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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):
May 18, 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 May 18, 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 May 18, 2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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: May 18, 2026 |
|
| |
|
| |
By: |
/s/ Bradley Burnam |
| |
Name: |
Bradley Burnam |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Turn Therapeutics Appoints
Physician-Scientist and Former FDA Commissioner, Dr. Stephen M. Hahn, as Executive Clinical and Regulatory Lead
Dr. Hahn Brings
Unparalleled Clinical and Regulatory Expertise to Support Advancement
of GX-03 for Moderate-to-Severe Atopic Dermatitis and Pipeline
Indications
Westlake Village, Calif. -- May 18, 2026 -
Turn Therapeutics Inc. (Nasdaq: TTRX), a clinical-stage biotechnology company developing targeted, localized therapies for inflammatory
skin diseases, today announced the appointment of Stephen M. Hahn, M.D., former Commissioner of the U.S. Food and Drug Administration
(FDA), to oversee the clinical and regulatory strategy for GX-03, the Company’s investigational topical therapy currently in a Phase
2 clinical trial for moderate-to-severe atopic dermatitis (eczema).
“Patients with inflammatory skin diseases
still lack adequate treatment options, especially therapies that work well without causing significant systemic effects. GX-03 represents
a differentiated approach focused on treating inflammation directly at the site of disease, potentially offering an important new localized
treatment option,” said Stephen Hahn. “This mission is deeply personal for me. My own family has struggled with atopic dermatitis,
and I know firsthand how difficult and frustrating it can be. Throughout my career, I have remained focused on advancing therapies that
are both scientifically rigorous and truly meaningful for patients. I look forward to working with the Turn Therapeutics team to help
bring this potential therapy forward responsibly and urgently.”
“There are very few people in this industry
who combine scientific rigor, regulatory expertise, and genuine compassion for patients the way Dr. Hahn does,” said Bradley Burnam,
Chief Executive Officer of Turn Therapeutics. “His interest in treatment options for inflammatory skin disease is not just professional,
it is personal, and you can see that in the way he approaches this work. Beyond his extraordinary experience leading major clinical and
regulatory organizations, he brings a level of thoughtfulness, integrity, and patient focus. We are incredibly fortunate to have him helping
guide our path forward.”
About Dr. Stephen M. Hahn
Stephen M. Hahn, M.D., is a physician, biotechnology
executive, and former Commissioner of the U.S. Food and Drug Administration with decades of leadership experience spanning clinical medicine,
regulatory science, healthcare operations, and medical product development. As the 24th FDA Commissioner from 2019 to 2021, Dr. Hahn oversaw
both COVID and non-COVID regulatory activities, including therapeutics, vaccines, diagnostics, medical devices, and clinical trials.
Prior to joining the FDA, Dr. Hahn served as Chief
Medical Executive, Deputy President, and Chief Operating Officer at MD Anderson Cancer Center, where he helped oversee one of the world’s
leading academic medical centers with more than 21,000 employees and a $5.2 billion operating budget. He also held senior academic and
clinical leadership positions at MD Anderson and the University of Pennsylvania’s Perelman School of Medicine. In the biotechnology
sector, Dr. Hahn has served in executive leadership roles including CEO-Partner at Flagship Pioneering and Chief Executive Officer of
Harbinger Health. He has extensive experience in clinical research and medical product development, including topical therapies, and has
authored more than 220 peer-reviewed scientific publications.
Dr. Hahn earned his M.D. from Temple University
and his B.A. in Biology from Rice University. He completed his internal medicine residency at University of California, San Francisco,
and his fellowship and residency training at the National Cancer Institute in Bethesda, Maryland.
###
About GX-03
GX-03 is a first-in-class, non-systemic, topical
cytokine-modulating therapy in development for moderate-to-severe atopic dermatitis (eczema). By stabilizing the cutaneous microenvironment
and modulating epithelial danger sensing, GX-03 is designed to address IL-36, IL-4, IL-13, and IL-31 signaling through upstream prevention
rather than downstream, systemic suppression. GX-03 is currently being evaluated in a Phase 2 randomized controlled trial, with topline
results expected in mid-2026.
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. Its lead
investigational therapy, GX-03, is a first-in-class, non-systemic topical inhibitor currently in development for the treatment
of moderate-to-severe atopic dermatitis. This therapy is designed to modulate key inflammatory pathways involved in eczema and other inflammatory
dermatological conditions.
Forward-Looking Statement
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,
other than statements of historical fact, contained in this press release are forward-looking statements. 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 Therapeutics’ 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, 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 Securities and Exchange Commission
(the “SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the
SEC on March 31, 2026. All such forward-looking statements speak only as of the date they are made, and Turn Therapeutics 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
# # #