Aptevo Therapeutics Inc. · NASDAQ:APVO
Aptevo Therapeutics — Investor Presentation (November 2017)
38 slides from Aptevo Therapeutics's investor presentation, Nov 9, 2017
Slide 1: Aptevo Therapeutics Investor Presentation November 2017
Aptevo Therapeutics Investor Presentation November 2017 Exhibit 99.2
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 Aptevo therapeutics innovating
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 Execute spin-off from Emergent Biosolutions Completed spin August 2016; Aptevo formed 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 co
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 $5.6M (6/30/17) $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 Aptevo therapeutics innovating
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 Improved potency Reduced toxicity Better manufacturability ü ü ü ü ü ü *Based on current preclinical data for various ADAPTIR candidates Aptevo therapeutics
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 41BB + Tumor Antigen Targeted Cytokines IL-10 AIID/Oncol
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 - More Potent than Heterodimer BispecificsTargeting Same Antigen Higher levels of maximal tumor cell lysis (killing) Lower concentrations needed to achieve same potency = manufacturing and COG efficiencies Redirected T-cell Tumor Killing ADAPTIR High Max Lysis Lower EC50 Protein EC50 ADAPTIR
Slide 15: Agenda
Agenda Executing On Our Strategy ADAPTIR – Developing Novel Protein Therapeutics Impressive Clinical and Preclinical Portfolio IXINITY – A Growing Commercial Opportunity Summary Aptevo therapeutics innovating
Slide 16: Product Candidate Pipeline
Product Candidate Technology Indication Target Pre-Clinical Clinical Development Stage Milestones/Highlights Phase I Phase II Phase III Otlertuzumab ADAPTIR Monospecific CLL; T cell Lymphomas CD37 Executing Phase 2b combination study APVO414 ADAPTIR Bispecific RTCC mCRPC Immuno-oncology CD3/PSMA Exe
Slide 17: Otlertuzumab – Clinical Candidate
Otlertuzumab – Clinical Candidate CANDIDATE OPPORTUNITY FUNCTION/ MOA INDICATIONS DEVELOPMENT STAGE PARTNERSHIP STATUS aCD37 scFv Human IgG1 Fc ADAPTIR monospecific antibody targeting CD37 Direct apoptosis, antibody-dependent cell cytotoxicity, complement-dependent cell cytotoxicity Chronic Lymphocy
Slide 18: 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 Aptevo therapeutics otlertuzumab and bendamustine
Slide 19: 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 Aptevo therapeutics
Slide 20: 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 21: APVO414 - ADAPTIR T-Cell Engager More Potent Than scFv-scFv Format
APVO414 - ADAPTIR T-Cell Engager More Potent Than scFv-scFv Format Assay utilizes MDA-PCa-2b target cells and primary T cells; 4 hr time point Protein EC50 APVO414 2.7 ± 0.6 pM scFv-scFv 99 ± 10 pM Concentration (pM) % Specific Lysis 0 5 10 15 20 25 1 10 100 1000 APVO414 (ADAPTIR molecule) αPSMA x α
Slide 22: 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 23: APVO436 Inhibits Tumor Growth in Xenograft Model of Human AML
APVO436 Inhibits Tumor Growth in Xenograft Model of Human AML Day 11: Tumor + T cells Alone Day 11: Tumor + T cells + APVO436, 0.6 mg Growth of AML tumor cells bioluminescence 1010 109 108 107 106 0 2 4 6 8 10 12 days post tumor cells engraftment apvo436 treatment tumor + t cells alone tumor alone t
Slide 24: 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 25: 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 26: 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 27: ALG.APV-527 Targeted Immunotherapeutic
ALG.APV-527 Targeted Immunotherapeutic Directs T-cell activation to 5T4 expressing tumor cells Exerts tumor-localized T-cell activation upon 5T4 binding Does not stimulate all T-cells Targeted immunotherapy offers the potential for enhanced efficacy and safety Tumor cell 5T4 T-cell 4-1BB Tumor killi
Slide 28: 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 29: ROR1 Bispecific - Delays Tumor Growth and Shows 80% Survival in a 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 Aptevo therapeutics Mean tumor volume (m
Slide 30: Agenda
Agenda Executing On Our Strategy ADAPTIR – Developing Novel Protein Therapeutics Impressive Clinical and Preclinical Portfolio IXINITY – A Growing Commercial Opportunity Summary Aptevo therapeutics innovating
Slide 31: 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 32: Hemophilia B Market Size
In 2011, factor IX market was $1.2B worldwide and >$400 million in US Growing at mid-single digits, driven by increased prophylaxis (IU/patient) and recombinant use Hemophilia B Market Size Total Global Hemophilia Market (in millions of USD) SOURCE: HealthObserver, Morningstar, Jan 2013 (a) actual (
Slide 33: Hemophilia B Market Background
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 34: Agenda
Agenda Executing On Our Strategy ADAPTIR – Developing Novel Protein Therapeutics Imprssive Clinical and Preclinical Pipeline IXINITY – A Growing Commercial Opportunity Summary Aptevo therapeutics innovating
Slide 35: Financial Snapshot
Financial Snapshot Shares Outstanding 21.4M 6/30/2017 Cash $107M 9/30/2017 Debt $20M MidCap Financial 2015 Revenue $28M Total Product Sales (2015 Pro Forma) 2016 Revenue $36M Total Product Sales 2017 Cash Burn $53M - $58M Estimated cash burn Aptevo therapeutics
Slide 36: Upcoming Milestones – 2017-2018
Upcoming Milestones – 2017-2018 Program Announce planned IND filings for multiple ADAPTIR candidates Commence expanded Phase 2 otlertuzumab clinical program Complete enrollment of Phase 1 dosing cohorts in APVO414 clinical trial Announce APVO414 Phase 1 dose escalation preliminary clinical data Expa
Slide 37: Why Aptevo? A Compelling Investment Opportunity
Mechanics of a spin-off often result in deep value disconnects APVO assets have been ‘under the radar’ of the investment and scientific communities Comparable bispecific company analysis suggests deep value opportunity for risk tolerant investors Why Aptevo? A Compelling Investment Opportunity Compa
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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