Todos Med Ltd Ord

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Totals Medical Business Update Conference Call. I am Helen Ngo, Chief of Staff at Totals Medical. In addition to myself, with us today are Gerald Kamiseong, our Chief Executive Officer, and Dan Hirsch, our Chief Financial Officer. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during this conference, please press the star followed by the zero on your telephone keypad. As a reminder, this conference is being recorded. Before we begin, I want to remind listeners that during the call, management's prepared remarks may contain forward-looking statements that are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the company claims protection under safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today, and therefore, we refer you to a more detailed discussion of these risks and uncertainties in the company's filing with the SEC. In addition, any projections as to the company's future performance represented by management include estimates as of today, August 23, 2022, and the company assumes no obligation to update these projections in the future as market conditions change. This webcast will be available at www.totalsmedical.com on the Investors Relations page. I would like to turn the call over to our CFO, Dan Hirsch. Dan?

Thank you, Helen. The first half of 2022 was a pivotal time for Todos Medical as financial markets cratered in the first half of the year. The company had to survive primarily on cash flow. This was accomplished by focusing on the operations of its Provista Diagnostic subsidiary, where we were able to establish a consistent and growing business in the COVID testing services area. which we had prioritized after negative experiences with certain large CLIA lab reference clients. As a result, Provista's team has grown from 15 to over 20 employees. We have now validated on our preparing to launch new diagnostic testing in the areas of urinary tract infection, wound, respiratory panel, gastrointestinal, and sexually transmitted infections, and now monkeypox. The investment to automate our clear cap lab has allowed us to significantly significant capacity leverage with each hire and to offer clients the potential of large volume with fast turnaround time. We are already seeing significant growth in testing at Provista and have some exciting growth plans moving forward, as Gerald will discuss later on this call. As far as the distribution arm that had previously been driving revenues, we are now formulating a new business model targeting customers that have direct access to patients, such as physicians. We expect to make announcements on this in the near future. Our joint venture with NLC Pharma, 3CL Pharma, has established a stable revenue stream of Tolavid sales and a loyal customer base who see the benefits of our Tolavid 3CL protease inhibitor dietary supplement. We have now completed the proof of concept phase through the collection of data from the first 100 patients in our IRB wave market research study for Tolavid in acute and long COVID. As a result, we can now begin to market more aggressively, sticking to the data that we have gathered as the source material to reference. At this time, I'd like to turn the call over to Gerald, our CEO, to discuss our strategic vision and plans for growth in order to build lasting value for our stockholders moving forward. Gerald.

Thank you, Dan, and good morning to everyone. As we've just outlined, there's been a great deal of progress made at TOTOS in the first half of 2022 as the potential begins to emerge and the market very recently seemed to take notice. I'm going to go over roughly eight or nine key items that we've been focused on. And we know that shareholders have questions, too. especially some of our new shareholders who've recently joined the company over the last several weeks. And we want to make sure that there's a firm understanding of what the company does and what our future growth plans are. One, the Tolivir emergency use authorization filing. As an update, we successfully completed the clinical portion of the clinical trial for a phase two in hospitalized COVID-19 patients in the first quarter of 2022. In the second quarter of 2022, we completed the biomarker analysis of that data and confirmed a biomarker benefits in addition to the clinical benefits, which we think are quite significant. As a reminder, Tolivir is a mixture of botanical extracts. We have not just using a homebrew, but identified the specific compounds within the extract, the actives that make up the necessary ingredients in order to derive the benefit that we're seeing both clinically and with the biomarkers. With that said, it is unusual and atypical for botanical derived drugs to be used in this type of setting. And really, it's a function of the emergency that we are under that is driving the potential of Tolivir in this market area. As a result, We have been making significant efforts to characterize and really fill in all of the necessary CMC and manufacturing gaps that will be required from regulatory agencies in order to ultimately approve Tolivir. And this has been a significant portion of the delay as we've made progress on the underlying fundamentals under the direction of 3CL Pharma's uh significant and important leadership dr dorita rod who's making these uh tremendous discoveries as a result of that work both in the clinic with the clinical biomarkers and with the fundamental characterization of the cmc that will allow us to deliver a streamlined application to regulatory agencies we're now much more comfortable that we will be able to submit and receive authorization to run clinical trials in additional jurisdictions, as well as ultimately be able to turn the trials that we now have into approvable material. As such, we have completed the design and are now preparing to implement the extension phase of the Tolivir clinical study, where we will enroll up to an additional 46 patients beyond the 20 patients of data that we gathered with the formulation that we intend to go to market with. We expect that along the way, we will be able to share data beginning with 10 patients with different regulatory agencies, and depending on the need of the regulatory agency, we expect that we will be able to get either limited or full authorization of Tolivir in that hospital market. Again, as we embark on this next phase, we expect that that first 10 patients and the submission will be able to go in in the fourth quarter of this year. And we will be very busy over the next several months in preparation for that filing, completing characterization and certain additional studies as recommended by our regulatory advisors to give ourselves the greatest opportunity to have a successful evaluation interaction with regulatory agencies, including the U.S. FDA. One important note as it relates to Tolivir, last year in November, we announced a partnership in Europe with a company called T-Cell Protect that was supposed to deliver investment. and regulatory assistance. We established a regulatory framework built around Greece that would accelerate work in Israel and ultimately lead to lock-on effects throughout Europe and other areas. After careful consideration And after extended negotiations and looking at alternatives based upon the increased profile of the positive Tolivir phase two data, as well as the successful efforts that we've made in long COVID, we have decided to terminate that agreement with T-Cell Protect. retake the rights for the TOLAVIR, TOLAVID, and TOLATES programs. And we have identified and are completing the negotiations with seasoned leadership based in Europe who have relationships with local distribution partners who can effectively launch TOLAVID in different European jurisdictions, as it is very much a fragmented market that we think a single company can from Greece may not ultimately have been successful and penetrated. With this significant shift, we do expect to make announcements on that leadership change in Europe in the weeks ahead, very soon, potentially in the next few days. And we expect that that will allow us to uh really begin to drive value and engage more closely with uh our european customers as we do know uh that about 15 1 5 percent of our business is international and of that 15 that's international for toll of it approximately 80 is in europe with the largest markets being in the uk um so for us We think that that is an important development. We know many shareholders have been asking about that. And we think that retaking the rights really will give us an opportunity to partner in a more robust manner and begin to deliver for the customers and for our shareholders in Europe. With that now in place, the next thing, of course, is our strategic plans as it relates to Israel. With regards to Israel, we are making substantial progress. With regards to Tol Avid, the team on the ground is advancing interactions with regulatory bodies in Europe to ultimately get approval to launch Tol Avid in Israel. And we think we're very close to that mark. Additionally, for the Tolivir program, after the biomarker data, And after consideration of the possibilities, there may be opportunities without a Greek approval, without a European approval to get a direct label in Israel for Tolivir. And we are looking at ways to accelerate that possibility based upon the data that we are gathering in Israel in parallel with looking at the U.S., regulatory agencies, which is the FDA and obviously also the European Medicines Agency. So that's really the update with regards to total of year. And we expect that there is going to be news that we will be able to share with the market very soon with regards to opening the enrollment of that extension phase, as well as certain regulatory filings that we expect to be coming up as progress on the CMC manufacturing process. details to allow for successful regulatory submission become clearer. Moving on to the next major question that we received from shareholders, the debt of the company, which we want to make sure that we address. The vast majority of the debt on the company's balance sheet which is the crossover round of financing led by Yozma, which is a Korean venture capital group, that all converts at a price of 4.792 cents per share. So recently, as recently as last night, there's been a concern that, you know, because of a potential dilution risk of the company, that we would dilute the shares at a per share price lower than that number and ultimately reset all of the debt to a lower price. While that was certainly at the end of the second quarter a significant risk, and it does remain a risk that shareholders obviously must consider, we have not raised money below that $4.792 per share price. And as a result, none of those instruments have reset their pricing. So while this is a risk, and we did note that risk in the 10Q filing, that has not happened as of yet, and that is the reason that there is a range of shares that could become issuable upon conversion. And on the worst end of that second quarter pricing, that could have been the fact at that point. However, right now, that has not happened and that has not changed. And we are focused on continuing to build value of the company. And hopefully, we can exceed that price per share very soon, at which point that will no longer be a concern for our shareholders. Following on with that, we have the question of a reverse split because we recently filed a proxy. And I want to make sure that we address that. The reverse split has been a part of our plan for the past two years. And we've been waiting for the right time, which is a mixture of milestones, runway, value in the market and future prospects in order to affect a reverse split. And our target ratio at the current time remains one for ten. We will only update and effect a reverse split in conjunction with a listing on a national exchange, and when we feel we have sufficient catalysts on the other side of a reverse split to drive value. At the current time, we are not doing a reverse split. The reason why the ratio of the reverse split was put in as one for two to one for 500 is simply because that was the ratio that was authorized last year. And we were in negotiations with an underwriter with whom we filed an S-1 on July 28th that is seen by the public. And that underwriter did require that we put the necessary pieces in place to be able to do an uplisting so that if we do achieve the catalyst and the timing and halo that we think is required to have a successful uplisting, that we would be positioned to do that and not have to wait on a new filing because, as we all know, opportunities in the stock market, especially on the OTC markets, are rare. And when the stars align, you need to be able to capitalize, which would be to the benefit of shareholders. As a result, we just extended what was done last year. We thought that was the most prudent course of action because we could come up with a rationale for a different ratio. And we thank shareholders for their understanding in terms of how we came to that conclusion and what our plans are. We believe we've proven that we will not affect a reverse split under the wrong conditions. And we believe we have tremendous value to continue to create here on the OTC markets. And we will be looking to continue executing and hopefully the market rewards us with continued value increase over time. With that said, we do believe we have multiple catalysts coming up in the near future, and that's what we intend to focus on for the rest of this call. The next major question I get asked is related to revenue. and revenue projections. In previous calls, we've indicated that we could see revenue in the eight figures, low eight figures, anywhere between 20 to 30 million in revenue for the year. To date, we have revenue of just over four and a half million dollars. And so many have questioned whether or not that is still possible. Our position is that it very much remains possible because of the history of the type of testing revenue that we generate. If you look not only at Todos Medical, but you look at virtually all other PCR testing labs for the last two years, the fourth quarter has been the quarter in which virtually all the revenues have been generated. I'm sure we all remember the significant COVID surges that happened over the last couple of years between Thanksgiving and the holiday season. And this is driven not only by new variants, but by an increased amount of travel to see family and a desire to not bring home COVID to family members during that period. While it's become clear that people are beginning to be more comfortable in how they interact with COVID-19, and that the political winds are shifting to want to cause people to, quote unquote, live with COVID, we believe that the desire to not infect family members remains high. So that even if you're open to infecting strangers or coworkers, which obviously we disagree with, but does happen, the desire to protect vulnerable family members, especially the elderly, is especially high. And so the potential for significant revenue in the fourth quarter around a surge in the holiday season remains possible. However, we cannot provide guidance to that effect. It remains a distinct possibility. With that said, in previous years, we were well positioned to support other labs And that is the basis for the significant revenue generated in Q4s and Q1s of the last couple of years. Our ability to deliver for other labs and those labs making between 5 and 10x what we make on those sales of testing services and COVID. This is, in large part, the reason why we focused on transitioning from delivering third-party reagents to other labs to, in fact, ourselves being the labs, because we've seen directly the impact that COVID testing can have on the balance sheet, the tremendous revenue it can generate. And in fact, this is part of the cause of why we got out of that business. As soon as we made some of those last significant amounts of money, they had alternatives beyond us. And this is why we are now in litigation with several of them trying to recover unpaid expenses because they thought they could cram us down. We understand that process. It was quite a learning experience. With that said, we now operate our own lab. And we repossessed and positioned the automation that we delivered to those other labs into Provista. And Provista is now capable of running significant volumes, up to 25,000 tests per day, with a view towards moving to 50,000 tests. Just to make sure that everyone understands the economics, COVID tests are reimbursed at a rate of $100 per test if you give fast turnaround within 48 hours. So during COVID surges, when we were delivering up to 10 or 15,000 tests per day to clients, those clients were making between a million and a million and a half dollars in revenue per day. And that's why we continue to believe that despite the drop in COVID testing and some of the changes, that the fourth quarter does remain a potential significant revenue opportunity for us. And we are now very well positioned to capture the full opportunity as we move forward. So while we're not providing guidance that we're going to hit that $20 to $30 million bogey, that does remain a distinct possibility. Beyond COVID testing revenue, we have made significant efforts to diversify our revenue base under the direction of Dr. Philippe Gouin, our chief commercial officer at Provista. And we have since validated multiple PCR tests. and identified a niche market that is underserved that has significant patient flow to be able to drive revenues. We have not forecast and are currently not forecasting any revenue between now and the end of the year for that business unit because we do not want to put significant pressure on it. However, we do believe that there is significant upside potential as we already have customers that we are serving. Those customers have completed the initial delivery of tests and have received the fast turnaround and the actionable information to change their prescribing habits in the skilled nursing facility setting. And we believe that this is now in a position to scale with the reimbursement for UTI alone being closer to the $800 range as compared with the $100 range for COVID. As we add beyond UTI, we add wound, The respiratory panel, which will be conducted in conjunction with COVID, of course. Our gastrointestinal panel and the sexually transmitted infection panel, we believe there's a significant opportunity. And one of the things that we've done that is unique, of course, is now the validation of monkeypox. which can be added to the SARS-CoV-2, to our UTI, our wound, and our STI and respiratory panels. And this will provide a unique advantage for Provista in winning contracts as compared to other labs that do not have the monkeypox testing capabilities that we have. So we do think that monkeypox testing Availability is a key selling tool, as we all know that if there is a monkeypox outbreak, we have already heard that there are significant challenges in gaining testing. And I'll talk more about that monkeypox opportunity towards the end of the call, as we've already had just some tremendous response and some very unusual findings in the first couple of days of that product launch. Additionally, with regards to revenue, we also haven't really been providing guidance on our Tolvid brand, but that brand is making substantial progress, has normalized sales much higher than in this second half of 2021 or the early part of 2022. And we have now completed several qualitative steps that we felt were important. in order to be able to drive Tollevit revenues. First and foremost, it's important to remind everyone that Tolovid is a dietary supplement. It is not approved to diagnose, treat, prevent, or cure any disease, including COVID or long COVID. Our scientific founder of 3CL Pharma, Dr. Dorita Rod, is a pioneer in the area of 3CL protease and 3CL protease inhibitors, and we have leveraged just her tremendous expertise to gain a foothold into that marketplace. With that said, the results that customers have seen as a result of using Tolivid in multiple settings where 3CL protease is significant have been nothing short of tremendous. beyond what we could have expected and hoped for when we opened certain research avenues. And with the data that we've generated through our IRB wave study, as well as through the case study series where we have already announced or posted on ResearchGate outcomes, with certain biomarkers associated from patients who have either acute COVID or long COVID really gives us confidence that we have something that is having a benefit. One of the things that's important for us as we prepare to accelerate marketing is to stay outside of areas where there are approved licensed drugs. We think that competing directly with pharmaceutical interventions is unlikely to yield a positive outcome with the FTC. or other regulatory agencies in the government, especially because they are heavily promoting the use of Paxlovid, which is Pfizer's three-cell protease inhibitor drug candidate. As a result of that, all of our marketing efforts are going to be outside of areas where Paxlovid is authorized, which currently is in vulnerable, compromised populations that are unvaccinated. So everything outside of that population is an area where we think we can market. We also think we can market around certain negative aspects associated with PaxLivid, where we can potentially support individuals who are having a negative experience, such as PaxLivid Rebound. So those are areas where we've gathered data, where we can point to either case studies or market research data, and where we can formulate marketing plans that do not cross with FDA and or FTC guidelines or CDC recommendations. And so that is going to be the focus of our marketing firm that we recently hired called ThinkFuel, who has a tremendous track record in digital marketing. And we are now leveraging them. to really drive our messaging. And we expect that we'll start to see the results from some of the work in the weeks ahead as we just hired them and we had our kickoff meeting early last week for Tolovid now that we have this data. We also are opening up wholesale distribution channels. We've recently made significant connections with functional medicine groups that are seeing patients that are looking for supplement solutions to assist them with their long COVID symptoms. We now have one of the key opinion leaders from that community who has completed their test with Tolavid and has now ordered and paid for their first wholesale order. And we have several others based upon that recommendation that are now going through that process. And we have several long COVID clinics whose physicians are either in process or have completed the trial phase with Tolivit and some of their patients and are now beginning to order. So we're starting to see a more medically oriented customer base that use Tolivet and experience benefit in a long COVID setting. And we think that this is the right direction for Tolivet to be marketed as we move forward. One of the big challenges, of course, of long COVID in general is that there are no approved drugs. So this fits in well with our marketing strategy. Coupled with the fact that there are no approved drugs, virtually 100% of long COVID patients rely on supplements to manage their symptoms. As a result, Tolavid fits right in line with what they're currently doing, and most long COVID physicians also recommend supplements. So we are hopeful that Tolovid can quickly become the standard of care as a supplement in the long COVID market. And we will continue to evangelize Tolovid and to drive interest in Tolovid, not only now through research, our case study series, our IRB wave study, which we will continue to gather data from, as well as our prospective phase two safety and efficacy clinical trial that we're preparing to start later on this quarter. But Importantly, um, we also think that we can now, uh, drive toll of its sales really, uh, based upon word of mouth, uh, and the, uh, tremendous, uh, social media, um, That toll of it is starting to develop as one of the key supplements that is helping people. We know that many long COVID patients are on social media. That's one of the only ways they can have social interaction because they're unable to leave their homes. And as a result, reaching them where they are is something that's important. for us to do, because unfortunately, long COVID patients are not in a good place, and we have to go to them as a result of that. We also, beyond just dealing with the medical community and social media relationships, we have established an affiliate program. that includes, of course, the physician in long COVID clinics, but we also now have several influencers that have expressed an interest in Tolovid. That can be either in the setting of long COVID or as one of them has put it as a quote unquote party drug. Obviously Tolovid is not a drug, but it is being used by healthy people to hopefully reduce 3CL protease content if they come in contact with the 3CL protease. And many people seem to be having success in that setting. And so based upon that marketing slogan, it does appear that there is an additional market that we can go after of healthier people who are not sick that are just looking for additional immune support in the face of what's going on. So that is really where we're going with our revenue around Tolavid. And now with regards to Corona Diagnostics, which is the third leg in the stool, Provista, Tolavid, and now Corona, our strategy is to target physician-owned labs who are looking to get into the molecular testing space and be able to do small volume for their patients right on site. and deploying a hub-and-spoke model, having those physicians who buy materials and reagents and supplies from us and the distribution partner that we're currently in discussions with to deploy to those physicians, we would provide the back-end support of the reagents as well as the training for the physicians to be able to run those small volume tests, we would have the hub of Provista where there are larger volume tests, more complicated tests would be sent to us. So this is also a marketing tool for Provista and allows the physicians to offer a broader suite of tests, faster turnaround time and greater service for their patients with an expectation that that there's going to be a significant increase in diagnostics in the years ahead as a result of COVID, leaving a trail of side effects and accelerating the pathogenesis of a number of diseases we believe include in cancer and Alzheimer's. We think it's going to become paramount to have new screening methods developed including cardiovascular screening methods to identify patients who are at risk and look for potential interventions that can reduce the risk and lower the likelihood that a patient transfers from healthy to unhealthy by early diagnosis and early intervention. Now, I do just want to touch briefly on on the long COVID efforts that we've made because they have been quite significant and quite public. What we're looking to do is really establish TOTOS subsidiary 3CL Pharma as the leader in long COVID. Obviously having a supplement that seems to help majority of long COVID patients is very helpful. in terms of positioning us in that way. But there are other things that also will be helpful, especially as we begin to profile patients and look at their immune systems, not just within the context of COVID or long COVID, but of human health. Because, you know, as society opens up and people interact, many other diseases will begin to impact people. And the integrity of the immune system as you face these other diseases is becoming critical story that is not being told. And we think that there could be significant risks that people do not understand that they're taking as a result of reinfections. So that is the main reason in both the long and the acute COVID setting why we partnered with Amerimune, a leader. in the area of immune diagnostics in the United States, because this will allow us to create profiles of patients and begin to think outside the box. It's not just about having COVID or not having COVID. It's not just about having long COVID and not having long COVID. It's about having an intact immune system that has the ability to mount defense against other pathogens. and maintain its integrity over time so you can live a long, healthy life. We think that the COVID pandemic and long COVID have really shed an important light on the immune system and its fragility. And now it's incumbent that people take a closer look at their immune systems and really look to fortify their immune system first by understanding where they may have weaknesses. And that is really the effort that we are pushing forward because ultimately, TOTOS is not just about long COVID. We have proprietary diagnostics in the area of cancer screening. and in the area of Alzheimer's screening. And we think that our efforts in COVID and long COVID, being able to establish a strong patient population, will ultimately give us access to customers that will be interested in monitoring for early diagnosis of cancer and Alzheimer's so that they may do something potentially over time and intervene. So this is a very synergistic strategy in terms of monitoring the immune system that we think is not only going to yield dividends in the pandemic or quote unquote endemic phase of COVID, but will also yield benefit for the longer term strategy of TOTOS around cancer and Alzheimer's screening. And speaking of our cancer panel, we have now collected 40 samples from a clinical trial that initiated in Mexico that the Mexican government is running as a general breast cancer study. We were lucky enough through our chief medical officer of infectious disease and oncology, Dr. Jorge Leon, get access to that study and begin to gather samples of women with breast cancer samples. so that we can ultimately use those samples and the data to complete the clear revalidation and launch of our laboratory-developed Videssa blood test in 2023. We intend to gather up to 750 samples, but we don't need that many to launch. And currently, Dr. Gua at Provista and Dr. Leone are harmonizing their strategy to be able to bring Vydessa to the market in the most effective way over the next year. And we expect to have updates on that in the reasonably near future. As another note, we have made some hires on a part-time basis with regards to research, grant writing, as well as through publications. And so we are going to be going after non-diluted funding in a pretty robust manner, especially now that we have data and long COVID. One of the things that we think separates us from many other groups that are talking about long COVID is we have a product on the market. with significant safety data, a clinical trial that is planned, sites that are ready to move forward, and a protocol that is ready to submit to IRB so that we can gain authorization to start. We think this is the ideal time to be able to attract grant funding, uh, for long COVID. And, uh, we will be, uh, engaged in an effort to discuss not only with government sources, but private foundations to get non-diluted funding to advance our, uh, long COVID development efforts. And then finally, um, obviously there's been a significant amount of interest in what we've been doing in monkeypox. Um, Just a couple of weeks ago, we started very early identifying suppliers, materials and supplies and strategies to be able to get into monkeypox. We started doing that in the May timeframe. We never really thought that it would get to the point where there was actually a market Um, but unfortunately that has happened. Um, and as a result, we have stepped in and, you know, we spent the money required to complete the validation, um, and now, um, have a, uh, CLIA authorized laboratory developed test, um, that we are now deploying, uh, for, uh, patients in the United States. Um, one of the things that really separates us, um, is both the sensitivity of the assay and the fact that we are validating alternative sample types to lesion swabs. As we know, lesion swabs first require lesion, and the incubation period of monkeypox can be up to three weeks. This incubation provides a window of opportunity to potentially intervene with therapeutics such as TPOX that are currently available under an early access IND, and hopefully, generate sufficient data to be able to be authorized as a therapeutic for monkeypox, as well as JYNNEOS, which is being used both as a prophylactic as well as a post-exposure prophylactic intervention for monkeypox. Unlike COVID, We have tools in the United States to deal with monkeypox, although not sufficient tools. And it seems as though one of the challenges has been deploying testing and contact tracing in the right way to identify patients with monkeypox early. We've heard now since we announced the launch from monkeypox horror stories from non-gay non-male patients who have all the classical symptoms of monkeypox but were denied testing or weren't seen and now have been experiencing monkeypox symptoms for up to 10 weeks. This is what we feared. When we heard of the challenges in terms of getting testing out to the marketplace, we saw the social media viral videos of patients with monkeypox talking about how difficult it was and how many physicians they needed to see to get diagnosed. And now I'm starting to see reports of people who have been diagnosed with monkeypox of unknown origin. which means that someone had monkeypox, was not tested, was out, either contacted them skin to skin or was in a close discussion and breathed in sufficient virion to generate a monkeypox infection or, although less likely, contracted monkeypox from some surface, whether that's a bed sheet at a hotel or a door handle. So it's quite clear that we don't have a handle on monkeypox. And with school opening, both colleges, high schools, middle schools, elementary schools, and daycares, we have already seen monkeypox diagnoses in each of those patient populations. And we've also seen them in the United States among caregivers in those populations. And given that we don't really know the extent to which monkeypox can spread through the air, just a few weeks ago, CDC indicated that monkeypox was not primarily spread through airborne disease. And just last Friday, the CDC changed its guidance and began recommending people wear masks to avoid monkeypox. It's quite clear that the science is changing rapidly, as is the guidance and the messaging that has been delivered to the market that monkeypox is limited to the male gay community and is a sexually transmitted infection has created a dangerous situation where people do not understand their risk level and do not take simple precautions. like using hand sanitizer, like showering more often after being out. And so we now fear that there could be increased incidence of monkeypox and that indeed there will be need to be increased testing. It's obviously great that monkeypox is not very lethal, but it does leave significant scars. And based upon the enrollees in a case study that we announced this morning, case study series that we announced this morning, some of these symptoms can last months and lead to itchiness and other negative effects, both inside the body and on the surface of the body, such as scars. And so we believe that New methods of testing beyond lesion-based testing to identify patients earlier, as well as identify patients later who are not properly diagnosed and who may have convalesced is critical now. to get a true handle on etiology and the spread of monkeypox so that we can get this situation under control. As a result, we've opened up a case study series. We now have four enrollees in the past 24 hours, including three women. who were unable to get proper testing, who are all symptomatic, who are unable to get that early access treatment, TPOX, who are unable to get JYNNEOS vaccination. We think it's critical that we identify these patients, that we raise awareness of the potential for other types of tests that we're developing that could help them in their diagnostic journey. And so we think that, you know, while monkeypox certainly is a small opportunity compared to everything else that we're doing and Dr. Gua is launching at Provista, we do think it's something that could be quite explosive because, you know, if monkeypox ends up at my kid's school, I certainly would want everyone to be tested to make sure that it's not spreading in other ways, right? So we have accomplished a great deal in the first half of 2022. Before I turn the call over to your questions, I would like to thank our employees for their dedication in helping us to position the company for sustainable long-term growth. I would also like to thank our investors for entrusting a portion of their investment dollars in our company. And we also welcome new shareholders to Totos on what we believe will be a tremendous journey as we move forward in the deployment and expansion of our testing for covid monkeypox and other genetic based tests at provista that build the basis for the launch of our cancer and alzheimer's suite and provide a springboard to gather the necessary immunological data to support the use of our dietary supplement Tolivir more broadly in the long COVID community, as well as identify key biomarkers that are generating positive outcomes with the use of our therapeutic drug candidate, Tolivir. We look forward to building on the positive momentum that we've generated thus far in the first half of 2022 as we implement and begin to see results from our future growth plans. Thank you.

Operator, this concludes our prepared remarks and can now open the call to questions.

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Sure. So multiple questions here. I've got 23. Hopefully I'll be able to answer them all. And I won't be able to commit to answering beyond this. First question, why did NLC write into their agreement with us? They could walk away if terms weren't met by September 15th, if they weren't prepared to do that. There was concern early on when we closed the transaction that, uh, TOTOS would not be able to, uh, operate as a going concern given the challenges and raising funding, um, in the first half of 2022. Uh, and this was something that they were quite concerned about. Um, and, uh, it's something that, you know, we felt that we could deliver on through execution. And that was a bet we made. Um, since that time we have executed and have delivered funds to, um, NLC, 3CL Pharma, and we intend to continue to do that. Obviously, we understand the concern from the market. We don't see that as a significant risk because we have executed on the requirements. But with that said, we do understand the concerns there, and we are going to be looking to address them more robustly here in the near future so that we There is no risk going into that September 15th date that shareholders can be concerned about. But that is the reason why it was put into the agreement. Is Moneta truly the best partner to spin off 3CL? Don't they know much 10 billion shares will undermine sentiment in the stock with a reverse split on the table? Certainly, we understand the risks around the reverse split and the authorized shares. I addressed them earlier in the conference call. Yes, we believe that Moneta is absolutely one of the best partners to help us position marketing of 3CL. Remember, our strategy with 3CL is very simple. TOTOS is providing the seed funding to get Tolivir sales to a stable place where it can help fund 3CL and fund the clinical study to support the EUA filing for Tolivir and hospitalized COVID. We have executed on those two things. And now the strategy is for 3CL to raise its own money directly through a crowdfunding effort so that Todos does not need to dilute itself or its revenue to further support 3CL. And we're in the middle of that transition of funding right now. So we will be launching a crowdfunding campaign directly for 3CL. And absolutely, we think that John Najarian and Mark Lopresti have tremendous reach with respect to marketing and will be able to help 3CL raised the necessary funds to achieve the long-term objectives. As a note, Moneta has assisted another company in crowdfunding that raised $72 million since the start of 2021. It's in a slightly different space, but the marketing infrastructure and efforts are the same. And as a result of that experience and the relationships that they've developed through that experience, that is why they felt they could be helpful with 3CL given just the tremendous impact. customer reach of our end products. So, you know, John used Tolovid when he had challenges over the Christmas holiday season. That's why he believes in it. That's why he was prepared to support us during our Super Bowl marketing efforts. and make a lot of introductions to us that will begin to pay dividends now that football season is getting started. That's also why he brought in his partner, Mark Lopresti, to really make sure that all the pieces are in place and buttoned up so that we can compliantly go out and do crowdfunding as their other client did. And so, yes, I believe that they are the right group to help us get that out to the market. What is the cost to acquire a new Tolvid customer? Currently, that cost has dropped from upwards of $80 to now below $40. And we see that going lower over time as we expand our marketing base. With little cash on hand, how will you drive a more intense marketing campaign for Tolovid? Well, we've hired a digital marketing group. And one of the ways in which digital marketing group will actually help us is they get much better leverage on their spend. This is something I didn't know, but I've learned in the last several months. The total dollar spend by an entity on digital marketing gets you better leverage on your investment with the social media companies as compared to a standalone. So for every $100 that we spend, because we only spend $100, for example, that same $100 would get $300 or $400 worth of marketing value if it is spent by a digital marketing firm. And so as we learn this and we started to see our own metrics, that's one of the reasons why we engage with the digital marketing firm so we can get much better leverage on our spend, as well as have them assist us in content creation and deployment. So we expand our marketing team. This is going to be especially important as we get out to the marketplace. and begin to market not only Tolovid, but the 3CL crowdfunding effort. We see that as very synergistic because obviously the people who are most likely to respond from crowdfunding campaigns are people who have successfully used the product and believe in it. And while we don't have a massive customer base for Tolovid, our customer base is extremely loyal with an over 80% return rate. People who used Tolovid come back and use it again because they felt it helped them. And we think that this loyalty, as we expand that customer base through digital marketing, can help our efforts with crowdfunding. What is the expense and time and money to bring in new tests at Provista? That really depends. If we're bringing on tests that have been validated and that are out there in the public literature and for which we simply need to validate and deploy, as we saw with Monkeypox, we can get it done in as little as two weeks and for under $10,000. If you're talking about a test like Provista that's proprietary, where we will be the only ones in the country running it, and we have to have data in order to be able to drive adoption for physicians, that's obviously much more expensive, as over $50 million has already been spent on Vydessa, and over $20 million has already been spent on Limpro. So those tests will take significant investment to get them to market. And that's one of the reasons why we are expecting their launch later on, not in the second half of 2022, because we're prioritizing our funds on what's going to generate revenue now, but something more like in 2023, where we expect that free cash flow to be able to complete the deployment of those tests. When do we expect monkeypox approval and how you become the test of choice for gay men? in New York. We have an inspection of our lab by the New York Department of Health in September, at which point we expect monkeypox to be added to the set of assays that can be deployed in New York. And we expect to become the test of choice, not only for gay men, but for everyone, by focusing on saliva, as saliva will really open up the market and ease provider angst of potential infection by allowing a simple collection with saliva and a simpler methods and requiring someone to remove their clothing and swabbing their lesions. Um, going through, we have a few, um, redundant questions. Um, For each of the lawsuits we filed to reclaim, how much could we hope to recover and when? So we are in arbitration with NOAA, and we expect that is going to be happening, I believe, in September. I mean, we expect to claim, you know, $4 million. We don't really expect to claim less than what we're owed because people used our products. They have a history of paying for the products and simply didn't pay. And so, you know, we don't see any reason why we would lose. Similarly, with some of our other clients, although the numbers are less and they may have tried to work with us for a little bit longer once they became sustainable, the net result is the same. People bought products, they used them, and they didn't pay. And we have the proof. So we expect we're going after something like $6 million. We expect to recover all of that. Obviously, if we recover some portion of that, any dollar that we do recover is beneficial. And so we're going to be going after every single dollar. What updates can we offer on the Tolivir IP? So I believe the first patents filed in February 2020 by Dr. Arad around 3CL protease and coronavirus have now published. If they have not published, they will publish shortly as we just funded the nationalization of that patent portfolio last week. And we're very confident. We've also made tremendous progress since that time in identifying key components that add significant IP value to the portfolio. And now the ratios and other aspects of formulation are also adding a third layer of IP protection to the portfolio. And this is all we're looking to nail down before we go into regulatory agencies for authorization. And one of the reasons why we've delayed filing the IND, we want to make sure all the ducks are in a row for a successful outcome. So currently, our biggest competitor in the Atlanta area is a lab called Ipsen, who's also doing lesion-based monkeypox testing, but they are not doing saliva testing. Are we targeting fall neural Alzheimer's conference for LIMPRO press release? Ideally, that would be a great time for Dr. Arendt to finally sign on the dotted line with respect to the data and allow us to put out the information once it becomes material, which will only be material once he signs off on the validation. So, you know, he's in the process now of the data analysis. And once that validation is signed off on, which hopefully coincides with those conferences, then we will put out the information to the market. Yes, we have several long COVID clinics and KOLs who have tried all of it and are now avid customers and supporters. Why does the retrospective narrative of Q2 not match the forward vision casting that was offered for Q2? Our strategy in Q2, we didn't put out or give guidance at the end of Q1. Part of the reason for that is we were mid-transition of moving from primarily distribution to direct sales through Provista. And that was something that, quite frankly, we weren't 100% confident we were going to be successful at because of the major challenges that we had. We changed our billing system. We've changed our laboratory information management system. We've hired a new lab management. We've hired a new chief commercial officer. We've hired a new sales team. And there's been quite a lot of changes as it became apparent that the government was giving up on COVID and trying to rely on rapid antigen tests that have significant false positives and false negatives to control the pandemic. It's become quite clear that that strategy has failed. Recently, the FDA has added yet another 48 hour testing requirement for rapid antigen negative tests, which dramatically reduces their value in the diagnostic market. It's clear the market hasn't quite figured that out yet. Mark is just mad with the FDA, although I think the FDA has done a tremendous job, the new FDA commissioner, in really using real world evidence to guide decision making. But the CDC guidance around testing is abominable. As a result of that, we think that the market will turn back to PCR because getting infected over and over and over again and infecting your family is not an option most people want. And Nobody has trust in the rapid antigen tests. You couple this with the administration that has indicated they want to get out of the business of distributing vaccines and a new vaccine coming onto the market that has zero data with respect to actually preventing transmission and a skeptical public that has done a yeoman's job in trying to get vaccinated, but now has vaccination fatigue. And we see the fourth quarter as a potential, exactly what the White House called it, the potential for over 100 million COVID infections. So we were quite surprised that the White House came out and said that, that Jha said that. We agree with him, but we do have problems reconciling that projected reality alongside with the guidance of of not testing, not masking, not really ventilating. And then, you know, the challenges associated with the new vaccine rollout. So while there are, you know, reasons for optimism and hopefully these new vaccines do get significant uptake and hopefully they also prevent transmission. We think obviously that would be tremendous for the country. We're taking the position that they have to show us that that's going to happen first because relying on the guidance has been a failing strategy. And we think that there's going to be significant blowback as reinfections happen, as long COVID increases, especially heading into the end of the year when everybody knows that over the last two years, there's been a huge surges in COVID. And then when will you pay off Leveston? Our intention is to do that as quickly as possible. We heard everyone and we've heard the concerns. with respect to dilution, and we're looking to kind of buttress all of the concerns around 3CL, dilution, et cetera, in the near future. So we will be making significant progress on this, but first and foremost, we want to continue to execute. All of the shareholders are obviously happy that the price has increased recently, and we intend to you know, continue to execute on our plan and hopefully the market responds and provides us the opportunity needed to be able to execute and finish paying off all of our debt. So we see revenue now that we've put out the market research data for Tolovid, we see revenue really starting to move up in that area. And we're hopeful that we can have a couple of big days that would allow us, you know, some, the financial wherewithal to complete that. When do we anticipate an uplist? Um, that's very unclear. Um, we, you know, we don't want to, um, do anything that's going to destroy value. And so we're going to be very, uh, strategic in when we do an uplisting and we're going to look to do that in and around significant milestones. So yes, you've been hearing it for some time and we haven't done it. That's because we haven't felt that we were properly positioned. We that is prepared to do it. With that said, we still want to make sure that we do it in a way that is best for shareholders. And so now our focus is not on the uplist. Our focus is on executing our business plan, growing our revenues and delivering on qualitative milestones that we think the market will appreciate and establishing ourselves as a leadership in PCR testing and monkeypox testing. And we think if we can do those things that we have an opportunity to see value increase. What are the limitations of an LDT? There really are no limitations of an LDT. Really, a laboratory-developed test is available under CLIA. The main limitation is that you cannot run it out of multiple labs. It needs to be run out of a single lab so that you have consistent results. That is the main difference between an LDT and a 510K review. So if the lab certifies that it's generating consistent results, that is enough to launch broadly. And in fact, 75% of the tests that are taken in the United States do not have 510K clearance. They are laboratory developed tests. So we are in a pretty good position to be able to deploy that. State by state is the requirement with respect to authorization, but Almost all states have reciprocity with Georgia. And so we can easily register with each of the health departments and begin testing there. The only states that really have any challenges are not really around the testing, but around the collecting are Washington, California, New York, California. You know, we are a certified lab at the state of California already. And so we're not doing necessary paperwork to add monkeypox testing. Obviously, we have our inspection with New York. coming up in September. And Washington has not been a significant market for us. Although, you know, over time, if we do get interest, we do have the ability to register there. Okay. Unfortunately, we are just about running out of time. And I have one last question that I believe I can answer here. What is the breakdown of the revenue between Tolivet and the diagnostic tests? So we did about $800,000 in revenue in the month of June alone for the diagnostic tests. April and May were relatively much slower. So I think the total revenue was about $1.3 million. for the diagnostics, but we really steadied the ship and got some significant contracts heading into June. So July was very consistent with June, and we see August tracking slightly higher now that we've launched the AmeriMune panel. So we have an increased uptake of the CPAS test, and we're preparing to launch these other PCR tests. We expect that September will be a very, very significant month for us, and so will October, November. So we had about 700,000 toll of its sales for the second quarter. And we see that with the data now out there in the marketplace and our ability to market more aggressively and also now. Some of the relationships we established in the sports community coming back into season, we see a big opportunity to start to drive a toll of its sales. And so we think that the third quarter and especially the fourth quarter could be quite significant for Todos. With that, I'd like to thank everyone for taking the time to join this call. And operator, we can close it out.