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LION B I O T E C H N O L O G I E S Leadership & Innova<on in - PowerPoint PPT Presentation

LION B I O T E C H N O L O G I E S Leadership & Innova<on in Oncology Ticker LBIO FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of


  1. LION B I O T E C H N O L O G I E S Leadership & Innova<on in Oncology Ticker LBIO

  2. FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that 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. In particular, management’s expectations regarding future results could be affected by, among other things, uncertainties relating to clinical trials and product development; unexpected regulatory delays or government regulation generally; the Company’s ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general. 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. 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. 2

  3. INVESTMENT HIGHLIGHTS: LBIO (NASDAQ) § Engaged in development of tumor-infiltrating lymphocytes • 25% complete remission rate in heavily pre-treated metastatic melanoma (NCI) § Lead product candidate, LN-144, in Phase 2 for metastatic melanoma • Orphan designation § Second product candidate, LN-145, entering Phase 2 for cervical and head & neck cancer § Worldwide, exclusive licenses from NIH for TIL in melanoma, lung, breast, bladder and HPV-associated cancers § Expanded CRADA with NCI and growing IP portfolio 3

  4. TIL CLINICAL TRIAL STATUS Phase 2 Phase 1 LN-144 (Melanoma) LN-144 + PD-L1 (Melanoma) durvalumab TIL ± TBI (Melanoma) (Completed) TIL + PD-1 (Melanoma) TIL + Nivolumab (Moffitt) LN-145 (Cervical) LN-145 (Head and neck) LN-145 + PD-L1 (Head and neck) Moffitt Lion NCI 4

  5. NCI: DURABLE REMISSIONS IN MELANOMA § Randomized Trial to Determine Effect of TBI: • Chemoablation + TIL + IL-2 • Chemoablation + TBI + TIL + IL-2 § N = 101 § ORR = 54% CR* Median follow-up about 35 24 (24%) months *23 CRs ongoing 30-47 NR months 47 (47%) PR 30 (30%) Updated 4/1/15 5

  6. NCI: EXCELLENT SURVIVAL IN MELANOMA § Survival of patients in TIL ± TBI study 6

  7. LN-144: PHASE 2 STUDY § Multi-center, single arm study § 20 patients • Metastatic melanoma • Refractory to at least one systemic treatment § Objectives: • Safety • Feasibility • Anti-tumor activity and other measures of efficacy • Immune correlates § Treatment • Lymphodepletion • TIL infusion • IL-2 7

  8. LN-144 MANUFACTURING 8

  9. TENTATIVE LONG-TERM DEVELOPMENT PLAN 2015 2016 2017 Phase 2 Ph 3 Metastatic Melanoma (LN-144) Phase 2 Cervical Cancer* IND Phase 2 Head and Neck Cancer* IND Triple-negative Breast Cancer* Ph 2 IND Lung Cancer* Ph 2 IND Bladder Cancer* IND * Order of indications may change 9

  10. NEXT GENERATION TIL § Pre-sorted TIL • Select higher potency TIL q Need lower cell numbers q Shorter manufacturing q Lower COGS q Stronger IP protection § Genetic engineering of TIL • Expression of certain cytokines to increase potency • Modulation of PD-1/CTLA-4/LAG-3 on cell surface q Persistence over longer time q Shorter manufacturing q Lower COGS q Stronger IP protection 10

  11. UPCOMING MILESTONES: 2016 TIL + PD-1 LN-145: Initiate (NCI) Phase 2 LN-145 + PL-L1: Initiate Cervical Trial Initiate preclinical Phase 2 collaboration TIL ± TBI data H&N Trial with publication MedImmune Q1 Q2 Q3 Q4 LN-144 + PD-L1: Initiate LN-145: Initiate Initiate TIL + PD-1 Phase 2 Phase 2 (Moffitt) H&N Trial Melanoma Trial LN-144: $2 M Interim Melanoma Data 11

  12. INTELLECTUAL PROPERTY Issue Number Title Date 8,034,334 Immunotherapy with in vitro-selected antigen- 10/11/11 specific lymphocytes after non-myeloablative lymphodepleting chemotherapy 8,287,857 Immunotherapy with in vitro-selected antigen- 10/16/12 specific lymphocytes after non-myeloablative lymphodepleting chemotherapy 8,383,099 Adoptive cell therapy with young T cells 2/26/13 2014/0030806 Adoptive cell therapy with young T cells N/A 2012/0244133 Methods of growing tumor Infiltrating N/A lymphocytes in gas-permeable containers 61/955,970 Compositions and methods for improving tumor- N/A 61/973,002 infiltrating lymphocytes for adoptive cell therapy WO Methods of producing enriched populations of N/A 2014/133567 tumor-reactive T cells from tumor 12

  13. MANAGEMENT TEAM Elma Hawkins, PhD, MBA President and CEO Molly Henderson, CPA CFO Howard Johnson, MBA VP, Corporate Development Greg MacMichael VP, Process Development James Bender, PhD, MPH VP, Product Dev & Mfg 13

  14. BOARD OF DIRECTORS Elma Hawkins, PhD, MBA President and CEO Sandy Hillsberg, JD Director Ryan Maynard Director Merrill McPeak Director Jay Venkatesan, MD Director 14

  15. SCIENTIFIC AND MEDICAL ADVISORY BOARD Dr. Mario Sznol Dr. Jeffrey Weber Dr. James Mulé Dr. Patrick Hwu Dr. Cassian Yee Dr. David DiGiusto Dr. Daniel Powell 15

  16. FINANCIAL SUMMARY Total Common Shares Outstanding 47.8 million Preferred Shares – as converted to Common Shares 1.8 million Warrants/Options 10.8 million Cash $110.1 million Debt 0 Data current as of September 30, 2015 16

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