Solasia Pharma K K : Announces Topline Data from Phase III AGENT Study of SP-05(arfolitixorin)

NEWS RELEASE

Solasia Announces Topline Data

from Phase III AGENT Study of SP-05(arfolitixorin)

TOKYO, August 4, 2022 - Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan,

President & CEO: Yoshihiro Arai, hereinafter "Solasia") today announced results that neither the primary endpoint of Overall Response Rate (ORR) nor the key secondary endpoint in Progression Free Survival (PFS) achieved statistical significance in the multi-center, international Phase III AGENT Study of arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC).

The AGENT Study is the first to evaluate a meaningful alternative to the standard of care for all patients with mCRC since 2004. In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not experience a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).

The AGENT Study will be completed in accordance with regulations and the full data set will be published in order to enable the scientific community to fully take advantage of learnings. Pending results of further analyses, patients remaining on treatment in the experimental arm of the study will be offered to move to the standard of care treatment arm.

About Solasia

Solasia is a specialty pharmaceutical company based in Asia, with a mission of "Better Medicine for a Brighter Tomorrow". In order to address the unmet medical needs within the oncology area, we develop innovative medicines to contribute to the patient's healthy living and to provide treatment options for the healthcare providers.

For more information, please visit https://www.solasia.co.jp/en/.

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(Contact)

Solasia Pharma K.K.

Toyokazu Ohata, Public Relations and Investor Relations

Tel: [phone] (TOKYO)

[e-mail]

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