ALT Altimmune Inc.

14.12
+0.1  (+1%)
Previous Close 14.02
Open 14.18
52 Week Low 1.51
52 Week High 35.1
Market Cap $464,715,082
Shares 32,911,833
Float 28,025,881
Enterprise Value $383,447,630
Volume 2,455,922
Av. Daily Volume 2,967,418
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Upcoming Catalysts

Drug Stage Catalyst Date
NASOSHIELD
Anthrax
Phase 1b
Phase 1b
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T-COVID
COVID-19
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
ALT-801
Non-alcoholic steatohepatitis (NASH)
Phase 1
Phase 1
Phase 1 trial to be initiated in 4Q 2020.
HepTCell
Hepatitis B
Phase 2
Phase 2
Phase 2 trial to be initiated in 4Q 2020.
Intranasal COVID-19 Vaccine
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 trial to commence 4Q 2020.
NasoVAX
Flu vaccine
Phase 2
Phase 2
Phase 2 additional data released March 19, 2019 noted all patients remained seroprotected.

Latest News

  1. GAITHERSBURG, 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…

    GAITHERSBURG, 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

     Ashley R. Robinson

    Managing Director LifeSci Advisors

    Phone: 617-430-7577

       
    Media Contact:

    Warren Rizzi  

    Sard Verbinnen & Co.

    Phone: 212-687-8080 

      
       

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  2. 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…

    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
      
    Media Contact: 
    Warren Rizzi 
    Sard Verbinnen & Co. 
    Phone: 212-687-8080 
     

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  3. GAITHERSBURG, Md., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced additional positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The studies were conducted as part of Altimmune's ongoing collaboration with the University of Alabama at Birmingham (UAB).

    The latest study showed potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice as early as 10 days following a single intranasal vaccination, with responses strongly biased toward CD8+ T cells. The mucosal T cell response in the respiratory tract is believed to be dependent on the intranasal route of administration and we believe…

    GAITHERSBURG, Md., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced additional positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The studies were conducted as part of Altimmune's ongoing collaboration with the University of Alabama at Birmingham (UAB).

    The latest study showed potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice as early as 10 days following a single intranasal vaccination, with responses strongly biased toward CD8+ T cells. The mucosal T cell response in the respiratory tract is believed to be dependent on the intranasal route of administration and we believe it has the potential to provide additional protection against COVID-19.  The induction of a mucosal T cell response in the lungs has not been shown, to date, with the intramuscularly administered COVID-19 vaccine candidates that are currently in the advanced stages of clinical development. Both CD4+ and CD8+ T cells displayed phenotypes consistent with the Th1 type immune response that is important for control of viral infections. CD8+ T cells, also known as killer T cells, can recognize and kill virally infected cells, and recent clinical reports in China and Europe have suggested the importance of T-cell responses in long-term protection from COVID-19.

    On July 13, the Company reported results from the initial studies at UAB that showed that AdCOVID stimulated a strong systemic neutralizing antibody response in addition to a 29-fold mucosal IgA antibody response against the spike protein in the respiratory tract. Additional data from CD-1 mice analyzed since the July 13 announcement showed mean serum neutralization titers 4-weeks after a single intranasal dose exceeded 1:400 in a foci reduction neutralization assay against wild-type SARS-CoV-2 virus. The Company is currently manufacturing AdCOVID for a Phase 1 safety and immunogenicity study expected to begin in Q4 2020.

    "The property that sets AdCOVID apart is that it has been shown preclinically to induce a potent T cell and IgA antibody response in the lungs, in addition to the systemic neutralizing antibody response induced by intramuscular vaccine candidates," said Dr. Frances Lund, Charles H. McCauley Professor and Chair, Department of Microbiology at UAB, and lead investigator for preclinical testing of the AdCOVID vaccine candidates. Dr. Lund added, "This local mucosal immune response is an important addition to the systemic immune response and has the potential to block infection and prevent transmission."  

    In addition to the potent immunogenicity results in mice after a single dose administration, AdCOVID is expected to confer additional practical benefits related to vaccine distribution and administration. Intranasal dosing provides AdCOVID with the potential to be administered rapidly and without the need for needles, syringes or trained healthcare personnel. In addition, AdCOVID's expected room temperature stability profile may allow for broad distribution of the vaccine without the need for expensive cold-chain logistics, such as refrigeration or freezing.

    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 AdCOVID Phase 1 clinical trial in Q4 2020, the potential immunization effects of AdCOVID, our ability to manufacture AdCOVID beginning this year, 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, enrollment, 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 AdCOVID 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; the Company's ability to secure manufacturing approval from its SARS-CoV-2 cell licensor 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
     
      
    Media Contact: 
    Warren Rizzi 
    Sard Verbinnen & Co. 
    Phone: 212-687-8080 
     



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  4. GAITHERSBURG, Md., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three and six months ended June 30, 2020 and provided a business update.

    "We are pleased with Altimmune's progress during 2020 as we have launched two new product candidates for COVID-19, progressed our NASH candidate toward clinical testing and forged strategic alliances with Vigene Biosciences and DynPort Vaccine Company" said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "With the support of our shareholders, we now have more than $200 million of cash and investments on hand to drive continued development of our product pipeline."

    Recent Highlights

    • Received

    GAITHERSBURG, Md., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three and six months ended June 30, 2020 and provided a business update.

    "We are pleased with Altimmune's progress during 2020 as we have launched two new product candidates for COVID-19, progressed our NASH candidate toward clinical testing and forged strategic alliances with Vigene Biosciences and DynPort Vaccine Company" said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "With the support of our shareholders, we now have more than $200 million of cash and investments on hand to drive continued development of our product pipeline."

    Recent Highlights

    • Received gross proceeds of $199.4 million from a public offering, warrant exercises and ATM sales since Q1 2020

      Since the first quarter, the Company has received $132.2 million in gross proceeds from a public offering of common stock and pre-funded warrants, $40.9 million from warrant exercises and $26.3 million in gross proceeds from ATM sales. The cash received will be used primarily for the development of AdCOVID and T-COVID, including scale up of manufacturing and advanced clinical trials; the continued development of ALT-801, a dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH), including the first-in-human trial later this year; and for capital expenditures and general working capital purposes.



    • Announced positive preclinical results for AdCOVID

      The Company announced positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The studies, which were conducted in collaboration with the University of Alabama at Birmingham (UAB), showed strong serum neutralizing activity and potent mucosal immunity in the respiratory tract. The induction of mucosal IgA antibody in the respiratory tract may be necessary to block both infection and transmission of the virus to prevent further spread of COVID-19. Based on these findings, the Company has initiated manufacturing of AdCOVID and plans to advance the vaccine candidate to a Phase 1 safety and immunogenicity study in Q4 of this year.



    • Announced manufacturing agreement with Vigene Biosciences for AdCOVID

      The Company announced that it has entered into an agreement with Vigene Biosciences to manufacture AdCOVID, the Company's single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization, specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, the Company plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.



    • Formed teaming agreement with DynPort Vaccine Company for AdCOVID

      The Company announced that it has entered into a teaming agreement with DynPort Vaccine Company (DVC), a General Dynamics Information Technology (GDIT) company, to coordinate U.S. Government funding efforts and, if successful, to provide program management, drug development activity integration, and regulatory support for AdCOVID.



    • Initiated T-COVID program and received $4.7 million award from the DoD to fund Phase 1/2 clinical trial

      The U.S. Food and Drug Administration (FDA) authorized the Company to proceed with a Phase 1/2 clinical trial of T-COVID, an investigational therapeutic agent for the treatment of early COVID-19. The EPIC Trial (Efficacy and Safety of T-COVID in the Prevention of Clinical Worsening in COVID-19) is being funded through a $4.7 million competitive award from the U.S. Army Medical Research & Development Command (USAMRDC) and Department of Defense (DoD) working in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium. Altimmune recently initiated multiple clinical sites across the United States and expects that enrollment will commence imminently.



    • Completed enrollment in Phase 1b clinical trial of NasoShield

      The Company completed enrollment in its Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. The NasoShield program is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA), with a total potential value of $133.7 million if all options in the contract (HHSO100201600008C) are exercised. At the conclusion of the Phase 1b NasoShield trial, BARDA will have the option of exercising the remaining contract options valued at approximately $105 million to enable Phase 2 development.



    • Advanced IND-enabling activities for ALT-801 GLP-1/glucagon dual receptor agonist for NASH

      The Company has successfully completed the in-life portion of the safety and toxicological assessment of ALT-801 and is manufacturing the clinical trial material for the first-in-human trial, expected to start in Q4 2020. The single and multiple ascending dose trial will be conducted in Australia and will evaluate the safety and activity of ALT-801 in overweight and obese volunteers. Data from that study, including validation of the compound's weight loss and liver fat-reducing effects, is expected to read out in the spring of 2021.



    • Received HepTcell IND clearance for Phase 2 trial

      The FDA cleared the Company's Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B (HBV). The Company is also filing CTAs in Canada and three European countries. Altimmune plans to initiate the multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.

    Financial Results for the Second Quarter Ended June 30, 2020

    • The Company had cash, cash equivalents and short-term investments of $80.3 million at June 30, 2020. Subsequent to the quarter ended June 30, 2020, the Company received approximately $136.2 million in net proceeds from the public offering of its common stock, warrant exercises, and ATM sales.
    • Revenue was $0.7 million for the quarter ended June 30, 2020 compared to $1.6 million in the prior year period. The change was primarily due to a decrease in billings under the Company's U.S. government contracts due to timing of manufacturing and clinical trials for the NasoShield program.
    • Research and development expenses were $16.5 million for the quarter ended June 30, 2020 compared to $2.9 million in the prior year period. The increase was primarily attributable to an increase in the contingent liability for stock-based milestone payments associated with the acquisition of ALT-801; development costs for IND-enabling preclinical studies for ALT-801; and development costs for the COVID-19 programs. These increases were partially offset by decreased spend on the NasoShield program.
    • General and administrative expenses were $2.5 million for the quarter ended June 30, 2020 compared to $2.2 million in the prior year period. The increase is attributable to higher employee compensation and legal costs.   
    • Income tax benefit was $1.6 million for the three months ended June 30, 2020, as compared to zero for the same period in 2019. The increase is attributable to the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act") passed on March 27, 2020 which made temporary changes regarding the utilization and carry back of net operating losses. The Company intends to file a tax refund claim with the Internal Revenue Service reflecting a partial refund of its 2016 tax liability by carrying back net operating losses arising during the three and six months ended June 30, 2020.
    • Net loss attributed to common stockholders for the quarter ended June 30, 2020 was $16.8 million, or $0.94 net loss per share, compared to $3.4 million in the prior year, or $0.26 net loss per share. The difference in net loss is primarily attributable to higher research and development expenses, lower revenue, offset by an increase in income tax benefit.
    Conference Call Information



    Altimmune will host a conference call to discuss the company's second quarter results and other business information.
    Date: Wednesday, August 12, 2020
    Time: 8:30 am Eastern Time
    Domestic: 877-423-9813
    International: 201-689-8573
    Conference ID: 13706947
    Webcast: http://public.viavid.com/index.php?id=140748

    Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company's website at www.altimmune.com. The company has used, and intends to continue to use, the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

    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, 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 and initiation of animal testing in Q2 2020 and a Phase 1 clinical study in Q4 2020 for AdCOVID, the initiation of a Phase 1 clinical study in Q4 2020 for ALT-801 and receipt of data from this clinical study in 2021, the initiation of a Phase 2 clinical trial for HepTcell in Q4 2020, 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, 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; funding delays, reductions in or elimination of U.S. government funding and/or non-renewal of expiring funding under the Company's agreement with Biomedical Advanced Research and Development Authority ("BARDA"), or the Company's contract with the National Institutes of Allergy and Infectious Diseases ("NIAID"); the Company's ability to satisfy certain technical milestones under the Company's contracts with BARDA and NIAID that would entitle the Company to receive additional funding over the period of the agreement; the receipt of future potential payments under government contracts or grants; 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 Brown                                                                             

    Chief Financial Officer                                                            

    Phone: 240-654-1450                                                              

                                                          

    Ashley R. Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Contact:

    Warren Rizzi  

    Sard Verbinnen & Co.

    Phone: 212-687-8080 

     
    ALTIMMUNE, INC.
    CONSOLIDATED BALANCE SHEETS
             
             
      June 30, 2020  December 31, 2019 
      (unaudited)     
    ASSETS        
    Current assets:        
    Cash and cash equivalents $64,741,921   $8,962,686  
    Restricted cash  34,174    34,174  
    Total cash, cash equivalents and restricted cash  64,776,095    8,996,860  
    Short-term investments  15,484,402    28,277,386  
    Accounts receivable  1,182,099    1,021,179  
    Tax refund receivable  5,506,946    629,096  
    Prepaid expenses and other current assets  1,020,876    470,228  
    Total current assets  87,970,418    39,394,749  
    Property and equipment, net  1,024,640    1,104,208  
    Right of use asset  662,074    698,321  
    Intangible assets, net  12,785,655    12,732,195  
    Other assets  100,980    128,547  
    Total assets $102,543,767   $54,058,020  
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities:        
    Accounts payable $195,217   $18,232  
    Accrued expenses and other current liabilities  4,089,749    3,904,767  
    Notes payable  632,000      
    Total current liabilities  4,916,966    3,922,999  
    Contingent consideration  16,390,000    2,750,000  
    Other long-term liabilities  1,715,024    1,864,875  
    Total liabilities  23,021,990    8,537,874  
    Commitments and contingencies (Note 14)        
    Stockholders' equity:        
    Common stock, $0.0001 par value; 200,000,000 shares authorized;  2,635    1,508  
      26,553,957 and 15,312,381 shares issued; 26,553,886 and 15,312,167
      shares outstanding at June 30, 2020 and December 31, 2019, respectively
    Additional paid-in capital  242,579,532    187,914,916  
    Accumulated deficit  (158,028,687)   (137,376,122) 
    Accumulated other comprehensive loss, net  (5,031,703)   (5,020,156) 
    Total stockholders' equity  79,521,777    45,520,146  
    Total liabilities and stockholders' equity $102,543,767   $54,058,020  
             





    ALTIMMUNE, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (unaudited)
                 
      For the Three Months Ended For the Six Months Ended
    June 30,June 30,
      2020  2019  2020  2019 
                 
    Revenues $721,636  $1,626,029  $2,934,330  $4,581,622 
    Operating expenses:            
    Research and development  16,594,250   2,945,096   23,781,781   6,162,768 
    General and administrative  2,545,356   2,231,817   4,877,273   4,298,299 
    Total operating expenses  19,139,606   5,176,913   28,659,054   10,461,067 
    Loss from operations  (18,417,970)  (3,550,884)  (25,724,724)  (5,879,445)
    Other (expense) income:            
    Changes in fair value of warrant liability     (46,000)     (46,000)
    Interest expense  (3,308)  (748)  (5,193)  (1,488)
    Interest income  81,458   239,964   233,027   425,211 
    Other (expense) income, net  (5,878)  (29,220)  19,664   17,528 
    Total other (expense) income, net  72,272   163,996   247,498   395,251 
    Net loss before income tax benefit  (18,345,698)  (3,386,888)  (25,477,226)  (5,484,194)
    Income tax benefit  1,578,782      4,824,661    
    Net loss  (16,766,916)  (3,386,888)  (20,652,565)  (5,484,194)
    Other comprehensive loss – unrealized gain (loss) on investments  20,888      (11,547)   
    Comprehensive loss $(16,746,028) $(3,386,888) $(20,664,112) $(5,484,194)
    Net loss $(16,766,916) $(3,386,888) $(20,652,565) $(5,484,194)
    Deemed dividends           (452,925)
    Net loss attributed to common stockholders $(16,766,916) $(3,386,888) $(20,652,565) $(5,937,119)
    Net loss per share attributed to common stockholders, basic and diluted $(0.94) $(0.26) $(1.25) $(0.52)
    Weighted-average common shares outstanding, basic and diluted  17,886,853   13,127,773   16,498,719   11,318,819 

     

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  5. GAITHERSBURG, Md., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced that it has completed enrollment in its Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. With this milestone, the data readout for the Day 28 immunogenicity endpoint remains on target for Q4 2020.

    The clinical trial has enrolled 42 evaluable healthy subjects to receive intranasally administered NasoShield or placebo and be followed for 6 months following dosing. The primary immunogenicity readouts are the serum antibody response to protective antigen and toxin-neutralizing antibody titer 28 and 56 days after dosing. As with Altimmune's other vaccine programs…

    GAITHERSBURG, Md., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced that it has completed enrollment in its Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. With this milestone, the data readout for the Day 28 immunogenicity endpoint remains on target for Q4 2020.

    The clinical trial has enrolled 42 evaluable healthy subjects to receive intranasally administered NasoShield or placebo and be followed for 6 months following dosing. The primary immunogenicity readouts are the serum antibody response to protective antigen and toxin-neutralizing antibody titer 28 and 56 days after dosing. As with Altimmune's other vaccine programs, stimulation of a mucosal IgA immune response in the nasal cavity will also be assessed as a potential additional benefit to other immunologic responses. Nasal mucosal immunity, which can play an important role in the body's defense against respiratory diseases, is best stimulated by the nasal route of vaccine administration.

    The NasoShield program is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA), with a total potential value of $133.7 million if all options in the contract (HHSO100201600008C) are exercised. At the conclusion of the Phase 1b NasoShield trial, BARDA will have the option of exercising the remaining contract options valued at approximately $105 million to enable Phase 2 development.

    NasoShield has the potential to be a convenient and simple alternative to the current approved multi-dose anthrax vaccine, as it is intended to confer protection after a single intranasal dose instead of the three-injection regimen required by the only licensed vaccine. Intranasal dosing provides the potential to be administered rapidly and without the need for needles, syringes or trained healthcare personnel in the event of an anthrax incident. In addition, NasoShield's expected room temperature stability profile may allow for broad distribution of the vaccine without the need for expensive cold-chain logistics, such as refrigeration or freezing.

    Earlier this quarter, the Company reported positive preclinical data on AdCOVID, a single dose intranasal COVID-19 vaccine candidate which is derived from the same replication-deficient adenovirus 5 vaccine platform technology as NasoShield. In these preclinical studies performed in collaboration with the University of Alabama at Birmingham (UAB), AdCOVID elicited a strong systemic antibody response against the receptor-binding domain (RBD) in mice, stimulated serum viral neutralization titers, and activated a 29-fold induction of mucosal IgA against SARS-CoV-2 in bronchoalveolar fluid of vaccinated mice. The Company plans to initiate a Phase 1 clinical trial of AdCOVID during the fourth quarter of 2020.

    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 treatment 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 NasoShield clinical trial and receipt of data from the clinical trial in 2020, the potential for additional funding from BARDA, the potential immunization effects of NasoShield, 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, 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; funding delays, reductions in or elimination of U.S. government funding and/or non-renewal of expiring funding under the Company's agreement with BARDA; the Company's ability to satisfy certain technical milestones under the Company's contracts with BARDA that would entitle the Company to receive additional funding over the period of the agreement; the Company's ability to obtain potential regulatory approvals on the timelines anticipated, or at all; 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 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 Ashley R. Robinson
    Chief Financial Officer LifeSci Advisors, LLC
    Phone: 240-654-1450 617-430-7577
     
       
    Media Contacts:  
    Warren Rizzi  
    Sard Verbinnen & Co.  
    Phone: 212-687-8080  
       











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