sec_mda · as of 2026-08-06]
What works
- Amtagvi is a first-in-class approved TIL therapy for advanced melanoma with a real-world ORR of ~44% [sec · filed 2026-04-28]
- Record Q2 2026 revenue of nearly $100M with a 56% margin, indicating commercial traction [news · published 2026-09-19]
- Pipeline expansion into NSCLC, sarcoma, and endometrial cancers, plus next-generation TIL and engineered IL-2 programs [news · published 2026-09-19]
- Company believes it has sufficient capital to fund operations for at least 12 months as of June 30, 2026 [sec_mda · as of 2026-08-06]
What to weigh
- Net income was -$47.3M as of 2026-06-30, indicating ongoing operating losses [sec]
- Amtagvi and Proleukin may not generate positive operational cash flows in the next 12 months [sec_mda · as of 2026-05-07]
- Regulatory approvals in the UK, EU, and Switzerland are pending and timelines uncertain (UK potential approval later 2026, EU 2026/2027, Switzerland 2027) [sec_mda · as of 2026-08-06]
- Company expects to continue incurring significant expenses for commercial launch, clinical programs, and pipeline development [sec_mda · as of 2026-08-06]
From the filings
Quoted directly from source documents.
Amtagvi real-world ORR
“A real-world retrospective study for commercial Amtagvi® demonstrated a physician-assessed ORR of ~44%.”
SEC filings · April 28, 2026
Regulatory submissions under review
“Regulatory submissions are under review with pending approvals in the United Kingdom, Australia and Switzerland.”
SEC filings · August 6, 2026
Ongoing registrational trials
“We are conducting two ongoing registrational trials in frontline advanced melanoma and previously treated advanced non-small cell lung cancer, or NSCLC.”
SEC MD&A · August 6, 2026
Catalyst timeline
- 2019-05-07 · Phase 2 start for solid tumors TIL study (LN 144/LN-145/LN-145-S1) — Multicenter study of autologous TIL in patients with solid tumors.
- 2020-02-19 · Phase 1/2 start for IOV-2001 in CLL/SLL — Study evaluating safety and efficacy of IOV-2001 in relapsed/refractory CLL or SLL.
- 2021-05-07 · Phase 2 start for TIL in metastatic NSCLC — Multicenter study of autologous TIL (LN-145) in metastatic non-small-cell lung cancer.
- 2021-08-20 · Trial readout for lifileucel in metastatic melanoma — ORR was 36% (95% CI, 25 to 49), with two complete responses and 22 partial responses.
Risks & what to watch (4)›
Key risks
- Cash flow uncertainty — Amtagvi and Proleukin may not generate positive operational cash flows in the next 12 months [sec_mda · as of 2026-05-07]
- Pending regulatory approvals — UK, EU, and Switzerland approvals are pending with uncertain timelines [sec_mda · as of 2026-08-06]
- Continued operating losses — Net income of -$47.3M as of 2026-06-30 indicates ongoing losses [sec]
- Clinical trial execution risk — Registrational trials in NSCLC and sarcoma may face enrollment or efficacy hurdles [sec_mda · as of 2026-08-06]
What to watch
- UK MHRA decision on Amtagvi MAA, expected later in 2026 [sec_mda · as of 2026-08-06]
- EMA resubmission and potential approval in the EU in 2026 or 2027 [sec_mda · as of 2026-08-06]
- Progress of registrational trials TILVANCE-301 (melanoma) and IOV-LUN-202 (NSCLC) [sec_mda · as of 2026-08-06]
- Commercial revenue growth and margin trends following record Q2 2026 [news · published 2026-09-19]
Sources: Catalysts · News · SEC filings · SEC MD&A · Generated October 13, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.24
Lead: Approved
5 candidates
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
283
Total value held
$910.0M
| Holder | Shares | Value |
|---|---|---|
| blackrock, inc. | 31,080,505 | $109.1M |
| mhr fund management llc | 28,967,103 | $101.7M |
| state street corp | 17,448,108 | $61.2M |
| vanguard capital management llc | 16,617,737 | $58.3M |
| two sigma investments, lp | 13,687,433 | $48.0M |
| vanguard portfolio management llc | 11,700,844 | $41.1M |
| millennium management llc | 9,414,292 | $33.0M |
| goldman sachs group inc | 8,760,060 | $30.7M |
| geode capital management, llc | 8,572,598 | $30.1M |
| invenomic capital management lp | 8,495,551 | $29.8M |
Showing top 10 of 283 institutional holders of IOVANCE BIOTHERAPEUTICS, INC.. Open the full 13F history after sign-in.
Short Interest
as of Apr 30, 2026- % of float
- 28.4%
- Days to cover
- 7.8
- Shares short
- 108,804,045
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
IOVA short interestGovernance
Frequently asked questions
What is the AI investment thesis for IOVANCE BIOTHERAPEUTICS, INC.?
Iovance Biotherapeutics is a commercial-stage biotechnology company focused on tumor-infiltrating lymphocyte (TIL) therapies, with its approved product Amtagvi for advanced melanoma and a pipeline extending into lung, sarcoma, and endometrial cancers.
What is IOVANCE BIOTHERAPEUTICS, INC.'s lead drug candidate?
IOVANCE BIOTHERAPEUTICS, INC.'s most advanced tracked candidate is amtagvi (Approved) for Unresectable Melanoma.
Who is the CEO of IOVANCE BIOTHERAPEUTICS, INC.?
Dr. Frederick G. Vogt Esq., J.D., Ph.D. is the chief executive officer of IOVANCE BIOTHERAPEUTICS, INC. (IOVA).
Where is IOVANCE BIOTHERAPEUTICS, INC. headquartered?
IOVANCE BIOTHERAPEUTICS, INC. (IOVA) is headquartered in San Carlos, CA, United States.
What therapeutic areas does IOVANCE BIOTHERAPEUTICS, INC. focus on?
IOVANCE BIOTHERAPEUTICS, INC. develops therapies across Oncology, Ophthalmology, Dermatology, Nephrology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.