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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):
July 29, 2025
ANI PHARMACEUTICALS, INC.
(Exact name of registrant as specified in
its charter)
| Delaware |
001-31812 |
58-2301143 |
(State or other jurisdiction of
incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
|
210 Main Street West
Baudette, Minnesota |
|
56623 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant's telephone number, including
area code: (218) 634-3500
Not Applicable
(Former name or former address, if changed since last report.)
Securities registered pursuant to Section 12(b) of the Act:
| Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which
registered |
| Common Stock |
ANIP |
Nasdaq Stock Market |
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 (see General Instruction A.2. below):
| ¨ |
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)) |
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. ¨
On March 4, 2024, ANI Pharmaceuticals, Inc.
(the “Company”) commenced a civil action against CG Oncology, Inc. f/k/a Cold Genesys, Inc. (“CG Oncology”)
in the Superior Court of the State of Delaware. The Company’s complaint alleges that, under an Assignment and Technology Transfer
Agreement dated as of November 15, 2010 (the “November 2010 Agreement”), CG Oncology is liable to pay the Company
a running royalty of 5% of the worldwide net sales of cretostimogene made by CG Oncology or any affiliate or sublicensee thereof; and
that in February 2024, CG Oncology wrongfully repudiated its royalty obligation to the Company.
On June 2, 2025, CG Oncology filed five motions
for summary judgment seeking dismissal of all of the Company’s claims and counterclaims, including breach of the royalty payment
provision, breach of good faith performance, breach of the implied covenant of good faith, and in the alternative, unjust enrichment.
Also on June 2, 2025, the Company filed a motion for partial summary judgment seeking dismissal of CG Oncology’s counterclaims
for unenforceability of the royalty payment provision under Brulotte, breach of good faith performance, breach of confidentiality
and trade secret misappropriation. On July 15, 2025, the court heard the parties’ arguments on their respective motions
for summary judgment and motions in limine filed on July 3, 2025. At a pretrial conference on July 16, 2025, the court
granted CG Oncology's motion for partial summary judgment on its Brulotte counterclaim and affirmative defense, but allowed the
case to proceed on the Company’s counterclaim for unjust enrichment. The court also granted the Company's motion for partial
summary judgment, dismissing CG Oncology's breach of confidentiality and trade secret misappropriation claims. As previously scheduled,
the jury trial commenced in Delaware Superior Court on July 21, 2025.
On July 29, 2025, a verdict was returned by
the jury, (1) finding that the unenforceability of the royalty payment provision in the November 2010 Agreement did not affect
the economic or legal substance of the transactions contemplated thereby in a manner that was materially adverse to the Company, and (2) awarding
no damages to the Company on its unjust enrichment counterclaim. The Company expects to challenge this verdict through post-trial motions
and/or an appeal.
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.
| Dated: July 29, 2025 |
ANI PHARMACEUTICALS, INC. |
| |
|
|
| |
By: |
/s/
Stephen P. Carey |
| |
Name: |
Stephen
P. Carey |
| |
Title: |
Senior
Vice President Finance and Chief Financial Officer |
