LUDG 8-K
Ludwig Enterprises, Inc. (LUDG)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
_____________________
FORM
_____________________
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): September 17, 2024 (
(Exact name of registrant as specified in its charter)
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Item 1.01 Entry into a Material Definitive Agreement.
On September 16, 2024, Ludwig Enterprises, Inc., a Nevada corporation (the “Company”), entered into an Intellectual Property Conveyance Agreement, to be effective as of August 26, 2024 (the “IP Agreement”), with Marvin S. Hausman, M.D., the Company’s Chief Science Officer and Director (“Hausman”), and Nova Mentis Life Science Corp. (“Nova”). The basis for the IP Agreement is that certain mRNA Neuro Panel and Serotonin Assay, lodged by Nova on or about April 26, 2024, as U.S. Patent Application 18/705375, International Publication Number WO 2023/077245, captioned as “Diagnosing, Monitoring and Treating Neurological Disease with Psychoactive Tryptamine Derivatives and mRNA Measurements” (the “Patent”), the invention of which was done by Hausman in collaboration with Nova.
The stated purpose of the IP Agreement was to resolve all obligations owed to Hausman by Nova, including but not limited to $245,712.00 in unpaid consulting consideration (the “Consulting Consideration”), by and through conveyance of all right, title and interest Nova may have held in the Patent and associated intellectual property associated therewith to the Company (the “Conveyance”) for further commercialization (the “Commercialization”).
In addition to the Patent, the Conveyance related to the following: (1) those serotonin assay(s) being developed by Dr. Kiminobu Sugaya at the University of Central Florida, including, but not limited to, preclinical and clinical data deriving therefrom or associated therewith; (2) exosome development protocol currently active at the laboratory of Dr. Kiminobu Sugaya at the University of Central Florida, including blood samples sent from the laboratory of Dr. Viviana Trezza and analysis data thereof obtained by Fabrizio Ascone; (3) work product and output of the Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FSX) Patient Observational Study commissioned by Nova and conducted by Dr. Sugaya; and (4) work product and output of the Ambert/Molinaro Evaluation of 30 to 40 ASD patient mRNA cheek swab samples sent to genetic lab of Irina Borodowsky and analyzed by Dr. Kyle Ambert PhD as to genetic biomarkers and indices in the ASD questionnaire developed by John Molinaro.
In consideration for the Conveyance, the Company, Hausman and Nova agreed to the following reciprocal terms:
| (a) | As to Hausman: Hausman shall accept the Conveyance, directed by Hausman to the Company for future potential Commercialization, as a full and non-recourse waiver, release and satisfaction of any obligations now owed or owing to him by Nova, including, but not limited to, payment of the Consulting Consideration. Other than as to a breach of the IP Agreement, Hausman expressly waived and released Nova from any and all claims, known or unknown, he might assert against it, which waiver and release is willful, knowing, intelligent, and voluntary. | |||
| (b) | As to the Company: As consideration for its receipt of the Patent from Nova, as directed thereto by Hausman, the Company agreed to: | |||
| (1) | for a term of 10 years (the “Royalty Term”), allocate a royalty (the “Nova Royalty”) comprised of 5% of all revenue derived from the Commercialization, to be paid in equal amounts of 2.5% each to Nova and Hausman, until such time as Hausman shall have received an amount equal to the Consulting Consideration, whereupon Nova shall, thereafter, receive the full 5% for the balance of the Royalty Term; and | |||
| (2) | issue to Nova 750,000 shares of Company common stock (the “Consideration Shares”), which Consideration Shares shall immediately vest upon the execution of the IP Agreement, though subject to the following “lock-up” restrictions, to wit: | |||
| (A) | the Consideration Shares shall be subject to a one-year “lock-up,” during which the Consideration Shares may not be sold; | |||
| (B) | at the expiration of such one-year “lock-up,” Nova may sell up to 50,000 Consideration Shares during the next six-month period; and | |||
| (C) | at the expiration of such six-month period, Nova may sell up to 100,000 Consideration Shares per quarter. | |||
| (c) | As to Nova: In consideration for the mutual promises and benefits in favor of Nova under the IP Agreement, Nova shall effect the Conveyance and shall be entitled to no further payment or consideration, other than as expressly set forth herein. Other than as to a breach of the IP Agreement, Nova expressly waived and released Hausman from any and all claims, known or unknown, it might assert against him, which waiver and release is willful, knowing, intelligent, and voluntary. | |||
The foregoing description of the IP Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the IP Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report, which is incorporated herein in its entirety by reference.
Item 7.01 Regulation FD Disclosure.
On September 17, 2024, the Company issued a press release announcing the IP Agreement.
The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The furnishing of the press release is not an admission as to the materiality of any information therein. The information contained in the press release is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.
The information in this Item 7.01 of this Current Report on Form 8-K and the press release shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the press release shall not be incorporated by reference into any filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description of Exhibit | |
| 99.1 | Press Release dated September 17, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL Document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: September 17, 2024.
LUDWIG ENTERPRISES, INC.
By: /s/ Jose Antonio Reyes
Jose Antonio Reyes
Chief Executive Officer
Exhibit 10.1
Exhibit 99.1
Ludwig Announces Acquisition of Intellectual Property and Patent
Sparks, NV, September 17, 2024, Ludwig Enterprises, Inc., (OTCPINK: LUDG), a USA-based biotechnology company, is pleased to announce it has acquired all the intellectual property and patent of the mRNA Neuro Panel and Serotonin Assay, along with all the data accumulated testing these Assays.
Significance of acquisition:
| - | Allows use of mRNA genetic biomarkers to study inflammatory changes in the brain in such diseases as autism, post-traumatic stress disorder (PTSD), Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, ALS, etc. |
| - | Acquisition of breakthrough technology in measuring serotonin levels in salivary exosomes. Serotonin, or 5-hydroxytryptamine (5-HT), is a neurotransmitter with an integral physiological role in the human body; it regulates various activities, including behavior, mood, memory, and gastrointestinal homeostasis. |
Serotonin has a wide variety of functions in the human body. People sometimes call it the “happy” chemical because it contributes to well-being and happiness. Serotonin appears to affect mood, emotions, appetite, and digestion. As the precursor for melatonin, it helps regulate sleep-wake cycles and the body clock.
| - | Analysis of autism questionnaire statements from ASD families or caregivers revealed an association between mRNA inflammatory markers and ASD survey responses. These score results open the door to the use of our mRNA neuroinflammatory markers in the diagnosis, evaluation, and treatment responses of ASD individuals. Survey questions include eye contact, social interaction, anxiety, etc. |
Ludwig acquired the following:
| - | U.S. Patent Application 18/705375, International Publication Number WO 2023/077245, captioned as “Diagnosing, Monitoring and Treating Neurological Disease with Psychoactive Tryptamine Derivatives and mRNA Measurements. |
| - | Serotonin assay(s) being developed by Dr. Kiminobu Sugaya at the University of Central Florida, including preclinical and clinical data. |
| - | Work product and output of the Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FSX) Patient Observational Study. |
“These patents represent the culmination of over 10 years of work in the field of mRNA research.” said Marvin S. Hausman, MD, Chief Science Officer of Ludwig Enterprises. “We think mRNA neurologic testing represents next-gen diagnostics that will bring affordable screening technology to the masses. It's well known that the quicker we uncover a disease, the greater the chance we will successfully treat it. We intend to start our screening business with breast cancer but hope to quickly expand to other disease indications like autism, PTSD, Alzheimer’s, and Parkinson’s.”
About Ludwig Enterprises, Inc.
Ludwig Enterprises, Inc., a biotech and healthcare holding company, is a global leader in mRNA genomics and machine learning AI technology. AI technology is used to extrapolate inflammatory signals that are correlated to different types of cancer and chronic diseases. The company developed an early screening cancer diagnostic kit Revealia™ utilizing a mail-order cheek swab that is sold directly to consumers. The proprietary test is patent-pending and contains multi-cancer early detection screening technology in a painless convenient solution that is highly accurate compared to alternative early screening test kits. The core research driving the diagnostic business opportunities comes from the ongoing identification and monitoring of patients that present varying degrees of chronic inflammation which is the causative agent of illnesses such as cancer and heart disease, which are responsible for more than 50% of deaths worldwide.
For more information please visit: http://www.ludwigent.com. https://www.revealia.com
SAFE HARBOR
Forward-looking statements in this release are made under the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Ludwig Enterprises Inc.'s forward-looking statements do not guarantee future performance. This news release includes forward-looking statements concerning the future level of business for the parties. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of Ludwig Enterprises, Inc., and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects and changes in products and competition.
CONTACT:
Ludwig Enterprises, Inc.
Antonia Reyes, CEO
www.ludwigent.com
Investor Relations
Resources Unlimited NW LLC
Mike Sheikh, Investor Relations
[email protected]