In partnership with Atos Therapeutics, I sat down with company CEO Doctor Stephen Quay to discuss his company's mission to fight breast cancer.
Take a look.
October marks Breast Cancer Awareness Month, a time to recognize the progress made in the fight against the disease and to remember that it still affects far too many families.
Atosa Therapeutics is on a mission to confront this harsh reality, and Ausa is a clinical stage biopharmaceutical company focused on developing advanced therapies for breast cancer and other breast-related conditions.
Now the company trades on Nasdaq under ticker symbol ATOS.
Joining me today is a.
Therapeutic CEO Dr.
Stephen Quay.
So welcome, Dr.
Quay.
Give us the headline.
Why Atosa now?
Yeah, so breast cancer is obviously a big problem.
We are developing a drug called the indoxifen, Atatosa.
We've now petitioned the FDA for permission to get this drug approved.
They will have to tell us what the pathway is.
So we're at a point where we have huge catalysts, and with a lot of discipline, we should be able to move forward very effectively in the next 4 to 6 months.
And what does a tosa actually do?
So we're developing this drug called Zinoxifen, and we have to take it through three aspects of development the clinical development studies and non-clinical studies, and then manufacturing it over and over again to be sure we can make it at a high quality level.
All of those activities are standard for a pharmaceutical company, and we're well into this.
And why should everyday investors care?
Because over the next 3 to 4 months we will have some key catalysts, both guidance from the FDA on what path forward will be to get approval, manufacturing updates on on our process to be sure we're making it properly, and other catalysts.
And in plain English, can you explain what's different?
Yeah, so you can imagine this as a as a software reboot for an app that you use on your phone.
Tamoxifen is the most commonly used drug in breast cancer, and it's been used for decades.
What we've done is we've extracted the most effective part of tamoxifen called Zandoxifen, and we give only that.
So there's 21 things in tamoxifen that are maybe doing mischief.
We want to give just the drug that has the efficacy around it.
And a regulatory question for you.
So how are you working with the FDA?
Yes, so there's a process called 505B2.
It's not a very catchy name, but it's, it's a process where Congress has authorized the FDA to take our data, to take FDA's understanding of tamoxifen, excuse me, and the literature and put them together to determine safety and efficacy.
It's a very efficient path through the FDA.
And I do want to ask you, what should investors be watching out for between now and year end.
So the key point is in December we'll give you guidance around what the FDA has said about our program, and then I'll be able to tell you on a month to month basis in 2026 what we'll be doing to prepare to apply for approval of this drug.
And as a biopharma company, if you are successful, what does this mean?
So there's 1.7 million women now taking tamoxifen, or it's alternative called aromatase inhibitors, and those drugs have significant side effects which we believe, at least in clinical trials to date, we have avoided.
And of course safety is key.
So tell us about safety so far.
So we've, we've studied this drug in over 700 women, and what we're seeing is very gratifying.
The side effect profile is significantly less than the other drugs during these clinical trials.
Now the FDA, of course, will be the final arbiter of safety and efficacy, but at least at this point in time it looks very promising.
And Dr.
Quay, tell us what's your moat?
Well, the Has two aspects.
One is the patents that we have.
So we have patents for manufacturing, patents for the drug itself, and patents for how you use it.
I've developed 92 patents and so this is one of the things I'm specialist that.
The other are the trade secrets around the manufacturing.
We're using a sustainability approach which is very important for the environment, and we think we're very pleased with that.
So, so it's patents and trade secrets.
And as a listed company, tell us about your balance sheet as well as execution.
Sure, this is really important.
So as of the end of the 2nd quarter we had $58 million in cash.
We have no debt, no warrants on our balance sheet, and we're very judicious with and disciplined with our use of cash.
And as with any company, the team is key.
So tell us about your team.
Well, so I'm a physician scientist.
I taught at Stanford Medical School.
I've developed 7 drugs that are FDA approved that have helped over 100 million people, but it is a team effort, so our employees, our advisers, are first rate in oncology and in manufacturing and in the process.
And Dr.
Quay, give us your 15 2nd elevator pitch.
OK, it's breast breast cancer.
It's a big opportunity.
We have great science. we've worked on the biology very carefully and over the next three months we're going to get clarity from the FDA on our path forward to get this approved.
We'd like to replace our drug with the 1.7 million women who are taking tamoxifen or another drug.
We have a strong balance sheet.
We have no debt.
If you want to find out about ATOS, our stocks timble, go to our regulatory filings, read about them, and make decisions wisely.
And how can investors follow along ATOS?
Yeah, so our website is Atosatherapeutics.com, and of course you would look at our AKs and our 10Ks and our 10Q filings with the SEC.
And what is your word to patients and families?
This is really important.
One woman a minute while we've had this interview has been diagnosed with breast cancer somewhere in the world.
So we are dedicated to get this drug approved as quickly and as safely as we can, of course, working with the FDA.
Well, Dr.
Quay, thank you so much for joining me today and thank you so much for sharing your insights and to be here.
Pleasure to be here.
Thank you.
