JanOne to Host Telebriefing to Discuss Drug Candidate JAN101 for Treatment of Peripheral Artery Disease (PAD) and Potential Applications for COVID-19 Vascular Complications

Rhea-AI Summary

JanOne Inc. (Nasdaq: JAN) announced a teleconference on August 25, 2020, at 4:15 PM ET to discuss updates on its lead drug candidate, JAN101. JAN101 targets peripheral artery disease (PAD) and may help with COVID-19 vascular complications. The drug has shown positive results in Phase 1 and 2a trials, with a pivotal Phase 2b study planned for early 2021. The global PAD market is projected to grow from $36.1 billion in 2017 to $52.0 billion by 2022. The company is also preparing an IND package for FDA submission to explore COVID-19 treatment applications.

Positive

• JAN101 demonstrated positive results in Phase 1 and Phase 2a trials for improving blood flow and vascular function.
• FDA authorization received for IND sponsorship transfer of JAN101.
• Pivotal Phase 2b study for PAD planned for early 2021.
• The global market for PAD is expected to grow significantly, potentially benefiting JAN's market position.

Negative

• None.

LAS VEGAS, Aug. 21, 2020 /PRNewswire/ -- JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, today announced that it intends to provide a public business update via teleconference regarding the advancements made through its lead drug candidate JAN101.  The company believes that JAN101 is a potential treatment for peripheral artery disease (PAD) and may have applications for COVID-19 vascular complications. The briefing will be held on Tuesday, August 25, 2020 at 4:15 PM ET.

JanOne's management update will be represented by Tony Isaac, CEO, Tony Giordano, PhD, Chief Scientific Officer, and Amol Soin, MD, Chief Medical Officer.

Conference Call Details:
Date: Tuesday, August 25, 2020
Time: 4:15 PM Eastern Time (ET)
Dial in Number for U.S. Callers: 877-407-8293
Dial in Number for International Callers: 201-689-8349

A replay will be available for two weeks starting on August 25, 2020 at approximately 7:15 P.M. ET. To access the replay, please dial 1-877-660-6853 in the U.S. and 1-201-612-7415 for international callers. The conference ID# is 13708885.

JanOne's first drug candidate, JAN101, is a patented sodium nitrite sustained release tablet formulated to treat PAD and other vascular conditions.  JAN101 (formerly referred to as TV1001SR) has demonstrated positive results in Phase 1 and Phase 2a trials for improving blood flow and vascular function.  The company has received authorization from the Food and Drug Administration (FDA) for the investigational new drug (IND) sponsorship transfer covering its sodium nitrite tablets and is currently preparing an investigator-initiated IND package for FDA submission, which it expects to submit in the coming weeks, as a potential treatment for certain aspects of bodily damage created by COVID-19.  A pivotal phase 2b study for PAD is planned for early 2021.

JAN101 is intended to address the 8.5 million Americans who suffer from PAD. In 2017, the global market for PAD was estimated at nearly $36.1 billion and is expected to grow at a compound annual growth rate (CAGR) of 7.6% to $52.0 billion by 2022, according to BCC Research.¹ 

About JanOne
JanOne (NASDAQ: JAN) is focused on developing medications to treat diseases that cause severe pain. By alleviating pain at the source, JanOne aims to reduce the need for opioid prescriptions to treat disease associated pain that can lead to opioid abuse. The company is also exploring solutions for non-addictive pain medications. Its lead candidate JAN101 is for treating peripheral artery disease (PAD), a condition that affects over 8.5 million Americans. JAN101 demonstrated positive results in a Phase 2a clinical trial, and Phase 2b trials are expected to begin in early 2021. JanOne is dedicated to funding resources toward innovation, technology, and education for PAD, associated vascular conditions and neuropathic pain. JanOne continues to operate its legacy businesses under their current brand names, ARCA Recycling and GeoTraq, both of which are undergoing review to determine appropriate strategic alternatives.  For more information, visit janone.com

Forward-Looking and Cautionary Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In accordance with the safe harbor provisions of this Act, statements contained herein that look forward in time that include everything other than historical information, including statements relating to (i) JAN101's expectation of when it will enter Phase 2b trials to treat PAD, (ii) whether JAN101 can treat vascular complications in COVID-19 patients, and (iii) the timing of the submission by the company of the IND package for the FDA. These forward-looking statements can be identified by terminology such as "will," "aims," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. JanOne may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC") on Forms 10-K and 10-Q, Current Reports on Form 8-K, in its annual report to stockholders, in press releases, and other written materials and in oral statements made by its officers, directors or employees to third parties. There can be no assurance that such statements will prove to be accurate and there are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the company, including, but not limited to, plans and objectives of management for future operations or products, the market acceptance or future success of our products, and our future financial performance. The company cautions that these forward-looking statements are further qualified by other factors including, but not limited to, those set forth in the company's Annual Report on Form 10-K for the fiscal year ended December 28, 2019 (available at http://www.sec.gov). JanOne undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events, or otherwise.

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

¹ https://www.bccresearch.com/market-research/healthcare/the-global-market-for-pain-management-drugs-and-devices.html

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SOURCE JanOne

FAQ

What is the date of JanOne's teleconference about JAN101?

JanOne's teleconference will be held on August 25, 2020, at 4:15 PM ET.

What is JAN101 and what conditions does it target?

JAN101 is a drug candidate developed by JanOne for treating peripheral artery disease (PAD) and potentially addressing vascular complications associated with COVID-19.

What clinical trial phases has JAN101 completed?

JAN101 has completed Phase 1 and Phase 2a clinical trials with positive results.

What is the expected market growth for PAD?

The global market for PAD is projected to grow from $36.1 billion in 2017 to $52.0 billion by 2022.

When is the pivotal Phase 2b study for JAN101 planned?

The pivotal Phase 2b study for JAN101 is planned for early 2021.