Tyme Technologies, Inc.
Q1 2021 Earnings Call Transcript

Published: 10 Jun 2021

[Operator:]

Hello, and welcome to the Tyme Technologies, Inc. Fiscal Year 2021 Financial Results and Business Update Conference Call. As a brief reminder, all participants are currently in a listen-only mode. Following the presentation, there will be a question-and-answer session. Note that this conference call is being recorded at the company's request, and will be made available on the company's website following the end of the call. At this time, I'd like to remind our listeners that remarks made during this call may state may state management intentions, beliefs, expectations or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the Federal Securities laws and are based on Tyme’s current expectations and actual results could differ materially.

[Richie Cunningham:]

Thank you, operator, and welcome everyone to our presentation this evening. I'm Richie Cunningham, CEO of Tyme, and it's my pleasure to meet with you to share the findings of our strategic review and the path forward. As you will learn today, every aspect of the company was contemplated, our pipeline, strategic vision, personnel, clinical process and data. I would say it was quite a significant and undertaking, and it took several months to complete. My prior work experience, which spans across the lifecycle of the pharmaceutical business came in handy throughout the review process, from leading an early drug discovery biotech, with having the understanding and knowing the importance of early translational data, to the launch and commercialization of several drugs throughout my career. Now, with that being said, the clear outlier on this slide is my time in the NFL. I get it, it really doesn't apply much to biotech, except for the fact that performing at a high level of success requires focus and discipline. Now personally, I always had a passion for finding opportunities that could positively impact the lives of people. And working in healthcare offered me a wonderful opportunity to do just that. When looking to transition from NFL, I was fortunate to meet the CEO of Premier. As many of you know, Premier is one of the largest buying groups for healthcare providers. Mr. O'Leary at the time gave me my first opportunity, and I will always be grateful to him for sharing with me as wealth of experience and knowledge. Now during that time, I also got a chance to meet with the CEOs from the largest and most successful hospital systems, and learned about the delivery of healthcare. I didn't follow that same leadership team from Premiere to return on opportunity, which was Valeant Pharmaceuticals, now Bausch Health, where I led and built commercial teams in sales and marketing.

[Jan Tornout:]

Thank you. Good afternoon. Good evening. My name is Dr. Jan Tornout, I'm a pediatric hematologist oncologist and genetic epidemiologist. I'm licensed as a physician both in the U.S. and Europe. I started my career as an attendee at Children's Hospital LA, University of Southern California, and as a physician scientist with NIH funded research program in genetic epi, and neural network and pediatric cancer.

[Frank Porfido:]

Thank you, Jan, and good afternoon to everyone. I'm Frank Porfido, I will be starting next week as the new CFO at Tyme. I've spent over 25-years at Novartis, specifically in their Oncology BU in various leadership positions, including U.S. CFO, Head of Global Finance for their Oncology Translational Medicine unit, and Global Head of Finance. Most recently, I was VP of Finance for UroGen Pharma, and was part of a team that brought our first product through FDA approval and commercialization. I have spent a number of years managing clinical trials spend, launching products, along with strategic planning. And I am very excited to join Tyme at such a pivotal point in their history, and look forward to doing my part as we endeavor to find ways to develop compounds that help patients.

[Richie Cunningham:]

Excellent. Thanks, Jan. Thanks, Frank, for those introductions. As I mentioned in my opening comments, we kicked-off a strategic review that started in January. We needed to have answers to several following questions that you'll see on this slide. What is Tyme’s drug development process? What's our product profile? What's the differentiation? Do we have the right data needed to make informed decisions? What do external experts think of our current data and development programs? What are our capabilities, strategic vision? And how are we communicating that vision? What's our IP position? What are we spending our precious capital on? In addition, do we have the right people in place? Are we pursuing the right programs? And what other opportunities should we be pursuing or should we not pursue? It was a robust effort. And as you will learn as part of that process, we had the benefit of seasoned professionals in their given fields to help us reach the answers to these questions. Today, I will share with you those findings, and how the process was conducted and the conclusions that were reached. Putting us on our path forward a path that we believe will unlock the full potential of Tyme. I want to take a minute to share with you the cross section of industry professionals and thought leaders that helped us with this processing to head down this path. We believed it was important to bring in an external and independent objective viewpoint. As you can see, we saw perspectives from multiple relevant disciplines that worked with internal teammates, as well as getting internal understanding of the data and information, and reaching the ultimate conclusions that we'll share with you today. So, one common theme amongst all involved, and I think the match that lit the fire at Tyme was the early dynamic results that we've seen with SM-88. That's the reason I'm here, and I believe that's the reason why the team is here. A few points here to make that excite me, broad activity across 15 cancer types with some intriguing responses, including complete responses. Those responses including unexpected positive results in advanced breast cancer, pancreatic cancers, and sarcomas. That's the most important, because it gives us multiple shots on goal, the safety profile, the lack of toxicity. It offers us an opportunity to potentially go in combination with the potential of not further compromising patients. We believe this is a huge differentiation for SM-88. Add to this, SM-88 can be delivered orally. These are the significant attributes that give us great optimism about its potential.

[Operator:]

Our first question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Your line is now open.

[Swayampakula Ramakanth:]

Thank you. Good afternoon, Ritchie. Thanks for giving a detailed plan for Tyme. So, we can see that the current portfolio as you're setting it up is to get a better use and better ROI and better use of capital. But at the same time, I'm trying to understand since you are not going to be owning any of these programs totally because they're being run by third-parties, how do you plan to utilize the data that is expected to come out of these three studies over the next year and a half to two years?

[Richie Cunningham:]

No, a good question RK, and thanks for asking the question. The programs we have right now is going to be the foundation of how we move forward. It's a start. It’s a start to build the data for the development path for SM-88. Ultimately, as that progresses, as an organization, we will certainly look towards the opportunity to design and execute on these trials ourselves. It's the current path forward, when you look at the Georgetown trial, it was an opportunity that was there for us. And we wanted to take advantage of the timing of doing that. And partnering with Georgetown beat the timing of us having to go back and do this ourselves. So there's a timing component and balance that goes to that. Now is the reason why we did that. And it just so happens pan can in the way that trial was designed with the pan can network is another trial that we believe in, and it's a Phase 2/3 three trial that gives us an opportunity to move pretty quickly. And so it comes down to timing at the end of the day. And, we're excited about it. We think if it works, the opportunity is there. We're going to take it and run with it. So it's positioned as well. And for this point in time where we're at, I think it's the right strategy.

[Swayampakula Ramakanth:]

Thanks. Regarding the second-line study and the third-line study of Tyme for the pancreatic cancer that were on as of until yesterday. So how much of the slowness in recruiting into the Phase 3 study is the contribution of having actually the same molecule being tested in a Phase 2 study, making not only KOLs but also patients wait to understand the data from the Phase 2 study before trying to think about it? I mean, sorry, second-line study before thinking of trying to get this drug in third-line patient.

[Richie Cunningham:]

Yeah. I think RK, it's more than likely a minimal impact. I don't see it as a major impact. That's my sense. I think, these third-line patients in looking for alternative treatments in our second-line trial, I don't think it had a real significant impact is my response to that.

[Swayampakula Ramakanth:]

Okay. And then, on the preclinical programs, we know that the management had had these programs for a while now. So, what sort of data should we expect from these over say, the next year or so, because that is pretty much going to drive the real pipeline of the company?

[Richie Cunningham:]

Yeah, absolutely. So, we've already started down that path. We’re working with Mayo Clinic as we indicated, and NYU we've worked with in the past. And what I can tell you is that, we are already at the point where we've developed a successful organoid model. And, now we're taking that to the next level. The next phase is start to do the experiments with SM-88, so we can confirm our understanding of how it works. That's going to lead us to those potential biomarkers, so expect to have a better understanding in the next, I would say 12-months RK.

[Swayampakula Ramakanth:]

Okay. And then the last question from me. Certainly, you have the cash to run these programs but also you have a little bit more than that. So, are you looking to doing any in-licensing so that you can beef up the pipeline outside of these molecules that you currently have?

[Richie Cunningham:]

So, I would just share with you this, we consider all options, as we consider, how we build our pipeline. I would just start with saying there's a lot of confidence in SM-88 and its potential. We think there's a multitude of shots on goal that we can take with that compound. That's where we're focused today. We don't want to take our eye off the ball. However, with that being said, you always look for optionality. And as those opportunities present themselves, we'll consider them.

[Swayampakula Ramakanth:]

Alright, thank you. Thanks for taking all my questions.

[Richie Cunningham:]

Thank you.

[Operator:]

Thank you. We received pre-submitted questions. When did you determine the third-line trial? Did it make sense to continue any longer? What factors was that decision based on?

[Richie Cunningham:]

So, as we spoke before, during the review, it was obvious that the slower than expected enrollment, it really changed the strategy outlook of an accelerated path for a second-line. And then, whereby the larger commercially viable opportunity existed in second-line versus third. And so, for us, when you analyze the cost benefit of continuing and further investing, that was going to be required and accelerating third-line, it was just really clear that more appropriate use of capital was going to be diversifying into opportunities, such as breast and focusing on second-line. And that for us that gave us was and is the greatest rationale and support to provide the greatest opportunity for the organization. So again, diversification, but ultimately the slow enrollment timing, and the lack of accelerated path focused on second-line was really the key output there.

[Operator:]

Thank you. We have another pre-submitted question. You are highlighting your focus now on preclinical and mechanism of action, but you are in late stage trials. Isn't it a bit late for this? Shouldn't it have been done before?

[Richie Cunningham:]

So, my response to that is it's never too late to better understand how and where your drug works best. In fact, I see it as a continuous process. With some commercial drugs, some still don't have an understanding of MOA. But it's definitely the preference, as it creates a more efficient development strategy, especially when you look back at the profile of SM-88 and the multiple potential shots on goal that can be created. We've got to be smart as to how we go about that and that's why we're investing in it now.

[Operator:]

We have time for a couple more questions. Our next question, with the implementation of your strategic review findings, what will be the new quarterly burn rate going forward for the next 24-months?

[Richie Cunningham:]

So, what I can tell you is that we anticipate a quarterly burn over the next 12-months to be anywhere from $6 million to $8 million. We have this spread in there and incorporate the wind down in third-line, as well as supporting the new initiatives that we're putting in place. So that's where our burn is positioned. And we're just communicating out for the next 12-months.

[Operator:]

Our next question is, how long do you anticipate the cash on hand will last, before you need to raise money?

[Richie Cunningham:]

So, based on the current strategy and plan, we expect to have at least a three plus year cash runway. This enables us to get through and to the key milestones that we expect that we've shared. And it gives us an ability to generate some of the initial -- the data around the initiatives around MOA and biomarker, and get to some key milestones and events for the organization. So, we feel comfortable with the cash on hand and our current position.

[Operator:]

At this time, I'm showing no further questions. I would like to turn the call back over to Richie Cunningham for closing remarks.

[Richie Cunningham:]

Thank you. I appreciate it, operator. And I'll just close by saying thanks for joining us this evening. Really appreciate your interest in Tyme. We believe we have the right team. Recently with 50-years of industry experience that we recently brought on board, at the right time and the right strategic plan moving forward. So we look forward to providing everyone update on that path as we move forward. And once again, we thank you for your time. And that's all. Thank you so much.

[Operator:]

This concludes today's conference call. Thank you for participating. You may now disconnect.