OUR NEW PROFILE IS:   (NASDAQ: GNPX)

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IN JUNE, THE FDA GRANTED FAST TRACK DESIGNATION FOR THE ACCLAIM-3 TREATMENT COMBINATION OF REQORSA AND TECENTRIQ AS MAINTENANCE THERAPY IN PATIENTS WITH ES-SCLC WHO DID NOT DEVELOP TUMOR PROGRESSION AFTER RECEIVING TECENTRIQ AND CHEMOTHERAPY AS INITIAL STANDARD TREATMENT

IN AUGUST, THE FDA GRANTED ORPHAN DRUG DESIGNATION TO REQORSA FOR THE TREATMENT OF SCLC

GENPREX COMPLETES A 1-FOR-40 REVERSE STOCK SPLIT EFFECTIVE FEBRUARY 2, 2024

BREAKING NEWS ANNOUNCED TODAY:  GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER

CHECK OUT THE INVESTOR PRESENTATION HERE

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Hello Everyone,

Thank you for taking the time to open up this email.  We feel like we have something that warrants your immediate attention.

This is a company you are definitely going to want to research immediately.

Pull up GNPX right away.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.

Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options.

Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches.

Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans.

ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body.

The Company’s lead product candidate, REQORSA™ is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer.

Genprex’s diabetes gene therapy approach consists of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas.

In models of Type 1 diabetes, the genes express proteins that 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.

In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished.

There are several reasons why you should research this one right now but first and foremost is the reverse split that took place just last week.  On the 2nd of February the company executed a 1 for 40 reverse split, drastically reducing the float.  We generally see these Nasdaq’s lose some significant value following a reverse split.  After 4 straight sessions to the downside we have witnessed this one level off today after some drastic swings.  It appears to have found a floor and some support for the time being.

The company dropped some extremely encouraging news this morning which drove it all the way to 7.99 at the open:

GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER

Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024

Acclaim-1 Study Has FDA Fast Track Designation

AUSTIN, Texas — (Feb. 5, 2024) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that in January 2024, the first patient was enrolled and dosed in the Phase 2a expansion portion of the Company’s Acclaim-1 clinical study of Reqorsa® Therapy (quaratusugene ozeplasmid) in combination with AstraZeneca’s Tagrisso® to treat patients with late-stage non-small cell lung cancer (NSCLC).

“We are encouraged by the very promising Phase 1 results in the Acclaim-1 trial, which demonstrated the combination of REQORSA and Tagrisso was well tolerated at all three dose levels with evidence of efficacy observed in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso,” stated Mark Berger, Chief Medical Officer of Genprex. “We are excited to begin the Phase 2a expansion portion of Acclaim-1, which will examine the toxicity profiles of different cohorts as well as efficacy and other clinical endpoints.”

Data from the Phase 1 dose escalation portion of the Acclaim-1 study were presented at the 2023 AACR-NCI-EORTC International Conference for Molecular Targets and Cancer Therapeutics Meeting in October 2023. The data reported results from twelve patients with advanced, epidermal growth factor receptor (EGFR) mutant NSCLC whose disease progressed after Tagrisso treatment. REQORSA was generally well tolerated, as there were no dose limiting toxicities.

While the Phase 1 portion of the clinical trial was designed primarily to assess safety, promising efficacy results were also observed. One patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed, and Tagrisso, had a partial remission (PR) by investigator evaluation and treatment is now ongoing in the trial after 28 cycles, which is approximately 19.5 months. Another patient who is at the 0.09 mg/kg dose level, previously treated with Tagrisso, had stable disease and treatment was ongoing after 14 cycles, or approximately 10 months. And a third patient previously treated with cisplatin, pemetrexed, carboplatin, and Tagrisso at the 0.12 mg/kg dose level has stable disease and is continuing to receive REQORSA after 14 cycles, or approximately 10 months. The extended progression free survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early stage clinical trials of REQORSA, and is not expected with treatment with Tagrisso alone after progression on Tagrisso¹. PFS is the primary endpoint of both the Phase 2a expansion portion and the Phase 2b randomized portion of the Acclaim-1 study.

“Advancing Acclaim-1 marks an important milestone for Genprex. We are proud of the progress we have made thus far and are encouraged by REQORSA’s potential to improve outcomes for patients battling NSCLC. We look forward to an interim analysis from the Phase 2a study in 2025 and expect those results will further validate our novel gene therapy approach to treating lung cancer patients,” said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.

REQORSA, the Company’s lead product candidate, is being evaluated in three clinical trials as a treatment for NSCLC and small cell lung cancer (SCLC). Each of the three lung cancer clinical programs has received a Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of that patient population, and the SCLC program has also received an FDA Orphan Drug Designation.

About Acclaim-1 Clinical Trial

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor (“EGFR”) mutations whose disease progressed after treatment with Tagrisso.

The Phase 1 dose escalation portion of the Acclaim-1 trial has been completed.  The Phase 2a expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment and the other half will have received Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. The Phase 2b randomized portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or platinum-based chemotherapy. The primary endpoint of the Phase 2b portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 28 events.

About Reqorsa® Therapy
REQORSA® (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex’s ONCOPREX® Nanoparticle Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA 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.

Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Tagrisso® is a registered trademark of AstraZeneca plc.Acclaim-1 Phase 2a and Acclaim-3 Phase 1 clinical studies opening for enrollment in January 2024

Poised for FDA guidance regarding diabetes gene therapy program in 2024

AUSTIN, Texas — (January 5, 2024) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today provides a review of its 2023 achievements and a preview of plans for advancing its diabetes and oncology gene therapy programs in 2024.

“We are very proud of what we accomplished in 2023, particularly with the successful completion of the Phase 1 portion of our Acclaim-1 clinical trial in lung cancer,” said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. “In 2023, we also received a third Fast Track Designation for Reqorsa® Immunogene Therapy from the U.S. Food and Drug Administration, this time in combination with Tecentriq® for the treatment of small cell lung cancer, and REQORSA was also granted Orphan Drug Designation for the treatment of small cell lung cancer. We believe these designations underscore and further validate the potential of REQORSA. Our accomplishments in 2023, which also include process improvements in our manufacturing operations and securing new supplies of REQORSA, sets the foundation for a strong 2024.”

Oncology Gene Therapy Platform

Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, REQORSA (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer (“NSCLC”) and small cell lung cancer (“SCLC”), andeach of the three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population.

REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In early studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Important events of the year included:

• In April, at the 2023 Annual Meeting of the American Association for Cancer Research (AACR 2023), Genprex collaborators presented preclinincal gene therapy data with NPRL2, another tumor suppressor gene, that further validates the ONCOPREX Nanoparticle Delivery System as a platform

• In October, Genprex hosted a Key Opinion Leader virtual event, “Bringing Gene Therapy to the Fight Against Lung Cancers” which discussed the use of gene therapies, including REQORSA, in the fight against lung cancer

• In December, Genprex completed the successful production of a new batch of REQORSA thereby securing REQORSA supply for its Acclaim clinical studies

• Collaborators submitted abstracts in 2023 and are expecting to present data at the American Association for Cancer Research (AACR) Meeting in April 2024

Acclaim-1:

The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation which has been completed, a Phase 2a expansion, and a Phase 2b randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca’s Tagrisso® in patients with late-stage NSCLC that has activating epidermal growth factor receptor mutations and progression after treatment with Tagrisso. This novel approach to targeting lung cancer has demonstrated a strong safety profile with early signs of efficacy.

• In May, Genprex completed the Phase 1 portion of the Acclaim-1 clinical trial and reported encouraging results. The Acclaim-1 Phase 1 study had no Dose Limiting Toxicities and results established a Phase 2 Recommended Dose, as well as provided data showing efficacy of REQORSA in combination with Tagrisso®

• In May, after completion of the Phase 1 portion of the Acclaim-1 trial, the Safety Review Committee (“SRC”) approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2a expansion portion of the trial

• In October, clinical collaborators presented a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics showing the Phase 1 results of the Acclaim-1 study

• In January 2024, Genprex expects to open the Phase 2a expansion portion of the Acclaim-1 study for enrollment

• Genprex expects to complete the enrollment of 19 patients in each cohort of the Phase 2a expansion portion of the study by the end of 2024

Acclaim-2:

The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion.  The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg.

• Expanding on the previously granted patents in the U.S., Japan, Mexico and Russia, Genprex was granted patents in Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibtors, e.g., PD1 and PDL1 inhibitors. These patents are applicable to Genprex’s Acclaim-2 and Acclaim-3 clinical trials.

• In the second half of 2024, Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study

Acclaim-3:

The Acclaim-3 study has two portions – a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.’s Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

• In June, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment

• In August, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC

• In January 2024, Genprex expects to open the Phase 1 portion of the Acclaim-3 study for enrollment, and expects to complete the Phase 1 portion of the study by the second half of 2024

• In the second half of 2024, Genprex expects to start the Phase 2 portion of the Acclaim-3 study

Diabetes Gene Therapy Platform

Genprex’s diabetes gene therapy approach is comprised of an infusion process that uses an adeno-associated virus (“AAV”) vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Genprex has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. In October 2023, Genprex entered into a one-year extension to the August 2022 sponsored research agreement with the University of Pittsburgh. The extension includes a revised research plan to encompass the Company’s most recent technologies to which Genprex acquired exclusive rights from the University of Pittsburgh in July 2023. These include a MafB promoter to drive expression of the Pdx1 and MafA transcription factors that can potentially be used for both Type 1 and Type 2 diabetes. This research is expected to be initially conducted in a Type 1 animal model.

• In February, Genprex’s research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002. These data, presented during an oral presentation at the 16^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023), showed  statistically significant decreases in insulin requirements, increased c-peptide levels and improved glucose tolerance compared to baseline.

• In April, the Company hosted a Key Opinion Leader virtual event, “Novel Gene Therapy to Treat Type 1 Diabetes,”  which discussed preclinical data reported at ATTD 2023 supporting gene therapy to treat Ttype 1 diabetes

• Finalized the components of the diabetes construct to take forward for nonclinical studies

• In December, Genprex submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug application and initiate first-in-human studies. As a result of the FDA’s response, the Company will continue with its planned additional nonclinical studies before requesting regulatory guidance in 2024 for the IND-enabling studies.
  

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

Research And Development Pipeline

CATALYSTS

– Addressing unmet medical need in large markets through the buildout of a robust pipeline of new drug candidates and drug combinations.

– Leveraging a gene therapy platform; Genprex’s non-viral ONCOPREX® Nanoparticle Delivery System is designed to deliver a variety of therapeutic genes to fight multiple types of cancer.

– REQORSATM immunogene therapy, the first systemically delivered gene therapy used for cancer in humans, can be combined with top-selling cancer drugs and may improve their benefits.

– Genprex has demonstrated clinical achievement with REQORSA in two clinical trials, showing a favorable safety profile and evidence of efficacy in lung cancer.

– GPX-002, Genprex’s diabetes gene therapy, works to transform alpha cells in the pancreas into insulin producing beta-like cells. A Phase 1 clinical trial could be the first-ever gene therapy tested in humans for diabetes.

– Advancing novel gene therapies in diseases with large markets and unmet needs.

– Two NSCLC trials currently enrolling; both with FDA Fast Track Designations.

– World class academic partners.

CLINICAL TRIALS

ONC-001

EVALUATING THE SAFETY OF REQORSA® IMMUNOGENE THERAPY AS A MONOTHERAPY (COMPLETED)

A Phase 1 dose escalation trial was conducted at The University of Texas MD Anderson Cancer Center evaluating the systemic, intravenous delivery of REQORSA® (TUSC2/FUS1) as a monotherapy in stage IV recurrent, metastatic lung cancer patients. The primary objective of this Phase 1 trial was to assess the toxicity of REQORSA administered systemically and intravenously, to determine the maximum tolerated dose, or MTD, and to determine a recommended Phase 2 dose of REQORSA alone.

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

The study showed for the first time that a tumor suppressor gene can be delivered systemically, intravenously and selectively to a patient’s cancer cells using a systemic nanoparticle vector. Although this trial was not designed to show changes in outcomes, a halt in cancer growth was observed in a number of patients. REQORSA was well tolerated with tumor responses noted in lung primary and metastatic cancers in the liver, pancreas, and lymph nodes. In addition, pre- and post-treatment patient biopsies demonstrated that intravenous REQORSA selectively and preferentially targeted patients’ cancer cells.

Metabolic Tumor Response in a Metastatic Lung Cancer Subject

This subject survived after subsequent therapy more than seven years after the final treatment with REQORSA, to our knowledge, without evidence of cancer progression in the responding sites.

ONC-002

COMBINING REQORSA® IMMUNOGENE THERAPY WITH TARCEVA (ERLOTINIB)

PHASE 1 PORTION COMPLETED; PHASE 2 PORTION NO LONGER ENROLLING DUE TO OUR CHANGE OF FOCUS TO CONDUCT ACCLAIM-1

A Phase 1/2 clinical trial evaluated REQORSA® in combination with Tarceva® in stage IIIB/IV lung cancer patients without an activating EGFR mutation and in patients with an activating EGFR mutation whose cancer has progressed on Tarceva therapy.  Patients without the EGFR mutation represent the vast majority of lung cancer patients. However, such patients generally are not candidates for Tarceva therapy.

In the Phase 2 trial combining REQORSA with Tarceva, subjects received REQORSA in combination with Tarceva every 21 days until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or study treatment discontinuation for other reasons, whichever occurred first. We believe that the results from the Phase 2 trial are encouraging. Out of 10 patients, 9 had received 2 or more cycles and were therefore evaluable for response. Four patients had tumor regression. The median duration of response is three months. The disease control rate (CR+PR+SD > 8weeks) was 78%, which substantially exceeds the 7% response rate (with no CRs) and 58% disease control rate reported for the LUX-Lung 1 trial, a clinical trial of Gilotrif (afatinib) in a comparable group of patients.

ACCLAIM-1

COMBINING REQORSA™ IMMUNOGENE THERAPY WITH TAGRISSO (OSIMERTINIB)

Preliminary analysis of the interim data from the Phase 2 portion of our ONC-002 trial supported our belief that REQORSA™ may provide medical benefit in several subpopulations of NSCLC patients for which there is an unmet medical need, and may provide pathways for accelerated approval by the U.S. Food and Drug Administration, or FDA. Data from our clinical trials, along with our preclinical data, provided the basis for our application for a Fast Track Designation, which was granted by FDA on January 14, 2020.

In granting our Fast Track Designation, the FDA found that REQORSA may provide a benefit over existing therapies for patients whose tumors progress on AstraZeneca’s Tagrisso. The FDA Fast Track Designation is for use of REQORSA in combination with TKI Tagrisso for the treatment of NSCLC patients with EGFR mutations whose tumors progressed after treatment with Tagrisso. We believe that the Fast Track Designation provides a clearly defined pathway toward FDA approval of the combination of REQORSA with Tagrisso.

We initiated the Acclaim-1 clinical trial in June 2021, a Phase 1/2 clinical trial of REQORSA combined with Tagrisso. To learn more about Acclaim-1, please visit ClinicalTrials.gov.

To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our TUSC2 Bibliography page.

ACCLAIM-2

COMBINING REQORSA™ IMMUNOGENE THERAPY WITH KEYTRUDA (PEMBROLIZUMAB)

Researchers at MD Anderson Cancer Center have conducted preclinical studies evaluating REQORSA™ in combination with anti-PD1 checkpoint inhibitors, including Merck’s Keytruda.

Positive and encouraging data indicate that REQORSA is synergistic with immunotherapies.

In April 2019, we reported that our collaborators at MD Anderson presented positive preclinical data for the combination of TUSC2 with pembrolizumab, demonstrating that TUSC2 combined with checkpoint blockade was more effective than checkpoint blockade alone in increasing the survival of mice with human immune cells, that had metastatic lung cancer.

In November 2019, we reported that our collaborators at MD Anderson presented positive preclinical data for the combination of TUSC2, pembrolizumab and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the combination of TUSC2 increases the effectiveness of pembrolizumab and chemotherapy, and thus, may improve on first-line standard of care for lung cancer.

In May 2020, we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson for the use of TUSC2 in combination with immunotherapies, including Keytruda, and also for the use of TUSC2 in a three-drug combination of TUSC2, immunotherapy and chemotherapy.

In December 2021, we received Fast Track Designation from the FDA for use of REQORSA in combination with the checkpoint inhibitor Keytruda for the treatment of advanced NSCLC patients whose tumors progressed after treatment with Keytruda.

In March 2022, we opened the Acclaim-2 clinical trial for patient enrollment, a Phase 1/2 clinical trial of REQORSA combined with Keytruda. To learn more about Acclaim-2, please visit ClinicalTrials.gov.

To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our TUSC2 Bibliography page.

DIA-001

STUDYING GPX-002 IN DIABETIC MICE

Researchers at the University of Pittsburgh have conducted preclinical studies evaluating GPX-002 in diabetic mice models. In vivo mice studies have found that GPX-002 restored normal blood glucose levels for an extended period of time, typically around four months. The duration of restored blood glucose levels in mice could translate to decades in humans.

These researchers are continuing to conduct preclinical studies in diabetic primates. Once sufficient preclinical data has been generated, we expect to begin a Phase 1 clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.

To learn more about scientific evidence and studies supporting GPX-002 and the Pdx1/MafA genes, please refer to our Pdx1/MafA Bibliography page.

ONCOLOGY COMBINATION TREATMENT APPROACH

Our oncology program uses a modern combinational treatment approach to fight cancer, utilizing our lead drug candidate, REQORSA™ immunogene therapy and our unique, proprietary, non-viral ONCOPREX® nanoparticle delivery system combined with approved targeted therapies and immunotherapies. This enables us to offer hope to large patient populations who would otherwise not be candidates for those therapies or who have become resistant to them.

ONCOLOGY COMBINATION TREATMENT APPROACH

Our research indicates that when REQORSA, our lead drug candidate for non-small cell lung cancer (NSCLC), is combined with targeted therapies such as Tarceva (erlotinib) or Tagrisso (osimertinib) or with immunotherapies such as Opdivo (nivolumab) or Keytruda (pembrolizumab), REQORSA is synergistic with those drugs, meaning that the combination is more effective than either drug alone. We believe that by combining REQORSA 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.

To learn more about our combination trials utilizing our oncology combination treatment approach, refer to our Pipeline and Clinical Trials pages.

TARGETED THERAPIES

Targeted therapies work by targeting the cancer or disease’s specific gene, protein or tissue that contributes to the disease while sparing normal tissue. Unfortunately, targeted therapies require patients to have an activating genetic mutation specific to the drug. In NSCLC, the vast majority of lung cancer patients do not have the genetic mutations that qualify them for targeted therapies, such as the EGFR or ALK gene. In addition, the few patients who do have the genetic mutation qualifying them to receive targeted therapies are likely to develop resistance to these drugs over time.

In January 2020, we received a United States FDA Fast Track Designation for use of REQORSA in combination with EGFR inhibitor Tagrisso for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. The median length of time that patients are treated with Tagrisso before their tumors progress is approximately eighteen (18) months.

IMMUNOTHERAPIES

Immunotherapy is a type of treatment that helps the immune system fight disease. Biomarker testing can help determine if high levels of PD-1/PD-L1 proteins are detected in the patient, signifying that the body’s immune system is not working to fight cancer or disease as it should. These patients could qualify for approved immunotherapies, however, not all patients benefit from immunotherapies.

Genprex is conducting preclinical studies to evaluate REQORSA in combination with checkpoint inhibitors. Preclinical data indicate that Genprex’s lead drug candidate is synergistic with checkpoint inhibitors, such as Merck’s Keytruda, meaning that the combination of drugs may be more effective than checkpoint inhibitors alone. Preclinical data also indicates that a three-drug combination of a checkpoint inhibitor, chemotherapy, and REQORSA may be more effective than the two-drug combination of a checkpoint inhibitor and chemotherapy.

MARKET OPPORTUNITY

AstraZeneca’s Tagrisso had more than $4 billion in worldwide gross sales in 2020, and Tagrisso is AstraZeneca’s highest grossing product. Given Genprex’s Fast Track Designation and Tagrisso’s status as the current standard of care in EGFR-mutated NSCLC, we have prioritized the clinical development of REQORSA in combination with Tagrisso. We believe this regulatory pathway positions us well in the $17.9 billion global lung cancer market, especially given the advantages of our Fast Track Designation status.

Merck’s Keytruda generated more than $14 billion in worldwide sales in 2020, and Keytruda is Merck’s highest grossing product. Keytruda is the standard of care in non-EGFR mutated NSCLC. Genprex plans to initiate a Phase I/II clinical trial evaluating REQORSA in combination with pembrolizumab.

PROGRAMS

LUNG CANCER

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 oncology program is focused on developing new treatments for cancer. Our initial therapeutic target is lung cancer, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

According to the World Health Organization in 2020, lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver, or stomach cancers. In 2020, there were more than 2 million new lung cancer cases and 1.8 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2022 there will be more than 236,000 new cases of lung cancer and more than 130,000 deaths from this disease. NSCLC represents 84% of all lung cancers and the five-year survival rate for patients with NSCLC with distant spread is 7 percent. SCLC represents about 13% of lung cancer patients and the five-year survival rate for patients with SCLC with distant spread is 3 percent. With limited benefit from current therapies, we believe there is a significant unmet medical need for new treatments for NSCLC and SCLC in the United States and globally, and we believe REQORSA may be suitable for the majority of lung cancer patients.

DIABETES

DIABETES

Our diabetes gene therapy candidate, GPX-002, is being developed for the treatment of diabetes.

According to the U.S. Center for Disease Control, 37 million Americans, or approximately 11% of the population, have diabetes. It is also believed that more than 96 million Americans have prediabetes, which represents approximately 38% of the U.S. population. The prevalence of this chronic disease is continuing to rise.

Chronic diabetes conditions include Type 1 diabetes and Type 2 diabetes, both of which lead to excess sugar in the blood and can cause serious health problems. Left untreated, high blood sugar levels can damage eyes, kidneys, nerves, and the heart, and can also lead to coma and death.

TECHNOLOGY

REQORSA® IMMUNOGENE THERAPY

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

Our lead product candidate, REQORSA®  immunogene therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. In 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® (osimertinib) in late-stage NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA in combination with Merck & Co’s Keytruda® (pembrolizumab) in late-stage NSCLC patients whose disease progressed after treatment with Keytruda.

The active ingredient in our lead product candidate, REQORSA, is the TUSC2 gene, a tumor suppressor gene.

REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA 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. REQORSA 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. REQORSA has also been shown to block mechanisms that create drug resistance.

We believe that REQORSA, unlike other gene therapies, which either need to be delivered directly into tumors or require cells to be removed from the body, re-engineered and then reinserted into the body, is the first systemic gene therapy used for cancer in humans.

OVERCOMING DRUG RESISTANCE

REQORSA is a pan-kinase inhibitor shown to simultaneously inhibit the EGFR and AKT oncogenic kinase pathways in vitro and in vivo. Once the cancer cell takes up the nanoparticle containing TUSC2, it is reprogrammed to die. Resistance to targeted drugs and checkpoint inhibitors develop through activation of alternate bypass pathways. For example, when PD-1 is blocked, the TIM-3 checkpoint is up-regulated. We believe that REQORSA’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.

To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our Clinical Trials and TUSC2 Bibliographypages.

GPX-002

DIABETES GENE THERAPY

GPX-002, a gene therapy for diabetes, is the most recent addition of our licensed technologies. GPX-002 was developed by researchers at the University of Pittsburgh. Diabetic mice studies have shown that GPX-002 restored normal blood glucose levels for an extended period of time, which could translate to decades in humans. This gene therapy could not only become a new treatment option for millions of diabetes patients who need insulin replacement therapy, but it holds the potential to provide long-term effectiveness, or may even be a cure, for diabetic patients.

The diabetes gene therapy, GPX-002, is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The genes express proteins that 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.

Diabetic mice studies show that the gene therapy restored normal blood glucose levels for an extended period of time, typically around four months. The duration of restored blood glucose levels in mice could translate to decades in humans.

The diabetes gene therapy was developed by Dr. George Gittes, a researcher at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, where preclinical research is ongoing. GPX-002 has been tested in vivo in mice and nonhuman primates. Once sufficient preclinical data has been generated, we expect to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.

To learn more about scientific evidence and studies supporting GPX-002 and the Pdx1/MafA genes, please refer to our Clinical Trials and Pdx1/MafA Bibliography pages.

ONCOPREX® NANOPARTICLE DELIVERY SYSTEM

THE FIRST SYSTEMIC GENE THERAPY DELIVERY PLATFORM USED IN HUMANS FOR CANCER

Our oncology drug development program utilizes our unique, proprietary non-viral ONCOPREX Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. This platform, originally developed through collaborative research between the University of Texas MD Anderson Cancer Center and the National Institutes of Health, has been optimized to work with our initial product candidate, REQORSA® immunogene therapy.

DESIGNED TO DELIVER CANCER-FIGHTING GENES SYSTEMICALLY

The ONCOPREX platform has been designed and optimized to deliver cancer-fighting genes into the patient’s body systemically. Using this system, we encapsulate plasmids that express tumor suppressor genes within lipid nanoparticles and intravenously administer the encapsulated plasmids which are taken up by the tumor cells, after which the tumor suppressor genes express proteins that are missing or found in low quantities in the tumor cells. Our nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and have been clinically shown to deliver molecular kinase inhibitors effectively.

OPTIMIZED PARTICLE SIZE

Our systemic, nanoparticle, non-viral delivery system, which is being used in our clinical trials for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), is designed to be small enough to cross tight barriers in the lungs but large enough to avoid accumulation in the liver, spleen and kidney. The nanoparticles have been shown to be taken up by tumor cells after REQORSA administration at up to 33 times the rate they are taken up by normal cells. The cationic charge of the lipid nanoparticles targets cancer cells, which facilitates endocytosis. Once inside the cancer cell, the TUSC2 gene activates signaling pathways that result in cell destruction or apoptosis.

ENHANCED SAFETY AND EFFICACY DESIGN

We have administered REQORSA to more than 50 patients in Phase 1 and 2 clinical trials using our systemic, proprietary, non-viral delivery system.

A Phase 1 clinical trial showed that systemic, intravenous therapy using the ONCOPREX Nanoparticle Delivery System was shown to selectively and preferentially target primary and metastatic tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.

Our earlier clinical trials have also shown that the ONCOPREX Nanoparticle Delivery System is well tolerated in humans and can safely deliver high therapeutic doses. We believe the ONC-001 clinical trial was the first systemic gene therapy clinical trial using a nanoparticle delivery system to deliver a tumor suppressor gene.

GENPREX (NASDAQ:GNPX) RELEASES NEW PATIENT VIDEO INTERVIEW DESCRIBING POSITIVE EXPERIENCE IN CLINICAL

AUSTIN, TX / ACCESSWIRE / June 2, 2023 / A clinical-stage gene therapy company is making splashes in the medical world. Genprex, Inc. (NASDAQ:GNPX) is developing potentially life-changing therapies for patients with cancer and diabetes that have limited treatment options. The company is working with world-class institutions in developing new drugs from the company’s pipeline of gene therapy candidates in order to provide novel treatment approaches. Its oncology program utilizes its proprietary non-viral ONCOPREX® Nanoparticle Delivery System, which Genprex believes is the first systemic gene therapy delivery platform used for cancer in humans. The company’s lead drug candidate is called REQORSA®. The immunogene therapy (also known as quaratusugene ozeplasmid) is for both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System. The drug may be helpful for treating patients who have already demonstrated drug resistance to other treatments.

On the heels of the release of recent positive safety and early efficacy data related to the phase 1 portion of its Acclaim-1 phase 1/2 clinical trial for non-small cell lung cancer evaluating REQORSA in combination with Tagrisso, Genprex has released a new patient video featuring an NSCLC patient from the phase 1 portion of its Acclaim-1.

All patients in the trial had disease progression on their previous cancer treatment. In the video, an NSCLC patient who experienced extended Progression Free Survival (PFS) in the trial describes her positive experience taking REQORSA – Genprex’s lead drug candidate which she is still taking – while participating in the phase 1 portion of the Acclaim-1 clinical trial.

“While on REQORSA treatment, my doctor noted that the lung cancer lesions have not grown and there is no new growth,” said the NSCLC patient in the Phase 1 portion of Acclaim-1. “I believe the REQORSA treatment has benefited my life and has increased my time.”

The patient’s positive experience is encouraging – she was able to continue working full-time while participating in the clinical trial. She experienced only minor side effects from REQORSA and so far has experienced more than 10 months of progression-free survival.

NSCLC is the most common type of lung cancer, accounting for about 82% of all cases. While there have been some advances in treatment options for NSCLC, such as chemotherapy, radiation therapy and targeted therapies, the overall survival rate for patients with advanced NSCLC remains low. The five-year survival rate for patients with distant spread is 7%.

Genprex has disclosed favorable preliminary clinical data from the Acclaim-1 clinical trial’s phase 1 dose-escalation segment in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings show that REQORSA was well tolerated with no dose-limiting toxicities. Furthermore, Genprex reported preliminary evidence of efficacy in the phase 1 portion of the study.

“We are thrilled to have our abstract, which reports positive results from the phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO Annual Meeting,” said Mark Berger, MD, Chief Medical Officer at Genprex. “We are encouraged by the favorable safety profile of REQORSA, as well as the preliminary efficacy data we have observed. In fact, the Safety Review Committee has just approved our advancement into the phase 2 expansion portion of the clinical trial.”

As noted above, the company also announced that its Safety Review Committee (SRC) has approved the advancement of the Acclaim-1 clinical trial to the phase 2 expansion portion of the trial. The SRC has examined the full safety data and has approved the recommended phase 2 dose of REQORSA, which is 0.12 mg/kg, twice the highest dose level delivered in Genprex’s previous clinical trials. This approval is a significant milestone in REQORSA’s development program. The SRC’s recommendation to advance the trial to the phase 2 expansion portion is a significant milestone for REQORSA.

Genprex’s REQORSA drug seems to be a promising innovation in cancer treatment. REQORSA’s unique approach of targeting the tumor suppressor gene TUSC2 sets it apart from other cancer treatments and other genetic medicines. Similar to companies like Bluebird Bio or Editas Medicine Inc., who are developing innovative therapies for rare diseases or using different gene editing techniques for cancer, Genprex’s REQORSA has the potential to be a game-changer in the field of cancer treatment through gene therapy.

NEWS

GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER

FEBRUARY 5, 2024

Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024

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GENPREX ANNOUNCES 1-FOR-40 REVERSE STOCK SPLIT EFFECTIVE FEBRUARY 2, 2024

JANUARY 31, 2024

Genprex today announced that on February 2, 2024, the Company will implement a 1-for-40 reverse split of its issued and outstanding common stock, par value $0.001 per share.

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GENPREX PROVIDES BUSINESS UPDATE AND OUTLOOK FOR 2024

JANUARY 5, 2024

Acclaim-1 Phase 2a and Acclaim-3 Phase 1 clinical studies opening for enrollment in January 2024

Poised for FDA guidance regarding diabetes gene therapy program in 2024

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GENPREX TO PRESENT AT BIO-EUROPE 2023 CONFERENCE

NOVEMBER 1, 2023

Presentation to be held on Tuesday, November 7, 2023 from 4:45 – 5:00 p.m. UTC

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GENPREX TO HOST A VIRTUAL KEY OPINION LEADER EVENT ON “BRINGING GENE THERAPY  TO THE FIGHT AGAINST LUNG CANCERS”

OCTOBER 20, 2023

Webinar to be held on Friday, October 27, 2023 from 12:30 pm – 1:45 pm Eastern Time

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GENPREX TO PRESENT DATA ON THE USE OF REQORSA® FOR THE TREATMENT OF LUNG CANCERS AT 2023 AACR-NCI-EORTC INTERNATIONAL CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS

OCTOBER 4, 2023

Acclaim-1 Phase 1 study had no Dose Limiting Toxicity, and results establish Phase 2 Recommended Dose as well as provide data showing efficacy of REQORSA® in combination with Tagrisso®

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GENPREX TO PRESENT AT UPCOMING SEPTEMBER INVESTOR CONFERENCE

SEPTEMBER 7, 2023

Presentation to Highlight Company’s Gene Therapies for Cancer and Diabetes

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GENPREX APPOINTS SUZANNE THORNTON-JONES AS SENIOR VICE PRESIDENT, REGULATORY AFFAIRS

AUGUST 22, 2023

Strengthens management team with seasoned regulatory expert to support pipeline of gene therapies for the treatment of cancer and diabetes, including two clinical trials in Non-Small Cell Lung Cancer and one in Small Cell Lung Cancer

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GENPREX GRANTED FDA ORPHAN DRUG DESIGNATION (ODD) FOR REQORSA® IMMUNOGENE THERAPY FOR THE TREATMENT OF SMALL CELL LUNG CANCER

AUGUST 10, 2023

ODD is in addition to Three FDA Fast Track Designations

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GENPREX ANNOUNCES CLOSING OF $7.5 MILLION REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET UNDER NASDAQ RULES

JULY 21, 2023

Genprex announced the closing of its previously announced registered direct offering to healthcare-focused institutional investors of 7,425,744 shares of the Company’s common stock and warrants to purchase up to 7,425,744 shares of common stock at a combined offering price of $1.01 per share of common stock and accompanying warrant.  The offering was priced at-the-market under the Nasdaq rules.

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BELL2BELL PODCAST FEATURING CEO RODNEY VARNER & CFO RYAN CONFER OF GENPREX, INC. (NASDAQ: GNPX)

JULY 6, 2023

Bell2Bell’s latest podcast features Chairman, President and CEO Rodney Varner and CFO Ryan Confer of Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients living with cancer and diabetes. In this interview, Varner and Confer discuss the journeys that led them to Genprex and the promise of the company’s drug development pipeline.

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GENPREX GRANTED CHINESE PATENT FOR REQORSA® IMMUNOGENE THERAPY IN COMBINATION WITH PD-1 ANTIBODIES TO TREAT CANCERS

JULY 5, 2023

Provides Additional Protection in Large Markets for Therapeutic Combination in Acclaim-2 Phase 1/2 Clinical Trial

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GENPREX RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR REQORSA® IMMUNOGENE THERAPY IN COMBINATION WITH TECENTRIQ® FOR THE TREATMENT OF SMALL CELL LUNG CANCER

JUNE 28, 2023

Third FDA Fast Track Designation Further Validates the Potential of REQORSA

AUSTIN, Texas — (June 28, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S.

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MANAGEMENT

Check out the management team here: https://www.genprex.com/about/company-management/

Sincerely,

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