Entasis Therapeutics Holdings Inc
Entasis Therapeutics — Investor Presentation (July 2020)
37 slides from Entasis Therapeutics's investor presentation, Jul 23, 2020
Slide 1: Targeted Solutions for Antibacterial Resistance
Non - Confidential Targeted Solutions for Antibacterial Resistance Precision antibiotics focused against critical pathogens July 2020
Slide 2: Disclaimer
Non - Confidential Disclaimer This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’
Slide 3: Accomplished Management Team
Non - Confidential Accomplished Management Team MANAGEMENT TEAM WITH EXTENSIVE ANTI - INFECTIVE EXPERIENCE Manos Perros, Ph.D. President and Chief Executive Officer Michael Gutch, Ph.D. Chief Financial Officer and Chief Business Officer Ruben Tommasi, Ph.D. Chief Scientific Officer John Mueller, Ph.
Slide 4: Company Highlights
Non - Confidential Company Highlights Abbreviations: CRE, Carbapenem - resistant Enterobacterales; MDR, Multidrug resistant ; UTIs, Urinary tract infections 3 Leader in targeted antibiotic development ► Multidrug - resistant, pathogen - targeted focus from discovery through commercialization Innovat
Slide 5: Pathogen Focus
Non - Confidential Pathogen Focus We focus on the resistance mechanisms of these multidrug resistant pathogens. Source: Centers for Disease Control and Prevention, Antibiotic Resistance Threats in the United States, 2019 4 CDC “ Urgent ” Threats CDC “ Serious ” Threat
Slide 6: Differentiated Business Model
Non - Confidential Differentiated Business Model Targeted medicines means streamlined research, development, and commercialization. Abbreviations: FDA, Food and Drug Administration; IP, intellectual property; QIDP, qualified infectious disease product 5 Focused on multidrug resistant pathogens with
Slide 7: Robust Pipeline of Novel Antibiotics
Non - Confidential Robust Pipeline of Novel Antibiotics Entasis has fully - integrated research and development in our Waltham site. Abbreviations: CRE, carbapenem - resistant Enterobacterales; ESBL, extended spectrum β - lactamases; IV, intravenous; NBP, non β - lac tam penicillin binding protein i
Slide 8: Sulbactam-durlobactam (SUL-DUR) for Acinetobacter Infections
Non - Confidential Sulbactam - durlobactam (SUL - DUR; formerly ETX2514SUL) For Acinetobacter Infections Partnered with 7
Slide 9: Carbapenem-Resistant Acinetobacter: Overview
Non - Confidential Carbapenem - Resistant Acinetobacter : Overview Global carbapenem - resistant Acinetobacter rates exceed 50%. Abbreviations: CRAB, carbapenem - resistant Acinetobacter baumannii; EU5, European Union Five (France, Germany, Italy, Spain, United Kingdom); Sources: 1. Data on file. De
Slide 10: Durlobactam: Overview
Non - Confidential Durlobactam: Overview Durlobactam is a molecule with best - in - class Class A,C & D β - lactamase coverage. Abbreviations: IV, intravenous; SUL - DUR, sulbactam - durlobactam. 9 ► A novel IV broad - spectrum β - lactamase inhibitor Differentiator is its broad Class D β - lactamas
Slide 11: SUL-DUR: Pre-Clinical Data
Non - Confidential SUL - DUR: Pre - Clinical Data Compelling preclinical data differentiates SUL - DUR from existing therapies, including colistin. Abbreviations: CFU, colony - forming unit; MIC, minimal inhibitory concentration; SUL - DUR, sulbactam - durlobactam 10 a Extensively drug - resistant (
Slide 12: SUL-DUR: Clinical Data Summary
Non - Confidential SUL - DUR: Clinical Data Summary We have conducted extensive clinical trials to optimize SUL - DUR heading into phase 3. Abbreviations: cUTI , complex urinary tract infection; FDA, Food and Drug Administration; PK, pharmacokinetics; QIDP, qualified infectious diseas e p roduct; SU
Slide 13: SUL-DUR: Single Global Phase 3 Pivotal Trial
Non - Confidential SUL - DUR: Single Global Phase 3 Pivotal Trial The ATTACK trial supports the basis for regulatory submissions in the US, Europe, and China. Abbreviations: BSI, bloodstream infection; CFDA, China Food and Drug Administration; DOT, days of therapy; EMA, European Medi cin es Agency;
Slide 14: SUL-DUR: Single Global Phase 3 Pivotal Trial, Part B
Non - Confidential SUL - DUR: Single Global Phase 3 Pivotal Trial The ATTACK trial also includes a Part B to provide safety and supportive efficacy data. Abbreviations: AP, acute pyelonephritis; cUTI , complicated urinary tract infection; HABP, hospital - acquired bacterial pneumonia; SUL - DUR, sul
Slide 15: ATTACK Phase 3 Pivotal Trial Update
Non - Confidential ATTACK Phase 3 Pivotal Trial As of July 2020, the ATTACK pivotal trial continues to progress despite the COVID - 19 pandemic. 14 ► The ATTACK Pivotal Phase 3 trial remains active in many countries and sites • As of July 2020, 87 clinical trial sites have been activated in 16 count
Slide 16: Commercial Model: Streamlined Execution
Non - Confidential Commercial Model: Streamlined Execution A lean, targeted sales force can efficiently reach key customers with compelling data. Abbreviations: DOT, days of therapy; LOS, length of stay; LTACs, long - term acute care centers. ► Carbapenem - Resistant Acinetobacter can be found in ve
Slide 17: Commercial Model: Product Positioning
Non - Confidential Commercial Model: Product Positioning SUL - DUR aims to replace colistin and polypharmacy in carbapenem - resistant Acinetobacter. Current Treatment Protocols Future Treatment Protocols Nephrotoxic Neurotoxic Slow onset, complex pharmacodynamics Cumbersome dosing protocol and AE m
Slide 18: Commercial Opportunity: Addressable Market
Non - Confidential Commercial Opportunity: Addressable Market At launch, annual worldwide addressable market for CRAB treatments should exceed $1 billion. Abbreviations: CRAB, carbapenem - resistant Acinetobacter; RoW , rest of world . Sources: 1. Data on file. Decision Resources. Note: Addressable
Slide 19: Commercial Opportunity: China
Non - Confidential Commercial Opportunity: China Our Zai Lab partnership will help address CRAB in China. Abbreviations: CRAB, carbapenem - resistant Acinetobacter 18 ► CRAB presents a significant unmet medical need in China and Asia - Pacific territory ► Partnership with Zai Lab (Nasdaq: ZLAB) prov
Slide 20: Zoliflodacin for Gonorrhea Infections
Non - Confidential Zoliflodacin Zoliflodacin For Gonorrhea Infections Partnered with 19
Slide 21: Gonorrhea: Overview
Non - Confidential Gonorrhea: Overview Only one drug remains effective for gonorrhea — intramuscular ceftriaxone. Sources: 1. Rowley J, et al. Bull World Health Organ . 2019;97:548 - 562P. 2. Unemo M, et al. Microbiol Spectr . 2016;4. 3. Gonorrhea - CDC fact sheet (detailed version). CDC website. ht
Slide 22: Gonorrhea: Overview
Non - Confidential Gonorrhea: Overview The CDC has changed its STD Guidelines five times in the last 18 years 1 due to resistance. Sources: 1. CDC: Sexually Transmitted Diseases Treatment Guidelines, MMWR, May 10, 2002; Sexually Transmitted Diseases Treatm ent Guidelines, MMWR, August 4, 2006; Updat
Slide 23: Zoliflodacin: Phase 2 Trial Results
Non - Confidential Zoliflodacin: Phase 2 Trial Results Landmark phase 2 trial results were published in the New England Journal of Medicine . Source: Taylor SN, et al. N Engl J Med. 2018;379:1835 - 1845. ► Phase 2 trial results showed urogenital efficacy in 47 out of 47 patients ► Zoliflodacin was g
Slide 24: Zoliflodacin: Single Global Phase 3 Pivotal Trial
Non - Confidential Zoliflodacin : Single Global Phase 3 Pivotal Trial The phase 3 trial supports the basis for regulatory submissions in the US and Europe. Abbreviations: DSMB, data safety monitoring board; EMA, European Medicines Agency; FDA, US Food and Drug Administration; GARD P, Global Antibiot
Slide 25: Zoliflodacin: Commercial Opportunity
Non - Confidential Zoliflodacin: Commercial Opportunity Zoliflodacin has the potential to be the oral product of choice for gonorrhea. Abbreviations: MIC, minimum inhibitory concentration. a 49 states allow patients diagnosed with gonorrhea to provide medications to take to his/her partner without t
Slide 26: Zoliflodacin: Partnership with GARDP
Non - Confidential Zoliflodacin: Partnership with GARDP The Phase 3 trial is sponsored by the Global Antibiotic Research & Development Partnership. Abbreviations: R&D, research and development Source: GARDP website, Entasis press release (July 6, 2017) ► Developed and fully funded in partnership wit
Slide 27: Commercial Opportunity: Worldwide Addressable Market
Non - Confidential Commercial Opportunity: Worldwide Addressable Market With over 85MM gonorrhea infections annually, the worldwide market could exceed $1 billion. Abbreviations: RoW , rest of world . Sources: 1. Centers for Disease Control and Prevention; 2. Rowley J, et al. Bull World Health Organ
Slide 28: ETX0282CPDP for Complicated UTIs
Non - Confidential ETX0282CPDP (ETX0282 + Cefpodoxime Proxetil ) for Complicated UTIs APPENDIX 27
Slide 29: ETX0282CPDP: Initial Target Addressable Market
Non - Confidential ETX0282CPDP: Initial Target Addressable Market ETX0282CPDP will initially target the 1 million hospital cUTIs resistant to oral treatments. Abbreviations: CPDP, cefpodoxime proxetil ; cUTI , complicated urinary tract infections. Sources: 1. Decision Resources and HCUPNet claims da
Slide 30: ETX0282CPDP
Non - Confidential ETX0282CPDP ETX0282CPDP is a best - in - class oral β - lactamase inhibitor. Abbreviations: CPDP, cefpodoxime proxetil ; CRE, carbapenem - resistant Enterobacterales; ESBL, extended - spectrum β - lactamases; MDR, multidrug - resistant; UTIs, urinary tract infections. ► ETX0282CPD
Slide 31: ETX0282CPDP Activity Against Multidrug-Resistant E. coli
Non - Confidential ETX0282CPDP Oral ETX0282CPDP shows in vitro and in vivo activity against multidrug - resistant E. coli. a ETX0282CPDP is an oral prodrug which is metabolized into ETX1317, the active BLI, and cefpodoxime. The in vitro activity is o f E TX1317 + cefpodoxime. b ARC2687 = multidrug -
Slide 32: ETX0282CPDP Phase 1 Status
Non - Confidential ETX0282CPDP Phase 1 Status Oral ETX0282CPDP has completed initial phase 1 testing. Abbreviations: CPDP, cefpodoxime proxetil 31 Fit - for - purpose formulation ► Drug substance in capsule (no excipients) First in Human study completed ► 99 healthy subjects were enrolled into 12 co
Slide 33: Key Pharmacokinetic (PK) and Safety Findings
Non - Confidential Key Pharmacokinetic (PK) and Safety Findings Oral ETX0282CPDP’s p lasma concentrations are in predicted therapeutic range. Abbreviations: C max , maximum plasma concentration; CPDP, cefpodoxime proxetil . 32 ► ETX0282 is rapidly converted to ETX1317 at all doses evaluated ► Plasma
Slide 34: ETX0462 for Pseudomonas Infections
Non - Confidential ETX0462 ETX0462 for Pseudomonas Infections APPENDIX 33
Slide 35: P. aeruginosa Infections
Non - Confidential P. aeruginosa Infections Pseudomonas infections remain a key priority due to high resistance rates and mortality. Sources: 1. ECDC/EMEA Joint Working Group. ECDC/EMEA Joint Technical Report. The bacterial challenge: time to react. https://www.ecdc.europa.eu/sites/default/files/med
Slide 36: ETX0462
Non - Confidential ETX0462 ETX0462 is a first of a novel class of PBP Inhibitors unaffected by all types of β - lactamases. Abbreviations: MDR, multidrug - resistant; MIC, minimal inhibitory concentration. 35 ► Penicillin Binding Protein inhibitors ( PBPi ) are β - lactam antibiotics representing so
Slide 37: Entasis: A Leader in Targeted Antibiotics
Non - Confidential Entasis: A Leader in Targeted Antibiotics We have hit all major milestones in our first 5 years. Two phase 3 programs (SUL - DUR, zoliflodacin) Phase 1 data (ETX0282CPDP) Fourth candidate selected (ETX0462) Initial Public Offering Second partnership Spinout from AstraZeneca with $
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