Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (September 2024)
28 slides from Spero Therapeutics's investor presentation, Sep 10, 2024
Slide 1: Corporate Presentation Sept 2024
Exhibit 99.1 Corporate Presentation Sept 2024
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
Developing Therapies for Rare and Multi-drug Resistant Infectious Diseases Diversified clinical stage portfolio SPR720, positioned for near-term inflection Indications with high unmet need in addressable Potential novel, oral, first-line treatment for non- patient populations tuberculous mycobacteri
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 Wholly Owned SPR720 First-line Preliminary Data NTM-PD (4Q 2024) Partnered Assets Tebipenem HBr Complete Enrollment cUTI (2H 2025) Worldwide Rights (ex. Asia) SPR206 1 HAB
Slide 5: SPR720 Oral Antibiotic for Non-Tuberculosis Mycobacterium Pulmonary Disease (NTM-PD)
SPR720 Oral Antibiotic for Non-Tuberculosis Mycobacterium Pulmonary Disease (NTM-PD)
Slide 6: NTM-PD: Chronic Debilitating Disease with Significant Patient Burden
NTM-PD: Chronic Debilitating Disease with Significant Patient Burden Patient with existing structural lung damage Exposure to NTM species Presentation of signs and symptoms of NTM-PD 1 2 3 and/or immunocompromised status Fatigue 83% Cough 78% Select pre-existing indications M. avium complex (80-85%)
Slide 7: High Unmet Need in First-Line Patients With Long Treatment Duration
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 Chronic condition ~35% Five-year all- patients in developed requiring long- 2 cause mortality rate 1 markets
Slide 8: SPR720, An Oral, Small Molecule Gyrase B Inhibitor
SPR720, An Oral, Small Molecule Gyrase B Inhibitor in Development to Address Unmet Patient Need in First-line Setting Oral Potency against multiple NTM pathogens, such as MAC absorption 1 (including macrolide-resistant MAC) and M. abscessus Novel mechanism of action for NTM-PD not exploited by curre
Slide 9: SPR720's Novel Mechanism of Action Not Exploited by Existing Antibiotics for NTM-PD
SPR720's Novel Mechanism of Action Not Exploited by Existing Antibiotics for NTM-PD SPR720/719 targets DNA gyrase (GyrB subunit), Azithromycin (AZM) disrupts ribosomal Ethambutol (EMB) disrupts 1 2 3 a critical enzyme for DNA replication and RNA activity; AZM blocks passage of growing Arabinogalacta
Slide 10: SPR719 Inhibits Growth of MAC Isolates at Lower Concentrations than SOC Agents
SPR719 Inhibits Growth of MAC Isolates at Lower Concentrations (MICs) than SOC Agents in vitro MIC 90% MAC organism (n) Agent (µg/mL) SPR719 2 Amikacin 64 Low MIC values for SPR719 M. avium (12) Clarithromycin 8 90 suggest consistent activity Linezolid 64 against most clinically Moxifloxacin 8 impor
Slide 11: In Vivo Murine Data Demonstrate Increased Potency When Combined with SOC Agents
In Vivo Murine Data Demonstrate Increased Potency When Combined with SOC Agents 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: colo
Slide 12: Phase 1 SAD/MAD Study in HV: Favorable Safety/Tolerability Profile
Phase 1 SAD/MAD Study in 96 HV: Favorable Safety/Tolerability Profile • SAD (100 to 2000 mg) • MAD evaluated over 7 days (500, 1000 and 1500 mg) and over 14 days (500 and 1000 mg) • Dose-dependent increase in plasma exposure observed • No SAEs reported; generally well tolerated at doses up to 1000 m
Slide 13: SPR720 Plasma Concentration Increases with Dose Escalation
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 dosing (SAD) of SPR720 SAD: single ascending dose. N=6 per group 13 Talley AK, et al. Antimicrob Agents Ch
Slide 14: SPR720 Aims to be the Foundation of First-line Combination Regimen for NTM-PD
SPR720 Aims to be the Foundation of First-line Combination Regimen for NTM-PD Therapeutic Landscape Challenges SPR720 Differentiation ❑ No approved oral therapy for newly ✓ SPR720 is the only oral agent in clinical diagnosed symptomatic patients, the development for first-line treatment of NTM- majo
Slide 15: Areas of Ongoing Focus for SPR720 Clinical Development
Areas of Ongoing Focus for SPR720 Clinical Development Question Study Phase 2a PoC study intended to determine Does SPR720 reduce MAC bacterial burden and ➔ SPR720 monotherapy activity in st demonstrate tolerability in 1 line patients? MAC infected patients Does SPR719 (active moiety of SPR720) get
Slide 16: Phase 2a Designed to Achieve SPR720 Proof-of-Concept
Phase 2a Designed to Achieve SPR720 Proof-of-Concept • Study SPR720-202 (NCT05496374): Phase 2a study in NTM-PD A study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SPR720, as compared with placebo for the treatment of patients with mycobacterium avium complex (MAC) pulmon
Slide 17: Phase 2a Focused on Non-refractory Patients
Phase 2a Focused on Non-refractory Patients Future indication SPR720 is currently being developed for treatment-naïve and expansion possibility in ➔ treatment-experienced non-refractory patients with MAC infection refractory NTM-PD Treatment-experienced Treatment-naïve Refractory non-refractory Neve
Slide 18: SPR720 Efficacy Will be Evaluated via CFU and TTP Assays
SPR720 Efficacy Will be Evaluated via CFU and TTP Assays 3-4 wk incubation Decreasing values indicate lowering of NTM burden Diluted sputum inoculated Visually count colonies Time of sample collection on culture plate Sputum Increasing values indicate lowering Assay device incubates and of NTM burde
Slide 19: Spero Plans to Share a Comprehensive Dataset in the Fourth Quarter
Spero Plans to Share a Comprehensive Dataset in the Fourth Quarter Question Study We hope to see 1) Numerical difference in key Does SPR720 reduce NTM bacterial Phase 2a PoC study to determine quantitative bacterial burden metrics burden and demonstrate tolerability SPR720 monotherapy activity ➔➔ st
Slide 20: Tebipenem HBr Oral Carbapenem
Tebipenem HBr Oral Carbapenem
Slide 21: cUTI Patients Often Cycle through Multiple Therapies
cUTI Patients Often Cycle through Multiple Therapies Tebipenem, in development to offer an Lack of effective oral treatment options has resulted in increased – oral alternative to cUTI patients nd • Outpatient visits 2 line Oral (Resistant/ • Emergency department visits Failed) • Unwarranted outpati
Slide 22: Tebipenem HBr: Potential to Reduce Treatment Burden for cUTI Patients
Tebipenem HBr: Potential to Reduce Treatment Burden for cUTI Patients, if Approved 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 Speci
Slide 23: 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 24: 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 Received $66 Million upfront and $9 Million in common stock investment costs of the Tebipenem HBr Phase 3 in Received $30 Million upon
Slide 25: SPR206 Direct Acting IV Potentiator
SPR206 Direct Acting IV Potentiator
Slide 26: 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
Slide 27: Leadership Team
Leadership Team Sath Shukla Esther Rajavelu Timothy Keutzer James Brady President and Chief Executive Chief Financial Officer Chief Operating Officer Chief Human Resource Officer Officer Chief Business Officer • Previously, Spero’s Chief Development • Prior CHRO at uniQure Therapeutics; • Prior CFO
Slide 28: Thank You
SPERG THERAPEUTICS Thank You
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