ATOS - NASDAQ

Good morning, everyone, and welcome to the Atossa Therapeutics Fourth Quarter and Full Year 2024 Earnings Conference Call. My name is Joelle, and I will be your conference operator today. All participants will be in a listen-only mode. [Operator Instructions] A replay of this call will be available on the Investor Relations section of the Atossa Therapeutics website after its conclusion. I will now turn the call over to Michael Parks, Vice President of Investor Relations at Atossa Therapeutics. Michael, please proceed.

Thank you, Joelle. Good morning, everyone, and welcome to Atossa Therapeutics conference call to discuss our year-end 2024 financial results and business update. The press release on these financial results was issued this morning and can be found in our Investors section of the corporate website at atossatherapeutics.com. On this morning's call, a team will provide a business overview of our progress in 2024 and recent events. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from those expressed and or implied by these statements. For more information on such risks and uncertainties, you are strongly encouraged to refer to our filings with the SEC, which are available from the SEC website or our corporate website. Any forward-looking statements represent our views as of today, March 25, 2025. Joining me today on the call are Dr. Steven Quay, Atossa’s Chairman, Chief Executive and President; as well as Heather Rees, our Chief Financial Officer. I will now turn the call over to Dr. Steven Quay for our business update. Dr. Quay?

Thank you, Michael, and good day to everyone joining us. We appreciate your time and continued support of Atossa during today's call, I'll provide an overview of our recent corporate developments and strategic priorities, as well as clinical progress updates on our lead program (

Thank you, Dr. Quay, and good morning, everyone. I will discuss our financial results for the full year 2024 period, which ended on December 31. On the next slide, I'll emphasize a few key financial highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our Annual Report on Form 10-K. In looking at our income statement, total operating expenses for the year were $27.6 million, down from $31.4 million in 2023, a decrease of $3.8 million. This reduction reflects disciplined spending in both R&D and G&A. R&D expenses declined by $3.2 million from $17.3 million in 2023 to $14.1 million in 2024. The key drivers were a reduction of $2.6 million in clinical and preclinical spending on our (

Thank you, Heather. We remain encouraged by our clinical progress and the broader potential of (

Thank you. We will now begin the question-and-answer portion of today’s call for analyst. [Operator Instructions] Your first question comes from Emily Bodnar with H.C. Wainwright. Your line is now open.

Hello, good morning. Thanks for taking my questions. I have a couple, but maybe just to start this one -- can you provide us some timing around when you'd be able to initiate a study in the metastatic setting and whether you are thinking about and starting with the Phase II study? Or is this going to be a Phase III study? Thank you.

Thanks for the question, Emily. Let me go ahead and take it, Michael and Heather. We are in the process now of consulting with a set of key opinion leaders will advise us on some of the nuances, some of the details in the metastatic setting. And then we will transition to discussions with the FDA in which some of these parameters were worked out. So it's a little premature to be talking about some of those details, but over the next, let's say, four months to six months, that will be the plan. So the KOL folks will weigh-in, and then we'll talk to the FDA.

Okay. Great. And then maybe on the EVANGELINE trial, could you just provide an update on where you are with enrollment of the trial and when we may see additional data from the 40 mg dose? And then separately, a question on the primary endpoint. So for the monotherapy, you said you're looking at [24-week 67] (ph) but in combo, only 4 weeks, so maybe just comment on why the discrepancy? Thank you.

Yes. So we'll be giving updates at some upcoming meetings with respect to enrollment and the interim data results. The primary endpoint difference has to do with the requirements around getting an early look at Ki-67 values at four weeks. And so that's why there is that difference in that particular arm of the trial.

Okay, great. Thanks for taking the questions.

Thank you.

[Operator Instructions] Your next question comes from Ed Woo with Ascendiant Capital. Your line is now open.

Yeah. Congratulations on the progress. As you continue or you pursue your metastatic breast cancer, do you anticipate pursuing it globally? Will you be also talking to European or Australian FDA counterparts?

Yes, that's a great question here. We are focusing pretty razor sharp on the U.S. FDA process because it's our opinion that if we can streamline that process and get full definition around the clinical trial, the parameters of the trial, the number of patients, et cetera, then and only then is it the right time to go outside to other major markets, if I could call it that. So 2025 is going to be a U.S. FDA focused year to get all of this part of it right. And I think you should assume those other kinds of markets and regions are going to be early next year.

Great, well, thank you for answering my questions and I wish you guys good luck. Thank you.

Thank you.

There are no further questions at this time. I will now turn the call over to Dr. Quay for closing remarks.

Well, thank you. I appreciate everyone's attention here and following us. 2024 was an excellent year, as you can see both clinically and financially, and 2025 looks equally exciting with a plan in metastatic breast cancer treatment with events coming up around meetings with the KOLs to define some of the parameters, the detailed parameters of a typical clinical trial concurrence with the FDA around what the proper design is and then we execute. So we thank you for your attention, and we thank you for your support for Atossa Therapeutics. And most of all, we think the patients were helping us with this path and hopefully, the patients we will help in the future. Thanks again, and we will end the call now.