Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (January 2022)
36 slides from Spero Therapeutics's investor presentation, Jan 25, 2022
Slide 1: Corporate Presentation January 2022
Corporate Presentation January 2022 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 potential approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for tebipenem HBr;
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 accepted by FDA, with Priority Review. PDUFA DATE: June
Slide 4: Multiple Catalysts Across the Pipeline
Multiple Catalysts Across the Pipeline Program Target Indication Preclinical Phase 1 Phase 2 Phase 3 Upcoming Milestone Partnerships/Alliances Oral Carbapenem for Gram Negative Multidrug Resistant (MDR) Infections Tebipenem HBr Complicated UTI (cUTI) NDA accepted for the treatment of cUTI with Prior
Slide 5: 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 6: Oral Carbapenem Tebipenem HBr
Oral Carbapenem Tebipenem HBr
Slide 7: 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 Positive results in landmark study unprecedented for the field Overall combined response rate: Oral tebipenem HBr response rate of 58.8% versus 61.6% for
Slide 8: Pivotal Phase 3 Trial Design: Oral Tebipenem HBr compared to IV Ertapenem
All Oral Tebipenem HBr 685 patients Pivotal Phase 3 Trial Design: Evaluation of Oral Tebipenem HBr compared to IV Ertapenem Randomization 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 9: 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 10: 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 11: 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 12: 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 First all oral regimen for cUTI in 26 years, if approved Non-inferior efficacy t
Slide 13: 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 base beyond infectious disease specialists Tebipenem HBr has the Potential to be a H
Slide 14: 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 15: Tebipenem HBr Developed to Address a Large and Existing UTI Population
Tebipenem HBr Developed to Address a Large and Existing UTI Population Stay Home: Hospital Avoidance 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
Slide 16: 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 17: 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 Lack of effective oral treatment options has resulted in incre
Slide 18: 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 19: 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 20: Tebipenem HBr Well Positioned to Recognize Significant Market Opportunity Upon Approval
Anticipated Favorable Payer Coverage Largest Unmet Need in Infection Today 2.7 Million resistant or failed cUTIs Robust IP Coverage through 2038; Granted QIDP designation Targeted Commercial Footprint Commercial Support: Tebipenem HBr for the treatment of cUTI Lack of Competition No branded or gener
Slide 21: 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 22: Next Steps for Tebipenem HBr
NDA package accepted by the FDA with Priority Review. Preparing for June 27, 2022 PDUFA date Exploring lifecycle management opportunities – Microbiological surveillance and clinical studies Manufacturing readiness – Process validation and launch planning Launch readiness – Market development work, p
Slide 23: Rare Disease Pipeline SPR720
Rare Disease Pipeline SPR720
Slide 24: NTM: Absence of Effective and Well-tolerated Drugs Leaves Patients Without Options
Non-tuberculous mycobacterial disease (NTM) is a chronic infection with debilitating pulmonary symptoms. Patients need therapy early in their disease journey. No approved options exist SPR720 has orphan drug designation and, if approved, could be the first and only novel oral treatment for NTM NTM:
Slide 25: 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 Approximately 95,000 patients in US. Total of 245,000 in US, Europe* and Japan1 More than 75% of NTM patients are non-refractory1; lack any ap
Slide 26: SPR719 Possesses Potent In vitro Activity Against a Range of NTM Species
SPR719* Possesses Potent In vitro Activity Against a Range of NTM Species Abbreviation: AMK: Amikacin Source: Brown-Elliott, B.A., et. al. Antimicrob Agents Chemother. 2018; 62 (11): e01503-18. *SPR719 is the active parent of SPR720 and is used for in vitro testing NTM Species N SPR719 MIC50 SPR719
Slide 27: SPR720: Effective as Monotherapy & Combination Therapy in M. abscessus Murine Model
SPR720 Combinations SOC Test Article MIC (mg/mL) SPR719 1 Amikacin 2 Clarithromycin >8 Poster presentation: “Activity of a Novel Gyrase Inhibitor In Vitro and in Mouse Models of Pulmonary Infection Caused by Mycobacterium abscessus” A. Rubio, D. Verma, D. Ordway; NITM IR Annual Conference, May 2018
Slide 28: SPR720 Pulmonary Activity versus M. avium in a Murine Chronic Infection Model
SPR720 Pulmonary Activity versus M. avium ATCC 700898 in a Murine Chronic Infection Model From the lab of Diane Ordway (CSU) Clarithromycin (CLR): QD x 28d at 250 mg/kg; Ethambutol (EMB): QD x 28d at 100 mg/kg SPR720 as monotherapy and in combination with SOC agents ++ - +++ ++ + + + + - - - + + - +
Slide 29: Direct Acting IV Potentiator: SPR206
Direct Acting IV Potentiator: SPR206
Slide 30: WHO Identifies These Bacteria as Critical Priority for New Antibiotics
Carbapenem-Resistant Acinetobacter >90% observed resistance rate in ATTACK trial 40-50% mortality rate on SoC >$100K potential cost per patient Carbapenem-Resistant Enterobacteriaceae 48 out of 50 states have documented CRE infections 2-4x increased mortality vs. carbapenem sensitive >$80K potential
Slide 31: SPR206 Has Potential to Address Significant Unmet Need
SPR206 Has Potential to Address Significant Unmet Need Infections caused by carbapenem-resistant pathogens (E. coli, Klebsiella, Pseudomonas, Acinetobacter, Enterobacteriaceae) are a significant unaddressed need 2-4X mortality rate for carbapenem-resistant Enterobacteriaceae versus carbapenem-suscep
Slide 32: SPR206 Phase 1 Data and Preclinical Potency Support Advancement
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 No evidence or nephrotoxicity at predicted therapeutic dose levels, pr
Slide 33: SPR206 Next Steps: Complete BAL and Renal Impairment Clinical Trials
SPR206 Next Steps: Complete BAL and Renal Impairment Clinical Trials Phase 1 trials initiated in 2Q21; results expected by early 2022 Trial Overview Target Enrollment: 30 Number of Cohorts: 5 Dosing: 3 doses (100 mg, q8h) in one day Objective: Evaluate intrapulmonary PK, including epithelial lining
Slide 34: Financial Overview
Financial Overview HCR Revenue Interest Financing (9/30/2021): $50M upfront in October 2021 plus $50M upon FDA approval of tebipenem HBr, extends cash runway into 2H 2023 BARDA/DTRA non-dilutive funding award for tebipenem HBr up to $69.7M; NIAID award for SPR206 of up to $23M; additional awards and
Slide 35: 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 36: 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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