Full Press Release Details
Altimmune Announces Second Quarter 2024 Financial Results and Provides a Business Update
Recent presentations at major medical meetings provide further support for the differentiated profile of pemvidutide in obesity and metabolic dysfunction-associated steatohepatitis (MASH)
Enrollment progressing in Phase 2b IMPACT trial of pemvidutide in MASH with topline data expected in Q1 2025
Cash, cash equivalents and short-term investments of $164.9 million on June 30, 2024
Webcast to be held today, August 8, 2024, at 8:30 am ET
GAITHERSBURG, MD - August 8, 2024 - Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2024, and provided a business update.
"During the second quarter, we continued to highlight the scientific evidence supporting the robust therapeutic potential of pemvidutide in metabolic diseases," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "The data presented at the European Association for the Study of the Liver (EASL) meeting highlighted the disease-modifying potential of pemvidutide in MASH and reinforces our confidence in achieving success on the MASH resolution and fibrosis improvement endpoints of our Phase 2b IMPACT trial. We also delivered two podium presentations at the American Diabetes Association (ADA) 84th Scientific Sessions that highlighted the robust reductions in body weight and serum lipids with pemvidutide treatment. In addition, we presented data demonstrating class-leading preservation of lean mass among incretin agents, an increasingly important consideration in the treatment of obesity. These data further exemplify the differentiation and broad utility we believe pemvidutide will bring to the rapidly evolving obesity marketplace. We continue to make progress toward expanding the development of pemvidutide in up to three additional indications where its dual GLP-1/glucagon agonism could provide benefit over currently available agents. In parallel with these efforts, our discussions with potential strategic partners continue to progress. We look forward to sharing further updates on each of these initiatives."
Recent Highlights and Anticipated Milestones:
Metabolic Dysfunction-Associated Steatohepatitis (MASH):
Financial Results for the Three Months Ended June 30, 2024
Conference Call Information:
| Date: | Thursday, August 8, 2024 |
| Time: | 8:30 am Eastern Time |
| Webcast: | To listen, the conference call will be webcast live on Altimmune's Investor Relations website at https://ir.altimmune.com/investors . |
| Dial-in: | To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call. |
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) 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 is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.
Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, 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, and the prospects for the utility of, regulatory approval, 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. 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: 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 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 most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov.
| Vipin Garg |
| President and Chief Executive Officer |
| Phone: 240-654-1450 |
| ir@altimmune.com |
| Lee Roth Burns McClellan |
| Phone: 646-382-3403 |
| lroth@burnsmc.com |
| Julia Weilman Burns McClellan |
| Phone: 646-732-4443 |
| jweilman@burnsmc.com |
| Danielle Cantey |
| Inizio Evoke, Biotech |
| Phone: 619-826-4657 |
| Danielle.cantey@inizioevoke.com |
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per-share amounts)
| June 30, | December 31, | |||||
| 2024 | 2023 | |||||
| (Unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 57,128 | $ | 135,117 | ||
| Restricted cash | 41 | 41 | ||||
| Total cash, cash equivalents and restricted cash | 57,169 | 135,158 | ||||
| Short-term investments | 107,780 | 62,698 | ||||
| Accounts and other receivables | 424 | 1,111 | ||||
| Income tax and R&D incentive receivables | 2,588 | 3,742 | ||||
| Prepaid expenses and other current assets | 3,225 | 6,917 | ||||
| Total current assets | 171,186 | 209,626 | ||||
| Property and equipment, net | 483 | 651 | ||||
| Other assets | 1,677 | 363 | ||||
| Total assets | $ | 173,346 | $ | 210,640 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 2,688 | $ | 2,070 | ||
| Accrued expenses and other current liabilities | 12,467 | 10,073 | ||||
| Total current liabilities | 15,155 | 12,143 | ||||
| Other noncurrent liabilities | 5,660 | 4,398 | ||||
| Total liabilities | 20,815 | 16,541 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity: | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 71,046,267 and 70,677,400 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 7 | 7 | ||||
| Additional paid-in capital | 673,081 | 665,427 | ||||
| Accumulated deficit | (515,365) | (466,331) | ||||
| Accumulated other comprehensive loss, net | (5,192) | (5,004) | ||||
| Total stockholders' equity | 152,531 | 194,099 | ||||
| Total liabilities and stockholders' equity | $ | 173,346 | $ | 210,640 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per-share amounts)
| Three Months Ended | Six Months Ended | |||||||||||
| June 30, | June 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenues | $ | 5 | $ | 6 | $ | 10 | $ | 27 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 21,155 | 13,253 | 42,642 | 30,502 | ||||||||
| General and administrative | 5,595 | 4,760 | 10,907 | 9,291 | ||||||||
| Total operating expenses | 26,750 | 18,013 | 53,549 | 39,793 | ||||||||
| Loss from operations | (26,745) | (18,007) | (53,539) | (39,766) | ||||||||
| Other income (expense): | ||||||||||||
| Interest expense | (1) | (2) | (2) | (4) | ||||||||
| Interest income | 2,182 | 1,835 | 4,595 | 3,503 | ||||||||
| Other income (expense), net | (76) | 113 | (88) | 132 | ||||||||
| Total other income (expense), net | 2,105 | 1,946 | 4,505 | 3,631 | ||||||||
| Net loss | (24,640) | (16,061) | (49,034) | (36,135) | ||||||||
| Other comprehensive income - unrealized (loss) gain on short-term investments | (31) | (79) | (188) | 47 | ||||||||
| Comprehensive loss | $ | (24,671) | $ | (16,140) | $ | (49,222) | $ | (36,088) | ||||
| Net loss per share, basic and diluted | $ | (0.35) | $ | (0.32) | $ | (0.69) | $ | (0.72) | ||||
| Weighted-average common shares outstanding, basic and diluted | 70,924,371 | 50,691,558 | 70,863,042 | 50,410,184 |