Pieris Pharmaceuticals Provides Strategic Update and Announces Restructuring

On July 18, 2023 Pieris Pharmaceuticals, Inc. (Nasdaq:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases and cancer, reported a strategic update following recent events that have impacted its inhaled respiratory franchise, including AstraZeneca’s discontinuation of enrollment of the Phase 2a study for elarekibep (Press release, Pieris Pharmaceuticals, JUL 18, 2023, View Source [SID1234633289]). AstraZeneca has now informed the Company of its decision to terminate the parties’ R&D collaboration agreement and hand back elarekibep along with discontinuing the remaining discovery program.

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Pieris’ management and board of directors have assessed several strategic options, which will include focusing on execution of new or expanded partnerships to advance its therapeutic programs, including cinrebafusp alfa (PRS-343), PRS-220 and PRS-400. While it explores potential transactions, Pieris will prioritize capital preservation, with cash, cash equivalents and investments totaling approximately $54.9 million as of June 30, 2023. As part of its cash preservation plan, Pieris initiated a corporate restructuring that will result in a reduction of the Company’s workforce by approximately 70%. These and other cost-saving measures are expected to maximize the opportunity to pursue a range of transactions across both its respiratory and immuno-oncology franchises and its discovery platform. Pieris has retained Stifel, Nicolaus & Company, Inc. as its exclusive financial advisor to evaluate a range of strategic options. These strategic options may include an acquisition, merger, reverse merger, other business combination, sale of assets, financing alternatives, licensing, or other strategic transactions involving the Company. There can be no assurance of a transaction, a successful outcome of these efforts, or the form or timing of any such outcome. The Company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by the Company’s board of directors or until the Company determines that further disclosure is appropriate.

"We are pursuing strategic options across three main areas following the recent developments that have impacted our ability to independently advance our respiratory programs," commented President and CEO Stephen Yoder. "One track is accelerating partnering discussions of PRS-220 and PRS-400. A second focal area is diligently selecting the best possible development partner and deal structure to re-initiate clinical development of cinrebafusp alfa, our former lead immuno-oncology asset, which has shown 100% ORR in five patients in a HER2+ gastric cancer trial that was discontinued for strategic reasons. Third, we will explore whether our balance sheet, position as a public company, and other assets are of strategic value to a range of third parties." Mr. Yoder continued, "While the challenges we recently experienced across our respiratory franchise have forced us to make very difficult personnel decisions, I cannot express enough gratitude to our departing colleagues for their dedication, collaborative spirit and integrity."