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Item 3. Legal Proceedings

2026-04-01 compared with 2025-03-20 · 5 added, 49 removed, 5 unchanged (92% of the section changed)

Legal Proceedings.

October 31, 2024, Eli Lilly and Company filed a complaint against us in the Northern District of Texas Dallas Division.

The complaint

alleges causes of action against us for false and misleading advertising and promotion in violation of Section 43(a)(1)(B) of the Lanham

and false advertising, in connection with the Company’s TRIM product, and seeks (a) a declaratory judgment, an injunction

from falsely stating or suggesting that our oral dissolvable tirzepatide tablets are approved by FDA, have been the subject of clinical

studies, or achieve certain therapeutic outcomes;

engaging in any unfair competition with Eli Lilly;

and engaging in any deceptive or

(b) an order requiring the Company and its officers, agents, servants, employees, and attorneys and all persons acting in

concert or participation with any of them, to engage in corrective advertising by informing consumers that:

our oral dissolvable tirzepatide

tablets do not contain the same formulation as MOUNJARO® or ZEPBOUND®;

our oral dissolvable tirzepatide tablets do not contain

the same dosage as MOUNJARO® or ZEPBOUND®;

our oral dissolvable tirzepatide tablets are not and have never been approved by FDA;

our oral dissolvable tirzepatide tablets have never been studied in clinical trials;

and our oral dissolvable tirzepatide tablets have

never been demonstrated to be safe or effective;

attorneys, thirty (30) days after the date of entry of any injunction, a report in writing and under oath setting forth in detail the

manner and form in which it has complied with the court’s injunction;

(e) an order requiring the Company to account for and pay

to Eli Lilly any and all profits arising from the foregoing acts of alleged false advertising;

(f) an order requiring the Company to

pay Eli Lilly compensatory damages in an amount as of yet undetermined caused by the false advertising and trebling such compensatory

damages for payment to Lilly in accordance with 15 U.S.C.

§ 1117 and other applicable laws;

(f) an order requiring the Company to

pay Eli Lilly all types of monetary remedies available under Texas state law in amounts as of yet undetermined caused by the foregoing

acts of unfair competition;

(g) pre-judgment and post-judgment interest on all damages;

and (h) attorney’s fees.

initial Complaint asserted two claims:

(i) false advertising under the federal Lanham Act;

and (ii) common law deceptive advertising.

The Company moved to dismiss the second claim, arguing that Texas does not recognize such a claim.

Thereafter on January 30, 2025, Eli

Lilly responded by filing an amended complaint wherein it removed the 2 nd cause of action.

On February 24, 2025, the Company filed its response along with its affirmative defenses and concluding with a

motion to dismiss.

the Action was filed, management responded by making changes to its website;

specifically, removing the allegedly offending references

to FDA studies.

The product is no longer identified on the MangoRx website, the product cannot

be purchased and no sales have been made.

The Company, by and through counsel, has been attempting to resolve the matter, but intends

to vigorously defend the matter if an early resolution is not reached.

a description of our material pending legal proceedings, see “Note 11, Commitments and Contingencies”, to the consolidated

financial statements included in “ Item 8.

Financial Statements and Supplemental Data ” of this Report.

impact and outcome of litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from

time to time that may harm our business.

The above claims and others, even if lacking merit, could result in the expenditure by us of

significant financial and managerial resources.

The claims and others, even if lacking merit, could result in the expenditure by us of significant

financial and managerial resources.

We may become involved in additional material legal proceedings in the future.

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 3. Legal Proceedings