Tyme Identifies Potential Method and Biomarker for Converting Malignant Tumors to Inert Calcified Mass

• Mechanism for conversion works in conjunction with SM-88’s core technology
  
  
• Confirmed ability to calcify osteosarcoma tumors in canine models
   
• Identified biomarker appears to have applicability to a range of breast cancers and other tumor subtypes

NEW YORK, Oct. 25, 2017 -- Tyme Technologies, Inc. (Nasdaq:TYME), a biotechnology company using cellular metabolism and oxidative stress to develop cancer therapeutics, today announced it has identified a mechanism and related biomarker that the Company believes could potentiate the calcification of tumors.  During clinical evaluation of the Company’s lead product candidate, it was observed that subsequent to SM-88 therapy some lytic bone lesions converted to benign sclerotic bone.  Following further examination, the Company believes it has isolated the cause of this conversion and developed a treatment method that can be used in combination with SM-88 to cause calcification of tumors with a particular biomarker.  The Company has conducted a small number of tests in canine osteosarcoma and observed positive results, including a rapid ossification of tumors.

“We are excited because this not only supports the potential role of SM-88 in cancer treatment, but could broaden the protection of Tyme’s platform,” stated Tyme CEO, Steve Hoffman. “Given this therapy originated from studying SM-88 treated patients, we hope that the results seen in dogs will have a clear translation back to human subjects.” Previous canine studies have shown no demonstrable side effects from long-term chronic treatment with high doses of Tyme’s proprietary tyrosine derivative.

The calcification of tumors is recognized in several cancer types, including a majority of breast cancers as well as sarcomas and lymphomas.  Based on previous independent studies, calcification of a tumor can mitigate its metastatic potential and is associated with favorable survival outcomes.  Similar to calcification, we believe that SM-88 has demonstrated an ability to convert some malignant tumors to benign tissue that is metabolically inactive based on positron emission tomography (PET) imaging.  This effect was seen in SM-88’s first human study of certain subjects with progressive metastatic disease, where median overall survival was 29 months for patients that achieved “stable disease” under traditional RECIST response criteria.  The ability to calcify tumors could lead to increased therapeutic benefit or tumor clearance, building on SM-88’s current effects.

About Tyme

Tyme Technologies, 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 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), their clinical potential (including potential tumor calcification and metabolic activity) and non-toxic safety profiles, our drug development plans and strategies, our completed studies, 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 as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “hopes,” “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 June 12, 2017 (available at www.sec.gov). The data set forth in this presentation are not necessarily predictive of future patient, animal or clinical data outcomes.

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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