PALATINE, Ill., June 14, 2021 (GLOBE NEWSWIRE) – Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced that Abuse Deterrent Pharma, LLC (“AD Pharma”) has converted the entire principle and accrued interest on its Promissory Notes (the “Note”) with the Company in ordinary shares of the Company. As of this conversion, the note is withdrawn and the Company works with AD Pharma to release its security interest in all of the Company’s assets. Pursuant to the note, AD Pharma elected to convert the outstanding principal of $ 6.9 million and accrued interest to $ 0.16 per share, resulting in 42,984,375 newly issued common shares. The total number of common shares outstanding of the Company now stands at 65,089,043.
Bob Jones, CEO of Acura, said: “AD Pharma’s conversion of our only outstanding secured loan to equity reduces future cash requirements to repay the note as it matures in 2023 and gives us greater flexibility for financing options, if applicable. AD Pharma and the Company’s minority shareholders are now aligned with Acura’s future results.
About Acura Pharmaceuticals
Acura Pharmaceuticals is an innovative drug delivery company engaged in the research, development and commercialization of technologies and products to ensure the safe use of drugs. We have discovered and developed three proprietary platform technologies that can be used to develop multiple products: LIMITx ™ technology, AVERSION® technology, and IMPEDE® technology.
LIMITx ™ technology, a technology in development, is designed to delay the release of active drug ingredients when too many tablets are accidentally or intentionally ingested by neutralizing stomach acid with buffering ingredients, but delivering effective amounts of the drug when taken as a single tablet with a nominal dose. buffer dose. In June 2020, we entered into a licensing, development and commercialization agreement, which was amended in October 2021, with Abuse Deterrent Pharma, LLC (“AD Pharma”), a Kentucky limited liability company and a company in special vocation representing a consortium of investors who will finance Acura operations until July 2021 and reimburse us for the development of the LTX-03. AD Pharma holds the exclusive rights to market LTX-03 in the United States as well as LTX-02 (oxycodone / acetaminophen) and LTX-09 (alprazolam).
AVERSION® technology, used in the FDA-approved drug OXAYDO® (oxycodone HCl) marketed by Assertio Holdings Inc., uses polymers designed to limit abuse of the product by nasal sniffing and injection. AVERSION® technology is also licensed to KemPharm for use in some of their products.
The IMPEDE® technology, used in NEXAFED® (pseudoephedrine HCl) and NEXAFED® Sinus (pseudoephedrine HCl / acetaminophen) marketed by MainPointe Pharmaceuticals, uses polymers and other ingredients to disrupt the extraction and processing of pseudoephedrine from tablets into methamphetamine.
Certain statements contained in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our results, performance or achievements are materially different from any future results, performances or achievements expressed or implied by these forward-looking statements. Forward-looking statements may include, but are not limited to:
- our ability to secure funding for our ongoing activities, including the development of our products using our LIMITx ™ and Impede® technologies;
- whether we can renegotiate the date we are required to gain FDA acceptance, currently July 31, 2021, for an NDA for LTX-03 by our agreement with AD Pharma on which we depend to fund operations;
- whether our licensing partners will develop additional products and use Acura for such development;
- the expected results of clinical studies with LTX-03, a combination product of hydrocodone bitartrate and LIMITx acetaminophen, or any successor candidate, the date on which these studies will be completed and the results will be available and whether the LTX-03 will eventually receive FDA approval;
- our business could be affected by health epidemics in regions where third parties we rely on, such as CROs or CMOs, have concentrations of clinical trial sites or other business activities, and could significantly disrupt operations third-party manufacturers and the CROs we rely on;
- whether LIMITx will delay the release of active opioid ingredients as dose levels increase;
- whether the extent to which products formulated with LIMITx technology reduce respiratory depression will be sufficiently determined by the FDA to support approval or labeling describing the safety characteristics;
- whether LTX-03 will successfully demonstrate appropriate shelf life studies;
- our ability and that of our licensees to successfully launch and commercialize our products and technologies, including Oxaydo® tablets and our Nexafed® products;
- the results and timing of our development of our LIMITx technology, including, but not limited to, submission of a new drug application and / or acceptance of the FDA filing;
- our ability or that of our licensees to obtain necessary regulatory approvals and to market products using our technologies;
- market acceptance, timing of commercial launch and competitive environment for any of our products;
- expectations regarding the 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 marketing of our products;
- the increase in the cost of insurance and the availability of product liability insurance coverage;
- the ability to prevent the 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;
- whether the FDA will approve or accept the results of our studies for our product candidates;
- the ability to meet FDA requirements for the approval of our product candidates for commercial manufacture and distribution in the United States, including, without limitation, the adequacy of the results of completed laboratory and clinical studies To date, the results of laboratory and clinical studies that we may be completing in the future to support the FDA approval of our product candidates and the adequacy of our development process to meet product monograph standards free (“OTC”), if applicable;
- the adequacy of the development program of our product candidates, including whether additional clinical studies will be required to support the approval of our product candidates by the FDA;
- changes in regulatory requirements;
- adverse safety results with respect to our marketed products or our product candidates in development;
- whether the FDA will agree with our analysis of our clinical and laboratory studies;
- whether further studies of our product candidates will be required to support FDA approval;
- whether or when we will be able to obtain FDA approval for the labeling of our product candidates for the proposed indications and whether we will be able to promote features of our technologies; and
- whether our product candidates will end up performing as intended in commercial contexts.
In some cases, you can identify forward-looking statements by words such as “could”, “will”, “should”, “could”, “could”, “expects”, “anticipates”, “estimates” , “Indicates”, “plans”, “predicted”, “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views regarding future events and are based on assumptions and subject to risks and uncertainties. In view of these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss several of these risks in more detail in our filings with the Securities and Exchange Commission.
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