Tyme Technologies Inc (TYME) 2021 Q4 法說會逐字稿

Hello, and welcome to the Tyme Technologies, Inc. Fiscal Year 2021 Financial Results and Business Update Conference Call. (Operator Instructions) 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 management's 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. As a result, you should not place undue reliance on any forward-looking statements.

Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports TYME files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully.

I would now like to turn the call over to Mr. Richie Cunningham, CEO of TYME. Mr. Cunningham, please proceed.

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 an undertaking, and it took several months to complete. My prior work experience, which spans across the life cycle 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 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 health care offered me a wonderful opportunity to do just that. When looking to transition from the NFL, I was fortunate to meet the CEO of Premier. As many of you know, Premier is one of the largest buying groups for health care providers. Mr. O'Leary at the time gave me my first opportunity, and I will always be grateful to him for sharing with me his 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 health care. I then follow that same leadership team from Premier to a turnaround opportunity, which was Valeant Pharmaceuticals, now Bausch Health, where I led and built commercial teams in sales and marketing. From there, I was recruited to Boehringer Ingelheim, where I had a great run launching a couple of blockbuster drugs in addition to the tyrosine kinase inhibitor by the name of Giotrif.

Now after my time in a large pharmaceutical organization, I then ventured out into biotech, where I became the CEO of an early-stage biotech company. While there, I made 2 acquisitions in my first 2 years, including a spinout from Pfizer by the name of Icagen and then later acquiring a Sanofi Genzyme R&D unit in rare disease. From those acquisitions, we've built an early-stage pipeline that led to multiple licensing deals with companies such as Roche, Sanofi, GSK and others before exiting via sale of the company.

Following the sale of Icagen, I became aware of the opportunity at TYME. After my due diligence, I was very intrigued. TYME, I believe, was a great fit. The SM-88's novel approach towards helping people without sacrifice, coupled with the initial data, in my view, was and is compelling. I've been here now for about 6 months, and I can share with you that my level of excitement for TYME and our future has only increased.

As you all know, a company is only as good as the people that comprise it. That was top of mind when I came on board. I'm fortunate to have the support of an accomplished team of individuals who have done it before in other organizations and know how to apply their experience towards making TYME a success.

Those of you who know TYME may be more familiar with the team on the left side of this slide. We have our Founder, Chairman and Chief Scientific Officer, Steve Hoffman; our Chief Business Officer, Dr. Jonathan Eckard; and James Biehl, our Chief Legal Officer. I also need to recognize the team who are not on this slide, and note that we have a very strong, committed and competent group that make up this company. I'm proud to be part of it.

I also want to take a minute to introduce the 2 recent team additions that we're pleased to have on board, and we will greatly benefit from the wealth of experience they each bring to us in their given fields.

At this time, I'll turn it over to Dr. Van Tornout and then Frank Porfido to introduce themselves. Jan?

Thank you. Good afternoon, and good evening. My name is Dr. Jan Van Tornout. I'm a pediatric hematologist, oncologist and genetic epidemiologist. I'm licensed as a physician both in the U.S. and Europe.

I start out my career as an attending at Children's Hospital L.A. University of Southern California and as a physician scientist with an NIH-funded research program in genetic epi and neural networks in pediatric cancer. Following my academic work, I joined Amgen as a safety officer in oncology and was part of a team that successfully filed an NDA for Kepivance.

Subsequently, I joined Bristol-Myers Squibb in their late-stage development program and was part of the team that successfully filed dasatinib in CML. Subsequently, I moved into the early-stage drug development as Senior Director at BMS, where I led several IND submissions of their pre-IND assets, as well as leading the team that brought elotuzumab, a monoclonal antibody against CS1, into BMS and led the early development phase of the compound that was later successfully approved in multiple myeloma.

I then joined Astellas Pharma as Executive Director, where I led the development of an anti-EGFR IR, a dual mTOR inhibitor and a FAC inhibitor. Subsequently, I moved to INOVIO as VP Clinical Development for Oncology, where I led several INDs and developed their DNA vaccine program in oncology. After INOVIO, I joined Natera as Senior VP and Head of Oncology, to develop their cell-free DNA technique that they had optimized in the neo --- the pre-neonatal space and apply it to oncology with the use of liquid biopsies in pre- and post-treatment diagnosis in oncology. I subsequently worked as a consultant, and I recently joined TYME after having been introduced by Richard Cunningham. And after having seen the very impressive first-in-human data and other elements in the pipeline, I accepted the position as acting CMO.

I'm very thrilled to join TYME at this time in their development. And I've been impressed by the experience of the management team as well as the opportunities that lay ahead of us to meet the unmet medical needs in patients with the assets that TYME has.

I'm now going to pass the mic to Frank Porfido, Chief Financial Officer.

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 Medicines 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 trial 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.

Now I'm going to turn it back to Richie.

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 answers to several following questions that you'll see on this slide.

What is TYME's drug development process? What's our product profile? And 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 process and 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.

So what were the key findings? What did we derive from the strategic review? First, SM-88 is backed by compelling early data that lends itself to multiple downstream opportunities. Next, we concluded having 2 separate pancreatic cancer trials in both second line and third line, that appear to be completing enrollment at the same time, was not optimal. And there are more efficient uses for capital. Therefore, for that reason, we decided to focus on second line and Precision Promise and wind down third line. More to discuss on the business rationale as to why we're doing this and what we see as the potential positive impact to that.

Another major decision was to diversify and reallocate third-line pancreatic cancer resources to pursue a breast cancer program. This is significant for TYME and SM-88, and one that we're incredibly excited about. We have high hopes. The potential, based on the data, the market dynamics, and it offers us an entry into a significantly large therapeutic category that we'll share with you.

Now with the broad activity observed in early preclinical programs -- early clinical programs and the SM-88 profile, there is a potential to go after a multitude of indications. If we're able to do this, we need to be smart about how we do it. We need to be strategic and capital efficient. We believe one way to do that is by better understanding SM-88's mechanism of action and identification of potential biomarkers that allow us the opportunity to select patients and have a greater probability -- that have a greater probability of responding to SM-88.

We are rethinking the role of TYME-19. The rapidly changing COVID landscape has changed the trajectory of TYME-19 and how we strategically approach that opportunity. We'll talk about that in further detail.

Now given our recent capital raise, TYME's capital position is in the strongest position it's ever been, and it's giving us significant runway to execute on the development goals that we put forth, and that we will be putting forward. We're building the right team that is critical to our success. And as you've just heard, we didn't wait around to act on this finding. With the addition of Jan and Frank, we have rounded out a very strong and experienced leadership team.

Now this particular slide, indication selection for a deep dive analysis, is a graphical depiction of the whittling down and filtering process we went through to determine our development path forward. Now this was a very extensive process, and it was a data-driven decision process focused on these 5 identified criteria: the strength of the data, the unmet need, path to validation, market opportunity and competitive landscape. Our clinical lead programs from the review that came out of this are pancreatic cancer second line, breast cancer that we'll discuss further as well as sarcomas.

The clinical path forward, although we concluded we have multiple avenues to pursue, we determined that the need to prioritize these opportunities, the ones that gave us the best opportunity for commercialization attributes in the shortest period of time, were the ones that we went with. There's a balance to this.

Now here's our view on the current primary areas of clinical focus. In the coming slides, we'll address each category in more detail.

Precision Promise is a Phase II/III study in second-line pancreatic cancer. OASIS is a Phase II breast cancer study in HR+/HER2- patients designed to confirm the strong single agent activity that was observed in the earlier studies. The HoPES trial is a Phase II metastatic sarcoma study with 2 arms looking at unisarcoma in one arm and all other sarcomas in the second arm.

Preclinically, in oncology, we also have SM-88 injectable. It's a preclinical program where our oral SM-88 therapy is not an option. In TYME-18, this is an intratumoral select surgically injected bile acid that is believed to have anticancer activity. While developing TYME-18 and researching bile acids, Steve Hoffman identified a bile acid that he believed had the potential for antiviral activity and was identified as a potential treatment for COVID-19. And this was brought -- this brought us this viral antiviral program called TYME-19. We'll discuss that further in the coming slides as well.

In addition to our preclinical and our clinical programs here, we have preclinical mechanism of action work in biomarker initiatives that we'll be doing to support the current and future development path.

So the OASIS breast cancer program, both early data and key opinion leader feedback strongly supported HR+/HER2- breast cancer patients who failed a CDK4/6 inhibitor as a priority setting for SM-88. The second bullet here is a very important one, and we believe this represents a significant opportunity for SM-88. The CDK4/6 class has been successful. And due to that success, it's migrating up the treatment paradigm, and it's leaving a significant gap to be filled before patients go on to chemotherapy. Lastly, we're looking to confirm strong data that we've seen in early trials, which will be a significant signal and validation for SM-88.

So when you look at breast cancer and HR+/HER2- and the opportunity that we're pursuing, we all know breast cancer is a large market. In particular, the category that we're pursuing with HR+/HER2- subtype represents 73% of those diagnosed. As such, we're looking to target the failing of the CDK4/6 inhibitors that are there. The bottom line is this is a significant market opportunity for SM-88 if successful.

I want to take the time to now talk a little bit about the landscape. Great market opportunity, significant unmet need and an area where SM-88's early clinical results were impressive. Our understanding is that these breast cancer patients, they're wanting to exhaust all alternatives before going on to chemotherapy. They are looking for a well-tolerated oral option. This is very important to our strategy as it fits the SM-88 oral and safety profile with low toxicities.

Now you'll notice on this slide, we have the chemotherapy path towards the bottom of the treatment paradigm in red. With the CDK4/6 class highlighted in blue moving up to first line, it leaves behind a treatment gap for better tolerated oral treatment options for us after CDK4/6 failure and before chemotherapy.

Now if I can get your attention to the upper right-hand chart, this was SM-88's results in our first-in-human early studies. We had 25 breast cancer patients, 12 were HR+/HER2-. In this group, 3 were complete responses, 2 were partial responses and 4 with stable disease. The key metric here that we're designing around is the overall response rate where SM-88 achieved 42% in these early trials. Now that being said, success in this trial is measured by beating mTOR plus aromatase inhibitors that had an overall response rate at 10%. And as we achieve greater results moving upwards towards the 19.5% observed by the CDK4/6 inhibitors as a single agent, the greater confidence that will provide us that SM-88 in this setting has real potential.

Now we're focusing once again on going after the failure of CDK4/6s. When you look at this in totality, this is why we're excited about this setting. Following the original development path of the CDK4/6 class, a multibillion-dollar opportunity where we observed positive results with SM-88 and our early first-in-human studies.

So let's shift gears to pancreatic cancer. I want to first be clear, pancreatic cancer is a high priority indication for us. A couple of observations during the review to share. As a company last year, greater than 90% of our clinical spend was in pancreatic cancer with 2 separate studies. When compared to the third line, the second line setting is clearly preferred for TYME and SM-88. It gives us greater cost benefit in ROI. The third line setting brings with it a much smaller opportunity with a somewhat similar investment cost over time.

Now with that being said, the initial position the company had was third line could be a faster path to approval. However, as we did our initial assessment, that didn't appear to be the case any longer. This was due to a couple of factors. First, the delay in enrollment impacted by the pandemic. And second, the fact that there is a limited number of patients in the third-line setting. Ultimately, the enrollment in timing with second and third line were lining up to be the same, and highlighted the real need to prioritize.

So knowing the importance of making such a decision, we took a deeper dive. And we discovered there was a high dropout rate where patients were randomized into the chemotherapy arm, and they were dropping out. It didn't appear they wanted to go back on the chemotherapy treatment. This also had an impact on our timing and recruitment of the study.

The conclusions, as a whole, treatment of patients earlier in second line offers the best opportunity for patients and SM-88. Second line is a more viable commercial opportunity. There's a better way to utilize our capital and diversify rather than continued investment in 2 concurrent pancreatic studies with similar time lines. The cost benefit didn't support continuing third line. Therefore, focus on second line pancreatic cancer with Precision Promise, that's our primary objective.

We ultimately determined it was best to also take and redirect these resources from third-line setting to both the second-line Precision Promise and the OASIS breast cancer trial. By doing this, we believe we offer our investors a portfolio with a significantly greater addressable market opportunity and greater diversification with no real meaningful uptick in spend, which ultimately provides a greater potential ROI.

So let's talk about HoPES sarcoma. This is an investor-initiated Phase II trial design studying SM-88. Based on the data from the earlier trials and KOL feedback, we determined sarcomas as a focused setting for us. It's a high unmet need, it's an orphan indication, a potential accelerated path to approval and it fits SM-88's profile, whereby safety and quality of life are priorities in this later setting.

We recently published interim data at ASCO. The abstracts highlighted durable duration of therapy in heavily pretreated patients. There were several cases of anti-tumor activity and other clinical benefits that were observed. We're continuing to work and complete enrollment. We're looking to allow that data to mature and assess the potential pathways for advancement. We also will be looking to apply some of the future learnings that we have in doing the biomarker initiative and the potential future value of how do we drive and develop these products moving forward, specifically around metastatic sarcomas.

So the use of biomarkers in MOA work, or mechanism of action. The use of biomarkers provides the path to personalized medicine. Having a specific treatment that fits a certain genetic marker of disease, this approach has become more and more common amongst drug developers and drug development strategies for its potential to increase the probability of success in the clinic. Ultimately, this is about working smarter. Understanding how a drug might respond best in a certain patient type that can have significant benefits for all. Increasing the probability of success, doing this by selecting patients that have a better probability of responding to a particular drug, knowing this earlier in the clinical development and has the potential to improve regulatory success and save development time and money. And also by doing this biomarker and MOA work, it allows us to identify what SM-88 might combine best with, ultimately offering alternative paths and better outcomes for patients.

So let me go back to the earlier discussion on broad activity and potential of multiple indications. We believe using biomarkers provides the most efficient approach to tap into the potential of SM-88. In a paradigm -- excuse me, in the diagram here, you can also see the partnerships that we have developed with credible leaders in the space to execute on our strategy. We haven't waited here. We've already begun this process.

So let's move now to COVID-19 and the landscape and what's happening. We are continuing to advance TYME-19 preclinically as we evaluate the COVID landscape and determine the best path. But it's important to note, this is a rapidly evolving space with the increase and success in the vaccinations, which we're all fortunate of, you add to that the therapeutic pipeline that is now getting even more crowded, and you add to it the challenges that come with the recruitment for those trials due to the number of patients available because of the success of the vaccines, this is a landscape that we need to be cautious about. We just need to make sure that we're navigating these challenges appropriately, and we're doing just that.

Let's talk about TYME-19. TYME-19 is an oral synthetically produced member of the bile acid family being developed for COVID-19. It's intriguing to us because we believe TYME-19's mechanism could be agnostic to the strain of coronavirus, therefore, potentially providing options for future preparedness for the next pandemic. So we will continue the preclinical advancement to understand its true potential. In addition, we'll also, as we generate the appropriate data, consider appropriate and alternative strategies and partnership opportunities. So more to come on TYME-19.

From a financial standpoint, TYME is well capitalized. And as we look to roll out a new clinical strategy here, we ended March 31, 2021, the fiscal year-end, with $107 million in cash. We're communicating an expected cash burn for 2022, $24 million to $32 million. That leaves us with $75 million to $83 million at the end of the fiscal year. We feel like we're positioned well.

The capital and the cash on hand and the focus of some of the key expected upcoming milestones that we'll talk about now and positions us to get there. First, I'll just communicate the OASIS breast trial. We're looking to get the first patient enrolled in the third quarter of 2021, so we're on our way to do that. That's an important milestone for us and for our company into breast cancer.

The sarcoma trial enrollment, we're looking to complete that by the first half of 2022. And we'll have a chance to see the data mature and further read out down the road. And then pancreatic cancer data update for Part 1 in the first half of 2022. We want to make sure that we're publishing that data. And then the preclinical biomarker initiative data by the second half of 2022.

And in Precision Promise, pancreatic cancer second-line trial, the graduation decision from a Phase II to a Phase III trial by the second half of 2022 or earlier. And then lastly, the OASIS breast cancer trial update that we have targeted for first half of 2023. These are the key milestones that we'll be looking towards, and we're excited about the path to see those come to fruition.

So closing remarks. We believe we've got a robust pipeline with multiple shots on goal. A solid plan that includes building a strong foundation and understanding of the potential of SM-88, focus and discipline, investing wisely and strategically in a data-driven development approach. We're well funded to advance these programs. We ended the year with $107 million in cash. And we've built an experienced management team with a proven track record that's ready and excited about the path to move forward.

Now I just want to share with you, because of the unique profile of SM-88 including the favorable tolerability that we see with it, we believe we're delivering scientific solutions without compromise, developing a novel therapeutic treatment that's dedicated to a better quality of life for all patients.

Now with that being said, I'd like to move into Q&A.

(Operator Instructions) Our first question comes from the line of Swayampakula Ramakanth from H.C. Wainwright.

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 3 studies over the next 1.5 years to 2 years?

No, 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. And that was the reason why we did that.

And it just so happens, PanCAN and the way that trial was designed with the PanCAN network is another trial that we believe in, and it's a Phase II/III 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 us well. And for this point in time and where we're at, I think it's the right strategy.

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

Yes. 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 and looking for alternative treatments -- and our second line trial, I don't think it had a real significant impact is my response to that.

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

Yes, 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're 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 we expect to have a better understanding in the next, I would say, 12 months, RK.

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?

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.

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?

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 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 in 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, thought 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 Instructions) 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?

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.

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?

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.

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

So based on the current strategy and plan, we expect to have at least a 3-plus year cash runway. This enables us to get through in 2 of 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.

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

Thank you. 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, it's the right time and the right strategic plan moving forward. So we look forward to providing everyone updates on that path as we move forward. And once again, we thank you for your time. And that's all. Thank you so much.

This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.