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Altimmune, Inc. (ALT)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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12.89+0.59 (+4.76%)
As of 2:39PM EDT. Market open.
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Previous close12.30
Open12.17
Bid12.51 x 800
Ask12.55 x 800
Day's range11.90 - 12.92
52-week range1.51 - 35.10
Volume944,420
Avg. volume3,894,920
Market cap424.069M
Beta (5Y monthly)1.42
PE ratio (TTM)N/A
EPS (TTM)-2.27
Earnings date11-Nov-2020 - 16-Nov-2020
Forward dividend & yieldN/A (N/A)
Ex-dividend date20-Jan-2017
1y target est49.00
  • GlobeNewswire

    Altimmune Presents Highlights of Intranasal COVID-19 Vaccine and Therapeutic Programs – AdCOVID™ and T-COVID™ – at the World Vaccine Congress

    GAITHERSBURG, Md., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that Scot Roberts, Ph.D., Chief Scientific Officer of Altimmune, Inc., presented an overview of the Company’s AdCOVID and T-COVID intranasal vaccine and therapeutic candidates during a special COVID-19 virtual session of the World Vaccine Congress Washington, taking place September 28 – October 1, 2020. A link to Dr. Roberts’ presentation is available on Altimmune’s website at www.altimmune.com. The presentation can be accessed under the ‘Investors’ section of the website under ‘Events and Presentations.’The World Vaccine Congress Washington 2020 brings together global leaders from industry, academia and public health to advance the development of vaccine technologies. This year’s conference features a special COVID-19 segment dedicated to expanding knowledge to facilitate the rapid development of vaccines to address the global COVID-19 pandemic.About AdCOVIDAdCOVID is a single-dose intranasal vaccine candidate for COVID-19 designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA, resident memory T cells) in the nasal cavity and respiratory tract.AdCOVID is designed to offer several important advantages over other vaccine approaches, including single-dose intranasal administration; a broad immune response that includes mucosal immunity, a durable immune response of a year or more, and the ability to ship and store the vaccine conveniently and inexpensively.By utilizing the Company’s proprietary intranasal vaccine technology, AdCOVID has the potential to activate multiple arms of the immune system as shown in recent preclinical studies where potent serum neutralizing antibody and T cell responses were induced in addition to a robust induction in mucosal immunity against the spike protein of the virus. Importantly, the mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both are believed to be important in fighting infection.Because intranasal dosing can stimulate local mucosal immunity, AdCOVID is expected to guard the respiratory tract from viral invasion and provide downstream protection against viral spread. Local mucosal immunity may be essential for creating sterilizing immunity that eliminates the last traces of viral infection in the nasal cavity. Recent studies have shown that in the absence of mucosal immunity, the nasal cavity may become a reservoir for the coronavirus, potentially prolonging infection while allowing for disease transmission. Importantly, nasal mucosal immunity can only be achieved by administering a vaccine intranasally.AdCOVID also provides an easier route of administration than an injection eliminating the need for administration by trained medical personnel and may even allow for self-administration. Finally, based on data from Altimmune’s other platform vaccines (NasoVAX™ and NasoShield™) AdCOVID is expected to have extended stability at room temperature allowing for cold chain-free distribution of the vaccine where it can then be stored in the common refrigerators found in community-based doctor’s offices and pharmacies for two years or more. The simple and convenient handling requirements may greatly increase the number of people willing to take the vaccine.Altimmune anticipates submitting an IND with the U.S. Food and Drug Administration and commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020.About T-COVIDT-COVID is a therapeutic candidate based on the same vaccine platform technology supporting Altimmune’s intranasal vaccine candidates, but it works through the mechanism of immune modulation.In preclinical animal studies, T-COVID modulated the innate immune response to decrease lung inflammation and significantly lower concentrations of inflammatory cytokines in response to respiratory virus infection. Excessive production of inflammatory cytokines has been associated with lung pathology and death in COVID-19.T-COVID is administered as a single intranasal dose and has the potential to be self-administered. Unlike the majority of therapeutic interventions for COVID-19, T-COVID is focused on non-hospitalized patients prior to the development of pulmonary dysfunction or the need for hospitalization. In this way T-COVID is used to prevent more severe disease instead of attempting to reverse it. Early intervention with T-COVID is expected to modulate the innate immune response to infection, blocking the progression to severe disease. T-COVID has a demonstrated stability profile that may allow for cold chain-free distribution and common refrigerator storage in community-based doctor’s offices and pharmacies for two years or more.T-COVID is currently being evaluated in a Phase 1/2 clinical study called the ‘EPIC’ trial (Efficacy and Safety of T-COVID in the Prevention of Clinical Worsening in COVID-19). EPIC is expected to enroll approximately 100 patients and will evaluate the potential protective effects of T-COVID to prevent clinical worsening in patients with early COVID-19. About AltimmuneAltimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. The Company’s diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell). For more information on Altimmune, please visit www.altimmune.com.Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, statements regarding the impact of COVID-19 on our business operations, clinical trials and results of operations, the timing of key milestones for our clinical assets, the development of our AdCOVID vaccine product candidate, submitting an IND with the U.S. Food and Drug Administration and commencing of a Phase 1 clinical study in Q4 2020 for AdCOVID, the development of our T-COVID therapeutic candidate and enrollment of patients in our EPIC trial, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in clinical trial enrollment, regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated, or at all; the Company’s ability to obtain additional patents or extend existing patents on the timelines anticipated, or at all; the Company’s ability to identify and consummate potential future strategic partnerships; and the Company’s ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Company’s ability to commercialize its products. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, which are available at www.sec.gov.Investor Contacts:  Will BrownAshley R. Robinson Chief Financial Officer LifeSci Advisors, LLC Phone: 240-654-1450617-430-7577 wbrown@altimmune.comarr@lifesciadvisors.com    Media Contact:  Warren Rizzi  Sard Verbinnen & Co.  Phone: 212-687-8080  altimmune-svc@sardverb.com

  • GlobeNewswire

    Altimmune Announces Successful Completion of Multiple Dose Toxicity and Toxicokinetic Studies of ALT-801, a GLP-1/Glucagon Dual Receptor Agonist for the Treatment of NASH

    Company anticipates first-in-human trials to start in Q4 2020GAITHERSBURG, Md., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of multiple dose toxicity and toxicokinetic studies of ALT-801, a GLP-1/glucagon dual receptor agonist for the treatment of NASH. The IND enabling studies were conducted in rats and cynomolgus monkeys. The Company believes the data provide clear validation of previously observed pharmacodynamic effects of the compound and pave the way for the anticipated Phase 1 single (SAD) and multiple ascending dose (MAD) clinical trials to start in Q4 2020, following the submission of a clinical trial application in Australia. ALT-801 was well tolerated in both rats and cynomolgus monkeys and the no-observed-adverse-effect levels (NOAEL) in both species were at the highest doses tested. The most remarkable finding was significant weight loss versus the control groups in both species, which is an expected and desired property of ALT-801. Importantly, no evidence of significant GI toxicity or intolerability, including vomiting, was observed in the animals. GLP-1 receptor agonists and dual agonists that are approved or in clinical development have been associated with significant levels of nausea and vomiting and have typically required the use of dose-titration over several months. The observations from the recently completed toxicology studies suggest that ALT-801 can be expected to be well tolerated in humans and not require dose titration, potentially enabling higher levels of weight loss and liver fat reduction than existing GLP-1 receptor agonist based compounds.The nonhuman primate data also showed an ALT-801 pharmacokinetic profile that is expected to support weekly dosing in humans. The Company believes that the proprietary EuPort™ modification on ALT-801 not only provides the longer half-life necessary for weekly dosing but also slows the rate of absorption of the compound into the bloodstream to avoid the tolerability issues typically associated with this class of agents. Based upon the successful completion of these preclinical toxicology studies, Altimmune plans to initiate first-in-human studies of ALT-801 in Q4 2020, with data readouts on safety, pharmacokinetics, and important measures of activity such as weight loss and liver fat reduction in the Spring of 2021.“Currently there are no approved treatments for NASH, and disease prevalence is growing worldwide as a consequence of an expanding obesity epidemic. These data are right in line with our expectation for ALT-801 and provide additional confidence as we look forward to initiating the first-in-human studies later this year,” said Dr. Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. Dr. Garg continued, “In addition to our significant efforts to develop a vaccine and a treatment for COVID-19, we are pleased to continue the development of other therapeutic candidates of importance to public health across our product portfolio.”About ALT-801 ALT-801 is a potent, peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon (GCGR) receptors. ALT-801 is designed to treat the underlying metabolic dysfunction that leads to NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD). NASH is considered by many to be the liver manifestation of metabolic syndrome and is characterized by abnormal accumulation of fat in the liver, toxic lipid metabolites, inflammation and liver cell damage leading to fibrosis/cirrhosis and liver cancer.ALT-801 activates both the GLP-1 and the glucagon receptors, resulting in appetite suppression, decreased insulin insensitivity, increased energy expenditure, and substantial decreases in both liver and body fat in relevant animal models. ALT-801 has a similar mechanism of action to the body’s natural dual-acting hormone, oxyntomodulin, which lowers food intake, stimulates energy expenditure and reduces body weight. ALT-801 is designed to achieve glycemic control comparable to or better than the approved GLP-1 agonists but with more robust weight loss with once-weekly subcutaneous dosing.ALT-801 demonstrated better outcome measures in comparison to semaglutide (an approved GLP-1 receptor agonist) in the Gubra/Amylin biopsy-proven, diet-induced mouse model of NASH. During a 12-week study, treatment with ALT-801 rapidly returned body weight to the range of lean normal animals. Histology revealed a near complete absence of liver steatosis, lobular inflammation and ballooning, as well as a significant reduction of fibrosis. Semaglutide showed only a modest body weight loss and a mild decrease in hepatosteatosis. ALT-801 also resulted in greater suppression of genes involved in de novo lipogenesis and fatty acid uptake, inflammation, hepatocellular death, and fibrosis.About Altimmune Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation and timing of the ALT-801 Phase 1 clinical trial in Q4 2020, its enrollment and the timing of the data readout expected in the spring of 2021, our ability to manufacture ALT-801, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to secure regulatory approval for its ALT-801 investigational new drug application submission to the U.S. Food and Drug Administration, the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.Investor Contacts:                                Will Brown Chief Financial Officer Phone: 240-654-1450 wbrown@altimmune.com Ashley R. Robinson Managing Director LifeSci Advisors Phone: 617-430-7577 arr@lifesciadvisors.com     Media Contact: Warren Rizzi   Sard Verbinnen & Co. Phone: 212-687-8080  altimmune-svc@sardverb.com

  • GlobeNewswire

    Altimmune Announces Data Presentation on ALT-801, its Balanced and Long-Acting GLP-1/Glucagon Receptor Dual Agonist for NASH, at the Digital International Liver Congress™ 2020

    GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced a preclinical data presentation on ALT-801, its balanced and long-acting GLP-1/glucagon receptor dual agonist under development for NASH, at the Digital International Liver Congress™ 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL), to be held virtually from August 27, 2020 to August 29, 2020. “We are excited to share the compelling preclinical body of work on the weight loss, NASH improvement and gene regulatory signatures induced by ALT-801 at EASL as we prepare to commence our first in human Phase 1 trial next quarter,” said M. Scott Harris, M.D., Chief Medical Officer of Altimmune. Dr. Harris continued, “As the Gubra mouse model has historically translated well into human studies, we believe that the data from this study will position ALT-801 as a promising candidate for NASH.”Employing the well-established Gubra mouse model, animals with biopsy-confirmed NASH received ALT-801 (5 or 10 nmol/kg), semaglutide (10 nmol/kg), a GLP-1 receptor agonist or vehicle subcutaneously for 12 weeks. ALT-801 demonstrated statistically superior reductions (p ≤ 0.05) in body weight, liver weight, plasma ALT, liver triglycerides and cholesterol, plasma cholesterol, NAFLD activity scores, and fibrosis markers compared to semaglutide. Principal component analysis differentially clustered genes regulated by ALT-801 from those regulated by semaglutide, consistent with a unique gene regulatory signature associated with glucagon receptor activation. ALT-801 also resulted in greater suppression of archetypal genes involved in de novo lipogenesis and fatty acid uptake, inflammation, hepatocellular death, fibrosis and stellate cell activation than semaglutide.The Phase 1 trial will be conducted in Australia and will evaluate the safety, pharmacokinetics and activity of ALT-801 over 6 weeks treatment in overweight and obese volunteers. The readout from this study, which will include validation of the compound’s weight loss and liver fat-reducing effects observed in preclinical studies, is expected in the spring of 2021.Details for the poster presentation are as follows:Title:     GLP-1/Glucagon Dual Receptor Agonist ALT-801 is Superior to Semaglutide in Improving NASH Endpoints in a Biopsy-Confirmed DIO Mouse Model (FRI-117)    Presenter:     M. Scott Harris M.D., Chief Medical Officer of Altimmune. Inc.               Date/Time:     August 28, 2020 at 8:30 to 18:30 GMT  A copy of the poster will be accessible on the Events section of the Altimmune website.About ALT-801 ALT-801 is a novel peptide-based dual GLP-1/glucagon receptor agonist that is designed to treat the obesity and metabolic dysfunction that causes non-alcoholic steatohepatitis, or NASH. NASH, the most severe form of non-alcoholic fatty liver disease, or NAFLD, involves multiple metabolic pathways leading to the abnormal accumulation of liver fat, toxic lipid metabolites, and inflammation, leading to fibrosis or eventually liver cancer. We believe the treatment of obesity is the cornerstone of treating NASH and the principal morbidities of NASH. As observed in a well-established preclinical model of the disease, ALT-801 was capable of inducing significant weight loss with concomitant decreases in liver fat, inflammation and fibrosis.About Altimmune Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation and timing of the ALT-801 Phase 1 clinical trial in Q4 2020, the timing of the date readout expected in the spring of 2021, our ability to manufacture ALT-801, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to secure regulatory approval for its ALT-801 investigational new drug application submission to the U.S. Food and Drug Administration, the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.Investor Contacts:  Will BrownAshley R. Robinson Chief Financial OfficerLifeSci Advisors, LLC Phone: 240-654-1450617-430-7577 wbrown@altimmune.comarr@lifesciadvisors.com    Media Contact:  Warren Rizzi  Sard Verbinnen & Co.  Phone: 212-687-8080  altimmune-svc@sardverb.com