GAITHERSBURG, Md., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three and six months ended June 30, 2022, and provided a business update.
“We continue to advance the development of pemvidutide, our GLP-1/glucagon dual receptor agonist, and look forward to reporting important readouts from our ongoing clinical trials during the coming months,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We expect to announce top line data from our 12-week trial in subjects with obesity/overweight and NAFLD in mid-September 2022, followed by 24-week data from an extension of that trial in Q4 2022. Enrollment in our Phase 2 MOMENTUM obesity trial has been very robust. As of August 10, 167 subjects have been randomized, and approximately 25 additional subjects are being randomized each week. At this rate, we expect to complete the randomization of all 320 subjects in September 2022. We have also made the decision to conduct the interim analysis of this trial when approximately 50%, or 160 study participants, complete 24 weeks of treatment, which we expect will occur in Q1 2023. While we had planned to conduct an interim analysis on approximately 100 subjects at year end 2022, it is our current belief that an interim analysis on 50% of the subjects would be more meaningful.”
“We believe that pemvidutide has the potential to deliver weight loss equaling or exceeding 20% after only 48 weeks of treatment. In addition, we believe that pemvidutide will have a highly differentiated product profile compared to other obesity products in development— including, no dose titration, faster weight loss and robust reductions in lipids. If achieved, we believe these features would translate into greater ease of administration, improved adherence to therapy, and greater potential for cardiovascular benefit,” Dr. Garg added.
Recent Highlights and Anticipated Milestones:
Pemvidutide1 (ALT-801)
1proposed INN
HepTcell
Financial Results for the Three Months Ended June 30, 2022
Conference Call Information:
Date: | Thursday, August 11 |
Time: | 8:30 am Eastern Time |
Webcast: | The conference call will be webcast live on Altimmune’s Investor Relations website at https://ir.altimmune.com/investors. |
Dial-in: | Participants who would like to join the call 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.
About Pemvidutide
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. By combining GLP-1 and glucagon activity in a single peptide, pemvidutide has the potential to achieve weight loss equaling or exceeding 20% after only 48 weeks of treatment. Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases its serum half-life for weekly dosing while slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability. In a 12-week Phase 1 clinical trial, pemvidutide-treated subjects demonstrated striking reductions in body weight, liver fat and serum lipids commonly associated with cardiovascular disease.
About HepTcell
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.
About Altimmune
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 NAFLD trials, diabetic subject trial, drug-drug interaction trial, and the Phase 2 obesity clinical trial of pemvidutide, the timing of the data readouts for the Phase 2 clinical trial of HepTcell, and the prospects for regulatory approval, use, 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 from the ongoing conflict in Ukraine and 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 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, 2021 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
[email protected]
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 135,858 | $ | 190,301 | ||||
Restricted cash | 34 | 34 | ||||||
Total cash, cash equivalents and restricted cash | 135,892 | 190,335 | ||||||
Short-term investments | 48,898 | — | ||||||
Accounts receivable | 195 | 429 | ||||||
Income tax and R&D incentive receivables | 5,900 | 5,410 | ||||||
Prepaid expenses and other current assets | 4,619 | 7,952 | ||||||
Total current assets | 195,504 | 204,126 | ||||||
Property and equipment, net | 1,236 | 1,448 | ||||||
Intangible assets, net | 12,419 | 12,419 | ||||||
Other assets | 747 | 872 | ||||||
Total assets | $ | 209,906 | $ | 218,865 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,872 | $ | 2,034 | ||||
Contingent consideration | — | 6,090 | ||||||
Accrued expenses and other current liabilities | 10,973 | 10,152 | ||||||
Total current liabilities | 13,845 | 18,276 | ||||||
Other long-term liabilities | 1,526 | 1,454 | ||||||
Total liabilities | 15,371 | 19,730 | ||||||
Commitments and contingencies (Note 14) | ||||||||
Stockholders’ equity: | ||||||||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 46,372,105 and 40,993,768 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 5 | 4 | ||||||
Additional paid-in capital | 532,398 | 497,342 | ||||||
Accumulated deficit | (332,708 | ) | (293,171 | ) | ||||
Accumulated other comprehensive loss, net | (5,160 | ) | (5,040 | ) | ||||
Total stockholders’ equity | 194,535 | 199,135 | ||||||
Total liabilities and stockholders’ equity | $ | 209,906 | $ | 218,865 | ||||
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||
Revenues | $ | 8 | $ | 137 | $ | 40 | $ | 975 | |||||||||
Operating expenses: | |||||||||||||||||
Research and development | 15,993 | 13,272 | 31,097 | 25,150 | |||||||||||||
General and administrative | 4,410 | 3,659 | 8,837 | 7,480 | |||||||||||||
Impairment loss on construction-in-progress | — | 8,070 | — | 8,070 | |||||||||||||
Total operating expenses | 20,403 | 25,001 | 39,934 | 40,700 | |||||||||||||
Loss from operations | (20,395 | ) | (24,864 | ) | (39,894 | ) | (39,725 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Interest expense | (65 | ) | (22 | ) | (127 | ) | (34 | ) | |||||||||
Interest income | 328 | 33 | 349 | 75 | |||||||||||||
Other income (expense), net | 25 | 26 | 135 | (7 | ) | ||||||||||||
Total other income (expense), net | 288 | 37 | 357 | 34 | |||||||||||||
Net loss | (20,107 | ) | (24,827 | ) | (39,537 | ) | (39,691 | ) | |||||||||
Other comprehensive income — unrealized (loss) gain on short-term investments | (120 | ) | 1 | (120 | ) | 6 | |||||||||||
Comprehensive loss | $ | (20,227 | ) | $ | (24,826 | ) | $ | (39,657 | ) | $ | (39,685 | ) | |||||
Net loss per share, basic and diluted | $ | (0.42 | ) | $ | (0.60 | ) | $ | (0.90 | ) | $ | (0.99 | ) | |||||
Weighted-average common shares outstanding, basic and diluted | 47,502,599 | 41,356,643 | 44,150,835 | 40,142,561 |
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