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Corporate Presentation September 2014 Corporate Presentation September 2014.

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Presentation on theme: "Corporate Presentation September 2014 Corporate Presentation September 2014."— Presentation transcript:

1 Corporate Presentation September 2014 Corporate Presentation September 2014

2 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 of approved products, regulatory approval of unapproved product candidates, sufficiency of our cash resources and anticipated levels of cash utilization, or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement herein represents XOMA’s views only as of the date of this presentation and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. 2

3 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) 3 Disruption of disease-causing inflammatory cascade IL-1β binds to IL-1β Receptor Inflammatory diseases induced through over-produced IL-1β by multiple Immune system cells Gevokizumab binds to IL-1β and down-modulates IL-1β signaling

4 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) –Report top-line results from EYEGUARD-B, Behçet's uveitis patients, approximately 6 weeks after achieving the target event –EYEGUARD-A and EYEGUARD-C studies in broad NIU population - results will follow Launch Phase 3 studies in next pivotal indication: pyoderma gangrenosum Use expansive proof-of-concept (POC) program to let gevokizumab lead us to next diseases for pivotal development –Multiple indications in POC testing at XOMA –Leveraging Servier’s development in additional POC indications 4

5 XOMA: Value Creation and Value Capture  Capture value for XOMA by commercializing gevokizumab directly in the U.S. Deal with Servier retains XOMA U.S. and Japanese commercial rights for gevokizumab Select indications served by specialty physicians to enable direct commercialization by XOMA in the U.S. Leverage Servier commercialization outside the U.S. and Japan; milestones and royalties to XOMA License gevokizumab to a Japanese development and commercialization partner  Use gevokizumab success to advance additional XOMA discoveries 30 years of leadership in antibody discovery and development Sizeable portfolio of potential antibodies to explore 5

6 Gevokizumab: Pipeline in a Product Indication Pre- clinical Phase 1 Phase 2 Phase 3 Upcoming Milestones XOMA’s Development Programs Non-infectious uveitis (NIU) – EYEGUARD™-A & -C* 2014/2015: Ph 3 Endpoints Pyoderma gangrenosum (PG) Comments on final protocols received Multiple POC Programs As Occurring Servier’s Development Programs Behçet's uveitis - EYEGUARD-B Q3 14: Ph 3 Endpoint Cardiovascular Ongoing Multiple POC programs As Occurring 6 *Worldwide development by both XOMA and Servier

7 Gevokizumab: Non-infectious Uveitis (NIU)

8 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 patients in U.S. is significant market opportunity yet retains orphan status (granted)  Multiple etiologies Behçet's uveitis is representative of multiple forms 8

9 Gevokizumab: Clinical Activity in XOMA’s First Phase 2 Trial of Behçet's Subset of NIU  7 of 7 patients showed rapid treatment effect for intraocular inflammatory attack  5 of 5 responded to second dose 9 Day 0: Day 1: Day 4: Flare score: 467 ph/msec * Anterior chamber cell: 4+ Vitreous haze: 3+ Fundus score: 8 Flare score: 45 ph/msec Anterior chamber cell: 4+ Vitreous haze: 3+ Fundus score: 4 Flare score: 62 ph/msec Anterior chamber cell: 4+ Vitreous haze: 2+ Fundus score: 4 hypopyon off-center iris * photon counts per millisecond

10 Gevokizumab: Phase 2 Behçet's Uveitis Studies Clearance of Vitreous Haze 10 Day 0 - Vit. Haze: 3+  Servier’s study in 21 patients with Behçet's uveitis patients included 15 patients with acute disease All responded to gevokizumab - most within 1 week Of 11 acute patients with a baseline vitreous haze score of ≥ 2+, 8 showed at least a 2-unit reduction at Day 70, remaining 3 had at least a 1-unit reduction 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  Patient from XOMA 7-patient Phase 2 study

11 Gevokizumab: Phase 3 EYEGUARD™ Program Study Designs 11 EYEGUARD-A (XOMA) EYEGUARD-B (SERVIER) EYEGUARD-C (XOMA) Active/ControlledActiveControlled # Patients300Up to 110300 # Sites14044140 Gevokizumab doses (Monthly) 30mg, 60mg Placebo 60mg Placebo 30mg, 60mg Placebo Randomization1:1:11:11:1:1 Start dateJune 2012September 2012October 2012 Estimated primary endpoint achievement Year-end 2014Q3 2014Early 2015

12 Gevokizumab: EYEGUARD-B Study Design and Status  Ex-U.S. Behçet's uveitis patients, randomized, double-masked  Receive 60mg gevokizumab or placebo subcutaneously monthly Randomized 1:1  Patients must be stable on corticosteroids prior to randomization  Steroids further tapered according to a pre-set fixed schedule  Primary endpoint is time to first exacerbation which is interpolated from Kaplan-Meier survival analysis  Hazard ratio of 0.3 gives ninety percent power at p≤ 0.05 12

13 Gevokizumab: Driving Toward First BLA in Behçet’s Uveitis  EYEGUARD-B results are expected first Servier reached targeted enrollment in Q2 Waiting for final pre-specified exacerbations  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 results  Initiate EYEGUARD-US study in up to 28 Behçet's uveitis patients to further supplement overall results May not be necessary for approval Interim results may be used for informational purposes Pivotal results may be required for approval 13

14 Gevokizumab: EYEGUARD-US Behçet’s Uveitis Supplemental Study  Enrolling patients with either active or controlled Behçet’s Uveitis Patients with active disease are brought under control with gevokizumab (open label)  Patients can be under control with other therapies Treatment control transferred to gevokizumab –From Infliximab (anti-TNF-a) –From Prednisone and/or other immunosuppressives  Once patients are controlled on gevokizumab for 28 days - Half of the patients continue to receive monthly 60mg subcutaneous treatment with gevokizumab Half of the patients receive placebo  Primary Endpoint is time to first ocular exacerbation 14

15 Gevokizumab: Pyoderma Gangrenosum (PG)

16 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 11,000 - 14,000 Typically takes >11 months to fully heal with corticosteroids* Orphan Drug Designation granted by FDA: February 2014  6 patients enrolled in pilot study at 60mg dose 5 patients showed improvement in ulcer size by Day 28 – 4 patients had total resolution of ulcer by Day 84 All patients demonstrated pain improvement 16 *Bennett ML et al. “Pyoderma gangrenosum. A comparison of typical and atypical forms with an emphasis on time to remission. Case review of 86 patients from 2 institutions.” Medicine (Baltimore) Jan;79(1):37-46. PMID: 10670408

17 DAY 0 DAY 84 1 Gevokizumab: Pyoderma Gangrenosum Subject 2300 Day 0Day 84 IDArea (cm 2 )  15.20100 Ulcer Size: Pain (0 - 10)Investigators Assessment of Target Ulcer Day 010 Day 847 0: Total resolution of target ulcer with no sign of active PG 1 17

18 DAY 0 DAY 84 1 1 Day 0Day 84 IDArea (cm 2 )  1160100 Ulcer Size: Pain (0 - 10)Investigators Assessment of Target Ulcer Day 04 Day 840 0: Total resolution of target ulcer with no sign of active PG Gevokizumab: Pyoderma Gangrenosum Subject 2802 18

19 Gevokizumab: Percent Clearance of Target Ulcer in Pyoderma Gangrenosum Patients 19

20 Gevokizumab: Pyoderma Gangrenosum Phase 3 Program Study Designs 20 Pyoderma Gangrenosum Phase 3 Studies U.S. Only (Study 172) U.S. & x-U.S. (Study 173) # Patients58 Gevokizumab doses (Monthly) 60mg : Placebo Randomization1:1 Primary endpointComplete healing of target ulcer at approximately Day 124 Secondary endpointsMultiple, including time to ulcer closure and pain Statistical Powering80%; p=0.05

21 XOMA Metabolic (XMet) Program

22 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 enable more effective use of own insulin for early stage diabetics Mouse model has shown a 20x increase in sensitivity to insulin  XMet D: antagonist (deactivator) of the insulin receptor 3 potential rare disease indications to be evaluated: –Congenital Hyperinsulinism (CHI) –Insulinomas –Hyperinsulinemic Hypoglycemia Post Gastric Bypass Surgery Patients concentrated in a few centers nationwide - development could be rapid IND to be filed in 2014 22 *Vigneri, R., Squatrito, S., Frittitta, L., Diabetes May 2012

23 Building Value Through Development Activities CompoundIndication Pre- clinical Phase 1 Phase 2 Phase 3 Marketed XOMA’s Development Programs GevokizumabNon-infectious uveitis (NIU) – EYEGUARD-A & -C Pyoderma gangrenosum (PG) Erosive osteoarthritis of the hand (EOA) Moderate-to-severe acne Non-infectious scleritis Autoimmune inner ear disease (AIED) XMet DExcess insulin – Rare disease indications Servier’s Development Programs GevokizumabBehçet's uveitis - EYEGUARD-B Cardiovascular Polymyositis/dermatomyositis Schnitzler syndrome Giant cell arteritis (GCA) XOMA Development Activities for Licensure XMet AType 1 & 2 diabetes mellitus XMet SType 2 diabetes mellitus 23

24 Financial Highlights  $75.9 million cash at June 30, 2014  Approximately 107 million shares outstanding 24

25 Investment Thesis – Committed to Become a U.S. Commercial Company  Complete gevokizumab global Phase 3 program in non-infectious uveitis (NIU) clinical trials EYEGUARD-B data may allow a “Behçet's first” BLA submission Initiate EYEGUARD-US study to supplement Behçet's uveitis BLA submission EYEGUARD-A and -C may expand label to broader NIU population  Launch gevokizumab pyoderma gangrenosum pivotal program  Assess gevokizumab’s potential in additional inflammatory indications through POC program  Advance proprietary allosteric modulating antibody pipeline towards an IND and commercialization or licensure, particularly XMet platform  Use gevokizumab to build XOMA into a fully integrated company with a commercial capability 25

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