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Pieris Pharmaceuticals Inc. (NASDAQ: PIRS) is a clinical-stage biotechnology company dedicated to developing novel Anticalin-based drugs. These drugs target specific disease pathways in innovative and transformative ways. The company's proprietary Anticalin proteins are engineered versions of human lipocalins, which naturally bind, store, and transport a wide range of molecules. This unique technology has been validated through clinical trials and partnerships with leading pharmaceutical companies.
Core Business and Products
Pieris specializes in creating a diverse pipeline of Anticalin-based therapeutics. Their current focus areas include:
- Immuno-Oncology: Multi-specifics tailored for the tumor micro-environment, such as PRS-344 targeting PD-L1 and 4-1BB, PRS-346 targeting CD228 and 4-1BB, and PRS-342 targeting GPC3 and 4-1BB.
- Respiratory Diseases: Inhaled Anticalin proteins to treat conditions like uncontrolled asthma, with ongoing projects such as elarekibep, an inhaled IL-4 receptor alpha inhibitor.
- Other Conditions: Including treatment for anemia through half-life-optimized Anticalin proteins.
Recent Achievements and Partnerships
Pieris continues to make significant strides in its research and development efforts. Despite recent setbacks such as AstraZeneca's decision to discontinue studies on elarekibep, Pieris is actively reassessing its corporate priorities and focusing on leveraging its strong partnerships with companies like Roche, Pfizer, Boston Pharmaceuticals, and Servier.
Financial Condition and Strategic Focus
As of June 30, 2023, Pieris reported cash, cash equivalents, and investments totaling approximately $54.9 million. The company has initiated a corporate restructuring to reduce workforce and operational costs, aiming to extend its cash runway. Pieris is also exploring strategic options, including new partnerships and potential acquisitions, to maximize shareholder value.
For more detailed information, visit www.pieris.com.
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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