Tyme Technologies, Inc. (NASDAQ:TYME) Q2 2020 Earnings Conference Call - Final Transcript

Nov 04, 2019 • 05:00 pm ET


Tyme Technologies, Inc. (NASDAQ:TYME) Q2 2020 Earnings Conference Call - Final Transcript


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Greetings, and welcome to the Tyme Technologies Second Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Brian Gill of Corporate Communications and Investor Relations for Tyme Technologies. Thank you. Mr. Gill, you may begin.

Brian Gill

Thanks, Tim, and welcome everyone to our second quarter fiscal 2020 investor conference call. The press release reporting on our business updates and financial and operating results can be accessed by going to the Investor Relations section of the corporate Web site at www.tymeinc.com.

Joining me today with prepared remarks are our Chairman and Chief Executive Officer, Steve Hoffman; our President and Chief Financial Officer, Ben Taylor; our Chief Operating officer, Michele Korfin; our Chief Medical Officer, Dr. Giuseppe Del Priore; and our Chief Business Officer, Dr. Jonathan Eckard.

As a reminder, during today's call, we will be making forward-looking statements regarding to our financial and operational outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

A description of these risks can be found in our most recent 10-K on file with the SEC. These statements speak only as of today's date and we specifically disclaim any obligation to update or revise them.

I'd now like to turn the call over to our Chairman and Chief Executive Officer, Steve Hoffman.

Steve Hoffman

Thank you, Brian. Good evening, everyone, and thanks for joining us today. Those who have been following our progress know that Tyme has reached a transformative point in our history. We are now ready for enrollment of two trials designed to be pivotal studying SM-88 for the treatment of pancreatic cancer. It goes without saying that we believe these milestones for Tyme will bring potential tremendous value and create value in the company going forward. We believe that the encouraging efficacy and safety data that has brought us to this point, increases our prospects for success where many before have failed. Furthermore, key opinion leaders in instrumental advocacy groups have told us that they share our optimism. Key opinion leaders and oncologists in both the pancreatic and prostate communities have expressed their enthusiasm for SM-88, driven by the compelling data presented at major international medical meetings. Those datas have led to a series of constructive interactions with the FDA, which has resulted in Tyme's pivotal study protocol having central IRB approval. We are now ready to enroll patients and expect to have Tyme's pivotal trial data as soon as 2021. Moreover, as you will hear this morning, we are also advancing our plans in sarcomas, prostate, breast and hematology. In fact, we are delighted to have renowned hematologist, Dr. Susan O'Brien, as the newest addition to our Medical Advisory Board. Our cancer metabolism-based therapies have demonstrated activity across a broad spectrum of