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Tyme Granted U.S. Patent Claims Covering Use of Tyrosine-Based Drug Delivery Method to Treat Cancer

BEDMINSTER, N.J.–()–Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced that it has received notification that the United States Patent and Trademark Office has granted additional patent claims related to the Company’s metabolomic technology platform. The patent, U.S. Patent No. 11,058,638, involves a targeted delivery of therapeutics to cancer cells.

Tyme has developed a technology by which the tyrosine isomer racemetyrosine (α-methylparatyrosine) can be fused with a second therapeutic agent in a manner that creates a fusion compound that may allow targeted delivery to the cancer cells in a novel manner. This method of delivery, is predicated on the metabolic phenomenon in which cancer cells consume higher quantities of non-essential amino acids, including tyrosine, from their surrounding environment to support their growth because they cannot make enough of these amino acids.

“This technology could provide Tyme an opportunity to expand its current cancer-metabolism based approach with a drug delivery platform that’s aimed to deliver toxic therapies in a targeted manner that could offer improved safety and efficacy for a range of anticancer drugs.” said Steve Hoffman, Tyme’s Chief Scientific Officer.

“This delivery technology is another example of our innovative spirit at Tyme. Even though this approach is still in its early stages, if proven, it has the potential to be a broadly leveraged platform technology.” said Richie Cunningham, CEO of Tyme.

The delivery technology is an investigational method of drug delivery in the pre-clinical phase of development that is not approved in the U.S. for any disease indication and requires further studies, which the Company plans to initiate this year.

About Tyme Technologies, Inc.

Tyme is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™) 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 cell death through oxidative stress and exposure to the body’s natural immune system. The Company is currently focused on developing its novel compound, SM-88. The Company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including pancreatic, prostate, sarcomas and breast, reinforce the potential of its emerging CMBT™ pipeline.

For more information about the Company, visit www.tymeinc.com and connect on Facebook, LinkedIn, and Twitter.

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. SM-88 is being evaluated in an adaptive randomized Phase 2/3 clinical trial for patients with second-line pancreatic cancer. The Company also anticipates beginning enrollment in a Phase 2 study evaluating SM-88 in breast cancer (HR+/HER2-) in the third quarter of calendar year 2021, as well as continuing enrollment of a Phase 2 study in high-risk metastatic sarcomas. SM-88 is an investigational therapy that is not approved for any indication in any disease.

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Forward-Looking Statements

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 and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical or clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates. The words “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “anticipates,” and similar expressions (including their use in the negative) are intended to identify forward-looking statements. Forward-looking statements can also be identified by discussions of future matters such as: the timing, scope, status, objectives and strategy of our ongoing and planned trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations and projections which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of our 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, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include but are not limited to: the severity, duration, and economic and operational impact of the COVID-19 pandemic; 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 in the ability to achieve adequate start and completion dates, as well as uncertainties in clinical trial design and patient enrollment, dropout or discontinuation rates; 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 trials 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 or other drug candidates 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 or other drug candidates; 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 10, 2021 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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