NEW YORK, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today provided a business update and reported its financial and operating results for the first quarter fiscal 2020 results ended June 30, 2019.

The first quarter of fiscal 2020 created meaningful momentum across all aspects of its business. During the quarter, TYME released new clinical data on its lead pipeline candidate, SM-88 (racemetyrosine), in patients with advanced metastatic pancreatic cancer at a major international medical meeting. TYME established a strategic research collaboration with NYU Langone Health and initiated a Phase II study exploring the clinical benefits of SM-88 in patients with Ewing’s sarcoma and other high-risk sarcomas.

Based on the promising data from the TYME-88-Panc study presented at the European Society of Medical Oncology 21st World Congress on Gastrointestinal Cancer (ESMO GI) on July 4, 2019 in Barcelona, Spain, TYME plans to initiate pivotal trials in the third quarter of calendar year 2019 for the first potential market entry of SM-88 in advanced pancreatic cancer. These studies include TYME’s third-line pivotal trial for patients with advanced metastatic pancreatic cancer through Part 2 of its TYME-88-Panc trial and a pivotal trial for second-line treatment for patients with metastatic pancreatic cancer in partnership with the Pancreatic Cancer Network (PanCAN) through its Precision Promise^(SM) program.

“We believe our science is unique, our approach is transformational, and our clinical results are very encouraging in patients with very poor prognosis,” said Mr. Steve Hoffman, Chairman and Chief Executive Officer of TYME. “We are committed to execute on our strategy of investing in the science of next-generation CMBTs to create disease-altering medicines for patients with metastatic cancers.”

First Quarter Fiscal 2020 Financial Results:

As of the first quarter ended June 30, 2019, the Company had approximately $19.5 million in cash and cash equivalents compared to $14.3 million as of the fourth quarter ended March 31, 2019. TYME’s operational cash burn rate for the first quarter of fiscal year 2020 was $6.2 million compared to $6.5 million for the first quarter of fiscal year 2019. The burn rate, consistent with our previous projections and $0.3 million lower than the comparable FY 2019 period, predominantly reflected costs associated with our ongoing TYME-88-Panc Phase II trial. Based on current clinical development plans, TYME expects cash operational expenses of approximately $5 million to $6 million per quarter for the remainder of fiscal year 2020.

Based on U.S. GAAP (Generally Accepted Accounting Principles), net loss was $3.2 million for the first quarter ended June 30, 2019, or a net loss per basic and diluted share of $0.03, as compared to a net loss of $6.7 million for the first quarter ended June 30, 2018, or a net loss per basic and diluted share of $ 0.07. The decrease in losses were substantially due to income associated with the change in warrant liability fair value, lower stock-based compensation expense, and lower legal and professional fees which offset expenses related to an increased employee base.

Adjusted net loss for the three months ended June 30, 2019 was $4.5 million, or an adjusted net loss per share of $0.04, compared to adjusted net loss of $4.4 million, or an adjusted net loss per share of $0.04, for the three months ended June 30, 2018, after adjusting for the change in fair value of warrant liability and amortization of employees, directors and consultants stock options. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See “Use of Non-GAAP Measures” below for a reconciliation to the comparable GAAP measures.

TYME has reported its full financial results for the quarter ended June 30, 2019 in the Company's 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

Anticipated Upcoming Key Events

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

• In third quarter calendar year 2019, initiation of Part 2 of SM-88 pivotal trial for patients with 3^rd line pancreatic cancer
• In third quarter calendar year 2019, initiation of the first PanCAN Precision Promise adaptive pivotal trial in pancreatic cancer with SM-88 in second-line monotherapy
• In third quarter calendar year 2019, start 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
• In fourth quarter calendar year 2019, report SM-88 preclinical data results
• Report TYME’s Phase Ib/II clinical trial results on prostate data at major international medical meetings
• Advance TYME-18 IND program

Recent Developments and Clinical Highlights

TYME Presented Updated Data at ESMO GI 2019 from TYME-88-Panc Phase II Study Demonstrating Encouraging Overall Survival Trends in Patients with Advanced Pancreatic Cancer

TYME presented updated results from the ongoing multicenter open-label Phase II TYME-88-Panc study (Abstract #160) that involved 49 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had significant disease related morbidity before receiving TYME’s investigational agent SM-88. More than 80% of patients had received at least two prior lines of therapy. Of the 49 patients, 38 patients were evaluable for efficacy, as defined in the protocol. TYME-88-Panc is a two-part study in which Part 1 was 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 of Part 2.

In this study, based on information available as of April 25, 2019, the median overall survival (OS) of evaluable patients (38 of 49) was 6.4 months. Certain efficacy indicators correlated with greater OS, including achieving stable disease (SD) or better and decreases in circulating tumor cells (CTCs). TYME believes these survival results compare very favorably to the analysis of 19 prospective pancreatic cancer trials where the median survival expected for a third-line patient would be 2.0 – 2.5 months based on reported historical trials.¹

Response evaluation criteria in solid tumors (RECIST) clinical benefit rate (CBR) of SD or better was achieved by 44% of evaluable patients with available imaging (11 of 25). Notably, evaluable patients achieving SD or better demonstrated a statistically significant (p=0.02) improvement in survival with a 92% reduction in risk of death (hazard ratio=0.08). The CBR was durable with the majority of these patients remaining in SD or better at more than 7 months after receiving treatment with SM-88.

The measurement of CTCs is emerging as an important prognostic indicator in patients with pancreatic cancer. This is now the second TYME study in cancer patients showing that SM-88 is associated with a reduction in CTCs.² In a previous study of patients with prostate cancer, SM-88 treatment was also associated with a reduction in CTC count (JCO 37, 2019 supp 7S; 83). In the TYME-88-Panc study, a median reduction of 63% in CTC burden was observed in evaluable patients (n=24). Importantly, evaluable patients with available results reaching an 80% reduction or greater in CTCs (10 of 24) demonstrated a 60% decrease in risk of death (hazard ratio=0.40).

“Responses are very rare in later line pancreatic cancer so overall response rates are close to zero. The SM-88 trial has demonstrated encouraging new data on efficacy indicators, including a meaningful clinical benefit rate, and a reduction in circulating tumor cells, that both correlate with extended survival,” 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. “Research results to date also indicate that SM-88 has a favorable toxicity profile. To have both encouraging efficacy and well tolerated safety with one drug is extremely important. There are no FDA approved treatments for 3^rd line pancreatic cancer and no NCCN or ASCO guideline recommendations. These patients are in desperate need of effective therapies.”

In addition to these findings from the TYME-88-Panc study, data were also presented on subgroup analyses. TYME identified several screening criteria that were associated with rapidly declining prognostic factors such as greater than two lines of prior therapy; age greater than 75 years old; and albumin less than 3.5 g/dl. Patients with no indicators of poor prognosis had a better trend in survival.

TYME identified key sub-groups of patients who performed better. Patients with 1 or 2 prior lines of therapy had a better trend in survival. Female patients had a statistically significant (p=0.01) trend toward better survival. These encouraging findings warrant further clinical evaluation of these subgroups.

As of April 25, 2019, the study reported that SM-88 was well tolerated with only 4.0% of patients (2 of 49) experiencing a serious adverse event (SAE) deemed at least possibly related to SM-88 (abdominal pain, arthralgia, and hypotension). One patient with reported SAEs continued on treatment.

The TYME-88-Panc research results are from an investigational study. SM-88 is not approved for the treatment of patients with any disease condition.

TYME Technologies Announced New Collaboration with NYU Langone to Advance TYME’s Cancer Metabolism-Based Therapy, SM-88

TYME entered into a collaboration with NYU Langone Health to advance the development of innovative treatments for patients with metastatic cancers, including pancreatic cancer. The collaboration will leverage NYU Langone’s state-of-the-art technologies to help inform the development of clinical therapies, focusing on identifying potential future biomarkers or combination approaches to treat cancer.

“We are excited to collaborate on this new effort to help uncover key findings about how specific biomarkers may help slow the development of certain cancer types,” said Diane Simeone, MD, Director of the Pancreatic Cancer Center at NYU Langone Health’s Perlmutter Cancer Center and Lead Principle Investigator for the Pancreatic Cancer Network’s Precision Promise^SM trials. “We believe our translational research can help affect future development of SM-88 and broaden our understanding of this novel approach by targeting cancer metabolism.”

The broad collaboration will examine the effects of SM-88 and each of the components of MPS (methoxsalen, phenytoin, and sirolimus) on primary pancreatic cancer cell lines, patient-derived pancreatic cancer organoids as well as specialized mouse xenograft models.

The studies will explore the impact of SM-88 on clinical models, including viability, general pharmacodynamics, genomic and RNA transcription analysis, and detailed impact on cancer metabolism. In addition, the specialized mouse tumor xenograft experiments should provide immunohistochemical signals of SM-88 effects and comprehensive immunomodulatory impact of the tumor microenvironment. This research will evaluate the potential of SM-88 in combination with standard approved cancer therapies, with a goal to identify optimal synergistic combinations with SM-88 for future development in metastatic cancers.

TYME’s SM-88 First Human Study in Patients with Metastatic Cancer Published in the Journal, Investigational New Drugs

TYME announced the publication of the results of its SM-88 first human study, which was designed to evaluate the safety and tolerability of SM-88 in patients with advanced metastatic cancers. Amazingly, encouraging clinical benefits started to emerge for patients across 15 different tumor types, including patients from TYME’s compassionate use program. This study was published in the peer-reviewed journal Investigational New Drugs. The article was titled “A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer,” and is available online at https://link.springer.com/article/10.1007/s10637-019-00758-8

Based on these clinical findings, TYME is developing new approaches, including SM-88, that target cancer metabolism. As metabolic changes in tumor cells are nearly universal (the Warburg Effect has been reported in over 90% of tumors³), TYME believes that targeting these mechanisms creates the possibility of delivering potent therapeutic benefit across a broad spectrum of solid tumors and blood cancers.

The SM-88 first human study was a TYME-sponsored, open-label, single-center first in human study of 30 patients with metastatic cancers who had failed or refused all available therapeutic options. In this study, SM-88 was used with low doses of melanin, melanotan 2, phenytoin, and sirolimus (M2PS). Based on results from the study, clinical researchers observed that patients reached a median overall survival of 29.8 months and 13 months of progression free survival (PFS) without additional therapy. 33% of patients (10/30) achieved RECIST complete response (CR) and partial response (PR) with median time to best response of greater than 3 months. 57% of patients (17/30) achieved RECIST SD with a median duration of 11 months.

SM-88 used with M2PS demonstrated a favorable safety profile and was well tolerated. All related adverse events (AEs) for SM-88 with M2PS were classified as mild or moderate. The most common treatment related AEs were hyperpigmentation by 100% of patients (30/30), fatigue by 56.7% of patients (17/30) and pain by 10% of patients (3/30). No dose limiting toxicities were observed.

SM-88 is an investigational therapy that is not approved for any disease indication.

TYME Announced Allowance of U.S. Patent Claims Broadly Covering Single Agent Treatment of Cancer with Tyrosine Hydroxylase Inhibitors

TYME broadened its global patent portfolio with the June 4 issuance of U.S. Patent No.10,307,465 directed to methods of treating cancer using tyrosine hydroxylase inhibitors, such as TYME’s lead compound SM-88, to make cancer cells more accessible to oxidative stress. Several of SM-88’s proposed mechanisms, including protein disruption, increased immune response and cell membrane perfusion, are all associated with increased oxidative stress in cancer, which can lead to cell death through apoptosis or necrosis. Issuance of the allowed claims expands TYME’s patent portfolio to 162 global patent applications granted and/or pending, which broadly cover compositions, methods, manufacturing and use of TYME’s pipeline through 2032 and beyond.

USAN Approved the Generic Name “Racemetyrosine” for SM-88

TYME announced that the United States Adopted Name (USAN) Council recently granted “racemetyrosine” as the generic name for SM-88, TYME’s lead pipeline candidate. The purpose of the United States Adopted Names Council is to serve the health professions in the United States by selecting simple, informative, and unique generic names for therapies by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.

TYME and The Joseph Ahmed Foundation Announced Initiation of the HopES Phase II Trial Evaluating the Potential Benefits of SM-88 for Patients with High-Risk Sarcomas

TYME announced the initiation of the HopES trial conducted in partnership with The Joseph Ahmed Foundation to better understand and help manage high-risk sarcomas which are ultra-rare cancers with high unmet medical need.

"There is an urgent need for more effective treatment options for patients with high-risk sarcomas, including Ewing’s sarcoma,” said Sant Chawla, M.D., Director of the Sarcoma Oncology Research Center, Santa Monica, CA and lead investigator for the HopES trial. "I was encouraged by the initial clinical data for SM-88 in metastatic sarcomas. This study has the potential to provide a new treatment option for patients with Ewing’s sarcoma who do not reach complete remission with first line treatment and patients with other sarcomas after progression. We are excited to partner with The Joseph Ahmed Foundation and TYME to further advance the science of cancer metabolism, research and education in these rare cancers so that patients can have better, safer options."

The HopES trial 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 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 is providing funding and patient support for this investigator-initiated HopES Phase II trial of SM-88 in patients with previously-treated metastatic sarcomas. The primary objectives are to measure overall response, SD and progression free survival. Secondary objectives include duration of response, OS, CBR using RECIST v1.1, and incidence of treatment-emergent AEs. Click here to learn more.

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.⁴ 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 modified proprietary tyrosine derivative that is hypothesized 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.

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. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.