# EDGAR Filing Document

**Accession Number:** 0001425205
**File Stem:** 0001104659-26-056782
**Filing Date:** 2026-5
**Character Count:** 28713
**Document Hash:** f7609c6beb20a2e7d1946d940af54ac2
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-26-056782.hdr.sgml**: 20260507

**ACCESSION NUMBER**: 0001104659-26-056782

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20260507

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260507

**DATE AS OF CHANGE**: 20260507

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** IOVANCE BIOTHERAPEUTICS, INC.
- **CENTRAL INDEX KEY:** 0001425205
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 753254381
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36860
- **FILM NUMBER:** 26951209

**BUSINESS ADDRESS:**
- **STREET 1:** 825 INDUSTRIAL ROAD
- **STREET 2:** 4TH FLOOR
- **CITY:** SAN CARLOS
- **STATE:** CA
- **ZIP:** 94070
- **BUSINESS PHONE:** 6502607120

**MAIL ADDRESS:**
- **STREET 1:** 825 INDUSTRIAL ROAD
- **STREET 2:** 4TH FLOOR
- **CITY:** SAN CARLOS
- **STATE:** CA
- **ZIP:** 94070

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Lion Biotechnologies, Inc.
- **DATE OF NAME CHANGE:** 20131015

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Genesis Biopharma, Inc
- **DATE OF NAME CHANGE:** 20100319

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** FREIGHT MANAGEMENT CORP
- **DATE OF NAME CHANGE:** 20080128

?xml version='1.0' encoding='ASCII'?

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**Current Report** 

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

Date of Report (date of earliest event reported): May 7, 2026

**IOVANCE BIOTHERAPEUTICS, INC.**

(Exact Name of Registrant as Specified in Charter)

---

| | |
|:---|:---|
| &nbsp;&nbsp;**Delaware** | &nbsp;&nbsp;**Delaware** |
| &nbsp;&nbsp;**(State of Incorporation)** | &nbsp;&nbsp;**(State of Incorporation)** |
| &nbsp;&nbsp;**001-36860** | &nbsp;&nbsp;**75-3254381** |
| &nbsp;&nbsp;**Commission File Number** | &nbsp;&nbsp;**(I.R.S. Employer Identification No.)** |
| &nbsp;&nbsp;**825 Industrial Road** **, Suite 100** |  |
| &nbsp;&nbsp;**San Carlos** **, California** | &nbsp;&nbsp;**94070** |
| &nbsp;&nbsp;**(Address of Principal Executive Offices)** | &nbsp;&nbsp;**(Zip Code)** |
| &nbsp;&nbsp;**(650) 260-7120** | &nbsp;&nbsp;**(650) 260-7120** |
| &nbsp;&nbsp;**(Registrant's Telephone Number, Including Area Code)** | &nbsp;&nbsp;**(Registrant's Telephone Number, Including Area Code)** |

---

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

◻ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

◻ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

◻ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).

◻ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ◻

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;Title of each class | &nbsp;&nbsp;Trading <br> Symbol(s) | &nbsp;&nbsp;Name of each exchange on which<br> registered |
| &nbsp;&nbsp;Common stock, par value $0.000041666 per share | &nbsp;&nbsp;IOVA | &nbsp;&nbsp;The Nasdaq Stock Market LLC |

---

---

| | |
|:---|:---|
| **Item 2.02.** | **Results of Operations and Financial Condition.** |

---

On May 7, 2026, Iovance Biotherapeutics, Inc. (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2026, and an update on recent developments. A copy of that press release is furnished as Exhibit 99.1.

The information furnished under this Item 2.02, including the accompanying Exhibit 99.1, shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of such section, nor shall such information be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.

---

| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.** |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits.

---

| | |
|:---|:---|
| **Exhibit<br> No.** | **Description** |
| [99.1](tm2613648d1_ex99-1.htm) | [Press Release of Iovance Biotherapeutics, Inc., dated May 7, 2026.](tm2613648d1_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded as Inline XBRL document) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **Iovance Biotherapeutics, Inc.** | **Iovance Biotherapeutics, Inc.** |
| Dated: May 7, 2026 | By: | /s/ Frederick G. Vogt |
|  | Name: | Frederick G. Vogt, Ph.D., J.D. |
|  | Title: | Interim CEO and President, and General Counsel |

---

## Exhibit 99.1

**Exhibit 99.1**

**Iovance Biotherapeutics Highlights Positive First Quarter 2026**

**Results, Business Achievements and Corporate Updates**

*1Q26 Total Revenue of ~$71M Delivers ~45% Year-over-Year Growth*

*2Q26 Revenue Guidance of $86M to $88M and FY26 of $350M to $370M*

*40% Confirmed Objective Response Rate in Metastatic Serous Endometrial Cancer*

**SAN CARLOS, Calif., May 7, 2026 --** Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported first quarter 2026 financial results, business achievements, and corporate updates.

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "We are accelerating the adoption and commercial expansion for Amtagvi after record high demand. Iovance is well positioned through 2026 for long-term revenue growth, while advancing multiple ongoing and new clinical trials, including our registrational trial in advanced sarcomas now underway and encouraging initial data reported today for lifileucel in metastatic serous endometrial cancer. Internal manufacturing efficiencies, operational improvements, and cost reductions will benefit gross margin and propel future profitability, sustainable growth, and long-term value for patients and shareholders."

**First Quarter 2026 Financial Highlights**

*Continued Strength in Execution and Cost Discipline*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Total
 product revenue of ~$71 million increased by ~45% over 1Q25, reflecting significant performance
 improvements over the prior annual maintenance period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o U.S. Amtagvi revenue was ~$60 million.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Global Proleukin revenue was ~$11 million.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Gross
 margin of 41% absorbed one-time costs for the annual maintenance period and the recent internal
 facility expansion.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Consistent
 with 1Q25, revenue was affected by maintenance of the Iovance Cell Therapy Center (*i* CTC).
 The facility has now been expanded to ensure continuous supply going forward during future
 maintenance periods.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Research
 and Development (R&D) expenses decreased by 12% compared to 4Q25, driven by operational
 efficiencies and marking the third consecutive quarter of improvements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Successful
 centralization of manufacturing at *i* CTC, significant operational excellence initiatives
 focused on Amtagvi production, and R&D optimization should further reduce costs and improve
 gross margins in 2026 and 2027.

**Second Quarter 2026 and Full Year 2026 Guidance**

*Strong Growth in Amtagvi Forecast for 2026*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Total
 product revenue guidance for 2Q26 is $86 million to $88 million and for FY26 is $350 million
 to $370 million.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· U.S.
 Amtagvi revenue for 2Q26 is expected to be $79 million to $81 million, reflecting an expected
 ~23% increase over 4Q25 (the quarter prior to *i* CTC maintenance).

**Amtagvi Commercial Business**

*Strong U.S. Commercial Business to Deliver Strong Growth in 2026*

&nbsp;&nbsp;&nbsp;&nbsp;· Increasing
 Amtagvi demand, catalyzed by real-world data, is driven by adoption and referrals toward
 earlier treatment. Recently published real world <u>objective response</u> rates were 52%
 in patients with two or fewer prior lines of therapy. Five-year follow-up clinical <u>data</u> demonstrated deep and durable responses in heavily pretreated patients, with a median duration
 of response of 3 years.

&nbsp;&nbsp;&nbsp;&nbsp;· Demand
 and referral patterns are accelerating across a growing network of more than 90 U.S. and
 Canadian academic and community authorized treatment centers (ATCs). By year-end 2026, at
 least 110 ATCs will be activated.

&nbsp;&nbsp;&nbsp;&nbsp;· Amtagvi
 turnaround time is 32 days or less with the first scaled, centralized commercial manufacturing
 process for TIL therapy. This is significantly faster than any other TIL therapy in development.

&nbsp;&nbsp;&nbsp;&nbsp;· Amtagvi
 global expansion is advancing:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Decisions on marketing authorization application (MAA) approvals are
 expected in Australia in the first half of 2026 and in Switzerland in the first half of 2027.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o In the United Kingdom, Iovance withdrew its initial MAA for lifileucel
 in May 2026 for procedural reasons. With the full agreement of the Medicines and Healthcare
 products Regulatory Agency (MHRA), Iovance will promptly resubmit the MAA with updated
 information for an expedited review by the MHRA, which is expected to be completed over the
 coming months.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Iovance is working to resubmit an MAA to the European Medicines Agency
 (EMA) in 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Other regulatory submissions are planned in markets with a high prevalence
 of advanced melanoma, non-small cell lung cancer (NSCLC), and soft tissue sarcomas.

**Pipeline Updates**

*New Data Across Several Pipeline Programs Anticipated Throughout 2026*

&nbsp;&nbsp;&nbsp;&nbsp;· Registrational
 Trials of Lifileucel Treatment in Solid Tumors

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o IOV-END-201: Positive initial data in previously treated metastatic
 serous endometrial cancer:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ The
 confirmed objective response rate (cORR) by RECIST v1.1 was 40% and disease control rate
 was 100% in the first five evaluable patients with a median of 2 prior lines of therapy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ All
 five patients were mismatch repair proficient and progressed on prior chemotherapy and checkpoint
 inhibitor therapy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ These
 initial responses build on established differentiation of lifileucel from immune checkpoint
 inhibitors, including in melanoma, and demonstrate its advantages for solid tumor indications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Serous
 endometrial cancer is a difficult to treat subtype accounting for ~40% of the approximately
 12,500 annual U.S. endometrial cancer deaths.<sup>1</sup> The second line setting represents
 an area of unmet medical need, with no therapy approved by FDA specifically for patients
 with serous endometrial carcinoma or for patients who have received prior PD-1 blocking antibodies.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Engagement
 on an expedited approval pathway with the ongoing IOV-END-201 trial is planned with the U.S.
 Food and Drug Administration (FDA).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o IOV-LUN-202: <u>initial results</u> in previously treated, metastatic
 non-squamous NSCLC supported FDA Fast Track Designation, reflecting the high unmet medical
 need in this population. Upcoming milestones include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Updated
 data at a major medical meeting in 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Completion
 of enrollment in 2026 to support a supplemental Biologics License Application (sBLA).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Potential
 for a U.S. accelerated approval and launch in the second half of 2027.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o IOV-SAR-201: a new registrational trial in undifferentiated pleomorphic
 sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS) is now underway, driven by <u>positive early data</u> with a cORR of 50% in the first six evaluable patients.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Site
 activation and enrollment are on track to begin in the third quarter of 2026.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Iovance
 is actively engaging with FDA on a path to expedited approval for lifileucel in UPS and DDLPS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o TILVANCE-301: A Phase 3 randomized trial of lifileucel and pembrolizumab
 in frontline advanced melanoma.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ Sites
 are actively enrolling patients across a broad global footprint.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ An
 early interim analysis based on cORR is intended for a potential sBLA in frontline advanced
 melanoma.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;▪ TILVANCE-301
 is also the confirmatory trial to support full approval in second line advanced melanoma.

&nbsp;&nbsp;&nbsp;&nbsp;· Next
 Generation Pipeline

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o An Investigational New Drug (IND) application was submitted to FDA
 for a Phase 1/2 basket trial of IOV-5001, a second-generation IL-12 tethered TIL therapy,
 to begin enrolling in 2H 2026. Cohorts include advanced colorectal cancer, triple negative
 and estrogen receptor low breast cancers, and other highly prevalent solid tumors representing
 more than 100,000 U.S. deaths annually.<sup>2</sup> IOV-5001 is designed to remodel the suppressive
 tumor microenvironment (TME) and activate immunologically cold tumors to support TIL responses.
 A first-generation IL-12 secreted TIL therapy showed a cORR of 63% in 16 melanoma patients
 at cell doses much lower than used with typical TIL therapies as well as those safely achievable
 with IOV-5001.<sup>3</sup>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o A Phase 1/2 trial, IOV-GM1-201, is enrolling using IOV-4001,
 a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC. IOV-4001
 is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight
 and kill cancer in the TME.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o A Phase 1 safety cohort using IOV-3001 is advancing through multiple
 dose levels in the Phase 1/2 trial of our second-generation, modified IL-2 analog for the
 TIL treatment regimen. <u>IOV-3001</u> selectively expands effector T cells while avoiding
 activation of regulatory T cells, with the potential for a lower dose IL-2 regimen with reduced
 adverse events. IOV-3001 exhibits favorable pharmacokinetics and is expected to be superior
 to Proleukin as a component of future TIL regimens.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Multiple investigator-sponsored clinical trials of lifileucel are
 enrolling in cutaneous squamous and Merkel cell carcinomas as well as other new solid tumor
 indications.

**Corporate Updates**

&nbsp;&nbsp;&nbsp;&nbsp;· Iovance
 currently owns or licenses nearly 400 granted or allowed U.S. and international <u>patents and patent rights</u> for Amtagvi and other TIL-related technologies, as well as more than
 1,000 patent applications worldwide, which are expected to provide exclusivity into 2042
 for Amtagvi and beyond for pipeline therapies.

&nbsp;&nbsp;&nbsp;&nbsp;· Dr. Friedrich
 Graf Finckenstein, Chief Medical Officer, will retire from Iovance in June 2026. The
 company thanks Dr. Finckenstein for his service and contributions to the development
 of Amtagvi and other pipeline products. A new Chief Medical Officer is expected to be announced
 in the near term.

&nbsp;&nbsp;&nbsp;&nbsp;· Iovance's
 cash position was ~$319 million on March 31, 2026.<sup>4</sup> The current cash position,
 bolstered by expense reductions, is expected to fund operations well into 2028.

**Webcast and Conference Call**

Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at <u>https://edge.media-server.com/mmc/p/wmx3s4fc</u>. The live and archived webcast can be accessed in the Investors section of the Company's website, IR.Iovance.com, for one year.

1. Hamilton, C., Cheung, M., Osann, K. et al. Uterine papillary serous and clear cell carcinomas predict for poorer survival compared to grade 3 endometrioid corpus cancers. Br J Cancer 94, 642–646

2. Surveillance, Epidemiology, and End Results Program <u>Cancer Stat Facts</u> (accessed May 2026).

3. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278–2288.

4. Cash, cash equivalents, short-term investments, and restricted cash as of March 31, 2026.

**About Iovance Biotherapeutics, Inc.**

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The <u>Iovance TIL platform</u> has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi<sup>®</sup> is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit <u>www.iovance.com</u>.

Amtagvi <sup>®</sup> and its accompanying design marks, Proleukin<sup>®</sup>, Iovance<sup>®</sup>, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance's broad, industry-leading patent portfolio is available on the Intellectual Property page on <u>www.iovance.com</u>.

**Forward-Looking Statements**

Certain matters discussed in this press release are "forward-looking statements" of Iovance Biotherapeutics, Inc. (hereinafter referred to as the "Company," "we," "us," or "our") within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Without limiting the foregoing, we may, in some cases, use terms such as "predicts," "believes," "potential," "achievable," "continue," "estimates," "anticipates," "expects," "plans," "intends," "forecast," "guidance," "outlook," "may," "can," "could," "might," "will," "should," or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our *i*CTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.

**IOVANCE BIOTHERAPEUTICS, INC.**

**Selected Condensed Consolidated Balance Sheets**

**(in thousands)**

---

| | | |
|:---|:---|:---|
|  | **March 31, 2026<br>(unaudited)** | **December 31, 2025** |
| Cash, cash equivalents, and investments | $313443 | $296980 |
| Restricted cash | $5992 | $5980 |
| Total assets | $925665 | $913170 |
| Stockholders' equity | $721754 | $698583 |

---

**Condensed Consolidated Statements of Operations**

**(in thousands, except per share information)**

---

| | | |
|:---|:---|:---|
|  | **For the Three Months Ended** | **For the Three Months Ended** |
|  | **March 31,** | **March 31,** |
|  | **2026<br> (unaudited)** | **2025 <br> (unaudited)** |
| **Revenue** | | |
| &nbsp;&nbsp;&nbsp;Product revenue, net | $71430 | $49324 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total revenue | 71430 | 49324 |
| **Costs and expenses\*** |  |  |
| &nbsp;&nbsp;&nbsp;Cost of sales **\*\*** | $42498 | $42715 |
| &nbsp;&nbsp;&nbsp;Research and development **\*\*** | 62487 | 75965 |
| &nbsp;&nbsp;&nbsp;Selling, general and administrative **\*\*** | 38949 | 43800 |
| &nbsp;&nbsp;&nbsp;Depreciation and amortization | 8539 | 8065 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total costs and expenses | 152473 | 170545 |
| **Loss from operations** | (81043) | (121221) |
| **Other income** |  |  |
| &nbsp;&nbsp;&nbsp;Interest and other income, net | 1333 | 3220 |
| **Net Loss before income taxes** | (79710) | (118001) |
| &nbsp;&nbsp;&nbsp;Income tax (expense) benefit | 665 | 1838 |
| **Net Loss** | $(79045) | $(116163) |
| **Net Loss Per Share of Common Stock, Basic and Diluted** | $(0.19) | $(0.36) |
| **Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted** | 418511 | 322868 |
| **\*Non-cash stock-based compensation included in cost of sales and operating expenses:** |  |  |
| &nbsp;&nbsp;&nbsp;Cost of sales | $1019 | $2420 |
| &nbsp;&nbsp;&nbsp;Research and development | 5117 | 9917 |
| &nbsp;&nbsp;&nbsp;Selling, general and administrative | 5133 | 10578 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stock-based compensation included in costs and expenses | $11269 | $22915 |
| **\*\* Excludes depreciation and amortization** |  |  |

---

**CONTACTS**

**Investors**

IR@iovance.com

<u>650-260-7120</u> ext. 150

**Media**

PR@iovance.com

<u>650-260-7120</u> ext. 150