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Amro Albanna (00:07): Okay, we're just gonna, we're just gonna go ahead and wait a few seconds, as we always do as attendees are joining. I do have Friedrich here, and I'm just looking at the attendee list. Let's see. I

Key Takeaway: Aditxt is working on its ADI-100 drug, aimed at treating autoimmune diseases, and aims to initiate clinical trials by the end of the year. The company highlighted encouraging preclinical data showing safety and efficacy for its drug candidates. They also discussed the importance of securing capital to support their ongoing development efforts. The call included updates on other programs within the company, emphasizing their commitment to innovation, particularly in addressing unmet medical needs.

Market Sentiment Analysis

POSITIVE FACTORS

  • Aditxt is advancing its ADI-100 drug towards clinical trials by the end of the year.
  • The drug has shown promising safety and efficacy data from preclinical studies.
  • The CEO expressed confidence in the transformative potential of their programs.

Full Press Release Details

Amro Albanna (00:07):
Okay, we're just gonna, we're just gonna go ahead and wait a few seconds,
as we always do as attendees are joining. I do have Friedrich here, and I'm just looking at the attendee list. Let's see. I see a few
people from our team. Okay. I am just waiting a couple more seconds. Very good. Welcome everybody. Thanks for joining us. Today I do have
Friedrich and Saundra joining us. And I'm sure, you know, almost everyone knows Friedrich and Saundra, but with that, maybe we should
still do a quick introduction. So Saundra, maybe you can go ahead and just do a quick intro.
Saundra Pelletier (00:56):
Okay, great. Thank you. I'm Saundra Pelletier, the CEO of Evofem Biosciences.
Our focus is on women's health, and currently we have two FDA approved assets that are both generating revenue, but we are really focused
on innovations that really deliver unmet needs for women.
Amro Albanna (01:16):
Wonderful. Thanks, Saundra. I know you and I spoke a couple weeks ago
already. I appreciate you joining. I know you're busy. Everybody's busy right now, but I thought this would be a really good opportunity
for us to continue to give these weekly updates, our team, our stakeholders, our vendors. And today I will focus on the theme we discussed
right before the call. But obviously before I go there, Friedrich, maybe you can do a quick intro as well.
Friedrich Kapp (01:40):
Yeah. Thank you very much. Amro. I'm Friedrich Kapp and I'm responsible
for the development of ADI-100, which is our first drug in the autoimmune space. And our goal is to get ready for clinical trials by the
end of the year. So we are really very far advanced and we, we'll probably have a chance to talk about this more during this call.
Amro Albanna (02:06):
Great. And I'm glad you said end of the year, because that is exactly
gonna be our focus, and we'll certainly talk about, again, the challenge that we must address collectively, frankly, as Aditxt, as Adimune
as Pearsanta, and as Evofem. And with that, actually Chris could not make it. We did announce that Chris will join. Chris is at the airport,
and we decided it's probably not a good idea for him to be, you know, to join while he's on the road. And Chris, we're probably gonna
do one with him either next week or the following week. So with that, again, I know, Saundra, I know you're, you're, you're really busy,
Friedrich, I know you're super busy. We're trying to keep the company moving forward. So I thought today, you know, as we do these weekly
updates, it's, it's important for us to make sure that whoever joins understand what it is that we are looking to do, and frankly, the
things that we're looking to address.
So, you know, Aditxt, with that background, Aditxt currently has two
programs. We have the Adimune program, which is focused on addressing autoimmunity, and we'll talk about that a little bit more. And then
we have Pearsanta, which is focused on addressing early disease detection, starting with endometriosis and prostate cancer. And then Evofem,
which is a pending transaction. We're still pushing to try to close it by end of September dealing with women's health. So that's a little
bit of the kind of the background and the focus today. Look, we must keep our eyes focused on what we need to accomplish by end of the
year, what that would mean for Adimune, what that would mean for Pearsanta, what that would mean for Evofem, and what that would mean
for Aditxt as a whole, right? So we can talk about that.
But reality is from here until then, the key ingredient that we must
address is capital. Now, I know every single company, every single early stage, every single startup will always talk about capital. But
let me be very clear, we're all experienced, seasoned entrepreneurs, I personally do not believe money is the solution for all, right?
We understand that companies raise money and lose money and go out of business, but I believe we have positioned Aditxt and each of its
programs, including the pending transaction of Evofem, to the point where capital can be very meaningful, can be very transformational.
So today I wanna really focus on these two aspects. One, what would Adimune achieve from now until end of the year? And why would that
be transformational for Adimune? I want to do the same, and I'll speak on behalf of Chris, what that would mean for Pearsanta. And then
of course, Saundra, you can talk about Evofem, what that would mean for you by end of the year where you see Evofem, you know, by end
of this year. And then we'll, we'll talk very frankly about capital, capital, capital, capital, right? And some of the challenges, whether
it's payroll vendors, lenders, all that needs to be done. So Friedrich, maybe we'll start with you, kinda, at a very high level, what
is it that you would like to accomplish by end of the year for Adimune? In terms of major milestones?
Friedrich Kapp (05:26):
I mean, the key, key milestone for us at this point, of course, is
to put everything that we have generated together in a document or documents for the health authority, then send it to the health authority
and ask for approval to go into application in patients. And, and I mean, we have everything that we need. We have toxicology. We show
that the gene the genes, the plasmids don't are not detected in the organs. We don't have antibody formation. So the safety aspects are
there. And the latest, of course is the these wonderful data that were generated at Mayo where we have shown, or they have shown that
with our ADI100 drug ex-vivo, so not for with cells from patients, then with our drug, the, the aggressive T-cells can be eliminated.
And that is of course, as close as you can get to data from patients at this point. So very encouraging. And I think the health authorities
will like that aspect particularly because it also has to do with safety, but also with efficacy. Efficacy. So both elements are there.
Uh, and so it's a matter of putting things together. You know, we are so far advanced.
Amro Albanna (07:01):
So, Friedrich, you know, ADI platform, we've been on, on a path a long
path to get it to this point by end of this year. Our goal is to, to to, to be able in a position to actually submit or have submitted
to the FDA and PEI in Germany for type one diabetes, psoriasis, and here in the US would be stiff person syndrome. And those are, you
know, obviously the initial indications. But our goal is to, you know, hopefully we can show not only safety, but potentially efficacy
and using these indications as proof of concept for Adimune. So by end of the year, do you at, you know, obviously our goal here is to
be to, to, to file in Q4 with these authorities. Is that, is that fair to say?
Friedrich Kapp (07:48):
Yeah, Absolutely. And you see, it's, it's not a normal drug. It's not
a normal drug that we are dealing with. It's something totally different. It's it's fundamentally changing the approach that it has been
going on for treating autoimmune disease because we are restoring immune tolerance. And that is unique essentially, because I don't know
of any drug that has that can do that. And therefore I think it's very exciting for us to be at this point where we can, we're so close
to go into patients and see that. The point is, and, and I mentioned that before, we are eliminating the cause, you know, of the disease,
be it especially easily to understand in type one diabetes. And when, you know, when you eliminate the cause of the disease, then the
disease is gone. So it's, you know, and the uniqueness of type one diabetes again is that it is a one medication disease right now insulin
and to replace insulin essentially is of course also a very attractive aspect of what we are doing. Because we're opening this market.
Amro Albanna (09:07):
You're, you're, you're, look, we've, we've, we've been at it for years,
Friedrich, and your excitement has never wavered truly, and your belief has never wavered. And I can tell you, and people that are, that
don't know you of course are, you know Friedrich is not an excitable person and, you know, his, his confidence. Look, we obviously cannot,
cannot predict efficacy in biology. We cannot but what we're focused on right now is the preclinical data that we've had so far certainly
looks pretty encouraging. And that's why by end of this year, transitioning ADI and Adimune to human trials, now we're not sure if we
can begin human trials, but at least, at least submit to the regulatory and possibly, possibly receive approval if we do. But certainly
that would position Adimune in 2026 for human trials, assuming we get the approvals that would become a big year for Adimune. So with
that, Saundra, maybe I can do the same with you. Okay. We, we, we know Evofem. We know Phexxi, we know Solosec. And again, I repeat myself
cause I just never know who else, you know, who, you know, who else is on the line and who, who heard you and who hasn't heard you before.
So just tell us, you know, aside from the capital, where do you see Evofem by end of the year, truly, where do you see Evofem as a company
focused on women's health and innovations?
Saundra Pelletier (10:38):
Well, I think it's a, I think the question is tricky because the answer
really does depend on capital. We right now have two assets that generate revenue. We brought in $20 million of net revenue last year.
We only just launched. Solosec at the end of the year, it was on a $20 million trajectory when the product was stopped being promoted.
So we have Phexxi and Solosec, the same call point. There's absolute efficiencies with our sales team. We have had no attrition in our
company based on everything that's happened to us. You would think we would, but we have had no investment in these brands in two and
a half years. We have payables that have to be addressed in order for us to manage our business. Our payables are, we have to buy raw
material supply. We have to manufacture this drug. We have to package this drug.
We have to distribute this drug. We have to pay FDA fees because we
are a prescription product. These aren't things like getting fancy lattes. These are things that are heavy and serious, and many companies
like ours have went out of business, but we had the grit and the resilience to go through painful, painful things. I talk to vendors every
day. I, I've become a hustler. I'm a professional hustler. I say truthful things. I beg, I, people are on payment plans. We know this
business is worth it. We do, we know the market opportunity is real. It's not fantasy. We know that there are windows of opportunity,
like with things like GLP-1s right now on social media. There were three articles that came up this morning of a pervasive epidemic of
women getting pregnant on GLP-1s. The only only birth control that has no systemic activity that will not interact with other products
that are women are on is Phexxi, period.

Frequently Asked Questions

What is Evofem Biosciences' main focus?

Evofem Biosciences focuses on women's health, offering two FDA approved products.

What is the goal for Adimune by year-end?

Adimune aims to compile data for regulatory submission to begin patient trials.

What is the significance of ADI-100?

ADI-100 is poised to transform autoimmune disease treatment by restoring immune tolerance.

What will Evofem's focus be by the end of this year?

Evofem is working on advancing its women's health programs through a pending transaction.

How important is capital for Aditxt's future?

Capital is crucial for Aditxt and its programs to drive innovation and achieve milestones.

Last updated: Jun 9, 2025