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Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced its financial results for the year ended December 31, 2021. Despite achieving internal objectives, the company reported a net revenue decrease to $2.2 million from $2.8 million in 2020, primarily due to a $2.0 million reserve related to a SYMJEPI recall. R&D expenses rose to $11.3 million, influenced by ZIMHI and Tempol developments. The company also launched its opioid overdose treatment, ZIMHI, in collaboration with US WorldMeds. Cash and equivalents stood at $23.2 million at year-end.
Adamis Pharmaceuticals, in partnership with US WorldMeds, has launched ZIMHI™, a high-dose naloxone injection approved for treating opioid overdoses, particularly those involving potent synthetic opioids like fentanyl. This device is critical as it delivers 5 mg of naloxone, significantly higher than existing products. The CDC reports that overdoses, particularly from fentanyl, have surged, resulting in over 100,000 deaths in a year. ZIMHI is priced affordably for first responders and offers a co-pay program, ensuring accessibility for patients in need.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) will host an investor conference call on March 31, 2022, at 2 p.m. PT to discuss its fourth quarter and full year 2021 financial results. The press release with the financial results will be available post 1 p.m. PT on the same day. The conference call will be led by CEO Dennis J. Carlo, Ph.D., providing updates on recent developments and future goals. A live audio webcast will also be accessible for public attendance.
Adamis Pharmaceuticals Corporation (ADMP) has announced findings from studies at Galveston National Laboratory showing that Tempol significantly reduces lung inflammation in hamsters challenged with the Omicron variant of SARS-CoV-2.
Dr. Tseng from UTMB noted the potential of Tempol as a treatment, especially as the Omicron BA.2 variant rises in prevalence in the US. The results support ongoing clinical studies aimed at mitigating symptoms related to COVID-19.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is recalling specific lots of SYMJEPI (epinephrine) Injection due to potential needle clogging that could prevent dispensing. This recall affects products distributed nationwide, managed by US WorldMeds. The recall is prompted by customer complaints of dispensing difficulties, though no adverse events have been reported. SYMJEPI is crucial for treating severe allergic reactions and anaphylaxis. Consumers are advised to stop using the affected products and contact US WorldMeds for further instructions.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced that the Data Safety Monitoring Board (DSMB) recommended continuing the Phase 2/3 clinical trial of Tempol for treating COVID-19 after a positive interim data review on March 11, 2022. The board found no need for modifications, which supports the trial's progress.
CEO Dr. Dennis J. Carlo expressed optimism about the trial's conduct and anticipates the next DSMB meeting in May.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has announced the retirement of Richard C. Williams, effective April 15, 2022. Williams has served nearly eight years, providing strategic leadership and valuable insights to the company. CEO Dr. Dennis J. Carlo expressed gratitude for Williams' contributions. Adamis focuses on developing biopharmaceuticals in various therapeutic areas, including allergy and opioid overdose, with FDA-approved products like SYMJEPI® for allergic reactions and ZIMHI™ for opioid overdose treatment. Tempol is also under development for COVID-19.
Adamis Pharmaceuticals Corporation (ADMP) announced that its Phase 2/3 clinical trial for Tempol, aimed at treating COVID-19, received a green light from the Data Safety Monitoring Board (DSMB). The DSMB held an ad-hoc meeting after noting accelerated patient enrollment, confirming no safety or clinical concerns in interim results. The trial has surpassed the enrollment target with 124 subjects. Further data analysis will occur in March. Tempol is considered a potential treatment option due to its unique mechanisms and favorable safety profile compared to existing antiviral therapies.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced on February 18, 2022, that its board of directors approved stock options for two new non-officer employees. The grant includes 130,000 shares priced at $0.62, the closing stock price on February 15, 2022. These options, designed as inducements for employment, will vest over three years. Adamis focuses on biopharmaceuticals for conditions like allergies and opioid overdose, with FDA-approved products such as SYMJEPI® and ZIMHI™. The company is also developing Tempol for COVID-19 treatment, currently in clinical trials.
Adamis Pharmaceuticals (Nasdaq: ADMP) announced enrollment of over 100 subjects in its Phase 2/3 study of Tempol for COVID-19 treatment. The Data Safety Monitoring Board will conduct an interim analysis on the first 50 subjects. Tempol's potential as an antiviral agent is bolstered by its anti-inflammatory effects, which may position it favorably against FDA-approved treatments. Adamis has applied for Fast Track designation to expedite regulatory review. The trial aims to enroll 248 patients, with results expected in March following the DSMB's evaluation.