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Prado has inspired me to redo my previous DD on Genprex and overall put more effort into the post and research. Below is my final product. Hope everyone enjoys and always thank you Prado!
What is Genprex?
- Genprex (GNPX) is a biotechnology company out of Austin, Texas that is focused on developing life-changing gene therapies for patients with cancer and diabetes through unique, innovative science.
Proprietary Technology Delivery Platform (ONCOPREX)
- Oncoprex is a nanoparticle delivery platform, which delivers cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanoparticles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.
Non-Viral Vectors vs. Viral Vectors
- A big issue with gene therapies is the need for viral vectors in order to go in and edit the genes. Viral vectors are the currently the most effective way to administer gene therapies, but pose many unwanted side effects.
- Genprex's non-viral vector delivery platform(Oncoprex) gives them an advantage against viral vector gene therapies.
- The nanovesicles are taken up by tumor cells after Oncoprex immunogene treatment at 10 to 25 times the rate at which they are taken up by normal cells.
- GPX-001 is their lead product candidate (non-proprietary name quaratusugene ozeplasmid).
- FDA Fast Track on January 14, 2020 specifically for non small cell lung cancer (NSCLC).
- The active ingredient is TUSC2 (Tumor Suppressor Gene 2).
- On May 5, 2020 GNPX entered into an exclusive agreement with University of Texas MD Anderson Cancer Center. Read more here.
- more information on GPX-001 here.
- GPX-002 is a gene therapy for Type 1 & 2 Diabetes and the most recent licensed technology addition.
- Developed by a team led by Dr. George Gittes at University of Pittsburgh.
- On February 11, 2020 signed an exclusive license agreement with University of Pittsburgh.
- Diabetic mice studies have shown restored normal glucose levels for up to 4 months which could translate to decades in humans. (checked the date of these studies... 2018).
- Currently finishing up non-human (primate) preclinical trials and to collect final data in preparation for human trials.
- Dr. Gittes awarded $2.59 million from NIH NIDDK to assist development for his research project titled, “Alpha Cell Conversion to Beta Cells in Non-human Primates” and will build upon his accumulating groundbreaking gene therapy work toward finding a cure for diabetes.
- more info on GPX-002 here.
Connecting the Dots (Manufacturing)
- On June 16, 2020 announced manufacturing partnership with Aldevron to advance Oncoprex clinical development.
- On June 3, 2020 (13 days prior), Aldevron announced plans to expand manufacturing capacity 10x with new 14-acre campus.
- Plans to be fully operational by Q1 2021.
- QUOTE: “This plan is designed to serve the biopharmaceutical industry with the world’s most advanced manufacturing platforms for gene and cell therapy,” - Michael Chambers, CEO of Aldevron.
- QUOTE: "Upon completion of the campus, the annual capacity will exceed $1 Billion of plasmid DNA, RNA, gene editing enzymes, and other biologics."
- Interview with Rodney Varner, CEO of Genprex, confirms GNPX and Aldevron relationship dates back to 2012.
- Aldevron scaling up tenfold while Genprex is in the midst of a FDA fast track approval AND both parties locking in that partnership gives me the sense both are fairly confident in the data.
GNPX was trading at .37 before it was FDA fast tracked in Jan 2020. That plus the following catalyst sent it all the way to $7. It has since dropped to the $3 area and found a base. I believe there are 15+ catalysts in the next 5 years that could easily send this stock way above $7. A few would be
- A $78 billion market for diabetes therapeutics in 2026.
- A $26 billion market for lung cancer in 2024.
- Have obtained preclinical data showing TUSC2 could be effective against Triple Negative Breast Cancer, Thyroid cancer, Glioblastoma, Kidney cancer, head & neck cancer, and tissue sarcomas.
- File IND application to initiate clinical trial of Oncoprex in combination with pembrolizumab (Merck's Keytruda).
- Possible FDA Fast Track Designation for Oncoprex & Dr. Gittes GEN-002 diabetes treatment.
- Update on data from current FDA Fast Track Designation for Oncoprex in combination with Osimertinib (AstraZeneca's Tagrisso).
This year they have done 2 offerings for approx. $25 million combined to help fund these trials and have received other additional fundings ($2.6 million NIDDK) and have no outstanding debt as of March 30, 2020.
Market Cap: $151.43 million (20% of this value GNPX has in CASH... approx. $30 million)
OS: 38.63 million
Float: 26.78 million
% held by Insiders: 23%
% held by Instituions: 12.82%
Genprex is built off the remains of biotech failure Introgen from 2009. Hindenburgh research has attempted to short attack the stock back in 2018 with an article
due to this connection so I will do my best to explain.
Introgen was a biotech company from Austin, Texas that misled investors which ultimately led to its bankruptcy as they could not get the FDA approval they needed. They were actually unable to even get the FDA to review their application at all. The connections between Introgen and Genprex are 2 things: David Nance
and TUSC2. David Nance
was CEO of Introgen. After Introgen collapsed, Rodney Varner came in and collected the remains of Introgen and turned it into Genprex. David Nance was apart of the founding team that Varner assembled to progess forward. To my understanding Nance was still a knowledgeable individual in the field they were working in (maybe just not the best CEO of a publicly trade company), and Varner utilized Nance to help propel Genprex forward. However, NANCE LEFT GENPREX IN 2012.
And has since passed away in 2016 due to cancer. It has been 8 years since Nance's affiliation and 4 since he passed away and not a single member of the Introgen team has been involved since. The head behind Genprex has always been and still is RODNEY VARNER, CEO and Chairman. TUSC2
is known as Tumor Suppressor Gene 2. It is the active ingredient in Genprex's Oncoprex immunogene therapy. This was the main research focus that came out of Introgen. Since then, TUSC2 has been proven to be effective throughout trials which are littered throughout this post. ALSO, the FDA has now granted FAST TRACK DESIGNATION to GPX-001 which shows there is valid data proof of its effectiveness.
I am very bullish for GNPX in the next 2-5 years specifically as the majority of these trials will take time. All of this information is provided within the links attached above. I invite comments, concerns, and additional information I missed. Hope everyone enjoys. Best of luck to everyone with their trades/research.
This is a LONG TERM INVESTMENT (4-6 year hold for me).
I hold 2875 shares @ $3.34 and still adding more.
EDIT 1: JULY 24, 2020 Insider Trading:
EDIT 2: August 4th, 2020 CEO Rodney Varner presents at Proactive's One2One Virtual Investor Forum. EDIT 3: August 5th, 2020
- Jose Toscano Moreno (Director) SEC Form 4: Buy Option of 42,068 common shares @ $3.69
- Brent Longnecker (Director) SEC Form 4: Buy Option of 42,068 common shares @ $3.69
- William Wilson Jr (Director) SEC Form 4: Buy Option of 42,068 common shares @ $3.69
GNPX files 2 new patent applications with the USPTO