Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company
focused on skin and hair health (“Carmell”, the “Company”, “we”,
“our”, or “us”), today announced the execution of a definitive
agreement to sell its wholly owned subsidiary, Axolotl Biologix
(“AxoBio”) to the initial sellers of AxoBio for 3,845,337 shares of
Carmell common stock, 4,243 shares of Carmell preferred stock and
notes payable to the initial sellers in the aggregate amount of $8
million.
“The sale of AxoBio enables our exit from the
tissue graft space thereby facilitating a sharper organizational
focus on the launch of our skincare products beginning in March
2024 and continuing over Summer 2024,” said Rajiv Shukla, Chief
Executive Officer of Carmell.
In August 2023, Carmell acquired AxoBio for $65
million, which consisted of unsecured promissory notes in the
aggregate amount of $8 million and $57 million in CTCX common and
preferred stock (8.09 million fully diluted shares at $7.05 per
share) issued by Carmell to the initial sellers. AxoBio’s product
portfolio consists of a commercial-stage amnion graft for use in
clinics, a pre-commercial stage hospital use product, and
pre-clinical and clinical stage products under development.
In September 2023, the Company announced the
appointment of Mr. Rajiv Shukla as CEO to lead a drive towards
near-term profitability and re-positioning as a bio-aesthetics
company, that included the following initiatives:
- Focus on high-margin programs in
aesthetics with shorter paths to commercialization.
- Discontinuation of clinical trials
with budgeted spend of more than $20 million over 3 years.
- Expected cost savings of nearly $3
million per annum from organizational restructuring.
- Re-alignment of Carmell’s Board of
Directors.
In November 2023, Carmell announced the addition
of new Independent Directors: Dr. Gilles Spenlehauer, the former
Worldwide Head of Advanced Research at L’Oreal, the world’s
biggest cosmetics company, and Mr. Scott Frisch, who currently
serves as Chief Operating Officer and Chief Financial Officer of
AARP, the nation’s largest nonprofit organization serving 100+
million people ages 50 and older.
In January 2024, Carmell announced the addition
of several Key Opinion Leaders in the Aesthetics industry to their
Scientific Advisory Board and commenced clinical product testing.
The Company also completed commercial-scale manufacturing testing
at its in-house clean room facility in Pittsburgh, PA. In
preparation for commercial launch, the Company also implemented a
fully functional direct-to-consumer online sales channel along with
a backend logistics platform, an electronic Quality Management
System and Oracle NetSuite ERP.
In February 2024, Carmell announced completion
of product development of its Gold Limited Edition Exclusive
(G.L.E.E.) product, Carmell’s first aesthetic product, for
commercial launch in March 2024. Following G.L.E.E. launch, Carmell
plans to launch 9 other skincare products that are in advanced
stages of development and slated for launch through Summer
2024.
Following the sale of AxoBio, Carmell’s
financial position is expected to improve as follows:
- $4 million drop in annualized cash
burn (net of revenue) based on AxoBio’s actual January 2024
financials.
- $15.6 million reduction in debt:
$7.6 million of AxoBio subsidiary level debt plus $8 million note
payable related to the AxoBio acquisition.
- $7 million increase in tangible
equity due to elimination of AxoBio’s negative tangible
equity.
- 29% reduction in EPS dilution due
to the return of 8.09 million CTCX common shares on a fully diluted
basis. After closing, Carmell will have 19.25 million common shares
outstanding.
About CarmellCarmell is a
bio-aesthetics company that utilizes the Carmell SecretomeTM to
support skin and hair health. The Carmell SecretomeTM consists of a
potent cocktail of growth factors and proteins extracted from
allogeneic human platelets sourced from U.S. Food and Drug
Administration-approved tissue banks. The technology underpinning
the Carmell SecretomeTM has been extensively tested for safety and
efficacy, significantly surpassing standards set by the aesthetics
industry, including robust results from a prospective, randomized,
multi-center Phase 2 human trial. Besides the Carmell SecretomeTM,
the Company has developed a novel micellar nanoparticle formulation
that enables delivery of lipophilic and hydrophilic ingredients
without relying on the Foul FourteenTM, 14 potentially harmful
excipients that are commonly used by other companies to impart
texture, stability, and other desirable physicochemical attributes
to cosmetic products. Additionally, Carmell’s micellar formulations
do not utilize mineral or vegetable oils across their entire
product line and are designed to be non-comedogenic. The Company is
also developing a line of men’s products and a line of topical
haircare products. All products are tailored to meet the demanding
technical requirements of professional care providers and
discerning retail consumers. For more information,
visit www.carmellcosmetics.com.
Forward-Looking StatementsThis
press release contains forward-looking statements that are based on
beliefs, assumptions and information currently available. In some
cases, you can identify forward-looking statements by the following
words: “may,” “will,” “could,” “would,” “should,” “expect,”
“intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “ongoing” or the negative of
these terms or other comparable terminology. However, not all
forward-looking statements contain these words. These statements
involve risks, uncertainties and other factors that may cause
actual results, levels of activity, performance or achievements to
be materially different from the information expressed or implied
by these forward-looking statements. Although we believe that we
have a reasonable basis for each forward-looking statement
contained in this press release, we caution you that these
statements are based on a combination of facts and factors
currently known by us and our projections of the future, about
which we cannot be certain. Forward-looking statements in this
press release include, but are not limited to, statements about the
closing of the sale of AxoBio, the impact of the AxoBio sale on our
financial condition, our business strategy, the commercial launch
of our G.L.E.E product and other products in our pipeline, and the
attributes and benefits of Carmell’s products including products
under development as well as commercial strategy, goals, plans and
timelines. We cannot assure you that the forward-looking statements
in this press release will prove to be accurate. These
forward-looking statements are subject to a number of significant
risks and uncertainties that could cause actual results to differ
materially from expected results, including, among others,
uncertainties as to the timing of the sale of AxoBio and the risk
that the transaction may not be completed in a timely manner or at
all, satisfaction or waiver of the conditions to closing of the
sale of AxoBio, risks related to the ability to realize the
anticipated benefits of the sale of AxoBio, risks related to the
diversion of management’s attention from our ongoing business, the
effect of the announcement or pendency of the AxoBio sale on our
business and employee relationships, the risk of litigation related
to the sale of AxoBio, the ability to recognize anticipated
benefits from our commercial products, R&D pipeline,
distribution agreements, changes in applicable laws or regulations,
the possibility that Carmell may be adversely affected by other
economic, business, and/or competitive factors, and other risks and
uncertainties, including those described under the header “Risk
Factors” in the Quarterly Report on Form 10-Q filed by Carmell with
the Securities and Exchange Commission (the “SEC”) on November 15,
2023, and in our other reports filed with the SEC. Most of these
factors are outside of Carmell’s control and are difficult to
predict. Furthermore, if the forward-looking statements prove to be
inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you
should not regard these statements as a representation or warranty
by us or any other person that we will achieve our objectives and
plans in any specified time frame or at all.. Except as required by
law, we undertake no obligation to publicly update any
forward-looking statement contained herein to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. You should, therefore, not rely on these
forward-looking statements as representing our views as of any date
subsequent to the date of this press release.
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