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FeNo) allow for early clin. read out NON CONFIDENTIAL Clear differentiation from systemic mAbs Broader therapeutic index Low systemic exposure may lead to better side effect profile long term (e.g. role of Th2 in metabolic balance) More convenient Inhalation preferred over s.c. injections More flexible Daily dosing may allow combination with SoC Micro dosing Lower COGS May allow reaching broader patient populations : : : : 17 Pulmonary Delivery of PRS 060 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 Time of single treatment prior to IL 13 challange SEC Diagrams Device Nebulizer Spray Dryer NON CONFIDENTIAL 0 0.2 0.4 0.6 0.8 1 1.2 Nebulization and spray drying feasibility demonstrated Appropriate particle size No aggregation Full functional activity High Yield NON CONFIDENTIAL PRS 060 in Asthma Market Opportunity 18 1 Major Markets: U.S., EU, Japan, Brazil, Russia, India, China Asthma Patients (Total 195M in Major Markets ) 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 Estimated yearly treatment costs: ~ $10,000 $15,000 Treating Th2 elevated uncontrolled Asthma patients with PRS 060 is a blockbuster opportunity Source: Artisan Healthcare Consulting market research study NON CONFIDENTIAL 1 NON CONFIDENTIAL PRS 300 Series Addressing Two High Unmet Needs in Oncology Potential benefits of tumor localized engagement of immune system: Increased efficacy in patients unresponsive to targeted therapies Enhanced tolerability with reduced on target off tumor effects mAb component drives therapeutic to tumor Anticalin engages the immune system locally Tumor Cell T cell Tumor targeting mAb Immune system targeting Anticalin 19 NON CONFIDENTIAL Mode of Action: NON CONFIDENTIAL PRS 300 Series Costimulatory T cell Engagement 20 Costimulatory T cell engagement in the tumor micro environment to maintain T cell receptor mediated tumor antigen specificity NON CONFIDENTIAL TNFRS Receptor No activation in periphery T cell receptor MHC peptide T Cell Costimulatory signal Primary TcR signal Activation Tumor Cell Clustering on tumor cells NON CONFIDENTIAL PRS 300 Series Differentiates from Current IO Approaches 21 Approach Tumor targeted activation TcR mediated specificity Toxicity Delivery Agonistic mAbs No Yes Low to significant Injection BiTE Yes No Observed Slow infusion CAR T Yes No Observed Individualized adoptive therapy PRS 300 Yes Yes Expected low Injection NON CONFIDENTIAL NON CONFIDENTIAL Differentiated Immuno Oncology Drugs Have Blockbuster Potential 22 Source: Citi Research Checkpoint agents have a market potential in excess of $20bn by 2021 Consensus forecasts in initial indications Price of therapy per patient set to increase due to migration to checkpoint combination therapy Combination strategies with chemo/ radio/mAbs/vaccines/cryo likely to expand potential indications x1.5 x1.5 x1.3 Duration of immunotherapy likely to expand given anticipated improvements in progression free and overall survival NON CONFIDENTIAL NON CONFIDENTIAL Anticalin Intellectual Property Safe Sound Exclusivity 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 23 Program (Target) CoM Patent Term cMet 2030 Hepcidin 2031 IL4Ra 2031 300 Series (IO) 2035+ NON CONFIDENTIAL NON CONFIDENTIAL 24 1H15 2H15 2016 value Key preclinical milestones for first Daiichi Sanofi programs Ph I initiated for Hepcidin Several partnered Anticalins in Ph I Ph I completed for Hepcidin IND readiness for IL4Ra New R D partnership Ph I completed for IL4Ra Corporate Objectives 2015 2017 Ph Ib/IIa compl. for Hepcidin 2017 IND readiness for IO NON CONFIDENTIAL NON CONFIDENTIAL 30 Month Projected Pipeline Progression 25 PRS 080 PRS 060 PRS 300 2015 2016 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Phase I GLP / GMP Phase Ib/IIa Phase Ia/Ib GLP / GMP In vivo POC Lead Opt Phase IIb GLP / GMP Phase I GLP / GMP Phase I GLP / GMP Phase I GLP / GMP Phase I GLP / GMP Phase I In vivo POC NON CONFIDENTIAL NON CONFIDENTIAL Corporate Financial Summary 26 Company founded in 2001 OTCBB: PIRS, December 2014, raised $13.6M Total capital raised $82.6M Major shareholders include Ally Bridge Group, Forbion Capital, Gilde, GLSV, Lombard Odier, Montrose Capital, Novo Nordisk, OrbiMed Advisors, Sphera Funds and Zydus Cadila Revenues $54M ($40M licensing and $14M grant revenue) At September 30, 2014 (9 months) Net Loss $ 5.7M Cash Cash Equivalents $ .9 M Debt $ 5.1M Shares Outstanding Fully Diluted: 33,021,882 Includes 3.2M option pool 542,360 warrants Validation through strategic partnerships and collaborations Sanofi, Daiichi Sankyo, Zydus, Stelis, Allergan NON CONFIDENTIAL NON CONFIDENTIAL Investment Highlights 27 Human PoC achieved with Anticalin platform Novel therapeutic proteins Superior drug like properties Validation through strategic partnerships and collaborations Sanofi, Daiichi Sankyo, Zydus, Stelis, Allergan Several differentiated proprietary and partnered drug candidates advancing towards or through clinical development Potential for rich news flow in 2015 Milestone payments; clinical data; new partnerships Proven management team and highly regarded Board of Directors NON CONFIDENTIAL NON CONFIDENTIAL 28 Pieris Pharmaceuticals, Inc.
PRS NN n.d. Ophthalmology PRS NN n.d. Ophthalmology Sanofi Group n.d. Sept 2010 Initiation Daiichi Sankyo n.d. April 2011 Initiation n.d. = not disclosed Pipeline: Today Planned Progression Through End of 2016 Status Today NON CONFIDENTIAL Validating Collaborations 12 Partner Overview Financials Comments Multispecifics drug discovery collaboration 2010 50M potential for each program; royalties 2 milestone payments to date Multispecifics project handover achieved 4Q14 Two program drug discovery collaboration 2011 100M potential for each program; royalties 5 milestone payments to date Several potential milestone payments 2015 17 Co development collaboration, incl. cMet oncology 2013 Funded through clinical POC Pieris retains major markets Retained strategic oversight Minimal investment through early clinical development Co development in ophthalmology 2013 Funded through first patient study Pieris retains 50% WW Anticalin program in ophthalmology 2009 $10M upfront Program handed off to Allergan NON CONFIDENTIAL PRS 080: Intended to Reverse Hepcidin Mediated Functional Iron Deficiency 13 PRS 080 reverses hepcidin mediated anemia by mobilizing iron trapped in the body s iron storage cells Addresses patients unresponsive to ESA and iron therapies PK profile of PRS 080 designed to match hepcidin biology Iron Ferroportin Inflammation Hepcidin PRS 080 PRS 080 NON CONFIDENTIAL NON CONFIDENTIAL PRS 080: Effective in vivo Currently in Phase 1 14 Demonstrated efficacy and safety in cynos Single dose serum iron response Increased reticulocyte hemoglobin after multiple doses No adverse events in GLP tox First in man study initiated December 2014 Single dose escalation in HVs (n=48) Endpoints: Safety, MTD, PK, immunogenicity Target engagement PD effects: serum iron, ferritin, transferrin saturation, reticulocyte count, hemoglobin Final cohort of subjects planned mid 2015 Reporting of results expected 2H 2015 Serum iron response in cyno following single i.v. administration Pre dose Day 30 i.v. 150 mg/kg Day 30 s.c. 20 mg/kg Funded through Ph I by ongoing 6M EU grant 15 20 25 30 Elevation of reticulocyte Hg in cyno following repeated administration Time [h] 0 20 40 60 0 20 40 60 80 100 10 mg/kg PRS 080 10 mg/kg NGAL wt PRS 080 in Chronic Kidney Disease Market Opportunity 15 Sources: USRDS 2014 Annual Data Report (2012 numbers): Atlas of Chronic Kidney Disease and End Stage Renal Disease in the U.S ESRD Patients in 2011 A Global Perspective, Fresenius Medical Care; Artisan Healthcare Consulting market research study Hemodialysis Patients (Total 1.9M Worldwide) No anemia 18% Anemic 82% Hemodialysis Patients with Anemia (Total 1.6M Worldwide) FID 24% No FID 76% Target Functional Iron Deficient (FID) population: U.S. 80,000 EU 61,000 JP 57,000 ROW 186,000 Estimated yearly treatment costs: ~ $5,000 $10,000 Treating FID anemic HD patients with PRS 080 has large commercial potential NON CONFIDENTIAL NON CONFIDENTIAL PRS 060 First in Class Inhaled Biologic Targeting IL4Ra 16 Strong target validation biomarker availability IL4Ra a key mediator in Th 2 pathway disorders including asthma IL4Ra mediates IL4 and IL13 signaling Patient selection with Th 2 pathway is now straight forward IL4/13 mAbs (e.g. dupilumab) with strong efficacy in Phase 2b Validated biomarkers (e.g.
IP, multispecifics, inhalation Industry validation Significant cash flow upfront and milestone payments Fully Proprietary Co Dev Fully Partnered 11 PRS 080 Hepcidin Anemia PRS 060 IL4Ra Asthma PRS 300 multiple IO PRS 050 VEGF A Oncology Discovery Preclinical Phase 1 Phase 1b Phase 2 Target(s) 1 Indication Pieris to fund Partner to fund PRS 110 cMet Oncology PRS NN n.d. n.d.
The Corporation (OTC:PIRS) NON CONFIDENTIAL Highly experienced international leadership team Experienced Management Team Stephen Yoder Ulrich Moebius Christine Rothe Shane Olwill Eckhard Niemeier Darlene Deptula Title CEO CSO Head Discovery Head Dev Head BD CFO Education JD BS/BA PhD Post doc PhD Post doc PhD Post doc MS MBA Prior Experience 5 NON CONFIDENTIAL NON CONFIDENTIAL 6 2010 2011 2012 2013 2014 value Ph I study with VEGF A program initiated (PRS 050) In vivo POC on cMet program (PRS 110) Broad Collaboration with Sanofi Group In vivo POC and 6M grant for hepcidin program (PRS 080) Alliance with Daiichi Sankyo PRS 050 Ph I study successfully completed Zydus Cadila Stelis Alliances Milestone payments from Daiichi Expansion of Sanofi Partnership milestone payment Significant Achievements 2010 to 2014 NON CONFIDENTIAL mAbs Fast Growing Rx Segment Anticalins Differentiated Fast Followers 7 Rx sales growth p.a. 2010 16 by drug type Source: Datamonitor + 8.2% + 4.6% + 2.2% +/ 0.0% Monoclonal Antibodies (mAbs) are highly successful drugs showing very high sales growth within prescription pharmaceuticals Anticalins share many of the beneficial properties of mAbs and are at the same time highly differentiated Formatting flexibility for multispecific drugs Alternative delivery routes (e.g. inhaled) due to size and biophysical properties Tunable kinetics to match biological need Lower COGS due to bacterial expression Anticalin NON CONFIDENTIAL Human Lipocalins Scaffold for Novel Anticalin Therapeutics 8 High affinity (pM) Anticalin bound to Medium target Large target Human lipocalin template 8 Small target Human, natural binding proteins Low molecular weight (~1/8 of mAb size) Extracellular Non immunogenic Very stable cup like structure Highly diverse libraries ( 10 11 ) of potential drug candidates Highly automated selection and screening technology (phage display) Deep protein engineering know how to yield ideal drug candidates NON CONFIDENTIAL 9 Pure Anticalin formats Tetracalin mAb Anticalin formats Fc Anticalin formats Anticalin Tricalin Duocalin Molecules designed for optimal target engagement and drug like properties Binding site geometry can be adjusted to biological need Choice Anticalins Meet the Industry Demand for Multispecifics NON CONFIDENTIAL Commercialization Strategy Multiple Shots on Goal: Partnered Proprietary 10 Pieris selects target, funds all costs Shared investment, shared ownership Partner selects target, funds all costs Alternative mechanism to advance several programs in a proprietary like fashion Retain commercialization rights in major markets Immuno oncology, anemia, respiratory: strong networks High barriers to entry: e.g.
The Corporation (OTC:PIRS) NON CONFIDENTIAL Protected by strong IP Strong pipeline validated by clinical data 4 Solid Financial Position $54M in total revenues $82.6M total capital raised Went public in Dec 2014 through reverse merger Raised $13.6M Straight common stock $18M in cash as of Dec 2014 year end Major shareholders include Ally Bridge Group, Forbion Capital, Gilde, GLSV, Lombard Odier, Montrose Capital, Novo Nordisk, OrbiMed Advisors, Sphera Funds and Zydus Cadila CEO, CSO, Head of Discovery, Head of BD all formerly at MorphoSys Potential to repeat German Biotech MorphoSys success story: MorphoSys currently with 20 clinical programs, multiple high value pharma partnerships, approx. $2bn market cap Pieris Pharmaceuticals, Inc.
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. 3 R D company developing first in class biologics Built on cutting edge Anticalin technology Highly differentiated next generation therapeutic proteins Multispecifics, Inhaled Delivery, Tunable Kinetics Superior drug like properties Strong patent position and no 3 rd party IP identified to date for FTO Clinical activity, lack of immunogenicity in cancer patients Proprietary pipeline in Immuno Oncology, Immunology, Anemia and Respiratory Proven track record for successful collaborations with Pharma Pieris Pharmaceuticals, Inc.
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.
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 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; competition in our industry; regulatory developments in the U.S. and foreign countries; as well as those risks more fully discussed in the Risk Factors section of our Current Report on Form 8 K filed with the SEC on December 18, 2014 and the other reports we file with the SEC.
March 2015 Pieris Pharmaceuticals, Inc. (OTC:PIRS) The 27th Annual ROTH CONFERENCE Stephen Yoder CEO Exhibit 99.1 NON CONFIDENTIAL Forward Looking Statements 2 NON CONFIDENTIAL 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.
Lise Meitner Strasse 30 85354 Freising Germany Tel.: +49 (0) 8161 1411 400 Fax: +49 (0) 8161 1411 444 info pieris.com www.pieris.com NON CONFIDENTIAL