Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Jefferies Healthcare Conference 2020
34 slides from Spero Therapeutics's conference presentation, Jun 4, 2020
Slide 1: Corporate Presentation - Jefferies Healthcare Conference
Corporate Presentation June 4, 2020 Jefferies 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, progress and results of the Company’s preclinical studies and clinical trials and its research an
Slide 3: Spero Company Overview
Spero Company Overview Spero Therapeutics, Inc. is a multi-asset, clinical-stage company focused on developing and commercializing novel treatments for multidrug-resistant bacterial infections and rare diseases 1) as of 6/2/2020 2) as of 3/31/20 NASDAQ GS SPRO Market Capitalization $254M1 Cash & equ
Slide 4: Tebipenem HBr: First oral carbapenem; pipeline summary
Tebipenem HBr (previously SPR994): First oral carbapenem Single Phase 3 trial required for approval in cUTI ongoing; Interim PK evaluation supports continuing trial at selected dose; Enrollment complete with topline data expected 3Q20 Phase 2 supports activity in cUTI; marketed since 2009 in Japan P
Slide 5: Leadership Team
Cristina Larkin I Chief Operating Officer Prior Vice President, Infection, Forest Laboratories Led the commercial hospital antibiotic franchise team at Actavis/Forest; launched Teflaro, Dalvance, Avycaz Over 22 years of experience in commercial strategy Leadership Team Ankit Mahadevia, MD I Chief Ex
Slide 6: Multiple Catalysts Across the Pipeline
Multiple Catalysts Across the Pipeline Program Indication Preclinical Phase 1 Phase 2 Phase 3 Status Partnerships/Alliances Partnerships/Alliances Oral Carbapenem for Gram Negative Multidrug Resistant (MDR) Infections Tebipenem HBr Complicated UTI (cUTI) Phase 3 (ADAPT – PO) enrollment complete; top
Slide 7: 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 8: First Oral Carbapenem Tebipenem HBr
First Oral Carbapenem Tebipenem HBr
Slide 9: 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 10: 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 11: 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 12: Pivotal Phase 3 Trial Evaluates Oral Tebipenem HBr Efficacy
2 Pivotal Phase 3 Trial Evaluates Oral Tebipenem HBr Efficacy Equivalence to IV Ertapenem Randomization All Oral Tebipenem HBr ~685 patients All IV Ertapenem ~685 patients Primary Endpoint Head-to-Head Comparison: Oral vs. IV† Oral Only Tebipenem HBr (600mg TID) IV Only Ertapenem (1g q24h) Duration
Slide 13: Safety, Efficacy and PK Data Support Ongoing Phase 3 Trial
Safety, Efficacy and Pharmacokinetic Data Support Ongoing Tebipenem HBr Phase 3 Trial Approximately 60% oral bioavailability High drug levels at infection site Interim Phase 3 data on plasma PK levels in patients confirms treatment dose Phase 2 cUTI studies demonstrate comparability to the efficacy
Slide 14: Tebipenem Pivoxil Phase Data are Supportive of Activity in cUTI
Tebipenem Pivoxil Phase 2 Data are Supportive of Activity in cUTI Tebipenem pivoxil hydrobromide = Spero’s API, orally available prodrug salt; listed doses refer to dose of active tebipenem. Tebipenem pivoxil = Meiji’s API, orally available prodrug; Phase 2 conducted by Meiji Note: No head-to-head s
Slide 15: Urine Concentration of Tebipenem HBr after a Single Dose
Urine Concentration of Tebipenem HBr after a Single Dose Free Plasma Concentrations of Tebipenem HBr 50% of TID dosing interval 600mg dose provides >50% fT>MIC for E. coli and K. pneumoniae, the most prevalent cUTI pathogens High urine concentration affords additional margin of exposure in cUTI High
Slide 16: Tebipenem HBr Stay Home Opportunity
Tebipenem HBr Stay Home Opportunity 1.2M (13%) patients have Resistant/ Recurrent infections or Fail oral therapies and have to receive IV antibiotics* ~$10,700 Hospitalization cost OR ~$5,000 OPAT cost + 25% complication rate *99% of patients are eligible for oral therapy 9.2M UTI patients will rec
Slide 17: Tebipenem HBr Go Home Opportunity
Tebipenem HBr Go Home Opportunity 1M (35%) are resistant to oral therapies and must remain on IV antibiotics +2 Days longer in Hospital & ~$2K/day Loss to Hospital per patient & ~$9,000 Post Acute Care costs per patient 3.3M UTI patients either require hospitalization or acquire UTI during hospitali
Slide 18: Tebipenem HBr is a Multi-Billion Dollar Market Opportunity
Total Patients Oral Resistant* Eligible for oral Target Population Community UTI Hospital Avoidance 9.2M 13% 99% 1.2M Hospital UTI Shorten LOS 3.3M 35% 85% 1M Infection Prevalence (In millions) Addressable DOT (In millions) Price Value (in billions) Branded Agents (approved or in late development) U
Slide 19: Zyvox 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 20: Rare Disease Pipeline SPR720
Rare Disease Pipeline SPR720
Slide 21: NTM: An Absence of Effective and Well-tolerated Drugs
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 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 29: 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 30: Direct Acting IV Potentiator: SPR206
Direct Acting IV Potentiator: SPR206
Slide 31: SPR206 Phase 1 Data and Preclinical Potency
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 32: Major Near-term Pipeline Catalysts
Major Near-term Pipeline Catalysts SPR720 SPR206 3Q20: Top-line pivotal Phase 3 ADAPT- PO clinical trial results in cUTI 2H20: Initiate Phase 1 BAL study in healthy subjects 1Q21: NDA filing with the FDA for cUTI indication Oral Carbapenem Gram-negative Infections Tebipenem HBr Oral DNA Replication
Slide 33: Financial Overview
Financial Overview Funded into the first quarter of 2021, beyond a potential tebipenem HBr NDA filing BARDA/DTRA non-dilutive funding support for tebipenem HBr up to $56.7M; additional awards and alliances provide funding for pipeline $ in 000’s Income Statement Three Months Ended March 31, 2020 Tot
Slide 34: 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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