Pieris Pharmaceuticals(US:PIRS)2022-11-02 16:23Financial Data and Key Metrics Changes - Cash and cash equivalents and investments totaled $69.8 million for the quarter ended September 30, 2022, down from $117.8 million for the quarter ended December 31, 2021, due to funding operations in the current year [23] - R&D expenses were $13.6 million for the quarter ended September 30, 2022, compared to $18.9 million for the same quarter in 2021, reflecting lower program costs and manufacturing costs [24] - G&A expenses were $3.9 million for the quarter ended September 30, 2022, slightly down from $4.1 million for the same quarter in 2021 [25] - The overall net loss was $9.7 million, or a $0.13 loss per share, for the quarter ended September 30, 2022, compared to a net loss of $16.5 million, or a $0.24 loss per share, for the same quarter in 2021 [27] Business Line Data and Key Metrics Changes - The company is advancing a pipeline of inhaled respiratory products, including elarekibep, PRS-220, and PRS-400, with significant progress reported in clinical trials [6][7][13][15] - The Phase IIa trial of elarekibep is ongoing, with AstraZeneca completing enrollment of the safety cohort and continuing enrollment for the efficacy cohort [9][10] - PRS-220 has entered Phase I study, targeting idiopathic pulmonary fibrosis, with results expected next year [13] - PRS-400, a new inhaled program, is being developed for muco-obstructive lung diseases, with promising preclinical data [15][17] Market Data and Key Metrics Changes - The company is focusing on both respiratory and immuno-oncology (IO) franchises, with multiple clinical programs expected to initiate in the coming year [6][18] - The IO pipeline includes PRS-344, which is in a Phase I/II study, and several partnered programs with Seagen and Boston Pharmaceuticals [18][20][21] Company Strategy and Development Direction - The company aims to achieve multiple inflection points across its clinical programs over the next year, particularly in respiratory and IO franchises [6][18] - The strategy includes leveraging partnerships for funding and development, with a focus on non-dilutive capital sources [21] - The company is committed to disciplined pipeline investments to support ongoing clinical trials and development [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about upcoming catalysts and the potential for positive data from ongoing trials, particularly for elarekibep and PRS-344 [6][11][18] - The management highlighted the importance of external partnerships in mitigating financial risks and enhancing development capabilities [21] - There is a focus on maintaining a strong cash runway into the second quarter of 2024, supported by anticipated milestone payments [23][52] Other Important Information - The company has received grant funding from the Bavarian Ministry of Economic Affairs to support the development of PRS-220 [14] - The management emphasized the significance of safety data from the 10 mg cohort of elarekibep for future dosing decisions [45][50] Q&A Session Summary Question: What clinical development does the runway guidance include? - The runway includes ongoing costs for PRS-220 and PRS-344, with limited costs for PRS-060 as it is funded by AstraZeneca [33] Question: What can be expected from the Phase I study of PRS-220? - The study will generate safety and tolerability data, with additional preclinical data to support the program's advancement [37][38] Question: Any preference for tumor types in PRS-344 enrollment? - There is no PD-L1 cutoff; all solid tumors are being enrolled, with backfilling options available for specific indications [41][43] Question: What are the enrollment trends for elarekibep? - Enrollment is expected to improve due to broader lifestyle changes, increased site engagement, and protocol amendments [49] Question: Will the 10 mg safety data influence future dosing decisions? - Confirmed safety at the 10 mg level will be crucial, and efficacy readouts will guide decisions on potential dose increases [50]