Full Press Release Details
Altimmune Announces Fourth Quarter and Full Year 2022 Financial Results and Provides a Business Update
Interim 24-week readout from MOMENTUM Phase 2 obesity trial expected March 2023
Initiation of Phase 2b non-alcoholic steatohepatitis (NASH) trial expected mid-2023
Webcast to be held today, February 28, 2023, at 8:30 am ET
GAITHERSBURG, Maryland -- February 28, 2023 -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.
"The next twelve-months is an important period for potential value-creating data readouts and the clinical development of pemvidutide, our GLP-1/glucagon dual-receptor agonist which is being developed for the treatment of both obesity and NASH. We are looking forward to announcing the top-line 24-week interim results from our MOMENTUM Phase 2 obesity trial in the second half of March," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "In addition, based on the compelling data from our recently completed trial in non-alcoholic fatty liver disease (NAFLD), which included greater than a 75% reduction in liver fat content and significant reductions in non-invasive markers of liver inflammation, we expect to initiate a Phase 2b biopsy-driven trial of pemvidutide in NASH in mid-2023. We expect the key endpoints of this trial to be NASH resolution and fibrosis improvement, both assessed following 24 weeks of treatment. Pemvidutide possesses key attributes that we expect to be important for both obesity and NASH, including the potential for robust reductions in body weight, liver fat, and liver inflammation, along with positive effects on serum lipids and blood pressure. We believe that the absence of dose titration further distinguishes pemvidutide from other incretin-based agents."
Recent Highlights and Anticipated Milestones:
Financial Results for the Three Months Ended December 31, 2022
Conference Call Information:
| Date: | Tuesday, February 28, 2023 |
| 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, may 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 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 NASH. 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, leading to rapid reductions in levels of liver fat. Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases its serum half-life for weekly dosing while likely slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability.
HepTcell is a novel, investigational, 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 the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The company's lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell , an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. 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, the timing of the data readouts of the HepTcell trial and the Phase 2 obesity and NASH clinical trials of pemvidutide, and the prospects for 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. (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: 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 impact of liver fat content and demographics in the Phase 1b NAFLD study on the success of future trials; 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.
Investor & Media Contacts:
| Rich Eisenstadt |
| Chief Financial Officer |
| Phone: 240-654-1450 |
| reisenstadt@altimmune.com |
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| December 31, | ||||||
| 2022 | 2021 | |||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 111,097 | $ | 190,301 | ||
| Restricted cash | 34 | 34 | ||||
| Total cash, cash equivalents and restricted cash | 111,131 | 190,335 | ||||
| Short-term investments | 73,783 | - | ||||
| Accounts receivable | 173 | 429 | ||||
| Income tax and R&D incentive receivables | 2,368 | 5,410 | ||||
| Prepaid expenses and other current assets | 5,358 | 7,952 | ||||
| Total current assets | 192,813 | 204,126 | ||||
| Property and equipment, net | 1,081 | 1,448 | ||||
| Intangible assets, net | 12,419 | 12,419 | ||||
| Other assets | 615 | 872 | ||||
| Total assets | $ | 206,928 | $ | 218,865 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 4,804 | $ | 2,034 | ||
| Contingent consideration | - | 6,090 | ||||
| Accrued expenses and other current liabilities | 12,250 | 10,152 | ||||
| Total current liabilities | 17,054 | 18,276 | ||||
| Other long-term liabilities | 4,581 | 1,454 | ||||
| Total liabilities | 21,635 | 19,730 | ||||
| Commitments and contingencies (Note 17) | ||||||
| Stockholders' equity: | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 49,199,845 and 40,993,768 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively | 5 | 4 | ||||
| Additional paid-in capital | 568,399 | 497,342 | ||||
| Accumulated deficit | (377,884) | (293,171) | ||||
| Accumulated other comprehensive loss, net | (5,227) | (5,040) | ||||
| Total stockholders' equity | 185,293 | 199,135 | ||||
| Total liabilities and stockholders' equity | $ | 206,928 | $ | 218,865 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
| Three Months Ended | Year Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues | $ | (110) | $ | 3,277 | $ | (68) | $ | 4,410 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 19,179 | 20,185 | 70,538 | 74,541 | ||||||||
| General and administrative | 3,805 | 3,777 | 17,134 | 15,413 | ||||||||
| Impairment loss on construction-in-progress | - | 3,300 | - | 11,370 | ||||||||
| Total operating expenses | 22,984 | 27,262 | 87,672 | 101,324 | ||||||||
| Loss from operations | (23,094) | (23,985) | (87,740) | (96,914) | ||||||||
| Other income (expense): | ||||||||||||
| Interest expense | 183 | 62 | (8) | (5) | ||||||||
| Interest income | 1,468 | 115 | 2,870 | 203 | ||||||||
| Other income (expense), net | (217) | (81) | (32) | (374) | ||||||||
| Total other income (expense), net | 1,434 | 96 | 2,830 | (176) | ||||||||
| Net loss before income taxes | (21,660) | (23,889) | (84,910) | (97,090) | ||||||||
| Income tax expense (benefit) | - | - | (197) | - | ||||||||
| Net loss | (21,660) | (23,889) | (84,713) | (97,090) | ||||||||
| Other comprehensive income - unrealized gain (loss) on short-term investments | 76 | - | (187) | 4 | ||||||||
| Comprehensive loss | $ | (21,584) | $ | (23,889) | $ | (84,900) | $ | (97,086) | ||||
| Net loss per share, basic and diluted | $ | (0.43) | $ | (0.57) | $ | (1.81) | $ | (2.35) | ||||
| Weighted-average common shares outstanding, basic and diluted | 50,026,686 | 41,705,563 | 46,926,349 | 41,283,498 |