Altimmune Announces Financial Results for the Year Ended December 31, 2019 and Provides a Corporate Update
“2019 was a productive year for the Company with the acquisition of ALT-801, a supplemental award for the development of NasoShield from BARDA, and the advancement of ALT-702 as a preclinical program,” said
Corporate Update and 2019 Highlights
- Initiated development of “AdCOVID”, our single-dose intranasal COVID-19 vaccine candidate
Utilizing our proprietary intranasal vaccine technology, the Company began development of AdCOVID, a vaccine candidate to protect against COVID-19. We believe, our vaccine technology is particularly well positioned to respond to pandemic respiratory infections as it combines intranasal dosing, a broad, rapid immune response and room temperature stability with avoidance of cold chain shipping requirements, making it easier to distribute across communities. The Company designed and created the vaccine candidate in February and plans to begin animal testing in Q2 2020. The Company is engaged in discussions with a number of organizations who are addressing this crisis, including
The United States Medical Countermeasures Task Force, The World Health Organization, academia, and other institutions engaged in the effort.
- Announced positive results for ALT-702 in a preclinical model of colorectal cancer
ALT-702 met a key preclinical milestone with the demonstration of systemic antitumor activity in a preclinical model of colorectal cancer following its local injection into solid tumors. ALT-702 is a depot-forming immune stimulant candidate designed to safely activate tumor immunity. In these studies, regression of both treated and non-treated tumors was observed following combination treatment with ALT-702 and a CTLA-4 immune checkpoint inhibitor, with overall survival in the combination group markedly better than either agent alone. These findings highlight the potential benefits of ALT-702 in both local and metastatic disease and support continued development activities.
Acquired Spitfire Pharma, Inc.with NASH Candidate ALT-801
The Company acquired
Spitfire Pharma, Inc.including the product candidate ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH). ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon receptors and a differentiated PK profile to improve tolerability. ALT-801 is designed to treat obesity, the basic underlying cause of NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD). The Company is preparing for a Phase 1 clinical trial anticipated to begin in 2020.
$3.7 millionBARDA funding for NasoShield Phase 1b trial
In Q3, the Company modified its existing anthrax vaccine development contract with the
Biomedical Advanced Research and Development Authority(BARDA), resulting in $3.7 millionof additional funding. The supplemental funding will support the initiation and conduct of a Phase 1b clinical trial of NasoShield in 2020 to evaluate alternative methods of intranasal dosing in humans. NasoShield is being developed as a single-dose, intranasal post-exposure anthrax vaccine, and is the only anthrax product candidate supported by BARDA. We believe it offers potentially transformational improvements over the current two and three dose vaccines. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 millionif all options in the contact are exercised.
Financial Results for the Year Ended
December 31, 2019, the Company had cash, cash equivalents and short-term investments of $37.3 million.
- Revenue was
$5.8 millionfor the year ended December 31, 2019compared to $10.3 millionin the prior year. The change was due to a decrease in billings under the Company’s U.S.government contracts due to timing of manufacturing and clinical trials for the NasoShield program and the 2018 completion of the primary activities under the SparVax-L contract.
- Research and development expenses were
$17.8 millionfor the year ended December 31, 2019compared to $18.5 millionin the prior year period. The decrease was attributable to lower manufacturing and clinical trial costs on existing programs offset by IPR&D expense recognized in conjunction with the acquisition of Spitfire Pharma, Inc.
- General and administrative expenses were
$8.5 millionfor the year ended December 31, 2019compared to $9.8 millionin the prior year period. The decrease was attributable to lower compensation, professional services and legal costs; offset by an increase in insurance premiums.
- Impairment charges were
$1.0 millionfor the year ended December 31, 2019compared to $24.9 millionfor the prior year. Impairment in both years was due primarily to the SparVax-L program as the development contract with NIAID ended in Q3 2019, with no further funding identified. As disclosed by BARDA, U.S.government funding for anthrax will now focus on post-exposure vaccines that offer transformational improvements over a two-dose vaccine. Since SparVax-L was being developed as a two-dose vaccine candidate and our NasoShield program fits the government’s funding profile with active funding, additional development of SparVax-L is not expected.
- Other income (expense) was
$0.9 millionfor the year ended December 31, 2019compared to ($2.5) millionin the prior year. The 2019 activity is attributable to interest income earned on cash and investments while the 2018 expense was primarily due to changes in the fair value of the Company’s warrant liability, including loss on exchange.
- Net loss attributed to common stockholders for the year ended
December 31, 2019was $20.97 million, or ( $1.60) per share, compared to $42.48 millionin the prior year, or ( $15.16) per share. The difference in net loss is primarily attributable to the $24.9 millionimpairment recognized in 2018.
Conference Call Information
Altimmune will host a conference call to discuss the company’s year end results and other business information.
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 investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
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 development of our AdCOVID vaccine product candidate and initiation of animal testing in Q2 2020 and a Phase 1 clinical study in Q3 2020 for AdCOVID, the filing of the IND for ALT-801 in 2020, the initiation of a Phase 1 clinical study in 2020 and receipt of data from this clinical study in 2021, the initiation of a NasoShield Phase 1b clinical study in the first quarter of 2020, the filing of the IND for HepTcell in 2020, 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: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; funding delays, reductions in or elimination of
|Chief Financial Officer||Managing Director LifeSci Advisors|
|Phone: 240-654-1450||Phone: 617-430-7577|
|Email: email@example.com||Email: firstname.lastname@example.org|
CONSOLIDATED BALANCE SHEETS
|As of December 31,|
|Cash and cash equivalents||$||8,962,686||$||33,718,713|
|Total cash, cash equivalents, and restricted cash||8,996,860||34,353,129|
|Tax refund receivable||629,096||1,008,973|
|Prepaid expenses and other current assets||470,228||548,094|
|Total current assets||39,394,749||39,372,134|
|Property and equipment, net||1,104,208||1,342,802|
|Right of use asset||698,321||—|
|Intangible assets, net||12,732,195||13,851,924|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity|
|Accrued expenses and other current liabilities||3,904,767||4,082,949|
|Total current liabilities||3,922,999||4,527,405|
|Deferred income taxes||—||58,500|
|Other long-term liabilities||1,864,875||1,852,071|
|Commitments and contingencies (Note 16)|
|Additional paid-in capital||187,914,916||170,207,844|
|Accumulated other comprehensive loss, net||(5,020,156||)||(5,040,163||)|
|Total stockholders’ equity||45,520,146||48,312,566|
|Total liabilities and stockholders’ equity||$||54,058,020||$||54,750,542|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|For the Year Ended December 31,|
|Research and development||17,765,553||18,459,310|
|General and administrative||8,500,783||9,765,581|
|Total operating expenses||27,266,336||53,165,578|
|Loss from operations||(21,464,935||)||(42,834,410||)|
|Other income (expense)|
|Changes in fair value of warrant liability, including loss on exchange||30,000||(2,878,484||)|
|Changes in fair value of embedded derivative||—||184,555|
|Other income, net||15,139||277,886|
|Total other income (expense)||886,304||(2,486,536||)|
|Net loss before income tax benefit||(20,578,631||)||(45,320,946||)|
|Income tax benefit||58,500||6,149,794|
|Other comprehensive loss — foreign currency translation adjustment||—||(463,177||)|
|Other comprehensive income — unrealized gains on investments||20,007||—|
|Preferred stock accretion and other deemed dividends||(452,925||)||(3,307,800||)|
|Net loss attributable to common stockholders||$||(20,973,056||)||$||(42,478,952||)|
|Weighted-average common shares outstanding, basic and diluted||13,124,951||2,802,382|
|Net loss per share attributable to common stockholders, basic and diluted||$||(1.60||)||$||(15.16||)|
Source: Altimmune, Inc.