November 13, 2020
Company Name: AnGes Inc.
Presentative: Ei Yamada, President & CEO

FDA Allowance of IND Application For AV-001 for the Treatment of HospitalizedPatients with COVID-19
November 13, 2020 – AnGes, Inc. and Vasomune Therapeutics, Inc., a clinical-stage
biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has
allowed its Investigational New Drug (IND) application for AV-001, a Tie2 tyrosine kinase
receptor agonist, as a potential treatment for hospitalized patients diagnosed with moderate-tosevere COVID-19 disease.
“FDA allowance of the IND application represents a significant milestone for Vasomune andmarks the transition of the company to clinical development of a novel investigational medicine
targeting the vascular response to SARS-CoV-2 infection for the treatment of seriously illpatients with COVID-19,” said Douglas Hamilton, President and CEO of Vasomune. “We areexcited about potential benefit this first-in-class therapy might have for patients in the fightagainst the COVID-19.”
Originally discovered and designed at Sunnybrook Hospital in Toronto, AV-001 is being
developed by Vasomune Therapeutics, Inc. under a co-development agreement with AnGes,Inc.
“There is an urgent need for therapeutics to treat patients with moderate-to-severe COVID-19
that require oxygen support”, said Ei Yamada, President and CEO of AnGes, Inc., “and we areencouraged by the preclinical findings that indicate this therapeutic approach might beparticularly well-suited for hospitalized patients with COVID-19.”
About AV-001
AV-001 is a novel investigational medicine that targets the Tie2 receptor, a transmembraneprotein target most highly expressed on the surface of endothelial cells in the vasculature. AV001 activates the Tie2-Angiopoietin pathway and restores normal vascular function andendothelial stability. Vascular dysfunction contributes to the underlying disease pathophysiology
in patients with COVID-19 and acute respiratory distress syndrome (ARDS), especially inpatients with preexisting vascular comorbidities, such as hypertension, diabetes and obesity.
Emerging evidence suggests SARS-CoV-2 infects pulmonary endothelial cells and causes
microvascular leaks, contributing to the initiation and propagation of respiratory distress andARDS in COVID-19 patients by altering blood vessel barrier integrity, promoting a coagulated
state, inducing vascular inflammation (endotheliitis) and mediating inflammatory cell migration.
In preclinical studies involving a lethal RNA virus infection animal model of influenza/ARDS, AV001 has been shown to stabilize the vasculature by enhancing endothelial cell stability, restoring
normal barrier defense and blocking vascular leak. Importantly, AV-001 monotherapy
significantly improved survival and lung function compared to untreated controls and showed
the benefit of enhanced recovery in combination with antiviral therapy. AV-001 is being
developed for the treatment of moderate to-severe COVID-19 and ARDS.

About Vasomune Therapeutics, Inc.
Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing
the next generation of medicines to harness the body’s ability to defend against illness.
Originally founded in 2006, Vasomune discovers and develops drugs using a novel therapeutic
approach focused on vascular normalization strategies. Vascular dysfunction is associated withthe pathology of several disease states, including COVID-19, influenza-associated ARDS, acutelung injury, acute kidney injury, hemorrhagic shock, sepsis and stroke. Vasomune’s corporate
headquarters and laboratory is located in Toronto, Canada with US offices in San Mateo, CA.
For more information about the company and its product candidates, please visit
www.vasomune.com
About AnGes, Inc.
AnGes, Inc. is a biopharmaceutical company founded in December 1999 based on innovative
discoveries by researchers at Osaka University and focuses on the development of gene-based
medicines. Regarding AnGes, Inc.’s lead product, Collategene® (HGF plasmid gene therapy) for
the treatment of critical limb ischemia, the company obtained conditional and time-limited
approval in March 2019 and its commercialization started in September 2019 in Japan.
Collategene® is the world’s first marketed drug using plasmid DNA. Development of NF-κB
decoy oligonucleotide for diseases, including lower back pain, and DNA vaccines for
hypertension is also underway. Furthermore, AnGes, Inc. began co-development of a DNA
vaccine for COVID-19 in Japan with Osaka University starting in March 2020. The DNA vaccinefor COVID-19 utilizes proprietary plasmid DNA technology. For more information, visit
https://www.anges.co.jp/en/
AnGes, Inc.
Public Relations & Investor Relations GroupTEL: +81-3-5730-2641, FAX: +81-3-5730-2635
https://www.anges.co.jp/en/