| Over a week ago | ||||
Pieris Pharmaceuticals… Pieris Pharmaceuticals announced the presentation of preclinical data from the Company's inhaled Jagged-1 targeting program, PRS-400, at the annual American Thoracic Society International Conference being held in Washington, D.C. May 19-24, 2023. The poster presentation will be available on May 22, 2023, from 2:15 PM to 4:15 PM and demonstrates that Pieris' lead candidate has reached desired in vitro and ex vivo potency goals while also demonstrating in vivo proof of concept when locally administered to the lung, showing the promise of PRS-400 as an inhaled therapy for patients with muco-obstructive lung diseases. PRS-400 is a potentially novel intervention for mucus hypersecretion as it both inhibits the formation of mucus-secreting cells and stimulates the creation of mucus-clearing cells, thereby addressing mucus-driven diseases at the root. Jagged-1, one of five human Notch receptor ligand members, is involved in cell fate specification in the lung, and aberrant Jagged-1/Notch signaling drives a pro-secretory cell phenotype leading to mucus hypersecretion. As the Notch signaling pathway has fundamental roles in multiple other organs, a systemically administered intervention may have undesirable side effects. PRS-400 offers a potential solution to this challenge when administered locally to the lung by targeting Jagged-1 expressed on lung epithelial cells and avoiding undesired target engagement peripherally. As shown in the poster presentation, Pieris' lead candidate reduced mucin expression and differentiation of goblet cells under pro-inflammatory conditions ex vivo. Further, the lead candidate dose-dependently reduced mucin expression and drove the differentiation of mucus-secreting goblet cells to a ciliated cell phenotype in both prophylactic and therapeutic models of disease in vivo. Additional preclinical studies are ongoing to support the advancement of PRS-400 to clinical development, with development candidate nomination anticipated in the second half of this year. | ||||
Cash, cash equivalents,… Cash, cash equivalents, and investments totaled $48.4 million for the quarter ended March 31, 2023, compared to a cash and cash equivalents balance of $59.2 million for the year ended December 31, 2022. The decrease was due to funding operations in the first quarter of 2023. The Company believes operations are sufficiently funded for more than the next 12 months. | ||||
Reports Q1 revenue $1.9M… Reports Q1 revenue $1.9M vs. $11M last year. We continue to be excited by the potential of our inhaled biologics pipeline to reshape the treatment paradigm for patients living with uncontrolled asthma and other chronic respiratory diseases. Our top priority remains the study completion and clinical data read out from the elarekibep Phase 2a study in asthma, which is benefitting from increased operational resources from our partner, AstraZeneca," said Stephen S. Yoder, President and CEO of Pieris. "Pieris continues to make measured investments in PRS-220 and PRS-400 while also expecting additional progress across partnered programs through our capital-efficient collaborations with Boston Pharmaceuticals, Genentech, Seagen and Servier." | ||||
"We continue to be… "We continue to be excited by the potential of our inhaled biologics pipeline to reshape the treatment paradigm for patients living with uncontrolled asthma and other chronic respiratory diseases. Our top priority remains the study completion and clinical data read out from the elarekibep Phase 2a study in asthma, which is benefitting from increased operational resources from our partner, AstraZeneca," said Stephen S. Yoder, President and CEO of Pieris. "Pieris continues to make measured investments in PRS-220 and PRS-400 while also expecting additional progress across partnered programs through our capital-efficient collaborations with Boston Pharmaceuticals, Genentech, Seagen and Servier." | ||||
Pieris Pharmaceuticals… Pieris Pharmaceuticals announced the safety review of the 10 mg dry powder dose safety cohort from the ongoing multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated elarekibep. The successful review of the 10 mg dose provides additional data supporting the elarekibep safety profile and enables doses of 10 mg or less to be evaluated in future clinical trials. Elarekibep is an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Pieris previously announced the successful completion of the safety review for the 1 mg and 3 mg doses, triggering the efficacy portion of the study, which is ongoing at the 3 mg dose. Upon completion of the phase 2a study and availability of topline data, which Pieris expects to be reported by mid-2024, the Company will have a co-development option for this program with AstraZeneca. For this safety review, 13 asthma patients, controlled on standard of care, received elarekibep twice daily over four weeks to establish the safety profile and pharmacokinetics of the dry powder formulation of elarekibep at the 10 mg dose. Following completion of enrollment and observation, AstraZeneca evaluated, compared to placebo, the incidence of adverse events, changes in laboratory markers, and forced expiratory volume in one second. | ||||
| Over a month ago | ||||
Pieris Pharmaceuticals… Pieris Pharmaceuticals announced the presentation of cinrebafusp alfa clinical results from the Company's study in 2L+ HER2-positive gastric cancer at the American Association for Cancer Research annual meeting being held in Orlando, Florida on April 14-19, 2023. The study's principal investigator, Dr. Geoffrey Ku, will present these encouraging results at 1:30 PM EDT on April 17, 2023, which include an unconfirmed 100% objective response rate and promising emerging durability profile in the five patients enrolled into the study before discontinuation of enrollment for strategic reasons. The presented data from the multi-center, open-label Phase 2 clinical study evaluating a combination of cinrebafusp alfa, ramucirumab and paclitaxel in HER2-positive gastric cancer patients provide further encouraging evidence of clinical activity for this program. The combination regimen was well tolerated, and all patients experienced a partial clinical response, with three patients remaining on study as of the abstract submission cut-off date of December 19, 2022. Each patient received trastuzumab and a checkpoint blockade in prior lines of therapy, and three patients previously received-and progressed on-trastuzumab deruxtecan. Pieris is considering a range of transactions to facilitate the continuation of cinrebafusp alfa, from an immuno-oncology focused spinout to traditional partnering transactions, given the emerging transformative activity seen in gastric cancer and exciting potential in other HER2 settings. | ||||
Cash, cash equivalents,… Cash, cash equivalents, and investments totaled $59.2 million for the year ended December 31, 2022, compared to a cash and cash equivalents balance of $117.8 million for the year ended December 31, 2021. The decrease was due to funding operations in 2022. The Company believes operations are sufficiently funded for more than the next 12 months. | ||||
Reports 2022 revenue… Reports 2022 revenue $25.9M vs. $31.4M last year. "Pieris continues to advance potentially transformative clinical and preclinical programs, while remaining committed to cost-effective operations. Our top priority is to obtain data from the elarekibep Phase 2a study in asthma. We are pleased that our partner and study sponsor, AstraZeneca, is significantly increasing operational resources to complete the trial. As an inhaled therapeutic, elarekibep offers the promise of a superior product profile compared to currently available injectable drugs and further validation of our broader respiratory franchise," said Stephen S. Yoder, President and CEO of Pieris. "Respiratory diseases such as asthma, IPF and chronic obstructive pulmonary disease are underserved by the biopharma industry despite high mortality rates, impaired quality of life, and a significant burden on the healthcare system. We believe Pieris is well positioned to develop differentiated inhaled biologics medicines that could fundamentally alter how respiratory diseases are managed. Alongside our lead program, elarekibep, Pieris is advancing additional clinical and preclinical programs that could result in meaningful new medicines. We are evaluating opportunities to support the long-term development of these promising therapeutic candidates." | ||||
| Over a quarter ago | ||||
Pieris Pharmaceuticals… Pieris Pharmaceuticals announced that the Company has achieved a $5 million milestone from Seagen. The milestone is based on dosing the first patient in a Seagen-sponsored phase 1 study of SGN-BB228, a novel bispecific antibody-Anticalin molecule (Mabcalin(TM)) that is designed to provide a potent costimulatory bridge between tumor-specific T cells and CD228 expressing tumor cells. The Seagen-sponsored open-label phase 1 study is evaluating the safety and tolerability of SGN-BB228 in patients with advanced melanoma and other solid tumors. Secondary endpoints in the study include pharmacokinetics and antitumor activity. This program is one of three ongoing immuno-oncology programs with Seagen and preclinical data were recently presented at the Society for Immunotherapy of Cancer's Annual Meeting in Boston. Pieris has an opt-in option to a U.S. co-promotion for one program in the collaboration. | ||||
Cash, cash equivalents,… Cash, cash equivalents, and investments totaled $69.8 million for the quarter ended September 30, 2022, compared to a cash and cash equivalents balance of $117.8 million for the year ended December 31, 2021. The decrease is due to funding operations in 2022. Including the proceeds from anticipated near-term milestones, the Company believes operations are sufficiently funded into the second quarter of 2024. | ||||
