Ampio Pharmaceuticals, Inc.

Thank you and welcome to the Ampio Pharmaceuticals 2021 Second Quarter Earnings Results and Corporate Update Webinar. As a reminder, this call is being recorded and all listeners will be in a listen-only mode. If you would like to ask a question, please dial star 1 on your telephone keypad. If you are accessing this call by webinar, you can submit your question online in the Ask a Question portion of your screen. At this time, I'd like to turn the floor over to Mr. Dan Stokely. Dan, please go ahead.

Thank you very much, Catherine. I hope everyone's having a great day. It's our pleasure, me and the rest of the Amphio executive management team, to be present here today. And we'd like to thank each one of you for attending our second quarter 2021 financial results and business update call, either via the phone or webcast. Prior to reading the Safe Harbor forward-looking statement, I'd like to introduce you to the members of the executive management team of Amphio, who will be presenting and or participating on the call today. First, here with us at the company headquarters in Englewood, Colorado, is Mr. Mike Macaluso, the chairman and chief executive officer. We also have present Dr. David Baror, who's director and founder, Holly Cherevka, the company's chief operating officer, and me, Dan Stokely, the chief financial officer. I'd like to start out by first reading our safe harbor statement. These slides and materials, which are not going to be applicable today, but including also any accompanying oral presentation, may contain forward-looking statements about our business. You should not place undue reliance on forward-looking statements, as these statements are based upon our current expectations, forecasts, and assumptions, and are subject to significant risks and uncertainties. These statements may be identified by words such as may, will, should, could, expect, intend, plan, anticipate, believe, estimate, predict, potential, forecast, continue, or the negative of these terms or other words or terms of similar meaning. Risks and uncertainties that could cause our actual results. to differ materially from those set forth in any forward-looking statements included but are not limited to the matters listed under the heading Risk Factors in our annual report on Form 10-K for the year ended December 31st, 2020, which is on file with the Securities and Exchange Commission, as well as other risks detailed in our subsequent filings with the Securities and Exchange Commission. These reports are available at www.sec.gov. Finally, statements and information in this presentation, including forward-looking statements, speak only as of the date they are made or provided unless earlier data is indicated and we do not undertake any obligation to publicly update any statements or information, including forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Now that we have all this out of our way, I'd like to discuss our financial results for the second quarter period ending June 30th, 2021. Cash and cash equivalents totaled $20.5 million on June 30th, 2021 compared to $17.3 million on December 31st, 2020. The increase of $3.2 million is primarily attributable to net proceeds that the company received from the utilization of our at-the-market or ATM equity offering of about $9.5 million, which represents about 5.9 million shares at an average stock price of $1.69 a share, which was partially offset by cash required to fund the business operations, totaling $6.5 million. We recognize a net loss of $3.6 million for the three months into June 30th, 2021, compared to a net loss of 2.7 million for the three months into June 30th, 2020. The net loss during the 2021 quarter was primarily attributable to operating expenses of 3.7 million and was partially offset by a non-cash modest derivative gain of 0.1 million. The net loss for the 2020 quarter was primarily attributable to operating expenses of $2.6 million and a non-cash derivative loss of about $0.7 million, partially offset by the gain the company recognized from the forgiveness of its PPP loan of $0.5 million. Operating expenses increased $1.1 million for the 2021 quarter as compared to the 2020 quarter, primarily due to a $1.2 million increase in research and development costs, partially offset by a $0.1 million decrease in G&A costs. We recognize the net loss of $7.2 million for the six months ended June 30th, 2021, compared to a net loss of $7.9 million for the six months ended June 30th, 2020. The net loss during the 2021 period were primarily attributable operating expenses of $7.5 million. That was partially offset by a derivative gain of $0.2 million. And the net loss during the 2020 period was primarily attributable operating expenses of $8.6 million, partially offset by gain realized from the forgiveness of the PPP loan of $0.5 million and a non-cast derivative gain of $0.2 million. The operating expenses decreased $1.1 million for the 2020 period compared to the 2021 period due to a $0.8 million decrease in research and development costs and a $0.3 million decrease in G&A costs. Moving on, research and development expenses for the three-month period ended June 30, 2021 were $2.3 million which reflects an increase of $1.2 million or 103% from already expenses for the same period in 2020, and which were consistent with expenses for the first quarter of 2021. The increase of $1.2 million compared with second quarter 2020 is primarily due to the incremental costs incurred from contracting CRO efforts to clean, scrub, and secure the AP 013 database In addition, during the current period, the company incurred incremental costs associated with several new trials, the AP-017, 018, and 019 trials, and preclinical research studies that were not present in the second quarter of 2020. R&D expenses for the six months ended June 30, 2021, decreased 0.8 million, or 15% from R&D expenses for the six months ended June 30, 2020. The decrease is primarily attributable to an overall decrease in clinical trials sponsored research expenses in the current period, totaling $1.4 million, which was attributable to the pause of the APO13 study in April of 2020, which was partially offset by incremental costs incurred during the current period associated with the the CRO efforts that were aligned to clean, scrub, and secure the AP-013 database, and also from incremental costs associated with new trials that were started in the current period. G&A expenses for the three months ended June 30, 2021, decreased $0.1 million. or 6% from total G&A expenses for the three months ended June 30th, 2020. And for the six months ended June 30th, 2021, the expenses decreased 0.3 million or 10% from G&A expenses for the six months ended June 30th, 2020. For both periods, the decrease is attributable to an overall decrease in the legal costs. as a result of the dismissal of the securities class action and derivative cases during the third quarter of 2020. Total shares of common stock outstanding were 200,070,419 shares on June 30, 2021, compared to 193,378,996 on December 31, 2020. The increase during the six-month period ending June 30, 2021, is attributable to A, issuance of shares under the ATM equity program, totaling approximately 5.9 million shares, and some nominal issuance of, or surrendering the warranted stock options totaling 5.9 million shares. And lastly, based on our current operating plans and expected access to additional equity financing, ABBEO expects to have cash and cash equivalents, along with access to external sources of liquidity, sufficient to fund research and development programs and business operations through the fourth quarter of 2022. And now I'll turn it over to Mike Macaluso, ABBEO's president and CEO, who will provide a corporate update on the overall business operations.

Thanks, Dan. I mean, I understand there's pressure on our sector and more personally on our stock, Let me share some positive truth on what's going on here. What is the status of AP013 Oak phase three study? Consistent with our ongoing public communications, the Oak trial was paused in April 2020 because of COVID-19. Since then, we have worked diligently with the FDA to gain better understanding of our viable options to preserve the study results to date, which include keeping the special protocol assessment or SPA in place. One, by adding more patients after the pandemic is over, or two, implementing the sensitivity analysis, which is basically a mathematical formula to minimize the impact of COVID-19. I have gone back and forth on which option to select and the circumstances and timing associated with that decision. We have decided to proceed forward and unblind the study, utilizing the sensitivity analysis to eliminate any bias from the pandemic. And I'll let Holly give you more details on this in a few minutes. The next question is timing. When are we going to do this? We have decided to do this as soon as the data has been properly cleaned and validated, meaning all queries have been addressed and answered, and the patient response data is properly reflected in the database. That's a requirement of the FDA. Ordinarily, this process takes several months. The ongoing pandemic has continued to add complexity towards completing this process, including the collection of data. After spending, already spending many months and incurring considerable costs, we expect to have this quality control or Clean data validation process finished later this quarter. And I'll give you a better clarity of the timing of the annual meeting, but hopefully August, early September will be done with that, but I'll update at that time. Validation process finished later this quarter with results released to the public shortly thereafter. Those results will be unblinded and shared with the public. Interested parties, who would that be? Potential partners. and later with the FDA. Of course, the FDA requires much more detailed investigative paperwork. All right, so just, again, to clarify, again, we will run the clean data through the mathematical filter, and at that point, the blinded data will be unblinded, and we'll share it with the public. I think that's pretty clear. Okay, now let's move to the phase two inhaled Ampion study, AP019. Recall several weeks ago we announced that we received regulatory approval to expand the enrollment of our AP019 Phase 2 study to India. As noted in the press release, India is not a separate trial, but rather an extension of the inhalation study that has already started in multiple hospitals in the United States. Some of you have been asking me, Mike, what's taking so long? Of course, I ask the same question every day. but in actuality, the response is simple. It's not taking any excessive length of time. India, similar to the United States, has very lengthy regulatory process similar to that of the U.S. as it relates to getting a hospital clinical site under contract, which includes receiving approval for clinical trials to be conducted, as well as regulating the sale and importation of drugs for the use of clinical trials from the Drug Controller General in India. Like the U.S., this process can take four, five, six months to get completed. The good news is we started this months and months ago, including the appropriate regulatory and import filings. In addition, we also needed agreement from the FDA to accept the clinical data from India for inclusion in the overall clinical trial results so that we could apply it to an emergency use application and eventually approval before we started the process. So before we could even think about India, we had to get the FDA to accept the clinical data we received there. We received confirmation in writing from the FDA to proceed. We currently expect to run this trial in seven to 10 hospital sites in India and finish enrollment, even with a slow start, faster than we would have if we focused the entire trial in the United States. So the purpose of going to India, enrolling 7 to 10 hospitals, will give us a result much quicker than if we just did it in the United States. As previously stated, the Phase II inhalation study is already treating patients. So the India study is an extension of what we're already doing, as are the Phase II IVs. and the long hauler studies. All these previously referenced studies are listed on clinicaltrials.gov. On clinicaltrials.gov, we estimated completion by December of this year. Now, obviously, with the addition of those sites, it could go sooner or take longer. We'll update that as we go along, but as right now, we'll sort of stick with that. Also, Amplio recently engaged a global strategic advisory firm to assist us with our partnering objective. Consistent with previous communications, we continue to be engaged in ongoing discussions and we'll expect these discussions to continue. And this is a new group, by the way, a very scientifically focused group. This is not the group we had before helping us, and they will focus on oak, of course, but also on OA and also inflammatory conditions, or to simplify the whole platform and the turnkey opportunity. So this is a new group for us to help us do what we're trying to do. One of the questions I continually get asked is, what is the expected timeframe to find the right partner or set of partners from both a domestic and global perspective? We asked the experts that are engaged in seeking and executing the partnerships, and I received basically the same consistent response as I would expect. Simple, right? However long it takes to find the right partner that see the benefit of the platform and provides a deal structure that we're willing to accept. And while we're going through this partnering process or discussions, we continue to add evidence of the platform potential so that there's no slowing down. So I'll let Holly sort of update you more clinically on what's going on and specifically with the trials, and then I'll pick up at the end.

Thank you, Mike. Thank you, everyone, for joining us today. Now let's walk through the details of the updates Mike just provided. As the Wall Street Journal reported in July of this year, we are nearly a year and a half into the COVID-19 pandemic, and researchers are still struggling to find effective, easy-to-use drugs to treat COVID-19. The COVID-19 public health emergency has disrupted clinical trials, medical practice, and patient care with unprecedented impact. By definition, a public health emergency in and of itself is an extraordinary event which is determined to constitute a public health risk through the spread of disease and potentially requires a coordinated international response, which implies a situation that is serious, unusual, or unexpected and carries implications for public health beyond the affected state's national border, and may require immediate international action. This has clearly been true for the Ampion clinical programs. Ampion is currently positioned as the first novel mechanism of action in osteoarthritis for OAK in quite literally decades. To our knowledge, Ampion is also the latest phase development asset in OAK. As such, we have worked closely with the FDA on the development path for Ampion and received detailed guidance from the agency on the steps needed to move the program forward during the COVID-19 public health emergency. Additionally, the FDA recently published a sensitivity and supplementary statistical analysis guidance in May of this year. We have incorporated this feedback into our approach with the OAK program and will perform a sensitivity and supplementary analysis to account for the impact of the COVID-19 public health emergency on the OAK clinical trial. And we expect to report those results to the public as soon as they are available. Many of our clinical sites utilized for the OAK study have been opened to allow study monitors or personnel to verify the data that is entered into our clinical database for analysis and presentation to the FDA, such that on-site visits are now occurring and we are steadily moving forward to verify or clean the clinical data for analysis. Once that activity is complete, the data will become frozen or locked, such that no additional changes will be made to the data entry from sites or patients, and the data will be ready for analysis. We look forward to analyzing the data in the timeline Mike just provided. Simultaneously, our active research and development team correctly identified an application for the anti-inflammatory mechanism of Ampion in COVID-19 patients. We reported that a Phase I study of inhaled Ampion reduced all-cause mortality by nearly 80% in hospitalized COVID-19 patients compared to standard-of-care treatment alone. This improvement was seen across clinical markers, including an improvement in oxygen use and decreased length of hospital stay. This data was presented to the FDA for Guidance of Potential Emergency Use Authorization, or EUA. The FDA provided detailed feedback on a Phase II clinical study for inhaled and for intravenous, or IV, Ampion treatment for COVID-19 patients. Both studies are actively enrolling patients in the United States, as Mike just discussed. Additionally, the FDA approved the expansion of inhaled Ampron to clinical sites in India. The company has engaged a global CRO to support expansion into India and is actively working with the Indian Regulatory Body, the Drugs Controller General of India, or DCGI, on the inhaled Ampron program for COVID-19 patients. We expect this expansion to shorten the timeline for overall study enrollment and potentially assist one of the world's highest density population of COVID-19 infections. At the same time, we are actively developing inhaled Ampion for at-home use and have launched and are enrolling long COVID patients in a phase one study of at-home inhaled Ampion. As reported in Nature Biotechnology in July, there is no known effective treatment for long COVID, which presents a potentially large untapped market and treatment gap. Ampion has a novel mechanism of action, which makes it uniquely positioned as a potential treatment for long COVID. Additionally, as we continue to present the Ampion data in scientific forums and peer-reviewed journals, next month at the 63rd Annual Thomas L. Petty Aspen Lung Conference, Ampio will present in vitro studies that indicate Ampion regulates cellular transcription to reduce inflammatory cytokines, such as tumor necrosis factor alpha, IL-1 beta, interferon gamma, IL-6, et cetera, along with the recently completed phase one clinical trial results of inhaled Ampion versus standard of care alone in COVID-19 patients. Prior to launching this initial study in humans, Ampio undertook preclinical research to establish the safety of inhaled anti-inflammatory Ampion treatment. The FDA identified a need to assess the no observed adverse effect level in animals with Ampion via inhalation as the intended route of administration. The company was able to work with the FDA to design, perform, and assess the potential local toxicity to the lung and other respiratory tissue at a range of inhalation doses in a study. The company will present this data at the American College of Toxicology's 42nd Annual Meeting in November. As a platform therapy with a novel mechanism of action, Ampia may have application in several inflammatory diseases, In October, at the 14th International Congress on Systemic Lupus and 6th International Congress on Controversies in Rheumatology and Autoimmunity, Ampio will present evidence that treatment utilizing Ampion suppresses toll-like receptor 7-8 signaling in monocytic macrophage lineages and suggests a role for Ampion in treating the dysregulation of these pathways observed in lupus. I will now turn the call back over to Dan, who will moderate questions and answers.

Thank you, Holly. Catherine, do you want to go ahead and give directions again for Q&A?

Certainly. Ladies and gentlemen, the floor is open for questions. If you have any questions or comments, please press star 1 on your phone now. We ask that while posing your question, you please pick up your handset if listening on speakerphone for optimum sound quality. I would now like to turn the floor back to Dan while we poll for questions.

Thank you, Catherine. I did receive a set of a few questions from Jonathan Ashoff from Roth Capital. He was not able to make the call today. His first question, and possibly, Holly, maybe you can give a response to this one. Has the Delta variant and or the vaccine hesitancy led to an increase in the rate of your COVID trial enrollment rate?

You know, Dan, per the Wall Street Journal in an article just published last month, quote, nearly a year and a half into the pandemic, researchers are still struggling to find effective, easy-to-use drugs to treat COVID-19. Ten drugs have been cleared or recommended in the U.S. for use. Two of those later had their authorizations rescinded after they failed to work. It's pretty staggering. Further, Dr. Janet Woodcock, acting director of the FDA, stated, quote, We had tens of thousands of people hospitalized around the country who were not getting enrolled into clinical studies. You know, American trials are often labor-intensive and time-consuming, requiring doctors to collect reams of data from patients. Contrary to popular belief, enrollment is not made easier, and there are several regulatory hurdles that must be overcome to provide patients access to care. We are working diligently to ensure patients have access to Ampion clinical trials, and we are actively conducting COVID trials in several hospitals across the country.

And the next question he had is, is the currently lower death rate from COVID versus the higher rate that it was more than six months ago complicating your ability to evaluate the mortality endpoint?

A lower death rate has always been the goal. The Ampsound study is designed to evaluate mortality, and it also looks at oxygen use, hospital length of stay, and overall clinical improvements. The study examines these endpoints in hospitalized patients, meaning we are still looking at severe and critical patients. The CDC reported that as late as March of this year, more than 40% of ventilated patients are not surviving, which is an astounding rate. In July of this year, a case study by the Washington Post showed that, for example, Missouri's case rate among unvaccinated people is as high as its overall case rate in mid-January near the state's peak of infection. Additionally, in this article, the post-adjustment for vaccinations revealed the rate among susceptible unvaccinated people is 91% higher than the unadjusted case rates reported on coronavirus websites and state tracking systems. With that adjustment, the national case rate for unvaccinated people is roughly the same as the unadjusted rate was more than two months ago, and it's rising. The national adjusted hospitalization rate has climbed to a point last seen in April, and the death rate is comparable to May's unadjusted figures. The article goes on to state that even though treatments are better than they were originally, a larger share of patients are ending up in intensive care, and the fatality rate for those patients remains high, stated by experts. Those are the patients currently enrolled in the Amsterdam clinical trials.

And Mike, this one's for you. What do you need to do to be comfortable viewing the unblinded Phase 3 OAK data to show a potential partner not materialized?

Well, we're unblinded. Dan, or Jonathan, who asked the question. Jonathan, we're unblinding the data. So we believe that good data will expand and escalate the interest. So we're unblinding the data. ASAP is no longer something we're weighing. It's happening, and we're going to do it as soon as possible.

Great. Thank you. Catherine, next question.

Your next question is coming from Jim Malloy with Alliance Global Partners. Your line is live.

Hey, guys. Thanks for taking my question. Could you walk me through, like if you could hear your voice, could you please walk me through sort of the unblind or continue the trial, the cost-benefit that you went through? I know we talked about it the other day, but sort of your thoughts on you came to the final decision to unblind and move forward. Can you sort of walk through how you came to that and edit the question?

Okay. You know, we were kicking it around back and forth whether we should wait to unblind. It's sort of, we have the biggest block of KL4 patients that we know of that exist in the world in our historical data. Now, that historical data is all one injection of Ampion, all KL4 patients, all randomized against saline. That's the biggest block of data. That includes every patient we've ever treated, and that data is excellent. So now we have a similar size trial that's sitting there blinded, that it's sort of like the elephant in the room when we're having our discussions. And rather than talk hypothetically to people, because I believe the data's gonna be good, based on not optimism, but historically, every trial we've ever done using those patients, has been effective and safe, I believe unblinding that data is going to help us create more interest and escalate what we're doing. It's complicated because the sensitivity analysis and guidance from the FDA has been ongoing. So it's not like we're working with guidance we received a year ago. We actually just received guidance, I think, the end of May, give or take a day or two, that really pushed us to help us make that final decision. So anyway, the debt we're going to unblind it. I'm looking forward to unblinding it and sort of taking that elephant out of the room so we're in discussions and also for our shareholders to be able to say, okay, this will be the fifth or sixth or seventh trial we've passed, which if I'm correct in making the statement, is more than all the currently approved drugs put together have passed. We're in a very difficult division, the OTAC division of CBER. So their requirements are much higher. But hopefully, with good data, this will be enough to put us over the threshold and move us forward. So I didn't really understand a whole part of your question. I talked a lot. I hope I answered it. No.

No, thank you. Just trying to get an idea of how you came to the decision to unblind and go forward with that call. And then just clarify, could you talk a little bit about, you know, hoping to have good data, obviously, and we're hoping that as well. Can you walk through what's good versus bad data? What do you expect to see? What are the equivalent data? And what's the clinically meaningful improvement you anticipate to see or hope to see when you unblind the data?

Yeah, well, I hope to see statistical significance. But also I would be happy with, A very, very strong trend. Remember, the trial was supposed to be 1,000 to 1,500 patients. I don't know exactly how many patients were going to pass through the filter until all the data is cleaned. My hope is that we have a similar number, if not a little bit larger, than our historic data. And therefore, we should have, could have, should have, enough evidence to show superiority, enough patients. So it really is just about being better than the placebo, having a safe drug. And remember, there is no approved. There's nothing to compare us to. It's not like we could look at steroids or hyaluronic acids as a comparator because they're not approved to treat the KL4 patients. So we're sort of in rare error by ourselves. Our goal, obviously, is the statistical threshold. And I'd be very happy with that, but also happy with a strong trend that's positive and that the trial is about a third the size of what it was planned to be.

Great. And the last question for me, talk about next steps. I guess, you know, assuming good data, and then I guess maybe assuming equivalent data, next steps, you know, for the drug, for Ampio.

Yeah, you know what? I hope that's not our decision, what we're going to do. Our goal was never to commercialize this drug ourself. Our goal was to put this in the hands of someone, hopefully with worldwide distribution. That's been our goal all along. Those are the discussions we're having. So I'd like to put that in the hands of a partner that has global representation and will manufacture the drug. and those market it and sell it.

Great. Thank you for taking the questions. You bet.

Catherine, let me take a few off the web, a few Q&A. First question I have is, I think, Holly, for you. Do we have a realistic timeline on when we'll be able to start distributing Ampeon in India?

Distributing Ampion in India. So I believe you're referring to when we're able to begin dosing patients in India under our current clinical trial. So the steps to move forward to do that, we've already identified the sites. We've already applied for an import license for clinical drug. And now we need the Drug Controller General of India, with whom we will be meeting shortly, to bless the study such that we can move forward. So we believe we'll be dosing this quarter. Mike, anything to add?

Yeah, I mean, the sooner the better. There's a lot of steps that we're involved in. We've covered most of them. What we need is an import license to send our drug. The hospitals are picked. There's a lot of hospitals. So a lot of work has been done. It's a matter of getting that done. And we're on the agenda that could happen any time within the next week or so to get that done. So as soon as possible, I wish I had a better answer, but I don't control, we don't control this. As soon as we can, we'll get it started. But we're all ready to ship the drug. Everything is packaged. We have the equipment. We have the nebulizers, all that's been ordered. It's here. It's boxed. All we need is a number to put on it, and it'll go. So ASAP.

Great. Thank you. Another question, I'll go ahead and answer this one. Will any of the potential partners, if you enter into a partner relationship, provide funding for Amplio? You know, funding or monetizing the platform is obviously part of a deal negotiation, and obviously partnering is different than M&A. Typically under a partnering type of an arrangement, you would seek some role of an upfront and milestones and royalty. So, you know, that's the best I can answer that question. And if and when, as talks materialize, you'll know more to be said on that. But that's obviously a path that we're looking for, for non-dilutive capital that has to be at the right price. Another question here, if there can be any more clarity provided on the lupus treatment.

Dr. B?

What is the question?

Can you please expand on the application?

Okay, yeah. So lupus is an autoimmune disorder. And one of the dreaded complications is what we call lupus nephritis, which is some kind of damage, inflammation of the kidney, or it leads to renal insufficiency and dialysis, etc. And what we know about lupus is that one of the factors involved is Toll-like receptor 7. And it's a Toll-like receptors are very specific receptors, fundamental in the innate immune system, that when activated do cause a cascade of inflammatory response. And we have identified that Ampion blocks TLR7 almost by 90%, which is a great, great result that could be applied to patients with lupus nephritis. So we are in the phases now of doing the preclinical research work on that. We're looking at animal models of lupus. And when we have results, we'll be able to convey to you. We are presenting at one of the large immunology and lupus meetings an abstract paper we wrote on the subject.

Thank you. Question here from Mike. Assuming you were to get EUA, how soon would you be in a position to produce products?

Immediately. Our factory is geared up. You know, that's a good question because we've been saying to people that our factory had capabilities beyond just making vials. So we could make anything. We used to say that. And people, pharma would say to me, prove it. And I would say, well, it's just obvious, right? We know we could do it, but I didn't have proof. The opportunity for us to just transition from OAK vials into IV, we started making the IV, filling the IV bags, and then the nebulized version, the snap-off caps, It was interesting because pharma wanted to know how we could make that transition so quickly. And we made it within a couple months, where ordinarily that would take a year or so. So like everything we do, we do it really quickly, and I believe very well. So we're ready to go. I mean, we have IV bags made, we have vials made, and we have the snap-off things made for the nebulizer made. And with emergency use, obviously, we'd have to increase production, but we'll do that really quickly.

Mike, I think that's it on the questions. Do you want to provide some closing remarks?

Sure. You know, we have a lot going on with a handful of people. It's amazing what we accomplished. We have three clinical trials going right now in multiple states and countries. We have quality discussions going on with pharma. What does that mean? It means that the first thing pharma looks at when they come into our data room is the data, right? That's what they look at. Is our data good? Is it good enough? Is it what they're looking for? I can tell you if they don't like the data, that's one day in and out of the data room and they're gone. That's never happened. So then the next thing they're looking at is the FDA correspondence. Does the FDA correspondence tie to our data and tie to what we've said publicly. Again, if there's complications with that, we're out of the data room. It goes on from there to manufacturing, to commercial opportunities, et cetera, et cetera, et cetera. I won't bore you with all this. But we're having quality, ongoing discussions with pharma. And that's important. And we think with our new group, that's only going to improve. We have multiple presentations that Holly referred to, toxicity and lupus, Why is that important? Because it adds credibility and substance to the platform. We don't want to talk about just OAK anymore. We want to talk about OA and a platform technology, and everything we're doing supports that. Of course, the unblinding of the data under FDA guidance, that's no small task. The sensitivity, I couldn't even read to you the formula for the sensitivity analysis. It looks like something Einstein would have on a major board, right? So we're running all of our data through that. It's complicated, but we're in the process now of finalizing that. We have cash, so we're not desperate to get a deal done. We're in a good position there. And Dr. Bauer's research, it's ongoing on rare children's diseases and inflammatory kidney disease, animal studies that are coming up to support that. All those things we're doing, again, support the platform technology. So there's no one sitting here moseying along, trying to figure out taking our time. We're sprinting, we're moving quickly, we're being fast, we're being quick. But as the great John Wooden said, we don't want to be in a hurry. So we're taking our time as we quickly get things done. So I'm proud of what we're doing, what we're accomplishing. We're making progress every day to accomplish our end. And that's where we are. So thank you for the time today. And if you guys have any other questions that you forgot or we didn't get to, email us and we'll be happy to answer them.

Thank you, ladies and gentlemen. This concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.