{"url_path":"/sec/cik-0000786947/8-k/2026-06-29/item-2-03","section_key":"item-2-03","section_title":"Item 2.03 Creation of a Direct Financial","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-29","source_url":"https://www.sec.gov/Archives/edgar/data/786947/0001104659-26-078839-index.html","accession_number":"0001104659-26-078839","cik":"0000786947","ticker":null,"issuer_name":"ACURA PHARMACEUTICALS, INC","edgar_url":"https://www.sec.gov/Archives/edgar/data/786947/0001104659-26-078839-index.html","primary_entity_key":"0000786947","primary_entity_name":"ACURA PHARMACEUTICALS, INC"},"word_count":1040,"has_tables":true,"body_markdown":"**Item 2.03 - Creation of a Direct Financial\nObligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant**\n\n \n\nThe contents of all Items 1.01 are incorporated herein by reference.\n\n \n\n**Acura Forward-Looking Statements**\n\n \n\nStatements in this Current\nReport constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and these forward-looking\nstatements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E\nof the Securities Exchange Act of 1934, as amended. Such forward-looking statements involve known and unknown risks, uncertainties and\nother factors which may cause our actual results, performance or achievements to be materially different from any future results, performance,\nor achievements expressed or implied by such forward-looking statements.\n\n \n\nForward-looking statements\nmay include, but are not limited to:\n\n \n\n \n●\nwhether\nthe FDA will agree with or accept the results of our studies for our product candidates;\n\n \n●\nthe\nability to fulfill the FDA requirements for approving our product candidates for commercial manufacturing and distribution in the\nUnited States, including, without limitation, the adequacy of the results of the laboratory and clinical studies completed to date,\nthe results of laboratory and clinical studies we may complete in the future to support FDA approval of our product candidates and\nthe sufficiency of our development process to meet over-the-counter (“OTC”) Monograph standards, as applicable;\n\n \n●\nwhether\nwe can successfully submit a New Drug Application for LTX-03, request a priority review and whether such filings and requests will\nbe accepted by the FDA;\n\n \n●\nour\nability to obtain funding from Abuse Deterrent Pharma, LLC or other parties for our continuing operations, including the development\nof our products utilizing our LIMITx™ and Impede® technologies;\n\n \n●\nwhether\nwe can renegotiate the date by which we are required to obtain FDA acceptance, currently December 31, 2026, for an NDA for LTX-03\nby our agreement with Abuse Deterrent Pharma, LLC on which we depend to finance operations;\n\n \n●\nwhether\nwe can renegotiate the date by which we are required to pay off the secured promissory note and accrued interest to Abuse Deterrent\nPharma, LLC, currently December 31, 2026, 2026;\n\n \n●\nwhether\nour licensing partners will develop any additional products and utilize Acura for such development;\n\n \n●\nthe\nexpected results of clinical studies relating to LTX-03, a LIMITx hydrocodone bitartrate and acetaminophen combination product, or\nany successor product candidate, the date by which such studies will be complete and the results will be available and whether LTX-03\nwill ultimately receive FDA approval;\n\n \n●\nour\nbusiness could be adversely affected by health epidemics in regions where third parties for which we rely, as in CROs or CMOs, have\nconcentrations of clinical trial sites or other business operations, and could cause significant disruption in the operations of\nthird-party manufacturers and CROs upon whom we rely;\n\n \n\n3\n\n \n\n \n\n \n●\nwhether\nLIMITx will retard the release of opioid active ingredients as dose levels increase;\n\n \n●\nwhether\nthe extent to which products formulated with the LIMITx Technology reduce respiratory depression will be determined sufficient by\nthe FDA to support approval or labelling describing safety features;\n\n \n●\nour\nand our licensee’s ability to successfully launch and commercialize our products and technologies;\n\n \n●\nthe\nresults and timing of our development of our LIMITx Technology, including, but not limited to, the submission of a NDA and/or FDA\nfiling acceptance;\n\n \n●\nour\nor our licensees’ ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;\n\n \n●\nthe\nmarket acceptance of, timing of commercial launch and competitive environment for any of our products;\n\n \n●\nexpectations\nregarding potential market share for our products;\n\n \n●\nour\nability to develop and enter into additional license agreements for our product candidates using our technologies;\n\n \n●\nour\nexposure to product liability and other lawsuits in connection with the commercialization of our products;\n\n \n●\nthe\nincreasing cost of insurance and the availability of product liability insurance coverage;\n\n \n●\nthe\nability to avoid infringement of patents, trademarks and other proprietary rights of third parties;\n\n \n●\nthe\nability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights\nin any paragraph IV patent infringement litigation;\n\n \n●\nthe\nadequacy of the development program for our product candidates, including whether additional clinical studies will be required to\nsupport FDA approval of our product candidates;\n\n \n●\nchanges\nin regulatory requirements;\n\n \n●\nadverse\nsafety findings relating to our commercialized products or product candidates in development;\n\n \n●\nwhether\nthe FDA will agree with our analysis of our clinical and laboratory studies;\n\n \n●\nwhether\nor when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications and whether we will\nbe able to promote the features of our technologies; and\n\n \n●\nwhether\nour product candidates will ultimately perform as intended in commercial settings.\n\n \n\nIn\nsome cases, you can identify forward-looking statements by terms such as “aim”, \"anticipate\", \"believe\",\n\"could\", \"design\", \"estimate\", \"expect\", \"forecast\", \"goal\", \"guidance\",\n\"imply\", “indicate”, \"intend\", \"may\", \"objective\", \"opportunity\", \"outlook\",\n\"plan\", \"position\", \"potential\", \"predict\", \"project\", \"prospective\", \"pursue\",\n\"seek\", \"should\", \"strategy\", \"target\", \"would\", \"will\", and\nother words of similar meaning, expressions, derivations of such words and the use of future dates intended\nto identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions\nand subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.\nWe discuss many of these risks in greater detail in Acura’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q\nfiled with the U.S. Securities and Exchange Commission (\"SEC\") and in other filings Acura makes with the SEC from time to time.\nInvestors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak\nonly as of this date of the Current Report and are based on the Company’s current beliefs, assumptions, and expectations. While\nAcura may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update\nor revise any forward-looking statements contained in this Current Report whether as a result of new information or future events, except\nas may be required by applicable law."}