Iovance Biotherapeutics : Corporate Presentation

Corporate Overview

May 31, 2024

© 2024, Iovance Biotherapeutics, Inc.

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Forward-Looking Statements

Certain matters discussed in this presentation are "forward-looking statements" of Iovance Biotherapeutics, Inc. (hereinafter referred to as the "Company," "we," "U.S.," 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," "continue," "estimates," "anticipates," "expects," "plans," "intends," "forecast," "guidance," "outlook," "may," "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, including Amtagvi and Proleukin, for which we obtain U.S. Food and Drug Administration ("FDA"), European Medicines Agency ("EMA"), or other regulatory authority approval; the risk that the EMA or other regulatory authorities may not approve or may delay approval for our biologics license application ("BLA") submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; our ability or inability to manufacture our therapies using third party manufacturers or at our own facility may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risk that future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; 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 enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); 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 effects of the COVID-19 pandemic; and other factors, including general economic conditions and regulatory developments, not within our control.

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© 2024, Iovance Biotherapeutics, Inc.

Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer

Commercial

Products

Commercial

100+ Amtagvi Patients Enrolled by 5/9/24

Payers responsible for

200 million+

patient lives have approved Amtagvi for at least 1 patient

50	Authorized Treatment
	Centers by 5/28/2024

Pipeline

2Registrational

Clinical Trials

7Active Clinical Trials

5Tumor Types in Clinic

3Fast 1BTD 1RMAT

Track

Designations

People & Assets

~$363M

Cash Position as of 3/31/24

120+

U.S. and International Patents

600+

Employees

Partners &

Collaborators

The University of Texas

MD Anderson Cancer Center

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© 2024, Iovance Biotherapeutics, Inc.

Abbreviations: BTD=Breakthrough Therapy Designation; FDA=U.S. Food and Drug Administration; RMAT=Regenerative Medicine Advanced Therapy Designation

Label Expansion Opportunities

Iovance Solid Tumor Portfolio Highlights

		INDICATIONS	PHASE 1	PHASE 2	PHASE 3	APPROVED
		Post-anti-PD-1 advanced melanoma (U.S.)
		Planned submissions: EU (2Q24), U.K. & Canada (2H24)
Commercial
		Amtagvi treatment regimen (U.S.)
		Advanced melanoma, renal cell carcinoma (U.S., ex-U.S.)
Registration-	Lifileucel + pembrolizumab	Frontline advanced melanoma	TILVANCE-301 Phase 3 (FTD, Confirmatory)
Directed	Lifileucel	2L post-chemo & anti-PD-1 advanced NSCLC	IOV-LUN-202: Cohorts 1&2
	Lifileucel	2L post-chemo & anti-PD-1 endometrial cancer	Planned
Lifileucel	Lifileucel, Lifileucel + ICI	2-4L incl. post-anti-PD-1 advanced NSCLC	IOV-COM-202: Cohorts 3A, 3B*, 3C
Pipeline	Lifileucel + ICI	1L advanced melanoma	IOV-COM-202: Cohort 1A
	Lifileucel core biopsy	2L post-chemo & post-anti-PD-1 advanced NSCLC	IOV-LUN-202: Cohort 3
	PD-1 Inactivated TIL (IOV-4001)	Post anti-PD1 advanced melanoma	IOV-GM1-201: Cohort 1
Next-	PD-1 Inactivated TIL (IOV-4001)	2-4L incl. post-anti-PD-1 advanced NSCLC	IOV-GM1-201: Cohort 2
Generation
Products	IL-2 analog (IOV-3001)	TIL Treatment Regimen (planned IND in 3Q 2024)	Planned
	IL-12 tethered TIL (IOV-5001)	Undisclosed (planned IND early 2025)	Planned

*Enrollment complete

Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; BTD=Breakthrough Therapy Designation; FTD=Fast Track Designation; ICI=immune checkpoint inhibitor; IL-2=interleukin 2; IL-12=interleukin 12; IND=investigational new drug application; NSCLC=non-small cell lung cancer; PD-1=programmed cell death protein-1; TIL=tumor infiltrating lymphocytes

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© 2024, Iovance Biotherapeutics, Inc.

Tumor Infiltrating Lymphocytes (TIL):

Leading Cell Therapy Platform for Solid Tumors

TIL - Unique Proposed Mechanism of Action

• Individualized
• One-timetherapy
• Deploys the patient's own T cells to fight cancer

TIL Treatment Regimen	Tumor Tissue
	Collection

Patient-specific T Cells

Grown into the Billions1

1. Amtagvi USPI

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© 2024, Iovance Biotherapeutics, Inc.

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First and only one-time, individualized T cell therapy approved by FDA for a solid tumor cancer

© 2024, Iovance Biotherapeutics, Inc.

First FDA Approved Treatment after Progression on Anti-PD-1 Therapy & BRAF/MEK Inhibitors1

1. Amtagvi USPI

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© 2024, Iovance Biotherapeutics, Inc.

U.S. Metastatic Melanoma Patient Population

~13k

Estimated eligible advanced melanoma patients per year in U.S.1

8k

Annual deaths

in U.S.2

U.S. Melanoma Drug-Treated Population in 2021

Unresectable / Metastatic1

9.9K

6.3K

4.8K

More than half of patients progress within 12 months on current 1L ICIs, regardless of BRAF mutation status3

Amtagvi is preferred second- line or subsequent therapy in National Comprehensive Cancer Network® (NCCN) guidelines for treatment of cutaneous melanoma

1L

2L

3L-4L

1. Clarivate DRG Disease Landscape (2021)
2. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2024 Estimates. https://seer.cancer.gov accessed May 2024
3. Larkin et al, NEJM 2019; Robert et al, Lancet Oncology 2019; Tawbi et al, NEJM 2022

Abbreviations: 1L=first line therapy, 2L=second line therapy, 3L=third line therapy; 4L=fourth line therapy; ICI=immune checkpoint inhibitor

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© 2024, Iovance Biotherapeutics, Inc.

Amtagvi Delivered Deep and Durable Responses

Cohort 4	ORR 31.5% mDOR Not Reached
Pivotal1	(95% CI: 21.1, 43.4)	18.6 months follow up
(n=73)
	(Range: 1.4+, 26.3+; 95% CI: 4.1, NR)

Supportive	ORR 31.4% mDOR Not Reached
Pooled Data1	(95% CI: 24.1, 39.4)	21.5 months follow up2
(n=153)

(Range: 1.4+, 45.0+)

1. C-144-01Clinical Trial, Amtagvi USPI
2. Data on file.

Abbreviations: CI=confidence interval; mDOR=median duration of response; NR=not reached; ORR=objective response rate

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© 2024, Iovance Biotherapeutics, Inc.

Amtagvi Durability at 4-Years

4-yearFollow-up of Pooled Analysis (n=153)

Median DOR not reached at 4-yearfollow-up

21.9% of patients were alive at 4-yearfollow-up

1. Medina et al, ESMO IO 2023

Abbreviations: CI=confidence interval; mDOR=median duration of response; NR=not reached; ORR=objective response rate

ORR 31.4%

(95% CI: 24.1, 39.4)

Not

mDOR Reached

(95% CI: 8.3, NR)

48.1 months follow-up

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© 2024, Iovance Biotherapeutics, Inc.