Interim Analysis Supports Expansion of GX-03 Phase 2 Study to a Broader Population of Atopic Dermatitis Patients, Including Patients with Moderate-to-Severe Lesions but Lower Overall Disease Extent

Dr. Stephen M. Hahn, Former FDA Commissioner, Appointed Executive Clinical and Regulatory Lead

First Peer-Reviewed Publication Shows GX-03 Significantly Reduced Skin Inflammation in Preclinical Study

Company Plans to Expand GX-03 Pipeline into Hidradenitis Suppurativa, with First Patient Dosing Targeted for Q2 2027

Phase 2 Enrollment Expected to Complete in Fourth Quarter of 2026; Company Expects Cash to Fund Operations into Third Quarter of 2027

WESTLAKE VILLAGE, Calif.--(BUSINESS WIRE)--August 12, 2026-- 

Turn Therapeutics Inc. (Nasdaq: TTRX), a clinical-stage biotechnology company developing targeted, non-systemic therapies for inflammatory and infectious skin diseases, today provided corporate updates and reported financial results for the three and six months ended June 30, 2026.

"The second quarter was one of the most productive periods in Turn Therapeutics' history. Our review of interim GX-03 Phase 2 data showed activity across a broader range of atopic dermatitis patients than anticipated, including patients with moderate-to-severe lesions despite lower EASI, or Eczema Area and Severity Index. This represents an important and underserved population that may need stronger treatment options but can be ineligible for certain advanced therapies because their disease does not affect enough of the body. These findings allowed us to refine Stage 2 around this broader population and the endpoints showing the most encouraging treatment separation. During the quarter, we also appointed Dr. Stephen Hahn to strengthen our clinical and regulatory leadership, published our first peer-reviewed preclinical data demonstrating GX-03's anti-inflammatory activity, and advanced our FDA Type B meeting package. The Phase 2 study continued uninterrupted, and we remain on track to complete enrollment by year-end," said Bradley Burnam, Chief Executive Officer of Turn Therapeutics.

Company expands Phase 2 study after interim data show activity in a broader and potentially underserved population of atopic dermatitis patients:

On July 7, 2026, Turn Therapeutics completed a detailed review of interim results from its ongoing Phase 2 trial of GX-03 in atopic dermatitis, led by the study's biostatistician, Dr. Bruce Stouch, and Dr. Stephen Hahn. The analysis showed encouraging treatment separation across a broader range of patients than originally anticipated, including patients with lower Eczema Area and Severity Index $(EASI)$ scores. EASI measures both the intensity of eczema and how much of the body it affects, meaning patients can have moderate-to-severe lesions but still have a relatively low EASI score when their disease affects a smaller portion of the body. These patients can fall into an important treatment gap, with clinically significant disease but insufficient overall body involvement to qualify for certain advanced therapies. When the final Stage 2 enrollment criteria were applied to patients from the completed interim analysis, GX-03 demonstrated treatment separation from vehicle across all four efficacy endpoints selected for Stage 2: 61.5% versus 8.3% achieved clear or almost clear skin at Week 4; 69.2% versus 25.0% achieved at least a 75% improvement in EASI at Week 4; 53.8% versus 16.7% achieved at least a 90% improvement in EASI at Week 8; and 46.2% versus 8.3% achieved complete EASI clearance (EASI-100) at Week 8.

Based on these findings, Turn expanded Stage 2 to enroll approximately 120 to 135 patients across a broader range of overall disease extent while continuing to require moderate-to-severe lesion severity, defined as an IGA score of at least 3. The study will evaluate four efficacy endpoints using a single pre-specified statistical analysis, and based on the treatment differences observed in the interim analysis, the planned Stage 2 sample size provides at least 99.8% statistical power across the four selected endpoints. The study continued without interruption during the interim review, and the Company remains on track to complete enrollment by the end of 2026. Stage 1 also showed a favorable safety profile, with no serious adverse events and no adverse events leading to study drug discontinuation.

Company appoints former FDA Commissioner to lead clinical and regulatory strategy:

On May 18, 2026, Turn Therapeutics appointed Stephen M. Hahn, M.D., as Executive Clinical and Regulatory Lead. Dr. Hahn served as the 24th Commissioner of the U.S. Food and Drug Administration from 2019 to 2021 and previously held senior leadership roles at MD Anderson Cancer Center. In his role at Turn Therapeutics, Dr. Hahn is helping guide clinical development and regulatory strategy for GX-03 and the Company's broader therapeutic pipeline.

First peer-reviewed scientific publication shows GX-03 reduced inflammation in a preclinical skin model:

On May 27, 2026, Turn Therapeutics announced the publication of a peer-reviewed article in the Journal of Dermatological Treatment reporting results from a preclinical study of GX-03. In the study, GX-03 was evaluated in an established animal model of skin inflammation designed to study an inflammatory pathway known as IL-36, which the Company believes may play an important role in GX-03's activity. Animals treated with GX-03 twice daily for seven days had substantially clearer skin, on average, than untreated animals, a difference that was statistically significant. No treatment-related adverse effects were observed. The publication is the first of several planned scientific publications examining GX-03. A follow-up manuscript providing additional data on GX-03's potential mechanism of action is currently in peer review.

Company plans to expand GX-03 development into Hidradenitis Suppurativa (HS):

Turn Therapeutics is planning a Phase 2a study of GX-03 in hidradenitis suppurativa, or HS, a chronic inflammatory skin disease that can cause painful lumps, abscesses, and tunnels beneath the skin. The Company's research suggests GX-03 targets IL-36, an inflammatory pathway believed to play an important role in both HS and atopic dermatitis, providing a strong scientific rationale for evaluating GX-03 in the disease. HS can also involve microbial imbalance and bacterial burden within affected skin, an additional aspect of the disease that may be relevant given GX-03's previously demonstrated antimicrobial activity. The Company believes GX-03's potential to address inflammation while also acting on microbial burden through a single, non-systemic topical therapy may offer a differentiated approach to treating HS. The planned study is expected to enroll approximately 60 patients, with approximately half receiving GX-03 and half receiving vehicle, and will evaluate multiple established measures of HS improvement and patient-reported skin pain at various timepoints. The Company is targeting first patient enrollment in the second quarter of 2027.

Second Quarter 2026 Financial Results

The following highlights summarize the Company's cash position and spending for the second quarter of 2026:

   --  Cash and Cash Equivalents: The Company had $10.3 million in cash and 
      cash equivalents as of June 30, 2026. Based on Company's estimate, the 
      cash and cash equivalents on hand as of June 30, 2026 provide operational 
      runway, including the ongoing Phase 2 trial in AD, into the third quarter 
      of 2027. 
 
   --  General and Administrative (G&A) Expenses: General and administrative 
      expenses for the three months ended June 30, 2026 were $1.2 million, a 
      decrease of $0.1 million compared to $1.3 million for the three months 
      ended June 30, 2025. 
 
   --  Research and Development (R&D): R&D expenses were $0.5 million for the 
      three months ended June 30, 2026, an increase of $0.4 million compared to 
      $0.1 million for the same period in 2025, reflecting increased trial 
      activity as patient enrollment in the Phase 2 study progressed. 

Financial Tables

 
Turn Therapeutics Inc. 
 Consolidated Statements of Operations 
 (Unaudited, in US Dollars) 
 
                         Three Months Ended            Six Months Ended 
                              June 30,                     June 30, 
                     --------------------------  ---------------------------- 
                         2026          2025          2026           2025 
                     ------------  ------------  ------------  -------------- 
Operating 
expenses: 
   General and 
    administrative   $ 1,152,996   $ 1,303,846   $ 2,258,325   $ 1,679,591 
   Research and 
    development          475,064        62,678       584,498        71,937 
                      ----------    ----------    ----------    ---------- 
      Total 
       operating 
       expenses        1,628,060     1,366,524     2,842,823     1,751,528 
                      ----------    ----------    ----------    ---------- 
      Loss from 
       operations     (1,628,060)   (1,366,524)   (2,842,823)   (1,751,528) 
                      ----------    ----------    ----------    ---------- 
 
Other income 
(expense): 
   Net loss from 
    change in fair 
    value of 
    derivative 
    liability 
    instrument        (3,341,568)            -    (2,644,007)            - 
   Amortization of 
    deferred 
    offering cost       (638,747)            -    (1,116,394)            - 
   Interest income 
    (expense), net      (241,359)        5,134      (223,219)       10,296 
   Other income                -       120,975         5,578       172,260 
                      ----------    ----------    ----------    ---------- 
   Total other 
    income 
    (expense)         (4,221,674)      126,109    (3,978,042)      182,556 
                      ----------    ----------    ----------    ---------- 
      NET LOSS       $(5,849,734)  $(1,240,415)  $(6,820,865)  $(1,568,972)