0000950103-18-009533.txt : 20180809 0000950103-18-009533.hdr.sgml : 20180809 20180809073536 ACCESSION NUMBER: 0000950103-18-009533 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20180809 FILED AS OF DATE: 20180809 DATE AS OF CHANGE: 20180809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InflaRx N.V. CENTRAL INDEX KEY: 0001708688 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: P7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38283 FILM NUMBER: 181003197 BUSINESS ADDRESS: STREET 1: WINZERLAER STR. 2 CITY: JENA STATE: 2M ZIP: 07745 BUSINESS PHONE: 49 3641 508180 MAIL ADDRESS: STREET 1: WINZERLAER STR. 2 CITY: JENA STATE: 2M ZIP: 07745 FORMER COMPANY: FORMER CONFORMED NAME: Fireman B.V. DATE OF NAME CHANGE: 20170606 6-K 1 dp94153_6k.htm FORM 6-K

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

__________________

 

FORM 6-K

__________________

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934

 

August 9, 2018

 

Commission File Number: 001-38283

__________________________________

 

InflaRx N.V.

__________________________________

 

Winzerlaer Str. 2

07745 Jena, Germany

(+49) 3641 508180

(Address of principal executive offices)

__________________________________

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

 

 

 

 

INCORPORATION BY REFERENCE

 

Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-1 (Registration Number 333- 224596) and Form S-8 (Registration Number 333-221656) of InflaRx N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

Exhibit 99.3 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Jena, Germany, August 9, 2018.

 

  INFLARX N.V.
   
  By:  /s/ Niels Riedemann
    Name:  Niels Riedemann
Title:    Chief Executive Officer

 

 

 

EXHIBIT INDEX

 

Exhibit Description of Exhibit
99.1 InflaRx N.V. Unaudited Condensed Consolidated Financial Statements as of and for the Three and Six Months Ended June 30, 2018
99.2 InflaRx N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
99.3 InflaRx N.V. Press Release dated August 9, 2018

 

 

EX-99.1 2 dp94153_ex9901.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

 

 

InflaRx N.V. 

Amsterdam

 

Condensed Consolidated Interim 

Financial Statements

 

 

 

 

 

 

 

InflaRx N.V. and subsidiaries

 

Unaudited condensed consolidated statements of comprehensive loss

 

      For the three months ended June 30,  For the six months ended June 30,
in € thousand  Note  2017  2018  2017  2018
                
Other income and expenses (net)     2  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     0  5,742  0  6,007
Finance expense     (843)  (37)  (1,655)  (2,226)
Finance result  7  (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)

 

The notes are an integral part of these condensed consolidated financial statements.

 

 

 

InflaRx N.V. and subsidiaries

 

Condensed consolidated statements of financial position

 

in € thousand  Note  31.12.2017  30.06.2018
          
ASSETS         
          
Non-current assets         
Intangible assets     41  47
Laboratory and office equipment     173  478
Other financial assets  3  20  39
Total non-current assets     233  565
          
Current assets         
Other assets  3  697  944
Other financial assets  3  0  8,017
Cash and cash equivalents  4  123,282  156,069
Total current assets     123,979  165,030
          
Total assets     124,212  165,595
          
EQUITY AND LIABILITIES         
          
Equity         
Issued capital  5  2,858  3,080
Other reserves  6  167,864  222,753
Accumulated deficit     (51,293)  (64,056)
Total equity     119,429  161,776
          
Non-current liabilities         
Deferred income     15  13
Provisions     2  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
          

 

The notes are an integral part of these condensed consolidated financial statements.

 

 

 

InflaRx N.V. and subsidiaries

 

Unaudited condensed consolidated statements of changes in equity

 

                  Other reserves            
in € thousand   Note   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       0   0   0   0   (8,473)   0   (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   6   0   0   0   1,489   0   0   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       0   0   0   0   (12,764)   0   (12,764)
Exchange differences       0   0   (16)   0   0   0   (16)
Total comprehensive loss       0   0   (16)   0   (12,764)   0   (12,780)
                                   
Recognition of equity-settled share-based payments   6   0   0   0   5,938   0   0   5,938
                                   
Issue of share capital                                
  Issued shares   5   222   52,769   0   0   0   0   52,991
  Transaction costs   5   0   (3,801)   0   0   0   0   (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

 

The notes are an integral part of these condensed consolidated financial statements.

 

 

 

InflaRx N.V. and subsidiaries

 

Unaudited condensed consolidated statement of cash flows

  

      For the six months ended June 30,
in € thousand  Note  2017  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  6  1,489  5,938
Finance income  7  (0)  (6,007)
Finance costs  7  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 other investments     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

 

The notes are an integral part of these condensed consolidated financial statements.

 

 

 

InflaRx N.V. and subsidiaries

 

Index to notes to the condensed consolidated interim financial statements

 

(1) Reporting entity 2
(2) Basis for preparation and changes to Group’s accounting policies 2
(3) Other financial assets and other assets 4
(4) Cash and cash equivalents 5
(5) Issue of share capital 5
(6) Share-based payments 5
(7) Finance costs (net) 6
(8) Related parties 7

 

1

 

InflaRx N.V. and subsidiaries

 

Notes to the condensed consolidated interim financial statements

 

(1)Reporting entity

 

The condensed consolidated interim financial statements of InflaRx N.V. (in the following, “InflaRx” or the “Company”) and its subsidiaries for the six months ended June 30, 2018 were authorized for issue in accordance with a resolution of the directors on August 8, 2018.

 

InflaRx N.V., is a Dutch public company with limited liability (naamloze vennootschap), incorporated in the Netherlands (Commercial Register of The Netherlands Chamber of Commerce Business Register under CCI number 68904312) and domiciled in Jena, Germany. The registered office is located in Jena, Germany, Winzerlaer Straße 2. The Company`s shares are publicly traded on the Nasdaq Global Select Market under the symbol IFRX.

 

InflaRx is a clinical-stage biopharmaceutical company focused on applying its proprietary technology to discover and develop first-in-class potent and specific inhibitors of the complement activation factor known as C5a.

 

These condensed consolidated interim financial statements (in the following “financial statements”) of InflaRx comprise the Company and its subsidiary InflaRx GmbH, and, since January 5, 2018, InflaRx N.V.’s wholly-owned subsidiary InflaRx Pharmaceutical Inc., a Delaware corporation (together, the “Group”).

 

(2)Basis for preparation and changes to Group’s accounting policies

 

a)Statement of compliance

 

The financial statements for the three and six months ended June 30, 2018 have been prepared in accordance with IAS 34 Interim Financial Reporting. The financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Group’s annual consolidated financial statements as at December 31, 2017.

 

This is the first set of the Group’s financial statements where IFRS 15 and IFRS 9 have been applied, as described in section e).

 

b)Critical judgements and accounting estimates

 

The preparation of the financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

 

In preparing these financial statements, the critical judgments made by management in applying the Group’s accounting policies and the key accounting estimates were the same as those that applied to the annual consolidated financial statements as at and for the year ended December 31, 2017.

 

2

 

c)Functional and presentation currency

 

These financial statements are presented in thousands of Euro, which is also the functional currency of InflaRx N.V. and InflaRx GmbH. The functional currency of InflaRx Pharmaceutical Inc. is US Dollar. All financial information presented in Euro has been rounded to the nearest thousand (abbreviated € thousand) or million (abbreviated € million).

 

d)Rounding

 

We have presented financial information in thousand and million euros. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them or may deviate from other tables by one thousand euros at a maximum.

 

e)Significant accounting policies

 

The accounting policies adopted in the preparation of the financial statements are consistent with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December, 31 2017, except for the adoption of new standards effective as of January 1, 2018.

 

The Group has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective.

 

The Group applies in the financial statements, for the first time, IFRS 15 Revenue from Contracts with Customers and IFRS 9 Financial Instruments, that require restatement of previous financial statements. As required by IAS 34, the nature and effect of these changes are disclosed below. Several other amendments and interpretations apply for the first time in 2018, but do not have an impact on the financial statements of the Group.

 

IFRS 15, Revenue from Contracts with Customers, replaces all current standards and interpretations dealing with revenue recognition and introduces a five-step model to account for revenue. As the Group is currently not generating revenues, the Group may only be affected by IFRS 15 in the future when entering into collaboration arrangements or similar transactions.

 

IFRS 9 contains a new classification and measurement approach for financial assets that reflects the business model in which assets are managed and their cash flow characteristics. IFRS 9 further replaces the ‘incurred loss’ model in IAS 39 with a forward-looking ‘expected credit loss’ (ECL) model. This will require considerable judgement about how changes in economic factors affect ECLs, which will be determined on a probability-weighted basis. IFRS 9 will require extensive new disclosures, in particular about hedge accounting, credit risk and ECLs.

 

The Group applies IFRS 9 with an initial application date of January 1, 2018. Because the Group held on the initial application date only immaterial non-current financial assets, cash and cash equivalents, no trade receivables and no derivative financial instruments or financial liabilities, the impact of IFRS 9 is determined to be nil, except for the disclosures required. Classification for other receivables and cash and cash equivalents changed from “loans and receivables” (IAS 39) to “amortized cost” (IFRS 9).

 

The consolidated statement of financial position as at January 1, 2018 was not restated, as the impact of IFRS 9 in the absence of material financial instruments was nil.

 

The following amendments, applicable to reporting periods started January 1, 2018, do not have any impact on the Group’s financial statements:

·Amendments to IFRS 2 Classification and Measurement of Share - based Payment Transactions IFRIC Interpretation 22 Foreign Currency Transactions and Advance Considerations

·Amendments to IAS 40 Transfers of Investment Property

·Amendments to IFRS 4, Applying IFRS 9 Financial Instruments with IFRS 4 Insurance Contracts

·Amendments to IFRS 1 First-time Adoption of International Financial Reporting Standards -Deletion of short-term exemptions for first-time adopters

·IFRIC 22 Foreign Currency Transactions and Advance Considerations

 

3

 

·Improvements to IFRS (2014-2016)

 

The following standards and amendments, applicable to reporting periods starting January 1, 2019, and later, are not expected to have any material impact on the Group’s financial statements, except as described below the table:

·IAS 19 Amendments - Plan Amendment, Curtailmentor Settlement

·IAS 28 Amendments - Long-term Interests in Associates and Joint Ventures

·IFRIC 23 Uncertainty over Income TaxTreatments

·Improvements to IFRS (2015-2017) IFRS 3, 11 IAS 12, 23

 

IFRS 16 Leases replaces existing guidance, including IAS 17 Leases, IFRIC 4 Determining whether an Arrangement contains a Lease, SIC-15 Operating Leases – Incentives and SIC-27 Evaluating the Substance of Transactions Involving the Legal Form of a Lease. The standard is effective for annual periods beginning on or after January 1, 2019. Early adoption is permitted for entities that apply IFRS 15 at or before the date of initial application of IFRS 16. So far, the most significant impact identified is that the Group will recognize new assets and liabilities for its operating leases. As at December 31, 2017, the Group’s future minimum lease payments under non-cancellable operating leases amounted €0.7 million, which is the currently estimated impact on the consolidated statement of financial position of the Group.

 

(3)Other financial assets and other assets

 

in € thousand  31.12.2017  30.06.2018
       
Other financial assets      
Other investments  0  7,993
Others  20  63
Other financial assets  20  8,056
       
in € thousand  31.12.2017  30.06.2018
       
Other assets      
Prepaid expenses  504  785
Others  193  159
Other assets  697  944

 

in € thousand  31.12.2017  30.06.2018
       
Financial assets at fair value through
   profit or loss:
      
Other investments  0  7,993
Financial assets at amortised cost:      
Other financial assets  20  63
   20  8,056

 

Carrying amounts and fair values of financial assets shown in the table above are identical. Other investments are investments in publicly traded funds that invest in various floating rate notes. These other investments are classified and measured at fair value through profit or loss. The net loss incurred since acquisition amounts to €21 thousand and is included in other finance costs.

 

4

 

(4)Cash and cash equivalents

 

in € thousand  31.12.2017  30.06.2018
Deposits held at banks  3,177  4,986
Money market funds  38,876  21,727
USD term deposits (1-30 days)  81,229  129,356
Cash and cash equivalents  123,282  156,069

 

(5)Issue of share capital

 

On May 8, 2018, a public offering of common shares was completed pursuant to which we sold an aggregate of 1,850,000 common shares with a nominal value of €0.12 per share, resulting in gross proceeds from the sale of common shares of €53.0 million. Directly attributable transaction costs of €3.8 million were incurred and paid in connection with the sale of these common shares and deducted from capital reserves. Certain of our selling shareholders sold an aggregate of 1,600,000 common shares. All of these common shares were sold at a price to the public of $34.00 per share.

 

(6)Share-based payments

 

2016 Option Plan

 

Under the Stock Option Plan 2016 Terms and Conditions, or the 2016 Plan, InflaRx GmbH granted rights to subscribe for InflaRx GmbH’s common shares to directors, senior management and key employees. Prior to the initial public offering, the outstanding awards under the 2016 Plan covered an aggregate of 1,239,252 common shares and the exercise price for each outstanding award was €7.81 per share (in each case after giving effect to the corporate reorganization). Any additional awards available under the 2016 Plan lapsed upon the closing of the Series D financing in October 2017.

 

2016 Other share-based awards

 

In 2016, InflaRx also established a share-based payment plan for its non-executive board members (the “Board Plan”) and granted 484 shares of common stock. Grants under the Board Plan are not subject to service or performance conditions.

 

2017 long-term incentive plan

 

In conjunction with the closing of our initial public offering, we established a new omnibus plan (‘the 2017 Plan’ or ‘LTI’) with the purpose of advancing the interests of our shareholders by enhancing our ability to attract, retain and motivate individuals who are expected to make important contributions to us. The 2017 Plan governs issuances of equity incentive awards from and after the closing of our initial public offering. The initial maximum number of common shares available for issuance under equity incentive awards granted pursuant to the 2017 Plan equals 2,341,097 common shares. On January 1, 2021 and on January 1 of each calendar year thereafter, an additional number of shares equal to 3% of the total outstanding common shares on December 31 of the immediately preceding year (or any lower number of shares as determined by the board of directors) will become available for issuance under equity incentive awards granted pursuant to the 2017 Plan.

 

The fair value of options granted in 2018 under the 2017 Plan program was determined using the Black-Scholes valuation model. As the Company’s common shares are listed on the Nasdaq Global Select Market, the closing price of the common shares at grant date was used. Other significant inputs into the model are as follows (weighted average):

 

Fair value per share in USD 37.85 (Q1-2018: 22.75)
Exercise price in USD 37.85 (Q1-2018: 22.75)
Volatility expected 73% (Q1-2018: 73%)
Expected life (midpoint based) 4.6 (Q1-2018: 4.9)
Dividend yield expected -
Risk-free rate (interpolated, US sovereign strips curve) 2.71% (Q1-2018: 2.58%)
Fair Value per option (in USD) 22.37 (Q1-2018: 13.79)
FX rate (EUR/USD) as of grant date 0.86 (Q1-2018: 0.82)
Fair Value per option (in EUR) 19.23 (Q1-2018: 11.24)

 

5

 

Expected volatility has been based on an evaluation of the historical and implied volatility of a peer group of companies. The range of outcomes for the expected life of the instruments has been based on expectations on option holder behavior in the scenarios considered.

 

The number of share options under the 2017 Plan was as follows:

 

Granted in 2017 1,869,192
Granted in Q1 2018 28,002
Granted in Q2 2018 20,000
Forfeited -
Outstanding at June 30, 2018 1,917,194
Thereof vested 0

 

The dividend yield has no impact due to the anti-dilution clause as defined in the LTI.

 

Expenses are determined based on the number of stock options granted within a tranche and the vesting period of a tranche. This implies two effects: (i) the more options granted within a tranche, the higher expense of a tranche, and (ii) the shorter the vesting period of a tranche, the higher expense of a tranche. For example, 33.33% of all stock options granted are allocated to the first tranche which vests over 1 year after the Grant Date, whereas 8.33% of all stock options granted are allocated to the ninth tranche which vests over 3 years.

 

Therefore the expenses recognized from the granted share options under the 2017 Plan were €0.6 million in 2017 and are anticipated to be €11.8 million for 2018, €4.3 million for 2019 and €1.3 million for 2020.

 

In the three and six month periods ending June 30, 2018, and 2017, compensation expenses of €3.0 million and €5.9 million (resulting solely from the LTI) and €0.8 million and €1.5 million (resulting solely from 2016 Option plan and other share-based awards) were recognized, respectively.

 

None of the share-based payments awards were dilutive in determining earnings per share due to the Group’s loss position.

 

(7)Finance costs (net)

 

   For the three months ended June 30,  For the six months ended June 30,
in € thousand  2017  2018  2017  2018
             
Finance income            
Unrealized FX-gains  0  5,304  0  5,304
Interest and other finance income  0  438  0  703
   0  5,742  0  6,007
Finance costs            
Interest on preferred shares  (749)  0  (1,472)  0
Cost of issuing preferred shares  (87)  0  (173)  0
Unrealized FX-losses  0  0  0  (2,163)
Other finance costs  0  (37)  (10)  (63)
   (843)  (37)  (1,655)  (2,226)
             
Finance result  (836)  5,705  (1,655)  5,944

 

InflaRx GmbH issued voting preferred shares for cash to investors in several financing rounds to fund its development activities. All of the preferred shares of InflaRx GmbH were exchanged for common shares of InflaRx N.V. in the corporate reorganization in 2017. InflaRx did not elect to recognize the preferred shares at fair value through profit or loss. In the three and six months ended June 30, 2017, interest expense of €0.7 million and €1.5 million was recognized for all outstanding preferred shares.

 

6

 

(8)Related parties

 

The Group’s executive management comprises the following persons: 

·Professor Niels C. Riedemann, Chief Executive Officer

·Professor Renfeng Guo, Chief Scientific Officer

·Arnd Christ, Chief Financial Officer

·Othmar Zenker, Chief Medical Officer

 

The Group’s board of directors comprises the following persons: 

Executive Directors 

·Professor Niels C. Riedemann (CEO), since November 8, 2017

·Professor Renfeng Guo (CSO), since November 8, 2017

Non-executive Directors 

·Nicolas Fulpius (Chairman, Chairman of the Audit Committee), since November 8, 2017

·Mark Kübler (Member of the Audit Committee), since November 8, 2017

·Katrin Uschmann, since November 8, 2017

·Anthony Gibney (Member of the Audit Committee), since February 6, 2018

·Lina Ma, since November 8, 2017

 

The compensation of the Group’s executive management comprises of the following for the three and six month period ending June 30:

 

   For the three months ended June 30,
   Executive
Management
  non-executive
Board of Directors
in € thousand  30.06.2017  30.06.2018  30.06.2017  30.06.2018
             
Short-term employee benefits  305  573  15  58
Share-based payments  564  2,475  0  267
Total  869  3,048  15  326

 

   For the six months ended June 30,
   Executive
Management
  non-executive
Board of Directors
in € thousand  30.06.2017  30.06.2018  30.06.2017  30.06.2018
             
Short-term employee benefits  609  1,181  30  113
Share-based payments  1,108  4,949  0  513
Total  1,717  6,130  30  627

 

Remuneration of InflaRx’s executive management comprises fixed and variable components and share-based payment awards. In addition, the executive management receives supplementary benefits such as fringe benefits and allowances.

 

7

EX-99.2 3 dp94153_ex9902.htm EXHIBIT 99.2

Exhibit 99.2

 

Management’s Discussion and Analysis
of Financial Condition and Results of Operations

 

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this discussion together with our unaudited condensed consolidated financial statements, including the notes thereto, as of and for the six-month periods ended June 30, 2018 and 2017 included as Exhibit 99.1 to the Report on Form 6-K to which this discussion is attached as Exhibit 99.2. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements for fiscal year 2017, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2017 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”).

 

The following discussion is based on our financial information prepared in accordance with IFRS as issued by the IASB, which may differ in material respects from generally accepted accounting principles in the United States and other jurisdictions. We maintain our books and records in euros. Unless otherwise indicated, all references to currency amounts in this discussion are in euros. We have made rounding adjustments to some of the figures included in this discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them.

 

The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described under “Risk Factors” in the Annual Report.

 

Unless otherwise indicated or the context otherwise requires, all references to “InflaRx” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to InflaRx N.V. and its subsidiaries InflaRx GmbH and InflaRx Pharmaceuticals, Inc.

 

Overview

 

We are a clinical-stage biopharmaceutical company focused on applying our proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of the complement activation factor known as C5a. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. Our lead product candidate, IFX-1, is a novel intravenously delivered first-in-class anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical settings. We are developing IFX-1 for the treatment of HS, a chronic debilitating systemic inflammatory skin disease, for which we have commenced a Phase IIb clinical trial in the first quarter of 2018. Beyond HS, we intend to develop IFX-1 and other proprietary antibodies to address a wide array of complement-mediated diseases with significant unmet needs, including AAV, a rare, life-threatening autoimmune disease.

 

Since our inception in December 2007, we have devoted substantially all of our resources to establishing our company, raising capital, developing our proprietary anti-C5a technology, identifying and testing potential product candidates and conducting clinical trials of our lead product candidate, IFX-1. To date, we have not generated any product revenue and have financed our operations primarily through our public offerings, the private placement of our securities and other income from various grants.

 

As of June 30, 2018, we had raised an aggregate of approximately €206 million, mainly from our initial public offering and the subsequent follow on (together approximately €131 million) and from private placements of our securities (approximately €74 million). As of June 30, 2018, we had cash and cash equivalents of €156.1 million.

 

As of June 30, 2018, we had an accumulated deficit of €64.1 million. We have incurred significant net operating losses in every year since our inception and expect to continue to incur increasing net operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase significantly if, and as we

 

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·continue to develop and conduct clinical trials with respect to our lead product candidate, IFX-1, including in connection with the conduct of our ongoing Phase IIb clinical trial of IFX-1 for HS and our planned Phase II clinical trials of IFX-1 AAV and other indications;

 

·initiate and continue research, preclinical and clinical development efforts for any future product candidates, including IFX-2;

 

·seek to identify additional product candidates;

 

·seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any;

 

·establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize various products for which we may obtain marketing approval, if any;

 

·require the manufacture of larger quantities of product candidates for clinical development and, potentially, commercialization;

 

·collaborate with strategic partners to optimize the manufacturing process for IFX-1 and IFX-2;

 

·maintain, expand and protect our intellectual property portfolio;

 

·hire and retain additional personnel, such as clinical, quality control and scientific personnel; and

 

·add operational, financial and management information systems and personnel, including continuing to add personnel to support our product development and help us comply with our obligations as a public company.

 

We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for a product candidate, which we expect will take a number of years and is subject to significant uncertainty. If we obtain regulatory approval for any product candidate, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we may seek to further fund our operations through public or private equity or debt financings or other sources, including strategic collaborations. We may, however, be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed, would have a negative impact on our financial condition and our ability to develop IFX-1 or any additional product candidates.

 

Our financial statements in 2017 were materially affected by the corporate reorganization conducted in connection with our initial public offering (see Note 1 to our consolidated financial statements as of and for the year ended December 31, 2017).

 

Recent Developments

 

On May 8, 2018, we completed a public offering of common shares pursuant to which we sold an aggregate of 1,850,000 common shares and certain of our shareholders sold an aggregate of 1,600,000 common shares, reflecting the underwriters’ full exercise of the option granted to purchase additional common shares. All of these common shares were sold at a price to the public of $34.00 per share, resulting in gross proceeds to us from the sale of common shares of € 53.0 million. Directly attributable transaction costs of € 3.8 million were incurred and paid in connection with the sale of these common shares and deducted from capital reserves.

 

Research and Development Expenses

 

Research and development expenses have consisted principally of:

 

·employee-related expenses, including salaries, benefits and stock-based compensation expense based upon employees’ role within the organization;

 

·professional fees for lawyers related to the protection and maintenance of our intellectual property; and

 

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·expenses incurred under agreements with contract research organizations, or CROs, contract manufacturing organizations, or CMOs, consultants and independent contractors that conduct research and development, preclinical and clinical activities on our behalf.

 

We expect that our total research and development expenses in 2018 will be significantly higher compared to our expenses in 2016 and 2017. Such increased research and development expenses primarily relate to the following key programs:

 

·IFX-1. In 2017, we completed enrollment and dosing in our Phase IIa clinical trial of IFX-1 in patients with HS. In the first quarter of 2018, we commenced our Phase IIb clinical trial of IFX-1 in patients with HS. We expect our expenses associated with IFX-1 will further increase as we conduct our Phase IIb clinical trial of IFX-1 in patients with HS, prepare to commence a Phase II clinical trial program in patients with AAV and to prepare Phase II clinical trials in two additional neutrophil-driven autoimmune and inflammatory diseases. We anticipate that our research and development expenses will increase substantially in connection with the commencement of these and any additional clinical trials. In addition, we are also incurring expenses related to the manufacturing of clinical trial material and investigating commercial scale production options.

 

·IFX-2. We are continuing preclinical development of IFX-2, expenses for which mainly consist of salaries, costs for preclinical testing conducted by CROs and costs for the production of preclinical material.

 

·Other development programs. Our other research and development expenses relate to our preclinical studies of other product candidates and discovery activities, expenses for which mainly consist of salaries, costs for production of preclinical compounds and costs paid to CROs.

 

In 2016 and 2017, we incurred research and development expenses of €5.3 million and €14.4 million, respectively. For the six months ended June 30, 2018 and 2017, we incurred research and development expenses of €5.5 million and €10.5 million, respectively. The principal driver of the increase in our research and development expenses was the clinical development and manufacturing of IFX-1. Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to timing of clinical trial initiation and enrollment. Research and development expenses are expected to increase as we advance the clinical development of IFX-1 and IFX-2 and further advance the research and development of our preclinical product candidates.

 

We expense research and development costs as incurred. We recognize costs for development activities, such as preclinical studies and clinical trials, based on an evaluation of the progress to completion of specific tasks. We use information provided to us by our vendors such as patient enrollment or clinical site activations for services received and efforts expended. Research and development activities are central to our business model. We expect research and development costs to increase significantly for the foreseeable future as our current development programs progress and new programs are added.

 

The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from, any of our product candidates.

 

For a discussion of our other key financial statement line items, please see “Item 5. Operating and Financial Review and Prospects—Financial operations overview” in the Annual Report.

 

Results of Operations

 

The numbers below were derived from our consolidated financial statements included elsewhere herein. The discussion below should be read along with these consolidated financial statements, and it is qualified in its entirety by reference to them.

 

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Comparison of the Three Months Ended June 30, 2018 and 2017

 

   Three Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Other income and expenses (net)  2  44  42
Research and development expenses  (3,101)  (5,031)  (1,929)
General and administrative expenses  (731)  (3,161)  (2,430)
Loss before interest and income taxes  (3,831)  (8,148)  (4,317)
Finance income  0  5,742  5,742
Finance costs  (843)  (37)  805
Loss before tax  (4,673)  (2,443)  2,230
Income tax expense       
Loss for the period  (4,673)  (2,443)  2,230
Foreign currency translation differences  (2)  (17)  (15)
Total comprehensive loss attributable to owners of the Company  (4,675)  (2,460)  2,215

 

Research and Development Expenses

 

   Three Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Third party expenses  2,025  2,815  790
Personnel expenses  882  2,004  1,123
Legal and consulting fees  153  83  (71)
Other expenses  42  129  87
Total Research and development expenses  3,101  5,031  1,929

 

We use our employee and infrastructure resources across multiple research and development programs directed toward developing IFX-1 and IFX-2. We manage certain activities such as contract research and manufacturing of IFX-1 and our discovery programs through our third-party vendors. We did not track the costs of these activities on a program-by-program basis until 2017.

 

Research and development expenses increased by €1.9 million to €5.0 million for the three months ended June 30, 2018, from €3.1 million for the three months ended June 30, 2017. This increase is primarily attributable to a €0.8 million increase in CRO and CMO expenses associated with preclinical studies and clinical trials conducted for IFX-1 as well as a €1.1 million increase in employee-related costs mainly caused by higher expenses associated with non-cash stock-based compensation, principally from equity award grants under our LTI Plan 2017, amounting to an increase of €0.8 million.

 

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General and Administrative Expenses

 

   Three Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Personnel expenses  440  2,156  1,716
Legal, consulting and audit fees  167  632  465
Other expenses  124  373  249
Total General and administrative expense  731  3,161  2,430

 

General and administrative expenses increased by €2.4 million to €3.2 million for the three months ended June 30, 2018, from €0.7 million for the three months ended June 30, 2017. This increase is primarily attributable to a €1.7 million increase in employee-related costs associated with non-cash stock-based compensation, principally from equity award grants under our LTI Plan 2017, amounting to an increase of €1.4 million. The increase of €0.5 million for legal, consulting and audit fees is mainly attributable to costs of being a publicly listed company, as well as tax services.

 

Finance result

 

   Three Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Finance income         
Unrealized FX-gains  0  5,304  5,304
Interest and other finance income  0  438  438
Total Finance income  0  5,742  5,742
Finance costs         
Interest on preferred shares  (749)  0  749
Cost of issuing preferred shares  (87)  0  87
Unrealized FX-losses  0  0  0
Other finance costs  0  (37)  (37)
Total Finance costs  (836)  (37)  799
Finance result  (836)  5,705  6,541

 

Finance result increased by €6.5 million to €5.7 million finance income for the three months ended June 30, 2018, from €0.8 million finance costs for the three months ended June 30, 2017. This increase is mainly attributable to unrealized foreign exchange gains of our USD term deposits. Interest and other finance income is attributable to interest on our US$ term deposits. For the three months ended June 30, 2017, interest expense in connection with preferred shares amounted to €0.8 million. Preferred shares were converted into common shares in connection with the initial public offering in the fourth quarter of 2017.

 

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Comparison of the Six Months Ended June 30, 2018 and 2017

 

   Six Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Other income and expenses (net)  30  117  87
Research and development expenses  (5,502)  (10,505)  (5,003)
General and administrative expenses  (1,346)  (6,158)  (4,812)
Loss before interest and income taxes  (6,817)  (16,545)  (9,727)
Finance income  0  6,007  6,007
Finance costs  (1,655)  (2,226)  (570)
Loss before tax  (8,473)  (12,764)  (4,291)
Income tax expense       
Loss for the period  (8,473)  (12,764)  (4,291)
Foreign currency translation differences  (1)  (16)  (16)
Total comprehensive loss attributable to owners of the Company  (8,473)  (12,780)  (4,307)

 

Research and Development Expenses

 

   Six Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Third party expenses  3,474  6,153  2,679
Personnel expenses  1,642  3,936  2,294
Legal and consulting fees  283  194  (89)
Other expenses  103  222  119
Total Research and development expenses  5,502  10,505  5,003

 

We use our employee and infrastructure resources across multiple research and development programs directed toward developing IFX-1 and IFX-2. We manage certain activities such as contract research and manufacturing of IFX-1 and our discovery programs through our third-party vendors. We did not track the costs of these activities on a program-by-program basis until 2017.

 

Research and development expenses increased by €5.0 million to €10.5 million for the six months ended June 30, 2018, from €5.5 million for the six months ended June 30, 2017. This increase is primarily attributable to a €2.7 million increase in CRO and CMO expenses associated with preclinical studies and clinical trials conducted for IFX-1 as well as a €2.3 million increase in employee-related costs mainly caused by higher expenses associated with non-cash stock-based compensation, principally from equity award grants under our LTI Plan 2017, respectively, amounting to an increase of €1.6 million.

 

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General and Administrative Expenses

 

   Six Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Personnel expenses  897  4,198  3,301
Legal, consulting and audit fees  222  1,162  940
Other expenses  227  798  571
Total General and administrative expense  1,346  6,158  4,812

 

General and administrative expenses increased by €4.8 million to €6.2 million for the six months ended June 30, 2018, from €1.3 million for the six months ended June 30, 2017. This increase is primarily attributable to a €3.3 million increase in employee-related costs associated with non-cash stock-based compensation, principally from equity award grants under our LTI Plan 2017, respectively amounting to an increase of €2.9 million. The increase of €0.9 million for legal, consulting and audit fees is mainly attributable to costs of being a publicly listed company, as well as tax services.

  

Finance result

 

   Six Months Ended June 30,
   2017  2018  Change
   (in thousands of €)
Finance income         
Unrealized FX-gains  0  5,304  5,304
Interest and other finance income  0  703  702
Total Finance income  0  6,007  6,007
Finance costs         
Interest on preferred shares  (1,472)  0  1,472
Cost of issuing preferred shares  (173)  0  173
Unrealized FX-losses  0  (2,163)  (2,163)
Other finance costs  (10)  (63)  (53)
Total Finance costs  (1,655)  (2,226)  (570)
Finance result  (1,655)  3,781  5,436

 

Finance result increased by €5.4 million to €3.8 million finance income for the six months ended June 30, 2018, from €1.7 million finance costs for the six months ended June 30, 2017. This increase is mainly attributable to unrealized foreign exchange gains of our USD term deposits. Interest and other finance income is attributable to interest on our US$ term deposits. For the six months ended June 30, 2017, interest expenses in connection with preferred shares amounted to €1.6 million. Preferred shares were converted into common shares in connection with the initial public offering in the fourth quarter of 2017.

 

Liquidity and Capital Resources

 

Since inception, we have incurred significant operating losses. For the six months ended June 30, 2018, we incurred a net loss of €12.8 million. To date, we have financed our operations primarily through the sale of our securities. As of June 30, 2018, we had cash and cash equivalents of €156.1 million.

 

Our cash and cash equivalents primarily consist of bank deposit accounts, fixed USD term deposits and money market investment funds.

 

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Cash Flows

 

The table below summarizes our consolidated statement of cash flows for the six months ended June 30, 2017 and 2018:

 

   Six Months Ended June 30,
   2017  2018
   (in thousands of €)
Cash used in operating activities  (5,230)  (11,148)
Net cash used in investing activities  (57)  (8,396)
Net cash from financing activities  1,500  49,189
Cash and cash equivalents at the beginning of the period  29,117  123,282
Exchange gains on cash and cash equivalents  0  3,142
Cash and cash equivalents at the end of the period  25,330  156,069

 

Net Cash Used in Operating Activities

 

The use of cash in all periods resulted primarily from our net losses, adjusted for non-cash charges and changes in components of working capital.

 

Net cash used in operating activities increased by €5.9 million to €11.1 million in the six months ended June 30, 2018, from €5.2 million in the six months ended June 30, 2017, 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 our own personnel expenses.

 

Net Cash Used in Investing Activities

 

Net cash used for investing activities increased by €8.3 million to €8.4 million in the six months ended June 30, 2018, from €0.1 million in the six months ended June 30, 2017, mainly due to investments in publicly traded funds that invests in various floating rate notes (€8.0 million) as well as investments in office and laboratory equipment of our new subsidiary in InflaRx Pharmaceutical Inc..

 

Net Cash Provided by Financing Activities

 

Net cash generated from financing activities increased by €47.7 million to €49.2 million in the six months ended June 30, 2018 due to our follow on registered public offering in May 2018, compared to €1.5 million in the three months ended June 30, 2017, when cash contributions from the sale of the Series C preferred shares were received.

 

Funding Requirements

 

We expect our expenses to increase in connection with our ongoing activities, particularly as we conduct Phase II clinical trials of IFX-1 in patients with HS and AAV, initiate two additional trials with IFX-1 in other indications, continue preclinical development of IFX-2, initiate new research and preclinical development efforts and seek marketing approval for any product candidates that we successfully develop and receive approval for. If the planned Phase IIb trial of HS is successful, we plan to commence a Phase III program of IFX-1 in HS and currently anticipate that the cost of such program could be in the range of €50 to €60 million. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to establishing sales, marketing, distribution and other commercial infrastructure to commercialize such products. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

 

We completed our initial public offering of common shares and listing of such common shares on the NASDAQ Global Select Market in the fourth quarter of 2017. We raised an aggregate of $93 million in net

 

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proceeds from our initial public offering. We raised an aggregate of $59.1 million in net proceeds from our public offering in May 2018. As such, we believe that our existing liquidity will enable us to fund our operating expenses and capital expenditure requirements for at least the next 24 months.

 

Until such time, if ever, that we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, royalty-based financings, future collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include voting or other rights that adversely affect your rights as a common shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

 

For more information as to the risks associated with our future funding needs, see “Risk Factors” in the Annual Report.

 

Off-Balance Sheet Arrangements

 

As of June 30, 2018, and during the periods presented, we did not have any off-balance sheet arrangements other as described under “Item 5. Operating and Financial Review and Prospects—Off-balance sheet arrangements” in the Annual Report.

 

Contractual Obligations and Commitments

 

As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, contractual obligations and commitments other than as described under “Item 5. Operating and Financial Review and Prospects—Contractual obligations and commitments” in the Annual Report.

 

Quantitative and Qualitative Disclosures about Market Risk

 

During the six months ended June 30, 2018, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “Item 5. Operating and Financial Review and Prospects–Quantitative and qualitative disclosures about market risk” in the Annual Report. 

 

Critical Judgments and Accounting Estimates

 

There have been no material changes to the significant accounting policies and estimates described in “Item 5. Operating and Financial Review and Prospects—Critical judgments and accounting estimates” in the Annual Report.

 

JOBS Act Exemptions

 

On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. This exemption will apply for a period of five years following the completion of our initial public offering or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than $1.0 billion in annual revenue, have more than $700 million in market value of our common shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.

 

Cautionary Statement Regarding Forward Looking Statements

 

Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking

 

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statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Risk factors” in the Annual Report. These risks and uncertainties include factors relating to:

 

·our operation as a development stage company with limited operating history and a history of operating losses; as of June 30, 2018, our accumulated deficit was €64.1 million;

 

·the timing of any submission of filings for regulatory approval of IFX-1 or any other product candidate, and the timing of and our ability to obtain and maintain regulatory approval of IFX-1 for any indication;

 

·the chance our clinical trials may be delayed or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials;

 

·our reliance on sponsors of, and clinical investigators in, trials of our product candidates, contract manufacturers and contract research organizations over which we have limited control;

 

·our lack of adequate funding to complete development of IFX-1 and our other product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates;

 

·our dependence on the success of IFX-1, which is still in clinical development and may eventually prove to be unsuccessful;

 

·uncertainty surrounding whether the clinical development steps up to commercialization will gain regulatory approval;

 

·our ability to leverage our proprietary anti-C5a technology to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases;

 

·the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if approved, in the commercial stage;

 

·if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview;

 

·our ability to comply with enacted and future legislation in seeking marketing approval and commercialization;

 

·our expectations regarding the size of the patient populations for, market opportunity for and clinical utility of IFX-1 or any other product candidates, if approved for commercial use;

 

·our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers for our planned future clinical trials;

 

·our competitive position and the development of and projections relating to our competitors in the development of C5a inhibitors or our industry;

 

·our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and

 

·other risk factors discussed under “Risk factors” in the Annual Report.

 

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Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events except as required by law.

  

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EX-99.3 4 dp94153_ex9903.htm EXHIBIT 99.3

EXHIBIT 99.3

 

  

 

 

 

 

 

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

 

·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, 9 August 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 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)  2  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  0  5,742  0  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
Other 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  2  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   0   0   0   0   (8,473)   0   (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   0   0   0   1,489   0   0   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   0   0   0   0   (12,764)   0   (12,764)
Exchange differences   0   0   (16)   0   0   0   (16)
Total comprehensive loss   0   0   (16)   0   (12,764)   0   (12,780)
                               
Recognition of equity-settled share-based payments   0   0   0   5,938   0   0   5,938
                               
Issue of share capital                            
  Issued shares   222   52,769   0   0   0   0   52,991
  Transaction costs   0   (3,801)   0   0   0   0   (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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