Enzolytics, Inc. Announces Letter of Intent for Exclusive Licensing Agreement for Patented Nitric Oxide Formulation
On May 22, 2024, Enzolytics announced a Letter of Intent with Enogenesis to exclusively license a patented Nitric Oxide Compound (NOC) for therapeutic use. The initial market focus includes combining NOC with Virogentics' nutraceutical products like IPF Immune. The NOC formulation can be used in various forms, including drops, pills, or sprays. Additionally, Virogentics is starting the pharmacokinetics investigation for ITV-1 in Europe. Enzolytics believes incorporating NOC with Metformin may enhance diabetes treatment, reducing adverse effects and improving drug delivery. They aim to commercialize these products quickly. SAGA, Virogentics' parent company, is expanding its product categories and pursuing a $25 million grant to support this venture.
- Enzolytics entered a Letter of Intent for the exclusive licensing of NOC.
- NOC can be used in various forms and combined with existing nutraceutical products.
- Virogentics is initiating pharmacokinetics investigation for ITV-1 in Europe.
- Potential enhancement of diabetes treatment by combining NOC with Metformin.
- SAGA is expanding its product categories to include consumer medical devices and home tests.
- SAGA is in the final stages of securing a $25 million grant.
- No concrete dates for market release of NOC products.
- Uncertainty around the successful completion of the pharmacokinetics investigation for ITV-1.
- Potential product efficacy and safety concerns given the new combination therapies.
- Risk of delays or non-approval by regulatory bodies like the EMA.
Updates on ETC Marketing, Inc and Ownership of ITV-1 and IPF
ALLEN, TX / ACCESSWIRE / May 22, 2024 / Enzolytics, Inc. (OTC PINK:ENZC) ("enzolytics.com")(the "Company") announced today that it has entered into a Letter of Intent with Enogenesis (ENGN) for the specific use of the therapeutic application of ENGN's patented Nitric Oxide Compound ( "NOC"). The initial focus for sales will be combining NOC with the nutraceutical products of the wholly owned subsidiary of Sagaliam Acquisition, Corp ("SAGA"), Virogentics Inc's ("VIRO"). The current products include IPF Immune, brain detox, liver detox and a new weight loss compound. The NOC patented compound can be produced in a liquid, solid or spray which can be included in the drops, pill or spray form currently being produced by VIRO. In addition, VIRO is the exclusive licensee of the patents on ITV-1, owned by Zhabilov Trust and invented and patented solely by Harry Zhabilov Jr. ITV-1 is beginning the pharmacokinetics investigation stage for future permitting in Europe with the European Medicine Agency (EMA) which the Company believes will be an additional market for NOC.
The discovery of nitric oxide's role as a signaling molecule in the cardiovascular system led to the 1998 Nobel Prize in Physiology or Medicine. The groundbreaking work by Robert F. Furchgott, Louis J. Ignarro, and Ferid Murad revealed how nitric oxide regulates blood vessels, influencing blood pressure and overall health. Their research spanned several decades, culminating in this prestigious recognition. It was named the "Molecule of the Year" in 1992 by the Journal of Science. Nitric oxide is a diatomic molecule in gaseous form. It is highly active, and its short half-life makes it difficult to convert it into other states than its gaseous form. Historically, a standard of care treatment for COPD has been the application of NOC in its gaseous form in a hospital setting, at a cost of over
One of the initial licensed applications will be for diabetes, where ENZC and ENGN will work to use NOC with Metformin. The Company believes the addition of NOC will significantly lower the gastro intestinal adverse effects (lactose acidosis) associated with the use of Metformin and other anti-diabetic drugs containing Metformin by increasing the effectiveness of the delivery allowing lower doses to be administered. The Company will also license the topical NOC cream for application to diabetic neuropathy.
It is anticipated that Enzolytics will be able to bring the NOC Metformin to market quickly. The Enogenesis technology allows for oral delivery of the combination of NOC with Metformin, and topical cream formulation of NOC with Metformin for Neuropathy. These products are formulated for timed release to deliver efficacy in prescribed dosage and timed Metformin delivery. NOC formulation with Metformin is a direct delivery that improves on the bioavailability of the current products on the market, and significantly reduces the quantity of Metformin needed. According to Statistica, Metformin is primarily used for the treatment of type 2 diabetes, and in 2020 and 2021, the annual number of prescriptions in the U.S. exceeded 90 million.
Robert Kremer, the President of Enogenesis commented, "Our team has devoted decades to exploring the development of commercial technology for delivering low-cost therapies incorporating NOC. The Metformin application is one of the most widely used prescription therapies for diabetes. We are excited about the opportunity to partner with Enzolytics on both the commercialization of the NOC Metformin application, as well as using our technology to accelerate the commercialization of Enzolytics and Virogentics' portfolio of current and future products. The NOC technology application is a versatile and highly innovative solution for the health industry that has the potential to address many markets."
Dr. Mahantesh Navati, the Chief Scientific Officer of Enogenesis, commented, "We have developed a unique combination drug therapy with nitric oxide that leads to many biomedical applications. The NOC technology can enhance the effectiveness of many drugs currently on the market, opening a vast field for licensing and sales opportunities, especially in brain diseases based on nitric oxide's ability to cross the blood brain barrier."
Steve Sharabura, Interim CEO of Enzolytics, commented: "This agreement with Enogenesis is exciting. It's a cutting-edge technology. This fits nicely with our existing expertise, and is the basis for Enzolytics' further technological expansion."
Harry Zhabilov, the Chief Scientific Officer of Enzolytics and Sagaliam commented, "The NOC technologically is a powerful compound to improve the effectiveness and bioavailability of other therapies. We believe that applying the Enogenesis technology to Virogentics' pharmaceutical and nutraceutical products will greatly accelerate our ability to commercialize our products. I would like to assure the shareholders of SAGA, the majority of which are Enzolytics shareholders, that all the misleading information currently being stated about ownership of my patents and the exclusive licensing of the patents to Virogentics will be vigorously protected. "
Marketing will be managed through ETC Marketing, the recently announced venture formed by ENZC, focusing on licensing of products in the medical devices, nutraceuticals, medical testing and other wellbeing and safety product markets. As part of the relationship with ETC Marketing, SAGA is expanding its product categories from nutraceuticals, to also partnerships in the distribution of consumer medical devices and home tests for multiple indications. To fund this opportunity, SAGA is in the final stages for an award of a
About Enzolytics, Inc.
Enzolytics, Inc. is transitioning from a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases to a sales, marketing and distribution entity focusing on medical devices, medical testing and nutraceutical products.
About Enogenesis
Enogenesis LLC is a unique applied technology-based specialty pharmaceutical company. Enogenesis' scientists are focused on delivering Nitric Oxide and our partner's molecule utilizing the Combination Drug Delivery Platform™ (CDDP) with enhanced therapeutic drug effects for patients.
Enogenesis' development team has written over 30 papers on nitric oxide and has over 30 years of collective experience in nitric oxide research before developing the technology over the last four years. Enogenesis was formed in 2020 by Robert Kremer and Mahantesh Navati to develop the next generation of nitric oxide ("NO") combination therapy for more efficient NO production and delivery. Enogenesis' Drug Delivery Platform™ of Nitric Oxide is INONOx™, which has been developed in its New York City laboratory.
Additional information on Enogenesis is available at: https://www.enogenesis.us/
Forward Looking Statements
The disclosure herein includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook," and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding projections, estimates and forecasts of revenue and other financial and performance metrics and projections of market opportunity and expectations, Company's ability to enter into a definitive business combination agreement and Company's ability to obtain the financing necessary to consummate the potential business combination transaction. These statements are based on various assumptions and on the current expectations of Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Company. These forward-looking statements are subject to a number of risks and uncertainties, including: Company's ability to enter into a definitive agreement with respect to the proposed business combination or consummate a transaction; the risk that the approval of the stockholders of Company for the potential transaction is not obtained; failure to realize the anticipated benefits of the potential transaction, including as a result of a delay in consummating the potential transaction or difficulty in integrating the businesses of Company; the amount of redemption requests made by Company's stockholders and the amount of funds remaining in Company's trust account after satisfaction of such requests; those factors discussed in Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 under the heading "Risk Factors," and other documents of Company filed, or to be filed, with the SEC. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Company presently does not know or that Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Company's expectations, plans or forecasts of future events and views as of the date hereof. Company anticipates that subsequent events and developments will cause Company's assessments to change. However, while Company may elect to update these forward-looking statements at some point in the future, Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Company's assessments as of any date subsequent to the date of this disclosure statement. Accordingly, undue reliance should not be placed upon the forward-looking statements.
CONTACT INFORMATION
Enzolytics, Inc.
Steve Sharabura, Chief Executive Officer
3002 Royal Palm
Baytown, Texas 77523
Tel: (845) 925-4597
X/Twitter: @EnzolyticsInc
SOURCE: Enzolytics, Inc.
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