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
“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
Recent Highlights and Anticipated Milestones:
- Enrollment in Phase 1b nonalcoholic fatty liver disease (NAFLD) trial is over 90% complete, and data readout is expected in Q3 2022
- The 12-week trial is being conducted at 15 sites in the
U.S., with Dr. Stephen A. Harrisonserving 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).
- The primary efficacy readouts of this trial are liver fat reduction and weight loss.
- A 52-week biopsy driven Phase 2 non-alcoholic steatohepatitis (NASH) trial is expected to follow the conclusion of the NAFLD trial.
- The 12-week trial is being conducted at 15 sites in the
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
- 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 1:1:1:1 to receive either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks.
- The primary endpoint of the MOMENTUM trial is the relative (percent) change in body weight at 48 weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
- An interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with an expected readout in Q4 2022.
- Initiated a double-blind, placebo-controlled 12-week extension to the ongoing NAFLD Phase 1b Trial
- This extension will allow subjects to receive up to a total of 24 weeks of pemvidutide or placebo and provide a read out on weight loss at 24 weeks.
- Topline data from the extension trial expected in Q4 2022.
- Completed 6-month and 9-month toxicology studies of pemvidutide in rats and non-human primates
- No significant findings, including no ALT or blood glucose elevations, were reported.
- Toxicology results support 24-week NAFLD extension and 48-week obesity studies.
- Initiated a 12-week Phase 1 trial to characterize effects of pemvidutide on glucose control in diabetic population
- This represents a follow-on to the evaluation of a pre-diabetic population in our first-in-human trial in which reductions of insulin resistance and maintenance of glucose control were observed.
- Results of a drug-drug interaction trial of pemvidutide expected in the first half of 2022
- Enrollment ongoing for the Phase 2 clinical trial in chronic hepatitis B subjects, with study readout expected H1 2023
- Readouts from this trial are expected to include virological markers of hepatitis B infection and functional cure.
Financial Results for the Three Months Ended
- Altimmune had cash, cash equivalents, short-term investments and restricted cash totaling
$190.3 millionat December 31, 2021.
- Revenue was
$3.3 millionfor the three months ended December 31, 2021compared to $2.3 millionin the same period in 2020. The increase in revenue quarter over quarter was primarily due to the receipt of prior period rate adjustments under the Company’s U.S.government contract for NasoShield, partially offset by the discontinuation of development work under prior programs.
- Research and development expenses were
$20.2 millionfor the three months ended December 31, 2021, compared to $9.0 millionin the same period in 2020. The change was primarily the result of the increased costs related to the development of pemvidutide and an increase in the contingent liability for stock-based milestone payments associated with the acquisition of pemvidutide, partially offset by the discontinuation of development work for prior clinical programs.
- General and administrative expenses were generally consistent period-over-period with
$3.8 millionrecognized for the three months ended December 31, 2021and $4.1 millionin the same period in 2020.
- Net loss for the three months ended
December 31, 2021was $23.9 million, or $0.57net loss per share, compared to $10.6 millionin the same period in 2020, or $0.29net loss per share, due to the factors noted above.
|Conference Call Information
|International Dial-in:||(918) 922-3148|
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. By combining GLP-1 and glucagon activity in a single peptide, pemvidutide has the potential to achieve weight loss comparable to bariatric surgery. 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.
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
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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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 initiation and timing of the Phase 2 clinical trial of pemvidutide, the timing of the data readouts for the Phase 2 clinical trial 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
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CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||190,300,776||$||115,917,807|
|Total cash, cash equivalents and restricted cash||190,334,950||115,951,981|
|Income tax and R&D incentive receivables||5,409,639||7,762,793|
|Prepaid expenses and other current assets||7,952,690||1,926,675|
|Total current assets||204,126,115||230,257,209|
|Property and equipment, net||1,447,786||1,056,920|
|Intangible assets, net||12,418,967||12,823,846|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||10,151,437||11,408,154|
|Total current liabilities||18,275,930||12,020,447|
|Other long-term liabilities||1,454,203||1,828,443|
|Commitments and contingencies (Note 17)|
|Additional paid-in capital||497,342,207||417,337,742|
|Accumulated other comprehensive loss, net||(5,040,163||)||(5,044,517||)|
|Total stockholders’ equity||199,134,711||225,876,323|
|Total liabilities and stockholders’ equity||$||218,864,844||$||245,115,213|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||20,185,064||8,950,572||74,541,115||49,774,328|
|General and administrative||3,777,281||4,111,929||15,413,282||13,209,440|
|Impairment loss on construction-in-progress||3,300,000||—||11,370,000||—|
|Total operating expenses||27,262,345||13,062,501||101,324,397||62,983,768|
|Loss from operations||(23,984,687||)||(10,749,795||)||(96,914,041||)||(54,798,741||)|
|Other income (expense):|
|Other (expense) income, net||(80,635||)||(24,735||)||(373,868||)||24,147|
|Total other (expense) income, net||95,366||17,672||(176,783||)||337,240|
|Net loss before income tax benefit||(23,889,321||)||(10,732,123||)||(97,090,824||)||(54,461,501||)|
|Income tax benefit||—||110,346||—||5,417,024|
|Other comprehensive income (loss) — unrealized gain (loss) on short-term investments||—||(2,245||)||4,354||(24,361||)|
|Net loss per share, basic and diluted||$||(0.57||)||$||(0.29||)||$||(2.35||)||$||(1.91||)|
|Weighted-average common shares outstanding, basic and diluted||41,705,563||36,295,023||41,283,498||25,637,023|
Source: Altimmune, Inc