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

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  • Received FDA clearance of IND for Phase II trial of IFX-1 in ANCA-associated vasculitis
  • Established U.S. research facility to continue advancing complement-based research
  • Completion of follow-on offering raising $62.9 million in primary proceeds
  • Cash position approximately €156.1 million (US$182.2 million) as of June 30, 2018

JENA, Germany, Aug. 09, 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 second quarter ended June 30, 2018.

"In the second quarter of 2018 we received FDA clearance of our IND application for a Phase II clinical trial with our lead product, IFX-1, in ANCA-associated vasculitis and expanded our presence in the United States with the opening of a new research facility in Ann Arbor, Michigan, where InflaRx's founders began their pioneering research on anti-C5a technology," said Arnd Christ, Chief Financial Officer of InflaRx.

"InflaRx is delivering on its operating plan and these achievements, in addition to the successful follow-on financing completed in May 2018, will allow the Company to continue advancing its proprietary complement-based therapies through clinical development, and evaluate their potential to bring clinical benefit to patients in additional indications."

Q2 2018 Corporate Highlights

  • On May 8th, 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 (€98.8 million) ($62.9 million to InflaRx and $54.4 million to the selling shareholders), including the full exercise of the underwriters' option to purchase additional shares.
  • On May 15th, InflaRx opened a research facility in Ann Arbor, Michigan to further develop and extend the Company's unique complement system-based therapeutics. Operations will be overseen by Chief Scientific Officer, Prof. Renfeng Guo, M.D. 
  • On June 28th, InflaRx received FDA clearance of an IND application from the FDA. This second open IND in 2018 allows InflaRx to start a phase II study to determine the safety and efficacy of IFX-1 in patients with ANCA-associated vasculitis (AAV), a life-threatening autoimmune disease.             

H1/Q2 2018 Financial Highlights

The figures for the second quarter (Q2, three months ended June 30, 2018) and six months of 2018 (H1, six months ended June 30, 2018) and 2017 represent unaudited figures.

Cash and cash equivalents totalled €156.1 million as of June 30, 2018 compared to €123.3 million as of December 31, 2017. This increase was due to the completion of InflaRx's follow-on offering in May 2018.

Net cash used in operating activities increased by €5.9 million to €11.1 million in the first half of 2018 compared to €5.2 million in the six months ended June 30, 2017, due to a loss for the first half of €12.8 million (H1 2017: €8.5 million).

Research and development expenses amounted to €5.0 million in Q2 2018, an increase by €1.9 million from €3.1 million in Q2 2017, primarily due to higher CMO and CRO expenses for manufacturing and clinical trials for IFX-1 as well as an increase in employee-related costs associated with non-cash share-based compensation.

General and administrative expenses increased by €2.4 million to €3.2 million in Q2 2018, compared to €0.7 in Q2 2017 primarily due to employee-related costs associated with non-cash share-based compensation (€1.4 million) and legal and consulting fees for being a publicly listed company (€0.5 million).

Finance result amounted to a net gain of €5.7 million in Q2 2018, compared to a net loss of €0.8 million in Q2 2017. The increase is mainly attributable to unrealized foreign exchange gains of the USD term deposits (€5.3 million). In the previous year period, a loss of €0.8 million was attributable to interest expenses in connection with preferred shares, which were converted into common shares at the IPO in Q4 2017.

Net loss for the second quarter of 2018 totalled €2.5 million or €0.1 per common share, compared to €4.7 million or €2.0 per common share for the second quarter of 2017.

Additional information regarding these results is included in the notes to the consolidated financial statements as of June 30, 2018.

InflaRx N.V. and subsidiaries

Unaudited condensed consolidated statements of comprehensive loss
for the three months ended June 30, 2018

         
    For the three months
ended June 30, 2018
  For the six months ended
June 30, 2018
in € thousand   Q2 2017   Q2 2018   H1 2017   H1 2018
                 
Other income and expenses (net)       44      30      117   
Research and development expenses   (3,101  )   (5.031  )   (5,502  )   (10,505  )
General and administrative expenses   (731  )   (3,161  )   (1,346  )   (6,158  )
Loss before interest and income taxes   (3,831  )   (8.148  )   (6,817  )   (16,545  )
Finance income       5,742          6,007   
Finance costs   (843  )   (37  )   (1,655  )   (2,226  )
Finance result   (842  )   5,705      (1,655  )   3,781   
Loss for the period   (4,673  )   (2,443  )   (8,473  )   (12,764  )
Other comprehensive loss for the period   (2  )   (17  )   (1  )   (16  )
Total comprehensive loss   (4,675  )   (2,460  )   (8,473  )   (12,780  )
                 
Loss per common share in € (basic/diluted)   (2.0  )   (0.1  )   (3.6  )   (0.5  )
                         

InflaRx N.V. and subsidiaries

Condensed consolidated statements of financial position

in € thousand   December
31, 2017
  June
30, 2018
            unaudited
ASSETS        
             
Non-current assets        
  Intangible assets   41      47   
  Laboratory and office equipment   173      478   
  Financial assets   20      39   
          Total non-current assets   233      565   
             
Current assets        
  Other assets   697      944  
  Other financial assets   0     8,017  
  Cash and cash equivalents   123,282      156,069   
  Total current assets   123,979      165,030   
             
Total assets   124,212      165,595   
             
EQUITY AND LIABILITIES        
             
Equity          
  Issued capital   2,858      3,080   
      Other reserves   167,864      222,753   
  Accumulated deficit   (51,293  )   (64,056  )
  Total equity   119,429      161,776   
             
Non-current liabilities        
  Deferred income   15      13   
  Provisions       54   
  Total non-current liabilities   17      67   
             
Current liabilities        
  Trade payables   4,464      2,226   
  Other liabilities, provisions   302      1,526   
  Total current liabilities   4,766      3,752   
             
Total equity and liabilities   124,212      165,595   
             

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                       (8,473 )         (8,473 )
Other comprehensive income / Exchange differences   0   0     (1 )   0   0     0     (1 )
Total comprehensive loss   0   0     (1 )   0   (8,473 )   0     (8,473 )
Recognition of equity-settled share-based payments                   1,489               1,489  
Balance as of June 30, 2017   31   0     8     3,164   (35,527 )   (350 )   (32,674 )
                                       
Balance as of January 1, 2018   2,858   161,639     0     6,225   (51,293 )   0     119,429  
Comprehensive loss                            
Loss for the period                       (12,764 )         (12,764 )
Exchange differences             (16 )                   (16 )
Total comprehensive loss   0   0     (16 )   0   (12,764 )   0     (12,780 )
Recognition of equity-settled share-based payments                   5,938               5,938  
Issue of share capital                            
  Issued shares   222   52,769                           52,991  
  Transaction costs       (3,801 )                         (3,801 )
Total issue of share capital   222   48,967     0     0   0     0     49,189  
Balance as of June 30, 2018   3,080   210,606     (16 )   12,163   (64,056 )   0     161,776  
                                       


InflaRx N.V. and subsidiaries

Unaudited Condensed consolidated statement of cash flows for the six months ended June 30, 2018

in € thousand   H1 2017    H1 2018  
             
Cash flow from Operations          
Loss before income taxes   (8,473 )   (12,764 )  
               
Reconciliation from result before taxes to net cash flows          
  Depreciation/amortization of intangible assets, laboratory and office equipment   22     50    
  Share based payment expense   1,489     5,938    
  Finance Income   (0 )   (6,007 )  
  Finance costs   1,655     2,247    
  Other non-cash adjustments   (11 )   (58 )  
  Change in Provisions and Government Grants   1,821     1,494    
Working capital adjustments          
  Change in trade payables and other liabilities   (927 )   (2,458 )  
  Change in other assets   (806 )   (271 )  
  Interest received   0     681    
Cash flow from Operations   (5,230 )   (11,148 )  
             
Cash flow from investing activities          
  Cash outflow from the purchase of intangible assets, laboratory and office equipment   (38 )   (361 )  
                 
  Cash outflow for the investment in non-current financial assets   (19 )   (33 )  
  Proceeds from the disposal of long-term financial assets   0     14    
  Purchase of quoted debt securities   0     (8,014 )  
Net cash flows used in investing activities   (57 )   (8,396 )  
             
Financing activities          
  Proceeds from issuance of stock   0     52,991    
  Transaction cost from issuance of stock   0     (3,801 )  
  Proceeds from issuance of preferred shares   1,500     0    
Net cash flows from financing activities   1,500     49,189    
             
Effect of exchange rate changes   0     3,142    
Change in cash and cash equivalents   (3,787 )   32,787    
             
Net change in cash and cash equivalents   (3,787 )   32,787    
  Cash and cash equivalents at beginning of period   29,117     123,282    
Cash and cash equivalents at end of period   25,330     156,069    
             

About InflaRx N.V.:

InflaRx (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 Munich, Germany as well as Ann Arbor, Michigan, USA. InflaRx is listed on the Nasdaq Global Select Market in the United States under the trading symbol "IFRX". For further information please visit www.inflarx.com.

About IFX-1:

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.

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
Hans Herklots
hherklots[at]lifesciadvisors.com
+41 79 598 7149


   

 
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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