Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (January 2023)
27 slides from Spero Therapeutics's investor presentation, Jan 9, 2023
Slide 1: Corporate Presentation January 2023
Corporate Presentation January 2023 Exhibit 99.1
Slide 2: Forward-looking Statement
Forward-looking Statement This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, the potential regulatory path forward for tebipenem HBr and the potential approval of tebipenem HBr by the U.S. Food and D
Slide 3: A Leader in Infectious and Rare Diseases
Spero Therapeutics, Inc. A Leader in Infectious and Rare Diseases SPR720: Potential Novel, First Line, Oral Therapy for NTM Infections Strong Balance Sheet Supported by World Class Partnerships for Tebipenem HBr, SPR206 NTM = non-tuberculous mycobacterial; MDR = multidrug resistant infections; Tebip
Slide 4: Late-Stage Pipeline Addressing Major Unmet Needs
Late-Stage Pipeline Addressing Major Unmet Needs NTM: Nontuberculous mycobacteria; MDR: Multi-drug resistant; BAL: Bronchoalveolar lavage; cUTI: Complicated urinary tract infection Spero Retains World-Wide Rights Spero Licensed World-Wide Rights to GSK Spero Retains Rights in United States
Slide 5: Spero Strategy: Invest in diseases supportive of blockbuster growth
Spero Strategy: Invest in diseases and settings of care supportive of blockbuster growth 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: SPR720
SPR720
Slide 7: NTM: Absence of Effective and Well-tolerated Drugs Leaves Patients Without Options
NTM: Absence of Effective and Well-tolerated Drugs Leaves Patients Without Options SPR720 has orphan drug designation and, if approved, could be the only novel first line oral treatment for NTM Infection Colonization Symptoms (progressive lung injury) Treatment No well-tolerated, effective treatment
Slide 8: SPR720: Novel, First Line Oral Candidate Designed to Treat NTM Infections
SPR720: Novel, First Line Oral Candidate Designed to Treat NTM Infections Broad spectrum, oral candidate: applicable to both first line 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
Slide 9: Robust in vitro data supporting advancement of the program
Robust in vitro data supporting advancement of the program SPR719 exhibits potent in vitro activity against a range of NTM species NTM Species N SPR719 MIC90 Amikacin MIC90 M. avium complex 41 2 32 M. abscessus subsp. abscessus 30 4 16 M. abscessus subsp. massiliense 10 2 16 M. chelonae 10 4 32 M. f
Slide 10: 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 ++ - +++ ++ + + + + - - - + + - + SPR720 Monotherapy CLR +/- EMB +/-SPR720 CLR + RFB +/- EMB +/-SPR720 D1 D27 D60 SPR720 (mg/kg/day) 10 QD 30 QD 100 BID 100 QD CLR CLR 72030 CLR EMB CLR EMB 72030 CLR RFB CLR RF
Slide 11: Phase 1: Favorable Tolerability at Doses with Predicted Therapeutic Activity
Phase 1: Favorable Tolerability at Doses with Predicted Therapeutic Activity Phase 1 results show SPR720 was well-tolerated with exposures above predicted therapeutic levels Single Ascending Dose Cohorts (N = 56) Multiple Ascending Dose Cohorts (N = 40) No Serious Adverse Events (SAE) reported; Mild
Slide 12: SPR720 Patient Focus: First line NTM-MAC
SPR720 Patient Focus: First line NTM-MAC 75% of NTM patients are treatment naïve or treatment inexperienced, and eligible for first line therapy Treatment Naïve Bronchial hygiene/clearance, exercise, education Treatment Inexperienced NTM Refractory Disease None approved; Generic antibiotic regimens:
Slide 13: Study SPR720-202 designed to achieve early and robust proof of concept
Study SPR720-202 (NCT05496374) designed to achieve early and robust proof of concept Study SPR720-202 (NCT05496374): Phase 2a study in NTM-PD N SPR719 MIC50 A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720, as Compared With Placebo for the Treatment of Participa
Slide 14: Oral Carbapenem Tebipenem HBr
Oral Carbapenem Tebipenem HBr
Slide 15: Large Market Opportunity for Patients Able to Be Treated at Home
Large Market Opportunity for Patients Able to Be Treated at Home Targeted patients often cycle through multiple therapies 7.9 M UTI Patients in the US 2.7 M Market 780 K IV Carbapenem Pip/tazo 1.9 M >2nd line Oral (Resistant/ Failed) Lack of effective oral treatment options has resulted in increased
Slide 16: Clinical Experience Supports Safety, Efficacy of Tebipenem
Clinical Experience Supports Safety, Efficacy of Tebipenem1 Tebipenem pivoxil evaluated in 24 trials enrolling over 2500 subjects Approved in Japan since 2009 Spero experience: Global cUTI Phase 3, enrolling 1372 subjects Meiji Seika experience 741 Adult subjects evaluated, across 17 efficacy and ph
Slide 17: ADAPT-PO Phase 3 Results Published in The New England Journal of Medicine
Results from Spero’s ADAPT-PO Phase 3 Clinical Trial Published in The New England Journal of Medicine Results from Spero’s Phase 3 ADAPT-PO study, as recently published in The New England Journal of Medicine (NEJM), demonstrated that oral tebipenem HBr was well-tolerated and non-inferior to IV ertap
Slide 18: Exclusive License Agreement with GSK for Tebipenem HBr and Equity Investment
Exclusive License Agreement with GSK for Tebipenem HBr and Equity Investment Global Collaboration Financial Terms GSK received exclusive license to develop and commercialize tebipenem pivoxil and tebipenem HBr in all territories, except Japan and certain other Asian countries (Meiji Seika Territorie
Slide 19: Direct Acting IV Potentiator SPR206
Direct Acting IV Potentiator SPR206
Slide 20: SPR206 Has Potential to Address Significant Unmet Need
SPR206 Has Potential to Address Significant Unmet Need 2-4X mortality rate for carbapenem-resistant versus susceptible Enterobacteriaceae infections Mortality rate of 40-50% for patients infected with carbapenem-resistant Acinetobacter baumannii Severely ill patients are typically treated with multi
Slide 21: SPR206 Preclinical Potency Against XDR Gram-Negative Pathogens
SPR206 Preclinical Potency Against XDR Gram-Negative Pathogens Support Advancement Preclinical Data Support Increased Efficacy Beyond Traditional Antibiotics P. aeruginosa E. coli Acinetobacter spp. Klebsiella spp. SPR206 Colistin Meropenem
Slide 22: Phase 1 Data Differentiates SPR206 and Supports its Advancement
Phase 1 Data Differentiates SPR206 and Supports its Advancement Phase 1 results show SPR206 was well-tolerated with exposures above predicted therapeutic levels Phase 1 SAD/MAD Preliminary Data (N = 96) Phase 1 Bronchoalveolar Lavage (BAL) Study Preliminary Data (N = 30) Successful Phase 1 doses lik
Slide 23: SPR206 Next Steps: Prepare for Phase 2 Trial
SPR206 Next Steps: Prepare for Phase 2 Trial SAD/MAD Phase 1 Trial No evidence of nephrotoxicity at predicted therapeutic dose levels Bronchoalveolar Lavage Phase 1 Trial Well-tolerated and achieved lung exposures consistent with predicted therapeutic levels Preclinical Studies Support increased eff
Slide 24: Spero Corporate Overview Update
Spero Corporate Overview Update
Slide 25: Financial Overview
Financial Overview $ in 000’s Income Statement Three Months Ended Sep 30, 2022 (unaudited) Twelve Months Ended December 31, 2021 Total Revenue $2,006 $18,256 R&D Expense $7,360 $64,526 G&A Expense $6,632 $41,701 Loss from Operations $(11,834) $(87,971) Net Loss Attributable to Common Stockholders $(
Slide 26: Leadership Team
Leadership Team *Trademarks are properties of their respective owners Ankit Mahadevia, MD Chief Executive Officer Prior Venture Partner at Atlas Venture; Genentech, McKinsey Formed eight companies in the life sciences sector; three as Acting CEO. Background in healthcare policy Timothy Keutzer Chief
Slide 27: Key Investment Highlights
Key Investment Highlights Experienced management team Significant near-term catalysts Multiple pipeline products targeting large market opportunities World class partnerships Strong balance sheet and cash runway
Spero Therapeutics — Investor Presentation (January 2023) on 6ix