UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 5, 2015
PIERIS PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
| Nevada | 333-190728 | EIN 30-0784346 | ||
| (State of Incorporation) | (Commission File Number) |
(IRS Employer Identification No.) |
Lise-Meitner-Strasse 30
85354 Freising-Weihenstephan, Germany
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: +49 81 6114 11400
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01 | Regulation FD Disclosure. |
Attached hereto as Exhibit 99.1 and incorporated by reference herein is a corporate presentation of Pieris Pharmaceuticals, Inc.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including the exhibit attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| 99.1 | Corporate Presentation of Pieris Pharmaceuticals, Inc. dated November 5, 2015. | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: November 5, 2015 | PIERIS PHARMACEUTICALS, INC. | |||||
| By: | /s/ Darlene Deptula-Hicks | |||||
| Name: | Darlene Deptula-Hicks | |||||
| Title: | Chief Financial Officer | |||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Corporate Presentation of Pieris Pharmaceuticals, dated November 5, 2015. | |
Pieris Pharmaceuticals, Inc. Nasdaq:PIRS Corporate Presentation November 2015 Exhibit 99.1
Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. In some cases, you can identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or the negative of these terms or other comparable terminology. Factors that could cause actual results to differ materially from those currently anticipated include, without limitation, risks relating to the results of our research and development activities, including uncertainties relating to the discovery of potential drug candidates and the preclinical and clinical testing of our drug candidates; the early stage of our drug candidates presently under development; our ability to obtain and, if obtained, maintain regulatory approval of our current drug candidates and any of our other future drug candidates; our need for substantial additional funds in order to continue our operations and the uncertainty of whether we will be able to obtain the funding we need; our future financial performance; our ability to retain or hire key scientific or management personnel; our ability to protect our intellectual property rights that are valuable to our business, including patent and other intellectual property rights; our dependence on third-party manufacturers, suppliers, research organizations, testing laboratories and other potential collaborators; our ability to successfully market and sell our drug candidates in the future as needed; the size and growth of the potential markets for any of our approved drug candidates, and the rate and degree of market acceptance of any of our approved drug candidates; developments and projections relating to our competitors and our industry; our ability to establish collaborations; our expectations regarding the time which we will be an emerging growth company under the JOBS Act; our use of proceeds from this offering; regulatory developments in the U.S. and foreign countries; and other factors that are described more fully in our preliminary prospectus filed with the SEC on June 17, 2015. In light of these risks, uncertainties and assumptions, the forward-looking statements regarding future events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements included in this presentation speak only as of the date hereof, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations. Non-confidential
Pieris Pharmaceuticals Corporate Profile We are a clinical-stage biotechnology company developing Anticalin®-based therapeutic proteins We target validated disease pathways in a unique and transformative way Proprietary to us, Anticalins are a novel class of drugs validated in the clinic and by partnerships with leading pharmaceutical companies. Our pipeline includes three fully proprietary Anticalin-based programs First-in-class immuno-oncology bispecific tailored for the tumor micro-environment First-in-class inhaled Anticalin to treat uncontrolled asthma Best-in-class half-life-optimized Anticalin to treat anemia We are headquartered in Boston, MA, and have operations in the US and Germany. Non-confidential
Anticalins are a Novel Class of Therapeutic Proteins Anticalin in complex with a small molecule (Y-DTPA) Anticalin bound to the Hepcidin peptide Anticalin bound to the CTLA4 protein Anticalins® are derived from lipocalins – human extracellular binding proteins Small and simple make-up Individual derivatives can be generated that bind to a broad range of targets lipocalin Non-confidential
Differentiating Features Human-derived √ √ Natural binding molecule √ √ Non-immunogenic √ √ High affinity and specificity √ √ Systemic delivery √ √ Tunable pharmacokinetics √ Local delivery (e.g., inhalation) √ Versatile bispecifics & multispecifics √ Protein class exclusivity √ Positive freedom to operate landscape √ Anticalins Share Several Features with mAbs yet are Highly Differentiated Monoclonal Antibodies (mAbs) are highly successful drugs Anticalins share many of the beneficial properties of mAbs yet are highly differentiated Antibody Anticalin Safety Related Efficacy Related IP Related Non-confidential
Human data demonstrating desired drug-like properties 26 solid tumor patients with VEGF-A antagonist 36 healthy volunteers with hepcidin antagonist Several R&D partnerships generating ~$44 M in revenue Potential for future milestone and royalties Retained commercial rights in major markets High-caliber Investors OrbiMed Advisors (~19%), Tekla Capital Management (~10%), Lombard Odier (~6.5%); Ally Bridge Group, Auriga, Emerald Mutual Fund, Forbion, Gilde, GLSV, Novo Nordisk, Sphera Funds, Zydus Validation of Technology Platform Proprietary Next-generation Therapeutic Proteins With Several Degrees of Validation Anticalins Non-confidential
Management and Operations Trans-Atlantic Synergies Munich Proven team in place Great drug discovery and protein engineering expertise ~33 FTEs Boston Corporate HQ September 2015 - CEO, CFO, CDO Becoming translational pharmacology and drug development hub © Lufthansa Non-confidential
Anticalin Product Pipeline Product Target(s) Indication Partner Discovery Preclinical Phase 1 Phase 2 PRS-080 Hepcidin Anemia PRS-060 IL4Ra Asthma PRS-343 CD137/HER2 Immuno-Oncology PRS-300s n.d. PRS-110 cMet Oncology PRS-NN n.d. n.d. PRS-NN n.d. Ophthal-mology PRS-NN n.d. Daiichi Sankyo n.d. n.d. n.d. n.d. Sanofi n.d. n.d. Stelis Milestones & Royalties Retained commercial rights in maj. mkts n.d. = not disclosed PEGylated Anticalin inhalable Anticalin mAb-Anticalin fusion bi-/multispecifics Validated Targets IO multi-specifics Partnered Programs Stelis Non-confidential
PRS-080: Best-in-Class Drug Candidate For Functional Iron Deficient Anemia Hepcidin is a clinically validated anemia target PRS-080 designed to reverse hepcidin-mediated anemia by mobilizing iron trapped in the body’s iron storage cells Addresses patients unresponsive to ESA and iron therapies PK profile (half-life) of PRS-080 designed for a best-in-class approach Iron Ferroportin Inflammation Hepcidin PRS-080 PRS-080 Non-confidential
PRS-080: Successfully Completed Ph I and Advancing Into Patients Non-confidential Ph I study highlights Safe and well tolerated in 48 healthy volunteers across six dose levels (0.08 to 16.0 mg/kg, i.v.), with no reported severe adverse events (SAE) Confirmation of desired 3-day half-life, as predicted from animal studies Confirmation of mode of action: a marked decrease in plasma hepcidin within one hour, followed by elevation of serum iron concentration and transferrin saturation Duration of serum iron elevation and transferrin saturation increased in a dose-dependent manner Detailed results to be presented at ASH Annual Conference in December 2015 First-in-patient trial in end-stage renal disease (ESRD) patients expected to begin by end of 2015
PRS-080: US Market Opportunity in Chronic Kidney Disease (Stage 5) Sources: USRDS 2014 Annual Data Report (2012 numbers): Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the U.S Competitive Landscape Report, Tech Atlas Group, September 2013; Artisan Healthcare Consulting market research study 2013 CKD Stage 5 Patients (Total 640K in U.S.) No anemia 30% Anemic 70% CKD Stage 5 Patients with Anemia (Total 450K in U.S.) FID 20% No FID 80% Target Functional Iron-Deficient (FID) population in U.S. is ~ 90,000 patients We believe treating FID anemic patients has large commercial potential Non-confidential
PRS-060: First-in-Class Inhaled Biologic Targeting IL4Ra Clear differentiation from injected mAbs PRS-060 optimized for reduced on-target, off-tissue targeting PRS-060 is administered directly to the lung and has a short half-life (several hours predicted in man, leading to predicted low systemic exposure) In contrast, ~1% of systemically administered mAb has been shown to reach the lung compartment, leading to high systemic exposure* More convenient: standard of care is inhaled ICS/LABA Predicted Lower COGS may enable reach to broader patient populations, where pharmaco-economic burden is not as pronounced Adapted from Wenzel, Nature Medicine, 2012 Strong target validation & biomarker availability IL4Ra mAb (dupilumab) with strong efficacy in Phase 2b Biomarker-based patient selection is straight-forward Validated biomarkers (e.g. FeNo) allow for early clin. read-out Non-confidential *(Hart et al. (2001) JACI. 108:250)
PRS-060: Pulmonary Delivery Effective in vivo & Feasible Formulation Inhibition of IL13-induced eotaxin expression following pulmonary administration of PRS-060 Early onset of inhibition and durability of effect up to 24h post pulmonary administration Relative Eotaxin Expression Time of single treatment prior to IL-13 challange SEC Diagrams Device Nebulizer Spray Dryer Nebulization and spray drying feasibility demonstrated Appropriate particle size No aggregation Full functional activity High yield Non-confidential
PRS-060: Market Opportunity in Asthma 1 Major Markets: U.S., EU, Japan, Brazil, Russia, India, China Asthma Patients (Total ~195M in Major Markets1) Mild/ Controlled 84% Mod./Severe uncontrolled 16% Moderate/Severe Uncontrolled Patients (Total ~32M in Major Markets) Th2 elevated 60% No Th2 elevation 40% Target Th2 elevated Asthma population: 19M in Major Markets Treating Th2-elevated uncontrolled Asthma patients with PRS-060 is a blockbuster opportunity Source: Artisan Healthcare Consulting market research study Non-confidential
PRS-343: HER2-CD137 Bispecifics Multiple Formats Under Preclinical Evaluation CD137 – a TNFR Costimulatory Target Preclinically and clinically validated Marker for tumor-reactive T cells Activation leads to tumor elimination in vivo Signaling included in clinical CAR-T cells mAbs struggle to find therapeutic window Activity depends on Fc receptor interaction Doses required for T cell activation have led to toxicity Current approaches focus on NK activation HER 2 – Validated but not fully exploited Upregulated on several solid tumors with significant unmet medical need Restricted expression on normal tissue favors immunotherapy approach Bispecific immunotherapy approach may expand responding population HER2+ tumors with lower expression levels not adequately addressed with current therapy Non-confidential PRS-343: HER2-CD137 Bispecifics CD137-targeting Anticalin HER2-targeting mAb (Trastuzumab derived)
CD137-Targeting Lead Anticalin® Has Demonstrated Agonistic Properties Binding to CD137 Affinity: KDhCD137 = 2nM “Non-competitive” CD137 engagement preserves ligand-binding capability to CD137L Biophysical properties 100% monomeric expression TM = 74°C (DSC) Fully stable after 1 week at 37°C in PBS, hu or mu plasma In vitro functional testing CD137 Anticalin Control Non-Confidential IL-2 production Assay Dose-dependent T-cell activation in ex vivo human donor cell assay by CD137 cross linking CD137-specific Anticalin coated together with subthreshold concentration of aCD3 antibody on ELISA plate
PRS-343: First-in-Class Bispecific for Tumor-localized Activation of T cells Non-Confidential No activation CD137 is activated via clustering (trimerization) HER2-mediated clustering of bispecific drives CD137-mediated T cell activation Activating via a co-stimulatory signal (instead of a primary signal) is expected to maintain tumor antigen specificity by T cell receptor No clustering Clustering T cell receptor MHC-peptide Her2 CD137 Tumor Cell Costimulatory signal Primary TcR signal Activation No T cell costimulation in periphery T cell costimulation in tumor T Cell
Bispecific Geometry Impacts Immune Synapse Straightforward access to a range of distances between target binding sites Several formats to interrogate optimal target synapse for tumor cell killing 13.4 nm Membrane-to-membrane distances play a role in immunoreceptor interactions TNFRS TNFRSL Visualization of Antibody-Anticalin fusion ~15nm Non-confidential ~15nm ~8nm ~5nm ~5nm Expected distances between binding sites in different formats
PRS-343 Bispecific Geometry Impacts T Cell Activation IL-2 response Construct A Construct B Construct C Construct D Non-Confidential
PRS-343 T Cell Activation is HER2 Target-Dependent Construct A Construct B Construct C Construct D Non-Confidential IL-2 response with Her2 blockade Excess trastuzumab Addition of excess HER2-targeting trastuzumab prevents PRS-343 binding to HER2-positive cells and results in a loss of activity, as intended, confirming mode of action
From Idea to Drug Candidate – Efficient Platformed Process Idea Leads Drug Candidates Multispecific Drug Candidates Tumor Cell T cell Target 1 Target 2 12 – 18 months Target (combination) rationale Target product profile Construct design Research plan Library screening Assay set up Lead characterization Pharmacological Biophysical Lead optimization Drug Candidate characterization Lead & backups Generation and characterization of multipecific Drug Candidates Multiple constructs In vitro PoC Non-confidential
Pieris IO Pipeline Progressing Multiple Options & Partnering Opportunities Strategy & Target Idea Discovery / Lead ID Lead Optimization Multispecifics & In vitro PoC Bispecific Program 2014 2015 2016 2017 IO Target Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 CD137 CD137 / HER2 CD137 / n.d. IO Target 2 n.d. / n.d. IO Target 3 n.d. / tbd n.d. / tbd IO Target 4 n.d. / tbd n.d. / tbd IO Target 5 n.d. / tbd n.d. / tbd In vivo PoC IND IND-enabling (GLP / GMP) Today n.d.: not disclosed tbd: 2nd target to be defined PRS-343 Non-Confidential
Anticalin Intellectual Property – Safe & Sound Broad Patent Portfolio Drug class protected through 2020s Controlled patent filings and prior art enable broad follow-on protection Unique IP for each program Freedom to Operate No third party IP identified to date for FTO on platform or therapeutic programs Program (Target) CoM Patent Term 080 Hepcidin 2031 060 IL4Ra 2031 343 HER2/CD137 2036 Non-confidential
Financial Highlights & Capitalization Non-confidential Cash & Cash Equivalents* $34.3M Total Debt $ 0.0M Revenue Since Inception ** ~ $44.0M Grant Revenue Since Inception $14.1M H1 2015 Cash Burn (includes $1.2M in debt repayment) $ 8.4M Market Cap – at November 3, 2015 $ 76.7M 52 Week Range $1.54 - $3.70 Common Shares Outstanding* 39,732,258 At July 31, 2015 ** Includes Revenue from Licensing, Collaborations & R&D Services
November 2015 through 2016 Positive preclinical data for PRS-343 bispecifics (IO) Initiation of first-in-patient study for PRS/080 (anemia) Continued milestone income from existing partnered programs Initiation of clinical development for first partnered program Additional Collaborations Potential Future Milestones Positive Phase I data for PRS-080 (anemia) Non-confidential First patient data for for PRS-080 (anemia)
Pieris Pharmaceuticals, Inc. 255 State Street, 9th Floor Boston, MA 02109 USA info@pieris.com Non-confidential