ALT Altimmune Inc.

15.56
-0.08  -1%
Previous Close 15.64
Open 15.61
52 Week Low 7.8
52 Week High 35.1
Market Cap $597,454,877
Shares 38,396,843
Float 33,446,214
Enterprise Value $388,813,955
Volume 843,730
Av. Daily Volume 1,451,355
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Upcoming Catalysts

Drug Stage Catalyst Date
AdCOVID
COVID-19 vaccine
Phase 1
Phase 1
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ALT-801
Non-alcoholic steatohepatitis (NASH) - Healthy Overweight and Obese Volunteers
Phase 1
Phase 1
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HepTCell
Hepatitis B
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
T-COVID
COVID-19
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing.
NASOSHIELD
Anthrax
Phase 1b
Phase 1b
Phase 1b data released April 1, 2021.
NasoVAX
Flu vaccine
Phase 2
Phase 2
Phase 2 additional data released March 19, 2019 noted all patients remained seroprotected.

Latest News

    • Weight loss of 5.4% achieved at 6 weeks of treatment with 1.8 mg once weekly dose, surpassing the 2% pre-established treatment target
    • Ascending multi-dose regimen well-tolerated without necessity for dose titration
    • Trial continuing with 12-week data expected in Q3 2021
    • Company plans to file an additional IND and initiate an obesity program in 2021
    • Altimmune to host a conference call today at 8:30 a.m. ET

    GAITHERSBURG, Md., June 16, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced results from a prespecified 6-week interim analysis of its ongoing 12-week, Phase 1, placebo-controlled, single and multiple ascending dose trial of ALT-801, an investigational GLP-1/glucagon dual receptor…

    • Weight loss of 5.4% achieved at 6 weeks of treatment with 1.8 mg once weekly dose, surpassing the 2% pre-established treatment target

    • Ascending multi-dose regimen well-tolerated without necessity for dose titration
    • Trial continuing with 12-week data expected in Q3 2021
    • Company plans to file an additional IND and initiate an obesity program in 2021
    • Altimmune to host a conference call today at 8:30 a.m. ET

    GAITHERSBURG, Md., June 16, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced results from a prespecified 6-week interim analysis of its ongoing 12-week, Phase 1, placebo-controlled, single and multiple ascending dose trial of ALT-801, an investigational GLP-1/glucagon dual receptor agonist, in healthy overweight and obese volunteers. The study is currently being conducted in Australia under a clinical trial application.

    The interim data showed a mean weight loss of 5.4% was achieved by Week 6 with a once weekly ALT-801 dose of 1.8 mg administered subcutaneously (sc) compared to a weight gain of 0.9% in the placebo group (net change from placebo of 6.3%, p < .0001), surpassing the pre-established treatment target of 2% weight loss. All but one subject who received the 1.8 mg sc dose achieved at least 3% weight loss by Week 6. A lower dose cohort that received a weekly 1.2 mg sc dose achieved a mean weight loss of 1.8% (net change from placebo of 2.7%, p < .05) at the same time point. ALT-801 was well-tolerated without dose titration, with transient nausea rates of 14.3% at the 1.2 mg dose and 22.2% at the 1.8 mg dose, and no reports of vomiting, diarrhea or constipation at either dose. All nausea events at the 1.8 mg dose were mild in severity. Gastrointestinal adverse events have required other GLP-1 based agents to dose titrate over 16 to 20 weeks to maintain adequate tolerability.

    "These data are encouraging considering that only a 2% weight loss was targeted at 6 weeks of treatment and that nausea rates were low, without emesis, which is particularly notable in the absence of dose titration," commented Stephen Harrison, MD, Visiting Professor of Hepatology, University of Oxford, and Medical Director, Pinnacle Research. "The high degree of weight loss, the very good safety and tolerability profile, and the absence of dose titration with short treatment duration is very favorable for ALT-801 and makes it an attractive candidate among the GLP-1 class of drugs. Based on the relationship between weight loss and liver fat reduction, and NASH resolution observed in other studies, ALT-801 appears to be a promising therapeutic candidate for both obesity and NASH."

    Because the recruited study population was young (mean age 29.8 years) and non-diabetic, the proportion of subjects with MRI-PDFF greater than 10% was insufficient to perform an analysis of liver fat reduction in this population. Consequently, the Company plans to expand the enrollment criteria and conduct a separate 12-week Phase 1b study of diabetic and non-diabetic subjects with non-alcoholic fatty liver disease (NAFLD) in the United States, which is anticipated to commence in Q3 2021, and to initiate a 52-week biopsy-driven NASH trial in Q1 2022. The expansion of enrollment criteria to diabetic and older subjects will accelerate the recruitment of the target NAFLD population and mirror the anticipated study population in the 52-week trial.

    The ALT-801 Phase 1 trial is currently progressing through higher dose cohorts, and the Company plans to report the results following 12-weeks of dosing in Q3 2021. Based on these latest results, Altimmune now plans to file a second IND in obesity in Q3 2021 to supplement its ongoing NASH program.

    "We are very excited about the potential for ALT-801 in the expanding GLP-1 therapeutics marketplace," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "We know that weight loss is strongly correlated with NASH resolution and that the obesity epidemic in developed nations has led to an unacceptable increase in chronic illnesses. Assuming ALT-801 is shown to improve upon the metabolic control and side effect profile of existing GLP-1 therapies, we believe that ALT-801 could enable more patients to benefit from this type of treatment."

    About the ALT-801 Phase 1 Trial

    The ALT-801 Phase 1 clinical trial is a placebo-controlled, first-in-human, single ascending dose (SAD) and multiple ascending dose (MAD) study in overweight and obese volunteers being conducted in Australia under a clinical trial application. Study subjects did not participate in behavioral weight loss programs or undergo caloric restriction. The primary objectives of the trial are to assess the safety and tolerability, pharmacokinetics, and weight loss in ALT-801 recipients compared to placebo over 12 weeks of weekly dosing. Reduction in liver fat content will be assessed in a separate 12-week Phase 1b trial of diabetic and non-diabetic subjects with NAFLD anticipated to commence in Q3 2021. Dosing in the MAD phase commenced with a cohort receiving ALT-801 1.2 mg sc or placebo once weekly and is progressing through higher dose cohorts. Subjects in the 1.2 mg and 1.8 mg cohorts currently have completed 6 weeks of treatment. Interim analyses at 6 weeks of dosing have been performed for the first two study cohorts, and the results of 12 weeks of dosing in these and additional cohorts are expected to be announced in Q3 2021.

    Conference Call Information
      
    Date:Wednesday, June 16, 2021
    Time: 8:30 am Eastern Time
    Domestic Dial-in:877-423-9813
    International Dial-in:201-689-8573
    Conference ID:13720570
    Webcast:http://public.viavid.com/index.php?id=145274

    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 IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

    About ALT-801

    ALT-801 is a novel, investigational, peptide-based dual GLP-1/glucagon receptor agonist that is designed to treat the obesity and metabolic dysfunction that causes NASH. As the most severe form of non-alcoholic fatty liver disease, or NAFLD, NASH involves multiple metabolic pathways leading to the abnormal accumulation of liver fat, toxic lipid metabolites, and inflammation, resulting ultimately in fibrosis (cirrhosis) or liver cancer. Altimmune believes the treatment of obesity is the cornerstone of treating NASH and the principal morbidities of NASH. Glucagon increases energy expenditure and adipose tissue browning and works synergistically with GLP-1 to facilitate greater degrees of weight loss than GLP-1 alone. As observed in a well-established preclinical model of the disease, ALT-801 induced significantly greater weight loss compared to semaglutide, a GLP-1 receptor agonist, along with significantly greater decreases in liver fat, plasma ALT, and other markers of NASH. The pharmacokinetic profile of ALT-801 may provide for once weekly administration without dose-titration and may have a low incidence of GI side effects, attributes that we believe could improve patient compliance and reduce treatment discontinuation.

    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.

    Follow @Altimmune, Inc. on LinkedIn

    Follow @AltimmuneInc on Twitter

    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 timing of the 12-week data readout from the ALT-801 Phase 1 clinical trial in Q3 2021, the timing of the filing of IND applications, the potential to initiate a 12 week NAFLD trial in Q3 2021, the timing of the filing of an additional IND and initiate an obesity program in 2021, the potential therapeutic effects of ALT-801, the prospects for regulatory approval, our ability to manufacture ALT-801 for our clinical trials and commercial needs, and 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 manufacture clinical trial materials and commercial supply 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, 2020 filed with the SEC, which is available at www.sec.gov.

    Altimmune Investor & Media Contacts: 
      
    Will BrownStacey Jurchison
    Chief Financial OfficerSr. Dir, Investor Relations
    Phone: 240-654-1450Phone: 410-474-8200
      





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  1. Dublin, Ireland, June 07, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Pan-European independent power producer ("IPP"), Alternus Energy Group Plc (OTC:ALT) (the "Company" or "Alternus"), is excited to announce the recent acquisition of 60% of the share capital in Unisun Energy Holding B.V (Unisun), a Netherlands-based developer, Engineering Procurement and Construction (EPC) and Operations and Maintenance (O&M) service provider of clean and sustainable energy solutions across Europe.

    The acquisition makes Alternus a fully vertically integrated independent solar power producer with activities in all elements of the solar PV value chain from project development and construction to operations and maintenance. Unisun supports Alternus in its…

    Dublin, Ireland, June 07, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Pan-European independent power producer ("IPP"), Alternus Energy Group Plc (OTC:ALT) (the "Company" or "Alternus"), is excited to announce the recent acquisition of 60% of the share capital in Unisun Energy Holding B.V (Unisun), a Netherlands-based developer, Engineering Procurement and Construction (EPC) and Operations and Maintenance (O&M) service provider of clean and sustainable energy solutions across Europe.

    The acquisition makes Alternus a fully vertically integrated independent solar power producer with activities in all elements of the solar PV value chain from project development and construction to operations and maintenance. Unisun supports Alternus in its goal to become a leading pan-European renewable energy company. It also provides a strong platform for growth in the Netherlands energy market with the addition of over 250 MW of solar projects at various stages of development.

    "This is truly significant development for Alternus. Unisun has a highly experienced and dedicated team that has a proven track record in successfully delivering high quality renewables projects in multiple countries in Europe. With this team and along with our recently recruited and experienced CTO, Gary Swan, we now have the proven ability to develop and construct our own solar PV parks. This capability will allow us to reduce the initial build costs and generate long-term operational savings. The lower capital costs reduce our need for external capital as the EPC margins otherwise paid to third parties can now be reinvested, thus creating immediate and lasting shareholder value. We can also plan more effectively to execute on our current 1.4 GW contracted backlog," said Vincent Browne, Executive Chairman and CEO of Alternus.

    Headquartered in Rotterdam, Unisun Energy Holding B.V is led by industry veterans CEO Andre Kempenaars and COO Leon Heijkoop, who between them have constructed and operated over 500 MW of wind and solar projects over the past decade. The Unisun team currently totals 10 international industry specialists, who have collectively managed and successfully completed over 1 GW of energy projects in their careers to date. With this expertise the Unisun Energy team encapsulate a wealth of technical expertise, proven process management and track record characteristics. Unisun also provides O&M services to existing customers through its wholly owned subsidiary Uper Energy Europe B.V.

    "On behalf of the Unisun Energy team, we welcome Alternus as our new majority owner and are looking forward to jointly growing both companies in the European renewables market, delivering on both companies' ambitious renewables strategy. We very much look forward to working together to unlock the potential we collectively see in the European renewables space," said Andre Kempenaars, CEO of Unisun Energy Holding B.V.

    Alternus paid a total consideration of EUR 650k in cash and approximately EUR 150k in shares (50,000 new shares issued) for a 60% ownership in Unisun Energy Holding B.V. The previous two owners will retain a 40% ownership and will remain with the business as CEO and COO of Unisun Energy.

    "As part of the acquisition, Alternus will receive an immediate 60% cost savings in the operations and maintenance of our Zonnerpak Rilland plant. Unisun was the original developer and EPC contractor, and currently provides the O&M services. We also expect additional financial benefits in our other operating parks as we consolidate the O&M activities in-house where possible. Unisun will further bring additional revenue opportunities to the group as it provides services to existing third party customers," said Joseph Duey, Chief Financial Officer of Alternus.

    About Alternus Energy Plc

    Alternus Energy Group (OTC:ALT) is a fast-growing pan-European independent power producer ("IPP"), headquartered in Ireland, with a focus on the midsized utility scale solar PV market. Alternus owns and operates a diverse portfolio of utility scale solar PV parks that connect directly to national power grids on long-term government contracts ("FiT") and/or Power Purchase Agreements ("PPAs") with investment grade off-takers. Having started in 2016 with two parks and 6 MWp capacity, the current portfolio consists of 39 owned or contracted parks in Germany, Italy, Netherlands, Romania and Poland in excess of 150 MWp capacity. Alternus works closely with both local and international specialist development partners that each provide a constant pipeline of new projects for acquisition by Alternus. Alternus aims to own and operate over 2 GWs of solar parks by the end of 2025 and to become one of the largest pan-European IPPs by the end of the decade.

    Forward Looking Statements: Certain information contained in this letter, including any information on the group's plans or future financial or operating performance and other statements that express the group's management's expectations or estimates of future performance, constitute forward-looking statements (when used in this document, the words "anticipate", "believe", "estimate" and "expect" and similar expressions, as they relate to the group or its management, are intended to identify forward-looking statements). Such statements are based on a number of estimates and assumptions that, while considered reasonable by management at the time, are subject to significant business, economic and competitive uncertainties. The group cautions that such statements involve known and unknown risks, uncertainties and other factors that may cause the actual financial results, performance or achievements of the group to be materially different from the group's estimated future results, performance or achievements expressed or implied by those forward-looking statements.

    www.alternusenergy.com

    About Unisun Energy Holding B.V

    Headquartered in Rotterdam, the Netherlands, Unisun Energy Holding BV is a leading pan-European developer, EPC and O&M service provider of clean and sustainable energy solutions. With a team that has collectively completed and managed over 1 GW of energy projects in their careers to date, the company offers strong industry knowledge, service and experience. Unisun Energy strives to make the world of solar energy more accessible to companies with sustainable ambitions. By applying rigorous quality control, technical design expertise and proven project management and procurement capabilities, the company consistently delivers successful turn-key services to its customers.

    www.unisunenergy-eu.com

    Contact:

    Michael Hansson

    479 945 3303



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  2. GAITHERSBURG, Md., May 27, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced that members of the management team will present during a fireside chat at the 2021 Jefferies Virtual Healthcare Conference, being held June 1 - 4, 2021.

    Details on the Jefferies fireside chat presentation are as follows:

     Title: 2021 Jefferies Virtual Healthcare Conference
        
     Presenters: Vipin Garg, Ph.D., Chief Executive Officer
       Scot Roberts, Ph.D., Chief Scientific Officer
       Scott Harris, M.D., Chief Medical Officer
        
     Date/Time: Wednesday, June 2, 2021 at 11:30 am ET

    A webcast link to the fireside chat presentation will be accessible on the Events section of the Altimmune website.

    About Altimmune

    GAITHERSBURG, Md., May 27, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced that members of the management team will present during a fireside chat at the 2021 Jefferies Virtual Healthcare Conference, being held June 1 - 4, 2021.

    Details on the Jefferies fireside chat presentation are as follows:

     Title: 2021 Jefferies Virtual Healthcare Conference
        
     Presenters: Vipin Garg, Ph.D., Chief Executive Officer
       Scot Roberts, Ph.D., Chief Scientific Officer
       Scott Harris, M.D., Chief Medical Officer
        
     Date/Time: Wednesday, June 2, 2021 at 11:30 am ET

    A webcast link to the fireside chat presentation will be accessible on the Events section of the Altimmune website.

    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.

    Investor & Media Contacts:  
       
    Will Brown Stacey Jurchison
    Chief Financial Officer  Sr. Dir, Investor Relations
    Phone: 240-654-1450 Phone : 410-474-8200
     



     



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  3. Similar Neutralization Titers Observed for Both Ancestral
    and B.1.351 South African Variant

    Phase I Clinical Trial of AdCOVID Expected to Report Data in June 2021

    GAITHERSBURG, Md., May 26, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa. B.1.351 carries multiple mutations in the receptor binding domain (RBD) including the E484K mutation that has been shown to substantially decrease the ability of authorized vaccines to neutralize the virus.

    In the current study, performed in…

    Similar Neutralization Titers Observed for Both Ancestral

    and B.1.351 South African Variant

    Phase I Clinical Trial of AdCOVID Expected to Report Data in June 2021

    GAITHERSBURG, Md., May 26, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa. B.1.351 carries multiple mutations in the receptor binding domain (RBD) including the E484K mutation that has been shown to substantially decrease the ability of authorized vaccines to neutralize the virus.

    In the current study, performed in collaboration with investigators at Saint Louis University, the neutralizing titer against the B.1.351 variant virus was only 4.4-fold lower than the neutralizing titer against an original or ancestral Wuhan-like isolate when measured seven weeks after a single intranasal dose of AdCOVID. Furthermore, in mice that received a booster dose of AdCOVID, the reduction in the neutralizing titer against the B.1.351 variant was only 1.8-fold lower at seven weeks post vaccination; statistically the same as the neutralization titer against the Wuhan isolate. The serum neutralizing antibody titers were determined using a live virus focus reduction neutralization titer (FRNT) assay with a 50% neutralization endpoint.

    "These data are impressive considering the B.1.351 variant has been consistently difficult to neutralize following vaccination with the original prototype vaccines," said James Brien, Ph.D., Assistant Professor, Molecular Microbiology and Immunology at Saint Louis University. "If the simple addition of an AdCOVID booster dose is able to provide effective coverage against variants of concern it would greatly simplify our response to the challenge presented by this virus by eliminating the need to develop new variant adapted vaccines."

    Importantly, AdCOVID also promoted a strong mucosal neutralizing response to the B.1.351 virus in the respiratory tract with bronchoalveolar lavages showing neutralization of the variant virus. These preclinical data suggest that vaccination with AdCOVID leads to a cross-neutralizing antibody response both systemically and locally within the respiratory tract that can effectively neutralize the B.1.351 virus.

    "We believe that our selection of the RBD of the spike protein as the vaccine antigen was key in obtaining these impressive results," said Scot Roberts, Ph.D., Chief Scientific Officer at Altimmune. "From a neutralization perspective, AdCOVID is designed to focus the immune response on RBD, the most important part of the SARS-CoV-2 virus. The likely result is the development of antibodies to sub-dominant or cryptic neutralizing epitopes not readily recognized when presented in the context of the entire spike protein, which is targeted by most other vaccine candidates."

    About AdCOVID

    AdCOVID is a single-dose intranasal vaccine candidate for COVID-19 currently being evaluated in a Phase 1 clinical trial. It is 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.

    In published preclinical studies (www.biorxiv.org/content/10.1101/2020.10.10.331348v1) conducted in collaboration with the University of Alabama at Birmingham, potent serum neutralizing antibody responses, T cell responses, and a robust induction in mucosal immunity were observed in mice following a single intranasal dose of AdCOVID. Mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both of which are believed to be important in fighting infection, and importantly, transmission. In preclinical efficacy studies, AdCOVID provided 100% protection against lethal SARS-CoV-2 challenge.

    Based on data from Altimmune's other intranasal platform vaccine candidates, AdCOVID is expected to have extended stability at room temperature that would allow for cold chain-free shipment of the vaccine. If demonstrated, AdCOVID could be stored in the common refrigerators found in community-based doctors' offices and pharmacies for two years or more. The Company believes that these simple and convenient handling requirements, together with the potential ability to block SARS-CoV-2 transmission, could position AdCOVID as a leading intranasal COVID-19 vaccine.

    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.

    Follow @Altimmune, Inc. on LinkedIn

    Follow @AltimmuneInc on Twitter

    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 timing of the data readout from the AdCOVID Phase 1 clinical trial in June 2021, the potential immunization effects of AdCOVID, the potential of AdCOVID to block SARS-CoV-2 transmission, the shipping and storage requirements for AdCOVID, our ability to manufacture AdCOVID for our clinical trials and commercial needs, the prospects for regulatory approval of our product candidates and 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 manufacture clinical trial materials and commercial supply 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, 2020 filed with the SEC, which is available at www.sec.gov.

    Altimmune Investor & Media Contacts:

    Will BrownStacey Jurchison
    Chief Financial OfficerSr. Dir, Investor Relations
    Phone: 240-654-1450Phone : 410-474-8200
    com


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  4. Data Readouts from Phase 1 AdCOVID™ and ALT-801 Clinical Trials Expected in June

           Approximately $227 Million in Cash and Short-Term Investments to Advance Pipeline

    GAITHERSBURG, Md., May 17, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three months ending March 31, 2021 and provided a corporate update.

    "With AdCOVID™, our single-dose intranasal vaccine candidate for COVID-19 and ALT-801, our GLP-1/glucagon dual agonist candidate for non-alcoholic steatohepatitis (NASH) now advancing in the clinic, 2021 has the potential to be a data-rich period for the Company," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune…

    Data Readouts from Phase 1 AdCOVID™ and ALT-801 Clinical Trials Expected in June

           Approximately $227 Million in Cash and Short-Term Investments to Advance Pipeline

    GAITHERSBURG, Md., May 17, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three months ending March 31, 2021 and provided a corporate update.

    "With AdCOVID™, our single-dose intranasal vaccine candidate for COVID-19 and ALT-801, our GLP-1/glucagon dual agonist candidate for non-alcoholic steatohepatitis (NASH) now advancing in the clinic, 2021 has the potential to be a data-rich period for the Company," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "We anticipate data readouts from both of these clinical trials in June. If the data from the AdCOVID Phase 1 trial are positive, we plan to quickly transition into a comprehensive global Phase 2 clinical development program. We strongly believe that a vaccine candidate like AdCOVID, which can be administered via a simple nasal spray along with what we hope will be an excellent safety and tolerability profile, could become an important tool for the global COVID-19 vaccination effort."

    Dr. Garg continued, "ALT-801 is also progressing as planned through its first-in-human clinical trial in Australia and we anticipate 6-week data to be available later this quarter. We are excited about the potential of ALT-801, and hope that clinical studies will show ALT-801 can deliver similar therapeutic benefits to current GLP-1 based treatment options in development but without the GI intolerability that leads to treatment discontinuation. The NASH opportunity, together with a potential indication in obesity, could be very large for ALT-801 and early clinical success could have a dramatic effect on Altimmune's growth."

    Recent Highlights:

    AdCOVID, a novel, needle-free, intranasal vaccine candidate for COVID-19

    • Enrollment target met in amended AdCOVID Phase 1 clinical trial evaluating the safety and immunogenicity of AdCOVID in healthy volunteers



      • The Phase 1 trial will measure systemic antibody responses including serum neutralizing antibody, T cell responses and mucosal IgA, a measure of mucosal immunity in the nasopharyngeal cavity

      • The study protocol was amended to reduce the number of adult subjects to approximately 80. The amendment was necessary due to the widespread availability of authorized vaccines. The final sample size of the study is comparable to the number of participants in Phase 1 studies of the U.S. authorized vaccines
      • A topline data readout is anticipated in June 2021

    • Progressed development of adapted AdCOVID vaccine candidates targeting emerging SARS-CoV-2 variants



      • Initiated preclinical evaluation of AdCOVID vaccine candidates targeting E484K variants, including P.1, B.1.351 and B.1.617

      • Initiation of a Phase 2 trial with a variant AdCOVID vaccine candidate expected in Q4 2021
    • Expanded manufacturing capabilities through an agreement with Lonza to commission a dedicated manufacturing suite for clinical and potential future commercial supply



      • Complements and extends existing network of strategic manufacturing partners, building extra capacity and redundancy into the AdCOVID manufacturing effort

      • Supports manufacturing of clinical supply material for potential late-stage clinical trials and commercial scale
    • Announced new data from preclinical studies conducted in collaboration with the University of Alabama at Birmingham (UAB)

    In these preclinical studies, a single intranasal dose of AdCOVID provided:

    • 100% protection against a lethal challenge from the SARS-CoV-2 virus, with 1000-fold reduction of replicating virus in the nasal cavity and respiratory tract following infection with SARS-CoV-2
    • Sterilizing immunity, i.e., undetectable levels of infectious virus in the lungs, believed to be essential to fully block viral transmission
    • Long-lived systemic and mucosal immune responses, which were essentially unchanged over 6 months

    • Established plans for a robust Phase 2 clinical development program, which is anticipated to include:



      • A multi-national study in adults 18 years of age and older in regions where vaccine access has been limited

      • An evaluation of AdCOVID as a potential booster for previously-infected and vaccinated individuals using a parental and P.1 variant AdCOVID vaccine
      • An age-based de-escalation study in children and adolescents
      • A study evaluating safety and immunogenicity in mother-infant pairs

    ALT-801, a novel GLP-1/glucagon dual agonist candidate for NASH

    • Progressed ongoing Phase 1 clinical trial of ALT-801 in Australia



      • Completed enrollment in the single ascending dose (SAD) phase and 3 planned cohorts of multiple ascending dose (MAD) phase of the trial, with 6-week data anticipated in June 2021, and 12-week data anticipated in Q3 2021

      • Plans to commence a 52-week, Phase 2, biopsy-trial based on NASH endpoints in early 2022
      • Anticipated mid-year IND filing to initiate U.S. NASH studies



    • Potential filing of a second IND for an obesity indication in 2H 2021



      • The filing of a second IND in obesity in 2H 2021 is being evaluated, with the final decision based on the weight loss data from the upcoming Phase 1 trial readout

    Other programs

    • Continued progress in Phase 1/2 clinical trial of T-COVID, a therapeutic candidate for the treatment of SARS-CoV-2 and other respiratory infections, and a Phase 2 clinical trial of HepTcell, an immunotherapeutic candidate for the treatment of chronic hepatitis B

    Financial Results for the Three Months Ended March 31, 2021

    • Altimmune had cash, cash equivalents and short-term investments totaling $226.5 million at March 31, 2021 compared to $216.0 million at December 31, 2020. The increase is primarily attributable to $34.2 million of net receipts during the quarter due to its utilization of the at-the-market offering program, partially offset by $19.6 million of cash used for operating activities.
    • Revenue was $0.8 million for the three months ended March 31, 2021 compared to $2.2 million in the prior period, a decrease of $1.4 million. The change in revenue quarter over quarter was primarily due to a decrease of $2.0 million in BARDA revenue during the current period due to the timing of clinical trials and development activities for NasoShield, partially offset by $0.5 million in revenue attributable to T-COVID.
    • Research and development expenses were $11.9 million for the three months ended March 31, 2021, compared to $7.2 million in the prior period, representing an increase of $4.7 million. The change was primarily the result of increased expenses of $5.4 million related to development activities for the Company's COVID-19 programs, partially offset by a decrease of $1.5 million resulting from a decrease in the fair value of contingent consideration liability connected with the acquisition and development of ALT-801.
    • General and administrative expenses were $3.8 million for the three months ended March 31, 2021 compared to $2.3 million in the prior period, an increase of $1.5 million. The increase during the quarter is primarily due to increased stock compensation expense and additional labor related costs.
    • Net loss for the three months ended March 31, 2021 was $14.9 million, or $0.38 net loss per share, compared to $3.9 million in the prior period, or $0.26 net loss per share. The difference in net loss is primarily attributable to higher research and development expenses and general and administrative expenses.
    Conference Call Information 
    Date:Monday, May 17, 2021
    Time:8:30 am Eastern Time
    Domestic Dial-in 877-423-9813
    International Dial-in:201-689-8573
    Conference ID:13719206
    Webcast:http://public.viavid.com/index.php?id=144634

    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 IR 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.

    Follow @Altimmune, Inc. on LinkedIn

    Follow @AltimmuneInc on Twitter

    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 timing of the data readout from the AdCOVID Phase 1 clinical trial in June 2021, the potential start of the AdCOVID Phase 2 clinical program in Q2 2021, the potential immunization effects of AdCOVID, the potential of AdCOVID to block SARS-CoV-2 transmission, the shipping and storage requirements for AdCOVID, our ability to manufacture AdCOVID for our clinical trials and commercial needs, the expected completion of the single ascending dose (SAD) and multiple ascending dose (MAD) phases of the ALT-801 study, with 6-week data expected in June 2021 and 12-week data in Q3 2021, the anticipated mid-year IND filing for ALT-801, the commencement of a 52-week, Phase 2, biopsy-trial based on NASH endpoints in early 2022, the HepTcell Phase 2 clinical efficacy trial data readout anticipated in 1H 2022, the prospects for regulatory approval of our product candidates and 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 manufacture clinical trial materials and commercial supply 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, 2020 filed with the SEC, which is available at www.sec.gov.

    Investor & Media Contacts:

    Will Brown                                                        

    Chief Financial Officer                                                 

    Phone: 240-654-1450                                                        

    Stacey Jurchison

    Sr. Dir, Investor Relations

    Phone : 410-474-8200





    ALTIMMUNE, INC.

    CONSOLIDATED BALANCE SHEETS

      March 31, 2021  December 31, 2020 
      (unaudited)     
    ASSETS        
    Current assets:        
    Cash and cash equivalents $149,932,387  $115,917,807 
    Restricted cash  34,174   34,174 
    Total cash, cash equivalents and restricted cash  149,966,561   115,951,981 
    Short-term investments  76,574,768   100,005,558 
    Accounts receivable  4,801,428   4,610,202 
    Tax refund receivable  7,898,067   7,762,793 
    Prepaid expenses and other current assets  5,950,999   1,926,675 
    Total current assets  245,191,823   230,257,209 
    Property and equipment, net  5,198,052   1,056,920 
    Right of use asset  866,336   903,825 
    Intangible assets, net  12,879,247   12,823,846 
    Other assets  115,300   73,413 
    Total assets $264,250,758  $245,115,213 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities:        
    Accounts payable $418,243  $612,293 
    Accrued expenses and other current liabilities  9,405,649   11,408,154 
    Total current liabilities  9,823,892   12,020,447 
    Contingent consideration  6,270,000   5,390,000 
    Other long-term liabilities  1,719,438   1,828,443 
    Total liabilities  17,813,330   19,238,890 
    Commitments and contingencies (Note 16)        
    Stockholders' equity:        
    Common stock, $0.0001 par value; 200,000,000 shares authorized;

    38,257,180 and 37,142,946 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively
      3,810   3,697 
    Additional paid-in capital  462,417,706   417,337,742 
    Accumulated deficit  (210,944,707)  (186,420,599)
    Accumulated other comprehensive loss, net  (5,039,381)  (5,044,517)
    Total stockholders' equity  246,437,428   225,876,323 
    Total liabilities and stockholders' equity $264,250,758  $245,115,213 



    ALTIMMUNE, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

      For the Three Months Ended

    March 31,
     
      2021  2020 
    Revenues $837,516  $2,212,694 
    Operating expenses:        
    Research and development  11,877,900   7,187,531 
    General and administrative  3,821,420   2,331,917 
    Total operating expenses  15,699,320   9,519,448 
    Loss from operations  (14,861,804)  (7,306,754)
    Other income (expense):        
    Interest expense  (11,671)  (1,885)
    Interest income  42,499   151,569 
    Other (expense) income, net  (33,132)  25,542 
    Total other (expense) income, net  (2,304)  175,226 
    Net loss before income tax benefit  (14,864,108)  (7,131,528)
    Income tax benefit     3,245,879 
    Net loss  (14,864,108)  (3,885,649)
    Other comprehensive income (loss) – unrealized gain (loss) on investments  5,136   (32,435)
    Comprehensive loss $(14,858,972) $(3,918,084)
    Net loss per share, basic and diluted $(0.38) $(0.26)
    Weighted-average common shares outstanding, basic and diluted  38,914,990   15,110,585 


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