Turn Therapeutics Inc.

What they do

Turn Therapeutics is developing GX-03, a topical formulation containing polyhexanide (PHMB), for atopic dermatitis (eczema) and onychomycosis. Its historical medical device portfolio includes three 510(k) cleared products (K160872, K171191, K183681), and the K183681 gauze product has been licensed to Medline Industries. The company's current model is to license or sell medical device products through partners while focusing internal resources on drug development. It has incurred operating losses since inception and had an accumulated deficit of approximately $29.2 million as of June 30, 2026.

Revenue drivers

• Medical device out-licensing (Medline) — K183681, an antimicrobial gauze saturated with the GX-03 formula, was licensed to Medline Industries, LP under a license and supply agreement; this is the only disclosed partnered medical device arrangement.
• GX-03 for atopic dermatitis — Lead drug program in an ongoing Phase 2 trial; no product revenue yet and the company states it will not generate revenue from product sales unless and until it obtains regulatory approval.
• GX-03 for onychomycosis — Second indication being advanced for the same formula, supported by in-vivo nail penetration and antifungal data; no revenue or approval to date.
• Other out-licensing / IP arrangements — The company states revenue may come from medical device or intellectual property out-licensing arrangements; historically GX-03 was distributed by McKesson from 2017 to 2019 for wound care before the company voluntarily ceased that activity.

Recent performance

For the six months ended June 30, 2026, net losses were approximately $6.8 million versus approximately $1.6 million for the same period in 2025. Annual net losses were $3.19 million in 2025 and $1.77 million in 2024, per the 10-K risk factors. As of June 30, 2026, the company reported cash and cash equivalents of approximately $10.3 million, total assets of $17.0 million, total liabilities of $16.3 million, long-term debt of $6.1 million, and shareholder equity of $686,888. The 10-K states the consolidated financial statements express substantial doubt about the company's ability to continue as a going concern.

Strategy

The company is prioritizing drug development of GX-03, starting with atopic dermatitis, while licensing medical device products to partners to avoid significant capital commitments. After a June 2026 interim analysis, it expanded the Phase 2 AD trial to enroll approximately 120-135 patients across a broader range of disease extent while requiring moderate-to-severe lesion severity (IGA at least 3). It plans to expand GX-03 into hidradenitis suppurativa, with first patient dosing targeted for Q2 2027, and is advancing an FDA Type B meeting package. It appointed former FDA Commissioner Dr. Stephen M. Hahn as Executive Clinical and Regulatory Lead in May 2026.

Risks

• Going concern and funding need — The 10-K states there is substantial doubt about the ability to continue as a going concern due to insufficient capital on hand to fund drug development plans.
• Clinical trial failure or delay — GX-03's lead program depends on the ongoing Phase 2 atopic dermatitis trial completing enrollment in Q4 2026 and producing positive results, with no approved drug product today.
• Regulatory pathway for PHMB as an API — PHMB has never been formally submitted or approved as an active pharmaceutical ingredient for a drug product in the United States, so GX-03 requires new drug approvals.
• Limited revenue base — The company states it will not generate product revenue unless and until it obtains regulatory approval, leaving it dependent on out-licensing, equity and debt financing.

Outlook

Management expects Phase 2 enrollment in atopic dermatitis to complete in the fourth quarter of 2026 and believes existing cash will fund operations into the third quarter of 2027. The company plans to expand GX-03 into hidradenitis suppurativa with first patient dosing targeted for Q2 2027 and is advancing an FDA Type B meeting package. It anticipates expenses and operating losses will increase substantially due to later-stage clinical trial costs.