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Corporate Presentation September 2014. Forward-looking Statements.

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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 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.

xoma value creation and value capture
XOMA: Value Creation and Value Capture

Inflammatory diseases induced through

over-produced IL-1β by multiple Immune system cells

Disruption of

disease-causing inflammatory cascade

IL-1β binds to

IL-1β Receptor

Gevokizumab binds to IL-1β and


IL-1β signaling

  • 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)
xoma value creation and value capture1
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
xoma value creation and value capture2
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
gevokizumab pipeline in a product
Gevokizumab: Pipeline in a Product

*Worldwide development by both XOMA and Servier

gevokizumab 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 patients in U.S. is significant market opportunity yet retains orphan status (granted)
  • Multiple etiologies
    • Behçet's uveitis is representative of multiple forms
gevokizumab clinical activity in xoma s first phase 2 trial of beh et s subset of niu
Gevokizumab: Clinical Activity in XOMA’s First Phase 2 Trial of Behçet's Subset of NIU


off-center iris

* photon counts per millisecond

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

7 of 7 patients showed rapid treatment effect for intraocular inflammatory attack

5 of 5 responded to second dose

gevokizumab phase 2 beh et s uveitis studies clearance of vitreous haze
Gevokizumab: Phase 2 Behçet's 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 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
gevokizumab eyeguard b study design and status
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
gevokizumab driving toward first bla in beh et s uveitis
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
gevokizumab eyeguard us beh et s uveitis supplemental study
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
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 11,000 - 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

*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

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 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

*Vigneri, R., Squatrito, S., Frittitta, L., Diabetes May 2012

financial highlights
Financial Highlights

$75.9 million cash at June 30, 2014

Approximately 107 million shares outstanding

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 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