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Altimmune Announces Third Quarter 2018 Financial Results and Provides Corporate Update

Nov 13, 2018

GAITHERSBURG, Md., Nov. 13, 2018 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced financial results for the three and nine months ended September 30, 2018.

Recent Corporate Highlights

  • Raised gross proceeds of $41.9 million in equity funding through October 10, 2018. After deducting the underwriter discount, placement agent fees, and other offering expenses the Company received net proceeds of approximately $37 million.
     
  • Announced additional positive data from its Phase 2a clinical study of its NasoVAX intranasal influenza vaccine candidate.  The new data showed that serum antibody levels for NasoVAX were stable over a six-month time period when compared to Fluzone’s antibody levels, which declined by over 50% during the same time period. Additionally, a significant mucosal immune response was observed one month after vaccination when compared to both placebo and Fluzone®.  As in the prior clinical studies, NasoVAX again had a clean safety profile.  The Company previously announced positive results from the study in 60 healthy individuals, which demonstrated NasoVAX to be well-tolerated at all doses and showed 100% seroprotection at the two highest dose levels.  Additionally, NasoVAX demonstrated the ability to elicit a significant T cell immune response as compared to Fluzone.  These new data identify another potentially important type of immunity induced by NasoVAX and indicate that NasoVAX may have a higher likelihood of protection throughout the entire flu season.
     
  • Received an award of $2.5 million in additional BARDA funding to support NasoShield development.  The funding is intended to allow vaccine characterization including key formulation parameters and batch consistency.  Additionally, Altimmune will assay clinical samples from its ongoing Phase 1 clinical trial for mucosal immune response and compare different methods of administration in preclinical models.
     
  • Announced initial single-dose data from its Phase 1 study of NasoShield, an anthrax vaccine candidate.  This portion of the ongoing study assessed the safety and immunogenicity of a single intranasal dose of NasoShield in four dose cohort levels and showed NasoShield to be safe and well-tolerated with no serious adverse events. The immunogenicity data suggest that NasoShield may require more than one dose for a robust immune response.  The program is funded through a contract with the Biomedical Advanced Research and Development Authority (“BARDA”) which runs through September 2021 and, if all options are exercised, is expected to provide funding through the end of Phase 2 development. Immunogenicity data for the two-dose cohort will be available in the fourth quarter of 2018.

“The proceeds provided by our recent financings will allow us to invest significantly in the development of NasoVAX and to support our Company going forward,” said William J. Enright, Chief Executive Officer of Altimmune. “Our developing pipeline and novel approaches to vaccines are quite differentiated from other approaches making these large markets attractive opportunities for Altimmune.”

Third Quarter 2018 Financial Highlights

  • During the quarter the Company received $4.3 million of net proceeds from a registered direct offering which brought September 30, 2018 cash on hand to approximately $8.0 million.
     
  • Subsequent to quarter end, the Company received additional net proceeds of approximately $32.7 million related to its October 2 Underwritten Public Offering and October 10 Registered Direct Offering.
     
  • Third quarter revenue was $2.6 million compared to $4.6 million in the prior year period.  Revenue fluctuated in proportion to our research and development expenses for the NasoShield and SparVax-L programs.
     
  • Research and development expenses were $4.7 million compared to $5.9 million in the prior year period.  The decrease is primarily attributable to lower spending on NasoShield manufacturing when compared to the same period in 2017.
     
  • General and administrative expenses were $2.0 million as compared with $3.0 million for the same period in 2017.  The decrease is primarily attributable to 2017 professional services related to the integration of the newly merged entity that did not recur in 2018.
     
  • Other Income (expense) was $0.9 million compared to ($0.5) million for the same period in 2017.  The change was primarily due to the release of warrant liability associated with warrant exchanges consummated during the quarter.
     
  • Net loss attributed to common stockholders was $2.3 million compared to $31.9 million for the same period in 2017.  The increase was due primarily to $26.6 million goodwill impairment in 2017 in addition to the activity described above.

About Altimmune
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 and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. The company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines.

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 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 terms of the Company’s Series B preferred stock offering and related warrants; our lack of financial resources and access to capital; realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; our ability to utilize the benefits of our tax assets and the results of a tax examination initiated by the IRS; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation. 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 reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, which are available at www.sec.gov.

Contacts
Bill Enright                                                                             
President and CEO                                                                  
Phone: 240-654-1450                                                              

Ashley R. Robinson
Managing Director LifeSci Advisors
Phone: 617-535-7742

 
 
ALTIMMUNE, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
                         
    Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2018   2017   2018   2017
Revenue                        
Research grants and contracts   $ 2,629,446     $ 4,565,251     $ 7,727,681     $ 7,892,919  
License revenue     4,947       26,689       14,833       36,565  
Total revenue     2,634,393       4,591,940       7,742,514       7,929,484  
Operating expenses                        
Research and development     4,728,726       5,905,552       15,394,616       13,946,403  
General and administrative     1,963,733       3,038,756       7,345,651       6,863,782  
Goodwill impairment charges           26,600,000       490,676       26,600,000  
Total operating expenses     6,692,459       35,544,308       23,230,943       47,410,185  
Loss from operations     (4,058,066 )     (30,952,368 )     (15,488,429 )     (39,480,701 )
Other income (expense):                        
Changes in fair value of warrant liability, including gain (loss) on exchange     806,224       (508,316 )     (2,874,484 )     (508,316 )
Changes in fair value of embedded derivatives     185,768       (1,157 )     183,638       (1,157 )
Interest expense     (166,946 )     (2,344 )     (169,737 )     (160,103 )
Interest income     21,100       15,372       78,306       19,538  
Other income (expense)     31,378       10786       289,053       9,839  
Total other income (expense)     877,524       (485,659 )     (2,493,224 )     (640,199 )
Net loss before income tax benefit     (3,180,542 )     (31,438,027 )     (17,981,653 )     (40,120,900 )
Income tax benefit     829,393       1,532,790       3,318,124       2,526,499  
Net loss     (2,351,149 )     (29,905,237 )     (14,663,529 )     (37,594,401 )
Other comprehensive income (loss) – foreign currency translation adjustments           (1,028,033 )     (463,177 )     (2,864,839 )
Comprehensive loss   $ (2,351,149 )   $ (30,933,270 )   $ (15,126,706 )   $ (40,459,240 )
Net loss   $ (2,351,149 )   $ (29,905,237 )   $ (14,663,529 )   $ (37,594,401 )
Preferred stock accretion, contributions, and dividends     64,139       (1,962,072 )     (2,527,275 )     (2,125,141 )
Net loss attributed to common stockholders   $ (2,287,010 )   $ (31,867,309 )   $ (17,190,804 )   $ (39,719,542 )
Weighted-average common shares outstanding, basic and diluted     1,321,289       517,596       983,651       386,524  
Net loss per share attributed to common stockholders, basic and diluted   $ (1.73 )   $ (61.57 )   $ (17.48 )   $ (102.76 )
                         
                         


ALTIMMUNE, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
             
             
    September 30,   December 31,
  2018
2017
ASSETS                
Current assets:                
Cash and cash equivalents   $ 7,964,002     $ 8,769,465  
Restricted cash     34,174       3,534,174  
Total cash, cash equivalents and restricted cash     7,998,176       12,303,639  
Accounts receivable     2,547,402       3,806,239  
Tax refund receivable     976,523       6,361,657  
Prepaid expenses and other current assets     443,929       994,332  
Total current assets     11,966,030       23,465,867  
Property and equipment, net     1,407,080       603,146  
Intangible assets, net     38,339,086       38,722,270  
Other assets     1,149,185       238,917  
Total assets   $ 52,861,381     $ 63,030,200  
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY                
Current liabilities:            
Notes payable   $ 1,467,260     $ 49,702  
Accounts payable     150,738       129,075  
Accrued expenses and other current liabilities     6,532,924       3,625,257  
Current portion of deferred revenue     19,753       19,753  
Current portion of deferred rent     173,952       15,914  
Total current liabilities     8,344,627       3,839,701  
Deferred income taxes     2,891,634       5,938,402  
Other long-term liabilities     1,941,932       4,574,507  
Total liabilities     13,178,193       14,352,610  
Contingencies (Note 16)            
Series B redeemable convertible preferred stock; $0.0001 par value; 16,000 shares designated; 0
and 12,177 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively.
          9,281,767  
Stockholders’ equity:            
Common stock, $0.0001 par value; 200,000,000 and 100,000,000 shares authorized; 1,726,198 and
609,280 shares issued; 1,725,630 and 608,499 shares outstanding at September 30, 2018 and
December 31, 2017, respectively
    173       61  
Additional paid-in capital     137,071,546       121,657,587  
Accumulated deficit     (92,348,368 )     (77,684,839 )
Accumulated other comprehensive loss – foreign currency translation adjustments     (5,040,163 )     (4,576,986 )
Total stockholders’ equity     39,683,188       39,395,823  
Total liabilities and stockholders’ equity   $ 52,861,381     $ 63,030,200  
             

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Source: Altimmune, Inc.