InflaRx N.V. Reports First Quarter 2018 Financial & Operating Results

Initiated international Phase IIb study of IFX-1 in Hidradenitis Suppurativa patients
Completion of primary and secondary offering of US$117 million
Cash position approximately US$137 million (€115 million) as of March 31, 2018

JENA, Germany, May 17, 2018 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, reported financial and operating results for the first quarter ended March 31, 2018.

"During the first quarter, we initiated an international Phase IIb clinical trial with our lead product, IFX-1, in Hidradenitis Suppurativa (HS) and we are currently preparing to start a Phase II clinical trial in ANCA Associated Vasculitis (AAV) until the third quarter of 2018," said Arnd Christ, Chief Financial Officer of InflaRx. "More recently, we successfully completed a follow-on financing in May 2018, which allows us to further accelerate our strategy and expand our clinical pipeline into additional inflammatory indications."

Corporate Highlights

  • On January 9, 2018, InflaRx received IND acceptance to proceed with a Phase IIb trial with lead candidate IFX-1 in Hidradenitis Suppurativa.
  • On February 6, 2018, InflaRx appointed Tony Gibney to its Board of Directors. Mr. Gibney has 23 years of experience as a life sciences-focused investment banker at Leerink Partners, Merrill Lynch, and Lehman Brothers.
  • On March 8, 2018, InflaRx enrolled the first patient in its Phase IIb trial with IFX-1 in Hidradenitis Suppurativa.
  • On May 8, 2018, InflaRx closed a primary and secondary offering of 3,450,000 common shares, consisting of 1,850,000 common shares offered by InflaRx and 1,600,000 common shares offered by the selling shareholders at price to the public of $34.00 per common share for total gross proceeds of $117.3 million, consisting of total gross proceeds to InflaRx of $62.9 million and total gross proceeds to the selling shareholders of $54.4 million, which includes the full exercise of the underwriters' option to purchase additional shares. 

Q1 2018 Financial Highlights

Cash and cash equivalents totaled €115.2 million as of March 31, 2018 compared to €27.9 million as of March 31, 2017. This increase was primarily due to the completion of InflaRx's initial public offering of common shares in November 2017, the exercised green shoe in December 2017, and the primary portion of the Series D financing executed in October 2017.

Net cash flow from operations increased from €2.7 million in the three months ended March 31, 2017 to €5.8 million in the three months ended March 31, 2018 mainly due to the increase of cash expenses, such as third-party expenses for manufacturing and clinical trials for our lead program IFX-1 and personnel-related expenses.

Research and development expenses incurred for the three months ended March 31, 2018 increased over the corresponding period in 2017 by €3.1 million. This increase is primarily due to a €1.9 million increase in CRO and CMO expenses associated with preclinical studies and clinical trials conducted for IFX-1 and a €1.2 million increase in employee-related costs caused by higher expenses associated with non-cash stock-based compensation, principally from equity award grants under our Stock Option Plans 2016 and 2017, respectively (€0.8 million increase).

General and administrative expenses increased by €2.4 million to €3.0 million for the three months ended March 31, 2018, from €0.6 million for the three months ended March 31, 2017. This increase is primarily due to a €1.7 million increase in employee-related costs associated with non-cash stock-based compensation, principally from equity award grants under our Stock Option Plans 2016 and 2017, respectively increased by €1.4 million. This €0.5 million increase in legal, consulting and audit fees is mainly attributable to costs of being a publicly listed company, as well as tax services.

Finance costs (net) increased by €1.1 million to €1.9 million for the three months ended March 31, 2018, from €0.8 million for the three months ended March 31, 2017.  Such increase is primarily due to unrealized foreign exchange losses of our USD term deposits (€2.2 million). This was partially offset by costs such as interest in connection with preferred shares (€0.8 million) in the three months ended March 31, 2017. Preferred shares were converted into common shares in connection with the initial public offering in the fourth quarter of 2017.

Net loss for the first quarter of 2018 was €10.3 million or €0.4 per common share, compared to €3.8 million or €1.6 per common share for the first quarter of 2017.

Additional information regarding these results is included in the notes to the consolidated financial statements as of March 31, 2018.

 
 
InflaRx N.V. and subsidiaries
 
Unaudited condensed consolidated statements of comprehensive loss 
for the three months ended March 31,
 
in € thousand   2017     2018  
         
Other income and expenses (net)   28     70  
Research and development expenses   (2,401 )   (5,474 )
General and administrative expenses   (615 )   (3,005 )
Loss before interest and income taxes   (2,987 )   (8,409 )
Finance income   0     265  
Finance costs   (813 )   (2,188 )
Finance costs (net)   (813 )   (1,924 )
Loss for the period   (3,800 )   (10,333 )
         
Other comprehensive loss for the period        
         
Total comprehensive loss   (3,799 )   (10,332 )
         
Loss per common share in € (basic/diluted)   (1.6 )   (0.4 )
             
             
InflaRx N.V. and subsidiaries
 
Condensed consolidated statements of financial position
 
in € thousand   31.12.2017     31.03.2018  
          unaudited
ASSETS          
           
Non-current assets          
  Intangible assets   41     39  
  Laboratory and office equipment   173     245  
  Financial assets   20     56  
  Total non-current assets   233      340   
           
Current assets          
  Other assets   697     654  
  Cash and cash equivalents   123,282     115,240  
  Total current assets   123,979      115,893   
           
Total assets     124,212      116,233   
           
EQUITY AND LIABILITIES          
           
Equity        
  Issued capital   2,858     2,858  
  Other reserves   167,864     170,802  
  Accumulated deficit   (51,293 )   (61,625 )
  Total equity   119,429      112,034   
           
Non-current liabilities        
  Deferred income   15     14  
  Provisions   2     2  
  Total non-current liabilities   17      16   
           
Current liabilities        
  Trade payables   4,464     3,133  
  Other liabilities, provisions   302     1,050  
  Total current liabilities   4,766     4,183   
           
Total equity and liabilities   124,212      116,233   
             
             
InflaRx N.V. and subsidiaries
 
Unaudited Condensed consolidated statements of changes in equity
            Other reserves            
in € thousand   Issued
capital
  Capital
reserve
  currency
translation
  share-
based
payments
  Accumulated
deficit
  Own
shares
  Total
equity
                             
Balance as of January 1, 2017   31   0   9   1,675   (27,055 )   (350 )   (25,690 )
                             
Comprehensive loss                            
Loss for the period                   (3,800 )         (3,800 )
Total comprehensive loss   0   0   0   0   (3,800 )   0     (3,800 )
                             
Recognition of equity-settled share-based payments               710               710  
Balance as of March 31, 2017   31   0   9   2,385   (30,854 )   (350 )   (28,779 )
                             
Balance as of January 1, 2018   2,858   161,639   0   6,225   (51,293 )   0     119,429  
                             
Comprehensive loss                            
Loss for the period                   (10,333 )         (10,333 )
Exchange differences           0                   0  
Total comprehensive loss   0   0   0   0   (10,333 )   0     (10,332 )
                             
Recognition of equity-settled share-based payments               2,937               2,937  
Balance as of March 31, 2018   2,859   161,639   0   9,163   (61,625 )   0     112,034  
                                   
                                   
InflaRx N.V. and subsidiaries
 
Unaudited Condensed consolidated statement of cash flows
for the three months ended March 31,
 
in € thousand   2017
  2018 
           
Cash flow from Operations        
Loss before income taxes   (3,800 )   (10,333 )
Reconciliation from result before taxes to net cash flows        
  Depreciation/amortization of intangible assets, laboratory and office equipment   10     22  
  Share based payment expense   710     2,938  
  Finance Income   0     (265 )
  Finance costs   813     2,188  
  other non-cash adjustments   (4 )   (25 )
  Change in Provisions and Government Grants   697     977  
Working capital adjustments        
  Change in Trade payables and other liabilities   (1,225 )   (1,561 )
  Change in other assets   73     43  
  Interest received   0     265  
Cash flow from Operations   (2,727 )   (5,751 )
           
Cash flow from investing activities        
  Cash outflow from the purchase of intangible assets, laboratory and office equipment   (26 )   (93 )
               
  Cash outflow for the investment in non-current financial assets   0     (36 )
Net cash flows used in investing activities   (26 )   (129 )
           
Financing activities        
  Proceeds from issuance of preferred shares   1,500     0  
Net cash flows from financing activities   1,500     0  
           
           
Effect of exchange rate changes   0     (2,163 )
Change in cash and cash equivalents   (1,252 )   (8,042 )
           
Net change in cash and cash equivalents   (1,252 )   (8,042 )
  Cash and cash equivalents at beginning of period   29,117     123,282  
Cash and cash equivalents at end of period   27,864     115,240  
             

IFX-1 is a first-in-class monoclonal anti-complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has demonstrated control of the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. IFX-1 is the first monoclonal anti-C5a antibody introduced into clinical development that has, to date, successfully completed three clinical Phase II studies. In total, more than 150 patients have so far been treated with IFX-1, which was well tolerated. IFX-1 is currently being developed for different inflammatory indications.

InflaRx N.V. (NASDAQ:IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007 and has offices in Jena and in Munich, Germany. For further information please visit www.inflarx.com.

Contacts:

InflaRx N.V.
Prof. Dr. Niels C. Riedemann
Chief Executive Officer
info[at]inflarx.de
+49-3641-508180

Arnd Christ
Chief Financial Officer
info[at]inflarx.de
+49-89-4141897800

   
Investor Relations
LifeSci Advisors
Chris Maggos
chris[at]lifesciadvisors.com
+41 79 367 6254
 

 

   
Media US
LifeSci Public Relations
Matt Middleman, M.D.
matt[at]lifescipublicrelations.com
+1 646 627 8384
Media Europe
MC Services AG
Katja Arnold
katja.arnold[at]mc-services.eu
+49 89 210 228 40

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "estimate," "predict," "potential" or "continue" and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading "Risk Factors" in InflaRx's periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

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