Xoma Royalty Corporation · NASDAQ:XOMA
Xoma Royalty — XOMA — Investor Presentation (June 2013)
29 slides from Xoma Royalty's investor presentation, June 2013
Slide 1: Corporate Presentation June 2013
Corporate Presentation June 2013
Slide 2: Forward-looking Statements
Forward-looking Statements Certain statements contained herein including, but not limited to, statements related to anticipated timing of initiation and completion of clinical trials, anticipated size of clinical trials, therapeutic and market potential of XOMA’s product candidates, continued sales
Slide 3: Gevokizumab: Pipeline in a Product
Gevokizumab: Pipeline in a Product 1H 2013 2H 2013 1H YE2013 2013 1H 2014 2H 2014 Positive Acne Phase 2 POC Data Decision on next Phase 3 Indication EOA Phase 2 POC Data EYEGUARD A, B, C Data from 3 Pivotal Trials BLA Filing Pyoderma Pilot Study Data / FDA Feedback Pivotal Study BLA Filing Gangrenos
Slide 4: XOMA Pipeline
XOMA Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Commercialized in U.S. by XOMA Gevokizumab Indications X X X XMet D: Insulinomas X Developed for Licensure XMet A: Type 1 & 2 diabetes mellitus X XMet S: Type 2 diabetes mellitus X 4
Slide 5: Creating Value - Capturing Value
Creating Value - Capturing Value Developing Gevokizumab Creates Expanding Pipeline Creates Value: Value: • Phase 3 NIU/BU program complete in 2014 • Gevokizumab additional indications • Phase 2 POC program to select next • XMet platform Phase 3 indication • Differentiating discovery activities • Rar
Slide 6: Commercial Decision Tree Provides the Opportunity to Capture Value
Commercial Decision Tree Provides the Opportunity to Capture Value What diseases might this drug treat? What will the competitive landscape look like if it is approved? If this compound has potential beyond an orphan indication, can we sell it by ourselves to specialty prescribers with a small targe
Slide 7: Gevokizumab: Potential Best-in-Class IL-1β Antibody
Gevokizumab: Potential Best-in-Class IL-1β Antibody High-affinity, humanized allosteric modulating antibody with subcutaneous monthly dosing Distinct properties differentiate gevokizumab from other biologics that inhibit the IL-1 cascade • Elevated levels of IL-1β play a role in many acute and c
Slide 8: Uveitis: Inflammation of the Uvea
Uveitis: Inflammation of the Uvea Uveitis can be infectious or non- infectious Non-infectious uveitis (NIU) can be anterior, intermediate, posterior or pan – Multiple etiologies; Behçet's uveitis is representative of multiple forms In general, only non-anterior NIU warrants treatment with syst
Slide 9: Clinical Activity in First Trial of Behçet's Subset of NIU
Gevokizumab: Clinical Activity in First Trial of Behçet's Subset of NIU All 7 patients showed rapid treatment effect for intraocular inflammatory attack 5 of 5 responded to second dose Gevokizumab was well-tolerated 4 patients treated monthly for >2 years • Maintained therapeutic gevokizumab
Slide 10: Rapid Response in Behçet's Uveitis Subset of NIU
Rapid Response in Behçet’s Uveitis 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
Slide 11: SERVIER Phase 2 Study in Behçet's Uveitis Patients
Gevokizumab: SERVIER Phase 2 Study in Behçet's Uveitis Patients Design Open-label, safety, PK/ADA, clinical and biological activity Study sites South Korea (3); Turkey (4); Tunisia (1) • 21 patients with history of Behçet’s disease and posterior uveitis − On corticosteroids ≤ 20mg/day and > 1 pre-sp
Slide 12: Preliminary Conclusions from SERVIER Phase 2 Study
Preliminary Conclusions from SERVIER Phase 2 Study in Behçet's Uveitis Patients All evaluable Acute patients (N=15) responded to gevokizumab treatment, most within one week 11 evaluable Acute patients with elevated vitreous haze (≥ 2+) at baseline • 8 showed at least 2-unit reduction in index ey
Slide 13: Single Dose Cleared Vitreous Haze in Posterior Uveitis Case
Single Dose Cleared Vitreous Haze in Posterior Uveitis Case in XOMA Phase 2 Study 13
Slide 14: Gevokizumab: Phase 3 EYEGUARD Program
Gevokizumab: Phase 3 EYEGUARD™ Program Study Designs EYEGUARD-A EYEGUARD-B EYEGUARD-C (XOMA) (SERVIER) (XOMA) Active/Controlled Active Controlled Controlled # Patients 300 110 300 # Sites 100-120 50 ~120 30 mg, 60 mg 60 mg 30 mg, 60 mg Gevokizumab doses Placebo Placebo Placebo Randomization 1:1:1 1:
Slide 15: Gevokizumab: Trials Proceeding on Schedule
Gevokizumab: Trials Proceeding on Schedule Phase 3 EYEGUARD program • Jointly performed by XOMA and SERVIER (50/50 cost share) • Manufacturing transferred to Boehringer Ingelheim XOMA-sponsored POC studies • Moderate to severe inflammatory acne; erosive osteoarthritis of the hand • Each party fu
Slide 16: Phase 2 Acne Vulgaris POC Study Design
Gevokizumab: Phase 2 Acne Vulgaris POC Study Design Patient population >100 patients with moderate to severe acne vulgaris Randomization 1:1:1 Gevokizumab dose 0.2 mg/kg, 0.6 mg/kg vs. placebo dosed once a month Total doses 3 Study initiated December 2011 Top-line data January 2013 Primary endpoint
Slide 17: Acne: Overall Effect on Lesion Count Top-Line Results
Acne: Overall Effect on Lesion Count Top-Line Results Gevokizumab Moderate to Severe Acne Vulgaris POC Study Inflammatory Lesion Count n=31 n=32 n=29 n=23 LS Mean Difference = 5.8 ±3.25 n=26 p-value = 0.077 n=25 (1st dose) (2nd dose) (3rd dose) Baseline Inflammatory Lesion Count: 30.6 30.6 31.0 Trea
Slide 18: Acne: Statistically Significant Improvement in IGA Score at Day 84
Acne: Statistically Significant Improvement in Investigator Global Assessment Score at Day 84 Gevokizumab Moderate to Severe Acne Vulgaris POC Study Treatment Responders at Day 84 p-value = 0.031 31% p-value = 1 8% 5% n=21 n=26 n=26 Treatment responders are defined as two or more improvement in the
Slide 19: Erosive Osteoarthritis of the Hand (EOA)
Erosive Osteoarthritis of the Hand (EOA) Distinct subset of osteoarthritis of the hand, affecting 1.8 - 2.2 million patients in U.S. Frequent intermittent inflammatory episodes and progressive joint damage confirmed by X-ray / MRI Pain is typically worse and hand function also more compromised
Slide 20: Phase 2 Erosive Osteoarthritis of the Hand POC Study Design
Gevokizumab: Phase 2 Erosive Osteoarthritis of the Hand (EOA) POC Study Design Patient population 90 patients with diagnosed EOA and elevated CRP Randomization 2:1 Gevokizumab dose 60 mg vs. placebo dosed once a month Total doses 6 Study initiated June 2012 Anticipated top-line September 2013 result
Slide 21: Supplemental Phase 2 EOA Study Design
Gevokizumab: Supplemental Phase 2 Erosive Osteoarthritis of the Hand (EOA) Study Design Patient population 90 patients with diagnosed EOA and non-elevated CRP Randomization 2:1 Gevokizumab dose 60 mg vs. placebo dosed once a month Total doses 3 Study initiated Summer 2013 Improvement in AUSCAN osteo
Slide 22: Phase 2 Pyoderma Gangrenosum Study Design
Gevokizumab: Phase 2 Pyoderma Gangrenosum (PG) Study Design Patient population 4 - 8 patients with acute inflammatory pyoderma gangrenosum • 60 mg dosed SC once a month (first 4-patient cohort) Gevokizumab dose • 120 mg dosed SC once a month (second cohort) Total doses 3 Study initiated June 2013 Pr
Slide 23: NEI-sponsored Non-infectious Scleritis Study Design
Gevokizumab: National Eye Institute-sponsored Non-infectious Scleritis Study Design • 10 patients with non-infectious active anterior scleritis Patient population • Scleral inflammatory grade ≥ 1-plus in at least 1 eye − NEI-developed standardized photographic scleritis grading system Gevokizumab do
Slide 24: XMet Program
XOMA XMet Program
Slide 25: Creating Value from Discovery
Creating Value from Discovery Investing to Capture Value from Future XMet Partnership Agreement XMet A: selective insulin receptor XMet S: insulin sensitizing modulator (SIRM) antibodies • May provide a long-acting alternative • May enable more effective use of own to basal insulin1 insulin for
Slide 26: XMet D: Unique Potential Therapeutic Opportunities
XMet D: Unique Potential Therapeutic Opportunities Antagonist (Deactivator) of the insulin receptor 3 potential rare disease indications to be evaluated: • Insulinomas • Congenital Hyperinsulinism • Hyperinsulinemic Hypoglycemia Post Gastric Bypass Surgery Patients treated in limited number of
Slide 27: Internal Development Pipeline
Internal Development Pipeline Pre- Compound Indication Phase 1 Phase 2 Phase 3 Marketed clinical Gevokizumab Non-infectious uveitis Moderate-to-severe acne Erosive osteoarthritis of the hand Pyoderma gangrenosum Non-infectious scleritis XMet A Type 1 & 2 diabetes mellitus XMet S Type 2 diabetes mell
Slide 28: Financial Highlights
Financial Highlights $70.4 million cash at March 31, 2013 • Cash runway through 2014 • Cash through Phase 3 EYEGUARD top-line data readouts Approximately 83 million shares outstanding Approximately 72% institutional ownership 2013 guidance: • Cash used in ongoing operating activities will be
Slide 29: XOMA
XOMA