Hallux Inc. Announces Closing Of $9.4M Series A-2 Financing

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Hallux Inc., a clinical stage pharmaceutical company, today announced the initial closing of $9.4 million in its Series A-2 preferred stock financing round. Proceeds will be used for further clinical development of the company’s novel subungual approach for treating onychomycosis.

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"We believe subungual - topical terbinafine applied safely and easily by a podiatrist or dermatologist may dramatically improve efficacy. We look forward to Dr. Freed’s findings." ~ Mark Taylor, Hallux Inc. CEO

Hallux Inc., a clinical stage pharmaceutical company, today announced the initial closing of $9.4 million in its Series A-2 preferred stock financing round led by existing investors in the company. The new proceeds will be used to fund the Company’s Phase 2a clinical study evaluating Hallux Subungual Gel (HSG) for the treatment of onychomycosis. The 52-week study, HSG-201, is now enrolling patients at the OrthoArizona Foot and Ankle Clinic in Mesa, Arizona. The principal investigator is Lewis H. Freed DPM and the site manager is Physicians Research Group, LLC.

The trial is testing a new topical formulation of terbinafine designed for subungual treatment of the nail bed, the primary site of fungal infection. Qualified trial participants will receive the investigational medication at no cost and be monitored for 52 weeks. Interested patients can schedule a free evaluation by visiting the clinical research website, calling (480) 532-2711 or emailing fungus@prgadvising.com.

Toenail fungus, clinically known as onychomycosis, is characterized by toenails that are yellow, thick, cracked, and crusty. This is most often caused by the particular dermatophyte trichophyton rubrum that invades the nail bed from the distal end of the toe and advances proximally.

Hallux CEO Mark Taylor said, “Toenail fungus is common. It is reported that over 35 million Americans have the infection that is very difficult to cure. In an area like Phoenix, where the weather is good and residents wear sandals and open-toed shoes year around, fungus-infested yellow toenails are not only embarrassing, but can be painful. Toenail fungus is commonly treated with oral terbinafine, but the medicine is underutilized because of its association with systemic safety issues. Alternatively, there are three FDA approved topical products, but their cure rates are absurdly low and each product has to be self-applied every day for a year or more. We believe subungual - topical terbinafine applied safely and easily by a podiatrist or dermatologist may dramatically improve efficacy without systemic risk or the burden of long daily treatment regimens. We look forward to Dr Freed’s findings, which if promising could advance HSG to its final phase of clinical testing in the United States and key markets around the world.

About Dr. Lewis Freed, DPM
Dr. Freed is a Phoenix-area podiatrist and the senior partner in OrthoArizona East Valley Foot & Ankle Specialists. He has offices in Mesa, Gilbert, Scottsdale, Queen Creek, and Globe. Dr. Freed is a Fellow of the American College of Foot and Ankle Surgeons and past-president of the Arizona Podiatric Medicine Association. In addition, he is a frequent lecturer on foot and ankle disease and injuries and has worked with numerous technology companies to develop procedures and products that are used to treat thousands of people each year.

About Physicians Research Group
Physicians Research Group (PRG) is a leading international, multispecialty research management organization that connects physician investigators with sponsors, patients, coordination, and support needed to conduct clinical trials within their practices. Conducting trials with PRG provides the most immediate and effective way to work at the forefront of medical research and discovery while focusing on patient care.

About Hallux
Hallux is clinical stage pharmaceutical company focused on developing novel medical solutions for common yet hard to treat disorders in podiatry and dermatology. Its lead clinical candidate is Hallux Subungual Gel (HSG), an investigational topical terbinafine formulation for direct to the nail bed treatment of onychomycosis.

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Hallux Inc
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