On March 12, 2019 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 its cash position for the fiscal year ended December 31, 2018 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, MAR 12, 2019, View Source [SID1234534237]).
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”2018 was an important year for the development of our two core franchises: respiratory diseases and immuno-oncology. On the respiratory front, we announced that PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma that we are developing with AstraZeneca and our first respiratory program to enter the clinic, was safe and well-tolerated in healthy volunteers in a single ascending dose phase 1 study. We also initiated a multiple ascending dose phase 1 study of PRS-060 in mild asthmatics, in addition to launching discovery efforts for two proprietary respiratory programs and two additional respiratory programs as part of the AstraZeneca collaboration. On the immuno-oncology front, we continue to enroll and dose patients in the phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and the phase 1 combination study of PRS-343 with atezolizumab. We also advanced PRS-344, a PD-L1/4-1BB bispecific drug candidate we are developing with Servier, into IND-enabling studies and plan to file an IND application for that program later this year,” said Stephen S. Yoder, President and CEO of Pieris. ”We believe that the tireless effort of our team and partners across our clinical and preclinical pipeline last year has created an opportunity for many catalysts this year.”
PRS-060: Pieris continues to enroll subjects with mild asthma and elevated levels of fractional exhaled nitric oxide (FeNO) in a multiple ascending dose phase 1 study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma. This study is evaluating the safety, tolerability and FeNO-reducing potential of PRS-060 versus placebo. The data from the PRS-060 phase 1 studies will be presented at upcoming medical meetings, including detailed data from the PRS-060 phase 1 single-ascending dose study, for which the Company reported topline data last year. PRS-060 is the lead candidate in Pieris’ respiratory collaboration with AstraZeneca. Pieris is sponsoring the phase 1 studies and AstraZeneca is funding the costs. Assuming successful completion of the ongoing phase 1 study, AstraZeneca would sponsor and fund the phase 2a study, after which Pieris will have options to co-develop and, subsequently, to co-commercialize the drug candidate.
Respiratory Pipeline: Pieris initiated an additional discovery-stage program in its alliance with AstraZeneca in the fourth quarter, bringing the total number of active programs to three; AstraZeneca may initiate up to two additional programs within the alliance. The Company also continues to advance the two proprietary discovery-stage respiratory programs initiated last year and intends to initiate additional proprietary respiratory programs in 2019.
PRS-343: Pieris continues to enroll and treat patients in a phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and intends to report comprehensive data from the study later this year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab and intends to report data from this trial later this year.
PRS-344: Pieris has exercised its opt-in right to co-develop and retain U.S. rights for PRS-344, a PD-L1/4-1BB antibody-Anticalin bispecific molecule, and achieved two preclinical milestones as part of the development of the drug candidate, receiving milestone payments totaling €2.0 million from Servier. In collaboration with Servier, Pieris plans to file an IND application for the candidate this year. PRS-344 is one of five bispecific programs that Pieris is developing as part of its immuno-oncology alliance with Servier and is the first program within the alliance scheduled to enter clinical development.
Seattle Genetics Collaboration: Pieris has generated and characterized the first tumor-targeting bispecific for further evaluation and development by Seattle Genetics as part of the companies’ three-program immuno-oncology collaboration.
PRS-080: Pieris has completed dosing all patients in the phase 2a multiple ascending dose study of PRS-080, a half-life-optimized hepcidin antagonist for anemia. This study is intended to evaluate the safety, tolerability, and pharmacological activity of 5 once-weekly doses of PRS-080 as well as the effect of repeated dosing on hemoglobin levels in this patient population. Pieris intends to present the full data set from this study in the first half of 2019. In addition, following delivery of a final study report, ASKA will decide whether to exercise its option to develop and commercialize PRS-080 in Japan and other Asian territories.
Cash Position: Cash, cash equivalents and investments totaled $128.1 million as of December 31, 2018, compared to a cash, cash equivalents and investments balance of $82.6 million as of December 31, 2017. The increase was driven primarily by the $47.2 million in net proceeds from the Company’s February 2018 equity financing, the $30.0 million in upfront payments received as part of the Seattle Genetics immuno-oncology collaboration, and the $12.5 million milestone payment from AstraZeneca that was triggered during the fourth quarter of 2017 and received during the first quarter of 2018.
Additional Financials: Our 2018 full-year audited financials will be released with our Annual Report on Form 10-K, expected to be filed by Monday, March 18, 2019.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM Eastern Daylight Time on Tuesday, March 12, 2019, to 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.