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Pieris Pharmaceuticals (NASDAQ:PIRS) Receives Approval From HREC To Initiate First-In-Human Study

Pieris Pharmaceuticals (NASDAQ:PIRS) has received clearance from the Human Research Ethics Committee and the authority of Therapeutic Goods Administration to start its first-in-human study for PRS-060/AZD1402 in Australia. The clinical-stage biotechnology company uses its proprietary Anticalin technology platform for carrying out advanced and novel biotherapeutics for cancer, respiratory and several other diseases.

PRS-060/AZD1402 is a type of inhaled Anticalin protein that is used in the treatment of moderate to severe asthma by targeting IL-4Rα for patients that are not controlled on the standard of care. Pieris is making a strategic alliance with AstraZeneca for the phase 1 study which will primarily focus on healthy subjects. As a part of the alliance agreement, AstraZeneca will be funding the study trial whereas Pieris will be conducting it.

According to the President and CEO of Pieris, Stephen S. Yoder, the company is looking forward to dosing the first individual in the first clinical PRS-060/AZD1402 trial by the end of 2018 for which Pieris will be receiving a milestone payment from AstraZeneca. Yoder said that this study program is the first inhaled Anticalin protein to enter clinical development and will cap the ambitious year of pipeline progression.

Pieris also have another clinical initiation called PRS-343 underway which is a lead immune-oncology bispecific program.

Analysts Predict Pessimistic Year For Pieris

Last year in September, the pharmaceutical company came out with its latest earnings which revealed that the losses are becoming smaller as compared to previous years. However, the analysts have predicted a pessimistic year for Pieris as its earnings will become more negative and generate $-30.3M in 2019. Analysts have predicted that the earnings will further fall off in the coming years reducing to $-35.3M in 2020 and -$40.5M in 2021.

There is a major difference between Pieris Pharmaceuticals and its competitors. 50.5% of Pieris Pharmaceuticals shares are in the possession of institutional investors whereas 49.8% of shares of all the “Bio Therapeutic Drugs” companies are owned by the institutional investors. Only 4.1% of shares are owned by the insiders of the Pieris Pharmaceuticals whereas 16.8% shares of all the “Bio Therapeutic Drugs” companies are owned by the respective company insiders.

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