Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Cantor Healthcare Conference 2020
37 slides from Spero Therapeutics's conference presentation, Sep 16, 2020
Slide 1: Corporate Presentation – Cantor Healthcare Conference
Corporate Presentation September 16, 2020 Cantor Healthcare Conference 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: Spero: Robust Rare and Infectious Disease Portfolio led by Oral Tebipenem HBr
Tebipenem HBr (previously SPR994): First 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; well-tolerated with comparable safety profile to intravenous ertapenem NDA submission planned for 2Q21
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 Assets Share Common Attributes With Other Successful ID Drugs
Spero 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
Slide 7: First Oral Carbapenem Tebipenem HBr
First 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 2Q21 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 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 ther
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 Demonstrates Statistical Non-inferiority Compared to Ertapenem Demonstrated non-inferiority at margin of -12.5%* Results were simila
Slide 12: ADAPT-PO 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 13: ADAPT-PO 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 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 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 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 Avoidable Hospitalizations Major Unnecessary Cost Growing Fluoroquinolone
Slide 16: Tebipenem HBr has the Potential to be a Highly Differentiated Therapy
Tebipenem HBr has the Potential to be a Highly Differentiated Therapy No branded or generic oral substitutes Existing, large, and growing unmet need Primary reimbursement outside of the hospital Current practice and financial incentives support usage Prescriber base beyond infectious disease
Slide 17: Tebipenem HBr Intended to Treat a Large and Existing UTI Population
Tebipenem HBr Intended to Treat 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,” she
Slide 18: 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 19: 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 20: 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 21: 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 22: Zyvox as 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 23: 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 24: Rare Disease Pipeline SPR720
Rare Disease Pipeline SPR720
Slide 25: NTM: An 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 26: 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 Well tolerated up to 1000 QD dose in P
Slide 27: SPR720: First Novel Oral Candidate Designed to Treat NTM Infections
SPR720: First Novel Oral Candidate Designed to Treat NTM Infections Broad spectrum, well-tolerated 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 c
Slide 28: SPR720 Patient Focus and 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 29: SPR720 Support for Advancement to Phase 2
SPR720 Support for Advancement to Phase 2 ✓ ✓ ✓ ✓ Recent 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 r
Slide 30: 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 31: 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 a well-tolerated dose (500 – 1000mg once daily) Well Tolerated No SAEs reported; Mild GI symptoms at >1500
Slide 32: SPR720 500mg–1000mg QD Dose Range Supported by 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 33: SPR720 Demonstrated Dose Response in Murine Lung Infection 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 34: Direct Acting IV Potentiator: SPR206
Direct Acting IV Potentiator: SPR206
Slide 35: SPR206 Phase 1 and Preclinical Data Against MDR Gram-negative Pathogens
Well-tolerated at 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 Inc
Slide 36: Financial Overview
Financial Overview September 2020 follow-on financing provides gross proceeds of $80M Funded into the first quarter of 2022, through the NDA submission and the approval process for tebipenem HBr BARDA/DTRA non-dilutive funding award for tebipenem HBr up to $56.7M; additional awards and alliances pro
Slide 37: 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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