— TYME-19 demonstrated an antiviral effect against SARS CoV-2 in human lung epithelial cells, a model frequently used for drug screening for antiviral efficacy —

— Completed toxicity studies with TYME-19 that are

— TYME-19 demonstrated an antiviral effect against SARS CoV-2 in human lung epithelial cells, a model frequently used for drug screening for antiviral efficacy —

— Completed toxicity studies with TYME-19 that are expected to enable an Investigational New Drug (IND) application and support a forthcoming clinical trial —

— Independent research indicates that the TYME-19 bile acid may have differentiated mechanisms from the emerging oral therapies in development based on the way it interrupts viral hijacking of cellular protein synthesis —

— TYME plans to advance toward an IND for TYME-19 in COVID-19, targeting a patient population for whom there remains unmet need —

TYME Technologies, Inc. (NASDAQ:TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today announced encouraging preclinical data on the effect of TYME-19 in SARS CoV-2 infections.

The Company believes that TYME-19, a synthetic bile acid, may have differentiated mechanisms that could offer alternatives for COVID-19 infected patients who may not be served by current and emerging oral agents. Bile acids can act to help overcome the viral hijacking of cells' translational machinery and the production and replication of virus proteins and particles. Based on these properties and recent research on COVID-19 disease processes, the Company anticipates that the TYME-19-based mechanisms of action may be independent of genetic shifts in the spike protein and, therefore, could have utility against a variety of current and future variants of SARS CoV-2, such as Alpha, Beta, Delta, and Omicron, regardless of their spike protein characteristics. As a result, the Company believes this has the potential to be a complementary effective mechanism to current and emerging therapeutic options in COVID-19.

"COVID-19 has affected virtually every aspect of our personal and business lives and is likely to be an endemic disease, requiring safe and effective treatments that work across a range of current and future variants. The pandemic has already exacted an enormous toll, and with the recent emergence of the Delta and Omicron variants, there is an even more urgent need to find novel and sustained antiviral treatments. As an organization, TYME aims to contribute to the body of knowledge in identifying novel treatment options to improve the outcomes of patients with this disease," stated Richie Cunningham, Chief Executive Officer of TYME.

The Company has retained virology experts at Evotec to assess the mechanisms of TYME-19. Evotec is one of a select number of global drug development companies with the capabilities to access the multiple emerging variants of the COVID-19 virus. TYME and Evotec are testing the ability of TYME-19 to interrupt the cellular pathways commonly used by viruses to produce viral proteins that would lead to the interruption of COVID-19's viral particle production and the shedding of such particles from infected cells. We expect the work by Evotec will provide us with critical information allowing us to assess the current and potential future utility of TYME-19 in this disease.

In this initial preclinical study, TYME-19 was tested post-COVID-19 infection in human lung epithelial cells (A549 cells), examining changes in viral mRNA levels. This cell model is well understood and frequently used for screening for antiviral effects for drugs against respiratory viruses.

As part of the study, a range of doses of TYME-19 were tested and were exposed to A549 cells one hour after the cells' exposure to the COVID-19 virus. At certain doses, viral mRNA inhibition of up to 90% was observed with TYME-19 treatment after 72 hours of exposure.

"We are encouraged by the A549 study, as well as recent toxicology studies that support the safety of our approach. Moreover, we are excited about the prospect that TYME-19 may offer different mechanisms of action from those currently in development. As we continue to gain a greater understanding of TYME-19's mechanisms of action, we believe it will provide us the necessary insight to position this product in the ever-changing SARS CoV-2 landscape," concluded Cunningham.