SIGY 10-K & 10-Q changes, risk factors and insider trading
Sigyn Therapeutics, Inc. · OTC · Surgical & Medical Instruments & Apparatus · CIK 1642159 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
This item is not applicable because we are a “smaller reporting company” as defined in Exchange Act Rule 12b-2.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Convertible Notes”
New heading “Use of Estimates”
Removed heading “Current Noteholders”
Removed heading “2024 Convertible Notes”
Removed heading “2023 Convertible Notes - $1,443,200”
Removed heading “Osher – $110,000”
Removed heading “Osher – $55,000”
Removed heading “Osher – $110,000”
Removed heading “Osher – $123,200”
Removed heading “Osher – $123,200”
Removed heading “Other – $341,000”
Removed heading “Osher – $94,314”
Removed heading “Osher – $63,302”
Removed heading “Brio – $128,020”
Removed heading “Osher – $127,979”
Removed heading “Osher – $129,721”
Removed heading “Brio – $129,964”
Removed heading “Osher – $225,377”
Removed heading “Osher – $74,621”
Removed heading “Osher – $564,138”
Removed heading “Other – $145,200”
Removed heading “Recent Accounting Pronouncements”
Largest changes
“The Company has not repaid the Brio January 8, 2024 convertible note of $44,000 that matured on January 8, 2025 and the convertible note is now in default. The Company is currently in discussions to restructure the terms of the note.”see in full comparison
“The Company has not repaid three Osher convertible notes totaling $316,350 that matured on March 31, 2025 and the convertible notes are now in default. The Company is currently in discussions to restructure the terms of these notes.”see in full comparison
“The Company has not repaid two Brio convertible notes totaling $125,000 that matured on March 31, 2025 and the convertible notes are now in default. The Company is currently in discussions to restructure the terms of these notes.”see in full comparison
“The Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to convert or restructure the terms of the note.”see in full comparison
“The Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to convert or restructure the terms of the note.”see in full comparison
“The Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to convert or restructure the terms of the note.”see in full comparison
Full comparison: every changed paragraph (115)
The
Company has 10,000,000 shares of par value $0.0001 preferred stock authorized, of which 322,403 and none1,287 shares preferred shares are issued
and outstanding at December, 31, 20232024 and 2022,2023, respectively.
DuringOn
fiscalApril 2023,10, holders2024, of 161,684 shares of common stockOsher elected to exchange these$621,000 sharesof Notes for an aggregate of 32823.86 shares of Series B Convertible
Preferred Stock.
Each Series B Convertible Preferred Share converts into 5,025.1125.63 shares of the Company’s common stock, subject
to antidilution adjustments
for any stock splits and recapitalizations, and for issuances of additional shares at an issue price of less
than the conversion ratio in the Warrant Exchange Agreement.ratio.
On April 9, 2024, Brio elected to exchange $220,420 of Notes for an aggregate of 292.4 shares of Series B Convertible Preferred Stock. Each Series B Convertible Preferred Share converts into 125.63 shares of the Company’s common stock, subject to antidilution adjustments for any stock splits and recapitalizations, and for issuances of additional shares at an issue price of less than the conversion ratio.
During fiscal 2023, holders of 161,684 shares of common stock elected to exchange these shares for an aggregate of 1,287 shares of Series B Convertible Preferred Stock. Each Series B Convertible Preferred Share converts into 125.53 shares of the Company’s common stock, subject to antidilution adjustments for any stock splits and recapitalizations, and for issuances of additional shares at an issue price of less than the conversion ratio in the Warrant Exchange Agreement.
On December 30, 2024, the Company filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation with the State of Delaware, which went effective immediately upon filing. The Certificate of Amendment decreased our authorized common stock to One Hundred Million (100,000,000) shares, par value $0.0001, of which 1,605,377 and 1,288,415 shares are outstanding as of December 31, 2024 and 2023, respectively.
During the year ended December 31, 2024, the holders of $707,730 of Original Issue Discount Senior Convertible Debentures converted their debentures in exchange for the issuance of 157,526 shares of Common Stock to the holders.
During the year ended December 31, 2024, the Company issued 38,325 common shares valued at $214,550 (based on the estimated fair value of the stock on the date of grant), respectively, for services rendered.
The
Company has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 1,288,415 shares were outstanding as of December
31, 2023.
On
November 23, 2022, an investor elected to convert the aggregate principal amount of the Note, $145,200, into 24,200 common shares.
Effective
October 10, 2022, the Company’s Board of Directors appointed Ms. Richa Nand, Mr. Jim Dorst, and Mr. Chris Wetzel and on January
11, 2025, appointed Mr. Michael Ryan as non-executive
members to the Company’s Board of Directors (“Director”). Effective January 1, 2023, each Each
Director shall receive an
annual grant of restricted stock units of $50,000. During the years ended December 31, 20232024 and 2022, respectively,2023, the Company
recorded recorded
stock-based compensation totaling $150,000 and $0,$150,000, respectively, in the consolidated Statements of Operations.
On August 24, 2024, the Company issued 2,617 warrants valued at $15,703 (based on the fair value of the options using the Black-Scholes option-pricing method on the date of grant), for services rendered.
On October 8, 2024, the Company offered a short-term inducement to the Company’s warrant holders in which the Company will issue ¾ of a share of the Company’s common stock in exchange for each warrant. In response to this offer, 246,257 warrants were exchanged for 184,700 shares of the Company’s common stock. The Company recognized a gain of $63,715 due to the modification of the warrants in October 2024.
On September 5, 2024, the Company entered into 2024 Notes that included warrants at an exercise price of $7.50 resulting in a modification of the warrants valued at $24,770 (based on the Black Scholes options pricing method on the modification date).
Current
Noteholders
2024 Convertible Notes
In
February 2024, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “2024 Notes”) totaling
(i) $50,050 aggregate principal amount of Note (total of $45,500 cash was received) due in February 2025 based on $1.00 for each $0.90909
paid by the noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 8,343
shares of the Company’s Common Stock at an exercise price of $10.00 per share. The conversion
price for the principal in connection with voluntary conversions by the holders of the convertible notes is $6.00 per share.
Brio
– $44,000
On
January 8, 2024, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd (“Brio”) of (i) $44,000 aggregate principal
amount of Note due January 8, 2025 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 7,333 shares of the Company’s Common Stock at an exercise price of $10.00 per share. The aggregate
cash subscription amount received by the Company from Brio for the issuance of the Note and Warrants was $40,000 which was issued at
a $4,000 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
2023
Convertible Notes - $1,443,200
During
the year ended December 31, 2023, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “2023
Notes”) with third party investors totaling (i) $1,443,200 aggregate principal amount of Note due on various dates from January
2024 through September 1, 2024 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase
Warrants (“Warrants”) to purchase up to an aggregate of 233,200 shares of the Company’s Common Stock at an exercise
price of $10.00 per share. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuance
of the Note and Warrants was $1312,000 which was issued at a $131,200 original issue discount from the face value of the Note. The conversion
price for the principal in connection with voluntary conversions by a holder of the convertible notes is $6.00 per share, subject to
adjustment as provided therein, such as stock splits and stock dividends.
On
June 2, 2023, a third-party investor elected to convert $181,500 of principal of the Note into 30,250 common shares.
In
October 2023, the holders of $997,700 of Original Issue Discount Senior Convertible Debentures converted their debentures at a contractual
exercise price of $10.00 per share in exchange for the issuance of 166,284 shares of Common Stock to the holders.
Osher
– $110,000
On
December 22, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principal
amount of Note due December 22, 2023 based on $1.00 for each $0.90909 paid by Osher noteholder and (ii) five-year Common Stock Purchase
Warrants (“Warrants”) to purchase up to an aggregate of 18,334 shares of the Company’s Common Stock at an exercise
price of $10.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and
Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The conversion price for
the principal in connection with voluntary conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to convert
or restructure the terms of the note.
Osher
– $55,000
On
November 14, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $55,000 aggregate principal
amount of Note due November 14, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 9,167 shares of the Company’s Common Stock at an exercise price of $10.00
per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,000
which was issued at a $5,000 original issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment as provided therein, such as
stock splits and stock dividends.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to convert
or restructure the terms of the note.
Brio
– $92,400
On
November 9, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd (“Brio”) of (i) $82,500 aggregate principal
amount of Note due November 9, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 13,750 shares of the Company’s Common Stock at an exercise price of $10.00 per share. The aggregate
cash subscription amount received by the Company from Brio for the issuance of the Note and Warrants was $75,000 which was issued at
a $7,500 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
Osher
– $110,000
On
October 20, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principal
amount of Note due October 20, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 18,334 shares of the Company’s Common Stock at an exercise price of
$10.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The conversion price for the principal
in connection with voluntary conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment as provided therein,
such as stock splits and stock dividends.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to convert
or restructure the terms of the note.
Osher
– $123,200
On
September 20, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principal
amount of Note due September 20, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 18,334 shares of the Company’s Common Stock at an exercise price of
$10.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The conversion price for the principal
in connection with voluntary conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment as provided therein,
such as stock splits and stock dividends.
Brio
– $92,400
On
September 9, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”) of (i) $82,500 aggregate principal
amount of Note due September 9, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 13,750 shares of the Company’s Common Stock at an exercise price of
$10.00 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance of the Note and Warrants
was $75,000 which was issued at a $7,500 original issue discount from the face value of the Note. The conversion price for the principal
in connection with voluntary conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment as provided therein,
such as stock splits and stock dividends.
Osher
– $123,200
On
August 31, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principal
amount of Note due August 31, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 18,334 shares of the Company’s Common Stock at an exercise price of $10.00 per share. The aggregate
cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $100,000 which was issued at
a $10,000 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $6.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
Other
– $341,000
In
July 2022, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “July 2022 Notes”) totaling
(i) $341,000 aggregate principal amount of Note (total of $310,000 cash was received) due in various dates in July 2023 based on $1.00
for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate
of 16,923 shares of the Company’s Common Stock at an exercise price of $20.00 per share. The conversion price for the principal
in connection with voluntary conversions by the holders of the convertible notes is $20.00 per share.
In
October 2023, the noteholders converted the remaining $324,500 in exchange for the issuance of 16,225 shares of Common Stock to the holders.
On
June 2, 2023, a third-party investor elected to convert $16,500 of principal of the Note into 825 common shares.
Osher
– $94,314
On
June 22, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $82,500 aggregate principal
amount of Note due June 22, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 4,125 shares of the Company’s Common Stock at an exercise price of $20.00 per share. The aggregate
cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $75,000 which was issued at
a $7,500 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $20.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
On
September 14, 2023, Osher agreed to extend the note to August 30, 2024 for original issue discount of $11,814.
Osher
– $63,302
On
June 1, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $55,000 aggregate principal
amount of Note due June 1, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 2,750 shares of the Company’s Common Stock at an exercise price of $20.00 per share. The aggregate
cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,000 which was issued at
a $5,000 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $20.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
On
September 14, 2023, Osher agreed to extend the note to August 30, 2024 for original issue discount of $8,302.
Brio
– $128,020
On
May 10, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”) of (i) $110,000 aggregate principal
amount of Note due May 10, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 5,500 shares of the Company’s Common Stock at an exercise price of $20.00 per share. The aggregate
cash subscription amount received by the Company from Brio for the issuance of the Note and Warrants was $100,000 which was issued at
a $10,000 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $20.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
On
September 14, 2023, Brio agreed to extend the note to August 30, 2024 for original issue discount of $18,020.
Osher
– $127,979
On
April 28, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principal
amount of Note due April 28, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 5,500 shares of the Company’s Common Stock at an exercise price of $20.00 per share. The aggregate
cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $100,000 which was issued at
a $10,000 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $20.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
On
September 14, 2023, Osher agreed to extend the note to August 30, 2024 for original issue discount of $17,979.
Osher
– $129,721
On
March 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principal
amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 5,500 shares of the Company’s Common Stock at an exercise price of $20.00 per share. The aggregate
cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $100,000 which was issued at
a $10,000 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is 20.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
On
September 14, 2023, Osher agreed to extend the note to August 30, 2024 for original issue discount of $19,721.
Brio
– $129,964
On
March 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”) of (i) $110,000 aggregate principal
amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year Common Stock Purchase Warrants (“Warrants”)
to purchase up to an aggregate of 5,500 shares of the Company’s Common Stock at an exercise price of $20.00 per share. The aggregate
cash subscription amount received by the Company from Brio for the issuance of the Note and Warrants was $100,000 which was issued at
a $10,000 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary
conversions by a holder of the convertible notes is $20.00 per share, subject to adjustment as provided therein, such as stock splits
and stock dividends.
What changed in the latest 10-Q
Risk Factors
We are a Smaller Reporting Company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Convertible Redeemable Note”
New heading “Recent Development”
New heading “About CardioDialysisTM”
New heading “Our Initial Clinical and Commercialization Focus to Treat ESRD Dialysis Patients”
New heading “A Medical Device Precedent to Treat Cardiovascular Disease”
New heading “Opportunity to Leverage the Global Dialysis Machine Infrastructure”
New heading “Potential Value of CardioDialysis™ to the Dialysis Industry”
New heading “Addressing the Unique Cardiovascular Disease Challenges of Dialysis Patients”
New heading “The Enrollment of ESRD Dialysis Patients in Clinic Studies”
New heading “First-in-Human Feasibility Study”
New heading “Convertible Redeemable Note”
Removed heading “Infectious Disease Disorders”
Removed heading “Previous Infectious Disease Industry Achievements”
Removed heading “Sigyn TherapyTM Human Studies”
Removed heading “Emerging Opportunity in Xenotransplantation”
Removed heading “ImmunePrepTM to Optimize Immunotherapeutic Antibodies”
Removed heading “ChemoPrepTM to Optimize Chemotherapy Delivery”
Removed heading “ChemoPureTM to Reduce Chemotherapy Toxicity”
Removed heading “About Sigyn Therapy - Our Lead Therapeutic Candidate”
Removed heading “Sigyn TherapyTM Clinical Plan”
Removed heading “Opportunities to Address Unmet Needs in Global Health”
Removed heading “Untreatable Viral Pathogens”
Removed heading “Antibiotic-Resistant Bacterial Infections”
Removed heading “Emerging Opportunity for Sigyn Therapy in Xenotransplantation”
Removed heading “ImmunePrepTM to Optimize Immunotherapeutic Antibodies”
Removed heading “ChemoPrepTM to Optimize Chemotherapy Delivery”
Removed heading “ChemoPureTM to Reduce Chemotherapy Toxicity”
Largest changes
“We plan to conduct first-human feasibility studies of CardioDialysis™ in 12-15 ESRD subjects at three dialysis clinic site locations. The protocol of this study has been incorporated into an Investigational Device Exemption (IDE) that we drafted for FDA submission. Based on our decision to advance CardioDialysis™ to address cardiovascular disease, we can now fulfill FDA’s requirement to clearly define the disease condition we intend to treat in our IDE submission.”see in full comparison
“On November 5, 2025, the Company entered into a Securities Purchase Agreement (“Redeemable Note”) with respect to the sale and issuance to institutional investor CFI Capital LLC (“CFI Capital”) of $150,000 aggregate principal amount of Redeemable Note (total of $130,000 cash was received) due November 6, 2026, based on $1.00 for each $0.90909 paid by CFI. …”see in full comparison
“On November 5, 2025, the Company entered into a Securities Purchase Agreement (“Redeemable Note”) with respect to the sale and issuance to institutional investor CFI Capital LLC (“CFI Capital”) of $150,000 aggregate principal amount of Redeemable Note (total of $130,000 cash was received) due November 6, 2026, based on $1.00 for each $0.90909 paid by CFI. …”see in full comparison
“Our Initial Clinical and Commercialization Focus to Treat ESRD Dialysis Patients”see in full comparison
“Addressing the Unique Cardiovascular Disease Challenges of Dialysis Patients”see in full comparison
“Opportunity to Leverage the Global Dialysis Machine Infrastructure”see in full comparison
Full comparison: every changed paragraph (157)
We are a development-stage Company advancing dialysis-like therapies to address cardiovascular disease and cancer. Sigyn CardioDialysis™ (previously known as Sigyn TherapyTM) is a novel blood purification technology to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs.
Sigyn
Therapeutics, Inc. (“Sigyn”, the “Company”, “we,” “us,” or “our”) is a development-stage
company focused on creating therapeutic solutions that address unmet needs in global healthcare. Our corporate address is 2468 Historic
Decatur Road, Suite 140, San Diego, California, 92106.
Sigyn
Therapy™, our lead product candidate, is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory
disorders that are not addressed with approved drug therapies. Candidate treatment indications include endotoxemia and inflammation in
end-stage renal disease (dialysis) patients, sepsis (a leading cause of hospital deaths), community acquired pneumonia (a leading cause
of death among infectious diseases), and emerging pandemic threats.
Our
development pipeline includes aof cancer treatmenttherapies systemis comprised of ImmunePrep™ to optimize the delivery of immunotherapeutic antibodies;
ChemoPrep™ to enhance the tumor sitetargeted delivery of chemotherapy,
chemotherapy; and ChemoPure™ to reduce treatmentthe toxicity and inhibit the spread of cancer metastasis.chemotherapy.
On November 6, 2025, we disclosed the filing of a trademark application with the United States Patent and Trademark Office to protect the name CardioDialysisTM. The action reflects our intent to shift the previous therapeutic focus of Sigyn TherapyTM toward cardiovascular disease.
This action provides us a pathway into a larger market opportunity, for which there is an FDA-approved device precedent that clinically demonstrates the ability of blood purification to reduce Major Adverse Cardiovascular Disease Events (MACE). As compared to our previously proposed treatment indications, we believe it will be significantly less burdensome to enroll cardiovascular disease subjects into pivotal efficacy studies that will be required for FDA market approval. Furthermore, we consider our potential value to the dialysis industry as a majority of their patients die from cardiovascular disease related events. Our previously proposed indications, which included the treatment of sepsis, drug-resistant bacterial infections, and life-threatening viruses will become downstream therapeutics opportunities.
The
Company has 10,000,000 shares of par value $0.0001 preferred stock authorized, of which 5,107 and 2,403 shares preferred shares are issued
and outstanding at JuneSeptember 30, 2025 and December, 31, 2024, respectively.
On
December 30, 2024, the Company filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation with the State
of Delaware, which went effective immediately upon filing. The Certificate of Amendment decreased our authorized common stock to One
Hundred Million (100,000,000) shares, par value $0.0001, of which 1,605,377 and 1,605,377 shares are outstanding as of JuneSeptember 30,
2025 2025
and December 31, 2024, respectively.
Effective
January 11, 2025 and October 10, 2022, the Company’s Board of Directors appointed Mr. Michael Ryan and Ms. Richa Nand, Mr. Jim
Dorst, and Mr. Chris Wetzel, respectively, as non-executive members to the Company’s Board of Directors (“Director”).
Effective January 1, 2023, each Director shall receive an annual grant of restricted stock units of $50,000. During the three and sixnine
months ended JuneSeptember 30, 2025 and 2024, respectively, the Company recorded stock-based compensation totaling $50,000 and $100,000,$150,000,
and $37,500 and $37,500
and $75,000,$112,500, respectively, in the unaudited condensed consolidated Statementsstatements of Operations.operations.
On
JuneJuly 9,3, 2025, the Company entered into a promissory note of $10,000$3,000 due JulyAugust 31,15, 2025 and is non-interest bearing. On October 23, 2025,
the note was repaid.
On June 9, 2025, the Company entered into a promissory note of $10,000 due July 31, 2025 and is non-interest bearing. On November 3, 2025, the noteholder agreed to extend the note to January 15, 2026 of original issue discount of $1,000.
On
January 9, 2025, the Company initiated a Regulation D offering to sell up to 750,000 Units at a price of $5,000 per unit with each Unit
consisting of one (1) $5,500 principal amount convertible debenture (convertible at two dollars ($2.00) per share into the Company’s
common stock) and a Warrant to purchase 1,250 shares of common stock at $4.00 per share. The Debentures have a principal amount equal
to 110% of such Purchaser’s subscription amount, convertible at $2.00 per share and maturing one (1) year from the date the subscription
amount is accepted by the Company. The Warrants for a number of shares equal to the subscription amount divided by the conversion price
with an exercise price of $4.00 per share, exercisable upon issuance and will expire five years from issuance. The Debentures will not
be redeemable but contain an automatic conversion feature, which will cause all principal and interest due under the Debenture to automatically
convert if our common stock is listed for trading on a national securities exchange, such as NASDAQ or the NYSE. As of JuneSeptember 30,
2025, 2025,
a total of 69 Units were sold to accredited investors at a price of $5,500 per Unit totaling $379,717 (total of $345,197 cash was
received).
Between
January 2020 and JuneSeptember 2025, the Company received cash of $4,934,885$5,224,385 through the issuance of 10% Original Issue Discount Senior Convertible
Debentures with third party investors. Between June 2023 and September 2024, $3,069,348 in aggregate principal amount of the notes were
converted into 371,110 common shares and 1,116.29 shares of Series B Convertible Preferred Stock. Each share of Series B Convertible
Preferred Stock converts into 125.63 shares of the Company’s common stock, subject to antidilution adjustments for any stock splits
and recapitalizations, and for the issuances of additional shares at an issue price of less than the conversion ratio.
In addition, in August and September 2025, the Company entered into two Notes totaling $232,100 (total of $207,500 cash was received) that provide for a variable conversion price. The Notes provide for a variable conversion rate per share equal to 65% and 75%, respectively, of the lowest trading price for the proceeding 10 trading days prior to a conversion, are due in one year and provide for interest of 7% to 8% per annum. The Company determined that in accordance with ASC 815-15, Embedded Derivatives, it should bifurcate and separately recognize the variable conversion rate at its fair value and at each subsequent measurement date, remeasure its fair value with such changes in fair value recorded in earnings. The Company recognized a total value of $181,362 as a derivative on the grant dates (based on the Binomial valuation model on the date of grant). During the three and nine months ended September 30, 2025 and 2024, the Company did not recognize a remeasurement to fair value as it was deemed immaterial. The issuances of the foregoing securities are exempt from registration pursuant to Section 4(a)(2) of the Securities Act promulgated thereunder as the Sellers are sophisticated investors and familiar with the Company’s operations. No stock purchase warrants were issued as part of the agreement.
Convertible Redeemable Note
On November 5, 2025, the Company entered into a Securities Purchase Agreement (“Redeemable Note”) with respect to the sale and issuance to institutional investor CFI Capital LLC (“CFI Capital”) of $150,000 aggregate principal amount of Redeemable Note (total of $130,000 cash was received) due November 6, 2026, based on $1.00 for each $0.90909 paid by CFI. The Note provides for a variable conversion rate per share equal to 70% of the lowest trading price for the proceeding 20 trading days prior to a conversion (including the day upon which a notice of conversion is received by the Company), are due in one year, and provide for interest of 6% per annum. The issuances of the foregoing securities are exempt from registration pursuant to Section 4(a)(2) of the Securities Act promulgated thereunder as the Sellers are sophisticated investors and familiar with the Company’s operations. No stock purchase warrants were issued as part of the agreement. Upon an event of default, the conversion price discount shall increase by 15%.
On August 29, 2025, noteholders Osher and Brio agreed to extend all of their outstanding notes to December 31, 2027 for original issue discount totaling $737,786. ASC 470-50-40-10, Modifications and Extinguishments, provides guidance on whether a modification or exchange of a term loan or debt security should be accounted for as a modification or an extinguishment. If the terms of a debt instrument are changed or modified and the cash flow effect on a present value basis is less than 10 percent, the debt instruments are not considered to be substantially different and deemed to be a modification of the debt instrument. If the terms of a debt instrument are changed or modified and the cash flow effect on a present value basis is greater than 10 percent, the debt instruments are considered to be substantially different and deemed to be an extinguishment of the debt instrument. The Company accounted for the extension of the notes as a modification with no gain or loss recognized since there were no notes where the cash flow effect on present value basis was greater than 10%.
On
August 29, 2025, noteholders Osher and Brio agreed to extend all of their outstanding notes to December 31, 2027 for original issue discount
totaling $737,786.
Sigyn Therapeutics, Inc. (“Sigyn”, the “Company” “we,” “us,” or “our”) is a development-stage Company advancing dialysis-like therapies to address cardiovascular disease and cancer. Sigyn CardioDialysis™ is a novel blood purification technology to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs.
Our development pipeline of cancer therapies is comprised of ImmunePrep™ to optimize the delivery of immunotherapeutic antibodies; ChemoPrep™ to enhance the targeted delivery of chemotherapy; and ChemoPure™ to reduce the toxicity of chemotherapy.
Recent Development
On November 6, 2025, we disclosed the filing of a trademark application with the United States Patent and Trademark Office to protect the name CardioDialysisTM, which reflects our intent to shift the previous therapeutic focus of Sigyn TherapyTM toward cardiovascular disease.
This action provides us a pathway into a larger market opportunity, for which there is an FDA-approved device precedent that clinically demonstrates the ability of blood purification to reduce Major Adverse Cardiovascular Disease Events (MACE). As compared to our previously proposed treatment indications, we believe it will be significantly less burdensome to enroll cardiovascular disease subjects into pivotal efficacy studies that will be required for FDA market approval. Furthermore, we consider our potential value to the dialysis industry as a majority of their patients die from cardiovascular disease related events. Our previously proposed indications, which included the treatment of sepsis, drug-resistant bacterial infections, and life-threatening viruses will become downstream therapeutics opportunities.
About CardioDialysisTM
We are advancing CardioDialysis™ to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowering levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE).
Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs. The annual market for MACE-reducing therapies is reported to exceed $100 billion.
Our Initial Clinical and Commercialization Focus to Treat ESRD Dialysis Patients
Our initial clinical and commercialization focus of CardioDialysisTM is directed toward the treatment of cardiovascular disease in end-stage renal disease (ESRD) patients. According to the U.S. Renal Data System (USRDS), cardiovascular disease is attributed to 67% of ESRD patient deaths and its incidence is 20 times higher in dialysis patients as compared to the general population.
Beyond high mortality rates, we believe cardiovascular disease is a well-defined, yet substantial market opportunity, given an estimated 550,000 ESRD patients receive ~85 million dialysis treatments in the U.S. each year. To optimize potential market penetration within the dialysis industry, CardioDialysis™ can be conveniently integrated with regularly scheduled dialysis treatments.
A Medical Device Precedent to Treat Cardiovascular Disease
CardioDialysis™ targets multiple key therapeutic pathways, including cholesterol-transporting lipoproteins that play a central role in the development and progression of cardiovascular disease.
Lipoprotein Apheresis (LA) is an FDA-approved device precedent that demonstrates blood purification can significantly reduce Major Adverse Cardiovascular Events (MACE) by lowering levels of lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) in the bloodstream. In a recent review article published by the American Heart Association, Lipoprotein Apheresis was reported to lower the incidence of MACE by 59% to 95% across 11 studies encompassing 1,387 treated patients. In contrast, pharmaceutical statins (Lipitor, Crestor, and Zocor) to reduce LDL-C levels are reported to reduce MACE by 20% to 45%.
However, the clinical adoption of Lipoprotein Apheresis has remained constrained by a limited delivery infrastructure, with fewer than 60 specialized apheresis centers able to provide access to the therapy in the United States.
Opportunity to Leverage the Global Dialysis Machine Infrastructure
CardioDialysis™ is not constrained by delivery infrastructure as it can be deployed on dialysis machines already located in hospitals and clinics around the world. An estimated 150,000 dialysis machines are located in more than 7,500 kidney dialysis clinics in the United States alone. By leveraging this infrastructure, we envision a future possibility to transform current kidney dialysis clinics into Renal and CardioDialysis™ treatment centers.
Potential Value of CardioDialysis™ to the Dialysis Industry
If successfully advanced, we believe CardioDialysis™ could improve and extend the quality of life of ESRD patients who rely on dialysis for survival. Beyond introducing a potential new revenue source to the dialysis industry, CardioDialysis™ may offer a potential pathway to treat cardiovascular disease in the general population, which is the current commercialization focus of Lipoprotein Apheresis.
Extending ESRD patient lives and reducing their hospitalizations may also provide quantifiable value to the dialysis industry. When ESRD patients are hospitalized, dialysis companies lose revenues as in-clinic dialysis treatments are suddenly administered at out-of-network hospitals. Based on average dialysis revenues of $400 per treatment, the U.S. dialysis industry could recoup up to $654 million in lost revenues for each week of reduced ESRD patient hospitalizations. The U.S. dialysis industry could also increase top-line revenues by ~$2.8 billion for each month of extending ESRD patient lives.
Addressing the Unique Cardiovascular Disease Challenges of Dialysis Patients
ESRD patients face unique cardiovascular disease challenges that are not addressed with drug therapies. Once they become dialysis dependent, the median length of ESRD patient survival is typically 3-5 years. Unlike the general population, clinical studies reveal that ESRD patients receive limited if any clinical benefit from LDL-C reducing statins, the leading class of drugs to treat cardiovascular disease. Additionally, circulating levels of cholesterol-transporting lipoprotein(a) are reported to be two to four times higher in ESRD dialysis patients.
Compounding these treatment challenges is an unfortunate reality. Dialysis treatments induce inflammatory responses that further contribute to cardiovascular disease progression. More specifically, circulating levels of endotoxin and inflammatory cytokines are often elevated in response to dialysis treatment.
At present, there are no market-cleared pharmaceutical products to address Lipoprotein(a), endotoxemia, or the broad-spectrum of inflammatory cytokines observed to be elevated in dialysis patients.
In response, we believe CardioDialysis™ could provide a strategy to reduce circulating LDL-C and Lipoprotein(a) levels, which is clinically proven to reduce major adverse cardiovascular events (MACE). Simultaneously, CardioDialysis™ offers to control dialysis-induced spikes of endotoxin and inflammatory cytokines that contribute to cardiovascular disease progression.
The Enrollment of ESRD Dialysis Patients in Clinic Studies
To obtain potential FDA market approval, we need to demonstrate the safety of CardioDialysis™ in a human feasibility (safety) study and then subsequently conduct pivotal studies to demonstrate treatment efficacy of CardioDialysis™.
Pivotal efficacy studies of our previously proposed indications (including sepsis, drug-resistant bacterial infections and life-threatening viruses) would have been limited to enrolling treatment subjects in a hospital intensive care unit (ICU) setting. Enrolling ICU subjects is a daunting challenge that can restrict the clinical advancement of extracorporeal blood purification technologies.
Whereas we plan to advance feasibility and pivotal efficacy studies of CardioDialysis™ in dialysis clinics, which we believe all reduce the challenge and cost of conducting studies. As per our treatment protocol, ESRD subjects will receive CardioDialysis™ during their regularly scheduled dialysis treatments, which is anticipated to further increase the efficiency of conducting clinical studies.
We plan to conduct first-human feasibility studies of CardioDialysis™ in 12-15 ESRD subjects at three dialysis clinic site locations. The protocol of this study has been incorporated into an Investigational Device Exemption (IDE) that we drafted for FDA submission. Based on our decision to advance CardioDialysis™ to address cardiovascular disease, we can now fulfill FDA’s requirement to clearly define the disease condition we intend to treat in our IDE submission.
Sigyn
Therapeutics, Inc. (“Sigyn”, the “Company” “we,” “us,” or “our”) develops
medical devices to treat cancer and infectious disease disorders. We believe our lineup of therapeutic candidates is among the most expansive
in the field of extracorporeal blood purification. To optimize the benefit of drugs to treat cancer, we invented the ImmunePrepTM
platform to enhance the performance of immunotherapeutic antibodies; ChemoPrepTM to improve the delivery of chemotherapy;
and ChemoPureTM to reduce chemotherapy toxicity. Our lead therapeutic candidate is Sigyn TherapyTM
to address infectious disease disorders that are not treatable with drugs. If successfully advanced, our therapies offer to provide strategic
value to the pharmaceutical, dialysis, and organ transplant industry.
Infectious
Disease Disorders
To
address infectious disease disorders that are not treatable with drugs, we designed Sigyn TherapyTM to extract deadly pathogens
and toxins from a patient’s bloodstream, while simultaneously providing a mechanism to dampen down excessive immune responses that
are associated with life-threatening infections. Sigyn TherapyTM has been validated to extract viral pathogens, bacterial
toxins (including endotoxin), hepatic toxins and inflammatory cytokines from human blood plasma. These expansive capabilities establish
Sigyn TherapyTM as a novel strategy to address several unmet needs in global health:
Previous
Infectious Disease Industry Achievements
We
have relevant experience in developing blood purification technologies to treat infectious disease disorders. Most members of our team
previously worked alongside our CEO while overseeing development of the first medical device to receive FDA “Emergency Use Authorization”
approval to treat an infectious viral pathogen (Ebola) and the first to receive two “Breakthrough Device” designation awards
from FDA. As a result of these achievements, TIME Magazine named the device to its list of “Top Inventions” and “Top
Medical Breakthroughs.”
Sigyn
TherapyTM Human Studies
First-in-human
clinical studies of Sigyn TherapyTM plan to enroll end-stage renal disease (ESRD) subjects with endotoxemia and concurrent
inflammation, which are prevalent, yet untreatable conditions that shorten the lives of dialysis patients. Approximately 550,000 individuals
suffer from ESRD in the United States. A therapeutic strategy that helped to extend the lives of ESRD patients may have quantifiable
value to the dialysis industry, which is dominated by Fresenius Medical Care and DaVita, Inc. in North America. Based on the number of
ESRD patients treated in their networks, every month of extended life would equate to approximately $1 billion in added revenues for
each company.
Emerging
Opportunity in Xenotransplantation
Beyond
the post-exposure treatment of infectious disease disorders, Sigyn TherapyTM offers a potential preventative strategy to reduce
the spread of infection in organ transplantations, including xenotransplantation, an emerging field related to the transplantation of
an organ from a donor animal species into a human recipient. The advancement of xenotransplantation is being fueled by a global shortage
of transplantable human organs and the recent emergence of gene-editing technologies that have increased the compatibility of porcine-derived
(pig) kidneys for human transplantation. In the United States, approximately 90,000 individuals are on the waitlist for a kidney transplant,
yet fewer than 30,000 kidney transplants are performed each year.
To
optimize xenotransplantation outcomes, Sigyn TherapyTM is proposed for administration to:
This
use of Sigyn TherapyTM in these applications corresponds with published FDA guidance on the need for strategies to mitigate
the risk of a known or unknown pathogen being transmitted from a porcine-derived organ to a human transplant recipient.
DevicesDevelopment-Stage
to Optimize the Benefit of Cancer TherapiesTherapy Pipeline
SIGY insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding SIGY (13F)
None of the 59 investors we track reported a position in their latest 13F.