Zacks Report Date: October 03, 2025

Iovance Biotherapeutic (IOVA) Long Term: 6-12 Months Zacks Recommendation: Neutral
(Since: 08/12/25)
$2.25 (Stock Price as of 10/02/2025)
Prior Recommendation: Underperform
Price Target (6-12 Months): $2.50
Short Term: 1-3 Months Zacks Rank: (1-5) 3-Hold

Zacks Style Scores: VGM:F

Value: F Growth: D Momentum: D

Summary Price, Consensus & Surprise(1)

Iovance’s top line is being driven by the sales of Amtagvi, the
first treatment option for advanced melanoma that has
progressed on or after prior anti-PD-1 therapy. Sales of
Proleukin are also rising as it is used in the Amtagvi regimen.
Iovance is advancing the development of its other pipeline
drugs, which showed encouraging data across studies for
different cancer indications. Based on these factors, we
expect Big Pharma to now eye Iovance as a takeover target.
However, Iovance has had its fair share of regulatory
setbacks related to Amtagvi’s potency assay matrix and
clinical hold on other pipeline drugs in the past. Recently, it
issued a warning for economic uncertainty and also lowered
its 2025 revenue guidance — instances that have spooked
investors. The stock has underperformed the industry year to
date.

Data Overview
Sales and EPS Growth Rates (Y/Y %)(2)
52 Week High-Low $12.51 - $1.64
Sales EPS
20 Day Average Volume
9,932,842
(sh)
Market Cap $814.2 M

YTD Price Change -69.6%

Beta 0.83

Dividend / Div Yld $0.00 / 0.0%

Medical - Biomedical and
Industry
Genetics
Zacks Industry Rank Top 30% (74 out of 245)

Sales Estimates (millions of $)(2)

Last EPS Surprise -13.8%
Q1 Q2 Q3 Q4 Annual*
Last Sales Surprise -9.6%
2026 102 E 112 E 122 E 134 E 469 E
EPS F1 Est- 4 week change 0.0%
2025 49 A 60 A 75 E 83 E 267 E
Expected Report Date 11/06/2025 2024 1A 31 A 59 A 74 A 164 A
Earnings ESP 0.0%
EPS Estimates(2)
Q1 Q2 Q3 Q4 Annual*
P/E TTM NA
2026 -0.24 E -0.20 E -0.15 E -0.13 E -0.73 E
P/E F1 NA
2025 -0.36 A -0.33 A -0.29 E -0.26 E -1.24 E
PEG F1 NA
2024 -0.42 A -0.34 A -0.28 A -0.26 A -1.28 A
P/S TTM 3.4
*Quarterly figures may not add up to annual.

1) The data in the charts and tables, except the estimates, is as of 10/02/2025.
2) The report's text, the analyst-provided estimates, and the price target are as of 10/03/2025.

© 2025 Zacks Investment Research, All Rights Reserved 101 N Wacker Drive, Floor 15, Chicago, IL 60606
 Overview
San Carlos, CA-based Iovance Biotherapeutics is a commercial-stage
pharmaceutical company primarily focused on developing and
commercializing novel T cell-based cancer immunotherapies. These
immunotherapies use Generation 2 (“Gen 2”) tumor-infiltrating
lymphocyte ("TIL"), which harnesses the power of a patient’s immune
system to eradicate cancer cells. The Gen 2 process is currently in use
in almost all studies in which the company manufactures TIL products,
including lifileucel and LN-145. The company is also focused on
developing a Generation 3 TIL.

In February 2024, Iovance received accelerated approval from the FDA

for TIL therapy Amtagvi (lifileucel) for the treatment of adult patients with
advanced melanoma previously treated with a PD-1 and targeted
therapy. The drug is also being studied in separate clinical studies for
treating cervical cancer, head and neck squamous cell carcinoma
(HNSCC) and non-small cell lung cancer (NSCLC) indications.

In May 2023, Iovance acquired worldwide rights to an FDA-approved

interleukin-2 (IL-2) product, Proleukin (aldesleukin), from U.K.-based
Clinigen Limited, for £166.7 million (around $200 million).The company
will pay double-digit royalties on global Proleukin sales to Clingen.

Iovance also has an early-stage, non-genetically modified, polyclonal T

cell product candidate, IOV-2001, which is being developed for chronic
As of 10/03/2025
lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). The
company is also developing other oncology candidates in collaboration
with academic institutions. In January 2020, the company in-licensed an antibody cytokine engrafted protein, IOV-3001, from Novartis.

Iovance generated total revenues worth $164.1 million in 2024 compared with $1.2 million in the year-ago period.

As of 10/02/2025

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 Reasons To Buy:
Amtagvi Sales Drive Top line: Amtagvi is the first FDA-approved individualized, one-time cell Based on the FDA
therapy for melanoma patients. Before the drug’s accelerated approval, there were no FDA-approved
therapies for advanced melanoma, which progressed on or after prior anti-PD-1/L1 therapy. Iovance
approval for
estimates that around 8,000 people in the U.S. die from melanoma every year. The approval for Amtagvi, we expect
Amtagvi will help address the needs of melanoma patients who have already been treated with that Iovance could
standard-of-care medications and have limited treatment options. The drug has also been added as a be eyed by big
preferred second-line or subsequent therapy in the National Comprehensive Cancer Network (NCCN)
guidelines for the treatment of cutaneous melanoma.
cancer drugmakers
as a takeover target.
Iovance started recording the drug’s sales in the second quarter of 2024 and claimed that the
demand for the drug has grown every month since its approval. The company recorded a total of
nearly $104 million from the drug’s sales in 2024. It expects this momentum to continue throughout 2025 and beyond, fuelled by patient
enrollments. This encouraging demand is also the reason for the surge in Proleukin sales since it is used in the Amtagvi regimen. Iovance
expects to generate total product revenues between $250-$300 million in 2025. Our model estimates Amtagvi sales to witness a CAGR of
nearly 70% over the next three years.

The company is evaluating Amtagvi in combination 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 for the drug in the approved indication.
Iovance believes the drug has the potential to generate more than a billion dollars in peak sales in the U.S. market alone from the melanoma
indication.

Health Canada recently approved the company’s regulatory filing for Amtagvi in August 2025. Similar regulatory applications are currently
under review in Australia and the U.K., with potential approvals expected in 2025 and early 2026.

Amtagvi Label Expansion Studies Progressing Well: Apart from melanoma, Iovance is developing Amtagvi in other cancer indications
across several label expansion studies. The drug is being evaluated as a potential treatment for cervical cancer, endometrial cancer, HNSCC
and NSCLC indications in separate mid-stage studies, C-145-04, IOV-END-201, C-145-03 and IOV-LUN-202, respectively.

An update from the IOV-LUN-202 study is expected before 2025-end. If the study's data is positive, Iovance expects to secure label
expansion for Amtagvi from the FDA in the NSCLC indication by 2027. Initial results from the IOV-END-201 study are also expected before
2025-end.

The ongoing phase II study, IOV-COM-202, which is composed of seven cohorts, is evaluating Amtagvi and Iovance’s TIL therapies in
multiple settings and for several indications, both as a monotherapy and in combination with Merck’s Keytruda or Bristol-Myers’
Opdivo/Yervoy/Opdualag.

Other Pipeline Candidates Show Promise: Other than Amtagvi, Iovance is also developing other pipeline candidates across clinical and
pre-clinical studies for different cancer indications.

The company is currently evaluating IOV-2001 in relapsed or refractory CLL and SLL in the phase I/II IOV-CLL-01 study. In 2022, Iovance
started the phase I/II IOV-GM1-201 study to evaluate its first TALEN-edited TIL therapy candidate, IOV-4001, in patients with advanced
melanoma and metastatic NSCLC in two separate cohorts. Data from the efficacy portion of this study is expected by the end of 2025.
Iovance is also evaluating IOV-3001, a second-generation modified IL-2 analog, for use in the TIL therapy treatment regimen in a phase I/II
study.

Agreements to Boost Pipeline: The company is boosting its pipeline through various agreements. In January 2020, Iovance entered into a
licensing agreement with Novartis and obtained rights to develop and commercialize IOV-3001. The company also entered into a research
collaboration and exclusive worldwide license agreement with Cellectis to use the latter’s TALEN technology to create more potent cancer
therapeutics targeting several cancer indications. The company has a similar agreement with H. Lee Moffitt Cancer Center, the National
Institutes of Health (NIH) and the National Cancer Institute (NCI) to gain the right patent-protected or patent-pending technologies to develop
TIL-based therapies.

Potential in the Target Market: Iovance’s pipeline candidates target oncology indications, which represent a significant potential. Per the
American Cancer Society, it is estimated that 104,960 new cases of melanoma will be diagnosed in the United States in 2025 and the disease
will result in 8,430 deaths. For cervical cancer, approximately 13,360 new cases of invasive cervical cancer will be diagnosed in 2025 and
4,320 women will die from cervical cancer, per the American Cancer Society. Cervical cancer is most frequently diagnosed in women aged
between 35 and 44, with an average age of 50 at the time of diagnosis.

Favorable Debt Profile: Iovance has a favorable debt profile. It had a debt of $1 million (short- and long-term debt) as of June 2025-end. The
company's cash, cash equivalents and marketable securities totaled $307 million, which should be more than sufficient to pay the debt in
case of insolvency.

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 Reasons To Sell:
Recent Developments Around the Stock: In February 2025, Iovance cautioned investors (in an Regulatory and
annual SEC filing) against facing economic uncertainty due to geopolitical conflicts and inflation that
could harm its business and market performance. In May 2025, the company also lowered its full-year
pipeline setbacks
2025 product revenue guidance to $250-$300 million from the prior projection of $450-$475 million remain a concern.
due to the anticipated growth in authorized treatment centers, adoption trends and patient referral
timelines. These recent developments are responsible for the negative sentiments surrounding the
company, leading to the stock’s 70% plunge year to date, underperforming the industry’s 9% growth.

Regulatory/Pipeline Setbacks: Though Iovance’s pipeline progress has been encouraging, the company has had its share of pipeline
setbacks. In August 2025, the company announced that it had voluntarily withdrawn the regulatory filing for the therapy in the EU due to a
lack of alignment with the EMA on clinical data supporting the submission. While Iovance is currently developing a new strategy to seek the
therapy’s EU approval, this setback delays the initial plan of securing a potential approval before this year’s end.

In December 2023, the FDA placed a clinical hold on the IOV-LUN-202 study evaluating LN-145 in the NSCLC indication following a grade 5
(fatal) adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study. While the
clinical hold was lifted in March 2024, it delayed the drug's clinical advancement.

The FDA’s queries on potency assay and assay matrix for Amtagvi, which began in 2020, had been one of the main reasons for the delayed
regulatory filing for the drug with the FDA. The resolution to these queries was necessary since Iovance could not proceed with a regulatory
filing for the candidate. Though Iovance subsequently resolved these queries in 2022, such setbacks do not bode well for the stock in the long
run. Any further setback related to regulatory filings and potential approval for its candidates could prove more detrimental to Iovance’s
prospects.

Competition: Several other companies are developing immuno-oncology therapies for treating various cancer indications. Iovance’s
marketed therapies compete with several approved as well as drugs under development from companies, including Bristol-Myers Squibb,
Merck and Nektar Therapeutics, among others. Companies developing genetically engineered T cell therapies include Adaptimmune,
Neogene and others.

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 Last Earnings Report
Q2 Earnings & Sales Miss Estimates FY Quarter Ending 12/31/2024

Iovance incurred a second-quarter 2025 loss of 33 cents per share, wider than the Zacks Earnings Reporting Date Aug 07, 2025
Consensus Estimate of a loss of 29 cents. In the year-ago quarter, the company reported a loss
Sales Surprise -9.64%
of 34 cents per share.
EPS Surprise -13.79%
Quarterly revenues rose 93% year over year to $60.0 million, entirely from the sales of its two Quarterly EPS -0.33
marketed drugs. Yet, this figure also missed the Zacks Consensus Estimate of $66.4 million. Annual EPS (TTM) -1.23

Quarter in Detail

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.

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.

Financial 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.

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 Recent News
Health Canada Approves Amtagvi – Aug. 18

Iovance announced that it has secured approval in Canada for Amtagvi to treat adult patients with unresectable or metastatic melanoma that has
progressed on or after at least one prior systemic therapy, including a PD-1 blocking antibody and targeted therapy.

Valuation
Iovance’s shares are down 69.6% year to date and 78.5% over the trailing 12-month period. Stocks in the Zacks sub-industry are up 8.8% while
those in the sector are up 2.4% over the year-to-date period. Over the past year, Zacks sub-industry and sector are down 5.2% and 9.9%,
respectively.

The S&P 500 Index is up 15.3% year to date and 19.0% in the past year.

The stock is currently trading at 1.08X trailing 12-month book value per share which compares to 3.40X for the Zacks sub-industry, 4.16X for the
Zacks sector, and 8.81X for the S&P 500 Index.

Over the past five years, the stock has traded as high as 11.75X and as low as 0.72X, with a 5-year median of 3.53X. Our Neutral
recommendation indicates that the stock will perform in line with the market. Our $2.50 price target reflects 1.20X trailing 12-month book value
per share.

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 Industry Analysis(1)Zacks Industry Rank: Top 30% (74 out of 245) Top Peers(1)
Company (Ticker) Rec Rank
Adaptimmune Therapeutics PLC Neutral
(ADAP)
Adaptive Biotechnologies Corporation
(ADPT) Neutral

Arcturus Therapeutics Holdings Inc. Neutral

(ARCT)
CRISPR Therapeutics AG (CRSP) Neutral

Kamada Ltd. (KMDA) Neutral

Maze Therapeutics, Inc. (MAZE) Neutral

Tarsus Pharmaceuticals, Inc. (TARS) Neutral

Immatics N.V. (IMTX) Underperform

Industry Comparison(1)Industry: Medical - Biomedical And Genetics Industry Peers

IOVA X Industry S&P 500 ALLO KMDA MAZE

Zacks Recommendation (Long Term) Neutral - - Neutral Neutral Neutral

Zacks Rank (Short Term) - -

VGM Score - -
Market Cap 814.17 M 153.92 M 39.32 B 286.23 M 391.03 M 1.16 B
# of Analysts 6 3 21 8 3 5
Dividend Yield 0.00% 0.00% 1.52% 0.00% 0.00% 0.00%
Value Score - -
Cash/Price 0.39 0.34 0.04 0.98 0.17 0.22
EV/EBITDA -1.50 -1.30 14.49 -0.05 11.69 15.83
PEG Ratio NA 1.82 2.34 NA 0.72 NA
Price/Book (P/B) 1.08 2.57 3.43 0.82 1.50 4.43
Price/Cash Flow (P/CF) NA 15.77 14.68 NA 13.83 173.10
P/E (F1) -1.87 19.42 20.17 NA 18.05 NA
Price/Sales (P/S) 3.37 6.43 3.06 NA 2.31 NA
Earnings Yield -52.44% -20.14% 4.95% -74.42% 5.59% -12.38%
Debt/Equity 0.00 0.00 0.58 0.00 0.00 0.00
Cash Flow ($/share) -1.11 -1.47 8.99 -1.13 0.49 0.15
Growth Score - -
Hist. EPS Growth (3-5 yrs) NA% 0.93% 9.18% NA 0.93% NA
Proj. EPS Growth (F1/F0) 3.13% 15.08% 7.79% 27.27% 52.00% NA
Curr. Cash Flow Growth -18.26% -4.52% 7.00% -22.77% 15.35% -106.96%
Hist. Cash Flow Growth (3-5 yrs) -21.18% 3.32% 7.27% -6.70% 1.10% NA
Current Ratio 3.27 4.39 1.21 8.92 4.00 13.63
Debt/Capital 0.00% 0.00% 38.13% 0.00% 0.00% 0.00%
Net Margin -161.44% -100.70% 12.52% NA 11.22% NA
Return on Equity -52.87% -65.07% 17.03% -55.99% 7.41% NA
Sales/Assets 0.26 0.31 0.53 NA 0.46 NA
Proj. Sales Growth (F1/F0) 62.80% 0.00% 5.12% NA 12.40% NA
Momentum Score - -
Daily Price Chg 1.81% 0.18% 0.06% 4.03% -0.58% 2.67%
1 Week Price Chg 2.93% 1.09% 1.67% 7.76% -3.47% 17.70%
4 Week Price Chg 2.27% 5.43% 3.28% 16.22% -3.68% 76.20%
12 Week Price Chg 16.58% 8.20% 6.92% 2.38% -15.21% 69.44%
52 Week Price Chg -76.95% -15.35% 17.81% -50.58% 31.53% NA
20 Day Average Volume 9,932,842 372,634 2,770,113 2,829,210 55,287 854,992
(F1) EPS Est 1 week change 0.00% 0.00% 0.00% 1.11% 0.00% 1.02%
(F1) EPS Est 4 week change 0.00% 0.00% 0.00% 1.90% 0.00% 4.14%
(F1) EPS Est 12 week change -2.75% 1.33% 0.90% 5.53% 14.14% 0.79%
(Q1) EPS Est Mthly Chg 0.00% 0.00% 0.00% 2.58% 0.00% 11.80%

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 Analyst Earnings Model(2)

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 Zacks Stock Rating System
We offer two rating systems that take into account investors' holding horizons: Zacks Rank and Zacks Recommendation. Each provides valuable
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Recommendation is trends in the company's estimate revisions and earnings outlook. The Zacks Recommendation is broken down into 3 Levels;
Outperform, Neutral and Underperform. Unlike many Wall Street firms, we have an excellent balance between the number of Outperform and
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Disclosures
This report contains independent commentary to be used for informational purposes only. The analysts contributing to this report do
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stock. The EPS and revenue forecasts are the Zacks Consensus estimates, unless otherwise indicated in the report’s first-page
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Additional information on the securities mentioned in this report is available upon request. This report is based on data obtained from sources we
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ZIR uses the following rating system for the securities it covers. Outperform- ZIR expects that the subject company will outperform the broader
U.S. equities markets over the next six to twelve months. Neutral- ZIR expects that the company will perform in line with the broader U.S.
equities markets over the next six to twelve months. Underperform- ZIR expects the company will underperform the broader U.S. equities
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