Inflammation Study Links Alzheimer’s Disease With Chronic Heart Disease

FY23 Reported With Reiteration of Milestones For Kidney and Inflammasome Trials

Research Study Details Role Of Inflammasomes In TNBC Brain Metastases

Novel Therapies For Renal Diseases and Inflammation

Robert LeBoyer

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ZyVersa Therapeutics Inc

Summary.&nbsp;&nbsp;ZyVersa Reported a FY2023 loss of $106.2 million or $(108.97) per share, including write-downs of In-process Research and Development of $81.4 million and Goodwill of $11.9 million that were recorded after the reverse merger of December 2022. Excluding these items, the operating loss would have been $14.4 million. Cash on hand was $3.1 million on December 31, and does not include $2.7 million from warrant exercise reported during February 2024.
ZyVersa Has Made Progress Toward Starting VAR 200 Clinical Trials.&nbsp;ZyVersa announced the selection of a CRO and approval by an Institutional Review Board (IRB). These are both required steps for the start the Phase 2a clinical trial for VAR 200, its lead molecule for modulating cholesterol and lipid accumulation in the kidney that causes cellular damage and starts pathways of declining function. The Phase 2a trial is expected to begin treating patients with diabetic kidney disease in 1H24. 
 
Inflammasomes Have Been In The Spotlight. In February 2024, a journal published a study from NodThera (Private) showing its NLRP3 inhibitors reversed diet-induced obesity (DIO) in an animal model of obesity. The study found that the anti-inflammatory effect of NLRP3 inhibition could reverse obesity, reduce biomarkers of cardiovascular inflammation, and had additional metabolic benefits. NodTheraâ€™s two anti-NLRP3 drugs are in Phase 2 testing. 
 
The news focused attention on inflammation as a cause of obesity and metabolic syndrome, leading to interest in ZyVersaâ€™s IC 100 program. This also led to the exercise of ZyVersa warrants that had brought $2.7 million to the company by mid-February. ZyVersa also published a white paper called &#8220;Inflammasome ASC: A Promising Therapeutic Target&#8221; describing its research on inflammasomes and IC 100.&nbsp;<a href="https://investors.zyversa.com/static-files/64964310-ab95-4a06-bc47-dd44c63dc5c7">Click here for a link to the paper on ZyVersa&#8217;s website.</a>
<a href="https://www.channelchek.com/research-reports/25764">As described in our Initiation Report on January 3</a>, ZyVersaâ€™s IC 100 is a monoclonal antibody directed against the ASC portion of the inflammasome. While NodTheraâ€™s products are targeted against the variable sensor portion of NLRP3 inflammasomes, ZyVersa targets the ASC portion common to all inflammasomes. Since many different types of inflammasome may be part of an inflammatory response, ZyVersaâ€™s â€œsensor agnosticâ€ approach could block all inflammasomes, enabling a broader range of targets with better efficacy. ZyVersa has a research collaboration with the University of Miami Miller School of Medicine to assess IC 100 in obesity and metabolic syndrome that is expected to begin in 2Q24.
Exhibit 1. IC 100 Is &#8220;Sensor Protein Agnostic&#8221;.&nbsp;Inflammasomes are formed from a sensor molecule, and adaptor ASC (apoptosis-associated speck-like protein containing a CARD), and pro-caspase-1. There are many types of sensor molecules that each detect a different type of signal or pathogen, but only one type of ASC. ZyVersa&#8217;s IC 100 targets this common portion, potentially making it active against multiple inflammasomes.
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/commoninflammasomes.jpg" /> 
 
Source: ZyVersa Therapeutics, Inc.
Preclinical Studies With IC 100 Are Underway In CNS diseases. Preclinical research in Parkinsonâ€™s disease has been funded by the Michael J. Fox Foundation (MJFF) at University of Miami Miller School of Medicine. This study investigates the role of inflammation in the pathway of cell death in Parkinson&#8217;s disease. The study is expected to begin in 2Q24. As previously announced, an IND submission is planned toward year-end 2024, with a Phase 1 trial to start shortly afterward.
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 Conclusion.&nbsp;ZyVersa is on track to start the Phase 2 clinical trial in diabetic kidney disease in 1H24. New research on inflammation has shown how it affects obesity and metabolic syndrome, as well contributing to other diseases. Inflammation has been implicated in many diseases, so new data showing its role in additional disease pathways may lead to more applications for anti-inflammasome drugs than previously thought. We have not included any potential use in obesity, metabolic syndrome, insulin resistance, and focused on the preclinical data in degenerative diseases of the CNS.&nbsp;A collaborative study to assess IC 100 in obesity and metabolic syndrome is expected to begin in 2Q24. Preclinical work in preparation for an IND for IC 100 continues, with an IND filing for a trial in degenerative CNS disease expected in 2025. We are reiterating our Outperform rating and $4 price target.

ZyVersa Therapeutics Inc (ZVSA)

FY23 Reported With Reiteration of Milestones For Kidney and Inflammasome Trials

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Inflammation Study Links Alzheimer’s Disease With Chronic Heart Disease (ZVSA)

FY23 Reported With Reiteration of Milestones For Kidney and Inflammasome Trials (ZVSA)

Research Study Details Role Of Inflammasomes In TNBC Brain Metastases (ZVSA)

Novel Therapies For Renal Diseases and Inflammation (ZVSA)

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