IR LIBRARY

CEO Message

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Dear Shareholders,

I would like to express my heartfelt sympathy to those impacted by coronavirus (COVID-19) and in difficult circumstances as the virus continues to produce struggles all over the world. I must express my deepest respect and gratitude to all those on the front lines of the response, including medical personnel.

"A World without Blindness" - the goal of the company hasn't changed since the company was founded in 2002. Our greatest mission is to translate innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Being able to see adds hope, comfort, excitement, and more to our lives. We, Kubota Pharmaceutical group, are more determined than ever to maximize our efforts and accelerate our development and marketing to meet patients' needs.

Looking back at 2021, we are excited and proud to inform you that our ongoing phase 3 clinical trial investigating emixustat in patients with Stargardt disease is on schedule. As for Kubota Glass™, a wearable device for myopia control, we received medical device registration approval in Taiwan, and "ISO 13485:2016" certification for the design and development of ophthalmic medical devices.

While we continue to evaluate new opportunities to expand our ophthalmic product pipeline, we are currently focusing on two fields of ophthalmology: drugs including emixustat hydrochloride, our leading investigational drug candidate; and medical devices, including Kubota Glass and Patient Based Ophthalmology Suite (PBOS).


Emixustat Hydrochloride

Currently, intraocular injections are mainly used in the treatment of retinal diseases, but there are many patients who are reluctant to undergo treatment due to anxiety about injections into the eye. With emixustat, no intraocular injection is required as it can be taken orally, thereby causing less stress on patients. Emixustat is designed to specifically target the visual cycle to reduce the accumulation of toxic by-products and oxidative stress. We are exploring emixustat's potential to stop or slow the progression of disease in patients diagnosed with Stargardt disease in an ongoing phase 3 clinical study.

This phase 3 clinical study was selected for the Orphan Products Clinical Trials Grants Program by the U.S. Food and Drug Administration (FDA) in August 2020. The enrollment of the last subject for the study was completed in April 2020 and database lock is expected to be completed in the third quarter of 2022. Positive results from this clinical trial would be a beginning of a new phase of our long-standing efforts.


Medical Devices

Our development project for mobile health (mHealth) is PBOS. Its key features are low cost and a patient-friendly design that will enable the monitoring of disease progression directly by patients in their homes, supporting an effective and optimal treatment regimen via 5G network connectivity and cloud-based technologies. The recent outbreak of COVID-19 has triggered more demand for remote medical monitoring, and we will advance the program to bring it to market as quickly as possible.

With our PBOS technology, we aim to develop a compact OCT device for NASA's deep space mission that can diagnose, monitor, and eventually enable treatment of Spaceflight Associated Neuro-ocular Syndrome (SANS) for spaceflight crewmembers, of which approximately 69% of long-duration spaceflight crewmembers present one or more signs. In April 2020, we completed the phase 1 of the project with high satisfaction by NASA and the Translational Research Institute for Space Health (TRISH). Details for the phase 2 are yet to be determined pending the government budget reallocation due to the pandemic; however, we continue discussing with NASA and TRISH to advance its development and to improve its technologies.

We are also in a phase of development of our wearable device for myopia control based on Kubota Glass technology that moves us toward commercialization and preparation for production and sales. Myopia is the most common eye disease worldwide, especially in children, and has been made worse by longer screen time during the pandemic.

I sincerely thank you for your trust and ongoing support towards Kubota Pharmaceutical group. We will continue to move forward together as a team dedicated to advancing and developing innovative therapeutics and medical technologies to help patients improve their quality of life.


Sincerely,


Ryo Kubota, MD, PhD
Representative Executive Officer, Chairman, President and CEO
Kubota Pharmaceutical Holdings Co., Ltd.
April 2022