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JanOne Inc. Acquires an Option for the Rights to a Worldwide, Exclusive License for a Novel Strategy for Treating Methamphetamine Use Disorder

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JanOne Inc. (NASDAQ: JAN) announced an option agreement with LSU Health Shreveport for a novel strategy to combat methamphetamine use disorder (MUD) by activating the Translocator Protein 18 kDa (TSPO). This agreement allows JanOne to explore new drug compounds targeting TSPO, aiming to reduce cravings for meth. The company's drug discovery program is set to begin in 2022, with a preclinical candidate expected in 2023. JanOne also plans to initiate a Phase 2b trial for its pain treatment drug, JAN101, by late 2022.

Positive
  • Acquisition of rights to novel TSPO activation strategy for treating methamphetamine use disorder.
  • Potential to identify new drugs targeting TSPO, expanding JanOne's therapeutic pipeline.
  • Plans to initiate drug discovery program in 2022, with a preclinical IND-candidate expected in 2023.
Negative
  • No FDA-approved treatment exists for methamphetamine use disorder, indicating high uncertainty in development.
  • Risks associated with reliance on forward-looking statements regarding drug discovery and clinical trials.

LAS VEGAS, Dec. 7, 2021 /PRNewswire/ -- JanOne Inc. (Nasdaq: JAN), a company that focuses on the development of drugs with non-addictive, pain-relieving properties - in an effort to further reduce the drug addiction epidemic - today announced an option agreement for the rights to a novel strategy to reduce methamphetamine (meth) use by activating the Translocator Protein 18 kDa (TSPO).  The agreement with LSU Health Shreveport, along with other intellectual property relating to TSPO's role in treating meth use disorder (MUD), provides JanOne Inc. with an opportunity to identify new drugs to enhance TSPO activity, and by doing so, reducing craving for meth. This new strategy for treating MUD was discovered by Nicholas Goeders, Ph.D., JanOne Inc.'s Scientific Advisory Board member, and Department Chairman, Department of Pharmacology, Toxicology & Neuroscience and Executive Director of the Louisiana Addiction Research Center (LARC) at LSU Health Shreveport.

"Drug addiction has been the focus of my research for close to forty years, and I am extremely excited about the potential for reducing methamphetamine use by activating the TSPO" said Dr. Goeders. "The misuse of meth has steadily increased over the past few years, resulting in an epidemic rivaling the opioid crisis. Unlike opioids, however, there is no known antidote for methamphetamine overdoses and no FDA-approved treatment for methamphetamine use disorder. Therefore, I am thrilled to be able to work with JanOne Inc.to develop a research program focused on identifying compounds that we can move into clinical trials to treat this drug that is devastating users and their families worldwide."

"While JanOne Inc. remains committed to developing JAN101 for the treatment of PAD, we acknowledge that the opportunity to have an impact on so many people struggling with methamphetamine was too great to pass up" commented Tony Giordano, Ph.D., JanOne Inc.'s Chief Scientific Officer. "We believe that the research Dr. Goeders has conducted to date provides us with the data we need to put together a robust drug discovery effort."

JanOne Inc. anticipates initiating a drug discovery program in 2022, with the goal of identifying a preclinical IND-candidate in 2023. This represents an additional therapeutic effort in JanOne Inc.'s pipeline, with the company anticipating beginning a critical Phase 2b trial with JAN101 in late 2022.

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 fact that JAN101 will treat PAD, the timing of the commencement of clinical trials, that the FDA will permit approval through a 505(b)(2) pathway, that upon approval JAN101 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 Inc.'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 Inc., are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause JanOne Inc.'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 Inc.'s filings with the United States Securities and Exchange Commission 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 Inc.  does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. JanOne Inc. 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.

About JanOne Inc.
JanOne Inc. is a unique Nasdaq-listed company offering innovative, actionable solutions that it believes can help create an end to the opioid crisis. JanOne Inc. is dedicated to funding resources toward innovation, technology and education to find a key resolution the national opioid epidemic, which is one of the deadliest and widespread in the country's history. The company continues to operate its legacy businesses – ARCA Recycling and GeoTraq – under their current brand names. JanOne Inc's subsidiary, ARCA Recycling, recycles household appliances by providing turnkey recycling and replacement services for utilities and other sponsors of energy efficiency programs. JanOne Inc.'s subsidiary GeoTraq engages in the development, design and, ultimately, expected sale of Mobile IoT modules. Please visit www.janone.com for additional information.

About LSU Health Shreveport
LSU Health Shreveport is one of two Health Sciences Centers of the Louisiana State University (LSU) System and one of only 155 in the nation accredited by the Liaison Committee on Medical Education (LCME). LSU Health Shreveport is home to three professional schools (School of Medicine, School of Graduate Studies and School of Allied Health Professions), Graduate Medical Education (GME) and a robust research enterprise. At any one time, more than 1,500 students are enrolled in degree programs, and more than 590 residents and fellows are being trained at LSUHS partner teaching hospitals in North Louisiana. The primary mission of the LSU Health Shreveport is to teach, heal, and discover, in order to advance the well-being of the region and beyond. At the heart of LSU Health Shreveport is a strong faculty that includes a number of nationally and internationally acclaimed physicians and scientists. More than 600 strong, they lead research efforts, educate students, train residents and fellows, and provide primary and specialty care to patients throughout the region. LSU Health Shreveport has strong community support, fostering a culture of diversity and inclusion that promotes mutual respect for all. For more information visit www.lsuhs.edu.

Investor Relations & Media Contact
IR@janone.com
1 (800)-400-2247

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/janone-inc-acquires-an-option-for-the-rights-to-a-worldwide-exclusive-license-for-a-novel-strategy-for-treating-methamphetamine-use-disorder-301438448.html

SOURCE JanOne Inc.

FAQ

What is JanOne's recent acquisition related to methamphetamine use?

JanOne LLC acquired an option agreement with LSU Health Shreveport for a strategy to activate TSPO to treat methamphetamine use disorder.

When will JanOne initiate its drug discovery program for treating meth use disorder?

JanOne plans to start its drug discovery program in 2022.

What are JanOne's plans for clinical trials in 2022?

JanOne anticipates beginning a Phase 2b trial for its drug JAN101 in late 2022.

What are the expected outcomes from the TSPO strategy acquisition?

The acquisition aims to identify new compounds that reduce cravings for meth, potentially leading to new treatment options.

What is the significance of the TSPO activation strategy in drug development?

TSPO activation represents a novel approach to tackling the methamphetamine crisis, which currently lacks effective treatments.

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