Strategic collaboration with Eagle Pharmaceuticals entitles TYME to receive up to a total of $40 million, which included $20 million upfront already received and $20 million in potential milestone payments.TYME-88-Panc pivotal trial started enrollment using oral SM-88 as a potential treatment for patients with third-line pancreatic cancer.PanCAN opened an initial site in its Precision PromiseSM adaptive randomized Phase II/III registration-intent trial for patients with pancreatic cancer using oral SM-88 in second-line monotherapy TYME & Joseph Ahmed Foundation’s sarcoma study started enrollment for the investigator-initiated HopES Phase II trial using oral SM-88 as maintenance monotherapy in patients with previously treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas.Capital resources better position TYME to complete current stages of trials in pancreatic cancer and sarcoma, advance planning for clinical trials in metastatic breast, prostate and hematological cancers, as well as continue developing pre-clinical and mechanism data. NEW YORK, Feb. 05, 2020 (GLOBE NEWSWIRE) — Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced financial and operating results for its fiscal third quarter ended December 31, 2019. Most recently, the TYME-88-Panc pivotal trial started enrollment using oral SM-88 (racemetyrosine) as a potential treatment for patients with third-line pancreatic cancer; in January 2020, PanCAN opened an initial site in its Precision PromiseSM adaptive randomized Phase II/III registration-intent trial for patients with pancreatic cancer using oral SM-88 in second-line monotherapy; and enrollment started in the investigator-initiated sarcoma HopES Phase II trial using oral SM-88 as maintenance monotherapy in patients with previously treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas.“We have quickly evolved our science of cancer metabolism-based therapies from the conceptual to its practical application as we begin enrollment of patients in multiple SM-88 pivotal trials this year,” said Mr. Steve Hoffman, Chairman and Chief Executive Officer of TYME. “Importantly, we continue to embark on new opportunities and build a model for sustainable growth by expanding our goals and objectives and broadening our clinical and regulatory plans. We look forward with great enthusiasm to executing on our strategy to advance potential therapies for patients with advanced cancer.”Third Quarter Fiscal 2020 Financial Results:As of the third quarter ended December 31, 2019, the Company had approximately $11.5 million in cash and cash equivalents compared to $15.3 million as of the second quarter ended September 30, 2019. On January 7, 2020, TYME received an additional $20.0 million from the sale and issuance of 10,000,000 shares of common stock of the Company to Eagle Pharmaceuticals in a private placement, which resulted in TYME having cash and cash equivalents of $31.5 million. TYME’s operational cash burn rate for the third quarter of fiscal year 2020 was $4.5 million compared to $4.2 million for the second quarter of fiscal year 2020 and $5.3 million for the third quarter of fiscal 2019. The burn rate which was generally consistent with our previous projections and predominantly reflected costs associated with our ongoing TYME-88-Panc Phase II trial as well as the launch of the pivotal phase of our TYME-88-Panc trial to evaluate SM-88 as a potential treatment for patients with third-line pancreatic cancer. Based on active clinical trials, the initiation of the Precision PromiseSM trial, and other business developments, TYME continues to anticipate that its quarterly cash usage, or “cash burn rate”, will average between $5.0 to 6.0 million per quarter for fiscal year 2020.Based on U.S. GAAP (Generally Accepted Accounting Principles), net loss was $7.0 million for the third quarter ended December 30, 2019, or a net loss per basic and diluted share of $0.06, as compared to a net loss of $8.0 million for the third quarter ended December 31, 2018, or a net loss per basic and diluted share of $ 0.08. The decrease in losses was substantially due to timing of activity related to Part 1 of our TYME-88-Panc trial as well our recently completed Phase II prostate clinical trial.Adjusted net loss for the three months ended December 31, 2019 was $4.9 million, or an adjusted net loss per share of $0.05, compared to adjusted net loss of $6.0 million, or an adjusted net loss per share of $0.06, for the three months ended December 31, 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 December 31, 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 EventsTYME currently expects the following key events in calendar year 2020:First half of calendar 2020:Present preclinical data for SM-88Advance enrollment in TYME-88-Panc pivotal study and the HopES Phase II TrialInitiate enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy Present preclinical data for TYME-18Present preliminary Health Economic Outcomes study on total cost of care for pancreatic cancer patientsSecond half of calendar 2020:Publish SM-88 Phase II prostate studyAdvance SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancersAdvance PanCAN’s Precision PromiseSM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and AbraxanePresent and/or publish final data from Part 1 of TYME-88-Panc studyComplete enrollment in TYME-88-Panc pivotal studyAdvance plans for TYME-18 IND programSummary of Recent DevelopmentsTyme Technologies and Eagle Pharmaceuticals Announce Strategic Collaboration to Advance Innovative Oral SM-88 for the Treatment of Patients with Cancer
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