JanOne Charts Ambitious Strategic Course for Non-Addictive Pain Management

In meetings hosted by Nasdaq MarketSite, the company reviewed its drug development programs that fight the opioid crisis through pharmaceuticals that reduce pain without causing addiction.

LAS VEGAS, Jan. 26, 2023 /PRNewswire/ -- JanOne (Nasdaq: JAN), which develops treatments for underlying causes of severe pain and brings to market drugs that relieve pain without the risk of addiction, held meetings at New York's Nasdaq MarketSite to review strategic plans and to facilitate integration of recently-acquired Soin Therapeutics.

JanOne was founded to tackle the society-wide crisis of opioid abuse by discovering non-addictive, non-sedating alternative treatments for pain. The need for such pharmaceuticals has never been more urgent. As the Centers for Disease Control and Prevention announced, an avalanche of overdose deaths—driven largely by the use of illicit fentanyl—killed a staggering 110,236 people in a recent 12-month period—a new record.

In its ongoing response to the crisis, JanOne has two late-stage clinical drug development programs: One is low-dose naltrexone (renamed JAN 123) that treats complex regional pain syndrome and was developed by Soin Therapeutics. The drug received orphan drug designation and is being readied for late-stage clinical trials to facilitate FDA approval.

The second weapon in the battle to reduce opioid-related deaths is JAN 101, a novel medication that treats peripheral artery disease (PAD), a source of severe pain for 8.5 million Americans. JAN 101 is also entering a late-stage registration trial with the FDA.

Other opportunities to treat pain without dangerous consequences were discussed at MarketSite by JanOne's executive team.   

"I am excited to spend the day discussing, reviewing, and outlining our plans to move our drugs forward," said Dr. Tony Giordano, PhD, Chief Scientific Officer. "PAD is a debilitating disease, often without many treatment options. Our JAN 101 holds promise to help those who suffer from it."

Also reviewed at the Nasdaq meeting were plans for integrating the newly acquired Soin Therapeutics. With that acquisition, Dr. Amol Soin, JanOne's Chief Medical officer, will play a more prominent role in the company. Dr. Soin invented JAN 123 and is founder of the Ohio Pain Clinic. He is among the nation's leading research and clinical specialists in pain management. Starting as a resident in anesthesiology at Chicago'sRush University, he has actively engaged in research in pain management and anesthesia.

"We have multiple exciting programs in store for the future," said Dr. Soin. "We're moving JAN 123 closer to eventual FDA approval. This holds a lot of promise to help people suffering from pain with an unmet clinical need."

Commenting on the day's deliberations, CEO Tony Isaac concluded that, "As a result of all we do, we hope to reduce the need for prescribing dangerous opioid drugs. It's a mission we feel passionate about. So often the tragedy of addiction and overdose starts at the physician's office—on a prescription pad. It's an innocent beginning with great potential harm. We aim to do everything we can to give physicians safer treatment options that effectively reduce pain."

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.

About JanOne Inc.

JanOne is a unique Nasdaq-listed company offering innovative, actionable solutions that it believes can help create an end to the opioid crisis. JanOne 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 business – ARCA Recycling – under its current brand name. JanOne's subsidiary, ARCA Recycling, recycles household appliances by providing turnkey recycling and replacement services for utilities and other sponsors of energy efficiency programs. Please visit www.janone.com for additional information.

Media Contact:
ir@JanOne.com

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SOURCE JanOne Inc.