株式会社ＥＶＡセラピューティクス

August, 2021

Corporate Profile
Combination of Young & Talented Researchersand Experienced Industry VeteransCompany

EVA Therapeutics, Inc.

HeadQuarters

Chotokuji Bldg. 1F
1-4-6, Doushin Kita-ku,
Osaka 530-0035
Japan

Director ofBoard

Hiromu Ozaki

Takanori Takebe, MD, Ph.D. :FounderHiromu Ozaki : Chief
Executive Officer

Hirofumi Nagai, DVM, Ph.D.,
DJSTP : CTO

Kazunori Sato, RPh : Head ofRegulatory and CMC

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Vision/Mission

VISION
Unlock New Potential of the Gut
MISSION
Deliver Enteral Ventilation (EVA) Therapy
PASSION
Help People, Care for Patients, Cure Diseases
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Executive Summary of Enteral Ventilation TechnologyUnmet medical needs✓

For severe respiratory failure, the mechanical ventilator and extracorporeal membrane oxygenation(ECMO) are commonly utilized at ICU setting. Given such treatment is highly invasive, there is anurgent need to develop a simpler treatment to prevent the acute exacerbation of respiratory failure
and the potential transition to invasive ventilator and ECMO

Opportunity✓✓

High Needs for medical device for the treatment of Acute Respiratory Distress Syndrome (ARDS)
due to ever increasing infection cases of COVID-19
By using perfluorocarbon (currently in clinical use as a medicine or a medical device) as the basematerial for our Enteral Ventilation product, the development timeline could be significantly
shortened

R&D strategy✓✓

Non-clinical studies can piggyback on the data from commercially available perfluorocarbon
products including Fluosol (Artificial Blood product using Intravascular Perfluorochemical Emulsion)
FDA SBA package
Regulatory Submission in Japan can be achieved in a relatively short period of time through a small
scale clinical trial

Market Potential✓ Japan USD 100-200 million✓ US&EU5 USD 1-2 billion
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O2 gas-based enteral ventilation via anus (EVA) rescue lethal hypoxia bysystemic oxygenation✓ g-EVA has systemic oxygenation effects and thus has therapeutic benefit

VEGF

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O2 loaded PFC-based EVA rescues lethal hypoxia with intact gut✓ l-EVA systemically and repeatedly oxygenates in porcine & mouse model of hypoxia✓ Confirmed proof of concept of I-EVA for human use

VEGF

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Concept of Enteral Ventilation for human clinical use✓

Due to the proven safety of perfluorochemicals in clinics, EVA potentially provides an adjunctive means ofoxygenation for patients under respiratory distress conditions.

The exploitation of intestinal breathingphenomenon in mammalian pre-clinicalmodels, potentially offering an additionalroute of O2 administration to patients
who are in critical need of immediate
respiratory support.
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Product and System
Oxygenated PFD for Intestinal Administration
System and Device

Clinical Practice
GMP grade Perfluorocarbon

Oxygenation at site
FFFO2gas O -PFD in liquid
F FFFEnemaF

Plastic Container
Injection Nozzle

PFD(perfluorodecalin)2

Devices such as catheter, filter, syringe, etc.

Protocols for Oxygenation, Administrationand Waste Disposal

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EVA Clinical Development Timeline
2020

2021

2022

2023

202420252026

医療機器
EVA101

Preclinical

IND

Phase I / II

Submission

EVA102

LaunchUS Phase IIb/III
Prevention of Rapid Erosion of AcuteRespiratory Failure (TBD)

Submission

LaunchNew Formulation
EVA201 or
EVA301

Basic ResearchPre-clinical

Phase IUS Phase II/III

Potential Patients in Japan for Liquid Ventilation Treatment

Difficult to intubate
patients
Up to 2000

Community
AcquiredInfections

Chronic carepatients (cancerand athma)

Paramedic/Emergency patients
Total of 0.5 milcases

Total number ofpneumonia
patients a year

Death/Year
100,000

1 million

ARDS patientsa year
30,000Survivingpneumonia
patients a year
900,000

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In Summary• EVA Therapeutics, Inc. will develop and commercialize Enteral
Ventilation Technology using perfluorocarbon.

• The intra-rectal delivery of a liquid form of O2 (oxygen) withperfluorocarbon is very well tolerated. Perfluorocarbon is acompound well-established for use in clinics for liquid ventilation
through airway administration.
• Balanced team of industry veterans and young researchers atTakebe Lab.
• FPI is expected in 202211