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TYME Provides Business Update and Announces Third Quarter Fiscal 2021 Financial and Operating Results

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·12 min read
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  • Announced Richie Cunningham as new Chief Executive Officer

  • Presented data from TYME-88-Panc Study at the American Society of Clinical Oncology 2021 Gastrointestinal Cancers Symposium

  • Continued enrolling patients in multicenter randomized controlled TYME-88-Panc pivotal trial evaluating oral SM-88 as a potential treatment for third-line pancreatic cancer; full enrollment not expected before calendar year 2022

  • PanCAN enrolling patients in multicenter Precision Promiseadaptive randomized Phase II/III registration-intent trial evaluating oral SM-88 as second-line monotherapy for pancreatic cancer

  • Continued enrolling patients in Joseph Ahmed Foundation’s HopES Sarcoma investigator-initiated Phase II trial studying oral SM-88 as maintenance monotherapy in previously treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas

  • Granted U.S. patent claims covering use of TYME-19 to treat COVID-19 infections

Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced financial and operating results for its third quarter ended December 31, 2020. During the quarter, TYME continued to build its leadership team with the announcement of Richie Cunningham as the new CEO; the Company continued to grow its global patent portfolio; expanded its body of peer-reviewed data presentations on SM-88 (racemetyrosine) at ASCO GI; continued enrolling patients in multiple studies including, second and third-line pancreatic cancer trials and the HopES Sarcoma Phase II trial; proceeded with next steps for initiation of the proof-of-concept trial (RESPOnD) evaluating TYME-19 as a potential new approach against COVID-19; advanced opportunities for clinical trials in metastatic breast cancer and hematological cancers.

"TYME is at an exciting juncture in its history. As I am getting acquainted with the many facets of the Company, I am deeply impressed with the spirit of innovation and dedication towards the development of products that improve the lives of people," said Richie Cunningham, Chief Executive Officer of TYME. "I am currently fully engaged in an ongoing strategic business review with a focus on setting forth our operational priorities to determine the best path forward to maximize stakeholder value and look forward to sharing our corporate vision at the next business update."

Third Quarter Fiscal 2021 Financial Results

As of the third quarter ended December 31, 2020, the Company had approximately $13.5 million in cash and cash equivalents compared to $19.4 million as of the second quarter ended September 30, 2020. TYME’s operational cash burn rate for the third quarter of fiscal year 2021 was $5.9 million compared to $6.6 million for the second quarter of fiscal year 2021 and $4.5 million for the third quarter of fiscal year 2020. The burn rate was below current estimates and predominantly reflected expenses associated with the ongoing clinical trials in pancreatic and sarcoma cancers.

Based on active clinical trials in pancreatic and sarcoma cancers and other business developments, TYME continues to anticipate that its quarterly cash usage, or "cash burn rate", will average approximately $6.0 to $6.5 million per quarter during fiscal year 2021.

Anticipated Upcoming Key Events

At present, TYME currently expects the following key events in calendar year 2021:

  • Continue to advance enrollment in the HopES Sarcoma Phase II Trial; expect data readout in calendar year 2021

  • Present clinical data on SM-88 at a major medical meeting

  • Continue to advance enrollment in TYME-88-Panc pivotal study; full enrollment and data readout are not expected before calendar year 2022

  • Continue to advance enrollment in PanCAN’s Precision Promiseadaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

  • Initiate the proof-of-concept trial (RESPOnD) to evaluate TYME-19 as a potential new approach against COVID-19

Corporate Developments

On November 30, 2020, TYME announced that Richie Cunningham, former Icagen CEO and Boehringer Ingelheim executive was appointed as TYME’s Chief Executive Officer. The Company also announced that Steve Hoffman remains in the role of Chairman of the board of directors and continues as the Company’s Chief Science Officer, after his successful tenure as Chief Executive Officer since 2015.

Summary of Recent Developments

TYME Presented Data From TYME-88-Panc Study at the American Society of Clinical Oncology 2021 Gastrointestinal Cancers Symposium

On January 17, 2021, TYME presented preliminary supporting data from the TYME-88-Panc pivotal study, at the American Society of Clinical Oncology Virtual 2021 Gastrointestinal Cancers Symposium. The new data demonstrate the potential role of SM-88 (racemetyrosine) in advanced pancreatic cancer through the analysis of circulating tumor cells (CTCs) and passively acquired biometrics data from a wearable device. TYME is presently enrolling patients in a multicenter randomized controlled pivotal trial evaluating SM-88 in patients with third-line pancreatic cancer. Learn more at https://tymesm88panctrial.com/.

CTCs correlate with poor prognosis at baseline and throughout treatment may be a clinically relevant biomarker for patients with metastatic pancreatic cancer. These results demonstrated that CTC collection and enumeration were feasible for correlation with traditional trial outcomes. Furthermore, passively acquired biometrics from a wearable device can be collected for correlation with other clinically meaningful outcomes. Also, given that the longest lesion diameter was correlated with CTCs at baseline, additional radiologic feature analysis may prove to validate the importance of CTCs as a predictive biomarker for patients with pancreatic ductal adenocarcinoma.

As of September 15, 2020, the study reported that SM-88 was well tolerated with no treatment-related Grade 4 or 5 adverse advents (AEs). There was one Grade 3 AE that was deemed possibly related to SM-88. The poster presentation is available on our website at (www.tymeinc.com/data-publications).

The select data from the TYME-88-Panc trial are from an investigational study. SM-88 is not approved for the treatment of patients with any disease condition. Patients and physicians can access www.TYMETRIALS.com for more information about ongoing SM-88 clinical trials.

TYME Granted U.S. Patent Claims Covering Use of TYME-19 to Treat COVID-19 Infections

On February 3, 2021, TYME announced that it received notification that the United States Patent and Trademark Office had granted additional patent claims related to the Company’s metabolomic technology platform. U.S. Patent No. 10,905,698 is directed to methods for treating COVID-19 with TYME-19. This patent expands TYME’s patent portfolio to nearly 200 global granted and/or pending patents, broadly covering compositions, methods, manufacturing and use of the Company’s pipeline to 2032, and beyond.

TYME-19 is an investigational compound that is not approved in the U.S. for any disease indication. TYME intends to initiate the appropriate clinical trials to substantiate the safety and efficacy of TYME-19.

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 an investigational therapy that is not approved for any indication in any disease. Learn more.

About TYME-18

TYME-18 is a CMBT compound under development that is delivered intratumorally. TYME-18 leverages a member of the bile acid family to create a potential treatment for inoperable tumors. Preliminary observations of the local administration of TYME-18, a combination of a proprietary surfactant system and natural sulfonic acid, suggested its potential as an important regulator of energy metabolism that may impede the ability of tumors to increase in size, which, in addition to its lytic functionality, could prove useful in difficult-to-treat cancers. In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11/12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals. Learn more.

About TYME-19

TYME-19 is an oral synthetic member of the bile acid family that the Company also uses in its anticancer compound, TYME-18. Because of its expertise in metabolic therapies, the Company was able to identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, like all steroids, they are messenger molecules that modulate a number of diverse critical cellular regulators. Bile acids modulate lipid and glucose metabolism and can remediate dysregulated protein folding, with potentially therapeutic effects on cardiovascular, neurologic, immune, and other metabolic systems. Some agents in this class also have antiviral properties. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

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. With the development of TYME-18 and TYME-19, the Company believes that it is also emerging as a leader in the development of bile acids as potential therapies for cancer and COVID-19. For more information, visit www.tymeinc.com. Follow us on social media: 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 our drug candidates (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 economic downturn and 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 products; expected releases of interim or final data from our clinical trials; possible collaborations; and the timing, scope, status, objectives and strategy of our ongoing and planned trials; the success of management transitions; and other statements that are not historical. The forward-looking statements contained in this report 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 and operational impact of the COVID-19 pandemic; that the 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 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; 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 May 22, 2020, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210204005263/en/

Contacts

For Investor Relations & Media Inquiries:
1-212-461-2315
Investor Relations
investorrelations@tymeinc.com
media@tymeinc.com