PALATINE, Ill., June 29, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR), a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse, announced today financial results for the three months ended March 31, 2020.
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.
LIMITx™ Technology utilizes acid neutralizing ingredients to precisely control gastric acidity, which limits the release of drug from tablets and its subsequent systemic absorption when multiple tablets are ingested. LIMITx™ Technology is useful with products whose side effect risks can be mitigated by limiting exposure to a drug in overdose situations.
AVERSION® Technology, used in the FDA approved drug OXAYDO® (oxycodone HCl) marketed by Zyla Life Sciences, utilizes polymers designed to limit the abuse of the product by nasal snorting and injection. AVERSION® Technology is also licensed to KemPharm for use in certain of their products.
IMPEDE® Technology, used in NEXAFED® (pseudoephedrine HCl) and NEXAFED® Sinus (pseudoephedrine HCl/acetaminophen) marketed by MainPointe Pharmaceuticals, utilizes polymers and other ingredients to disrupt the extraction and processing of pseudoephedrine from the tablets into methamphetamine.
Forward-looking Statements:
Certain statements in this press release 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:
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.
Contact:
Acura Investor Relations
investors@acurapharm.com
847-705-7709
ACURA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited) | (audited) | |||||
March 31, | December 31, | |||||
2020 | 2019 | |||||
Assets - current | $ | 1,388 | $ | 1,178 | ||
Property, plant and equipment, net | 525 | 540 | ||||
Other assets | 91 | 844 | ||||
Total assets | $ | 2,004 | $ | 2,562 | ||
Other liabilities - current | $ | 968 | $ | 1,074 | ||
Accrued interest to related party – current | 341 | - | ||||
Debt to related party – current | 6,000 | - | ||||
Accrued interest to related party – noncurrent | - | 229 | ||||
Debt to related party – noncurrent | - | 6,000 | ||||
Stockholders' deficit | (5,305 | ) | (4,741 | ) | ||
Total liabilities and stockholders' deficit | $ | 2,004 | $ | 2,562 |
ACURA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(in thousands, except per share amounts)
Three Months Ended March 31, | ||||||
2020 | 2019 | |||||
Revenues: | ||||||
Royalties | $ | 33 | $ | 67 | ||
Collaboration | 8 | - | ||||
License fees | 1,050 | - | ||||
Total revenues | 1,091 | 67 | ||||
Operating expenses: | ||||||
Research and development | 387 | 313 | ||||
General and administrative | 1,187 | 437 | ||||
Total operating expenses | 1,574 | 750 | ||||
Operating loss | (483 | ) | (683 | ) | ||
Interest expense - related party | (112 | ) | (105 | ) | ||
Loss before provision for income taxes | (595 | ) | (788 | ) | ||
Provision for income taxes | - | - | ||||
Net loss | $ | (595 | ) | $ | (788 | ) |
Net loss per share: | ||||||
Basic | $ | (0.02 | ) | $ | (0.04 | ) |
Diluted | $ | (0.02 | ) | $ | (0.04 | ) |
Weighted average number of shares outstanding: | ||||||
Basic | 32,270 | 21,493 | ||||
Diluted | 32,270 | 21,493 | ||||