Genprex Makes Significant FDA Announcement
(GNPX) After Hours close at $1.38/share / Volume 53.6M shares traded, on watch for continuation…
Fast Track Designation for Lung Cancer Treatment
Good day everyone,
We are continuing our coverage on Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company, involved in developing various approaches to treating cancer, based upon a proprietary technology platform.
Current price $1.32 per share
Public float (est.) 6.41 million shares
In our initial coverage, we said “It seems as though any news regarding the development of the GNPX products may serve as a significant catalyst for the company share price.”
Genprex just announced, at 8:00 this morning, it has received Fast Track designation for its lead product candidate and delivery platform in combination with an AstraZeneca product.
The recent news did just that. We vetted GNPX shares to alert at $.36 per share, then the news broke. The company shares opened at $1.20 and at this writing hit a high of the day of $1.74 per share representing a potential gain of 45% for our members. Congratulations to those of you realizing a profit.
Link to today’s GNPX news:
GNPX is collaborating with AstraZeneca (market cap $136B and sales of $24B) in clinical trials that combine the GNPX drug delivery system along with Oconoprex, the GNPX lead drug candidate, and Tagrisso, an AstraZeneca EGFR inhibitor product with worldwide sales of $2.31 billion in the first 9 months of 2019 and is currently AstraZeneca’s highest grossing product.
The epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer (NSCLC) patients are present in approximately 10-20% of NSCLC cases.
The collaboration with AstraZeneca not only gives credence to the GNPX science, it has the potential to impact funding in the company’s upcoming clinical trials.
GNPX stated “We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment.”
The initial disease indication for Oncoprex is on Small Cell Lung Cancer (NSCLC), a condition that represents 84% of all lung cancers and reports 2 million cases worldwide on an annual basis.
We want to underscore the fact that the clinicals for Oncoprex and the nanovesticles delivery system to treat NSCLC is the INITIAL DISEASE INDICATION. The potential indications, down the road, could include other forms of cancer.
Genprex’s platform technologies are designed to administer cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.
EvaluatePharma’s forecast calls for oncology medicines to rack up an astonishing $237 billion in total sales in 2024. That figure exceeds diabetes drugs (#2) by a factor of 4.
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
So, what is the value of GNPX shares given the recent news? Let’s keep in mind that the company only has 19.26 million (est.) shares outstanding. Before the recent news GNPX had a market cap just under $7M. What do you think a sustainable market cap is for a company with a clinical collaboration with AstraZeneca, a leading-edge drug and delivery platform, and a fast track designation from the FDA?
These are some NASDAQ development stage companies involved with cancer treatment that we feel are similar in scope to GNPX
Corvus Pharmaceuticals, Inc. Market Cap $158M
Immutep Limited Market Cap $73M
Lineage Cell Therapeutics, Inc. Market Cap $121M
Oncolytics Biotech Inc. Market Cap $74M
Genprex (GNPX) Market Cap at yesterday’s close $22.15M
Do your due diligence and see what you discover about the potential near-term prospects for GNPX shares.
The Traders News Group
original report below
Low Float NASDAQ Stock Looking Oversold
Biopharma gem at a good value
Good day everyone,
We are initiating coverage on Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company, involved in developing various approaches to treating cancer, based upon a proprietary technology platform.
Current price $.36 per share
Shares outstanding (est.) 19.26 million
Shares in float (est.) 6.41 million
52-week range $.231 to $2.26 per share
Insider ownership 40.82%
This low float stock has some attractive qualities. Leading edge technology with potential verticals, not only for its lead drug candidate, but for monetization of their delivery platform. A current price at the low end of the 52-week range and a chart setup that may indicate a near term gain.
The GNPX lead drug candidate is being evaluated in a phase 2 clinical trial for efficacy as a treatment for Non-small-cell lung cancer.
GNPX shares have crossed their 50 DMA of $.33 per share and seem to be getting some traction. Their 200 DMA is at $.95 and the 52-week high is $2.26. We believe the true value of GNPX shares may be closer to the 200 DMA and the 52-week high, than the current price of $.36 per share is.
The company shares are currently trading 15.4% over their SMA20 possibly indicating a bullish near-term trend.
Two Wall Street analysts have issued ratings and price targets for Genprex in the last 12 months. Their average twelve-month price target is $5.00, suggesting that the stock has a possible upside of 1,288.89%. The high price target for GNPX is $5.00 and the low-price target for GNPX is $5.00. There are currently 1 hold rating and 1 buy rating for the stock, resulting in a consensus rating of “Buy.”
The large insider holdings (40%) indicate that management may have a vested interest in the success of the company and the creation of shareholder value. Eleven institutions, including Vanguard and Sabby, own another 10% of the shares.
The GNPX lead product candidate, Oncoprex, consists of a TUSC2 gene encapsulated in a positively charged nanovesicle made from lipid molecules with a positive electrical charge. Oncoprex is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once Oncoprex is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.
GNPX is also conducting research into other tumor suppressor genes associated with chromosome 3p21.3, as well as other potential applications of our immunogene therapy platform.
The Genprex gene therapy platform consists of anti-cancer genes encapsulated in nanovesicles that are delivered intravenously. The Oncoprex TUSC2 gene is encapsulated in a positively charged nanovesicle that binds to actively replicating (and, therefore, negatively charged) cancer cells and then enters the cancer cell through selective endocytosis.
The GNPX platform is applicable to delivery of a range of therapeutic and prophylactic plasmid DNAs and RNA interference constructs. The nanovesicle manufacturing methods have been optimized and are useful for a wide array of disease treatments. The nanovesicles are clinically proven to deliver molecular kinase inhibitors effectively.
We note on the chart below that trading volumes have increased significantly in 2020. Further, the gap between the 50 DMA of $.33 and the 200 DMA of $.95 could indicate that GNPX shares are oversold given the absence of adverse events.
Note the spike in the share price on November 19th. This occurred the day the company announced positive news regarding their lead product candidate TUSC2 gene in a study done by the MD Anderson Cancer Center.
It seems as though any news regarding the development of the GNPX products may serve as a significant catalyst for the company share price.
Once again, the public float is only 6.41 million shares (est.)
An updated report on GNPX will be available soon.
The Traders News Group
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