from new mechanisms to new standards of care

From New Mechanisms to New Standards of Care Corporate Presentation - PowerPoint PPT Presentation

From New Mechanisms to New Standards of Care Corporate Presentation October 2018 Forward-Looking Statements Statements in this presentation, other than statements of historical fact, constitute forward-looking statements within the meaning of

  1. From New Mechanisms to New Standards of Care Corporate Presentation October 2018

  2. Forward-Looking Statements Statements in this presentation, other than statements of historical fact, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding Summit’s clinical trials supporting the safety and efficacy of its product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for clinical trials, product development and regulatory filings, Summit’s collaboration with Eurofarma Laboratorios SA, Summit’s award from BARDA, Summit’s Discuva Platform, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Actual results or events may differ materially from those expressed or implied in any forward-looking statements due to various factors, including the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the preliminary results from a clinical trial will be predictive of final results of that trial or whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom Summit relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk that any third-party collaborator, including Eurofarma, terminates or fails to meet its obligations to Summit, the risk of the ability of BARDA to terminate our contract for convenience at any time, the risk that Summit’s discovery and development platform may not identify new potential drug development candidates, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA or other regulatory agencies; and the other risks and uncertainties described in Summit’s public filings with the Securities and Exchange Commission. Summit may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Summit disclaims any intent or obligation to revise or update these forward-looking statements, except as required by applicable law. 2 Company presentation October 2018

  3. Creating a Different Antibiotic Company NEW SCIENCE NEW OPPORTUNITY NEW PHILOSOPHY New bacterial targets The right drug for the Beat standard of care right bug New drugs against them Economic and clinical Real unmet needs data to support premium price Innovative development plans 3 Company presentation October 2018

  4. Past Commercial Success Associated with Innovation Macrolides Glycopeptides, Nitroimidazoles, Streptogramins Cycloserine, Novobiocin Rifamycins Pleuromutilins Trimethoprim Cephalosporins Quinolones Polymyxins, Phenicols Fosfomycin Nitrofurans Mupirocin Tetracyclines Carbapenems Aminoglycosides, Bacitracin Oxazolidinones Monobactams Sulfonamides Lipopeptides Penicillin 1990s 2000s 2010s 1920s 1930s 1940s 1950s 1960s 1970s 1980s YEAR ANTIBIOTIC CLASS DISCOVERED 1920s-1980s Since 1990 • Multiple novel mechanisms & classes • No new mechanisms; only • Multiple examples of significant commercial incremental benefits success • Niche market positioning with • Ciprofloxacin; azithromycin; ceftriaxone low commercial return • Resistance not clinical issue • Resistance is a clinical issue 4 Company presentation October 2018 Adapted from ReAct Group 2015

  5. Only Two Late Stage Antibiotics are Novel Drug name Company Phase Drug Class Basilea 3/ Marketed (ex-US) Cephalosporin Ceftobiprole Plazomicin Achaogen Marketed (US) Aminoglycoside Eravacycline Tetraphase Marketed (US) Tetracycline Paratek Approved (US) Tetracycline Omadacycline Iclaprim Motif Bio Pre-Reg 2,4 diaminopyrimidine Cefiderocol Shionogi 3 Cephalosporin Theravance 3 Glycopeptide beta lactam Cefilavancin Imipenem & relebactam Merck 3 Carbapenem/BLI Lefamulin Nabriva 3 Pleuromutilin Cefepime & tazobactam Wockhardt 3 Cephalosporin/BLI Murepavadin Polyphor 3 Novel; P. aeruginosa specific Ridinilazole Summit 3-ready Novel; C. difficile specific 5 Company presentation October 2018

  6. Stewardship and Commercial Success Aligned Stewardship ultimately about upfront use of Vancomycin for CDI and the correct drug ceftriaxone for gonorrhoea • Novel mechanism agents address specific used front-line indications and unmet needs do not equate to • Their use improves clinical outcomes and stewardship reduces healthcare costs Summit’s approach aligns with stewardship and could result in commercial success Ridinilazole for CDI and • Development programs designed to meet needs SMT-571 for gonorrhoea of patients, providers and payors used front-line • Data from these programs promote market do equate to stewardship uptake of agents into front-line settings • Acceptable pricing achieved through clear and demonstrable package of benefits 6 Company presentation October 2018

  7. Our New Mechanism Antibiotic Pipeline Preclinical Phase 1 Phase 2 Phase 3 Funding source Discovery CDI BARDA (ridinilazole) 1 Gonorrhoea (SMT-571) 1 Roche Collaboration 2 Gonorrhea (Target #2) 1 ESKAPE Program 1 Discuva Platform (1) We own worldwide rights to ridinilazole, outside of certain Latin American countries and Caribbean islands, and own worldwide rights to our gonorrhea and ESKAPE programs 7 (2) Roche holds worldwide development and commercialization rights to these compounds and Summit is Company presentation entitled to specified development, commercialization and sales milestone payments from Roche. October 2018

  8. New Science Discovering new mechanism antibiotics with our Discuva Platform October 2018

  9. Discuva Platform: Enabling Optimized Candidate Selection From discovery through candidate selection, our Discuva Platform delivers optimized antibiotics with: Targeted New Low spectrums of mechanisms propensities for activity of action resistance We advance those new mechanism candidates where a major commercial opportunity exists and we can show significant advantages over the current standard of care 9 Company presentation October 2018

  10. Proprietary Libraries Cover Major Unmet Needs, Enable Potential Pipeline Expansion K. pneumoniae CDC Serious CDC Urgent / Threats / WHO Critical Other ESKAPE Threats Pathogens N. gonorrhoeae* E. faecalis E. coli E. faecium P. aeruginosa S. aureus A. baumannii S. pneumoniae Gram negative Gram positive 10 *Current Summit preclinical program Company presentation October 2018

  11. Discuva Platform: Rapid Screening to Identify New Bacterial Targets Through the process of creating hundreds of thousands of mutant bacteria of a single species, genes essential for the survival of that species can be identified as those which have no insertions Library of mutant Next-generation Genome map of engineered bacteria sequencing mutation insertions 11 Company presentation October 2018

  12. Discuva Platform: Elucidate Mechanism of Action and Optimize Against Resistance • Our libraries of mutant bacteria allow us to have exquisite control over gene expression in a given species • These mutants have increased, decreased or disrupted gene expression levels • In the presence of an antibiotic, the mutant libraries can help us to rapidly elucidate mechanisms of action and optimize against potential resistance mechanisms -drug of interest Next-generation +drug of interest sequencing +gene manipulation Which genes are involved in MOA? Are there any resistance liabilities? 12 Company presentation October 2018

  13. Ridinilazole Our Phase 3-ready precision antibiotic in development for front-line treatment of C. difficile infection October 2018

  14. About C. difficile Infection (CDI) >1.0m cases Initial treatment Failure likely per year in US fails to cure or connected to and EU 1 , 29,000 sustain cures in microbiome deaths per year around a third impact of standard in the US 2 of cases of care 14 1. Decision Resources, 2015 Company presentation 2. New England Journal of Medicine, 2015 October 2018

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