Full Press Release Details
Aptevo Therapeutics Investor
Presentation November 2016 Exhibit 99.1
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 containing the words "believes", "expects", "anticipates", "intends", "plans", "forecasts", "estimates" and similar expressions in conjunction with,
among other things, discussions of financial performance or financial condition, growth strategy, product sales, manufacturing capabilities, product development, regulatory approvals or expenditures are forward-looking statements. These
forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement
speaks only as of the date of this presentation, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could
cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including possible negative effects on Aptevo's business operations, assets or financial results as a result of the separation; a
deterioration in the business or prospects of Aptevo; adverse developments in Aptevo's customer-base or markets; our ability to enter into and maintain selective collaboration and partnership arrangements; the timing of and our ability to
achieve milestones in collaboration and partnership contracts; our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; the rate and degree
of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; and our commercialization,
marketing and manufacturing capabilities and strategy and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange
Commission, including Aptevo's most recent Quarterly Report on Form 10-Q, as filed on November 14, 2016. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any
forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements. Aptevo , ADAPTIR and any
and all Aptevo Therapeutics Inc. brand, product, service, and feature names, logos, and slogans are trademarks or registered trademarks of Aptevo Therapeutics Inc. or its subsidiaries in the United States or other countries. All rights
reserved. Forward-Looking Statements
AGENDA Leadership in Bispecific
Antibody Development Aptevo today What sets us apart Summary
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 Strong IP Estate Will own or exclusively license patent rights for entire product portfolio Will seek exclusive licenses for supporting technologies Focus Oncology/Hematology Commercial Products 4 Product Pipeline Clinical: 2
Preclinical: Multiple Platform Technologies ADAPTIR Employees ~130 Headquarters Seattle, WA 2016 Revenue (9/30/16) $27.5M 2015 Revenue $33.6M Cash $61M (9/30/16) $20M EBS future contribution $15M MidCap 2nd tranche option
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, Global Mfg & Supply, GSK; Former VP, Mfg Ops & Quality, Human Genome Sciences Dr. Scott Stromatt - SVP, CMO Former Emergent SVP, CMO; Former CMO, Trubion Dr. Jane Gross - SVP, CSO
Emergent VP, Research/Non-Clinical Development; Former VP Immunology Research ZymoGenetics Inc. Mike Adelman - VP, Commercial Ops. Former Emergent VP, Commercial Operations; Former, VP Commercial Operations, Cangene Corporation Shawnte
Mitchell - VP, Gen'l Counsel/HR Former Emergent VP, Associate General Counsel Board of Directors Marvin White Former Emergent Director; Former CFO, St. Vincent's Health; Former Exec. Director & CFO, Lilly USA Fuad El-Hibri
Founder, Executive Chairman, Emergent BioSolutions Daniel Abdun-Nabi President & CEO, Emergent BioSolutions Grady Grant, III Mead Johnson Nutrition; Eli Lilly & Co. Zsolt Harsanyi, Ph.D. N-Gene Research Labs; Exponential Biotherapies; Porton
Int'l Barbara Lopez Kunz DIA; Battelle; Thermo Fisher Scientific; ICI/Uniqema John Niederhuber, M.D. Inova Translational Medicine Institute; NCI; Johns Hopkins Univ. Deep R&D, Commercial and Financial Expertise and Experience
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 standard in vitro assays to assess function Determine PK and in vivo activity in mouse models Assess NHP PK and tolerability with CRO Process Development Generate CHO production cell lines Develop platform cell culture and
purification processes, optimize as needed Produce material for toxicology studies Develop & qualify analytical methods Clinical Research /Ops Regulatory Affairs Medical Affairs Pharmacovigilence Biostatistics Clinical Manufacturing GMP process
validation, scale-up and tech transfer; QA/QC Supply chain management CMO oversight Expertise and Leadership in Bispecific Antibody Development Facilitates Rapid Drug Development from Concept to Clinic
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
AGENDA Leadership in Bispecific
Antibody Development Aptevo today What sets us apart Summary
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 HBV $10.3M WW in 2015 $7.1M (9/30/2016) VARIZIG Hyper Immune Varicella $2.3M WW in 2015 $2.8M (9/30/2016) Otlertuzumab ADAPTIR Monospecific CLL Executing combination clinical trials MOR209/ES414* ADAPTIR Bispecific RTCC mCRPC
Immuno-oncology Executing Phase 1 clinical trial ROR1 ADAPTIR Bispecific RTCC Hematological, Solid Tumor Malignancies Preclinical in vitro and in vivo POC, developing lead candidate Multiple ADAPTIR Candidates ADAPTIR Bispecific Hematological, Solid
Tumor Malignancies Multiple RTCC candidates and ADAPTIR with novel MOA ES210 ADAPTIR Targeted cytokine IBD Preclinical POC in IBD, CHO production cell line 5E3 mAb Monoclonal Antibody Alzheimer's Disease Pursuing partnerships Robust and
Diversified Product Portfolio * Partnered with MorphoSys AG RTCC - Redirected T-Cell Cytotoxicity
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 Thrombocytopenic Purpura (ITP) and suppression of Rhesus (Rh) isoimmunization US: [Hepatitis B Immune Globulin Intravenous (Human)] Canada: (Hepatitis B Immune Globulin (Human) Injection) Prevention of hepatitis B recurrence
following liver transplantation in HBsAg-positive patients and post exposure prophylaxis after acute hepatitis B exposure US: VARIZIG [Varicella Zoster Immune Globulin (Human)] Canada: VariZIG (Varicella Zoster Immune Globulin (Human))
Post-exposure prophylaxis of varicella zoster in high risk individuals
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 of bulk drug substance for IXINITY Aptevo is continuing to work with its BDS supplier to resolve the IXINITY manufacturing issue IXINITY customers (patients, health care providers, specialty pharmacies, advocacy groups) have been
notified of the temporary supply interruption Aptevo remains committed to supporting our patients and IXINITY as we address the manufacturing challenge IXINITY Supply Interruption
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 Cytokine Delivery Potential for additional MOAs ADAPTABLE Applicable to a variety of solid and hematologic cancers, i.e.: breast, lung, ovarian, prostate, kidney, melanoma, pancreatic SYNERGISTIC Potential for single, sequential, or
combination immunotherapeutic approaches ADAPTIR - Proprietary Platform Technology Fc scFv scFv Bispecific ADAPTIR Therapeutic
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 studies Improved stability & physical characteristics GMP manufacturing up to 2000L scale Longer Half Life Reduced Toxicity Ease of Manufac-turing mAB-like manufacturing advantages "Off the shelf" technology vs
"cell-based" therapies Improved Economics
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 tumor cell T cell Tumor cell
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 Executing Phase 1 clinical trial RTCC - Redirected T-Cell Cytotoxicity * Partnered with MorphoSys AG
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 (mouse /NHP) vs antibody fragments 100% owned by Aptevo Actively pursuing potential partnership opportunities Ongoing: Phase 2 Study for chronic lymphocytic leukemia (CLL) Planning: Combination study Multiple clinical trial
data published at ASH 2013, establishing clinical proof-of-concept PHASE 2 STUDY (16201): Combination of otlertuzumab and bendamustine in patients with relapsed CLL produced higher response rates than bendamustine alone PHASE 1b STUDY (16009):
Combination of otlertuzumab and rituximab in patients with previously untreated CLL was active and well tolerated Description Partnering Development Status ADAPTIR
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 antibody fragments Co-development/Co-commercialization partnership with MorphoSys AG established August 2014 Open-label Phase 1 Study underway (U.S. & Australia) Safety, tolerability, and clinical activity in patients
with metastatic castration-resistant prostate cancer (mCRPC) to be conducted in 2 stages Stage 1: Primary Objective -- identify MTD administered intravenously. Secondary Objectives -- evaluate tolerability, PK, PD, immunogenicity, cytokine response,
and clinical activity Stage 2: Primary Objective -- evaluate clinical activity in patients that have or have not received prior chemotherapy Description Partnering Development Status ADAPTIR
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 malignancies Multiple RTCC candidates Undisclosed targets Immuno-oncology ADAPTIR with Novel MOA Undisclosed targets Immuno-oncology * Validated Platform Technology: Bispecific ADAPTIR molecules can redirect T-cell cytotoxicity
against multiple tumor targets in preclinical models Modular Bispecific Platform: ADAPTIR platform can be used to generate bispecifics with novel MOA in immuno-oncology and other diseases
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 - ROR1
AGENDA Leadership in Bispecific
Antibody Development Aptevo today What sets us apart 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 YTD Total Product Sales Estimated Cash Burn $50M-$55M 2016 Pro Forma *Includes $20M cash from Emergent Biosolutions to be paid by August 1, 2017
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 into the clinic Operational/Financial Capture incremental market share of Hemophilia B market with expanded sales of IXINITY Expand ex-US commercial market opportunities through new regulatory filings in select foreign
jurisdictions Continue current and initiate future partnering discussions around product candidates Multiple Upcoming Valuation Catalysts
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 model with commercial product portfolio to support R&D funding
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 cycle management File new patent applications as products and related methods evolve Will seek broad geographic scope Will seek exclusive licenses as available for supporting technologies Intellectual Property