Spero Therapeutics(SPRO) - 2020 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q2 2020 was $1.7 million, a decrease from $2.2 million in Q2 2019 [34] - R&D expenses increased to $15.7 million in Q2 2020 from $12 million in the same period of 2019, primarily due to higher spending on the tebipenem HBr program [36] - Net loss for Q2 2020 was $17.5 million, or $0.85 per share, compared to a net loss of $13.2 million, or $0.74 per share, in Q2 2019 [39] - Cash and cash equivalents as of June 30, 2020, were $71.4 million, expected to fund operations into Q1 2021 [40] Business Line Data and Key Metrics Changes - The ADAPT-PO trial for tebipenem HBr completed enrollment of 1,372 patients, with follow-up now complete [18] - The Phase I bronchoalveolar lavage clinical trial for SPR206 has been delayed to the first half of 2021 due to COVID-19-related issues [26] Market Data and Key Metrics Changes - There is a rising resistance to fluoroquinolone antibiotics, with over 20% resistance to E. coli in the community setting, which is a significant concern for treating complicated urinary tract infections (cUTI) [29] - The company estimates that over two million patients annually could benefit from a new oral therapy for cUTI [30] Company Strategy and Development Direction - The company aims to file a rolling NDA submission for tebipenem HBr in Q1 2021, pending positive Phase III data, with completion expected in Q2 2021 [11][19] - The focus is on developing oral antibiotics that can keep patients out of the hospital, especially in light of the COVID-19 pandemic [13][32] - The company is also exploring partnerships and funding opportunities, such as the AMR Action Fund, to support antibiotic development [15][82] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the data set for the ADAPT-PO trial, despite challenges posed by COVID-19 [73] - The ongoing pandemic has highlighted the need for effective outpatient treatments to prevent hospital admissions [13] - The company is monitoring the market environment closely and developing a digital strategy to engage healthcare providers [79] Other Important Information - BARDA has committed a total of $44 million in nondilutive funding, with $16.3 million received as of June 30, 2020 [35] - The company is preparing for the commercial launch of tebipenem HBr, emphasizing its potential to meet significant unmet needs in the antibiotic market [27][32] Q&A Session Summary Question: What are the outstanding Phase I studies needed for the NDA submission? - The ongoing Phase I studies include a bioequivalence study, a drug-drug interaction study, and a study in renally impaired patients [42] Question: Can you provide insights on potential pricing for tebipenem HBr? - Pricing discussions are ongoing, with initial estimates suggesting treatment costs could be around $5,000 per course [48] Question: How will the extension on the NDA filing impact commercial build-out? - The company plans to engage with customers early and often, regardless of the NDA timeline, to build demand for tebipenem [64] Question: What are the microbiological endpoints for the SPR720 Phase II study? - The study will focus on safety and pharmacokinetics, with microbiological endpoints measuring changes in bacterial burden via quantitative sputum cultures [50] Question: Are there any data integrity issues for the ADAPT-PO study due to COVID-19? - Management confirmed there are no data integrity issues and expressed confidence in the data set [73] Question: How is the company preparing for the commercialization of tebipenem HBr? - The company is developing a digital strategy and monitoring access to clinicians' offices as part of its commercialization efforts [79]