On November 11, 2019 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 its financial results for the third quarter of 2019 ended September 30, 2019, and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, NOV 11, 2019, View Source [SID1234550862]).
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"The recent presentations of clinical data for our two lead programs, PRS-060 and PRS-343, represent critical inflection points in the history of Pieris," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "In October, we presented positive data from our ongoing phase 1b study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, and we continue to be excited about the program as we plan with AstraZeneca to move into phase 2 next year. Over the weekend, we presented promising data from our phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, demonstrating single-agent activity that we believe is linked to 4-1BB engagement, and we look forward to initiating an indication-specific expansion study for this drug candidate next year. Our recently-announced financing, supported not only by key existing shareholders but also by fundamental focused new investors, will enable more near-term data-driven clinical development investment and is intended to provide a funding mechanism to facilitate Pieris’ ability to opt-into co-development of PRS-060 with AstraZeneca if phase 2a data are positive."
PRS-060: Pieris presented data from the phase 1b placebo-controlled multiple ascending dose study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, at the 2019 European Respiratory Society International Congress on October 1st. In that analysis, PRS-060/AZD1402 was found to be safe and well tolerated at all doses, led to a statistically significant reduction in fractional exhaled nitric oxide (FeNO) relative to placebo, and showed dose-dependent systemic target engagement in patients with mild asthma and elevated levels of FeNO (≥ 35 ppb). Following the presentation of these encouraging data, AstraZeneca and Pieris have been preparing to move into a phase 2a study in moderate-to-severe asthmatics next year. Upon completion of that study, which will be sponsored and funded by AstraZeneca, Pieris will have options to co-develop and co-commercialize the drug candidate in the United States.
PRS-343: Pieris presented data from its phase 1 dose-escalation monotherapy study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting on November 9th. PRS-343 was safe and well tolerated at all doses and schedules tested, demonstrated anti-tumor activity in a heavily pre-treated patient population across multiple tumor types, and showed a potent increase in CD8+ T cell numbers in the tumor microenvironment of responders, indicative of 4-1BB agonism on T cells. Pieris continues to enroll patients in that study at higher dose cohorts and plans to initiate an indication-specific expansion trial next year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab, with the objective of interrogating the synergy between 4-1BB agonism and PD(L)-1 blockade, and will report emerging data from that study at the Pieris R&D day on November 19th.
Immuno-oncology Pipeline: Pieris plans to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific that the Company is developing as part of its collaboration with Servier, in the first half of next year. Pieris holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales for this program.
R&D Day: Pieris will host an R&D day in New York on Tuesday, November 19th from 12:00-3:30 PM EST. The event will be accessible via a live webcast through this link beginning at 12:30 PM EST.
Private Placement: The Company completed a $32 million private placement led by BVF Partners L.P., with significant additional participation from EcoR1 Capital, Aquilo Capital Management, Surveyor Capital (a Citadel company), and Samsara BioCapital. The placement consisted of 9,014,960 units at a price of $3.55 per unit, with each unit consisting of (i) one share of common stock or 0.001 non-voting Series C convertible preferred stock and (ii) one warrant to purchase one share of common stock at an exercise price of $7.10 per share. Each share of non-voting Series C convertible preferred stock is convertible into 1,000 shares of Pieris common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.99% of the total number of shares of Pieris common stock then outstanding. The warrants are intended to facilitate Pieris’ exercise of its co-development option for PRS-060/AZ1402 following the conclusion of a positive phase 2a study. If top-line results of that study disclose achievement of the primary efficacy endpoint and the stock reaches a pre-specified price, then the warrants will expire 60 days following such disclosure and may only be exercised for cash. Otherwise, the warrants will be exercisable for a period of five years from the date of issuance.
Third Quarter Financial Update:
Cash Position – Cash, cash equivalents, and investments totaled $86.2 million as of September 30, 2019, compared to cash equivalents, and investments totaling $128.1 million as of December 31, 2018. This amount excludes the $32 million in gross proceeds from the November 2019 financing. Included in the Company’s cash spend during the third quarter of 2019 was a one-time $2.3 million payment to the Technical University of Munich for sub-license royalties due on upfront and milestone payments related to collaboration agreements signed in 2017 and 2018.
R&D Expense – R&D expenses were $13.2 million for the quarter ended September 30, 2019, compared to $11.4 million for the quarter ended September 30, 2018. The Company’s increase in R&D expenses reflects higher (albeit reimbursable) manufacturing efforts related to PRS-060/AZD1402 as part of phase 2a readiness activities for the program, as well as higher personnel and allocated facility costs due to growth in the Company’s R&D organization to support higher levels of pre-clinical and clinical activities.
G&A Expense – G&A expenses were $4.8 million for the quarter ended September 30, 2019, compared to $4.7 million for the quarter ended September 30, 2018. There was no significant change in the composition of G&A expenses on a quarter over quarter basis.
Net Loss – Net loss was $2.6 million or $(0.05) per share for the quarter ended September 30, 2019, compared to a net loss of $6.6 million or $(0.11) per share for the quarter ended September 30, 2018.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM EST on Monday, November 11, 2019 to provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.