Filed by Trimeris, Inc.
Pursuant to Rule 425 under the
Securities Act of 1933 (the “Securities Act”) and
deemed filed pursuant to Rule 14a-12 under the
Securities Exchange Act of 1934 (the “Exchange Act”)
Securities Act File Number: 333-175512
Subject Company: Trimeris, Inc.
Exchange Act File Number: 000-23155
This filing relates to the proposed merger involving Synageva BioPharma Corp. (“Synageva”) and Trimeris, Inc. (“Trimeris”), pursuant to the terms of an Agreement and Plan of Merger and Reorganization, dated as of June 13, 2011, by and among Trimeris, Tesla Merger Sub, Inc., a wholly owned subsidiary of Trimeris, and Synageva. Beginning on July 20, 2011, the following PowerPoint slides are being used for presentations by Synageva’s management to certain investors:
 © Copyright 2011 Synageva BioPharma™ Company Presentation Company Presentation July 2011 July 2011 |
 These materials and oral statements made from time to time by Synageva representatives in respect of the same subject matter may contain “forward-looking statements.” These statements can be identified by introductory words such as “expects,” “plans,” “intends,” “believes,” “will,” “estimates,” “forecasts,” “projects,” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Synageva undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Synageva cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials or how quickly patent enrollment in clinical trials will occur. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Synageva will obtain regulatory approval for any “phase” of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. 2 © Copyright 2011 Synageva BioPharma™ Forward-Looking Statements |
 Vehicle Vehicle Focus Focus Synageva Strategy & Direction 3 © Copyright 2011 Synageva BioPharma™ Count- Down |
 Deal Synageva and Trimeris merge in all-stock transaction 3:1 exchange ratio Transaction has been unanimously approved by both boards Rationale Provides Synageva financial resources to aggressively pursue corporate strategy Gives Synageva access to public markets Allows Synageva to maintain focus 4 © Copyright 2011 Synageva BioPharma™ Synageva Transaction |
 Synageva Investment Highlights 5 © Copyright 2011 Synageva BioPharma™ Team Rare Disease Experience Rare Disease Experience Rare Disease Unmet Medical Need Unmet Medical Need Lead Product ERT for LSD – Model is Predictive ERT for LSD – Model is Predictive Status Patient Dosing Commenced Patient Dosing Commenced Commercial Pull-through Expertise Pull-through Expertise Manufacturing Robust, Efficient and Scalable Robust, Efficient and Scalable |
 Chief Executive Officer Sanj K. Patel Sanj K. Patel Chief Medical Officer Anthony Quinn Anthony Quinn Commercial Operations Eric Grinstead Eric Grinstead Manufacturing Joe DeCourcey Joe DeCourcey Program Management Christine Maurer Christine Maurer Chief Financial Officer Carsten Boess Carsten Boess 6 Clinical Operations Tara O’Meara Tara O’Meara © Copyright 2011 Synageva BioPharma™ Proven Management Team |
 7 © Copyright 2011 Synageva BioPharma™ Program SBC-102 (rhLAL) SBC-103 (rhNAGLU) SBC-104 SBC-105 SBC-106 Therapeutic Recombinant Lysosomal Acid Lipase Recombinant a-N-acetyl- glucosaminidase Extra Cellular Protein Enzyme Replacement Therapy Enzyme Replacement Therapy Disease LAL Deficiency (LSD) MPS IIIB/ Sanfilippo B (LSD) Severe Genetic Condition Severe Metabolic Disorder Severe Genetic Condition Development Status Clinical Preclinical Preclinical Preclinical Preclinical Regulatory Opportunity Orphan Designation • Granted US • Granted EU Fast Track Designation Potential for Orphan & Fast Track Designation Potential for Orphan & Fast Track Designation Potential for Orphan & Fast Track Designation Potential for Orphan & Fast Track Designation Significant unmet medical need Synageva Pipeline |
 Lead Program 8 © Copyright 2011 Synageva BioPharma™ ERT for Lysosomal Acid Lipase Deficiency |
 Liver lipid content in model of LAL Deficiency SBC-102 Lysosomal Acid Lipase (LAL) Biology Cholesterol esters & TG FFA Free Cholesterol Free cholesterol and fatty acids are key regulators of lipid synthesis LDL LDL receptors lysosome coated vesicle ENDOCYTOSIS 9 © Copyright 2011 Synageva BioPharma™ LAL Deficient Normal Cholesteryl Ester Triglyceride LAL Deficient LAL Deficient Normal Normal |
 Shortened lifespan and morbidity Prominent hepatic manifestations – Fatty liver – Elevated transaminases – Fibrosis – Liver failure Other manifestations: splenomegaly, type II hyperlipidemia Rare disease in a common phenotype Abdominal distention due to liver failure Liver biopsy showing cirrhosis in CESD 10 © Copyright 2011 Synageva BioPharma™ SBC-102 Late Onset LAL Deficiency (CESD) |
 Prominent hepatic and GI manifestations – Hepatomegaly and liver failure – Splenomegaly – Persistent vomiting – Abdominal distension – Profound growth failure Adrenal calcification Rapidly progressive and fatal 4.4 6.6 8.8 11 13.2 15.4 17.6 19.8 22.1 24.3 26.5 28.7 30.9 33.1 3rd 15th 50th 85th 97th 1 2 3 4 5 6 7 8 9 10 11 12 LAL Deficient Age (months) Weight-for-age percentiles: Boys, birth to 12 months © Copyright 2011 Synageva BioPharma™ 11 SBC-102 Early Onset LAL Deficiency (Wolman) |
 Terminal mannose/GlcNac and mannose-6-phosphate (M6P) for targeted delivery Uptake into key cells, including macrophages* Lysosomal localization demonstrated Corrects enzyme deficiency Lysotracker red Overlap images Oregon green- labeled SBC-102 0 0.16 0.5 1.6 5.0 12 © Copyright 2011 Synageva BioPharma™ * * * SBC-102 Targeting and Activity SBC-102 (ug/ml) Normal Human Fibroblasts LD Fibroblasts 0 1 2 3 4 5 6 |
 13 Normal 4 weeks 8 weeks Normalizes liver Untreated LAL Deficient © Copyright 2011 Synageva BioPharma™ SBC-102 Corrects Key Disease Related Abnormalities |
 14 Normal LAL Deficient SBC-102 Treated, qw © Copyright 2011 Synageva BioPharma™ SBC-102 Rapid Correction of Growth Failure in LAL Model |
 Liver Spleen Marked Reduction In Liver Cholesteryl Ester Content Across A Broad Range Of Doses © Copyright 2011 Synageva BioPharma™ 15 LAL Deficient Normal SBC-102 Efficacy With Every Other Week Dosing |
 Therapy Pre-Clinical Effective Dose Approved Dose Disease Model Key Results Aldurazyme 0.5-2mg/kg once weekly (canine) QW 0.58 Lysosomal targeting & substrate reduction Fabrazyme 0.3-3mg/kg twice monthly (rodent) QOW 1 Naglazyme 1-2mg/kg once weekly (feline) QW 1 Myozyme 10-100mg/kg once weekly or twice monthly (rodent) QOW 20 SBC-102 0.35-3mg/kg once weekly or twice monthly (rodent) Under investigation Lysosomal targeting & substrate reduction Endpoints that translate to humans Frequency mg/kg 16 © Copyright 2011 Synageva BioPharma™ SBC-102 ERT Models Predict Efficacy and Dose |
 Proof of concept established in disease model Small patient numbers accelerate development timelines (~5 years vs 5-10 years for common diseases) Patient dosing initiated within 3 months of IND and CTA clearance 2020 2020 2011 2011 PIVOTAL PHASE I/II Late Onset Early Onset 17 © Copyright 2011 Synageva BioPharma™ COMMERCIALIZATION Conventional Development Programs SBC-102 Clinical Development |
 18 Adult patients with liver dysfunction due to LAL Deficiency Open label dose escalation 4 week dosing 3 dose levels Multicenter N = 9 Patient dosing underway Followed by extension protocol Phase I/II Open-Label Phase I/II Open-Label Primary endpoint: Safety Secondary endpoint: Pharmacokinetics Trial Measurements: Pharmacodynamic markers Liver Function Tests Randomized, placebo-controlled study 6 months dosing 3 arm study Multicenter N = ~24 Randomized, Double-Blind, Randomized, Double-Blind, Placebo-controlled Trial Placebo-controlled Trial Late Onset Natural History Study On-going © Copyright 2011 Synageva BioPharma™ SBC-102 Clinical Development Late Onset (CESD) Patients with liver dysfunction due to LAL Deficiency Endpoints: Safety, Efficacy and Pharmacokinetics |
 19 Growth failure in children due to LAL Deficiency Open label dose escalation 4 month dosing Multicenter N= 8 Active Phase I/II Open-Label Phase I/II Open-Label Primary endpoint: Safety and tolerability Secondary endpoints: Efficacy (including growth, weight gain) Pharmacokinetics Pharmacodynamics Primary endpoint: Long term efficacy and safety (including survival) Secondary endpoint: Efficacy (including growth, weight gain, organ function) Pharmacokinetics Patients from Phase I/II study Continuation with dose regimen from Phase I/II Dosing for > 6 months Multicenter N= ~8 Open-Label Long-term Extension Open-Label Long-term Extension © Copyright 2011 Synageva BioPharma™ SBC-102 Clinical Development Early Onset (Wolman) Early Onset Natural History Study On-going |
 IND filed on schedule and cleared within 30 days EU CTAs filed 3 months ahead of schedule US & EU orphan drug designations granted 2010 Proof of concept data presented at key meetings Clinical production for studies on schedule, internal manufacturing Initiated multiple US and EU clinical trial sites Patient dosing commenced 20 © Copyright 2011 Synageva BioPharma™ SBC-102 Clinical and Regulatory Milestones |
 An infant with LAL Deficiency has received treatment with SBC-102 on a compassionate use basis – Presented with anemia, increasingly abnormal liver function tests, and growth failure prior to treatment – Child has received 13+ infusions with no complications and is demonstrating substantial improvements in: • Growth rate • Liver function tests (reduction in serum transaminases) • Other disease-associated abnormalities consistent with Synageva’s preclinical data for SBC-102 Infant continues to receive treatment with SBC-102 © Copyright 2011 Synageva BioPharma™ 21 SBC-102 Compassionate Use: Patient Data |
 22 © Copyright 2011 Synageva BioPharma™ ERT for MPS IIIB / Sanfilippo B SBC-103 (rhNAGLU) |
 Heparan sulfate accumulation in CNS, liver, spleen, skin and joints May affect as many as 8 lives per million Progressive mental impairment with sleep disturbances and behavioral manifestations – Severe phenotype - wheelchair dependent and death within first two decades – Attenuated phenotype – early onset intellectual disability with delayed progression Strategy – Builds on ERT experience with SBC-102 – Slow CNS onset provides Rx window – Leverages progress in intrathecal delivery © Copyright 2011 Synageva BioPharma™ 23 From curekirby.org Age 9 Age 18 SBC-103 MPS IIIB / Sanfilippo B |
 24 Historical attempts to produce NAGLU ERT for MPS IIIB have failed due to lack of cell uptake © Copyright 2011 Synageva BioPharma™ Yogalingham G et al, 2000 NAG (nmol/h per mg) Normal fibroblasts 25.12 2.23 MPS-IIIB fibroblasts 0.101 0.025 MPS-IIIB fibroblasts + MPS-IIIB/LNCNAG 0.388 0.048 conditioned medium Synageva Demonstrated good uptake into enzyme-deficient human Markedly increased cellular enzyme levels Properties substantially better than cell culture produced SBC-103 NAGLU Production for ERT fibroblasts material in previous publications |
 Proprietary Vector System Human Biopharmaceutical Expression in Egg White FDA-accepted Aseptic Protein Harvest GMP compliant facilities Automated commercial scale infrastructure Finished Product Stable commercial supply Consistent and Reliable Scale-up Purification Established industry standard IND approved process Consistent Scalable Efficient Clinically validated – Studies included over 250 patients, including 189 pt Ph II GCSF trial Multiple cleared INDs – 4 INDs Pipeline generator 25 © Copyright 2011 Synageva BioPharma™ Synageva Expression Platform |
 Drug SBC-102 Cerezyme Fabrazyme Myozyme Soliris SBC-103 Indication LAL Deficiency Type I Gaucher Disease Fabry Disease Pompe Disease PNH MPS IIIB/ Sanfilippo B Estimated Prevalence 1 in 40,000 1 in 59,000 to 86,000 1 in 40,000 to 476,000 1 in 40,000 to 146,000 1 in ~77,000 1 in 125,000 to 211,000 Reported 2010 Revenue ($M) Significant Unmet Need $719.6 $188.2 $411.8 $540.9 Significant Unmet Need 1. Muntoni, et al 2007. Prevalence of Cholesteryl Ester Storage Disease, Arteriosclerosis, Thrombosis, and Vascular Biology, 27, p.1866 2. Genzyme, AMCP Dossier for Cerezyme 3. Alexion, AMCP Formulary Dossier 4. Héron B, et al. Incidence and natural history of mucopolysaccharidosis type III in France and comparison with United Kingdom and Greece. Am J Med Genet A. 2011 Jan;155A(1):58-68. 5. Meikle, P.J., Hopwood, J.J., Clague, A.E. & Carey, W.F., 1999. Prevalence of lysosomal storage disorders. JAMA, 281(3), p.249. 6. www.medtrack.com, 2010 revenues 26 © Copyright 2011 Synageva BioPharma™ 2 1 2 2 3 4 5 6 6 6 6 SBC-102 Commercial: Ultra-Orphan Opportunity |
 ~17,000 homozygotes with LAL mutation ~17,000 homozygotes with LAL mutation 1 1 Estimated distribution for US, EU and BR Estimated distribution for US, EU and BR © Copyright 2011 Synageva BioPharma™ 27 Enzyme DNA Simple blood test Enzyme Assay DNA Sequencing Lab Prototypes 1. Baylor College of Medicine 2. Willink Lab, St Mary’s Manchester, UK Simple blood test Enzyme Assay DNA Sequencing Lab Prototypes 1. Baylor College of Medicine 2. Willink Lab, St Mary’s Manchester, UK Right Practice Right Patient Right Test Geneticists Suspected Patients Hepatologists Lipidologists Liver Phenotype Lipid Phenotype SBC-102 Commercial: Finding Patients 1 |
 30-60M Americans have NAFLD 1 6-10M Americans have NASH 1 http://www.digestive.niddk.nih.gov/ddiseases/pubs/NASH/ 2 Muntoni, et al; “Prevalence of Cholesteryl Ester Storage Disease”, Arteriosclerosis, Thrombosis, and Vascular Biology, July 19,2010 28 © Copyright 2011 Synageva BioPharma™ Commercial: Rare & Devastating Disease in a 1 6K Americans are predicted to have CESD 2 SBC-102 Common Phenotype –Muntoni .…CESD should more often be considered as a differential diagnosis liver diseases of unknown (nonalcoholic steatohepatitis or NASH) or known (alcoholic steatohepatitis) origin and in dyslipidemic patients with combined hyperlipidemia and low HDL- cholesterol (Familial Combined Hyperlipidemia). in |
 Multiple Value Drivers Stage 1 Investing in the future Valued as a clinical stage biotech First-ever ERT for LAL in humans Stage 2 Commercial-stage biotech Potential Five product Valued on revenue and margin Synageva Value Drivers in Two Distinct Stages 29 © Copyright 2011 Synageva BioPharma™ Proof of Concept Established Human Data on SBC-102 Pipeline products entering clinic Filing and Approval for SBC-102 Fast Revenue Ramp Attractive Margin Profile company company introductions expected development |
 Financials Pro forma Synageva would have approximately $70 million in cash ending Q1 2011 Trimeris received $4.9 million upfront fee Trimeris to receive a 16% royalty on global sales of Fuzeon, an HIV drug marketed globally by Roche (55 countries) 30 © Copyright 2011 Synageva BioPharma™ Cash balance will allow Synageva to reach multiple value creating events Trimeris cash ending Q1 2011 was approx $47 million Synageva cash ending Q1 2011 was approx $23 million May 25th, 2011 Trimeris signed new agreement with Roche: Summary |
 MULTIPLE VALUE DRIVING EVENTS 31 © Copyright 2011 Synageva BioPharma™ Synageva Pipeline of Opportunity Program Therapeutic Disease Development Status Regulatory Opportunity SBC-102 (rhLAL) Recombinant Lysosomal Acid Lipase LAL Deficiency (LSD) Clinical Orphan Designation • Granted US • Granted EU Fast Track Designation SBC-103 (rhNAGLU) Recombinant -N-acetyl- glucosaminidase MPS IIIB/ Sanfilippo B (LSD) Preclinical Potential for Orphan & Fast Track Designation SBC-104 Extra Cellular Protein Severe Genetic Condition Preclinical Potential for Orphan & Fast Track Designation SBC-105 SBC-106 Enzyme Replacement Therapy Enzyme Replacement Therapy Severe Metabolic Disorder Severe Genetic Condition Preclinical Preclinical Potential for Orphan & Fast Track Designation Potential for Orphan & Fast Track Designation |
 © Copyright 2011 Synageva BioPharma™ Every Second Counts! |
Important Merger Information and Additional Information and Where to Find It
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities of Trimeris or Synageva or the solicitation of any vote or approval. In connection with the proposed merger, Trimeris filed a Registration Statement on Form S-4, filed with the U.S. Securities and Exchange Commission (the“SEC”) on July 13, 2011 (the“Registration Statement”), which includes a preliminary joint proxy statement of Synageva and Trimeris and constitutes a preliminary prospectus of Trimeris. These materials are not yet final and will be further amended. The joint proxy statement/prospectus of Synageva and Trimeris will be mailed to the respective stockholders of Synageva and Trimeris once it is final.Investors are strongly urged to read the definitive joint proxy statement/prospectus when it becomes available and other documents filed with the SEC by Trimeris, because they will contain important information about Synageva, Trimeris and the proposed merger.
Investors and security holders of Synageva will be able to obtain free copies of the joint proxy statement/prospectus for the merger by contacting Synageva BioPharma Corp., Attn: Secretary, 128 Spring Street, Suite 520, Lexington, MA 02421. Investors and security holders of Trimeris may obtain free copies of the joint proxy statement/prospectus for the proposed merger and other documents filed with the SEC by Trimeris through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders of Trimeris will be able to obtain free copies of the joint proxy statement/prospectus for the proposed merger by contacting Trimeris, Inc., Attn: James Thomas, Chief Financial Officer, 2530 Meridian Parkway, 2nd Floor, Durham, NC 27713.
Synageva and Trimeris, and their respective directors and certain of their executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the agreement between Synageva and Trimeris. Information regarding Synageva’s directors and officers and a more complete description of the interests of Synageva’s and Trimeris’ respective directors and officers in the proposed transaction is available in the Registration Statement. Information regarding Trimeris’ directors and executive officers is contained in Trimeris’ Annual Report on Form 10-K for the fiscal year ended December 31, 2010, which was filed with the SEC on March 14, 2011, and in its proxy statement prepared in connection with its 2010 Annual Meeting of Stockholders, which was filed with the SEC on March 16, 2010.
Cautionary Note Regarding Forward-Looking Statements
Statements in this communication regarding the development of Synageva’s product candidates, including SBC-102 and SBC-103, preclinical and clinical results from trials involving Synageva’s product candidates, the predictability of enzyme replacement therapy models, regulatory review and the likelihood and timing of approval of any product candidate, the impact of obtaining fast track designation from the FDA, the potential for SBC-102 to treat LAL Deficiency, the size of the commercial opportunity for any of Synageva’s product candidates, the proposed merger between Synageva and Trimeris, including the timing, conditions to and anticipated completion of the proposed merger, the expected ownership of the combined company and the combined company’s board of directors, the anticipated cash balance of the combined company, and any other statements about Synageva’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “plans,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the risk that Synageva cannot demonstrate safety and/or efficacy of its product candidates in clinical trials; the risks involved with development and commercialization of product candidates; the potential inability of Synageva to obtain, maintain and enforce patent and other intellectual property protection for its products, discoveries and drug candidates; the risk that Synageva and Trimeris may not be able to complete the proposed merger as anticipated or at all; and other risks and uncertainties that are more fully described in the Registration Statement. Investors and stockholders are urged to read the risk factors set forth in the Registration Statement.
In addition, the statements in this communication reflect our expectations and beliefs as of the date of this communication. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this communication.