On August 10, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three- and six-months ending June 30, 2021 and provided a corporate update (Press release, Altimmune, AUG 10, 2021, View Source [SID1234586343]).

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"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

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.