ADMP Adamis Pharmaceuticals Corporation

1.04
+0.01  (+0%)
Previous Close 1.04
Open 1.02
52 Week Low 0.3755
52 Week High 2.34
Market Cap $155,586,017
Shares 148,886,141
Float 148,035,493
Enterprise Value $153,355,844
Volume 438,146
Av. Daily Volume 3,470,570
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Upcoming Catalysts

Drug Stage Catalyst Date
ZIMHI (naloxone HCI Injection)
Opioid overdose
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
Tempol
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 trial initiated dosing September 2, 2021.
APC-1000
Asthma/COPD
Phase 2
Phase 2
Phase 3 development on hold - noted May 9, 2019.
APC-8000 (sublingual tadalafil)
Erectile dysfunction
NDA Filing
NDA Filing
Refusal to file letter received February 26, 2019.
Symjepi - low dose
Anaphylaxis
Approved
Approved
FDA Approval announced September 27, 2018.
Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
Approved
Approved
CRL issued March 27 2015. CRL issued again June 6, 2016. Approval announced June 15, 2017 following third submission.

Latest News

  1. SAN DIEGO, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the initiation of patient dosing in the Phase 2/3 clinical trial for Tempol, an oral antiviral product candidate, in adult patients with confirmed COVID-19 infection. In preclinical studies, Tempol has been shown to have antiviral, anti-inflammatory and antioxidant activity. The trial is designed to enroll 248 patients.

    Shyam Kottilil, MBBS, Ph.D., Professor of Medicine at the University of Maryland School of Medicine (UMSOM), Chief of the Division of Clinical Care and Research at UMSOM's Institute of Human Virology, and Principal Investigator for the trial, commented: "The timing for this trial could not be more important as the…

    SAN DIEGO, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced the initiation of patient dosing in the Phase 2/3 clinical trial for Tempol, an oral antiviral product candidate, in adult patients with confirmed COVID-19 infection. In preclinical studies, Tempol has been shown to have antiviral, anti-inflammatory and antioxidant activity. The trial is designed to enroll 248 patients.

    Shyam Kottilil, MBBS, Ph.D., Professor of Medicine at the University of Maryland School of Medicine (UMSOM), Chief of the Division of Clinical Care and Research at UMSOM's Institute of Human Virology, and Principal Investigator for the trial, commented: "The timing for this trial could not be more important as the delta variant spreads and breakthrough infections in vaccinated individuals occur in the U.S. and worldwide. Tempol as an oral antiviral and anti-inflammatory may be an important countermeasure if proven safe and effective in this trial."

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented: "We are pleased to begin patient dosing in this Phase 2/3 clinical trial for Tempol, which has demonstrated highly encouraging preclinical data in several disease models of infection and inflammation. Worldwide appearance of new variants with increased transmissibility and resistance necessitates the development of new therapeutic agents. The data from Israel should be a wake-up call to the U.S. and the rest of the world. Israel has among the highest levels of vaccination for COVID-19, yet the country is now showing one of the world's highest infection rates (breakthrough). Currently, in Israel, the majority of the hospitalized patients are fully gene vaccinated. If approved, Tempol may not only prove to be a very important drug for the treatment of COVID-19, but it may also play a role in curbing the pandemic."

    Recently, the National Institutes of Health (NIH) highlighted Tempol as a potential home treatment for COVID-19 (NIH Study) The NIH news stated that, "This treatment would likely prevent severe disease." Recent studies conducted by NIH researchers suggested that Tempol had potent antiviral activity against the virus that causes COVID-19 in laboratory studies. The NIH news article further describes how Tempol could possibly reduce COVID-19 symptoms by calming inflammation, protecting organs from damage, and decreasing the clumping of platelets.

    The Company recently announced (Stanford Study) the results of a published study in collaboration with Stanford University researchers suggesting that Tempol has strong, broad in-vitro anti-cytokine activity. Suppression of inflammatory cytokines with an antioxidant may be a beneficial treatment strategy in early COVID-19 infection.

    About the Phase 2/3 Clinical Trial

    This Phase 2/3 adaptive, randomized, double-blind, placebo-controlled clinical trial is designed to enroll approximately 248 high risk unvaccinated subjects with early COVID-19 infection age 18 years of age and older. The primary endpoint is the rate of hospitalization for patients receiving Tempol, versus those receiving placebo. Eligible subjects with positive COVID-19 infection within five days of study entry plus at least one co-morbidity will be randomized 1:1 to receive either Tempol or placebo. Co-morbidities include hypertension, diabetes, obesity, cancer, chronic renal disease, and immunodeficiency, and in the opinion of the investigator, the co-morbidity is not acutely life threatening. Patients randomized to Tempol (n=124), will receive 800mg daily in two divided doses of 400mg for up to 21 days. Similarly, placebo capsules will be administered twice daily to subjects in the placebo group (n=124) for up to 21 days.

    As part of the initial Phase 2 portion of the study, 50 COVID positive subjects will be enrolled and randomized 1:1 to receive either Tempol or placebo. An interim analysis by the data and safety monitoring board (DSMB) will examine safety and markers of systemic inflammation during a Stage 1 interim analysis. Based on the DSMB analysis, the Phase 3 portion of the trial designed to enroll 198 patients may begin, with a second interim analysis planned after enrollment of 124 patients. A thorough safety assessment will be conducted, and all treatment related adverse events will be recorded, evaluated and compared for the treated and placebo groups.

    Adults who are interested in joining this study can visit https://earlycovidstudy.com/.

    Adamis licensed exclusive worldwide rights under patents, patent applications and related know-how relating to Tempol for certain licensed fields including the treatment of respiratory diseases including asthma, respiratory syncytial virus infection, influenza and COVID-19.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company's SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company's resubmitted New Drug Applications (NDA) for its naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose, is currently under FDA review. Tempol is in development for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma, and COPD. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the opinions and beliefs of NIH researchers summarized in the NIH article discussed in this press release concerning the potential of Tempol as a treatment for COVID-19 and the results of previous studies of Tempol; the Company's beliefs concerning the safety and effectiveness of Tempol or the Company's other product candidates; the timing, progress or results of the Company's Phase 2/3 clinical trial for Tempol or other studies or trials relating to Tempol; funding for clinical trials relating to Tempol and the Company's ability to receive any government funding relating to clinical development, studies or trials relating to Tempol; the Company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the Company's beliefs concerning the benefits, enforceability, and extent of intellectual property rights and protection afforded by patents and patent applications that it owns or has licensed; and other statements concerning the Company's future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis' actual results to be materially different from the results anticipated by such forward-looking statements. There can be no assurances regarding the timing, progress or outcome of trials or studies relating to Tempol, or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. There are no assurances that the Company will receive any government funding relating to clinical investigations, development or trials relating to Tempol or concerning the timing, amount of, or terms and conditions relating to, any such governmental funding that might be received. In addition, as previously disclosed, each of the Company and its US Compounding Inc. subsidiary has received a subpoena from the U.S. Attorney's Office for the Southern District of New York issued in connection with a criminal investigation. Accordingly, all forward-looking statements are subject to the outcome of this investigation and any related governmental investigations or proceedings, as well as the related internal investigation being conducted by the Company's Audit Committee. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020 and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.

    Contact:

    Adamis Investor Relations

    Robert Uhl

    Managing Director

    Westwicke ICR

    619.228.5886

    robert.uhl@westwicke.com



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  2. SAN DIEGO, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that David C. Benedicto, who has been serving as the Company's Chief Accounting Officer, will succeed Robert O. Hopkins as Chief Financial Officer, effective immediately. Mr. Hopkins is departing to pursue new opportunities after serving the Company for the past 14 years. Management has established a comprehensive transition plan to maintain full continuity across all finance functions as Mr. Hopkins departs.

    Dr. Dennis J. Carlo, Chief Executive Officer of Adamis, commented: "David has been an important member of our finance team since he joined Adamis nearly seven years ago. In addition to possessing strong experience in the biotechnology…

    SAN DIEGO, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that David C. Benedicto, who has been serving as the Company's Chief Accounting Officer, will succeed Robert O. Hopkins as Chief Financial Officer, effective immediately. Mr. Hopkins is departing to pursue new opportunities after serving the Company for the past 14 years. Management has established a comprehensive transition plan to maintain full continuity across all finance functions as Mr. Hopkins departs.

    Dr. Dennis J. Carlo, Chief Executive Officer of Adamis, commented: "David has been an important member of our finance team since he joined Adamis nearly seven years ago. In addition to possessing strong experience in the biotechnology and pharmaceutical sectors, he knows our assets and pipeline exceedingly well. Our leadership is confident that he is prepared to step into the Chief Financial Officer role and oversee all of the Company's finance functions. I also want to take the opportunity to thank Robert for his many years of partnership and service to Adamis. Most recently, he helped facilitate the sale of assets of our US Compounding, Inc. subsidiary. We wish Robert well as he pursues new opportunities."

    Mr. Benedicto has more than two decades of experience operating in finance roles at public and private companies. Since joining Adamis in late 2014, he has served as Controller and then as Chief Accounting Officer. He previously held a senior accounting manager role at Trius Therapeutics, Inc. prior to the business being acquired. He has also held controller positions and led finance functions at HERC Products, Inc. and BAE Systems Inc. Mr. Benedicto is a CPA and a CMA (Certified Management Accountant) and holds a bachelor's degree in Accounting from the University of Saint La Salle and a Master of Business Administration from the University of Redlands.     

    Deficiency Letter from Nasdaq

    The Company also announced that, as expected, on August 20, 2021, it received a standard notification letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC notifying the Company that, because the Company has not timely filed its Quarterly Report on Form 10-Q for the period ended June 30, 2021, as well as its 10-Q for the period ended March 31, 2021, the Company does not comply with Nasdaq Marketplace Rule 5250(c)(1), which requires timely filing of periodic reports with the Securities and Exchange Commission. In response to a previous notification letter from Nasdaq relating to the Form 10-Q for the period ended March 31, 2021, the Company has previously submitted to Nasdaq a plan to regain compliance. In connection with its review of the plan, Nasdaq has requested that the Company submit an updated plan to regain compliance. The letter indicated that if Nasdaq accepts the plan, Nasdaq may grant an exception of up to November 22, 2021, to regain compliance. If an exception is granted, the Company may regain compliance at any time during the permitted period upon filing the Form 10-Qs with the SEC, as well as any other required periodic reports that are due within that period. If Nasdaq does not accept the Company's plan, the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel. The Notice was issued in accordance with standard Nasdaq procedures and has no immediate effect on the listing of the Company's common stock on the Nasdaq Capital Market.

    Adamis will provide additional information related to the promotion of Mr. Benedicto, the separation of Mr. Hopkins and the NASDAQ deficiency letter in a Form 8-K to be filed with the SEC.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company's SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company's resubmitted New Drug Application (NDA) for its naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose is currently under FDA review. Adamis is developing additional product candidates, including treatments for acute respiratory diseases, such as COVID-19, and radiation dermatitis. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com.

    Forward Looking Statements

    In addition to historical information, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the Company's beliefs concerning matters relating to the transition of activities and responsibilities following the appointment of a new chief financial officer; the expected timing for the filing of the Company's Quarterly Reports on Form 10-Q and our ability to regain compliance with the Nasdaq continued listing standards; the Company's beliefs concerning the safety and effectiveness of its products and product candidates; the Company's ability to successfully commercialize the products and product candidates described in this press release, itself or through commercialization partners, and the Company's beliefs concerning its product development activities; and other statements concerning our future operations, activities and financial results. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including those related to whether Nasdaq will accept our plan to regain compliance, our ability to file the Form 10-Qs before the time period specified in the Notice and our ability to regain compliance with the Nasdaq continued listing standards. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis' actual results to be materially different from the results anticipated by such forward-looking statements. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020 and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.

    Contacts

    Investor Relations

    Robert Uhl

    Managing Director

    Westwicke ICR

    619.228.5886

    robert.uhl@westwicke.com



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  3. Tempol: A potential home treatment for COVID-19 (https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19). Trial to begin shortly.

    SAN DIEGO, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced a publication in the peer reviewed journal, Clinical Immunology, entitled "Tempol, a novel antioxidant, inhibits both activated T cell and APC (Antigen Presenting Cell) derived cytokines in-vitro from COVID-19 patients" (https://www.sciencedirect.com/journal/clinical-immunology/articles-in-press). The studies conducted at the Human Immune Monitoring Center at Stanford University investigated the effects of Tempol, an investigational drug, on immune cells from COVID-19 patients…

    Tempol: A potential home treatment for COVID-19 (https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19). Trial to begin shortly.

    SAN DIEGO, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced a publication in the peer reviewed journal, Clinical Immunology, entitled "Tempol, a novel antioxidant, inhibits both activated T cell and APC (Antigen Presenting Cell) derived cytokines in-vitro from COVID-19 patients" (https://www.sciencedirect.com/journal/clinical-immunology/articles-in-press). The studies conducted at the Human Immune Monitoring Center at Stanford University investigated the effects of Tempol, an investigational drug, on immune cells from COVID-19 patients. The authors conclude "Preincubation of immune cells with Tempol resulted in a significant (P<0.05) decrease in multiple T cell and APC-derived cytokines from both cells of COVID-19 and uninfected donors. These results suggest that Tempol has strong in-vitro anti-cytokine activity and supports additional studies examining the use of Tempol for the treatment of COVID-19."

    Dr. Holden Maecker, Director of the Human Monitoring Center at Stanford University commented: "These results suggest that Tempol has strong, broad in-vitro anti-cytokine activity. Suppression of inflammatory cytokines with an antioxidant may be a beneficial strategy in early COVID-19 infection."

    Inflammatory cytokines and reactive oxygent species (ROS such as O*2 -) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm) and lung inflammation. In additon, Tempol works as an antixodant and has demonstrated decreasing harmful ROS. In addition, Tempol has been shown to decrease platelet aggregration, a problem observed in many COVID-19 patients.

    Recently, the National Institutes of Health (NIH) highlighted Tempol as a potential home treatment for COVID-19 (https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19). The NIH news stated that, "This treatment would likely prevent severe disease." Recent studies conducted by NIH researchers suggested that Tempol has potent antiviral activity against the virus that causes COVID-19 in laboratory studies. The NIH news article further describes how Tempol could possibly reduce COVID-19 symptoms by calming inflammation, protecting organs from damage, and decreasing the clumping of platelets. The U.S. Food & Drug Administration has given the go-ahead to Adamis Pharmaceuticals to conduct a clinical study using Tempol as an at home treatment to prevent disease progression and thereby releasing the burden of COVID-19 on the healthcare system. Adamis plans to initiate a randomized placebo-controlled study shortly.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented: "Tempol's significant activities, such as decreasing inflammation in the lungs, protecting organs such as the heart from damage, inhibiting blood clotting and lowering viral burden, all make it an ideal candidate for the home treatment of COVID-19. Tempol is safe and it does not come with the side effects or adverse events associated with gene vaccination. In addition, its mechanism of action lends it to having activity independent of any new COVID-19 variants. Even though Israel is the model country for almost everyone being vaccinated, there are significant increases in breakthroughs and hospitalizations occurring in vaccinated individuals. Tempol may very well be in a unique position and may prove to be a very important "medical tool" in the treatment of COVID-19. In addition to COVID-19, Tempol might very well be used to treat other viral respiratory infections including influenza and respiratory syncytial virus."

    Adamis has previously licensed exclusive worldwide rights under patents, patent applications and related know-how to use Tempol for the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company's SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company's resubmitted New Drug Application (NDA) for its naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose. is currently under FDA review. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma, and COPD. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the opinions and beliefs of NIH researchers summarized in the NIH article discussed in this press release concerning the potential of Tempol as a treatment for COVID-19 and the results of previous studies of Tempol; the Company's beliefs concerning the safety and effectiveness of Tempol or the Company's other product candidates; the timing, progress or results of the Company's Phase 2/3 clinical trial for Tempol or other studies or trials relating to Tempol; funding for clinical trials relating to Tempol and the Company's ability to receive any government funding relating to clinical development, studies or trials relating to Tempol; the Company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the Company's beliefs concerning the benefits, enforceability, and extent of intellectual property rights and protection afforded by patents and patent applications that it owns or has licensed; and other statements concerning the Company's future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis' actual results to be materially different from the results anticipated by such forward-looking statements. There can be no assurances regarding the timing, progress or outcome of trials or studies relating to Tempol, or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. There are no assurances that the Company will receive any government funding relating to clinical investigations, development or trials relating to Tempol or concerning the timing, amount of, or terms and conditions relating to, any such governmental funding that might be received. In addition, as previously disclosed, each of the Company and its US Compounding Inc. subsidiary has received a subpoena from the U.S. Attorney's Office for the Southern District of New York issued in connection with a criminal investigation. Accordingly, all forward-looking statements are subject to the outcome of this investigation and any related governmental investigations or proceedings, as well as the related internal investigation being conducted by the Company's Audit Committee. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020 and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.

    Contact:

    Adamis Investor Relations

    Robert Uhl

    Managing Director

    Westwicke ICR

    619.228.5886

    robert.uhl@westwicke.com

     



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  4. SAN DIEGO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today highlighted that the NIH has identified Tempol as a potential home treatment for COVID-19 (TEMPOL: A Potential Home Treatment for COVID-19 | NIH COVID-19 Research). The NIH news stated that, "This treatment would likely prevent severe disease." The article went on to describe how Tempol could reduce COVID-19 symptoms by calming inflammation, protecting organs from damage, and decreasing the clumping of platelets. The U.S. Food & Drug Administration (FDA) has given the go-ahead to Adamis Pharmaceuticals to conduct a clinical study using Tempol as an at home treatment to prevent disease progression and thereby releasing the burden of COVID-19…

    SAN DIEGO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today highlighted that the NIH has identified Tempol as a potential home treatment for COVID-19 (TEMPOL: A Potential Home Treatment for COVID-19 | NIH COVID-19 Research). The NIH news stated that, "This treatment would likely prevent severe disease." The article went on to describe how Tempol could reduce COVID-19 symptoms by calming inflammation, protecting organs from damage, and decreasing the clumping of platelets. The U.S. Food & Drug Administration (FDA) has given the go-ahead to Adamis Pharmaceuticals to conduct a clinical study using Tempol as an at home treatment to prevent disease progression and thereby releasing the burden of COVID-19 on the healthcare system. Adamis plans to initiate the study shortly.

    Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented: "Tempol's multiple activities, including antioxidant, anti-inflammatory, and antiviral, suggest that Tempol could be an ideal treatment for COVID-19. It would eliminate the concerns regarding the introduction of new variants. As new variants arise and vaccines become less effective, Tempol's antiviral and anti-inflammatory effects are independent of the evolving virus. Furthermore, the oral delivery of the drug may be an ideal outpatient treatment, preventing increased healthcare utilization. Tempol's mode of action makes it an ideal candidate to treat not only COVID-19, but many other types of viral respiratory infections, including influenza and respiratory syncytial virus."

    Adamis has previously licensed exclusive worldwide rights under patents, patent applications and related know-how to use Tempol for the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company's SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company's resubmitted New Drug Application (NDA) for its Adamis' naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose, is currently under FDA review. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma, and COPD. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the opinions and beliefs of NIH researchers summarized in the NIH article discussed in this press release concerning the potential of Tempol as a treatment for COVID-19 and the results of previous studies of Tempol; the Company's beliefs concerning the safety and effectiveness of Tempol or the Company's other product candidates; the timing, progress or results of the Company's Phase 2/3 clinical trial for Tempol or other studies or trials relating to Tempol; funding for clinical trials relating to Tempol and the Company's ability to receive any government funding relating to clinical development, studies or trials relating to Tempol; the Company's ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the Company's beliefs concerning the benefits, enforceability, and extent of intellectual property rights and protection afforded by patents and patent applications that it owns or has licensed; and other statements concerning the Company's future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis' actual results to be materially different from the results anticipated by such forward-looking statements. There can be no assurances regarding the timing, progress or outcome of trials or studies relating to Tempol, or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. There are no assurances that the Company will receive any government funding relating to clinical investigations, development or trials relating to Tempol or concerning the timing, amount of, or terms and conditions relating to, any such governmental funding that might be received. In addition, as previously disclosed, each of the Company and its US Compounding Inc. subsidiary has received a subpoena from the U.S. Attorney's Office for the Southern District of New York issued in connection with a criminal investigation. Accordingly, all forward-looking statements are subject to the outcome of this investigation and any related governmental investigations or proceedings, as well as the related internal investigation being conducted by the Company's Audit Committee. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020 and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.

    Contact:

    Adamis Investor Relations

    Robert Uhl

    Managing Director

    Westwicke ICR

    619.228.5886

    robert.uhl@westwicke.com



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  5. SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that it has entered into a definitive agreement to sell a significant portion of the assets of its subsidiary, US Compounding Inc. (USC), related to USC's human compounding pharmaceutical business and customers, in exchange for total gross consideration estimated to be up to $15 million before transaction fees and expenses. The consideration will be paid by the buyer to Adamis in monthly installments over the course of approximately 12 months based on a multiple of gross revenue generated by the assets during the measurement period.

    The transaction aligns with Adamis' stated goal of focusing its efforts on the development of its prescription…

    SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that it has entered into a definitive agreement to sell a significant portion of the assets of its subsidiary, US Compounding Inc. (USC), related to USC's human compounding pharmaceutical business and customers, in exchange for total gross consideration estimated to be up to $15 million before transaction fees and expenses. The consideration will be paid by the buyer to Adamis in monthly installments over the course of approximately 12 months based on a multiple of gross revenue generated by the assets during the measurement period.

    The transaction aligns with Adamis' stated goal of focusing its efforts on the development of its prescription pharmaceutical pipeline. Adamis expects to use the proceeds from the sale for general corporate purposes and to fund ongoing development of its pipeline.

    Further details related to the transaction and related matters will be contained in a report on Form 8-K to be filed by the Company within four business days of the effective date of the agreement.

    About Adamis Pharmaceuticals

    Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company's SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis' naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose, is currently under FDA review. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, and radiation dermatitis. The company's subsidiary, USC, compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use by hospitals, clinics, surgery centers, and vet clinics throughout most of the United States. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com.

       

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results, including, but not limited to, the following statements: the consideration expected to be generated as a result of the sale of USC assets; the Company's ability to develop and commercialize the product candidates described in this press release, itself or through development and/or commercialization partners; the potential of the Company's prescription pharmaceutical pipeline, including the Company's ability to develop such pipeline; and other statements concerning our future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis' actual results to be materially different from the results anticipated by such forward-looking statements. In addition, as previously disclosed, each of the Company and USC has received a subpoena from the U.S. Attorney's Office for the Southern District of New York issued in connection with a criminal investigation. Accordingly, all forward-looking statements are subject to the outcome of this investigation, as well as the related investigation being conducted by the Company's Audit Committee. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K for the year ended December 31, 2020 and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's website at http://www.sec.gov.

    Contact:

    Adamis Investor Relations

    Robert Uhl

    Managing Director

    Westwicke ICR

    619.228.5886

    robert.uhl@westwicke.com



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