Pieris Pharmaceuticals(US:PIRS)2022-08-06 21:14Financial Data and Key Metrics Changes - Cash and cash equivalents decreased to $80.9 million for the quarter ended June 30, 2022, down from $117.8 million for the quarter ended December 31, 2021, due to funding operations in the first half of 2022 [21] - R&D expenses were $11.9 million for the quarter ended June 30, 2022, compared to $15.8 million for the same quarter in 2021, reflecting lower program costs [21] - Net loss was $10.3 million or a loss of $0.14 per share for the quarter ended June 30, 2022, compared to a net loss of $15.5 million or a $0.25 loss per share for the same quarter in 2021 [22] Business Line Data and Key Metrics Changes - The lead respiratory program, PRS-060 (AZD1402), is currently in a Phase IIa study with AstraZeneca, focusing on moderate to severe asthma [7][8] - The company is winding down the CINRA program, which was a 4-1BB bispecific for gastric cancer, to focus resources on other programs [14][18] - PRS-220, a proprietary inhaled Anticalin protein for idiopathic pulmonary fibrosis, is expected to enter a Phase I study later this year [12] Market Data and Key Metrics Changes - The company is facing challenges in recruiting for respiratory clinical trials due to the ongoing impact of COVID-19, which has affected enrollment rates [9][45] - The company has made strategic decisions to simplify trial protocols to enhance recruitment rates [10][60] Company Strategy and Development Direction - The company is prioritizing its lead respiratory program, PRS-060, while also making high-impact investments in proprietary assets like PRS-220 [6][12] - The company is focusing on a streamlined pipeline and resource allocation to navigate the tough economic climate for small-cap biotech firms [6][20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the tough economic climate and the need for focused decision-making due to resource constraints [6] - The company believes it is sufficiently funded into the second quarter of 2024, despite the challenges faced [20] Other Important Information - Dr. Tim Demuth, Senior Vice President and Chief Medical Officer, will be leaving the company [18] - The company has retained co-development and U.S. co-commercialization options for two discovery-stage programs with AstraZeneca [12] Q&A Session Summary Question: What data is AstraZeneca using to determine the optimal dose for PRS-060? - Management indicated that safety data from the 1 and 3-milligram cohorts and preclinical modeling informed the decision to focus on the 3-milligram dose [26][29] Question: Will the sample size for the 3-milligram efficacy trial be increased? - Management confirmed that the sample size will remain at 80 patients in both the placebo and treatment groups, as they believe it is well powered for the study [30][33] Question: What are the next steps after the Phase IIa data for PRS-060? - Management indicated that a Phase IIb is more probable than moving directly to Phase III, depending on the data readout [35][36] Question: What clinical benefits were observed in the CINRA program? - Management noted that the ongoing Phase II study showed responses consistent with the Phase I study, indicating clinical benefit [38] Question: How has COVID-19 impacted enrollment in asthma trials? - Management explained that COVID-19 has significantly affected recruitment and disease control, impacting the timelines for the trial [44][45] Question: What is the status of PRS-220's regulatory filing? - Management clarified that a regulatory filing has been submitted in Australia, similar to the approach taken with PRS-060 [51] Question: Are there any collaborations likely to deliver near-term milestones? - Management mentioned that while there are modest milestones expected from various partnerships, they are not of the magnitude seen with AstraZeneca [53]