Aptevo Therapeutics Inc. · NASDAQ:APVO
Aptevo Therapeutics — Investor Presentation (January 2018)
38 slides from Aptevo Therapeutics's investor presentation, Jan 8, 2018
Slide 1: Aptevo Therapeutics Investor Presentation January 2018
Aptevo Therapeutics Investor Presentation January 2018 Exhibit 99.1
Slide 2: Forward-looking statements
This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including our financial guidance, product portfolio, product sales, capabilities and any other statements contai
Slide 3: Aptevo: At a Glance
Aptevo: At a Glance Leading Oncology Platform Innovative ADAPTIR platform technology utilizing a novel approach in the highly attractive immuno-oncology field Leveraging Technology Targeted investments in bispecific ADAPTIR therapeutics Robust IP Estate Own and exclusively licensed patents and trade
Slide 4: Aptevo – A Compelling Investment Opportunity
Aptevo – A Compelling Investment Opportunity Solid cash position to advance R&D and commercial strategy 1 2 3 4 5 Strong leadership with a track record of execution Advancing ADAPTIR to generate novel first-in-class therapeutics Broad pipeline of wholly-owned clinical and preclinical candidates Comm
Slide 5: Agenda
Agenda Executing on our Strategy ADAPTIR – Developing Novel Protein Therapeutics Impressive Clinical and Preclinical Portfolio IXINITY – A Growing Commercial Opportunity Summary
Slide 6: Experienced Leadership Team
Experienced Leadership Team Senior Management Marvin White – President & CEO Former Emergent Director; Former CFO, St. Vincent’s Health; Former Exec. Director & CFO, Lilly USA Jeff Lamothe – SVP, CFO Former Emergent VP, Finance; Former CFO, Cangene Corporation Randy Maddux – SVP, Operations Former V
Slide 7: Executing on our Strategy to Build Value
Executing on our Strategy to Build Value Objective Result Solidly capitalize Aptevo to advance R&D and commercial programs Obtained: $65M in start-up funding from Emergent $20M in debt financing from MidCap $75M commercial asset sale Cash balance: $91M (12/31/2017) Build proprietary ADAPTIR bispecif
Slide 8: Product/Candidate pipeline
Product/Candidate Target Technology Indication Pre-Clinical Clinical Development Stage Marketed Milestones/Highlights Phase I Phase II Phase III COMMERCIAL PORTFOLIIO IXINITY Recombinant Protein Hemophilia B $8.1M (9/30/17) $9.8M (2016) $1.0M (2015) ADAPTIR PORTFOLIO Otlertuzumab CD37 ADAPTIR Monosp
Slide 9: Agenda
Agenda Executing On Our Strategy ADAPTIR – Developing Novel Protein Therapeutics Impressive Clinical and Preclinical Portfolio IXINITY – A Growing Commercial Opportunity Summary
Slide 10: Advancing ADAPTIR Technology to Generate Novel First-In-Class Therapeutics
ADAPTIR is Aptevo’s platform technology for generating novel monospecific and bispecific antibody therapeutics for immuno-oncology and autoimmune/inflammatory diseases ADAPTIR is a robust, flexible platform that can be used to generate bispecific molecules with different mechanisms of action The ADA
Slide 11: Key Advantages of ADAPTIR Bispecifics
Key Advantages of ADAPTIR Bispecifics* ADAPTIR Bispecifics Unique homodimer structure Longer half-life Enhanced stability Bivalent binding for improved potency Better manufacturability Increased flexibility ü ü ü ü ü ü *Based on current preclinical data for various ADAPTIR candidates
Slide 12: ADAPTIR – A Versatile Therapeutic Platform
Platform produces drugs with multiple mechanisms to stimulate the body’s own immune system for the treatment of autoimmune diseases and cancer ADAPTIR – A Versatile Therapeutic Platform T-cell Engagers CD3 + Tumor Antigen T-cell Co-stimulators + Tumor Antigen (e.g. 4-1BB) Targeted Cytokines IL-10 AI
Slide 13: Bispecific ADAPTIR Therapeutic
Bispecific ADAPTIR Therapeutic Anti-tumor Anti-CD3 * MOR209/ES414, A Novel Bispecific Antibody Targeting PSMA For The Treatment of Metastatic Castration-Resistant Prostate Cancer, Hernandez-Hoyos et al. Molecular Cancer Therapeutics, July 12 2016 DOI: 10.1158/1535-7163.MCT-15-0242 Unique Features of
Slide 14: ADAPTIR - More Potent than Heterodimer Bispecifics
ADAPTIR RTCC molecules have more potent tumor killing compared to heterodimer formats targeting the same tumor antigen Lower concentrations (EC50) needed to achieve same potency in Tumor Lysis Assays ADAPTIR - More Potent than Heterodimer Bispecifics Targeting Same Antigen ADAPTIR T cell Tumor cell
Slide 15: ADAPTIR RTCC Candidates Induce Lower Levels of Cytokines
ADAPTIR RTCC Candidates Induce Lower Levels of Cytokines than Competitor scFv-scFv Formats Cytokines measured after 20 hr stimulation of T cells with ADAPTIR and tumor cells ADAPTIR bispecifics generate lower levels of cytokines when tumor antigen present compared to other formats (scFv-scFv) target
Slide 16: Agenda
Agenda Executing On Our Strategy ADAPTIR – Developing Novel Protein Therapeutics Impressive Clinical and Preclinical Portfolio IXINITY – A Growing Commercial Opportunity Summary
Slide 17: Product Candidate Pipeline
Product Candidate Technology Indication Target Pre-Clinical Clinical Development Stage Milestones/Highlights Phase I Phase II Phase III Otlertuzumab ADAPTIR Monospecific PTCL/CLL CD37 Executing Phase 2 combination study in PTCL APVO414 ADAPTIR Bispecific RTCC mCRPC CD3/PSMA Executing Phase 1 dose es
Slide 18: Otlertuzumab – Clinical Candidate
Otlertuzumab – Clinical Candidate CANDIDATE OPPORTUNITY FUNCTION/ MOA INDICATIONS DEVELOPMENT STAGE PARTNERSHIP STATUS aCD37 scFv Human IgG1 Fc ADAPTIR monospecific antibody Targets CD37 Direct apoptosis, antibody-dependent cell cytotoxicity PTCL - Peripheral T-Cell Lymphoma (PTCL) CLL – Chronic Lym
Slide 19: Otlertuzumab + Bendamustine Significantly Increased Overall Response Rate
Otlertuzumab + Bendamustine Significantly Increased Overall Response Rate Overall Response Complete Response Partial Response Stable Disease Progressive Disease Percent Response 100% 80% 60% 40% 20% 0% 69% 39% 59% 9% 3% 36% 16% 30% 16% 30% p = 0.026
Slide 20: Otlertuzumab + Bendamustine Significantly Increased Progression Free Survival
5 month difference in PFS Otlertuzumab + Bendamustine Significantly Increased Progression Free Survival p = 0.019 0 5 10 15 20 25 0 20 40 60 80 100 Months Since Randomization Progression Free Survival (%) Otlertuzumab +Bendamustine Bendamustine
Slide 21: APVO414 – Clinical Candidate
APVO414 – Clinical Candidate CANDIDATE OPPORTUNITY FUNCTION/MOA INDICATIONS DEVELOPMENT STAGE PARTNERSHIP STATUS Bispecific protein therapeutic targeting prostate specific membrane antigen (PSMA) & CD3 Demonstrates redirection of T-cells to kill tumor cells expressing PSMA in vitro and in vivo Metas
Slide 22: APVO414 Phase 1 Dose Escalation for mCRPC
Currently in Cohort 6 Well tolerated; enrollment continues Amended study with Continuous Infusion to reduce Anti-Drug Antibody (ADA) Clinical data with other drugs suggests continuous exposure desensitizes immune system and reduces ADA Dramatic reduction in ADA with continuous infusion; 1,000 fold r
Slide 23: APVO436 – Preclinical Candidate
APVO436 – Preclinical Candidate CANDIDATE OPPORTUNITY FUNCTION/MOA INDICATIONS DEVELOPMENT STAGE PARTNERSHIP STATUS CD123 x CD3 bispecific candidate Engages T cell via binding to CD3 to specifically kill tumor cells expressing CD123 Targets multiple hematological malignancies AML, ALL, hairy cell le
Slide 24: APVO436 Activity with AML Patient Samples
Addition of healthy donor T cells increased cytotoxicity in a E:T-dependent manner Significant cytotoxicity achieved even at the lowest levels of blast CD123 expression No consistent linear relationship between the level of blast CD123 expression and cytotoxicity APVO436 Activity with Newly Diagnose
Slide 25: APVO436 Eliminates Skeletal Tumor Burden in Mice
Treatment of established disseminated MOLM-13 tumors in mice with APVO436 resulted in rapid reduction in skeletal tumor burden APVO436 Eliminates Skeletal Tumor Burden in Mice with Established Tumors Day 15 T cells + APVO436 (d4) T cells + APVO436 (d5) T cells only (d4) NSG mice implanted IV with MO
Slide 26: APVO210 – Preclinical Candidate
APVO210 – Preclinical Candidate CANDIDATE OPPORTUNITY FUNCTION/ MOA INDICATIONS DEVELOPMENT STAGE PARTNERSHIP STATUS Targeted cytokine based on ADAPTIR platform Anti-CD86 scFv delivers IL-10 specifically to antigen presenting (CD86+) cells to suppress inflammation and induce tolerogenic T cells Auto
Slide 27: APVO210 Suppresses Inflammation Through a Different Mechanism of Action
Inhibits monocyte, macrophage, dendritic cell function Inhibits antigen presentation and subsequent T-cell activation Functions below levels required for CD86 saturation 10-100 fold more potent than abatacept in preclinical animal studies Inhibits release of pro-inflammatory cytokines by innate immu
Slide 28: ALG.APV-527 – Preclinical Candidate
ALG.APV-527 – Preclinical Candidate CANDIDATE OPPORTUNITY FUNCTION/MOA INDICATIONS DEVELOPMENT STAGE PARTNERSHIP STATUS Engages T-cells through co-stimulatory receptor 4-1BB Reactivates antigen-primed T cells to specifically kill tumor cells; Promotes CD8 T-cell survival and effector function Multip
Slide 29: ALG.APV-527 Targeted Immunotherapeutic Bispecific Targeting 41BB x 5T4
ALG.APV-527 Targeted Immunotherapeutic Bispecific Targeting 41BB x 5T4 Targeted immunotherapy offers the potential for enhanced efficacy and safety Targets 4-1BB (Costimulatory Receptor, member of TNFR super family) and 5T4 Tumor Antigen 5T4 expressed on multiple solid tumors: NSCLC, renal, pancreas
Slide 30: ROR1 – Preclinical Candidate
ROR1 – Preclinical Candidate CANDIDATE OPPORTUNITY FUNCTION/MOA INDICATIONS DEVELOPMENT STAGE PARTNERSHIP STATUS Novel therapeutic that redirects T cells to kill ROR1-expressing tumor cells Engages T cell via binding to CD3 to specifically kill tumor cells expressing ROR1 Multiple solid tumor indica
Slide 31: ROR1 Bispecific Delays Tumor Growth and Shows 80% Survival in Xenograft Model
ROR1 Bispecific - Delays Tumor Growth and Shows 80% Survival in a Xenograft Model Statistically significant delay of tumor growth and increase in overall survival in subcutaneous xenograft model 80% (8/10) of mice at top dose (3 mg x3) tumor free at study end
Slide 32: Agenda
Agenda Executing On Our Strategy ADAPTIR – Developing Novel Protein Therapeutics Impressive Clinical and Preclinical Portfolio IXINITY – A Growing Commercial Opportunity Summary
Slide 33: IXINITY – Targeting the Hemophilia B Market with a Unique Strategy
Intravenous blood coagulation therapy to replace factor IX in individuals with Hemophilia B U.S. launch: June 2015 Strong growth opportunity in US and ROW Worldwide rights owned by Aptevo* Opportunity to partner for U.S. and ex-U.S. markets Indication: Individuals with hemophilia B ages 12 and older
Slide 34: Hemophilia B Market Overview
Hemophilia B affects ~4,000 patients in the United States A bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood Almost exclusively affects males; women are carriers Usually inherited, but 30% are spontaneous mutations Classified a
Slide 35: Agenda
Agenda Executing On Our Strategy ADAPTIR – Developing Novel Protein Therapeutics Imprssive Clinical and Preclinical Pipeline IXINITY – A Growing Commercial Opportunity Summary
Slide 36: Financial Snapshot
Financial Snapshot Shares Outstanding 21.4M 9/30/2017 Cash $91M 12/31/2017 Debt $20M MidCap Financial IXINITY Revenue 2017 (9/30/17) 2016 2015 $8.1M $9.8M $1.0M 2018 Cash Burn $55M - $60M Estimated cash burn
Slide 37: 2018 Milestones
2018 Milestones Program Commence dosing of otlertuzumab in Phase 2 Peripheral T-Cell Lymphoma (PTCL) clinical trial File IND for APVO436 for Acute Myeloid Leukemia (AML) Complete enrollment of Phase 1 dosing cohorts in APVO414 clinical trial Announce APVO414 Phase 1 dose escalation preliminary clini
Slide 38: Aptevo – A Compelling Investment Opportunity
Aptevo – A Compelling Investment Opportunity Solid cash position to advance R&D and commercial strategy 1 2 3 4 5 Strong leadership with a track record of execution Advancing ADAPTIR™ to generate novel first-in-class therapeutics Broad pipeline of wholly-owned clinical and preclinical candidates Com
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