Spero Therapeutics, Inc. · NASDAQ:SPRO
Spero Therapeutics — Investor Presentation (January 2024)
28 slides from Spero Therapeutics's investor presentation, Jan 8, 2024
Slide 1: Corporate Presentation January 8, 2024
Corporate Presentation January 8, 2024 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: Diversified clinical-stage portfolio
Diversified clinical-stage portfolio Developing Therapies for Rare and Multi-drug Resistant Infectious Diseases SPR720, positioned for near-term inflection Partnership milestones, cash and cash equivalents, expected to provide runway into late 2025 NTM-PD: non-tuberculous mycobacterial pulmonary dis
Slide 4: Maturing Pipeline with Differentiated Clinical Assets
Maturing Pipeline with Differentiated Clinical Assets Wholly Owned Asset Indication Preclinical Phase 1 Phase 2 Phase 3 Partnered Assets SPR720 Tebipenem HBr SPR206 Anticipated Milestone NTM-PD Top-line Data (2H 2024) Complete Enrollment (2H 2025) Initiate Phase 21 Non-dilutive Funding Alliances: Wo
Slide 5: SPR720
SPR720
Slide 6: Progressive Lung Damage
Progressive Lung Damage NTM: non-tuberculous mycobacteria; NTM-PD: NTM pulmonary disease; Kim RD, et al. Am J Respir Crit Care Med 2008; 178:1066-74. 1. All cause mortality Patients Need an Effective Oral Therapy Early in Their Disease Journey NTM-PD: Chronic Debilitating Disease with 5-year Mortali
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 Guidance-based 1L SOC aims to reduce microbial burden measured by SCC Environmental exposure to MAC Pre-existing risk factors lead to MAC colonization in pulmonary tissue Clinical manifestations emerge and worsen over time Di
Slide 8: Strong NTM-PD Patient Community Voices Unmet Therapeutic Need
Strong NTM-PD Patient Community Voices Unmet Therapeutic Need 97% 84% 72% 53% 42% NTM: non-tuberculous mycobacteria; NTM-PD: NTM pulmonary disease; 1. Flume PA, et al. Chest 2021; 159:537-43. N=465 US patients with NTM-PD1 If your treatment could change one thing about your NTM lung infection, what
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 across US, Europe*, and Japan1 Increasing prevalence estimated at 6−10% annually in the US2 Europe: ~15,000 Japan: ~135,000 US: ~95,000 SPR720 Aims to be the Principal
Slide 10: SPR720 Well-positioned for Unmet Patient Needs in First-line Setting
SPR720 Well-positioned for Unmet Patient Needs in First-line Setting M.: Mycobacterium; MAC: M. 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 W
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 not exploited by current antibiotics No cross resistance to current SOC agents Low propensity for selection of resistance Penetrates lung macrophages Differentiated advantages in
Slide 12: Novel Mechanism of Action Not Exploited by Existing Antibiotics
Novel Mechanism of Action Not Exploited by Existing Antibiotics 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 traps chromosome i
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 MIC90 (mg/L) Amikacin MIC90 (mg/L) 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 16
Slide 14: In Vivo Data Demonstrate Increased Potency When Combined with SOC
In Vivo Data Demonstrate Increased Potency When Combined with SOC Untreated SPR720 as monotherapy and in combination with SOC agents SPR720 monotherapy activity Dose-response Improved efficacy of current SOC combination regimen BID: twice daily; CFU: colony forming units; CLR: clarithromycin; EMB: e
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 Talley AK, et al. Antimicrob Agents Chemother 2021; 65:e0120821.
Slide 16: Phase 1 SAD/MAD: Favorable Safety/Tolerability Profile
Phase 1 SAD/MAD: Favorable Safety/Tolerability Profile 500 mg and 1000 mg doses evaluated over 7- and 14-days Dose-dependent increase in plasma exposure No SAEs reported; mild GI symptoms at ≥1500 mg doses One discontinuation at 1500 mg dose: Grade 2 pancreatic enzyme elevation that was asymptomatic
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 N SPR719 MIC50 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 (M
Slide 18: Comprehensive Data Set Anticipated in 2H 2024
Comprehensive Data Set Anticipated in 2H 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 Patient-reported outcomes to inform primary endpoint in later trials PK i
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 Key Attribute* SPR720 SPRO Epatraborole ANTX Arikayce INSM MNKD101 MNKD Novel MOA ✓ ✓ X X MAC MIC90 ≤2 mg/L ✓ X1 X2 ✓ Low Propensity for Resistance ✓ X3 ✓ ? Macrolide-Resistant MAC Activity ✓ ? ✓ ✓ Oral Administration ✓ ✓ X
Slide 20: Tebipenem HBr Oral Carbapenem
Tebipenem HBr Oral Carbapenem
Slide 21: Large Market Opportunity for cUTI Patients to Be Treated at Home
Large Market Opportunity for cUTI Patients 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 Piperacillin/tazobactam 1.9 M 2nd line Oral (Resistant/ Failed) Lack of effective oral treatment options has resulte
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 oral carbapenem Phase 3 enrolling Global commercial partnership Potential treatment of complicated UTI in the outpatient setting Broad prescriber base beyond infectious disease specialists Robust I
Slide 23: 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 24: Phase 3 Clinical Trial PIVOT-PO: Pivotal Design Negotiated FDA SPA
Phase 3 Clinical Trial PIVOT-PO: Pivotal Design Negotiated 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 c
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 SAD/M
Slide 27: Leadership Team
Leadership Team Timothy Keutzer Chief Operating Officer Previously, Spero’s Chief Development Officer Prior VP Program and Portfolio Management, Cubist Extensive antibiotic development experience from pre-clinical to approval Over 30 years in the pharmaceutical industry James Brady Chief Human Resou
Slide 28: Thank You
SPERG THERAPEUTICS Thank You
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