Acura Pharmaceuticals, Inc (ACUR) SEC Filing 10-Q Quarterly report for the period ending Tuesday, June 30, 2020

Exhibit 99.1

Acura Pharmaceuticals Announces

First Quarter 2020 Financial Results

Palatine, IL – (June 29, 2020) - Acura Pharmaceuticals, Inc. (OTCQB: ACUR),

The Company reported revenues of $1.1 million and an operating loss of $483 thousand for the first quarter 2020 compared to revenues of only $67 thousand and an operating loss of $683 thousand for the same period in 2019. Included in expenses for the first quarter 2020 was a one-time charge of $668 thousand to recognize an impairment in our Aversion intangible asset.

The Company reported a net loss of $595 thousand or $0.02 per diluted share for the first quarter 2020 compared to a net loss of $788 thousand or $0.04 per diluted share for the same period in 2019.

Revenue for the three month period ended March 31, 2020 included $1.05 million in license fees derived from the license agreement with Abuse Deterrent Pharma. The Company also recorded royalty revenue of $33 thousand and $67 thousand, respectively, for the three month periods ended March 31, 2020 and 2019.

Research and development expense was $387 thousand for the three month period ended March 31, 2020, compared to $313 thousand for the same period in 2019. The expenses for both periods were for our research facility primarily associated with development of LTX-03.

General and administrative expense was $519 thousand (excluding the one-time $668 thousand charge for the impairment of the intangible asset) for the three month period ended March 31, 2020, versus $437 thousand in the same period last year.

As of June 26, 2020, the Company had a cash balance of approximately $1.0 million.

On June 28, 2019, we entered into a License, Development and Commercialization Agreement (the “Agreement”) with Abuse Deterrent Pharma, LLC (”AD Pharma”) for our lead product candidate, LTX-03 (hydrocodone bitartrate with acetaminophen immediate-release tablets utilizing Acura’s patented LIMITx™ technology). The Agreement is described in our press release dated July 2, 2019 and our Form 8-K filed July 5, 2019. Included in the Agreement is the requirement that the NDA for LTX-03 be accepted by the FDA by November 30, 2020, or AD Pharma has the option to terminate the Agreement and take ownership of the LIMITx intellectual property. Importantly, such failure to meet this date will be an event of default under their $6.0 million note to Acura. The NDA acceptance date of November 30, 2020 was predicated upon a timeline prepared at June 28, 2019 which included the purchase and installation of auxiliary production manufacturing equipment. At this time, all auxiliary manufacturing equipment needed for production has been received but recent COVID-19 risk mitigation strategies implemented at the New Jersey based contract manufacturer has delayed the installation of the equipment for several weeks. Acura currently expects the submission and FDA acceptance of a new drug application (“NDA”) for LTX-03 to occur in the second quarter of 2021, unless additional development delays are experienced. The Parties are in negotiations to amend the AD Pharma Agreement to extend the date of the FDA acceptance of the NDA for LTX-03 which would allow for these unforeseen delays, although no guarantee can be given that these negotiations will be successful. AD Pharma has deferred the remittance of the required monthly license payments for May and June, 2020 pending the completion of these negotiations.

About Acura Pharmaceuticals

Acura Pharmaceuticals is an innovative drug delivery company engaged in the research, development and commercialization of technologies and products intended to address safe use of medications. The Company has three proprietary technologies: LIMITx™ Technology, AVERSION® Technology and IMPEDE® Technology.