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TYME Secures Capital to Advance Pivotal Studies of SM-88 in Metastatic Pancreatic Cancer

Announces Closing of Registered Offering

NEW YORK, April 03, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTsTM), announced the closing of its underwritten registered offering with a group of three existing and one new investors resulting in gross proceeds of $12 million. The Company intends to primarily use the net proceeds from the offering to continue development of its clinical and preclinical programs, including two upcoming pivotal trials in pancreatic cancer, as well as for general corporate purposes. 

TYME is in the process of finalizing a randomized pivotal trial protocol amendment for use of SM-88 in third-line pancreatic cancer. TYME also will be studying SM-88 in a pivotal trial for second-line pancreatic cancer in partnership with the Pancreatic Cancer Action Network as part of its innovative Precision Promise℠ adaptive design study.  Both trials are expected to initiate in mid-2019.

“We believe this funding demonstrates that the investors who reached out to TYME saw the promise of advancing SM-88 in late stage pancreatic cancer,” said Steve Hoffman, Chairman and CEO of TYME. “Our goal is to give these patients a new treatment option that can help them live longer while also maintaining better quality of life. There is no standard of care for the 10,000 patients actively seeking treatment for third-line pancreatic cancer and the expected prognosis for these patients is only a few months survival. We appreciate the investors' support in providing us the necessary capital to accelerate our upcoming trials to reach multiple potential near- and long-term milestones.”

About Tyme-88-Panc
SM-88 is an investigational oral metabolic-based cancer therapy. Preliminary results from the Part 1 of TYME-88-Panc, a Phase II trial studying SM-88 in predominately 3rd line or later pancreatic cancer, demonstrated that 68% of evaluable patients were still alive at a median of 4.3+ months of follow up. Stable disease and partial responses were observed in 47% (8/17) of evaluable patients at two-months using CT imaging scans. Circulating tumor cells, a biomarker used to measure cancer response, decreased in 70% (16/23) of patients who completed one full cycle of treatment. The data suggested SM-88 was also safe and well-tolerated in heavily pretreated patients.

The TYME-88-Panc results are from an investigational study. SM-88 is not approved for the treatment of patients with advanced pancreatic cancer. 

About SM-88
SM-88 is an oral investigational therapy that utilizes a proprietary dysfunctional tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells, breaking down the cells’ key defenses and making them vulnerable to oxidative stress and death. Clinical trial data have shown that SM-88 has demonstrated encouraging results 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 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 the intended use of offering proceeds, 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 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 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 June 13, 2018, 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.


Ashley R. Robinson
LifeSci Advisors, LLC

Source: Tyme Technologies, Inc.