Item 1.01 - Entry into a Material Definitive Agreement

On July 26, 2021, Acura Pharmaceuticals, Inc. ("we" "Acura" or the "Company"), entered into a second amendment to the June 28, 2019 License, Development and Commercialization Agreement (the "Second Amended Agreement") with Abuse Deterrent Pharma, LLC ("AD Pharma"). The Second Amended Agreement extends the FDA's acceptance of a New Drug Application ("NDA") for LTX-03 from July 31, 2021 to February 28, 2022.

AD Pharma may terminate the Amended Agreement at any time. Additionally, if the NDA for LTX-03 is not accepted by the FDA by February 28, 2022, AD Pharma may terminate the Amended Agreement and take ownership of the intellectual property rights of the Company to LTX-03. Should AD Pharma choose not to exercise this option to terminate and the NDA for LTX-03 is subsequently accepted by the FDA, such option expires.

The inclusion of a description of the Amended Agreement with AD Pharma under Item 1.01 of this Current Report on Form 8-K shall not be deemed an acknowledgement that the Amended Agreement is a material agreement not made, or deemed not to be made, in the ordinary course of our business.

AD Pharma is our largest shareholder and, as of June 16, 2021, to our knowledge owns approximately 66% of our common stock, which does not include their Warrant to purchase 10.0 million shares of the Company's common stock.

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.




Item 8.01 - Other Events

On July 26, 2021, Acura Pharmaceuticals, Inc. issued a press release announcing a second amendment to the License, Development and Commercialization Agreement. A copy of that press release is attached as Exhibit 99.1 to this report. The contents of Item 1.01 are incorporated herein by reference.





Forward-Looking Statements

Statements in the attached exhibit that are not strictly historical may be "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:

· our ability to fund or obtain funding for our continuing operations, including

the development of our products utilizing our LIMITx and IMPEDE technologies;

· whether we will receive FDA acceptance for an NDA for LTX-03 by the target

date;

· whether our licensees will terminate the license prior to commercialization;

· 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;

· the ability of LTX-03 single tablets to achieve bioequivalence or to

demonstrate efficacy in a clinical study;

· whether our licensing partners will develop any additional products and utilize

Acura for such development;

· 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

mitigate respiratory depression risk will be determined sufficient by the FDA;

· our and our licensee's ability to successfully launch and commercialize our

products and technologies;

· our and our licensee's 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;

· our ability to develop and enter into additional license agreements for our

product candidates using our technologies;

· the ability to avoid infringement of patents, trademarks and other proprietary


   rights of third parties;




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· 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 an NDA and FDA

approval of our product candidates;

· changes in regulatory requirements;

· adverse safety findings relating to our commercialized products or product

candidates in development;

· 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 "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.

Item 9.01 - Financial Statements and Exhibits

Exhibit Number Description


  99.1           Press Release of the Registrant dated June 26, 2021




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