TYME Reports Third Quarter Fiscal 2019 Financial and Operating Results

• TYME’s novel metabolic-based investigational cancer therapy, SM-88, demonstrated encouraging results and a well-tolerated safety profile in a preliminary analysis from a Phase II study of patients with advanced pancreatic cancer
• TYME is in discussions with the FDA regarding pivotal trial design for third-line pancreatic cancer based on preliminary results from the TYME-88-Panc Phase II trial
• TYME partners with the Pancreatic Cancer Action Network’s (PanCAN) “Precision Promise^(SM)” program to advance SM-88 pivotal paths for first- and second-line treatment in patients with pancreatic cancer
• Initiation of investigator-sponsored Phase II trial using SM-88 as monotherapy in patients with previously-treated high-risk sarcoma expected in 1Q19
• TYME expands senior leadership team and research capabilities
• Presentation of data from clinical trial evaluating SM-88 in biochemically recurrent prostate cancer scheduled for Thursday, February 14th at American Society of Clinical Oncology’s (ASCO) 2019 Genitourinary Cancers Symposium

NEW YORK, Feb. 11, 2019 (GLOBE NEWSWIRE) — Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing metabolic-based cancer therapies, today reported its financial and operating results and provided a business update for the fiscal quarter ended December 31, 2018. Based on encouraging preliminary results from the TYME-88-Panc Phase II study, the Company’s lead pipeline candidate SM-88 is moving forward into pivotal trials for first- and second-line treatment of pancreatic cancer in partnership with PanCAN and its “Precision Promise^(SM)” program. TYME is also in discussions with the FDA to pursue a pivotal path for SM-88 in third-line treatment of pancreatic cancer.

Mr. Steven Hoffman, Chairman and Chief Executive Officer of Tyme Technologies, Inc., stated, “Based on the broad support that we have received during the quarter from pancreatic physicians, patients, and patient advocacy groups, we are excited to advance SM-88 into the next stage of pivotal trials.”

“Pancreatic Cancer is a devastating disease, predicted to be the second cause of cancer death by 2030,”¹ said Martin E. Fernandez-Zapico, MD, a Professor of Medicine and Pharmacology at the Department of Oncology at the Mayo Clinic. “In advanced pancreatic cancers, there is an urgent need for new treatment options. SM-88 represents a new therapeutic approach aimed at disrupting the tumor metabolic program.”

TYME continues to focus on advancing SM-88 in pancreatic cancer research, while also planning for development into other indications where SM-88 has shown encouraging results and a well-tolerated safety profile in previous clinical testing.

Third Quarter and Key Corporate Highlights

TYME highlights the following developments that took place during the quarter completed December 31, 2018 and through January 2019:

TYME-88-Panc Phase II Clinical Trial Results

TYME announced that its open-label Phase II clinical trial, TYME-88-Panc, evaluating SM-88 as an oral monotherapy in end-stage patients with advanced pancreatic cancer, demonstrated encouraging preliminary results and a well-tolerated safety profile.
 
The preliminary TYME-88-Panc Phase II results involved 38 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had received a median of two prior systemic therapies and had significant disease related morbidity before receiving TYME’s investigational agent. TYME-88-Panc is a two-stage Phase II study intended to determine optimal dosing and assess if early clinical benefit supported further development of SM-88 in pancreatic cancer. This study is being performed under a TYME IND with input from the FDA prior to study initiation. As a Phase II, open-label study, the design involved comparison of two dose levels with an independent Data and Safety Monitoring Board determining continuation.

Preliminary results of the first stage of TYME-88-Panc, using information available as of January 6, 2019, demonstrated that 68% of evaluable patients (19 of 28) were alive at a median follow-up of 4.3+ months (with further survival data to be evaluated as the patients and study progress) and that patients also avoided significant grade 4/5 toxicities normally associated with standard of care treatments. Median survival had also not been reached on an intent-to-treat (ITT) basis, with 60% (23 of 38) of patients still alive.  In addition, to assess the natural history for survival, as a comparator, in these advanced cancer patients, TYME performed a review of published studies to determine expected patient outcomes in collaboration with PanCAN.

We believe that these outcomes justify further development of SM-88. The results compare favorably to the analysis of 19 prospective second-line+ pancreatic cancer trials where the mean and median reported survival after progressing on second-line therapy was 3 months² based on reported historical trials.
TYME-88-Panc also demonstrated monotherapy activity with SM-88 in some patients based on common measures of anti-tumor activity, including computed tomography (CT), positron emission tomography (PET), and reductions in biomarkers carcinoembryonic antigen (CEA), CA-19.9 and circulating tumor cell (CTC) burden.

As of January 6, 2019, the study reported that SM-88 was well tolerated with only 2 out of 31 (6.5%) serious adverse events deemed at least potentially-related to the study drug. These SAEs both occurred in one patient, who continued on the investigational SM-88 treatment.

The 88-Panc research results are from an investigational study. SM-88 is not approved for the treatment of patients with advanced pancreatic cancer. 

“I am encouraged by the early signs of efficacy in this research involving this heavily pretreated population of advanced pancreatic cancer patients,” said Allyson Ocean, MD, a pancreatic cancer specialist at New York-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Medicine at the Weill Medical College of Cornell University. “It’s very hard to administer therapy in the 3rd-line and beyond setting, so these patients are in desperate need of effective therapies. Research results to date also indicate that SM-88 has a favorable toxicity profile so that’s extremely important.” 

American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium

At the ASCO GI Meeting in January, TYME presentations, which are available on our website (www.tymeinc.com/data-publications), included:

Phase II trial of SM-88 in Patients with Metastatic Pancreatic Cancer: Preliminary Results of the 1^st Stage:

• 68% of patients were still alive at a median of 4.3+ months of follow up
• Clinical benefit included stable disease and partial response observed in 47% (8 of 17) of evaluable patients at two-months using PET imaging scans
• CTCs, a potential indicator of disease status, decreased in 70% (16 of 23) patients who completed one full cycle of treatment
• Despite approximately 85% of patients having had two or more prior lines of therapy, SM-88 was safe and well-tolerated in heavily pretreated patients

Designing Clinical Trials in Third-Line+ Pancreatic Cancer:

• Patient demand, along with a lack of standard of care, makes third-line pancreatic cancer treatments a critical area for further study
• Therapeutic effect must be evaluated in terms of both quality and quantity of life
• Approximately 10,000 patients annually seek third-line or greater treatment for pancreatic cancer and interest continues to grow            

Feasibility of SM-88 in Pancreatic Cancer After Multiple Prior Lines & ECOG <2:       

• In a prospective Phase II trial studying SM-88 in refractory pancreatic ductal adenocarcinoma (PDAC), only one out of 38 patients (2.6%) experienced possibly related SAEs
• In a heavily pretreated pancreatic cancer subject population with extensive co-morbidities, SM-88 was well-tolerated. The study data confirms the feasibility of treating patients with ≥ third-line PDAC with SM-88

Phase II Pharmacokinetics of Oral SM-88 in Heavily Pretreated Advanced Pancreatic Ductal Adenocarcinoma:

• D,L alpha-metyrosine exhibits predictable pharmacokinetic properties
• Concentration-time profile of D,L alpha-metyrosine regimen was similar to expectations based on previous literature
• Patients treated with SM-88 are at low risk of experiencing adverse events related to the three adjuvant components

PanCAN’s Novel “Precision Promise^(SM)” Adaptive Pivotal Pancreatic Cancer Trials

In 2019, PanCAN’s Precision Promise^(SM) plans to launch its adaptive pivotal trials at 14 high-volume pancreatic cancer treatment centers in the United States, which represent some of the nation’s most prestigious medical institutions and oncologists in the field. Initiation of the first adaptive randomized pivotal trial evaluating SM-88 as second-line monotherapy in patients with pancreatic cancer is expected for the first half of 2019. SM-88 is expected to be evaluated in an adaptive pivotal trial as a first-line combination therapy with gemcitabine (Gemzar^®) and nab-paclitaxel (Abraxane^®) in patients with pancreatic cancer. The primary end point of these randomized trials is expected to be overall survival.

SM-88 Phase II Prostate Cancer Trial

TYME is nearing enrollment completion of its multi-center, open label Phase II study of patients with biomarker-recurrent prostate cancer who have rising prostate specific antigen (PSA) levels and no radiographically detectable lesions. The Company will provide updated data from this trial at the 2019 ASCO Genitourinary Cancers Symposium, which will be held February 14-16, 2019.

SM-88 as Maintenance Therapy for Advanced Ewing’s Sarcoma Patients and as Salvage Therapy for Sarcoma Patients (HopES)

This is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following standard primary or palliative treatments for Ewing’s sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. The Joseph Ahmed Foundation, a 501(c) not for profit organization is providing funding and patient support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously-treated metastatic sarcoma. The trial is expected to begin in the first quarter of 2019.

Corporate Developments

TYME expanded its leadership team and research capabilities with the addition of:

• Michele Korfin, a former Kite Pharma and Celgene Corporation executive, joined TYME as its Chief Commercial Officer with over 20 years of experience in oncology product launches, oncology marketing strategy, commercial sales, market access and government affairs.

• Dr. Martin Fernandez-Zapico MD, of the Mayo Clinic in Rochester MN, joined TYME’s Scientific Advisory Board. Dr. Fernandez-Zapico is a Professor of Medicine and Pharmacology in the Department of Oncology at Mayo Clinic, focused on preclinical pancreatic cancer mechanisms.
• Dr. Alexander Vandell, PharmD PhD, joined the Company as its Vice President of Clinical Research to oversee preclinical development. Dr. Vandell joined TYME from Daiichi Sanyo where he managed pharmacogenomics, clinical pharmacology and clinical development.

Anticipated Upcoming Key Events

TYME currently expects to provide informational updates or initiation of activities as follows:

• Update on SM-88 regulatory 3^rd-line pancreatic registrational pathway: first quarter of calendar year 2019
• Update SM-88 Phase Ib/II clinical results on prostate data at ASCO GU 2019: first quarter of calendar year 2019
• Planned start of enrollment for the investigator-initiated Phase II trial of oral SM-88 as maintenance monotherapy in patients with previously-treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas: first quarter of calendar year 2019
• Initiation of the first PanCAN “Precision Promise^(SM)” adaptive pivotal trial in pancreatic cancer with SM-88 in second-line monotherapy: first half of calendar year 2019
• Update on the first stage of TYME-88-Panc Phase II data expected in mid-2019
• Publication of SM-88’s First in Human Study in a peer-reviewed journal: first half of calendar year 2019

Third Quarter 2019 Financial Results:

Cash Position: As of the third quarter ended December 31, 2018, the Company had approximately $16.7 million in cash and cash equivalents compared to $21.1 million as of the second quarter ended September 30, 2018. TYME’s operational cash burn rate for the third quarter of fiscal year 2019 was $5.3 million compared to $4.7 million for the second quarter. The burn rate, consistent with our previous projections, predominantly reflected costs associated with our ongoing TYME -88-Panc Phase II trial, as well as initial costs related to our agreement with PanCAN. Based on current clinical development plans, TYME expects a cash burn rate of approximately $5.0 million for the quarter ending March 31, 2019.

Net Loss: Net loss was $8.0 million for the third quarter ended December 31, 2018, or a net loss per basic and diluted share of $0.08, as compared to a net loss of $5.6 million for the third quarter ended December 31, 2017 or a net loss per basic and diluted share of $ 0.06. The increase in losses were due to the expanded clinical activities, primarily the Company’s Phase II pancreatic and prostate clinical trials.

TYME has reported its full financial results for the quarter ended December 31, 2018 in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”). TYME’s 10-Q is located on the Company’s website under recent SEC filings at ir.tymeinc.com
 
About Advanced Pancreatic Cancer
Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease.³ The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer – adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors.  Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.  

About SM-88
SM-88 is an oral investigational therapy that utilizes a proprietary dysfunctional tyrosine derivative to interrupt the metabolic processes of cancer cells, breaking down the cells’ key defenses and making them vulnerable to oxidative stress and death. Clinical trial data have shown that SM-88 has demonstrated encouraging results across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers without serious grade 4/5 adverse events.

About Tyme Technologies
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, 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.  Follow us on social media: @tyme

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 candidate SM-88 and its clinical potential and non-toxic safety profiles, our drug development plans and strategies, 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 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, the timing, scope and objectives of our ongoing and planned clinical trials 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 13, 2018, 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.

¹Cancer Res; 1–9. ©2014 AACR.
²Manax et al 2019 J Clin Oncol 37, 2019 (suppl 4; abstr 226)
³Statistics adapted from the American Cancer Society’s (ACS) publication, Cancer Facts & Figures 2018.

IR & Media Contact:
Ashley R. Robinson 
LifeSci Advisors, LLC 
617-535-7742
arr@lifesciadvisors.com