Aptevo Therapeutics Inc. · NASDAQ:APVO
Aptevo Therapeutics — Investor Presentation (November 2016)
30 slides from Aptevo Therapeutics's investor presentation, Nov 28, 2016
Slide 1: Aptevo Therapeutics Investor Presentation November 2016
Aptevo Therapeutics Investor Presentation November 2016 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: Agenda
AGENDA Leadership in Bispecific Antibody Development Aptevo today What sets us apart Summary
Slide 4: Aptevo: At a Glance
Aptevo: At a Glance Leading Oncology Platform Innovative ADAPTIR™ platform technology utilizing a promising approach in the highly attractive immuno-oncology field Leveraging Technology Targeted investments in bispecific ADAPTIR™ therapeutics Increased awareness of the RTCC Mechanism of Action Stron
Slide 5: Executive Leadership
Executive Leadership 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 VP, Glob
Slide 6: Our Capabilities
Our Capabilities Protein Engineering Generate new binding domains or take partner’s mAbs and convert to ADAPTIR format Optimize for: Screening to reduce potential for immunogenicity Binding affinity Activity Expression Manufacturability Preclinical Development Evaluate new ADAPTIR bispecifics using
Slide 7: Our Strategy
Our Strategy 1 2 3 Advance novel ADAPTIR™ product candidates, primarily in I/O Expand collaborations and partnerships Maximize cash flow from commercial portfolio to support R&D funding
Slide 8: Agenda
AGENDA Leadership in Bispecific Antibody Development Aptevo today What sets us apart Summary
Slide 9: Product/Candidate Pipeline and Marketed Products
Product/Candidate Technology Indication Pre-Clinical Clinical Development Stage Marketed Milestones/Highlights Phase I Phase II Phase III IXINITY Recombinant Protein Hemophilia B $1.0M WW in 2015 $7.0M (9/30/2016) WinRho Hyper Immune ITP $14.2M WW in 2015 $10.6M (9/30/2016) HepaGam B Hyper Immune HB
Slide 10: Commercial Products to Support R&D Funding
Commercial Products to Support R&D Funding [coagulation factor IX (recombinant)] An intravenous recombinant human coagulation factor IX therapeutic for use in patients with Hemophilia B US: [Rho (D) Immune Globulin Intravenous (Human)] Canada: (Rho(D) Immune Globulin (Human) for injection) Immune Th
Slide 11: IXINITY Supply Interruption
On November 14, 2016 Aptevo reported that it anticipated experiencing a supply interruption of IXINITY as follows: 1,500 IU dosage form - beginning December 2016 All remaining dosage forms - beginning January 2017 The supply interruption relates to ongoing challenges associated with the manufacture
Slide 12: ADAPTIR Proprietary Platform Technology
MODULAR New bispecifics readily assembled with potent preclinical activity Ultimate flexibility; able to generate candidates with novel MOA Single chain format optimized for CHO cell production; avoids issues found with other bispecifics VERSATILE Redirected T-Cell Cytotoxicity (RTCC) Targeted Cytok
Slide 13: ADAPTIR RTCC Key Advantages vs Other Bispecifics
ADAPTIR™ RTCC Key Advantages vs Other Bispecifics Longer half-life in preclinical studies supports less frequent administration Induce target-dependent cytotoxicity at low concentrations in preclinical studies Highly potent Induce low levels of cytokine engagement of target cells in preclinical stud
Slide 14: ADAPTIR RTCC Mechanism of Action
ADAPTIR™ – RTCC Mechanism of Action ADAPTIR Bispecific Molecules Mediate RTCC: Potent Immunotherapeutic for Cancer Tumor Antigen Bispecific molecule activates T cell to kill tumor cell CD3/TCR complex Target-dependent release of cytolytic granules from T cells kills tumor T cell expansion Death of t
Slide 15: ADAPTIR Clinical Pipeline
ADAPTIR™ Clinical Pipeline Product Candidate Technology Indication Pre-Clinical Clinical Development Stage Milestones Highlights Phase I Phase II Phase III Otlertuzumab ADAPTIR Monospecific CLL Executing combination clinical trials MOR209/ES414* ADAPTIR Bispecific RTCC mCRPC Immuno-oncology Executin
Slide 16: Clinical Stage Candidate – otlertuzumab (CLL)
Clinical Stage Candidate – otlertuzumab (CLL) aCD37 scFv Human IgG1 Fc Humanized monospecific protein therapeutic Targeting the CD37 signaling pathway involved in B-cell malignancies Built on ADAPTIRTM (modular protein therapeutic) platform Demonstrated anti-tumor activity Prolonged serum half-life
Slide 17: Clinical Stage Candidate – MOR209/ES414 (mCRPC)
Clinical Stage Candidate – MOR209/ES414 (mCRPC) Anti-PSMA Anti-CD3 Humanized bispecific protein therapeutic Targeting PSMA and CD3, a component of the T-cell receptor Demonstrated redirection of T-cells to kill tumor cells expressing PSMA in vitro and in vivo Prolonged serum half-life (mouse/NHP) vs
Slide 18: ADAPTIR Novel Preclinical Product Pipeline
ADAPTIR™ Novel Preclinical Product Pipeline Molecule Target Antigen Type Target Indication(s) Development Activity Design in vitro RTCC in vivo POC Tox/IND Clinical: Phase 1 aROR1 x aCD3 Tyrosine Kinase (ROR1) Hematologic malignancies; solid tumors RTCC Candidate Undisclosed target Hematological mal
Slide 19: ADAPTIR RTCC Preclinical Candidate – ROR1
Targets hematologic malignancies and solid tumors Triple-negative breast cancer Ovarian cancer Non-small cell lung cancer Prostate cancer Kidney cancer Preclinical in vitro and in vivo proof of concept established Improved preclinical PK Developing lead candidate ADAPTIR™ RTCC Preclinical Candidate
Slide 20: Agenda
AGENDA Leadership in Bispecific Antibody Development Aptevo today What sets us apart Summary
Slide 21: Financial Summary
Financial Summary Spin Date: August 1, 2016 Shares Outstanding 20.2M 9/30/2016 Cash $61M $20M* $15M 9/30/2016 Future Emergent payment MidCap Financial - 2nd tranche option 2015 Revenue $34M $28M $6M 2015 Pro Forma Total Product Sales Contracts, Grants, Collaborations 2016 Revenue $27.5M 9/30/2016 YT
Slide 22: Key Milestones – 18-24 Months
Key Milestones – 18-24 Months Development Complete Phase 1 study of MOR209/ES414 and advance into Phase 2 development in partnership with MorphoSys Generate new ADAPTIR-based RTCC candidates Expand application of ADAPTIR-based candidates into new MOA Advance new preclinical ADAPTIR-based candidates
Slide 23: Why Aptevo?
Why Aptevo? Solid financial position with runway into 2018 1 2 3 4 5 Established leadership and capabilities in protein-based therapies for cancer Proprietary, versatile, differentiated ADAPTIR™ technology platform Broad pipeline of clinical and preclinical development candidates Capital efficient m
Slide 24: Appendix
Appendix
Slide 25: Intellectual Property Estate
APTEVO owns or exclusively licenses patent rights protecting IXINITY ADAPTIR otlertuzumab MOR209/ES414 ES210 ROR1 5E3mAb APTEVO’S General Patent Filing and Prosecution Strategy Will seek patent protection on all products and platforms Exception – existing hyperimmune products Will practice life cycl
Slide 26: Portfolio of Marketed Products – IXINITY
Portfolio of Marketed Products IXINITY® [coagulation factor IX (recombinant)] IXINITY® is an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, ≥12 years of age, with Hemophilia
Slide 27: Portfolio of Marketed Products – WinRho
Portfolio of Marketed Products US: [Rho (D) Immune Globulin Intravenous (Human)] Canada: (Rho (D) Immune Globulin (Human) for injection) WinRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) product indicated for use in clinical situations requiring an increase in platelet count to prevent exc
Slide 28: Portfolio of Marketed Products – HepaGam B
Portfolio of Marketed Products US: [Hepatitis B Immune Globulin Intravenous (Human)] Canada: (Hepatitis B Immune Globulin (Human) Injection) HepaGam B® is the only Hepatitis B Immune Globulin approved by the FDA for the prevention of hepatitis B recurrence following liver transplantation in HBsAg-po
Slide 29: Portfolio of Marketed Products – VARIZIG
Portfolio of Marketed Products US: VARIZIG® [Varicella Zoster Immune Globulin (Human)] Canada: VariZIG® (Varicella Zoster Immune Globulin (Human)) VARIZIG® is intended for use as post-exposure prophylaxis to reduce the severity of chickenpox infections in high risk patient groups (see respective U.S
Slide 30: Aptevo Therapeutics
Aptevo Therapeutics Investor Presentation November 2016
Aptevo Therapeutics — Investor Presentation (November 2016) on 6ix