TYME Announces Abstracts Selected for Publication at the 2020 American Society of Clinical Oncology Annual Meeting

Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced that two abstracts will be published at the American Society of Clinical Oncology (ASCO) 2020 Virtual Meeting to be held from May 29 to May 31.

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, our lead cancer metabolism-based compound, 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 adverse events.

Radiomics Abstract:

SM-88 is an oral dysfunctional tyrosine derivative. Previous studies reported a well-tolerated profile with encouraging efficacy. Recently, advances in image analysis using quantitative textural analysis have uncovered noninvasive biomarkers that correlate with molecular drivers of cancer and prognostic signatures of response. Earlier radiomic data from patients treated with SM-88 showed a positive correlation between circulating tumor cells and tumor radiomics at baseline. This study extends those findings to focus on radiomic changes associated with SM-88 in a Phase II dose escalation trial (NCT03512756).

Health Economic Outcomes Research Abstract:

Over the past 20 years, innovative cancer medicines have contributed to increased life expectancy, reduced mortality, decreased hospitalization and decreased use of medical services. Recently, a health economic study presented at ASCO GI 2020 cited that for every additional $1 spent on innovative medicines for pancreatic cancer between 2009 and 2016, there was a reduction in non-medicine spending of $8 to $9, thereby lowering the total cost of care for pancreatic cancer patients. Accordingly, the commercial opportunity of a new disease-altering therapy should be measured by some combination of the clinical, economic and social value created. This study demonstrates the value of a novel pancreatic cancer therapy from this perspective.

Additional information on the meeting can be found on the ASCO website at: https://meetings.asco.org/am/virtual-format

Details for the abstracts are as follows

Title: Radiomic texture analysis correlates with PDAC patient outcomes on SM-88
Virtual Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Virtual Session Date: May 29-31, 2020
Virtual Session Location: ASCO Virtual Scientific Program
Abstract Number: e16776

Title: Value-Based Estimate of Market Size and Opportunity for Economic Benefit Through Innovative Pancreatic Cancer Therapies
Virtual Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Virtual Session Date/Time: May 29-31, 2020
Virtual Session Location: ASCO Virtual Scientific Program
Abstract Number: e16790

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 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, those regarding the potential benefits of, and plans relating to the collaboration between Eagle Pharmaceuticals and Tyme Technologies; the potential of SM-88 as a therapeutic drug; and the benefit of each company's strategic plans and focus. Statements regarding our drug candidate SM-88 and its 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 ability to achieve clinical study 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 Phase II data may differ from prior study data or preliminary Phase II 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; 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 May 22, 2020, 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.

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