XOMA Royalty Corporation · NASDAQ:XOMA
XOMA Royalty — XOMA — Investor Presentation (March 2015)
33 slides from XOMA Royalty's investor presentation, March 2015
Slide 1: Corporate Presentation March 2015
Corporate Presentation March 2015
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: XOMA: Value Creation and Value Capture
XOMA: Value Creation and Value Capture Create value by focusing on lead asset ─ gevokizumab • Potent, fully humanized allosteric-modulating monoclonal antibody • Once-a-month, subcutaneous injection • Modulates inflammatory response to cytokine interleukin-1 beta (IL-1 β) Inflammatory diseases ind
Slide 4: XOMA: Value Creation and Value Capture
XOMA: Value Creation and Value Capture Create value by developing gevokizumab broadly across multiple inflammatory indications • Execute ongoing Phase 3 EYEGUARD™ studies in non-infectious uveitis (NIU) • Initiated Phase 3 study in second pivotal indication: pyoderma gangrenosum • Use expansive pr
Slide 5: Gevokizumab: Pipeline in a Product
Gevokizumab: Pipeline in a Product Pre- Upcoming Indication Phase 1 Phase 2 Phase 3 clinical Milestones XOMA’s Development Programs Non-infectious uveitis (NIU) – EYEGUARD™-A & -C* Ph 3 Endpoints Q3 14: Behçet's disease uveitis (BDU) – EYEGUARD-US Initiated Ph 3 Trial Q4 14: Pyoderma gangrenosum (PG
Slide 6: Behçet's Disease Uveitis & Non-infectious Uveitis
Gevokizumab: Behçet's Disease Uveitis (BDU) & Non-infectious Uveitis (NIU)
Slide 7: Three EYEGUARD Phase 3 Studies Ongoing in Non-infectious Uveitis
Gevokizumab: Three EYEGUARD™ Phase 3 Studies Ongoing in Non-infectious Uveitis Inflammation of the uvea which can occur in front, middle and/or back of the eye • Can be infectious or non-infectious • Gevokizumab targeted for non-infectious patients where back of the eye is affected 150,000 NIU p
Slide 8: Clinical Activity in XOMA's First Phase 2 Trial of Behçet's Disease
Gevokizumab: Clinical Activity in XOMA’s First Phase 2 Trial of Behçet's Disease Subset of NIU 7 of 7 patients showed rapid treatment effect for intraocular inflammatory attack 5 of 5 responded to second dose hypopyon off-center iris * photon counts per millisecond Day 0: Day 1: Day 4: Flare sco
Slide 9: Phase 2 Behçet's Disease Uveitis Studies Clearance of Vitreous Haze
Gevokizumab: Phase 2 Behçet's Disease Uveitis Studies Clearance of Vitreous Haze Patient from XOMA 7-patient Phase 2 study Day 0 - Vit. Haze: 3+ Day 1 - Vit. Haze: 3+ Day 4 - Vit. Haze: 2+ Day 7 - Vit. Haze: 1+ Day 14 - Vit. Haze: 0.5+ Day 21 - Vit. Haze: 0 Servier’s study in 21 patients with Be
Slide 10: EYEGUARD-B Study Design and Status
Gevokizumab: EYEGUARD-B Study Design and Status Strong Phase 2 data in Behçet's disease uveitis patients (BDU) led to Servier run EYEGUARD-B study Ex-U.S. BDU patients, randomized, double-masked Receive 60mg gevokizumab or placebo subcutaneously monthly • Randomized 1:1 Patients must be stab
Slide 11: Driving Toward First BLA in Behçet's Disease Uveitis
Gevokizumab: Driving Toward First BLA in Behçet’s Disease Uveitis EYEGUARD-B results are expected first • Await final pre-specified exacerbation Use EYEGUARD-B results to request pre-BLA Meeting with FDA Perform statistical analysis of XOMA and Servier Phase 2 results to support EYEGUARD-B res
Slide 12: Phase 3 Behçet's Disease Uveitis Program
Gevokizumab: Phase 3 Behçet's Disease Uveitis Program EYEGUARD-B EYEGUARD-US (SERVIER) (XOMA) Active/Controlled Controlled Active & Controlled # Patients Up to 110 Up to 28 # Sites 44 (ex-U.S.) 15 (U.S.) Gevokizumab doses 60mg 60mg (Monthly SubQ) Placebo Placebo Randomization 1:1 1:1 Start date Sept
Slide 13: EYEGUARD-US Behçet's Disease Uveitis Supplemental Study
Gevokizumab: EYEGUARD-US Behçet’s Disease Uveitis Supplemental Study Patients can have active Behçet’s disease uveitis • Patients with active disease are brought under control with gevokizumab (open label), or Patients can be under control with other therapies • Treatment control transferred to
Slide 14: Regulatory Submission Strategy
Gevokizumab: Regulatory Submission Strategy Behçet's disease Non-infectious Non-infectious Other Other follow-on follow-on uveitis uveitis uveitis indications: indications EYEGUARD-B EYEGUARD-B Ophthalmology + + Scleritis Two Phase 2 Trials EYEGUARD-A and/ or Dermatology Supplemented w/ EYEGUARD-C P
Slide 15: Broad NIU Phase 3 EYEGUARD Study Designs
Gevokizumab: Broad NIU Phase 3 EYEGUARD Study Designs EYEGUARD-A EYEGUARD-C (XOMA & Servier) (XOMA & Servier) Active/Controlled Active Controlled # Patients 300 300 # Sites 140 140 Gevokizumab doses 30mg, 60mg 30mg, 60mg (Monthly SubQ) Placebo Placebo Randomization 1:1:1 1:1:1 Start date June 2012 O
Slide 16: Additional Ophthalmologic Opportunity - Anterior Scleritis
Gevokizumab: Additional Ophthalmologic Opportunity - Active, Non-infectious, Anterior Scleritis Scleritis is a chronic, painful inflammatory disease that affects the sclera (the white outer coating of the eye) - often associated with systemic autoimmune disorders • If left untreated, can lead to v
Slide 17: Pyoderma Gangrenosum (PG)
Gevokizumab: Pyoderma Gangrenosum (PG)
Slide 18: Pyoderma Gangrenosum: XOMA's Next Phase 3 Indication
Pyoderma Gangrenosum: XOMA’s Next Phase 3 Indication Severe inflammatory, ulcerative disease of the skin with undetermined cause • One of several indications collectively known as neutrophilic dermatoses • Claims data over past 3 years indicate U.S. pyoderma gangrenosum patient population of 11,00
Slide 19: Pyoderma Gangrenosum Subject 2300
Gevokizumab: Pyoderma Gangrenosum Subject 2300 DAY 0 DAY 84 1 1 Pain Ulcer Size: Day 0 Day 84 (0 - 10) Investigators Assessment of Target Ulcer ID Area (cm2) Area (cm2) D% Day 0 10 1 5.2 0 100 0: Total resolution of target ulcer with no sign Day 84 7 of active PG 19
Slide 20: Percent Clearance of Target Ulcer in PG Patients
Gevokizumab: Percent Clearance of Target Ulcer in Pyoderma Gangrenosum Patients Percent Ulcer Clearance 20
Slide 21: PG: Retreatment of Pilot Study Patients Produced Similar Results
Pyoderma Gangrenosum: Retreatment of Pilot Study Patients Produced Similar Results PG typically reoccurs in approx. 50% of patients within 1 year* Four of 6 patients from the pilot study entered follow-up • Three had fully healed at Day 84 • One had fully healed at Day 56, reopened due to injury
Slide 22: PG: Retreated Patients Obtained 100% Ulcer Closure
Pyoderma Gangrenosum: Retreated Patients Obtained 100% Ulcer Closure • Patient developed new ulcer at 7.5 months Day 28 • Obtained 100% ulcer closure prior to Day 56 • Continues in follow-up Day 0 Day 56 • Patient developed new ulcer at 7 months • Obtained 100% ulcer closure prior to Day 84 • Contin
Slide 23: Pyoderma Gangrenosum Phase 3 Program Study Designs
Gevokizumab: Pyoderma Gangrenosum Phase 3 Program Study Designs Pyoderma Gangrenosum U.S. Only U.S. & x-U.S. Phase 3 Studies (Study 172) (Study 173) # Patients 58 58 Gevokizumab doses 60mg : Placebo 60mg : Placebo (Monthly) Randomization 1:1 1:1 Primary endpoint Complete healing of target ulcer at a
Slide 24: XOMA Metabolic (XMet) Program
XOMA Metabolic (XMet) Program
Slide 25: Creating Value from XMet Discovery Program
Creating Value from XMet Discovery Program XMet A: selective insulin receptor modulator (SIRM) • May provide a long-acting alternative to basal insulin* • Data from non-human primates should be predictive and is being used for partnering discussions XMet S: insulin sensitizing antibodies • May e
Slide 26: XMetD Program: Antibodies Negatively Modulating the Insulin Receptor
XMetD Program: Monoclonal Antibodies which Negatively Modulate the Insulin Receptor Potential indications typified by excess insulin produced by the body Excess insulin results in hypoglycemia – high Insulin, low glucose • Diseases are opposite of diabetes – low insulin, high glucose Clinical
Slide 27: XOMA 358: A Negative Allosteric Modulator of the Insulin Receptor
XOMA 358: A Negative Allosteric Modulator of the Insulin Receptor Fully-human IgG2 mAb to the insulin receptor which inhibits insulin action with potential in several indications Congenital Hyperinsulinism (CHI) • Due to unregulated secretion of insulin from pancreatic beta-cells leading to severe
Slide 28: XOMA 358: First-in-Human Study Overview
XOMA 358: First-in-Human Study Overview Phase 1, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of XOMA 358 in healthy adult male subjects Ascending doses of 0.1, 0.3, 1 and 3 mg/kg 3mg/kg dose provided n
Slide 29: XOMA 358: Blocks Exogenous and Endogenous Insulin Signaling
XOMA 358: Blocks Exogenous and Endogenous Insulin Signaling in Human subjects INSULIN TOLERANCE TEST 2-hr POST PRANDIAL GLUCOSE (Following 3mg/kg IV infusion) (Day 3) Insulin Administration 28
Slide 30: Building Value Through Development Activities
Building Value Through Development Activities Pre- Compound Indication Phase 1 Phase 2 Phase 3 Marketed clinical XOMA’s Development Programs Gevokizumab Non-infectious uveitis (NIU) – EYEGUARD-A & -C Behçet's disease uveitis (BDU) – EYEGUARD-US Pyoderma gangrenosum (PG) Erosive osteoarthritis of the
Slide 31: Financial Highlights
Financial Highlights $78.4 million cash at December 31, 2014 Approximately 116 million shares outstanding 31
Slide 32: Investment Thesis – Committed to Become a U.S. Commercial Company
Investment Thesis – Committed to Become a U.S. Commercial Company Complete gevokizumab global Phase 3 program in Behçet's disease uveitis (BDU) and non-infectious uveitis (NIU) • EYEGUARD-B data may allow a “Behçet's first” BLA submission • EYEGUARD-US study to supplement a BLA submission • EYEGUA
Slide 33: XOMA
XOMA