# EDGAR Filing Document

**Accession Number:** 0000786947
**File Stem:** 0001104659-23-034342
**Filing Date:** 2023-3
**Character Count:** 11649
**Document Hash:** 5d06ee4bf9729d3378fd4e1858698d5b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-034342.hdr.sgml**: 20230320

**ACCESSION NUMBER**: 0001104659-23-034342

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20230320

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Completion of Acquisition or Disposition of Assets

**ITEM INFORMATION**: Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant

**FILED AS OF DATE**: 20230320

**DATE AS OF CHANGE**: 20230320

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ACURA PHARMACEUTICALS, INC
- **CENTRAL INDEX KEY:** 0000786947
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 110853640
- **STATE OF INCORPORATION:** NY
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-10113
- **FILM NUMBER:** 23745426

**BUSINESS ADDRESS:**
- **STREET 1:** 616 N. NORTH COURT, SUITE 120
- **CITY:** PALATINE
- **STATE:** IL
- **ZIP:** 60067
- **BUSINESS PHONE:** 847-705-7709

**MAIL ADDRESS:**
- **STREET 1:** 616 N. NORTH COURT, SUITE 120
- **STREET 2:** .
- **CITY:** PALATINE
- **STATE:** IL
- **ZIP:** 60067

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** HALSEY DRUG CO INC/NEW
- **DATE OF NAME CHANGE:** 19920703

?xml version="1.0" encoding="utf-8"?

**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 20, 2023**

**___________________________________________________________**

**ACURA PHARMACEUTICALS, INC.**

(Exact Name of Registrant as specified in its Charter)

**___________________________________________________________**

---

| | | |
|:---|:---|:---|
| **New York** | **1-10113** | **11-0853640** |
| (State or other jurisdiction of | (Commission File Number) | (I.R.S. Employer |
| incorporation or organization) |  | 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:

---

| | | |
|:---|:---|:---|
| **<u>Title of Each Class</u>** | **<u>Trading Symbol(s)</u>** | **<u>Name of Each Exchange on Which Registered</u>** |
| 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 March 20, 2023 we received a $250,000 loan from Abuse Deterrent Pharma, LLC ("AD Pharma"). This loan combined with previous loans and with the $2,319,279 under the November 10, 2022 Amended Consolidated and Restated Secured Promissory Note, now totals $3,319,279, bears interest at 5.25% and matures on December 31, 2023, at which time all principal and interest is due. 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 they 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 for operations through end of April 2023. There can be no assurance we will be successful in receiving additional financing. In the absence of the receipt of additional financing by the end of April 2023, we will be required to scale back or 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 March 15, 2023, AD Pharma directly owns approximately 66% 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 March 15, 2023, Mr. Schutte directly owns approximately 14% of the outstanding common stock of the Company.

**Item 2.01 – Completion of Acquisition or Disposition of Assets**

The contents of Item 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 Item 1.01 are incorporated herein by reference.

**Forward-Looking Statements**

Statements in this Current Report constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our
ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITx and IMPEDE
technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• whether
we will receive FDA acceptance for an NDA for LTX-03 by the target date, currently June 30, 2023;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• whether
our licensees will terminate the license prior to commercialization;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the
expected results of clinical studies relating to LTX-03 or any successor product candidate, the date by which such studies will complete
and the results will be available and whether any product candidate will ultimately receive FDA approval;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the
ability of LTX-03 single tablets to achieve bioequivalence or to demonstrate efficacy in a clinical study;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• whether
our licensing partners will develop any additional products and utilize Acura for such development;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• whether
LIMITx will retard the release of opioid active ingredients as dose levels increase;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• whether
the extent to which products formulated with the LIMITx technology mitigate respiratory depression risk will be determined sufficient
by the FDA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our
and our licensee's ability to successfully launch and commercialize our products and technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our
and our licensee's ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the
market acceptance of, timing of commercial launch and competitive environment for any of our products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our
ability to develop and enter into additional license agreements for our product candidates using our technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the
ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 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;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the
adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support
an NDA and FDA approval of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• changes
in regulatory requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• adverse
safety findings relating to our commercialized products or product candidates in development;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 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 "may," "will", "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "indicates", "projects," "predicts," "potential" and similar expressions 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 our filings with the Securities and Exchange Commission.

 **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.

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| | |
|:---|:---|
| **ACURA PHARMACEUTICALS, INC.** | **ACURA PHARMACEUTICALS, INC.** |
| By: | /s/ Peter A. Clemens |
|  | Peter A. Clemens |
|  | Senior Vice President & Chief Financial Officer |

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Date: March 20, 2023