On November 8, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported financial and operating results for its second fiscal quarter ended September 30, 2021 (Press release, TYME, NOV 8, 2021, View Source [SID1234594744]).
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Second Fiscal Quarter 2022 Business and Recent Highlights:
Commenced enrollment and dosed first patient in OASIS breast cancer trial, a multicenter Phase II single-arm, open-label study examining SM-88 with methoxsalen, phenytoin, and sirolimus (MPS) in patients with metastatic disease who have received two prior hormonal therapies. The trial is being conducted by Georgetown University (NCT04720664) at five MedStar Health hospitals. (MedStar Health is Georgetown’s academic clinical partner).
Five new sites planned to be added in early 2022 with an additional 10 sites expected by the end of 2022, on top of the 15 already participating (for a total of 30 sites), in the Precision Promise trial, a Phase II/III randomized adaptive trial in metastatic pancreatic cancer sponsored by the Pancreatic Cancer Action Network (PanCAN). These sites are among the top research institutions in the country for pancreatic cancer treatment.
The HOPES Sarcoma trial, an investigator-sponsored trial, had a meaningful increase in the rate of enrollment during the quarter. We anticipate completing trial enrollment by the end of the first half of calendar year 2022.
Launched preclinical initiative with Evotec to evaluate the potential of expanding SM-88 platform to other targeted indications.
Announced plans to explore the development of a Tyrosine-based tumor targeted technology and the receipt of a patent on such platform.
"Our second quarter was a period of significant action at TYME as we continued to implement our strategic imperatives. We commenced the OASIS breast cancer study with the first patient dosed in late September, and initiated our preclinical work, including our all-important biomarker research. We believe this will provide us with a better understanding of how best to address treatment opportunities. Our existing trials are also progressing, as planned. PanCAN’s Precision Promise trial is in the process of seeking five new sites early next year with plans to add 10 more by the end of the year and enrollment continues in our HopES sarcomas study. This is particularly noteworthy given how difficult it is to recruit patients with this ultra-rare sarcoma. Finally, we began early discovery work on a tyrosine-based tumor targeted technology platform," stated Richie Cunningham, Chief Executive Officer of TYME.
"Given all the positive momentum, these are exciting times at TYME, and we are in a strong financial position to advance these programs. We look forward to sharing information on our progress in the upcoming quarters," concluded Cunningham.
Second Fiscal Quarter 2022 Financial Results
As of the quarter ended September 30, 2021, the Company had approximately $96.6 million in cash and marketable securities, compared to $101.5 million as of the quarter ended June 30, 2021. TYME’s operational cash burn rate for the second quarter of fiscal year 2022 was $5.0 million compared to $6.0 million for the first quarter and $6.6 million for the second quarter of fiscal year 2021.
The burn rate was below the Company’s previous guidance and reflected expenses associated with ongoing clinical trials in pancreatic cancer (Precision Promise), breast cancer (Oasis), and sarcoma cancers (HopES), as well as reduced costs associated with our discontinued pancreatic cancer trial, 88-Panc-Part II. TYME continues to anticipate that its quarterly cash usage or "cash burn rate" will range from $6.0 to $8.0 million for the remaining quarters of fiscal year 2022, based on costs associated with the Company’s active clinical trials, the ongoing and close out activities related to our discontinued pancreatic cancer study, our pre-clinical studies in biomarker and mechanism of action research of SM-88, and TYME-19 pre-clinical studies.
Net loss was $5.6 million for the quarter ended September 30, 2021, or ($0.03) per basic and diluted share, as compared to a net loss of $6.9 million for the quarter ended September 30, 2020, or ($0.05) per basic and diluted share. The decrease reflected lower ongoing trial costs primarily due to the discontinued TYME—88- Panc Part 2 trial.
After adjusting for the change in fair value of warrant liability, and amortization of employee, director and consultant stock options, adjusted net loss for the three months ended September 30, 2021, was $5.3 million, or ($0.03) per share, compared to adjusted net loss of $6.5 million, or ($0.04) per share, for the three months ended September 30, 2020. 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 September 30, 2021, in the Company’s Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located in the SEC filings section of the Company’s website.
Conference Call and Webcast Details
The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the event.
Use of Non-GAAP Measures
Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liability, amortization of employees, directors and consultants stock options and gain on warrant exchange. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant noncash charges and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.