This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk03: Hello, and welcome to the Time 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. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. 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 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 times, 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 these contemplated by such forward-looking statements are discussed in the periodic report, Time Flies 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 Time. Mr. Cunningham, please proceed.
spk02: Thank you, operator, and welcome everyone to our presentation this evening. I'm Richie Cunningham, CEO of Time, 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 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 the NFL. I get 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 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 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 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 followed that same leadership team from Premier to a turnaround opportunity, which was Valiant Pharmaceuticals, now Bosch Health, where I led and built commercial teams in sales and marketing. From there, I was recruited to Beringer Ingelheim, where I had a great run, launching a couple blockbuster drugs in addition to the tyrosine kinase inhibitor by the name of GeoTriff. Now, after my time in a large pharmaceutical organization, I then ventured out to biotech, where I became the CEO of an early stage biotech company. While there, I made two acquisitions in my first two years, including a spin-out from Pfizer by the name of Icogen, and then later acquiring a Sanofi Genzyme R&D unit in rare disease. From those acquisitions, we built an early stage pipeline that led to multiple licensing deals with companies such as Roche, Sanofi, GSK, and others before exiting via a cell of the company. Following the cell of ICOGEN, I became aware of the opportunity at time. After my due diligence, I was very intrigued. Time, I believe, was a great fit. The SM88'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 six months, and I can share with you that my level of excitement for time 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 time a success. Those of you who know time, 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 Eckerd, and James Bill, our Chief Legal Officer. I also need to recognize the team who are not on this slide. 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 two recent team additions that we're pleased to have on board. and 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 Turno and then Frank Profito to introduce themselves. Jan?
spk01: Thank you. Good afternoon, good evening. My name is Dr. Jan Van Turno. 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 attending at Children's Hospital LA, University of Southern California, and as a physician scientist with an NIH-funded research program in genetic epi and neural network 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 Kip Evans. Subsequently, I joined Bristol-Myers Squibb in their late-stage development program and was part of the team that successfully filed the satinib 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, I 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-IGFR-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, a senior VP and head of oncology, to develop their cell-free DNA technique that they had optimized in 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 Time 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 Time 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 time has. I'm now going to pass the mic to Frank Porfido, Chief Financial Officer.
spk00: Thank you, Dan, and good afternoon to everyone. I'm Frank Porfido. I will be starting next week as the new CFO at Time. I have spent over 25 years at Novartis, specifically in our 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 URGEN 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 time 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.
spk02: Excellent. Thanks, John. 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 answer to questions several following questions that you'll see on this slide. What is Time'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 time. 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 sought 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 time, was the early dynamic results that we've seen with SM88. 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 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 SM88. Add to this, SM88 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, SM88 is backed by compelling early data that lends itself to multiple downstream opportunities. Next, we concluded having two 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 were 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 time and SM88, 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 SM88 profile, there is a potential to go after a multitude of indications. If we're able to do this, we need to be smart by how we do it. We need to be strategic and capital efficient. We believe one way to do that is by better understanding SM88's mechanism of action and identification of potential biomarkers that allow us the opportunity to select patients and have a greater probability of responding to SM88. We are rethinking the role of Time 19. The rapidly changing COVID landscape has changed the trajectory of Time 19 and how we strategically approach that opportunity. We'll talk about that in further detail. Now, given our recent capital raise, Time'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 forth. 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 five identified criteria. The strength of the data, the unmet need, task 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 2-3 study in second-line pancreatic cancer. OASIS is a Phase 2 breast cancer study in HR-positive HER2-negative patients designed to confirm the strong single-agent activity that was observed in the earlier studies. The Hope Stroud is a Phase 2 metastatic sarcoma study with two arms looking at Ewing sarcoma in one arm and all other sarcomas in the second arm. Preclinically, in oncology, we also have SM88 injectable. It's a preclinical program where oral SM88 therapy is not an option. In TIME18, this is an intratumoral, surgically injected bile acid that is believed to have anti-cancer activity. While developing TIME18 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 brought us this antiviral program called Time-19. We'll discuss that further in the coming slides as well. In addition to our preclinical and our clinical programs here, we'll have preclinical mechanism of action work and 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-positive and HER2-negative breast cancer patients who failed a CDK4-6 inhibitor as a priority setting for SM88. The second bullet here is a very important one, and we believe this represents a significant opportunity for SM88. 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 SM88. So when you look at breast cancer and HR positive, HER2 negative, 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 positive HER2 negative SEP type 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 SM88 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 SM88'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're looking for a well-tolerated oral option. This is very important to our strategy, as it fits the SM88 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 SM88's results in our first in human early studies. We had 25 breast cancer patients. Twelve were HR positive, HER2 negative. In this group, three were complete responses, two were partial responses, and four with stable disease. The key metric here that we're designing around is the overall response rate, where SM88 achieved 42 percent 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 it would provide us that SM88 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 multi-billion dollar opportunity where we observed positive results with SM88 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 observations during the review this year. As the company last year, greater than 90 percent of our clinical spend was in pancreatic cancer with two separate studies. When compared to the third line, the second line setting is clearly preferred for time and SM88. 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 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 and 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 SM88. Second line is a more viable commercial opportunity. There's a better way to utilize our capital and diversify rather than continued investment in two concurrent pancreatic studies with similar timelines. 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 Hope Sarcoma. This is an investor-initiated phase two trial design studying SM88. Based on the data from the earlier trials and KOL feedback, We determined sarcomas as a focus setting for us. It's a high unmet need, it's an orphan indication, a potential accelerated path to approval, and it fits SM88'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-tumoral activity and other clinical benefits that were observed. We're continuing to work on completing 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, it 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 SM88 might combine best with, ultimately offering alternative paths and better outcomes for patients. So, when we 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 SM88. 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 time 19 pre-clinically 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 Time 19. Time 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 Time 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 time 19. From a financial standpoint, time is well capitalized. And as we look to roll out a new clinical strategy here, we ended March 31st, 2021, the fiscal year end with 107 million in cash. We're communicating an expected cash burn for 2022 24 to 32 million. That leaves us with 75 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 at 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 readout down the road. And then the pancreatic cancer data update for part one 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 then precision promise, pancreatic cancer second line trial, the graduation decision from a phase two to a phase three 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 SM88, focus and discipline, investing wisely and strategically in a data-driven development approach. We're all funded to advance these programs. We ended the year with $107 million in cash. And we're both 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 SM88, 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 it to Q&A.
spk03: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Swayama Pakula Ramakhan from HC Wainwright. Your line is now open.
spk04: Thank you. Good afternoon, Richie. Thanks for giving a detailed plan for time. 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 that is expected to come out of these three studies over the next year and a half to two years?
spk02: Good question, R.K., 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 SM88. 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 it. 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 two, 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 us well. And for this point in time and where we're at, I think it's the right strategy.
spk04: Thanks. Regarding the second-line study and the third-line study for the pancreatic cancer that were on 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 two study making not only KOLs but also patients wait to understand the data from the phase two study before trying to think about a, I mean, sorry, second line study before thinking of trying to get this drug into a third line patient.
spk02: Yeah, I think RK, It's more than likely a minimal impact. I don't see it as a major impact. You know, that's my sense. I think, you know, these third-line patients, you know, in looking for, you know, alternative treatments in our second-line trial, I don't think it had a real significant impact is my response to that. Okay.
spk04: And then on the preclinical programs, you know, we know that the management had 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, of the company.
spk02: Yeah, absolutely. So, you know, we've, we've already started down that path. We were working with Mayo Clinic as, As we indicated in 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 to start to do the experiments with SM88 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 or so.
spk04: 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 licensing so that you can beef up the pipeline outside of these molecules that you currently have?
spk02: 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 SM88 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.
spk04: All right, thank you. Thanks for taking all my questions.
spk02: Thank you.
spk03: Thank you. We received pre-submitted questions. When did you determine the third-line trial didn't make sense to continue any longer? What factors was that decision based on?
spk02: So, as we spoke before, you know, 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, you know, when you analyze the cost benefit of continuing and further investing that was going to be required in accelerating, you know, 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, was and is the greatest rationale and support to provide the greatest opportunity for the organization. So again, diversification, but also ultimately the slow enrollment timing and the lack of accelerated path focused on second line was really the key output there.
spk03: Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. 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?
spk02: 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, you know, 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 SM888 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.
spk03: 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?
spk02: So what I can tell you is that we anticipate a quarterly burn over the next 12 months to be anywhere from 6 to 8 million. We have this spread in there and incorporate the wind down and 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.
spk03: Our next question is, How long do you anticipate the cash on hand will last before you need to raise money?
spk02: 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 into the key milestones that we expect that we've shared, and it gives us an ability to generate some of 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.
spk03: At this time, I'm showing no further questions. I would like to turn the call back over to Richie Cunningham for closing remarks.
spk02: Thank you. Appreciate it, operator. And I'll just close by saying thanks for joining us this evening. Really appreciate your interest and time. We believe we have the right team. We recently, you know, 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.
Disclaimer