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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):
March 9, 2026
ACURA
PHARMACEUTICALS, INC.
(Exact Name of Registrant as specified in its
Charter)
| New York |
1-10113 |
11-0853640 |
(State or other jurisdiction of
incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer
Identification Number) |
616
N. North Court, Suite 120
Palatine,
Illinois 60067
(Address of principal executive offices) (Zip
code)
(847)
705-7709
(Registrant’s telephone number, including
area code)
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, $0.01 par value per share |
ACUR |
OTC Market – OTC Expert 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:
| ¨ | 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 (17CFR240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17CFR 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. ¨
Item 1.01 - Entry into a Material Definitive
Agreement.
On each of February 6, 2026, February 13,
2026 and March 9, 2026, we received loans of $100,000 from Abuse Deterrent Pharma, LLC (“AD Pharma”). These loans combined
with previous loans made to the Company and combined with the $2,319,279 under the November 10, 2022 Amended Consolidated and Restated
Secured Promissory Note, now has a principal balance of $9,894,279 with accrued interest of approximately $1,040,000 as of February 28,
2026, and bears interest at 5.25% (“Note”). The Events of default under the Note include, among other items, bankruptcy events,
failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to,
or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without
regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default,
such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full.
The funding provided by AD Pharma will be used
to meet day-to-day operation activity. There can be no assurance we will be successful in receiving additional financing. In the absence
of the receipt of additional financing by end of March 2026, we will be required to scale back our operations, including the furlough
and lay-off of employees, or to terminate operations and/or seek protection under applicable bankruptcy laws. This could result in a complete
loss of shareholder value in the Company. Even assuming we are successful in securing additional sources of financing to fund continued
operations, there can be no assurance that the proceeds of such financing will be sufficient to fund operations until such time, if at
all, that we generate sufficient revenue from our products and product candidates to sustain and grow our operation.
The inclusion of a description of the Note under
Item 1.01 of this Current Report on Form 8-K shall not be deemed an acknowledgement that the Note is a material agreement not made,
or deemed not to be made, in the ordinary course of our business.
At February 28, 2026, AD Pharma directly
owns approximately 65% of the outstanding common stock of the Company. The ownership percentage of the Company held by AD Pharma does
not include their warrant to purchase 10.0 million shares of common stock of the Company. AD Pharma is an entity controlled by Mr. Schutte,
of which Mr. Schutte is the managing partner and investor. At February 28, 2026, Mr. Schutte directly owns approximately
13% of the outstanding common stock of the Company.
Item 2.01 – Completion of Acquisition
or Disposition of Assets
The contents of all Items 1.01 are incorporated herein by reference.
Item 2.03 - Creation of a Direct Financial
Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant
The contents of all Items 1.01 are incorporated herein by reference.
Acura Forward-Looking Statements
Statements in this Current
Report constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and these forward-looking
statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended. Such forward-looking statements involve known and unknown risks, uncertainties and
other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance,
or achievements expressed or implied by such forward-looking statements.
Forward-looking statements
may include, but are not limited to:
| · | whether the FDA will agree with or accept the
results of our studies for our product candidates; |
| · | the ability to fulfill the FDA requirements for
approving our product candidates for commercial manufacturing and distribution in the United States, including, without limitation, the
adequacy of the results of the laboratory and clinical studies completed to date, the results of laboratory and clinical studies we may
complete in the future to support FDA approval of our product candidates and the sufficiency of our development process to meet over-the-counter
(“OTC”) Monograph standards, as applicable; |
| · | whether we can successfully submit a New Drug
Application for LTX-03, request a priority review and whether such filings and requests will be accepted by the FDA; |
| · | our ability to obtain funding from Abuse Deterrent
Pharma, LLC or other parties for our continuing operations, including the development of our products utilizing our LIMITx™ and
Impede® technologies; |
| · | whether we can renegotiate the date by which
we are required to obtain FDA acceptance, currently June 30, 2026, for an NDA for LTX-03 by our agreement with Abuse Deterrent Pharma,
LLC on which we depend to finance operations; |
| · | whether we can renegotiate the date by which
we are required to pay off the secured promissory note and accrued interest to Abuse Deterrent Pharma, LLC, currently June 30, 2026; |
| · | whether our licensing partners will develop any
additional products and utilize Acura for such development; |
| · | the expected results of clinical studies relating
to LTX-03, a LIMITx hydrocodone bitartrate and acetaminophen combination product, or any successor product candidate, the date by which
such studies will be complete and the results will be available and whether LTX-03 will ultimately receive FDA approval; |
| · | our business could be adversely affected by health
epidemics in regions where third parties for which we rely, as in CROs or CMOs, have concentrations of clinical trial sites or other business
operations, and could cause significant disruption in the operations of third-party manufacturers and CROs upon whom we rely; |
| · | whether LIMITx will retard the release of opioid
active ingredients as dose levels increase; |
| · | whether the extent to which products formulated
with the LIMITx Technology reduce respiratory depression will be determined sufficient by the FDA to support approval or labelling describing
safety features; |
| · | our and our licensee’s ability to successfully
launch and commercialize our products and technologies; |
| · | the results and timing of our development of
our LIMITx Technology, including, but not limited to, the submission of a NDA and/or FDA filing acceptance; |
| · | our or our licensees’ ability to obtain
necessary regulatory approvals and commercialize products utilizing our technologies; |
| · | the market acceptance of, timing of commercial
launch and competitive environment for any of our products; |
| · | expectations regarding potential market share
for our products; |
| · | our ability to develop and enter into additional
license agreements for our product candidates using our technologies; |
| · | our exposure to product liability and other lawsuits
in connection with the commercialization of our products; |
| · | the increasing cost of insurance and the availability
of product liability insurance coverage; |
| · | the ability to avoid infringement of patents,
trademarks and other proprietary rights of third parties; |
| · | the ability of our patents to protect our products
from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation; |
| · | the adequacy of the development program for our
product candidates, including whether additional clinical studies will be required to support FDA approval of our product candidates; |
| · | changes in regulatory requirements; |
| · | adverse safety findings relating to our commercialized
products or product candidates in development; |
| · | whether the FDA will agree with our analysis
of our clinical and laboratory studies; |
| · | whether or when we are able to obtain FDA approval
of labeling for our product candidates for the proposed indications and whether we will be able to promote the features of our technologies;
and |
| · | whether our product candidates will ultimately
perform as intended in commercial settings. |
In
some cases, you can identify forward-looking statements by terms such as “aim”, "anticipate", "believe",
"could", "design", "estimate", "expect", "forecast", "goal", "guidance",
"imply", “indicate”, "intend", "may", "objective", "opportunity", "outlook",
"plan", "position", "potential", "predict", "project", "prospective", "pursue",
"seek", "should", "strategy", "target", "would", "will", and
other words of similar meaning, expressions, derivations of such words and the use of future dates intended
to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions
and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
We discuss many of these risks in greater detail in Acura’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q
filed with the U.S. Securities and Exchange Commission ("SEC") and in other filings Acura makes with the SEC from time to time.
Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak
only as of this date of the Current Report and are based on the Company’s current beliefs, assumptions, and expectations. While
Acura may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update
or revise any forward-looking statements contained in this Current Report whether as a result of new information or future events, except
as may be required by applicable law.
Item 9.01 - Financial Statements and Exhibits
| Exhibit Number |
Description |
| 99.1 |
Amended Loan Schedule dated March 9, 2026 to the November 10, 2022 Amended, Consolidated and Restated Secured Promissory Note with Abuse Deterrent Pharma, LLC |
| 104 |
Cover Page Interactive Data File (embedded within 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 thereunto duly authorized.
| |
ACURA
PHARMACEUTICALS, INC. |
| |
|
| |
By:
|
/s/
Robert A. Seiser |
| |
|
Robert
A. Seiser |
| |
|
Senior
Vice President & Chief Financial Officer |
Exhibit 99.1
Amended
Loan Schedule to Secured Promissory Note dated November 10, 2022
between
Acura Pharmaceuticals, Inc. and Abuse Deterrent Pharma, LLC
| | |
Date | | |
Principal | | |
Aggregated
Principal | |
| Original Secured Promissory Note | |
| 11/10/2022 | | |
$ | 2,319,279 | | |
$ | 2,319,279 | |
| Additional Loans to be included: | |
| | | |
| | | |
| | |
| Loans #1 dated 12/22/2022 through Loans #50 dated 12/31/2025 | |
| | | |
$ | 7,075,000 | | |
$ | 9,394,279 | |
| Loan #51 | |
| 1/02/2026 | | |
$ | 100,000 | | |
$ | 9,494,279 | |
| Loan #52 | |
| 1/16/2026 | | |
$ | 100,000 | | |
$ | 9,594,279 | |
| Loan #53 | |
| 2/06/2026 | | |
$ | 100,000 | | |
$ | 9,694,279 | |
| Loan #54 | |
| 2/13/2026 | | |
$ | 100,000 | | |
$ | 9,794,279 | |
| Loan #55 | |
| 3/09/2026 | | |
$ | 100,000 | | |
$ | 9,894,279 | |
ACURA PHARMACEUTICALS, INC.
| By: |
/s/
Robert A. Seiser |
|
| Robert
A. Seiser |
|
| Senior
Vice President & CFO |
|
| Date:
March 9, 2026 |
|
