Form 8-K
8-K — Turn Therapeutics Inc.
Accession: 0001213900-26-063177
Filed: 2026-06-01
Period: 2026-06-01
CIK: 0002023016
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — ea0292880-8k_turn.htm (Primary)
EX-99.1 — PRESS RELEASE, DATED JUNE 1, 2026 (ea029288001ex99-1.htm)
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8-K — CURRENT REPORT
8-K (Primary)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
June 1, 2026
TURN THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
Delaware
001-42875
32-0456090
(State or other jurisdiction of
incorporation)
(Commission File Number)
(IRS Employer
Identification Number)
250 N. Westlake Blvd., Westlake Village, California
91362
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including
area code: (818) 564-4011
N/A
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Trading Symbol
Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share
TTRX
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01
Regulation FD Disclosure.
On June 1, 2026, Turn Therapeutics
Inc. issued a press release (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 to this Current
Report on Form 8-K.
The information in Item 7.01
of this Current Report on Form 8-K and the Press Release furnished as Exhibit 99.1 hereto shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended,
or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
Description
99.1
Press Release, dated June 1, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
1
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
TURN THERAPEUTICS INC.
Date: June 1, 2026
By:
/s/ Bradley Burnam
Name:
Bradley Burnam
Title:
Chief Executive Officer
2
EX-99.1 — PRESS RELEASE, DATED JUNE 1, 2026
EX-99.1
Filename: ea029288001ex99-1.htm · Sequence: 2
Exhibit 99.1
Turn Therapeutics Reports Interim Analysis Findings
and Adaptive Optimization Strategy from Phase 2 GX-03 Trial in Moderate-to-Severe Atopic Dermatitis
92.6% of GX-03-treated subjects achieved a 50%
reduction in eczema severity in 4 weeks (EASI-50); 70.4% achieved a 75% reduction in 4 weeks (EASI-75); 44.4% achieved a 90% reduction
in 4 weeks (EASI-90); and 51.9% achieved a 90% reduction in 8 weeks (EASI-90)
Interim analysis informed refinement of enrollment
criteria, endpoint hierarchy, and overall trial optimization strategy
No treatment-related serious adverse events observed
in either treatment group; no treatment-related tolerability issues or discontinuations reported during the interim analysis period
Westlake Village, Calif. – June 1, 2026 – Turn Therapeutics
Inc. (Nasdaq: TTRX), a clinical-stage biotechnology company developing targeted, localized therapies for inflammatory skin diseases, today
announced interim analysis findings from the first 50 completed subjects enrolled in its ongoing randomized, double-blind, vehicle-controlled
Phase 2 clinical trial evaluating GX-03 in adults with moderate-to-severe atopic dermatitis.
The interim review was conducted under the study’s established
independent data monitoring committee (“IDMC”) framework. Upon the advice of the Company’s independent statisticians
and clinical and regulatory advisors, including former FDA Commissioner Dr. Stephen Hahn, Turn Therapeutics elected to utilize the completed
cohort as an integrated Stage 1 analysis to comprehensively evaluate responder dynamics, endpoint sensitivity, inflammatory burden behavior,
and opportunities to optimize the second stage of the trial while enrollment continued. The Company believed that the complexity of atopic
dermatitis and the evaluation of efficacy across multiple clinical endpoints and timepoints warranted a broader assessment than conditional
probability analysis of a single endpoint to inform trial optimization, future regulatory planning, and better characterize where GX-03
treatment effects appear most visible.
Within the completed interim cohort, 92.6% of GX-03-treated subjects
achieved at least a 50% reduction in overall eczema severity within 4 weeks (EASI-50) compared to 65.2% for vehicle-treated subjects.
Additional separation was observed across deeper responder thresholds designed to measure near-clearance of disease, including Week 4
EASI-90 responses (90% reduction) of 44.4% for GX-03 versus 30.4% for vehicle, which further increased to 51.9% versus 34.8%, respectively,
by Week 8. These findings suggest that a substantial proportion of GX-03-treated subjects experienced rapid and progressively deeper reductions
in eczema severity over the course of treatment.
There were no observed or reported treatment-related serious adverse
events during the interim analysis period, no treatment-related tolerability concerns reported by subjects, and no treatment-related discontinuations,
with GX-03 continuing to demonstrate a favorable safety and tolerability profile.
“What became increasingly apparent during the interim review
was the speed with which responses emerged,” said Bradley Burnam, Chief Executive Officer of Turn Therapeutics. “The review
identified opportunities to refine enrollment criteria and endpoint selection while providing valuable insight into where GX-03 activity
appears most visible. The consistency of response across earlier efficacy measures suggests clinically meaningful improvement may emerge
sooner than originally anticipated, which could have important implications for both future regulatory strategy and patient outcomes.”
Skin and inflammatory disease expert Dr. Stephen Bresnick, who recently
coauthored a peer-reviewed publication on GX-03 and its role in modulating inflammatory signaling within the skin microenvironment, commented:
“In inflammatory skin disease, earlier control can have a meaningful impact on both disease burden and patient quality of life.
Seeing rapid responder activity alongside a favorable safety and tolerability profile is encouraging and supports the potential for GX-03
to become an important first-line treatment option if these findings continue to be observed as development progresses.”
The Company is now strategically utilizing the interim findings to
optimize the remainder of the trial, including refinement of enrollment criteria to better control for baseline EASI and body surface
area involvement in a manner more consistent with comparable atopic dermatitis studies, as well as increased focus on earlier inflammatory
burden endpoints following observation of higher-than-anticipated vehicle response within subsets of the study population. Enrollment
has continued throughout the interim analysis process and is nearing completion of the originally planned target population. In parallel,
the Company is preparing to initiate FDA interactions, including a requested meeting to discuss the evolving regulatory strategy for GX-03
and potential pathways that may support more efficient advancement of the program toward market following successful completion of the
trial.
Turn Therapeutics plans to present detailed findings during the Jefferies Global Healthcare conference in New York on June 4, 2026. A
live webcast of the presentation may be accessed on the Investors section of the Turn Therapeutics website at https://ir.turntherapeutics.com/news-events/events.
###
2
About GX-03
GX-03 is an investigational extended-release topical formulation designed
to provide sustained localized exposure to polyhexanide at the skin surface. GX-03 is being developed as a targeted, localized therapy
for inflammatory skin diseases.
About Turn Therapeutics
Turn Therapeutics is a clinical-stage biotechnology company focused
on developing targeted, localized therapies for inflammatory and infectious skin diseases.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this press
release are forward-looking statements, including statements regarding clinical development plans, optimization of enrollment criteria
and endpoints, interpretation of interim clinical observations, expected trial timing, regulatory interactions, and the therapeutic potential
of GX-03. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,”
“believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,”
“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
“suggest,” “target,” “aim,” “should,” “will,” “would,” or the
negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking
statements are based on Turn’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult
to predict, including risks related to the success of development programs, the availability of additional financing, and the Company’s
ability to execute its strategic plan. Further, certain forward-looking statements are based on assumptions as to future events that may
not prove to be accurate. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed
in these forward-looking statements, as well as risks relating to the business of Turn Therapeutics in general, see the risk disclosures
in the Company’s filings with the SEC. All such forward-looking statements speak only as of the date they are made, and Turn undertakes
no obligation to update or revise these statements, whether as a result of new information, future events, or otherwise.
Investor Relations / Media Contact
Sasha Damouni
Damouni Group LLC
Sasha@damounigroup.com
3
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