TYME Provides Business Update and Announces Preliminary First Quarter Fiscal 2021 Financial and Operating Results - Seite 2

TYME Presents New Preclinical Data Supporting SM-88 Mechanism of Action at AACR 2020

TYME announced new preclinical findings that describe the unique mechanism of action of its lead cancer metabolism-based candidate, SM-88 (racemetyrosine). The data were presented at the American Association for Cancer Research (AACR) 2020 Virtual Meeting from June 22 to June 24, 2020. Key highlights are as follows:

• Preclinical data demonstrated statistically significant tumor reduction in SM-88 treated arms versus controls
• Builds on confirmed tumor responses achieved in human clinical studies across 15 different cancer types
• Multiple monotherapy effects of SM-88 were shown, including increased oxidative stress, disruption of autophagy, and tumor immunomodulation
• Preclinical results were demonstrated across multiple tumor types including, pancreatic, colon, breast, and ovarian
• Reduction of immunosuppressive cells in the tumor microenvironment supports exploring combination with immuno-oncology treatments
• Oral SM-88 is designed to selectively disrupt cancer’s metabolic process and cause cancer cell death; SM-88 is currently in a pivotal trial for third-line pancreatic cancer

TYME-18 Demonstrates Anti-Cancer Effect in New Preclinical Data Presented at AACR 2020

TYME announced new preclinical findings that described the unique anti-cancer effects of its cancer metabolism-based pipeline candidate, TYME-18. The data were presented at the AACR 2020 Virtual Meeting from June 22 to June 24, 2020. Key highlights are as follows:

• TYME-18 leverages unique metabolism of cancer to create an intra-tumoral treatment for inoperable cancers
• Preclinical animal studies demonstrated TYME-18’s potential to dramatically shrink and/or resolve tumors
• TYME-18 treatment resulted in a 91.6% (11/12) complete resolution of established tumors within two weeks
• Novel mechanism of action contributes to a strong anti-cancer effect while minimizing systemic and local toxicity
• Preclinical studies are ongoing with a goal of identifying an IND-enabling program

TYME Announced Health Economic Research Study Presented at ISPOR and Published in the Journal Value in Health Demonstrated Reduction in Total Cost of Care with Increased Use of New Medicines for Treatment of Patients with Pancreatic Cancer