On March 1, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the fiscal year ended December 31, 2021 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAR 1, 2022, View Source [SID1234609284]).
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"Last year was one of steady execution as we laid the groundwork for 2022, which we believe promises to be the most important catalyst year in the Company’s history, including key efficacy data for cinrebafusp alfa and PRS-060/AZD1402. We announced a collaboration with R&D leader Genentech, reported data from several clinical and preclinical programs, and initiated multiple clinical trials. Later this year, we expect to report topline data from the phase 2a trial of PRS-060/AZD1402, which has recently cleared the safety gate for the 1 mg and 3 mg dose cohorts. Beyond PRS-060/AZD1402, we currently have two bispecific immuno-oncology programs in clinical development and plan on initiating clinical development for our proprietary inhaled-delivery idiopathic pulmonary fibrosis (IPF) drug program, PRS-220, later this year, with generous grant support from the Bavarian government," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Through these initiatives, we have advanced our pipeline assets while strengthening our balance sheet through partnerships, grant funding, and focused utilization of our ATM facility, all with the focus of driving toward our key inflection points."
PRS-060/AZD1402 and AstraZeneca Collaboration: Enrollment of part 2a (efficacy of 1 mg and 3 mg cohorts) and part 1b (safety of 10 mg cohort) has begun following successful completion of the sponsor safety review of part 1a (safety of 1 mg and 3 mg cohorts) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402. PRS-060/AZD1402 is an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Pieris and AstraZeneca expect to announce topline data from the phase 2a study this year, although the companies are actively evaluating the feasibility of study timelines in the current geopolitical environment and will update guidance in the orderly course of business, if needed.Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris may choose to exercise its co-development option, which would be on a 25% cost-share basis with a cost cap or a 50% cost-share basis without a cost cap. Separately, Pieris will have a future option to co-commercialize PRS-060/AZD1402 in the United States.
Cinrebafusp Alfa (PRS-343 ) : In January 2022, the first patient was dosed in the phase 2 study of cinrebafusp alfa, a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer. The two-arm, multicenter, open-label phase 2 study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with standard of care agents ramucirumab and paclitaxel in patients with HER2-high gastric cancer and in combination with tucatinib in patients with HER2-low gastric cancer. Pieris plans to report data from the HER2-low arm this year. Separately, the Company plans to disclose data from the HER2-high arm in 2023.
PRS-344/S095012 and Servier Collaboration: The first patient was dosed in November 2021 in the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 Anticalin-based bispecific for the treatment of solid tumors, triggering an undisclosed milestone payment to Pieris. Pieris holds exclusive commercialization rights for PRS-344/S095012 in the United States and will receive royalties on any ex-U.S. sales for this program. Additionally, Servier is continuing development of PRS-352, an undisclosed Anticalin-based bispecific beyond 4-1BB.
PRS-220: Pieris remains on track to begin a phase 1 trial this year for PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor for the treatment of IPF.
Year End Financial Update:
Cash Position – Cash and cash equivalents totaled $117.8 million for the year ended December 31, 2021, compared to a cash and cash equivalents balance of $70.4 million for the year ended December 31, 2020. The increase since December 2020 is due to cash received from new and existing collaboration agreements, including milestone achievements. In addition, during 2021, the ATM program was utilized to raise a total of $38.5M in net proceeds at an average price of $4.85 per share. These increases were partially offset by cash used to fund operations in 2021.
R&D Expense – R&D expenses were $66.7 million for the year ended December 31, 2021, compared to $46.5 million for the year ended December 31, 2020. The increase reflects higher spending on preclinical and manufacturing activities for PRS-220, an increase in manufacturing costs across multiple immuno-oncology programs, higher clinical costs on cinrebafusp alfa and higher employee related costs. These increases were partially offset by lower manufacturing costs on PRS-060, which were fully reimbursed.
G&A Expense – G&A expenses were $16.5 million for the year ended December 31, 2021, compared to $16.7 million for the year ended December 31, 2020. Total G&A spending was consistent year-over-year as higher fixed and variable compensation and higher insurance costs in 2021 were offset by lower legal, accounting, and project management costs, along with lower one-time office and building equipment costs related to the move to the new R&D facility in Hallbergmoos, Germany in the prior year.
Other Income – For the year ended December 31, 2021, $3.7 million of other income was recorded for PRS-220 program costs that qualified for reimbursement under the Bavarian grant that was announced in June 2021. The Bavarian government reimburses these qualifying program costs as incurred over the PRS-220 development period.
Net Loss – Net loss was $45.7 million or $(0.71) per share for the year ended December 31, 2021, compared to a net loss of $37.2 million or $(0.68) per share for the year ended December 31, 2020.
Conference Call :
Pieris management will host a conference call beginning at 8:00 AM EST on Tuesday, March 1, 2022, to discuss the full-year financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). Alternatively, a listen-only audio webcast of the call can be accessed here .
For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com .