Tyme Technologies, Inc. Announces the Issuance of Two New Platform Patents

NEW YORK, Aug. 14, 2017 -- Tyme Inc. (Nasdaq:TYME), a biotechnology company using cellular metabolism and oxidative stress to develop cancer therapeutics, announced the United States Patent and Trademark Office has issued patents, #9,585,841 (‘841) and #9,724,657 (‘657), that, individually and in combination, substantially expand the scope of intellectual property for Tyme’s pipeline. 

“Tyme is focused on using a truly new perspective to solve old problems.  For our immediate pipeline, these two patents represent the next generation of SM-88, joining tyrosine and melanin into what we believe will be a more potent combination,” said Steve Hoffman, Tyme’s CEO.  “Equally important, both of these patents represent substantial internal and external development opportunities to create novel combinations in the battle against cancer.”

Patent ‘841 describes the process for combining tyrosine derivatives with other compounds, including melanin, as a drug delivery pathway into cancer cells.  Tyrosine is the core component of Tyme’s SM-88 therapy and melanin is believed to enhance the oxidative effect of SM-88, which could be further amplified by intracellular delivery. Tyme believes both SM-88’s human clinical trials as well as tyrosine-based products for diagnostic imaging have demonstrated that tyrosine is highly selective to cancer cells. Future development projects could combine other drugs with tyrosine to achieve targeted delivery of additional therapeutics into the tumor.

Patent ‘657 describes a novel manufacturing technique to combine compounds under exceptional force.  Tyme has demonstrated the use of this technique to combine tyrosine and melanin while maintaining the functionality of their original, separate components.  ‘657 is not limited to Tyme’s current product portfolio and could be utilized with a multitude of drug combinations.

About Tyme

Tyme Inc. is a clinical-stage 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, our 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. Our lead clinical program, SM-88, is a first-in-class combination therapy in Phase II development for prostate cancer, and we are preparing to initiate an additional Phase II clinical trial for pancreatic cancer. For more information, visit our website: www.tymeinc.com.

Forward-Looking Statements/Disclosure Notice

In addition to historical information, this press release contains forward-looking statements 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), our drug development plans and strategies, our completed and planned clinical trials 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 as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. 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, uncertainties inherent in 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 analysis, final results of additional clinical trials, or both, may be different from the preliminary data analysis and may not support further clinical development; 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 March 30, 2016 (available at www.sec.gov).

The information contained in this press release is as of 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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