Ticker LBIO
LION
B I O T E C H N O L O G I E S
Leadership & Innova<on in Oncology
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
Ticker LBIO
B I O T E C H N O L O G I E S
Leadership & Innova<on in Oncology
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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”,
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
§ Engaged in development of tumor-infiltrating lymphocytes
melanoma (NCI)
§ Lead product candidate, LN-144, in Phase 2 for metastatic melanoma
§ 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
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INVESTMENT HIGHLIGHTS: LBIO (NASDAQ)
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TIL CLINICAL TRIAL STATUS
TIL ± TBI (Melanoma) (Completed) TIL + Nivolumab (Moffitt) TIL + PD-1 (Melanoma)
Phase 1 Phase 2
LN-144 (Melanoma) LN-144 + PD-L1 (Melanoma) durvalumab LN-145 (Cervical) LN-145 (Head and neck) LN-145 + PD-L1 (Head and neck) Moffitt NCI Lion
§ Randomized Trial to Determine Effect of TBI:
§ N = 101 § ORR = 54%
NCI: DURABLE REMISSIONS IN MELANOMA
NR 47 (47%) PR 30 (30%) CR* 24 (24%) Median follow-up about 35 months *23 CRs ongoing 30-47 months
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Updated 4/1/15
§ Survival of patients in TIL ± TBI study
NCI: EXCELLENT SURVIVAL IN MELANOMA
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§ Multi-center, single arm study § 20 patients
§ Objectives:
§ Treatment
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LN-144: PHASE 2 STUDY
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LN-144 MANUFACTURING
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TENTATIVE LONG-TERM DEVELOPMENT PLAN
2015 2016 2017
Metastatic Melanoma (LN-144) Cervical Cancer* Head and Neck Cancer* Triple-negative Breast Cancer* Lung Cancer* Bladder Cancer*
Phase 2 IND Phase 2 IND IND IND IND Phase 2
Ph 2
Ph 3
Ph 2
* Order of indications may change
§ Pre-sorted TIL
q Need lower cell numbers
q Shorter manufacturing q Lower COGS q Stronger IP protection
§ Genetic engineering of TIL
q Persistence over longer time q Shorter manufacturing q Lower COGS q Stronger IP protection
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NEXT GENERATION TIL
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UPCOMING MILESTONES: 2016
$2 M
Initiate TIL + PD-1 (Moffitt) LN-145: Initiate Phase 2 H&N Trial LN-145: Initiate Phase 2 Cervical Trial Q1 Initiate preclinical collaboration with MedImmune TIL + PD-1 (NCI) LN-144: Interim Melanoma Data Q2 Q3 Q4 TIL ± TBI data publication LN-144 + PD-L1: Initiate Phase 2 Melanoma Trial LN-145 + PL-L1: Initiate Phase 2 H&N Trial
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INTELLECTUAL PROPERTY
Number Title Issue Date
8,034,334 Immunotherapy with in vitro-selected antigen- specific lymphocytes after non-myeloablative lymphodepleting chemotherapy 10/11/11 8,287,857 Immunotherapy with in vitro-selected antigen- specific lymphocytes after non-myeloablative lymphodepleting chemotherapy 10/16/12 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 lymphocytes in gas-permeable containers N/A 61/955,970 61/973,002 Compositions and methods for improving tumor- infiltrating lymphocytes for adoptive cell therapy N/A WO 2014/133567 Methods of producing enriched populations of tumor-reactive T cells from tumor N/A
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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
BOARD OF DIRECTORS
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Elma Hawkins, PhD, MBA President and CEO Sandy Hillsberg, JD Director Ryan Maynard Director Merrill McPeak Director Jay Venkatesan, MD Director
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SCIENTIFIC AND MEDICAL ADVISORY BOARD
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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
Data current as of September 30, 2015