Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (August 2024)
28 slides from Spero Therapeutics's investor presentation, Aug 5, 2024
Slide 1: Corporate Presentation August 2024
Exhibit 99.2 Corporate Presentation August 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 potential regulatory path forward for tebipenem HBr and the potential approval of tebipenem HBr by the U.S. Food and D
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 • Potential novel, oral, first-line treatment for • Indications with high unmet need in addressable non-tuberculous mycobacterial pulmonary dise
Slide 4: Maturing Pipeline with Differentiated Clinical Assets
Maturing Pipeline with Differentiated Clinical Assets Anticipated Milestone Wholly Owned Asset Indication Preclinical Phase 1 Phase 2 Phase 3 First-line Preliminary Data SPR720 NTM-PD (4Q 2024) Partnered Assets Tebipenem HBr Complete Enrollment cUTI (2H 2025) Worldwide Rights (ex. Asia) SPR206 1 Ini
Slide 5: SPR720
SPR720
Slide 6: NTM-PD: Chronic Debilitating Disease with 5-year All-cause Mortality Rate of 35%
NTM-PD: Chronic Debilitating Disease with 5-year All-cause Mortality Rate of 35% NTM Species Patient Characteristics Sign/Symptom Frequency (%) M. avium complex (80-85%) Fatigue 83 M. abscessus Cough 78 Structural lung disease M. xenopi Sputum (phlegm) 67 M. fortuitum Short of breath 65 M. kansasii
Slide 7: NTM-PD Patient Journey To Diagnosis Leads to Sub-optimal Treatment Choices
NTM-PD Patient Journey To Diagnosis Leads to Sub-optimal Treatment Choices Guidelines-based 1L SOC aims to reduce microbial No approved oral first-line treatment for NTM-PD patients burden measured by SCC Arikayce® currently in Phase 3 study for inhaled administration Azythromycin + Non-cavitary Eth
Slide 8: Strong NTM-PD Patient Community Voices Unmet Therapeutic Need
Strong NTM-PD Patient Community Voices Unmet Therapeutic Need If your treatment could change one thing about your “Less Coughing, less shortness of NTM lung infection, what would that be? breath, less fatigue” Improved Quality of Life 97% 97% “I am most concerned with TOTAL lung health … getting thi
Slide 9: SPR720 For Treatment-naïve and Treatment-experienced Non-refractory Patients
SPR720 For Treatment-naïve and Treatment-experienced Non-refractory Patients • Diagnosed patient opportunity estimated to be ~245,000 1 across US, Europe*, and Japan • Increasing prevalence estimated at 6−10% annually in the Once diagnosed, up to 50% of patients are treated with 2 2 guidelines-based
Slide 10: SPR720 Well-positioned to Address Unmet Patient Needs in First-line Setting
SPR720 Well-positioned to Address Unmet Patient Needs in First-line Setting Improve first-line SOC regimen 1 ü Potency against multiple NTM pathogens, including MAC and M. abscessus ü Novel mechanism of action for NTM-PD, with no evidence of cross resistance against 1 marketed antibiotics 2 ü Low pr
Slide 11: SPR720 is an Aminobenzimidazole, a Novel Pharmacophore
SPR720 is an Aminobenzimidazole, a Novel Pharmacophore • Oral, small molecule Gyrase B inhibitor • Novel mechanism of action for NTM-PD, not Oral exploited by current antibiotics absorption • No cross resistance to current SOC agents • Low propensity for selection of resistance • Penetrates lung mac
Slide 12: Novel Mechanism of Action Not Exploited by Existing Antibiotics for NTM-PD
Novel Mechanism of Action Not Exploited by Existing Antibiotics for NTM-PD • SPR719, active moiety of SPR720 pro-drug, inhibits ATPase activity of bacterial DNA gyrase B • DNA gyrase B is distinct from gyrase A, the target of fluoroquinolones • Blocks introduction of negative supercoils in DNA and t
Slide 13: In vitro Data Demonstrate Potent Activity Against Range of NTM Species
In vitro Data Demonstrate Potent Activity Against Range of NTM Species NTM Species N SPR719 MIC (mg/L) Amikacin MIC (mg/L) 90 90 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. fortuitum group 10 1 ≤1 M. immunogenum 10 8 1
Slide 14: In Vivo Data Demonstrate Increased Potency When Combined with SOC
In Vivo Data Demonstrate Increased Potency When Combined with SOC SPR720 as monotherapy and in combination with SOC agents • SPR720 monotherapy activity and dose response • Improved efficacy of current SOC combination regimen BID: twice daily; CFU: colony forming units; CLR: clarithromycin; EMB: eth
Slide 15: Phase 1 SAD/MAD: Dose Response Observed With No Evidence Of Food Effect
Phase 1 SAD/MAD: Dose Response Observed With No Evidence Of Food Effect Mean plasma concentration-time curves following single ascending dosing (SAD) of SPR720 MAD: multiple ascending dose; SAD: single ascending dose 15 Talley AK, et al. Antimicrob Agents Chemother 2021; 65:e0120821.
Slide 16: 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 and 1000 mg) and over 14 days (500, 1000 and 1500 mg) • Dose-dependent increase in plasma exposure observed • No SAEs reported; generally well tolerated at doses up to 1000 m
Slide 17: Phase 2a Designed to Achieve Proof-of-Concept
Phase 2a Designed to Achieve 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 Participants With Mycobacterium avium Complex (MAC) Pulmonary D
Slide 18: Comprehensive Data Set Anticipated in 4Q 2024
Comprehensive Data Set Anticipated in 4Q 2024 We anticipate a robust dataset to inform the registrational path for SPR720 as first-line therapy for NTM-PD • Microbiological response to demonstrate anti-NTM activity in patients • PK in patients • Intrapulmonary PK from bronchoalveolar lavage (BAL) st
Slide 19: SPR720 Well Positioned to Become the Foundation of First-line NTM-PD Therapy
SPR720 Well Positioned to Become the Foundation of First-line NTM-PD Therapy SPR720 Epatraborole Arikayce MNKD101 * Key Attribute SPRO ANTX INSM MNKD Novel MOA✓✓ X X 1 Low Propensity for Resistance✓ X✓ ? 2 3 MAC MIC ≤2 mg/L✓ X X✓ 90 Macrolide-Resistant MAC Activity✓ ?✓✓ Oral Administration✓✓ X X No
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 Lack of effective oral treatment options has resulted in increased… • Outpatient visits st 1 line Oral • Emergency department visits • Unwarranted outpatient IV use • Unnecessary hospitalizations • Hospital days nd IV 2 line Oral • Home health and
Slide 22: Tebipenem HBr: Potentially Differentiated Oral Therapy for cUTI, if Approved
Tebipenem HBr: Potentially Differentiated Oral Therapy for cUTI, if Approved Potential first-to-market Global commercial Phase 3 enrolling oral carbapenem partnership • Out-licensed global • PIVOT-PO trial protocol • Potential treatment of commercial rights (except approved under FDA Special complic
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) • GSK received exclusive license to obtain regulatory approval and commercialize tebipenem HBr in all territories, except Japan and certain other Asian countries (Meiji Seika Territories) • Sp
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 Esther Rajavelu Sath Shukla Chief Financial Officer President and Chief Executive Officer Chief Business Officer • Prior CFO at Spero Therapeutics; Prior CFO at Ziopharm Oncology; VP • Over two decades of life science sector and Global Head of Corporate experience, combining equities
Slide 28: Thank You
SPERG THERAPEUTICS Thank You
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