On June 16, 2021,
the Company 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.
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.
Forward-Looking Statement
The Company cautions you that
statements included in this Current Report on Form 8-K 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 applications, the potential
to 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 some cases, forward-looking
statements can be identified by terminology such as “may,” “could,” “should,” “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and
similar expressions and their variants or the negative of these terms or other comparable terminology, although not all forward-looking
statements contain these words. 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. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking
statements contained in this Current Report on Form 8-K in the event of new information, future developments or otherwise. These forward-looking
statements speak only as of the date hereof.