Iovance Biotherapeutics : June 2021 Corporate Presentation

Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors

June 2021

© 2021, Iovance Biotherapeutics, Inc

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Forward Looking Statements

Certain matters discussed in this presentation are "forward-looking statements" of Iovance Biotherapeutics, Inc, 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"). All such written or oral statements made in this presentation, other than statements of historical fact, are forward-looking statements and are intended to be covered by the safe harbor for forward-looking statements provided by 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 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 effects of the COVID-19 pandemic; risks related to the timing of and our ability to successfully develop, submit, obtain and maintain U.S. Food and Drug Administration ("FDA") or other regulatory authority approval of, or other action with respect to, our product candidates, and our ability to successfully commercialize any product candidates for which we obtain FDA approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials; 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 new version of the protocol which further defines the patient population to include more advanced patients in our cervical cancer trial may have an adverse effect on the results reported to date; 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 or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA may differ from the interpretation of such results or communications by the FDA; the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved; our ability or inability to manufacture our therapies using third party manufacturers or our own facility may adversely affect our potential commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk that unanticipated expenses may decrease our estimated cash balances and increase our estimated capital requirements; and other factors, including general economic conditions and regulatory developments, not within our control.

© 2021, Iovance Biotherapeutics, Inc

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NASDAQ: IOVA

Iovance: Developing to commercialize TIL Cell Therapy

450+ Patients Treated with Iovance TIL Using Proprietary Process

Platform

• Leading cell therapy platform in solid tumors
• Clinical data in multiple indications
• Consistent GMP manufacturing process across solid tumors
• Next gen research in selected and genetically modified TIL

Pipeline

• Pivotal programs in metastatic melanoma and advanced cervical cancers
• Registration-supportingstudy in non-small cell lung carcinoma (NSCLC)
• Combinations with immune-checkpoint inhibitors in earlier lines
• Academic collaborations in new indications

Assets Partners

• ~$610M cash (3/31/21)
• Global rights to all programs, IP and technology
• Iovance manufacturing

facility (iCTC)

© 2021, Iovance Biotherapeutics, Inc

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Investment Highlights

Leading TIL cell therapy company focused on treatment of solid tumors

Large market opportunity & strong unmet need

• Initial focus in post-checkpoint solid tumors
• Expansion into combinations and earlier lines of therapy
• Five company-sponsored programs in melanoma, cervical, head & neck, NSCLC, and chronic lymphocytic leukemia (CLL) indications

Potential to be

the first cell therapy approved for solid tumors in melanoma and cervical

• Accelerated path to approval in melanoma and cervical cancer
• BLA submission expected 2022
• Melanoma: RMAT, Orphan Drug, and Fast Track
• Cervical: BTD, Orphan Drug, and Fast Track

Efficient &

scalable proprietary manufacturing

• US and EU capacity with contract manufacturers
• Iovance Cell Therapy Center (iCTC) under construction in Philadelphia
• Rapid 22-day Gen 2 manufacturing with 90%+ success rate
• 450+ patients treated with Iovance proprietary process

© 2021, Iovance Biotherapeutics, Inc

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Corporate Goals and Updates

2020 Accomplishments; Anticipated 2021 Milestones

		2020
		Agreement with FDA on melanoma Cohort 4
Regulatory		clinical follow up; Cohort 2 supportive

2021

BLA: FDA feedback received for potency assays; additional assay data submission and interactions planned in 2H21

Clinical









Melanoma: early pivotal Cohort 4 data and updated Cohort 2 data

Cervical: last patient dosed in cervical pivotal cohort

NSCLC: Moffitt TIL data; registration directed study initiated

HNSCC: initial data for TIL + pembrolizumab

Melanoma: TIL + pembrolizumab data at ASCO

• Cervical: last patient dosed in Cohort 2, potential to include in BLA

NSCLC: patient dosing in IOV-LUN-202

• HNSCC:study expanding TIL + pembrolizumab in basket

Manufacturing 



Gen 3 process in clinic	 Melanoma: 16-day Gen 3 process in clinic

>90% success rate in >400 patients	Completion of Navy Yard GMP facility (iCTC); start
clinical manufacturing at iCTC

© 2021, Iovance Biotherapeutics, Inc

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