TYME Announces First Patient Dosed in Phase II OASIS Trial Evaluating the Potential Benefits of Oral SM-88 for Patients with Metastatic HR+/HER2- Breast Cancer After Treatment with a CDK4/6 Inhibitor

-- Novel oral approach aimed at disrupting cancer metabolism in metastatic HR+/HER2- breast cancer –

-- HR+/HER2- represents 73% of diagnoses and is the largest subtype of breast cancer¹ –

-- Breast cancer patients from prior first-in-human studies showed broad anti-tumor activity, including complete responses --

TYME Technologies, Inc. (“TYME” or the “Company”) (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today announced that the first patient has been dosed in the Phase II OASIS trial in patients with metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (“HR+/HER2-“) breast cancer who previously received a CDK4/6 inhibitor regimen being conducted by Georgetown University (NCT04720664) at several MedStar Health hospitals. (MedStar Health is Georgetown’s academic clinical partner.)

“Metastatic breast cancer is still an incurable disease and represents the second-leading cause of cancer death in women.² The sobering statistics speak to the urgent need to find novel effective therapies that address this difficult-to-treat cancer. As this important trial begins, we are encouraged by the results in breast cancer patients from our prior first-in-human study and compassionate use program, which showed broad anti-tumor activity, including complete responses. We believe the compelling data support our strategic decision to further evaluate oral SM-88 in this setting, and we are hopeful that we will repeat the promising early activity. If so, we believe an effective drug with SM-88’s demonstrated tolerability profile would offer patients an attractive treatment option, while maintaining quality of life,” said Richie Cunningham, Chief Executive Officer of TYME.

“We are pleased to be collaborating with Georgetown University to work toward transforming the treatment landscape for these metastatic HR+/HER2- patients. Dosing the first patient is a critical milestone in advancing oral SM-88 as a potential treatment option prior to chemotherapy for this patient population. This is a significant opportunity for TYME, and we look forward to providing updates as the OASIS trial progresses,” concluded Cunningham.

The Phase II OASIS Trial

The OASIS clinical trial is an investigator-initiated multicenter Phase II single-arm, prospective open-label study of oral SM-88 used with methoxsalen, phenytoin, and sirolimus (“MPS”) in metastatic HR+/HER2- breast cancer who have received a prior CDK4/6 inhibtor regimen. The study is designed to determine efficacy, defined as the overall response rate (“ORR”) of this investigational treatment. It is designed as a two-stage trial, initially enrolling 30 patients, with potential expansion up to a total of 50 patients without concurrent cancer therapies. The primary endpoint is RECIST v1.1 tumor response; collection of cell-free DNA from patients will also occur at several time points in their treatment. If anti-tumor activity or a signal is observed among the first 30 patients, the trial may be expanded to confirm the findings.

With this trial, the Company is also incorporating mechanism-of-action and biomarker research, both preclinically and clinically. Preclinically, the Company is working with a Georgetown laboratory on SM-88’s effect in breast cancer models, including models of CDK4/6 inhibitor resistance. Clinically, the Company is collecting cell-free DNA samples from patients at multiple timepoints in their treatment and through progression to possibly identify biomarkers that could further inform future development work.

CMBTs™ are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma, with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease.

About Breast Cancer

According to the American Cancer Society, in 2021 in the United States, approximately 1 in 8 women will be diagnosed with invasive breast cancer in their lifetime, and 1 in 39 women will die from the disease. Breast cancer is the most commonly diagnosed cancer in women, with approximately 280,000 women diagnosed in the U.S. annually and more than 3.8 million breast cancer survivors in the United States today. In the United States, HR+/HER2- represents 73% of diagnoses and is the largest subtype of breast cancer.

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 our 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 is enrolling a Phase II study evaluating SM-88 in breast cancer (HR+/HER2-) and continues 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.

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 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 including the proposed TYME-19 proof-of-concept study, 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 novel coronavirus (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 and strategy 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 cerain 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 analyses 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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¹ Howlader, Nadia, Sean F. Altekruse, Christopher I. Li, Vivien W. Chen, Christina A. Clarke, Lynn AG Ries, and Kathleen A. Cronin. "US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status." JNCI: Journal of the National Cancer Institute 106, no. 5 (2014).

² National Cancer Institute.

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