Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Evercore ISI HealthCONx Conference 2020
38 slides from Spero Therapeutics's conference presentation, Dec 3, 2020
Slide 1: Corporate Presentation, Evercore ISI HealthCONx Conference
Corporate Presentation Evercore ISI HealthCONx Conference December 3, 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 design, initiation, timing and submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (N
Slide 3: Robust Infectious Disease and Rare Disease Portfolio led by Oral Tebipenem HBr
Tebipenem HBr (previously SPR994): oral carbapenem ADAPT-PO Phase 3 met its primary endpoint in landmark trial – Oral tebipenem HBr demonstrated noninferiority to IV ertapenem in cUTI and AP; safety results similar to intravenous ertapenem NDA submission planned for 2H21 Pipeline of assets supported
Slide 4: Leadership Team
Cristina Larkin I Chief Operating Officer Prior Vice President, Infection, Forest Laboratories 25+ years of commercial expertise with multiple antibiotic launches including Teflaro, Dalvance, Avycaz, Levaquin Launched seven products across variety of therapeutic categories in retail and hospital Lea
Slide 5: Multiple Catalysts Across the Pipeline
Multiple Catalysts 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 treatment
Slide 6: Spero Pipeline Assets Share Common Attributes With Other Successful ID Drugs
Spero Pipeline Assets Share Common Attributes With Other Successful ID Drugs Non-DRG reimbursement High unmet need with strong economic benefit $1 B+ Sales* *Estimated Peak Year Worldwide Sales *Trademarks are properties of their respective owners
Slide 7: Oral Carbapenem Tebipenem HBr
Oral Carbapenem Tebipenem HBr
Slide 8: 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 2H21 One well-controlled pivotal trial to form
Slide 9: Pivotal Phase 3 Trial Design: Oral Tebipenem HBr vs IV Ertapenem
Pivotal Phase 3 Trial Design: Evaluation of Oral Tebipenem HBr compared to 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 q8h) IV Only Ertapenem (1g q24h) Duration of t
Slide 10: ADAPT-PO Safety Population Demographics
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 11: ADAPT-PO 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 Demonstrated Statistical Non-inferiority Compared to Ertapenem Demonstrated non-inferiority at margin of -12.5%* Results were simila
Slide 12: ADAPT-PO Key Secondary Endpoints
ADAPT-PO Key Secondary Endpoints Evaluating Patient Outcomes Clinical cure rates at test-of cure (TOC) 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
Slide 13: ADAPT-PO Safety and Tolerability Results
ADAPT-PO Safety and Tolerability Results Safety and tolerability profiles similar across the oral tebipenem HBr and IV ertapenem arms TEAE rates generally consistent with that of the carbapenem/beta-lactam class Diarrhea and headache were the most commonly reported TEAEs in both treatment groups No
Slide 14: ADAPT-PO: Landmark Trial with Potential to Change Clinical Practice
ADAPT-PO: Landmark Trial with Potential to Change Clinical Practice Head-to-head results support regulatory submission of tebipenem HBr for the treatment of cUTI/AP ✓ ✓ ✓ Landmark trial demonstrating value of all oral regimen Safety results similar to IV ertapenem Met primary endpoint of combined cl
Slide 15: Lack of Oral Options for cUTI is Widespread, Costly, and Addressable
Lack of Oral Options for cUTI is Widespread, Costly, and Addressable 2000-2004 Hospital Community $10,741 $7,083 76% Increase in hospitalizations +2 Days Longer Stays in Hospital Resistance + No Viable Oral cUTI Option = 2.3M Potentially Avoidable Hospitalizations Major Unnecessary Cost Growing Fluo
Slide 16: Tebipenem HBr Potential to be a Highly Differentiated Therapy
Tebipenem HBr has the Potential to be a Highly Differentiated Therapy if Approved No branded or generic oral substitutes in the carbapenem class Existing, large, and growing unmet need Primary reimbursement outside of the hospital Current practice and financial incentives support usage Prescriber ba
Slide 17: Tebipenem HBr Developed to Address a Large and Existing UTI Population
Tebipenem HBr Developed to Address a Large and Existing UTI Population Katrina, college student at the University of Kansas, experienced “a U.T.I. that did not respond to three different rounds of antibiotics.” “It got so bad that I was out of school for months and had to get a medical withdrawal,”
Slide 18: Carbapenem Market Estimated at $3B in United States Alone
Source: IQVIA NDS Database, Accessed 11/06/2018; AMR data on use by indication; 2017 UTI data projected Source: IQVIA NDS Database, accessed 11/06/2018 Ertapenem is the most used carbapenem to treat UTI Outpatient calculated as volume in “Clinics” and “Home Health and Long Term Care” channels *Analy
Slide 19: Large Market Opportunity for Patients Able to Be Treated at Home
Large Market Opportunity for Patients Able to Be Treated at Home Source: IQVIA 2019; Komodo 2020 data; Becton Dickinson Market Research, 2020 Pip/tazo = Piperacillin and tazobactam Targeted patients often cycle through multiple therapies Spero Focus 2.7M UTI prescriptions 2nd line+ Oral or IV therap
Slide 20: 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 Pip/tazo = Piperacillin and tazobactam Initial sales team focused on high volume retail practices
Slide 21: Unmet Need Identified by Healthcare Providers; Expect Broad Access Across Payer Channels
Unmet Need Identified by Healthcare Providers; Expect Broad Access Across Payer Channels HCPs identify carbapenems as a preferred drug class for our target patients HCPs and Payers see potential value of tebipenem HBr Interactions with 100+ Health Care Professionals and 150M Payer Lives There is hig
Slide 22: Tebipenem HBr Well Positioned to Recognize Significant Market Opportunity
Value-Based Pricing Consistent with other unmet need antibiotics Anticipated 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 failed cUTIs Robust IP Coverage through 2038; Granted QIDP and Fa
Slide 23: Zyvox Go-Home/Stay Home Analogue for Tebipenem HBr Launch
Zyvox MRSA Gram-positive Market Tebipenem HBr FQ-R Gram-negative Market Mkt size (pts) 1.8 M 2.2 M Resistance to oral options at launch 29% 36% Resistance to oral options at peak 64% 66%* Reimbursement landscape Restricted Restricted Pricing model Premium Premium Zyvox Launch Curve-Time to Peak 5 Ye
Slide 24: Next Steps for Tebipenem HBr
Next Steps for Tebipenem HBr Complete NDA package - Meeting with FDA and finalizing 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 25: Rare Disease Pipeline SPR720
Rare Disease Pipeline SPR720
Slide 26: NTM: Absence of Effective and Well-tolerated Drugs Leaves Patients Without Options
Severe cough “It [coughing] could go on for a good 90 minutes, and I'm just down on the floor, on my knees, grabbing my ribs, hacking.” Fatigue “I've been in the grocery store with the shopping cart, but I didn't have the energy to wait in line to check out.” Dyspnea Limits the types of activities t
Slide 27: Current Therapies for NTM Have Limitations
Current Therapies for NTM Have Limitations Better options are needed for the more than 75% of non-refractory patients without approved therapies Arikayce® (Approved Inhaled Therapy) Generic Standard of Care SPR720 (Oral Product Candidate) Tolerability Poor Poor Tolerability in Phase 1 supports advan
Slide 28: SPR720: First Novel Oral Candidate Designed to Treat NTM Infections
SPR720: First Novel Oral Candidate Designed to Treat NTM Infections Broad spectrum, oral candidate: applicable to both non-refractory and refractory patients More than 75% of NTM patients are non-refractory; lack any approved options to treat NTM Planned once daily dose supported by clinical and non
Slide 29: SPR720 Target Population
Refractory Inhaled Arikayce® approved for NTM Anatomical disease (fixed lung injury) Treatment benefits limited by: Declining lung function Additional co-morbidities SPR720 Patient Focus Inflammatory disease (tissue burden drives inflammatory response) Treatment Naïve Bronchial hygiene/ clearance, e
Slide 30: SPR720 Support for Advancement to Phase 2
SPR720 Support for Advancement to Phase 2 ✓ ✓ ✓ ✓ FDA meeting supportive of stepwise development plan Acknowledged Phase 2a trial including the clinical trial endpoints and duration of therapy as an appropriate next development step Longer-term development of SPR720 as part of a combination regimen
Slide 31: Proposed Phase 2a: Early and Robust Clinical Proof of Concept
Proposed Phase 2a: Early and Robust Clinical Proof of Concept Next Steps for the Development Plan Phase 2a Trial in NTM If trial results are positive, SPR720 would be the only agent shown to drive early microbiological response as a stand-alone agent versus placebo Treatment Population Treatment Arm
Slide 32: Phase 1 SAD/MAD Data Supports Advancing to Phase 2 Trial
Multiple Ascending Dose Cohorts (N = 40) Single Ascending Dose Cohorts (N = 56) Phase 1 SAD/MAD Data Supports Advancing to Phase 2 Trial Data indicates therapeutic exposure can be attained with dose associated with low incidence of adverse events (500 – 1000mg once daily) No SAEs reported; Mild GI s
Slide 33: SPR720 500mg–1000mg QD Dose Range Supported by Several Models
SPR720 500mg – 1000mg QD dose range supported by: Proposed Once Daily Phase 2 Treatment Dose is Supported by Several Models In vitro models In vivo models Hollow fiber M. avium infection model Inhibitory concentrations (MIC90) <4mg/mL for clinically relevant NTM strains. Favorable to amikacin Activi
Slide 34: SPR720 Demonstrated Dose Response in Murine Models
SPR720 Demonstrated Dose Response Lung Infections in Multidrug Resistant M. abscessus Strains in Murine Models 8 6 4 2 0 Lung burden (Log10CFU) Control – day 27 Control – day 61 SPR720 25 mg/kg SPR720 50 mg/kg SPR720 100 mg/kg AMK 150 mg/kg n = 6 n = 6 n = 6 n = 6 n = 6 n = 6 Multidrug resistant M.
Slide 35: Direct Acting IV Potentiator: SPR206
Direct Acting IV Potentiator: SPR206
Slide 36: SPR206 Phase 1 Doses Likely Within a Therapeutic Range
Successful Phase 1 doses likely to be within a therapeutic range for MDR Gram-negative bacterial infections Mean plasma drug exposures concordant with models predictive for clinical efficacy against target Gram-negative pathogens Phase 1 SAD/MAD Preliminary Data (N = 96) Preclinical Data Supports In
Slide 37: Financial Overview
Financial Overview Funded into the second quarter of 2022, through the NDA submission for tebipenem HBr BARDA/DTRA non-dilutive funding award for tebipenem HBr up to $56.7M; additional awards and alliances provide funding for pipeline $ in 000’s Income Statement Three Months Ended September 30, 2020
Slide 38: Key Investment Highlights
Experienced management team Key Investment Highlights Accelerated path to market Significant near-term catalysts Pipeline products with a solid value proposition Multiple drugs in clinical development Large and existing market opportunities
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