Pieris Pharmaceuticals(PIRS) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Cash, cash equivalents, and investments totaled $48.4 million for the quarter ended March 31, 2023, down from $59.2 million at the end of 2022, reflecting funding operations during the first quarter [24] - The company's net loss was $13.2 million or $0.45 loss per share for the quarter ended March 31, 2023, compared to a net loss of $5.1 million or $0.07 loss per share for the same quarter in 2022 [44] - Research and development expenses were $13.4 million for the quarter ended March 31, 2023, down from $14.1 million for the same quarter in 2022, primarily due to lower clinical costs [66] Business Line Data and Key Metrics Changes - The ongoing Phase 1 study for PRS-220 is on track, with top-line data expected in the second half of the year [47] - The Elarekibep Phase 2a study in asthma is a top priority, with AstraZeneca committed to additional resources and expanding the clinical footprint [31][12] - PRS-400 is advancing towards clinical development candidate nomination later this year, supported by preclinical data showing its potential [60] Market Data and Key Metrics Changes - The asthma therapeutics market is currently valued in the multibillion-dollar range, with Elarekibep targeting this significant opportunity [33] - The company anticipates a meaningful uptick in patient enrollment for the Elarekibep study due to protocol amendments and expanded clinical sites [14] Company Strategy and Development Direction - The company is focused on advancing its inhaled biologics pipeline for respiratory diseases, with a strategic emphasis on PRS-220 and PRS-400 [29] - The company is considering various transactions, including a potential spinout of its immune-oncology programs, to facilitate ongoing development [62] - The company aims to leverage anticipated modest milestones from existing collaborations while assessing opportunities in the equities market [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash reach objectives through appropriate investment decisions and partnerships [25] - The company remains committed to its respiratory franchise and is prepared to gate future investments based on the outcomes of ongoing studies [42] - Management highlighted the importance of the upcoming data readouts, particularly for the pamrevlumab program, which could significantly impact the company's strategy [71] Other Important Information - The company reported an increase in interest income to approximately $400,000 for the quarter ended March 31, 2023, due to rising interest rates [26] - The first quarter is typically a higher cash-burning quarter due to annual bonuses and insurance payments, but the operating cash burn decreased by more than $8 million compared to the first quarter of 2022 [65] Q&A Session Summary Question: What is the path forward for the PRS-220 program if FibroGen's Phase 3 looks good? - Management indicated that the ongoing Phase 1 is budgeted and on plan, with top-line data expected by the end of the year. Positive results from pamrevlumab could lead to a strong inflection point for PRS-220 [47][49] Question: What will be considered if the pamrevlumab trial fails? - Management stated that understanding the reasons for missing the endpoint is crucial. They believe that targeting the lung directly with an inhaled Anticalin will achieve better results [79][80] Question: What is the timeline for strategic decisions regarding the PRS-343 program? - Management noted that while no specific discussions could be disclosed, there is real interest in the program, and they expect to provide updates towards the back half of 2023 [75][76]