Form 8-K

8-K — Curanex Pharmaceuticals Inc

Accession: 0001493152-26-022898

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0002025942

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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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 14, 2026

Curanex

Pharmaceuticals Inc

(Exact

name of registrant as specified in its charter)

Nevada

001-42815

83-0741390

(State

or other jurisdiction

incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

No.)

Jericho Plaza, Suite 101B

Jericho,

11753

(Address

of principal executive offices)

(Zip

Code)

(718)

673-6078

(Registrant’s

telephone number, including area code)

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(s)

Name

of exchange on which registered

Common

Stock, par value $0.0001 per share

CURX

The

Nasdaq Capital 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 ☒

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.

Curanex

Pharmaceuticals Inc (the “Company”) today issued a press release with the business update of its developments during first

quarter of 2026, highlighting its continued progress with Phyto-N, the Company’s lead drug candidate.

copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The

information contained in this Item 7.01, as well as Exhibit 99.1 referenced herein, shall not be deemed “filed” for purposes

of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be deemed incorporated by reference in any filing under

the Securities Act of 1933, as amended.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release of Curanex Pharmaceuticals Inc dated May 14, 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, as amended, the registrant has duly caused this report to be signed on its

behalf by the undersigned hereunto duly authorized.

Curanex

Pharmaceuticals Inc

Date:

May 14, 2026

By:

/s/

Jun Liu

Name:

Jun

Liu

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Curanex Reports First Quarter 2026 Business Progress

as Phyto-N Advances Toward Planned FDA Submission

Completed GMP manufacturing and toxicology milestones

supporting planned Q4 2026 IND submission for ulcerative colitis

Expanded pipeline strategy to include cancer cachexia,

a serious cancer-associated wasting condition with no FDA-approved therapies specifically indicated for the condition

Jericho, New York, May 14, 2026 (GLOBE NEWSWIRE)

— Curanex Pharmaceuticals, Inc. (Nasdaq: CURX) (“Curanex” or the “Company”), a pharmaceutical development

company focused on advancing therapeutic assets for serious diseases with significant unmet medical need, today provided a first quarter

2026 business update highlighting continued progress with Phyto-N, the Company’s lead drug candidate.

Curanex is advancing Phyto-N toward a planned Investigational

New Drug (“IND”) submission to the U.S. Food and Drug Administration (“FDA”) for ulcerative colitis in the fourth

quarter of 2026. During the first quarter, the Company completed two important development milestones: production of a Good Manufacturing

Practice (“GMP”)-compliant pilot-scale batch of Phyto-N and completion of a dose-range finding toxicology study in rats and

dogs.

“Curanex made meaningful progress during the

first quarter as we continued advancing Phyto-N toward a planned FDA submission,” said Jun Liu, Chief Executive Officer of Curanex.

“We completed key manufacturing and toxicology milestones, continued building the development package for our lead ulcerative colitis

program, and expanded our pipeline strategy to include cancer cachexia, a serious condition with significant unmet medical need. Looking

ahead, we are focused on completing the IND-enabling work required to support our planned submission and moving Phyto-N toward clinical

development.”

First Quarter and Recent Highlights

Advanced Phyto-N toward planned Q4 2026 IND submission

Curanex continues to advance Phyto-N as its lead development

candidate, with ulcerative colitis as the Company’s initial target indication. The Company is preparing Phyto-N for a planned IND

submission in the fourth quarter of 2026. If the IND is allowed to proceed by the FDA, Curanex expects to initiate a Phase I clinical

trial following the applicable FDA review period.

Completed GMP pilot-scale manufacturing

In February 2026, Curanex completed a pilot-scale

batch of Phyto-N manufactured under GMP standards. The GMP-compliant pilot material is intended to support Good Laboratory Practice (“GLP”)-compliant

toxicology, pharmacokinetic and other IND-enabling nonclinical studies.

The Company believes this milestone strengthens the

manufacturing and quality-control foundation for Phyto-N and supports the IND-enabling studies required for the planned FDA submission.

Completed dose-range finding toxicology study with

favorable reported findings

In March 2026, Curanex completed a 28-day repeat-dose,

dose-range finding toxicology study of Phyto-N in Sprague-Dawley rats and dogs. The study evaluated oral tolerability at multiple dose

levels and was designed to inform dose selection and study design for subsequent GLP-compliant toxicology studies.

As previously announced, the Company reported no treatment-related

adverse findings of toxicological significance at any dose level in either species, including at the maximum feasible dose. The maximum

feasible dose is expected to serve as the high-dose anchor for the planned GLP toxicology program, a core component of the IND-enabling

package.

Expanded pipeline strategy to include cancer cachexia

Following the end of the first quarter, Curanex expanded

its pipeline strategy to include cancer cachexia as a new core indication.

Cancer cachexia is a serious cancer-associated wasting

syndrome marked by progressive weight loss, muscle depletion, weakness, metabolic disruption and declining physical function. There are

currently no FDA-approved therapies specifically indicated for cancer cachexia. According to Grand View Research, the global cancer cachexia

market was estimated at approximately $2.54 billion in 2024 and is projected to reach approximately $3.90 billion by 2033.

Curanex believes cancer cachexia may represent a strategically

relevant expansion opportunity because the condition involves biological processes aligned with the Company’s broader development

focus, including inflammation, metabolic dysfunction and physical decline. The Company intends to evaluate this opportunity through additional

development planning and future research activities.

Financial Position and Liquidity

As of March 31, 2026, the Company had approximately

$4.0 million in cash and cash equivalents, which the Company believes provides sufficient capital to support key upcoming development

activities for Phyto-N, including toxicology, pharmacokinetic, manufacturing and regulatory initiatives.

Outlook

Curanex’s primary objective for 2026 remains

advancing Phyto-N toward a planned fourth quarter IND submission for ulcerative colitis.

Near-term priorities include advancing GLP toxicology

and pharmacokinetic studies, continuing manufacturing and regulatory preparation, and evaluating longer-term pipeline opportunities, including

cancer cachexia.

“Our goal is to build on first-quarter execution

as we work toward an IND package for FDA review,” Mr. Liu added. “If allowed to proceed, that submission would position Phyto-N

to enter human clinical testing.”

About Curanex Pharmaceuticals Inc.

Curanex Pharmaceuticals Inc. is a pharmaceutical development

company headquartered in Jericho, New York. The Company is focused on advancing therapeutic assets for serious diseases with significant

unmet medical need. Its lead asset, Phyto-N, is currently being developed for ulcerative colitis and is being advanced through preclinical

and IND-enabling activities in support of a planned IND submission in the fourth quarter of 2026. The Company is also evaluating broader

pipeline opportunities intended to expand its long-term therapeutic platform.

Forward-Looking Statements

All statements other than statements

of historical fact in this announcement are forward-looking statements. These forward-looking statements are made as of the date hereof

and involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial

trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors

can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,”

“anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,”

“potential,” “continue,” “is/are likely to” or other similar expressions. The Company undertakes

no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations,

except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are

reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors to read “Risk

Factors” section of the Company’s Annual Report on Form 10-K dated March 30, 2026 (Inline Viewer: CURANEX PHARMACEUTICALS

INC 10-K 2025-12-31) and risk factors contained in other filings with the Securities and Exchange Commission (the “SEC”)

to gain understanding of the important factors that could cause actual results differ materially from the anticipated results and projections

about future events contained in this press release.

Contact:

Curanex Pharmaceuticals Inc

Tel: (212) 671-1020 / (718) 673-6078

Email: ir@curanexpharma.com

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