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Form 8-K

sec.gov

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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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

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