Full Press Release Details
Altimmune Announces Third Quarter 2021 Financial Results
and Provides a Corporate Update
Exploratory MRI-PDFF analysis of subjects with hepatic steatosis in recently completed Phase 1 study of pemvidutide shows reduction of liver fat to undetectable levels after 6 weeks of treatment
Approximately $200 Million in cash and short-term investments to advance pipeline
GAITHERSBURG, MD, -- November 9, 2021 -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three- and nine-months ending September 30, 2021 and provided a corporate update.
"The third quarter was a momentous time for our pemvidutide (ALT-801) program, as we delivered on positive topline data for the 12-week Phase 1 trial, cleared an IND in non-alcoholic steatohepatitis (NASH) with the FDA and initiated a 12-week Phase 1b study in non-alcoholic fatty liver disease (NAFLD)," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "In addition to the previously announced 12-week data showing double-digit weight loss in the 1.8 mg arm without the need for dose titration, we now have MRI-PDFF data in a subset of subjects with hepatic steatosis, or fatty liver, from that study demonstrating a remarkable reduction in liver fat to undetectable levels after only 6 weeks of pemvidutide treatment. These findings show the potential of pemvidutide in the treatment of both obesity and NASH, and we look forward to sharing the data from our ongoing Phase 1b trial in NAFLD and initiating Phase 2 trials for obesity and NASH in 2022."
Pemvidutide1 (ALT-801)
Financial Results for the Three and Nine Months Ended September 30, 2021
Conference Call Information
| Date: | Wednesday, November 10 |
| Time: | 8:30 am Eastern Time |
| Domestic Dial-in: | (844) 615-6509 |
| International Dial-in: | (918) 922-3148 |
| Conference ID: | 5783655 |
| Webcast: | https://edge.media-server.com/mmc/p/zgrrmubx |
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.
Pemvidutide (proposed INN, formerly known as ALT-801) is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist for obesity and non-alcoholic steatohepatitis (NASH). Altimmune believes the treatment of obesity is the cornerstone of treating NASH and its co-morbidities and views these conditions as significant unmet medical needs.
HepTcell is a novel immunotherapeutic comprised of nine synthetic peptides representing conserved hepatitis B (HBV) sequences formulated with IC31 , a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.
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
(pemvidutide), 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 our Investigational New Drug application (IND) for obesity expected by year end, the commencement of a 48-week Phase 2 obesity study expected to commence in the first half of 2022, the timing of the data readout from the pemvidutide 12-week Phase 1b NAFLD trial in the first half of 2022, the timing of the data readout of the pemvidutide drug/drug interaction trial in the first half of 2022, the commencement of a 52-week, Phase 2, biopsy-trial based on NASH endpoints following the conclusion of the NALFD trial, the timing of a 12-week Phase 1 study to further characterize safety, pharmacokinetics of pemvidutide subjects in diabetic expected to be initiated in Q1 2022, the timing of the data readout from the HepTcell Phase 2 trial in the second half of 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 |
CONSOLIDATED BALANCE SHEETS
| September 30, | December 31, | |||||
| 2021 | 2020 | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 174,863,565 | $ | 115,917,807 | ||
| Restricted cash | 34,174 | 34,174 | ||||
| Total cash, cash equivalents and restricted cash | 174,897,739 | 115,951,981 | ||||
| Short-term investments | 25,020,738 | 100,005,558 | ||||
| Accounts receivable | 1,573,760 | 4,610,202 | ||||
| Income tax receivable | 9,476,435 | 7,762,793 | ||||
| Prepaid expenses and other current assets | 7,294,360 | 1,926,675 | ||||
| Total current assets | 218,263,032 | 230,257,209 | ||||
| Property and equipment, net | 4,718,146 | 1,056,920 | ||||
| Intangible assets, net | 12,993,575 | 12,823,846 | ||||
| Other assets | 931,904 | 977,238 | ||||
| Total assets | $ | 236,906,657 | $ | 245,115,213 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 6,083 | $ | 612,293 | ||
| Accrued expenses and other current liabilities | 19,120,902 | 11,408,154 | ||||
| Total current liabilities | 19,126,985 | 12,020,447 | ||||
| Contingent consideration | 6,950,000 | 5,390,000 | ||||
| Other long-term liabilities | 1,565,611 | 1,828,443 | ||||
| Total liabilities | 27,642,596 | 19,238,890 | ||||
| Commitments and contingencies (Note 16) | ||||||
| Stockholders' equity: | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 39,702,768 and 37,142,946 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 3,959 | 3,697 | ||||
| Additional paid-in capital | 483,582,367 | 417,337,742 | ||||
| Accumulated deficit | (269,282,102) | (186,420,599) | ||||
| Accumulated other comprehensive loss, net | (5,040,163) | (5,044,517) | ||||
| Total stockholders' equity | 209,264,061 | 225,876,323 | ||||
| Total liabilities and stockholders' equity | $ | 236,906,657 | $ | 245,115,213 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| For the Three Months Ended | For the Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Revenues | $ | 157,559 | $ | 2,937,991 | $ | 1,132,698 | $ | 5,872,321 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 29,205,739 | 17,041,975 | 54,356,051 | 40,823,756 | ||||||||
| General and administrative | 4,155,928 | 4,220,238 | 11,636,001 | 9,097,511 | ||||||||
| Impairment loss on construction-in-progress | - | - | 8,070,000 | - | ||||||||
| Total operating expenses | 33,361,667 | 21,262,213 | 74,062,052 | 49,921,267 | ||||||||
| Loss from operations | (33,204,108) | (18,324,222) | (72,929,354) | (44,048,946) | ||||||||
| Other income (expense): | ||||||||||||
| Interest expense | (32,866) | (2,275) | (66,763) | (7,468) | ||||||||
| Interest income | 12,485 | 45,127 | 87,847 | 278,154 | ||||||||
| Other (expense) income, net | (286,199) | 29,218 | (293,233) | 48,882 | ||||||||
| Total other (expense) income, net | (306,580) | 72,070 | (272,149) | 319,568 | ||||||||
| Net loss before income tax benefit | (33,510,688) | (18,252,152) | (73,201,503) | (43,729,378) | ||||||||
| Income tax benefit | - | 482,017 | - | 5,306,678 | ||||||||
| Net loss | (33,510,688) | (17,770,135) | (73,201,503) | (38,422,700) | ||||||||
| Other comprehensive (loss) income - unrealized (loss) gain on short-term investments | (1,923) | (10,569) | 4,354 | (22,116) | ||||||||
| Comprehensive loss | $ | (33,512,611) | $ | (17,780,704) | $ | (73,197,149) | $ | (38,444,816) | ||||
| Net loss per share, basic and diluted | $ | (0.81) | $ | (0.54) | $ | (1.79) | $ | (1.74) | ||||
| Weighted-average common shares outstanding, basic and diluted | 41,370,768 | 33,056,971 | 40,843,905 | 22,058,424 |