JanOne Earns US Patent for the Use of its Novel Formulation of Low-Dose Naltrexone, Jan123, to Treat Chronic Pain

The Broad Patent Coverage is a Major Milestone for the Commercial Success of Jan123

LAS VEGAS, Aug. 29, 2023 /PRNewswire/ -- JanOne (Nasdaq: JAN), the visionary biotech company dedicated to discovering non-addictive treatments for pain, as well as causes of pain, has earned a US patent for its innovative formulation of low-dose naltrexone, Jan123, for treating pain.

The Broad Patent Coverage is a Major Milestone for the Commercial Success of Jan123 

Jan123 is being developed to treat complex regional pain syndrome (CRPS), a rare and often life-altering condition characterized by severe pain and hypersensitivity to touch. Tony Isaac, JanOne's CEO, said that the broad language of the new patent—covering methods of using our formulation of low-dose naltrexone to treat chronic pain — provides robust and broad coverage and protection, and lengthens the timeline for sales significantly.

"Today, patients with complex regional pain syndrome must resort to long-term opioid and narcotics for relief," Isaac said. "If Jan123 is approved, sufferers of CRPS will finally have proven, non-addictive relief."

Low-dose naltrexone has been shown in multiple studies and case reports to provide symptom relief in patients who suffer from CPRS, an orphan disease with no current FDA approved treatments. "This allowance from the US Patent Office speaks to the novelty of our approach, as well as the inventive spirit of JanOne's scientific team," said Dr. Tony Giordano, the company's Chief Scientific Officer. "Our low-dose naltrexone has the potential to help patients who are suffering from CRPS, and we look forward to testing it in large-scale human trials."

Dr. Amol Soin, the inventor of Jan123 and its novel uses, expressed great satisfaction with the US Patent Office's action. "This patent will allow us to help many patients who struggle with CRPS and is a validation of years of hard work by our team."

In citing features of the drug's formulation, the new patent explains Jan123's mechanism of action, including that "it increases endogenous enkephalins and endorphins which are the body's natural pain killers," resulting in a decrease in patient pain.

The full benefits of Jan123 may not yet to be known, but as stated in the patent: "Not only does low-dose naltrexone treat the pain symptom of CRPS, but it can also treat the disease process and disease cascades… It may actually treat the underlying disease state, which would be extremely beneficial to the patient."

"All in all," CEO Isaac concluded, "this patent approval is an important milestone in our company's brief history—and a welcome confirmation of our strategic vision."

About JanOne Inc. 
JanOne is a unique Nasdaq-listed company offering innovative, actionable solutions intended to help end the opioid crisis. JanOne is dedicated to funding resources toward innovation, technology, and education to find a key resolution to the national opioid epidemic, which is one of the deadliest and most widespread in the nation's history. Its drugs in the clinical trial pipeline have shown promise for their innovative targeting of the causes of pain as a strategic option for physicians averse to exposing patients to addictive opioids.

Forward Looking Statements

This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the statements that JAN 101 will treat PAD, that JAN 123 will treat CRPS, the timing of the commencement of clinical trials, that the FDA will permit approval through a 505(b)(2) pathway for JAN 123, that upon approval JAN 101 will immediately disrupt the PAD market, and other statements, including words such as "continue", "expect", "intend", "will", "hope" "should", "would", "may", "potential" and other similar expressions. Such statements reflect JanOne's current view with respect to future events, are subject to risks and uncertainties, and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by JanOne, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause JanOne's actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others, those detailed in the Company's periodic reports filed with the Securities and Exchange Commission (the "SEC"). Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in JanOne's filings with the SEC underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and JanOne does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. JanOne cannot assure that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Individuals are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.

Please visit www.janone.com for additional information.

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SOURCE JanOne Inc.