On May 11, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the first quarter of 2020 ended March 31, 2020 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, MAY 11, 2020, View Source [SID1234557451]).
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"We continue to stay the course with regard to the advancement of our lead assets, PRS-060 and PRS-343, despite the general disruptions caused by the coronavirus pandemic. We have been preparing for the start of the phase 2a trial of PRS-060 with AstraZeneca, which we still anticipate initiating in the second half of this year. Additionally, we have seen further clinical benefit in the monotherapy study of PRS-343, and we will be advancing that asset into a phase 2 study in combination with ramucirumab and paclitaxel in second-line gastric cancer in the second half of this year," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "I am very proud of the diligence and resolve of our team during these trying times."
PRS-060: Pieris and AstraZeneca are preparing to initiate the phase 2a study of PRS-060/AZD1402 in moderate-to-severe asthmatics in the second half of 2020. The study will be sponsored, funded, and delivered by AstraZeneca and upon completion of that study, Pieris will have the options to co-develop and, subsequently, co-commercialize PRS-060/AZD1402 in the United States.
PRS-343: Based on the totality of the data in the phase 1 dose-escalation monotherapy study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, Pieris will initiate a phase 2 single-arm study of PRS-343 in combination with ramucirumab and paclitaxel in the second-line of treatment for gastric cancer in the second half of this year. At the active dose levels for which the Company presented interim data last year in cohorts 9 (2.5 mg/kg Q3W) through 11b (8 m/kg Q2W), a partial response was observed in three patients and stable disease was observed in 11 patients as best response out of 21 evaluable patients, translating to an objective response rate (ORR) of 14% and a disease control rate (DCR) of 67%. All three objective responses in these cohorts were observed in cohort 11b, in which disease stabilization was also observed in three patients out of seven evaluable patients, translating to an ORR of 43% and a DCR of 86%. Additional clinical benefit, including complete response, was also observed in the higher dose cohorts, which are still open for enrollment to generate a larger data set. Pieris plans to present detailed data from both the monotherapy study and atezolizumab combination study at a medical meeting in the second half of this year.
Immuno-oncology Pipeline: Pieris and Servier have been working on furthering the development of PRS-344 and PRS-352. Due to scale-up challenges recently encountered with the manufacture of drug product for PRS-344, a 4-1BB/PD-L1 bispecific, Pieris and Servier have jointly decided to invest in additional CMC activities, given the strategic importance of this program. As a result, Pieris now anticipates filing an IND application for PRS-344 next year. The Company holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales for this program. Pieris is also focused completing the non-GLP work for PRS-352, a preclinical stage program addressing undisclosed targets, and expects to hand it over to Servier this year. Pieris continues to make progress in the Seattle Genetics collaboration.
Preclinical Respiratory Pipeline: Beyond PRS-060, Pieris continues to advance three discovery programs in its five-program respiratory collaboration with AstraZeneca. Pieris expects AstraZeneca will initiate the fourth discovery program in the collaboration later this year. The Company also continues to advance several proprietary discovery-stage respiratory programs. Pieris expects to share data and rationale for advancement of one of its proprietary programs in the second half of this year.
Board of Directors Transition: Jean-Pierre Bizzari, M.D. transitioned from the Board of Directors to serve as an advisor to the Company on oncology development strategies.
Fiscal Year Financial Update:
Cash Position – Cash, cash equivalents, and investments totaled $86.8 million for the quarter ended March 31, 2020, compared to a cash, cash equivalents, and investments balance of $104.2 million for the quarter ended December 31, 2019. The decrease was due to operating cash expenses, annual bonus payments, and both capital and one-time expenditures associated with the move to a new facility in Hallbergmoos.
R&D Expense – R&D expenses were $12.8 million for the quarter ended March 31, 2020, compared to $14.3 million for the quarter ended March 31, 2019. The decrease in research and development expenses reflects lower manufacturing spending on PRS-344. Partially offsetting this decrease were higher personnel expenses due to an overall increase in R&D headcount and an increase in allocated facility costs due to the new Hallbergmoos site, both associated with the advancement of our preclinical and clinical programs.
G&A Expense – G&A expenses were $4.4 million for the quarter ended March 31, 2020, compared to $4.9 million for the quarter ended March 31, 2019. The decrease in G&A expenses reflects lower personnel costs and a reduction in audit and tax professional fees.
Net Loss – Net loss was $3.6 million or $(0.07) per share for the quarter ended March 31, 2020, compared to a net loss of $10.3 million or $(0.20) per share for the quarter ended March 31, 2019.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM EDT on Monday, May 11, 2020, to discuss the first quarter financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.