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spk04: Good day, and thank you for standing by. Welcome to the TALIS Biomedical Business Update. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Emily Fawcett, Senior Vice President, Corporate Communications and Investor Relations. Please go ahead.
spk01: Good afternoon and thank you. Joining me today are Rob Kelly, our Chief Executive Officer, and Becky Markovich, our newly appointed Interim Chief Financial Officer. Earlier today, the company released a business update and financial results for the quarter ended March 31st, 2023. A copy of that press release can be accessed on the investor page of our website at talusbio.com. Before we get started, I would like to remind you that management will make remarks during this call that are forward-looking statements within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward Looking Statements in the press release TALISbio issued today. For a more complete list and description, please see the company's filings with the SEC, including the Risk Factors section of the company's annual report on Form 10-K, filed on March 22, 2023, as may be supplemented from time to time in its other filings. Except as required by law, TALIS-Bio disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast on May 11th, 2023. With that, I would like to turn the call over to Rob.
spk03: Thanks, Emily. Good afternoon, everyone, and thank you for joining us. During today's call, I will provide an update on the notable progress we have made to advance our business in women's and sexual health, including the tests we are prioritizing for development and our regulatory strategy to bring them to market as quickly as possible. Becky will then review our financial results for the first quarter of 2023. Let me begin by reminding everyone of our mission. Thales Bio is dedicated to advancing health equity and outcomes by delivering accurate infectious disease testing in the moment of need at the point of care. We are currently executing a focused plan to deliver the objectives of this mission. The significant opportunity in the women's and sexual health markets is growing and bolstered by industry tailwinds. The incidence of sexually transmitted infections, including chlamydia and gyneorrhea, continues to rise. According to new data released by the CDC in April, both increased by nearly 4% between 2020 and 2021 due in part to lack of testing. To address this major health challenge, the CDC is encouraging better availability of STI testing across more organizations and settings. Their call to action reinforces a critical need for rapid testing of these infections to enable timely patient treatment management, and prevention. In addition, the American Congress of Obstetricians and Gynecologists recommends annual screening for chlamydia and gyneorrhea in all sexually active women age 25 and younger. Despite this, recent research shows that only 56% of these sexually active females have been screened for chlamydia, further demonstrating this significant unmet need. With testing traditionally conducted by central labs, there is a great opportunity to move testing to OBGYN offices and potentially other sexual health testing centers, including urgent care clinics or primary care facilities. Today, patients are becoming more engaged consumers, expecting convenient and immediate diagnoses and treatments. With turnaround time for centralized lab tests taking up to five days, physicians' practices are looking for more efficient solutions that could also redirect reimbursement from central labs to their own practices. Providers are eager to test at the point of care where treatment can be immediately prescribed or ruled out and are increasingly comfortable with molecular point of care testing due in part to the recent pandemic. While the benefits of testing at the point of care are clear, the market has yet to decentralize. We believe this is because currently few, if any, point of care systems sufficiently meet the needs of providers due to limitations around test performance, turnaround time, workflows, clinical utility, and economic rationale. The capability to address all of these requirements with one solution is critical to win this market. We estimate the immediate addressable market opportunity for Talus Bio in the women's and sexual health markets is approximately $3 billion in the United States alone. based on the point of care conversion opportunity for the initial menu of tests we are developing. Demand for these tests in these markets is large and growing, and it is our goal to expand this total addressable market as we broaden our test menu. We believe the TALIS I system is strongly positioned to address the current limitations around point of care testing with its high accuracy, rapid turnaround, ease of use, flexible cartridge design for multiplexing, and low manufacturing costs. Specifically, we believe TALIS-1 is differentiated by the robust nature of our sample preparation, which includes nucleic acid extraction and purification to enable rapid detection of infectious pathogens in a variety of unpurified patient sample types. This automated on-cartridge sample preparation paired with our isothermal amplification technique and multiple reaction chambers is critical and delivers high sensitivity and specificity for a wide range of pathogens in less than 30 minutes. We believe the unique combination of these capabilities on the TALIS I system is an important competitive advantage of our planned test menu. The women's and sexual health untapped markets are primed for decentralized testing in our differentiated TALIS I system. We have validated this belief through extensive customer surveys that revealed strong interest in our platform, with approximately 84% of respondents indicating that they would adopt TALIS I for in-office STI and vaginal testing. Further, approximately 40% of the respondents indicated that they would also leverage the platform to offer point of care respiratory testing for women in the course of their care. To capture this significant opportunity ahead, our business strategy is focused on three key activities to drive profitable growth and build a foundation for long-term success. First, continue to increase the flexibility of our manufacturing capabilities to support the development of commercialization of the TALIS I system that puts us on a path to meaningful margins in the future. Second, complete development and regulatory submissions for a targeted menu of tests to address the needs of the women's and sexual health markets within the US. And finally, pursue commercialization of multiple tests on the TALIS I platform. Now, I'd like to walk you through the progress we have made against our strategic investments in each of these areas. We are pleased to report that we have demonstrated our ability to manufacture cartridges and instruments with high throughput lines at the pace and the quality needed today and with what we believe will be attractive margins at scale. To support this, we have established three tiers of cartridge manufacturing capabilities consisting of a manual line at our Redwood City, California facility with the capacity to produce 300 cartridges per day to support our research and development efforts. a semi-automated line at our Chicago facility with the capacity to produce 2,000 cartridges per day to support clinical studies and early commercialization, and three fully automated lines operated at our contract manufacturing facility that will enable the production of 40,000 cartridges per day at full commercial scale. With respect to instruments, we have built several hundred to date and have invested in and received raw materials to build thousands more. We have consistently passed lots through our quality control protocols, and this level of quality has also been demonstrated through investigational use only studies. Looking ahead, our team is now working on driving further operational efficiencies and cost reductions, including restructuring relationships with contract manufacturing partners. We are laser focused on refining our production capabilities to lower manufacturing costs and are tracking toward expanded margins at scale. Ultimately, what we previously saw as one of our greatest challenges, we now believe we have transformed into one of our greatest strengths. With confidence in our manufacturing capabilities established, we are moving forward with a targeted menu and disciplined regulatory strategy that we believe minimizes risk and accelerates time to commercial launch. We have created a deliberate plan for commercialization by prioritizing the development of four test panels consisting of a respiratory panel for influenza A, influenza B, and COVID-19, or a fluid panel. chlamydia, gonorrhea, and trichomonas vaginalis, or CTNG-TV, herpes simplex virus, or HSV1 and 2, and a vaginal infection panel. In order to bring these tests to market as soon as possible, we are leveraging progress made to date with our COVID-19 test in pursuit of a 510K clearance of the TALIS-1 system. Knowing OBGYNs are interested in offering respiratory testing, we plan to pursue full 510K 10 clearance, 510 clearance of our fluid panel to create initial demand and experience with our target market while we finalize development of our CT and GTV test. We then aim to drive robust commercial adoption with testing for CT and GTV in asymptomatic and symptomatic patients. To grow market share further or with further differentiation, we are targeting the development of a test for HSV1 and 2 and a vaginal infection panel. On the regulatory front, our team is initiating a clinical study to support our COVID-19 510 submission and has completed pre-submissions for our respiratory and CT and GTV test panels. Additionally, we are pleased to have received feedback from the FDA and are solidifying timelines for executing clinical studies based upon this feedback. Longer term, we plan to develop additional tests such as group B strep and urinary tract infection that we believe will address the most critical infectious disease testing needs in women's and sexual health. By focusing on a menu of high-value tests tailored to the needs of OBGYNs, we believe we can successfully establish Talus Bio as a trusted name in this large market. In summary, with the strategic investments and progress we have made, we now have a differentiated, high-performing diagnostic platform at the point of care, a demonstrated ability to manufacture at scale, flexibility to drive our business strategy, and a pathway to attractive margins, an established, strong commercial infrastructure to be well positioned for launch, a refocused product roadmap targeting the women's and sexual health markets, and a highly efficient and experienced organization. Importantly, to execute our mission, we have streamlined our resources and reduced monthly cash burn to targeted levels, which we believe will extend our cash runway of $113 million into 2025 as of the first quarter of 2023. With that, I'll turn the call over to Becky to walk through the progress we're making against long-term financial objectives and our first quarter results.
spk00: Thanks, Rob. I'm pleased to participate in my first earnings call as interim CFO of Talus Bio. I had the pleasure of joining the company as the controller over a year ago and was attracted to the business because of its compelling mission, large growth opportunity, and talented team. In this new role, I look forward to further increasing our financial discipline as we continue to drive our business strategy and deliver on our objectives. During the first quarter, CalisBio made significant strides towards achieving its long-term financial objectives. First, we entered into a license agreement and terminated our supply agreement with one of our contract manufacturers that puts us on a path to deliver attractive margins at scale. Second, we reduced our facilities footprint in Redwood City, California by two-thirds. Importantly, due to our cash conservation efforts, we delivered a 62% improvement in net cash use and operating activities year over year, and have achieved the goal we set in August to bring our monthly recurring burn rate down to between $4 and $5 million. Turning now to our first quarter financial results. We recognized $1 million in revenue during the first quarter, which was driven mostly by NIH grant income. First quarter total operating expenses were $20 million compared to $36 million in the same period last year. Research and development spending for the first quarter of 2023 was $14 million, compared to $20 million in the same period of 2022. These decreases were driven primarily by raw card inventory investments in 2022, as well as lower headcount costs from our spending reduction program. Included in the first quarter were $3 million of non-recurring expenses to obtain a license for patents and cartridge raw materials in connection with the termination of a supply agreement with one of our contract manufacturers. This is a significant step toward our financial goal of achieving meaningful margins at scale. Selling general and administrative expenses in the first quarter was $6 million compared to $12 million in the first quarter of 2022, primarily due to lower headcount costs. Unrestricted cash and cash equivalents as of March 31st, 2023 were $113 million. In the first quarter, We have $16 million in cash compared to $44 million in the same period of 2022. We have a strong balance sheet with no debt, and we continue to focus on conservative cash management. Our objective is to ensure that our current cash reserves are sufficient to fund operations into 2025. I'll now turn the call back over to Rob for closing remarks.
spk03: Thank you, Becky. With a clearly defined product menu and disciplined regulatory strategy, Thales Bio is executing a plan to deliver multiple women's and sexual health test panels at the point of care where treatment can be immediately prescribed or ruled out. I'm confident in our ability to unlock these large and untapped markets because of the progress the team has made in the following. Establishing a highly differentiated platform that can address the limitations of current testing modalities. Demonstrating the ability to manufacture with the flexibility and stability to address all stages of our business and a path to attractive margins at scale. And lastly, leveraging previous strategic investments and reducing costs to preserve capital. With these achievements, cash runway that takes us into 2025, and our experienced team, we believe that Thales Bio is uniquely positioned to decentralize women's and sexual health testing. With that, I'll now turn it over to the operator to open it up for questions.
spk04: Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. And to withdraw your question, just press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Rachel from JP Morgan. Your line is open.
spk05: Hi, guys. This is Casey Woodring on for Rachel. Thanks for taking our questions. So I want to start with the thought process around the shift back in priority to the respiratory panel. So I think the last update you gave, you were pivoting towards exclusively focusing on the women's health market. Now it seems from your comments and from the deck that you're shifting back towards trying to commercialize the respiratory panel first. I guess, can you talk towards, you know, sort of why the pivot back and then, you know, just what those OBGYN customers that were interested in doing respiratory testing, you know, what they were kind of telling you and if they had been doing that sort of testing before or is this kind of new greenfield?
spk03: Yeah. Hey, Casey. Thanks for the question. So, yes, we have done extensive market research and we found a number of interesting points. Obviously, first of all, was what menu they'd like to see, and that's the menu that we're putting together here with this regulatory strategy. But also, the interest in respiratory panel. Almost 40% of the people that we queried mentioned that they would be interested in running a respiratory panel on the TALIS I system if they had it. The rationale was that because they are oftentimes treating their patients when they see them, as a internal medicine doctor as well as OBGYN, that their patients were asking for this type of thing, especially when they're symptomatic. And so it doesn't surprise me that if they had the opportunity to provide direct patient care, potentially prescribe something for their patient for a respiratory illness, and get a share of the reimbursement by doing so, it seems like a pretty good value proposition for them. So that's the first piece. The second piece is, The pivot back to COVID alone was not necessarily the idea. The first part of our plan is to leverage all of the investments that we've already made and to get our 510 of our instrument as quickly as possible. And the best way to do that was to utilize a panel that we had already developed, already brought through an EUA and understood that it was really well-designed. So we're leveraging that right now to get that respiratory panel clinical studies started, I'm sorry, the COVID-19 clinical studies started for the 510K on our instrument as soon as possible. And that's the first foundational piece of our regulatory strategy. Shortly thereafter, we would leverage the work we also did on COVID flu and flu AB. And so that would be the respiratory panel. And again, it's a de-risking strategy for us to get to market. The CTNG-TV assay is a much more complicated study. And therefore, we think the combination of these three gets us the most value in the shortest period of time. And we think this strategy is actually going to align very nicely with when we'd like to get these onto market.
spk05: Got it. That's helpful. Wanted to touch on the feedback you got from the FDA on the pre-submissions for 510K. Can you just elaborate on what, you know, the feedback was? Was it positive, negative? I think going back probably years ago now, there was feedback on the comparator assay that kind of held up the EUA process. So, can you just kind of touch on, you know, what you've been hearing from the FDA so far?
spk03: Well, I can't talk about it in too much detail. What I can say is we did file presubs and get feedback on both the respiratory panel and CT and GTV. In many cases, we proposed what we would like to do, and they gave us feedback on whether or not they supported that or not. And so it was very helpful feedback, and we've incorporated that into our plans. And as we're finalizing those plans and getting our timetables aligned for both of these products to begin clinical studies, it has been very helpful, and I'm happy that we did it. Got it.
spk05: Wanted to touch on the manufacturing scale-up that you noted in the prepared remarks. You know, the investment in automation to scale up to 40,000 cartridges a day capacity. You know, just kind of walk me through why that's the right number and, you know, why wouldn't you kind of start with the semi-automated line and then sort of scale up as you grow?
spk03: Casey, that is a really good question. As you probably remembered, we began our manufacturing scale-up sort of right at the peak of COVID. Our goal was to get a COVID EUA approval and then take the product to market as quickly as possible to help address the pandemic. The volumes that they were talking about back then wouldn't have even been accessible with that much volume. There was no way we could have met the needs of the market even with 440 000 tests per day but that is something that we have invested in and we've been working on and making sure that we can operate it effectively when we need to but we did realize with the same conclusion you just came to that as we pivoted back to the women's health market that we don't need that volume that amount of volume out of the gates and so what we've done is staged our manufacturing lines to accommodate different aspects of the business. The first aspect of the business is R&D. We need to make cartridges for them, and we need to make different types of cartridges for them throughout the day to meet the needs of the studies that they're doing. So we developed a manual line in Redwood Shores to do that, and that has been extremely helpful for us to keep on time and track with the needs of R&D. Now, if you start thinking about clinical studies, that's a higher request for higher volume for the cartridges on a regular basis. And so we took a lot of the learnings from the large automated lines and built one, designed one, and built one that's scaled down that we now have here in Chicago. And it's an amazing system. It's semi-automated, and it can do up to 2,000 cards per day on a single shift. That will be significant and more than sufficient for both clinical trials and even early commercialization and IEO studies and things along those lines. So for the foreseeable future, we're going to be manufacturing our cartridges ourselves until we get to the kind of scale that we would need to turn on the fully automated lines. But the good news is we've already invested in them. They're ready to go. And I think it's a leg up we have on other technologies. startup companies in the market who are going to, it's going to take a long time to do what we've done. And we've, we can, we lived through it, but it was difficult. And then one other piece too, just to make sure that it's clear. So we still, while we were scaling up for the high throughput manufacturing, we ordered parts for close to 5,000 instruments. And we also have, I think, a million raw cards. So From a supply chain perspective, we're in really good shape that when we want to turn the knob and start cranking out a lot of these cards and instruments, we're in a really good position to do it.
spk05: Got it. $113 million in cash right now, runway into 2025. Can you give us a sense on what your quarterly cash burn will look like for this upcoming year? And then where is most of that near-term spend going?
spk00: Thanks for the question, Casey. So as we mentioned last August, our target is to maintain our average monthly cash burn rate to $4 to $5 million. So that would be about $12 to $15 million per quarter. And that's what we're looking at going forward. And we are achieving that currently as well. And most of it we are spending on R&D activities. That's kind of the focus of where we are right now.
spk05: Got it. That's it for me.
spk04: Thank you. Thanks, Casey. Thanks, Casey. One moment for our next question. Our next question will come from the line of Mark Massaro from BTIG. Your line is open.
spk02: Hey, guys. Thank you for the questions. Great to hear from you again. My first one is around CTNG trick. You know, Rob, I think I heard you indicate that it's a relatively or somewhat complex study. I'd be curious if you could elaborate if you're planning to go after both women as well as male samples and maybe discuss some of the
spk03: Both the opportunities as well as some of the challenges with respect to the complexity of the trial Sure, so obviously our focus is on the women's and sexual health Market and therefore Vaginal swab is sort of the gold standard. So that's something that we're absolutely going to be focused on As we continue to solicit feedback You know, obviously we could make some decisions to add additional sample types and we are kicking around that option right now and But it has a great impact on the duration of the study and the complexity of the study and the cost of the study for that reason, too. And so on top of the sample type complexity, we also have prevalence. If you're looking at NG, for example, the prevalence is about 3%. And that's, you know, obviously a lot of samples to collect to find your positives. And we will need a lot of positives. And then on top of that, we're testing asymptomatic patients. which will be even more difficult for us to identify positives than you would normally see in a symptomatic patient. And then lastly, the algorithm that we have to use for this type of study is called a composite comparator algorithm, which makes it even more difficult to evaluate samples. I think you have to have three comparator systems as opposed to just one or two like you would have with a respiratory study. And so all these things layered on top of each other just make an STI study significantly longer than it would be for a respiratory study.
spk02: Yep, that makes sense. Do you have an idea for the clinical trial size that you'll need for the flu COVID and the CTNG trick? Just trying to get a sense for how many patients you think you might need to enroll and what the cost of these studies is. will be roughly how long do you think the enrollment might take?
spk03: So, unfortunately, our head of regulatory is not here who would have all those details. I think it's a pretty standard how they evaluate that, the number of patients that are required, et cetera, for each of those phases. And I know that that's something that we do have dialed in for each of these studies. And I guess I could get that information for you at another time if it's possible.
spk01: I think at a high level market, it's significantly more time and money for CTNG. And so given our overarching goal of bringing as many tests to market on the Talisman platform that we know our target customer is looking for, staging it this way with leveraging the work that we've done on the respiratory panel while we continue to do the necessary work to bring a meaningful CTNG product to market is the best way that we get to a point where we can actually go to our customers with a system that has more than one test that they're looking for.
spk02: Okay, that's helpful. And maybe just last question for me. How much is left on the NIH grant? I'm just trying to maybe fine tune the model and see what the duration of that might look like.
spk00: And so we just executed an extension on that grant, so it'll expire in April of 2024, and we have $1.2 million left of an opportunity to earn under that grant.
spk02: Gotcha. Thanks so much, guys.
spk03: Yeah, thank you, Mark. And I would just like to point out one thing that, you know, It's been a while since we've come out on our earnings call and we've made a lot of progress. And the biggest thing that's enabled us to start our next step is that we have very high confidence and we believe that our manufacturing systems are going to be very helpful for us as we start to scale the company. We now are enabled to build multiple tests on our system, tests that are going to be attractive and desired by the women's and sexual health market. And the fact that we're being as efficient as possible by leveraging prior investments to keep down our cash burn and get us into 2025 has been a huge help. So all of these aspects combined make us very optimistic about the future.
spk04: Thank you. And now I'd like to turn the call back over to Rob for any closing remarks.
spk03: Okay, thank you for joining us today and for your time and interest in TALISbio. Goodbye.
spk04: This is today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day.
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