Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (November 2018)
29 slides from Spero Therapeutics's investor presentation, Nov 13, 2018
Slide 1: Company Presentation November 13, 2018
Company Presentation November 13, 2018 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, development plans, regulatory activities, anticipated milestones, product candidate benefits, competitive position, busin
Slide 3: Building the Next Great ID Company
Building the Next Great ID Company Clinical Assets with Multiple Near Term Catalysts Significant Commercial Opportunity with SPR994 SPR994 has Supportive Safety and Efficacy Data Strong Management Team & Capital Base A multi-billion dollar U.S. market opportunity Focus on community setting and early
Slide 4: Development Activities through 2019: Three Clinical-Stage Programs
Development Activities through 2019 Three Clinical-Stage Programs Phase 1 SPR994* SPR741 Phase 1b GRAM-NEGATIVE PROGRAM POTENTIATOR PLATFORM SPR720 Preclinical NTM PROGRAM 2018 SPR206 Preclinical Phase 3 Initiation in cUTI: Around YE18 As of November 13, 2018 Ongoing Development Activity Planned Fut
Slide 5: Blockbuster Anti-infectives Share Common Attributes
Blockbuster Anti-infectives Share Common Attributes *Estimated Peak Year Worldwide Sales High unmet need, limited generic competition Community Focus** Community focus �� �� ✓ �� ✓ ✓ ✓ < $200 M Sales* Dalvance; Orbactive; Sivextro $200 - 500 M Sales* Avycaz; Vabomere; Tygacil $1 B+ Sales* Zyvox; Cub
Slide 6: Spero's Vision: High Value, Sustainable Products
Spero’s Vision: High Value, Sustainable Products Do not compete with generics Focus outside hospital DRG payment system Phase 3 data drives clinical and economic decisions Pipeline products that leverage sales force
Slide 7: First Oral Carbapenem: SPR994
First Oral Carbapenem: SPR994
Slide 8: SPR994: Fills Major Unmet Need for New Oral Therapies for Resistant Infections
SPR994: Fills Major Unmet Need for New Oral Therapies for Resistant Infections QuintilesIMS NDTI and MIDAS Database; Quintiles/IMS Market Assessment 2017, Simmering, Jacob E. et al. “The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998–201
Slide 9: SPR994 Activity Comparable to IV Carbapenems
SPR994 Activity Comparable to IV Carbapenems JMI Laboratories, 2017 Data on file; N=66 FQR: Fluoroquinolone resistant SPR994 against FQR Isolates of E. coli Result (mg/mL) SPR994 (tebipenem) Ertapenem (ETP) MIC90 0.06 0.25 MIC50 0.03 0.03 Range ≤0.015-0.25 ≤0.015-0.5 SPR994 ETP
Slide 10: SPR994: Clinical Data Supportive of "IV Therapy in a Pill"
SPR994: Clinical Data Supportive of “IV Therapy in a Pill” Unique Molecule: Only carbapenem with >50% Oral Bioavailability High drug serum levels and urine concentrations at site of infection Phase 1 SAD/MAD final data supports 600 mg PO TID dose for Phase 3; comparable to IV Ertapenem Enables power
Slide 11: Phase 1 SAD/MAD Data: High Urine and Plasma Exposures Relative to MIC90
Phase 1 SAD/MAD Data: High Urine and Plasma Exposures Relative to MIC90 600 mg 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 Free Plasma Concentrations of SPR994 Urine Concentration of
Slide 12: Planned Phase 3 Study to Demonstrate Oral-IV Equivalency
Ertapenem IV + placebo oral SPR994 600 mg TID + placebo IV Planned Phase 3 Study to Demonstrate Oral-IV Equivalency Primary Endpoint: Microbiological response and Clinical Response at TOC (micro-ITT). Resolution of symptoms of cUTI present at screening and no new symptoms of cUTI, and reduction of b
Slide 13: SPR994 Has Differentiated Profile vs Current and Future Oral Agents for cUTI
SPR994 Has Differentiated Profile vs Current and Future Oral Agents for cUTI ESBL Coverage Class A & Amp C High Bioavailability Safety & Tolerability Oral Only Trial for cUTI SPR994 Quinolones Sulopenem Etzadroxil/ Probenecid Omadacycline Source: Sulopenem scientific posters; Paratek investor slides
Slide 14: SPR994: Multi-Billion Dollar Market Opportunity
Hospital UTI FQ-Resistant SPR994: Multi-Billion Dollar Market Opportunity Market Segment LOT DAYS 7 DAYS 5.5 Community UTI FQ-Resistant Source: Estimates derived primarily from QuintilesIMS market assessment (August 2017); *Resistance estimates directly from market assessment FQ: Fluoroquinolone Ass
Slide 15: Zyvox $1.4B Peak Year Analogue for Launch Success of SPR994
Zyvox $1.4 B Peak Year Analogue for Launch Success of SPR994 Zyvox MRSA Gram-positive Market SPR994 FQ-R Gram-negative Market Mkt size (pts) community 1 M 1.2 M IV/Oral switch 700 K 1.1 M Resistance to oral options at launch 29% 36% Resistance to oral options at peak 64% 66%* Reimbursement landscape
Slide 16: SPR994: Differentiated Antibiotic for a Large, Unmet Need
SPR994: Differentiated Antibiotic for a Large, Unmet Need Innovative oral carbapenem Safety and tolerably backed by a dataset of over 4,000 subjects and patients High drug serum levels and urine concentrations at the site of infection support utility in cUTI Rapid development plan with single pivota
Slide 17: First Novel Oral NTM Treatment: SPR720
First Novel Oral NTM Treatment: SPR720
Slide 18: NTM is a Rare Chronic Infectious Disease A Growing Market
NTM is a Rare Chronic Infectious Disease A Growing Market 50,000-100,000 patients in U.S. suffer from NTM 8% annual increase in prevalence predicted YOY in the U.S. Unsatisfied Market No currently approved oral agents for NTM SOC has limited efficacy, high toxicity 5-yr mortality rate of 35% Promisi
Slide 19: Current NTM Treatment Options Have Limitations
Current NTM Treatment Options Have Limitations Approved Inhaled Therapy Generic Standard of Care FDA Approved Yes No Sputum Clearance: Refractory Patients 29% 9% Patient Outcomes: Refractory Patients No Improvement No Improvement Activity in Naïve Patients No No Broad Spectrum No No No Black Box War
Slide 20: SPR720: First Novel Oral Candidate to Treat NTM Infections
SPR720: First Novel Oral Candidate to Treat NTM Infections Clinical Stage Small Molecule Phase 1 SAD/MAD trial initiation in early 1Q19 - double-blind, placebo-controlled in healthy volunteers Oral Therapy Potentially first approved oral regimen for NTM Potent, Broad Spectrum of Activity Potent acti
Slide 21: Dose Responsive Efficacy Against Difficult to Treat NTM Pathogens
Dose Responsive Efficacy Against Difficult to Treat NTM Pathogens Multidrug resistant M. abscessus strain infection set for 27 days, dosing in SCID mice days 27 to 61. AMK=Amikacin SQ dosed every 24h. SPR720 dosed every 48h at the doses listed above Lung Infections in Multidrug Resistant M. abscessu
Slide 22: Potentiator Platform: SPR741 & SPR206
Potentiator Platform: SPR741 & SPR206
Slide 23: Potentiators Allow Entry of Antibiotics Into Gram-Negative Bacteria
Potentiators Allow Entry of Antibiotics Into Gram-Negative Bacteria TREAT WITH POTENTIATOR Ab Ab Ab Ab Inner membrane Outer membrane Lipopolysaccharide Ab Ab Ab Peptidoglycan layer Ab Ab Ab Inner membrane Outer membrane Peptidoglycan layer Ab Ab Ab Ab Ab Lipopolysaccharide Ab Ab Ab Ab Ab Zgurskaya,
Slide 24: Potentiator Platform Addresses IV MDR Gram-Negative Hospital Market
Potentiator Platform Addresses IV MDR Gram-Negative Hospital Market SPR741+partner SPR206 single agent WHO Priority Pathogens Potency against ESBLs Potency against CRE Potency against P. aeruginosa Potency against A. baumannii MOA Expands coverage of partner agents Single agent activity ✓ ✓ ✓ ✓ ✓ ✓
Slide 25: SPR206 as Single Stand Alone Agent Demonstrates Potency Against MDR & XDR Gram-Negative Pathogens
SPR206 as Single Stand Alone Agent Demonstrates Potency Against MDR & XDR Gram-Negative Pathogens SPR206 Meropenem Amikacin % isolates inhibited (n=20) MIC (μg/mL) MIC (μg/mL) MIC (μg/mL) IND Enabling Studies: Demonstrated wide therapeutic margins for the treatment of serious Gram-negative infection
Slide 26: Leadership Team
Leadership Team Prior Venture Partner at Atlas Venture; Arcion Therapeutics, Genentech, McKinsey Formed eight companies in the life sciences sector; three as Acting CEO Background in healthcare policy Ankit Mahadevia, MD Chief Executive Officer Prior Chief Scientific Officer at Fedora Pharma and Tar
Slide 27: Financial Overview
Financial Overview Income Statement Three Months Ended September 30, 2018 Grant Revenue $658 R&D Expense $8,459 G&A Expense $3,134 Loss from Operations $(10,935) Net Loss Attributable to Common Stockholders $(10,463) Balance Sheet As of September 30, 2018 Cash and Cash Equivalents $131,225 Strong fi
Slide 28: Major Catalysts for All Programs through 2019
Major Catalysts for All Programs through 2019 SPR994 SPR720 Potentiator Platform Oral Carbapenem – Gram-negative Infections 4Q18: Pre-IND FDA Meeting Around year-end 2018: Initiate Phase 3 cUTI trial 2H19: Phase 3 cUTI trial initial data and DSMB review Oral DNA Replication Inhibitor - NTM Early 201
Slide 29: Experienced management team; multiple drugs in clinical development
Experienced management team Multiple drugs in clinical development Large opportunity in complementary markets Significant near-term catalysts Accelerated path to market Novel approaches to antibacterial development
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