About DMK Pharmaceuticals

DMK Pharmaceuticals Corporation (DMK) operates as a specialty biopharmaceutical company. The company focuses on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The company’s products in the allergy, respiratory, and opioid overdose markets include: SYMJEPI (epinephrine) Injection 0.3mg, which was approved by the U.S. Food and Drug Administration, or FDA, in 2017 for use in the emergency treatment of acute allergic reactions, including anaphylaxis, for patients weighing 66 pounds or more; SYMJEPI (epinephrine) Injection 0.15mg, which was approved by the FDA in September 2018, for use in the treatment of anaphylaxis for patients weighing 33-65 pounds; and ZIMHI (naloxone HCL Injection, USP) 5 mg/0.5 mL, which was approved by the FDA in October 2021 for the treatment of opioid overdose. In June 2020, the company entered into a license agreement with a third party entity to license rights under patents, patent applications and related know-how of licensor relating to Tempol, an investigational drug. As previously disclosed in the company’s filings with the SEC, in September 2021 the company commenced patient dosing in a Phase 2/3 clinical trial to examine the safety and efficacy of Tempol in COVID-19 patients. The Data Safety Monitoring Board, or DSMB, overseeing the Phase 2/3 clinical trial met in March and June 2022 to evaluate interim clinical and safety data and, following its evaluation, recommended that the study continue as planned. On September 21, 2022, the company announced that the DSMB’s third interim analysis of the Phase 2/3 clinical trial, which was the first interim review where the DSMB evaluated the primary efficacy endpoint, determined that the trial did not achieve its primary endpoint and recommended that the study be halted early due to lack of efficacy. Based on the recommendation from the DSMB, the company halted the trial and has stopped further development of Tempol. On October 3, 2022, the company initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value, and that the company intended to pursue expense reduction measures. Such measures included, without limitation, employee headcount reductions and reduction or discontinuation of certain product development programs. The company engaged the investment bank Raymond James & Associates, Inc. to act as strategic advisor to assist the company in evaluating certain alternatives. Anaphylaxis; SYMJEPI; Epinephrine Injection Pre-Filled Single Dose Syringe The company’s SYMJEPI (epinephrine) Injection 0.15mg and 0.3mg products allow users to administer a pre-measured epinephrine dose quickly with a device that, based on human factors studies, to be intuitive to use. On June 15, 2017, the FDA approved the company’s SYMJEPI (epinephrine) Injection 0.3mg product for the emergency treatment of allergic reactions (Type I) including anaphylaxis. SYMJEPI (epinephrine) Injection 0.3mg is intended to deliver a dose of epinephrine, which is used for emergency, immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to certain foods, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis for patients weighing 66 pounds or more. On September 27, 2018, the FDA approved the company’s lower dose SYMJEPI (epinephrine) Injection 0.15mg product, for the emergency treatment of allergic reactions (Type I) including anaphylaxis in patients weighing 33 to 66 pounds. The company’s SYMJEPI injection products were fully launched in July 2019 by the company’s then-commercialization partner Sandoz Inc. The company’s SYMJEPI products are marketed and sold by USWM, LLC, or USWM or US WorldMeds, with which the company entered into an exclusive distribution and commercialization agreement, or the USWM Agreement, in May 2020 for the United States commercial rights for the SYMJEPI products, as well as for the company’s ZIMHI product. On March 21, 2022, the company announced a voluntary recall of four lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The four lots were recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. The recall was conducted with the knowledge of the FDA and USWM handled the entire recall process for the company, with company oversight. As of the date of this Report, neither USWM nor the company has received, or are aware of, any adverse events related to this recall. SYMJEPI is manufactured and tested for the company by Catalent Belgium S.A. For the manufacture of SYMJEPI, the company utilizes ‘Ready-to-Fill,’ or RTF, syringes that consist of a pre-assembled glass syringe barrel with a staked-in stainless steel needle. On March 21, 2022, the company announced a voluntary recall of four lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The four lots were recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. The recall was conducted with the knowledge of the FDA and USWM handled the entire recall process for the company, with company oversight. As of December 31, 2022, neither USWM nor the company has received, or is aware of, any adverse events related to this recall. SYMJEPI is manufactured and tested for the company by Catalent Belgium S.A. For the manufacture of SYMJEPI, the company utilizes ‘Ready-to-Fill,’ or RTF, syringes that consist of a pre-assembled glass syringe barrel with a staked-in stainless steel needle. During routine inspection of epinephrine pre-filled syringe batches, a small number of syringes with clogged needles were identified. An initial investigation suggested a syringe component issue as the likely cause of the observed needle clogging. Catalent’s investigation determined the steel used in a stainless steel needle batch as the root cause for the clogged syringes observed. The company and the manufacturer have developed corrective and preventive actions. New RTF syringes, which used a different batch of steel for their needles, were sourced and Catalent has resumed manufacturing of SYMJEPI at its Belgium facility. However, the company has not reviewed data that would permit the company to release this latest batch. While the company is committed to returning SYMJEPI to the market, as of December 31, 2022, it is unlikely that SYMJEPI will be relaunched and commercially available during the first half of 2023. The company may be able to be reimbursed by certain third parties for some of the costs of the recall under the terms of its manufacturing agreements, but there are no assurances regarding the amount or the timing of any such recovery. On February 8, 2023, the company received notice from the FDA that the FDA considers the voluntary recall of the company’s SYMJEPI products to be terminated. Opioid Overdose ZIMHI (naloxone Injection) Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone, which is generally considered the drug of choice for immediate administration for opioid overdose, blocks or reverses the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. The Centers for Disease Control and Prevention (CDC) stated in that in 2020 more than 932,000 people have died since 1999. Additional statistics published by the CDC, report that drug overdoses resulted in approximately 107,764 deaths in the United States during the 12-month period ending March 2022, which was an 11% increase over the prior 12-month period. Overdose deaths involving opioids (including both prescription and synthetic) are now the leading cause of death for Americans under age 50, with more powerful synthetic opioids, like fentanyl and its analogues, responsible for the largest number of those deaths. In June 2021, the National Institute on Drug Abuse; National Institutes of Health; U.S. Department of Health and Human Services, published the policy brief, ‘Naloxone for Opioid Overdose: Life-Saving Science’, which reported that statistical modeling suggests that high rates of naloxone distribution among laypersons and emergency personnel could avert 21 percent of opioid deaths. The brief also stated that overdoses involving highly potent synthetic opioids, such as fentanyl or large quantities of opioids may require multiple doses of naloxone. And, if respiratory function does not improve, naloxone doses may be repeated every two to three hours. On December 31, 2018, the company filed an NDA with the FDA relating to the company’s higher dose naloxone injection product, ZIMHI, for the treatment of opioid overdose. Following the receipt of two Complete Response Letters, or CRLs, from the FDA regarding the company’s NDA for ZIMHI and the company’s resubmissions of the NDA, on October 18, 2021, the company announced that the FDA had approved ZIMHI for the treatment of opioid overdose. On March 31, 2022, the company’s commercial partner USWM and the company issued a press release announcing the commercial launch of ZIMHI. Tempol On June 12, 2020, the company entered into a license agreement with a third party, or the Licensor, to license rights under certain patents, patent applications and related know-how of Licensor relating to Tempol, an investigational drug. The exclusive license included the worldwide use under the licensed patent rights and related rights for the fields of COVID-19 infection, as well as certain other indications. Tempol is a redox cycling nitroxide that promotes the metabolism of many reactive oxygen species and improves nitric oxide bioavailability. It has been studied extensively in animal models of oxidative stress and inflammation. Overall, Tempol acts as both a super-oxide dismutase mimetic and also has demonstrated anti-inflammatory, anticoagulant activity and antiviral activity. Inflammation and oxidative stress occur in various disease states, including COVID-19. Tempol has been shown to have antiviral activity against the virus that causes COVID-19 in-vitro. In January 2021, the company submitted an IND to the FDA for the investigational use and proposed Phase 2/3 clinical trial of Tempol for the treatment of COVID-19, with the goal of the study to examine the safety and activity of Tempol in COVID-19 patients early in the infection. In addition to safety, the study examined markers of inflammation and the rate of hospitalization for patients taking Tempol versus placebo early in COVID-19 infection. The company commenced Phase 2/3 clinical trial start-up activities to examine the safety and efficacy of Tempol in COVID-19 patients early in the infection and on September 2, 2021, the company announced the initiation of patient dosing in the trial. The Data Safety Monitoring Board, or DSMB, overseeing the Phase 2/3 clinical trial, which is composed of infectious disease experts that oversee and review the safety and efficacy of the trial, met in March and June 2022 to evaluate interim clinical and safety data and, following its evaluation, recommended that the study continue as planned. During the trial and interim review process, the company did not have access to unblinded trial data and did not have access to unblinded data until the final study data was compiled and reviewed. On September 21, 2022, the company announced that the DSMB’s third interim analysis of the Phase 2/3 clinical trial, which was the first interim review where the DSMB evaluated the primary efficacy endpoint, determined that the trial did not achieve its primary endpoint, as measured by comparing the rate of sustained clinical resolution of symptoms of COVID-19 at day 14 of Tempol versus placebo, and recommended that the study be halted early due to lack of efficacy. Based on the recommendation from the DSMB, the company has halted the trial and have stopped further development of Tempol. On October 27, 2022, the company received a communication from the Licensor asserting that the license agreement between the Licensor and the company relating to Tempol has terminated by virtue of alleged noncompliance by the company with certain financial covenants contained in the agreement. The company disputes, and do not agree, that the agreement has terminated. The company is also evaluating potential claims against the Licensor including possible breach of its obligations under the agreement, and the company intend to vigorously defend the company’s rights relating to the agreement. US Compounding, Inc. The company’s US Compounding Inc. subsidiary, or USC, which the company acquired in April 2016 and which was registered as a human drug compounding outsourcing facility under Section 503B of the FDCA and the U.S. Drug Quality and Security Act, or DQSA, provided prescription compounded medications, including compounded sterile preparations and nonsterile compounds, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States. On July 30, 2021, the company and the company’s USC subsidiary entered into an Asset Purchase Agreement, or the USC Agreement, effective as of July 30, 2021, or the Effective Date, with Fagron Compounding Services, LLC d/b/a Fagron Sterile Services (the ‘Purchaser’), providing for the sale and transfer by USC and the purchase by the Purchaser, effective as of the Effective Date, of certain assets of USC related to its human compounding pharmaceutical business, or the Business, including certain customer information and information on products sold to such customers by USC, together, the ‘Book of Business,’ including related formulations, know-how, and expertise regarding the compounding of pharmaceutical preparations, clinical support knowledge and other data and certain other information relating to the customers and products, collectively referred to as the ‘Assets.’ Purchaser could use the Book of Business, including to secure customers for its products and services. The Purchaser did not assume any liabilities of USC, and the transaction did not include the sale or transfer of any USC equipment, buildings or real property, or other USC assets. Clinical Supplies and Manufacturing The company’s SYMJEPI (epinephrine) Injection 0.3mg and 0.15mg products are manufactured by a third-party manufacturer, Catalent Belgium SA/NV, utilizing materials to complete the manufacturing process obtained from various companies and suppliers. The company’s ZIMHI (naloxone) Injection 5 mg product is also manufactured by a third-party manufacturer, Siegfried, Irvine, USA, utilizing materials to complete the manufacturing process obtained from various companies and suppliers. The assembly and final packaging of all the company’s products are implemented by a third-party entity, Phillips-Medisize, LLC. Sales and Marketing The company’s SYMJEPI (epinephrine) products were initially marketed and sold in the U.S. markets by Sandoz pursuant to the company’s commercialization agreement with Sandoz. Following termination of the Sandoz Agreement in 2020, the company’s SYMJEPI products and the company’s ZIMHI product are marketed and sold in the U.S. markets by USWM pursuant to the company’s USWM Agreement. Customers and Distribution The company’s SYMJEPI (epinephrine) 0.15 mg and 0.3 mg Injection products and the company’s ZIMHI product are distributed in the U.S. markets by the company’s commercialization partner USWM pursuant to the USWM Agreement. The FDA approved ZIMHI for marketing in October 2021, and on March 31, 2022, the company’s commercialization partner USWM and the company issued a press release announcing the commercial launch of ZIMHI. Pursuant to the company’s agreement with USWM, the company is responsible for supplying the SYMJEPI and ZIMHI products to USWM at a supply price for quantities of products ordered. Intellectual Property As of December 31, 2022, the company had 28 issued patents in the United States and 7 pending United States patent applications; 121 issued and 30 pending foreign patent applications, three of which have been allowed, relating to the company’s Symject injection device, as well as certain other product candidates and technologies that the company is not pursuing, among other things. The issued patents and allowed patents applications are expected to expire between 2023 and 2041, not taking into account any potential patent-term extensions that may be available in the future. The Adamis Pharmaceuticals logo and other trademarks or service marks are the property of the company. Government Regulation Following receipt of regulatory approval, any products that the company markets continue to be subject to extensive regulation including, among other things, record-keeping requirements; reporting of adverse experiences with the product; providing the FDA with updated safety and efficacy information; product storage, sampling and distribution requirements; complying with certain electronic records and signature requirements; and complying with FDA promotion and advertising requirements, which include, among others, restrictions on direct-to-consumer advertising, promoting drugs for uses or in patient populations that are not described in the product’s approved labeling, known as ‘off-label’ use, and requirements relating to industry-sponsored scientific and educational activities and promotional activities involving the internet. The company is also subject to other federal, state and local laws of general applicability, such as laws regulating working conditions, and various federal, state and local environmental protection laws and regulations, including laws, such as the Occupational Safety and Health Act; the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended; the Toxic Substances Control Act; the Resource Conservation and Recovery Act; and other federal and state laws regarding, among other things, occupational safety, the use and handling of radioisotopes, environmental protection and hazardous substance control. Research and Development (R&D) The company’s R&D expenses were approximately $10,380,000 for the year ended December 31, 2022. History The company was formerly known as Adamis Pharmaceuticals Corporation and changed its name to DMK Pharmaceuticals Corporation in September 2023.