Spero Therapeutics, Inc 8-K, filed Sep 10, 2024
Spero Therapeutics, Inc. (SPRO)
About this 8-K
Spero Therapeutics, Inc filed this 8-K on September 10, 2024, reporting on events of September 9, 2024.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 9, 2024, Spero Therapeutics, Inc. (the “Company”) updated its investor presentation (the “Investor Presentation”), which the Company intends to use from time to time in connection with corporate presentations, investor communications and conferences. A copy of the Investor Presentation is attached hereto as Exhibit 99.1 and is also available on the “Investor Relations” portion of the Company’s website at https://www.sperotherapeutics.com/investor-relations#ir-corp-presentation. The Investor Presentation is current as of September 9, 2024, and the Company disclaims any obligation to update the Investor Presentation after such date.
The information in this Current Report on Form 8-K, including Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Corporate Investor Presentation of Spero Therapeutics, Inc. as of September 9, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document and incorporated as Exhibit 101) | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 10, 2024 | SPERO THERAPEUTICS, INC. | |||||
| By: | /s/ Esther Rajavelu | |||||
| Esther Rajavelu | ||||||
| Chief Financial Officer and Chief Business Officer | ||||||
Exhibit 99.1 Corporate Presentation Sept 2024
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 by SPR 720 and tebipenem HBr and market demand for SPR720 and tebipenem HBr generally; the potential regulatory path forward for tebipenem HBr, the potential approval of tebipenem HBr by the U.S. Food and Drug Administration (FDA) and the timing thereof; the potential commercialization of tebipenem HBr and its future value, the potential receipt of milestone payments and royalties on future sales of tebipenem HBr under the GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) license agreement; the effectiveness of tebipenem HBr and its potential impact on healthcare resource utilizations; the anticipated shift in treating patients from intravenous to oral administration; the initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and its research and development programs, including management’s assessment of such results; the timing of the availability of data from the Company’s clinical trials; the timing of the Company’s filings with regulatory agencies; product candidate benefits; competitive position; business strategies; potential growth opportunities; potential market size; projected costs and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. In some cases, forward- looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. All statements other than statements of historical facts contained in this presentation are forward- looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would add costs for the Company, delay approval and/or reduce the commercial prospects of tebipenem HBr; the Company’s need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; the Company’s reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to develop and commercialize the Company’s product candidates, if approved; the Company’s ability to retain key personnel; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials and whether preliminary data from the Company’s clinical trials will be predictive of final results from such trials; the Company’s dependence on raising capital and whether the Company’s product candidates will advance through the preclinical development and clinical trial process on a timely basis, or at all, taking into account such factors as the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design, clinical data requirements and clinical outcomes; whether the results of such clinical trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; decisions made by the FDA and equivalent foreign regulatory agencies with respect to the development and commercialization of the Company’s product candidates; the commercial potential of the Company’s product candidates; the Company’s ability to obtain adequate third-party reimbursement for its product candidates; whether the Company will satisfy all of the pre-conditions to receipt of the milestone payments under its various license and collaboration agreements; the Company’s ability to implement its strategic plans; the Company’s ability to obtain, maintain and enforce intellectual property and other proprietary rights for its product candidates; the risks and uncertainties related to market conditions; whether the Company’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the “Risk Factors” section of the Company’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC), and risks described in other filings the Company may make with the SEC in the future. The forward-looking statements included in this presentation represent the Company’s views as of the date of this presentation. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this presentation. 2
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 mycobacterial pulmonary disease (NTM-PD) Late-stage development pipeline Rare disease with ~245,000 diagnosed patients in 1 developed markets Focused on oral, small molecule drugs No first-line therapies approved Orphan drug and/or QIDP designations Proof-of-concept data anticipated in 4Q 2024 Strong global intellectual property Supported by world class partnerships Partnership milestones, cash and cash equivalents are expected to provide runway into late 2025 NTM-PD: non-tuberculous mycobacterial pulmonary disease; QIDP: qualified infectious disease product 3 1.Winthrop KL, et al. Ann Am Thorac Soc 2020; 17:178-85 and Spero internal analysis.
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 HABP/VABP Initiate Phase 2 China OUS, ex. China Spero Retains Rights in United States Non-dilutive Funding Alliances NTM-PD: non-tuberculous mycobacterial pulmonary disease; cUTI: complicated urinary tract infection; HABP: hospital-acquired bacterial pneumonia; VABP: ventilator-associated bacterial pneumonia 4 1. Contingent on non-dilutive funding availability.
SPR720 Oral Antibiotic for Non-Tuberculosis Mycobacterium Pulmonary Disease (NTM-PD)
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%)* include: Sputum (phlegm) 67% Short of breath 65% Additional species, including M. abscessus Bronchiectasis Night sweats 54% Fever 44% COPD Hemoptysis 29% Cystic fibrosis Weight loss 3.7 ± 5.2 kg Worsening of lung damage First-line treatment options include 6-12 4 5 High-Resolution CT Scans (HRCT) Confirms NTM-PD diagnosis and severity months (or more) on a combination of antibiotics, including a macrolide Drug-resistance &/or exacerbations 6 eventually leads to 5-yr all-cause 1,2 mortality rate of ~35% NTM: non-tuberculous mycobacteria; NTM-PD: NTM pulmonary disease; *SPR720 is being developed for MAC NTM-PD. 6 1. Marras TK, et al. Respir Med 2018; 145:80-88. 2. Kim RD, et al. Am J Respir Crit Care Med 2008; 178:1066-74; mortality rate represents midpoint of published range.
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 term treatment Current SOC Treatments Have Severe Limitations Poor outcomes driven Safety & tolerability ~50% of treated by emergence of concerns & high rate patients experience 3 resistance of treatment drop-offs infection recurrence No Approved First-Line Treatment Off-label use of No other oral agent Inhaled amikacin in • Azithromycin in clinical • Ethambutol Phase 3 trial development • Rifampin Inhaled amikacin approved for refractory (2L) patients; 1.Winthrop KL, et al. Ann Am Thorac Soc 2020; 17:178-85 and Spero internal analysis. 2.Kim RD, et al. Am J Respir Crit Care Med 2008; 178:1066-74; 7 mortality rate represents midpoint of published range 3. Hamed KA and Tillotson G. Expert Rev Respir Med 2023;17:973-88.
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 current antibiotics 1 No evidence of cross resistance against marketed antibiotics 2 Low propensity for selection of resistance Data support potential for efficacy, lung macrophage penetration, and safety/tolerability May be administered with or without food Composition of matter patent into 2032 Active moiety Phosphate ester prodrug Granted Orphan Drug, QIDP and Fast Track designations M.: Mycobacterium; MAC: Mycobacterium avium complex; NTM: non-tuberculous mycobacteria; SOC: standard of care; QIDP: qualified infectious disease product 8 1. Brown-Elliott BA, et al. Antimicrob Agents Chemother. 2018; 62:e01503-18. 2. Aragaw WW, et al. Microbiol Spectr 2022;10:e0132121.
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 Arabinogalactan formation, a critical 1 transcription peptide & RNA through ribosome cell wall component Arabinosyl DNA replication DNA gyrase transferase Peptide Ribosome mRNA transcription AZM ethambutol SPR720/719 Arabinose Arabinogalactan Cell wall production DNA replication Translation 1 2 3 and integrity and transcription mRNA Ribosomes Arabinogalactan Critical component of mycobacterial cell walls Novel target and differentiated MOA potentially position SPR720 to improve current SOC regimen 1. Winthrop KL, et al. Expert Rev Anti Infect Ther 2023; 21:1177-87. 9
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 important NTM species SPR719 2 Amikacin >64 Low variability in MIC values 90 M. intracellulare (19) Clarithromycin >64 across species support thesis Linezolid 64 that SPR719 has a novel mechanism with minimal Moxifloxacin 8 pre-existing drug resistance SPR719 1 Amikacin 32 MAC-X (10) Clarithromycin 4 Linezolid 64 Moxifloxacin >8 MIC : 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. 90 10 Brown-Elliott BA, et al. Antimicrob Agents Chemother 2018; 62:e01503-18. SPR720, Investigator Brochure Edition 5; 07Apr2022, on file with Spero
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: colony forming units; CLR: clarithromycin; EMB: ethambutol; SOC: standard of care; QD: once daily 11 Cotroneo N, et al. J Antimicrob Chemother 2024; doi: 10.1093/jac/dkae046. Online ahead of print.
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 mg • One discontinuation of study drug at 1500 mg dose: Grade 2 pancreatic enzyme elevation that was asymptomatic, monitorable and reversible SPR720 is Generally Well-tolerated with Predicted Therapeutic Exposures Attainable with 500 to 1000 mg HV: Healthy Volunteers; GI: gastrointestinal; MAD: multiple ascending dose; SAD: single ascending dose; SAE: serious adverse event 12 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 dosing (SAD) of SPR720 SAD: single ascending dose. N=6 per group 13 Talley AK, et al. Antimicrob Agents Chemother 2021; 65:e0120821.
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- majority with MAC infections PD patients infected with MAC ❑ Regimen tolerability✓ Dosing to date support a tolerable profile ❑ Emergence of resistance even with ✓ SPR720 in vitro data suggest low evidence combination therapy of emergence of resistance when used in combination with current oral SOC agents ❑ Limited efficacy in current SOC 14
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 to Phase 1 HV BAL study to understand exposure ➔ the site of infection? in lung Phase 1 HV and HFIM SOC combo studies to Does SPR720 exposure change when co- ➔ explore potential for therapeutic effectiveness administered with primary SOC agents? when used with AZM and EMB Does SPR720 provide a better resistance ➔ In vitro studies to evaluate resistance profile profile when used with SOC agents? HV: Healthy volunteers; BAL: Bronchoalveolar lavage; HFIM: Hollow fiber infection model; 15
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) pulmonary disease Endpoints Treatment Population Treatment Groups Primary Endpoint: Placebo 1. The rate of change in log 10 Treatment-naïve/ SPR720 (500 mg) R Colony Forming Units per experienced (non- patients milliliter (CFU/ml) SPR720 (1000 mg) refractory) patients with randomized 1:1:1 NTM due to M. avium Secondary Endpoints: (blinded) complex 1. The rate of change in time SPR720 (1000 mg) to positivity (TTP) 25 patients enrolled Intense PK SPR720 (500 mg BID) 2. Safety & tolerability 56 Days of Dosing sub-study (open label) 3. Plasma PK BID: twice daily; MAC: Mycobacterium avium complex; NTM-PD: non-tuberculous mycobacterial pulmonary disease; PK: pharmacokinetics 16
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 Never received SOC multidrug Received SOC multidrug Received multidrug SOC treatment for NTM-PD treatment for NTM-PD and treatment for NTM-PD, but successfully converted cultures after 6 months of therapy, to negative fail to convert cultures to negative Culture conversion defined as: 3 consecutive lower respiratory cultures, obtained 1 month apart, negative for acid-fast bacilli (AFB) SOC: Standard-Of-Care 17 17
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 burden detects growth Time of sample collection Diluted sputum inoculated Assay device automatically in liquid medium records time to positive growth signal 18 Danho, Rabi et al., CHEST, Volume 161, Issue 2, 370 - 372 Time to positive signal # of colonies
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 in 1 line patients? in MAC infected patients 2) A well tolerated dosing regimen Higher concentration of active drug in Does SPR719 (active moiety of Phase 1 HV BAL Study to understand epithelial lining fluid and alveolar ➔➔ SPR720) get to the site of infection? exposure potential in lung macrophages compared to plasma Phase 1 HV and HFIM SOC combo Consistent SPR719 plasma PK when Does SPR720 exposure change when studies to explore potential for co-administered with primary SOC SPR720 is administered as a monotherapy ➔➔ therapeutic effectiveness when agents? vs in combination with SOC agents used with AZM and EMB 1) Low SMF values for SPR719 Does SPR720 provide a better In vitro resistance study to monotherapy resistance profile when used with demonstrate lack of resistance ➔➔ 2) Ability of SPR719 to suppress SOC agents? development resistance to SOC drugs SMF: spontaneous mutation frequency; HV: Healthy volunteers; BAL: Bronchoalveolar lavage; HFIM: Hollow fiber infection model; 19
Tebipenem HBr Oral Carbapenem
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 outpatient IV use • Unnecessary hospitalizations IV Therapy/ • Hospital days rd 3 line Oral (Resistant/ • Home health and long-term care stays Failed) post-hospitalization All translating to patient suffering Annual cUTI treatment episodes 1 and high financial burden estimated to be 3.4M IV: intravenous; tebipenem HBr: tebipenem pivoxil hydrobromide (formerly SPR994); UTI: urinary tract infection 21 1. GSK Epidemiology data - fy-2023-epidemiology-report.xlsx (live.com)
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 Special commercial rights (except setting vs current hospitalized Protocol Assessment (SPA) Japan and certain other Asian setting countries) to GSK • Enrollment began with first • Expand prescriber base beyond patient dosed in Q4 2023• Robust financial terms infectious disease specialists including developmental, • Global trial with centers in regulatory, and commercial • Robust IP through 2038 the North and South America, milestones, as well as tiered Europe, Africa, and Asia • QIDP designation sales royalties IP: intellectual property; tebipenem HBr: tebipenem pivoxil hydrobromide (formerly SPR994); QIDP: qualified infectious disease product; SPA: Special Prot ocol Assessment (by FDA); UTI: urinary tract infection 22
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 Intravenously Administered Imipenem- cilastatin in Patients with Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Endpoints Treatment Population Treatment Arms Primary Endpoint: TBP-PI-HBR (600 mg) orally and “dummy” infusion IV, every 6 hours, days 1-10 Overall response at TOC in Patients with a diagnosis (n=1324) of cUTI (incl. AP) micro-ITT population Approximately 2648 R Primary Analysis: patients Imipenem-cilastatin (500 mg) IV and matched (Stratified by age, patients Assessment of non-inferiority “dummy” tablets, orally every 6 hours, days 1-10, baseline diagnosis, etc.) randomized (NI) in micro-ITT population, (n=1324) 7-10 Days of Dosing 1:1 based on a 10% NI margin (blinded) 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, including pyelonephritis, for a limited use indication AP: acute pyelonephritis; cUTI: complicated urinary tract infection; NI: non-inferiority; TBP-PI-HBr/tebipenem HBr: tebipenem pivoxil hydrobromide (formerly SPR994) 23
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 SPA agreement with the FDA the United States Upon FPFD, Spero qualified to receive $95 Million in development • GSK received exclusive license to: milestones payable in equal installments over two years • Develop Tebipenem in territories Spero is eligible to receive up to $400 Million in additional potential regulatory, outside of United States (not including Japan and certain other commercial and sales milestone payments, as well as royalties Asian countries where rights are o $25 Million to be paid upon GSK’s submission of tebipenem HBr’s New Drug held by Meiji Seika); and Application (NDA) o Up to $150 million in potential commercial milestones based on first • Obtain regulatory approval and commercial sales (US/EU) commercialize tebipenem HBr in all territories, except Meiji Seika o Up to $225 million in sales related milestone payments Territories o Spero to receive tiered low-single digit to low-double digit (if sales exceed $1 billion) tiered royalties on net product sales FPFD: first patient first dose. SPA: Special Protocol Assessment 24
SPR206 Direct Acting IV Potentiator
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 • Received FDA Fast Track designation Current standard of care involves drug combinations that are often associated with nephrotoxicity Preclinical SAD/MAD Bronchoalveolar Renal Impairment 1 2 3 Studies Phase 1 Trial Lavage Phase 1 Trial Phase 1 Trial Support increased efficacy beyond No evidence of nephrotoxicity at Well-tolerated and achieved lung Supportive of renal dosing in subsequent trials for patients impacted by traditional antibiotics and potential for predicted therapeutic dose levels exposures consistent with predicted differences in renal function single agent activity therapeutic levels 4 Next Steps: Phase 2 HABP/VABP Proof of Concept Study SPR206 has potential to fulfill unmet need for a well tolerated, efficacious therapeutic against carbapenem-resistant pathogens HABP: hospital-acquired bacterial pneumonia; MAD: multiple ascending dose; SAD: single ascending dose; VABP: ventilator-associated bacterial pneumonia. 1. Bruss J, et al. Antimicrob Agents Chemother 2021;65:e0073921; 26 2.Rodvold KA, et al. Antimicrob Agents Chemother 2023;67:e0042623. 3. Bruss JB, et al. Antimicrob Agents Chemother 2023;67:e0050523; 4. Contingent on non-dilutive funding availability.
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 at Spero Therapeutics; Prior Officer Vice President, Human Resources at • Over two decades of life science CFO at Ziopharm Oncology; VP and Intarcia Therapeutics sector experience, combining equities • Prior VP Program and Portfolio Global Head of Corporate Finance at research, investment banking, strategy Management, Cubist• Over 30 years of senior human Vertex consulting, and M&A resources leadership with over 17 • Extensive antibiotic development • Over 20 years of financial leadership, years in the life science space • Prior CFO at Fulcrum Therapeutics. experience from pre-clinical to executing within commercial and Senior equity research analyst at UBS, approval clinical companies Oppenheimer and Deutsche Bank. Healthcare Investment Banker at Bank • Over 30 years in the pharmaceutical of America Merrill Lynch industry 27
Thank You