The acquisition of Soin provides JanOne with its second, late stage clinical stage asset

LAS VEGAS, Jan. 10, 2023 /PRNewswire/ -- JanOne Inc. ("JanOne") (NASDAQ:JAN), a company that focuses on the development of drugs with non-addictive, pain-relieving properties, announced today that it has completed the acquisition of Soin Therapeutics, LLC and its product, a patent-pending, novel formulation of low-dose naltrexone. This all stock transaction has a value of $13M, with up to an additional $17M depending on revenues generated by the product, for a total value of up to $30M. The transaction includes restrictions on the maximum number of shares of preferred stock and common stock that can be issued to or transferred by Soin Therapeutics at any given time.

The acquisition of Soin provides JanOne with its second, late stage clinical stage asset

The product, now named Jan123, is being developed for the treatment of Complex Regional Pain Syndrome (CRPS), an indication that causes severe, chronic pain generally affecting the arms or legs. There are no truly effective treatments for CRPS, which, together with the relatively small number of patients afflicted with the disease, resulted in the FDA granting Orphan Drug Designation. This designation will provide JanOne with tax credits for its clinical trials, exemption of user fees, and the potential of seven years of market exclusivity following approval. In addition, development of orphan drugs also involves smaller trials and quicker times to approval, given the limited number of patients available to study.

"We are very happy to complete this transaction and become part of JanOne," said Amol Soin, M.D., Soin Therapeutics' CEO. "In my pain management medical practice, we have been searching for effective alternatives to opioids and believe that our product will complement JanOne's mission to develop non-addicting pain medications. We are excited about working with them to get a pivotal trial underway as soon as possible so we can bring JAN123 to the market for treating patients with CRPS."

Tony Isaac, JanOne's CEO commented, "JanOne remains very committed to tackling the opioid crisis by developing non-addicting pain medications. With JAN123, we have added another product that could reduce the need for opioids in pain management." Mr. Isaac further stated, "Given the lack of any truly effective therapies for treating CRPS, we believe JAN123 can capture a significant share of this $100+ million market."

Jan123 represents the second product JanOne is developing for treating pain. Its first product, JAN101, is a potential treatment for PAD, a vascular disease that affects more than 8.5 million people in the U.S. and more than 60 million people worldwide. JAN101 has been used successfully in clinical trials to reduce pain and improve nerve function.

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 JAN101 will treat PAD, that JAN123 will treat CRPS, the timing of the commencement of clinical trials, that the FDA will permit approval through a 505(b)(2) pathway for JAN123, 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'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.

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SOURCE JanOne Inc.

JanOne Inc. Completes Acquisition of Soin Therapeutics, LLC