Entasis Therapeutics Holdings Inc
Entasis Therapeutics — Investor Presentation (March 2021)
42 slides from Entasis Therapeutics's investor presentation, Mar 23, 2021
Slide 1: Targeted Solutions for Antibacterial Resistance
Company Confidential Targeted Solutions for Antibacterial Resistance Precision antibiotics against critical pathogens March 2021
Slide 2: Disclaimer
Company 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
Company 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: Highlights
Company Confidential Company Highlights Abbreviations: CRE, Carbapenem-resistant Enterobacterales; MDR, Multidrug resistant; cUTIs, Complicated urinary tract infections Leader in targeted antibiotic development ► Multidrug-resistant, pathogen-targeted focus from discovery through commercialization I
Slide 5: Pathogen Focus
Company 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 CDC “Urgent” Threats CDC “Serious” Threat 4
Slide 6: Differentiated Business Model
Company 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 Focused on multidrug resistant pathogens with
Slide 7: Robust Pipeline of Novel Antibiotics
Company Confidential Robust Pipeline of Novel Antibiotics Fully-integrated research and development. Abbreviations: CRE, carbapenem-resistant Enterobacterales; ESBL, extended spectrum β-lactamases; IV, intravenous; NBP, non β-lactam penicillin binding protein inhibitor. a Zai Lab has licensed Asia-P
Slide 8: Key Metrics - unaudited
Company Confidential Key Metrics - unaudited As of 12.31.2020 Cash and cash equivalents $53.2 M Debt $0 M Common shares outstanding 36,637,357 Common warrants outstanding1 23,345,794 Financial Highlights 1. Five-year warrants; 14,000,000 at $2.50 exercise price and 9,345,794 at $2.675 exercise price
Slide 9: Sulbactam-durlobactam (SUL-DUR) For Acinetobacter Infections
Company Confidential Sulbactam-durlobactam (SUL-DUR; formerly ETX2514SUL) For Acinetobacter Infections Partnered with
Slide 10: Carbapenem-Resistant Acinetobacter: Overview
Company 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. Decisio
Slide 11: Durlobactam: Overview
Company Confidential Durlobactam: Overview Durlobactam has broad Class A,C & D β-lactamase coverage. Abbreviations: IV, intravenous; SUL-DUR, sulbactam-durlobactam. ► A novel IV broad-spectrum β-lactamase inhibitor Differentiator is its broad Class D β-lactamase coverage, essential for the treatme
Slide 12: SUL-DUR: Pre-Clinical Data
Company Confidential SUL-DUR: Pre-Clinical Data Preclinical data potentially differentiates SUL-DUR from existing therapies, including colistin. Abbreviations: CFU, colony-forming unit; MIC, minimal inhibitory concentration; SUL-DUR, sulbactam-durlobactam a Extensively drug-resistant (XDR) Acinetoba
Slide 13: SUL-DUR: Clinical Data Summary
Company 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 disease product; SUL-DUR
Slide 14: SUL-DUR: Single Global Phase Pivotal Trial
Company 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 Medicines Agency; FD
Slide 15: SUL-DUR: Single Global Phase Pivotal Trial Part B
Company 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, sulbacta
Slide 16: SUL-DUR: Regulatory Update
Company Confidential SUL-DUR: Regulatory Update FDA willing to collaborate with Entasis to ensure meaningful and successful outcome. Several interactions with FDA from 2016 to present to discuss clinical development plan During August 2020 Type C meeting, Entasis sought flexibility on alpha leve
Slide 17: The ATTACK Trial Projected Timeline
Company Confidential The ATTACK Trial Projected Timeline We currently anticipate top-line data 2H 2021. 16 ► As of March 15, 2021 we have randomized 159 patients into Part A • 90 clinical trial sites active across 17 countries, including China • 107/112 (96%) were carbapenem-resistant; 13/112 (13%)
Slide 18: ATTACK Data and Safety Monitoring Board (DSMB)
Company Confidential DSMB Meeting 1 Feb-2020 No safety findings Recommended that the study continue without modifications Initiate Part B of the study after review of PK data in the first 30 patients DSMB Meeting 2 Jul-2020 No new safety findings Recommended that the study continue without modificat
Slide 19: Commercial Model: Streamlined Execution
Company 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 very
Slide 20: Commercial Model: Product Positioning
Company 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 an
Slide 21: Commercial Model: Minimal Competition
Company Confidential Commercial Model: Minimal Competition Unlike the CRE market, the CRAB market has no labeled competition for 5-10 years. Abbreviations: CRAB, carbapenem-resistant Acinetobacter; CRE, carbapenem-resistant Enterobacterales Source: 1. https://clinicaltrials.gov/ct2/results?cond=Acin
Slide 22: Commercial Opportunity: Addressable Market
Company 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 ma
Slide 23: Commercial Opportunity: China
Company Confidential Commercial Opportunity: China Our Zai Lab partnership will help address CRAB in China. Abbreviations: CRAB, carbapenem-resistant Acinetobacter ► CRAB presents a significant unmet medical need in China and Asia-Pacific territory ► Partnership with Zai Lab (Nasdaq: ZLAB) provides
Slide 24: Zoliflodacin For Gonorrhea Infections
Company Confidential Zoliflodacin Zoliflodacin For Gonorrhea Infections Partnered with
Slide 25: Gonorrhea: Overview
Company 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. https:
Slide 26: Gonorrhea: Overview
Company Confidential Gonorrhea: Overview The CDC has changed its STD Guidelines five times in the last 18 years1 due to resistance. Sources: 1. CDC: Sexually Transmitted Diseases Treatment Guidelines, MMWR, May 10, 2002; Sexually Transmitted Diseases Treatment Guidelines, MMWR, August 4, 2006; Updat
Slide 27: Zoliflodacin: Phase 2 Trial Results
Company 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 ge
Slide 28: Zoliflodacin: Single Global Phase Pivotal Trial
Company 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; GARDP, Global Antibiot
Slide 29: Zoliflodacin: Commercial Opportunity
Company 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
Slide 30: Zoliflodacin: Partnership with GARDP
Company 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 w
Slide 31: Commercial Opportunity: Worldwide Addressable Market
Company 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 32: Zoliflodacin: Competition
Company Confidential Zoliflodacin: Competition GSK’s gepotidacin is the only near-term competitor in phase 3 development. Sources: 1. ClinTrials.gov: NCT04010539; 2. Taylor, CID 2018:67 (August) 4 tablets (750mg each) taken at clinic 4 tablets 750mg taken at home 6-12 hours later After food, with wa
Slide 33: ETX0282CPDP for Complicated UTIs
Company Confidential ETX0282CPDP (ETX0282 + Cefpodoxime Proxetil) for Complicated UTIs APPENDIX
Slide 34: ETX0282CPDP: Initial Target Addressable Market
Company 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 35: ETX0282CPDP
Company Confidential ETX0282CPDP ETX0282 is a novel broad-spectrum oral β-lactamase inhibitor. Abbreviations: CPDP, cefpodoxime proxetil; CRE, carbapenem-resistant Enterobacterales; ESBL, extended-spectrum β-lactamases; MDR, multidrug-resistant; UTIs, urinary tract infections. ► ETX0282CPDP could be
Slide 36: ETX0282CPDP In Vitro and In Vivo Activity
Company 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 of ETX1317 + cefpodoxime. bARC2687 = multidrug-resi
Slide 37: ETX0282CPDP Phase 1 Status
Company Confidential ETX0282CPDP Phase 1 Status Oral ETX0282CPDP has completed initial phase 1 testing. Abbreviations: CPDP, cefpodoxime proxetil Fit-for-purpose formulation ► Drug substance in capsule (no excipients) First in Human study completed ► 99 healthy subjects were enrolled into 12 cohorts
Slide 38: Key Pharmacokinetic (PK) and Safety Findings
Company Confidential Key Pharmacokinetic (PK) and Safety Findings Oral ETX0282CPDP’s plasma concentrations are in predicted therapeutic range. Abbreviations: Cmax, maximum plasma concentration; CPDP, cefpodoxime proxetil. ► ETX0282 is rapidly converted to ETX1317 at all doses evaluated ► Plasma conc
Slide 39: ETX0462 for Pseudomonas Infections
Company Confidential ETX0462 ETX0462 for Pseudomonas Infections APPENDIX
Slide 40: P. aeruginosa Infections
Company 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/m
Slide 41: ETX0462
Company 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. ► Penicillin Binding Protein inhibitors (PBPi) are β-lactam antibiotics representing some of the
Slide 42: Entasis: A Leader in Targeted Antibiotics
Company 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 $
Entasis Therapeutics Holdings — Investor Presentation (March 2021) on 6ix