0001642159
false
0001642159
2023-10-04
2023-10-04
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): October 4, 2023
SIGYN
THERAPEUTICS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware |
|
333-204486 |
|
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
October 4, 2023, Sigyn Therapeutics, Inc. (the “Company”) issued a press release announcing a PCT patent submission to enhance
chemotherapy delivery and reduce cancer treatment toxicity. A copy of the press release is furnished 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:
October 4, 2023 |
By: |
/s/
James A. Joyce |
|
|
James
A. Joyce, Chairman and CEO |
Exhibit
99.1
Sigyn
Therapeutics™ Discloses PCT Patent Submission to Enhance Chemotherapy Delivery and Reduce Cancer Treatment Toxicity
OCTOBER
04, 2023 8:30AM EDT SAN DIEGO, CA, Oct. 04, 2023 (GLOBE NEWSWIRE) — via NewMediaWire — Sigyn Therapeutics, Inc. (“Sigyn”
or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today disclosed the submission of a Patent
Cooperation Treaty (PCT) application entitled: “SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY.”
The
PCT submission is associated with medical technologies being advanced by Sigyn Therapeutics to enhance the clinical benefit of chemotherapeutic
drugs administered to cancer patients. Among therapeutic technologies being developed by the Company are ChemoPrep™ and ChemoPure™.
Chemotherapy is the most commonly administered drug to treat cancer, the second leading cause of death in the United States. Despite
utility across a broad-spectrum of cancers, there remains a critical need to optimize chemotherapy delivery as less than 5% of administered
doses reach their tumor-site target.
ChemoPrep™
is being advanced to extract circulating molecules that restrict the tumor-site delivery of chemotherapy and induce an unresponsiveness
to therapy (chemoresistance) associated with 90% of metastatic cancer deaths. The clinical intent of ChemoPrep™ is to safely
increase the tumor-site saturation of chemotherapeutic agents with reduced doses. Achievement of this objective will likely improve treatment
outcomes yet reduce treatment toxicity and long-term health consequences associated with chemotherapy administration. Beyond the potential
to increase survival and enhance patient quality of life, reduced dosing of chemotherapeutic agents may alleviate ongoing supply chain
issues associated with nationwide shortages of chemotherapy.
Post
infusion of chemotherapy, Sigyn Therapeutics designed ChemoPure™ to extract off-target drug agents from the bloodstream as
a means to further reduce patient toxicity.
The
Patent Cooperation Treaty (PCT) is an international treaty with more than 150 Contracting States. A PCT submission makes it possible
to seek patent protection for an invention simultaneously in a large number of countries by filing a single “international”
patent application instead of filing multiple national or regional patent applications. However, the granting of patents remains under
the control of the national or regional patent offices. Sigyn Therapeutics previously disclosed that a related provisional patent application
was filed with the United States Patent and Trademark Office (“USPTO”).
About
Sigyn Therapeutics™
Sigyn
Therapeutics is a development-stage medical technology company headquartered in San Diego, California. The Company plans to become a
clinical-stage organization through first-in-human studies of Sigyn Therapy, a blood purification technology to treat pathogen-induced
disorders that are not addressed with FDA approved therapies. Candidate treatment indications include community-acquired pneumonia, drug-resistant
virus and bacterial infections, endotoxemia, and sepsis, the leading cause of hospital deaths in the United States.
Sigyn
Therapeutics also develops therapeutic technologies to enhance the performance of cancer therapies. Sigyn Therapeutics designed ChemoPrep™
to improve the tumor-site delivery of chemotherapeutic agents and reduce their toxicity. ChemoPure™ extracts off-target
chemotherapy from the bloodstream to further reduce treatment toxicity. ImmunePrep™ is a novel commercialization platform
to enhance efficacy of monoclonal antibodies (including cancer checkpoint inhibitors) and antibody drug-conjugates (ADCs).
To
learn more about Sigyn Therapeutics, visit: www.SigynTherapeutics.com
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 its therapeutic
technologies in human studies required for market clearance, the Company’s ability to manufacture its therapeutic technologies,
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:
Sigyn
Therapeutics, Inc.
Charlene Owen
Director of Operations
858-353-0800 x100
Charlene@SigynTherapeutics.com
v3.23.3
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Sigyn Therapeutics (QB) (USOTC:SIGY)
Historical Stock Chart
From Jul 2024 to Aug 2024
Sigyn Therapeutics (QB) (USOTC:SIGY)
Historical Stock Chart
From Aug 2023 to Aug 2024