Genprex, Inc. (NASDAQ: GNPX)

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Genprex Enters Into Exclusive Worldwide Patent and Technology License Agreement for Combination of its TUSC2 Gene Therapy with Immunotherapies

New license agreement expands Genprex’s oncology franchise

 

Licensed technologies include use of Genprex’s TUSC2 gene therapy combined with immunotherapy drugs, including:

 

  • Pembrolizumab (Merck’s largest selling drug Keytruda)
  • Nivolumab (Bristol-Myers Squibb’s Opdivo)
  • Ipilimumab (Bristol-Myers Squibb’s Yervoy)

 

AUSTIN, Texas — (May 5, 2020) — Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that it has entered into a Patent and Technology License Agreement (“License Agreement”) with The University of Texas MD Anderson Cancer Center (“MD Anderson”) in which MD Anderson granted to Genprex an exclusive worldwide license to a portfolio of 16 patent applications and related technology (“Licensed IP”) for the treatment of cancer using Genprex’s lead drug candidate and TUSC2 gene therapy, known as “Oncoprex” or “GEN-001,” in combination with immunotherapies. This is a distinct therapeutic approach from that of combining Oncoprex with targeted therapies such as osimertinib (marketed as Tagrisso® by AstraZeneca).

 

Genprex was recently awarded U.S. FDA Fast Track designation for use of Oncoprex combined with Tagrisso for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations whose tumors progressed after treatment with Tagrisso alone. The Company is now preparing to file an Investigational New Drug application to initiate a clinical trial of Oncoprex in combination with pembrolizumab (marketed as Keytruda® by Merck) in NSCLC.

 

“We are pleased to advance the intellectual property that is covered by this License Agreement,” said Rodney Varner, Genprex’s Chairman and Chief Executive Officer. “We are excited to be developing two distinct therapeutic approaches to lung cancer utilizing the combination of our gene therapy with successful targeted therapies, such as Tagrisso, and immunotherapies, such as Keytruda, to potentially improve patient outcomes and increase the number of patients who may benefit from these important therapies.”

 

Immunotherapy or immunotherapy combined with chemotherapy is now the first-line standard of care for the majority of lung cancer patients. Published preclinical data indicate that when Oncoprex is combined with immunotherapies such as Keytruda, Oncoprex is synergistic with those drugs, meaning that the combination is more effective than either drug alone. The combination of Oncoprex and Keytruda may lead to better outcomes for many lung cancer patients.

 

The Licensed IP covers the use of Oncoprex in combination with one or more immunotherapies, including anti-PD1 antibodies, anti-PDL1 antibodies, anti-PDL2 antibodies, anti-CTLA-4 antibodies and/or anti-KIR antibodies for the treatment of cancer. These immunotherapies include pembrolizumab (Merck’s largest selling drug Keytruda), nivolumab (Bristol-Myers Squibb’s Opdivo), ipilimumab (Bristol-Myers Squibb’s Yervoy), and others. Use of chemotherapy in combination with Oncoprex and immunotherapy is also covered by the Licensed IP. While the initial disease indication for Oncoprex is NSCLC, the Licensed IP claims patent protection for combination use of Oncoprex in all types of cancers.

 

The License Agreement also provides for payment to MD Anderson of an up-front license fee and annual maintenance fees, with the potential for milestone payments, sublicensing fees, and product royalties.

 

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, Oncoprex™, is being evaluated as a treatment for non-small cell lung cancer (NSCLC). Oncoprex has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for Oncoprex immunogene therapy for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®). For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

 

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of Oncoprex™, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships; the timing and success of obtaining FDA approval of Oncoprex™ and our other potential product candidates including whether we receive fast track or similar regulatory designations; and whether patents will ever be issued under patent applications that are the subject of our license agreements. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

 Genprex, Inc.

(877) 774-GNPX (4679)

 

Investor Relations

GNPX Investor Relations

(877) 774-GNPX (4679) ext. #2

investors@genprex.com

 

Media Contact

Genprex Media Relations

Kalyn Dabbs

(877) 774-GNPX (4679) ext. #3

media@genprex.com

 

SOURCE Genprex, Inc.

Genprex and University of Pittsburgh Sign Exclusive License Agreement for Potentially Curative Gene Therapy Candidate for Diabetes
  • Company licenses patented diabetes gene therapy technology designed by researchers at the University of Pittsburgh
  • Results from in vivo animal studies indicate that normal glucose levels in the blood may be restored for an extended period of time
  • Company plans to partner for the clinical development and commercialization of this therapy in the U.S. and internationally

 

Austin, TX & Cambridge, MA – February 11, 2020 — Genprex, Inc. (NASDAQ: GNPX) (“Genprex” or the “Company”), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and other serious diseases, today announced that it signed an exclusive license agreement with the University of Pittsburgh for a diabetes gene therapy that may have the potential to cure Type 1 and Type 2 diabetes, which together currently affect approximately 30.3 million people in the U.S, or 9 percent of the U.S. population.

 

The diabetes gene therapy, which was developed by lead researcher and Harvard graduate, Dr. George Gittes, at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, works by reprogramming beta cells in the pancreas to restore their function, thereby replenishing levels of insulin. The novel infusion process uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The proteins these genes express transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

 

The diabetes gene therapy has been tested in vivo in mice and nonhuman primates. In studies of diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. Following preclinical studies, Dr. Gittes and his team plan to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.

 

“One of the biggest advantages of this gene therapy is that it could eliminate the need for insulin replacement therapy for diabetic patients,” said Dr. Gittes. “Lifting this huge burden for the millions of patients who must continuously monitor blood glucose levels and inject insulin daily would be a breakthrough in modern medicine. This therapy has the potential to truly disrupt the diabetes market.”

 

Genprex will add this exciting technology to its research and development pipeline, diversifying its portfolio and expanding its clinical development programs. The company will continue its focus on developing its immunogene therapies for cancer, including Oncoprex™ immunogene therapy, its lead drug candidate for non-small cell lung cancer, in parallel with development of the new diabetes gene therapy.

 

“We are excited to announce the licensing agreement with The University of Pittsburgh, and we look forward to working with Dr. Gittes and his team to develop this groundbreaking treatment for diabetes,” said Rodney Varner, Genprex’s Chairman and Chief Executive Officer. “At Genprex, we have always put patient needs first, focusing on ways to bring new treatment options to patient populations who have large unmet medical needs. We believe this diabetes gene therapy may potentially become a new treatment option for the millions of diabetes patients who now must take insulin replacement therapy, and it may be effective for patients who do not benefit sufficiently from that therapy. Even more moving, the diabetes gene therapy could hold the potential to provide long term effectiveness, or even be a cure, for diabetes patients.”

 

Genprex plans to pursue potential partnerships for the development of this therapy globally and in the U.S.

 

According to the American Diabetes Association, more than 30 million Americans have diabetes, and approximately 1.5 million Americans are diagnosed with diabetes every year. Diabetes patients have the continuous burden of checking and monitoring their blood glucose levels and injecting insulin on a daily basis. Without effective management of diabetes, patients are at risk of stroke, hyperglycemia, cardiovascular disease, diabetic ketoacidosis and extremity amputation. Diabetes is the seventh leading cause of death in the U.S.

 

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and other serious diseases. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and other serious diseases who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches for patients with cancer and other serious diseases. The company’s lead product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary platform which delivers 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. In January 2020, the FDA granted Fast Track Designation for Oncoprex in combination with AstraZeneca’s Tagrisso® for the treatment of NSCLC. For more information, please visit the company’s website at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

 

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effects of the licensed gene therapy on diabetes and the effect of Genprex’s other product candidates, alone and in combination with other therapies, on cancer, as well as Genprex’s ongoing and planned preclinical and clinical studies and potential partnerships. Risks that contribute to the uncertain nature of the forward-looking statements include risks relating to the effects of the safety and effectiveness of the licensed gene therapy and of Genprex’s other product candidates, alone and in combination with other therapies, as well as the success of Genprex’s ongoing and planned preclinical and clinical studies and the success of Genprex’s efforts in concluding potential partnering arrangements for product development and commercialization. Other risks and uncertainties associated with Genprex and its product candidates are described more fully under the caption “Risk Factors” and elsewhere in Genprex’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Genprex undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

Genprex, Inc.

(877) 774-GNPX (4679)

 

Investor Relations

GNPX Investor Relations

(877) 774-GNPX (4679) ext. #2

investors@genprex.com

 

Media Contact

Genprex Media Relations

Kalyn Dabbs

(877) 774-GNPX (4679) ext. #3

media@genprex.com

 

 

Source:  Genprex, Inc.

Genprex to Focus Its Clinical Efforts on Oncoprex™ in Combination Therapy with Osimertinib for Non-Small Cell Lung Cancer (NSCLC)

Austin, TX & Cambridge, MA – Feburary 5, 2020-  Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, today provides a clinical update and focus for its Oncoprex™ immunogene therapy program for 2020, prioritizing the development of Oncoprex in combination with osimertinib for the treatment of non-small cell lung cancer (NSCLC).

 

On January 14, 2020, the Company received U.S Food and Drug Administration (FDA) Fast Track Designation for its Oncoprex immunogene therapy in combination with the EGFR tyrosine kinase inhibitor (TKI) osimertinib (AstraZeneca’s Tagrisso®, which had worldwide sales in 2018 of $1.86 billion and $2.31 billion in the first nine months of 2019, and it is currently AstraZeneca’s highest grossing product) for the treatment of NSCLC patients with EFGR mutations that progressed after treatment with osimertinib alone. Oncoprex consists of the TUSC2 (Tumor Suppressor Candidate 2) gene, the active agent in Oncoprex, complexed with a lipid nanovesicle.

 

The Company’s current Phase I/II clinical trial utilizes the combination of the EGFR inhibitor erlotinib (marketed by Genentech in the U.S. and elsewhere by Roche as Tarceva®) and Oncoprex against NSCLC. The current Phase I/II trial is active but is not currently enrolling patients, though the Company had planned to resume enrollment in mid-2020. Tumor shrinkage in patients resistant to erlotinib enrolled in this trial showed that Oncoprex can overcome resistance to TKIs and provided support for the Fast Track Designation.

 

Osimertinib is now considered a new standard of care for NSCLC patients with an EGFR mutation. Given this and receipt of FDA’s Fast Track Designation for use of Oncoprex combined with osimertinib in patients whose tumors progress on osimertinib, the Company has decided to prioritize this drug combination and patient population. Therefore, the Company plans to initiate a Phase I/II clinical trial of Oncoprex combined with osimertinib in mid-2020 at multiple cancer centers across the United States, and it does not intend to reopen enrollment in the current Phase I/II trial using the combination of Oncoprex and erlotinib at this time.

 

Genprex plans to file an amendment to its Investigational New Drug (IND) application with the FDA for the Oncoprex and osimertinib combination therapy trial within the first quarter of 2020. Upon FDA acceptance of the amendment, the Company expects to be in a position to enroll patients shortly thereafter. The Company believes that enrollment in the new clinical trial may be rapid, as the tumors of almost all patients who are treated with osimertinib progress after treatment, and these patients may be candidates for its clinical trial combining Oncoprex with osimertinib, for which the Company received Fast Track Designation.

 

Thus, given the changing landscape in NSCLC and the recent Fast Track Designation, the Company believes prioritizing the combination therapy of Oncoprex with osimertinib represents the most efficient way to advance its lead drug candidate through the clinical process for FDA approval, to have the best commercial success in the $17.9 billion global lung cancer market and to make its treatment available to patients as soon as possible.

 

While prioritizing the combination therapy of Oncoprex with osimertinib, the Company will also proceed with its plan to file an IND for the additional combination therapy of Oncoprex combined with the immunotherapy drug pembrolizumab (marketed as Keytruda® by Merck in the U.S.) for NSCLC.

 

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients based upon a unique proprietary technology platform. 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. The company’s lead product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC), has a multimodal mechanism of action whereby it has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. In January 2020, the FDA granted Fast Track Designation for Oncoprex™ immunogene therapy for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®). For more information, please visit the company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

 

Forward-Looking Statements

 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of TUSC2, alone and in combination with targeted therapies and/or immunotherapies, on cancer, and regarding Genprex’s current and planned INDs and clinical trials. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of TUSC2’s effect, alone and in combination with targeted therapies and/or immunotherapies, on cancer; the safety and effectiveness of Oncoprex, alone and in combination with immunotherapies and chemotherapies, the timing of Genprex’s IND filings and amendments, the timing and outcome of FDA action with respect to Genprex’s IND filings and amendments, the timing and ability of Genprex to enroll patients in its clinical trials, the timing and success of Genprex’s clinical trials and planned clinical trials of Oncoprex™, alone and in combination with targeted therapies and/or immunotherapies, and Genprex’s other potential product candidates; the timing and success of obtaining FDA approval of Oncoprex™ and Genprex’s other potential product candidates, and the timing and ability of Genprex to commercialize Oncoprex. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Genprex’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Genprex undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

(877) 774-GNPX (4679)

Investor Relations
GNPX Investor Relations
(877) 774-GNPX (4679) ext. #2
investors@genprex.com

Media Contact
Genprex Media Relations
Kalyn Dabbs
(877) 774-GNPX (4679) ext. #3
media@genprex.com

 

Source: Genprex, Inc.

About Genprex


REPROGRAMMING THE COURSE OF CANCER

 

At Genprex, we are committed to pioneering a new approach to treating cancer, based upon our novel proprietary technology platform, including our initial product candidate, Oncoprex™ immunogene therapy, or Oncoprex. Our 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.

 

Our mission is to develop life-changing gene technologies for cancer patients through unique, innovative science.

 

Genprex is a clinical stage gene therapy company committed to pioneering a new approach to treating cancer. We are developing potentially life-changing gene technologies based upon our novel proprietary technology platform, including our initial product candidate, Oncoprex™ immunogene therapy, or Oncoprex. Our platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles. The nanovesicles are then administered intravenously and are taken up by tumor cells where they express proteins that are missing or found in low quantities.

 

Our lead product candidate, Oncoprex™, targets non-small cell lung cancer. This initial cancer target represents about 85 percent of all lung cancers and causes more deaths each year than any other type of cancer. Lung cancer is the second most common form of cancer, and the five-year survival rate for late stage lung cancer has not improved substantially in a quarter century. Research indicates that our platform technologies may deliver a number of other cancer fighting genes, alone or in combination with other cancer therapies, to combat additional types of cancer.

 

Commitment – We are committed to fighting cancer by continuing to develop unique and innovative gene therapies.

 

Excellence – Our pioneering technologies are at the forefront of gene therapy and we stand behind our high-quality technology platform.

 

Integrity – We have integrity and high ethical standards, and we believe in responsibly transforming the lives of those affected with cancer.

 

Leadership – Our commitment, excellence in technology, and integrity behind what we do enables us to be trailblazers in the effort to change the lives of cancer patients.

 


 

OUR TECHNOLOGY

 

Cancer

 

Cancer is a complex disease that can start in any site in the body when a tissue grows out of control and inhibits the body’s normal functioning. At the cell level, cancer often involves the dysregulation of multiple genes and cellular pathways, leading to the cell’s inability to maintain proper cellular functions. Re-establishing or blocking these pathways can be done through many therapeutic approaches, including gene therapy. More general information about cancer can be found at The American Cancer Society

 

Lung Cancer

 

Genprex’s research and development projects are focused on developing new treatments for cancer. Our initial therapeutic target is non-small cell lung cancer (NSCLC). Lung cancer is one of the most prevalent and deadly cancers worldwide, and NSCLC comprises about 85 percent of lung cancers. The five year survival rate for late stage lung cancer has not improved significantly in the past 25 years despite advances in drug development and novel therapeutic standards. Our objective at Genprex is to develop cutting-edge gene therapies to improve patient outcomes.

 

The Genprex Approach

 

We are developing gene therapies for treatment of cancer, including our initial drug candidate Oncoprex immunogene therapy. Our gene therapies 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. Our research indicates that when Oncoprex is combined with targeted therapies (such as Tarceva or Iressa) or immunotherapies (such as Opdivo and Yervoy), Oncoprex is synergistic with those drugs, meaning that the combination is more effective than either drug alone. We believe that by combining Oncoprex with targeted therapies and immunotherapies, we can extend the benefit of these approved lung cancer drugs into the large majority of patients who do not now benefit from them, either because the patients’ tumors do not have the molecular profiles that indicate effectiveness of those drugs, or because the patients have developed resistance to those drugs after receiving them for some period of time.

 

We hold a portfolio of more than 30 patents covering our technologies and targeted molecular therapies.

 

We are also conducting pre-clinical research to identify biomarkers that will identify patients most likely to benefit from our gene therapies; and to identify additional cancer drugs that will be synergistic with our gene therapies.

 

Targeted molecular therapies and immunotherapies offer new options for cancer patients.

 

As targeted therapies and immunotherapies supplant conventional chemotherapies in lung cancer, many lung cancer patients who do not meet specific genomic profiles are unable to benefit from these new therapies. In fact, a majority of lung cancer patients cannot benefit from targeted therapies or immunotherapies. Genprex seeks to bridge a critical gap by combining its gene therapies with targeted therapies and immunotherapies to provide treatments to large patient populations who would otherwise not be candidates for those important drugs.

 

In a phase I/II clinical trial, Genprex’s leading drug candidate, Oncoprex, is being combined with the EGFR TKI drug Tarceva® (erlotinib) in Stage IIIb/IV non-small cell lung cancer (NSCLC) patients without an activating EGFR mutation and in patients with an activating EGFR mutation who progressed on erlotinib, whether or not they had prior chemotherapy. Patients without an activating EGFR mutation represent the vast majority of lung cancer patients, however these patients are usually not candidates for EGFR TKI therapies due to the absence of this mutation.

 

Oncoprex is being developed to overcome this genomic limitation and provide a new treatment solution to this majority of lung cancer patients who do not have the activating EGFR mutation that would allow them to benefit from EGFR TKI therapies such as Tarceva.

 

In addition, patients who have the EGFR activating mutation and do receive an EGFR TKI inhibitor such as Tarceva usually become resistant to these drugs at some point, and no longer benefit from them. Data indicate that Oncoprex may re-sensititize these patients to EGFR TKI drugs such as Tarceva, allowing the patients to benefit for a longer period time.

 

Source:  https://www.genprex.com/

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