PIRS : Pieris Pharmaceuticals Stock Analysis and Research Report

2017-10-20 - by Asif, Contributing Analyst

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Pieris Pharmaceuticals is a clinical-stage biopharmaceutical company that discovers and develops Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Pieris' pipeline includes immuno-oncology multi-specifics tailored for the tumor micro-environment, an inhaled Anticalin to treat uncontrolled asthma and a half-life-optimized Anticalin to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of low molecular-weight therapeutic proteins derived from lipocalins, which are naturally occurring low-molecular weight human proteins typically found in blood plasma and other bodily fluids.

Each of its development programs focus on the following:

  • 300-Series oncology drug candidates are multispecific Anticalin®-based proteins designed to engage immunomodulatory targets and consist of a variety of multifunctional biotherapeutics that genetically link antibody with one or more Anticalin proteins, thereby constituting a multispecific protein;

    • PRS-343 Pieris's lead immune-oncology program is a 4-1BB/HER2 targeting bispecific, comprised of an anti-HER2- antibody genetically linked to a 4-1BB-targeting Anticalin protein, in which tumor-targeted drug clustering mediated by HER2 expressed on certain solid tumors is intended to drive tumor localized T cell activation for patient unresponsive to current standard of care.

    • PRS-332 is a bispecific Anticalin-antibody fusion protein comprising an anti-PD-1 antibody genetically fused to an Anticalin protein targeting an undisclosed checkpoint target. In order to improve on existing PD-1 therapies, Pieris is developing PRS-332 with the intent to simultaneously block PD-1 and another immune checkpoint co-expressed on exhausted T cells.

    • In connection with its efforts to develop multispecific Anticalin®-based proteins designed to engage immunomodulatory targets, during the second quarter, the Company entered into a License and Transfer Agreement with Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. (Kelun). Under that Agreement, Kelun has granted to the Company a non-exclusive worldwide license (with the right to sublicense) under certain intellectual property owned or controlled by Kelun to research, develop, manufacture, and commercialize bi- and multi- specific fusion proteins that include a monoclonal antibody developed by Kelun specific for an undisclosed target and one or more Anticalin proteins.

  • PRS-080 is an Anticalin protein that binds to hepcidin, a natural regulator of iron in the blood. PRS-080 has been designed to target hepcidin for the treatment of functional iron deficiency in anemic patients with chronic kidney disease particularly in end-stage renal disease patients requiring dialysis.

  • PRS-060 is an inhaled Anticalin that binds to the IL receptor alpha, thereby inhibiting the signaling of IL-4 and IL-13, two cytokines, small proteins mediating signaling between cells within the human body), known to be key mediators in the inflammatory cascade that causes asthma and other inflammatory diseases.

Key programs are in varying stages:

  • PRS-343 Pieris filed an investigational new drug application (IND) for its lead immuno-oncology drug candidate, PRS-343, and FDA has accepted that IND. The Company is diligently engaged with its clinical trial sites toward initiation of patient dosing in a Phase I study in HER2-positive solid tumors.

  • Other PRS-300 Series Pieris Pharmaceuticals is conducting activities relating to lead candidate identification, lead candidate optimization, preclinical evaluation, or IND filing preparation on several of its other 300-Series (immuno-oncology) candidate drugs, including the lead product in its collaboration with Servier, PRS-332, and have initiated activities for two of the Servier collaboration programs beyond PRS-332.

  • PRS-080 Pieris completed a Phase Ia single-ascending dose clinical trial with PRS-080 in healthy volunteers in 2015. Based on the data Pieris obtained in the Phase I clinical trial, Pieris initiated a Phase Ib clinical study in CKD5 patients requiring hemodialysis. Pieris completed that Phase Ib study and presented the results in June 2017, which reflected that intravenous administration of PRS-080 was both safe and well-tolerated at all doses, and resulted in a profound decrease in free hepcidin within one hour after infusion, followed by robust mobilization of serum iron, with dose-proportional increases in both the level and duration of serum iron concentration and transferrin saturation following treatment. The Company filed separate clinical trial applications (CTAs) with the German and Czech Republic regulatory authorities to conduct a multi-dose Phase IIa trial for PRS-080 in FID anemia patients in a randomized placebo-controlled trial at doses up to 8 mg per kg body weight. Pending timely regulatory approvals, the Company intends to initiate enrollment of patients for this study in the third quarter of this year. ASKA has the option, following completion of this trial, to obtain an exclusive license to develop and commercialize PRS-080 in Japan, South Korea and certain other Asian markets (excluding China).

  • PRS-060 In collaboration with AstraZeneca, Pieris plans, as trial sponsor, to initiate and dose healthy subjects in the fourth quarter of 2017 in a single ascending dose trial followed by a multi-ascending dose trial under a clinical trial notification to the Therapeutic Goods Administration in Australia. The dosing of the first subject will trigger a milestone payment of $12.5 million by AstraZeneca to Pieris.

Its core Anticalin® technology and platform was developed in Germany, and Pieris has partnership arrangements with major multi-national pharmaceutical companies headquartered in the U.S., Europe and Japan and with regional pharmaceutical companies headquartered in India. These include existing agreements with Daiichi Sankyo, and Sanofi, pursuant to which its Anticalin platform has consistently achieved its development milestones. Furthermore, Pieris established a collaboration with Roche in December 2015, a collaboration with Servier in January 2017, and a collaboration with AstraZeneca in May 2017. Pieris has discovery and preclinical collaboration and service agreements with both academic institutions and private firms in Australia.

Since inception, Pieris has devoted nearly all of its efforts and resources to its research and development activities and have incurred significant net losses. For the three months ended June 30, 2017 and the six months ended June 30, 2017 Pieris reported a net loss of $10.1 million and $18.1 million, respectively. For the three months ended June 30, 2016 and the six months ended June 30, 2016 Pieris reported a net loss of $5.9 million and $10.0 million, respectively. As of June 30, 2017, Pieris has an accumulated deficit of $120.7 million.

Pieris expect to continue incurring substantial losses for the next several years as Pieris continue to develop its clinical and preclinical drug candidates and programs. Its operating expenses are comprised of research and development expenses and general and administrative expenses.

Pieris has not generated any revenues from product sales to date, and Pieris do not expect to generate revenues from product sales for at least the next several years. Its revenues for the periods presented were primarily from license and collaboration agreements with its partners.

A significant portion of Pieris' operations are conducted in countries other than the United States. Since Pieris conduct its business in U.S. dollars, its main exposure, if any, results from changes in the exchange rates between the euro and the U.S. dollar. All assets and liabilities denominated in euros are translated into U.S. dollars at the exchange rate on the balance sheet date. Revenues and expenses are translated at the average rate during the period. Equity transactions are translated using historical exchange rates. Adjustments resulting from translating foreign currency financial statements into U.S. dollars are included in accumulated other comprehensive loss. Pieris may incur negative foreign currency translation changes as a result of changes in currency exchange rates.

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