July 20, 2023
SymBio Pharmaceuticals LimitedFuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

Notice of Personnel Changes at SymBio Pharma USA, Inc.
TOKYO, July 20, 2023 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, hereinafter“SymBio”) today announced the appointment of Stephane Berthier as CEO and President of SymBio
Pharma USA, Inc. (established in May 2016; wholly owned US subsidiary; representative: FuminoriYoshida; hereinafter “SPU”), effective August 1, 2023, and at the same time, as a Corporate Officer ofSymBio. With this appointment, SPU will further develop its full-scale operations with a mission todrive the development of the intravenous formulation of brincidofovir (“IV BCV”) towardcommercialization in Europe, the U.S., and Japan.
Statement from Dr. Stephane Berthier: “This is an exciting time to join SPU as SymBio enters anexciting phase of global development to deliver innovative medicines in underserved therapeutic areas
across the globe. I look forward to building a strong global organization from both a culture andcapabilities standpoint to support SymBio's patient-oriented approach.”Statement from Fuminori Yoshida, President and CEO of SymBio: “We are very pleased to welcome Dr.
Stephane Berthier, with his outstanding knowledge and experience, to our management team. We willfurther accelerate SymBio's global business development and our transformation into a global specialty
pharmaceutical company with him. ”
Effective August 1, Fuminori Yoshida, President and CEO, will also serve as Chairman of the Board ofSPU, and Takaaki Fukushima, Managing Corporate Officer and CFO, will also serve as Director ofSPU. Dr. Carolyn Yanavich will step down as President and COO of SPU.
SymBio Pharma USA, Inc. (summary)
Name
Address

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

Representative
Establishment DateShareholders
Business Activities

Fuminori Yoshida
May 10, 2016
A 100% subsidiary of SymBio Pharmaceuticals Limited
Research and development of pharmaceutical products

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Appointment of Corporate Officer of SymBio

Name
Stephane Berthier

Title
Corporate Officer(CEO and President of SPU)

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Date of appointment: August 1, 2023

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Profile of the newly appointed Corporate Officer
1999
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2006
2011
2013
2016
20192021
1997
2006

Laboratory Head Pharmacokinetics & Bioanalytics, Novartis (Switzerland)
Director, Global Program Management, Novartis Oncology (Switzerland)
Sales Manager, US Sales, Novartis Oncology (USA)Director, Global Commercial,
Novartis Oncology (USA)US Brand Lead, Hematology, Novartis Oncology (USA)Global Business Head - Lymphoma & Leukemia, Janssen Pharmaceuticals (USA)Vice President, US Sales, Marketing & Operations, MorphoSys (USA)US General Manager, Atara Biotherapeutics (USA)
PharmD (Doctor of Pharmacy), University René Descartes, FranceMBA, Lancaster University Management School, United Kingdom

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 and smallpox virus including monkeypox, etc.), with superior features such as highactivity 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 attachedto 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 toidentify synergistic effects when combined with its antiviral activity.

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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 Phase II clinical trial in patients with BK virus infection after renal transplantation (May2022).
- 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
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: Fuminori Yoshida). 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.
[Contact]
Investor Relations, Administrative Division
Tel: +81(0)3 5472 1125

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