IOVA Q2 Earnings Miss, Stock Down on EMA Filing Withdrawal for Amtagvi

Iovance Biotherapeutics IOVA incurred a second-quarter 2025 loss of 33 cents per share, wider than the Zacks Consensus Estimate of a loss of 29 cents. In the year-ago quarter, the company reported a loss of 34 cents per share.

Quarterly revenues rose 93% year over year to $60.0 million, entirely from the sales of its two marketed drugs. Yet, this figure also missed the Zacks Consensus Estimate of $66.4 million.

More on IOVA’s Earnings

Iovance currently has two marketed drugs in its portfolio, the IL-2 product Proleukin and the TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults, Amtagvi is approved for the advanced melanoma indication.

Iovance recorded $54.1 million from Amtagvi sales during the quarter, compared with $43.6 million in the previous quarter, driven by robust demand for the therapy. This figure marginally beat both the Zacks Consensus Estimate of $53.3 million and our model estimate of $53.5 million. Per IOVA, over 100 patients were infused during the quarter.

Proleukin added $5.9 million during the quarter, down 68% year over year. The metric also missed both the Zacks Consensus Estimate and our model estimate of $18 million, each.

Discussion on IOVA’s Operating Costs

Research & development expenses totaled $79.4 million, up 28% from the year-ago quarter’s level. The uptick was driven primarily by higher employee costs and clinical expenses incurred during the quarter.

Selling, general and administrative expenses declined 5% from the prior-year quarter’s figure to $37.7 million, primarily due to a fall in stock compensation expenses.

IOVA’s Guidance

Iovance reiterated its product revenue guidance for the full year, driven by strong demand for both of its marketed products. It expects this metric to be between $250 million and $300 million.

Alongside the earnings results, Iovance also announced that it is initiating a strategic restructuring plan to save more than $100 million annually in costs starting in 2025. To achieve this target, the company has decided to lay off nearly 19% of its workforce before the end of next month, as well as optimize and refine its cost structure over the next two to three quarters.

Based on the above plan, Iovance expects net cash burn for the next four quarters through the second quarter of 2026 to be less than $245 million. The savings in costs are expected to extend the existing cash runway into the fourth quarter of 2026.

Iovance expects significant growth in total product revenues for 2026 and beyond. It expects gross margins to increase through near-term optimization of manufacturing capacity utilization over the next several years.

Updates on IOVA’s Pipeline & Other News

Regulatory applications for Amtagvi in the melanoma indication are currently under review in the United Kingdom, Canada and Australia, with potential approvals expected throughout this year and early next year. However, the company announced that it had voluntarily withdrawn the regulatory filing for the therapy in the European Union recently due to a lack of alignment with the EMA on clinical data supporting the submission.

Shares of Iovance plummeted nearly 29% in after-market trading yesterday, likely due to this development. Though the company stated that it is currently developing a new strategy for seeking the therapy’s EU approval, it delayed the initial plans of securing a potential approval before this year’s end. This downward trajectory also continued in pre-market today.

Year to date, the stock has plunged 64% compared with the industry’s 1% decline.

Iovance is evaluating Amtagvi, combined with Merck’s PD-L1 inhibitor, Keytruda, in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will also serve as a confirmatory study seeking full approval for Amtagvi in the melanoma indication.

The company remains on track to share an update from the phase II IOV-LUN-202 study, evaluating Amtagvi in post-anti-PD-1 non-small cell lung cancer (NSCLC), before this year’s end. If results from the study are positive, Iovance expects to secure label expansion for the drug from the FDA in the given indication in 2027. Amtagvi is also being evaluated in separate mid-stage studies for cervical and endometrial cancer indications. Initial results from the endometrial cancer study are expected by this year’s end.

The company also expects to report data from the efficacy portion of the phase II IOV-GM1-201 study, evaluating IOV-4001 in previously treated advanced melanoma, later this year.

IOVA’s Zacks Rank

Iovance currently has a Zacks Rank #4 (Sell).

Iovance Biotherapeutics, Inc. Price

 

Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote

Our Key Picks Among Biotech Stocks

Some other better-ranked stocks from the industry are Genmab GMAB, CorMedix CRMD and Immunocore IMCR. While GMAB sports a Zacks Rank #1 (Strong Buy) at present, CRMD and IMCR each carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Genmab’s 2025 EPS have increased from $1.52 to $1.58 over the past 60 days, while the same for 2026 has increased from $1.85 to $1.93. GMAB shares have gained 9% year to date.

Genmab’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 14.90%.

Estimates for CorMedix’s 2025 EPS have increased from 93 cents to 97 cents over the past 60 days, while the same for 2026 has increased from $1.64 to $1.65. CRMD shares have surged 33% year to date.

CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 25.82%.

In the past 60 days, estimates for Immunocore’s 2025 loss per share have improved from 86 cents to 68 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from $1.34 to $1.10. IMCR stock has gained 8% so far this year.

Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.

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This article originally published on Zacks Investment Research (zacks.com).

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