Full Press Release Details
[00:05.340 - 00:05.700] Amro Albanna:
[00:05.980 - 00:06.220] Amro Albanna:
[00:06.620 - 00:07.440] Amro Albanna:
[00:08.140 - 00:09.120] Amro Albanna:
Thank you for joining. I have Jeff Ramson here joining me and Chris Mitton.
[00:09.560 - 00:14.460] Amro Albanna:
Maybe with that, Jeff, why don't we get started? Maybe a little bit of intro-your background, who you are. I know that you
and I have done this before, but it may not be a bad idea for you to just share with everybody what you bring to the table, what your
focus is, and what we want to discuss today.
[00:14.820 - 00:16.960] Amro Albanna:
[00:17.120 - 00:21.200] Amro Albanna:
So, Jeff, take it away.
[00:21.340 - 00:32.820] Amro Albanna:
I know that you and I have done this before, but it's probably good for everyone to hear your background, your focus, and what we're
going to cover today.
[00:32.820 - 00:33.720] Jeff Ramson:
[00:33.860 - 00:34.360] Jeff Ramson:
Thank you, Amro. And thanks.
[00:34.460 - 00:34.760] Jeff Ramson:
[00:34.820 - 00:35.280] Jeff Ramson:
So, yeah, my name is Jeff Ramson. I'm the CEO of PCG Advisory. We are a full-service investor relations firm. I've been an
investor and advisor for over 40 years, and I've been running PCG Advisory for about 16 years. I'm an original investor in
Aditxt and have been an advisor for a number of years-over the last four or five years. I've taken a very, very special interest
in the company over the last five or six months. And so I'm really kind of spearheading communications in general for Aditxt, as
we navigate forward through these really exciting times.
[00:47.840 - 00:51.920] Amro Albanna:
Wonderful. Thank you, Jeff. And folks, I see almost 400 people joining us. This is wonderful. I know that we're getting a lot of
visibility lately, and we want to take this opportunity to reiterate what Aditxt is all about, what our business model is all about.
With today's announcement regarding Pearsanta's planned
IPO, I thought it would be a good opportunity to introduce Chris to our stakeholders, and for Chris to get a chance to talk about Pearsanta,
the mission, and why the IPO. So maybe, Chris, you can share a little bit of your background with everybody-just a quick intro-and
then we can take it from there.
[00:52.020 - 00:52.420] Chris Mitton:
[00:52.640 - 00:53.180] Chris Mitton:
Thanks, Amro. Thanks for having me. It's certainly an exciting time. I'm Chris Mitton, President at Pearsanta. I'm thrilled
to step into this new role and really lead the charge. We've announced recently that we're planning an IPO this year, so there's
quite a bit of work ahead of us, but definitely an exciting time for the company as we tackle early detection in cancer and various diseases.
We're certainly passionate about that at Pearsanta, and we look forward to developing a whole new platform and a new approach to
liquid biopsy testing.
[00:56.400 - 01:02.460] Amro Albanna:
Great. We continue to talk about our business model at Aditxt. As a platform, the way we look at innovations-or the way we conduct
business-is we identify innovations that have significant potential to address some of our most pressing health challenges. That's
what we do. We bring them in-house, we build them as businesses, and we advance every aspect of the business: innovation, capital, operational
support, finance, communications-everything required to advance that innovation and that business forward, with a goal to position
them for global commercialization. Pearsanta is certainly an example of that.
Let's start with Pearsanta and talk about the status of what
it is, what the plan is, and what the commercialization plan is. Then we'll talk about Adimune-there's been quite a
bit of progress just in the last few months-and then the status of Evofem and Appili, which I know there's quite a bit of
interest in. But maybe we'll start with Pearsanta.
If you don't mind, Chris, I'll start high level: why Pearsanta?
Bottom line, we appreciate that the best way to provide a higher probability of success against cancer is early detection. The earlier,
the better. Pearsanta, being a precision diagnostic company, believes cancer is one of the most pressing health challenges to be addressed.
About a year ago-or maybe a bit longer-Pearsanta identified an innovation and a company focused on cancer. They have a very
promising platform for early detection in a non-invasive, economically feasible, and logistically feasible way. Using mitochondrial DNA,
the company was focused on seeing if we can detect cancer early, starting with prostate cancer. That's the asset we acquired, and
you, Chris, were the former CEO of MDNA. You joined the team and are the one pushing Pearsanta forward with the team toward that mission.
Why don't you talk about where we are, what the platform does, some of the statistics you share, and why the IPO?
[01:04.980 - 01:11.960] Chris Mitton:
Sure, thanks, Amro. As you mentioned, it's really all about early detection. We're thrilled to have the "mitomic"
platform we recently acquired to develop as a tool enabling patients and clinicians to get powerful, actionable information for early
detection. We know cancer is still the second-leading cause of death, and we know that millions every year are getting late diagnoses.
Those late diagnoses cost lives. We say that early detection saves lives, and it's true.
Detecting cancers in the early stages yields survival rates in the
90s (percent), but when detected too late, survival rates plummet. In prostate cancer, for example, when detected in later stages, survival
rates are 32%. In ovarian cancer, late-stage detection plummets to 29%. In lung cancer, when detected in later stages, it drops to 7%.
It's not just cancer. Diseases like endometriosis, which affect
10% of women worldwide, represent a debilitating disease. There's a delay of 10 years between the onset of symptoms and a diagnosis,
and the only way to diagnose it now is through invasive surgeries. That disease also represents an enormous clinical gap and diagnostic
So our aim is to leverage mitochondrial DNA and this new platform to
detect these diseases earlier in a simple blood sample. The mitochondrial DNA is powerful-obviously, it generates power for the
cells, but what you may not know is that it mutates at a very high rate. The cells do not repair the DNA in the mitochondria like we do
in nuclear DNA, and these mutations are disease-specific; they persist and accumulate. So mitochondrial DNA presents an opportunity as
an ideal biosensor for early detection.
We're quite excited about our two lead candidate programs this
year. Our first test is a blood-based test for endometriosis, to detect that disease early-significantly compressing the time to
diagnosis for those women and getting them into the right treatment pathways sooner. The second test is for prostate cancer in blood,
to identify clinically significant prostate cancer. Not just detecting cancer, but detecting the cancer that is clinically significant
and a good candidate for biopsy, helping many men avoid unnecessary biopsies and surgeries. That's really just the beginning of
our pipeline: we'll be moving on to blood-based tests for ovarian cancer, lung cancer, liver, esophageal, stomach, and pancreatic.
So, a true platform.
We're certainly excited about the IPO initiative for this year.
Access to the capital markets will allow us to fuel these commercial launches, fuel product development for 2026 and beyond, and help
us expand not only nationally but globally. We'll be launching these tests initially out of our state-of-the-art CLIA CAP-certified
lab in Richmond, Virginia, and expanding through distribution in over 40 countries outside the U.S. We're currently engaging in
dialogue with distributors who already have boots on the ground-sales and marketing teams in place, calling on the right touchpoints.
We're excited to partner with these leading healthcare providers in other countries as well to expand access to these life-changing
[02:26.840 - 02:31.100] Amro Albanna:
Chris, that's an important point. Jeff, feel free to jump in as well. Part of our business model-part of Aditxt's business
model-is, again, we identify and acquire these assets or companies, we build them, and it's important to highlight that Pearsanta
is not going IPO focused solely on research and development. Yes, R&D will continue, as you mentioned, but you're in a position
now to go commercial, planning commercial in the second half of this year, right? The IPO is to advance that commercial launch and beyond.
You have the facility in Richmond, the CLIA CAP facility. Can you clarify the FDA approval vs. LDT difference, and what your plan is regarding
launching these tests commercially?
[02:31.700 - 02:40.600] Chris Mitton:
Sure. The initial launch will be as a Lab Developed Test (LDT), clinically validated in our CLIA CAP-certified lab, which is governed
by CMS. That allows us to establish the clinical performance characteristics-precision, reproducibility, etc.-and make these
tests available commercially much faster than the traditional pre-market approval routes with the FDA. As the regulatory environment continues
to evolve, we will be putting together the dossiers for the necessary FDA submissions down the road, but initially we'll launch
as an LDT out of our CLIA lab in Richmond.
[02:40.810 - 02:42.280] Jeff Ramson: