0001140361-21-017005.txt : 20210512 0001140361-21-017005.hdr.sgml : 20210512 20210512163029 ACCESSION NUMBER: 0001140361-21-017005 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20210512 FILED AS OF DATE: 20210512 DATE AS OF CHANGE: 20210512 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: 21915550 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 brhc10024473_6k.htm 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

May 12, 2021

Commission File
Number: 001-38283



InflaRx N.V.



Winzerlaer Str. 2
07745 Jena,
Germany
(+49) 3641508180
(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 (i) the registration statement on Form S-8 (Registration Number 333-221656) and (ii) the registration statement on Form F-3 (Registration Number 333-239759) of InflaRx N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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, May 12, 2021.

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

3

EXHIBIT INDEX

Exhibit
Description of Exhibit
   
InflaRx N.V. Unaudited Condensed Consolidated Financial Statements as of and for the Three Months Ended March 31, 2021
   
InflaRx N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
   
InflaRx N.V. Press Release dated May 12, 2021


4

EX-99.1 2 brhc10024473_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

INFLARX N.V.
 
UNAUDITED CONDENSED CONSOLIDATED
 
FINANCIAL STATEMENTS – MARCH 31, 2021
 
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 MONTHS ENDED MARCH 31, 2021
 
Unaudited Condensed Consolidated Financial Statements
 
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2021 and 2020
3
Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2021 and December 31, 2020
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2021 and 2020
5
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020
6
Notes to the Unaudited Condensed Consolidated Financial Statements
7
1.
Summary of significant accounting policies and other disclosures
7
(a)
Reporting entity and Group’s structure
7
(b)
Basis of preparation
7
(c)
New and amended standards adopted by the Group
7
(d)
Significant events of the quarter and changes in circumstances
8
2.
Net Financial Result
8
3.
Other assets
10
4.
Financial assets and financial liabilities
10
5.
Cash and cash equivalents
11
6.
Equity
11
7.
Share-based payments
12
(e)
Equity settled share-based payment arrangements
12
(f)
Share options exercised
13
(g)
Share-based payment expense recognized
13
8.
Protective foundation
13
9.
Contractual Obligations and Commitments
14

F-2

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2021 and 2020

         
For the three months ended March 31,
 
(in €, except for share data)
 
Note
   
2021
(unaudited)
   
2020
(unaudited)
 
                   
Operating Expenses
                 
Research and development expenses
         
(4,906,885
)
   
(7,298,799
)
General and administrative expenses
         
(3,022,338
)
   
(2,564,803
)
Total Operating Expenses
         
(7,929,224
)
   
(9,863,601
)
Other income
         
5,462
     
94,960
 
Other expenses
         
(565
)
   
(5,720
)
Operating Result
         
(7,924,327
)
   
(9,774,362
)
Finance income
         
22,962
     
401,435
 
Finance expenses
         
(3,684
)
   
(2,147
)
Foreign exchange result
         
1,731,671
     
1,141,677
 
Other financial result
   
2
     
48,000
     
 
Income Taxes
           
     
 
Loss for the Period
           
(6,125,378
)
   
(8,233,397
)
                         
Share Information
                       
Weighted average number of shares outstanding
           
33,807,774
     
26,105,255
 
Loss per share (basic/diluted)
           
(0.18
)
   
(0.32
)
                         
Loss for the Period
           
(6,125,378
)
   
(8,233,871
)
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:
                       
Exchange differences on translation of foreign currency
           
3,504,699
     
1,713,868
 
Total Comprehensive Loss
           
(2,620,679
)
   
(6,519,529
)

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, 2021 and December 31, 2020

(in €)
 
Note
   
March 31,
2021
(unaudited)
   
December 31,
2020
 
                   
ASSETS
                 
Non-current assets
                 
Property and equipment
         
383,762
     
408,263
 
Right-of-use assets
         
457,513
     
546,694
 
Intangible assets
         
320,645
     
350,183
 
Other assets
   
3
     
358,767
     
353,522
 
Financial assets
   
4
     
272,443
     
272,268
 
Total non-current assets
           
1,793,130
     
1,930,930
 
Current assets
                       
Current other assets
   
3
     
6,527,973
     
3,734,700
 
Current tax assets
           
1,360,125
     
1,419,490
 
Financial assets
   
4
     
58,834,268
     
55,162,033
 
Cash and cash equivalents
   
5
     
78,734,662
     
25,968,681
 
Total current assets
           
145,457,028
     
86,284,904
 
TOTAL ASSETS
           
147,250,158
     
88,215,834
 
                         
EQUITY AND LIABILITIES
                       
Equity
                       
Issued capital
   
6
     
5,302,354
     
3,387,410
 
Share premium
   
6
     
280,261,994
     
220,289,876
 
Other capital reserves
   
7
     
27,980,274
     
26,259,004
 
Accumulated deficit
           
(174,470,998
)
   
(168,345,620
)
Other components of equity
           
(222,091
)
   
(3,726,791
)
Total equity
           
138,851,532
     
77,863,880
 
Non-current liabilities
                       
Lease liabilities
           
137,586
     
220,525
 
Other liabilities
           
34,352
     
33,323
 
Total non-current liabilities
           
171,938
     
253,847
 
Current liabilities
                       
Trade and other payables
   
4
     
7,107,880
     
8,258,133
 
Lease liabilities
           
330,969
     
338,516
 
Employee benefits
           
429,621
     
1,368,731
 
Other liabilities
           
358,217
     
117,727
 
Provisions
           
     
15,000
 
Total current liabilities
           
8,226,687
     
10,098,107
 
Total Liabilities
           
8,398,626
     
10,351,954
 
TOTAL EQUITY AND LIABILITIES
           
147,250,158
     
88,215,834
 

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, 2021 and 2020

(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, 2021
         
28,228,415
     
3,387,410
     
220,289,876
     
26,259,004
     
(168,345,620
)
   
(3,726,790
)
   
77,863,880
 
Loss for the period
         
     
     
     
     
(6,125,378
)
   
     
(6,125,378
)
Exchange differences on translation of foreign currency
         
     
     
     
     
     
3,504,699
     
3,504,699
 
Total comprehensive loss
         
     
     
     
     
(6,125,378
)
   
3,504,699
     
(2,620,679
)
Issuance of common shares and warrants
   
6
     
15,610,022
     
1,873,203
     
63,269,346
     
     
     
     
65,142,549
 
Transaction costs
   
6
     
     
     
(4,219,222
)
   
     
     
     
(4,219,222
)
Equity-settled share-based payments
   
7
     
     
     
     
1,721,270
     
     
     
1,721,270
 
Share options exercised
   
7
     
347,842
     
41,741
     
921,994
     
     
     
     
963,735
 
Balance as of March 31, 2021*
           
44,186,279
     
5,302,354
     
280,261,994
     
27,980,274
     
(174,470,998
)
   
(222,091
)
   
138,851,532
 
                                                                 
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
)
Equity-settled share-based payments
   
7
     
     
     
     
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
 

*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 three months ended March 31, 2021 and 2020

(in €)
 
Note
   
For the three months ended March 31, 2021
(unaudited)
   
For the three months ended March 31, 2020
(unaudited)
 
             
Operating activities
                 
Loss for the period
         
(6,125,378
)
   
(8,233,397
)
Adjustments for:
                     
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
         
168,343
     
182,356
 
Net finance income
   
2
     
(1,798,949
)
   
(399,288
)
Share-based payment expense
   
7
     
1,721,270
     
901,033
 
Net foreign exchange differences
           
193,847
     
(1,141,678
)
Other non-cash adjustments
           
     
(129,122
)
Changes in:
                       
Other assets
           
(2,739,152
)
   
188,476
 
Employee benefits
           
(952,820
)
   
(428,526
)
Other liabilities
           
240,229
     
1,953
 
Trade and other payables
           
(1,150,252
)
   
(1,922,724
)
Interest received
           
33,189
     
462,342
 
Interest paid
           
(3,780
)
   
(2,246
)
Net cash used in operating activities
           
(10,413,453
)
   
(10,520,819
)
Investing activities
                       
Purchase of intangible assets, property and equipment
           
(17,062
)
   
(27,686
)
Purchase of current financial assets
           
(14,985,026
)
   
(23,412,469
)
Proceeds from the maturity of financial assets
           
13,952,522
     
20,724,386
 
Net cash used in investing activities
           
(1,049,566
)
   
(2,715,769
)
Financing activities
                       
Proceeds from issuance of common shares
   
6
     
65,142,549
     
 
Transaction costs from issuance of common shares
   
6
     
(4,219,222
)
   
 
Proceeds from exercise of share options
   
7
     
963,735
     
 
Repayment of lease liabilities
           
(90,716
)
   
(88,339
)
Net cash from/(used in) financing activities
           
61,796,346
     
(88,339
)
Net increase/(decrease) in cash and cash equivalents
           
50,333,328
     
(13,324,927
)
Effect of exchange rate changes on cash and cash equivalents
           
2,432,654
     
1,277,255
 
Cash and cash equivalents at beginning of period
           
25,968,681
     
33,131,280
 
Cash and cash equivalents at end of period
   
5
     
78,734,662
     
21,083,608
 

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.
Summary of significant accounting policies and other disclosures
 
(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, 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-month reporting periods ended March 31, 2021 and 2020 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, 2020 on Form 20-F.
 
The interim condensed consolidated financial statements were authorized for issue by the board of directors on May 11, 2021.
 
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, 2020, except for the adoption of new standards effective as of January 1, 2021 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.
 
(c)
New and amended standards adopted by the Group
 
The below listed amendments and interpretations were adopted effective January 1, 2021, but did not have a material impact on the consolidated financial statements of the Group:
 

Interest Rate Benchmark Reform — Phase 2, Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16

COVID-19-related Rent Concessions, Amendment to IFRS 16
 
The following standards issued will be adopted in a future period and the potential impact, if any, they will have on the Group’s consolidated financial statements is being assessed:
 

IFRS 17 Insurance Contracts, including Amendments to IFRS 17

[7]


Amendments to IAS 1 Presentation of Financial Statements: Classification of Liabilities as Current or Non-current and Classification of Liabilities as Current or Non-current

Amendments to IFRS 3 Business Combinations; IAS 16 Property, Plant and Equipment; IAS 37 Provisions, Contingent Liabilities and Contingent Assets; Annual Improvements 2018-2020

Amendments to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of Accounting policies

Amendments to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates
 
(d)
Significant events of the quarter and changes in circumstances
 
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.
 
During the first quarter of 2021, the Company`s employees have continued to be able to work from their home offices or return to the Company’s offices. Our service providers also continued at regular operational levels and the recruitment of patients and new clinical trial sites likewise continued in the first quarter of 2021 through the date of issuance of these interim financial statements.
 
On June 17, 2020, the Company announced interim results from the first 30 patients treated in the adaptive randomized Phase II/III trial in patients with severe COVID-19 induced pneumonia. On September 14, 2020, we announced the initiation of the Phase III part of the study with the first clinical site open for enrollment in the Netherlands. So far, 178 patients have been included in the study. An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility.
 
2.
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 €)
 
2021
(unaudited)
   
2020
(unaudited)
 
             
Finance income
           
Interest income
   
22,962
     
401,435
 
Finance expenses
               
Interest expenses
   
(2,580
)
   
 
Interest on lease liabilities
   
(1,104
)
   
(2,147
)
Total
   
19,278
     
399,288
 

Interest income results from marketable securities and short-term deposits in U.S. Dollars held by the Company and its subsidiary InflaRx GmbH.
 
   
For the three months ended March 31,
 
(in €)
 
2021
(unaudited)
   
2020
(unaudited)
 
             
Foreign exchange result
           
Foreign exchange income
   
2,457,039
     
1,257,557
 
Foreign exchange expense
   
(725,368
)
   
(115,879
)
Total
   
1,731,671
     
1,141,678
 

[8]

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.
 
   
For the three months ended March 31,
 
(in €)
 
2021
(unaudited)
   
2020
(unaudited)
 
             
Other financial result
   
48,000
     
 

Other financial result for the three months ended March 31, 2021 includes a €48 thousand gain from a reduction in the allowance for expected credit loss on marketable securities (2020: nil).
 
[9]

3.
Other assets
 
(in €)
 
As of
March 31, 2021
(unaudited)
   
As of
December 31,
2020
 
             
Non-current other assets
           
Prepaid expense
   
358,767
     
353,522
 
Total
   
358,767
     
353,522
 
Current other assets
               
Prepayments on research & development projects
   
5,085,261
     
2,340,643
 
Current tax assets
   
1,360,125
     
1,419,490
 
Prepaid expense
   
1,442,712
     
1,295,682
 
Other
   
     
98,374
 
Total
   
7,888,098
     
5,154,190
 

Prepaid expense mainly consists of prepaid insurance expense.
 
Prepayments on research & development projects consists of prepayments on clinical and production contracts. Mainly due to our COVID-19 trial and the payments made under the related CRO contract, prepayments have increased as of March 31, 2021 compared to December 31, 2020.
 
Current tax assets as of March 31, 2021 include VAT of €0.2 million and tax reclaims because of dividend tax withheld of €1.1 million. Such tax is withheld by our banks from securities interest payments, and the Company is reimbursed after filing a tax return.
 
4.
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 March 31, 2021 and December 31, 2020:
 
(in €)
 
As of
March 31, 2021
(unaudited)
   
As of
December 31,
2020
 
             
Financial assets at amortized cost
           
Non-current financial assets
   
272,443
     
272,268
 
Current financial assets
   
58,834,268
     
55,162,033
 
Financial liabilities at amortized cost
               
Trade and other payables
   
7,107,880
     
8,258,133
 
Interest bearing loans and borrowings
               
Non-current lease liabilities
   
137,586
     
220,525
 
Current lease liabilities
   
330,969
     
338,516
 

As of March 31, 2021, the fair value of current and non-current financial assets (primarily quoted debt securities) amounted to €59,065 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.
 
[10]

5.
Cash and cash equivalents
 
(in €)
 
As of
March 31, 2021
(unaudited)
   
As of
December 31,
2020
 
             
Short-term deposits
           
Deposits held in U.S. Dollars
   
70,775,597
     
22,616,767
 
Deposits held in Euro
   
     
1,800,000
 
Total
   
70,775,597
     
24,416,767
 
Cash at banks
               
Cash held in U.S. Dollars
   
6,880,249
     
1,189,126
 
Cash held in Euro
   
1,078,816
     
362,788
 
Total
   
7,959,065
     
1,551,914
 
Total cash and cash equivalents
   
78,734,662
     
25,968,681
 

6.
Equity
 
On July 8, 2020, the Company filed a Form F-3 (Registration Statement) with the United States Securities and Exchange Commission (SEC) with respect to the offer and sale of securities of the Company. The Company also filed with the SEC a prospectus supplement (Prospectus Supplement) relating to an at-the-market program providing for the sale of up to $50,000,000 of its common shares over time pursuant a Sales Agreement with SVB Leerink LLC.
 
During the three months ended March 31, 2021, the Company issued 610,022 common shares under its at-the-market program resulting in €2.8 million in net proceeds. Following these and previous issuances under this program, the remaining value authorized for sale under the Sales Agreement amounts to $35.2 million.
 
On February 25, 2021, the Company sold an aggregate of 15,000,000 common shares through a public offering. The common shares were sold at a price of $5.00 per share and have a nominal value of €0.12 per share. For each common share purchased, an investor also received a warrant to purchase a common share at an exercise price of $5.80. The warrants are exercisable immediately and have a term of up to one year. The shares and warrants were issued and the transaction closed on March 1, 2021 with gross offering proceeds to the Group from this offering being $75.0 million (€62.2 million), before deducting $4.5 million (€3.7 million) in underwriting discounts and other offering expenses of $0.4 million (€0.3 million). As of the date that these interim condensed consolidated financial statements were authorized for issue, no warrants had been exercised.
 
[11]

7.
Share-based payments
 
(e)
Equity settled share-based payment arrangements
 
During its historical financing rounds prior to 2016 InflaRx GmbH granted options under the 2012 Stock Option Plan. Those InflaRx GmbH options were converted into options for common shares of InflaRx N.V. in November 2017:
 
Number of share options
 
2021
   
2020
 
Outstanding as of January 1,
   
148,433
     
148,433
 
Exercised during the three months ended March 31
   
     
 
Outstanding as of March 31,
   
148,433
     
148,433
 
thereof vested
   
148,433
     
148,433
 

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
 
2021
   
2020
 
Outstanding as of January 1,
   
1,094,852
     
1,181,484
 
Exercised during the three months ended March 31
   
(202,020
)
   
 
Outstanding as of March 31,
   
892,832
     
1,181,484
 
thereof vested
   
892,832
     
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 amounts to 2,341,097 common shares.
 
Number of share options
 
2021
   
2020
 
Outstanding as of January 1,
   
2,146,478
     
2,181,105
 
Granted during the three months ended March 31
   
870,928
     
 
Exercised during the three months ended March 31
   
(145,822
)
   
 
Forfeited during the three months ended March 31
   
     
 
Outstanding as of March 31,
   
2,871,584
     
2,181,105
 
thereof vested
   
1,731,506
     
697,482
 

[12]

The number of share options granted during the three months ended March 31, 2021 under the plan was as follows:
 
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)
 
2021
                                               
January 4
   
839,260
   
$
4.53
     
0.8133
   
3.68
   
$
5.14
     
1.35
     
5.31
     
0.5
%
January 4
   
31,668
   
$
4.57
     
0.8133
   
3.72
   
$
5.14
     
1.35
     
5.50
     
0.5
%
     
870,928
                                                         

Of the 870,928 options granted in the three months ended March 31, 2021, 795,000 were granted to members of the executive management or Board of Directors

Expected dividends are nil for all share options listed above.

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:


increasing the maximum annual number of common 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 common shares (determined as of December 31 of the immediately preceding year); and
 

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.
 
(f)
Share options exercised
 
In the three months ended March 31, 2021, 347,842 shares were issued upon the exercise of share options, resulting in proceeds to the Company in the amount of €964 thousand. Of the share options exercised, 202,020 were granted under the 2016 Share Option Plan and 145,822 were granted under the 2017 Long-Term Incentive Plan.
 
In the three months ending March 31, 2020, no options under the 2012 Stock Option Plan were exercised.
 
(g)
Share-based payment expense recognized
 
For the three months ended March 31, 2021, the Company has recognized €1,721 thousand (2020: €901 thousand) of share-based payment expense/(benefit) in the statements of operations and comprehensive loss.
 
None of the share-based payments awards were dilutive in determining earnings per share due to the Group’s loss position.
 
8.
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.
 
[13]

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 require us to cancel its preferred shares once the perceived threat to the Company and its stakeholders 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 cancelled by us.
 
In the three months ended March 31, 2021, the Company expensed €15 thousand (2020: €17 thousand) of ongoing costs to reimburse expenses incurred by the protective foundation.
 
9.
Contractual Obligations and Commitments
 
The Group enters contracts in the normal course of business with CROs and clinical sites for the conduct of clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services.


[14]

EX-99.2 3 brhc10024473_ex99-2.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 three-month periods ended March 31, 2021 and 2020 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 2020, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2020 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”). In addition, we recommend that you read any public announcements made by InflaRx N.V.
 
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, vilobelimab (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 vilobelimab for the treatment of hidradenitis suppurativa (HS), a chronic debilitating systemic inflammatory skin disease. In June 2019, we announced that our Phase IIb clinical trial of vilobelimab in HS did not meet its primary endpoint. On July 18, 2019, we published a post-hoc analysis showing multiple signals of efficacy for the vilobelimab high dose group compared to the placebo group within the initial phase of the SHINE study. In June 2020, we completed an end of Phase II meeting with the FDA to discuss a Phase III development program for the use of vilobelimab in the treatment of HS. Additionally, in July 2020, we received scientific advice from the European Medicines Agency (EMA) regarding the Phase III development program for the use of vilobelimab in the treatment of HS. In March 2021, we submitted a Special Protocol Assessment (SPA) to the U.S. FDA for the Phase III HS program for vilobelimab in Hidradenitis Suppurativa (HS), suggesting IHS4 as primary efficacy endpoint and in May the Company received an official response. The FDA agreed to the dosing regimen in the protocol but did not agree with the assessment of the primary endpoint using the International Hidradenitis Suppurativa Severity Score (IHS4). At the FDA’s suggestion, InflaRx plans to request a Type A meeting to discuss the primary endpoint measure in more detail.
 
II-1

We are also developing vilobelimab in severe COVID-19. On March 31, 2020, we initiated a Phase II/III clinical development program with vilobelimab in patients with severe COVID-19 and enrolled the first patient in the Phase II part of the study. On June 17, 2020, we announced interim results from the first 30 patients treated in the adaptive randomized Phase II part of the trial in patients. On September 14, 2020, we announced the first patient enrolled in the Phase III part of the study. In the randomized, double-blinded and placebo-controlled Phase III part of the Phase II/III trial, we began enrollment and plan to enroll up to 400 early intubated, critically ill patients with severe COVID-19 across sites in the US, EU, South America and other regions. Patients will be randomized 1:1 to receive either vilobelimab or placebo; all patients will receive standard of care. The primary endpoint will be 28-day all-cause mortality; key secondary endpoints will include assessment of organ support and disease improvement. Patients are currently being enrolled and undergoing treatment. So far, 178 patients have been included in the study. An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility.
 
We are also developing vilobelimab for the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (AAV), a rare, life-threatening autoimmune disease associated with powerful inflammatory flares that impair kidney function and lead to fatal organ dysfunction. In October 2018, we dosed the first patient in the randomized, triple blind, placebo-controlled US Phase II IXPLORE study of vilobelimab in patients with AAV. The main objective of the study was to evaluate the efficacy and safety of two dosing regimens of vilobelimab in patients with moderate to severe AAV, when dosed in addition to standard of care, which includes treatment with high dose glucocorticoids and either cyclophosphamide or rituximab. The primary endpoint of the study is the number and percentage of subjects who experience at least one treatment-emergent adverse event (TEAE) per treatment group at week 24. In October 2020, we announced that 19 patients had finished treatment and in May 2021, we reported top-line data for the study, indicating that vilobelimab, when given in addition to best standard of care proved to be safe and well tolerated. Furthermore, in May 2019, we initiated a randomized, double-blind, placebo-controlled European Phase II IXCHANGE clinical study of vilobelimab in patients with AAV. The main objective of the study is to evaluate the efficacy and safety of vilobelimab 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 is being conducted in two parts. In part 1, patients were randomized to receive either vilobelimab plus a reduced dose of glucocorticoids, or placebo plus a standard dose of glucocorticoids. Patients in both arms will receive standard of care dosing of rituximab or cyclophosphamide. In part 2 of the study, patients will be randomized to receive either vilobelimab plus placebo, glucocorticoids or placebo plus a standard dose of glucocorticoids (both in addition to standard of care therapy consisting of rituximab or cyclophosphamide). After analyzing the impact of the ongoing COVID-19 pandemic on the study, we conducted a blinded interim analysis of part 1. Based on our analysis, we decided to continue with part 2 of the study but decreased the number of enrolled patients. On January 5, 2021, we announced that both part 1 and part 2 of the study are fully enrolled. The final data read-out is planned for the end of 2021. Our goal remains to gain Phase III readiness for this program.
 
We are also developing vilobelimab for the treatment of pyoderma gangraenosum (PG), a rare neutrophilic dermatosis associated with chronic cutaneous ulcerations. PG usually has a devastating effect on patient’s life due to severe pain and induction of significant movement impairment depending on lesions’ location. In February 2019, we initiated an open label, multi-centric Phase IIa exploratory study enrolling 18 patients with moderate to severe PG in Canada, the U.S. and Poland. The objectives of this study are to evaluate the safety and efficacy of vilobelimab in this patient population in three different doses. In February 2020, we announced initial data from the first five patients in this trial two patients achieved complete closure of the target ulcer. The drug was well tolerated, and no drug-related severe adverse events (SAE) have been recorded to date in the study. On April 15, 2021, we announced the completion of the enrollment target in this study. A second interim analysis, including six patients treated in the second dose group until day 99, will be available by the end of 2021. Final results from all patients, including the highest dose group, are expected in 2022.
 
We are also developing vilobelimab for the treatment of PD-1/PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). cSCC is the second most common skin cancer. The incidence of cSCC increases with increasing sun exposure and age and individuals with fair skin and hair are more often concerned. The potential for local recurrence or metastasis of cSCC varies with the pathologic variant and localization of the primary lesion, the risk for metastasis in cSCC is approximately 2-5%. Advanced cSCC 10-year survival rates are less than 20% with regional lymph node involvement and less than 10% with distant metastases. We plan to initiate an open-label non-comparative 2-arm Phase II proof of concept study within the first half of 2021.
 
II-2

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, vilobelimab. To date, we have no approved products for commercial use, have not generated any revenue and have financed our operations primarily through public offerings and private placements of our shares as well as other income from various grants. As of March 31, 2021, we had raised an aggregate of approximately €276.7 million, comprised of €74.0 million in gross proceeds from private placements of our securities, €81.8 million in net proceeds from our initial public offering in November 2017, €49.2 million in net proceeds from a follow-on public offering in May 2018, €9.0 million in net proceeds from the at-the-market program from during 2020, as well as €2.8 million in net proceeds from the at-the-market program and €62.2 million in net proceeds from a public offering in the three months ended March 31, 2021.
 
As of March 31, 2021, we had cash and cash equivalents of €78.6 million and financial assets of €59.3 million. As of March 31, 2021, we had an accumulated deficit of €174.5 million. We have incurred significant net operating losses in every year since our inception and expect to continue to incur 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 might increase in the next years if and as we:
 

continue to develop and conduct clinical trials with respect to our lead product candidate, vilobelimab, including in connection with the evaluation of any additional clinical development in HS, the ongoing Phase III trial in severe COVID-19, the ongoing Phase II clinical trials in AAV and PG as well as the planned Phase II study in cSCC;
 

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

actively seek to identify additional research programs and 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 vilobelimab and IFX-2;
 

maintain, expand and protect our intellectual property portfolio;
 

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

our use of share-based employee retention instruments that may involve significant future expense; and
 

add operational, financial and management information systems and personnel, including personnel to support our product development and help us comply with our obligations as a public company.
 
Our expenses in any quarter may not be indicative of our expenses in future periods, and in particular we expect that our expenses, and therefore our net losses, could vary depending on the going forward strategy relating to the clinical development of vilobelimab in HS, COVID-19, AAV, PG, cSCC and additional indications as well as any potential addition of a technology platform or asset.
 
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 vilobelimab or any additional product candidates.
 
II-3

Recent Developments
 
In March 2021, we submitted a Special Protocol Assessment (SPA) to the U.S. FDA for the Phase III HS program for vilobelimab in Hidradenitis Suppurativa (HS), suggesting IHS4 as primary efficacy endpoint and in May the Company received an official response. The FDA agreed to the dosing regimen in the protocol but did not agree with the assessment of the primary endpoint using the International Hidradenitis Suppurativa Severity Score (IHS4). At the FDA’s suggestion, InflaRx plans to request a Type A meeting to discuss the primary endpoint measure in more detail.
 
During the first quarter we have further advanced the Phase III part of the currently ongoing Phase II/III clinical trial in severe COVID-19 patients. The interim analysis based on the first 180 patients enrolled is planned to take place during the first half of 2021. So far, 178 patients have been included in the study.
 
In the US IXPLORE clinical Phase II study of IFX-1 in AAV, all patients have completed treatment.  In May 2021, we reported top-line data for the study, indicating that vilobelimab, when given in addition to best standard of care proved to be safe and well tolerated. Furthermore, in January 2021 we announced that both Part 1 and Part 2 of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled. Final data read-out is planned for the end of 2021. Our goal remains to gain Phase III readiness for this program.
 
On April 15, we announced the completion of the enrollment target of 18 patients with moderate to severe PG at sites in the US, Canada and Europe in the open-label Phase IIa exploratory study in PG. The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG. Efficacy will be evaluated by (i) a responder rate defined as Physician Global Assessment ≤3 of the target ulcer at various timepoints and (ii) time to complete closure of the target ulcer. Both endpoints will be compared with historical data. During 2020, InflaRx had announced positive initial data from the first five patients in the lowest dose group. The drug was well tolerated and no drug-related severe adverse events (SAEs) have been recorded to date in the study. A second interim analysis, including six patients treated in the second dose group until day 99, will be available by the end of 2021. Final results from all patients, including the highest dose group, are expected in 2022.
 
The preparatory activities for the Phase IIa oncology program in cSCC are ongoing, with expected initiation of this clinical trial in the first half of 2021.
 
Research and Development Expenses
 
Research and development expenses consisted principally of:
 

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;
 

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

professional legal fees related to the protection and maintenance of our intellectual property.
 
We anticipate that our total research and development expenses in 2021 might increase compared to 2020, principally due to the initiation of the Phase II trial of vilobelimab in cSCC, the preparation and initiation of clinical Phase III trials of vilobelimab in HS and the continuation of the Phase III part of our Phase II/III clinical study of vilobelimab in severe COVID-19. Our research and development expenses primarily relate to the following key programs:
 
II-4


vilobelimab (IFX-1). We expect our expenses associated with vilobelimab will further increase in the remainder of 2021, compared to the level on March 31, 2020, as we are conducting the Phase III part of the clinical study in severe COVID-19, evaluate initiating a Phase III study in HS, conduct our Phase II clinical program of vilobelimab in patients with AAV and our Phase II clinical trial program in patients with PG and plan to initiate a Phase II clinical program in cSCC along with potentially additional indications. In addition, we are also incurring expenses related to the manufacturing of clinical trial material and by 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 2020, we incurred €25.6 million of research and development expenses. For the three months ended March 31, 2021 and 2020, we incurred research and development expenses of €4.9 million and €7.3 million, respectively. The principal driver of the decrease in our research and development expenses was the conclusion of the Phase IIb clinical development of vilobelimab in HS in 2020, which was offset by expenses for the COVID-19 trial. 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. Overall, research and development expenses are expected to increase over time as we advance the clinical development of vilobelimab into more advanced stages of clinical development and further advance the research and development of our preclinical product candidates.
 
We expense research and development costs as incurred. We recognize costs for certain 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.
 
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 “Management’s discussion and analysis of financial condition and results of operations—Financial operations overview” in the Annual Report.
 
General and Administrative Expenses
 
We expect that our general and administrative expenses will increase in the future as our business expands and we incur additional costs associated with operating as a public company. These public company-related costs relate primarily to additional personnel, additional professional and legal fees, audit fees, directors’ and officers’ liability insurance premiums and costs associated with investor relations.
 
In 2020, we incurred €8.5 million of general and administrative expenses. For the three months ended March 31, 2021 and 2020, we incurred general and administrative expenses of €3.0 million and €2.6 million, respectively. The principal driver of the increase in our general and administrative expenses was higher expenses from equity-settled share-based compensation recognized in personnel expenses €0.5 million
 
II-5

Results of Operations
 
The information below was derived from our condensed consolidated financial statements included elsewhere herein. The discussion below should be read along with these condensed consolidated financial statements and our Annual Report on Form 20-F for the year ended December 31, 2020 filed with the SEC.
 
Comparison of the Three Months Ended March 31, 2021 and 2020
 
   
Three Months Ended March 31,
 
(in €)
 
2021
   
2020
   
Change
 
Operating Expenses
                 
Research and development expenses
   
(4,906,885
)
   
(7,298,799
)
   
2,391,914
 
General and administrative expenses
   
(3,022,339
)
   
(2,564,803
)
   
(457,535
)
Total Operating Expenses
   
(7,929,224
)
   
(9,863,601
)
   
1,934,377
 
Other income
   
5,462
     
94,960
     
(89,498
)
Other expenses
   
(565
)
   
(5,720
)
   
5,155
 
Operating Result
   
(7,924,327
)
   
(9,774,362
)
   
1,850,035
 
Finance income
   
22,962
     
401,435
     
(378,473
)
Finance expenses
   
(3,684
)
   
(2,147
)
   
(1,537
)
Foreign exchange result
   
1,731,671
     
1,141,678
     
589,993
 
Other financial result
   
48,000
     
     
48,000
 
Income Taxes
   
     
     
 
Loss for the Period
   
(6,125,378
)
   
(8,233,397
)
   
2,108,019
 
Exchange differences on translation of foreign currency
   
3,504,699
     
1,713,868
     
1,790,831
 
Total Comprehensive Loss
   
(2,620,679
)
   
(6,519,529
)
   
3,898,850
 

Research and Development Expenses
 
   
Three Months Ended March 31,
 
(in €)
 
2021
   
2020
   
Change
 
Third-party expenses
   
2,989,062
     
5,548,990
     
2,559,928
 
Personnel expenses
   
1,590,678
     
1,183,002
     
(407,676
)
Legal and consulting fees
   
220,120
     
431,097
     
210,977
 
Other expenses
   
107,025
     
135,709
     
28,684
 
Total Research and development expenses
   
4,906,885
     
7,298,798
     
2,391,913
 

We use our employee and infrastructure resources across multiple research and development programs directed toward developing vilobelimab and our pre-clinical programs. We manage certain activities such as contract research and manufacturing of vilobelimab and our discovery programs through our third-party vendors.
 
Research and development expenses incurred for the three months ended March 31, 2021 decreased over the corresponding period in 2020 by €2.4 million. This decline was primarily due to completion of the Phase IIb clinical development of vilobelimab in HS in 2019, with continuously decreasing, limited residual activities thereafter, which was partly offset by expenses for the COVID-19 trial. These two factors led to €1.1 million of lower manufacturing costs, which significantly contributed to an overall decline in third-party expenses of €2.6 million. The €0.4 million increase in personnel expenses was mainly related to equity-settled share-based compensation.
 
II-6

General and Administrative Expenses
 
   
Three Months Ended March 31,
 
(in €)
 
2021
   
2020
   
Change
 
Personnel expenses
   
2,000,459
     
1,509,593
     
(490,866
)
Legal, consulting and audit fees
   
341,148
     
198,550
     
(142,598
)
Other expenses
   
680,731
     
856,660
     
175,929
 
Total General and administrative expense
   
3,022,339
     
2,564,802
     
(457,537
)

General and administrative expenses increased by €0.5 million to €3.0 million for the three months ended March 31, 2021, from €2.6 million for the three months ended March 31, 2020. This increase is attributable to higher expenses from equity-settled share-based compensation recognized in personnel expenses (€0.5 million). Additionally, legal, consulting and other expenses decreased to €1.0 million for the three months ended March 31, 2021, from €1.1 million for the three months ended March 31, 2020.
 
Net financial result
 
Financial Result
 
Three Months Ended March 31,
 
(in €)
 
2021
   
2020
   
Change
 
Finance income
                 
Interest income
   
22,962
     
401,435
     
(378,473
)
Finance expenses
                       
Interest expenses
   
(2,580
)
   
     
(2,580
)
Interest on lease liabilities
   
(1,104
)
   
(2,147
)
   
1,043
 
Total
   
19,278
     
399,288
     
(380,010
)
                         
 
Foreign exchange result
 
Three Months Ended March 31,
 
(in €)
 
2021
   
2020
   
Change
 
Foreign exchange result
                 
Foreign exchange income
   
2,457,039
     
1,257,557
     
1,199,482
 
Foreign exchange expense
   
(725,368
)
   
(115,879
)
   
(609,489
)
Total
   
1,731,671
     
1,141,678
     
589,993
 
                         
 
Other financial result
 
Three Months Ended March 31,
 
(in €)
 
2021
   
2020
   
Change
 
Other financial result
   
48,000
     
     
48,000
 

Net financial result increased by €0.3 million to €1.8 million for the three months ended March 31, 2021, from €1.5 million for the three months ended March 31, 2020. This increase is mainly attributable to higher foreign exchange gains, which increased by €1.2 million and higher foreign exchange losses of €0.6 million while interest on marketable securities declined by €0.4 million. Other finance expenses for the three months ended March 31, 2021 include a €48 thousand gain from a reduction in the allowance for expected credit loss on marketable securities.
 
Liquidity and Capital Resources
 
Since inception, we have incurred significant operating losses. For the three months ended March 31, 2021, we incurred a net loss of €6.1 million. To date, we have financed our operations primarily through the sale of our securities. As of March 31, 2021, we had cash and cash equivalents of €78.6 million, plus financial assets of 59.3 million. Our cash and cash equivalents primarily consist of bank deposit accounts and fixed U.S. Dollar term deposits. Our quoted debt securities have AAA credit ratings.
 
II-7

Cash Flows
 
The table below summarizes our consolidated statement of cash flows for the three months ended March 31, 2021 and 2020:
 
   
Three Months Ended March 31,
 
(in €)
 
2021
   
2020
 
Net cash used in operating activities
   
(10,413,453
)
   
(10,520,819
)
Net cash used in investing activities
   
(1,049,566
)
   
(2,715,769
)
Net cash from/ (used in) financing activities
   
61,796,346
     
(88,339
)
Cash and cash equivalents at the beginning of the period
   
25,968,681
     
33,131,280
 
Exchange gains on cash and cash equivalents
   
2,432,654
     
1,277,255
 
Cash and cash equivalents at the end of the period
   
78,734,662
     
21,083,608
 

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 to €10.4 million in the three months ended March 31, 2021, from €10.5 million in the three months ended March 31, 2020.
 
Net Cash used in Investing Activities
 
Net cash from investing activities increased by €1.7 million in the three months ended March 31, 2021 mainly due to lower proceeds from the maturing of marketable securities in the three months ended March 31, 2021 compared to the three months ended March 31, 2020.
 
Net Cash from/ (used in) Financing Activities
 
Net cash from financing activities increased by €61.9 million in the three months ended March 31, 2021.
 
In the three months ended March 31, 2021, we issued an additional 610,022 common shares under our at-the-market program (refer to Note 6 “Equity”), resulting in €2.8 million in net proceeds. Following these and previous issuances under this program, the remaining value authorized for sale under the Sales Agreement amounts to $35.2 million.
 
On February 25, 2021, we sold an aggregate of 15,000,000 common shares through a public offering. The common shares were sold at a price of $5.00 per share and have a nominal value of €0.12 per share. For each common share purchased, an investor also received a warrant to purchase a common share at an exercise price of $5.80. The warrants are exercisable immediately and have a term of up to one year. The shares and warrants were issued and the transaction closed on March 1, 2021 with gross offering proceeds to the Group of $75.0 million (€62.2 million), before deducting $4.5 million (€3.7 million) in underwriting discounts and other offering expenses of $0.4 million (€0.3 million) and excluding the exercise of any warrants.
 
II-8

Funding Requirements
 
We anticipate that our expenses increase in the next years in connection with our ongoing activities. In particular, we anticipate that we will continue and complete Phase II clinical trials in AAV and PG, continue planning Phase II clinical development in oncology, we may start Phase III clinical development in HS and we will continue to run the Phase III clinical trial in COVID-19. Additionally, we may pursue additional indications as well. We also want to continue preclinical development of IFX-2. We plan to initiate new research and preclinical development efforts and we may seek marketing approval for any product candidates that we successfully develop and where we receive approval. If we commence a Phase III clinical development program with vilobelimab in HS, additional costs in connection with such development will be incurred. 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 believe that our existing cash and cash equivalents and financial assets will enable us to fund our operating expenses and capital expenditure requirements under our current business plan 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, the interest of our current shareholders 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 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 March 31, 2021, and during the periods presented, we did not have any off-balance sheet arrangements other as described under “Management’s discussion and analysis of financial condition and results of operations—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 “Management’s discussion and analysis of financial condition and results of operations—Contractual obligations and commitments” in the Annual Report.
 
Quantitative and Qualitative Disclosures about Market Risk
 
During the three months ended March 31, 2021, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “Management’s discussion and analysis of financial condition and results of operations—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 “Management’s discussion and analysis of financial condition and results of operations—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 $1.07 billion in annual revenue, have more than $700 million in market value of our common shares held by non-affiliates as of the specified testing date or issue more than $1.0 billion of non-convertible debt over a three-year period.
 
II-9

Cautionary Statement Regarding Forward Looking Statements
 
This discussion contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of this discussion 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. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about the following:
 

our operation as a development stage company with limited operating history and a history of operating losses; as of March 31, 2021, our accumulated deficit was €(174.5) million;
 

the timing, progress and results of clinical trials of vilobelimab and any other product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally;
 

the timing and outcome of any discussions or submission of filings for regulatory approval of vilobelimab or any other product candidate, and the timing of and our ability to obtain and maintain regulatory approval of vilobelimab for any indication;
 

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

our ability to protect, maintain and enforce our intellectual property protection for vilobelimab and any other product candidates, and the scope of such protection;
 

whether the Food and Drug Administration (FDA), European Medicines Agency (EMA) or comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials;
 

the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials;
 

our expectations regarding the size of the patient populations for, market opportunity for and clinical utility of vilobelimab 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 and our ability to engage additional third-party manufacturers for our planned future clinical trials and potentially for commercial supply of vilobelimab;
 

our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;
 

our expectations regarding the scope of any approved indication for vilobelimab;
 
II-10


our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales;
 

our ability to commercialize vilobelimab or our other product candidates;
 

if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview;
 

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

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

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

our expectations regarding the time during which we will be an emerging growth company under the JOBS Act or a foreign private issuer;
 
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. You should refer to the “ITEM 3. KEY INFORMATION: - C. Risk factors” section of the Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this discussion will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risks and other information we describe in the reports we will file from time to time with the SEC after the date of this discussion.
 

II-11

EX-99.3 4 brhc10024473_ex99-3.htm EXHIBIT 99.3

Exhibit 99.3
 

InflaRx Reports First Quarter 2021
Financial & Operating Results
 
Severe COVID-19 trial enrollment reaches 178 patients; interim analysis expected in Q3
At the FDA’s suggestion, planning to request a Type A meeting to further discuss primary endpoint for the Phase III clinical development of vilobelimab in Hidradenitis Suppurativa
Vilobelimab proved safe and well tolerated as add-on therapy to standard of care in US ANCA-associated vasculitis safety trial
Completed target enrollment in Phase IIa Pyoderma Gangraenosum trial
Cash, cash equivalents and financial assets of approximately €137.8 million as of March 31, 2021
 
Jena, Germany, May 12, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three months ended March 31, 2021.
 
“We have made significant progress with our vilobelimab clinical programs in the first few months of 2021,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “The team has worked tirelessly to progress the enrollment of our severe COVID-19 trial and we now expect the interim analysis to occur in the third quarter of this year. Despite the increase in vaccinations, patients remain in urgent need of better treatments for severe COVID-19. For HS, following feedback on the Special Protocol Assessment, we plan to continue our discussions with the FDA about the design of our Phase III trial in a Type A meeting.  Following the positive safety data from our US ANCA-associated vasculitis trial, we are looking forward to data readouts in our European AAV trial by the end of the year. In our Pyoderma Gangraenosum trial we have reached target enrollment and expect additional data readouts in 2021.”
 


Recent Highlights and R&D Update
 
Issuance of Common Shares and Warrants
 
On February 25, 2021, the Company sold an aggregate of 15,000,000 common shares through a public offering. The common shares were sold at a price of $5.00 per share. For each common share purchased, an investor also received a warrant to purchase a common share at an exercise price of $5.80. The warrants are exercisable immediately and have a term of up to one year. The shares and warrants were issued and the transaction closed on March 1, 2021 with gross offering proceeds to the Group (not including any potential proceeds from the exercise of warrants) of  $75.0 million (€62.2 million), before deducting $4.5 million (€3.7 million) in underwriting discounts and other offering expenses of $0.4 million (€0.3 million).
 
Vilobelimab for Hidradenitis Suppurativa (HS)
 
In Q1, InflaRx submitted a Special Protocol Assessment (SPA) to the U.S. FDA for the Phase III HS program and in May the Company received an official response. The FDA agreed to the dosing regimen in the protocol but did not agree with the assessment of the primary endpoint using the International Hidradenitis Suppurativa Severity Score (IHS4). At the FDA’s suggestion, InflaRx plans to request a Type A meeting to discuss the primary endpoint measure in more detail.
 
In Europe, as previously reported in 2020, InflaRx received scientific advice from the European Medicines Agency (EMA) about the European pathway for regulatory approval, including supporting the use of the IHS4 score as the primary endpoint.
 
Once InflaRx receives final feedback from the FDA on the proposed Phase III primary endpoint, the Company will determine the best path forward for the global development program in HS.
 
Vilobelimab for Severe COVID-19
The Phase III part of the global Phase II/III trial evaluating vilobelimab in mechanically ventilated patients with COVID-19 was initiated in mid-September 2020, and recruitment has reached 178 patients, with 38 sites initiated across several countries in Europe and Latin America. Once 180 patients are enrolled and reach the 28-day endpoint, a blinded interim analysis will be conducted by an independent Data Safety Monitoring Board (DSMB) to continue the trial or stop for efficacy or futility. The recommendation of the DSMB based on the interim analysis is anticipated in Q3 of this year. Additional sites in other countries are expected to be added, including in the US. Topline data for all 360 enrolled patients at the 28-day mortality primary endpoint from the trial are expected to be available by the end of 2021.



Vilobelimab for ANCA-associated Vasculitis (AAV)
In the US IXPLORE clinical Phase II study of IFX-1 in AAV, all patients have completed treatment. In May 2021, InflaRx reported topline data for the study, indicating that vilobelimab, when given in addition to best standard of care proved to be safe and well tolerated. Furthermore, InflaRx previously reported that both Part 1 and Part 2 of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled. Data from the randomized, double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021.

Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC)
The Company has recently announced plans to initiate an open label, multicenter Phase II study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cSCC.

The Phase II trial is expected to start enrolling patients in the second quarter of 2021 at sites in Europe, the US and other countries. The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess antitumor activity and safety of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm.

Vilobelimab in Pyoderma Gangraenosum
The Phase IIa open label trial has reached the target enrollment goal of 18 patients with moderate to severe PG at sites in the US, Canada and Europe. Promising initial data from the first five patients in the study were announced in 2020. A second interim analysis, including six patients treated at the second dose group until day 99, are expected to be available by the end of 2021.  Final results from all patients, including the highest dose group, are expected in 2022.

Financial highlights – Q1 2021
 
Research and development expenses incurred for the three months ended March 31, 2021 decreased over the corresponding period in 2020 by €2.4 million. This decline was primarily due to no contribution of expense in the period from the Phase IIb clinical development of vilobelimab in HS since this study was completed in 2020, with only limited residual activities thereafter. This was partly offset by the expenses in relation to the COVID-19 trial. These two factors led to €1.1 million of lower manufacturing costs which significantly contributed to an overall decline in third-party expenses of €2.6 million. The €0.4 million increase in personnel expenses was mainly related to equity-settled share-based compensation.




General and administrative expenses increased by €0.5 million to €3.0 million for the three months ended March 31, 2021, from €2.6 million for the three months ended March 31, 2020. This increase is attributable to higher expenses from equity-settled share-based compensation recognized in personnel expenses (€0.5 million). Additionally, legal, consulting and other ex-penses decreased by €0.1 million to €1.0 million for the three months ended March 31, 2021, from €1.1 million for the three months ended March 31, 2020.
 
Net financial result increased by €0.3 million to €1.8 million for the three months ended March 31, 2021, from €1.5 million for the three months ended March 31, 2020. This increase is mainly attributable to higher foreign exchange gains, which increased by €1.2 million and higher foreign exchange losses of €0.6 million while interest on marketable securities declined by €0.4 million. Other finance expenses for the three months ended March 31, 2021 include a €48 thousand gain from a reduction in the allowance for expected credit loss on marketable securities.
 
Net loss for the three months ended March 31, 2021 was €6.1 million, compared to €8.2 million for the three month ended March 31, 2020. On March 31, 2021, the Company’s total funds available were approximately €137.8 million, composed of cash and cash equivalents (€78.7 million) and financial assets (€59.1 million).

Net cash used in operating activities decreased to €10.4 million in the three months ended March 31, 2021, from €10.5 million in the three months ended March 31, 2020.
 
Additional information regarding these results and other relevant information is included in the notes to the unaudited Condensed Consolidated Financial Statements as of March 31, 2021, as well as the financial statements as of December 31, 2020 in “ITEM 18. Financial statements,” which is included in InflaRx’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).
 


InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2021 and 2020
 
   
For the three months ended
March 31,
 
(in €, except for share data)
 
2021
(unaudited)
   
2020
(unaudited)
 
             
Operating Expenses
           
Research and development expenses
   
(4,906,885
)
   
(7,298,799
)
General and administrative expenses
   
(3,022,339
)
   
(2,564,803
)
Total Operating Expenses
   
(7,929,224
)
   
(9,863,601
)
Other income
   
5,462
     
94,960
 
Other expenses
   
(565
)
   
(5,720
)
Operating Result
   
(7,924,327
)
   
(9,774,362
)
Finance income
   
22,962
     
401,435
 
Finance expenses
   
(3,684
)
   
(2,147
)
Foreign exchange result
   
1,731,671
     
1,141,677
 
Other financial result
   
48,000
     
 
Income Taxes
   
     
 
Loss for the Period
   
(6,125,378
)
   
(8,233,397
)
                 
Share Information
               
Weighted average number of shares outstanding
   
33,807,774
     
26,105,255
 
Loss per share (basic/diluted)
   
(0.18
)
   
(0.32
)
                 
Loss for the Period
   
(6,125,378
)
   
(8,233,871
)
Other comprehensive income (loss) that may be reclas-sified to profit or loss in subsequent periods:
               
Exchange differences on translation of foreign currency
   
3,504,699
     
1,713,868
 
Total Comprehensive Loss
   
(2,620,679
)
   
(6,519,529
)



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2021 and December 31, 2020
 
in €
 
March 31,
2021
(unaudited)
   
December 31,
2020
 
             
ASSETS
           
Non-current assets
           
Property and equipment
   
383,762
     
408,263
 
Right-of-use assets
   
457,513
     
546,694
 
Intangible assets
   
320,645
     
350,183
 
Other assets
   
358,767
     
353,522
 
Financial assets
   
272,443
     
272,268
 
Total non-current assets
   
1,793,130
     
1,930,930
 
Current assets
               
Current other assets
   
6,527,973
     
3,734,700
 
Current tax assets
   
1,360,125
     
1,419,490
 
Financial assets
   
58,834,268
     
55,162,033
 
Cash and cash equivalents
   
78,734,662
     
25,968,681
 
Total current assets
   
145,457,028
     
86,284,904
 
TOTAL ASSETS
   
147,250,158
     
88,215,834
 
                 
EQUITY AND LIABILITIES
               
Equity
               
Issued capital
   
5,302,354
     
3,387,410
 
Share premium
   
280,261,994
     
220,289,876
 
Other capital reserves
   
27,980,274
     
26,259,004
 
Accumulated deficit
   
(174,470,998
)
   
(168,345,620
)
Other components of equity
   
(222,091
)
   
(3,726,791
)
Total equity
   
138,851,532
     
77,863,880
 
Non-current liabilities
               
Lease liabilities
   
137,586
     
220,525
 
Other liabilities
   
34,352
     
33,323
 
Total non-current liabilities
   
171,938
     
253,847
 
Current liabilities
               
Trade and other payables
   
7,107,880
     
8,258,133
 
Lease liabilities
   
330,969
     
338,516
 
Employee benefits
   
429,621
     
1,368,731
 
Other financial liabilities
   
358,217
     
117,727
 
Provisions
   
     
15,000
 
Total current liabilities
   
8,226,687
     
10,098,107
 
Total Liabilities
   
8,398,626
     
10,351,954
 
TOTAL EQUITY AND LIABILITIES
   
147,250,158
     
88,215,834
 



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2021 and 2020
 
(in €, except for share data)
 
Issued capital
   
Share premium
   
Other capital reserves
   
Accumulated deficit
   
Other components of equity
   
Total equity
 
                                     
Balance as of January 1, 2021
   
3,387,410
     
220,289,876
     
26,259,004
     
(168,345,620
)
   
(3,726,790
)
   
77,863,880
 
Loss for the period
   
     
     
     
(6,125,378
)
   
     
(6,125,378
)
Exchange differences on translation of foreign currency
   
     
     
     
     
3,504,699
     
3,504,699
 
Total comprehensive loss
   
     
     
     
(6,125,378
)
   
3,504,699
     
(2,620,679
)
Issuance of common shares and warrants
   
1,873,203
     
63,269,346
     
     
     
     
65,142,549
 
Transaction costs
   
     
(4,219,222
)
   
     
     
     
(4.219.222
)
Equity-settled share-based pay-ments
   
     
     
1,721,270
     
     
     
1,721,270
 
Share options exercised
   
41,741
     
921,994
     
     
     
     
963,735
 
Balance as of March 31, 2021
   
5,302,354
     
280,261,994
     
27,980,274
     
(174,470,998
)
   
(222,091
)
   
138,851,532
 
                                                 
Balance as of January 1, 2020
   
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
)
Equity-settled share-based pay-ments
   
     
     
901,033
     
     
     
901,033
 
Balance as of March 31, 2020
   
3,132,631
     
211,006,606
     
26,043,246
     
(142,595,403
)
   
3,941,097
     
101,528,177
 



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020
 
in €
 
For the three months ended March 31, 2021
(unaudited)
   
For the three months ended March 31, 2020
(unaudited)
 
             
Operating activities
           
Loss for the period
   
(6,125,378
)
   
(8,233,397
)
Adjustments for:
               
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
   
168,343
     
182,356
 
Net finance income
   
(1,798,949
)
   
(399,288
)
Share-based payment expense
   
1,721,270
     
901,033
 
Net foreign exchange differences
   
193,847
     
(1,141,678
)
Other non-cash adjustments
   
     
(129,122
)
Changes in:
               
Other assets
   
(2,739,152
)
   
188,476
 
Employee benefits
   
(952,820
)
   
(428,526
)
Other liabilities
   
240,229
     
1,953
 
Trade and other payables
   
(1,150,252
)
   
(1,922,724
)
Interest received
   
33,189
     
462,342
 
Interest paid
   
(3,780
)
   
(2,246
)
Net cash used in operating activities
   
(10,413,453
)
   
(10,520,819
)
Investing activities
               
Purchase of intangible assets, property and equipment
   
(17,062
)
   
(27,686
)
Purchase of current financial assets
   
(14,985,026
)
   
(23,412,469
)
Proceeds from the maturity of financial assets
   
13,952,522
     
20,724,386
 
Net cash from/ (used in) investing activities
   
(1,049,566
)
   
(2,715,769
)
Financing activities
               
Proceeds from issuance of common shares
   
65,142,549
     
 
Transaction costs from issuance of common shares
   
(4,219,222
)
   
 
Proceeds from exercise of share options
   
963,735
     
 
Repayment of lease liabilities
   
(90,716
)
   
(88,339
)
Net cash from/ (used in) financing activities
   
61,796,346
     
(88,339
)
Net increase/(decrease) in cash and cash equivalents
   
50,333,328
     
(13,324,927
)
Effect of exchange rate changes on cash and cash equivalents
   
2,432,654
     
1,277,255
 
Cash and cash equivalents at beginning of period
   
25,968,681
     
33,131,280
 
Cash and cash equivalents at end of period
   
78,734,662
     
21,083,608
 



About vilobelimab (IFX-1):
 
Vilobelimab is a first-in-class monoclonal anti-human 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, vilobelimab 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. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum and COVID-19 pneumonia.
 
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 the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information please visit www.inflarx.com.
 
Contacts:
 
InflaRx N.V.
 
Jordan Zwick – Chief Strategy Officer
Email: IR@inflarx.de
Tel: +1 917-338-6523
 
MC Services AG
 
Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +1-339-832-0752
 


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,” “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 impact of the COVID-19 pandemic on the Company; the timing and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, 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.
 


GRAPHIC 5 image00008.jpg begin 644 image00008.jpg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end