Best-in-Class Anti-Infectives
Forward Looking Statements
Statements made in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited
to, statements regarding Trius’ ability to successfully complete its ongoing clinical trials and development programs, the expected timing
for reporting of top-line data for the TR701-113 study, Trius’ ability to obtain regulatory approval for tedizolid, market penetration and
acceptance of tedizolid and the initiation of clinical studies for Trius’ Gyrase B program. Risks that contribute to the uncertain nature of
the forward-looking statements include: Trius’ future preclinical studies and clinical trials may not be successful; changes in regulatory
requirements in the United States and foreign countries may prevent or significantly delay regulatory approval of Trius’ products; Trius
may change its plans to develop and commercialize its product candidates; the FDA may not agree with Trius’ interpretation of the data
from recently-completed clinical trials of tedizolid; Trius may decide, or the FDA may require Trius, to conduct additional clinical trials or
to modify Trius’ ongoing clinical trials; Trius may experience delays in the commencement, enrollment, completion or analysis of clinical
testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical
trials, which could result in increased costs and delays, or limit Trius’ ability to obtain regulatory approval; the third parties with whom
Trius has partnered with for the development of tedizolid and upon whom Trius relies to conduct its clinical trials and manufacture its
product candidates may not perform as expected; tedizolid may not receive regulatory approval or be successfully commercialized;
unexpected adverse side effects or inadequate therapeutic efficacy of tedizolid could delay or prevent regulatory approval or
commercialization; Trius’ may be unable to obtain and maintain intellectual property protection for its product candidates; the loss of key
scientific or management personnel; Trius’ ability to obtain additional financing; and the accuracy of Trius’ estimates regarding
expenses, future revenues and capital requirements. These and other risks and uncertainties are described more fully in Trius’ most
recent Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those
factors discussed under the caption “Risk Factors” in such filings. All forward-looking statements contained in this press release speak
only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or
circumstances that exist after the date on which they were made.

Trius has filed a registration statement (including a base prospectus) with the United States Securities and Exchange Commission for
the offering to which this communication relates. Before you invest, you should carefully review the prospectus supplement and the
accompanying prospectus, together with the information incorporated by reference therein, as well as any free writing prospectus that
Trius or the underwriters provide you in connection with the offering, for more information about Trius and the offering. Trius files annual
reports, quarterly reports and other documents with the Securities and Exchange Commission. You should read the documents we
have filed with the Securities and Exchange Commission for more complete information about Trius. You may get these documents for
free by visiting EDGAR on the Securities and Exchange Commission web site at www.sec.gov, or by visiting the Trius Therapeutics’
website at www.triusrx.com.

                                                                                                                                                  2
Record of Successful Execution
                       All Efficacy and Safety Objectives Achieved
                       •    Unsurpassed efficacy & improved safety with shorter
112 Trial Successful        course of therapy and better convenience
                       •    Successful efficacy and safety results triggered $5M
                            milestone payment from Bayer
                       Enrollment on track
 113 Trial Enrolling   •    Top line data expected early 2013


                       Asia-Pacific/Emerging Markets
                       •    A strong partner with comprehensive development
     Bayer Deal             and commercial infrastructure in Asia
                       •    Accelerates development in skin and lung infections
                            globally

                       Funded through Phase 1 by $28M NIAID Contract
GyrB Gram Program      •    Broad spectrum potency goals achieved
                       •    IND enabling studies underway


                                                                                   3
Trius Pipeline

      Tedizolid Development Program Matched with Market Opportunity

 Product and                 Dosage   Discovery /
 Target Indications           Form    Pre-Clinical   Phase 1   Phase 2   Phase 3

                             Oral
 Tedizolid Phosphate
 ABSSSI                       IV/
                              Oral


 Tedizolid Phosphate          IV/
                              Oral
 HAP/VAP
 Tedizolid Phosphate          IV/
                              Oral
 Bacteremia
 GyrB/ParE
 Drugs for Gram-Negative       IV
 Infections
 Marine Natural Products
 Drugs for Gram-Positive &     IV
 Gram-Negative Infections

                                                                                   4
Gram Positive Market Has Doubled in Value
Market has grown to over $2.5B globally ($1.5B in USA) with declining Vancomycin
susceptibility contributing to growth of branded agents

          U.S. Sales 2005 – $700MM                                      U.S. Sales 2011 - $1.68B
                                                                                                       Vibativ
                                                                                                    (Telavancin)
                                                                                     Vancomycin         $10M*
         Tygacil
      (Tigecycline)                                                           Tygacil (Generic)
         $10MM         Vancomycin                                                      $186MM*
                                                                           (Tigecycline)
                        (Generic)                                            $148MM
                         $137MM

                Cubicin                                                                              Zyvox
             (Daptomycin)
                                                                                                  (Linezolid)
               $114MM            Zyvox
                                                                                                   $640MM
                              (Linezolid)                                     Cubicin
                               $437MM                                      (Daptomycin)
                                                                             $699MM




                                   18% CAGR in Branded Sales from 2005-2011
                            Each market share point for a branded agent is worth $50MM

Source: Company Reports / IMS-National Sales Perspectives; *=Estimate                                              5
Tedizolid Combining the Strength of Current Products



                                   Generic

Attribute              Linezolid   Vancomycin   Daptomycin   Tedizolid

IV/Oral


In-Vivo Bactericidal

Active in Lung
Infections

Once Daily Treatment

Short Course of
Therapy




                                                                         6
Market Research Indicates Formulary Acceptance
 For Core Indications


                          Priced at Parity Per Course of                                            Priced at Significant Premium Per
                                Therapy to Zyvox                                                       Course of Therapy to Zyvox
          cSSSi




                                                                                        cSSSi
                                    60%                        40%                                       30%                 40%              30%
    Pneumonia




                                                                                  Pneumonia
    (HAP/VAP)




                                                                                  (HAP/VAP)
                                          80%                        20%                                         50%               20%        30%
    Endocarditis /




                                                                                  Endocarditis /
     Bacteremia




                                                                                   Bacteremia
                                   50%                   40%           10%                               30%                 40%              30%



                     0%       20%         40%      60%         80%         100%                    0%       20%        40%         60%      80%       100%

                     Very Likely     Moderately Likely    Not At All Likely                        Very Likely     Moderately Likely     Not At All Likely



                                     Based upon the response of 10 HMO/PBMS and 10 Formulary Directors

PG Decision Metrics market research of 10 Formulary Directors & 10 HMO/PBMs. Commissioned by Trius in 2009                                                   7
…and Good Placement of the Oral Formulation
 in the Outpatient Setting


             Priced at Parity Per Course of                                        Priced at Significant Premium Per
                   Therapy to Zyvox                                                   Course of Therapy to Zyvox


    100%                                                                   100%
                                     90%                                                                         90%
     90%                                                                    90%
     80%                                                                    80%
     70%                                                                    70%
     60%                                                                    60%
     50%                                                                    50%
     40%                                                                    40%
     30%                                                                    30%
     20%                                                                    20%
                                                      10%                                            10%
     10%                                                                    10%
                    0%                                                                   0%
       0%                                                                     0%
                  Tier 1           Tier 2            Tier 3                            Tier 1       Tier 2      Tier 3


                                         Based upon the response of 10 HMO/PBMS


PG Decision Metrics market research of 10 HMO/PBMs. Commissioned by Trius in 2009.                                       8
Tedizolid Phosphate Phase 3 Study Design:
 Oral (112) and IV/Oral (113) Trials Under SPA


                 FDA and EMA Endpoints for Global Registration

                                                  Safety Analyses
 Patient
Screening
                    6-Days Tedizolid QD     4-Days Placebo
                                                                 Post Treatment
667
                                                                   Evaluations
 Randomization      10-Days Linezolid BID


             Baseline


                                                            FDA          EMA          EMA
                         FDA Primary Endpoint            Secondary     Primary     Secondary
                        48-72 hrs from Baseline          Endpoints   Endpoint at    Endpoint
                                                           at EOT        PTE          LFU



                                                                                               9
Primary Outcome: All Current and Contemplated Trial 112
Primary Endpoints Achieved in Pre-Specified Analyses

     Primary Outcome at 48-72 hour visit                                             Treatment


       Lesion Criteria                                                     Tedizolid            Linezolid
                                           Fever Criteria              (200 mg QD 6 days)   (600 mg BID 10 days)

 112 SPA Primary Endpoint          Temperature measurements
No increase in lesion area          required within 24 hrs of                79.5%                79.4%
from baseline*                           48-72 hr visit*

      FNIH recommended to FDA to exclude temperature as a component of the primary endpoint
                    and to assess a >20% reduction in lesion size at 48 to 72 hours.
    Under these pre-specified analysis tedizold shows additional numerical separation from linezolid


No increase in lesion area
from baseline                        Temperature excluded**                  87.0%                85.4%


FNIH Primary Endpoint
≥ 20% reduction of lesion            Temperature excluded**                  78.0%                76.1%
are from baseline**

* Primary endpoint as agreed to under Study 112 and 113 SPA
** FNIH recommendations to FDA: ABSSSI Docket ID: FDA--2010--D--0433
                                                                                                                   10
Secondary Outcomes: Tedizolid Demonstrates
    Comparable Efficacy with Shorter Course of Therapy

         Secondary Outcome at EOT or PTE                                                   Treatment


       Secondary Outcome                                                         Tedizolid            Linezolid
                                                   Criteria                  (200 mg QD 6 days)   (600 mg BID 10 days)

              112 SPA                                                            69.3% (ITT)          71.9% (ITT)
                                         Early clinical failures carried
    Clinical Response at EOT*
                                                forward to EOT*
              (Day 11)                                                           80.2% (CE)            81.1% (CE)


    In August 2010 draft guidance the FDA adopted changes to the secondary outcomes of clinical response
     at the end of therapy (EOT). These were prospectively measured in Study 112 sensitivity analyses and
                                      are captured in the Study 113 SPA.


                                                                                 80.7% (ITT)          80.9% (ITT)
    Clinical Response at EOT*          Early clinical failures not carried
              (Day 11)                          forward to EOT**
                                                                                 87.5% (CE)            87.1% (CE)

                                       Early clinical failures not carried       87.0% (ITT)          87.8% (ITT)
              113 SPA
                                             forward to EOT** and
    Clinical Response at EOT*            presence/absence of patient
              (Day 11)                reported pain at EOT excluded*/**          94.5% (CE)            95.1% (CE)

*  Primary and secondary endpoints as agreed to under Study 112 SPA
** Consistent with FDA draft ABSSSI Guidance for Industry (August 2010)
                                                                                                                         11
Tedizolid was Well Tolerated with a Favorable AE
Profile Compared to Linezolid
Tedizolid had a numerically lower rate of drug-related treatment emergent adverse events
(TEAE) and a statistically significant lower number of gastrointestinal adverse events


                                         Tedizolid                      Linezolid
   Adverse Event
                                    (200 mg QD 6 Days)             (600 mg BID 10 Days)

   Any Treatment Emergent
                                            40.8%                           43.3%
   Adverse Event (TEAE)


   Any Drug Related TEAE                    24.2%                           31.0%


   Gastrointestinal
                                           16.3%**                          25.4%
   Disorders*

           * Gastrointestinal AEs include: Diarrhea, Nausea, Vomiting and Dyspepsia
           ** Statistically significant (p=0.004).

                        No Unexpected Safety Signals
                            •  Liver enzymes/function tests
                            •  QTc
                                                                                           12
Hematology: Tedizolid Had Significantly Lower Impact
on Platelets than Linezolid




                                           Percent of Patients with Value below the
                                                Lower Limit of Normal (LLN)

                                          Tedizolid                     Linezolid
  Hematology Parameter
                                      (200mg QD 6 days)            (600mg BID 10 days)

  Platelets*
                                               9.2%                       14.9%
  Below LLN

  Platelets – Substantially
  Abnormal Value                               2.3%                       4.9%
  (<75% LLN)

   * Statistically significant (p=0.038)




                                                                                         13
Phase 3 Trial Summary

   £    Study 112 design and outcomes are consistent with both FDA and EMA
         regulatory requirements

   £    All efficacy and safety objectives of Study 112 were successfully
         achieved
          –  Efficacy: All primary and secondary trial endpoints met with a once-daily
             short course of therapy
          –  Safety: statistically significant lower incidence in key tolerability and
             safety parameters
          –  Successful results triggered $5M milestone payment from Bayer

   £    Results align with surveyed physician and payer preferences for fast
         acting drugs with improved tolerability and safety*




* PG Decision Metrics market research of 10 Formulary Directors & 10 HMO/PBMs. Commissioned by Trius in 2009
AMR – Hospital Insight Series, US Data, August 2011
Hawk Partners - Target Product Profile Research with 29 US Physicians. Commissioned by Trius, Sept 2011

                                                                                                               14
Bayer Strategic Collaboration for Asia-Pacific and
Emerging Markets




                          Exclusive license to develop and
Retains rights to                                              Obtains key asset for
                          commercialize tedizolid in Asia,
largest commercial                                             largest therapeutic
                        Africa, Latin America and the Middle   area in licensed
opportunity                        East (ex-Korea)             territory
Trius leads
                                                               Responsible for all
development of global   $25M upfront                           independent regional
clinical studies                                               development
                        $69M in development, regulatory
Enables early           and commercial milestones              Responsible for all
execution of ex-U.S.                                           marketing activities in
commercial strategy                                            its territory
                        25% of the future development costs
                        in ABSSSI and pneumonia


                               Double digit royalties


                                                                                         15
Gyrase-B Program: Novel Class of Broad Spectrum Antibiotics

  £    Funded through Phase 1 by $28MM NIAID Contract
  £    Lead molecules have potent activity against gram-negative and
        gram-positive bacterial pathogens
         £    including MRSA, ESBL strains, Pseudomonas, Acinetobacter & Klebsiella
               (including NDM1)
  £    Efficacy demonstrated in multiple animal models
         £    Lung, urinary tract, thigh, septicemia
  £    Clean nonclinical toxicity and no CYP450 interactions
         £    Including dog CV telemetry study up to 10x efficacious drug exposure.
               No effect on all CV parameters (Qtc, HR, BP etc.).
  £    Clinical studies expected to start 2012




                                                                                       16
Evolution of MICs in Lead Series Against Gram Negative
and Gram Positive Pathogens



                       Antibacterial Potency MIC (µg/mL)
 Adverse Event                 1491         1710           1722    1852

 S. aureus                     0.008        0.008          0.008   0.008

 S. pneumoniae                 0.008        0.008          0.008   0.004

 E. coli (wt)                   0.25        0.13           0.25    0.13

 K. pneumoniae (MDR)             2           2              2       1

 A. baumannii                   0.50        0.25           0.50    0.25

 P. aeruginosa (wt)              4           2              1      0.50




   Gram +        Gram —

                                                                           17
MIC90 of GyrB/ParE Development Candidate vs
Comparators against Gram-Positive Pathogens

                                                    MIC90	
  of	
  TR-­‐1852	
  vs.	
  G+	
  isolates	
  

                                                                        >16	
  



                                   16	
  
                                                                                            >4	
                        >4	
                          >4	
  
                                   14	
  

                                   12	
  
                                                                8	
  
            MIC90	
  (µg/ml)	
  




                                                                                  4	
  
                                    10	
                                                                                                      4	
  
                                                                                                                2	
  
                                       8	
  
                                                                                                                                                                       ciprofloxacin	
  
                                       6	
                                                           0.25	
                          1	
                           linezolid	
  
                                        4	
                                                                                  2	
  
                                                                                          0.5	
                                                                vancomycin	
  
                                        2	
        ≤0.001	
  
                                                                           ≤0.001	
                                                                    daptomycin	
  
                                         0	
                                                                    0.03	
  
                                                                                                                                             TR-­‐1852	
  




                                            Number of isolates is shown in parentheses


                                                                                                                                                                                          18
MIC90 of GyrB/ParE Development Candidate vs
Comparators against Gram-Negative Pathogens




                      **
                                                                   *
                                                                                                                ***




  *	
  Includes	
  ESBL	
  isolates	
  
  **	
  includes	
  	
  MDR,	
  ESBL	
  isolates	
  
  ***	
  includes	
  ESBL,	
  NDM-­‐1,	
  KPC-­‐2,	
  KPC-­‐3,	
  and	
  randomly	
  selected	
  isolates	
  


                                                                                                                      19
P. aeruginosa MIC90 Results for TR-1852 (50 strains)


                                                                                        P.	
  aeruginosa	
  MIC90	
  panel	
  
                                100	
  
                                                   MIC90 = 1 µg/mL
                                  90	
  


                                  80	
  


                                  70	
  
%	
  strains	
  cumulaKve	
  




                                  60	
                                                                                                                           1852	
  

                                                                                                                                                                 Cefepime	
  
                                  50	
  
                                                                                                                                                                 Cipro	
  

                                                                                                                                                                 Gent	
  
                                  40	
  
                                                                                                                                                                 Imipenem	
  

                                  30	
  


                                  20	
  


                                  10	
  


                                    0	
  
                                            0.06	
     0.125	
     0.25	
     0.5	
      1	
        2	
     4	
     8	
     16	
     32	
     64	
     128	
  

                                                                                                 MIC value µg/mL
                                                                                                                                                                                20
E. coli Mouse Urinary Tract Infection Model

                                       Mouse Ascending UTI Model − E. coli
                                              Drugs Dosed IV 10 mg/kg/day
                               7
                                                                                    Bladder
  Average Log10 CFU/g Tissue




                               6
                                                                                    Kidney
                               5
                               4
                               3
                               2
                               1
                               0
                                   C   1852       Levo                 C     1852     Levo




                                                                                              21
Safety Summary: Clean In-Vitro & In-Vivo to Date


£    No CYP450 inhibition – low drug-drug interaction potential
£    No Relevant Off-Target Enzyme Activities – bacterial selective
£    No Genotoxicity Signals (human cell line)
£    Clean in Dog Cardiovascular Study – all parameters including QTc
£    Single Dose MTD in Mice & Rats >100 mg/kg
£    Rat Chronic 14 Day Dose NOAEL ~50 mg/kg*
      –  Therapeutic Margin Estimate (~13x)**




*Pending histopathology, based on gross necropsy, blood biochemistry & hematology
**AUC @ NOAEL dose/AUC @ efficacious dose
                                                                                    22
Capitalization


    Cash & Equivalents (at 9-30-11)                                          $70MM


    Long Term Debt (at 9-30-11)                                               $0MM


    Federal Contracts Awarded                                                $60MM


    Shares Outstanding                                                     38.6MM


    Market Capitalization (at 2-10-12)                                     $211MM


    Cash Runway*                                                           Q3 2013


  * Assumes initiation of global HAP study in 2013 and no additional partnerships



                                                                                     23
Upcoming Goals


 §    Potential European partnership


 §    Regulatory agreement enabling initiation of Phase 3 pneumonia study


 §    IND filing for Gyrase clinical candidate


 §    Completion of enrollment for 113 Phase 3 ABSSSI trial




                                                                             24
Best-in-Class Anti-Infectives

Trius Therapeutics Bio CEO & Investor Conference

  • 1.
  • 2.
    Forward Looking Statements Statementsmade in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trius’ ability to successfully complete its ongoing clinical trials and development programs, the expected timing for reporting of top-line data for the TR701-113 study, Trius’ ability to obtain regulatory approval for tedizolid, market penetration and acceptance of tedizolid and the initiation of clinical studies for Trius’ Gyrase B program. Risks that contribute to the uncertain nature of the forward-looking statements include: Trius’ future preclinical studies and clinical trials may not be successful; changes in regulatory requirements in the United States and foreign countries may prevent or significantly delay regulatory approval of Trius’ products; Trius may change its plans to develop and commercialize its product candidates; the FDA may not agree with Trius’ interpretation of the data from recently-completed clinical trials of tedizolid; Trius may decide, or the FDA may require Trius, to conduct additional clinical trials or to modify Trius’ ongoing clinical trials; Trius may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Trius’ ability to obtain regulatory approval; the third parties with whom Trius has partnered with for the development of tedizolid and upon whom Trius relies to conduct its clinical trials and manufacture its product candidates may not perform as expected; tedizolid may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of tedizolid could delay or prevent regulatory approval or commercialization; Trius’ may be unable to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; Trius’ ability to obtain additional financing; and the accuracy of Trius’ estimates regarding expenses, future revenues and capital requirements. These and other risks and uncertainties are described more fully in Trius’ most recent Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in such filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Trius has filed a registration statement (including a base prospectus) with the United States Securities and Exchange Commission for the offering to which this communication relates. Before you invest, you should carefully review the prospectus supplement and the accompanying prospectus, together with the information incorporated by reference therein, as well as any free writing prospectus that Trius or the underwriters provide you in connection with the offering, for more information about Trius and the offering. Trius files annual reports, quarterly reports and other documents with the Securities and Exchange Commission. You should read the documents we have filed with the Securities and Exchange Commission for more complete information about Trius. You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission web site at www.sec.gov, or by visiting the Trius Therapeutics’ website at www.triusrx.com. 2
  • 3.
    Record of SuccessfulExecution All Efficacy and Safety Objectives Achieved •  Unsurpassed efficacy & improved safety with shorter 112 Trial Successful course of therapy and better convenience •  Successful efficacy and safety results triggered $5M milestone payment from Bayer Enrollment on track 113 Trial Enrolling •  Top line data expected early 2013 Asia-Pacific/Emerging Markets •  A strong partner with comprehensive development Bayer Deal and commercial infrastructure in Asia •  Accelerates development in skin and lung infections globally Funded through Phase 1 by $28M NIAID Contract GyrB Gram Program •  Broad spectrum potency goals achieved •  IND enabling studies underway 3
  • 4.
    Trius Pipeline Tedizolid Development Program Matched with Market Opportunity Product and Dosage Discovery / Target Indications Form Pre-Clinical Phase 1 Phase 2 Phase 3 Oral Tedizolid Phosphate ABSSSI IV/ Oral Tedizolid Phosphate IV/ Oral HAP/VAP Tedizolid Phosphate IV/ Oral Bacteremia GyrB/ParE Drugs for Gram-Negative IV Infections Marine Natural Products Drugs for Gram-Positive & IV Gram-Negative Infections 4
  • 5.
    Gram Positive MarketHas Doubled in Value Market has grown to over $2.5B globally ($1.5B in USA) with declining Vancomycin susceptibility contributing to growth of branded agents U.S. Sales 2005 – $700MM U.S. Sales 2011 - $1.68B Vibativ (Telavancin) Vancomycin $10M* Tygacil (Tigecycline) Tygacil (Generic) $10MM Vancomycin $186MM* (Tigecycline) (Generic) $148MM $137MM Cubicin Zyvox (Daptomycin) (Linezolid) $114MM Zyvox $640MM (Linezolid) Cubicin $437MM (Daptomycin) $699MM 18% CAGR in Branded Sales from 2005-2011 Each market share point for a branded agent is worth $50MM Source: Company Reports / IMS-National Sales Perspectives; *=Estimate 5
  • 6.
    Tedizolid Combining theStrength of Current Products Generic Attribute Linezolid Vancomycin Daptomycin Tedizolid IV/Oral In-Vivo Bactericidal Active in Lung Infections Once Daily Treatment Short Course of Therapy 6
  • 7.
    Market Research IndicatesFormulary Acceptance For Core Indications Priced at Parity Per Course of Priced at Significant Premium Per Therapy to Zyvox Course of Therapy to Zyvox cSSSi cSSSi 60% 40% 30% 40% 30% Pneumonia Pneumonia (HAP/VAP) (HAP/VAP) 80% 20% 50% 20% 30% Endocarditis / Endocarditis / Bacteremia Bacteremia 50% 40% 10% 30% 40% 30% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Very Likely Moderately Likely Not At All Likely Very Likely Moderately Likely Not At All Likely Based upon the response of 10 HMO/PBMS and 10 Formulary Directors PG Decision Metrics market research of 10 Formulary Directors & 10 HMO/PBMs. Commissioned by Trius in 2009 7
  • 8.
    …and Good Placementof the Oral Formulation in the Outpatient Setting Priced at Parity Per Course of Priced at Significant Premium Per Therapy to Zyvox Course of Therapy to Zyvox 100% 100% 90% 90% 90% 90% 80% 80% 70% 70% 60% 60% 50% 50% 40% 40% 30% 30% 20% 20% 10% 10% 10% 10% 0% 0% 0% 0% Tier 1 Tier 2 Tier 3 Tier 1 Tier 2 Tier 3 Based upon the response of 10 HMO/PBMS PG Decision Metrics market research of 10 HMO/PBMs. Commissioned by Trius in 2009. 8
  • 9.
    Tedizolid Phosphate Phase3 Study Design: Oral (112) and IV/Oral (113) Trials Under SPA FDA and EMA Endpoints for Global Registration Safety Analyses Patient Screening 6-Days Tedizolid QD 4-Days Placebo Post Treatment 667 Evaluations Randomization 10-Days Linezolid BID Baseline FDA EMA EMA FDA Primary Endpoint Secondary Primary Secondary 48-72 hrs from Baseline Endpoints Endpoint at Endpoint at EOT PTE LFU 9
  • 10.
    Primary Outcome: AllCurrent and Contemplated Trial 112 Primary Endpoints Achieved in Pre-Specified Analyses Primary Outcome at 48-72 hour visit Treatment Lesion Criteria Tedizolid Linezolid Fever Criteria (200 mg QD 6 days) (600 mg BID 10 days) 112 SPA Primary Endpoint Temperature measurements No increase in lesion area required within 24 hrs of 79.5% 79.4% from baseline* 48-72 hr visit* FNIH recommended to FDA to exclude temperature as a component of the primary endpoint and to assess a >20% reduction in lesion size at 48 to 72 hours. Under these pre-specified analysis tedizold shows additional numerical separation from linezolid No increase in lesion area from baseline Temperature excluded** 87.0% 85.4% FNIH Primary Endpoint ≥ 20% reduction of lesion Temperature excluded** 78.0% 76.1% are from baseline** * Primary endpoint as agreed to under Study 112 and 113 SPA ** FNIH recommendations to FDA: ABSSSI Docket ID: FDA--2010--D--0433 10
  • 11.
    Secondary Outcomes: TedizolidDemonstrates Comparable Efficacy with Shorter Course of Therapy Secondary Outcome at EOT or PTE Treatment Secondary Outcome Tedizolid Linezolid Criteria (200 mg QD 6 days) (600 mg BID 10 days) 112 SPA 69.3% (ITT) 71.9% (ITT) Early clinical failures carried Clinical Response at EOT* forward to EOT* (Day 11) 80.2% (CE) 81.1% (CE) In August 2010 draft guidance the FDA adopted changes to the secondary outcomes of clinical response at the end of therapy (EOT). These were prospectively measured in Study 112 sensitivity analyses and are captured in the Study 113 SPA. 80.7% (ITT) 80.9% (ITT) Clinical Response at EOT* Early clinical failures not carried (Day 11) forward to EOT** 87.5% (CE) 87.1% (CE) Early clinical failures not carried 87.0% (ITT) 87.8% (ITT) 113 SPA forward to EOT** and Clinical Response at EOT* presence/absence of patient (Day 11) reported pain at EOT excluded*/** 94.5% (CE) 95.1% (CE) * Primary and secondary endpoints as agreed to under Study 112 SPA ** Consistent with FDA draft ABSSSI Guidance for Industry (August 2010) 11
  • 12.
    Tedizolid was WellTolerated with a Favorable AE Profile Compared to Linezolid Tedizolid had a numerically lower rate of drug-related treatment emergent adverse events (TEAE) and a statistically significant lower number of gastrointestinal adverse events Tedizolid Linezolid Adverse Event (200 mg QD 6 Days) (600 mg BID 10 Days) Any Treatment Emergent 40.8% 43.3% Adverse Event (TEAE) Any Drug Related TEAE 24.2% 31.0% Gastrointestinal 16.3%** 25.4% Disorders* * Gastrointestinal AEs include: Diarrhea, Nausea, Vomiting and Dyspepsia ** Statistically significant (p=0.004). No Unexpected Safety Signals •  Liver enzymes/function tests •  QTc 12
  • 13.
    Hematology: Tedizolid HadSignificantly Lower Impact on Platelets than Linezolid Percent of Patients with Value below the Lower Limit of Normal (LLN) Tedizolid Linezolid Hematology Parameter (200mg QD 6 days) (600mg BID 10 days) Platelets* 9.2% 14.9% Below LLN Platelets – Substantially Abnormal Value 2.3% 4.9% (<75% LLN) * Statistically significant (p=0.038) 13
  • 14.
    Phase 3 TrialSummary £  Study 112 design and outcomes are consistent with both FDA and EMA regulatory requirements £  All efficacy and safety objectives of Study 112 were successfully achieved –  Efficacy: All primary and secondary trial endpoints met with a once-daily short course of therapy –  Safety: statistically significant lower incidence in key tolerability and safety parameters –  Successful results triggered $5M milestone payment from Bayer £  Results align with surveyed physician and payer preferences for fast acting drugs with improved tolerability and safety* * PG Decision Metrics market research of 10 Formulary Directors & 10 HMO/PBMs. Commissioned by Trius in 2009 AMR – Hospital Insight Series, US Data, August 2011 Hawk Partners - Target Product Profile Research with 29 US Physicians. Commissioned by Trius, Sept 2011 14
  • 15.
    Bayer Strategic Collaborationfor Asia-Pacific and Emerging Markets Exclusive license to develop and Retains rights to Obtains key asset for commercialize tedizolid in Asia, largest commercial largest therapeutic Africa, Latin America and the Middle area in licensed opportunity East (ex-Korea) territory Trius leads Responsible for all development of global $25M upfront independent regional clinical studies development $69M in development, regulatory Enables early and commercial milestones Responsible for all execution of ex-U.S. marketing activities in commercial strategy its territory 25% of the future development costs in ABSSSI and pneumonia Double digit royalties 15
  • 16.
    Gyrase-B Program: NovelClass of Broad Spectrum Antibiotics £  Funded through Phase 1 by $28MM NIAID Contract £  Lead molecules have potent activity against gram-negative and gram-positive bacterial pathogens £  including MRSA, ESBL strains, Pseudomonas, Acinetobacter & Klebsiella (including NDM1) £  Efficacy demonstrated in multiple animal models £  Lung, urinary tract, thigh, septicemia £  Clean nonclinical toxicity and no CYP450 interactions £  Including dog CV telemetry study up to 10x efficacious drug exposure. No effect on all CV parameters (Qtc, HR, BP etc.). £  Clinical studies expected to start 2012 16
  • 17.
    Evolution of MICsin Lead Series Against Gram Negative and Gram Positive Pathogens Antibacterial Potency MIC (µg/mL) Adverse Event 1491 1710 1722 1852 S. aureus 0.008 0.008 0.008 0.008 S. pneumoniae 0.008 0.008 0.008 0.004 E. coli (wt) 0.25 0.13 0.25 0.13 K. pneumoniae (MDR) 2 2 2 1 A. baumannii 0.50 0.25 0.50 0.25 P. aeruginosa (wt) 4 2 1 0.50 Gram + Gram — 17
  • 18.
    MIC90 of GyrB/ParEDevelopment Candidate vs Comparators against Gram-Positive Pathogens MIC90  of  TR-­‐1852  vs.  G+  isolates   >16   16   >4   >4   >4   14   12   8   MIC90  (µg/ml)   4   10   4   2   8   ciprofloxacin   6   0.25   1   linezolid   4   2   0.5   vancomycin   2   ≤0.001   ≤0.001   daptomycin   0   0.03   TR-­‐1852   Number of isolates is shown in parentheses 18
  • 19.
    MIC90 of GyrB/ParEDevelopment Candidate vs Comparators against Gram-Negative Pathogens ** * *** *  Includes  ESBL  isolates   **  includes    MDR,  ESBL  isolates   ***  includes  ESBL,  NDM-­‐1,  KPC-­‐2,  KPC-­‐3,  and  randomly  selected  isolates   19
  • 20.
    P. aeruginosa MIC90Results for TR-1852 (50 strains) P.  aeruginosa  MIC90  panel   100   MIC90 = 1 µg/mL 90   80   70   %  strains  cumulaKve   60   1852   Cefepime   50   Cipro   Gent   40   Imipenem   30   20   10   0   0.06   0.125   0.25   0.5   1   2   4   8   16   32   64   128   MIC value µg/mL 20
  • 21.
    E. coli MouseUrinary Tract Infection Model Mouse Ascending UTI Model − E. coli Drugs Dosed IV 10 mg/kg/day 7 Bladder Average Log10 CFU/g Tissue 6 Kidney 5 4 3 2 1 0 C 1852 Levo C 1852 Levo 21
  • 22.
    Safety Summary: CleanIn-Vitro & In-Vivo to Date £  No CYP450 inhibition – low drug-drug interaction potential £  No Relevant Off-Target Enzyme Activities – bacterial selective £  No Genotoxicity Signals (human cell line) £  Clean in Dog Cardiovascular Study – all parameters including QTc £  Single Dose MTD in Mice & Rats >100 mg/kg £  Rat Chronic 14 Day Dose NOAEL ~50 mg/kg* –  Therapeutic Margin Estimate (~13x)** *Pending histopathology, based on gross necropsy, blood biochemistry & hematology **AUC @ NOAEL dose/AUC @ efficacious dose 22
  • 23.
    Capitalization Cash & Equivalents (at 9-30-11) $70MM Long Term Debt (at 9-30-11) $0MM Federal Contracts Awarded $60MM Shares Outstanding 38.6MM Market Capitalization (at 2-10-12) $211MM Cash Runway* Q3 2013 * Assumes initiation of global HAP study in 2013 and no additional partnerships 23
  • 24.
    Upcoming Goals §  Potential European partnership §  Regulatory agreement enabling initiation of Phase 3 pneumonia study §  IND filing for Gyrase clinical candidate §  Completion of enrollment for 113 Phase 3 ABSSSI trial 24
  • 25.