Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Corporate Update (September 2020)
16 slides from Spero Therapeutics's corporate update, Sep 8, 2020
Slide 1: ADAPT-PO Phase 3 Topline Data Conference Call
ADAPT-PO Phase 3 Topline Data Conference Call September 8, 2020 Exhibit 99.1
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, the initiation, timing and submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for
Slide 3: ADAPT-PO Phase 3 Results: Tebipenem HBr
ADAPT-PO Phase 3 Results Tebipenem HBr Building Spero as the leader in the field of antibiotic drug development Trial met primary endpoint of non-inferiority of oral tebipenem HBr versus IV ertapenem for the treatment of complicated urinary tract infections and acute pyelonephritis
Slide 4: Tebipenem HBr: Positive ADAPT-PO Phase 3 Trial Results
Tebipenem HBr: Positive ADAPT-PO Phase 3 Trial Results Robust Results Support NDA Submission and Potential Treatment Shift from IV to Oral in cUTI Landmark ADAPT-PO Trial Met Primary Endpoint Positive ADAPT-PO Trial Results Support an NDA Submission in 2Q21 One well-controlled pivotal trial to form
Slide 5: Pivotal Phase 3 Trial Design: Oral Tebipenem HBr vs IV Ertapenem
Pivotal Phase 3 Trial Design: Evaluation of Oral Tebipenem HBr compared IV Ertapenem Randomization All Oral Tebipenem HBr 685 patients All IV Ertapenem 687 patients Primary Endpoint Head-to-Head Comparison: Oral vs. IV† Oral Only Tebipenem HBr (600mg TID) IV Only Ertapenem (1g q24h) Duration of ther
Slide 6: Safety Population Demographics: Representative of Anticipated cUTI Population
ADAPT-PO Safety Population Demographics: Representative of Anticipated cUTI Population Parameters balanced across treatment arms Mean age: 57 years; 43.6% age 65 years of age or older 55% female, 45% male population Baseline diagnosis of cUTI (52%) vs. AP (48%) within range anticipated based on hist
Slide 7: Met Its Primary Efficacy Endpoint
ADAPT-PO Met Its Primary Efficacy Endpoint ADAPT-PO primary endpoint: Clinical cure + microbiological eradication at test-of-cure in micro-ITT population Tebipenem HBr Demonstrates Statistical Non-inferiority Compared to Ertapenem Demonstrated non-inferiority at margin of -12.5%* Results were simila
Slide 8: Key Secondary Endpoints Support Robust Patient Outcomes
ADAPT-PO Key Secondary Endpoints Support Robust Patient Outcomes Clinical cure rates at test-of cure for micro-ITT groups comparable between the oral tebipenem HBr and IV ertapenem treatment arms Comparable Clinical Cure Rates at TOC Median duration of therapy was similar for both treatment groups M
Slide 9: Safety and Tolerability Results
ADAPT-PO Safety and Tolerability Results Safety and tolerability well balanced across the oral tebipenem HBr and IV ertapenem arms TEAE profile consistent with that of the carbapenem/beta-lactam class Diarrhea and headache were the most commonly reported TEAEs in both treatment groups No C. difficil
Slide 10: Landmark trial with potential to change clinical practice
ADAPT-PO: Landmark trial with potential to change clinical practice Head-to-head results support potential effectiveness of tebipenem HBr with a favorable safety and tolerability profile in the treatment of cUTI/AP ✓ ✓ ✓ Landmark trial demonstrating value of all oral regimen First all oral regimen f
Slide 11: Large Market Opportunity for Go Home & Stay Home Patients
Large Market Opportunity for Go Home & Stay Home Patients Source: IQVIA 2019; Komodo 2020 data; Becton Dickinson Market Research, 2020 Targeted patients often cycle through multiple therapies 7.9 M UTI Patients in the US Spero Focus 2.7M UTI prescriptions 2nd line+ Oral or IV therapy Lack of oral tr
Slide 12: Targeted Launch Based on Concentrated Prescribers and Focus on Urology
Targeted Launch Based on Concentrated Prescribers and Focus on Urology Source:: IQVIA 2019; 1.35 = 50% of volume (deciles 6-10) from IQVIA 2019; Komodo 2020 data; Becton Dickinson Market Research, 2020 Initial sales team focused on high volume retail practices and hospitals 7.9 M UTI Patients in the
Slide 13: Unmet Need Identified by Healthcare Providers; Expect Broad Access Across Payer Channels
Unmet Need Identified by Healthcare Providers; Expect Broad Access Across Payer Channels HCP identify carbapenems as the agent of choice for our target patients HCPs and Payers see value of tebipenem HBr Interactions with 100+ Health Care Professionals and 150M Payer Lives There is high agreement th
Slide 14: Tebipenem HBr Well Positioned to Recognize Significant Market Opportunity
Tebipenem HBr Well Positioned to Recognize Significant Market Opportunity Value-Based Pricing Consistent with other unmet need antibiotics Favorable Payer Coverage Primarily reimbursed as a pharmacy benefit and not under hospital DRG Largest Unmet Need in Infection Today 2.7 Million resistant or fai
Slide 15: Next Steps for Tebipenem HBr
Next Steps for Tebipenem HBr Complete NDA package - Meeting with FDA and completing Phase 1 trials Exploring lifecycle management opportunities – Microbiological surveillance and clinical studies Manufacturing readiness – Process validation and launch planning Launch readiness – Market development w
Slide 16: Multiple Catalysts Planned Across the Pipeline
Multiple Catalysts Planned Across the Pipeline Program Indication Preclinical Phase 1 Phase 2 Phase 3 Upcoming Milestone Partnerships/Alliances Partnerships/Alliances Oral Carbapenem for Gram Negative Multidrug Resistant (MDR) Infections Tebipenem HBr Complicated UTI (cUTI) NDA submission for the tr
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