EX-99.1 2 brhc10013829_99-1.htm EXHIBIT 99.1

Exhibit 99.1

INFLARX N.V.

UNAUDITED CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS – JUNE 30, 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, Jena, Germany, 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 SIX MONTHS ENDED JUNE 30, 2020
 
Unaudited Condensed Consolidated Financial Statements
 
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2020 and 2019
3
Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2020 and December 31, 2019
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2020 and 2019
5
Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 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
8
 
5. Share-based payments
9
 
6. Protective foundation
10
 
7. Summary of significant accounting policies
10
 
(a)
Reporting entity and Group’s structure
10
 
(b)
Basis of preparation
11
 

(c)
New and amended standards adopted by the Group
11
 

(d)
Significant events of the quarter and changes in circumstances
12
 
(e)
Significant events after the reporting date
12

F-2

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
for the three and six months ended June 30, 2020 and 2019

         
For the three months
ended June 30,
   
For the six months
ended June 30,
 
(in €, except for share data)
 
Note
   
2020
(unaudited)
   
2019
(unaudited)
   
2020
(unaudited)
   
2019
(unaudited)
 
                               
Operating Expenses
                             
Research and development expenses
         
(7,356,326
)
   
(12,497,222
)
   
(14,655,125
)
   
(20,192,372
)
General and administrative expenses
         
(2,326,895
)
   
(3,647,849
)
   
(4,891,698
)
   
(6,949,015
)
Total Operating Expenses
         
(9,683,221
)
   
(16,145,071
)
   
(19,546,822
)
   
(27,141,387
)
Other income
         
102,332
     
2,866
     
197,292
     
67,702
 
Other expenses
         
(3,450
)
   
(79,183
)
   
(9,170
)
   
(83,068
)
Operating Result
         
(9,584,339
)
   
(16,221,387
)
   
(19,358,701
)
   
(27,156,753
)
Finance income
         
609,444
     
1,338,755
     
2,268,436
     
2,497,960
 
Finance expenses
         
(1,057,937
)
   
(388,097
)
   
(1,175,964
)
   
(449,807
)
Net Financial Result
   
1
     
(448,493
)
   
950,659
     
1,092,472
     
2,048,153
 
Loss for the Period
           
(10,032,832
)
   
(15,270,729
)
   
(18,266,229
)
   
(25,108,600
)
                                         
Share Information
                                       
Weighted average number of shares outstanding
           
26,172,023
     
25,964,379
     
26,138,639
     
25,964,379
 
Loss per share (basic/diluted)
           
(0.38
)
   
(0.59
)
   
(0.70
)
   
(0.97
)
                                         
Loss for the Period
           
(10,032,832
)
   
(15,270,729
)
   
(18,266,229
)
   
(25,108,600
)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
                                       
Exchange differences on translation of foreign currency
           
(1,452,973
)
   
(1,622,079
)
   
260,895
     
695,468
 
Total Comprehensive Loss
           
(11,485,805
)
   
(16,892,807
)
   
(18,005,334
)
   
(24,413,132
)

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 June 30, 2020 and December 31, 2019

(in €)
 
Note
   
June 30,
2020
(unaudited)
   
December 31,
2019
 
                   
ASSETS
                 
Non-current assets
                 
Property, plant and equipment
         
493,377
     
576,373
 
Right-of-use assets
         
716,871
     
836,924
 
Intangible assets
         
404,251
     
452,400
 
Other assets
   
2
     
419,424
     
452,217
 
Financial assets
   
3
     
272,627
     
272,614
 
Total non-current assets
           
2,306,550
     
2,590,528
 
Current assets
                       
Other assets
   
2
     
2,973,228
     
3,500,884
 
Financial assets
   
3
     
62,191,912
     
82,353,867
 
Cash and cash equivalents
   
4
     
36,398,578
     
33,131,280
 
Total current assets
           
101,563,718
     
118,986,031
 
TOTAL ASSETS
           
103,870,268
     
121,576,558
 
                         
EQUITY AND LIABILITIES
                       
Equity
                       
Issued capital
           
3,152,427
     
3,132,631
 
Share premium
           
211,483,756
     
211,006,606
 
Other capital reserves
           
26,627,185
     
25,142,213
 
Accumulated deficit
           
(152,628,234
)
   
(134,362,006
)
Other components of equity
           
2,488,124
     
2,227,228
 
Total equity
           
91,123,258
     
107,146,673
 
Non-current liabilities
                       
Lease liabilities
           
203,636
     
330,745
 
Other non-financial liabilities
           
37,644
     
39,013
 
Total non-current liabilities
           
241,280
     
369,758
 
Current liabilities
                       
Trade and other payables
   
3
     
10,630,462
     
12,413,662
 
Lease liabilities
           
524,034
     
515,203
 
Employee benefits
           
867,121
     
975,629
 
Social security, other taxes and other non-financial liabilities
           
448,113
     
105,634
 
Provisions
           
36,000
     
50,000
 
Total current liabilities
           
12,505,730
     
14,060,128
 
Total Liabilities
           
12,747,010
     
14,429,886
 
TOTAL EQUITY AND LIABILITIES
           
103,870,268
     
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 six months ended June 30, 2020 and 2019

(in €, except for share data)
 
Note
   
Shares
outstanding
   
Issued
capital
   
Share
premium
   
Other
capital
reserves
   
Accumulated
deficit
   
Other com-
ponents 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
         
     
     
     
     
(18,266,229
)
   
     
(18,266,229
)
Exchange differences on
translation of foreign currency
         
     
     
     
     
     
260,895
     
260,895
 
Total comprehensive loss
         
     
     
     
     
(18,266,229
)
   
260,895
     
(18,005,334
)
Contributions
                                                             
Equity-settled share-based payments
   
6
     
     
     
     
1,484,972
     
     
     
1,484,972
 
Share options exercised
   
6
     
164,974
     
19,797
     
477,149
     
     
     
     
496,946
 
Total Contributions
           
164,974
     
19,797
     
477,149
     
1,484,972
     
     
     
1,981,918
 
Balance as of June 30, 2020
           
26,270,229
     
3,152,427
     
211,483,756
     
26,627,185
     
(152,628,234
)
   
2,488,124
     
91,123,258
 
                                                                 
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
           
     
     
     
     
(25,108,600
)
   
     
(25,108,600
)
Exchange differences
on translation of foreign currency
           
     
     
     
     
     
695,468
     
695,468
 
Total comprehensive loss
           
     
     
     
     
(25,108,600
)
   
695,468
     
(24,413,132
)
Contributions
                                                               
Equity-settled share-based pay-ments
   
6
     
     
     
     
3,889,767
     
     
     
3,889,767
 
Total Contributions
           
     
     
     
3,889,767
     
     
     
3,889,767
 
Balance as of June 30, 2019
           
25,964,379
     
3,115,725
     
211,021,835
     
22,199,770
     
(106,215,788
)
   
745,663
     
130,867,206
 

[5]

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows
for the six months ended June 30, 2020 and 2019
(in €)
 
Note
   
For the six
months ended
June 30, 2020
(unaudited)
   
For the six
months ended
June 30, 2019
(unaudited)
 
             
Operating activities
                 
Loss for the period
         
(18,266,229
)
   
(25,108,600
)
Adjustments for:
                     
Depreciation & amortization of property, plant, equipment, right-of-use assets and intangible assets
         
353,976
     
307,130
 
Net financial result
   
1
     
(1,092,472
)
   
(2,048,153
)
Share-based payment expense
   
6
     
1,484,972
     
3,889,767
 
Net foreign exchange differences
           
(789,528
)
   
(205,103
)
Changes in:
                       
Other assets
           
560,449
     
(2,063,491
)
Employee benefits
           
(122,411
)
   
(84,890
)
Social security and other current non-financial liabilities
           
341,012
     
(184,120
)
Trade and other payables
           
(1,783,200
)
   
5,513,355
 
Interest received
           
1,096,651
     
1,269,745
 
Interest paid
           
(5,455
)
   
(16,308
)
Net cash used in operating activities
           
(18,222,235
)
   
(18,730,669
)
Investing activities
                       
Purchase of intangible assets, laboratory and office equipment
           
(35,107
)
   
(503,881
)
Purchase of non-current other financial assets
           
     
(75,543
)
Disposal of non-current other financial assets
           
     
3,088
 
Purchase of current financial assets
           
(59,196,096
)
   
 
Proceeds from the maturity of financial assets
           
79,504,059
     
17,709,459
 
Net cash from investing activities
           
20,272,857
     
17,133,122
 
Financing activities
                       
Proceeds from exercise of share options
           
496,946
     
 
Repayment of lease liabilities
           
(183,970
)
   
(125,075
)
Net cash from/ (used in) financing activities
           
312,976
     
(125,075
)
Net (decrease)/increase in cash and cash equivalents
           
2,363,597
     
(1,722,622
)
Effect of exchange rate changes on cash and cash equivalents
           
903,700
     
399,266
 
Cash and cash equivalents at beginning of period
           
33,131,280
     
55,386,240
 
Cash and cash equivalents at end of period
   
4
     
36,398,578
     
54,062,885
 

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 and six months ended June 30:
 
   
For the three months ended
June 30,
   
For the six months ended
June 30,
 
(in €)
 
2020
(unaudited)
   
2019
(unaudited)
   
2020
(unaudited)
   
2019
(unaudited)
 
                         
Finance income
                       
Foreign exchange income
   
261,123
     
271,886
     
1,518,680
     
628,357
 
Interest income
   
348,321
     
1,066,869
     
749,756
     
1,869,603
 
Total
   
609,444
     
1,338,755
     
2,268,436
     
2,497,960
 
Finance expenses
                               
Foreign exchange expense
   
(854,826
)
   
(380,764
)
   
(970,706
)
   
(434,786
)
Other
   
(203,111
)
   
(7,333
)
   
(205,258
)
   
(15,021
)
Total
   
(1,057,937
)
   
(388,097
)
   
(1,175,964
)
   
(449,807
)
Net Financial Result
   
(448,493
)
   
950,659
     
1,092,472
     
2,048,153
 

Interest income results from marketable securities and short-term deposits in U.S. Dollars 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.
 
Other Finance expenses contains €0.2 million adjusted expected credit loss on marketable securities.
 
2. Other non-financial assets
 
(in €)
 
As of
June 30, 2020
(unaudited)
   
As of December
31, 2019
 
             
Non-current other assets
           
Prepaid expense
   
419,424
     
452,217
 
Total
   
419,424
     
452,217
 
Current other assets
               
Current tax assets
   
1,225,552
     
1,134,968
 
Prepayments on research & development projects
   
770,795
     
698,891
 
Prepaid expense
   
596,839
     
1,467,936
 
Costs directly attributable to a future equity transaction
   
281,668
     
 
Other
   
98,374
     
199,088
 
Total
   
2,973,228
     
3,500,884
 

Prepaid expense mainly consists of prepaid insurance expense. Total prepaid expense as of June 30, 2020 decreased as compared to December 31, 2019, primarily due to amortization of prepayments of Directors and Officers insurance which is prepaid annually in the fourth quarter of the year.
 
Current tax assets as of June 30, 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 a tax return.
 
[7]

3. Financial assets and financial liabilities
 
Set out below is an overview of financial assets and liabilities, other than cash and cash equivalents, held by the Group as of June 30, 2020 and December 31, 2019:
 
(in €)
 
As of
June 30, 2020
(unaudited)
   
As of December
31, 2019
 
             
Financial assets at amortized cost
           
Non-current financial assets
   
272,627
     
272,614
 
Current financial assets
   
62,191,912
     
82,353,867
 
Financial liabilities at amortized cost
               
Trade and other payables
   
10,630,462
     
12,413,662
 
Interest bearing loans and borrowings
               
Non-current lease liabilities
   
203,636
     
330,745
 
Current lease liabilities
   
524,034
     
513,834
 

As of June 30, the fair value of current and non-current financial assets (primarily quoted debt securities) amounted to €62,522 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.
 
4. Cash and cash equivalents
 
(in €)
 
As of
June 30, 2020
(unaudited)
   
As of December
31, 2019
 
             
Short-term deposits
           
Deposits held in U.S. Dollars
   
22,506,614
     
27,803,153
 
Deposits held in Euro
   
9,900,000
     
 
Total
   
32,406,614
     
27,803,153
 
Cash at banks
               
Cash held in Euro
   
2,164,827
     
1,211,478
 
Cash held in U.S. Dollars
   
1,827,136
     
4,116,649
 
Total
   
3,991,963
     
5,328,127
 
Total cash and cash equivalents
   
36,398,578
     
33,131,280
 

[8]

5. Share-based payments
 
1.          Equity settled share-based payment arrangements
 
During its historical financing rounds, InflaRx GmbH established equity-settled share-based payment programs. Those InflaRx GmbH options were converted into options for common shares of InflaRx N.V. in November 2017:
 
Number of share options
 
2020
   
2019
 
Outstanding as of January 1,
   
148,433
     
533,820
 
Exercised during the six months ended June 30
   
     
 
Outstanding as of June 30,
   
148,433
     
533,820
 
thereof vested
   
148,433
     
533,820
 

Under the terms and conditions of the share option plan 2016, InflaRx GmbH granted rights to subscribe for InflaRx GmbH’s common shares to directors, senior management, and key employees. Those InflaRx GmbH options were converted into options for common shares of InflaRx N.V. in November 2017:
 
Number of share options
 
2020
   
2019
 
Outstanding as of January 1,
   
1,181,484
     
1,181,484
 
Exercised during the six months ended June 30
   
86,632
     
 
Outstanding as of June 30,
   
1,094,852
     
1,181,484
 
thereof vested
   
1,094,852
     
1,181,484
 

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.
 
Number of share options
 
2020
   
2019
 
Outstanding as of January 1,
   
2,181,105
     
2,051,009
 
Granted during the six months ended June 30
   
     
54,450
 
Exercised during the six months ended June 30
   
78,342
     
 
Forfeited during the six months ended June 30
   
7,686
     
 
Outstanding as of June 30,
   
2,095,077
     
2,105,459
 
thereof vested
   
1,557,157
     
994,879
 

The number of share options granted during the six months ended June 30, 2019 under the plan was as follows, whereas in the six months ended June 30, 2020 there were no new grants:
 
Share options granted
 
Number
   
Fair
value
per
option
   
FX rate
as of
grant
date
   
Fair
value
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
%
May 14
   
36,000
   
$
22.54
     
0.89
   
20.08
   
$
41.39
*
   
0.65
     
4.7
     
2.30
%
     
54,450
                                                         

* On July 3, 2019, the board approved an amendment of the 2016 Option Plan and the 2017 Long-Term Incentive Plan. Following the amendment, the strike price of all vested and unvested options, other than those held by persons who were not employees or directors at the time of the amendment, was reduced to $3.35 per share.
Expected dividends are nil for all share options listed above.
None of the options granted in the six months ended June 30, 2019 were granted to members of the executive management or Board of Directors.

[9]

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.          Share options exercised
 
In the six months ended June 30, 2020, 164,974 shares were issued upon the exercise of share options, resulting in proceeds to the Company in the amount of €497 thousand. 86,632 share options exercised were granted under the 2016 Share Option Plan and 78,342 share options exercised were granted under the 2017 Long-Term Incentive Plan. In the six months ended June 30, 2019, no share options were exercised.
 
3.          Share-based payment expense recognized
 
For the three and six months ended June 30, 2020, the Company has recognized €584 thousand and €1,485 thousand, respectively, (2019: € 1,792 thousand, €3,890 thousand) of share-based payment expense in the statements of comprehensive loss.
 
None of the share-based payments awards were dilutive in determining earnings per share due to the Group’s loss position.
 
6. 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 provide, 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 three and six months ended June 30, 2020, the Company expensed €13 thousand and €30 thousand, respectively, (2019: €20 thousand, €35 thousand) of ongoing costs to reimburse expenses incurred by the protective foundation.
 
7. 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.
 
[10]

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, Jena, Germany and InflaRx Pharmaceutical Inc., Ann Arbor, Michigan, United States (together referred to as the “Group”).
 
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.
 

(b)
Basis of preparation
 
These interim condensed consolidated financial statements for the three- and six-month reporting periods ended June 30, 2020 and 2019 have been prepared in accordance with IAS 34 Interim Financial Reporting. These condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements. Accordingly, this report is to be read in conjunction with the financial statements in our annual report for the year ended December 31, 2019 on Form 20-F.
 
The interim condensed consolidated financial statements were authorized for issue by the board of directors on July 29, 2020.
 
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. The Group has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective.
 
For better clarity, the Group presented right-of-use assets separately from property, plant and equipment in the unaudited condensed consolidated statements of financial position as of June 30, 2020 and reclassified comparatives as of December 31, 2019 accordingly. The Group also renamed some line items in the Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss, Financial Position and Cash Flows to better reflect their substance.
 

(c)
New and amended standards adopted by the Group
 
The below listed amendments and interpretations apply for the first time in 2020, but do not have an impact on the 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 1 Presentation of Financial Statements, 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 3 Business Combinations, Definition of a business, effective January 1, 2020

IAS 39 Financial Instruments: Recognition and Measurement, IFRS 7 Financial Instruments Disclosures, IFRS 9 Financial Instruments, Interest Rate Benchmark Reform, effective January 1, 2020

IAS 1 Presentation of Financial Statements, IAS 8 Accounting Policies, Definition of Material, as of January 1, 2020
 
[11]


(d)
Significant events of the quarter and changes in circumstances
 
Phase 3 development program for the use of IFX-1 in the treatment of hidradenitis suppurativa
 
In June 2020, the Company completed an end of Phase II meeting with the U.S. Food and Drug Administration (the “FDA”) to discuss a Phase III development program for the use of IFX-1 in the treatment of hidradenitis suppurativa (“HS”). During the course of the meeting, the FDA agreed to key proposals to support a biologics license application (BLA) submission, including aspects of the Phase III trial design, IFX-1 dosing, target study population, and the nonclinical and clinical pharmacology packages. As part of the Phase III design, the Company proposed using the International Hidradenitis Suppurativa Severity Score (“IHS4”) as the primary efficacy endpoint. While the FDA did not agree that the IHS4 score is fit for purpose as a primary efficacy endpoint tool to support labeling, the FDA recommended that the Company obtain HS patient input to help determine the validity of the IHS4 score. The FDA also indicated a reasonable primary endpoint would be the Hidradenitis Suppurativa Clinical Response Score 50 (“HiSCR”). The Company is now assessing different strategies for a potential pathway to regulatory approval for IFX-1 in the United States and plans to engage with the FDA on next steps. See (e) Significant events after the reporting date below.
 
Effect of COVID-19 Pandemic
 
The COVID-19 pandemic, which began in December 2019 has spread worldwide and continues to cause many governments to maintain measures to slow the spread of the outbreak through quarantines, travel restrictions, closure of borders and requiring maintenance of physical distance between individuals.
 
By the end of June 2020, the company was able to resume full operations. During the second quarter of 2020 employees were able to work from their home offices or return to their work at the offices. Our service providers also resumed full operations, and the recruitment of patients and new sites likewise continued in the second quarter.
 
The full extent to which the global COVID-19 pandemic may impact our business will depend on future developments, which are highly uncertain and cannot be predicted at this time. As such, we cannot presently predict the scope and severity of any potential business shutdowns or disruptions, the impacts on our business, financing or clinical trial activities or on the healthcare system and the global economy.
 

(e)
Significant events after the reporting date
 
Advice from the European Medicines Agency

The Company requested scientific advice from the European Medicines Agency about the European pathway for regulatory approval and received feedback in July 2020. Although the EMA noted certain considerations regarding the Company’s proposal, the EMA acknowledged that HiSCR response does not account for the clinical relevance of a reduction in draining fistulas and the effort to construct a new endpoint that better captures these changes was endorsed in principle. According to the EMA, although HiSCR was used as an endpoint in previous studies, IHS4 could be an appropriate tool to evaluate efficacy of a novel compound in HS. The Company is working diligently to address the additional feedback received and analyzing the strategy for its Phase III development in HS.

At the Market Transaction - Offering of Common Shares
 
On July 7, 2020, the Company filed with the United States Securities and Exchange Commission (SEC) a Form F-3 with respect to the offer and sale of up to $200 million of securities of the Company (Shelf Registration Statement). Furthermore, the board authorized the Company to file with the SEC a supplement to the prospectus (Prospectus Supplement) filed with the Shelf Registration Statement describing the offering of common shares with an aggregate offering price of up to $50 million.
 
The Company implemented an at-the-market program providing for the sales over time. The offering is conducted under the Company’s effective Registration Statement pursuant to the Prospectus Supplement. On July 20, 2020, the Company entered into a Sales Agreement with SVB Leerink LLC. The total value authorized under the Sales Agreement is up to $50.0 million of the Company`s common shares. As of July 28, 2020, the Company had issued 1,800,000 common shares resulting in €10.1 million in net proceeds to the Company. Following these issuances, the remaining value authorized for sale under the sales agreement is $39.6 million.
 
Changes to the Board and Management
 
On July 16, 2020, Jens Holstein resigned as member of the Board and Audit Committee.
 
On July 29, 2020, Mark Kübler was elected to the Audit Committee.
 
Arnd Christ has notified the Company of his decision to resign as Chief Financial Officer. Mr. Christ will continue to serve as Chief Financial Officer during the notice period under his employment agreement with the Company. Jason Marks has notified the Company of his decision to resign as Chief Legal Officer and General Counsel, effective July 31, 2020.
 
[12]

Modification of the 2017 Long-Term Incentive Plan
 
The annual general meeting on July 16, 2020, approved an amendment to the 2017 Long-Term Incentive Plan (LTIP) with effect from January 1, 2021:
 
a)
increasing the maximum annual number of ordinary shares in the Company’s capital available for issuance under the LTIP, starting on January 1, 2021, to 4% (from 3%) of the Company’s outstanding ordinary shares (determined as of December 31 of the immediately preceding year); and
 
b)
removing certain restrictions from the LTIP, which will allow the committee administering the LTIP and the Board to (i) lower the exercise price per share of any options and/or share appreciation rights issued under the LTIP or take any other action treated as a ‘repricing’ of an award and (ii) cancel any option and/or share appreciation rights in exchange for cash or another award granted under the LTIP, in either case, without prior approval of the Company’s shareholders.

The Company intends to file a Registration Statement on Form S-8 to register 6,800,000 additional common shares to be distributed under the Plan.
 
[13]