UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
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Item 2.04 Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.
As previously reported in a Current Report on Form 8-K filed by Marizyme, Inc. (the “Company”) on February 7, 2023, on February 6, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with Walleye Opportunities Master Fund Ltd (the “Investor”), pursuant to which the Company issued to the Investor an Unsecured Subordinated Convertible Promissory Note (the “Note”) in the aggregate principal amount of $1,000,000 (the “Subscription Amount”) and a Class D Common Stock Purchase Warrant (the “Warrant”) to purchase up to a number of shares of the Company’s common stock equal to the quotient of 250% of the Subscription Amount divided by the price per share at which shares are sold under the registration statement on Form S-1 of the Company (File No. 333-262697) (the “Public Offering Registration Statement”) registering units to be issued in the proposed public offering of the Company (the “Warrant Shares”).
The principal amount of the Note must be repaid in full by the Company to the holder of the Note on or before the date that is 90 days following the issuance of the Note, or May 7, 2023 (the “Maturity Date”). The Note bears no interest. If an event constituting an event of default under the Note occurs, including non-payment, defaults of covenants, an adverse judgment for payment of $500,000 or more, defaults on certain other indebtedness, bankruptcy-type events, or failure to maintain directors and officers insurance coverage of at least $1,000,000, and such event of default is not cured with the period specified, the obligations of the Company under the Note will become subject to immediate repayment obligations. If all obligations arising under the Note are not paid or otherwise satisfied in full on the Maturity Date, then the principal amount of the Note shall be increased from $1,000,000 to $1,250,000.
As of the Maturity Date, the balance under the Note was not repaid or otherwise satisfied in full. The principal amount of the Walleye Note therefore increased from $1,000,000 to $1,250,000. The number of Warrant Shares was also increased accordingly; however, the Public Offering Registration Statement was withdrawn as of April 21, 2023. Due to the non-payment, the obligations of the Company under the Note have become subject to immediate repayment obligations.
The foregoing summary of the terms and conditions of each of the Securities Purchase Agreement, the Note and the Warrant does not purport to be complete and is qualified in its entirety by reference to such documents which are filed hereto as Exhibits 10.1, 4.1 and 4.2.
Item 7.01 Regulation FD Disclosure.
On May 10, 2023, the Company issued two press releases announcing certain developments relating to the Company’s intellectual property assets, one of which was issued for distribution in the United States, and one of which was issued for distribution outside the United States. Copies of the press release are furnished as Exhibit 99.1 and Exhibit 99.2 to this Current Report on Form 8-K, respectively.
The information furnished pursuant to this Item 7.01 (including the information contained in Exhibit 99.1 and Exhibit 99.2 to this Current Report on Form 8-K), shall not be deemed “filed” for 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 deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as expressly set forth by specific reference in such a filing.
The press releases furnished with this Current Report on Form 8-K contain statements that do not relate to historical facts but are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can generally (although not always) be identified by their use of terms and phrases such as anticipate, appear, believe, continue, could, estimate, expect, indicate, intend, may, plan, possible, predict, project, pursue, will, would and other similar terms and phrases, as well as the use of the future tense. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on current beliefs, expectations and assumptions regarding the future of the business of the Company, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control, including the risks described in the Company’s Annual Reports on Form 10-K under the heading “Risk Factors” as filed with the Securities and Exchange Commission. Actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in the press releases speak only as of the date thereof. Unless otherwise required by law, the Company undertakes no obligation to publicly update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d)
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 10, 2023 | MARIZYME, INC. | |
| By: | /s/ David Barthel | |
| Name: David Barthel | ||
| Title: Chief Executive Officer | ||
Exhibit 99.1
Marizyme Announces IP Developments for DuraGraft® and its Pipeline Products
JUPITER, FL, May 10, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Marizyme, Inc. (“Marizyme” or the “Company”) (OTCQB: MRZM), a multi-technology biomedical company focused on the accelerated development and commercialization of medical technologies that improve patient health outcomes, announced today that it has recently received additional granted patents and notices of allowance for three of its core technologies in several key markets further strengthening the Company’s intellectual property.
Patents have recently been granted in the United States, India, South Korea, and Vietnam covering the Company’s flagship commercial product, DuraGraft™, and patent applications have additionally been allowed in Canada and Vietnam. The issued patents and allowed patent applications protect Marizyme’s flagship commercial product DuraGraft, a first-in-class CE marked intra-operative graft storage solution used during bypass surgeries that is authorized for use in Europe and other countries outside of the United States. It is considered an investigational product in the United States and is not yet authorized for use in the United States.
“The countries in which patents are allowed or granted represent large and rapidly expanding cardiac surgery markets and significantly expand our patent estate for DuraGraft and present tremendous commercialization and licensing opportunities for us,” said David Barthel, Marizyme’s CEO.
The DuraGraft patent portfolio now includes granted patents and pending applications in over 30 countries throughout the world, including patents granted in the United States, Europe, Australia, India, Argentina, South Africa, Mexico, and several Asian countries, and pending related applications in the U.S. and other countries.
Another patent application covering Marizyme’s Krillase™ enzyme technology was recently allowed in Europe resulting in additional patent protection. The patent relates to mixtures of enzymes from Antarctic krill for use in the treatment of a disease related to, or an inflammatory condition caused by, a biofilm formed on a soft tissue of a mammal with the treatment including treating soft tissue with Krillase to remove or prevent formation of a biofilm. Krillase products are currently under development and not yet authorized for use.
Additionally, a patent application covering Marizyme’s MATLOC™ technology was also recently allowed in Europe. The patent application relates to a method for mixing two reagents to produce a detectable reaction in a microfluidic chip. The method allows for the detection of albumin and/or creatinine using a passive mixing microfluidic chip to be potentially used for chronic kidney disease assessment. MATLOC devices are currently under development and not yet authorized for use.
Marizyme’s global patent and IP portfolio is managed by Dentons US LLP, the world’s largest law firm with hundreds of patent lawyers and IP professionals in more than 80 countries. Dentons US LLP provides quality seamless legal services on an international scale. Dentons has been consistently ranked for the past years as a top leading life sciences and health care law firm. “Joining forces with Dentons has allowed Marizyme to step up innovation, growth and value creation in markets around the world, which is important as we continue to expand and protect our intellectual property,” said David Barthel.
About Marizyme:
Marizyme is a multi-technology biomedical company dedicated to the accelerated development and commercialization of medical technologies that improve patient health outcomes. Marizyme is focused on the development and commercialization of medical technologies, devices and related products. Currently, we are focused on developing three medical technologies and products – DuraGraft™, MATLOC™ and Krillase™ – each of which is backed by a portfolio of patented or patent-pending assets.
DuraGraft® is approved for use in the EU as well as certain other markets. DuraGraft™ has not been approved for use in the U.S. MAR-FG-001, MATLOC™ and Krillase™ are not approved for sales in any market. For more information about Marizyme, please visit www.marizyme.com.
For information relating to the IP of Marizyme, Inc. please contact info@marizyme.com or 914-714-8615.
Forward Looking Statements
This press release contains statements that do not relate to historical facts but are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can generally (although not always) be identified by their use of terms and phrases such as anticipate, appear, believe, continue, could, estimate, expect, indicate, intend, may, plan, possible, predict, project, pursue, will, would and other similar terms and phrases, as well as the use of the future tense. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on current beliefs, expectations and assumptions regarding the future of the business of the Company, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control, including the risks described in the Company annual reports on Form 10-K under the heading “Risk Factors” as filed with the SEC. Actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date hereof. Unless otherwise required by law, the Company undertakes no obligation to publicly update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
For more information please contact:
Harrison Ross, Marizyme, Inc.
561-433-6626
Hross@marizyme.com
Exhibit 99.2
Marizyme Announces IP Developments for DuraGraft® and its Pipeline of Products
JUPITER, FL, May 10, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Marizyme, Inc. (“Marizyme” or the “Company”) (OTCQB: MRZM), a multi-technology biomedical company focused on the accelerated development and commercialization of medical technologies that improve patient health outcomes, announced today that it has recently received additional granted patents and notices of allowance for three of its core technologies in several key markets further strengthening the Company’s intellectual property.
Patents have recently been granted in the United States, India, South Korea, and Vietnam covering the Company’s flagship commercial product, DuraGraft™, and patent applications have additionally been allowed in Canada and Vietnam. The issued patents and allowed patent applications protect DuraGraft, a first-in-class CE marked intra-operative graft storage solution used during bypass surgeries. DuraGraft protects vascular grafts against ischemic injury during bypass surgeries thereby reducing the incidence of complications associated with vein graft failure, leading to improved clinical outcomes. DuraGraft is the only approved product to preserve and protect vascular grafts during bypass and other vascular surgeries.
“The countries recently allowing or granting these patents represent large and rapidly expanding cardiac surgery markets and significantly expand our patent estate for DuraGraft and present tremendous commercialization and licensing opportunities for us,” said David Barthel, Marizyme’s CEO.
The DuraGraft patent portfolio now includes granted patents and pending applications in over 30 countries throughout the world, including patents granted in the United States, Europe, Australia, India, Argentina, South Africa, Mexico, and several Asian countries, and related applications pending in the US and other countries.
Another patent application covering Marizyme’s Krillase™ enzyme technology was recently allowed in Europe resulting in additional patent protection. The patents relate to mixtures of enzymes from Antarctic krill for use in the treatment of a disease related to, or an inflammatory condition caused by, a biofilm formed on a soft tissue of a mammal with the treatment including treating soft tissue with Krillase to remove or prevent formation of a biofilm. The soft tissue can be a mucosa or an epithelium of the skin. The enzyme technology can be used for treating or preventing a biofilm of a surface of a graft or graft contact area, a chronic or an acute wound, or a burn wound, and to treat reflux, oral mucositis, and aphtha.
Additionally, a patent application covering Marizyme’s MATLOC™ technology was also recently allowed in Europe. The patent application relates to a method for mixing two reagents to produce a detectable reaction in a microfluidic chip. The method allows for the detection of albumin and/or creatinine using a passive mixing microfluidic chip for chronic kidney disease assessment.
Marizyme’s global patent and IP portfolio is managed by Dentons US LLP, the world’s largest law firm with hundreds of patent lawyers and IP professionals in more than 80 countries. Dentons US LLP provides quality seamless legal services on an international scale. Dentons has been consistently ranked for the past years as a top leading life sciences and health care law firm. “Joining forces with Dentons has allowed Marizyme to step up innovation, growth and value creation in markets around the world, which is important as we continue to expand and protect our intellectual property,” said David Barthel.
About Marizyme:
Marizyme, based in Jupiter, FL is a multi-technology biomedical company focused on the accelerated development and commercialization of medical technologies that improve patient health outcomes. The Company’s flagship product, DuraGraft™, is an intra-operative vascular graft storage solution that inhibits endothelial damage and leads to improved clinical outcomes by reducing the incidence of complications associated with vein graft failure in bypass surgery. DuraGraft is approved for use in the EU and several Asian countries but is not yet approved for use in the U.S. Marizyme is also focused on the development and marketing of products based on proprietary Krillase and MATLOC platforms. Krillase and MATLOC-based products are not approved for use in the U.S. For more information about Marizyme, visit www.marizyme.com.
For information relating to the IP of Marizyme, Inc. please contact info@marizyme.com or 914-714-8615.
Forward Looking Statements
This press release contains statements that do not relate to historical facts but are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can generally (although not always) be identified by their use of terms and phrases such as anticipate, appear, believe, continue, could, estimate, expect, indicate, intend, may, plan, possible, predict, project, pursue, will, would and other similar terms and phrases, as well as the use of the future tense. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on current beliefs, expectations and assumptions regarding the future of the business of the Company, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control, including the risks described in the Company annual reports on Form 10-K under the heading “Risk Factors” as filed with the SEC. Actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date hereof. Unless otherwise required by law, the Company undertakes no obligation to publicly update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
For more information please contact:
Harrison Ross, Marizyme, Inc.
561-433-6626
Hross@marizyme.com
Cover |
May 10, 2023 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | May 10, 2023 |
| Entity File Number | 000-53223 |
| Entity Registrant Name | MARIZYME, INC. |
| Entity Central Index Key | 0001413754 |
| Entity Tax Identification Number | 82-5464863 |
| Entity Incorporation, State or Country Code | NV |
| Entity Address, Address Line One | 555 Heritage Drive |
| Entity Address, Address Line Two | Suite 205 |
| Entity Address, City or Town | Jupiter |
| Entity Address, State or Province | FL |
| Entity Address, Postal Zip Code | 33458 |
| City Area Code | (561) |
| Local Phone Number | 935-9955 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Not applicable. |
| Entity Emerging Growth Company | false |