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Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) is a clinical-stage biotechnology company headquartered in Boston, Massachusetts, specializing in the discovery and development of Anticalin-based therapeutics. Anticalins are a proprietary class of engineered proteins derived from lipocalins—human proteins naturally involved in binding, storing, and transporting molecules. These innovative therapeutics are designed to address validated disease pathways in transformative ways, offering targeted treatments for a range of complex medical conditions.
Core Technology: Anticalin Platform
The foundation of Pieris Pharmaceuticals lies in its proprietary Anticalin platform. This technology enables the creation of highly specific and versatile protein-based drugs that can be tailored to interact with a broad spectrum of therapeutic targets. With a library of over 100 billion Anticalin variants, the platform has consistently delivered promising drug candidates across multiple disease areas. Unlike traditional antibody-based treatments, Anticalins offer advantages such as smaller size, ease of production, and the ability to address previously inaccessible biological targets.
Pipeline and Therapeutic Focus
Pieris has developed a diverse pipeline of clinical and preclinical programs targeting significant unmet medical needs:
- Immuno-Oncology: The company is advancing multi-specific Mabcalin® (antibody-Anticalin fusion) proteins, designed to modulate the tumor microenvironment. These assets are being developed in collaboration with leading pharmaceutical companies like Pfizer and Boston Pharmaceuticals.
- Respiratory Diseases: Pieris is leveraging its expertise to develop inhalable Anticalin-based therapeutics, including treatments for uncontrolled asthma.
- Hematology: The pipeline includes half-life-optimized Anticalins for anemia, aimed at improving patient outcomes through innovative therapeutic mechanisms.
Collaborations and Strategic Partnerships
A key pillar of Pieris' business model is its ability to form high-value partnerships with global pharmaceutical leaders. These collaborations provide the company with funding for research and development, while also enabling it to share in future milestone and royalty payments. Notable partnerships include agreements with Pfizer (formerly Seagen), Boston Pharmaceuticals, and Servier. These alliances not only validate the potential of Pieris' Anticalin platform but also diversify its revenue streams and reduce financial risk.
Revenue Model and Market Position
Pieris generates revenue primarily through licensing agreements, milestone payments, and royalties from its partnered programs. The company's lean operational model and focus on out-licensing allow it to minimize costs while maximizing the value of its proprietary assets. Operating in the competitive biotechnology sector, Pieris differentiates itself through its unique Anticalin technology and its ability to address complex disease pathways that are often challenging for traditional therapeutics.
Competitive Landscape
Pieris operates within a highly competitive biotechnology market, characterized by rapid innovation and significant R&D investments. Its primary competitors include companies specializing in biologics and protein-based therapeutics. Pieris' proprietary Anticalin platform, coupled with its strategic partnerships, positions it as a niche player with the potential to address unmet medical needs in immuno-oncology, respiratory diseases, and hematology.
Significance and Value Proposition
Pieris Pharmaceuticals stands out for its innovative approach to drug development, leveraging its Anticalin platform to create therapeutics that are both versatile and highly targeted. Its collaborative strategy with industry leaders not only validates its technology but also provides a pathway to commercialization. For investors and stakeholders, Pieris represents a biotechnology company with a strong scientific foundation, a diversified pipeline, and the potential for significant milestone and royalty revenues.
Pieris Pharmaceuticals and Boston Pharmaceuticals have entered into an exclusive license agreement to develop PRS-342, a preclinical immuno-oncology bispecific fusion protein. The deal includes an upfront payment of $10 million to Pieris, with potential additional milestone payments totaling approximately $353 million, along with tiered royalties on sales. Boston will lead the development, with Pieris collaborating during the IND-enabling stage. This partnership aims to advance the innovative program in areas with significant unmet medical needs.
Pieris Pharmaceuticals presented updated clinical data for cinrebafusp alfa (PRS-343) at the AACR Virtual Congress 2021, demonstrating a dose-dependent response in treating HER2-expressing tumors. Key findings included an overall response rate (ORR) of 25% and a disease control rate (DCR) of 63% in the highest dose cohort. Additionally, preclinical data for PRS-344/S095012 showed promising anti-tumor activity. The company plans to initiate a phase 2 study in gastric cancer targeting both HER2-high and HER2-low patients, aiming to explore the drug's efficacy further.
Pieris Pharmaceuticals (NASDAQ:PIRS) announced a $13 million milestone from AstraZeneca for the initiation of the PRS-060/AZD1402 phase 2a study, along with a $10 million equity investment. Seagen also invested $13 million, advancing their collaboration to evaluate cinrebafusp alfa (PRS-343) in HER2-low gastric cancer. The fiscal year 2020 showed a net loss of $37.2 million, with reduced R&D and G&A expenses. Cash and equivalents totaled $70.4 million at the end of 2020, a decrease from the previous year. Additional data will be presented at AACR Annual Meeting 2021.
Pieris Pharmaceuticals (NASDAQ:PIRS) announced a strategic partnership with Seagen to evaluate the combination of cinrebafusp alfa (PRS-343) with TUKYSA (tucatinib) in treating gastric cancer patients with low HER2 expression. The collaboration includes a $13 million equity investment from Seagen, which will strengthen Pieris' financial position. The combination aims to address significant unmet medical needs in patients who don't respond to traditional HER2 therapies. A phase 2 study is planned, with updated details expected soon.
Pieris Pharmaceuticals (NASDAQ:PIRS) will hold a full-year 2020 investor call on March 30, 2021, at 8:00 AM EDT to discuss financial results and corporate updates. Participants can join by calling 877-407-8920 (Toll Free US & Canada) or 412-902-1010 (International). An archived replay will be available for 30 days at 877-660-6853 (Toll Free US & Canada) with Conference ID #13661472. Pieris specializes in developing Anticalin proteins targeting respiratory diseases and cancer through partnerships with firms like AstraZeneca and Seagen.
Pieris Pharmaceuticals (NASDAQ:PIRS) announced that CEO Stephen S. Yoder will participate in a GI Oncology and Pancreatic Cancer panel at the Cowen 41st Annual Healthcare Conference on March 2, 2021, at 9:50 AM EST. Pieris focuses on developing innovative biotherapeutics using its proprietary Anticalin® technology for various diseases, including respiratory conditions and cancer. The company aims to advance its pipeline of inhalable therapies and immuno-oncology treatments. For more details, visit www.pieris.com.
Pieris Pharmaceuticals has announced that the FDA has lifted the partial clinical hold on the phase 1 studies of PRS-343, allowing the company to advance to a proof-of-concept study for gastroesophageal cancer. The CEO, Stephen S. Yoder, highlighted the encouraging clinical data showing the therapeutic's potential in improving patient lives. The company is expected to share more details about this study later in the quarter, marking a significant step forward in their development pipeline.
Pieris Pharmaceuticals (NASDAQ:PIRS) reported its third-quarter 2020 financial results and ongoing developments. The company initiated the first global phase 2a study for PRS-060/AZD1402, focusing on moderate asthma, with patient screening expected soon. PRS-343 showed promising results in phase 1 studies, with a complete response noted. Financially, Pieris raised $9.7M through an ATM facility, with total cash reserves at $82.6M. However, net loss was $14.3M, or $(0.26) per share, significantly higher than last year’s loss of $2.6M, indicating increased operational costs.
Pieris Pharmaceuticals (NASDAQ:PIRS) has announced an investor call for Q3 2020, scheduled for November 4, 2020, at 8:00 AM EST. The call will cover financial results and provide a corporate update. Participants can join by dialing 877-407-8920 (US) or 412-902-1010 (International). A replay will be available for 30 days at 877-660-6853 (US) or 201-612-7415 (International) using Conference ID #13661472. Pieris focuses on Anticalin technology for developing therapeutics targeting respiratory diseases and cancer.
Pieris Pharmaceuticals (NASDAQ:PIRS) presented promising clinical data for PRS-343, a 4-1BB/HER2 bispecific treatment for HER2-positive solid tumors, at the ESMO Virtual Congress 2020. The phase 1 trials exhibited clinical benefits, including one complete response and three partial responses in the monotherapy trial, and four partial responses in the atezolizumab combination trial. The treatment showed durable responses, lasting over 18 months in some cases, with significant CD8+ T cell expansion linked to 4-1BB activity. PRS-343 is set to enter phase 2 trials in second-line gastric cancer.
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