Q4 2024 Atossa Therapeutics Inc Earnings Call
Good morning, everyone and welcome to the Costar Therapeutics fourth quarter and full year 'twenty 'twenty four earnings conference call. My name is Joelle and I will be your conference operator today.
Joelle: Good morning everyone and welcome to the Atossa Therapeutics 4th Quarter and Full Year 2024 Earnings Conference Call.
Joelle: My name is Joelle and I will be your conference operator today. All participants will be in a listen-only mode, with a question and answer session following the company's prepared remarks.
All participants will be in a listen only mode with a question and answer session. Following the Companys prepared remarks.
Joelle: A replay of this call will be available on the Investor Relations section of the Atossa Therapeutics website after its conclusion.
This call will be available on the Investor Relations section of the auto Saar Therapeutics website. After its conclusion I will now turn the call over to Michael Parks, Vice President of Investor Relations at autos that Therapeutics Michael. Please proceed.
Michael Parks: I will now turn the call over to Michael Parks, Vice President of Investor Relations at Atossa Therapeutics.
Michael Parks: Michael, please. Thank you, Joelle.
Michael Parks: Thank you Joelle good morning, everyone and welcome to adjust the Therapeutics conference call to discuss our year end 2024 financial results and business update.
Michael Parks: Good morning, everyone, and welcome to a Tossa 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 investor's section of the corporate website at attosatherapeutics.com. On this morning's call, the team will provide a business overview of our progress in 2024 and recent events.
Michael Parks: The press release on these financial results was issued this morning and can be found in our investors section of our corporate website at Joseph Therapeutics Dot com.
Michael Parks: On this morning's call with the team will provide a business overview of our progress in 2024 and reason of events.
Michael Parks: 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 in 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.
Michael Parks: 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.
Michael Parks: 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 in or implied by these statements.
Michael Parks: For more information on such risks and uncertainties you are strongly encouraged to refer to our filings with the SEC.
Michael Parks: Which are available from the SEC website or our corporate website any forward looking statements represent our views as of today March 25 2025.
Michael Parks: Joining me today on the call are Dr. Stephen Quay, Atossa's Chairman, Chief Executive, and President, as well as Heather Reese, our Chief Financial Officer.
Speaker Change: Joining me today on the call are Dr. C. The Guizhou <unk>, Chairman Chief Executive and President.
Heather: As well as Heather reached our Chief Financial Officer.
Dr. Stephen Quay: I will now turn the call over to Dr. Stephen 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, Z and Oxygen. Then Heather will discuss our full year 2024 financial results, and we will conclude with a Q&A session.
Heather: I will now turn the call over to Dr. Steven Quay Bar business update Dr Quay.
Steven Quay: Thank you Michael and good day to everyone. Joining us we appreciate your time and continued support of a toaster.
Steven Quay: 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 Z. Doxepin, then Heather will discuss our full year 2024 financial results and we will conclude with a Q&A session.
Dr. Stephen Quay: However, before we provide those updates, I just want to take a moment to talk about the critical challenges practitioners face with endocrine therapy in breast cancer and the significant unmet needs that remain in this treatment landscape. First, we all know that endocrine therapy has been a cornerstone of treatment for hormone receptor-positive breast cancer. However, despite being a means-to-take therapy, there are still major gaps and areas for improvement. One of the biggest issues we see is patient adherence. 30 to 50% of patients stop taking their adjuvant endocrine therapy before they're supposed This can be caused by side effects, daily pill fatigue, or other quality-of-life factors, all of which underscore the need for more tolerable and patient-friendly...
Steven Quay: However, before we provide those updates I just want to take a moment to talk about the critical challenges practitioner space with Andrew can say it would be in breast cancer and the significant unmet needs that remain in this treatment landscape.
Speaker Change: First we all know that endocrine therapy has been a cornerstone of treatment for hormone receptor positive breast cancer.
Speaker Change: However, despite being a mainstay therapy, there are still major gaps and areas for improvement.
Speaker Change: One of the biggest issues, we see is patient adherence.
30% to 50% of patients stop taking your adjuvant, Andrew could therapy before they're supposed to.
Speaker Change: This can be caused by side effects daily pill fatigue, or other quality of life factors, all of which underscore the need for more tolerable and patient friendly options.
Speaker Change: Another point to consider is efficacy.
Dr. Stephen Quay: Another point to consider is efficacy. While endocrine therapy can be highly effective for many women, not all patients get the long-term benefits they need. We're looking to develop a treatment that not only prevents recurrence, but also improves overall outcomes, especially for those with tougher disease profiles. Resistance to endocrine therapy remains a serious hurdle, ultimately leading to disease progression in many cases. There is a pressing need for therapies that can circumvent or delay the onset of resistance to extend the window of effective treatment. We also need strategies that can effectively induce apoptosis or programmed cell death in the tumor.
Andrew can therapy can be highly effective for many women.
Speaker Change: Not all patients get the long term benefits they need.
Speaker Change: We're looking to develop a treatment not only prevent recurrence, but also improves overall outcomes, especially for those with tougher disease profile.
Speaker Change: Resistance to endocrine therapy remains a serious hurdle ultimately leading to disease progression in many cases.
Speaker Change: There is a pressing need for therapies that can circumvent or delay the onset of resistance to extend the window of effective treatment.
Speaker Change: We also need strategies that can effectively induce apoptotic cells or programmed cell death in the tumor cells.
Dr. Stephen Quay: A therapy that reliably triggers tumor specific cell death could significantly enhance treatment results and patient survival. Finally, beyond these points, the broader breast cancer community is calling for treatments with fewer side effects, better tolerability, and higher patient adherence. Meeting these needs could greatly improve both patients' quality of life and the clinical efficacy of endocrine therapy.
Speaker Change: A therapy that reliably triggers tumor specific cell death could significantly enhance treatment results in patients survive.
Speaker Change: Finally beyond these points the broader breast cancer community is calling our treatments with fewer side effects, better tolerability and higher patient adherence.
Speaker Change: Meeting these needs could greatly improve both patient quality of life and the clinical efficacy of endocrine therapy.
Dr. Stephen Quay: Now that we've identified the high unmet needs in endocrine therapy for breast cancer, ranging from early patient discontinuation to drug resistance, let's turn our focus to what we believe is a very promising solution, Zendoxine. This is an innovative next generation anti-estrogen therapy that we believe could address many of the gaps we just discussed. V-indoxin stands apart from current endocrine therapies due to its potent anti-estrogenic activity. It not only targets estrogen receptors very effectively, but may also help overcome issues related to patient metabolism and drug resistance, challenges clinicians often face with existing treatments like tamoxifen, the prodrug form from which zeandoxifen derives.
Speaker Change: Now that we've identified the high unmet needs and endocrine therapy for breast cancer, ranging from early patient discontinuation to drug resistance, let's turn our focus to what we believe is a very promising solution.
Speaker Change: <unk> and oxygen.
Speaker Change: As an innovative next generation anti estrogen therapy that we believe could address many of the gaps we just discussed.
Speaker Change: <unk> stands apart from crude endocrine therapies due to its potent anti estrogenic activity.
Speaker Change: It not only targets estrogen receptor is very effectively but may also help overcome issues related to patient metabolism and drug resistance challenges conditions, often face with existing treatments like tamoxifen, the pro drug form from which Z index and drives.
Dr. Stephen Quay: Definite Factors Set Z-indexes and First, there's enhanced... Compared to older agents, Zeaxanthin is able to achieve higher, more consistent blood levels. Resistant mitigation. Its unique mode of action may help delay or reduce development of resistance. And finally, tumor cell apoptosis. Laboratory research suggests Z-endoxin can induce robust apoptosis in breast cancer cells, a key goal in stopping disease progression.
Speaker Change: That's the factors set <unk> apart.
Speaker Change: First there is enhanced potency.
Speaker Change: Compared to older agents. These docs when he's able to achieve higher more consistent blood levels.
Speaker Change: Resistant migrate mitigation.
Speaker Change: Its unique motive action may help delay or reduce development of resistance.
Speaker Change: And finally tumor cell a pop ptosis.
Speaker Change: Laboratory research suggests as Ian Doxepin can induce robust E apoptosis in breast cancer cells, a key goal in stopping disease progression.
Dr. Stephen Quay: One of the most exciting aspects of Z-endoxin is its flexibility. We believe it could play a role across the spectrum of breast cancer care, from early prevention treatment to more advanced metastatic disease. Its versatility may also offer a valuable backbone for combination therapies, particularly in settings where common mutations like HIC3CA, AKT1, and P10 are factors in driving tumor growth. With a more tolerable safety profile and a dosing strategy designed to minimize side effects, we believe that Z-Indoxalant could also improve patient adherence. By addressing some of the quality-of-life challenges that often lead to early discontinuation of an endocrine therapy, we hope this agent will help more patients complete their full course.
Speaker Change: That's the most exciting aspects of <unk> is it flexibility we believe it could play a role across the spectrum of breast cancer care from early prevention treatment to more advanced metastatic disease.
Speaker Change: First agility. They also offer a valuable backbone for combination therapies, you can really in settings, where common mutations like <unk> C. A H one N. P 10 are factors in driving tumor growth.
Speaker Change: With a more tolerable safety profile and dosing strategy designed to minimize side effects.
Speaker Change: We believe that <unk> could also improve patient adherence.
Speaker Change: By addressing some of the quality of life challenges that also lead to early discontinuation with interconvert IP.
Speaker Change: Hope this agent will help more patients complete their full course.
Dr. Stephen Quay: So, in summary, Z-doxone aims to tackle the exact issues we discussed on the third slide. enhancing efficacy, reducing resistance, inducing meaningful tumor cell apoptosis, and improving overall adherence and tolerability. This is precisely why we view it as a next-generation anti-estrogen with the potential to set a new benchmark in breast cancer treatment.
Speaker Change: So in summary, the docks.
Speaker Change: <unk> aims to tackle the exact issues, we discussed on the third slide enhanced.
Enhancing efficacy reducing resistance in to see meaningful tumor cell apoptosis and improving overall adherence and Tolerability. This is precisely why we view it as a next generation anti estrogen with the potential to set a new benchmark in breast cancer treatment.
Dr. Stephen Quay: Our goal is simple but ambitious, to deliver a best-in-class therapy that significantly improves patient outcomes. So the question is how do we get from where we are today to delivering a treatment that tens or hundreds of thousands of women may benefit from tomorrow?
Speaker Change: Our goal is simple, but ambitious to deliver a best in class therapy that significantly improves patient outcomes.
Speaker Change: Oh. The question is how do we get from where we are today to delivering a treatment that tens or hundreds of thousands of women they benefit from tomorrow.
Dr. Stephen Quay: Let me begin by elaborating on our recent decision to advance our lead program, Z-endoxifen, in metastatic breast cancer. We are incredibly excited to advance this indication and confident in our impact that we can have for patients at this stage. It is a clinical setting of high unmet need marked by limited durability of response and significant side effects from existing treatment options. We believe there is a compelling rationale to prioritize this area first. Potentially leading to a more streamlined path to regulatory approval and faster time to market, not only in metastatic, but for earlier disease as well.
Speaker Change: Let me begin by elaborating on our recent decision to advance our lead programs <unk> in metastatic breast cancer.
Speaker Change: We're incredibly excited to advance this indication and confident in our impact we can have for patients at this stage.
Speaker Change: It is a clinical setting of high unmet need marked by limited durability of response and significant side effects from existing treatment options. We believe there is a compelling rationale to prioritize this area first potentially leading to a streamlined path to regulatory approval.
Speaker Change: <unk> and faster time to market.
Speaker Change: Only in metastatic but for earlier disease as well.
Dr. Stephen Quay: Importantly, our confidence in zeandoxone for metastatic breast cancer is supported by compelling clinical investigation. First, in a phase one study by Dr. Matthew Goetz, the lead investigator of the Evangeline trial, Z-indoxin demonstrated robust plasma concentration, unaffected by cytochrome genotypes, and showed clinically meaningful activity in women. Endocrine refractory, ER positive, HER2 negative metastatic breast cancer, is a remarkable ability for a drug. Next, notably, the study observed a clinical benefit rate of approximately 26% in patients who had already progressed on multiple prior therapies, underscoring the agent's potential in difficult-to-treat settings. And additionally, a related phase 2 study further suggested that zeandoxifant can prolong progression-free survival relative to amoxifant in certain subgroups.
Speaker Change: Importantly, our confidence in <unk> for metastatic breast cancer is supported by compelling clinical investigations.
Speaker Change: First in a phase one study by Dr. Matthew gets the lead investigator of the Evangeline trial Z indexes and demonstrated robust plasma concentration unaffected by Sadiqul phenotypes and showed clinically meaningful activity in women Andrew.
Speaker Change: Andrew can refractory ER positive <unk> negative metastatic breast cancer.
Speaker Change: A remarkable ability for drugs.
Speaker Change: Next notably the study observed a clinical benefit rate of approximately 26% in patients who had already progressed on multiple prior therapies underscoring the agent's potential in difficult to treat settings and.
Speaker Change: And Additionally, it related phase two study further suggested that zander accident, Ken prolonged progression free survival relative tamoxifen in certain subgroups, such as those who have not been treated previously with CDK <unk> inhibitors with nearly a five month greater progression free survival.
Dr. Stephen Quay: such as those who have not been treated previously with CDK4-6 inhibitors with nearly a five-month greater progression-free survival. These data are very encouraging, and by pursuing a metastatic indication first, we believe we can expedite patient access to Z-index. especially for those who urgently need new therapeutic approaches.
Speaker Change: These data are very encouraging and by pursuing a metastatic indication first we believe we can expedite patient access to <unk>, especially for those who urgently need new therapeutic approaches.
Dr. Stephen Quay: More information on our registrational path will be forthcoming, including our target subpopulation, trial design, and the potential for a combination therapy. We're excited about this path and look forward to keeping you up to date. We also announced our commitment to continue an active dialogue with the FDA regarding the potential for Z-endoxifen in earlier disease settings like breast cancer prevention and neoadjuvant therapy, which generally require larger and longer clinical trials. Importantly, we believe the metastatic indication first approach will help us with this goal.
Speaker Change: More information on a registrational path will be forthcoming, including our target sub population trial design and the potential for a combination therapy.
Speaker Change: We're excited about this path and look forward to keeping you updated.
Speaker Change: We also announced our commitment to continue an active dialogue with the FDA regarding the potential for ASEAN doxepin in earlier disease settings, like breast cancer prevention, and neo adjuvant therapy, which generally require a larger and longer clinical trials.
Speaker Change: Importantly, we believe the metastatic indication first approach will help us with this goal.
Dr. Stephen Quay: Late last year, we presented five abstracts, three of which were Evangeline-focused, at the San Antonio Breast Cancer Symposium. These presentations outline strong pharmacokinetic and tolerability data for our Phase II Evangeline trial in premenopausal women with ER-positive HER2-negative breast Substantial tumor suppression was observed with zeandoxin at multiple dose levels, and the four-week KI-67 was less than 10%, generally above 85% of the women. Moreover, Zn-doxin was very well tolerated with no significant grade 3 or 4 toxicity. previously disclosed gynecological events at the 80 milligram dose, we plan to continue under an amended protocol that compares a 40 milligram per day regimen of Zn-oxygen plus ovarian function suppression to XMS stain plus OFS.
Speaker Change: Late last year, we presented five abstracts, three of which were Evangeline focused at the San Antonio breast cancer Symposium.
Speaker Change: These presentations outlined strong pharmacokinetic and Tolerability data for our phase II Evangeline trial in premenopausal women with ER positive her two negative breast cancer.
Speaker Change: Substantial tumor suppression was observed with the endorsement at multiple dose levels and the four week kit <unk> hundred 67 was less than 10%.
Speaker Change: Generally.
Speaker Change: Above 85% of the women.
Speaker Change: Moreover, as the index was very well tolerated with no significant grade three or four toxicities.
Speaker Change: The previously disclosed gynecological events at the 80 milligram dose we plan to continue under an amended protocol that compares a 40 milligram per day regimen of XE in boxes, and plus ovarian function suppression to exemestane plus this year.
Dr. Stephen Quay: using the four-week Ki-67 reduction as the primary antigen. We'll also include a single-arm cohort of Z-indoxin monotherapy at 40 milligrams per day over 24 weeks to gather additional safety and efficacy data.
Speaker Change: Using the four week Ti 67 reduction as the primary endpoint.
Speaker Change: We will also include a single arm cohort ASEAN docs in monotherapy at 40 milligrams per day over 24 weeks together additional safety and efficacy data.
Dr. Stephen Quay: Additionally, the San Antonio data from our Phase II Charisma endoxifen study showed that low doses of Z-endoxifen significantly reduced mammographic breast density, a key marker in breast cancer. A 1 milligram dose lowered MBD by 17.3 percentage points, while a 2 milligram dose achieved a 23.5 percent reduction, both highly significant when compared to the placebo group. Importantly, the one milligram dose exhibited no meaningful difference in adverse events relative to placebo, suggesting Z-indoxin's favorable safety and tolerability profile.
Speaker Change: Additionally, the San Antonio data from our phase II charisma, and Doxepin study showed that low doses of <unk> and DOCSIS and significantly reduced mammographic breast density a key marker in breast cancer.
Speaker Change: A one milligram dose lowered mbd by 17, three percentage points, while a two milligram dose achieved a 23, 5% reduction both highly significant when compared to the placebo group.
Speaker Change: Importantly, the one milligram dose exhibited no meaningful difference in adverse events relative to placebo, suggesting Z indoxyl favorable safety and Tolerability profile.
Dr. Stephen Quay: Our focus on metastatic breast cancer first is driven by both clinical urgency for patients and a potential pathway to expedited approval. We believe this approach can enable a quicker route to market and pave the way for future label expansions into prevention and neoadjuvant settings, which, as I said, are larger and longer trials in any case. We remain steadfast in executing our research and regulatory strategies, confident that de-indoxin can transform how we treat and ultimately prevent various stages of breast cancer.
Speaker Change: Our focus on metastatic breast cancer first is driven by both clinical urgency for patients and a potential pathway to expedited approval.
Speaker Change: We believe this approach can enable a quicker route to market and pave the way for future label expansion into prevention, and Neo adjuvant settings, which as I said are larger and longer trials in any case.
Speaker Change: We remain steadfast in executing our research and regulatory strategies confident that being docs when can transform how we treat and ultimately prevent various stages of breast cancer.
Heather Reese: I'll now hand the call over to our Chief Financial Officer, Heather Reese, to walk us through our financial results for the full year 2024. Please go ahead, Heather. 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.
Speaker Change: I'll now hand, the call over to our Chief Financial Officer, Heather Reis to walk us through our financial results for the full year 2024. Please go ahead Heather.
Heather Reis: 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.
Heather Reis: On the next slide I'll emphasize a few key financial highlights from the quarter.
Heather Reis: I encourage you to consider those remarks in the context of the full disclosure is covered in our annual report on Form 10-K.
Heather Reis: 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.
Heather Reese: This reduction reflects discipline 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 Dendoxifen trials and drug development program. R&D compensation also decreased by $500,000, mainly reflecting lower non-cash stock-based compensation expense year over year. G&A expenses totaled $13.5 million in 2024 versus $14.0 million in the prior year, a $500,000 decrease. Compensation expense was down $1.9 million due to lower non-cash stock-based compensation expense year-over-year and lower salary bonus and benefits due to the payment of severance costs to our previous CFO in 2023.
Heather Reis: This reduction reflects disciplined spending in both R&D and G&A.
Heather Reis: R&D expenses declined by $3 2 million from $17 3 million in 2023 to $14 1 million in 2024.
Heather Reis: The key drivers work.
Heather Reis: A reduction of $2 6 million in clinical and preclinical spending on our docks within trials and drug development program.
Heather Reis: R&D compensation also decreased by 500000, mainly reflecting lower noncash stock based compensation expense year over year.
Heather Reis: G&A expenses totaled $13 5 million in 2024 versus 14.0 million in the prior year at 500000 decrease.
<unk> expense was down $1 9 million due to lower noncash stock based compensation expense year over year, and lower salaries bonus and benefits due to the payment of severance costs to our previous CFO in 2023.
Heather Reese: Professional fees increased by $1.8 million year over year, primarily stemming from higher legal and investor relation costs, along with accounting fees tied to public company expenses incurred in 2024. Insurance expenses down by $400,000 reflecting successfully renegotiated premiums. Interest income was $4.1 million for the year, a slight decrease from 2023 due to a lower average invested balance in 2024. As previously disclosed, we wrote off our remaining investment in dynamic cell therapies of 1.7 million as they ceased operations in the fourth quarter of 2024. Our net loss for 2024 was $25.5 million, or $0.20 per share, versus $30.1 million, or $0.24 per share in 2023.
Heather Reis: Professional fees increased by $1 8 million year over year, primarily stemming from higher legal and investor relation costs, along with accounting fees tied to public company expenses incurred in 2024.
Heather Reis: Insurance expense was down by 400000, reflecting successfully renegotiated premiums.
Heather Reis: Interest income was $4 1 million for the year, a slight decrease from 2023 due to a lower average and that's the balance in 2024.
Heather Reis: As previously disclosed we wrote off our remaining investment in dynamic cell therapies, and $1 7 million as they ceased operations in the fourth quarter of 2024.
Heather Reis: Our net loss for 2024 was $25 5 million or <unk> 20 per share versus $30 1 million or <unk> 24 cents per share in 2023.
Heather Reese: We closed the year with $71.1 million in cash and cash equivalents, providing a healthy runway to advance zeandoxifen and other research initiatives. Overall, from a cash and operating standpoint, we're well positioned to keep hitting clinical milestones. We'll continue to focus our resources on programs that we believe have the biggest potential for patient impact and shareholder return.
Heather Reis: We closed the year with $71 1 million in cash and cash equivalents, providing a healthy runway to advanced <unk>, DOCSIS and and other research initiatives.
Heather Reis: Overall from a cash and operating standpoint, we're well positioned to keep hitting clinical milestones. We will continue to focus our resources on programs that we believe have the biggest potential for patient impact and shareholder return.
Dr. Stephen Quay: With that, I'll turn the call back to Dr. Quay for closing remarks. Thank you, Heather. We remain encouraged by our clinical progress and the broader potential of Z-endoxifen to address critical gaps in breast cancer treatment, especially in metastatic disease where new options are urgently needed.
Heather Reis: With that I'll turn the call back to Dr. Rick Wayne for closing remarks.
Rick Wayne: Thank you Heather we remain encouraged by our clinical progress and the broader potential Z and docs to.
Rick Wayne: To address critical gaps in breast cancer treatment, especially in metastatic disease, where new options are urgently needed. We are grateful for the support of our shareholders clinical partners and most importantly, the patients who inspire our emissions.
Dr. Stephen Quay: We are grateful for the support of our shareholders, clinical partners, and most importantly, the patients who inspire our mission. We appreciate your attention today.
Rick Wayne: Appreciate your attention today, operator, we are now ready to open the call for questions.
Joelle: Operator, we are now ready to open the call for questions. Thank you.
Rick Wayne: Thank you we will now begin the question and answer portion of today's call friend of US should you have a question. Please press star followed by the one on your Touchtone phone, you'll hear a prompt that your hand has been raised should you wish to decline from the polling process. Please press star followed by the two.
Joelle: We will now begin the question and answer portion of today's call for analysts. Should you have a question, please press star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. If you wish to decline from the polling process, please press star followed by the 2. If you are using a speakerphone, please lift the handset before pressing any button.
Speaker Change: If you are using a speaker phone please lift the handset before pressing any keys one moment. Please for your first question. Your first question comes from Emily.
Joelle: One moment, please, for your first question.
Emily Bognar: Your first question comes from Emily Bognar with H.C. Wainwright. Your line is now open.
Ignore: Ignore with H C. Wainwright your line is now open.
Dr. Stephen Quay: Hi, good morning. Thanks for taking the 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're thinking about starting with the phase 2 study? Or is this going to be a phase 3 study? Thanks for the question, Emily.
Emily: Oh, Hi, good morning, Thanks for taking my questions I have a couple but maybe just to start can you provide us some timing around when you'd be able to initiate the study in the metastatic setting and whether you're thinking about starting with the phase II study are those going to be a phase III study.
Heather Reis: Thanks for the question Emily Let me, let me go ahead and take that Michael I'm Heather.
Dr. Stephen Quay: Let me go ahead and take that, Michael and Heather. We are in the process now of consulting with a set of key opinion leaders who 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 are worked out. So it's a little premature to be talking about, you know, some of those details, but over the next, let's say, four to six months, that will be the plan. So the KOL folks will weigh in, and then we'll talk to the FDA.
Speaker Change: 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.
Heather Reis: And then we will transition to discussions with the FDA.
Heather Reis: In which some of these parameters were worked out so it's a little premature to be talking about some of those details but.
Heather Reis: Over the next let's say four to six months that will be the plan. So the cable folks will weigh in and then we will talk to the FDA.
Emily Bognar: Okay, great.
Speaker Change: Okay, Great and then maybe on the Evangeline trial could you just provide an update on where you are with enrollment of that trial and when we may see additional data from the 40 million dose.
Dr. Stephen Quay: 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 usage, you're looking at 24-week K67, but in combo, only four weeks. So, maybe just comment on why the discrepancy. Thank you. Yeah. 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, you know, getting an early look at KI-67 values at four weeks.
Speaker Change: Separately a question on the primary endpoint so for the mono therapy.
Speaker Change: Gerry looking at 'twenty, four we care 67.
Speaker Change: In combo only four of them.
Speaker Change: Just comment on why the discrepancy.
Speaker Change: Yeah.
Speaker Change: Yeah. So so we will be giving updates at some upcoming meetings with respect to enrollment in the in the interim data results of the primary endpoint difference has to do with the requirements around getting an early look at Ti 67 values at four weeks.
Dr. Stephen Quay: And so that's why there is that difference in that particular arm of the trial.
Speaker Change: And so that's that's why there is that difference and in that particular onto the trial.
Emily Bognar: Okay, great. Thanks for taking the question. Thank you.
Speaker Change: Okay, great. Thanks for taking the questions.
Speaker Change: Thank you.
Joelle: Ladies and gentlemen, as a reminder, should you have a question, please press star 1.
Speaker Change: Ladies and gentlemen, as a reminder, should you have a question. Please press star One. Your next question comes from Ed Woo with <unk> Capital. Your line is now open.
Ed Wu: Your next question comes from Ed Wu with Ascendiant Capital. Your line is now open. Yeah, congratulations on the progress.
Ed Woo: Yes, congratulations on the progress as you continue are you pursue your metastatic breast cancer do you anticipate.
Dr. Stephen Quay: As you continue or you pursue your metastatic breast cancer, do you anticipate pursuing it globally? Will you be also talking to your European or Australian FDA counterparts? Yeah, that's a great question here. We are focusing pretty razor sharp on the US 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 US FDA focused year to get all of this part of it right.
Ed Woo: Pursuing it globally, where you'd be also talking to European or Australia.
Ed Woo: Counterparts.
Ed Woo: Yes.
Ed Woo: Great question here, we are focusing pretty razor sharp on the U S F D a process.
Ed Woo: 'cause, it's our opinion that if we can.
Ed Woo: 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 it is at the right time to go to go outside to other <unk> you.
Speaker Change: Your markets, if I could call. It that so 2025 is going to be a U S. F. T. A focused year to get all of this part of it right and I think I think you should assume those those other kinds of markets.
Ed Wu: 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.
Ed Woo: Markets and regions are going to be are going to be early next year.
Speaker Change: Great well. Thank you for answering my questions and I wish you guys. Good luck. Thank you.
Ed Woo: Thank you.
Joelle: There are no further questions at this time.
Speaker Change: There are no further questions at this time I will now turn the call over to Dr. Quay for closing remarks.
Dr. Stephen Quay: 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.
Steven Quay: 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.
Dr. Stephen Quay: 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. We thank you for your support for Atossa Therapeutics. And most of all, we thank the patients who are helping us with this path and hopefully the patients we will help in the future.
Steven Quay: In 2025 looks equally exciting with a plan in metastatic breast cancer treatment.
Steven Quay: With events coming up around meetings with 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.
Steven Quay: And then we execute so we thank you for your attention. We thank you for your support for Tulsa Therapeutics and most of all we thank the patients who are helping us with this path and hopefully the patients we will help in the future. Thanks.
Joelle: Thanks again, and we will end the call now.
Steven Quay: Thanks, again, and we will end the call now.
Joelle: Ladies and gentlemen, this concludes today's conference call. You may now disconnect. A replay will be available on our website for the next 30 days. We appreciate your participation. Have a great day.
Steven Quay: Ladies and gentlemen. This concludes today's conference call. You may now disconnect a replay will be available on our website for the next 30 days. We appreciate your participation have a great day.
Steven Quay: Oh.
Steven Quay: Yes.
Steven Quay: Okay.
Steven Quay: Yes.
Steven Quay: Yeah.
Steven Quay: [music].
Steven Quay: Yeah.
Steven Quay: [music].