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): January 8, 2018
PIERIS PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
Nevada | 001-37471 | EIN 30-0784346 | ||
(State of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
255 State Street, 9th Floor
Boston, MA 02109
United States
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: 857-246-8998
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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging Growth Company ý
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01: Regulation FD Disclosure.
Attached hereto as Exhibit 99.1 and incorporated by reference herein is an investor presentation of Pieris Pharmaceuticals, Inc.
The information set forth under this “Item 7.01. Regulation FD Disclosure,” including the exhibits 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.
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.
PIERIS PHARMACEUTICALS, INC. | ||
Dated: January 8, 2018 | /s/ Allan Reine | |
Allan Reine | ||
Chief Financial Officer | ||
Investor Presentation
January 2018
(Nasdaq: PIRS)
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 Annual Report on form 10-K filed with the SEC on March 30, 2017. 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.
2
Anticalin Proteins – A Novel Therapeutic Class
3
BenefitsFeatures
Small size (1/8th the size of a mAb)
Engineerable scaffold
Derived from lipocalins
(human epithelial proteins)
Engineerable binding pocket
No observed
immunogenicity to date
Potent target engagement
Unique bi/multispecifics
Inhaled therapeutics
Our pipeline addresses clinically-validated targets in new ways by leveraging unique
features of the Anticalin® protein drug class, effectively taking reduced target biology risk
AstraZeneca Alliance
• Clinical-stage inhaled IL-4Ra antagonist (PRS-060) with
retained US co-dev/co-commercialization rights
• Additional programs will initiate this year
− US co-dev/co-comm rights on several assets
Core Value Drivers: Anticalin Proteins Targeted Locally in Two Therapeutic Areas
Proprietary
• Clinical-stage 4-1BB/HER2 bispecific (PRS-343) is fully owned
• Additional preclinical IO bispecifics
Alliance
• Several bispecific multi-checkpoint
blockers and targeted costim agonists
− Full US rights retained on several assets
Respiratory
Immuno-oncology
Industry Validation - Commercial opportunities within Alliances - Fully Proprietary Assets
4
Financial Update (9/30/17)
5
Cash & Cash Equivalents $89.9M
Debt $0.0M
YTD Opex (as of 9/30) $29.1M
CSO 44.4M
2018 Anticipated Milestones
Pipeline Highlights
DISCOVERY PHASE I PHASE II
PRS-343
Initial safety
and PD data
PRS-060
First-in-human
data
PRS-080
Phase IIa data: safety, PK, hemoglobin
change post 5QW dosing
Core
Clinical
Non-core
Clinical
Next-generation
Pipeline
IO
Advance
multiple
programs
Respiratory
Advance
multiple
programs
PRECLINICAL
PRS-343
PRS-060
PRS-080
Servier
AZ
PRS-300s
Immuno-oncology Franchise
6
Proprietary Clinical
• PRS-343
- First-in-class bispecific to
preferentially activate T cells in the
tumor microenvironment (TME)
- In Phase I – HER2-positive patients
- Safety and PD data in 20184-1BB-targeting Ac
HER2-targeting mAb
Checkpoint/costim Acs
Checkpoint/costim mAbs Servier Alliance
• 5-program deal (all bispecifics)
• Pieris retains full U.S. rights for 3 out of 5 programs
• $31M upfront payment
• $1.8B milestone potential
• Up to low double-digit royalties on non-codev products
Proprietary Research
• Multiple ongoing research and
preclinical programs with bispecific
and multi-specific antibody/Anticalin
protein constructs
PRS-343: Why did we design this?
4-1BB systemically agonizing antibody has shown
mono-therapy efficacy yet significant toxicity in the clinic
(narrow therapeutic window)
PRS-343 preferentially agonizes 4-1BB in the TME by
using its anti-HER2 component to drive drug clustering
and, therefore, 4-1BB cross-linking
7
4-1BB-targeting Acs
HER2-targeting mAb
PRS-343 Targets Local Biology
4-1BB (CD137) – Key Costimulatory Target
• Marker for tumor-specific T cells in TME
• Ameliorates T cell exhaustion
• Critical for T cell expansion
• Induces anti-tumor cytolytic activity
• Drives central memory T cell differentiation for
sustained response
8
HER2 – Strongly Validated Tumor Target
• Restricted expression on normal tissue
• Multiple HER2+ tumors with high-unmet need
- Bladder, Gastric, Breast and several others
- Mediates drug mobilization and immune receptor
activation within the tumor bed
High HER2
Expression
Clustering &
T cell Activation
T cell costimulation in TME
Tumor-specific
T cell
PRS-343 Shows Bifunctional Activity – Dose-dependent Tumor Growth
Inhibition & CD8(+)TIL Expansion in HER2+ Ovarian Cancer Model
• PRS-343 shows dose-dependent tumor growth inhibition in HER2-sensitive model
• PRS-343 leads to strong and dose-dependent lymphocyte infiltration in tumors; monospecific anti-HER2
mAb (IgG4 backbone) inhibits tumor growth but lacks this immuno-stimulatory activity
• Monospecific anti-4-1BB benchmark mAb shows insignificant response compared to isotype control and no
significant tumor infiltration of lymphocytes
9
Tumor growth (median)
SK-OV-3 tumor model
Incomplete
group due to
mortality
100µg
Isotype Ctrl
100µg
PRS-343
100µg
Anti-4-1BB
0
10
20
30
F
re
q
u
en
cy
[
%
] C
D
3
C
D
45
C
D
4
C
D
8
0
10
20
30
F
re
q
u
en
cy
[
%
]
C
D
3
C
D
45
C
D
4
C
D
8
0
10
20
30
F
re
q
u
en
cy
[
%
] C
D
3
C
D
45
C
D
4
C
D
8
hCD4hCD3 hCD8 Plot
TIL phenotyping by IHC
PRS-343 Avoids Unwanted Effect of Peripheral T Cell Activation,
Unlike Systemically Agonistic 4-1BB mAb
• Toxicity observed with anti-4-1BB mAb likely corresponds to indiscriminate peripheral T cell
activation
• Unlike PRS-343, anti-4-1BB benchmark mAb shows accelerated graft-versus-host-disease with
significant mortality in line with literature data1
10
Survival
% CD8+
of CD45+
1Sanmamed et al., Cancer Res. 2015 Sep 1;75(17):3466-78.
PRS-343 First-in-Patient Clinical Trial
11
Phase I Trial (Initiated 3Q17)
Multiple Ascending Dose Escalation Phase
Enrolling HER2+ cancer patients
Starting with single patient cohorts (modified 3+3 design)
Determine MTD and/or efficacious dose level
Initial safety and PD data 2H18
Expansion Phase
Gastric Bladder Other
Novel Inhaled Biologics Platform: Targeting Lung Diseases Locally
• PRS-060 (Part of AstraZeneca alliance)
- First-in-class inhaled IL-4Ra antagonist for asthma
- Phase I initiated in 4Q17
- Pieris retains opt-in for co-development/co-
commercialization rights in the US
• Proprietary inhaled discovery programs ongoing
12
Alliance Highlights
5 committed novel inhaled
Anticalin protein programs
Including lead asthma program
PRS-060 (IL-4Ra)
Retained co-development and
co-commercialization (US) options on
PRS-060 and up to 2 additional
programs
$57.5M upfront & Phase I MS in 2017;
up to ~$2.1B in milestones,
plus double-digit royalties
Access to complementary
formulation and device know-how
for inhaled delivery
PRS-060 For Uncontrolled Asthma: Why Did We Design This?
13
What We Know
Regeneron/Sanofi’s Dupilumab (systemically administered anti-IL-4Ra) has demonstrated the following:
67%
reduction in
high-EO
patients
What We Are Testing
• Is this a local phenomenon?
• First-in-man study underway
Reduction in FeNO Exacerbation Reduction Steroid Sparing
80%
avg. reduction
in corticosteroid
use
Improved lung function
PRS-080 for Anemia – Why We Made This?
14
What We Know
Hepcidin is up-regulated in
functional iron deficiency anemia
Antagonizing hepcidin with
single-dose PRS-080 in CKD5
patients led to Fe mobilization
What We Are Testing
Will antagonizing hepcidin
with PRS-080 lead to a
hemoglobin increase after
5 q/wk. doses?
0
10
20
30
40
50
60
0 48 96 144
Mean Iron Concentrations
Se
ru
m
Ir
on
[µ
M
]
Ph Ib SAD in CKD5 patients
• Phase IIa study
underway testing two
dose cohorts: 4mg/kg
and 8mg/kg vs. pbo
• Data expected 2H18
Pieris Investment Opportunity
• An industry-validated class of novel therapeutics
- Anticalin proteins
- $90+M in upfront payments and milestones in 2017 with
billions of milestone potential
• Potentially transformative, wholly owned IO program
- Clinical-stage, tumor-targeted 4-1BB bispecific
• High-value, inhaled targeted respiratory program
- Clinical-stage inhaled IL-4Ra antagonist
- partnered with AstraZeneca – retained US co-dev/comm rights
• Robust IND engine that has yielded several clinical-stage
candidates with excellent drug-like properties
• Proven management team
15
Respiratory
Immuno-oncology
Pieris Pharmaceuticals, Inc.
Corporate HQ: 255 State Street, 9th Floor, Boston, MA 02109, USA
R&D Hub: Freising, Germany (Munich)
info@pieris.com
www.pieris.com