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

August 25, 2022

NASDAQ US Health Care Biotechnology special 40 min

Earnings Call Speaker Segments

John Heerdink

attendee
#1

Good morning, everyone. This is John Heerdink, and I'm the founding member of Tribe Public. And also, as many of you know, the managing member of Vista Partners, a registered investment adviser in San Francisco. I wanted to thank you all for coming in from around the world, representing close to 30 countries now that are members of the Tribe and growing. Thank you from some new members out of Saudi Arabia, some members out of England that came in here in Netherlands and, of course, all across North America, and thank you for all the Americans for jumping in here today. We're looking forward to meeting with the management team of Atossa Therapeutics, trades on the NASDAQ, symbol ATOS. And we have both the CEO and CFO of Atossa Therapeutics. [ I ] want to allow them to introduce themselves. First, I want to point out that there are 2 websites that I have to point you to for disclaimers as I'm an investor in the company and an adviser. We have at Vista Partners, please visit W-W-W-V-I-S-T-A-P-G-L-O-B-A-L, dot-com, vistapglobal.com; and then at Tribe Public, T-R-I-B-E, public, dot-com, P-U-B-L-I-C-K -- C, I'm sorry, dot-com. Reminder that this presentation came about because of you. The Tribe members wanted to speak with management of Atossa, and you expressed your interest through the wish list and have registered today. And I appreciate your participation and look forward to having both you and the management team of Atossa Therapeutics to come back as we progress. And I'll invite Kyle Guse, the CFO and General Counsel of Atossa to begin. Thank you so much. Kyle?

Kyle Guse

executive
#2

Great. Thank you very much, John. It's a pleasure to be back here. Again, I'm Kyle Guse. I'm the CFO and General Counsel of Atossa Therapeutics. I've been with the company about 10 years. Before that, I spent most of my career doing biotech, M&A and capital markets work in Silicon Valley as a lawyer. I hold an MBA and a CPA and a JD degree in law. Dr. Quay is also on with us. Steve is the founder of the company. He has a PhD and MD. He did his residency at Mass General, which I think is Harvard's largest teaching hospital. He did post-doc work in the MIT, in the lab of a Nobel Prize winner. Steve started about half a dozen companies. He has about a half a dozen products that he has invented and taken through FDA approval, probably most famously gadolinium, which is a contrast agent, which has been used, I think, over 70 million times and is currently owned and marketed by GE Healthcare. Before we jump into the slides, maybe, Steve, you can just tell people what the story is behind starting Atossa because I always find it interesting how people start companies. And so maybe we can start there, and then I'll jump into the slides.

Steven Quay

executive
#3

Yes, happy to, Kyle. And John, again, thank you so much for hosting us today. So I had this first slide up here Atossa Therapeutics, and you see this profile of a woman. It turns out to be Princess Atossa. So the story of the founding is pretty simple. About a decade ago, I was at the UCLA library doing some research around the discovery of the Pap smear for cervical cancer. George Papanicolaou, a pathologist from New York City, had developed a way of looking at scrapings of the cervix under the microscope and not being able to see cancer but be able to see the 10-year process that cervical cancer went through before it actually became cancer. And I remember the day as like it was yesterday. I said, "Why isn't there a similar test for breast cancer?" So Atossa was launched with that as our aspirational goal to basically identify the precursors to breast cancer and to intervene in that 10-year period of time. This has led me to invent Endoxifen, which you are currently using in mammographic breast density studies in Sweden. We're now with the FDA, looking at additional indications for Endoxifen. But every great story has a first step or every journey has a first step, and that was how Atossa got started.

Kyle Guse

executive
#4

Thanks. Thanks, Steve. Why don't I jump into the slides here? Atossa, of course, is a NASDAQ public traded company. Please refer to our SEC filings before making an investment. So Atossa Therapeutics is a clinical-stage biopharmaceutical company, is seeking to develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases. And we're currently focused on breast cancer and COVID-19. Corporate summary. We're headquartered in Seattle, Washington. As of the end of June, we have no debt. We have $126 million in cash, which is multiple years of runway based on our historic burn, and I also produced a snapshot of the cap table here to simplify things for folks. Essentially, we have common shares outstanding and some warrants around the money and some convertible preferred, so pretty straightforward cap table for a biotech company. Our management consists of Dr. Quay and myself, also Dr. Heather Fraser, Delly Behen and Heather Rees. Each of the members of management have decades of experience in biotech. So let me jump in by talking about the pipeline here a little bit. On Endoxifen, our lead program, we have a Phase II study under way in Stockholm, Sweden, where we are using our Endoxifen to attempt to reduce mammographic breast density. We are also in the process of starting a Phase II study here in the United States in what's called the neoadjuvant setting, which is where women who have breast cancer, but it's before they go in for their surgery. Now this will be the first study in Endoxifen that we've conducted in the United States. So this will be a major event for Atossa to bring a Phase II study here in the U.S. with Endoxifen. We have also recently completed a Phase II study down in Australia in this neoadjuvant setting, and the success from that study is really the impetus for us continuing the development here now in the United States. We also have our inhalation therapy drug, which we also call AT-H201. We recently completed a Phase I study with this inhalation therapy, and we have recently announced that we're going to shift the focus of this therapy to address compromised lung function, which many cancer patients suffer from, particularly from a radiation therapy Dr. Quay will talk more about that in a minute. And then finally, we have our COVID-19 nasal spray program, which we also call AT-301. So I want to talk on the market opportunities here because our philosophy has been that if we're going to work on something, we'll work on something with a big market opportunity. So oral Endoxifen in this neoadjuvant setting, again, which will be -- the next step for that will be a study here in the United States. That's for ER-positive HER2-negative breast cancers. Each of those categories consists of about 80% of all breast cancers. So that's a patient population of about 200,000 here in the United States. The mammographic breast density that indication is also very large. There are about 25 million women in the United States that have breast density and that gets reported to them now through mammography. So women goes in every year, every 2 years, they have their mammogram, and it is now a law in the United States that, that woman be notified if she has a dense breast tissue because it's a significant health concern. And then we also have our nasal spray for COVID-19 at-home treatment. That, of course, is an enormous potential patient population I checked this a day or 2 ago, and there are now almost 600 million reported, reported cases of COVID-19. Obviously, there are many more that have gone unreported. And finally, our inhalation therapy for lung injury caused by cancer treatments. This is a surprisingly prevalent about 30% to 40% of lung cancer patients suffer from lung injury caused by the therapy. So those are the markets. At this point, why don't I turn it over to Dr. Quay and so you go ahead and I'll drive the slides from here.

Steven Quay

executive
#5

Okay. Great. Thanks, Kyle. And for those who are following maybe on the website, we're on Slide 9. So breast cancer is obviously a major problem. It's -- 1 out of 8 women will experience breast cancer in their life, again, about 281,000 diagnosed in the U.S. And as Kyle indicated, the most common of the 4 or 5 different types is ER positive, which is about 200,000 in the U.S., much closer to 1 million worldwide. And it's the second leading cause of cancer death in American women. Next slide, please. So if you think about the care path for breast health, which begins with prevention, goes to the neoadjuvant or a window of opportunity. This is when the at the time of diagnosis, treatments are sometimes used. And finally, the adjuvant setting when radiation and surgery has been done and now we're in the mode of trying to prevent local recurrence and metastatic disease. So in the area of prevention, just like the Pap smear identifies not cervical cancers but the precancerous changes, mammographic breast density does the same thing in the breast. And so doing a study in Sweden to see can we reduce density? Because we know in women where density is reduced by -- in other ways, their risk of breast cancer also goes down. And then looking at the durability of that change, once it does go down, can the women come off drug and maybe you basically reset their lifetime risk. Now the second group is women, who are newly diagnosed. There's this period of time and sometimes called a window of opportunity between the diagnosis. So they've had a mammogram or a physical exam. There's a lesion. There's a needle biopsy. It's been put on the microscope, and we know it's ER positive. Surgery radiation is then 2 to 4 weeks, 5 weeks maybe into the future. And during that period of time, we want to treat those cancers to stop the growth of the cancer even before we get to the definitive surgery. So this neoadjuvant window of opportunity is something that surprisingly is not available for most ER-positive breast cancers, definitely available for HER2 positive, definitely available for triple-negative because they're more aggressive. But all the Endoxifen has the rapid PK, the rapid dynamic that allows it to get in the bloodstream fast enough to do something within that 2- to 6-week period of time. And finally, again, after definitive surgery and radiation, you want to keep the woman in the state where she doesn't have a local recurrence and she doesn't have distant mets. And that's called the adjuvant setting. And that typically is 3 to 5 years of therapy. Next slide, please. Next slide. So our Phase II study that will -- that we did in Australia was a precursor for what we filed with the U.S. with. It basically took women during the screening period of time and then treated them with Endoxifen for the period between their diagnosis and their definitive surgery. We were able to take a biopsy, of course, at the time of diagnosis. We had surgical specimens, and we could compare the tumor response. Was the tumor not reproducing in the presence of Endoxifen? Next slide, please. So the measure of whether a cancer is dividing is called Ki-67, basically is a percentage where the numerator is the number of cells that are dividing, 1 cell becoming 2, the denominator is all cells. You want to see a reduction of that as much as you can. And in a very quick time in our first 7 patients, 6 out of 7 had a 65% reduction in Ki-67, and it actually went below 25%, which meant only less than 1 in 4 cells was dividing. That's been shown in the past to be very predictive of what happens 2 to 3 -- 2 to 3 years into the future. So we met both a statistical -- strong statistical signature of reduction and a strong clinically significant signal reduction in all patients getting below 25%. This trial was designed by our statistician to have gone much longer because we expect that we might not get a strong an efficacy effect. We got such a strong effect. He said, look, we've proven that Endoxifen works in this setting. Let's pivot to a definitive trial in the U.S., and that's where we are right now. Next slide. So our goal is obviously to conduct this additional study in the U.S. We filed a protocol in the U.S. with the FDA, got some feedback from them, are responding to that feedback now in real time, and we'll be updating you in the next few months on what our progress is. And when we do that, we'll lay out who the lead investigator is, who the sites are and those sorts of things. Next slide. So we've talked about mammographic breast density, but what is it? Well, as shown here, there's a slide -- a picture of a mammogram on the left with a cancer shown as a small discrete white spot. The mammogram on the right is a woman who may or may not have breast cancer, but definitely has what's called mammographic breast density. Translation, her breast is mostly white. And some radiologists said, finding cancer in that breast is like finding a polar bear in a snowstorm because it's a white cancer dot that you're looking for on pack on the top of a white background. What we want to do is reduce that. Next slide shows the trial design is being done at the Karolinska Institute in Stockholm, Sweden by Dr. Per Hall, who has one of the largest collections of women, over 70,000 women who have underdrawn various investments collections and histories for whom companies like Atossa and many other companies, frankly, around the world, leading biopharmaceutical companies go to him to do clinical trials. And he's a very sought-after investigator. He's very excited about this trial among all the things he does. Next slide. So now pivoting to the inhalation therapy, what we call AT-H201. We have now completed the Phase I trial to show that this is safe under the conditions that we'd like to use in the clinical setting. And in doing the Phase I trial in Australia and then listening to clinicians, frankly, the clinicians came to us and said, "Look it, this looks extremely safe, and it looks like it could be very valuable in an indication for which we really don't have much clinical opportunity." And that is the iatrogenic or physician-induced lung damage that occurs in radiation -- when radiation is given to the chest for lung cancer, mediastinum cancers, esophageal cancers and the like. So the oncologists, they get a little bit of tunnel vision. So their focus is, can I kill this cancer? And then when the cancer is dead, I hand the patient off to the other physicians. But in that pass-off, the internal medicine doctor, whoever that patient goes to is now stuck with a patient, who may have significant reductions in pulmonary function because of the very therapy that probably saved their life. The question is, can we both save their life with the radiation, but prevent the damage to the lung by an intervening nebulized formulation. And the clinicians think this has -- meets the criteria being something that's very much worth testing. Next slide. Dr. Paul Wabnitz is the physician, who came to us and really championed that we should do this. And I'm reminded of a doctor at UCLA, who came to the Genentech's Board of Directors when they were going to kill a particular antibody drug for breast cancer and pounded the table and basically said, look it, you need to develop this for HER2-positive breast cancer and of course, the most successful breast cancer antibody in the history came about from that interaction. Paul came to us in much the same light. He said, "Look it, I've just been your monitor for your Phase I study with this drug." But he really likes the safety profile, but I've also done some research. I think this has important legs in another indication." So we are now putting together a protocol to actually address that, where we'll take patients who are going to have radiation for some cancer in their just cavity. And immediately after, we'll pivot to a placebo-controlled trial of intervention with our nebulized formulation with the endpoint being can we reduce the damage to the lungs. Paul is an esteemed executive, MD, PhD, also from the Ann Arbor area where I went to University of Michigan. He was at Parke-Davis, Pfizer, there for a long time and is now back in his -- in Australia. But the next slide, I think, is the very telling slide because this is what an oncologist cause a major success. In the left panel, you have a chest X-ray, CT scan of a patient with a discrete white circle in the right lobe, which is a lung cancer. So this is before radiation. The picture on the slide on the right is 1 year later, same image, same section through the chest CT. And what you see now is a lot of white scaring. It almost looks like the tumor is still there because it actually got bigger. You also see the lung, the black part of the lung pulling away from the wall of the chest, the bony part of the rib cage, the oncologist says, this is as good as it gets because this patient probably would have died and I've saved his life. His internist is saying, well, yes, but he now has only about a 30% lung capacity of a normal person, which we didn't have before that radiation. Next slide is even more telling. So a lot of lines and colors, but I'll focus on just the A panel on the left on the top, where you have percents from 100 to 0 on the Y-axis and you have months on the X-axis, 0 to 72 or about 6 years. If you look at the yellow one in the middle, you actually see patients having about a 50% 5-year, 6-year survival for their -- these are patients with lung cancer that are treated. Did they die of their lung cancer though. That's the question I want to focus on here. No, they die of the ancillary damage to their lung that occurred because of the radiation therapy. So this is an oncology success, but a collateral damage failure. And this is a really big population because even I wasn't aware of that 1 out of 2 people who die of lung cancer 6 years out, didn't die of the cancer. They died of the reduced lung capacity, pneumonia or other side effects from the treatment itself. This is what we want to address. Next slide. So what you're going to hear over the next few months from Atossa is, we're going to define the target patient population. We're developing clinical study protocols. This is an ongoing process. We meet several times a week in various groups to fine-tune this. We need to refine the API and make supplies for the study and identify any additional preclinical studies. We don't think there are at this point in time and identify a location for the next clinical studies and then file regulatory filing. So this will be a lot of activity for Atossa now and into the fall and into next year. Next slide.

Kyle Guse

executive
#6

Do you want me to take it over from here, Steve and wrap up the slides, and now we can go into Q&A?

Steven Quay

executive
#7

Why do we do that? Sounds good.

Kyle Guse

executive
#8

I'll skip our Board of Directors just in the interest of time here. Milestones coming up. So I'll start here at the bottom of the slide. I'm on Slide 23 for people following along. The study that we're conducting in Stockholm to reduce breast density is under way. And people are asking how far along is that study? And so we hear you, and we will provide news on that before the end of the quarter here, which is 5 weeks away. And what we plan on doing is provide an update on how many patients have enrolled in that study. It's a total of 240 patients and by telling folks how many have enrolled, you can kind of see the trajectory that the study is under aiming towards ultimate completion. Our other milestones coming up here like Dr. Quay was just explaining, we've shifted the focus of our inflation therapy now to compromise lung function caused by cancer treatment, and the news on that coming up. And then finally, on the neoadjuvant study in the United States, we filed an IND with the FDA to start that study here in the United States. We got feedback from them. They requested more information. So we're in the process of gathering that information and we plan on filing that information with the FDA by the end of this quarter, the third quarter, and then we hope to get approval to open the study in the fourth quarter. So we should have some very significant developments on that program coming up between now and the end of the year. And John, that's it for the formal presentation. I think we have a few minutes left for Q&A. And I know we've received a number of questions. So do you want to tee those up for us, John?

John Heerdink

attendee
#9

I think, yes. Thank you, gentlemen, for presenting the latest on Atossa. Yes, we do have a number of questions that the Tribe has sent in, which is part of this process to give you this direct corporate access to the companies you care about, in this case, it's Atossa. Let me start with the first question here in no certain order. And by the way, you tried but we don't get all questions answered today, if something else pops up, we'll look to get Atossa back on, so continue to express your interest through the wish list process at prior public website. First question is with regards to the inhalation delivery, is there a competing drug in the market now? If so, what is AT-H201 delivering that is unique?

Steven Quay

executive
#10

Yes. So that's a great question. I mean it is a proprietary formulation of 2 drugs that are previously FDA approved, but only one is for inhalation and the other is approved for subcutaneous injection. Its mechanism of action is unique in the effect that it has on pulmonary epithelium, which is where it has its action. And there is no currently approved drug or drug investigation that I'm aware of for the preliminary damage from oncology radiation to the chest. So we're really excited about this opportunity. It's a significant unmet medical need. As I indicated, oncologists don't see this as a problem, but certainly, the internist who take care of patients afterwards do. And it's hundreds and hundreds of thousands of patients.

John Heerdink

attendee
#11

Yes. Thank you, Steve. It's a follow-up and similar, and you've sort of answered this already, but we're going to go with it. It says, help us understand the shift towards compromised lung function patients. Can you give us a little more color there?

Steven Quay

executive
#12

Yes. Sure. I mean, look at -- I mean, Princess Atossa, the first woman with breast cancer recorded history. So we started as pure oncology company, preventing and treating breast cancer. And we've expanded into oncology in general. And I think that this fits exactly in that because you can't treat a lung cancer patient without causing the damage from that, and being able to provide a solution to that would be really gratifying.

John Heerdink

attendee
#13

Thanks, Steve. This next question says, how far long are -- is Atossa in looking at MBD enrolling? How many people do you have signed up so far? What can you tell us?

Kyle Guse

executive
#14

Yes. I can take all of that, John. Again, we'll provide an update by the end of this quarter, which is only 5 weeks away from now. An update on how many patients have enrolled. We're just not ready to provide an update yet.

John Heerdink

attendee
#15

Got it. Okay. Thank you, Kyle. The next question says, as for the AT-H201, now let's say you're redirecting the growth towards oncology, do they -- do you have to go back to Phase I since it will be used for something other than COVID?

Steven Quay

executive
#16

Another great question. But just a reminder, after having developed 7 drugs, I probably could do a master class on the topic. Phase I is always in normal volunteers, and it's always primarily looking at the safety of the drug. You can sometimes get signals of efficacy, but these are, by definition, people who do not have a disease. So Phase I will cover -- in almost 90-plus percent of cases will cover all of your future indications. And in Phase II is the first time you're getting into patients with the condition that you hope to get approval for. Phase II is to define all the parameters around that final trial design, so that you don't get surprised in your Phase III trial.

John Heerdink

attendee
#17

Got it. Thanks, Steve. Makes sense. With regard to oral Endoxifen, the Phase II FDA submission, how close is the company to meeting the delivery of the additional data requested by the FDA?

Kyle Guse

executive
#18

Yes. So again, we're in the process of gathering that data and supplying it to the FDA. Our published time line is that we will provide that by the end of the quarter. And so I suspect when we sat with the FDA, we put out a press release to let people know where we're at. And our hope and expectation is that the FDA accepts what we will be sending them and that we'll then be able to open our study before the end of the year.

John Heerdink

attendee
#19

Okay. Thank you, Kyle. Next question is, why didn't you put the SAP back in place -- the SAB back in place? And can you speak a little bit more about Paul Wabnitz? And how do you submit the value he's going to drive by joining this?

Steven Quay

executive
#20

Well, sure. Look at -- I mean, everybody, including Atossa had a before COVID and during COVID and now hopefully an after-COVID phase. So we really wanted to emphasize being able to really get back together again in person or through Zoom processes. So reestablishing the SAB, we seem like a very good thing to do at this point in time. Adding Paul is just -- he has such an advocate for this process and is a deeply steep clinician in oncology, probably 15, 20 years of being an oncology doc, taking care of cancer patients, watching and being successful getting rid of the cancer and being unsuccessful having the residual lung damage. And when you saw an opportunity to fix that part of it, he is really excited about this.

John Heerdink

attendee
#21

Okay. Switching gears a little bit here. This is a question about the authorized shares and says, when will there be another boat to increase authorized shares?

Kyle Guse

executive
#22

Yes, I'll take that one. We don't have a date for that. I'd say we're evaluating and monitoring the situation, getting feedback from our investors and the investment community in general. I suspect at some point in the future, we'll put it back on the ballot and see what our stockholders are saying. I mean, ultimately, it’s up to our stockholders. So management thinks it's the right thing to do, but it requires a stockholder road. So at this point, we're just -- like I say, monitoring the situation. We don't have a specific date on this when this might happen.

John Heerdink

attendee
#23

Okay. Switching gears again. Travis got us some interesting questions here. This one says, recently there was a major announcement with the intent to acquire a U.S.-based startup with licensing from a prominent U.S. adult and pediatric cancer treatment facility. Would you be able to shed more light on this acquisition or possible acquisition?

Kyle Guse

executive
#24

Yes. Thanks, John. It's a good question. We don't have more details to provide right now. We're in the process of negotiating with this company to potentially acquire them or alternatively make a significant investment in them, so the diligence process is well underway. And that process is confidential and be really just premature to say anything more about it. I can say though that we're very excited about immunotherapy in the CAR-T space, in particular. I think that is an area of biotech that the investment community continues to be very excited about. And those companies were getting very nice valuations in general for the work that they're doing. And so we are constantly looking for ways to enhance our pipeline to grow our product pipeline in a way that will create stockholder value. And we think that this particular area, CAR-T cell therapy, is pretty compelling. And we do have significant cash on our balance sheet to finance a transaction. So more to come on that. As folks know, we have until November 1 under our agreement with this company. And so we'll have a news on or before that.

John Heerdink

attendee
#25

Got it. Switching gears back to -- I guess, back in the balance sheet you sort of spoke to. It says, since cash burn will be concerning the [ YMD ] acquisition, would you be able to provide any guidance?

Kyle Guse

executive
#26

Yes. Unfortunately, we can't, John. We just like most biotech companies, we do not provide guidance on cash flow projections.

John Heerdink

attendee
#27

Okay. The next question is any definitive timeline for a readout on the MBD trial?

Steven Quay

executive
#28

Yes. So I guess I'll take that. As a reminder, each woman enters the trial by having a mammogram and identifying here as being a high density to begin with. And then she goes into a placebo-controlled arm where she gets drug once a day for 6 months, gets repeat mammograms in that period of time to show the decline. And as she goes off drug and will be monitored for another 18 months to look for durability. If the density did go down, does it stay down. So all of that process is ongoing, and I think Kyle has indicated, we're going to make an update in the next few months on that program.

Kyle Guse

executive
#29

Yes. I would just supplement that by saying that, as Dr. Quay mentioned, is the dosing period for the study of 6 months. This is not your typical large, expensive cancer study where patients are followed for 5 or 10 years to see if they have a recurrence. This is enrolling quickly, the dosing is relatively short term at 6 months. And so we're excited about this completing and getting out data on it.

Steven Quay

executive
#30

Yes, Kyle, just one more thing on this. The vision we would have is that look at a woman would not think about her breast health until she's 40, has their first mammogram and then she -- we typically spend the next 20 to 30 years doing mammograms every other year. In our picture of the future, the women who are at high density at 40, the doctor would say, "well, I got some good news and bad news." The bad news is you had to increase risk of breast cancer. But look at the good news is there's this drug you can take for 6 months and in the clinical trials if we're successful, the doctor will be saying, it showed that it reduced the risk of breast cancer in this population. So you do it for 6 months, we'll check your mammogram if it goes down, we know you're in the group of people who will perhaps have a future benefit. So that's our vision of the future here. And again, that's 2 out of 3, 3 out of 4 breast cancers worldwide are in that ER-positive group. And they all come from high density. I mean, not every high-dense woman gets breast cancer, but all breast cancers keen from high -- from women who had high density at the time of their first mammogram. There's 10% of everything in biology violates whatever rule you make, but that's something you can kind of take to the bank.

John Heerdink

attendee
#31

Well, I personally, as you know, a long head and breast cancer and many of the relatives have known, and it's something that it means a lot to me and I'm wishing you the best success here in this in this exploration and looking forward to getting heads to the market very soon. The next question is what -- can you give us a status update on AT-301?

Steven Quay

executive
#32

Yes. Okay. So I think we've said before, the FDA wants some additional studies on this, and we're diligently doing those studies. And when there's a data readout, and we can talk about it, and we'll update you folks.

John Heerdink

attendee
#33

I think you sort of addressed this, but let's get it out there. So it's for AT-H201, is there any further pipeline update that you might provide at this time?

Steven Quay

executive
#34

I think...

Kyle Guse

executive
#35

Yes. No. I mean the pipeline is that we're going to develop it for compromised lung function caused by cancer treatment. So we don't have further details now. We're conversely not continuing the development in COVID patients.

John Heerdink

attendee
#36

Okay. Switching back to Endoxifen in the Phase II trial, can you give us any idea of how many locations, where these are for the trial, et cetera?

Steven Quay

executive
#37

Yes. I mean I appreciate the anxiousness to have these details. We think the best way to do this is to put them all out at the same time where we're announcing on the back of FDA clearance to begin the trial on the back of Institutional Review Board approvals to begin the trial, and then we'll lay that out. I think one thing we'll be adding at that point in time is an important point is we'll be using our patented Endoxifen for the trials, which is something which was recently achieved by the company. So it's always an important milestone to get patents around everything you've done at 88 patents. So this was -- well, the I said before is my 88 patents. So it's an important achievement for Atossa's shareholders and stakeholders.

John Heerdink

attendee
#38

Thank you, Steve. In respect of time and our sort of approximate 30 minutes sort of window, we've exceeded that a bit. Some of the -- and we've exhausted some questions that Tribe had sent. So I want to, I guess, put it back to you for any closing statements and then I'll think to drive after that. Can you -- is there anything else you'd like to add?

Steven Quay

executive
#39

I would just say again that the vision I had in the UCLA library a decade ago that a company could be developed that could make a major impact on most important cancer, breast cancer. And then because of your willingness to finance Atossa. We've been able to expand looking at immunotherapies or looking at other ancillary diseases like pulmonary damage in radiation. So we really appreciate the investors, who are along on this journey with us. And I look forward to the day when we can change the paradigm of some of these cancers in a major way.

John Heerdink

attendee
#40

Well, again, thank you, Steve and Kyle, for joining us today. And of course, all of the Tribe members that have joined us from around the world appreciate your participation, your questions and your expression of interest through the wishlist process. Please keep that coming. If we didn't, again, get everything answered today, we – please, again, express your interest in having Atossa back on through the wishlist at the prior public website on a go-forward basis. It sounds like we have an exciting fall and end of the year run here with Atossa, and I'm looking forward to your success. Again, remember the symbol is NASDAQ ATOS. And gentlemen, I appreciate the time and everybody today, and I will wish you good rest of the week and look forward to hearing more about your success in the future. Thank you so much, and we'll talk to you soon.

Kyle Guse

executive
#41

Thank you, John.

John Heerdink

attendee
#42

Thank you.

Steven Quay

executive
#43

Bye-bye.

For developers and AI pipelines

Programmatic access to Atossa Therapeutics, Inc. earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.