TYME Tyme Technologies Inc New

TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today announced the availability of the poster abstract, “SM-88, D/L-alpha-metyrosine, is a novel anti-cancer agent in estrogen receptor positive breast cancer,” which was submitted by researchers from Georgetown University. The abstract will be presented by Dr. Ayesha Shajahan-Haq at the American Association for Cancer Research (AACR) Annual Meeting 2022 in New Orleans, LA. Dr. Shajahan-Haq, PhD is an Assistant Professor in the Department of Tumor Biology at Georgetown University, and her research focuses on resistance mechanisms in breast cancer.

“In earlier studies, SM-88 showed encouraging efficacy in breast cancer patients, including patients with HR+/HER2- disease. We are excited to see more preclinical data to deepen our understanding of SM-88's utility in this setting. Activity in this CDK4/6 resistant model is especially encouraging, as this is the population that the OASIS trial is being conducted in, and these patients have continued unmet medical needs. Given that resistance to today’s standard therapies is prevalent, and metastatic breast cancer remains an incurable disease, we look forward to building on this important work,” stated Richie Cunningham, Chief Executive Officer of TYME.

Through the OASIS breast cancer study, TYME is collaborating with Georgetown University to work toward testing SM-88 as a treatment for patients with hormonal positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer who have received two prior hormonal therapies and failed or progressed after receiving a CDK4/6 inhibitor agent. The HR+/HER2- subtype represents 73% of breast cancer diagnoses in the United States.

Enrollment is ongoing in the OASIS study, which is being conducted by Georgetown University through MedStar Health, its academic clinical partner, at five sites. The trial is focused on tumor objective response rates, with the goal of finding an effective, well-tolerated, oral treatment for patients before they advance to chemotherapy treatment.

Abstract Highlights:

• The initial studies were focused on assessing the effects of SM-88 (D/L-alpha-metyrosine; racemetyrosine) as a potential anti-cancer agent for ER+ tumor models that were either resistant or sensitive to antiestrogens agents and CDK4/6 inhibitors.
• The results that SM-88 alone showed antiproliferative effects in each of the sensitive and resistant cells lines, and that the combination of SM-88 and MPS had an additive effect in these models.
• Ongoing work is focused on further defining the biochemical pathways in drug sensitive and resistant cells that will further support the current clinical use of SM-88 in advanced ER+ /HER2- breast cancer (ClinicalTrials.gov Identifier: NCT04720664).

Poster Presentation Details:

Abstract Title: SM-88, D/L-alpha-metyrosine, is a novel anti-cancer agent in estrogen receptor positive breast cancer

Authors: Diane M. Demas, Julie Collins, Ayesha N. Shajahan-Haq. Georgetown University Medical Center, Washington, DC, Georgetown University Medical Center, MedStar Hospital, Washington, DC

Abstract Number: 4122

Session Title: Breast Cancer Drug Resistance and Novel TargetsSession Start Time: April 11, 2022, 1:30pm ET

The OASIS TrialThe TYME/Georgetown University OASIS breast cancer trial is a multicenter phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to significant anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.

About TYME Technologies, Inc. TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively 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 cause cancer cell death.

The Company is currently focused on developing its novel compound, SM-88, its preclinical pipeline of novel CMBTTM programs, as well as TYME-19 as a potential therapeutic for SARS CoV-2 diseases. The Company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including 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 lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is being evaluated in a Phase II study evaluating SM-88 in breast cancer (HR+/HER2-), as well as continuing enrollment of a Phase II 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 StatementsIn 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 technologies (including SM-88 and TYME- 18) 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 effect of the COVID-19 pandemic and the associated impact on the national and global economy as well as impacts on the Company's ongoing clinical trials and ability to analyze data from those trials; the cost of development and potential commercialization of our lead drug candidate and of other new product candidates; expected releases of interim or final data from our clinical trials; possible collaborations; the timing, scope, status, objectives of our ongoing and planned trials; the success of management transitions and strategic initiatives; 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 impact of the COVID-19 pandemic; our ability to achieve the intended benefits of our strategic initiatives; that certain 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, additional analyses of existing data and results that may lead to a discontinuation of trials; 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 or analyses and may not support further clinical development; and 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; the ability of TYME to maintain compliance with Nasdaq listing standards; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K for the fiscal year ended March 31, 2021 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.

Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com

Source: Tyme Technologies, Inc.