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Exhibit 99.1
Altimmune Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update
Data readouts from multiple clinical trials expected during the next 6 to 12 months
Strong cash position of $190.3 million as of December 31, 2021
GAITHERSBURG, MD, -- March 15, 2022 -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.
“We expect the next 12 months to be a period of intense execution with value-creating data readouts from multiple clinical trials. We are extremely pleased with the progress of our pemvidutide (ALT-801) program as we showed double-digit weight loss after 12 weeks of treatment, good tolerability without the use of dose titration, and pronounced decreases in serum lipids commonly associated with cardiovascular disease. We also observed a remarkable reduction in liver fat content to undetectable levels after only 6 weeks of pemvidutide treatment in subjects with hepatic steatosis, or fatty liver,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. “In addition to our ongoing 12-week Phase 1b NAFLD trial, we expect to initiate a 48-week Phase 2 trial of pemvidutide in obesity, the MOMENTUM trial, in the next few weeks and look forward to sharing data from both of these trials later this year. In addition, we expect to read out our HepTcell trial in the first half of 2023.”
Recent Highlights and Anticipated Milestones:
Pemvidutide1 (ALT-801)
● | Enrollment in Phase 1b nonalcoholic fatty liver disease (NAFLD) trial is over 90% complete, and data readout is expected in Q3 2022 |
o | The 12-week trial is being conducted at 15 sites in the U.S., with Dr. Stephen A. Harrison serving as Principal Investigator. The trial will be comprised of 72 non-diabetic and diabetic subjects across four treatment arms (pemvidutide 1.2, 1.8, 2.4 mg and placebo). |
o | The primary efficacy readouts of this trial are liver fat reduction and weight loss. |
o | A 52-week biopsy driven Phase 2 non-alcoholic steatohepatitis (NASH) trial is expected to follow the conclusion of the NAFLD trial. |
● | Received U.S. Food and Drug Administration (FDA) clearance of pemvidutide investigational new drug application (IND) for obesity – Initiation of the Phase 2 MOMENTUM trial of pemvidutide in obesity expected in the first quarter of 2022 |
o | The trial is expected to enroll approximately 320 non-diabetic subjects with either obesity or overweight with at least one obesity-related complication. Subjects will be randomized |
1 proposed INN
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Altimmune, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:
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We do not allocate personnel-related costs, costs associated with our general research platform improvements, depreciation or other indirect costs to specific programs.
Research and development costs consist of payroll and personnel expense, consulting costs, external contract research and development expenses, which includes fees paid to other entities that conduct certain research and development activities on our behalf, such as clinical research organizations ("CROs") and contract manufacturing organizations ("CMOs"), raw materials, drug product manufacturing costs, laboratory supplies and allocated overhead, including depreciation and amortization, rent and utilities.
The increased expense was primarily due to: an increase of $22.5 million primarily due to development activities for the COVID-19 program, AdCOVID (which was discontinued in June 2021); an increase of $12.2 million due to the development activities for pemvidutide; a net increase of $5.7 million due to the timing of clinical trial and development activities related to our other programs, along with costs associated with our pre-clinical projects and non-project specific research and development costs including employee compensation and facility costs; and a decrease of $15.6 million primarily due to a decrease in the fair value of contingent consideration liability with respect to the acquisition of pemvidutide.
Material advance payments for goods or services that will be used or rendered for future research and development activities are recorded as a prepaid asset and recognized as expense as the related goods are delivered or the related services are performed.
We also anticipate increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and the SEC requirements, director and officer insurance, investor relations costs and other costs associated with being a public company.
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Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
Material Contracts, Statements, Certifications & more
Altimmune, Inc. provided additional information to their SEC Filing as exhibits
Ticker: ALT
CIK: 1326190
Form Type: 10-K Annual Report
Accession Number: 0001558370-22-003659
Submitted to the SEC: Tue Mar 15 2022 4:06:20 PM EST
Accepted by the SEC: Tue Mar 15 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations