Annovis Bio Achieves Major Alzheimer’s Trial Milestone

Aniso is a phase 3 clinical stage biotech that treats right here at the New York Stock Exchange under ticker symbol ANBS.

Now Anavist is focused on developing treatments including for neurodegenerative disorders including Alzheimer's and Parkinson's, and the company's leading drug candidate, a daily pill bentana, does aim to stop brain diseases from worsening.

And improve patients' memory as well as movement by blocking the creation of toxic proteins that cause nerve damage and data readouts for this trial are anticipated in Q1 of next year as well as Q1 of 2028 with the company announcing today full enrollment in its phase 3 trial of Mott targeting early Alzheimer's.

Well joining me here live at the New York Stock Exchange.

Fresh off this morning's announcement is Chang Fang, Chief Scientific Officer, as well as Sarah McCallum, who's VP of clinical operations for Animus Bio.

Ladies, thank you so much for joining me.

So first and foremost, Sarah, I do want to start with you.

I know that full enrollment for phase 3 is a big one.

So from an operational perspective, tell us how you hit that target.

Well, this trial is complicated because we use biomarkers to identify the patients who have Alzheimer's disease, so enrollment was a little slow at the beginning, but we partnered with our sites.

We have fantastic clinical research sites that have been so proactive about finding the right patients to fit the trial, and they got very good at identifying patients who are biomarker positive, and that really sped things along.

And speaking of biomarkers, I do want to turn to you.

So, tell us exactly how you found the right patients.

Yeah, having right patients at the right time, giving them the right drug, that is, uh, critical for any clinical trial success.

So, finding the right patient in Alzheimer's sounds easy.

Actually it's not.

So, previously, what you rely on is going to a neurologist, go to your doctor, and then they diagnose based on your symptoms.

Say you have Alzheimer, but that actually is not accurate.

Right now, we know that 30% of the patients, even from a very credible neurologist diagnosis for Alzheimer's disease, actually do not have Alzheimer's disease.

There are so many different types of dementia.

So, with the blood based bowel marker, now we can accurately, Determine whether you have Alzheimer's disease, um, biology or not.

And also it's noninvasive.

It's very different from previously.

You have to do either a PET scan or have your spinal tap to determine that.

So, we're really excited to incorporate this, you know, novel biomarker into our clinical trial.

And it's wonderful to have both of you here on the heels of this announcement.

So what is your on the ground strategy to keep these patients as well as families engaged until 2028?

Yeah, this trial is a big ask because we do incorporate a study partner, so a caregiver who spends quality time with the patient, so we're asking two people to participate.

So um early on we decided that it was really important to make sure that our participants and their families understand what the aims are of the study, what we're working toward, so.

We host patient and family webinars where we allow them to ask questions about the research and you know what we're learning and you know why we're testing the things that we're testing so they understand why their blood is being drawn or why they're getting a cognitive assessment and I think it's been really beneficial and that's people feel more connected with the research.

And I do want to turn back to you.

So, what are the next milestones heading into 2027 as well as 2028?

Yes.

We're so excited for this full enrollment.

Cause people possibly don't know, 20% of the clinical trials fail because they couldn't get the full enrollment, get enough patients who took a statistical, Power to test their hypothesis.

So, we're very excited about this milestone.

Um.

The next one is going to our six months, um, readout.

So, that's testing bot's symptomatic treatment effects in Alzheimer's patient population.

And the next one will be even more exciting.

That's to go to 18 month.

That's why we test whether bone TNA have disease modifying effects in Alzheimer's patients.

That means we not only make you symptomatically better, but underlying we can halt the disease pathology.

So, we're either slow the disease progression or even possibly stop the disease progression right there.

And ladies, finally, before I let you go, what should we be looking forward to from Anavus?

Well, we are going to be, uh, wrapping up the, uh, data collection for the six month in, um, Q1 of 2027.

So, uh, I'll let you address that a little bit more, but we'll, we'll be, uh, we'll be coming out with, uh, with some news in Q1.

This is a very novel mechanism.

Um-hum.

So, this is the first drug and the novel design of the clinical trial to test both symptomatic and disease modifying.

So, we're so excited to, um, for the readout of the clinical trial and we really appreciate all the, Patients, their families, and also all the clinical sites and staff and our small but mighty team for this milestone.

Well, ladies, thank you so much for joining me here at the New York Stock Exchange on the heels of this announcement today.

Thank you.

Thank you so much.

Thank you.