On February 12, 2022 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that financial and operating results for its third fiscal quarter ended December 31, 2021 (Press release, TYME, FEB 12, 2022, View Source [SID1234608038]).
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Third Fiscal Quarter 2022 Business and Recent Highlights:
OASIS Breast Cancer Trial
Patient enrollment in the Phase II OASIS breast trial continued during the third fiscal quarter 2022. The Company is collaborating with Georgetown University in a multicenter Phase II single-arm, open-label study examining SM-88 with methoxsalen, phenytoin, and sirolimus (MPS). The OASIS trial is an investigator-initiated prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic HR+/HER2- breast cancer after treatment with a CDK4/6 inhibitor. This indication represents approximately 73% of the annual breast cancer diagnoses in the US each year. The trial is being conducted at Georgetown University at a total of five sites within the Georgetown/MEDSTAR system. The Company plans to provide an update on the OASIS breast cancer study during the first half of calendar year 2023.
HopES Sarcomas Trial
Patient enrollment in the HopES sarcomas trial continued during the third fiscal quarter 2022. The HopES trial is an open-label Phase 2 investigator-sponsored trial of SM-88 therapy in sarcoma, sponsored by The Joseph Ahmed Foundation. This trial has two cohorts, each expecting to enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients with mixed rare sarcomas, and the other is SM-88 with MPS as maintenance treatment for patients with metastatic Ewing’s sarcoma who had not progressed on prior therapy. The primary objective is to measure Overall Response Rate and Progression Free Survival. The Company anticipates that the trial will complete enrollment by mid-2022.
Pre-clinical Pipeline Program
The Company has begun a comprehensive translational preclinical program focused on SM-88 MOA and Biomarker Identification/Validation and has engaged Evotec, a leading global research and development company, to aid in the execution of these activities. TYME is also incorporating several complementary academic collaborations into this multi-faceted program. The overall goal of these activities is to potentially identify actionable biomarkers of sensitivity and activity to SM-88 in various cancers, complementary combination drugs strategies for SM-88, and other cancer metabolism targets that could be targeted for treatment. The goal of the biomarker preclinical program is to identify areas where SM-88 produces a significant response, with the aim of expanding to other indications.
"We had good momentum this past quarter enrolling patients in our breast and sarcoma trials. We also continued to advance our tumor targeting technology and COVID–19 pre-clinical programs. Additionally, our MOA and Biomarker work has commenced as planned," said Richie Cunningham, Chief Executive Officer of TYME Technologies.
Precision Promise Trial
On January 26, 2022, the Company announced the discontinuation of SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC) upon learning from the trial sponsor, Pancreatic Cancer Action Network (PanCAN), that it discontinued the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC. Based on the information provided by PanCAN, the overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX.
Strategic Review Update
A key goal coming out of the Company’s 2021 strategic review was to diversify the development pipeline by disease state, and TYME has commenced a process to examine additional options. A strong balance sheet, including $92.0 million of cash on hand, enables the Company to explore a number of avenues. Prior data indicated that SM-88 demonstrated confirmed responses in 15 different cancer types in both a First in Human study and a Compassionate Use program, and the Company is continuing its biomarker work to determine whether there is additional compelling data to commence a trial utilizing SM-88 in a new indication. Concurrently, TYME will be initiating searches for promising in-development cancer drugs that could be brought into the Company’s pipeline.
"I can assure you the process to diversify our pipeline will be a thorough and thoughtful one. We will carefully consider the benefits of commencing another internal SM-88 program versus looking outside the Company for a new compound. We firmly believe that SM-88 can be an effective agent in the fight against cancer. We also recognize that bringing in a product candidate with a different mechanism of action than SM-88 would add further diversity to our pipeline," stated Cunningham.
Third Fiscal Quarter 2022 Financial Results
As of the quarter ended December 31, 2021, the Company had approximately $92.0 million in cash and marketable securities, compared to $96.6 million as of the quarter ended September 30, 2021. TYME’s operational cash burn rate for the third quarter of fiscal year 2022 was $4.5 million compared to $5.0 million for the second quarter and $5.9 million for the third quarter of fiscal year 2021.
The burn rate was below the Company’s previous guidance and reflected expenses associated with ongoing clinical trials in breast cancer (OASIS), and sarcoma cancers (HopES), and the newly discontinued Precision Promise trial, as well as reduced costs associated with the discontinued pancreatic cancer trial, TYME-88-Panc Part 2. TYME anticipates that its quarterly cash usage or "cash burn rate" will range from $6.0 to $7.0 million for the remaining quarter of fiscal year 2022, based on costs associated with the Company’s active clinical trials, the ongoing and closeout activities related to the discontinued pancreatic cancer studies, the pre-clinical studies in biomarker and mechanism of action research of SM-88, and TYME-19 pre-clinical studies.
Net loss was $5.3 million for the quarter ended December 31, 2021, or ($0.03) per basic and diluted share, as compared to a net loss of $6.1 million for the quarter ended December 31, 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.
Adjusted net loss for the three months ended December 31, 2021, was comparable to the GAAP net loss noted above, as the change in fair value of the warrant liability largely offset employee, director, and consultant 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, 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.
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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.