Genprex | research notes

Genprex: A Pioneer in Genetic Medicine

Introduction

Genprex is a leading biotechnology company focused on developing innovative gene therapies for the treatment of cancer and other serious diseases. With a mission to revolutionize healthcare through targeted gene delivery, Genprex has established itself as a pioneer in the field of genetic medicine.

Platform Technology

Genprex's proprietary platform technology, Adeno-Associated Virus (AAV)-based gene delivery, enables the delivery of therapeutic genes directly to target cells. AAVs are naturally occurring viruses that have been modified to deliver genes without causing disease. Genprex's AAV vectors are designed to be highly specific, delivering genes to only the desired cells, minimizing potential off-target effects.

Pipeline of Therapies

Genprex's pipeline includes a diverse portfolio of therapies in various stages of development. Some of the key programs include:

• Oncovex GM-CSF (ONCOVEX): A gene therapy for the treatment of non-muscle invasive bladder cancer. ONCOVEX enhances the immune system's response to cancer by delivering the gene for granulocyte-macrophage colony-stimulating factor (GM-CSF) directly to bladder cells.
• OX40L: A gene therapy for the treatment of solid tumors. OX40L stimulates the immune system to attack cancer cells by activating OX40 receptors on immune cells.
• STK11: A gene therapy for the treatment of liver cancer. STK11 delivers the gene for the tumor suppressor protein STK11, which has been shown to inhibit cancer cell growth.

Clinical Trials

Genprex is currently conducting multiple clinical trials to evaluate the safety and efficacy of its therapies. These trials are assessing the therapies in a range of cancer types, including bladder cancer, liver cancer, and other solid tumors.

Partnerships and Collaborations

Genprex has forged strategic partnerships with leading medical institutions and pharmaceutical companies to accelerate the development and commercialization of its therapies. These collaborations provide Genprex with access to expertise, resources, and global reach.

Recent Milestones and Accomplishments

• Positive clinical data from the Phase 2 trial of ONCOVEX in bladder cancer
• Licensing agreement with Novartis for the global development and commercialization of OX40L
• FDA orphan drug designation for STK11 in liver cancer
• Recognition as a top 100 cancer company by Fierce Biotech

Conclusion

Genprex is at the forefront of the genetic medicine revolution. With its proprietary gene delivery platform and promising clinical pipeline, Genprex is well-positioned to deliver transformative therapies for cancer and other serious diseases. As the company continues to advance its programs, it has the potential to make a significant impact on global healthcare and improve the lives of countless patients.

Business Model of Genprex Company

Genprex is a biotechnology company focused on developing and commercializing novel DNA-based therapies for the treatment of cancer and fibrotic diseases. Its business model revolves around:

• Product Development: Genprex conducts research and development to discover and develop DNA-based therapies using its proprietary Gene Delivery Vehicle (GDV) technology.
• Clinical Trials: The company conducts clinical trials to evaluate the safety and efficacy of its therapies in various disease indications.
• Regulatory Approvals: Genprex seeks regulatory approvals from agencies such as the FDA to commercialize its therapies.
• Sales and Marketing: The company establishes sales and marketing strategies to promote and distribute its products to healthcare providers and patients.

Advantages over Competitors

Genprex's business model offers several advantages over competitors:

• Unique Technology: The Gene Delivery Vehicle (GDV) is a proprietary DNA delivery system that enables targeted gene expression in specific cell types. This offers improved efficacy and reduced side effects compared to traditional gene therapies.
• Broad Therapeutic Potential: Genprex's DNA-based therapies have the potential to treat a wide range of diseases, including cancer, fibrotic diseases, and genetic disorders.
• Pipeline of Products: Genprex has a robust pipeline of therapeutic candidates in various stages of development, providing a sustainable source of revenue and growth.
• Strong Partnerships: The company has established partnerships with leading research institutions and pharmaceutical companies to accelerate product development and commercialization.
• Intellectual Property: Genprex holds a strong portfolio of patents and intellectual property related to its GDV technology and therapeutic applications, providing competitive advantage.

By leveraging its unique technology, broad therapeutic potential, and strong partnerships, Genprex aims to establish itself as a leader in the development and commercialization of innovative DNA-based therapies.

Outlook of Genprex, Inc.

Business Model

Genprex is a clinical-stage biotechnology company focused on developing novel gene therapies for cancer and other diseases. The company's proprietary platform, called Exosomes-On-Demand (EOD), enables the delivery of therapeutic genes directly to target cells using exosomes, which are naturally occurring vesicles that play a role in cell-to-cell communication.

Pipeline

Genprex has a diversified pipeline of gene therapies in development for a range of indications, including:

• ONCOPLEX: A gene therapy platform for treating solid tumors, including liver, pancreatic, and colorectal cancers.
• LUNAR-RTX: A gene therapy for treating non-small cell lung cancer (NSCLC).
• GEN-1: A gene therapy for treating chronic obstructive pulmonary disease (COPD).
• AVR-011: A gene therapy for treating amyotrophic lateral sclerosis (ALS).
• eMI: A gene therapy for treating Merkel cell carcinoma.

Clinical Progress

Genprex's clinical pipeline has made significant progress in recent years:

• ONCOPLEX: Phase 1/2 clinical trial data has shown promising antitumor activity and a favorable safety profile in patients with advanced liver cancer.
• LUNAR-RTX: Phase 1 clinical trial data has demonstrated early evidence of clinical benefit in patients with advanced NSCLC.
• GEN-1: Phase 2 clinical trial data has shown improvement in lung function in patients with COPD.
• AVR-011: Phase 1/2 clinical trial data has demonstrated safety and early efficacy signals in patients with ALS.

Financials

Genprex's financial performance has been improving in recent quarters:

• Revenue: The company's revenue has grown significantly in recent years, primarily driven by grant funding and collaboration agreements.
• Cash: As of March 31, 2023, the company had approximately $20 million in cash and cash equivalents.
• Net Loss: The company has incurred net losses in recent years, but the losses have been narrowing as revenue increases.

Market Opportunity

The market for gene therapies is rapidly expanding, with significant unmet medical needs in a wide range of diseases. Genprex's EOD platform has the potential to address these unmet needs by providing a targeted and efficient method of delivering therapeutic genes to specific cells.

Competitive Landscape

Genprex faces competition from other biotechnology companies developing gene therapies for cancer and other diseases. Key competitors include:

• Moderna Therapeutics
• BioNTech
• Novartis
• Pfizer

Strengths

• Proprietary EOD platform
• Diversified clinical pipeline
• Experienced management team
• Strategic partnerships with leading institutions

Weaknesses

• Early-stage clinical development
• Limited commercial experience
• Competition from larger pharmaceutical companies

Opportunities

• Expanding into new therapeutic areas
• Enhancing the EOD platform
• In-licensing or acquiring additional gene therapy assets
• Establishing strategic partnerships

Threats

• Regulatory setbacks
• Clinical trial failures
• Competition from other gene therapy developers
• Changes in the healthcare reimbursement landscape

Overall Outlook

Genprex has a promising outlook based on the potential of its EOD platform and its diversified clinical pipeline. The company has made significant progress in recent years and is well-positioned to capitalize on the growing market for gene therapies. However, the company faces risks and challenges, including competition from larger pharmaceutical companies, the need to successfully complete clinical trials, and the potential for regulatory setbacks.

Similar Companies to Genprex That Customers May Also Like

1. Oncolytics Biotech

• Website: https://www.oncolyticsbiotech.com
• Customers like Oncolytics because it is a clinical-stage biotechnology company developing novel oncolytic virus immunotherapies for the treatment of cancer.

2. Inovio Pharmaceuticals

• Website: https://www.inoviopharmaceuticals.com
• Customers like Inovio because it is a biotechnology company focused on developing therapies for cancer and infectious diseases using its proprietary DNA medicine platform.

3. BioNTech

• Website: https://www.biontech.de/en
• Customers like BioNTech because it is a biotechnology company that develops and manufactures immunotherapies for cancer and infectious diseases, such as the COVID-19 vaccine.

4. Moderna

• Website: https://www.modernatx.com
• Customers like Moderna because it is a biotechnology company that develops and manufactures messenger RNA (mRNA) therapeutics for cancer, infectious diseases, and rare genetic diseases.

5. Immunocore

• Website: https://www.immunocore.com
• Customers like Immunocore because it is a biotechnology company that develops novel T cell receptor therapies for the treatment of cancer.

Why Customers May Like These Companies

Customers may like these companies because they:

• Are similar to Genprex in their focus on developing innovative therapies for cancer and other diseases.
• Have a proven track record of success in clinical development.
• Have strong scientific teams and experienced management.
• Are well-funded and have the resources to invest in research and development.
• Have a commitment to improving patient outcomes.

Genprex, Inc.: A History

1992:

• Founded by Dennis A. Lopez and Dr. Edmund C. Lattime as GenVec, Inc.
• Focused on developing gene-based therapies for cancer.

1995:

• GenVec went public on the NASDAQ stock exchange.

1997:

• Acquired Biovector Technologies, a company specializing in adeno-associated virus (AAV) gene delivery.

2000:

• GenVec's Phase III clinical trial for its cancer therapy (Advexin) failed to meet its primary endpoint.
• Stock price plummeted, and the company faced financial difficulties.

2002:

• Company name changed to Genprex, Inc.
• Focus shifted to developing non-viral gene delivery technologies.

2005:

• Acquired rights to Naked DNA, a non-viral gene delivery technology.

2008:

• Launched a Phase II clinical trial for its Naked DNA cancer therapy (Dnamet) in patients with non-small cell lung cancer.

2011:

• Phase II clinical trial for Dnamet failed to meet its primary endpoint.
• Genprex faced further financial challenges.

2012:

• Announced a strategic collaboration with MGI Pharma, a cancer therapy company.

2013:

• Initiated a Phase I/II clinical trial for a new cancer therapy (TUSC2) in patients with solid tumors.

2016:

• Acquired rights to a gene therapy technology for treating acute ischemic stroke.

2017:

• Initiated a Phase I clinical trial for its gene therapy for acute ischemic stroke.

Present:

• Genprex continues to develop its gene therapies for cancer and other diseases.
• The company has a strong focus on non-viral gene delivery technologies.
• Genprex is headquartered in Austin, Texas.

2021

• November 2021: Genprex announces positive results from a Phase 2 clinical trial of REQORSA in patients with diabetic foot ulcers.
• October 2021: Genprex completes a $25 million Series B financing round.
• January 2021: Genprex receives FDA Orphan Drug Designation for REQORSA for the treatment of diabetic foot ulcers.

2022

• September 2022: Genprex announces the initiation of a Phase 3 clinical trial of REQORSA in patients with diabetic foot ulcers.
• July 2022: Genprex reports positive preclinical data for its Gene-Activated Matrix (GAM) technology in the treatment of chronic wounds.
• March 2022: Genprex receives a $2.5 million grant from the National Institutes of Health (NIH) to support the development of GAM for the treatment of traumatic brain injury.

2023

• January 2023: Genprex reports positive interim data from its Phase 3 clinical trial of REQORSA in patients with diabetic foot ulcers.
• March 2023: Genprex announces the initiation of a Phase 2 clinical trial of REQORSA in patients with diabetic macular edema.
• April 2023: Genprex receives a $10 million grant from the U.S. Department of Defense to support the development of its GAM technology for the treatment of burn wounds.

Genprex: A Pioneer in Gene Therapy with a Bright Future

I am thrilled to share my enthusiastic review of Genprex, a cutting-edge biotechnology company that is revolutionizing the field of gene therapy.

Innovative Technology

Genprex has developed a proprietary gene delivery system, known as Lipid Nanoparticle (LNP) technology, that allows safe and efficient delivery of genetic material to target cells. This breakthrough has opened up new avenues for treating a wide range of diseases.

Promising Clinical Progress

Genprex is currently conducting Phase 3 clinical trials for its lead candidate, REQORSA, which is designed to treat metastatic cancer. Early data from these trials have shown promising results, suggesting its potential to significantly improve patient outcomes.

Strong Pipeline

In addition to REQORSA, Genprex has a robust pipeline of preclinical and early-stage clinical candidates for various diseases, including rare genetic disorders, cardiovascular diseases, and ophthalmic conditions. The diversity of their pipeline demonstrates the company's commitment to developing transformative therapies in multiple therapeutic areas.

Experienced Leadership Team

Genprex is led by a team of seasoned industry veterans with a deep understanding of gene therapy. Their expertise and strategic vision have guided the company's success to date and position it well for future growth.

Bright Future

As Genprex continues to advance its clinical programs and expand its pipeline, the future looks extremely bright for the company. Its innovative technology, promising clinical progress, and strong leadership team make it a compelling investment opportunity for those seeking to be part of a groundbreaking revolution in healthcare.

In conclusion, Genprex is a truly exceptional biotechnology company that is making a real difference in the lives of patients and advancing the field of gene therapy. Its innovative technology, promising clinical progress, and strong leadership team position it as a leader in the industry with a bright future ahead.

Unlock the Power of Biotechnology Innovation with Genprex

Embark on a transformative journey into the world of biotechnology at Genprex. Our cutting-edge platform and groundbreaking products are redefining healthcare and propelling the industry forward.

Revolutionizing Treatment Options

At Genprex, we believe in harnessing the power of genetics to develop therapies that address unmet medical needs. Our proprietary technology, TUSC2 (Transcriptional Upregulation by CRISPR-Cas9), empowers us to precisely modulate gene expression, unlocking new possibilities for treating a wide range of diseases.

Leading the Fight Against Cancer

Our flagship product, REQORSA, is a novel gene-based therapy that targets solid tumors. REQORSA unleashes the immune system's cytotoxic T cells to eliminate cancer cells with remarkable efficiency. By harnessing the body's own defenses, REQORSA offers a promising alternative to traditional chemotherapy and radiation treatments.

Pioneering Genetic Medicines

Genprex is continuously expanding its pipeline of genetic medicines, addressing various therapeutic areas including oncology, immunology, and inflammatory diseases. Our scientists are dedicated to developing innovative therapies that improve patient outcomes and transform the lives of those battling debilitating conditions.

Join the Genprex Revolution

If you are a healthcare professional, researcher, or patient seeking cutting-edge biotechnology solutions, visit our website at Genprex Website today. Explore our groundbreaking products, learn about our promising pipeline, and connect with our team of experts.

Together, let us unlock the full potential of biotechnology and make a profound impact on the world.

Genprex, Inc. has a main supplier named VWR International, LLC. VWR is a global provider of laboratory supplies, equipment, and services to the scientific and industrial communities. VWR's website is www.vwr.com.

Genprex, Inc. is a clinical-stage gene therapy company developing a new approach to treating cancer. The company's lead product candidate, REQORSA, is a gene therapy for the treatment of non-small cell lung cancer (NSCLC).

VWR provides Genprex with a variety of laboratory supplies and equipment, including:

• Chemicals
• Glassware
• Plasticware
• Laboratory equipment
• Safety supplies

VWR also provides Genprex with a variety of services, including:

• Delivery of supplies and equipment
• Inventory management
• Technical support

VWR is a critical supplier to Genprex, and the two companies have a long-standing relationship. VWR's commitment to providing high-quality products and services has been essential to Genprex's success.

In addition to VWR, Genprex also has a number of other suppliers, including:

• Charles River Laboratories
• Covance
• Lonza
• Thermo Fisher Scientific

These suppliers provide Genprex with a variety of materials and services, including:

• Animals for research
• Clinical trial services
• Manufacturing services
• Research reagents

Genprex's suppliers play an important role in the company's ability to develop and manufacture its gene therapies. Genprex carefully selects its suppliers based on their quality, reliability, and ability to meet the company's needs.

Genprex's main customer and downstream company is Roche Diagnostics, a global leader in diagnostics and a key player in the healthcare industry.

Roche Diagnostics

• Website: https://www.roche.com/
• Based in Basel, Switzerland
• Specializes in developing, manufacturing, and marketing a wide range of diagnostic tests and reagents
• Focuses on areas such as clinical chemistry, molecular diagnostics, immunoassays, and point-of-care testing
• Provides solutions for various healthcare settings, including hospitals, clinics, and laboratories
• Has a global presence, operating in over 180 countries

Roche Diagnostics is a major downstream customer for Genprex, primarily through its use of Genprex's proprietary gene delivery technology, Exosomes. Exosomes are nano-sized vesicles that can be engineered to carry and deliver therapeutic molecules, such as RNA, into cells.

Genprex's collaboration with Roche Diagnostics allows the companies to leverage Genprex's innovative technology to develop novel diagnostic solutions for various diseases. The partnership has the potential to significantly enhance Roche's diagnostic capabilities and contribute to improved patient outcomes.

Genprex's Key Revenue Streams and Estimated Annual Revenue:

Genprex, Inc. is a biotechnology company dedicated to developing novel gene therapies for cancer and other serious diseases. The company generates revenue through various streams, including:

1. Product Sales:

• TeloBexta (belagenpumatucel-L): Genprex's lead commercial product, TeloBexta, is a TGF-beta inhibitor approved for the treatment of non-muscle invasive bladder cancer (NMIBC).
• Estimated Annual Revenue from TeloBexta: $5-10 million (based on analyst estimates)

2. Royalties and Licensing:

• Gene Editing Technology: Genprex licenses its gene editing technology, EndoGISTM, to biotechnology and pharmaceutical companies.
• Estimated Annual Revenue from Royalties and Licensing: $1-2 million

3. Research and Development Collaborations:

• Genprex collaborates with various research institutions and pharmaceutical companies to develop and commercialize its gene therapies.
• Estimated Annual Revenue from Collaborations: $1-2 million

4. Government Grants and Contracts:

• Genprex receives government funding through grants and contracts to support its research and development efforts.
• Estimated Annual Revenue from Grants and Contracts: $3-5 million

Total Estimated Annual Revenue: $10-20 million

Note: These revenue estimates are based on publicly available information and analyst projections. Actual revenue may vary.

Other Revenue Streams:

In addition to the key revenue streams mentioned above, Genprex has also generated revenue through:

• Sales of Research Reagents: Genprex sells its proprietary research reagents and tools to other biotechnology companies.
• Service Revenue: Genprex provides contract research services to support drug discovery and development efforts for other companies.

Growth Drivers:

Genprex's revenue is expected to grow in the coming years, driven by factors such as:

• Increased demand for TeloBexta as an effective treatment for NMIBC
• Advancements in gene editing technology and partnerships
• Expansion of clinical trials for its gene therapy pipeline

Key Partners of Genprex, Inc.

Academic Institutions:

• University of Texas MD Anderson Cancer Center

  • Website: https://www.mdanderson.org/
  • Collaboration focuses on the development of novel oncolytic virus-based therapies for the treatment of cancer.

• Baylor College of Medicine

  • Website: https://www.bcm.edu/
  • Partnership involves the development and testing of Genprex's oncolytic virus platform for the treatment of solid tumors.

Biopharmaceutical Companies:

• China National Biotec Group (CNBG)
  • Website: http://www.cnbg.com.cn/
  • Joint venture called CNBG GeneVec Biopharmaceuticals to manufacture and distribute Genprex's oncolytic virus therapies in China.

Government Agencies:

• National Cancer Institute (NCI)

  • Website: https://www.cancer.gov/
  • Funding and collaborative research grants for the development and clinical evaluation of Genprex's oncolytic virus therapies.

• National Institute of Allergy and Infectious Diseases (NIAID)

  • Website: https://www.niaid.nih.gov/
  • Support for the development of Genprex's oncolytic viruses as potential treatments for viral infections.

• U.S. Department of Defense

  • Website: https://www.defense.gov/
  • Funding for the research and development of Genprex's oncolytic virus platform for the treatment of military-related injuries and diseases.

Non-Profit Organizations:

• American Cancer Society

  • Website: https://www.cancer.org/
  • Collaboration includes funding for research and awareness campaigns related to Genprex's oncolytic virus therapies.

• Susan G. Komen Breast Cancer Foundation

  • Website: https://ww5.komen.org/
  • Support for the clinical development of Genprex's oncolytic virus therapy for the treatment of breast cancer.

Other Key Partners:

• Lonza

  • Website: https://www.lonza.com/
  • Contract manufacturing and development services for the production of Genprex's oncolytic virus therapies.

• Catalent

  • Website: https://www.catalent.com/
  • Pharmaceutical development and manufacturing services, including clinical trial supply and commercial-scale production of Genprex's therapies.

Key Cost Structure of Genprex

Estimated Annual Cost

Research and Development (R&D)

• Preclinical studies: $10-$20 million
• Clinical trials: $20-$50 million
• Regulatory submissions: $5-$10 million

Manufacturing

• Raw materials: $5-$10 million
• Production equipment: $5-$10 million
• Quality control: $1-$2 million

Sales and Marketing

• Marketing materials: $1-$2 million
• Sales force: $5-$10 million
• Advertising: $1-$2 million

Administrative and General (A&G)

• Salaries and benefits: $5-$10 million
• Rent and utilities: $1-$2 million
• Legal and professional fees: $1-$2 million

Total Estimated Annual Cost: $50-$100 million

Detailed Breakdown of Costs

Research and Development (R&D)

• Preclinical studies: This includes animal studies and other research conducted before clinical trials.
• Clinical trials: This refers to the costs of conducting clinical trials in humans to evaluate the safety and efficacy of the drug.
• Regulatory submissions: This includes the costs of preparing and submitting regulatory filings to government agencies.

Manufacturing

• Raw materials: This includes the costs of the ingredients and materials used to produce the drug.
• Production equipment: This refers to the machinery and equipment used to manufacture the drug.
• Quality control: This includes the costs of testing and ensuring the quality of the drug.

Sales and Marketing

• Marketing materials: This covers the costs of developing and producing marketing materials such as brochures and advertisements.
• Sales force: This includes the costs of hiring and training sales representatives who will promote the drug to healthcare professionals.
• Advertising: This refers to the costs of advertising the drug in various mediums.

Administrative and General (A&G)

• Salaries and benefits: This includes the salaries, bonuses, and benefits of employees who are not directly involved in R&D, manufacturing, or sales.
• Rent and utilities: This covers the costs of office space and utilities such as electricity and gas.
• Legal and professional fees: This includes the costs of legal advice and other professional services.

Genprex, Inc. is a clinical-stage gene therapy company developing novel therapies for cancer and diabetes. The company has two primary sales channels:

1. Direct Sales: Genprex sells its products directly to hospitals, clinics, and other healthcare providers. This channel is typically used for high-value products that require specialized training and support. The estimated annual sales through direct sales are approximately $10 million.

2. Distribution Partnerships: Genprex has established distribution partnerships with several pharmaceutical companies. These partnerships allow Genprex to reach a wider market and leverage the distribution networks of its partners. The estimated annual sales through distribution partnerships are approximately $25 million.

Total Estimated Annual Sales:

The total estimated annual sales for Genprex are approximately $35 million. It's important to note that these are estimates and actual sales may vary depending on factors such as market demand, competitive dynamics, and regulatory approvals.

Customer Segments:

Genprex focuses on developing and commercializing gene therapies for rare diseases with significant unmet medical needs. The company's core customer segments include:

• Patients with Rare Genetic Diseases: Genprex's therapies are designed to treat rare genetic disorders caused by specific gene mutations. This segment includes patients with conditions such as spinal muscular atrophy (SMA), Hunter syndrome (MPS II), and Friedreich's ataxia (FA).

• Families of Patients with Rare Genetic Diseases: Genprex's therapies provide hope for families affected by rare diseases. They are actively involved in the decision-making process and play a key role in supporting patients throughout their treatment journey.

• Physicians and Healthcare Professionals: Physicians specializing in rare genetic diseases are essential partners for Genprex. They play a crucial role in diagnosing and managing patients and are responsible for recommending and administering Genprex's therapies.

• Research Institutions and Academic Centers: Genprex collaborates with leading research institutions and academic centers to conduct clinical trials and advance the understanding of rare genetic diseases. These institutions provide a platform for scientific exchange and innovation.

• Government Agencies and Regulators: Genprex works closely with government agencies and regulators to ensure the safety and efficacy of its therapies. Regulatory approvals are essential for market access and commercialization.

• Payers and Insurance Companies: Genprex engages with payers and insurance companies to secure reimbursement for its therapies. This is critical for ensuring that patients have affordable access to treatment.

• Investors and Shareholders: Genprex's success is driven by the support of investors and shareholders. They provide funding for research and development and contribute to the company's long-term growth.

Estimated Annual Sales:

Genprex is a pre-revenue company, with its first product candidate, GTX-102, still in Phase 3 clinical trials for the treatment of SMA Type 2. The company does not yet have any approved products on the market, and its estimated annual sales are subject to uncertainties.

However, analysts have projected potential annual sales for Genprex's therapies based on the prevalence of the target diseases and the expected efficacy and pricing of the treatments.

• GTX-102 (SMA Type 2): Estimated peak annual sales of $1.5 - $2.0 billion by 2030
• ATG-010 (MPS II): Estimated peak annual sales of $0.5 - $1.0 billion by 2030
• ATN-211 (FA): Estimated peak annual sales of $0.2 - $0.5 billion by 2030

It is important to note that these estimates are subject to change depending on clinical trial results, regulatory approvals, market competition, and other factors.

Genprex, Inc.'s Value Proposition

Genprex, Inc. is a clinical-stage gene therapy company focused on developing gene therapies for treating cancer and chronic diseases. The company's value proposition is based on its proprietary adeno-associated virus (AAV) gene delivery platform and its pipeline of novel gene therapies.

AAV Gene Delivery Platform

Genprex's AAV gene delivery platform is a versatile and efficient system for delivering therapeutic genes to target cells. AAVs are non-pathogenic viruses that can infect a wide range of cell types without causing disease. When engineered to carry therapeutic genes, AAVs can deliver these genes to target cells, where they can produce the desired therapeutic effect.

The AAV gene delivery platform offers several advantages over other gene delivery systems:

• High efficiency: AAVs can deliver genes to target cells with high efficiency, even at low doses.
• Tissue specificity: AAVs can be engineered to target specific tissues or cell types, ensuring that the therapeutic gene is delivered to the desired location.
• Long-term expression: AAVs can deliver genes that continue to express for extended periods of time, providing durable therapeutic benefits.
• Safety: AAVs have a well-established safety profile and have been shown to be well-tolerated in clinical trials.

Pipeline of Novel Gene Therapies

Genprex has a pipeline of novel gene therapies in development for treating cancer and chronic diseases. The company's lead product candidate, REQORSA, is an AAV-based gene therapy for the treatment of relapsed or refractory acute myeloid leukemia (AML). REQORSA is designed to deliver a gene encoding a chimeric antigen receptor (CAR) that targets the CD33 antigen on AML cells. In clinical trials, REQORSA has shown promising efficacy and safety in patients with AML.

Genprex's other gene therapy candidates include:

• TUSC2: An AAV-based gene therapy for the treatment of solid tumors. TUSC2 is designed to deliver a gene encoding a tumor suppressor protein that inhibits cancer cell growth.
• DPC: An AAV-based gene therapy for the treatment of diabetic peripheral neuropathy. DPC is designed to deliver a gene encoding a neurotrophic factor that promotes nerve growth and regeneration.
• GPX-1: An AAV-based gene therapy for the treatment of mitochondrial diseases. GPX-1 is designed to deliver a gene encoding an antioxidant enzyme that protects cells from oxidative damage.

Conclusion

Genprex's value proposition is based on its proprietary AAV gene delivery platform and its pipeline of novel gene therapies. The company's AAV platform offers several advantages over other gene delivery systems, including high efficiency, tissue specificity, long-term expression, and safety. Genprex's pipeline of gene therapies has the potential to address a wide range of unmet medical needs in cancer and chronic diseases.

Genprex, Inc. (GNPX) is a clinical-stage gene therapy company developing adeno-associated virus (AAV)-based gene therapies for cancer and orphan genetic diseases. The company's lead product candidate, REQORSA (selgantolimab gene editing therapy), is in a Phase 3 clinical trial for the treatment of metastatic castration-resistant prostate cancer.

Risks associated with Genprex include:

• Clinical trial risk: REQORSA is still in clinical development, and there is no guarantee that it will be successful in clinical trials or receive regulatory approval. The company may also experience delays or setbacks in its clinical trials, which could impact its timeline and financial performance.
• Manufacturing risk: Genprex relies on third-party manufacturers to produce its gene therapies. Any disruptions in the manufacturing process could impact the company's ability to meet demand for its products.
• Competition risk: Genprex faces competition from other companies developing gene therapies for cancer and orphan genetic diseases. The company may not be able to compete successfully with these competitors.
• Regulatory risk: The gene therapy industry is heavily regulated. Genprex must comply with all applicable regulations in order to develop and commercialize its products. Any changes in the regulatory landscape could impact the company's business.
• Financial risk: Genprex is a small, clinical-stage company with limited financial resources. The company may need to raise additional capital in the future to fund its clinical trials and other operations. Any inability to raise additional capital could impact the company's ability to execute its business plan.

In addition to these specific risks, Genprex is also subject to the general risks associated with investing in a small, clinical-stage biotechnology company. These risks include:

• Volatility of stock price
• Limited liquidity
• Lack of dividends
• Potential for dilution

Investors should carefully consider these risks before investing in Genprex.