PharmaEssentia · BUFFALO, N.Y., Sept. 05, 2018 (GLOBE NEWSWIRE) -- Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization

PharmaEssentiaA fully integrated biopharmaceutical company

Investor Presentation

Confidential: For approved distribution only Page 2

Exploring our company

Company snapshot

Our journey

Market focus

Strategic direction

Appendix

Milestone targets

Meet our executive leadership

Financial summary

Technology overview

Trial results

Confidential: For approved distribution only

What is PharmaEssentia delivering to the market?

Developing better science to create better lives

Global leader in

delivering

efficacious, safe,

and cost-

effective

therapeutic

products to treat

human

diseases, while

bringing long

lasting value to

stakeholders.

Our Vision

Novel Technology

Deep Industry Expertise

Late Stage Development

Global Operations

The best in class α-

Interferon with PEGylation

patent protection beyond

2034

Highly accomplished

scientists from leading

pharma companies led by

seasoned executives with

100+ years of experience at

biotechs / regulatory

agencies

Completed Phase III clinical

trial with additional

compounds entering late

stage, global clinical trials

200+ employees with HQ in

Taiwan; GMP certified

manufacturing in Taipei and

Taichung; and established

operations in Japan, China,

and the USA

Page 3


Our journey to date

Selected highlights since initial founding

20032008

2016

2018

2003: PharmaEssentia was

founded by a group of

Taiwanese-American

executives and high-ranking

scientists from leading U.S.

biotech and pharma

companies

2012: Ground

breaking for

Taichung

manufacturing

facility

2016: Publicly listed on Taipei

Exchange on July 19, 2017

2017: Marketing Authorization Application

filed, and a 2nd confirmatory Phase III

clinical trial ongoing (CONTINUATION-PV)

2012

2008: P1101 discovered, patents secured

2016: 1st Phase III clinical

trial completed (PROUD-PV)

2017

2012: 1st human patient in clinical trial,

HCV Genotype 1

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Our foundation

PEGylation technology

Potential for:

• Development of longer lasting proteins

across therapeutic areas

• More pure product (single PEGylation site)

Why is it important?

Proprietary polyethylene glycol conjugate

and method of conjugating to protein

What is it?

Low development riskLarge potential for diversification of pipeline

Bottom Line

Page 5


Our technology

P1101 in action

Non-PEGylated

interferon

Clinically Proven

Results

• Long-acting

• Less frequent dosing

• Less serious adverse

events

• Higher maximum

tolerated dose

• Flexible dosing

• Multiple therapeutic

areas

2nd Generation

interferon

After

1 week

156

per year

52

per year

After

6 hoursPharmaEssentia’s

Interferon

26

per year

After

2-4 weeks

Multiple

Isoforms

Multiple

Isoforms

Pure

Product

Conventional

Interferon

Lasts 1 Day

Multiple

Isoforms

Lasts 1 Wk

Best-in-class

Interferon

Lasts 2-4

Weeks

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Our competitive advantage

Summary of P1101 trial results

Completed Phase III clinical trial

Late stage development success

Comprehensive end point

Not achieved by Incyte’s Jakafi, the only FDA

approved PV drug (2nd line treatment only)

Demonstrated superiority

Compared to Best Available Therapy (BAT)

Potential for disease modification

Delivering value add for PV by effectively reducing worsening prognosis

Market Impact

from P1101’s

Success

Application across markets

Increased prescription & use

Market

exclusivity

Page 7


Financial highlights

Late stage development with tactical operations

Clinical success with prudent

R&D capital deployment

GMP biologics manufacturing

facilities

Flagship product nearing

approval

Market Valuation

$1.25 Billion

revenue stream

One of the few research

stage Biotechs with a

Milestone paymentsreceived to date

and more projected

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Strategic direction

Multi-phased approach towards global commercialization

Fully operational and commercial ready for P1101

Ongoing product development and increased market

awareness

Global manufacturing scaleScale up manufacturing capabilities to meet global demand

and explore contract manufacturing for new revenue stream

Beyond PEGylationApply PharmaEssentia’s innovation

capabilities to develop better drugs

Expand into other high-value indications

Leverage propriety PEGylation tech to improve

products of other large pharma companiesShort / mid-term

Longer term

Page 9


Milestone targets supported by capital raise

Together with you - we can positively change more lives faster

Launch of P1101

Market registration for

each global market (i.e.

compliance with studies)

Global Presence

Selling novel products

and great quality

services to world market

Increased Manufacturing

Substantial completion of

Taiwan (Chubei) facility as

expanded revenue stream

Exploratory Applications

Proof of Concept to enable

enhancement of protein

product beyond PEGylation

Market Expansion

Maintain pipeline

development in new markets

and via clinical development

of combination therapies

2019

2020

2023

2026

2028

Page 10


Meet our executive team

Experienced leaders in biotech

Ching-Leou Teng

Chairperson

Past Experience:

Ionis Pharmaceuticals,

Food and Drug

Administration (FDA)

Ko-Chung Lin

Founder and CEO

Past Experience:

Biogen Inc., Monsanto

YenTung Luan

GM/Development Lead

Past Experience:

Wyeth, Pfizer

Pharmaceuticals

Albert Qin

Chief Medical Officer

Past Experience:

China Health Group, SymBio

Pharmaceuticals,

ImmunoGen, Pfizer

Jack Hwang

General Manager

Past Experience:

Optimer Pharma, Array

Biopharma and Amgen Inc.

Page 11


Meet our executive team

Experienced leaders in biotech

Marija Sebastian

VP of Marketing, USA

Past Experience:

Novartis Pharmaceuticals, McKinsey & Company

Craig Zimmerman

VP of US Operations

Past Experience:

Molecular Insight Pharmaceuticals, Ironwood

Pharmaceuticals, Biogen Inc.

Katsuya Yonezu

Head, Japan Operation

Past Experience:

Shire Japan KK, Novartis Pharmaceuticals,

Janssen Pharmaceutical, Astellas Pharmaceutical

Warren Shen

Head, China Operation

Past Experience:

AGTech, BearingPoint Consulting, Biogen Inc.,

Shanghai Institute of Pharmaceutical Industry

Page 12


Pipeline development

As of Q2 2018, continued progression on all product fronts

Concentratio

n

PharmaEssentia

TechnologyTarget

Pipeline Status

Phase

I

Phase

II

Phase

III

Regulatory

Review

Hematology P1101

PV

Market

EU

PV US

CML EU

GlobalET

PMF US

Infectious

DiseaseP1101

HCV-G2 TW, KR

HBV+HCB TW

GlobalHBV

HBV+HDV TW

Oncology

Oraxol Breast TW, KR

GlobalGastricOraxol+Ramucirumab

PD-1

Dermatology KX01

GlobalHCC

TWPsoriasis

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A Phase III, Open-Label Multicenter, Randomized,

Active-controlled Study to Compare the Efficacy,

Pharmacokinetics, Safety and Tolerability of

P1101 vs Physician Choice as Second Line

Therapy for Essential Thrombocythemia (ET)

Page 14

Expansion in MPN Arena


Study Design

ET Global Phase III Study Randomized, Stratified, Open-label, Active-controlled


A Phase III, Open-label, Randomized, Active

Control Study to Compare the Efficacy and Safety

of P1101 450µg Biweekly Versus Entecavir 0.5mg

Daily in HBeAg-Positive Chronic Hepatitis B

Page 16

Treating Patients

Most benefited by interferon therapy


Study Design

HBV e+ Global Phase III Study Randomized, Open-label, Active-controlled


A Phase III, Open-label, Randomized, Active

Control Study to Evaluate HBV Reactivation

and Safety of P1101 in Combination with

Sofosbuvir/Velpatasvir in Patients

Co-infected with HBV and HCV

Page 18

Treating Patients

Most benefited by interferon therapy


Study Design

HBV/HCV Global Phase III Study Randomized, Open-label, Active-controlled


The Next BIG Four

Utilizing our novel PEGylation Technology

A ~20 billion opportunities

1. PEG-GCSF (~5b)

2. PEG-Erythropoietin (~5b)

3. PEG-Human growth hormone (~2b)

4. PEG β-Interferon (~7b)

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BUFFALO, N.Y., Sept. 05, 2018 (GLOBE NEWSWIRE) -- Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the planned second interim analysis of the Oraxol001 Phase III Clinical Trial in metastatic breast cancer has been conducted and reviewed by an independent Drug Safety Monitoring Board (DSMB). The DSMB congratulated Athenex on the rapid patient recruitment and the promising results achieved. The DSMB noted that more than 320 patients have already been recruited and recommended that Athenex continue this study and complete the recruitment of patients.

The Oraxol 001 Phase III Clinical Trial is a randomized controlled clinical trial comparing Oraxol monotherapy against intravenous (IV) paclitaxel monotherapy in patients with metastatic breast cancer. The study is designed to compare the safety and demonstrate the superiority of Oraxol over IV paclitaxel. Clinical activity is based on confirmed response rate as assessed by RECIST Criteria, a generally accepted clinical response criteria for efficacy in tumor reduction. Assessment of tumors scans are made by a blinded independent radiologic imaging analysis center.

Athenex Announces Positive Recommendation

by the Drug Safety Monitoring Board Upon the Second Interim

Analysis and to Continue the Oraxol Phase III Program

Page 21


Chimeric Antigen Receptors-

engineered T cells (CAR-T)

Page 22


Sources: Cancer Sci. 108 1109-18; 2017.

CAR-T Cell Therapy

Page 23


Manufacturing of CAR-T Cell Therapy

Page 24


GMP Certified Manufacturing in Taipei & Taichung

EMA & TFDA 2018 Certification

Page 25



Cell Therapy Model

Page 27


Next Opportunity

CAR-T Cell Therapy

Sources: National Cancer Institute

Page 28


TCR-T

The next generation opportunity

Sources: LionTCR

• Science well established

• For solid tumor i.e. HCC

Page 29


Our team

Global operating model

HeadquartersTaipei, Taiwan

Manufacturing PlantTaichung, Taiwan

Japan OperationsTokyo, Japan

US OperationsWaltham, MA

China OperationsBeijing, China

Page 30


Medical Team

Experienced leaders in clinical research

Page 31

Albert Qin

Chief Medical Officer

Past Experience:

China Health Group,

SymBio Pharmaceuticals,

ImmunoGen, Pfizer

M.D. Ph.D. (Harvard)Yi-Wen Huang

Senior Director

Past Experience:

Cathay General Hospital

M.D. Ph.D. (NTU)Chung-Wei Lee

Director

Past Experience:

LifeSpring Immuno,

Axcella Health,

Brigham and Women’s Hospital

M.D. Ph.D. (MIT)Oleh Zagrijtschuk

Therapeutic Head

Past Experience:

Boehringer Ingelheim,

AOP Orphan

Pharmaceuticals

M.D. MSc. (U of Vienna)Joe Tseng

Director

Past Experience:

Far Eastarn Polyclinic,

NTUH

M.D. Ph.D. (Harvard)


13F, No. 3, Park St.,

Nangang District, Taipei 115,

Taiwan (Nangang Software Park)

Taipei Headquarters

Other Information

@PharmaEssentia

[email protected]

Better Science,

Better Lives.

Investor Relations Contact Information

+886-2-2655-7688 #7836

[email protected]

Page 32

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PharmaEssentia · BUFFALO, N.Y., Sept. 05, 2018 (GLOBE NEWSWIRE) -- Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization