SEC Filing – IOVANCE Biotherapeutics, Inc.

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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): September 5, 2018

IOVANCE BIOTHERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware

(State of Incorporation)

001-36860		75-3254381
Commission File Number		(I.R.S. Employer Identification No.)

999 Skyway Road, Suite 150
San Carlos, California		94070
(Address of Principal Executive Offices)		(Zip Code)

(650) 260-7120

(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. ¨

Item 8.01.

Other Events.

Iovance Biotherapeutics, Inc. (the “Company”) from time to time makes presentations at healthcare conferences and to analysts, current stockholders, and others. A copy of the Company’s presentation that it intends to use during September 2018 is furnished as Exhibit 99.1 to this current report on Form 8-K and incorporated by reference herein.

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits

Exhibit No.		Description
99.1		Iovance Biotherapeutics, Inc., Corporate Presentation - September 2018.

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.

Date: September 5, 2018	IOVANCE BIOTHERAPEUTICS, INC.


	By:	/s/ MARIA FARDIS
		Maria Fardis, Chief Executive Officer

Exhibit 99.1

This presentation contains forward - looking statements reflecting management’s current beliefs and expectations . These forward looking statements can be identified with words such as “expects”, “plans”, “projects”, “potential”, “suggests”, “may”, or similar expressions . Such forward - looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements . Forward - looking statements in this presentation include statements regarding (i) the success and timing of our product development activities and clinical trials, (ii) our ability, and the ability of our commercial partners, to manufacture, process and deliver our product candidates and to further improve on the manufacturing process, (iii) the size of the potential markets for our product candidates, (iv) our ability to develop next generation TIL and other more effective and efficient therapeutics, (v) our ability to maintain our collaborations and other relationships with third parties, (vi) our ability to attract and retain key management and scientific personnel, (vii) our ability to obtain and maintain intellectual property protection for our product candidates, (viii) our ability to compete with other therapeutics that target the same indications as our product candidates, and (ix) our ability to achieve our manufacturing, clinical, regulatory, and other key milestones, including the progression of third - party sponsored studies, which may require additional clinical trials and manufacturing development . For more detailed information about the risks and uncertainties that could cause actual results to differ materially from those implied by, or anticipated in, these forward - looking statements, please refer to the Risk Factors section of the Company’s Annual Report on Form 10 - K and subsequent updates that may be contained in the Company’s Quarterly Reports on Form 10 - Q and current reports on Form 8 - K on file with the SEC . Forward - looking statements speak only as to the date they are made . Except as required by law, the Company does not undertake to update forward - looking statements to reflect circumstances or events that occur after the date the forward looking statements are made . This presentation does not constitute an offer to sell or buy securities, and no offer or sale will be made in any state or jurisdiction in which such offer or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction . Forward - Looking Statements © 2018, Iovance Biotherapeutics, Inc. 2

• Developing and commercializing tumor infiltrating lymphocyte (TIL) therapies as a platform for treatment of cancers • Robust Clinical Development Pipeline: ̶ Iovance pipeline of 5 company - sponsored Phase 2 trials • Metastatic melanoma C - 144 - 01 ̶ Orphan Drug Designation: malignant melanoma stages IIB - IV ̶ Fast Track: advanced melanoma • Head and neck C - 145 - 03 • Cervical C - 145 - 04 ̶ Orphan Drug Designation: tumor size >2 cm in diameter • NSCLC IOV - LUN - 201 • Basket study IOV - COM - 202 • Manufacturing Fully in Place: ̶ TIL clinical and commercial manufacturing capabilities in U.S. and E.U. ̶ 22 day manufacturing process ̶ Greater than 90% manufacturing success • Large Team of Collaborators for TIL Development: • MD Anderson Cancer Center • Moffitt Cancer Center • MedImmune /AstraZeneca • National Cancer Institute/NIH • Ohio State University • Roswell Park Cancer Institute Iovance Corporate Highlights 3 © 2018, Iovance Biotherapeutics, Inc.

(1) Rosenberg, S. A., et al. Clinical Cancer Research, 2011, 17, 4550. (2) Goff, S. L. et al. Journal of Clinical Oncology, 2016, 34(20), 2389 - 2397. (3) https://seer.cancer.gov/statfacts/html/all.html Data from third parties may not be representative of Iovance’s data. © 2018, Iovance Biotherapeutics, Inc. History of TIL: From NCI to Iovance Indication: Solid Tumors • Iovance License: ̶ Rights to method of growth of TIL, selection of certain TIL, indications which include HPV associated, breast, lung, and bladder cancers and metastatic melanoma • Strong collaboration with Dr. Steven Rosenberg at the National Cancer Institute (NCI) with rights to data and collaboration expansion opportunities 4 Leveraging and enhancing the utility of TIL therapy as demonstrated by Dr. Rosenberg for metastatic melanoma: 56% ORR (1) 24% CR rate in 101 metastatic melanoma patients, durable CRs (2) ESTIMATED NEW CASES 2017 (3) HEMATOLOGIC 134K SOLID TUMORS 1,554K K

• Leverages and enhances the body’s natural defense against cancer using a patient’s own TIL • Polyclonal and can recognize multiple neoantigens ̶ Solid tumors are heterogeneous • Durable response with single treatment • Potential to establish immunological memory, requiring no additional maintenance therapy after infusion ̶ Responses seen both in treatment naïve and refractory melanoma patients who have failed other options, including checkpoint inhibitors ̶ Complete responses observed at 53 and 67 months in cervical cancer patients 1 1 Stevanovic , et al., Treatment of Metastatic Human Papiliomavirus - Associated Epithelial Cancers with Adoptive Transfer of Tumor - Infiltrating T Cells, ASCO 2018, Abstract #3004 TIL Therapy Elicits a Highly Individualized, Specific and Potent Attack Against Solid Tumors 6 © 2018, Iovance Biotherapeutics, Inc.

1. EXCISE 2. EXTRACT 3. EXPAND 4. PREPARE & INFUSE • EXCISION: Patient’s TIL are removed from suppressive tumor microenvironment (via surgical resection of a lesion) • EXTRACTION: Tumor is fragmented and placed in media for TIL to leave the tumor and enter media • EXPANSION: TIL expanded exponentially ex vivo to yield 10 9 – 10 11 TIL • PREPARATION: Patient receives non - myeloablative lymphodepletion to eliminate potentially suppressive tumor microenvironment and maximize engraftment and potency of TIL therapy: ̶ cyclophosphamide: 60 mg/kg x 2 doses ̶ fludarabine: 25 mg/m 2 x 5 doses • INFUSION: Patient is infused with their expanded TIL and IL - 2 (600,000 IU/kg, up to 6 doses) to promote activation, proliferation and anti - tumor cytolytic activity of TIL TIL Therapy Process © 2018, Iovance Biotherapeutics, Inc. 7

© 2018, Iovance Biotherapeutics, Inc. Competitive Advantages of TIL in Solid Tumors 8 CHECKPOINTS TCR CAR - T (LIQUID TUMORS) TIL (SOLID TUMORS) Utility in several solid tumors Few solid tumors treated so far No examples of successful utility in solid tumors Available data in melanoma, head & neck, cervical and lung cancers Long maintenance period One - time treatment One - time treatment One - time treatment No genetic modification Genetic modification Genetic modification Currently, no genetic modification Potential Long - term irreversible toxicities Potential o n - target, off - tissue effects Potentially immunogenic: cytokine release syndrome Minimal chance of unpredicted on - target, off - tissue effects found to date Target multiple tumor antigens Target only single tumor antigen Mainly target only single/ surface tumor antigen Target multiple tumor antigens Off - the - shelf Autologous Autologous Autologous No HLA restriction HLA restriction No HLA restriction No HLA restriction TIL cells target a diverse array of cancer antigens; we believe this approach represents a highly differentiated, customized, and targeted immunotherapy

19/20 CR were ongoing at more than 3 to 7 years Durable remissions in melanoma regardless of prior therapies NCI Study Survival Benefit in Second and Third Line Patients Rosenberg, S.A., et al. Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T - Cell Transfer Immunotherapy. Clinical Cancer Research , 17(13), 4550 - 4557. Data from third parties may not be representative of Iovance’s data. Abbreviations: CR, complete response; ORR, objective response rate. © 2018, Iovance Biotherapeutics, Inc. 9 IN SECOND AND THIRD LINE MELANOMA (no prior anti - PD - 1) CR 22% ORR 56%

INDICATION REGIMEN N PARTNER PRECLINICAL PHASE 1 PHASE 2 Melanoma lifileucel 85 — Cervical Cancer TIL LN - 145 47 — Head & Neck Cancer TIL LN - 145 47 — Non - Small Cell Lung Cancer TIL LN - 145 vs TIL LN - 145 + durvalumab 24 Melanoma, Head & Neck, Non - Small Cell Lung Cancer TIL LN - 144 + pembrolizumab TIL LN - 145 + pembrolizumab TIL LN - 145 36 — Iovance Clinical Pipeline 10 © 2018, Iovance Biotherapeutics, Inc. Open to Enrollment Open to Enrollment Enrolling Enrolling Enrolling

Iovance Collaboration Pipeline Chandran, S. S et al., Lancet Oncol 2017; 18: 792 - 802. For the studies listed in our collaboration pipeline table, the partner listed above is the sponsor of the clinical trial. Su ch partner may not use our Gen 2 manufacturing process and/or the therapeutic dosing may differ from our clinical trials. As a result, such partner data may n ot be representative of our data. 11 © 2018, Iovance Biotherapeutics, Inc. INDICATION REGIMEN N PARTNER PRECLINICAL PHASE 1 PHASE 2 Melanoma Combination TIL ± TBI 101 Melanoma Combination TIL + ipilimumab 13 Melanoma Combination TIL + pembrolizumab 170 Melanoma Combination TIL + nivolumab 12 Ocular (Uveal) Melanoma TIL 23 Ovarian, Sarcomas, new indication TIL LN - 145 ~54 Ovarian, Sarcomas, pancreatic MDA TIL ~54 Non - small cell lung cancer Combination TIL + nivolumab 18 Oral Presentation, World Conference on Lung Cancer 2018 Open to Enrollment Trial completed, 54% ORR, 24% CR Trial completed Enrolling Enrolling Trial completed, 35%ORR Enrolling

Phase 2, multicenter study to assess the efficacy and safety of autologous Tumor Infiltrating Lymphocytes LN - 144 for treatment of patients with metastatic melanoma (NCT02360579) Key Inclusion Criteria: • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • Progression on at least one prior line of systemic therapy including immune checkpoint inhibitor • Age ≥ 18 • ECOG PS 0 - 1 Endpoints: • Primary: Efficacy defined as ORR • Secondary: Safety and efficacy Study Updates: • Cohort 2 was expanded to 60 patients • Patient dosing commenced in EU in June 2018 Iovance Phase 2 Trial in Metastatic Melanoma (C - 144 - 01) 13 © 2018, Iovance Biotherapeutics, Inc. Unresectable or metastatic melanoma progressed after prior anti - PD - 1 therapy and, if BRAF mutant, after BRAF inhibitor Cohort 1: Non - cryopreserved TIL product, n=30 Closed to enrollment Cohort 2: Cryopreserved TIL product, n=60 Cohort 3: TIL Re - treatment, n=10 CURRENTLY ENROLLING

CHARACTERISTIC Cohort 2 N= 17 , (%) Gender, n (%) Male 8 (47) Female 9 (53) Age Median 54 Min, Max 35, 66 Prior therapies, n (%) Mean # prior systemic therapies 3.6 Anti - CTLA - 4 15 (88) Anti - PD - 1 16 (94) Target Lesion Sum of Diameter (mm) Mean (SD) 140 (93) Min, Max 38, 342 CHARACTERISTIC Cohort 2 N= 17 , (%) Baseline ECOG score, n (%) 0 11 (65) 1 6 (35) BRAF Status, n (%) Mutated 5 (29) Wild Type 9 (53) Unknown 3 (18) Baseline LDH (U/L) 1 - 2 times ULN 8 (47) > 2 times ULN 2 (12) Number of Target & Non - Target Lesions (at Base Line) >3 12 (71) Mean 5.9 * Database cut off of 1 Dec 2017 Iovance C - 144 - 01 Patient Characteristics: Interim Data as of Dec. 2017 Data Cut © 2018, Iovance Biotherapeutics, Inc. 14 COHORT 2 Cohort 2 has: • 3.6 median prior therapies • High tumor burden at baseline as reflected by 140 mm sum of diameters for target lesions

Notes: Patients with multiple events for a given preferred term are counted only once using the maximum grade under each pref err ed term. Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of pre - treatment chemotherapy (Fludarabine and Cyclophosphamide ) up to the last dose of IL - 2 + 30 days. Iovance C - 144 - 01 Safety: Treatment Emergent Adverse Events (≥ 30%) PREFERRED TERM Cohort 2 (N=17) Any Grade n (%) Grade 3/4 n (%) Grade 5 n (%) Number of patients reporting at least one Treatment - Emergent AE 16 (94.1) 16 (94.1) 0 Pyrexia 13 (76.5) 1 (5.9) 0 Anaemia 11 (64.7) 10 (58.8) 0 Neutrophil count decreased 10 (58.8) 10 (58.8) 0 Platelet count decreased 10 (58.8) 8 (47.1) 0 Febrile neutropenia 10 (58.8) 8 (47.1) 0 Fatigue 10 (58.8) 0 0 Chills 9 (52.9) 1 (5.9) 0 Nausea 9 (52.9) 0 0 White blood cell count decreased 8 (47.1) 8 (47.1) 0 Lymphocyte count decreased 6 (35.3) 6 (35.3) 0 Diarrhoea 6 (35.3) 0 0 Decreased appetite 6 (35.3) 0 0 15 COHORT 2 © 2018, Iovance Biotherapeutics, Inc.

Of 10 patients in Efficacy Set, one patient (Patient 10) is not evaluable (NE) due to melanoma - related death prior to first tumor assessment not represented on figure. © 2018, Iovance Biotherapeutics, Inc. Time to Response for Evaluable Patients (SD or Better) • DCR is: 80% • Time to response is similar to Cohort 1 16 COHORT 2

• Mean number of TIL cells infused: 34 x 10 9 • Median number of IL - 2 doses administered was 4.5 • Patients with BRAF mutation responded as well as patients with wild type BRAF One patient (Patient 10) had passed away prior to the first assessment (still considered in the Efficacy Set). * Refers to patients with BRAF mutation Abbreviations: PR, partial response; SD, stable disease, PD, progressive disease Iovance C - 144 - 01 Efficacy © 2018, Iovance Biotherapeutics, Inc. 17 COHORT 2

• All efficacy - evaluable patients had received an anti - PD - 1 and anti - CTLA - 4 checkpoint inhibitor 1 Dec 2017 Data Cut * NE due to not reaching first assessment. Iovance C - 144 - 01 Efficacy: Evaluable Patient Data © 2018, Iovance Biotherapeutics, Inc. 18 RESPONSE PATIENTS, N=10 n (%) Objective Response Rate 4 (40%) Disease Control Rate 8 ( 80%) Partial Response 4 (40%) Stable Disease 4 (40%) Progressive Disease 1 (10%) Non - Evaluable* 1 (10%) COHORT 2

CT Scan for Patient with PR in C - 144 - 01 Study TL1: Lt low. quad. abdom. - BL: 8.8 cm / 18 wk: 3.7 cm TL2: Lt uppr quad abdom. - BL: 5.2 cm / 18 wk: 0 cm TL3: Lt renal – BL: 4.1 cm / 18 wk: 2.1 cm TL5: Rt femoral LN - 4 cm (short axis) / 18 wk: 2.3 cm © 2018, Iovance Biotherapeutics, Inc. 19 Pre - Treatment 18 wks Post - Treatment

Head and Neck Squamous Cell Carcinoma (HNSCC) Abbreviations: HPV, human papillomavirus infection; OPC, oropharyngeal cancer; ORR, objective response rate; TIL, tumor infil tra ting lymphocytes. (1) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost , Y ears Lived With Disability, and Disability - Adjusted Life - years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2017;3(4):524 (2) https://seer.cancer.gov/statfacts/html/oralcav.html and https://seer.cancer.gov/statfacts/html/laryn.html 21 © 2018, Iovance Biotherapeutics, Inc. HNSCC Cancer Facts (1,2) ORR 13 - 16 % For population receiving immunotherapy (e.g, PD - 1 inhibitors) TIL Prognostic value in HPV + & HPV - tumor specimens HNSCC Well - suited for immunotherapy New Cases WW each year 765k 63k Diagnoses in U.S. each year 303k 13k Deaths WW each year Deaths in U.S. each year

Phase 2 study to evaluate the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN - 145) for the treatment of patients with recurrent metastatic squamous cell carcinoma of the head and neck (NCT03083873) Key Inclusion Criteria: • Measurable metastatic disease and ≥ 1 lesion resectable for TIL generation • Relapsed or refractory recurrent metastatic squamous cell carcinoma of the head and neck and have received at least one prior systemic therapy • Age ≥ 18 • ECOG PS 0 - 1 Endpoints: • Primary: Efficacy defined as ORR • Secondary: Safety and efficacy Study Updates: • N=47; Simon’s two - stage design triggered Iovance Phase 2 Trial in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (C - 145 - 03) © 2018, Iovance Biotherapeutics, Inc. 22 Incurable recurrent, metastatic, or persistent SCCHN with 1 prior therapy Simon’s two - stage design Expanded cohort n= 47 CURRENTLY ENROLLING

Iovance C - 145 - 03 Phase 2 Trial in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Preliminary Evidence of Efficacy Abbreviations: ORR, objective response rate; PR, partial response. 23 © 2018, Iovance Biotherapeutics, Inc. BASELINE DEMOGRAPHICS PATIENTS, N= 8 n (%) Prior therapies, n (%) Median prior therapies 4 Anti - PD - 1 8 (100) Anti - CTLA - 4 2 (25) SAFETY: TREATMENT EMERGENT ADVERSE EVENTS (≥30%) BY PREFERRED TERM PATIENTS, N=8 n (%) Pyrexia 7 (88) Chills 6 (75) Hyponatremia 6 (75) Hypotension 6 (75) CURRENTLY ENROLLING Efficacy: 3 have PR (per RECIST 1.1) ORR = 38%

Abbreviations: HPV, human papillomavirus infection; ORR, objective response rate; TIL, tumor infiltrating lymphocytes. (1) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost , Y ears Lived With Disability, and Disability - Adjusted Life - years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2017;3(4):524 (2) https://seer.cancer.gov/statfacts/html/oralcav.html and https://seer.cancer.gov/statfacts/html/laryn.html Cervical Cancer 25 © 2018, Iovance Biotherapeutics, Inc. Cervical Cancer Facts (1,2) ORR 14.3 % For PD - L1 + patients receiving immunotherapy TIL Prognostic value in HPV + tumor specimens Cervical Cancer Well - suited for immunotherapy New Cases WW each year 765k 13k Diagnoses in U.S. each year 239k 4k Deaths WW each year Deaths in U.S. each year

Stevanovic , et al., Treatment of Metastatic Human Papiliomavirus - Associated Epithelial Cancers with Adoptive Transfer of Tumor - Infiltrating T Cells, ASCO 2018, Abstract #3004 This type of response may not be representative of all patients. NCI Cervical Cancer and TIL Treatment Data © 2018, Iovance Biotherapeutics, Inc. 26 PATIENTS (%) DURATION (MONTHS) Total 18 (100) PR 3 (17) 3 CR 2 (11) 53+, 67+ ORR 28%

Phase 2, multicenter study to evaluate the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN - 145) in patients with recurrent, metastatic or persistent cervical carcinoma (NCT03108495) Key Inclusion Criteria: • Measurable recurrent, persistent, or metastatic disease and ≥ 1 lesion resectable for TIL generation • One to three prior systemic therapies and either progressed or had no response on such therapies • ECOG PS 0 - 1 Endpoints: • Primary: Efficacy defined as ORR • Secondary: Safety and efficacy Key Updates : • First patient dosed in U.S. in Sept. 2017 • Open to enrollment in Europe • Of two evaluable cervical patients, one has a confirmed PR, one SD Iovance Phase 2 Trial in Recurrent, Metastatic or Persistent Cervical Carcinoma (C - 145 - 04) © 2018, Iovance Biotherapeutics, Inc. 27 Incurable recurrent, metastatic, or persistent cervical cancer with 1 - 3 prior therapies, excluding immunotherapy Simon’s two - stage design Expanded cohort n= 47 CURRENTLY ENROLLING

INDICATION NEW CASES (1) DEATHS (1) Melanoma 87,110 9,730 Cervix Uteri 12,820 4,210 Oral Cavity, Pharynx & Larynx 63,030 13,360 Lung & Bronchus 222,500 155,870 Bladder 79,030 16,870 Breast 2 52,710 40,610 Pancreatic 53,670 4 3,090 Brain & Other Nervous System 23,800 16,700 (1) https://seer.cancer.gov (2) https://seer.cancer.gov/statfacts/html/lungb.html Lung Cancer Has the Highest Mortality Rate Among Solid Tumors in the U.S. © 2018, Iovance Biotherapeutics, Inc. 29 LUNG CANCER 222K New cases in 2017 5YR SURVIVAL RATE (2) <20% for NSCLC

Moffitt Cancer Center sponsored trial • TIL + anti - PD - 1, nivolumab ( Opdivo ® ) • An Investigator Initiated Trial (IIT), Phase 1 study in 18 advanced NSCLC patients (1) • Early results to be presented at World Lung on September 24 in Toronto, Safety and Clinical Activity of Adoptive Cell Transfer Using Tumor Infiltrating Lymphocytes (TIL) Combined with Nivolumab in NSCLC Iovance sponsored trial in collaboration with MedImmune / AstraZeneca • TIL +/ - anti - PD - L1, durvalumab: • Iovance - sponsored, Phase 2, two - cohort clinical trial to anti - PD - 1/PD - L1 naïve NSCLC (1) A Stand Up to Cancer (SU2C) supported clinical trial. Additional collaborators include Bristol - Myers Squibb and Prometheus Inc. Ongoing Collaborations and Partnerships © 2018, Iovance Biotherapeutics, Inc. 30 Two Ongoing Trials in Non - Small Cell Lung Cancer (NSCLC) CURRENTLY ENROLLING

Phase I clinical trial combining nivolumab and Tumor Infiltrating Lymphocytes (TIL) for patients with advanced Non - Small Cell Lung Cancer (NCT03215810) • N=18 • First patient harvested in 4Q 2017 Key Inclusion Criteria: • PD - 1/PD - L1 naïve • Confirmed or suspected diagnosis of stage IV or recurrent NSCLC Endpoints: • Primary: Safety • Secondary: Efficacy (ORR and PFS) Moffitt Phase 1 NSCLC Study 31 © 2018, Iovance Biotherapeutics, Inc. PD - 1/PD - L1 naïve stage IV or recurrent NSCLC Tumor harvest TIL prepared and cryo - preserved 4 - Cycles of Nivo Patient responding: Continue with Nivo for 1 year Patient not responding: TIL therapy + Nivo for 1 year CURRENTLY ENROLLING

A Phase 2 study (IOV - LUN - 201) to assess the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN - 145) alone and in combination with anti - PD - L1 inhibitor durvalumab (MEDI4736) in patients with locally advanced or metastatic Non - Small Cell Lung Cancer (NSCLC) (NCT03419559) Key Inclusion Criteria: • Histologically and/or cytologically confirmed diagnosis of Stage III or Stage IV NSCLC • ≥ 1 lesion resectable for TIL generation Key Exclusion Criteria: • Prior anti - PD - 1 or anti PD - L1 use Endpoints: • Primary: Efficacy (ORR) and safety • Secondary: Efficacy Iovance - Sponsored NSCLC Phase 2 Study 32 © 2018, Iovance Biotherapeutics, Inc. OPEN TO ENROLLMENT PD - 1/PD - L1 naïve stage III or IV NSCLC Cohort 1: TIL, N=12 (Cohort will be removed) Cohort 2: TIL + durvalumab N=12

A Phase 2, multicenter study of autologous Tumor Infiltrating Lymphocytes (LN - 144/LN - 145) in patients with solid tumors (NCT0364592) Key Inclusion Criteria: • Histologically confirmed diagnosis of unresectable or metastatic melanoma, recurrent or metastatic squamous cell carcinoma of the head and neck, or recurrent or metastatic NSCLC • ≥ 1 lesion resectable for TIL generation Key Exclusion Criteria: • Cohorts 1 and 2: No prior anti - PD - 1 or anti - PD - L1 use • Cohort 3: 1 - 3 prior systemic anticancer therapies Endpoints: • Primary: Efficacy (ORR) and safety • Secondary: Efficacy IOV - COM - 202: Co - Administration of TIL and Pembrolizumab 34 © 2018, Iovance Biotherapeutics, Inc. OPEN TO ENROLLMENT Melanoma PD - 1/PDL - 1 Naïve Melanoma or H&N H&N Cohort 1: TIL+ Pembro , N=12 Cohort 2: TIL+ Pembro , N=12 NSCLC with 1 - 3 prior therapies NSCLC Cohort 3: TIL, N=12

Iovance TIL Research Focus 1. Expand the TIL platform into new indications ̶ Heme indication (OSU collaboration) ̶ Bladder cancer (Roswell Park Cancer Institute) 2. Prepare or select more potent TIL ̶ Use anti - 4 - 1BB, anti - OX40, or IL - 2/ IL - 15/ IL - 21 cocktails in ex vivo growth of TIL • License to uses of 4 - IBB agonists obtained from Moffitt Cancer Center ̶ Select more potent TIL such as high PD1 expression 3. Genetically modify to make a more tumor - reactive TIL ̶ Cellectis TALEN ® collaboration ̶ RXi RNAi collaboration 4. Identify biomarkers to find a better TIL product or better patient population 36 © 2018, Iovance Biotherapeutics, Inc.

Excise tumor Express courier from clinical s ite to CMO Express courier in cryoshipper from CMO to clinical s ite Thaw and i nfuse. Follow by IL - 2 administration Cut into fragments Expansion ex vivo scale up ex vivo culture IL - 2 + OKT3 Co - culture TIL and feeder cells Rapid Expansion (REP) 11 days Tumor Fragment Culture (Pre - REP) 11 days + IL - 2 LN 2 cryopreserved TIL infusion product controlled rate freeze Harvest Direct to REP NMA - LD preconditioning therapy Iovance Cryopreserved 22 Day TIL Manufacturing Process - US; Wuxi, EU: Lonza 38 - 150 o C © 2018, Iovance Biotherapeutics, Inc. SM8

© 2018, Iovance Biotherapeutics, Inc. Financial Summary June 30, 2018 (unaudited) 40 IN MILLIONS Common shares outstanding 93 Preferred shares 7 (1) Warrants/options/RSU’s 10 Cash, cash equivalents, short - term investments $276 Debt $0 (1) Preferred shares are shown on an as - converted basis.

© 2018, Iovance Biotherapeutics, Inc. Summary of Recent Accomplishments • Built a broad TIL clinical development program - entered new indications and announced new collaborations ̶ 70 clinical sites now active across five IOVA studies ̶ Data in melanoma trial with preliminary results indicating clinically meaningful benefit in patients with relapsed/refractory disease ̶ Cervical and head and neck studies ongoing ̶ TIL is going to be investigated in NSCLC in combination in earlier lines of therapies ̶ Moving to earlier line of therapy with activation of Basket Study ̶ Two studies in MD Anderson collaboration are enrolling in sarcomas, ovarian and pancreatic cancers • Streamlining manufacturing ̶ Capacity fully established in U.S. and EU ̶ Developed shorter duration Gen 2 for all future TIL therapy development and commercialization • Building IP ̶ A broad portfolio of immuno - oncology patent applications including coverage for Gen 2 manufacturing 41

x Partner with our suppliers and vendors, as well as technology providers x Organizations with technologies for genetic modification x Continue collaborating with new clinical sites and hospitals to assure preparation for commercialization x 70 Clinical sites active across four studies x Roswell Park PARTNERSHIPS x Activate melanoma and cervical studies in Europe in 1H 2018 • FDA interaction to define the registration path for LN - 144 ( lifileucel ) x Continue enrollment into the melanoma program x Continue to advance head & neck, cervical, and NSCLC x Pursue new indications x Ovarian, Sarcomas • Actively move TIL therapy to earlier line of treatment • IOV - COM - 202 • Present data from melanoma and at least one other indication at 2018 medical meetings x NSCLC x Transition all trials over to Gen 2 manufacturing process x Start up in manufacturing and clinical trials in Europe • Optimization of the process in anticipation of commercialization MANUFACTURING Key Anticipated 2018 Milestones © 2018, Iovance Biotherapeutics, Inc. 42 REGULATORY CLINICAL