Tyme Technologies Inc (TYME) 2020 Q4 法說會逐字稿

Good evening, and welcome to Tyme's Fourth Quarter and Fiscal Year 2020 Investor Conference Call. I'd like to remind you that this call is being recorded. I'd now like to turn the call over to Brian Gill, Corporate Communications and Investor Relations for Tyme.

Thanks, Daniel, and welcome, everyone, to our Fourth Quarter and Fiscal Year 2020 Investor Conference Call. The press release reporting our financial and operating results can be accessed by going to the Investor Relations section of Tyme's corporate website 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 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 to be filed 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.

Thank you, Brian. Good afternoon, and thanks for joining us today. In fiscal 2020, our fourth full year as a public company, Tyme delivered extraordinary results, culminating with the launch of our first pivotal trial that will evaluate SM-88 for patients with third-line pancreatic cancer. Our highest corporate priorities for 2020 were to present our growing body of clinical data at major international medical meetings, initiate pivotal studies in second- and third-line pancreatic cancer, expand clinical study programs into sarcomas, ensure capital resources that better position Tyme to carry out its pivotal trial, and advance planning for clinical trials in metastatic breast, prostate and hematological cancers as well as continue to develop preclinical and mechanism data studies. We anticipate multiple catalysts and drivers of value in fiscal year 2021, including the release of new preclinical SM-88 and TYME-18 data. We truly believe that our accomplishments demonstrate our leadership position in this emerging class of cancer metabolism based therapies.

I'd like to take a moment and discuss the effect of COVID-19 on Tyme and our ability to continue pursuit of our objectives. Tyme has developed techniques to allow its executives to maintain uninterrupted pursuit of responsibilities and duties as well as incorporated adaptations to continue group and committee endeavors. We have also inventoried sufficient clinical supplies like drug product to allow us to serve patients in our trials. It is important to note that our clinical trials have been minimally affected by the COVID crisis. This is in part because of the essential nature of treatment in third-line pancreatic cancer and sarcoma and because we offer an oral drug that can be taken remotely and doesn't require a hospital or infusion center for application. Additionally, SM-88 has shown a historically small amount of adverse events. Making patient management by the treating oncologists potentially easier.

Now I'd like to turn the call over to our leadership team to share with you in more detail their perspectives on fiscal 2020 and key value drivers expected in fiscal 2021. I'd like to turn it over to Michele Korfin.

Thank you, Steve. We are truly excited about the launch of our Tyme pivotal trial in pancreatic cancer using SM-88 and the launch of the Precision Promise study, which also has registration intent. And importantly, we are excited about the opportunity to bring the potential of SM-88 to patients with advanced pancreatic cancer where their therapeutic options are limited.

Before I move on to our regulatory focus, I wanted to provide a brief summary on key highlights that we will touch on today, covering Tyme, our science, clinical development and commercial opportunities. Fiscal 2020 represented our fourth full year as a public company, but Tyme has been a leader in the field of cancer metabolism for over a decade with experience studying cancer metabolism based therapies, or CMBTs, which are protected by a strong global patent portfolio of more than 190 patent applications granted and/or pending. Our patent portfolio broadly covers composition, methods, manufacturing and use patents extending beyond 2032. From a mechanism of action perspective, Tyme is pursuing a unique approach that exploits the extensively studied Warburg effect by developing first-in-class compounds that kill cancer cells through disrupting their cancer metabolism with multiple mechanisms of action. Tyme believes this unique approach can provide broad therapeutic efficacy without the unnecessary off-target toxicity that is found in today's current cancer treatment regimens. Dr. Jonathan Eckard will go into more detail on our encouraging new insights from our preclinical data.

We are equally excited about the progress we are making in moving our clinical trials forward with the ongoing enrollment of patients in our pivotal TYME-88-Panc Part II trial for third line pancreatic cancer. Panc's Phase II/III Precision Promise registration intent trial in second-line pancreatic cancer and in the HopES sarcoma Phase II trial for Ewing's and high-risk sarcomas. And importantly, in today's uncertain environment, we can't emphasize enough the benefits of delivering an oral cancer therapy to the market, an oral therapy with the potential advantages of SM-88 can be delivered to the patient's home, administered with a glass of water, and the patient can be potentially monitored by the doctor through existing telemedicine platforms.

Now let me turn the call over to Dr. Jonathan Eckard, our Chief Business Officer, for his preliminary analysis of preclinical data on SM-88 and TYME-18.

Thank you, Michele. We recently announced the acceptance of abstracts for SM-88 and another pipeline program, TYME-18, for poster presentation at the AACR's June virtual meeting. While additional results will be presented at the meeting, the abstract highlights some interesting information.

Regarding SM-88, SM-88 is a proprietary CMBT investigational compound that leverages the altered cancer metabolism to target various cancer functions and tumor processes. These may include disrupting immunoacid transport, protein production or survival processes like autophagy. There are also indications that SM-88 could have broader impacts, including altering the immune dynamics of the tumor microenvironment. This abstract is focused on cellular effects that single-agent SM-88, that's without the MPS components, had on in vitro and in vivo cancer models. One main observation reported was that SM-88 significantly reduced tumor size in mouse xenograft models compared to controls. Abstract also reported dose-dependent SM-88 increases of cellular reactive oxygen species in several cancer cell lines as well as alterations in cellular autophagy. Just for background, autophagy is the digestion and recycling of the cells own components, and it is an important mechanism employed by many cancers. Autophagy has had increased focus as a target in cancer therapy and is currently being studied in independent clinical trials. Additionally, the abstract outlines the potential impact SM-88 may have on immune alteration, specifically on the tumor-associated macrophages, or TAMs. These cells are a focus in current immuno-oncology research, and we look forward to presenting additional detail on these and other related immune findings during the upcoming AACR meeting. We are deepening our investigation of SM-88 effects in multiple cancer models, both internally and with our academic partners at NYU and Mayo Clinic. We aim to leverage the learning from these data to inform us on the optimal future development settings and combination paths with SM-88.

Moving to TYME-18. TYME-18 is another cancer metabolism based compounds designed for intratumoral delivery. TYME-18 is distinctive composition, but like SM-88, it aims to leverage susceptibilities of the cancer that are related to its altered metabolism. Solid tumors have a different physiological environments compared to normal tissue. Many of these differences stem from the alteration of the cancer cell metabolism. Whether it's the lower pH from an excess lactic acid resulting from glycolysis or other metabolic byproducts that build up around the tumor. TYME-18 is a combination of a proprietary surfactant with a specific steroid asset. This combination alters the permeability of the cancer cell membranes, increasing their susceptibility to the toxic byproducts they have produced. And the steroid asset is aimed to target metabolism pathways used by cancer cells. Importantly, a core goal in the creation of TYME-18 was to create a product that will be effective in the tumor microenvironment while minimizing detrimental impacts to normal tissue, local tissue or systemic toxicities. In the AACR abstract, we outlined encouraging initial preclinical results. These included in vivo xenograft mouse models, where 11 out of 12 mice treated with TYME-18 had complete responses of their tumors within 2 weeks. And this is compared to all 12 tumors in the control trade mice that continued to grow aggressively. And importantly, there was no reported local or systemic toxicities in the TYME-18 treated animals.

While intratumoral delivery represents a different market than oral SM-88, we believe the opportunity for a safe and effective intratumoral agent like TYME-18 could be substantial, not only in patients with tumors that may not be surgically resectable, but also in patients with tumors where radio oncology therapy could be considered high risk. We continue to conduct additional TYME-18 preclinical studies with a goal of identifying an IND-enabling path this year. And in parallel, we will work with our medical advisory board and external partners to identify potential initial treatment setting. And at this time, we will assess the most strategic path to advance TYME-18 program into the clinic. So we look forward to sharing more detailed preclinical data on both SM-88 and TYME-18 at the AACR virtual meeting in late June.

And now I'd like to turn the call back over to Michele to share with you our regulatory updates. Michele?

Thank you, John. Based on the encouraging clinical data presented at multiple medical meetings in fiscal year 2020, Tyme launched our own pivotal trial evaluating SM-88 as a potential therapy for patients with third-line pancreatic cancer. We received very helpful guidance from our esteemed Medical Advisory Board and from the FDA prior to initiating the trial. We had announced in January that the first patient was involved. It is important to note that we do not know the extent to which the COVID-19 pandemic will continue to spread and impact society. We have worked closely with all of our clinical trial sites, and all of our clinical trials are still actively enrolling. We are proud we were able to keep our trials active despite the challenging pandemic. We will continue to monitor the situation and evaluate the potential impact to our business.

Patients with third-line pancreatic cancer have limited options and a very poor prognosis. Expected survival for a third-line patient is only 2 to 2.5 months. There are over 10,000 patients in the U.S., actively seeking third-line treatment for pancreatic cancer. We have a great sense of urgency to advance SM-88 for patients who so need a treatment option. We continue to work closely with the clinical trial sites to address any potential challenges and ensure that clinical supplies and services are available to support the continuity of care of all enrolled patients. We do anticipate full enrollment of TYME-88-Panc Part II by the end of calendar year 2020 or early 2021, and we anticipate data could follow in 2021. This brings us one step closer to the potential commercialization of our lead CMBT candidate, SM-88.

Members of our team have broad experience and expertise in launching multiple disease altering cancer therapies into the U.S. market, including ABRAXANE for pancreatic cancer, and we are confident that we will be ready to commercialize SM-88 with successful completion of the trial.

The first part of the TYME-88-Panc study still has patients on study, and we expect to present the final data and publication and/or presentation in the second half of 2020. In addition, working in close partnership with the Pancreatic Cancer Action Network the Precision Promise study initiated and has enrolled the first patient. This trial is also designed with registration intent. SM-88 is the first experimental therapy in this adaptive design trial and will be studied in second-line pancreatic cancer patients as a monotherapy. For those of you who are not familiar with PanCAN, I encourage you to learn about this exceptional organization. It is the world's largest advocacy group focused on pancreatic cancer, and we are honored that SM-88 was chosen as the first therapy to be examined in its second-line trial. As you can see on the slide, the trial is being conducted at highly regarded institutions around the country. Sarcoma also represents a great unmet medical need and significant opportunity for all stakeholders. There are approximately 12,000 patients diagnosed each year without good treatment options. Ewing's sarcoma, one of our treatment arms, often afflicts teenagers and young adults. We are passionate about advancing SM-88 through our trial partnership with Dr. Chawla and the Joseph Ahmed Foundation. The trial is also actively enrolling. The primary end point is overall response rate so we would anticipate data becoming available starting in 2021. We are very fortunate to have the opportunity to develop a compound such as SM-88, which has already demonstrated clinical responses in 15 different cancer types across 4 separate studies, both solid tumors and hematologic malignancies. As a result, these data will help drive our decisions in expanding into large, growing markets that are addressing the needs of patients with advanced cancers where there are limited and ineffective treatment options. We will continue to make appropriate investments in our CMBT pipeline, including potentially expanding our clinical trials into prostate, breast cancer and/or hematology. We are encouraged by what we have accomplished and are very excited about the opportunities that lie ahead.

Now I will turn the call over to Dr. Giuseppe Del Priore, who will share his perspective on the clinical data that he has presented at multiple medical meetings this year and opportunities in fiscal year 2021 to continue to expand on our growing body of clinical data in the field of cancer metabolism based therapies.

Thank you, Michele. We have shared promising clinical data on our lead clinical candidate, SM-88, also known as racemetyrosine with key opinion leaders across multiple international events, including ASCO, ESMO, ASCO GI, ESMO GI and AACR pancreas. I will now review a few of the key highlights of TYME-88-Panc in our prostate cancer trial that have guarded the enthusiasm of leading oncologists on the world. I will also share with you a new look at our previous clinical data in metastatic breast cancer.

Let's start with our pancreas data. Important to emphasize is the nearly unprecedented poor prognosis of patients entered at the start of Part 1 of the TYME-88-Panc trial. This is evidenced by the permissive enrollment criteria that allowed actively progressing disease with no restrictions on tumor size, number of metastases or tumor locations and an ECOG performance status. Despite this, we were able to leverage the specificity predicted by the mechanism of action into a tolerable regimen even for these frail heavily pretreated patients.

On this slide, we recall last year, when we had a good fortune to share overall survival results for SM-88, our lead cancer metabolism-based compound. In the evaluable patient population from Part I of our TYME-88-Panc trial, the overall survival compared favorably to an analysis by Manax et al. of 19 prospective pancreas cancer trials where the purported survival was only 2 to 2.5 months in a similar patient population. The results led to our ongoing FDA guided third-line pivotal trial and continues to drive interest even now despite the added challenges of COVID.

This slide demonstrates important circulating tumor cell results. In Part I of the TYME-88-Panc, patients who had at least an 80% reduction in the circulating tumor cells trended towards a greater survival, with a 60% reduction in the risk of death. Overall, about half of patients achieved at least an 80% reduction in their circulating tumor cell burden. This is important since Tyme is playing a significant role in advancing the development of circulating tumor cells as a potential surrogate for overall survival in pancreas and prostate cancer.

Last year, in the TYME-88-Panc Part I study, we learned that our clinical benefit rate was 44% in evaluable patients, including stable disease and partial response. Furthermore, these patients also demonstrated a 92% reduction in the risk of death. Part I results matter because responses are rare or not observed at all in advanced pancreatic cancer. Our goal is to develop and deliver better and safer medicines to cancer patients with advanced disease. It is extremely important to deliver a therapy with a tolerable safety profile when working with frail extremely poor prognosis groups that typically are not able to receive any additional therapy.

Remarkably, we continue to observe and report impressive safety data for SM-88 across a variety of companies. In the TYME-88-Panc Part I study, SM-88 was well tolerated with only 4% of patients or 2 of 49, reported serious adverse events at least potentially related to therapy. In aggregate, SM-88 has demonstrated an entering safety profile across 15 different tumor types, including solid tumors and hematologic malignancies in 4 separate studies, representing approximately 180 patients. It is important to note that the TYME-88-Panc study part I is still ongoing, albeit now it's part II, a pivotal randomized controlled trial. We continue to follow-up part I patients and look forward to presenting and publishing the final data near the end of 2020.

On this slide, we move on to prostate cancer. In the setting of advanced prostate cancer, Tyme captured the attention of key thought leaders of major institutions when we shared our final Phase II data on patients being treated with SM-88 for recurrent prostate cancer. At 6 months, 100% of patients were free of metastatic progression and 87% of patients remained free of any radiographic progression. These data are important because SM-88 demonstrated meaningful clinical results without typical hormone-related sign effects. If confirmed in a randomized study, SM-88 could postpone the need for hormone therapy and change the current treatment paradigm for patients with biochemically recurrent prostate cancer. As we discussed earlier, Tyme is playing a leadership role in clinical development circulating tumor cells. In our Phase II Prostate study, improve in circulating tumor cell number was documented. Based on these findings, we are working with a leading institution and investigators in prostate cancer, including Memorial Sloan Kettering, University of California, San Francisco and the Albert Einstein College of Medicine. We continue to pursue opportunities for prospective trials to confirm SM-88 unique results, leveraging outside functions. Moreover, we understand that scientific and clinical data are the heartbeat of any biotech. As such, we intend to share the final data from our Phase II recurrent prostate cancer study in a peer-reviewed publication in the second half of this calendar year.

On this slide, we see a summary of our previously presented experience with SM-88 in breast cancer. It was the first human trial and our capacity use experience, we have gathered a sample of approximately 25 patients with metastatic breast cancer. These patients experienced the clinical benefit with a favorable safety profile. The overall response rate was 44%. There's no indication of resistance based on hormone receptor status, prior treatment or metastatic site. There are no unanticipated or drug-related adverse events. These clinical results are encouraging for patients with metastatic breast cancer and their health care providers who are looking for a new approach and potentially a better option. Based on these findings and strong support from key opinion leaders and their institutions, we are exploring opportunities for the development of SM-88 as a potential treatment for patients with advanced metastatic breast cancer.

Now let me turn the call over to Ben Taylor for his comments on our financial and operating results.

Thank you, Giuseppe. As of the fourth quarter ended March 31, 2020, we had approximately $26.7 million in cash and equivalents compared to $11.5 million in the third quarter. Our fourth quarter cash balance includes $20 million from the January strategic investment by Eagle Pharmaceuticals at $2 per share. Our operational cash burn rate for the fourth quarter of fiscal year 2020 was $5.9 million compared to $4.9 million (sic) [$4.5 million] for the previous quarter and $4.2 million for the quarter -- for the fourth quarter of fiscal 2019. The increase over the prior quarter was primarily attributable to timing of payments rather than a difference in operational activity. Operational cash burn for the full fiscal year 2020 was $19.6 million compared to $20.1 million in the prior year. The burn rate for both the most recent quarter and the year was generally consistent with our previous guidance and predominantly reflected costs associated with our ongoing clinical trials for SM-88. Based primarily on our active clinical trials, preparation for a potential SM-88 new drug application with the FDA and our preclinical activities, Tyme anticipates that its quarterly operational cash burn is expected to average approximately $7 million to $8 million per quarter for fiscal year 2021. As has generally been shown in previous quarters, we expect the actual net quarterly cash burn to be lower than the operational cash burn based on anticipated opportunities for cash inflows across multiple channels, including private, public and strategic markets to support our long-term goals and objectives. We believe that our cash and equivalents as of March 31, 2020, together with anticipated access to additional capital, is adequate to carry our pivotal trials in pancreatic cancer, our trials in sarcoma, advanced potential programs in breast and hematological cancers as well as continue our preclinical mechanistic studies. It is important to note that Tyme significantly increased its inventory of SM-88 and MPS components during the fourth quarter of fiscal 2020 to ensure supply chain continuity for our ongoing clinical studies during any uncertainty caused by the COVID pandemic. The company remains confident in its ability to continue to supply SM-88 for existing and potential future trials. Today, we also announced the conversion of all $8 million of our outstanding 2019 warrants. Further, all the warrant holders have agreed to a leak out agreement that restricts potential sales of shares associated with the warrants for 6 months and bans initiating any short sales during that period. A majority of the warrants are converting to common shares at a ratio of 0.4125:1. In other words, 5.8 million warrants to 2.4 million common shares. The remaining 2.2 million warrants are being exchanged for new warrants with $1.80 strike price and renews the price protection, anti-dilution and governance provisions from the previous warrants. For a more detailed review of the revised warrant agreements, please see the 8-K that was filed today after not to close.

At this time, I'll turn the call back over to Steve Hoffman for closing comments.

Thank you, Ben. Tyme can proudly say that we have met or exceeded all corporate goals for 2020, and our outstanding team plans to continue that performance goal through 2021 and beyond. For fiscal 2021, we have no higher priority than to successfully execute our TYME-18-Panc pivotal trial that is evaluating our lead cancer metabolism-based candidate, oral SM-88 as a potential treatment for patients with third-line pancreatic cancer. For those 10,000 patients with pancreatic cancer actively seeking third-line treatment, there are currently no FDA-approved therapies and no oncology guideline recommendations for active therapy. We believe we can fill that unmet need for pancreatic patients with a new approach that applies the latest advances in the field of cancer metabolism. By targeting the mechanisms of pancreatic cancer at its source, we hope to deliver significantly improved outcomes for patients. We are excited about the potential of SM-88 as a first-in-class therapy, and we're looking forward to the results of this promising new approach for patients in our pivotal study. As time -- at time, we aspire to play a leading role in advancing the field of cancer metabolism where we can serve as a valuable resource for health care providers, their patients and advocates or hope for and deserve better, safer medicines. We are prepared and ready to execute our strategy in fiscal year 2021 and to maximize our value proposition for all of our stakeholders.

Thank you for your interest and time. That concludes my prepared remarks. I would now like to turn the call over to the operator for a question-and-answer session.

(Operator Instructions) And our first question comes from Sean Lee with H.C. Wainwright.

My first question is on the ongoing impact from the COVID-19 pandemic. I know in the prepared remarks, you mentioned that so far, the clinical studies have been minimally affected. I was just wondering, does that refer to the Panc-88 study or for the precision Promise study as well? And how much visibility do you have into that study?

Sean, this is Michele Korfin. Thank you so much for joining us, and thank you for the question. So in regards to COVID-19, our prepared remarks were intended for all of the SM-88 ongoing clinical trials in terms of pancreatic cancer and sarcoma. I'll talk specifically about in TYME-88-Panc, which is our pivotal third line study. As Steve indicated in his prepared remarks, and I reiterated, we've fortunately have seen minimal impact. This is such a challenging pandemic but I will say for time, we had our 88 study up and running in most sites before the pandemic hit. We've seen minimal impact since the pandemic hit this is a situation where advanced pancreatic cancer is such a great unmet need. Our trial has stayed active throughout the pandemic. We also have the benefit of an oral therapy in the sense that the patient does not need to go to the treatment center for administration, and we're excited to continue to partner with our clinical trial sites, and if any future challenges do arise to continue to work with them to address the challenges.

Great. So I take it that patient enrollment is also going along as expected. You haven't seen any slowdown to that?

Yes. So thank you, Sean. We had previously guided that we anticipated full enrollment by the end of 2020. We did give a slight update today in terms of saying we anticipate full enrollment either by the end of 2020 or the beginning of 2021. But as Steve and I said in our prepared remarks, to date, the impact has been minimal in terms of the impact on enrollment.

Great. That's good to hear, and thank you for the additional color. My second question is on the prostate cancer program. So with the final data from the Phase II to be published later this year, does the company plan to advance the SM-88 into a pivotal study in prostate cancer as well?

Yes. So excellent question. Let me start, and then I'll ask Giuseppe if he would like to add anything on. So in terms of prostate, the key next milestone for us in prostate will be the publication of the manuscript from the Phase II study. The Phase II data had been presented by Giuseppe at ESMO, and if you note on the poster from ESMO, really some very well recognized thought leaders on prostate participated with Giuseppe on that final analysis. So we have continued to engage with thought leaders in terms of what the future potential might be for SM-88 in prostate. We have not to date initiated a registration study or discussed one, but as we indicated during our prepared remarks that it's an area that we may look to for further expansion. So let me turn now to Dr. Del Priore for any additional comments on prostate.

I think Michele was right on with the answers, and I will emphasize the enthusiasm that is reflected. So we look forward to that in the future.

Great. That was helpful. My last question is on the TYME-18. So with the AC -- sorry, AACR, also have a first look at how that molecule performs. I was wondering what would be the potential time line for advancing into the clinic.

Hello, Sean, this is Jonathan Eckard. So our goal right now is to do more preclinical work, identify precisely what would be needed to get to the clinic but before making an official decision on moving to the clinic, assess with both our internal and external partners and the advisers on exactly how to optimally develop such a drug where to optimally develop based on all the preclinical findings. And then, of course, strategically try to figure out the best way to finance the support to move that drug forward into the clinic. So as I said in my prepared remarks that over the course of the year, we will be certainly identifying all those all those steps. And at the right time, once we have some more clarity, we should be able to make some more announcements about what the next steps would be in advancing it into the -- towards the clinic.

And our next question comes from Kevin DeGeeter with Oppenheimer.

And John, thanks for the update with regard to the interesting work you've been doing on mechanism of action. Could you just maybe try to pull some of that work back full circle to pancreatic patients and help us better understand how that sort of informs your thought process on the activity in that patient population, which we've seen now empirically? And I think we've all been a little curious, I don't understand the mechanism.

Yes. Thank you very much, Kevin. So there's still there's going to be more data coming out at AACR, obviously, than what was in the abstract submitted in December. But one of the things that was highlighted in the prepared remarks was the effect of autophagy, which is a very important process in pancreatic cancer. Not only to survival but to a whole bunch of other aspects of how that cancer performs and survive in the patient. And so I think that each of the aspects of SM-88, and we've said it several times, and in this call as well, is that there seems to be multiple mechanisms of which our SM-88 appears to be working. And so we look forward to not only explaining what we found so far, but also digging deeper in. And again, this information will not only help us in understanding more about specifically in pancreas, but also other diseases where those biological processes are known to be important. So I guess the best answer would be please stay tuned to AACR. There's going to be a lot of interesting information to share there and certainly be able to probably dig in deeper to your question after that time.

Got it. And maybe just as a follow-up, and this may need to wait until after AACR. But if one looks at -- some of the other prior studies of compounds that purport to have a direct impact on autophagy, such as the hydroxychloroquine study that sort of read out mixed results in metastatic Panc. I mean, do you kind of have any thought processes on some of those prior data sets in terms of perhaps or the compounds not sort of optimal to test the hypothesis here that's consistent with the mechanism of other things that you think might help kind of inform why some of those prior experiences shouldn't necessarily be applicable to what we've seen, is promising activity with SM-88.

The only thing I'll say is that there are several aspects of autophagy and compounds like hydroxychloroquine and chloroquine impact it in certain ways. And so there are probably better ways or worse ways to impact autophagy. So those were drugs that were found to happen to do that. And so -- hence have been studied for. But there are other drugs that could alter it in different ways, such as the MEK inhibitors, for example. So I think that additional clarity about not only what the impacts of autophagy are, but how they come to pass and how they differ or similar to other approaches would be important. So again, I -- still early days for the study of autophagy. It still remains a focus of people because it's certainly known to be an important process for many different cancers. So again, more to be learned about not only ours but other approaches in targeting autophagy.

(Operator Instructions) I'm not showing any further questions at this time. I would now like to turn the call back over to Brian Gill for any closing remarks.

Thank you, Daniel. Our leadership team will be available after the call if there are any opportunities for follow up discussions. And I just wanted to let everybody know that fiscal 2021 prompts us to be another exciting year with multiple catalysts and milestones. We'll certainly keep you current on all of our developments, and we thank you again for your interest and support in Tyme.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.