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Engineering batch for JAN101 complete and expectations are for GMP batch production to begin within 30 days
Las Vegas, NV – August 26, 2020 – JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, has successfully completed its initial engineering batch of JAN101. The JAN101 formulation is a patented sodium nitrite proprietary compound that demonstrated success in Phase 1 and Phase 2a trials for improving blood flow and vascular function, necessary in the treatment of Peripheral Artery Disease (PAD) and potentially for Covid-19 vascular complications that is believed to be the cause of severe vital organ and tissue damage.
According to Dr. Tony Giordano, JanOne’s chief scientific officer, “We are very fortunate to have had the foresight to initiate the manufacturing process this past February. Should we gain FDA approval for our Covid-19 study, we will be in a position to start patient trials immediately and still remain on track for our planned PAD phase 2b trials to begin in early 2021.”
The company expects to submit the investigational new drug (IND) for the treatment of Covid-19 vascular complications in the coming weeks and continues to advance plans to scale-up production of JAN101. The company has secured a partner for bottling and labeling, GMP batch production, including placebo batches. The company expects to deliver 250,000 doses within 30 days after start of manufacturing and have GMP batches of more than 20 million doses ready next year.
About JanOne
JanOne (NASDAQ: JAN) is focused on developing treatments for 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 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) whether JAN101 can treat vascular complications in Covid-19 patients, (ii) whether the company can obtain FDA approval for its Covid-19 study, (iii) when the phase 2b trials for PAD commence, (iv) when and whether the company will submit an IND for the treatment of Covid-19 vascular complications, and (v) how many doses the company will be able to deliver. 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
Source: JanOne Inc.
-Introduction to JanOne scientific team
-Strategy for upcoming planned Phase 2b trial of JAN101
-Business development updates, including planned COVID-19 treatment study and focus on commercialization and production capabilities
Las Vegas, NV – August 21, 2020 – 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
SOURCE JanOne
About JanOne Inc.
JanOne was formed in 2019 to find medications that treat diseases with severe pain that result in the potential of prescribing of harmful opioid medications to treat associated pain. It is estimated that 40% of opioid overdose deaths involve prescription opioids, often a direct result to treat those who suffer from chronic pain and neuropathic pain. Our choice was to tackle the issue by treating diseases that cause severe pain at the source so pain is no longer the issue and that means the potential for less opioid prescriptions to treat associated pain. We are fighting opioid abuse at the prescription pad, one disease at a time.
Formerly Appliance Recycling Centers of America, Inc., JanOne is publicly traded on the NASDAQ under the trading symbol JAN. The company has a long history of operating companies with social intent, thus its subsidiary company primarily focused on recycling household appliances and energy efficiency programs.
When we launched JanOne and entered into the world of pharmaceuticals, our aim was to ensure we remained true to maintaining businesses with social responsibility. The result was the creation of a new, dynamic pharmaceutical organization focused on conditions that cause severe pain and to find non-addictive pain reduction alternatives. Our vision is to see a world without pain and that starts with treating diseases that cause pain to millions around the world. If we can treat the disease, we can alleviate associated pain and the need for opioid prescriptions. Ultimately, we hope our efforts lead to the development of non-addictive pain relieving medications to treat the many forms of chronic pain without the risk of addiction, abuse and overdose.
Headquartered in Las Vegas, Nevada, and with access to a global research community, we see a world without pain and work tirelessly towards that goal. We can’t solve that problem alone, but we can certainly have an impact in the years ahead.
Developing treatments for conditions that cause pain.
On a mission to reduce the need for opioid prescriptions.
Our mission is to bring treatments to the market for diseases that cause severe pain and to find non-addictive answers for treating pain. JanOne – a biotechnology company.
Why? We treat disease at the source and we do our part to reduce the need for opioid prescriptions.
Why we are focusing on diseases that cause severe pain.
At JanOne, our focus is to treat diseases that cause severe pain at the source and, in the process, we hope to bring non-addictive answers to the market to treat pain. We are starting with Peripheral Artery Disease (PAD), a condition that affects over 8.5 million Americans, many of whom are at risk for addiction when opioids are prescribed to treat the associated pain. JanOne – a biotechnology company.
If we can treat diseases that cause severe pain at the source, we believe we can do our part to reduce opioid addiction at the prescription pad.
Source: https://janone.com/
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