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Press Release

Tyme Provides Clinical and Corporate Update for the Fiscal First Half 2017


Posted on: 08 Nov 17

NEW YORK, Nov. 08, 2017 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (Nasdaq:TYME), a clinical-stage biotechnology company developing cancer therapeutics, today announced an update of its clinical and corporate progress for the first half of fiscal 2017.  The Company’s lead clinical program, SM-88, is a first-in-class combination therapy designed to achieve cancer cell death using cellular metabolism and oxidative stress. SM-88 is in a Phase II clinical trial development for prostate cancer and the Company is preparing to initiate an additional Phase II clinical trial for pancreatic cancer.

Steve Hoffman, Co-Founder and Chief Executive Officer, remarked, “2017 has already been a transformational year for Tyme, both in advancing SM-88 through Phase II trials and putting in place the corporate infrastructure to help the Company grow rapidly.  We have recently reported five-year follow-up on our First Human Study in metastatic cancer and an interim analysis on our Phase II study in prostate cancer.  During the second half of our fiscal year, we plan to initiate a Phase II trial in pancreatic cancer, as well as continue publishing data on the over 100 metastatic cancer patients have treated with SM-88 since 2012.”

Clinical Developments:

  • Prostate Cancer –  Presented positive interim data (n=9) at ESMO 2017 from an ongoing Phase II clinical trial in biomarker-recurrent prostate cancer
     • All subjects (100 percent) receiving SM-88 showed radiographic progression free survival throughout treatment
     • All subjects (100 percent) receiving SM-88 experienced greater than 20 percent reduction in circulating tumor cells (CTCs)
     • No moderate or serious adverse events related to drug with an average of six months of daily oral therapy
     • Results suggest SM-88 may help prostate cancer patients avoid or delay more intensive treatments, such as chemical castration with androgen-deprivation therapy
  • Metastatic Cancer – Provided multiple long-term and subgroup analyses from its 30 patient First Human Study in progressive metastatic cancer patients  
     • Median overall survival of 30 months despite patients entering with progressive disease and having failed or refused standard-of-care treatment options
     • 90 percent experienced clinical benefit while on monotherapy by achieving complete response (4/30), partial response (6/30) or stable disease (17/30)
     • Stable disease patients had a median overall survival of 29 months, demonstrating that RECIST criteria may not directly correlate with SM-88’s therapeutic effect
     • All patients improved or maintained their ECOG PS, a quality of life measurement, after initiating SM-88 therapy. Average ECOG PS improved from 1.6 at baseline to 0.6 after six weeks of therapy
     • Median overall survival of metastatic breast cancer patients (n=14) was 35 months despite an average of 2.5 prior lines of systemic therapy.  Responses were seen across genetic profiles, including triple negative (ER/PR/HER2-) patients
  • Compassionate Use Program – Published at ASCO 2017 initial data on late-stage pancreatic (n=11) and prostate cancer (n=6) from the 76 compassionate use patients treated with SM-88
     • Out of eleven metastatic pancreatic cancer patients, three achieved complete or partial responses under RECIST guidelines and two additional patients achieved sustained stable disease with survival of over two years
     • All pancreatic patients reported an improvement in quality of life and reduction in pain
     • Two of six prostate cancer patients experienced RECIST complete responses and PSA improvement

Other Corporate Developments in 2017:

  • Uplisting to NASDAQ Capital Market –Tyme’s common stock commenced trading on the NASDAQ Capital Market in July under the ticker symbol “TYME”
  • Management Expansion – Added three new operating executives with >50 years combined experience
     • Ben Taylor, President and Chief Financial Officer, (previously with Goldman Sachs, Barclays)
     • Jonathan Eckard, PhD, Chief Scientific Affairs Officer, (previously with NYU Medical, Barclays, Citi)
     • Shabnam Stanicky, Chief Operations Officer, (previously with Quintiles, Eli Lilly)
  • Board and Advisor Appointments – Appointed four new members to expand advisory experience
     • Dr. Briggs Morrison, former CMO of AstraZeneca and current CEO of Syndax, joined the Medical Advisory Board
     • David Carberry, with over 40 years of experience in J&J’s Finance group, joined as a Director and Audit Committee Chair
     • Paul Sturman, a former executive at Pfizer and current CEO of Nature’s Bounty, joined as a Director
     • Jim Biehl, a Partner at Drinker Biddle with over 25 years of experience, joined as a Director
  • Intellectual Property – Four additional patents issued in the U.S. with earliest expiration of 2032

Second Quarter Fiscal 2017 Financial Results
As of September 30, 2017, the Company had approximately $7.5 million of cash and cash equivalents. During the fiscal first half ended September 30, 2017, the Company’s average cash used in operations was less than $1.0 million per month.

Conference Call and Webcast Information
Tyme will host a conference call at 10:00 a.m. EST on Wednesday, November 8, 2017, to provide the second quarter fiscal year update and discuss its financial results. The call is open to all parties. You can access the conference by dialing (866) 601-3896 or (636) 234-7404 and using the conference ID: 2778299 approximately 10 minutes prior to the call.  The accompanying slide presentation and conference call webcast can be accessed from the Investor Relations page of Tyme’s website at www.tymeinc.com/investors/.

A replay will be available beginning shortly after the end of the call through February 8, 2018, by visiting the Investor Relations page of Tyme’s website at www.tymeinc.com.

About Tyme
Tyme Technologies, 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, our 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. Our lead clinical program, SM-88, is a first-in-class combination therapy in Phase II development for prostate cancer, and we are preparing to initiate an additional Phase II clinical trial for pancreatic cancer. For more information, visit our website: 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 (including potential tumor calcification and metabolic activity) 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 as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “hopes,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. 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, 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 analysis, final results of additional clinical trials, or both, may be different from the preliminary data analysis and may not support further clinical development; 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 (available at www.sec.gov). The data set forth in this presentation are not necessarily predictive of future patient, animal 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

GlobeNewswire
globenewswire.com

Last updated on: 08/11/2017

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