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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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): January 4, 2024
SIGYN
THERAPEUTICS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware |
|
000-55575 |
|
47-2573116 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
2468
Historic Decatur Road |
|
|
Suite
140 |
|
|
San
Diego, California |
|
92106 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: 619.368.2000
Prior
address and phone number:
2468
Historic Decatur Road, Suite 140 |
|
|
San
Diego, CA |
|
92106 |
(Address
of principal executive offices) |
|
(Zip
Code) |
619.353.0800
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 |
|
Name
of each exchange on which registered |
None |
|
None |
|
None |
Indicate
by check mark whether the registrant is an emerging growth company 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
January 4, 2024, Sigyn Therapeutics, Inc. (the “Company”) issued a press release announcing the release of a shareholder
letter authored by James A. Joyce, Chairman and Chief Executive Officer of the Company. A copy of the press release is attached as Exhibit
99.1 to this Current Report on Form 8-K. The information included in this Item 7.01 “Regulation FD Disclosure” and Exhibit
99.1 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be incorporated
by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth
by specific reference in such a filing.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
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.
|
SIGYN
THERAPEUTICS, INC. |
|
|
|
Date:
January 8, 2024 |
By: |
/s/
James A. Joyce |
|
|
James
A. Joyce, Chairman and CEO |
Exhibit
99.1
Sigyn
Therapeutics Releases Letter to Shareholders
SAN
DIEGO, January 4, 2024 — Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage
medical technology company, today announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim
Joyce.
Dear
Fellow Shareholder,
As
a small organization operating in a world with short-term expectations, we have not wavered from making decisions and sacrifices that
support our long-term objective to build an enduring organization whose therapies save lives. The goal of this letter is to help you
better understand our opportunities, our challenges, and decision-making processes.
Over
the past eighteen months, we set the stage for first-in-human studies of Sigyn TherapyTM and quietly built a foundation for
therapeutic devices to enhance the performance of cancer therapies. More specifically, we leveraged industry relationships to redefine
our lead treatment indication for Sigyn TherapyTM and we designed novel devices that offer to overcome the delivery limitations
of chemotherapy and immunotherapeutic antibodies to treat cancer. As you will learn, these critically important drug agents are inadequately
delivered to intended cancer targets.
Our
decision process to develop a new therapy is guided various factors but must include two prerequisites: 1.) the candidate therapy must
offer to overcome a clearly defined limitation in healthcare, and 2.) the successful clinical advancement of the candidate would establish
a potential competitive advantage that could disrupt the business model of established therapeutic organizations. I urge you to read
the entirety of this letter with the hope you concur our product candidates meet these development prerequisites.
However,
I first want to provide an update on our proposed underwritten financing. At present, we have an S-1 registration statement on file with
the U.S. Securities and Exchange Commission (SEC) (available at www.sec.gov) to support a financing whose proceeds will advance
our clinical programs and potentially allow us to meet the exchange listing requirements of the Nasdaq Capital Market. While our S-1
is on file, we remain in a quiet period that limits the information we can release until the SEC staff declares our registration statement
to be effective. However, we are permitted to publish factual information that is material to our business.
This
process seems to overshadow the extent to which we transformed our business since the initial submission of our S-1 to the SEC. In that
submission, our endeavors were solely predicated on the development and clinical advancement of Sigyn TherapyTM. As reflected
in recent S-1 amendments, our endeavors today are comprised of Sigyn TherapyTM to address pathogen-associated inflammatory
disorders, the ImmunePrepTM platform to enhance the performance of immunotherapeutic antibodies, ChemoPrepTM to
improve the delivery of chemotherapy, and ChemoPureTM to reduce chemotoxicity. Furthermore, our clinical plan to advance Sigyn
TherapyTM has evolved to become more expansive and enrollable, with clinical sites and principal investigators now in place
for first-in-human studies.
With
support from industry colleagues and the steadfast dedication of our team, we established a lineup of therapeutic candidates that is
unique within in our industry.
The
ImmunePrepTM Platform
Immunotherapeutic
antibodies to treat cancer are among the most valued assets in global medicine. However, these drugs suffer from a severe limitation.
They are poorly delivered to cancer cell targets and as a result, a majority of patients don’t respond to therapy. FACT!
Only
a fraction of an antibody dose reaches its cancer cell target, yet a significant portion of the same dose can be sequestered from delivery
by circulating decoys that display the target (antigen) binding site of the antibody. Amazingly, with more than 1,000 therapeutic antibodies
being evaluated in human studies, there was no strategy to reduce the circulating presence of decoys that block the delivery of these
drugs.
In
response, we designed the ImmunePrepTM platform. Mechanistically, ImmunePrepTM is intended to leverage the use
of therapeutic antibodies to create extracorporeal blood purification devices that sweep antibody decoys from the bloodstream prior to
the subsequent infusion (normal delivery) of the same therapeutic antibody. We believe this reverse decoy mechanism will increase the
availability of antibodies to interact with their intended targets and simultaneously, ImmunePrepTM devices are expected to
extract disease targets from the bloodstream to further improve patient benefit. Our regulatory strategy is initially directed toward
the development of ImmunePrepTM products that incorporate market-cleared antibodies already demonstrated to be safe and effective
in human studies.
Regarding
my statement of therapeutic antibodies being among the most valued assets in global medicine, consider that Pfizer’s $43 billion
acquisition of Seagen, Inc. and Amgen’s $27.8 billion acquisition of Horizon Therapeutics were the highest valued M&A deals
of 2023. In both cases, transaction values were driven by market-cleared antibody assets.
Perhaps
more revealing were the values placed on clinical-stage (pre-revenue) therapeutic antibody candidates. In this regard, consider Merck’s
$10.8 billion acquisition of Prometheus Biosciences and Roche’s $7 billion acquisition of a clinical-stage antibody from Roivant
Sciences.
In
the backdrop of these M&A transactions, the immune checkpoint antibody Keytruda (Merck) became the world’s best-selling (non-vaccine)
drug in 2023 with anticipated revenues of ~$24 billion.
ImmunePrepTM
is a development-stage platform that introduces a device strategy to synergistically enhance the performance of these highly valued
drug assets.
ChemoPrepTM
& ChemoPureTM
Recent
scientific publications have reported that only 1% of chemotherapy is successfully delivered to the tumor cell targets of cancer patients.
In response, we began to investigate strategies to overcome the delivery limitations of the most commonly administered drug to treat
cancer. Inversely, we recognized if 99% of chemotherapy was missing its therapeutic target, then there was an additional need to remove
off-target chemotherapy from the bloodstream to reduce toxicity and limit organ damage.
These
thoughts, along with some pre-clinical data evolved into a patent submission entitled: “Systems and Methods to Enhance Chemotherapy
Delivery and Reduce Toxicity.” This pending patent underlies our therapeutic system comprised of ChemoPrepTM which
is intended to enhance the tumor site delivery of chemotherapy and ChemoPureTM to reduce its toxicity.
To
enhance chemotherapy delivery, we designed ChemoPrepTM to reduce the circulating presence of tumor-derived exosomes (cancer
exosomes) that interfere with chemotherapy delivery and contribute to treatment resistance. As might be expected, high concentrations
of cancer exosomes in the bloodstream correspond with poor treatment outcomes, whereas low concentrations are associated with more favorable
outcomes. As compared to non-cancer subjects, exosome populations are reported to be 10x to 500x higher in the bloodstream of cancer
patients.
There
is a compelling scientific rationale to reduce the circulating presence of cancer exosomes prior to chemotherapy administration. In this
regard, we envision the possibility of improving chemotherapy delivery with lower doses. Such an achievement could contribute to addressing
ongoing drug shortages that have limited the availability of chemotherapy to cancer patients.
Post-chemotherapy
administration, ChemoPureTM is intended to reduce treatment toxicity by depleting the presence of off-target chemotherapy
from the bloodstream. A reduction in chemotoxicity may also alleviate treatment-related fatigue and temper the long-term health consequences
associated with chemotherapy administration.
Sigyn
TherapyTM
We
are advancing Sigyn TherapyTM to treat pathogen-associated inflammatory disorders that are not addressed with FDA approved
drugs. Our candidate treatment indications include community-acquired pneumonia, drug-resistant viral & bacterial infections, endotoxemia,
and sepsis, the leading cause of hospital deaths in the United States.
Our
technology has the following attributes and capabilities:
| ● | Sigyn
TherapyTM incorporates a formulation of adsorbent components that have more than
200,000 square meters (~50 acres) of surface area on which to adsorb and remove therapeutic
targets from the bloodstream. |
| | |
| ● | In
vitro studies have demonstrated the ability of Sigyn TherapyTM to reduce life-threatening
pathogen and inflammatory disease targets from human blood plasma. In these studies, twelve
relevant targets, including viral pathogens, bacterial toxins, and inflammatory cytokines
were validated. Subsequent animal studies have been conducted at the University of Michigan.
GO WOLVERINES! |
| ● | Sigyn
TherapyTM is highly efficient as the entire circulatory system of a patient can
pass through the device ~15-times during a four-hour treatment. |
| | |
| ● | To
allow for potential broad-market deployment, we designed Sigyn TherapyTM for use
on the established infrastructure of dialysis and continuous renal replacement machines already
located in hospitals and clinics around the world. |
We
believe the successful clinical advancement of Sigyn TherapyTM could offer a strategic competitive advantage within the dialysis
industry. As such, the treatment protocol of first-in-human studies calls for the enrollment of dialysis dependent end-stage renal disease
(ESRD) patients with endotoxemia and concurrent inflammation. These are untreatable conditions associated with cardiovascular disease,
the leading cause of ESRD patient deaths. Endotoxemia and inflammation also underly other common causes of ESRD mortality, including
viral and bacterial infections that induce sepsis.
A
strategy that extended the lives of ESRD patients should be of considerable value to the dialysis industry. Consider that there are more
than 550,000 individuals with ESRD in the United States, which results in approximately 85 million dialysis treatments being administered
each year. Once on dialysis, the five-year survival rate of an ESRD patient is just 42%. A large percentage of ESRD patients suffer from
endotoxemia and/or chronic inflammation. Most are treated by either Fresenius Medical Care or DaVita Kidney Care.
In
2022, Fresenius generated $14.5 billion in revenues through the administration of 31.8 million dialysis treatments to the 208,310 ESRD
patients in their North American network. During the same year, DaVita generated $11.6 billion in revenues based on administering 30
million dialysis treatments to the 199,400 ESRD patients in their North American network.
Based
on 2022 numbers, extending the life of Fresenius network patients by just one month would be worth ~ $1.2 billion in added revenues to
Fresenius, whereas DaVita would add almost $1 billion in revenues per month of extended life of their patients. Fresenius and DaVita
also lose revenues when their patients are hospitalized, which is a common occurrence. In this regard, each week of reduced hospitalization
is worth ~ $300 million in added revenues for Fresenius and ~$240 million for DaVita.
Our
business and clinical strategy to enroll ESRD patients was established with feedback from dialysis industry executives. Furthermore,
we leveraged our industry relationships to craft the protocol of our first-in-human clinical studies, to establish multiple clinical
site locations, and identify our principal investigators.
To
support our proposed study, we have drafted an Investigational Device Exemption (IDE) for submission to the FDA that calls for the enrollment
of 12-15 ESRD patients with endotoxemia and concurrent inflammation. In the proposed study, Sigyn TherapyTM will be combined
in series with each enrolled subjects normally scheduled dialysis treatments. While our primary objective is to demonstrate treatment
safety, we will also quantify changes in endotoxin and inflammatory cytokine levels that result from Sigyn TherapyTM administration.
The successful completion of this study would then set the stage for us to pursue pivotal efficacy studies necessary for market approval.
In
closing, we have created an expansive lineup of therapeutic candidates with support from industry colleagues and the steadfast dedication
of our team. A team that is not naïve to the challenges of advancing medical devices through FDA. A team focused on building an
enduring organization whose therapies save lives.
On
behalf of Sigyn’s board of directors and employees, I thank you for your support and belief in our endeavors.
James
A. Joyce
Chairman
and Chief Executive Officer
January
4, 2024
Cautionary
Note Regarding Forward-Looking Statements
This
information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve
substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements
containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,”
“plan,” “project,” “will,” “projections,” “estimate,” “potentially”
or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties
and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements
are based upon Sigyn’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors
that may contribute to such differences may include, without limitation, the Company’s ability to clinically advance Sigyn Therapy
in human studies required for market clearance, the Company’s ability to manufacture Sigyn Therapy, the Company’s ability
to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive.
Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under
the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and in
the Company’s other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking
statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company
does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Contact:
Jim
Joyce
Chairman,
CEO
Phone:
619.353.0800
Email:
jj@SigynTherapeutics.com
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