On March 12, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory, cancer, and other diseases, reported financial results for its fiscal year ended December 31, 2019 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, MAR 12, 2020, View Source [SID1234555449]).
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"2019 was a milestone year for Pieris as we reported two positive clinical data sets, one from each of our core focus areas of respiratory diseases and immuno-oncology," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma that we are developing with AstraZeneca, demonstrated robust fractional exhaled nitric oxide, or FeNO, reduction in mild asthmatics in a phase 1 multiple-ascending dose study. We are very pleased with the data and are currently enrolling the final cohorts in that study to help inform the phase 2a study, which we anticipate will begin in the second half of this year. Additionally, PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, demonstrated both single-agent and checkpoint-combination anti-tumor activity, including partial responses, in heavily pre-treated patients across multiple HER2-positive tumors with correlative biomarker data indicative of 4-1BB agonism on T cells in phase 1 dose-escalation studies. These data strengthen our conviction in a 4-1BB-targeted immuno-oncology approach, and we look forward to completing the ongoing dose-escalation studies and moving this program into the next phase of development in gastric cancer. Finally, we look forward to advancing PRS-344, a 4-1BB/PD-L1 bispecific that is partnered with Servier, into the clinic."
PRS-060: In October, Pieris presented data from the phase 1b placebo-controlled multiple ascending dose study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, at the 2019 European Respiratory Society International Congress. In that analysis, PRS-060/AZD1402 was found to be safe and well tolerated at all doses, led to a statistically-significant reduction in FeNO (a marker of airway inflammation) relative to placebo, and showed dose-dependent systemic target engagement in patients with mild asthma and elevated levels of FeNO (≥ 35 ppb). Dosing of additional cohorts by Pieris is ongoing and will inform the phase 2a study; AstraZeneca and Pieris plan to initiate the phase 2a study 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: In November, Pieris presented data from its phase 1 dose-escalation monotherapy study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting. PRS-343 was safe and well tolerated at all doses and schedules tested, demonstrated anti-tumor activity in a heavily pre-treated patient population across multiple tumor types, and showed a marked increase in CD8+ T cell numbers in the tumor microenvironment of responders, indicative of 4-1BB agonism on T cells. The Company also presented emerging data from the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab at the Company’s R&D day in November, showing clinical responses and correlative increases in CD8+ T cells in responding patients. Pieris plans to present detailed data from both studies at a medical meeting in the second half of this year. Based on emerging data from the ongoing clinical studies, the Company expects to initiate the next phase of PRS-343’s development in gastric cancer this year.
Preclinical Respiratory Pipeline: Beyond PRS-060, Pieris continues to advance three of four discovery programs in its five-program respiratory collaboration with AstraZeneca. AstraZeneca will have the option to initiate the fourth discovery program in the collaboration 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 at a medical meeting in the second half of this year.
Asthma Research Collaboration with the University of Pittsburgh: As part of the Company’s commitment to building a novel respiratory pipeline, in the fourth quarter, Pieris entered into research collaboration with the laboratories of University of Pittsburgh Professors Sally Wenzel, MD, and Anuradha Ray, PhD, focused on comprehensive immune phenotyping of severe asthmatic patients. Key objectives of the multi-year collaboration include patient stratification strategies for more streamlined development of therapeutic interventions as well as identifying and validating novel asthma targets.
Immuno-oncology Pipeline: Pieris plans to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific that the Company is developing as part of its collaboration with Servier, in the first half of this year. Pieris holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales for this program. The Company’s immuno-oncology collaboration with Seattle Genetics continues to progress on schedule.
Private Placement: In the fourth quarter, the Company completed a $32 million private placement with new and existing healthcare-focused institutional investors that resulted in a year-end cash and investment position exceeding $100 million.
Fiscal Year Financial Update:
Cash Position – Cash, cash equivalents, and investments totaled $104.2 million for the year ended December 31, 2019, compared to a cash, cash equivalents, and investments balance of $128.1 million for the year ended December 31, 2018. The decrease in cash, cash equivalents, and investments was primarily due to the Company’s operational needs during 2019, offset by proceeds from the private placement financing completed in November 2019.
R&D Expense – R&D expenses were $55.0 million for the year ended December 31, 2019, compared to $41.5 million for the year ended December 31, 2018. The increase in R&D expenses was primarily due to higher manufacturing costs supporting planned and ongoing clinical studies as well as higher personnel, facility, and IT costs supporting the ongoing advancement of the Company’s pipeline. The increase was offset by a decline in royalty expenses due to lower upfront and milestone payments compared to 2018.
G&A Expense – G&A expenses remained flat at $18.4 million for both years ended December 31, 2019 and December 31, 2018. The Company incurred higher hardware and software costs to support operations growth and efficiency, and higher audit and tax fees due to new accounting regulations and internal control requirements. These costs were offset by both lower professional service fees as the Company better leveraged internal resources in 2019 and lower facilities and IT costs attributed to G&A functions.
Interest Income – Interest income was $1.7 million for the year ended December 31, 2019, compared to $2.0 million earned for the year ended December 31, 2018. The decrease was due to lower average cash amounts invested during the year and declining interest rates on investments in 2019.
Net Loss Attributable to Common Stockholders – Net loss attributable to common stockholders was $28.3 million or $(0.56) per share for the year ended December 31, 2019, compared to a net loss of $26.8 million or $(0.50) per share for the year ended December 31, 2018.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM Eastern Daylight Time on Thursday, March 12, 2020, to discuss the full year 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.