Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (January 2025)
21 slides from Spero Therapeutics's investor presentation, Jan 10, 2025
Slide 1: Corporate Presentation January 2025
Corporate Presentation January 2025
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, as amended, including without limitation, statements regarding, among other things, the potential number of patients who could be treated by tebipenem H
Slide 3: Developing Therapies for Rare and Multi-drug Resistant Infectious Diseases
Developing Therapies for Rare and Multi-drug Resistant Infectious Diseases Clinical stage Tebipenem HBr in Strong financial portfolio Phase 3 for cUTI foundation • Indications with high • In development, with potential • Cash runway into mid-2026 unmet need in addressable to be the first and only or
Slide 4: Maturing Pipeline with Differentiated Clinical Assets
Maturing Pipeline with Differentiated Clinical Assets Asset Indication Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestone Partnered Assets Tebipenem HBr Complete Enrollment cUTI Worldwide Rights (ex. Asia) (2H 2025) SPR206 HABP/VABP Initiate Phase 21 China OUS, ex. China Spero Retains Rights
Slide 5: Tebipenem HBr Oral Carbapenem for cUTI
Tebipenem HBr Oral Carbapenem for cUTI
Slide 6: Complicated Urinary Tract Infection (cUTI)
Complicated Urinary Tract Infection (cUTI) Typically caused by an abnormality of the Complicated Uncomplicated • urinary tract or in the presence of Functional or anatomical No functional or anatomical abnormality of urinary tract abnormality of urinary tract catheterization • Characterized by pyuri
Slide 7: Overview of cUTI Therapeutic Landscape
Overview of cUTI Therapeutic Landscape Resistance and lack of effective treatments Lack of effective oral treatment options has result in a large addressable cUTI patient resulted in increased –population • Outpatient visits • Emergency department visits nd IV Therapy/ • Outpatient IV use 2 line Ora
Slide 8: Tebipenem HBr: Potential to Reduce Treatment Burden for cUTI Patients
Tebipenem HBr: Potential to Reduce Treatment Burden for cUTI Patients Potential first-to-market Global commercial Phase 3 enrolling oral carbapenem partnership • Potential treatment of • PIVOT-PO trial protocol • Out-licensed global complicated UTI in outpatient approved under FDA Special commercial
Slide 9: Compound Structures and Definitions
Compound Structures and Definitions Tebipenem Tebipenem Pivoxil Tebipenem Pivoxil Hydrobromide Active drug Orally bioavailable prodrug of Spero’s orally bioavailable prodrug + tebipenem (Orapenem® fine granules HBr salt, enabling high dosage and for pediatrics; Meiji Seika, Japan) room temperature-s
Slide 10: Clinical Experience Supports Safety, Efficacy of Tebipenem
Clinical Experience Supports Safety, Efficacy of Tebipenem1 • 741 Adult subjects evaluated, across 17 efficacy and pharmacology trials Tebipenem Pivoxil evaluated in 23 • 440 pediatric subjects evaluated, across 6 efficacy and pharmacology trials trials enrolling over 1,300 subjects (Meiji-Seika exp
Slide 11: Activity of Tebipenem and Comparator Carbapenems against Uropathogens
Activity of Tebipenem and Comparator Carbapenems against Gram-negative and -positive Uropathogens MIC90 (μg/mL) Pathogen N Tebipenem Imipenem Meropenem Ertapenem Enterobacterales (Surveillance US & EU, 2022) E. coli 1,444 0.03 ≤0.12 0.03 0.015 K. pneumoniae 404 0.12 0.5 0.06 0.25 P. mirabilis 170 0
Slide 12: Tebipenem is Active Against Clinically Important Resistant Enterobacterales
Tebipenem is Active Against Clinically Important Resistant Enterobacterales UTI Pathogens from Europe and the USA in 2022 Organism/ MIC90 (μg/mL) Phenotype N phenotype Tebipenem Imipenem Meropenem Ertapenem Enterobacterales All 2,447 0.12 1 0.06 0.06 All 1,444 0.03 ≤0.12 0.03 0.015 E. coli ESBL* 20
Slide 13: Tebipenem Pharmacokinetic Profile
Tebipenem Pharmacokinetic Profile • Prodrug rapidly converts to tebipenem in enterocytes of GI tract • Plasma Half-life ~1 hour • Dose-proportional PK relationship when administered fed or fasted state • Low potential for drug-drug interactions • No CYP450-dependent metabolism • No induction of CYP4
Slide 14: PIVOT-PO: Pivotal Phase 3 Clinical Trial Design
Phase 3 Clinical Trial PIVOT-PO: Pivotal Design Study Tebipenem HBr (NCT06059846): Phase 3 Clinical Trial in cUTI A Phase 3, Randomized, Double-blind, Double-dummy, Multi-center Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr), Compared to In
Slide 15: Exclusive License Agreement with GSK for Tebipenem HBr and Equity Investment
Exclusive License Agreement with GSK for Tebipenem HBr and Equity Investment Global Collaboration (ex-Asia) Financial Terms Received $66 Million upfront and $9 Million in common stock investment Received $30 Million upon SPA agreement with the FDA Spero is responsible for execution and costs of the
Slide 16: SPR206 Direct Acting IV Potentiator
SPR206 Direct Acting IV Potentiator
Slide 17: SPR206: Ongoing Clinical Development Lends Potential to Address Significant Unmet Need
SPR206: Ongoing Clinical Development Lends Potential to Address Significant Unmet Need • Innovative, investigational IV direct-acting polymyxin antibiotic • Destabilization of phospholipids and lipopolysaccharides (LPS) present in the outer membrane • Increased permeability, cell membrane disruption
Slide 18: SPR720 Oral Antibiotic for NTM-PD
SPR720 Oral Antibiotic for Non-Tuberculosis Mycobacterium Pulmonary Disease (NTM-PD) The company has suspended its current development for SPR720
Slide 19: SPR720 is An Oral Small Molecule Gyrase B Inhibitor
SPR720 is An Oral Small Molecule Gyrase B Inhibitor • Novel mechanism of action for NTM-PD not exploited by current antibiotics • May be administered with or without food • No evidence of cross resistance against marketed antibiotics based on in vitro trials • Low propensity for development of resis
Slide 20: Leadership Team
Leadership Team Esther Rajavelu Timothy Keutzer James Brady Interim President and Chief Chief Operating Officer Chief Human Resource Officer Executive Officer • Previously, Spero’s Chief • Prior CHRO at uniQure Therapeutics; • Over two decades of life science Development Officer Vice President, Huma
Slide 21: Thank You
SPER® THERAPEUTICS Thank You
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