NEW YORK, Feb. 07, 2018 (GLOBE NEWSWIRE) — Tyme Technologies, Inc. (NASDAQ:TYME), a clinical-stage biotechnology company developing cancer therapeutics, today announced a clinical and corporate update for the fiscal third quarter ended December 31, 2017. The Company’s lead clinical program, SM-88, is a novel combination therapy designed to use cellular metabolism and oxidative stress to drive cancer cell death. SM-88 is being evaluated in a Phase II clinical trial in prostate cancer, and the Company is finalizing the preparations for the Phase II clinical trial in metastatic pancreatic cancer.
Steve Hoffman, Tyme’s Co-Founder and Chief Executive Officer, remarked, “During the fiscal third quarter, we advanced our ongoing Phase II trial in prostate cancer, prepared for the initiation of our Phase II trial in metastatic pancreatic cancer and presented clinical data for SM-88 in multiple oncology indications. The positive efficacy and safety data demonstrated by SM-88 to date reinforce its potential to be an effective treatment option with a low toxicity profile for a wide range of cancer patients. We look forward to reporting Phase II data in prostate cancer and advancing our planned Phase II trial in pancreatic cancer over this year.”
Clinical Updates
- Metastatic Cancers: Provided subgroup analyses from First Human Study of SM-88 monotherapy in patients with progressive metastatic breast cancer.
• Objective tumor responses were observed in 6/14 (43 percent) of breast cancer patients across different genetic profiles, including in triple negative (ER-/PR-/HER2-) patients.
• Median overall survival of metastatic breast cancer patients (n=14) was 35 months despite an average of 2.5 prior lines of systemic therapy.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) meaningfully improved from a median baseline of 1.8 to 0.6 after the first six-week cycle.
- Pancreatic Cancer: Presented efficacy and safety data on SM-88 in advanced metastatic pancreatic cancer at the 2018 ASCO Gastrointestinal Cancers Symposium.
• 40 percent of evaluable patients achieved survival of more than 12 months, with 30 percent demonstrating a complete or partial tumor response.
• 80 percent of patients showed improvement in ECOG PS during the first treatment cycle, with 30 percent demonstrating an improvement of greater than one point during this six-week period.
• All patients improved or maintained quality of life measures and pain scores.
- Prostate Cancer: Announced Mack Roach III, M.D., FASTRO, FACR, Professor of Radiation Oncology, Medical Oncology and Urology at the University of California, San Francisco (UCSF), will present data from the ongoing Phase II trial of SM-88 in non-metastatic, biochemical-recurrent prostate cancer at the 2018 ASCO Genitourinary Cancers Symposium.
Corporate Developments
- At-The-Market (ATM) Financing: Established ATM financing facility with Canaccord Genuity, Inc., which acts as the Company’s sales agent for the program.
• Raised aggregate net proceeds to the Company of approximately $5.8 million during the quarter ended December 31, 2017.
- Research Collaboration: Established prostate cancer trial collaboration with Dr. Mack Roach III, UCSF.
• Company will provide support to Dr. Roach to conduct a randomized, investigator-sponsored trial comparing active surveillance to SM-88 maintenance therapy in patients prior to definitive therapy.
• Collaboration may also evaluate SM-88 in trials in select patient populations after relapsing from definitive therapy.
Fiscal Third Quarter 2017 Financial Results
As of December 31, 2017, the Company had approximately $10.8 million in cash and cash equivalents.
Operating expenses for the fiscal third quarter 2017 were $5.6 million and were comprised of research and development expenses of $2.6 million and general and administrative expenses of $3.0 million, including non-cash expenses of $3.1 million, (principally stock-based compensation). During the nine months ended December 31, 2017, the Company’s cash used in operations was $8.2 million.
For additional information about the Company’s financial condition and results of operations, please refer to the Company’s quarterly report on Form 10-Q for the quarterly period ended December 31, 2017, filed with the U.S. Securities and Exchange Commission earlier today.
About Tyme
Tyme 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, 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.
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 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 “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 of new products, technology enhancements, possible collaborations, the timing, scope and objectives of our planned clinical trials, funding plans and planned uses of proceeds, 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 12, 2017, 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 data analyses discussed above are not necessarily predictive of future patient 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.
Contacts
Tyme
Jonathan Eckard
Chief Scientific Affairs Officer
Email: jon.eckard@tymeinc.com
Investors:
ICR
Stephanie Carrington
Tel: +1-646-277-1282
Email: Stephanie.Carrington@icrinc.com
Media:
6 Degrees PR
Sarah Hall
Tel: +1 215 313 5638
Email: shall@6degreespr.com
