XOMA Royalty Corporation · NASDAQ:XOMA
XOMA Royalty — XOMA — Investor Presentation (July 2012)
28 slides from XOMA Royalty's investor presentation, July 2012
Slide 1: Corporate Presentation
Corporate Presentation July 2012
Slide 2: Forward-looking Statements
Forward-looking Statements Certain statements contained herein concerning regulatory consideration of proposed clinical trial and filing plans, anticipated size of clinical trials, anticipated timing of initiation of clinical trials and expected availability of clinical trial results, or that otherw
Slide 3: XOMA Highlights
XOMA Highlights Gevokizumab is a potential best-in-class IL-1β antibody • Phase 3 program initiated Q2 2012 • Exhibited strong Phase 2 data in Behçet's uveitis • Established regulatory pathway for IL-1 inhibitors (Kineret®, Ilaris®, Arcalyst®) • Lead indication, non-infectious uveitis (NIU), is si
Slide 4: XOMA Business Strategy
XOMA Business Strategy Advance gevokizumab in collaboration with Servier • XOMA retains all U.S. and Japan rights in all indications except cardiovascular and diabetes with option rights to these • Phase 3 NIU program initiated Q2 2012 – Data expected within 18-24 months from initiation – Servier
Slide 5: Building Commercial Capability
Building Commercial Capability Initiated U.S. commercial capability with ACEON® (perindopril erbumine) license • Deepens Servier relationship • Puts commercial capability in place upon which we can build • Scalable for increased volume and additional products Perindopril arginine plus other anti
Slide 6: Gevokizumab Profile
Gevokizumab Profile Potential best-in-class IL-1β antibody High-affinity, humanized antibody with subcutaneous monthly dosing Distinct properties differentiate gevokizumab from other biologics that inhibit the IL-1 cascade • Leaves regulatory, clearance and homeostatic mechanisms associated wi
Slide 7: Gevokizumab Targets Interleukin-1 Beta (IL-1β)
Gevokizumab Targets Interleukin-1 Beta (IL-1β) IL-1β is a pro-inflammatory cytokine (signaling protein) secreted by a wide variety of cell types IL-1β is a key initiator and mediator of the inflammatory cascade Elevated levels of IL-1β play a major role in many acute and chronic inflammatory a
Slide 8: Approved IL-1 Biologics
Approved IL-1 Biologics Approved Indications Drug Class Biology Pharmacology Clinical Supporting Clinical Evidence Approved: rheumatoid arthritis IL-1 Short half-life Kineret® Blocks IL-α & IL- Positive clinical data: type 2 diabetes, Receptor Daily dosing; Injection site 1β by occupying osteoar
Slide 9: Gevokizumab Clinical Experience in 480 Patients
Gevokizumab Clinical Experience in 480 Patients Exposure: as of June 2012, 480 total subjects have received gevokizumab for up to 2 years including: Range of treatment # of Subjects > 2 years 4 = 6 months 316 < 6 months 87 Single dose 73 Total 480 Age range: 24 to 75 years of age Pharmacokinet
Slide 10: Gevokizumab Significantly Reduced C-reactive Protein in Type 2 Diabetes
Gevokizumab Significantly Reduced C-reactive Protein in Patients with Type 2 Diabetes CRP a validated surrogate marker of systemic inflammation * * Responders defined as subjects NS with hsCRP NS > 3 mg/L at baseline and ≤ 3 mg/L at the end of trial Reported p-values based on Fisher’s Exact test com
Slide 11: Uveitis: Inflammation of the Uvea
Uveitis: Inflammation of the Uvea Central Retinal and Artery and Vein Uveitis can be infectious or non-infectious Non-infectious uveitis can be anterior, intermediate, posterior or pan • Multiple etiologies; Behçet's uveitis is representative of multiple forms In general, only non-anterior NIU
Slide 12: Clinical Activity in First Trial of Behçet's Subset of Non-Infectious Uveitis
Clinical Activity in First Trial of Behçet's Subset of Non-Infectious Uveitis All 7 patients showed rapid treatment effect for intraocular inflammatory attack 5 of 5 responded to second dose Gevokizumab was well-tolerated 4 patients have received monthly treatment for almost 2 years • Mainta
Slide 13: Rapid Response in Behçet's Subset of NIU
Rapid Response in Behçet’s Subset of NIU hypopyon Off-center iris Day 0 Day 1 Day 4 Flare score: 467 ph/msec * Flare score: 45 ph/msec Flare score: 62 ph/msec Anterior chamber cell: 4+ Anterior chamber cell: 4+ Anterior chamber cell: 4+ Vitreous haze: 3+ Vitreous haze: 3+ Vitreous haze: 2+ Fundus sc
Slide 14: Single Dose Clears Vitreous Haze in Posterior Uveitis Case
Single Dose Clears Vitreous Haze in Posterior Uveitis Case Page 14
Slide 15: NIU Global Clinical Plan
NIU Global Clinical Plan XOMA held End-of-Phase 2 meeting with FDA in Q4 2011 • Resulted in plan for two pivotal trials, NIU and Behçet’s uveitis, to form basis for BLA for NIU indication, including Behçet’s uveitis Received EMA feedback on global plan • Consistent with FDA and expectations Pr
Slide 16: Gevokizumab Phase 3 NIU Study Design
Gevokizumab Phase 3 NIU Study Design 300 patients with non-anterior non-infectious uveitis with Patient population vitreous haze score >2 on SUN/NEI scale Randomization 1:1:1 30 mg / 60 mg / placebo dosed once a month for 12 Gevokizumab doses months Sites 100-120: 50% patients enrolled in U.S. Vitre
Slide 17: Anticipated Gevokizumab Phase 3 Behçet's Uveitis Study Design
Anticipated Gevokizumab Phase 3 Behçet's Uveitis Study Design 110 Behçet's Uveitis patients whose disease is Patient population stable on current steroid dose Randomization 1:1 Gevokizumab dose TBD vs. placebo dosed once a month Steroid tapering Undisclosed schedule Study duration Complete when 22 e
Slide 18: Gevokizumab Proof-of-Concept Clinical Trials to Increase Value Quickly
Gevokizumab Proof-of-Concept Clinical Trials to Increase Value Quickly Multiple studies designed to demonstrate clinical benefit in relatively short period • Cost efficient • Rapid enrollment and completion Powered to show clear response using validated tools All indications have demonstrated
Slide 19: Moderate to Severe Inflammatory Acne Vulgaris – POC 1
Moderate to Severe Inflammatory Acne Vulgaris – POC 1 IL-1 shown to be involved in acne • Stimulation of keratinocytes with P. acnes shown to modulate IL-1β(1) • Anakinra had positive effect on acne of PAPA Syndrome(2) Study initiated December 2011 • 170 patients, 15 sites in U.S. • 3 monthly su
Slide 20: Gevokizumab Acne Vulgaris Phase 2 POC Study Design
Gevokizumab Acne Vulgaris Phase 2 POC Study Design Patient population 171 patients with moderate to severe acne vulgaris Randomization 1:1:1 0.3 mg/kg, 0.6 mg/kg vs. placebo dosed subQ once a Gevokizumab dose month Total doses 3 Study initiated December 2011 Anticipated completion Q4 2012 Primary en
Slide 21: Erosive, Inflammatory Osteoarthritis of the Hand (EIOAH) – POC 2
Erosive, Inflammatory Osteoarthritis of the Hand (EIOAH) – POC 2 Subset of osteoarthritis of the hand, affecting several million patients in U.S. In situ analysis of affected tissues (synovium, cartilage, bone) show presence of IL-1β involvement Prior experience with anakinra showed clinical e
Slide 22: Gevokizumab Erosive Osteoarthritis of the Hand Phase 2 POC Study Design
Gevokizumab Erosive Osteoarthritis of the Hand (EOA) Phase 2 POC Study Design Patient population 90 patients with active EOA Randomization 2:1 Gevokizumab dose 60 mg vs. placebo dosed once a month Total doses 6 Study initiated June 2012 Anticipated completion 12 months Improvement in total AUSCAN® o
Slide 23: Creating Value from XOMA Discovery
Creating Value from XOMA Discovery XMet: next generation of XOMA allosteric modulators • XMetA: selective insulin receptor modulator (SIRM) (published online in Diabetes March 2012) – May provide a long-acting alternative to basal insulin for mid- to late-stage diabetics • XMetS: insulin sensitizi
Slide 24: XMetA Paper Published by DIABETES
XMetA Paper Published by DIABETES ORIGINAL ARTICLE A Fully Human, Allosteric Monoclonal Antibody That Activates the Insulin Receptor and Improves Glycemic Control Vinay Bhaskar,1 Ira D. Goldfine,2 Daniel H. Bedinger, 1 Angela Lau, 1 Hua F. Kuan, 1 Lisa M. Gross, 1 Masahisa Handa, 1 Betty A. Maddux,2
Slide 25: Two Years of Anticipated Milestones Build Additional Value
Two Years of Anticipated Milestones Build Additional Value Timing Milestone Program Q2:12 Initiated POC 2 trial in erosive osteoarthritis – Phase 2 gevokizumab Q2:12 Initiated pivotal trials (NIU & Behçet's uveitis) – Phase 3 gevokizumab Q3:12 Initiate POC 3 trial in additional indication – Phase 2
Slide 26: Financial Highlights
Financial Highlights $74.9 million cash at March 31, 2012 $36.2 million net proceeds from March 2012 public offering • 68 million shares o/s post-offering • Approx 60% institutional ownership post-offering 2012 guidance • Cash used in ongoing operating activities: approximately $35 million • S
Slide 27: XOMA Highlights
XOMA Highlights Gevokizumab is a potential best-in-class IL-1β antibody • Phase 3 program initiated Q2 2012 • Exhibited strong Phase 2 data in Behçet's uveitis • Established regulatory pathway for IL-1 inhibitors (Kineret®, Ilaris®, Arcalyst®) • Lead indication, non-infectious uveitis (NIU), is si
Slide 28: XOMA
XOMA