TYME Announces Abstracts Selected for Presentation at the American Association for Cancer Research, AACR 2020

• Preclinical data suggests multiple mechanisms of action for SM-88, including an increase in reactive oxygen species, alterations in autophagy and immunomodulation
• Preclinical data for TYME-18, an intra-tumoral delivered therapy, displayed statistically significant anti-cancer effects in animal cancer models, including the complete resolution of a majority of tumors
• Lead pipeline investigational compound, SM-88, represents a new approach designed to selectively disrupt cancers metabolic process leading to cancer cell death
• SM-88 has demonstrated clinical responses in 15 different cancer types across four separate studies

NEW YORK–(BUSINESS WIRE)–$TYME—Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced that two posters will be presented at the American Association for Cancer Research (AACR) 2020 Virtual Meeting to be held from June 22 to June 24, 2020.

TYME’s presentations include findings from preclinical data on two CMBTs: SM-88 and TYME-18. TYME’s CMBTs are proprietary investigational compounds that leverages cancer’s altered metabolism and associated vulnerabilities to specifically disrupt fundamental cellular processes. This can include altering protein synthesis, increasing oxidative stress, decreasing pH levels, and compromising protein or lipid barriers. In addition, CMBTs may target select survival mechanisms including autophagy, as well as altering the tumor microenvironment to improve immune recognition of the cancer. In clinical trials, SM-88 (racemetyrosine) has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher drug-related adverse events.

The first abstract describing SM-88 showed that mice receiving SM-88 monotherapy demonstrated significantly reduced tumor size as compared to control mice. The preclinical data suggest SM-88 monotherapy increases oxidative stress from reactive oxygen species (ROS) and interferes with autophagy, an important survival mechanism utilized by cancer cells. Both of these effects may be associated with SM-88’s intended mechanism of specifically disrupting cancer cell metabolism with a dysfunctional amino acid. Additionally, preclinical data supports that SM-88 modulates tumor immunity, specifically tumor associated macrophages (TAMs) reducing immunosuppressive (M2) macrophages that have demonstrated a critical role in overall tumor immune dynamics.

Separately, new data will be presented for TYME’s CMBT compound, TYME-18. TYME-18 is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions.

Additional information on the meeting can be found on the AACR website at: https://www.aacr.org/meeting/aacr-annual-meeting-2020/aacr-virtual-annual-meeting-i/

Details for the poster presentations are as follows:

Title: In Vitro and In Vivo Anticancer effects of D/L-alpha-metyrosine (SM-88), a Novel Metabolism-Based Therapy

Virtual Session Date: June 22-24, 2020

Virtual Session Location: AACR e-poster website

Abstract Number: 20-A-7314

Title: In Vivo Mouse Model Data Demonstrating Reduction in Tumor Cell Proliferation Following Intratumoral Administration of TYME-18

Virtual Session Date: June 22-24, 2020

Virtual Session Location: AACR e-poster website

Abstract Number: 20-A-6858

About Autophagy

Autophagy plays a housekeeping role in removing misfolded or aggregated proteins, clearing damaged organelles, such as mitochondria, endoplasmic reticulum and peroxisomes, as well as eliminating intracellular pathogens. Thus, autophagy is generally thought of as a survival mechanism, although its deregulation has been linked to non-apoptotic cell death.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

About TYME-18

TYME-18 is a cancer metabolism-based investigational cancer therapy designed for the intra-tumoral delivery to increase the permeability of cancer cells while delivering a therapy that will have a selective cytotoxic effect on the tumor. TYME-18 is distinct in composition, but like SM-88, it aims to enhance the susceptibility of a cancer to the highly acidic and toxic tumor microenvironment, while minimizing the impact to normal tissues.

About Tyme Technologies

Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cancer cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

Forward-Looking Statements/Disclosure Notice

In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates, including SM-88 and TYME- 18, and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words including their use in the negative or by discussions of future matters such as the cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trial may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM- 88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on June 12, 2019, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.

The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

Contacts

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Brian Gill

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