GlobeNewswire Inc | Aug 10, 2021 04:01PM EDT

August 10, 2021

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 AustraliaIn 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 targetThe multi-dose regimen was well-tolerated without the need for dose titrationNo 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 202112-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 administeredData 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 homeostasisInsulin resistanceHOMA-IR2, adiponectinLipids (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 sitesPrimary efficacy end point will be reduction in liver fat by MRI-PDFFStudy 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 2022Development program expected to include diabetic and non-diabetic subjects

-- Additional clinical development to support NASH and obesity programs during 2021Phase 1 drug-drug interaction study to initiate in Q4 2021 to evaluate ALT-801 interaction with commonly used drugs12-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-801Molecular 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 Companys 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 Companys 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, 2021Time: 8:30 am Eastern TimeDomestic Dial-in (844) 615-6509International Dial-in: (918) 922-3148Conference ID: 9484516Webcast: 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 Companys 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.

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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 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 toAltimmune, 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 Companys product candidates; the Companys 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 Companys filings with theU.S. Securities and Exchange Commission, including under the heading Risk Factors in the Companys annual report on Form 10-K for the fiscal year endedDecember 31, 2020filed with theSEC, which is available atwww.sec.gov.

Investor & Media Contacts:

Will Brown

Chief Financial Officer

Phone: 240-654-1450

wbrown@altimmune.com

ALTIMMUNE, INC.CONSOLIDATED BALANCE SHEETS June30, December31, 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 174,136,556 115,951,981 cashShort-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 7,674,536 11,408,154 liabilitiesTotal 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; 39,693,524and 37,142,946 shares issued and 3,956 3,697 outstanding at June30,2021 andDecember31,2020, respectivelyAdditional 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 June30, June30, 2021 2020 2021 2020Revenues $ 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 3,658,653 2,545,356 7,480,073 4,877,273 administrativeImpairment loss on 8,070,000 ? 8,070,000 ? construction-in-progressTotal 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), 26,098 (5,878 ) (7,034 ) 19,664 netTotal other income, net 36,735 72,272 34,431 247,498 Net loss before income (24,826,707 ) (18,345,698 ) (39,690,815 ) (25,477,226 )tax benefitIncome tax benefit ? 1,578,782 ? 4,824,661 Net loss (24,826,707 ) (16,766,916 ) (39,690,815 ) (20,652,565 )Other comprehensiveincome (loss) ?unrealized gain (loss) 1,141 20,888 6,277 (11,547 )on short-terminvestmentsComprehensive loss $ (24,825,566 ) $ (16,746,028 ) $ (39,684,538 ) $ (20,664,112 )Net loss per share, $ (0.60 ) $ (0.94 ) $ (0.99 ) $ (1.25 )basic and dilutedWeighted-average commonshares outstanding, 41,356,643 17,886,853 40,142,561 16,498,719 basic and diluted