Altimmune Announces Financial Results for the Year Ended December 31, 2018 and Provides Corporate Update
"We made great progress in 2018, starting with encouraging data from our NasoVAX and HepTcell trials, re-capitalizing the Company, and bolstering the leadership team," said
Dr. Garg continued, “2019 is shaping up to be just as transformative as we advance HepTcell toward Phase 2 clinical development, perform proof-of-concept studies for ALT-702, pursue acquisitions of complementary immunotherapeutic assets, and seek a partner to advance NasoVAX. We are optimistic that focusing on the development of early to mid-stage product candidates that address significant unmet needs will lead to long-term success for Altimmune.”
Leadership team highlights
- The Board of Directors appointed
Vipin K. Garg, Ph.D. as President and Chief Executive Officer. Vipin is a seasoned executive with over three decades of experience in the biotechnology and pharmaceutical industries and possesses a proven track record of building and managing both private and publicly traded companies.
- The Company engaged
Will Brownas Acting Chief Financial Officer. He is responsible for all accounting and finance matters including equity offerings, SECreporting, and investor relations. Will is a CPA with significant public accounting experience at PwC and was formerly a controller at Rheem, a multi-national manufacturing company.
- The Company hired José Ochoa as Chief Business Officer. Jose is leading all business development activities including acquisitions, in-licensing, partnerships and out-licensing. José comes to the Company with a wealth of experience including senior business development positions at
IDT Biologika Corporationand Emergent BioSolutions.
Corporate development highlights
- The Company fully retired its 2017 preferred shares and related warrants, and raised gross proceeds of
$56 million, including from a registered direct offering in March 2019.
- The Company completed a comprehensive review of its clinical development pipeline with a strategic decision to focus its resources on immunotherapeutic programs in early to mid-stage development. Accordingly, the Company is seeking a partner for its NasoVAX program and is reviewing in-licensing and acquisition candidates to broaden its development pipeline.
ALT-702 is a tumor immunostimulant product candidate that has the potential to safely elicit or improve immune responses in a variety of cancers. It is a conjugated TLR-7/8 agonist designed to reverse immune-suppressive effects in the tumor microenvironment and promote antitumoral responses without the systemic side effects associated with other injected TLR-7 and TLR-7/8 agonists. This localized immune stimulation is anticipated to turn “cold” tumors to “hot” and to synergize with immune checkpoint inhibitors. The Company is currently developing a full preclinical dataset in murine tumor models with the intention of advancing this program into the clinic.
The Company completed a Phase 2 study for NasoVAX in 2018 and presented the data at the
NasoShield is an anthrax vaccine designed to provide rapid and stable protection after a single intranasal administration. The Company developed the product candidate and launched a Phase 1 study of NasoShield with the support of the
Financial Results for the Year Ended
- The Company received net proceeds of approximately
$37.4 millionfrom a follow-on public offering and two registered direct offerings during 2018. Subsequent to year end, the Company received net proceeds of approximately $12.7 millionfrom its March 2019registered direct offering.
- At December 31, 2018, the Company had
$34.4 millionin cash, cash equivalents, and restricted cash.
- Revenue was
$10.3 millionfor the year ended December 31, 2018 compared to $10.7 millionin the prior year . The decrease was primarily the result of a decrease of $0.6 millionin BARDA revenue due directly to changes in spending on the NasoShield research and development, and an increase of $0.3 millionin NIAID revenue due directly to changes in spending on the SparVax-L research and development.
- Research and development expenses were
$18.5 millionfor the year ended December 31, 2018 compared to $18.4 millionin the prior year. The increased expense was primarily due to:
- an increase of
$0.8 millionin non-project specific research and development costs driven by employee compensation and additional allocated facility costs;
- a decrease of
$0.6 milliondue to timing of manufacturing development activities for NasoShield; and,
- a decrease of
$0.1 millionin direct costs related to NasoVAX, SparVax-L and HepTcell.
- an increase of
- General and administrative expenses were
$9.8 millionfor the year ended December 31, 2018 compared to $8.5 millionin the prior year. The increased expenses were primarily due to increases in severance, professional services, insurance and board of director fees; offset by a decrease in reorganization expenses related to the 2017 merger with Pharmathene which were incurred in 2017.
- Impairment charges were
$24.9 millionfor the year ended December 31, 2018compared to $35.9 millionfor the prior year. Impairment charges in 2018 are related primarily to a write-down of IPR&D assets related to SparVax-L and Oncosyn. Impairment charges in 2017 are due to fully impairing the carrying value of goodwill.
- Other income (expense) was
$(2.5) millionfor the year ended December 31, 2018 compared to ($18.5) thousandin the prior year. The increased expense was primarily due to changes in the fair value of the Company’s warrant liability.
- Net loss attributed to common stockholders for the year ended December 31, 2018 was
$42.5 millioncompared to $51.4 millionin the prior year.
|Conference Call Details|
|Date:||Tuesday, April 2, 2019|
|Time:||8:30am Eastern Time|
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease. HepTcell is a synthetic peptide immunotherapeutic candidate designed to break immune tolerance in chronic Hepatitis B infection. ALT-702, a TLR-7/8 agonist conjugate, is an immunostimulant product candidate that has the potential to safely elicit or improve immune responses in a variety of therapeutic settings. NasoVAX, our influenza vaccine candidate, has unique characteristics that stimulate multiple arms of the immune system and offers the potential to stop infection and the spread of flu, while being easier to administer through an intranasal spray. NasoShield is a next-generation intranasal anthrax vaccine candidate that is intended to improve protection and safety while having favorable dosage and storage properties compared to other anthrax vaccines. By leveraging the complementary attributes of its proprietary technology platforms, Altimmune is able to design and develop immunotherapeutic products tailored to address a wide range of disease indications including both acute and chronic infections and cancer.
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 prospects for 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: 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 U.S. government funding and/or non-renewal of expiring funding under the Company’s agreement with
|Vipin K. Garg, Ph.D.||Ashley R. Robinson|
|President and CEO||Managing Director LifeSci Advisors|
|Phone: 919-434-6643||Phone: 617-535-7742|
|Email: email@example.com||Email: firstname.lastname@example.org|
CONSOLIDATED BALANCE SHEETS
|As of December 31,|
|Cash and cash equivalents||$||33,718,713||$||8,769,465|
|Total cash, cash equivalents, and restricted cash||34,353,129||12,303,639|
|Tax refunds receivable||1,008,973||6,361,657|
|Prepaid expenses and other current assets||548,094||994,332|
|Total current assets||39,372,134||23,465,867|
|Property and equipment, net||1,342,802||603,146|
|Intangible assets, net||13,851,924||38,722,270|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity|
|Accrued expenses and other current liabilities||4,082,949||3,660,924|
|Total current liabilities||4,527,405||3,839,701|
|Deferred income taxes||58,500||5,938,402|
|Other long-term liabilities||1,852,071||4,574,507|
|Commitments and contingencies (Note 15)|
|Series B redeemable convertible preferred stock; $0.0001 par value; 16,000 shares designated; zero and 12,177 shares issued and outstanding at December 31, 2018 and 2017, respectively; aggregate liquidation and redemption value of $9,281,767 at December 31, 2017||—||9,281,767|
|Common stock, $0.0001 par value; 200,000,000 and 100,000,000 shares authorized; 9,078,735 and 609,280 shares issued; 9,078,238 and 608,499 shares outstanding at December 31, 2018 and 2017, respectively||876||61|
|Additional paid-in capital||170,207,844||121,657,587|
|Accumulated other comprehensive loss — foreign currency translation adjustments||(5,040,163||)||(4,576,986||)|
|Total stockholders’ equity||48,312,566||39,395,823|
|Total liabilities and stockholders’ equity||$||54,750,542||$||63,030,200|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|For the Year Ended December 31,|
|Research grants and contracts||$||10,311,388||$||10,696,819|
|Research and development||18,459,310||18,406,329|
|General and administrative||9,765,581||8,457,557|
|Total operating expenses||53,165,578||62,783,581|
|Loss from operations||(42,834,410||)||(52,045,259||)|
|Other income (expense)|
|Changes in fair value of warrant liability, including loss on exchange||(2,878,484||)||97,763|
|Changes in fair value of embedded derivative||184,555||(7,379||)|
|Other income, net||277,886||5,670|
|Total other income (expense)||(2,486,536||)||(18,506||)|
|Net loss before income tax benefit||(45,320,946||)||(52,063,765||)|
|Income tax benefit||6,149,794||5,638,375|
|Other comprehensive income (loss) — foreign currency translation adjustments||(463,177||)||2,997,826|
|Preferred stock accretion and other deemed dividends||(3,307,800||)||(4,930,010||)|
|Net loss attributable to common stockholders||$||(42,478,952||)||$||(51,355,400||)|
|Weighted-average common shares outstanding, basic and diluted||2,802,382||431,878|
|Net loss per share attributable to common stockholders, basic and diluted||$||(15.16||)||$||(118.91||)|
Source: Altimmune, Inc.