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Acura Pharmaceuticals announced an amendment to its agreement with Abuse Deterrent Pharmaceuticals to extend the NDA Acceptance Date for their product candidate LTX-03 to December 31, 2022. The extension aims to allow completion of necessary clinical studies for regulatory filing. LTX-03, which combines hydrocodone and acetaminophen, seeks to provide effective pain relief while mitigating overdose risks by limiting high peak drug levels in the bloodstream. This aligns with FDA’s new opioid product approval guidelines.
Acura Pharmaceuticals, Inc. (OTCQB: ACUR) announced that its LTX-03 hydrocodone and acetaminophen tablets have successfully passed six-month testing for shelf life at controlled room temperature. The LIMITx technology aims to reduce overdose risks by limiting peak drug levels. However, testing under high-temperature conditions revealed a known hydrocodone derivative that requires further evaluation. Acura updated three pharmacokinetic study protocols based on FDA feedback and plans to advance studies for regulatory approval.
Acura Pharmaceuticals, Inc. (OTCQB: ACUR) reported its financial results for Q3 and the first nine months of 2021. Revenues stood at $270K in Q3 and $1.5M for the nine-month period, down from $410K and $2.9M in the same periods of 2020. The operating loss for Q3 was $531K, with a net loss of $262K, showing improvement from last year's losses. The company benefited from $269K in SBA loan forgiveness, contributing to its financial position. As of November 12, 2021, cash reserves were approximately $130K. Future commercialization of LTX-03 remains critical, with FDA NDA submission deadlines approaching.
Acura Pharmaceuticals, Inc. (OTCQB: ACUR) reported Q2 2021 revenues of $613,000, down from $1.4 million in Q2 2020, leading to an operating loss of $300,000. For H1 2021, revenues were $1.3 million, a decline from $2.4 million in H1 2020, with a net loss of $646,000 or $0.02 per diluted share. License fees from Abuse Deterrent Pharma decreased significantly, impacting revenue. AD Pharma has missed license payments totaling $600,000, creating a potential event of default. The company also has a cash balance of approximately $220,000 as of August 2021.
Acura Pharmaceuticals announced an amendment to its licensing agreement with Abuse Deterrent Pharma to extend the NDA Acceptance Date for the LTX-03 product candidate to February 28, 2022. LTX-03 is a hydrocodone combination drug designed to mitigate opioid overdose risks by limiting peak blood levels (Cmax) through stomach acid buffering. Recent clinical trials have shown a reduction in Cmax by up to 34% under certain conditions. The company aims to address the opioid crisis while complying with FDA guidelines for safer opioid formulations.
Acura Pharmaceuticals, Inc. (OTCQB: ACUR) announced the conversion of a $6.9 million secured promissory note from Abuse Deterrent Pharma, LLC into 42,984,375 shares of common stock at $0.16 per share. This conversion fully retires the note, improving Acura's financial flexibility by reducing cash needs for repayment due in 2023. Consequently, total common shares outstanding have increased to 65,089,043. CEO Bob Jones highlighted alignment with AD Pharma and future financing options as a key benefit of this conversion.
Acura Pharmaceuticals (OTCQB: ACUR) announced the successful manufacturing of three NDA registration batches for the LTX-03 formulation, designed to mitigate opioid overdose risks. The tablets passed quality assurance tests and will be used in upcoming clinical studies and a six-month stability study. The company plans three clinical studies under the FDA guidelines. LTX-03 aims to provide pain relief with overdose protection, potentially becoming safer than existing opioid therapies. Acura's LIMITx Technology may support FDA approval by addressing overdose risks associated with high Cmax levels.
Acura Pharmaceuticals (OTCQB: ACUR) reported Q1 2021 financial results, showing a reduced operating loss of $146,000 compared to $483,000 in Q1 2020. The net loss was $259,000 or $0.01 per diluted share versus $595,000 or $0.02 per share a year earlier. Revenue from license fees dropped from $1.05 million to $0.6 million, while royalty revenue remained nearly flat. R&D expenses increased slightly to $405,000, and general administrative costs fell significantly due to a prior impairment charge. Current cash stands at approximately $200,000.
Acura Pharmaceuticals (OTCQB: ACUR) reported its financial results for the year ending December 31, 2020, showing an operating loss of $0.8 million, compared to a loss of $0.7 million in 2019. The fourth quarter of 2020 reflected a net loss of $0.1 million, down from net income of $0.2 million in Q4 2019. Key revenues included $3.0 million in license fees, while R&D expenses rose to $1.8 million. A significant impairment charge of $668,000 negatively impacted results. As of March 30, 2021, the cash balance was approximately $350,000, with concerns around a $200,000 license payment delinquency from Abuse Deterrent Pharma.
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