On November 4, 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 third quarter of 2020 ended September 30, 2020 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, NOV 4, 2020, View Source [SID1234569809]).
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"Within our respiratory franchise, we are pleased with AstraZeneca’s commitment to the continued clinical development of PRS-060/AZD1402 and are happy to announce that preparations for a global phase 2a study of that program are complete. The study will be performed using a dry powder formulation in moderate asthmatics and will assess FEV1 improvement," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "In immuno-oncology, we presented additional data from our phase 1 studies of PRS-343 at ESMO (Free ESMO Whitepaper), which showed single-agent clinical benefit, including a confirmed complete response, robust durability of response, and biomarker data suggesting 4-1BB-driven activity. Further, I am proud of the diligence of our team in completing the in-use studies to address the partial clinical hold of PRS-343. In a planned upcoming meeting with FDA, we intend to confirm the sufficiency of these data to remove the hold and align on the path to initiate our planned proof of concept study in gastric cancer."
PRS-060: AstraZeneca submitted the first Clinical Trial Application for a global phase 2a study of PRS-060/AZD1402. Dependent on regulatory approval, site initiation and patient screening are expected to begin this year. The first patients will be dosed thereafter, which we anticipate will be in the first quarter of next year, triggering a milestone payment from AstraZeneca. The phase 2a study will be performed using a dry powder formulation and will evaluate the efficacy, safety, and pharmacokinetics of PRS-060/AZD1402 in moderate uncontrolled asthmatics over four weeks with FEV1 improvement as the primary endpoint, following a four-week dosing arm in moderate controlled asthmatics to establish the safety and pharmacokinetics of the dry powder formulation. The study of PRS-060/AZD1402, which is being developed for the treatment of moderate-to-severe asthma, is being sponsored, funded, and delivered by AstraZeneca. 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: Pieris presented a clinical data update from the phase 1 monotherapy and atezolizumab combination studies of PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. In that presentation, PRS-343 demonstrated durable clinical benefit in the active dose cohorts, including a confirmed complete response, in heavily pre-treated patients across multiple HER2-positive tumor types. Additionally, a significant expansion of CD8+ T cells in the tumor microenvironment of responders and a substantial increase of soluble 4-1BB were observed in the active dose cohorts, suggesting 4-1BB-mediated target engagement driving clinical benefit. The Company has completed the in-use studies it deems necessary to remove the previously announced partial clinical hold. As part of the completed in-use studies, Pieris has optimized the level of an existing excipient to enhance the stability of PRS-343 in preparation for administration. The Company will shortly submit the data from these studies to FDA as part of a Type A meeting request to align on the next phase of development for PRS-343. As a result of this more thorough engagement with FDA, Pieris now expects to initiate the phase 2 study of PRS-343 in combination with ramucirumab and paclitaxel in the second line of treatment of HER2-positive gastric cancer next year.
Servier Collaboration: Pieris and Servier remain on track to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific, next year. The Company holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales by Servier for this program. Pieris intends to complete non-GLP preclinical work for PRS-352 this year before handing the program over to Servier, who would be fully responsible for further development. PRS-352 is a preclinical-stage program within the Servier alliance addressing undisclosed targets for immuno-oncology.
Preclinical Respiratory Pipeline: AstraZeneca initiated the fourth program in the collaboration in the third quarter, taking full advantage of all available potential new project starts envisioned in the alliance. Pieris continues to advance several proprietary discovery-stage respiratory programs and now expects to share data and rationale for advancement of one of its proprietary programs next year.
ATM Deployment: The Company raised $9.7 million in net proceeds from investment fund Pontifax through its at-the-market (ATM) equity facility. This transaction provides a meaningful yet focused amount of working capital to advance the pipeline, while further strengthening the Company’s shareholder base.
Fiscal Year Financial Update:
Cash Position – Cash, cash equivalents, and investments totaled $82.6 million for the quarter ended September 30, 2020, compared to a cash, cash equivalents, and investments balances of $77.2 million and $104.2 million for the quarters ended June 30, 2020 and December 31, 2019, respectively. The decrease since year end was primarily due to operating cash expenses and capital, as well as one-time expenditures, associated with the move to a new R&D facility in Hallbergmoos, Germany in the first quarter of 2020, partially offset by third quarter 2020 cash inflows of $9.7 million in net proceeds from an ATM offering and $5.0 million collected for the prior achievement of a milestone.
R&D Expense – R&D expenses were $11.8 million for the quarter ended September 30, 2020, compared to $13.2 million for the quarter ended September 30, 2019. The decrease in R&D expenses was primarily due to lower manufacturing and clinical spending on PRS-060, lower preclinical and manufacturing costs, and lower travel-related expenditures due to COVID-19 restrictions. The overall decrease was partially offset by an increase in allocated IT and facility costs due to the move to the new facility, higher consulting spend, and higher license costs.
G&A Expense – G&A expenses were $4.1 million for the quarter ended September 30, 2020, compared to $4.8 million for the quarter ended September 30, 2019. The decrease in G&A expenses was primarily due to lower personnel costs, lower audit and professional fees, and lower travel-related expenditures due to COVID-19 restrictions. These decreases were partially offset by higher allocated IT and facility costs due to the move to the new facility.
Net Loss – Net loss was $14.3 million or $(0.26) per share for the quarter ended September 30, 2020, compared to a net loss of $2.6 million or $(0.05) per share for the quarter ended September 30, 2019.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM EST on Wednesday, November 4, 2020, to discuss the third 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.