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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): February 21, 2025
Aditxt, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-39336 |
|
82-3204328 |
(State
or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
Identification No.) |
2569 Wyandotte Street, Suite 101, Mountain View, CA |
|
94043 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (650) 870-1200
N/A
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425 ) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common Stock, par value $0.001 |
|
ADTX |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
7.01 Regulation FD Disclosure.
On
February 21, 2025, Aditxt, Inc. (the “Company”) hosted a virtual fireside chat featuring Amro Albanna, the Company’s
Chief Executive Officer, and Christopher Mitton, the President of the Company’s subsidiary, Pearsanta, Inc., who provided updates
on key corporate developments, including the status of current subsidiaries, potential transactions, and notable advancements in the
Company’s pipeline. A copy of the transcript of the virtual fireside chat is furnished as Exhibit 99.1 to this Current Report on
Form 8-K and is incorporated herein by reference.
The
information contained in this item, including that incorporated by reference, is being furnished to the Securities and Exchange Commission.
Such information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise
subject to the liabilities of that Section. The information shall not be deemed incorporated by reference into any registration statement
or other document filed pursuant to the Securities Act of 1933, except as expressly set forth by specific reference in such filing.
Cautionary
Note on Forward-Looking Statements
This
Current Report on Form 8-K contains certain forward-looking statements within the meaning of the “safe harbor “provisions
under the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained
in this Current Report on Form 8-K,
including statements regarding the Company’s future results of operations and financial position are forward-looking statements.
These forward-looking statements generally are identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “target,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will
be,” “will continue,” “will likely result,” and similar expressions. These statements are based
on various assumptions, whether or not identified in this Current Report on Form 8-K, and on the current expectations of the management
team of the Company and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes
only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive
statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions.
Many actual events and circumstances are beyond the control of the Company.
These
forward-looking statements are subject to a number of risks including, but not limited to, the following risks relating to the proposed
transactions: (1) the risk that the proposed transactions may not be completed in a timely manner or at all, which may adversely affect
the price of the Company’s securities; (2) the failure to satisfy the conditions to the closing, including the approval by the
stockholders of the Company; (3) the ability to realize the anticipated benefits of the proposed transactions; and
(4) other risks and uncertainties indicated from time to time in the Company’s public filings with the SEC. If any of these risks
materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these
forward-looking statements. You should carefully consider the risks and uncertainties described in the “Risk Factors” section
of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and other documents we filed, or will file, including the
proxy statement/prospectus, with the SEC. There may be additional risks that the Company does not presently know, or that the Company
currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements.
In addition, forward-looking statements reflect the Company’s expectations, plans or forecasts of future events and views as of
the date of this Current Report on Form 8-K. The Company anticipates that subsequent events and developments will cause the Company’s
assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the
Company specifically disclaim any obligation to do so, except as otherwise required by law. These forward-looking statements should not
be relied upon as representing the Company’s assessments of any date subsequent to the date of this Current Report on Form 8-K.
Accordingly, undue reliance should not be placed upon the forward-looking statements.
Disclaimer:
The
information contained in the transcript furnished as Exhibit 99.1 is a textual representation of an audio recording of the virtual fireside
chat and while efforts are made to provide an accurate transcription, there may be material errors, omissions or inaccuracies in the
reporting of the substance of the audio recording. The Company does not assume any responsibility for any investment or other decisions
made based upon the information provided in this transcript. Users are advised to review the audio recording and the Company’s
SEC filings before making any investment or other decisions. An archived recording of the virtual fireside chat will be available for
30 days on the “Investor Relations” section of the Company’s website at www.aditxt.com.
Item 9.01. Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURE
Pursuant
to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Dated:
February 24, 2025
|
Aditxt,
Inc. |
|
|
|
|
By: |
/s/
Amro Albanna |
|
Name: |
Amro
Albanna |
|
Title: |
Chief
Executive Officer |
Exhibit 99.1
[00:05.340 – 00:05.700] Amro Albanna:
Great.
[00:05.980 – 00:06.220] Amro Albanna:
Welcome.
[00:06.620 – 00:07.440] Amro Albanna:
Welcome, everybody.
[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:
(Brief pause)
[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:
Sure, sure.
[00:33.860 – 00:34.360] Jeff Ramson:
Thank you, Amro. And thanks.
[00:34.460 – 00:34.760] Jeff Ramson:
And thanks, Chris.
[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:
Sure.
[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
gap.
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
tests.
[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:
Chris, maybe you can just explain what LDT looks like, for people to understand?
[02:42.460 – 02:46.780] Chris Mitton:
Sure. In molecular diagnostics, an LDT is a workflow validated under CLIA and CAP, governed by CMS. The clinical performance characteristics
are established in our lab (precision, reproducibility, etc.). It’s much faster to bring these tests to market, compared to a traditional
FDA pre-market approval route.
[03:42.510 – 03:46.310] Amro Albanna:
Chris, maybe tell us a bit more about your background—industry, field, and why you decided to continue after the acquisition of
the mitomic platform?
[03:46.950 – 04:05.270] Chris Mitton:
Sure. My academic background is in molecular biology, so I’ve always been interested in the science. I’ve been in diagnostics
for over 24 years, starting at companies like Abbott, Bayer, and Qiagen. I was focused on novel molecular tools for early detection of
disease, specifically in oncology. Prior to Pearsanta, I spent over eight years at MDNA Life Sciences, moving the mitomic technology from
tissue-based testing over to a more cost-effective blood-based testing approach and expanding the pipeline of product candidates for that
platform.
Through the recent acquisition, Pearsanta acquired the company. We
bring along a very experienced science team as well. I’ve stayed on because I’m passionate about using these tools to deliver
cost-effective, actionable information to patients and clinicians, to broaden access across all socioeconomic groups globally for early
detection and better outcomes in a broad range of diseases, starting in oncology.
[04:26.390 – 04:33.790] Amro Albanna:
Great. Chris, we might have more questions as we move forward, but I’m looking at the clock to ensure we give as much information
as we can in the time we have. To clarify, Pearsanta is organized as a majority-owned subsidiary of Aditxt. That’s how all our programs
are structured. Now, let’s talk about Adimune.
[04:35.690 – 05:02.290] Amro Albanna:
Similar to Pearsanta, Adimune is another innovation with the potential to address a pressing health challenge—autoimmunity. At a
high level, the approach for autoimmunity has historically been immunosuppression. Adimune’s approach, with its ADI platform, is
fundamentally different: retraining the immune system using our body’s own mechanisms, so it “remembers” not to attack
itself, causing conditions like type 1 diabetes, psoriasis, multiple sclerosis, and so forth.
This IP was licensed from Loma Linda University. It was in research
for about 20 years, and we formed Adimune around it, with Dr. Friedrich Kapp leading the charge. The key inflection point for ADI is to
get it into human trials. As of right now, we’re working on finalizing certain aspects that are required to ship the product—the
actual drug substance, ADI-100—for type 1 diabetes and psoriasis in Germany, and stiff person syndrome in the U.S. in partnership
with the Mayo Clinic. The product itself is completed, sitting at our contract manufacturer; it does require a payment before releasing
it, but we’re moving forward with the auditing process of the facility that will receive the drug. Our planned milestone is the
second half of this year.
If you haven’t yet, please go back to previous press releases
to see preclinical results, which were very promising.
[05:02.350 – 05:18.010] Amro Albanna:
Jeff, let’s move on to Appili. We continue to work closely with Appili’s team. Why Appili, similar to why Pearsanta (addressing
cancer) and Adimune (autoimmunity)? We believe infectious diseases need a fundamentally different approach, beginning with understanding
someone’s immune profile and then looking at antiviral and vaccine development. That’s the overall concept and mission of
Appili if we close the transaction. It’s not done yet—we continue working with the Appili shareholders, who approved it, but
it does require capital for their shareholders, existing vendors, and noteholders.
Appili is not just another scientific concept. They have an experienced
team in infectious diseases, having secured grants and partnerships with programs focused on infectious diseases—around $33 million
in the past from the U.S. DOD and Air Force. They continue to submit future proposals, which, if approved, can be a non-dilutive source
of capital. That’s where we are with Appili.
[05:18.010 – 05:27.010] Amro Albanna:
Now to Evofem. We’re similarly in communication with Sandra (their CEO) and her team. The outside date for the agreement was the
end of January. They withdrew their proxy for a special meeting last year, but the agreement continues to be in effect unless someone
terminates it. We continue working in good faith to see if we can move the transaction forward.
Evofem has a senior lender that must be addressed, and other security
holders as well. Every transaction has its unique dynamics. Why Evofem? Women’s health and health innovations for women require
focus. We see Evofem as a foundation for building innovations in that space—diagnosis of endometriosis (which Chris was talking
about), preventative products like Phexxi (and taking Phexxi beyond the U.S. to global markets), plus sexually transmitted disease prevention,
and other treatments like Solosec in the future. We see Evofem as a strong foundation for women’s health overall.
As a young company, we operate in a microcap environment that hasn’t
been very supportive. That’s where we are: we have two programs—Adimune and Pearsanta—and two pending acquisitions (Evofem
and Appili). We’ll continue to update everyone on material developments.
[05:19.190 – 05:36.550] Jeff Ramson:
Great. Let’s talk about capital. I look at myself as an advocate for investors. I am one, and I know how investors think—we
get a lot of questions, and they usually have a common theme: people understand and are excited about the businesses you’re building,
but they ask, “How do you pay for it? You’re a microcap company, you have a complicated cap structure you’re working
to clean up.” Maybe you can address that?
[05:36.950 – 05:51.990] Amro Albanna:
Sure, Jeff. I know stakeholders understand this, but as a business, our North Star—our success—will ultimately be defined
by the success of each program. It’s not by daily trading, or whether we’re trading up or down. Our success is when Pearsanta
(Chris and his team) successfully launches early detection for cancer. Our success is Adimune advancing ADI into human trials for conditions
like psoriasis and type 1 diabetes, and hopefully addressing stiff person syndrome. Our success is if Appili succeeds in solutions for
infectious diseases, and if we can advance solutions to help women worldwide. That’s how we define success as a company.
As a young, pre-profit company, we must have fuel (capital) to advance
those innovations. There’s no other way. We’re not Merck, Pfizer, Google, or Nvidia—we don’t have large piles
of cash. So how do you go about it? Equity Strategy, many companies, including us, use structured financing—it’s tough on
the company but necessary to get the capital. Or you can use an equity line or ATM (“at the market”) off a shelf, which is
easier on the stock because you’re only raising capital with common shares. There are pros and cons. We do both sometimes. Over
the past months, we’ve been using our shelf for about 10% of the total volume in dollar and share terms. We haven’t been aggressive
there, but we need some capital to keep fueling the business. Debt, we’re exploring some debt options to minimize dilution, though
as a young company, it’s challenging to get ideal terms. Grants, for example, Appili has received $33 million in non-dilutive funding
historically, so that’s a route we’re exploring wherever possible—non-dilutive funding to advance these innovations.
Staying on NASDAQ, a big reason to maintain NASDAQ listing is to access capital more efficiently. Regarding the possibility of a reverse
split, nobody wants that, but as a microcap at $0.10–$0.11, it’s something to consider to remain listed. Ultimately, we want
our stock to be $10 or $20, but right now we need to focus on fundamentals.
We use the capital we raise not only to advance the businesses—Pearsanta,
Adimune, etc.—but also to improve our balance sheet. You’ll see those numbers in our upcoming Ks and Qs. We’ve also
significantly improved our cap table to align it with our growth plans.
[05:57.210 – 06:04.210] Amro Albanna:
Jeff, you’ve been spearheading communications. You know how vital that is for us. Why don’t you share what your vision is,
how you want to accomplish it, and how we’ll keep stakeholders informed?
[06:04.450 – 06:26.610] Jeff Ramson:
Absolutely. I’ve worked with hundreds of companies, and it’s never easy. I admire how you handle these difficult situations—it’s
perfectly suited to transparent communication. We want to build a global platform for Aditxt to communicate with all stakeholders, not
just shareholders. That means building out social media profiles, being on all the necessary platforms in a high-quality way, and providing
regular updates. There will be good and bad days, but consistent communication is key.
Amro is committed to engaging with anyone who reaches out, so we’ll
do our best to keep that high level of authenticity and clarity. That’s our plan: building a global presence to expand everyone’s
understanding of the mission here, and keep them updated with both successes and challenges.
[06:26.650 – 06:37.010] Amro Albanna:
Chris, you mentioned that you’re also seeking non-dilutive funding. In the latest press release, you said one proposal didn’t
get approved, but one is still outstanding. And you’ll continue seeking these opportunities?
[06:37.010 – 06:45.510] Chris Mitton:
Yes, exactly. We have a deep pipeline and many possible biomarkers, so there are multiple grant opportunities. We did submit one for ovarian
cancer—it was too early. We have one for prostate cancer still under review. We’re also looking at opportunities in neuro,
such as Alzheimer’s, and other categories representing potential pipeline growth.
[07:03.930 – 07:06.390] Amro Albanna:
We’re probably way over time, so unless you have something else, Jeff, I’ll wrap it up.
[07:06.730 – 07:09.670] Jeff Ramson:
No, I think you covered it, Amro. We’ll keep communicating, but I think this covers today.
[07:09.870 – 07:20.190] Amro Albanna:
Thank you. We really appreciate everyone who joined—about 500 people, which is a large number compared to past calls. We’ll
continue doing this and improving our communications. Our North Star, again, is addressing autoimmunity with Adimune, addressing cancer
with Pearsanta, and hopefully addressing infectious diseases through Appili and women’s health through Evofem. By 2025, our goal
is commercial launch at Pearsanta, human trials for Adimune, and seeing the rest of the programs reach their inflection points.
Thanks, Chris, for joining us. Jeff, thank you for helping. We’ll
connect again next time.
[07:50.810 – 07:52.310] Amro Albanna:
Thank you.
[07:52.310 – 07:52.490] Chris Mitton:
Thanks for having me.
6
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