ALT Altimmune Inc.

15.38
+0.34  (+2%)
Previous Close 15.04
Open 15.01
52 Week Low 7.8
52 Week High 24.61
Market Cap $610,676,496
Shares 39,705,884
Float 39,275,708
Enterprise Value $362,339,724
Volume 457,741
Av. Daily Volume 1,130,319
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Upcoming Catalysts

Drug Stage Catalyst Date
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 enrollment to be terminated - June 29, 2021.
AdCOVID
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 data released June 29, 2021 did not stimulate an adequate immune response. Development to be discontinued.
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

  1. GAITHERSBURG, Md., Sept. 07, 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 H.C. Wainwright 23rd Annual Global Investment Conference, being held virtually on September 13-15, 2021.

    Details on the H.C. Wainwright fireside chat presentation are as follows:

     Title:   H.C. Wainwright 23rd Annual Global Investment Conference 
         
     Presenters:     Vipin Garg, Ph.D., Chief Executive Officer 
       Scott Harris, M.D., Chief Medical Officer 
         
     Date/Time:   Monday, September 13, 2021 (virtual pre-record available at 7 a.m. EST) 

    A webcast link to the fireside chat presentation will be accessible on the…

    GAITHERSBURG, Md., Sept. 07, 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 H.C. Wainwright 23rd Annual Global Investment Conference, being held virtually on September 13-15, 2021.

    Details on the H.C. Wainwright fireside chat presentation are as follows:

     Title:   H.C. Wainwright 23rd Annual Global Investment Conference 
         
     Presenters:     Vipin Garg, Ph.D., Chief Executive Officer 
       Scott Harris, M.D., Chief Medical Officer 
         
     Date/Time:   Monday, September 13, 2021 (virtual pre-record available at 7 a.m. EST) 

    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 treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for obesity, NASH (ALT-801), and chronic hepatitis B (HepTcell™). For more information, please visit www.altimmune.com.

    Follow @Altimmune, Inc. on LinkedIn

    Follow @AltimmuneInc on Twitter

    Investor & Media Contacts:

    Will Brown                                                        

    Chief Financial Officer                                                 

    Phone: 240-654-1450                                                        

    wbrown@altimmune.com



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  2. 12-week Data Readout from ALT-801 Phase 1 Clinical Trial Expected in September

           Approximately $218 Million in Cash and Short-Term Investments to Advance Obesity and Liver Disease Pipeline

    GAITHERSBURG, Md., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three- and six-months ending June 30, 2021 and provided a corporate update.

    "Following data readouts in Q2, Altimmune has focused its efforts on our NASH and emerging obesity pipeline with the encouraging interim data from the ALT-801 Phase 1 trial reinforcing the potential of these programs," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "Our…

    12-week Data Readout from ALT-801 Phase 1 Clinical Trial Expected in September

           Approximately $218 Million in Cash and Short-Term Investments to Advance Obesity and Liver Disease Pipeline

    GAITHERSBURG, Md., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three- and six-months ending June 30, 2021 and provided a corporate update.

    "Following data readouts in Q2, Altimmune has focused its efforts on our NASH and emerging obesity pipeline with the encouraging interim data from the ALT-801 Phase 1 trial reinforcing the potential of these programs," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "Our strong financial position enables us to proceed with a robust ALT-801 development program in the second half of 2021 with the goal of initiating Phase 2 trials in early 2022 for both obesity and NASH indications."

    Recent Highlights:

    • Reported encouraging 6-week interim data from the ongoing Phase 1 clinical trial of ALT-801 in Australia



      • In the study of overweight and obese subjects, a placebo-adjusted weight loss of 6.3% was achieved at 6 weeks of treatment with 1.8 mg once weekly dose, surpassing the 2% pre-established treatment target

      • The multi-dose regimen was well-tolerated without the need for dose titration
      • No subject dropouts related to drug administration reported within the first 6 weeks of treatment



    • Advancing to ALT-801 12-week data readout on three cohorts, expected in September 2021



      • 12-week data on three dose cohorts at the 1.2mg, 1.8mg and 2.4mg dose levels are expected to be reported. The final 12-week dose for all cohorts has been administered
      • Data readouts are expected to include update on weight loss and adverse events, in addition to the following measures:
        • Pharmacokinetics (PK)
        • Lean body mass, calorie intake, resting energy expenditure (REE)
        • Glucose homeostasis
        • Insulin resistance—HOMA-IR2, adiponectin
        • Lipids (HDL, LDL, TG, & lipoprotein (a))
        • Markers of inflammation

    • Filing of ALT-801 investigational new drug (IND) application for non-alcoholic steatohepatitis (NASH) on track for Q3 2021, which will be followed by the initiation of a clinical trial in non-alcoholic fatty liver disease (NAFLD)



      • The Phase 1b, 12-week NAFLD study will include diabetic and non-diabetic subjects and is expected to be conducted at approximately 10 US sites

      • Primary efficacy end point will be reduction in liver fat by MRI-PDFF
      • Study expected to enable a 52-week biopsy driven NASH study in Q1 2022



    • IND in obesity expected to be filed in Q4 2021



      • Phase 2 obesity trial is expected to initiate in Q1 2022
      • Development program expected to include diabetic and non-diabetic subjects
    • Additional clinical development to support NASH and obesity programs during 2021



      • Phase 1 drug-drug interaction study to initiate in Q4 2021 to evaluate ALT-801 interaction with commonly used drugs
      • 12-week Phase 1 study to initiate in Q4 2021 to evaluate ALT-801 effects on glucose control, hemoglobin A1C and insulin resistance in subjects with type 2 diabetes

    • Initiated development of an oral formulation for ALT-801



      • Molecular weight and potency of ALT-801 are well-suited for oral administration

    Financial Results for the Three and Six Months Ended June 30, 2021

    • Altimmune had cash, cash equivalents, short-term investments and restricted cash totaling $217.9 million at June 30, 2021 compared to $216.0 million at December 31, 2020. Through utilization of at-the-market (ATM) offerings during the second quarter of 2021, Altimmune raised net proceeds of $18.2 million and a total of $52.4 million since the beginning of the year.
    • Revenue was $0.1 million for the three months ended June 30, 2021 compared to $0.7 million in the same period in 2020. The change in revenue quarter over quarter was primarily due to a decrease in BARDA revenue during the current period due to the timing of clinical trials and development activities for NasoShield.
    • Research and development expenses were $13.3 million for the three months ended June 30, 2021, compared to $16.6 million in the same period in 2020. The change was primarily the result of increased expenses of $9.7 million primarily related to development activities for the Company's COVID-19 programs, offset by a decrease of $13.0 million resulting from changes in the fair value of contingent consideration liability connected with the acquisition and development of ALT-801.
    • General and administrative expenses were $3.7 million for the three months ended June 30, 2021 compared to $2.5 million in the same period in 2020. The increase during the quarter is primarily due to increased stock compensation expense and additional labor related costs.
    • An impairment on construction-in-progress of $8.1 million was recognized for the three months ended June 30, 2021 related to the build out of a commercial scale manufacturing suite for the Company's recently terminated COVID-19 vaccine program. No impairment was recognized in the prior year.
    • Net loss for the three months ended June 30, 2021 was $24.8 million, or $0.60 net loss per share, compared to $16.8 million in the same period in 2020, or $0.94 net loss per share. Net loss for the six months ended June 30, 2021 was $39.7 million, or $0.99 net loss per share, compared to $20.7 million in the same period in 2020, or $1.25 net loss per share.

    Conference Call Information

    Date:Wednesday, August 11, 2021
    Time:8:30 am Eastern Time
    Domestic Dial-in(844) 615-6509
    International Dial-in:(918) 922-3148
    Conference ID:9484516
    Webcast:https://edge.media-server.com/mmc/p/ne5cqqtf

    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 treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for obesity, 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 ALT-801 Phase 1 clinical trial in September 2021, the potential start of the ALT-801 12-week NAFLD trial in September 2021, the potential start of the ALT-801 drug/drug interaction trial and Type 2 diabetes trial by year end 2021, the potential filing of a NASH IND in Q3 2021, the potential filing of an obesity IND in Q4 2021, the commencement of a 52-week, Phase 2, biopsy-trial based on NASH endpoints in Q1 2022, the commencement of a 24-week, Phase 2, obesity trial in Q1 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; 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                                                        

    wbrown@altimmune.com                                        





     
    ALTIMMUNE, INC.
    CONSOLIDATED BALANCE SHEETS
          
     June 30,  December 31, 
     2021 2020
     (unaudited)   
    ASSETS     
    Current assets:     
    Cash and cash equivalents$174,102,382  $115,917,807 
    Restricted cash 34,174   34,174 
    Total cash, cash equivalents and restricted cash 174,136,556   115,951,981 
    Short-term investments 43,723,840   100,005,558 
    Accounts receivable 4,463,442   4,610,202 
    Tax refund receivable 6,887,981   7,762,793 
    Prepaid expenses and other current assets 9,413,070   1,926,675 
    Total current assets 238,624,889   230,257,209 
    Property and equipment, net 4,751,010   1,056,920 
    Intangible assets, net 12,956,112   12,823,846 
    Other assets 928,839   977,238 
    Total assets$257,260,850  $245,115,213 
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    Current liabilities:     
    Accounts payable$1,421,192  $612,293 
    Accrued expenses and other current liabilities 7,674,536   11,408,154 
    Total current liabilities 9,095,728   12,020,447 
    Contingent consideration 5,270,000   5,390,000 
    Other long-term liabilities 1,617,150   1,828,443 
    Total liabilities 15,982,878   19,238,890 
    Commitments and contingencies (Note 16)     
    Stockholders' equity:     
    Common stock, $0.0001 par value; 200,000,000 shares authorized; 39,693,524

    and 37,142,946 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively
     3,956   3,697 
    Additional paid-in capital 482,083,670   417,337,742 
    Accumulated deficit (235,771,414)  (186,420,599)
    Accumulated other comprehensive loss, net (5,038,240)  (5,044,517)
    Total stockholders' equity 241,277,972   225,876,323 
    Total liabilities and stockholders' equity$257,260,850  $245,115,213 



     
    ALTIMMUNE, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (unaudited)
     
     For the Three Months Ended     For the Six Months Ended
     June 30,  June 30, 
     2021    2020 2021    2020
    Revenues$137,623  $721,636  $975,139  $2,934,330 
    Operating expenses:           
    Research and development 13,272,412   16,594,250   25,150,312   23,781,781 
    General and administrative 3,658,653   2,545,356   7,480,073   4,877,273 
    Impairment loss on construction-in-progress 8,070,000      8,070,000    
    Total operating expenses 25,001,065   19,139,606   40,700,385   28,659,054 
    Loss from operations (24,863,442)  (18,417,970)  (39,725,246)  (25,724,724)
    Other income (expense):           
    Interest expense (22,226)  (3,308)  (33,897)  (5,193)
    Interest income 32,863   81,458   75,362   233,027 
    Other income (expense), net 26,098   (5,878)  (7,034)  19,664 
    Total other income, net 36,735   72,272   34,431   247,498 
    Net loss before income tax benefit (24,826,707)  (18,345,698)  (39,690,815)  (25,477,226)
    Income tax benefit    1,578,782      4,824,661 
    Net loss (24,826,707)  (16,766,916)  (39,690,815)  (20,652,565)
    Other comprehensive income (loss) — unrealized gain (loss) on short-term investments 1,141   20,888   6,277   (11,547)
    Comprehensive loss$(24,825,566) $(16,746,028) $(39,684,538) $(20,664,112)
    Net loss per share, basic and diluted$(0.60) $(0.94) $(0.99) $(1.25)
    Weighted-average common shares outstanding, basic and diluted 41,356,643   17,886,853   40,142,561   16,498,719 


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  3. GAITHERSBURG, Md., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced that it will report its second quarter 2021 financial results on Wednesday, August 11, 2021.

    Altimmune management will host a conference call for investors beginning at 8:30 am E.T. to discuss the second quarter 2021 financial results and provide a business update.

    Conference Call Information:

    Date:Wednesday, August 11
    Time: 8:30 am Eastern Time
    Domestic Dial-in: (844) 615-6509
    International Dial-in:(918) 922-3148
    Conference ID: 9484516
    Webcast:https://edge.media-server.com/mmc/p/ne5cqqtf

    About Altimmune
    Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for obesity…

    GAITHERSBURG, Md., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced that it will report its second quarter 2021 financial results on Wednesday, August 11, 2021.

    Altimmune management will host a conference call for investors beginning at 8:30 am E.T. to discuss the second quarter 2021 financial results and provide a business update.

    Conference Call Information:

    Date:Wednesday, August 11
    Time: 8:30 am Eastern Time
    Domestic Dial-in: (844) 615-6509
    International Dial-in:(918) 922-3148
    Conference ID: 9484516
    Webcast:https://edge.media-server.com/mmc/p/ne5cqqtf

    About Altimmune

    Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for obesity, 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

    Investor and Media Contact:

    Will Brown

    Chief Financial Officer

    Phone: 240-654-1450

    wbrown@altimmune.com



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    • AdCOVID was well tolerated but did not stimulate an adequate immune response in healthy volunteers
    • Altimmune will discontinue further development of AdCOVID and focus its resources on its ongoing obesity and liver programs
    • Altimmune also provides an update on its T-COVID™ Phase 1/2 Clinical Trial

    GAITHERSBURG, Md., June 29, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19. The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.

    AdCOVID Update

    The Phase 1 AdCOVID clinical trial is…

    • AdCOVID was well tolerated but did not stimulate an adequate immune response in healthy volunteers

    • Altimmune will discontinue further development of AdCOVID and focus its resources on its ongoing obesity and liver programs
    • Altimmune also provides an update on its T-COVID™ Phase 1/2 Clinical Trial

    GAITHERSBURG, Md., June 29, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19. The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.

    AdCOVID Update

    The Phase 1 AdCOVID clinical trial is evaluating the safety and immunogenicity of the intranasally administered vaccine candidate in approximately 80 healthy adult volunteers between the ages of 18 and 55. Subjects received either 1 or 2 doses of AdCOVID as a nasal spray at 3 dose levels. In addition to the primary study endpoint of safety and tolerability, the immunogenicity evaluation of AdCOVID included serum binding and neutralizing antibody titers and mucosal IgA antibody from nasopharyngeal swabs post-vaccination.

    AdCOVID appeared to be well tolerated with an overall adverse event profile similar to intranasal saline placebo. The immunogenicity data demonstrated lower than expected immune responses for each of the immune parameters tested. Although antibodies were detected that bound the SARS-CoV-2 Spike protein and neutralized the virus in a subset of subjects, the magnitude of the response and the percent of subjects responding to AdCOVID were substantially lower than what had been demonstrated for other vaccines already authorized for emergency use. Based on these data, and in view of the highly competitive COVID-19 vaccine landscape, Altimmune is discontinuing further development of AdCOVID beyond the completion of this Phase 1 trial.

    "The immune response to AdCOVID was inferior to that seen in our NasoVAX influenza vaccine trial," commented Scot Roberts, PhD, Chief Scientific Officer at Altimmune. "Unlike the NasoVAX study, the AdCOVID study population lacked immunity from prior infection or vaccination. We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID."

    "The top-line Phase 1 clinical data are disappointing given the encouraging preclinical data and our substantial efforts in advancing a differentiated, intranasal vaccine candidate in the fight against COVID-19," said Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "However, we are fortunate to have a strong pipeline with highly differentiated product candidates targeting indications of significant unmet need. Moving forward, Altimmune will focus its resources on the development of ALT-801 and HepTcell, its novel peptide-based therapeutics for obesity and liver diseases."

    Dr. Garg continued, "Encouraging 6-week interim data were recently demonstrated in our ongoing ALT-801 12-week Phase 1 clinical trial in overweight and obese volunteers, demonstrating significant weight loss without the need for dose titration and only transient nausea with no reports of vomiting, diarrhea or constipation. With our strong balance sheet providing a cash runway into 2023, we look forward to advancing our obesity and liver disease programs in the second half of 2021 and beyond."

    T-COVID Update

    The Phase 1/2 trial completed dosing in 2 of the 3 planned dose cohorts. The first 2 cohorts were designed to assess the safety of T-COVID treatment and were comprised of COVID-19 infected patients 49 years or younger with a low risk of progression to serious disease. In these cohorts, T-COVID was well tolerated without any serious adverse events observed. The 3rd cohort was intended to evaluate the efficacy of treatment and enroll patients over the age of 65 or with increased risk of serious sequelae by virtue of pre-existing comorbidities. However, the effective rollout in the United States of authorized COVID-19 vaccines and decreasing incidence of disease significantly reduced the number of patients meeting these criteria, and Altimmune has been unable to enroll subjects in the final cohort.

    As a result of these enrollment challenges, the Company has decided to terminate further enrollment and evaluate options for future T-COVID development following an assessment of the available data and discussions with its partners, the U.S. Army Medical Research & Development Command (USAMRDC) and the Medical Technology Enterprise Consortium (MTEC).

    About Altimmune

    Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver disease and intranasal vaccines. Our pipeline includes next generation peptide therapeutics for obesity, NASH (ALT-801), and chronic hepatitis B (HepTcell™); proprietary intranasal vaccines; and an immune modulating therapeutic for COVID-19 (T-COVID™). 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 data readouts from ALT-801 clinical trials in the second half of 2021 and beyond, sufficient cash on hand to fund the Company into 2023, the prospects for regulatory approval, our ability to manufacture material for our clinical trials and commercial needs, and commercializing or selling any product or drug candidates, including ALT-801 and HepTcell, 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 obtain potential regulatory approvals on the timelines anticipated; the success of future product advancements, including the success of future clinical trials; and funding delays, reductions in or elimination of U.S. government funding with USAMRDC. 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 Brown                                                        

    Chief Financial Officer                                                 

    Phone: 240-654-1450                                                        

    wbrown@altimmune.com



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    • 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.

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    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
    wbrown@altimmune.com sjurchison@altimmune.com 





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