On August 10, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the second quarter of 2022 and provided an update on recent corporate developments (Press release, Adamis Pharmaceuticals, AUG 10, 2022, View Source [SID1234618044]).

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"I committed to the CEO role in May because I could see beyond Adamis’ current position to where it could go. I knew the Company had strong assets which we could leverage to unlock shareholder value," said David J. Marguglio, CEO of Adamis. "We have two FDA-approved products competing in large markets. We have an ongoing Phase 2/3 trial for Tempol that, if it shows significant efficacy, could not only potentially become a blockbuster treatment for COVID-19, but could be potentially expanded to treat other respiratory diseases. Most importantly, we have a small, yet devoted team of highly qualified and experienced individuals committed to both saving patient lives and growing Adamis."

Product and Pipeline Updates and Other Corporate Developments

ZIMHI (naloxone) Injection

US WorldMeds (USWM) began shipping ZIMHI to wholesalers at the end of March. The commercial launch is proceeding as planned.
USWM-relayed feedback from the field has been decidedly positive. Many customers feel ZIMHI’s combination of a higher dose with intramuscular delivery provides an advantage and significantly differentiates it from the leading competitors.
A recently launched website enables institutional customers to order and receive product directly through ZimhiDirect.com.
Progress continues in adding ZIMHI to formularies for payors and PBMs. It has been added to the standing orders in 25 states – which permits pharmacies to dispense ZIMHI without a prescription.
While market access is increasing, USWM has fielded a team of sales reps detailing doctors and clinics to increase awareness and ultimately drive scripts.
SYMJEPI (epinephrine) Injection

In March, the Company announced that manufacturing issues had led to a voluntary recall of four lots of SYMJEPI due to the potential for clogged needles.
An investigation lasting several months determined a single batch of stainless-steel needles was the root cause of the failures. Adamis and the manufacturer have developed corrective and preventive actions, and new syringes have been sourced.
Adamis is committed to returning SYMJEPI to the market as soon as all stakeholders are satisfied that these corrective actions should prevent a similar failure in future batches.
TEMPOL

Adamis believes that patient enrollment in the Phase 2/3 clinical trial is nearly completed.
The Data Safety Monitoring Board is scheduled to meet near the end of September to review unblinded interim data including safety and efficacy. Adamis will remain blinded to the data until the final study data is compiled and reviewed.
If interim trial data shows significant efficacy, the DSMB may recommend stopping the trial in light of the significant efficacy, and Adamis would likely seek to meet with FDA to discuss next steps and requirements for applying for Emergency Use Authorization, which could be a significant positive development for the Company, patients and healthcare providers.
The Company is exploring other potential indications for Tempol and seeking both government and non-government funding to further development.
Financial Results

Revenues for the six months ending June 30, 2022 and 2021 were approximately $1.2 million and $2.6 million, respectively. The decrease in revenues was primarily due the manufacturing hold and recall of SYMJEPI in 2022, offset by the product launch of ZIMHI.
Selling, general and administrative expenses for the first six months ending June 30, 2022 and 2021 were approximately $7.6 million and $8.5 million, respectively. The decrease was primarily due to the decreases in compensation and legal expenses.
Research and development expenses were higher for the first six months of 2022, at approximately $7.5 million, compared to $4.4 million in the same period in 2021. The increase was primarily related to the ongoing clinical trial for Tempol.
Net loss from discontinued operations for the six months ended June 30, 2022 and 2021 was approximately $0.2 million and $3.1 million, respectively. This decreased loss was primarily attributable to the cessation of US Compounding’s operations.
Cash and cash equivalents at the end of the second quarter totaled $8.9 million. Cash expenses were higher than expected due to approximately $5.2 million in disbursements relating to the repayment of the Second Draw Paycheck Protection Program loan, expenses related to the SYMJEPI recall and employment separation expenses. Although there are no assurances, the Company expects to receive additional proceeds during the second half of 2022, which could range from collections of approximately $2.0 to 3.5 million pursuant to the sale of certain USC assets to Fagron in 2021, and from the disposition of the remaining USC assets.
Conference Call Information

Management will host a live webcast/conference call today, August 10, 2022 at 4:30 p.m. ET / 1:30 p.m. PT, during which Company executives will review financial information for the second quarter of 2022 and provide a corporate update.

A live audio webcast of the conference call will also be available via this link. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source