Spero Therapeutics(US:SPRO)2023-05-12 00:59Financial Data and Key Metrics Changes - Total revenues for Q1 2023 were $2.1 million, unchanged from Q1 2022 [27] - Net loss for Q1 2023 was $13.3 million or $0.25 per share, compared to a net loss of $32.8 million or $1.01 per share in Q1 2022 [43] - Research and development expenses decreased to $9 million in Q1 2023 from $17 million in Q1 2022, primarily due to lower costs related to the tebipenem HBr program and decreased clinical activity for the SPR206 program [28] - General and administrative expenses for Q1 2023 were $7.3 million, down from $15.3 million in the same period in 2022, mainly due to reduced personnel costs and professional fees [60] Business Line Data and Key Metrics Changes - The SPR720 program is advancing as planned, with a Phase 2 proof of concept trial currently enrolling at over 15 active sites, with top-line data expected in the first half of 2024 [24] - The tebipenem HBr program is being developed in partnership with GSK, with ongoing engagement with the FDA regarding a potential Special Protocol Assessment for a planned Phase 3 trial [26] Market Data and Key Metrics Changes - The company is focusing on the NTM-PD market, where there is a significant unmet need for effective treatments, particularly for frontline patients who often fail existing therapies [45][70] - The SPR720 program aims to address the needs of early-stage NTM patients, who represent 75% of the target population [45] Company Strategy and Development Direction - The company aims to create value through the advancement of its pipeline, supported by a strong management team, industry partnerships, and a solid balance sheet [23] - The strategy includes expanding the SPR720 development program into Japan, where NTM-PD has a higher prevalence [25] - The company is also focused on developing and validating patient-reported outcomes for NTM-PD to align with FDA guidance [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of their clinical programs and the potential for SPR720 to meet significant medical needs [23] - The company expects to provide updates on the Special Protocol Assessment agreement and trial design by mid-2023 [40] - The management highlighted the importance of the upcoming data from the ARIKAYCE study and its potential influence on the SPR720 development plan [71] Other Important Information - The company reported having $96.3 million in cash and cash equivalents as of March 31, 2023, which is expected to be sufficient to fund operations beyond 2024 [41] Q&A Session Summary Question: What are the competitive advantages of SPR720 and upcoming inflection points with GSK? - Management highlighted the unmet need in frontline NTM treatment and the potential of SPR720 to address this gap, with expected development milestones from GSK during the Phase 3 trial [61][46] Question: Can you provide updates on enrollment progress for SPR720? - Management reiterated that they are on track for trial data in the first half of 2024 and mentioned ongoing site openings [73] Question: Will the company consider adding a fatigue scale to the PRO development? - Management confirmed that fatigue will be assessed in studies, including the use of the PROMIS scale in the ongoing Phase 2a study [51]