Atossa Therapeutics, Inc. (ATOS) Earnings Call Transcript & Summary

[Audio Gap] And really embracing what we're about, which is connecting and giving this direct corporate access that is not usually available to many investors around the world to meet the CEOs, founders, CFOs, leaders of NYSE and NASDAQ companies that you care about. And thank you for being part of the process and forwarding your question today. And in this session, we have a Atossa Therapeutics and we have the CEO and Founder, Dr. Steven Quay, MD, Phd; and also the CFO of Atossa, Kyle Guse. I appreciate you gentlemen for joining us today as well. Gentlemen, we have literally investors from around the world from -- Dr. Quay [indiscernible] from the Far East to New York to Israel to Canada to all over the U.S. and beyond. I really appreciate all of you joining. Dr. Quay, would you start today by introducing yourself, a little bit about your background? You have a fascinating life, career, et cetera. And I do appreciate getting to know you so well over the years and I'm excited about Atossa and where you're headed to. But could you tell us a little about yourself today?

Sure, [ Ken -- John ]. And thank you for having us here. It's really a pleasure to be with the tribe, as you call it here. So yes, I'm Dr. Steven Quay, MD, Phd in biochemistry from University of Michigan. And then a postdoc in chemistry at MIT, while I was doing my residency at the Mass General. Talked for about 10 years at Stanford Medical School when I started my first company to commercialize the MRI contrast agent of the gadolinium that's now been used about 80 million times around the world. Now sort of a fast-forward to Atossa Therapeutics which I founded and which is dedicated to both infectious diseases and oncology and we're a clinical stage company. So it's really exciting to be here. We'll be telling you more about Atossa as we go forward here. I'd like to introduce my CFO and General Counsel, Kyle Guse.

Thanks, Steve. I hate following Dr. Quay because he has such an impressive background. I came to Atossa about 8 years ago. Prior to that I was a CPA at one of the big 4 accounting firms, and I spent 20-plus years practicing law at some big international law firms, where I focused on M&A transactions and capital markets work largely for biotech companies. And so that was my career before coming into Atossa. And now I am in charge of finance, accounting and legal for Atossa. So thanks, everybody for having us here. We look forward to answering, hopefully, many of your questions there.

For sure. Well, again, tribe, thanks for sitting and forwarding your questions today. I'm going to invite the company to tell a little bit about -- more about Atossa at the beginning. But a quick reminder, we're going to try to get this all done an efficient 30-minute session here. We've got a long list of questions. But if you do think of another, you can forward it through the Zoom tab and we'll try to get that on. If not, we'll look forward to getting Dr. Quay and Kyle back on maybe in the first quarter, if we don't get everything addressed today. It's okay. Companies are meant to evolve and so are your questions. Thanks again. But, yes, gentlemen, maybe Steve, could you start -- tell us a little bit about Atossa. A reminder everyone, Atossa is on the NASDAQ. Trades under the symbol ATOS. And so you can pull it up on whatever system you're using to check in with its financials, et cetera. Maybe, Steven, can you start with maybe introducing Atossa again and its programs?

Absolutely, John. So as a reminder, we are a clinical stage oncology and infectious disease company. As a reminder, clinical trials for pharmaceuticals involve 3 stages; Phase I, which is primarily safety; Phase II is your first test of efficacy and safety in the patient population; and then Phase III is the official trials that you do to support the labeling that allows you to market your drugs. After the gadolinium, I've invented actually 6 other drugs. So I've gone from sort of a white piece of paper and a pencil and drawing a molecule to getting FDA approval for 7 different drugs and formulations. So this is what I really have a passion for. So -- and with respect to oncology, our first program is in breast cancer, and our first program is to commercialize all of the aspects of a molecule called Endoxifen, which is proprietary to Atossa. We're really excited about the IP we have developed around this. And its function is to block the action of estrogen on the estrogen receptor, which is really important for about 3 out of 4 breast cancers. So this term ER-positive, you may have heard of this estrogen receptor. That's what the ER stands for. When you look into the microscope, you see positive cells. About 3 out of 4 breast cancers are ER positive. The good news is that many of those are well handled by current surgery, radiation and chemo or other therapies. But there's a very large subset that's frankly larger than maybe triple-negative or larger than HER2-positive of women who have ER-positive breast cancer, but there's other things driving it that make it grow more quickly and be more aggressive. And that's the unmet medical need we're focusing on. These Endoxifen molecules is quite unique. It doesn't structurally look at all like estrogen, but it fits the receptor better than estrogen or any other molecule that's ever been tested. So we really want to find the metes and bounds of what this molecule can do, not only in breast cancer but in other areas. The estrogen receptor itself is a modulator of many, many functions in the cell, and there may actually be opportunities for us to look for other roles for Endoxifen in the area of oncology. Specifically with Endoxifen, we have a program looking at its pharmacodynamic or its clinical effect on a biomarker in humans, that is mammographic breast density. So we've completed regulatory requirements and IRB approvals, and we'll be beginning to recruit a 6-month trial in Sweden, where we're looking at women who have high breast density as a starting point. So basically, they get a mammogram and their breasts are very, very white because dense breast tissue is white in mammography. And we're going to look in a placebo-controlled trial to doses to see if we can modify that density over a 6-month period of time. So we'll talk a little bit more about specific timing, but you've already heard me. We've covered some of the regulatory hurdles for that trial. It's 6 months long, we'll be talking about when we launch in a minute. Another important area is a little farther along, women who are newly diagnosed with breast cancer, ER-positive breast cancer. And there's a window of opportunity, a period of time between the diagnosis of their breast cancer and the definitive surgery or the beginning of some other therapy. And this window of opportunity is a time where you can test whether giving a drug allows a very quick action because you have sort of the perfect experiment in a clinical setting. You'll have a biopsy to prove the diagnosis. You'll have a 2, 3, 4 week or a few month period of time of treatment, then you'll have an additional biopsy, maybe it's an incisional biopsy to remove the cancer. And you now have 2 specimens that you can compare analytically with very, very good experimental controls. So this neoadjuvant treatment is very common with non-estrogen driven cancers. So for those 1/4 of women with breast cancer that are not ER-positive, there is very typically therapy given so if a woman goes in with their partner, significant other, gets your diagnosis, is now pretty upset about learning she has breast cancer, but given a prescription and will immediately begin treatment to modify the growth of that cancer. It currently is not what's going on with ER-positive and that's the unmet need we'd like to address with Endoxifen. We conducted a window of opportunity trial in Australia and frankly, powered it to do between 15 and 20 subjects -- patients, excuse me. And in fact, the early findings indicated that we really should stop that trial and move very quickly to enter the regulatory process in the U.S. And we're now going to have a meeting with the FDA to discuss some of the design issues around that trial. So 2 programs in breast cancer, although we have ambitions to be in broader aspects of oncology, mammographic breast density is a pharmacodynamic safety endpoint and then the neoadjuvant setting. And we have 2 programs in infectious diseases. Those are both focused on COVID and both focus on 2 different aspects of COVID. Now probably before I get into any of our programs, you want to know, well, we have this brand new variant. It seems to be spreading out of South Africa, what is its relationship with the therapeutics that were developed here at Atossa. And I think the answer -- the Twitter version would be, it's good news in the sense of being able to treat it. When we develop these 2 treatment formats, a nasal spray and a nebulized form, we focused on the single feature of SARS-CoV-2 that makes it different from all other beta coronaviruses and that is responsible for its increased infectivity. That's the pure [ and clear site ]. So if it loses that site, we don't have any experiments to know very well what would happen clinically. But all indications in a laboratory setting would be, if it lost that site, it would be almost non-infective. So targeting the site that's responsible for infectious means no matter what the virus tries to do with the other aspects of its surface, our therapeutics will still be able to treat it. The nasal spray program is finishing some nonclinical studies to support clinical trials. And we are gradually increasing the dose and frequency of the nebulized inhaled program that's being conducted in Phase I subjects in Australia. So probably more than people that know about the company in terms of an overview, but I want to be sure that I bring everyone up to the commonality of where we are as we sit looking at 2022, which is 2 programs in oncology and infectious diseases in the clinic and some really strong milestones coming up. I'll turn it back to you, John.

Yes. I guess -- thank you, Steven. It's very exciting, the breadth of research that you are conducting at Atossa. It's always fascinating me. And with your breadth of patents too that -- and intellectual property here, maybe you could speak a little bit more than that, but that is a potentially “gold mine” that you're sitting on as well that you brought to the table for Atossa. Could you speak to that quickly before we go to comp?

Sure. Yes. So again, having done as many companies and 7 drugs and FDA approved, I've obviously been involved with a lot of patents and they have 87 issued patents. So the value of the patent portfolio of a company really accrues behind the scenes quietly as the products develop. Because at the time when a company is sold to a large pharmaceutical company or a product is launched and major valuation increments are met, the foundation of those is the IP protection around the product. So it's kind of your back office, if I could call it that, for a pharmaceutical company, but absolutely essential. Because if you don't have your patent family in line and in place, it's a bit of a house of cards. So we have a very strong foundation here around IP around all our programs. It's really part of the culture of Atossa from the very beginning and based on my own success in getting 7 drugs approved and really generating billions of dollars of revenue for the drugs that I invented.

One of those 7 drugs, was it in the nasal spray form, if I'm not mistaken, you've had experience in that area, right?

Well, yes, yes. 2 of the drugs are nasal sprays. One is for anemia and one is for osteoporosis and they are currently being marketed by Endo Pharmaceuticals in various forms. So it is -- it was kind of a unique opportunity to get back into some of my prior experience because, again, I don't want to get into the weeds, but nasal spray formulations are a bit of the rocket science of pharmaceuticals, if I can call it that, because there's a huge amount of physics around the spray [ blooms ] that are generated using laser light scattering and density measurements and that sort of thing. So a lot of really hardcore physics and chemistry behind a pharmaceutical that is typically a biologic or a medical product. So it's one of the harder things to develop and it was grateful that I could bring to bear some of that prior knowledge to affect the COVID situation.

Fantastic. By the way, I probably should have mentioned instead of virtual gold mine, maybe cryptocurrency or bitcoin mining today. Maybe I should have mentioned that. It's amazing the world is headed here. But if you will, maybe skip over to Kyle, maybe you could speak from your perspective as the CFO about your cash position, et cetera. Maybe could you give us a little color on the -- Yes. Quick overview. As of September 30, we had $140 million in cash in the bank. We had no debt. And you can see each of the first 3 quarters of this year that we are burning about $4.2 million per quarter. So everything is relational. Our cash balance and our balance sheet is very strong. To put things in perspective, 12 months ago, we had $10 million in cash and $20 million market cap. So we have really transformed the company over the last 12 months and people should understand that. We get questions all the time about, well, your stock has come down off its 52-week high. What are you doing about that? That's bad? Well, okay, it's 300% down off its 52-week high, but it's also up 300% off its 52-week low. So I'd like to think of it as the glass half full there. We've really transformed the company into a multi-hundred million dollar market cap company over the last 12 months. Yes. Yes. Congratulations on doing that. It's exciting to see them. Excited to see with the $140 million reported, where you're taking this company and really the position that has put you in, one, from a development standpoint and even possibly from an acquisition standpoint, some ways I've seen biotech companies develop. And the main source is having the capital to go after it and the currency. And so excited to see where you're going to be taking this company. Let's get into some of the [ tranche ] questions here, if you will. The first one is, do we have any initial feedback from FDA for the 505(b)(2) filing for the [indiscernible] oral Endoxifen, if yes, what was it? I guess, Kyle maybe you could address that.

Yes. Our meeting is scheduled with the FDA in December and so we don't have that feedback yet. We have not announced a specific date in December because dates can change for unforeseen reasons. But we have the meeting coming up with them here in December and should have a response from them soon.

Okay. Great. So that's coming up real soon. December is around the corner. Why were the funds -- here's the next question -- why were the funds from R&D used towards stock-based compensation for employees? This is not a typical use of R&D funds. This is one of the tribe's questions.

Yes. I'll take that. I think there's a bit of a misunderstanding there. Stock-based compensation, by definition, is compensation based on stock, stock options, restricted stock, et cetera. It's not based on cash. And so I think there's a misunderstanding there. It's very common for U.S. companies to compensate its employees, including employees in the R&D department with noncash compensation, including options, which is what we do for all our employees. It's a way to conserve the company's cash and align the employees' incentives with the incentives of the stockholders, which is to create shareholder value. And so I think there was just a misunderstanding in that question. Hopefully, that clears it up a little bit.

Well, the great thing about, I think, this type of session is to really understand the value of the company but also disprove any sort of misunderstandings in the marketplace. So thanks for being available to handle these. The next one is the current 10-Q suggests that the $120 million will provide a runway of at least 12 months. Currently Atossa uses about $4.2 million per quarter, as you mentioned. Can you elaborate where the accelerated use of funds is going to be, specifically which trial or which pipeline? Kyle, I guess, that's probably directed towards you.

Yes. The reference to the 12 months in our financial statements is really an accounting requirement to make it clear that we don't have a going concern issue with the company. And so people sometimes see that 12 months and think, oh, you only have 12 months. That's not what it says. It says we have at least 12 months. And then the other part of that question, what are we doing to accelerate our programs and utilize some of that cash. I think the primary area of acceleration is in our Endoxifen program and particularly with our window opportunity or as we also call it neoadjuvant indication that we're pursuing. And so we're accelerating that in the United States. We're able to terminate a study early this year based on overwhelmingly positive results. We have a meeting now set with the FDA to hopefully get their input in December on the next steps for that program here in the United States. That's where we'd like to take the program, conduct future studies, and that's where we're really focusing our efforts in terms of acceleration.

Okay. Thank you, Kyle. The next question from the tribe was, why has the management PR been silent since the no vote. Now that the no vote to add more shares, which would have been used for partnership or not there, what's the plan? Kyle?

Yes. Yes, we've been mostly silent because I don't think there's a whole lot to say about it. I mean, our proposal was to increase our authorized shares for potential future uses and the stockholders according in the way the voting rules work to integrate with that. And so it didn't pass. And that's -- I'm not sure what else to say about it other than that. We are continuing to evaluate it, though, and -- including for a potential future special meeting or including the proposal in a future general meeting because as management, we do believe that having authorized shares that have not been spoken for is a necessary tool for a number of purposes. One is successful biotech companies typically do not ultimately succeed with the programs they started with, right, the collaborate along the way, they'll acquire new technologies. So how are we going to do that? Are we going to utilize our precious cash? Maybe, but it might make more sense to use stock to finance these potential collaborations, acquisitions, et cetera. And so these authorized shares are really to add a tool to the toolbox that frankly our competitors have. And we're at a competitive disadvantage if we can offer stock and finally. I mean, I would challenge people to find a highly successful biotech company that does not have authorized shares of stock that they can use. So part of my goal -- my job is to make us look and feel like a highly successful much larger biotechnology company. And this is one way to do that, to create some authorized shares to facilitate these future transactions.

Yes. I mean, John, if I can just [ slight ] in there after a few decades of negotiating these kinds of things. So, aid, not a typical situation. As you go out, you find some great technology and some bright young folks who have come up with it, and you want to bring it in-house. And maybe they want some money at the time that you do that particular transaction, but they want to be part of the growth of the thing they brought with them. And the way you do that is you reward them with stock from the company. So in a sense that their contribution, not only they get a financial benefit on the tie, the day of the transaction, but they get to have some of that benefit accrue. And it's -- I'm really kind of surprised, but that just didn't pass, given that this is so part of the fabric of biotechnology. But as Kyle said, we'll always continue to evaluate because we are always going to do what we think is in the best interest of the shareholders. That's what this proposal was, and we will continue to do that despite the stope.

It's my experience, gentlemen, and I've been at this for a while now, too. And as you know, and many of you know I have been on the banking side and the fund side and advisory side of this business and particularly biotech and pharmaceutical companies for 20-plus years now and I have seen this played out before. And one of the things that from my experience in evaluating these situations in the past is that the institutional world around this, typically, one has to vote because it's a responsibility. And usually, when they vote, they usually vote for approval when it comes to authorization. I know that your institutional base year-over-year has grown quite significantly. Could you speak, in this case, was the institutional crowd that voted? And I think all of them had to vote, did they primarily vote on the positive way? Can you speak to that or not, but I thought it might be an interesting point to make here.

Yes. I mean, I can probably speak to that. Institutions have a fiduciary duty in general, to vote on proposals. And so the voting turnout from institutions was much higher than from retail. Of the people that did vote, the vast majority voted in favor of the proposal. The issue was that not enough people turned out to vote. If more people would have turned out to vote the same ratio that they were voting when they did turn out, the proposal would have passed. Just to put a finer point on it, if we are talking to a potential business to acquire maybe another oncology program, and they are interested in participating in the upside and having equity in the combined company. It would be very difficult to tell them, well, our stockholders aren't going to allow us to issue more shares yet, we need to go back and ask for approval. We'll talk to you again in a couple of months, once that works out. I mean we're dead in the water with a strategy like that. So this is really a useful and I'd go as far as to say, necessary tool.

Sure. No, I would agree. I for one would say that, one of the things that we've all learned today is that; one, as a shareholder, we have a right to vote. One, just like a citizen of the United States or wherever -- country are in, if you have the right to vote, exercise it. First and foremost, that's the first thing. And the second thing is, yes, this is a growth company. Growth companies use shares to grow their company and they need authorized to do so. So hopefully, at some point, it's my personal wish that this happens sometime in the near future as well. Let's move on here, because we have a few more questions here and want to be efficient. Let's see, can you put approximate timelines for all items in the pipelines? I guess this is maybe directed to Steve.

Well, I can't -- but I sometimes know more than I should be talking about in this space. So I sometimes leave these questions to Kyle. But so we've spoken about the program in Sweden, which I think the next step is going to be beginning to recruit patients and coming up to the end of the year, that sometimes gets in the way of patient recruitment, but that's a very near-term event. We've spoken about a meeting in December with the FDA, giving us guidance around next steps for our U.S. launch of Endoxifen programs. We have a Phase I trial of the nebulized formulation in Australia, which we'll continue to give updates on. We've completed 2 cohorts and are now dosing in the third cohort, which is -- we increased the dose and we increased the frequency of the material. And then finally, the nasal spray program has nonclinical studies, which are being completed to allow us to begin clinical trials there. So I think a lot of milestones in the first half of 2022 and I think I can't emphasize enough that we are aggressively looking at additional programs in oncology and in infectious diseases to broaden our portfolio and to make use of some of the intrinsic assets we have internally.

Okay. Thanks Steve. Anything to add, Kyle, or you...

Well, we did update our corporate slide deck, which we always keep on our website, and we posted that this morning. So I would encourage people to look at that and read through it.

Okay. Just a point of clarification. It seems like there was a couple of questions with regards to the authorized shares. And why not do a stock split to get extra shares? Obviously, that's not -- maybe Kyle could speak to that, if you want, but obviously, could you just explain that, why that's not a possibility?

Yes. I suppose anything is possible. The sense I get from our stockholders, is that they don't like reverse stock splits and so, that has not been our first choice of ways to create more authorized shares?

Yes. Yes. Just had come up in the meantime, a few times, I thought I'd might well address that. The next question is, what has the increase in institutional investment done changed? Any insight for metro would be appreciated?

Well, we have seen institutional holdings continue to grow throughout the year. I mean, I think it's been driven by a number of things. One is, our significantly improved balance sheet, I think, is attracting more sophisticated institutional investors. I think the progress we've had with our programs, is tracking institutional investors. And I think conclusion on the Russell 2000-3000 has also attracted a lot of new institutional investors. And so we have seen a growth in that part of our shareholder base. 12 months ago, it was predominantly retail investors and we've seen a significant increase in the institutions.

Great. Back on the science side, who has Atossa contacted to help navigate the final 5b application for Oral Endoxifen. Can you divulge the name? A name Dr. Goetz keeps coming up, number of folks. Maybe could you speak to that, Kyle, I guess or...

Yes. I mean, we don't really comment on the names of the parties that we contract with. We largely have confidentiality agreements with third parties, and so we don't typically mention the name of -- I will call them vendors, but other parties to contracts with us. Dr. Goetz's name comes up, because he's one of the leaders in conducting research with a form of Endoxifen, and so we're following what he does very closely because it's absolutely supportive of what we are doing, with our proprietary Endoxifen.

And got it. Okay. So switching here to provinces, are you planning a similar 505(b)(2) pathway for AT-H201 and AT-301, or would you be going for approvals in Europe first? Any clarity here would help?

Yes. I mean, it's a little bit early to talk about the path for those programs. But as you know, a lot of the COVID vaccines and therapeutics took the emergency use authorization path, which is very common in this space. And unfortunately, for the way COVID is continuing to evolve, there's going to continue to be a strong need for therapeutics, perhaps new vaccines in this space. But it would be premature to talk about the pathway. Although if I -- if I had to bet right now, would be the emergency use authorization, which I believe is present both in the U.S. and there's a European equivalent to that. Non-U.S. equivalent to that. I think many countries have it on an individual basis.

Yes. I think you just answered this. But what is -- the next question is, what is the current status of AT-301? Per last update, there were preclinical trials to be completed before moving into Phase II, Phase I completed in January 2021.

Yes. Yes, we are continuing to do preclinical trials. That is the status of it. And when those are completed, when we can pivot to doing clinical trials, we'll speak to that.

Okay. Kind of a follow-on. Again, any updates at AT-H201 Phase II, what's going on? How is the enrollment? When do you expect to complete the trial?

Yes. So again, the trial is a nebulized version of 2 pharmaceuticals that have a synergistic effect, if I can call it that, on preventing the spiked protein to facilitate entry into H2, containing cells in the lung. So it's -- the design of the trial is a single dose in a group and then a safety panel, which I am an observer member of, as a physician and as the sponsor's physician. And then additional doses per day, getting to 3 doses per day, and then we'll be able to pivot into patients with COVID. So the trial is going along. We've had 2 meetings that have led to the conclusion that it was safe to go to the next cohort, the next higher level of dose and frequency. And we'll continue to update you, as that progresses.

And we do plan, John, to finish the part a of that study in the first quarter of 2022. So that's one of our near-term milestones, just finishing up the first part of that study.

Got it. Switching back to Endoxifen, when do you expect to complete the cellular oral Endoxifen in women with MBD? How is enrollment and any interim updates?

Yes. As I mentioned at the beginning of this, we will begin recruiting very soon, either in December or early January for the trial. It's a 6-month placebo-controlled double blind trial. So recruitment will begin at some point in time, and then each woman in the trial will be 6 months in duration. People said, well, why did you go to Sweden for a trial like that? The answer is that Dr. Per Hall is probably the world's leader in having a collection of women under study that he's had for almost a decade now, about 70,000 women, that he can bring into clinical trials in a very efficient fashion. And there's really very few places in the world, that have that particular set of features. So we didn't go there for any other reason, and the fact that we always look for the best investigators in our studies, and he was the leader in this particular space.

Going on with the Endoxifen, will you seek to partner in Endoxifen in 2022 to carry on or Fund a Phase III, if the 5, 5b process is not successful?

Yes. So I mean, the partnering decision is both a business and medical and science decision. But -- and again, we're always looking to maximize shareholder value. You typically can do that, some point after having some significant Phase II data and an understanding from the FDA with what the Phase III program will be, for ultimate approval. So everyone -- the accountants can sharpen their pencils and come up with a market potential. So that point in time, Phase II data completed, agreement from the FDA on what Phase III will look like. So the parameters around size and that. You can sometimes start that study yourself and partner during that. You sometimes partner at the beginning of that. But that's the kind of point you should be looking for Atossa seeking a partner. We're clearly not there. But 2022 is going to be really exciting with our neoadjuvant Endoxifen program.

Okay. Steven, I think you've already addressed the -- why you're doing trials in Sweden. Maybe, Kyle, could you speak to why you're doing trials in Australia?

Yes. I mean Australia offers a wonderful rebate for qualified R&D dollars spent there. It's $0.42 on the dollar spent there -- is sent back to us, by way of a check every year. So just to be clear, this is not a tax deduction. This is not a credit of some future tax as you owe. This is a check we get in the mail from the Australian government, for spending R&D dollars there. So that is a huge incentive. On top of that, Australia, maybe partially because of the tax incentive for the tax rebate, is probably one of the top 5 venues to conduct early stage studies in the world. They're very, very highly respected. They're very experienced in these early-stage studies. And so, those are the reasons we're doing the studies there, cheaper, faster, I guess, what I would say.

Makes sense. There's a follow-up question there. Are you not required to conduct trials here again, which will cost more money, take further time? So what...

Yes. I mean, I think our goal -- our broader goal is to bring our programs in the United States and get approvals in the United States. The question is how do you get there the fastest and by spending with U.S. dollars. The U.S. FDA will accept well controlled, well conducted studies in other countries. And so, we fully expect that the studies we're doing in Sweden or in Australia will be part of our FDA submission, and will be a valuable part of our package here, and by and large, accepted by the U.S. FDA.

Yes. I mean, John, we're following the path that I and other companies have followed, again for decades here, which is to do your Phase I trial in normals, in a place like Australia where you have English language documents and high-quality research. And then, maybe an early proof of principle, wherever you can get the most patients the quickest. And then you pivot at the end of Phase II, Phase III into the U.S. for approval. And this is exactly the playbook that I think the shareholders would appreciate and gets us there the quickest.

Makes sense. Here's sort of a summary sort of question, what would you tell investors in the near-term and long term, why should they keep invested in Atossa, in ATOS? And such that, that can support operations, you're feeling confident investors [ will get a ] return on their investment. How would you respond to that? That make sense?

Well, yes, sure. So I mean, a year ago, I mean biotech companies sort of have -- they have 2 fuels. They have money and they have ideas and products and that sort of thing. A year ago, we had great products and not much money. And now we have great products and a lot of money this next year. I mean, if you saw what we could do with $20 million in the bank in the last 12 months, I think you should kind of imagine what we can do with our current balance sheet and our current programs where they are. We've also obviously -- I've never had patient recruitment issues like we did during the COVID process, and that continue to pop up in new ways. So being able to advance clinical programs during the greatest pandemic in the last century, increasing our balance sheet. I mean, I think if a management team need to be tested by fire -- by the crucible of fire over the last year and come out on the other end, I think we stand in very good position for the next year, and the next year is really exciting.

Sure. Maybe it makes sense. It's an opportunity to sort of review your near-term milestones over the next -- from it's not like it's -- is my understanding as early as December here, you've got milestones on the docket here. Could you maybe review those?

Yes. I mean I can roll through those, John, and again, they're in our PowerPoint presentation we put up on the website. But these are milestones that are coming up in the next 30 days or in one case in the next quarter. So we will commence the Endoxifen study in Stockholm, Sweden by the end of the year. We will hold the meeting with the FDA about potential pathway for our neoadjuvant Endoxifen program. Here in the United States, we will have that meeting in December. We will finish Part A of our inhalation therapy, H201, as we call it, in the first quarter of 2022. So these are all very important, significant milestones, that will show that we're executing on our plan, and we're driving shareholder value. These are coming up very soon. So I don't mean to be too short term focused, but those are the reasons to stay in the stock, certainly in the near term. And for the longer term, for all the reasons Steve has been talking about.

Sure. Just a quick follow-up on the drugs. There's a question that just surfaced. Can there be any argument for -- that there might be an emergency approval for anything in your pipeline currently? What would you say to that? Is that a possibility from the FDA standpoint? Or...

Well, I mean, I guess it's -- to me, it's too speculative to be talking about the regulatory approval processes where they are. So I think you've already mentioned, that COVID therapeutics are likely to be first approved through the emergency use authorization, I think that's as much as I could say on that.

Okay. Quick question in regards to the Mayo Clinic. I don't know if you can comment on this or not, but they're doing a lot of research in and around Endoxifen. Is there any relationship or a possible partnership or any patent infringement possibilities? Anything of that nature around what you're doing and what they're doing?

Well, there's no current relationship and as I think Kyle has mentioned, Dr. Matthew Goetz is one of the world's leaders in moving and looking at the academic uses of Endoxifen in breast cancer and in other areas. And so it would be appropriate to be watching what he's doing, but there is no relation -- there is no current relationship with the institution or Dr. Goetz.

Okay. I think we've kind of summarized almost everything, and we've gone over the time that you've allotted. I do appreciate you guys allowing us to take a bit of your day and help us understand the growth and opportunities that you have with Atossa. I guess I would turn it back to you quickly, is there anything you'd like to say in closing this? And again, know the invitation's there. I know there's going to be questions that I missed today. We do apologize at Tribe, we'll do our best, but -- and do remind you that, if you missed anything in the early part of this, I'll try by later today, if not tomorrow, to get up the video on our YouTube channel at Tribe Public's YouTube channel, and you can review and/or view it, if you didn't get to see the whole thing, if you have others that missed, that you might want to pass it on to. Is there anything guys you would like to add in conclusion?

Kyle?

Yes, I mean, I would just say that we appreciate everyone's support. I mean, the things that we're doing at Atossa are truly remarkable. We're solving the world's greatest healthcare problems in COVID-19, in breast cancer. So we appreciate the support, and we hope you'll continue to provide support as our stockholders. It's critical to our success.

Yes, I agree, Kyle. I mean it's -- part of the reason we went over, is I hope you're sensing the enthusiasm we both have for the mission we're on, which is to save lives, to improve the quality of life for people with cancers, for people with infectious diseases, COVID, and we're going to continue to do that and we really appreciate the last year of support we've had. Our programs are strong. Our balance sheet is strong, and 2022 is going to be a very good year for Atossa Therapeutics.

Well, thank you, gentlemen. Thank you Tribe for joining us. Look forward to having you back on the program soon, and here's a wish for much success for you and Atossa and all of the shareholders. Thank you so much. Have a great rest of the week.

Thanks, John.

Thanks a lot, John. Talk to you later.