EX-99.1 2 ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

INFLARX N.V.

UNAUDITED CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS – MARCH 31, 2020
 
These unaudited condensed financial statements are consolidated financial statements for the group consisting of InflaRx N.V. and its wholly-owned subsidiaries InflaRx GmbH, and InflaRx Pharmaceutical Inc., Ann Arbor, Michigan, United States (together, the “Group”). The financial statements are presented in Euro (€).
 
InflaRx N.V. is a company limited by shares, incorporated and domiciled in Amsterdam, The Netherlands.
Its registered office and principal place of business is in Germany, Jena, Winzerlaer Str. 2.
 
F-1

INDEX TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2019
 
Unaudited Condensed Consolidated Financial Statements
 
Unaudited Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2020 and 2019
3
Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2020 and December 31, 2019
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2020 and 2019
5
Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended March 31, 2020 and 2019
6
Notes to the Unaudited Condensed Consolidated Financial Statements
7
 
1. Net Financial Result
7
 
2. Other non-financial assets
7
 
3. Financial assets and financial liabilities
8
 
4. Cash and cash equivalents information
8
 
5. Related party transactions
9
 
6. Share-based payments
10
 
7. Protective foundation
12
 
8. Summary of significant accounting policies
12
   
(a)    Reporting entity and Group’s structure
12
   
(b)    Basis of preparation
12
   
(c)    New and amended standards adopted by the Group
13
   
(d)    Summary of new accounting policies
13
   
(e)    Significant events after the reporting date
14

F-2

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Comprehensive Loss
for the three months ended March 31, 2020 and 2019

         
For the three months ended
March 31,
 
(in €)
 
Note
   
2020
(unaudited)
   
2019
(unaudited)
 
                   
Operating Expenses
                 
Research and development expenses
         
(7,298,799
)
   
(7,695,150
)
General and administrative expenses
         
(2,564,803
)
   
(3,301,166
)
Total Operating Expenses
         
(9,863,601
)
   
(10,996,316
)
Other income
         
94,960
     
64,836
 
Other expenses
         
(5,720
)
   
(3,886
)
Operating Result
         
(9,774,362
)
   
(10,935,366
)
Finance income
         
1,658,991
     
1,159,205
 
Finance expenses
         
(118,026
)
   
(61,710
)
Net Financial Result
   
1
     
1,540,965
     
1,097,495
 
Loss for the Period
           
(8,233,397
)
   
(9,837,871
)
                         
Share Information
                       
Weighted average number of shares outstanding
           
26,105,255
     
25,964,379
 
Loss per share (basic/diluted)
           
(0.32
)
   
(0.38
)
                         
Loss for the Period
           
(8,233,397
)
   
(9,837,871
)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
                       
Exchange differences on translation of foreign currency
           
1,713,868
     
2,317,546
 
Total Comprehensive Loss
           
(6,519,529
)
   
(7,520,325
)

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

[3]

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Financial Position
as of March 31, 2020 and December 31, 2019

(in €)
 
Note
   
2020
(unaudited)
   
2019
 
                   
ASSETS
                 
Non-current assets
                 
Property, plant and equipment
         
540,606
     
576,373
 
Right-of-use assets
         
748,785
     
836,924
 
Intangible assets
         
430,368
     
452,400
 
Non-current other assets
   
2
     
445,403
     
452,217
 
Non-current financial assets
   
3
     
272,718
     
272,614
 
Total non-current assets
           
2,437,880
     
2,590,528
 
Current assets
                       
Current other assets
   
2
     
3,319,222
     
3,500,884
 
Current financial assets
   
3
     
86,680,961
     
82,353,867
 
Cash and cash equivalents
   
4
     
21,083,608
     
33,131,280
 
Total current assets
           
111,083,791
     
118,986,031
 
TOTAL ASSETS
           
113,521,671
     
121,576,558
 
                         
EQUITY AND LIABILITIES
                       
Equity
                       
Issued capital
           
3,132,631
     
3,132,631
 
Share premium
           
211,006,606
     
211,006,606
 
Other capital reserves
           
26,043,246
     
25,142,213
 
Accumulated deficit
           
(142,514,552
)
   
(134,362,006
)
Other components of equity
           
3,860,246
     
2,227,228
 
Total equity
           
101,528,177
     
107,146,673
 
Non-current liabilities
                       
Lease liabilities
           
245,478
     
330,745
 
Other non-financial liabilities
           
39,148
     
39,013
 
Total non-current liabilities
           
284,625
     
369,758
 
Current liabilities
                       
Trade and other payables
   
3
     
10,490,938
     
12,413,662
 
Lease liabilities
           
513,374
     
515,203
 
Employee benefits
           
571,960
     
975,629
 
Social securities, other taxes and other non-financial liabilities
           
108,221
     
105,634
 
Provisions
           
24,374
     
50,000
 
Total current liabilities
           
11,708,869
     
14,060,128
 
Total Liabilities
           
11,993,494
     
14,429,886
 
TOTAL EQUITY AND LIABILITIES
           
113,521,671
     
121,576,558
 

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

[4]

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity
for the three months ended March 31, 2020 and 2019

(in €, except for share data)
 
Note
   
Shares
outstanding
   
Issued
capital
   
Share
premium
   
Other
capital
reserves
   
Accumulated
deficit
   
Other
components
of equity
   
Total equity
 
                                                 
Balance as of January 1, 2020
         
26,105,255
     
3,132,631
     
211,006,606
     
25,142,213
     
(134,362,006
)
   
2,227,228
     
107,146,673
 
Loss for the period
         
     
     
     
     
(8,233,397
)
   
     
(8,233,397
)
Exchange differences on translation of foreign currency
         
     
     
     
     
     
1,713,868
     
1,713,868
 
Total comprehensive loss
         
     
     
     
     
(8,233,397
)
   
1,713,868
     
(6,519,529
)
Transactions with
owners of the Company
                                                             
Contributions
                                                             
Equity-settled share-based payment
   
6
     
     
     
     
901,033
     
     
     
901,033
 
Total Contributions
           
     
     
     
901,033
     
     
     
901,033
 
Total transactions with
owners of the Company
           
     
     
     
901,033
     
     
     
901,033
 
Balance as of March 31, 2020*
           
26,105,255
     
3,132,631
     
211,006,606
     
26,043,246
     
(142,595,403
)
   
3,941,097
     
101,528,177
 
                                                                 
Balance as of January 1, 2019
           
25,964,379
     
3,115,725
     
211,021,835
     
18,310,003
     
(81,107,188
)
   
50,196
     
151,390,571
 
Loss for the period
           
     
     
     
     
(9,837,871
)
   
     
(9,837,871
)
Exchange differences on translation of foreign currency
           
     
     
     
     
     
2,317,546
     
2,317,546
 
Total comprehensive loss
           
     
     
     
     
(9,837,871
)
   
2,317,546
     
(7,520,325
)
Transactions with owners of the Company
                                                               
Contributions
                                                               
Equity-settled share-based payment
   
6
     
     
     
     
2,097,780
     
     
     
2,097,780
 
Total Contributions
           
     
     
     
2,097,780
     
     
     
2,097,780
 
Total transactions with
owners of the Company
           
     
     
     
2,097,780
     
     
     
2,097,780
 
Balance as of March 31, 2019*
           
25,964,379
     
3,115,725
     
211,021,835
     
20,407,783
     
(90,945,059
)
   
2,367,742
     
145,968,026
 
* unaudited

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

[5]

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows
for the nine months ended March 31, 2020 and 2019

   
Note
   
2020
(unaudited)
   
2019
(unaudited)
 
         
(in €)
 
Operating activities
                 
Loss for the period
         
(8,233,397
)
   
(9,837,871
)
Adjustments for:
                     
Depreciation & Amortization of property, plant, equipment, right-of-use assets and intangible assets
         
182,356
     
116,519
 
Net financial result
   
1
     
(1,540,965
)
   
(1,097,495
)
Share-based payment expense
   
6
     
901,033
     
2,097,780
 
Other non-cash adjustments
           
(129,122
)
   
81,346
 
Changes in:
                       
Other assets
           
188,476
     
(581,651
)
Employee benefits
           
(428,526
)
   
(333,864
)
Social securities and other current non-financial liabilities
           
1,953
     
457,497
 
Trade and other payables
           
(1,922,724
)
   
364,158
 
Interest received
           
462,342
     
241,817
 
Interest paid
           
(2,246
)
   
(6,682
)
Net cash from operating activities
           
(10,520,819
)
   
(8,498,447
)
Investing activities
                       
Purchase of intangible assets, laboratory and office equipment
           
(27,686
)
   
(254,316
)
Purchase of current financial assets
           
(23,412,469
)
   
(10,599
)
Disposal of current financial assets
           
     
3,088
 
Securities matured
           
20,724,386
     
 
Net cash used in investing activities
           
(2,715,769
)
   
(261,827
)
Financing activities
                       
Repayment of leasing liabilities
           
(88,339
)
   
(54,781
)
Net cash from financing activities
           
(88,339
)
   
(54,781
)
Net (decrease)/increase in cash and cash equivalents
           
(13,324,927
)
   
(8,815,054
)
Effect of exchange rate changes on cash and cash equivalents
           
1,277,255
     
592,005
 
Cash and cash equivalents at beginning of period
           
33,131,280
     
55,386,240
 
Cash and cash equivalents at end of period
   
4
     
21,083,608
     
47,163,191
 

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

[6]

InflaRx N.V. and subsidiaries
Notes to the Unaudited Condensed Consolidated Financial Statements
 
1. Net Financial Result
 
The net financial result is comprised of the following items for the three months ended March 31:
 
   
For the three months ended
March 31,
 
(in €)
 
2020
(unaudited)
   
2019
(unaudited)
 
             
Finance income
           
Interest income
   
401,435
     
802,734
 
Foreign exchange income
   
1,257,557
     
356,471
 
Total
   
1,658,991
     
1,159,205
 
Finance costs
               
Foreign exchange expense
   
(115,879
)
   
(54,022
)
Other
   
(2,147
)
   
(7,688
)
Total
   
(118,026
)
   
(61,710
)
Net financial result
   
1,540,965
     
1,097,495
 

Interest income results from marketable securities and short-term deposits in U.S. Dollar held by the Company and its subsidiary InflaRx GmbH.
 
Foreign exchange income and expense is mainly derived from the translation of the U.S. Dollar cash, cash equivalents and securities held by InflaRx GmbH.
 
2. Other non-financial assets
 
(in €)
 
As of
March 31, 2020
(unaudited)
   
As of December
31, 2019
 
             
Non-current other assets
           
Prepaid expense
   
445,403
     
452,217
 
Total
   
445,403
     
452,217
 
Current other assets
               
Current tax assets
   
1,051,858
     
1,134,968
 
Prepayments on research & development projects
   
959,727
     
698,891
 
Prepaid expense
   
1,018,143
     
1,467,936
 
Other
   
289,493
     
199,088
 
Total
   
3,319,222
     
3,500,884
 

Prepaid expense mainly consists of accrued insurance expense. Total prepaid expense mainly has decreased compared to December 31, 2019, because Directors and Officers insurance is an annual insurance payment in the fourth quarter of the year.
 
Current tax assets in 2020 include tax reclaims because of capital yields tax withheld. Such tax is withheld by our banks from securities interest payments, and the Company is reimbursed after filing the tax return. The decrease is due to lower interest rates compared to the first quarter of 2019.
 
[7]

3. Financial assets and financial liabilities
 
Set out below is an overview of financial assets and liabilities, other than cash and short-term deposits, held by the Group as of March 31, 2020 and December 31, 2019:
 
(in €)
 
As of
March 31, 2020
(unaudited)
   
As of December
31, 2019
 
             
Financial assets at amortized cost
           
Non-current financial assets
   
272,718
     
272,614
 
Current financial assets
   
86,680,961
     
82,353,867
 
Financial liabilities at amortized cost
               
Trade and other payables
   
10,490,938
     
12,413,662
 
Interest bearing loans and borrowings
               
Non-current lease liabilities
   
245,478
     
330,745
 
Current lease liabilities
   
512,099
     
513,834
 

The fair value of current and non-current financial assets (primarily quoted debt securities) amounted to €86,661 thousand (level 1). The Group’s debt instruments at amortized cost consist solely of quoted securities that are graded in the top investment category (AAA) by credit rating agencies such as S&P Global and, therefore, are considered low credit risk investments. Based on statistical historical probabilities of default, adjusted for forward-looking factors specific to the debtors and the economic environment, the Group believes that the expected credit losses for these debt instruments are immaterial. Furthermore, since the acquisition of these debt securities, their credit ratings have remained stable.
 
4. Cash and cash equivalents information
 
(in €)
 
As of March
31, 2020
(unaudited)
   
As of December
31, 2019
 
             
Short-term deposits
           
Deposits held in U.S. Dollars
   
19,535,311
     
27,803,153
 
Total
   
19,535,311
     
27,803,153
 
Cash at banks
               
Cash held in Euro
   
1,069,355
     
1,211,478
 
Cash held in U.S. Dollars
   
478,942
     
4,116,649
 
Total
   
1,548,297
     
5,328,127
 
Total cash and cash equivalents
   
21,083,608
     
33,131,280
 

[8]

5. Related party transactions
 
The Group’s executive management comprises the following persons:
 

Professor Niels C. Riedemann, Chief Executive Officer (CEO)
 

Professor Renfeng Guo, Chief Scientific Officer (CSO)
 

Arnd Christ, Chief Financial Officer (CFO)
 

Jason Marks, Chief Legal Officer, General Counsel (CLO)
 
The Group’s board of directors comprises the following persons:
 
Executive Directors
 

Professor Niels C. Riedemann, CEO
 

Professor Renfeng Guo, CSO
 
Non-executive Directors
 

Nicolas Fulpius, Chairman of the board of directors and Chairman of the Audit Committee
 

Jens Holstein, Member of the Audit Committee
 

Richard Brudnick, Member of the Audit Committee
 

Katrin Uschmann
 

Lina Ma
 

Mark Kübler
 
The compensation of the Group’s executive management comprises the following for the three months ended March 31:
 
   
For the three months ended
March 31,
 
(in €)
 
2020
(unaudited)
   
2019
(unaudited)
 
             
Executive Management
           
Short-term employee benefits
   
638,288
     
771,820
 
Share-based payments
   
657,172
     
1,607,456
 
Total
   
1,295,460
     
2,379,276
 
Non-executive Board of Directors
               
Short-term employee benefits
   
63,864
     
70,432
 
Share-based payments
   
108,453
     
227,552
 
Total
   
172,317
     
297,984
 
Total Compensation
   
1,467,777
     
2,677,260
 

Remuneration of InflaRx’s executive management consists of fixed and variable components and share-based payment awards. In addition, the executive management receives supplementary benefits and allowances.
 
[9]

We entered into indemnification agreements with our directors and senior management. The indemnification agreements and our articles of association require us to indemnify our directors and certain officers and employees as designated by our board of directors to the fullest extent permitted by law.
 
6. Share-based payments
 
1.
Equity settled share-based payment arrangements
 
In conjunction with the closing of its initial public offering, InflaRx N.V. established a new incentive plan (the “2017 Long-Term Incentive Plan”). The initial maximum number of common shares available for issuance under equity incentive awards granted pursuant to the 2017 Long Term Incentive Plan equals 2,341,097 common shares. The number of share options under the plan was as follows:
 
Share options
granted
 
Number
   
Per
option
   
FX rate
as of
grant
date
   
Per
option
   
Share price at
grant date /
Exercise price
   
Expected
volatility
   
Expected
life
(midpoint
based)
   
Risk-free rate
(interpolated,
U.S. sovereign
strips curve)
 
2019
                                               
January 1
   
   
$
14.45
     
0.88
   
12.69
   
$
26.02
     
0.65
     
4.8
     
3.00
%
February 4
   
18,450
   
$
18.17
     
0.87
   
15.87
   
$
32.63
     
0.65
     
4.9
     
2.60
%
     
18,450
                                                         
Expected dividends are nil for all share options listed above.
None of the options were granted to the executive management or board of directors.

Number of stock options
 
2020
   
2019
 
Outstanding as of January 1,
   
2,181,105
     
2,051,009
 
Granted during the three months ended March 31
   
     
18,450
 
Forfeited during the three months ended March 31
   
     
 
Outstanding as of March 31,
   
2,181,105
     
2,069,459
 
thereof vested
   
1,483,623
     
728,722
 
thereof exercised
   
     
 

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 Long-Term Incentive Plan.
 
2.
Stock options exercised
 
In 2020 no stock options were exercised.
 
In 2019, 140,876 shares were issued following the exercise of stock options, resulting in proceeds to the Company in the amount of €1.7 thousand. All stock options exercised were granted under the 2012 Stock Option Plan.
 
3.
Measurement of fair values of stock options granted
 
The fair value of options granted under the 2017 long-term incentive plan 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.
 
Expected volatility has been based on the historical volatility of InflaRx’ share price. Considering a significant price drop on June 5, 2019, we calculated averages including and excluding said trading day which results in an average volatility of 124%. For grants after June 2019 we have selected a volatility of 135% that accounts for expectations of the management.
 
[10]

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 dividend yield has no impact due to the anti-dilution clause as defined in the 2017 Long-Term Incentive Plan.
 
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:
 

the more options are granted within a tranche, the higher the expense of a tranche is, and

the shorter the vesting period of a tranche is, the higher the expense of a tranche is.
 
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 three years.
 
The following table shows the recognized compensation expenses per stock option plan and the repricing of stock options, consummated on July 3, 2019. Anticipated expenses for the twelve-month period ending December 31, 2022, 2021 and 2020 were converted with the exchange rate as of March 31, 2020, 1 Euro = 1.0956 USD:
 
   
2022
   
2021
   
2020
   
2019
   
2018
   
2017
 
               
(in million €)
             
2016 Plan
   
     
     
     
     
     
4.0
 
2017 Long-Term Incentive plan
   
     
0.3
     
2.1
     
5.2
     
12.1
     
0.6
 
Repricing consummated on July 3, 2019
   
     
     
0.3
     
1.6
     
     
 
2016 Plan
   
     
     
     
0.5
     
     
 
2017 Long-Term Incentive plan
   
     
     
0.3
     
1.1
     
     
 
Total compensation expense
   
     
0.3
     
2.4
     
6.8
     
12.1
     
4.6
 

For the three months ended March 31, 2020, the Company has recognized €793 thousand of share-based payment expense in the statement of profit or loss (March 2019: €2,098 thousand).
 
None of the share-based payments awards were dilutive in determining earnings per share due to the Group’s loss position.
 
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7. Protective foundation
 
According to the articles of association of the Company, up to 55,000,000 common shares and up to 55,000,000 preferred shares with a nominal value of €0.12 per share are authorized to be issued. All shares are registered shares. No share certificates shall be issued.
 
In order to deter acquisition bids, the Company`s general meeting of shareholders approved the right of an in-dependent foundation under Dutch law, or protective foundation, to exercise a call option pursuant to the call option agreement, upon which preferred shares will be issued by the Company to the protective foundation of up to 100% of the Company’s issued capital held by others than the protective foundation, minus one share. The protective foundation is expected to enter into a finance arrangement with a bank or, subject to applicable restrictions under Dutch law, the protective foundation may request us to provide, or cause the Company`s subsidiaries to pro-vide, sufficient funding to the protective foundation to enable it to satisfy its payment obligation under the call option agreement.
 
These preferred shares will have both a liquidation and dividend preference over the Company`s common shares and will accrue cash dividends at a pre-determined rate. The protective foundation would be expected to re-quire us to cancel its preferred shares once the perceived threat to the Company and its stake-holders has been removed or sufficiently mitigated or neutralized. We are of the opinion that the call option does not represent a significant fair value based on a level 3 valuation, since the preference shares are restricted in use and can be can-celled by us as stated above.
 
In the quarter ended March 31, 2020, the Company expensed €17 thousand of ongoing costs to reimburse expenses incurred by the protective foundation.
 
8. Summary of significant accounting policies
 

(a)
Reporting entity and Group’s structure
 
InflaRx N.V. is a Dutch public company with limited liability (naamloze vennootschap) with its corporate seat in Amsterdam, The Netherlands, and is registered in the Commercial Register of The Netherlands Chamber of Commerce Business Register under CCI number 68904312. The Company’s registered office is at Winzerlaer Straße 2 in 07745 Jena, Germany. Since November 10, 2017, InflaRx N.V.’s common shares have been listed on The NASDAQ Global Select Market under the symbol IFRX.
 
InflaRx is a clinical-stage biopharmaceutical Group focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of the complement activation factor known as C5a.
 
These consolidated financial statements of InflaRx comprise the Company and its wholly-owned subsidiaries InflaRx GmbH and InflaRx Pharmaceutical Inc., Ann Arbor, Michigan, United States.
 
InflaRx GmbH is a clinical-stage biopharmaceutical company founded in 2008. In 2017, InflaRx N.V. became the sole shareholder of InflaRx GmbH through the contribution of the subsidiary’s shares to InflaRx N.V. by its existing shareholders in exchange of new shares issued by InflaRx N.V.
 
These consolidated financial statements of InflaRx N.V. comprise the Group.
 

(b)
Basis of preparation
 
These interim condensed consolidated financial statements for the three-month reporting period ended March 31, 2020 have been prepared in accordance with IAS 34 Interim Financial Reporting. The interim report does not include all the notes of the type normally included in an annual financial report. Accordingly, this report is to be read in conjunction with the annual report for the year ended December 31, 2019 in the 20-F.
 
The condensed consolidated financial statements were authorized for issue by the board of directors on May 20, 2020.
 
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The financial statements are presented in Euro (€). Euro is the functional currency of InflaRx GmbH. The functional currency of InflaRx N.V. and InflaRx Pharmaceutical Inc. is U.S. Dollars. All financial information presented in Euro has been rounded. 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.
 
The accounting policies adopted are consistent with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December 31, 2019, except for the adoption of new standards effective as of January 1, 2020 as set out below.
 

(c)
New and amended standards adopted by the Group
 
The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended 31 December 2019, except for the adoption of new standards effective as of 1 January 2020. The Group has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective.
 
The below listed amendments and interpretations apply for the first time in 2020, but do not have an impact on the interim condensed consolidated financial statements of the Group:
 

Conceptual Framework Amendments, References to the Conceptual Framework in IFRS Standards (IFRS 2 Share-Based Payment,  IFRS 3 Business Combinations, IAS 8 Accounting Policies, IAS 34 Interim Financial Reporting, IAS 37 Provisions, Contingent Liabilities and Contingent Assets, IFRIC 12 Service Concession Arrangements, IFRIC 19 Extinguishing Financial Liabilities with Equity Instruments,, IFRIC 22 Foreign Currency Transactions and Advance Consideration, SIC 32 Intangible Assets — Web Site Costs,), effective as of January 1, 2020

IFRS 7 Financial Instruments Disclosures, effective January 1, 2020, IAS 38 Intangible Assets, as of January 1, 2020

IAS 39 Financial Instruments: Recognition and Measurement, as of January 1, 2020

IFRS 9 Financial Instruments, Interest Rate Benchmark Reform, effective January 1, 2020

IAS 1 Presentation of Financial Statements, Definition of Material / References to Conceptual Framework in IFRS Standards, as of January 1, 2020
 

(d)
Summary of new accounting policies
 
No new accounting policies were adopted within the Group.
 
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(e)
Significant events after the reporting date
 
Clinical Study AAV
 
As of October 2018, 19 patients have been recruited in the randomized, triple blind, placebo-controlled US Phase II IXPLORE study with IFX-1 in patients with AAV. The main objective of the study is to evaluate the efficacy and safety of two dose regimens of IFX-1 in patients with moderate to severe AAV, when dosed on top of standard of care, which includes treatment with high dose glucocorticoids. The trial originally planned to enroll approximately 36 patients at centers in the US. Based on a blinded interim analysis and assessment of the potential impact of the COVID-19 pandemic, the Company has decided to stop the study and read out the existing results earlier than initially planned as part of a strategy to align and streamline the US and EU AAV development pro-gram.
 
In May 2019, the Company initiated a randomized, double-blind, placebo-controlled European Phase II IXCHANGE study with IFX-1 in patients with AAV. The main objective of the study is to evaluate the efficacy and safety of IFX-1 in patients with moderate to severe AAV. The primary endpoint of the study is a 50% reduction in Birmingham Vasculitis Activity Score (BVAS) at week 16. The study was originally planned to enroll approximately 80 patients at about 60 sites in up to 12 European countries and Russia. The study is being conducted in two parts. In Part 1, patients are being randomized to receive either IFX-1 plus a reduced dose of glucocorticoids, or placebo plus a standard dose of glucocorticoids. Patients in both arms receive the standard of care dosing of immunosuppressive therapy (rituximab or cyclophosphamide). In Part 2 of the study, patients will be randomized to receive either IFX-1 plus placebo glucocorticoids or placebo plus a standard dose of glucocorticoids (both on top of standard of care immunosuppressive therapy with rituximab or cyclophosphamide). The first part of the study has been fully enrolled. After analyzing the impact of COVID-19 on the study, a blinded interim analysis of Part 1 has been completed. Based on the analysis, the Company intends to continue with Part 2 of the study but decrease the number of enrolled patients.
 

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