Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer and other diseases, today reported financial results for the third quarter of 2016 and provided an update on the Company’s recent developments.
“I am pleased to report that during the third quarter, we built on the progress we made in the prior quarter, with continued advancement of both our pipeline and partnerships. Our most advanced Anticalin® program, PRS-080, for anemia of chronic disease, remains on track to complete dosing in our Phase 1b single ascending dose study by year end and to complete the multiple ascending dose phase in mid-2017. At the CRI-CIMT-AACR International Cancer Immunotherapy Conference, we presented preclinical data demonstrating a differentiated mode of action for PRS-343, our lead 4-1BB (CD137)-based bispecific immuno-oncology program, which is poised to enter clinical development in the first half of 2017,” said Stephen Yoder, President and CEO. “Our inhaled asthma program, PRS-060, is differentiated from systemically administered competitor mAb efforts targeting the same pathway, and it remains on track for the initiation of a Phase 1 study in the first half of 2017. Beyond PRS-343, we continue to advance a next generation immuno-oncology portfolio of multispecific therapeutic proteins, as well as our partnerships with Roche, Sanofi and Daiichi-Sankyo, including the achievement last month of a significant preclinical milestone in our second program with Daiichi-Sankyo, while continuing to explore additional collaborations. Finally, we ended the third quarter in a solid financial position with sufficient capital to fund us through multiple milestones.”
Recent Highlights:
| • | Advancing PRS-080 through an ongoing Phase 1 single ascending dose study in anemia of chronic disease, with an expected completion of dosing by year end |
| • | Presented new preclinical data demonstrating in vivo efficacy and a differentiated mode of action for our lead 4-1BB (CD137)-based bispecific cancer immunotherapeutic drug candidate, PRS-343, at the 2016 CRI-CIMT-AACR International Cancer | |
| Immunotherapy Conference. The data demonstrated the potential benefits of tumor microenvironment-localized costimulatory T cell activation for both reduced systemic toxicity and higher efficacy in comparison to conventional agonistic anti-4-1BB antibodies, as well as a positive manufacturability profile | ||
| • | Advancing PRS-343 through IND-enabling studies and towards a first-in-patient study for a range of HER-2 positive cancers, expected to commence in the first half of 2017 |
| • | Advancing PRS-060 through IND-enabling studies for moderate to severe asthma as an inhaled therapeutic, and towards a first-in-human study, expected to commence in the first half of 2017 |
| • | Continued preclinical development of a novel multi-checkpoint blockade bispecific, PRS-332, comprised of an anti-PD-1 antibody genetically linked to an existing Anticalin against an undisclosed checkpoint |
| • | Appointed Julian Adams, Ph.D. to Pieris’ Board of Directors. Dr. Adams is the President of Research & Development at Infinity Pharmaceuticals and leads the full spectrum of Infinity’s drug discovery, preclinical and clinical development, and regulatory affairs activities |
| • | Appointed Christopher Kiritsy to Pieris’ Board of Directors. Mr. Kiritsy is the Chief Executive Officer of Arisaph Pharmaceuticals and was previously the Chief Financial Officer of Kos Pharmaceuticals, which was acquired by Abbott |
| • | Achieved a preclinical milestone in October with our second partnered program with Daiichi |
Third Quarter Financial Update:
Cash Position – Cash and cash equivalents totalled $36.6 million at September 30, 2016, compared to $29.3 million at December 31, 2015. The increase in cash was driven primarily by the $16.5 million gross private placement financing completed in June 2016.
R&D Expense – Research and development expenses were $4.6 million for the quarter ended September 30, 2016, compared to $2.0 million for the quarter ended September 30, 2015. The $2.6 million increase was due primarily to a $1.6 million increase in pre-clinical development and CMC costs for PRS-343 as we carry out IND enabling studies and increased development costs for our other PRS-300 series programs, a $0.2 million increase for our PRS-080 program due to the initiation of the Phase Ib clinical trial in the first quarter 2016, and a $0.2 million increase in CMC and other preclinical costs associated with PRS-060 as we carry out IND enabling studies. Other R&D expenses also increased by $0.6 million primarily due to a $0.5 million increase in personnel related expenses, including stock-based compensation expense, an increase of $0.1 million for legal and patent fees, and $0.1 million increase for general lab costs. These increases were offset by a decrease of $0.1 million in recruiting and other costs.
G&A Expense – General and administrative expenses for the quarter ended September 30, 2016 were $2.3 million, compared to $2.2 million for the quarter ended September 30, 2015. The $0.1 million increase in G&A expenses was primarily due to $0.3 million in higher personnel related costs, including stock compensation, and $0.2 million increase for recruiting and rent expense, offset by $0.4 million in lower legal, consulting, and other costs.
Net Loss – Net loss was $6.2 million or ($0.14) per share for the quarter ended September 30, 2016, compared to a net loss $3.9 million or ($0.10) per share for the quarter ended September 30, 2015.
Conference Call
Pieris management will host a conference call beginning at 10:00 AM Eastern Time on Thursday, November 10, 2016, to discuss the third quarter financial results and provide a corporate update. To access the call, participants may dial 877-407-8920 (US & Canada) or 1-412-902-1010 (International) at least 10 minutes prior to the start of the call. An archived replay of the call will be available by dialling 877-660-6853 (US & Canada) or 1-201-612-7415 (International) and providing the Conference ID # 13603006.
About Pieris
Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes immuno-oncology multi-specifics tailored for the tumor microenvironment, an inhaled Anticalin protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin® is a registered trademark of Pieris. For more information, visit www.pieris.com.
