August 29, 2023
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Notice of Change of Global Chief Medical Officer andAppointment of Senior Vice President of SymBio Pharma USA, Inc.
TOKYO, August 29, 2023 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, hereinafter“SymBio”) today announced that effective September 11, 2023, Dr. Nkechi E. Mbanefo-Azie, MD,FISDA , MBA, (hereinafter “Nkechi Azie”) will be joining SymBio as Global Chief Medical Officer(“CMO”) and concurrently, as Senior Vice President of R&D of SymBio Pharma USA, Inc. (wholly owned
US subsidiary; CEO ＆ President: Stephane Berthier; hereinafter “SPU”)
With the addition of Dr. Nkechi Azie, along with Dr. Stephane Berthier who joined as CEO andPresident of SPU on August 1, 2023, the foundation of SPU with a mission to lead the global businessof brincidofovir (BCV), will be further strengthened to accelerate the global development andcommercialization of BCV.
Statement from Dr. Nkechi Azie: “SymBio is poised to tackle some life-threatening and debilitatingunmet medical needs. I am honored and thrilled to join the company as they tackle these needs tobring much needed relief to the waiting patients around the world. Working with SymBio’s team ofhighly experienced professionals I am convinced that together we can realize SymBio’s vision.”
Statement from Fuminori Yoshida, President and CEO of SymBio: “I’m thrilled to welcome Dr. Nkechi
Azie to our management team as CMO. Nkechi will bring to SymBio her extensive knowledge andexperience of global pharmaceutical development and a strong expertise in infectious disease to advanceour BCV pipeline. With the strong management team in place, SymBio will further accelerate the global
development and commercialization of BCV to enable its transformation into a global specialty
pharmaceutical company.”
Dr. Koji Fukushima, currently Corporate Officer and CMO, will remain as Corporate Officer, Deputy
CMO and Medical Lead for the transplantation Area.

[Contact]
Investor Relations, Administrative Division
Tel: +81(0)3 5472 1125

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SymBio Pharma USA, Inc. (summary)
NameAddress

SymBio Pharma USA, Inc. (SPU)
Durham, North Carolina, USA

CEO and President
Establishment Date
Shareholders
Business Activities

Stephane BerthierMay 10, 2016
A 100% subsidiary of SymBio Pharmaceuticals Limited
Research and development of pharmaceutical products

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Appointment of Global Chief Medical Officer of SymBio

Name
Nkechi E. Mbanefo-Azie

Title
Global Chief Medical Officer(SVP, R&D Head of SPU)

2.

Date of appointment: September 11, 2023

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Profile of the newly appointed Global Chief Medical Officer
1998
2003
2006
2008
2016
2019
2023
1988
1997

2012
QualificationAssociate Research Director, Clinical Pharmacovigilance, Pharmacia (US)
Director, Ant-infective Clinical Development, Pfizer (US)
Medical Director, Medical Sciences, Astellas (US)Senior Medical Director, Medical, Astellas (US)Senior Vice President, Head Medical Affairs, The Medicines Company (US)Vice President, Clinical Dev. & Medical Affairs / Medical Sciences, Scynexis Inc. (US)Senior Vice President, R&D Head of SymBio Pharma USA and Global Chief Medical
Officer of SymBio Pharmaceuticals Limited
Bachelor of Medicine, Bachelor of Surgery
University of Nigeria College of Medicine
Infectious Disease & Clinical Pharmacology FellowshipIndiana University Medical Center
Executive MBA, Notre Dame University (US)MD, MBA, FIDSA

About the Anti-viral Drug Brincidofovir
Brincidofovir (BCV) has a new mechanism of action as a lipid conjugate of cidofovir (CDV). CDV is anantiviral drug already approved and marketed in the United States and the European Union, but
unapproved in Japan. BCV is expected to be an effective treatment against a wide spectrum of dsDNAvirus infections (cytomegalovirus, adenovirus, Epstein-Barr virus, herpes virus, BK virus,
papillomavirus, smallpox virus and monkeypox virus, etc.), with superior features such as high activity
antiviral effect in comparison with CDV and other antiviral drugs.
Due to the breakthrough nature of the BCV molecule, in which a specific length of lipid chain is attached2

to the CDV, BCV is converted into a molecule that acts directly within the cell, thereby dramaticallyincreasing the efficiency of cellular uptake and showing a high antiviral activity.

In September 2019, SymBio entered into a license agreement with Chimerix for the exclusive worldwide
rights to develop, market, and manufacture BCV for all diseases except orthopoxviruses (such as
smallpox and monkeypox).
The tablets and oral suspension (oral formulation) were approved on June 4, 2021, for the treatment ofsmallpox in adults and pediatric patients, including neonates.
In addition to its high antiviral activity, BCV is also expected to have anti-tumor effects. We are
currently conducting collaborative studies with the National Cancer Center of Singapore, theUniversity of California, San Francisco, and other institutions to confirm its anti-cancer activity and to
identify synergistic effects when combined with its antiviral activity.

Clinical trials and major R&D collaborations with prominent research institutions are underway as
follows:- Initiated a Phase II clinical trial in patients with adenovirus infection after hematopoietic stem celltransplantation (March 2021) and received Fast Track designation from the FDA (April 2021). Proof ofConcept (POC) of antiviral efficacy established based on data up to cohort 3 (May 2023).
- Initiated a non-clinical trial at the University of California, San Francisco Neurosurgery Brain Tumor
Center to evaluate the anti-tumor effect of BCV on refractory brain tumors (September 2021).
- With regard to multiple sclerosis, an intractable disease that has recently been proven to be associatedwith the EB virus, SymBio has entered into an Cooperative Research and Development Agreement(CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS), affiliated with theNational Institutes of Health (NIH), to examine BCV's efficacy against the EB virus in the treatmentof multiple sclerosis, and to obtain information needed to conduct future clinical trials (March 2023).
- CRADA with the National Institute of Allergy and Infectious Diseases (NIAID), affiliated with theNIH, to evaluate the efficacy of BCV for EB virus-associated lymphoproliferative diseases (April 2023).
- Research on the involvement of infection by reactivation of latent viruses in various neurologicalseverity diseases of the brain, including Alzheimer's disease, has been ongoing for the past several years,
and a simple three-dimensional mimicry of human neural stem cell cultures and brain tissue
established by Tufts University in the United States, the A Sponsored Research Agreement was signed(December 2022) to examine the effect of BCV on HSV infection using a herpes simplex virus (HSV)
infection/reactivation model established by Tufts University in the U.S., which uses human neural stem

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cells cultured to mimic brain tissue in three dimensions.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Limited was established in March 2005 by Fuminori Yoshida who previously
served concurrently as Corporate VP of Amgen Inc. and founding President of Amgen Japan. In May
2016, the Company incorporated its wholly-owned subsidiary in the U.S., called SymBio Pharma USA,Inc. (Headquarters: Durham, North Carolina, representative: Stephane Berthier). The Company’s
underlying corporate mission is to “deliver hope to patients in need” as it aspires to be a leading global
specialty biopharmaceutical company dedicated to addressing underserved medical needs.

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