SEC 8-K filings with transcript text
Aug 12, 2026
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Exhibit 99.1
Turn Therapeutics Provides Corporate Updates and Reports Second Quarter 2026 Financial Results
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 cl
May 11, 2026
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Exhibit 99.1
Turn Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Phase 2 Trial for GX-03 in Moderate-to-Severe Atopic Dermatitis (AD) on Track, Topline Results Expected Mid-2026
Initial Tranche of $7 Million in Growth Capital has been Funded by Avenue Capital Group
Westlake Village, CA — May 11, 2026 — Turn Therapeutics Inc. (Nasdaq: TTRX), a clinical-stage biotechnology company developing targeted inflammatory and immunological therapies for dermatologic conditions, today reported financial results for the three months ended March 31, 2026, and provided corporate updates.
“The first quarter of 2026 materially strengthened Turn Therapeutics both operationally and financially,” said Bradley Burnam, Chief Executive Officer of Turn Therapeutics. “With the Avenue Capital facility now in place, we believe the Company is well positioned to advance our clinical programs through multiple near-term catalysts while maintaining focus on disciplined execution. Our Phase 2 trial evaluating GX-03 in moderate-to-severe atopic dermatitis remains on schedule, with an independent committee expected to assess conditional probability of success at the interim analysis and determine whether the study should continue as designed or expand enrollment based on the strength of the observed trend. We continue to expect topline results in mid-2026 and believe these upcoming milestones have the potential to meaningfully shape the future of both our platform and pipeline.”
Corporate Updates
●Avenue Capital growth capital secured. On March 23, 2026, the Company closed a growth capital facility with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group, providing access to up to $25 million in term loans. The initial $7 million tranche was funded on March 24, 2026, with up to an additional $18 million available upon achievement of clinical and corporate milestones.
●GX-03 in AD advancing. The Company’s lead product candidate, GX-03, is being evaluated in an ongoing randomized, double-blind, vehicle-controlled Phase 2 clinical trial in adults with moderate-to-severe AD. An interim assessment will be conducted at approximately 50% trial completion by an independent data monitoring committee. Interim results are expected in the second quarter of 2026, with topline data expected to follow in mid-2026.
●Onychomycosis (nail fungus) program planned. GX-03 has demonstrated nail-plate penetration and significant reduction of fungal burden in in-vivo studies, supporting its development as a topical treatment for onychomycosis. Additional clinical steps are expected following completion of the AD program.
First Quarter 2026 Financial Results
●Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2026 were $11.2 million as compared to $5.08 million as of December 31, 2025.
●General and Administrative (G&A) Expenses: General and administrative expenses for the three months ended March 31, 2026 were $1.1 million, an increase of $0.8 million compared to $0.4 million for the three months ended March 31, 2025.
Financial Tables
Turn Therapeutics Inc.
Consolidated Statements of Operations
(in US Dollars)
Three Months Ended March 31,
2026 2025
Operating expenses:
General and administrative $1,136,709 $375,738
Research and development 109,434 9,259
Total operating expenses 1,246,143 384,997
Loss from operations (1,246,143) (384,997)
Other income:
Net gain from change in fair value of derivative liability instrument 697,561 —
Amortization of deferred offering cost (477,647) —
Interest income 49,679 5,165
Other income 5,578 51,285
Total other income 275,171 56,450
$(970,972) $(328,547)
Basic and diluted net loss per common share $(0.03) $(0.01)
Weighted-average common shares outstanding, basic and diluted
29,476,002 26,956,217
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Turn Therapeutics Inc.
Selected Balance Sheet Data
(in US Dollars)
March 31, 2026 December 31, 2025
Cash and cash equivalents $11,217,671 $5,076,144
Total assets 18,644,136 12,162,241
Total liabilities 12,526,588 7,475,518
Total stockholders’ equity 6,117,548 4,686,723
About Turn Therapeutics
Turn Therapeutics is a biotechnology company focused on developing innovative, precision therapies that target the underlying causes of inflammatory diseases with high unmet needs. Turn’s lead investigational therapy, GX-03, is a potentially first-in-class, non-systemic topical inhibitor currently in late-stage development for the potential treatment of moderate-to-severe atopic dermatitis (eczema). This therapy is designed to modulate key inflammatory pathways involved in eczema and other inflammatory dermatological conditions.
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements,
Mar 31, 2026
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Exhibit 99.1
Turn Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate Updates
Phase 2 Trial for GX-03 in Moderate-Severe Atopic Dermatitis on Track, Topline Results Expected Mid-2026
Secured up to $25 Million in Growth Capital from Avenue Capital Group
Strengthened Leadership Team via Appointments of Dr. Robert Redfield and Martin Dewhurst
Los Angeles, CA — March 31, 2026 — Turn Therapeutics Inc. (Nasdaq: TTRX), a clinical-stage biotechnology company developing targeted inflammatory and immunology therapies for dermatologic conditions, today reported financial results for the year ended December 31, 2025, and provided corporate updates.
“Our first months as a public company have been highly productive, with strong progress across our clinical, financial, and strategic priorities,” said Bradley Burnam, Chief Executive Officer of Turn Therapeutics. “Our Phase 2 trial of GX-03 for moderate-to-severe atopic dermatitis remains on track for topline results in mid-2026, positioning us to advance a potential first-line therapy in atopic dermatitis. Securing up to $25 million in growth capital from Avenue Capital extends our expected runway through the end of 2027 and supports focused investment in the Company’s therapeutic programs. In parallel, our global license, supply, and distribution agreement with Medline creates the opportunity to begin generating revenue in late 2026 while also validating the commercial viability of our technology across multiple applications.”
Recent Corporate Updates
●Secured up to $25 million in growth capital from Avenue Capital. In March 2026, the company entered into a venture debt facility for up to $25 million in growth capital to support cash runway through the end of 2027 and advance GX-03, Turn’s lead investigational drug, in atopic dermatitis and onychomycosis. The loan facility has a 42-month term and includes an initial tranche of $7 million and two additional tranches totaling up to $18 million which may be drawn by the Company, subject to certain milestones and criteria.
●Appointed Dr. Robert Redfield, former CDC Director to provide strategic guidance on GX-03 development and regulatory path. Dr. Redfield is a nationally recognized public health leader who served as the 18th Director of the U.S. Centers for Disease Control and Prevention (CDC). Dr. Redfield’s expertise and guidance will be instrumental in navigating the regulatory pathway of GX-03 through development and commercialization.’
●Appointed Martin Dewhurst to the Board of Directors. Mr. Dewhurst brings more than 30 years of experience in life sciences strategy and M&A. He previously served as global co-lead of McKinsey & Company’s life sciences practice and currently serves as a senior advisor to PJT Partners and an external advisor to Lightrock. His experience is expected to support the Company’s long-term growth and strategic development.
●In the fourth quarter of 2025, the Company entered into a global supply, development, and license agreement with Medline, the largest provider of medical-surgical products and supply chain solutions serving all points of care. The agreement establishes a long-term collaboration to develop, manufacture, and commercialize products leveraging Turn Therapeutics’ proprietary PermaFusion® delivery platform in the professional and retail markets.
●Expansion of intranasal vaccine pipeline to include intranasal Influenza candidate that may stimulate systemic immunity via targeted intranasal exposure. Leveraging the Company’s proprietary delivery technology to potentially provide a thermostable intranasal influenza vaccine capable of being rapidly deployed and administered in pandemics.
Full Year 2025 Financial Results
●Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2025 were $5.08 million, which excludes the receipt of $7.0 million in gross proceeds from the facility with Avenue Capital.
●Research and Development (R&D) Expenses: Research and development expenses for the year ended December 31, 2025 were $0.3 million compared to $0.2 million for the year ended December 31, 2024.
●General and Administrative (G&A) Expenses: General and administrative expenses for the year ended December 31, 2025 were $5.5 million, an increase of $4.0 million, compared to $1.5 million for the year ended December 31, 2024. The increase was a result of an increase in legal, advisory, accounting, and other services and fees associated with the Company’s public listing in 2025.
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Financial Tables
Turn Therapeutics Inc.
Consolidated Statements of Operations
(in US Dollars)
Years Ended December 31,
2025 2024
Operating expenses:
General and administrative $5,593,078 $1,551,168
Research and development 265,570 245,956
Total operating expenses 5,858,648 1,797,124
Loss from operations (5,858,648) (1,797,124)
Other income:
Net gain from change in fair value of derivativ
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