Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (October 2024)
25 slides from Spero Therapeutics's investor presentation, Oct 29, 2024
Slide 1: Corporate Presentation October 2024
Corporate Presentation October 2024 Exhibit 99.2
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 future development and commercialization of SPR720 and SPR206; the potential number of patients who could be treated b
Slide 3: Developing Therapies for Rare and Multi-drug Resistant Infectious Diseases
Indications with high unmet need in addressable patient populations Orphan drug and/or QIDP designations Strong global intellectual property Late-stage development pipeline Diversified clinical stage portfolio Developing Therapies for Rare and Multi-drug Resistant Infectious Diseases QIDP: qualified
Slide 4: Maturing Pipeline with Differentiated Clinical Assets
Asset Indication Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestone Partnered Assets Tebipenem HBr cUTI Complete Enrollment (2H 2025) SPR206 HABP/VABP Initiate Phase 21 Wholly Owned SPR720 First-line NTM-PD Program suspended2 Maturing Pipeline with Differentiated Clinical Assets Non-dilutive
Slide 5: Tebipenem HBr Oral Carbapenem
Tebipenem HBr Oral Carbapenem
Slide 6: cUTI Patients Often Cycle through Multiple Therapies
cUTI Patients Often Cycle through Multiple Therapies Lack of effective oral treatment options has resulted in increased – Outpatient visits Emergency department visits Unwarranted outpatient IV use Unnecessary hospitalizations Hospital days Home health and long-term care stays post-hospitalization I
Slide 7: Tebipenem HBr: Potential to Reduce Treatment Burden for cUTI Patients
Tebipenem HBr: Potential to Reduce Treatment Burden for cUTI Patients Potential first-to-market oral carbapenem Phase 3 enrolling Global commercial partnership Potential treatment of complicated UTI in outpatient setting vs current hospitalized setting Expand prescriber base beyond infectious diseas
Slide 8: PIVOT-PO: Pivotal Phase 3 Clinical Trial Design
Phase 3 Clinical Trial PIVOT-PO: Pivotal Design Entered FDA Special Protocol Assessment Agreement (SPA): The FDA has indicated that positive and persuasive results from PIVOT-PO, along with previously completed studies, could be sufficient to support approval of tebipenem HBr as a treatment for cUTI
Slide 9: 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 Spero is responsible for execution and costs of the Tebipenem HBr Phase 3 in the United States GSK received exclusive license to: Develop Tebipenem in territories outside of Un
Slide 10: SPR206 Direct Acting IV Potentiator
SPR206 Direct Acting IV Potentiator
Slide 11: 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 Increased permeability, cell membrane disruption, bacterial cell death Recei
Slide 12: SPR720 Oral Antibiotic for NTM-PD
SPR720 Oral Antibiotic for Non-Tuberculosis Mycobacterium Pulmonary Disease (NTM-PD) The company is suspending its current development for SPR720
Slide 13: NTM-PD is a Chronic Debilitating Disease with Significant Patient Burden
First-line treatment options include 6-12 months (or more) on a combination of antibiotics, including a macrolide NTM-PD is a Chronic Debilitating Disease with Significant Patient Burden NTM: non-tuberculous mycobacteria; NTM-PD: NTM pulmonary disease; *SPR720 is being developed for MAC NTM-PD. 1. M
Slide 14: High Unmet Need in First-Line Patients
High Unmet Need in First-Line Patients With Long Treatment Duration, and Lack of Efficacy and Tolerability from Current Treatment Options Rare Disease with High Unmet Need ~245,000 diagnosed patients in developed markets1 ~35% Five-year all-cause mortality rate2 Chronic condition requiring long-term
Slide 15: SPR720 is An Oral Small Molecule Gyrase B Inhibitor
SPR720 is An Oral Small Molecule Gyrase B Inhibitor M.: Mycobacterium; MAC: Mycobacterium avium complex; NTM: non-tuberculous mycobacteria; SOC: standard of care; QIDP: qualified infectious disease product 1. Brown-Elliott BA, et al. Antimicrob Agents Chemother. 2018; 62:e01503-18. 2. Aragaw WW, et
Slide 16: SPR720's Novel Mechanism of Action Not Exploited by Existing Antibiotics
SPR720's Novel Mechanism of Action Not Exploited by Existing Antibiotics for NTM-PD SPR720/719 targets DNA gyrase (GyrB subunit), a critical enzyme for DNA replication and RNA transcription1 1 Azithromycin (AZM) disrupts ribosomal activity; AZM blocks passage of growing peptide & RNA through ribosom
Slide 17: SPR720 Provides a Better Resistance Profile When Used with SOC Agents
SPR720 Provides a Better Resistance Profile When Used with SOC Agents MIC90: minimum inhibitory concentration at which 90% of isolates were inhibited; NTM: non-tuberculous mycobacteria; SPR719 is the active moiety of the prodrug SPR720 and is used for in vitro testing. Brown-Elliott BA, et al. Antim
Slide 18: SPR719 Low Propensity for Resistance Development, No Antagonism with SOC
SPR719 had a low propensity for resistance development and showed no instances of antagonism when combined with SOC agents Selective agent Organism Putative mutant ID MIC (µg/mL) Clarithromycin SPR719 Clarithromycin at 4 x MIC M. avium ATCC 700898 Parent 1 1 Mutant 8* >256 1 Mutant 31 >256 1 Mutant
Slide 19: In Vivo Murine Data Demonstrate Increased Potency When Combined with SOC
In Vivo Murine Data Demonstrate Increased Potency When Combined with SOC SPR720 as monotherapy and in combination with SOC agents SPR720 active as monotherapy with evidence of dose response Demonstrates improved efficacy when used in combination with SOC agents BID: twice daily; CFU: colony forming
Slide 20: SPR720 Plasma Concentration Increases with Dose Escalation; No Food Effect
SAD: single ascending dose. N=6 per group Talley AK, et al. Antimicrob Agents Chemother 2021; 65:e0120821. SPR720 Plasma Concentration Increases with Dose Escalation; No Clinically Significant Food Effect Observed Phase 1 SAD/MAD study Mean plasma concentration-time curves following single ascending
Slide 21: SPR719 Penetrates Well into ELF and Alveolar Macrophages
SPR719 Penetrates Well into Epithelial Lining Fluid (ELF) and Alveolar Macrophages (AM) Ratios: ELF to plasma AUC0-24 ELF to plasma Cmax AM to plasma AUC0-24 AM to plasma Cmax Total Plasma 1.14 1.26 2.44 3.02 Unbound Plasmaa 19.87 21.88 42.50 52.53 a Corrected for 94.25% protein-bound fraction and 5
Slide 22: SPR720 Proof-of-Concept Phase 2a Trial Design Overview
SPR720 Proof-of-Concept Phase 2a Trial Design Overview Study SPR720-202 (NCT05496374): Phase 2a study in NTM-PD – suspended following interim analysis Intense PK sub-study (open label) Treatment-naïve/ experienced (non-refractory) patients with NTM due to M. avium complex 25 patients enrolled 56 Day
Slide 23: Overview of CFU and TTP Microbiological Endpoints
Overview of CFU and TTP Microbiological Endpoints Sputum CFU Analysis Diluted sputum inoculated on culture plate Visually count colonies TTP Analysis Diluted sputum inoculated in liquid medium Assay device incubates and detects growth Assay device automatically records time to positive growth signal
Slide 24: Leadership Team
Esther Rajavelu Chief Financial Officer and Chief Business Officer Over two decades of life science sector experience, combining equities research, investment banking, strategy consulting, and M&A Prior CFO at Fulcrum Therapeutics. Senior equity research analyst at UBS, Oppenheimer and Deutsche Bank
Slide 25: Thank You
SPERG THERAPEUTICS Thank You
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