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$JAN Is Our Low-Float Nasdaq Listed Biotech Alert.

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NASDAQ:JAN   JanOne Inc
JanOne Inc. (NASDAQ: JAN)
Alert Price: $7.63
Float: 1.38M
Please turn your immediate attention to JanOne Inc. (NASDAQ: JAN).

JAN could be the next pharma stock to take Wall St. by storm.

The company is focused on finding treatments for conditions that cause severe pain and bringing to market drugs with non-addictive pain-relieving properties. As a result, they hope to reduce the need for prescribing dangerous opioid drugs. Their first drug candidate (JAN101) is a treatment for Peripheral Arterial Disease (PAD), a condition that can cause severe pain and affects over 8.5 million people in the US alone.

The Company recently announced some exciting developments that could serve as a catalyst towards bringing its share price to levels not yet seen.

JAN has 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 the treatment of Covid-19 vascular complications that is believed to be the cause of severe vital organ and tissue damage.

JAN 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.

The Bullish Case for JanOne (NASDAQ: JAN)

Has a razor thin float
A history of monster single day moves
Has tremendous upside
Trading well under book value of $8.71
52.97% Insider ownership
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.
This is one of the most exciting opportunities we've seen in quite some time, we suggest that you act now, and add JAN to the top of your watchlist.

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

Key Growth Drivers

Product Candidate: JanOne acquired an exclusive license to the worldwide right to TV1001SR, now known as JAN101, a twice-daily, orally dosed slow-release formulation. Over $13.5 million1 has been spent on the development in research and clinical work, excluding patent and Intellectual property expenses. Sodium nitrite is an approved drug for acute use and is on the list of The World Health Organizations list of 100 essential medications. Results from Phase 2a clinical trials support the use of sodium nitrite for the treatment and prevention of PAD and as a non-addictive treatment for Diabetic Neuropathy. While not a predetermined endpoint for the trial, subjects who participated in the trial also reported a reduction in pain as a result of the increased blood flow to the extremities and prompted a clinical study into diabetic pain where patients reported a significant reduction in pain.

Market Opportunity: 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.2

Patent Portfolio: The company has a portfolio of 30 worldwide patents and other intellectual property relating to sodium nitrite, the sustained release of sodium nitrite, and a provisional application to assist in the treatment of COVID-19 vascular complications. The patent portfolio presents diverse licensing opportunities and potentially royalty opportunities if JanOne intellectual property is used with other drug candidates.

Manufacturing underway: The company has a manufacturing agreement with CoreRx Inc. for the formulation and manufacturing of JAN101. CoreRx operates over 150,000 square feet of cGMP lab and manufacturing facilities, including six formulation suites, 18 manufacturing suites, and two analytical labs.

FDA 505 (b)(2) pathway: To streamline development and approval of the U.S. Food and Drug Administration (the “FDA”), the company expects to pursue FDA 505(b)(2) pathway for new drug approval as a result of an already approved acute use associated with JAN101.

Recent Highlights

In July 2020, several esteemed colleagues joined JanOne's Scientific Advisory Board
In July 2020, JanOne received confirmation from the FDA for the investigational new drug (IND) sponsorship transfer covering its sodium nitrite tablets previously held by Soin Neuroscience
In August 2020, JanOne engages CATO-SMS a world leading clinical research organization to assist in the development of JAN101 to Treat COVID-19 Vascular Complications
In August 2020, JanOne completes stable formulation of JAN101 in preparation for its first GMP manufacturing batch to support upcoming clinical trials
JAN Working Towards Treatment Of Covid-19

JanOne Advances its Potential Peripheral Artery Disease and Covid-19 Vascular Inflammation Treatment Towards Trial Readiness

Engineering batch for JAN101 complete and expectations are for GMP batch production to begin within 30 days

JAN 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.

In various animal studies, JAN101 has demonstrated positive benefits that align with COVID-19 complications

Reduces kidney damage
Prevents tissue necrosis
Reduces thrombosis
Increases angiogenesis
The JAN101 COVID-19 Vascular Treatment Opportunity

As indicated in multiple human trials, our current sodium nitrate compound may be a successful treatment for the vascular complications experienced by COVID-19 patients

Shown to improve vascular function
Shown to reduce vascular complications such as thrombosis
Protects major organs from tissue damage due to poor blood flow
Inhibits inflammation, including mitigating the “cytokine storm”, a massive release of cytokine proteins that destroy endothelial cells (cells that protect the lining of vessel tissue)
Nitrite has proven to be well tolerated and safe
Peripheral Artery Disease Market Projected Be Valued At $52B By 2022

In the US alone, PAD affects nearly 12 million people, and if left untreated will lead to Critical Limb Ischemia with an annual cost of care estimated at $10 billion. 1 in every 20 adults over the age of 50 years, and 1 in every 4 adults over the age of 70 years are likely to develop PAD.

JAN's JAN101 is intended to address the 12 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

Growing number of patients suffering from peripheral artery disease across the globe and surge in population of ageing people across the European countries drive the growth of the global peripheral artery disease market.

Technical Analysis

We've done our very own chart analysis and see the potential for a big move from here!

JAN's share structure also seems attractive to those looking for a ticker with tremendous breakout potential!

Bullish Indicators:

Stock continues to run higher within a very bullish ascending channel , which remains perfectly respected.
20 moving average remains as support.
Stock has moved above VWAP
RSI is in bullish uptrend
Stochastic has bottomed and crossed bullishly.
The Bottom Line

JAN could be our next Nasdaq listed alert to run-up big.

The Company's razor thin float is a day traders dream come true.

JAN is in the midst of a major growth period, and has several bullish catalysts on the horizon.

Now may be the perfect time to take a closer look at JAN.

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