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): October 26, 2017

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 7.01. Regulation FD Disclosure.

Iovance Biotherapeutics, Inc. (the “Company”) from time to time makes presentations to analysts, current stockholders and others. A copy of the Company’s October 2017 presentation is furnished as Exhibit 99.1 to this current report on Form 8-K and incorporated under this Item 7.01 by reference.

The information contained in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference to any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

Item 9.01 Financial Statements And Exhibits

(d) Exhibits

Exhibit No.		Description
99.1		Iovance Biotherapeutics, Inc., Corporate Presentation-October 2017.

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: October 26, 2017	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, including in particular with the National Cancer Institute/NIH, (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 . 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 © 2017, Iovance Biotherapeutics 2

© 2017, Iovance Biotherapeutics Manufacturing Capacity in US and EU • Clinical and commercial manufacturing capabilities are in place in the US and EU ̶ WuXi established at multiple suites in US ̶ LonzaNL (formerly PharmaCell ) tech transfer in process in EU • All currently planned clinical studies can be supported with available capacity • We chose WuXi because additional capacity exists and our commercial capacity is fully scalable at this site ̶ 55,000 ft² ISO accredited facility operating under strict cGMP compliance ̶ Designed to meet US and EU requirements ̶ Continuous monitoring of equipment and environment ̶ Back up redundancy ̶ Produce multiple products and tumor type in suite at same time ̶ Expand to additional suites and/or utilize existing personnel to meet demand ̶ Separation of in - flow and out - flow of all materials 3

• Iovance’s manufacturing process is centralized at the following CMO sites: ̶ Lonza, Walkersville ̶ Wuxi AppTec ̶ Moffitt as CMO ̶ LonzaNL (EU) • Iovance developed the Gen 1 process through modification of the NCI’s TIL manufacturing method. Gen 2 and all manufacturing SOPs were developed by Iovance. • Iovance has certain IP rights relating to the method of manufacturing used by Polybiocept (PBC) and MDA Manufacturing Capacity © 2017, Iovance Biotherapeutics 4 Adequate Manufacturing Capacity and IP Rights # INDICATIONS GENERATION 1 2 IL - 2, 15, 21 41BB 1 Melanoma Lonza Moffitt/Wuxi 2 Cervical Wuxi 3 Head and Neck Wuxi 4 Pt Resistant Ovarian Wuxi MDA 5 Chondrosarcoma Wuxi MDA 6 Soft tissue sarcoma Wuxi MDA 7 Pancreatic ductal carcinoma MDA 8 GBM PBC 9 Pancreatic PBC Manufacturing IP rights

x Development of a new manufacturing cycle from 5 - 6 weeks to under 3.5 weeks x Complete tech transfer and ramp volumes at WuXi AppTec and H. Lee Moffitt Cancer Center and Research Institute x Continue working with Lonza x Expand capacity into additional CMOs x LonzaNL (EU) x Continue efforts to reduce manufacturing cycle time and costs COMPLETED Accomplishments and Upcoming Objectives © 2017, Iovance Biotherapeutics 5 • Continuous improvement in process development: • Component Optimization • Staffing optimization • Select Generation 1 or 2 process • Additional data on alternative processes • Establishment of TrakCel Integrated Scheduling Solution • First clinical product manufactured in Europe in early 2018 ANTICIPATED

Iovance Manufacturing Process & Logistics © 2017, Iovance Biotherapeutics Gen 1 Duration: ~5 - 6 Weeks Gen 2 Duration: ~3.5 Weeks Cryopreserved Product Excise tumor Shipment IV infusion Post - Lymphodepletion + IL - 2 Dissect tumor into fragments Expansion with IL - 2 Co - culture TIL with feeder cells and OKT3 Expand TILs with IL - 2 Prepare infusion bag Shipment 6

© 2017, Iovance Biotherapeutics WuXi US Clinical & Commercial Manufacturing Facility 7 Commercial Cell Therapy Center of Excellence Commerce Center 3 • 55,000ft 2 manufacturing site • Warehouse space • In - process QC testing • Compliant with US & EU regulations • Up to 8 - 10 large GMP manufacturing suites Clinical Cell Therapy Center of Excellence League Island Blvd 1 • 16,000ft 2 manufacturing area in 75,000 SF facility • Warehouse space • In - process and release QC testing • CBER & CDER registered • 15 small/medium GMP Manufacturing suites + 6 cell banking suites

© 2017, Iovance Biotherapeutics WuXi US Clinical & Commercial Manufacturing Facility 8 LI1 Production Facility • Satellite Warehouse • Central QC Lab CC3 Production Facility • Central Warehouse Manufacturing Facilities Inbound Supplies Tumor Receipt Samples to QC Lab (CC3 to LI 1) Final TIL Product • Separation of in - flow and out - flow of all materials

© 2017, Iovance Biotherapeutics Tumor Harvest & Shipment to Manufacturing • Once resected tumor is placed in a bottle with media and packaged in accordance with validated shipping procedures • Courier is notified days before scheduled pickup and arrives at site to receive package • In conjunction with couriers we employ next flight out strategies with commercial airlines and delivers tumor to CMO for processing • Built in redundancy with flights to ensure on - time delivery to manufacturing • Process will be automated with the TrakCel implementation capturing chain of custody to courier, uploading forms and alerting all parties on ETA at CMO 9

CC3: Inbound Tumor Receipt and Gowning © 2017, Iovance Biotherapeutics 10 • In - bound: • In - bound receipt area where tumor is received • Delivered by courier and verified by a unique site and patient number • Product is matched with WuXi lot number • Temperature data downloaded and product is delivered to manufacturing 1. Inbound Tumor Receipt 2. Gowning 3. Manufacturing 4. Cryopreservation • Gowning: • Process necessary to enter manufacturing facility • Ensure standard of cleanliness of a room depending on room classification • To protect the product being manufactured

CC3: Manufacturing and Final Packaging/Cryopreservation (Gen 2) © 2017, Iovance Biotherapeutics 11 • Controlled rate freezing and LN2 storage area • Courier notified to provide Cryoshipper in conjunction with manufacturing completion • Prepare shipment utilizing validated procedures for cryofreezing product and loading into cassette racks and into Cryoshipper • Real - time temperature monitor and GPS features 1. Inbound Tumor Receipt 2. Gowning 3. Manufacturing 4. Cryopreservation TIL bag placed in cassette Cassette placed in Cryoshipper Cryoshipper ready for pickup by courier • Manufacturing receives tumor • Tumor is fragmented into approximately 3x3x3mm • Placed into cell culture device with media • Various media exchanges, transferred to larger cell culture devices, volume reduced and filled into final product bags

© 2017, Iovance Biotherapeutics Gen 2 Manufacturing Process • 3.5 week cell expansion process with a cryopreserved product delivered to clinical sites for patient infusion • Robust, efficient and scalable process • Provides flexibility to manufacturing and clinical sites • Provides flexibility to sites for infusion schedules due to cryopreserved final product • Reduced COGS • Additional data on attributes of Gen 2 manufacturing to be presented at SITC 12

© 2017, Iovance Biotherapeutics TrakCel : Integrated Scheduling Solution • In September 2017, announced new partnership with TrakCel ̶ An automated process integrating scheduling, capacity and logistics throughout the supply chain ̶ Compliance – 21 CFR Chapter 21 compliant with electronic audit record. Maintains traceability through effective chain of identity and cus tody process ̶ Resource Optimization – Efficient management of internal and external resources which will streamline the scheduling process and enable scalability ̶ Improved Visibility – Provide real time visibility to selected stakeholders across the supply chain ̶ Improved Communications – Provide a tool to improve communication with collection centers /clinical sites and CMOs to improve service and confidence ̶ Customer - Friendly Experience – Simplifies and streamlines the experience for physicians and other third parties 13 Establish Courier Integrations – pick - up/drop off confirmations, time stamps, temperature data, location, excursions, etc.

Cell & Gene Therapy Manufacturing

Our Journey 2017 Global Platform 2017 16,000+ employees worldwide >5 million ft 2 existing & upcoming R&D space leading capability and technology platfor m 15

Our Platform Comprehensive R&D Enabling Capabilities Small Molecules Biologics Cell & Gene Therapies Medical Devices Molecular Testing and Genomics 16

Manufacturing Experience / Capabilities

Philadelphia Facilities Cell & Gene Therapy Manufacturing and Testing 2004 2015 55,000 SF - Manufacturing for Autologous / Allogeneic Cell Therapies 75,000 SF - QC Testing, PD, Cell Therapy Manufacturing 150,000 SF - CAR - T Cell Therapies and Gene Therapy Manufacturing 2004 2015 18

Manufacturing Team Cell Culture, PD and Tech Transfer Teams (~200 staff Q1 2017) ▪ Cross trained for Cell Banking and Cellular Therapeutics processing ▪ 7 days a week coverage ▪ Currently 2 shifts - Sun - Wed and Wed - Sat; with Manufacturing Supervisors Quality Assurance Team ▪ QA Raw Materials ▪ QA Manufacturing ▪ QA Validation Environmental Monitoring Team ▪ Facility, equipment, personnel monitoring Metrology Team ▪ Calibration, maintenance Facilities Team ▪ Facility Maintenance 19

Chain of Identity (COI) Meeting FDA Expectations ▪ Tracking of all products from the donor to the consignee or final disposition, and from consignee or final disposition to donor (21 CFR 1271.290(b)) ▪ Appropriate patient identifiers and procedures to prevent product mix - ups ▪ Procedures in place to ensure product segregation WuXi AppTec Program for COI 20

Facilities for CT Manufacturing FDA and EMA Expectations ▪ Establish adequate facility and equipment performance standards and monitoring plans ▪ Ensure aseptic environment for cell processing through design and monitoring* ▪ Use closed systems where possible ▪ Use disposable equipment and process aids ▪ Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing -- Current Good Manufacturing Practice - 9/29/2004 WuXi AppTec 3 Commerce Center Keith Wonnacott, PhD, The Office of Cellular, Tissue, and Gene Therapies, U.S. FDA, Web Seminar Series, Cellular Therapy Products *Current European Union (EU) requirements for aseptic processing environments are more stringent than US FDA requirements – All New WuXi AppTec CFT/GT Manufacturing Facilities are designed to meet both US and EU requirements. 21

Process Development for Commercialization Early and Late Phase Development Program Pre - clinical PhI PhII PhIII Commercial Late Development Process Final Manufacturing Process Early Development Process Continuous Process Verification Process Improvement Process Validation Research Process • The development of a sustainable manufacturing process is a key aspect of preparing a product for marketing approval and commercialization, and consideration should be given at the earliest phases of development. • However, to provide rapid entry to the clinic, WuXi applies a two - tier development paradigm (EDP/LDP) to most advanced therapies. A single development cycle may be possible in some cases where program timelines allow. 22

Capabilities – Cell Therapies Established QC & Analytical Testing ▪ GMP Cell Banking & Characterization ▪ Viral Bank Safety & Characterization ▪ Raw Material Testing ▪ Extractables / Leachables Testing ▪ Lot Release / Stability Testing • Mycoplasma( PCR, Points To Consider, EP) • Sterility(USP, BacT Alert) • Endotoxin • Purity (Residuals – multiple methods) • Potency (cell - based and/or other functional assays) • Virus / Retrovirus testing (endogenous & adventitious agents) • Identity (Karyology, Flow Cytometry, qPCR for Expression) 23