EX-99.3 4 dp90977_ex9903.htm EXHIBIT 99.3

Exhibit 99.3

 

 

 

 

 

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, 17 May 2018 – 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 InflaRxand 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    0    0 
            
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   December 31, 2017  March 31, 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.