Spero Therapeutics(US:SPRO)2022-05-17 01:42Financial Data and Key Metrics Changes - Total revenues for Q1 2022 were $2.1 million, a decrease from $7.3 million in Q1 2021, primarily due to reduced funding under the BARDA contract for tebipenem HBr and the NIAID agreement related to SPR206 [42][43] - Research and development expenses for Q1 2022 were $17 million, down from $18.4 million in Q1 2021, mainly due to the completion of significant activities for the NDA for tebipenem HBr [44] - General and administrative expenses increased to $15.3 million in Q1 2022 from $8.3 million in Q1 2021, attributed to an increase in headcount [45] - The net loss for Q1 2022 was $32.8 million, or $1.01 per share, compared to a net loss of $19.4 million, or $0.66 per share, in Q1 2021 [45] Business Line Data and Key Metrics Changes - The company has suspended commercialization activities for tebipenem HBr and reduced its workforce by approximately 75% due to insufficient data for FDA approval [9][10] - Focus has shifted to the development of SPR720 and SPR206, with plans to initiate a Phase 2 study for SPR720 later in 2022 [31][32] Market Data and Key Metrics Changes - The company believes that the long-term prospects for tebipenem remain bright, with a patent life extending to 2038 and a large addressable market for patients resistant to oral options [54] - The market for tebipenem is viewed as a long-term durable opportunity, despite the current challenges in the approval process [54] Company Strategy and Development Direction - The company aims to achieve key clinical and regulatory milestones within its capital runway, clarify the path forward for tebipenem, and execute on milestones while managing capital prudently [11][12][21] - Strategic partnerships are being pursued to support the development of SPR720 and SPR206, with existing collaborations with Pfizer and others providing funding avenues [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of tebipenem to address unmet medical needs, particularly in the context of increasing antibiotic resistance [18][19] - The company is focused on gaining clarity on the requirements for tebipenem's approval and is engaging with the FDA for guidance [20] Other Important Information - The company had approximately $122 million in cash, cash equivalents, and marketable securities as of March 31, 2022, which is expected to fund operations through late 2023 [40][41] Q&A Session Summary Question: Partnership discussions and additional products - Management confirmed ongoing partnership discussions and emphasized the focus on achieving key objectives before considering additional programs [48] Question: Tebipenem situation compared to sulopenem - Management noted that tebipenem's long-term prospects remain unchanged and highlighted differences in trial designs between tebipenem and sulopenem [54][55] Question: Duration of dosing for SPR720 study - Management indicated that the FDA is open to longer dosing periods for the SPR720 study, which could enhance study efficiency [61] Question: Lead indication for SPR206 - Management highlighted pneumonia as a significant indication for SPR206 due to the prevalence of resistant pathogens [67] Question: Feedback from FDA - Ongoing discussions with the FDA are taking place, and management will provide updates as more definitive feedback is received [69]