Reglagene, Inc. Company Profile

Background

Reglagene, Inc. is a pioneering therapeutics company specializing in the development of brain-penetrant medicines aimed at treating high-grade gliomas, metastatic brain cancers, and other serious central nervous system diseases. Founded in 2016, the company is headquartered in Tucson, Arizona, with an additional office at the Texas Medical Center Innovation Factory in Houston, Texas. Reglagene's mission is to overcome the challenges posed by the blood-brain barrier (BBB) by designing small-molecule therapies that effectively cross this barrier, thereby providing new hope for patients with brain cancers. The company's vision is to revolutionize the treatment landscape for brain diseases by delivering innovative, orally administered therapies that are both safe and effective.

Key Strategic Focus

Reglagene's strategic focus centers on the development of orally bioavailable, low molecular weight tubulin-targeting therapies capable of penetrating the BBB. The company's core objectives include:

• Therapeutic Development: Creating treatments that disrupt tubulin function, a key component in cell division, to induce apoptosis in cancer cells.

• Oral Administration: Formulating therapies that are easy to administer at home, enhancing patient compliance and quality of life.

• Broad Application: Extending the utility of their therapies to various cancers, including glioblastoma, breast, lung, and melanoma metastases to the brain.

The company employs proprietary scientific methodologies to design and test over 800 molecules, leading to the identification of promising candidates for clinical development.

Financials and Funding

As of February 2026, Reglagene has raised a total of approximately $13.56 million in funding. In December 2023, the company completed a non-brokered private placement of convertible preferred stock, resulting in gross proceeds of $5.4 million. This funding round was oversubscribed and included participation from management and accredited investors such as Desert Angels, the Cancer Fund, Tech Coast Angels, Angel Star Ventures, and Viva BioInnovator. The capital is allocated for:

• Finalizing the selection of the clinical development candidate for brain cancers.

• Conducting toxicology and drug disposition studies to confirm safety and pharmacokinetics.

• Initiating regulatory and clinical trial planning.

• Expanding the product pipeline to include treatments for neuroinflammatory and ocular diseases.

Pipeline Development

Reglagene's lead candidate, RGN6024, is an orally administered, low molecular weight tubulin-targeting therapy designed to cross the BBB. In preclinical studies, RGN6024 demonstrated an 84% reduction in tumor growth compared to standard treatments, remaining active in the brain without being expelled by efflux pumps. The company has received FDA Orphan Drug Designation for RGN6024, facilitating its development for glioblastoma, a rare and aggressive brain cancer. Reglagene is also exploring the use of RGN6024 in treating breast, lung, and melanoma metastases to the brain, as well as neuro-inflammatory diseases, age-related macular degeneration, and diabetic retinopathy.

Technological Platform and Innovation

Reglagene's technological platform is centered on the design and development of brain-penetrant small-molecule therapies targeting tubulin, a protein essential for cell division. The company's proprietary approach involves:

• DNA Quadruplex Master Switch Technology: Utilizing DNA quadruplex structures to regulate gene expression, enabling the development of agents that can modulate specific genes to combat cancer.

• Efflux Pump Evasion: Designing molecules that evade efflux pumps in the brain, ensuring sustained drug concentrations within the central nervous system.

• Oral Bioavailability: Formulating therapies that are orally bioavailable, facilitating patient-friendly administration.

These innovations position Reglagene at the forefront of developing effective treatments for brain diseases.

Leadership Team

Reglagene's leadership team comprises seasoned professionals with extensive experience in drug discovery and development:

• Richard Austin, Ph.D., MBA: Chief Executive Officer and President. Dr. Austin leads the company's strategic direction and operations, leveraging his background in pharmaceutical research and development.

• Vijay Gokhale, Ph.D.: Senior Vice President, Preclinical Development. Dr. Gokhale oversees the preclinical development of Reglagene's therapies, bringing expertise in computational chemistry and drug discovery.

• Laurence Hurley, Ph.D.: Chief Scientific Officer. Dr. Hurley directs the scientific research efforts, focusing on the application of DNA quadruplex master switch technology in drug development.

Market Insights and Competitive Landscape

The market for brain cancer therapeutics is characterized by significant unmet needs, particularly due to the challenges posed by the BBB. Current treatments often have limited efficacy, leading to poor survival rates. Innovative therapies that can effectively cross the BBB and target brain tumors are in high demand, presenting substantial market opportunities.

Reglagene operates in a competitive landscape with several companies developing brain-penetrant therapies. Key competitors and collaborators include:

• Viva BioInnovator: Partnered with Reglagene to develop new medicines targeting therapy-resistant cancers.

• Tech Coast Angels (TCA) Orange County: Provided investment support to Reglagene for critical FDA-required studies related to brain cancer therapy.

Numerous biotechnology firms are focused on developing treatments for brain cancers, aiming to overcome the BBB challenge and deliver effective therapies.

Strategic Collaborations

Reglagene has established strategic collaborations to enhance its research and development capabilities:

• Partnering with Viva BioInnovator to advance the development of cancer medicines targeting therapy-resistant cancers.

• Securing funding from Tech Coast Angels (TCA) Orange County to support essential studies required for FDA approval of brain cancer treatments.

These partnerships contribute to accelerating Reglagene's progress towards clinical development and regulatory milestones.

Operational Approach

Reglagene's operational strategy emphasizes:

• Innovative Drug Development: Applying proprietary technologies to create therapies capable of effectively penetrating the BBB.

• Strategic Partnerships: Collaborating with investors and research organizations to support development and commercialization efforts.

• Regulatory Navigation: Leveraging designations such as the FDA Orphan Drug status to facilitate clinical advancement.

Future Directions

Reglagene is focused on several key growth opportunities:

• Advancing RGN6024 through clinical trials to establish safety and efficacy profiles.

• Expanding the therapeutic pipeline into neuro-inflammatory diseases and ocular conditions.

• Strengthening collaborations with academic entities and industry partners to enhance innovation and resource access.

Contact Information

• Website: Reglagene's official website.

• LinkedIn: Reglagene's LinkedIn profile.