On August 4, 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 second quarter of 2022 ended June 30, 2022, and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, AUG 4, 2022, View Source [SID1234617468]).

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"AstraZeneca’s deep support of PRS-060/AZD1402 and the Anticalin platform continues and has resulted in thoughtful adjustments to the PRS-060/AZD1402 phase 2a study design, allowing us to enroll patients amidst the challenges presented by COVID-19 precautions, as well as an extension of our research collaboration for two earlier-stage programs," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Since the PRS-060/AZD1402 phase 2 study will take more time to enroll than originally planned, we have made the difficult but necessary decision to discontinue cinrebafusp alfa (PRS-343), despite showing clear single-agent activity in phase 1 and meaningful clinical benefit in the ongoing phase 2 study in HER2-expressing gastric cancer patients. We will continue the cost-effective development of PRS-344/S095012, our 4-1BB/PD-L1 bispecific co-developed with Servier, and PRS-220, our fully proprietary inhaled CTGF antagonist that has the generous grant support from the Bavarian government, through key clinical readouts over the next twelve months. With a more focused pipeline and co-funding mechanisms in place for our most advanced assets, we are better positioned to deliver on our overall pipeline objectives in 2023, retain a leadership position in both inhaled respiratory medicines and 4-1BB biology, and now project that our cash runway extends into the second quarter of 2024."

PRS-060/AZD1402 and AstraZeneca Collaboration: AstraZeneca continues to enroll part 2a (efficacy of 1 mg and 3 mg cohorts) and part 1b (safety of 10 mg cohort) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402, an IL-4 receptor alpha inhibitor Pieris is developing with AstraZeneca for the treatment of moderate-to-severe asthma. AstraZeneca conducted a reforecast of the study, which has taken into account the global challenges of recruiting for respiratory clinical trials caused by the continued impact of the COVID-19 pandemic, is broadening enrollment criteria to facilitate recruitment of the study, and plans to focus on the 3 mg cohort for the efficacy readout. Topline results are now expected to be reported by the third quarter of 2023. Upon delivery of these results, Pieris may choose to exercise its co-development option. Separately, Pieris will have a future option to co-commercialize PRS-060/AZD1402 in the United States. Beyond PRS-060/AZD1402, Pieris continues to work on two discovery-stage programs with AstraZeneca, for which the research term was recently extended. Pieris retains co-development and U.S. co-commercialization options for these two programs.
Cinrebafusp Alfa (PRS-343): Cinrebafusp alfa, a 4-1BB/HER2 Anticalin-based bispecific, has demonstrated clinical benefit in phase 1 studies, including single-agent activity in a monotherapy setting, and in the phase 2 study in HER2-expressing gastric cancer, giving the Company confidence in its broader 4-1BB franchise. However, Pieris will cease further enrollment in the ongoing two-arm, multicenter, open-label phase 2 study as part of a strategic pipeline prioritization to focus its resources.
PRS-344/S095012 and Servier Collaboration: Pieris and Servier continue to enroll the escalation portion of the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 Anticalin-based bispecific for the treatment of solid tumors for which Pieris holds full U.S. rights and will receive royalties on ex-U.S. sales by Servier. The companies expect to initiate expansion cohorts in jointly-vetted indications next year. Additionally, Servier is continuing development of PRS-352/S095025, an OX40/PD-L1 bispecific.
PRS-220: Pieris has submitted the first regulatory filing for PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor for the treatment of idiopathic pulmonary fibrosis. The Company expects to dose the first healthy volunteer in a phase 1 study later this year and to report the outcome from the study next year.
PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific, towards the clinic, with phase 1 expected to begin in the first half of 2023.
Seagen Collaboration: Seagen continues development of two undisclosed bispecific programs as part of its immuno-oncology collaboration with the Company. Pieris has a U.S. co-promotion option for one program in the collaboration.
Second Quarter Financial Update:

Cash Position – Cash, cash equivalents, and investments totaled $80.9 million for the quarter ended June 30, 2022, compared to a cash and cash equivalents balance of $117.8 million for the quarter ended December 31, 2021. The decrease is due to funding operations in the first half of 2022. With the wind down of the cinrebafusp alfa phase 2 trials, along with the expectation of modest near-term development milestones, the Company believes operations are sufficiently funded into the second quarter of 2024.

R&D Expense – R&D expenses were $11.9 million for the quarter ended June 30, 2022, compared to $15.8 million for the quarter ended June 30, 2021. The decrease is due to lower program costs, as work related to the Company’s sponsored phase 1 trial of PRS-060/AZD1402 was largely complete in 2021, as well as due to lower manufacturing costs across all later-stage respiratory and immuno-oncology programs, lower collaboration license fees, and lower consulting costs. These lower costs were partially offset by higher clinical costs for PRS-344/S095012, higher manufacturing and pre-clinical costs for earlier stage programs, and an increase in personnel costs.

G&A Expense – G&A expenses were $4.1 million for the quarter ended June 30, 2022, compared to $4.2 million for the quarter ended June 30, 2021. The period-over-period decrease was driven primarily by lower professional service costs and lower facilities costs, partially offset by higher travel expenses.

Other Income – For the quarter ended June 30, 2022, $1.2 million of grant income was recorded with respect to PRS-220 compared to $0.8 million for the quarter ended June 30, 2021. The increase is due to higher levels of activity as the Company plans to initiate a phase 1 study for PRS-220 this year.

Net Loss – Net loss was $10.3 million or $(0.14) per share for the quarter ended June 30, 2022, compared to a net loss of $15.5 million or $(0.25) per share for the quarter ended June 30, 2021.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Thursday, August 4, 2022, to discuss the second quarter financial results and provide a corporate update. Individuals can join the call by dialing (800) 285-6670 (Toll Free US & Canada) or (713) 481-1320 (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.