On November 2, 2021 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 third quarter of 2021 ended September 30, 2021 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, NOV 2, 2021, View Source [SID1234594125]).
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"I am pleased to report that AstraZeneca has completed dosing in part 1a of the phase 2a study of PRS-060/AZD1402. We look forward to announcing the completion of the safety review by AstraZeneca before initiating the second part of that study and presenting topline data informing our co-development opt-in decision next year. Also within our respiratory franchise, we are progressing PRS-220 toward the clinic next year, and we recently presented preclinical data for that program, reinforcing our enthusiasm about it. Additionally, we have made important strides in getting the next phase of clinical trials for our immuno-oncology programs cinrebafusp alfa and PRS-344 activated, and we are excited to see those trials progress," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We have a solid balance sheet of over $125 million as we continue to advance a diverse and rich pipeline of fully proprietary and co-developed assets into and through the clinic this year and anticipate several key inflection points in 2022."
PRS-060/AZD1402 and AstraZeneca Collaboration: Dosing has been completed in part 1a (safety) of the global phase 2a study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Data unblinding and review will now follow, the outcome of which the Company will publicly disclose, gating progression to the second part of the study, where efficacy will be assessed in moderate, uncontrolled asthmatics. Pieris and AstraZeneca expect to announce topline data from the entire phase 2a study next year.Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris will have the options to co-develop and, separately, co-commercialize PRS-060/AZD1402 in the United States. Pieris and AstraZeneca continue to advance each of the four programs in the collaboration beyond PRS-060/AZD1402.
Cinrebafusp Alfa (PRS-343): Pieris plans to dose the first patient in a two-arm phase 2 study for cinrebafusp alfa, a 4-1BB/HER2 bispecific for the treatment of HER2-expressing solid tumors, in gastric cancer this quarter and reconfirms its plan to report initial data from the arm evaluating cinrebafusp alfa in combination with tucatinib in HER2-low gastric cancer next year. The Company has decided to focus enrollment on second line patients and now expects to report data from the arm evaluating cinrebafusp alfa in combination with ramucirumab and paclitaxel in HER2-high gastric cancer in 2023.
PRS-344/S095012 and Servier Collaboration: Regulatory approval for the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 bispecific, has been granted by multiple countries. Pieris holds exclusive commercialization rights for PRS-344/S095012 in the United States and will receive royalties on ex-U.S. sales for this program, should it receive regulatory approval. Additionally, Servier is continuing development of PRS-352, an undisclosed Anticalin-based bispecific beyond 4-1BB.
PRS-220: Pieris presented initial preclinical data for PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of idiopathic pulmonary fibrosis (IPF), at the European Respiratory Society International Congress 2021 (ERS) demonstrating a more potent and durable target engagement profile compared to a clinical-stage, systemically delivered anti-CTGF antibody benchmark. Additionally, the targeting of CTGF locally in the lung showed increased attenuation of fibrotic lung remodeling in vivo compared to the systemically delivered antibody. This outcome correlates with superior lung tissue exposure of PRS-220 compared to that of the systemically administered antibody in head-to-head studies, where intratracheally administered PRS-220 efficiently penetrates the fibrotic, interstitial lung tissue of mice. Clinical development for the program in IPF and post-COVID pulmonary fibrosis, as supported by a grant from the Bavarian government, is expected to begin next year.
Seagen Collaboration: Pieris has initiated the second program within the bispecific immuno-oncology collaboration with Seagen, a program that includes a co-promotion option for Pieris in the United States. Additionally, Seagen is continuing development of the first program, an undisclosed Anticalin-based bispecific.
Genentech Collaboration: Pieris and Genentech initiated joint discovery activities for the two committed programs, one in respiratory and one in ophthalmology, as part of their research collaboration and license agreement to discover, develop, and commercialize locally delivered therapies that leverage Pieris’ proprietary Anticalin technology.
Executive Leadership: Pieris announced the promotion of Thomas Bures to Senior Vice President and Chief Financial Officer. Mr. Bures oversees all financial matters at the company, including treasury, tax, financial planning, procurement and investor relations. Pieris additionally announced the promotion of Ahmed Mousa to Senior Vice President and Chief Business Officer. In his new role, Mr. Mousa heads business development and portfolio strategy, in addition to serving as General Counsel and Boston site head.
First Quarter Financial Update:
Cash Position – Cash and cash equivalents totaled $125.1 million for the quarter ended September 30, 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 and use of the Company’s ATM program. This increase was partially offset by cash used to fund operations for the first nine months of 2021. The September 30th cash position does not include the impact of the Bavarian government grant, as those proceeds will be reimbursed for qualifying program costs incurred over the PRS-220 development period. In the third quarter ended September 30, 2021, the Company raised more than $23 million in cash through the use of the ATM program.
R&D Expense – R&D expenses were $18.9 million for the quarter ended September 30, 2021, compared to $11.8 million for the quarter ended September 30, 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 are fully reimbursable.
G&A Expense – G&A expenses were $4.1 million for the quarter ended September 30, 2021, compared to $4.1 million for the quarter ended September 30, 2020. There were no significant changes in categories of spending as G&A departments continue to efficiently leverage spending to support the Company’s overall needs.
Other Income – For the quarter ended September 30, 2021, $1.8 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.
Net Loss – Net loss was $16.5 million or $(0.24) per share for the quarter ended September 30, 2021, compared to a net loss of $14.3 million or $(0.26) per share for the quarter ended September 30, 2020.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM EDT on Tuesday, November 2, 2021, to discuss finance results for the third quarter of 2021 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.