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

From New Mechanisms to New Standards of Care Corporate Presentation September 2018

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 discovery and development 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 September 2018

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

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 • No new mechanisms • Multiple novel mechanisms & classes • Incremental benefits • Multiple examples of significant commercial • Niche market positioning with low success commercial return • Ciprofloxacin; azithromycin; ceftriaxone • Resistance becoming clinical issue • Resistance not clinical issue 4 Company presentation September 2018 Adapted from ReAct Group 2015

New Mechanisms Deliver Strong Commercial Returns 1959 Methicillin introduced to treat penicillin resistant S. aureus 2011 1968 First reported MRSA case in US Linezolid - Peak sales = $1.4 billion • Novel mechanism agent 1980 • Label and launch clearly focused on treatment of Healthcare associated MRSA – the unmet need MRSA outbreaks • Clinical superiority over vancomycin demonstrated for MRSA nosocomial pneumonia and skin infections 1989-1991 • Additional tangible benefits over SoC vancomycin Community acquired MRSA demonstrated outbreaks • IV/oral switch & community use • Reduced length of stay 2000 • Possible mortality benefits Linezolid approved 5 Company presentation September 2018

Stewardship: Alignment with Summit’s Strategy Need for stewardship driven by a lack of CDC Definition innovation against a background of …provide every patient with antimicrobial resistance the right antibiotics , at the • Stewardship an integrated multidisciplinary approach to right time, at the right dose, optimize clinical outcome and for the right duration - Stewardship is not purely about reservation to reduce adverse events of agents. Reservation alone: associated with antibiotics • Promotes inappropriate empiric therapy and resistance and improve patient development to standard of care outcome … 6 Company presentation September 2018

Stewardship and Commercial Success Aligned Stewardship ultimately about upfront use of Vancomycin for CDI and the correct drug ceftriaxone for gonorrhoea • Improves clinical outcomes and reduces healthcare costs used front-line • Novel mechanism agents address specific indications and do not equate to unmet needs stewardship Summit’s approach aligns with stewardship and could result in commercial success • Development program designed to meet needs of patients, providers and payors • Promotes market uptake of agents into front-line settings Ridinilazole for CDI and • Acceptable pricing achieved through clear and SMT-571 for gonorrhoea demonstrable package of benefits used front-line do equate to stewardship 7 Company presentation August 2018

Executing Across Drug Development Pathway DISCOVER DEVELOP COMMERCIALIZE Discovered several programs Expect to initiate Phase 3 Seeking to maximize pipeline of distinct new mechanism clinical trials in C. difficile value antibiotics to date infection (CDI) Q1 2019 Expect to file for FDA approval Discuva Platform allows for Expect to initiate Phase 1 for ridinilazole in 2022, expansion of pipeline clinical trial in gonorrhea if Phase 3 results are positive covering serious pathogenic H2 2019 threats Potential global peak sales ~$700M for ridinilazole 8 Company presentation September 2018

Our New Mechanism Antibiotic Pipeline Phase 3 Preclinical Phase 1 Phase 2 Funding source Discovery CDI BARDA (ridinilazole) Gonorrhoea (SMT-571) Roche Collaboration 1 Gonorrhea (Target #2) ESKAPE Program Discuva Platform 9 (1) Roche holds worldwide development and commercialization rights to these compounds and Summit is entitled to specified Company presentation development, commercialization and sales milestone payments from Roche. September 2018

New Science Discovering new mechanism antibiotics with our Discuva Platform September 2018

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 11 Company presentation September 2018

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 12 Company presentation September 2018

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? 13 Company presentation August 2018