0001140361-22-018767.txt : 20220512 0001140361-22-018767.hdr.sgml : 20220512 20220512083029 ACCESSION NUMBER: 0001140361-22-018767 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20220512 FILED AS OF DATE: 20220512 DATE AS OF CHANGE: 20220512 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: 22915835 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 brhc10037458_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

For the month of May 2022
Commission File Number: 001-38283

InflaRx N.V.
(Translation of registrant's name into English)

Winzerlaer Str. 2
07745 Jena, Germany
(Address of principal executive office)

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): ☐



EXPLANATORY NOTE

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 (File No. 333-221656) and (ii) the registration statement on Form F-3 (File No. 333-239759) of InflaRx N.V. and to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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, as amended (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, as amended, 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.

 
INFLARX N.V.
   
Date: May 12, 2022
By:
 
/s/ Niels Riedemann
 
Name:
Niels Riedemann
 
Title:
Chief Executive Officer


EXHIBIT INDEX
Exhibit
Description of Exhibit
InflaRx N.V. Unaudited Condensed Consolidated Financial Statements as of and for the Three Months Ended March 31, 2022
InflaRx N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
InflaRx N.V. Press Release, dated May 12, 2022



EX-99.1 2 brhc10037458_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

INFLARX N.V.
 
UNAUDITED CONDENSED CONSOLIDATED
 
FINANCIAL STATEMENTS – MARCH 31, 2022
 
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, 2022
 
Unaudited Condensed Consolidated Financial Statements
 
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2022 and 2021
3
Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2022 and December 31, 2021
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2022 and 2021
5
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2022 and 2021
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)          Significant events of the quarter and changes in circumstances
8
2.
Net Financial Result
9
3.
Other assets
11
4.
Financial assets and financial liabilities
11
5.
Cash and cash equivalents
12
6.
Equity
12
7.
Share-based payments
13
(d)          Equity settled share-based payment arrangements
13
(e)          Share-based payment expense recognized
14
8.
Liabilities from government grants received
14
9.
Protective foundation
14
10.
Subsequent Events
15

F-2

 InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2022 and 2021

         
For the three months ended March 31,
 
(in €, except for share data)
 
Note
   
2022
(unaudited)
   
2021
(unaudited)
 
                   
Operating Expenses
                 
Research and development expenses
         
(10,471,923
)
   
(4,906,885
)
General and administrative expenses
         
(4,387,443
)
   
(3,022,338
)
Total Operating Expenses
         
(14,859,366
)
   
(7,929,224
)
Other income
         
1,593
     
5,462
 
Other expenses
         
(565
)
   
(565
)
Operating Result
         
(14,858,338
)
   
(7,924,327
)
Finance income
         
27,962
     
22,962
 
Finance expenses
         
(24,586
)
   
(3,684
)
Foreign exchange result
         
727,933
     
1,731,671
 
Other financial result
   
2
     
125,000
     
48,000
 
Income Taxes
           
     
 
Loss for the Period
           
(14,002,030
)
   
(6,125,378
)
                         
Share Information
                       
Weighted average number of shares outstanding
           
44,203,763
     
33,807,774
 
Loss per share (basic/diluted)
           
(0.32
)
   
(0.18
)
                         
Loss for the Period
           
(14,002,030
)
   
(6,125,378
)
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:
                       
Exchange differences on translation of foreign currency
           
1,309,875
     
3,504,699
 
Total Comprehensive Loss
           
(12,692,154
)
   
(2,620,679
)

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

1

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2022 and December 31, 2021

(in €)
 
Note
   
March 31,
2022
(unaudited)
   
December 31,
2021
 
                   
ASSETS
                 
Non-current assets
                 
Property and equipment
         
251,713
     
274,373
 
Right-of-use assets
         
1,314,691
     
1,408,078
 
Intangible assets
         
209,818
     
235,216
 
Other assets
   
3
     
331,539
     
336,566
 
Financial assets
   
4
     
9,272,352
     
27,206,990
 
Total non-current assets
           
11,380,114
     
29,461,224
 
Current assets
                       
Current other assets
   
3
     
12,521,363
     
10,983,458
 
Current tax assets
           
1,154,604
     
1,282,177
 
Financial assets
   
4
     
49,925,236
     
57,162,266
 
Cash and cash equivalents
   
5
     
40,096,286
     
26,249,995
 
Total current assets
           
103,697,489
     
95,677,896
 
TOTAL ASSETS
           
115,077,603
     
125,139,120
 
                         
EQUITY AND LIABILITIES
                       
Equity
                       
Issued capital
   
6
     
5,304,452
     
5,304,452
 
Share premium
   
6
     
280,310,744
     
280,310,744
 
Other capital reserves
   
7
     
33,121,984
     
30,591,209
 
Accumulated deficit
           
(227,977,709
)
   
(213,975,679
)
Other components of equity
           
4,360,146
     
3,050,270
 
Total equity
           
95,119,617
     
105,280,996
 
Non-current liabilities
                       
Lease liabilities
           
973,905
     
1,066,354
 
Other liabilities
           
35,628
     
35,019
 
Total non-current liabilities
           
1,009,533
     
1,101,373
 
Current liabilities
                       
Trade and other payables
   
4
     
9,502,770
     
8,574,244
 
Liabilities from government grants received
   
8
     
8,300,000
     
8,300,000
 
Lease liabilities
           
369,676
     
366,171
 
Employee benefits
           
644,646
     
1,378,130
 
Other liabilities
           
131,362
     
138,206
 
Total current liabilities
           
18,948,452
     
18,756,751
 
Total Liabilities
           
19,957,985
     
19,858,124
 
TOTAL EQUITY AND LIABILITIES
           
115,077,603
     
125,139,120
 

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

2

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2022 and 2021

   
Note
   
Shares
outstanding
   
Issued capital
   
Share
premium
   
Other capital reserves
   
Accumulated deficit
   
Other com--ponents of equity
   
Total equity
 
                                                 
Balance as of January 1, 2022
         
44,203,763
     
5,304,452
     
280,310,744
     
30,591,209
     
(213,975,679
)
   
3,050,271
     
105,280,996
 
Loss for the period
         
     
     
     
     
(14,002,030
)
   
     
(14,002,030
)
Exchange differences on
translation of foreign currency
         
     
     
     
     
     
1,309,875
     
1,309,875
 
Total comprehensive loss
         
     
     
     
     
(14,002,030
)
   
1,309,875
     
(12,692,155
)
Equity-settled share-based pay-ments
   
7
     
     
     
     
2,530,775
     
     
     
2,530,775
 
Balance as of March 31, 2022*
           
44,203,763
     
5,304,452
     
280,310,744
     
33,121,984
     
(227,977,709
)
   
4,360,146
     
95,119,617
 
                                                                 
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 trans-la-tion 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 pay-ments
   
7
     
     
     
     
1,721,270
     
     
     
1,721,270
 
Share options exercised
           
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
 
                                                                 
*unaudited

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

3

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2022 and 2021

(in €)
 
Note
   
For the three
months ended
March 31, 2022
(unaudited)
   
For the three
months ended
March 31, 2021
(unaudited)
 
             
Operating activities
                 
Loss for the period
         
(14,002,030
)
   
(6,125,378
)
Adjustments for:
                     
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
         
153,321
     
168,343
 
Net finance income
   
2
     
(856,308
)
   
(1,798,949
)
Share-based payment expense
   
7
     
2,530,775
     
1,721,270
 
Net foreign exchange differences
           
135,826
     
193,847
 
Changes in:
                       
Other assets
           
(1,405,328
)
   
(2,739,152
)
Employee benefits
           
(732,876
)
   
(952,820
)
Other liabilities
           
(6,844
)
   
240,229
 
Trade and other payables
           
928,526
     
(1,150,252
)
Interest received
           
420,916
     
33,189
 
Interest paid
           
(24,641
)
   
(3,780
)
Net cash used in operating activities
           
(12,858,662
)
   
(10,413,453
)
Investing activities
                       
Purchase of intangible assets, property and equipment
           
(7,828
)
   
(17,062
)
Purchase of current financial assets
           
     
(14,985,026
)
Proceeds from the maturity of financial assets
           
26,488,950
     
13,952,522
 
Net cash from/ (used in) investing activities
           
26,481,122
     
(1,049,566
)
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
           
(90,806
)
   
(90,716
)
Net cash from/ (used in) financing activities
           
(90,806
)
   
61,796,346
 
Net increase/(decrease) in cash and cash equivalents
           
13,531,653
     
50,333,328
 
Effect of exchange rate changes on cash and cash equivalents
           
314,639
     
2,432,654
 
Cash and cash equivalents at beginning of period
           
26,249,995
     
25,968,681
 
Cash and cash equivalents at end of period
   
5
     
40,096,286
     
78,734,662
 
                         
The accompanying notes are an integral part of these condensed consolidated financial statements.

4

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 was 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, 2022, and 2021 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, 2021 on Form 20-F.
 
The interim condensed consolidated financial statements were authorized for issue by the board of directors on May 11, 2022.
 
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, 2021, except for the adoption of new standards effective as of January 1, 2022 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.
 
The following amendments have been adopted effective January 1, 2022 and do not have a material impact on the consolidated financial statements of the Group:

 

Reference to the Conceptual Framework – Amendments to IFRS 3
 
Property, Plant and Equipment: Proceeds before Intended Use- Amendments to IAS 16
 
Onerous Contracts – Costs of Fulfilling a Contract –Amendments to IAS 37
 
AIP IFRS 9 Financial Instruments – Fees in the ’10 per cent’

5

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

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 IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates

Amendments to IAS 12 Deferred Tax related to Assets and Liabilities arising from a Single Transaction

Disclosure of Accounting Policies - Amendments to IAS 1 and IFRS Practice Statement 2


(c)
Significant events of the quarter and changes in circumstances
 
Russian-Ukraine Conflict
 
The conflict between Russia and Ukraine has resulted, and is expected to further result, in significant disruption, instability and volatility in global markets, as well as higher energy and other commodity prices. However, since the company is not currently conducting any business or receiving any services from vendors located in these countries, it does not think that the ongoing war will have a direct impact on its operation in the near term. The Company may be affected by certain policy changes in Germany where the Company is headquartered, although at this point, it does not foresee any such policy changes that might have a direct impact on its business operations.
 
COVID-19 Pandemic
 
The COVID-19 pandemic continues to impact our operations as many governments continue to maintain measures to slow the spread of the outbreak through quarantines, travel restrictions, closure of borders and requiring maintenance of social distancing measures .
 
During the first quarter of 2022, the Company has continued to use a hybrid working model that supports a blend of in-office and remote employees, depending on their role and location. Our service providers have continued at regular operational levels, and the recruitment of patients and new clinical trial sites also continued in the first quarter of 2022 through the date of issuance of these interim financial statements. Business travel, however, has been significantly reduced and widely replace by other means of communication, e.g. through video-conferencing.
 
Development programs
 
On January 10, 2022, the Company reported that it has been granted a composition of matter patent for INF904 and associated compounds by the U.S. Patent and Trademark Office and that it has completed IND-enabling (preclinical) studies that demonstrated no obvious toxicological findings even in the highest dose groups in required GLP toxicity analyses. In these preclinical studies, oral INF904 showed higher plasma exposure in animals, including non-human primates, and improved inhibitory activity in a hamster neutropenia model compared to the marketed C5aR inhibitor. Anti-inflammatory therapeutic effects in several preclinical disease models were also demonstrated by INF904. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments showed INF904 has substantially less inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of drugs, including glucocorticoids. The Company expects to initiate a Phase I program in the second half of 2022 and plans to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.
 
6

On February 16, 2022, the Company reported that in the combination Arm B of its ongoing clinical Phase II study of vilobelimab in cSCC, three patients have been treated for at least 36 days in the first dosing cohort of the study, receiving intravenous infusions of 400 mg of vilobelimab on Days 1, 4, 8, and 15 and from Day 22 onwards, 800 mg every two weeks. Patients are also receiving 400 mg of pembrolizumab starting on Day 8 of the first cycle and every six weeks thereafter. The data from the first 36 days of treatment have been reviewed by an independent Steering Committee and no safety concerns were raised. The Steering Committee recommended to continue the study as planned and to open enrollment for the second dosing cohort with 1200 mg vilobelimab every two weeks after administration of 600 mg vilobelimab on Days 1,4, 8 and 15. The interim analysis in Arm B which is required to move to the second stage of the Phase II trial, is expected after ten patients have been treated and are evaluable for response assessment at the recommended Phase II dose level, which will be selected based on data from the safety run-in phase of the study. In parallel, enrollment continues in the monotherapy Arm A. Eight patients are now enrolled in this arm. In this arm, patients are receiving a dose of 800 mg vilobelimab on Days 1, 4, 8, and 15 of the first cycle, followed by a dose of 1600 mg vilobelimab every two weeks starting on Day 22. The interim analysis in Arm A required to proceed to the second stage is expected to be available after ten patients are evaluable for response assessment.
 
Final data of the Phase IIa study of vilobelimab in PG were presented at the 2022 American Academy of Dermatology Association (AAD) Annual Meeting on March 26, 2022. With these results, an end-of-Phase II meeting has been scheduled with the FDA for mid-2022 to discuss the pivotal program in this indication.
 
On March 31, 2022, the Company announced Phase III top-line results from the PANAMO study of vilobelimab in patients with severe COVID-19 disease. Vilobelimab treatment results in relative reduction in 28-day all-cause mortality of 23.9% compared to placebo, but did not show statistical significance on the pre-specified primary endpoint. The Company is engaged in ongoing discussions with regulatory authorities to determine next steps towards a potential approval in this indication.
 
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 €)
 
2022
(unaudited)
   
2021
(unaudited)
 
             
Finance income
           
Interest income
   
27,962
     
22,962
 
Finance expenses
               
Interest expenses
   
(19,859
)
   
(2,580
)
Interest on lease liabilities
   
(4,727
)
   
(1,104
)
Total
   
3,376
     
19,278
 

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 €)
 
2022
(unaudited)
   
2021
(unaudited)
 
             
Foreign exchange result
           
Foreign exchange income
   
1,110,408
     
2,457,039
 
Foreign exchange expense
   
(382,475
)
   
(725,368
)
Total
   
727,933
     
1,731,671
 

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 €)
 
2022
(unaudited)
   
2021
(unaudited)
 
             
Other financial result
   
125,000
     
48,000
 

Other financial result is due to the expected credit loss allowance, which is deducted from the Company’s current and non-current financial assets.
 
7

3.
Other assets
 
(in €)
 
As of
March 31, 2022
(unaudited)
   
As of December 31, 2021
 
             
Non-current other assets
           
Prepaid expense
   
331,539
     
336,566
 
Total
   
331,539
     
336,566
 
Current other assets
               
Prepayments on research & development projects
   
10,605,359
     
10,649,174
 
Prepaid expense
   
1,916,004
     
334,284
 
Total
   
12,521,363
     
10,983,458
 

Prepaid expense mainly consists of prepaid insurance expense.
 
As of March 31, 2022, prepayments on research & development projects amount to €10.6 million compared to €10.6 million as of December 31, 2021, and consist of prepayments on clinical and R&D material production contracts.
 
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, 2022 and December 31, 2021:
 
(in €)
 
As of
March 31, 2022
(unaudited)
   
As of
December 31, 2021
 
             
Financial assets at amortized cost
           
Non-current financial assets
   
9,272,352
     
27,206,990
 
Current financial assets
   
49,925,236
     
57,162,266
 
Financial liabilities at amortized cost
               
Trade and other payables
   
17,802,770
     
16,874,244
 
Interest bearing loans and borrowings
               
Non-current lease liabilities
   
973,905
     
1,066,354
 
Current lease liabilities
   
369,676
     
366,171
 

As of March 31, 2022, the fair value of current and non-current financial assets (primarily quoted debt securities) amounted to €58.5 million (Level 1). The Group’s debt instruments at amortized cost consist solely of quoted securities that are graded highly by credit rating agencies such as S&P Global and, therefore, are considered low credit risk investments.
 
8

5.
Cash and cash equivalents
 
(in €)
 
As of
March 31, 2022
(unaudited)
   
As of December
31, 2021
 
             
Short-term deposits
           
Deposits held in U.S. Dollars
   
8,065,624
     
12,584,892
 
Total
   
8,065,624
     
12,584,892
 
Cash at banks
               
Cash held in U.S. Dollars
   
28,004,492
     
7,612,467
 
Cash held in Euro
   
4,026,171
     
6,052,636
 
Total
   
32,030,662
     
13,665,103
 
Total cash and cash equivalents
   
40,096,286
     
26,249,995
 

          As of March 31, 2022, we have received €8.3 million in cash from the German Federal Government grant, which is presented in “Liabilities from government grants received”; our right to retain these funds is contingent on meeting all grant conditions.
 
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 $50.0 million of its common shares over time pursuant to a Sales Agreement with SVB Leerink LLC. 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). The warrants were exercisable immediately and expired on March 1, 2022. No warrants were exercised.
 
9

7.
Share-based payments
 

(d)
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
 
2022
   
2021
 
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
 
2022
   
2021
 
Outstanding as of January 1,
   
888,632
     
1,094,852
 
Exercised during the three months ended March 31
   
-
     
(202,020
)
Outstanding as of March 31,
   
888,632
     
892,832
 
thereof vested
   
888,632
     
892,832
 

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.
 
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.
 
Number of share options
 
2022
   
2021
 
Outstanding as of January 1,
   
3,170,046
     
2,146,478
 
Granted during the three months ended March 31
   
1,561,666
     
870,928
 
Exercised during the three months ended March 31
   
-
     
(145,822
)
Forfeited during the three months ended March 31
   
(18,334
)
   
 
Outstanding as of March 31,
   
4,713,378
     
2,871,584
 
thereof vested
   
2,846,155
     
1,731,506
 

10

The number of share options granted during the three months ended March 31, 2022 under the LTIP 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)
 
2022
                                               
January 12
   
1,516,666
   
$
3.66
     
0.9008
   
3.30
   
$
4.13
     
1.35
     
5.31
     
1.57
%
January 12
   
45,000
   
$
3.68
     
0.9008
   
3.32
   
$
4.13
     
1.35
     
5.50
     
1.59
%
     
1,561,666
                                                         
Of the 1,561,666 options granted in the three months ended March 31, 2022, 1,362,500 were granted to members of the Executive Management or Board of Directors.
 

Expected dividends are nil for all share options listed above.

         

(e)
Share-based payment expense recognized
 
For the three months ended March 31, 2022, the Company has recognized €2.5 million (ended March 31, 2020: €1.7 million) 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.
Liabilities from government grants received
 
As of March 31, 2022, we have received €8.3 million in cash from the German Federal Government grant, which is presented in “Liabilities from government grant received”; our right to retain these funds is contingent on meeting all grant conditions.
 
9.
Protective foundation
 
According to the articles of association of the Company, up to 110,000,000 common shares and up to 110,000,000 preferred shares with a nominal value of €0.12 per share are authorized to be issued. All shares are registered shares. No share certificates shall be issued.
 
In order to deter acquisition bids, the Company`s general meeting of shareholders approved the right of an in-dependent foundation under Dutch law, or protective foundation, to exercise a call option pursuant to the call option agreement, upon which preferred shares will be issued by the Company to the protective foundation of up to 100% of the Company’s issued capital held by others than the protective foundation, minus one share. The protective foundation is expected to enter into a finance arrangement with a bank or, subject to applicable restrictions under Dutch law, the protective foundation may request us to provide, or cause the Company’s subsidiaries to provide, sufficient funding to the protective foundation to enable it to satisfy its payment obligation under the call option agreement.
 
These preferred shares will have both a liquidation and dividend preference over the Company`s common shares and will accrue cash dividends at a pre-determined rate. The protective foundation would be expected to 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 believe 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, 2022, the Company expensed €15 thousand (2021: €15 thousand) of ongoing costs to reimburse expenses incurred by the protective foundation.
 
11

10.
Subsequent Events
 
Strategic Program Review
 
After the end of the first quarter, in April 2022, the Company performed a strategic review of its development programs considering the current financing environment. As a result of this strategic review, management has decided to halt the clinical development of vilobelimab in HS for the time being. Furthermore, given the resources required and long duration of necessary Phase III studies of vilobelimab in AAV needed to potentially gain regulatory approval in this indication, the Company has also decided to halt the clinical development of vilobelimab in AAV for the time being. Since the first Phase III study of vilobelimab in HS had already been initiated in January 2022, the Company estimates the cost for winding down the development activities in this indication to be in the range of €0.25 to €0.35 million to be incurred in the second quarter of 2022. No costs for winding down development activities in AAV are anticipated.
 
Repricing of options under the 2017 Long-Term Incentive Plan
 
Following the significant and persistent decrease of the stock price of the Company's ordinary shares during the first quarter 2022 and especially after March 31, 2022, on April 13, 2022, the Board assessed the impact thereof on the value of the options for ordinary shares in the Company's capital awarded under the 2017 Long Term Incentive Plan (“LTIP”) and concluded that due to the extraordinary situation and in order to ensure that the options continue to be an appropriate performance incentive for the Company’s management, employees and directors, the exercise price of all outstanding and unexercised options held by active employees or directors of the Company or its affiliates shall be adjusted to $1.86 per share. The financial impact of this decision is currently being evaluated, will result in the increase in fair value of the affected options and is estimated to result in recognition of additional share-based compensation expense in the range of €0.65 to €0.85 million in future periods, most of it in Q2 2022 and the remainder over future periods over the remaining vesting term of the outstanding options.
 

12

EX-99.2 3 brhc10037458_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 interim condensed consolidated financial statements, including the notes thereto, as of March 31, 2022 and December 31, 2021 and for the three-month periods ended March 31, 2022 and 2021 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 “ITEM 5. Operating and Financial Review and Prospects” and our audited consolidated financial statements for fiscal year 2021, and the notes thereto, in each case, which appear in our Annual Report on Form 20-F for the year ended December 31, 2021 (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 “ITEM 3. Key Information––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 and C5aR technology to discover and develop first-in-class, potent and specific inhibitors of the complement activation factor known as C5a and its receptor known as C5aR. 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, 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.
 
Hidradenitis Suppurativa (HS)
 
We have been 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. We subsequently announced the results of additional analysis and first interim results of the open label extension trial. In light of all available data from the post-hoc analysis of the completed SHINE study and our interaction with the regulatory authorities, we initiated a Phase III study with vilobelimab in HS in January 2022, which we subsequently paused in February 2022, after having received conflicting advice from the FDA regarding the proposed clinical trial protocol and the primary endpoint of the study described therein. In March 2022, the FDA corrected its advice to us. However, after performing a strategic review of our development programs and considering the current financing environment, we have decided to halt the development of vilobelimab in HS for the time being.
 
II-1

Severe COVID-19
 
We are also developing vilobelimab in severe COVID-19. In March 2020, we initiated a randomized open label multicenter trial Phase II/III clinical development program (PANAMO) with vilobelimab in severe COVID-19 patients with severely progressed pneumonia. In the Phase II part of the study, we evaluated vilobelimab treatment plus best supportive care compared to best supportive care alone for up to 28 days. Vilobelimab treatment was associated with a lower 28-day all-cause mortality when compared to the best supportive care group, along with trends in disease improvement, as evidenced by fewer patients experiencing renal impairment assessed by estimated glomerular filtration rates, more patients showing reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations.
 
On March 31, 2022, we announced Phase III top-line results from the PANAMO study of vilobelimab in mechanically ventilated patients with COVID-19. Vilobelimab treatment resulted in a relative reduction in 28-day all-cause mortality by 23.9% compared to placebo but did not show statistical significance on the pre-specified primary endpoint. Three pre-specified subgroup analyses assessed the treatment effect of vilobelimab in patients with higher baseline disease severity. These analyses all showed a signal towards a reduction in 28-day all-cause mortality in the vilobelimab arm compared to the placebo arm in mechanically ventilated patients with one or more additional organ support, captured as baseline ordinal scale of 7, in patients with severe acute respiratory distress syndrome (ARDS) and in patients with kidney impairment. A pre-specified analysis of patients from Western European countries showed a relative reduction in 28-day all-cause mortality of 43% (p=0.014), suggesting an improvement in mortality in line with the reported Phase II data of the PANAMO trial. Sixty-day all-cause mortality, a key secondary endpoint, showed a continued reduction of mortality in the vilobelimab arm. We are engaged in ongoing discussions with regulatory authorities to determine next steps towards a potential approval in this indication.
 
On October 19, 2021, we announced that we received a grant of up to EUR 43.7 million from the German Ministry of Education and Research and the German Ministry of Health to support our development of vilobelimab for the treatment of severe COVID-19 patients. The initial tranche amounts to up to EUR 25.8 million and is structured as reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab. The remainder of the grant will be awarded in three additional subsequent tranches, each conditional on reaching agreed-upon development and manufacturing-related milestones for the preceding tranche and structured as reimbursement for Company expenses. Individual tranches will not be paid if the preceding milestone of a tranche is not met. To date, we have received €8.3 million in grant funds; however, our right to retain these funds is contingent on meeting all grant conditions.
 
ANCA-associated Vasculitis (AAV)
 
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 May 2021, we reported top-line data for the study, indicating that vilobelimab, when given in addition to 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 was to evaluate the efficacy and safety of vilobelimab in patients with moderate to severe AAV. The primary endpoint of the study was a 50% reduction in Birmingham Vasculitis Activity Score (BVAS) at week 16. The study was 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 received standard of care dosing of rituximab or cyclophosphamide. In part 2 of the study, patients were 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).
 
II-2

In November 2021, we announced that the double-blind, placebo-controlled trial with 57 patients achieved its principal objective, demonstrating comparable clinical response of vilobelimab to standard of care, while significantly reducing the need for glucocorticoid (GC) treatment in this life-threatening indication. We plan to discuss the data from both the U.S. and EU studies with regulatory authorities before determining next steps with the program. However, given the resources required and long duration of necessary Phase III studies to gain regulatory approval for vilobelimab in AAV, we have decided to halt the clinical development of vilobelimab in AAV for the time being.
 
Pyoderma Gangraenosum (PG)
 
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 a patient’s life due to severe pain and induction of significant movement impairment depending on the lesions’ locations. In February 2019, we initiated an open label, multicentric Phase IIa exploratory study enrolling 18 patients with moderate to severe PG in Canada, the United States. and Poland. The objectives of this study were to evaluate the safety and efficacy of vilobelimab in this patient population in three different doses.
 
On April 15, 2021 the study reached its enrollment target with 19 patients. On October 27, 2021, we announced preliminary results from the study. In the third dosing cohort at 2400mg biweekly, six of the seven patients achieved clinical remission with a PGA score of ≤ 1, which reflects a closure of the target ulcer. All patients in cohort 3 had elevated C5a levels at baseline that were continuously suppressed after initiation of vilobelimab treatment. From all cohorts, two patients had related SAEs that were reported: one patient experienced an erysipelas leading to hospitalization (judged as non-related by sponsor), another developed a rash due to a delayed hypersensitivity reaction and withdrew from the study (which had been previously disclosed from cohort 2). No dose-related AEs were found. Overall, the observed AE profile was in line with the underlying diseases. Final data of the study were presented at the 2022 American Academy of Dermatology Association (AAD) Annual Meeting on March 26, 2022. With these results, an end-of-Phase II meeting has been scheduled with the FDA for mid-2022 to discuss the pivotal program in this indication.
 
Cutaneous Squamous Cell Carcinoma (cSCC)
 
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 affected. The potential for local recurrence or metastasis of cSCC varies with the pathologic variant and localization of the primary lesion, and 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.
 
In June 2021, we announced the dosing of the first patient in the study. After five weeks of treatment with the first three patients in the monotherapy arm, a safety assessment was completed, and enrollment in the combination arm was opened.
 
On February 16, 2022, we reported that in the combination Arm B of our ongoing clinical Phase II study of vilobelimab in cSCC, three patients have been treated for at least 36 days in the first dosing cohort of the study, receiving intravenous infusions of 400 mg of vilobelimab on Days 1, 4, 8, and 15 and from Day 22 onwards, 800 mg every two weeks. Patients are also receiving 400 mg of pembrolizumab starting on Day 8 of the first cycle and every six weeks thereafter. The data from the first 36 days of treatment have been reviewed by an independent Steering Committee and no safety concerns were raised. The Steering Committee recommended to continue the study as planned and to open enrollment for the second dosing cohort with 1200 mg vilobelimab every two weeks after administration of 600 mg vilobelimab on Days 1,4, 8 and 15. The interim analysis in Arm B which is required to move to the second stage of the Phase II trial, is expected after ten patients have been treated and are evaluable for response assessment at the recommended Phase II dose level, which will be selected based on data from the safety run-in phase of the study. These data are expected to be available in the second half of 2023.
 
II-3

In parallel, enrollment continues in the monotherapy Arm A. Eight patients are now enrolled in this arm. In this arm, patients are receiving a dose of 800 mg vilobelimab on Days 1, 4, 8, and 15 of the first cycle, followed by a dose of 1600 mg vilobelimab every two weeks starting on Day 22. The interim analysis in Arm A required to proceed to the second stage is expected to be available after ten patients are evaluable for response assessment. These data are expected to be available in the third quarter of 2022.
 
INF904
 
We are developing INF904, an oral, small molecule drug candidate that targets the C5aR receptor. C5aR, a G-protein-coupled-receptor expressed primarily by granulocytes, mediates the pathophysiological effects of C5a. We plan on targeting complement-mediated, chronic auto-immune and inflammatory conditions where an oral small molecule is needed for patients. All IND-enabling studies have been completed and we plan to initiate the Phase I program in the second half of 2022.
 
On January 10, 2022, we reported that we have been granted a composition of matter patent for INF904 and associated compounds by the U.S. Patent and Trademark Office and have completed investigational new drug (IND)-enabling (preclinical) studies that demonstrated no obvious toxicological findings even in the highest dose groups in required GLP toxicity analyses. In these preclinical studies, oral INF904 showed higher plasma exposure in animals, including non-human primates, and improved inhibitory activity in a hamster neutropenia model compared to the marketed C5aR inhibitor. Anti-inflammatory therapeutic effects in several preclinical disease models were also demonstrated by INF904. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments showed INF904 has substantially less inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of drugs, including glucocorticoids. We expect to initiate a Phase I program in the second half of 2022 and plan to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.
 
IFX002
 
To expand the breadth of our anti-C5a technology, we are developing IFX002 for the treatment of chronic inflammatory indications. IFX002 shares the same mechanism of action as vilobelimab, blocking C5a with high specificity, but is designed with a dosing regimen that may be more suitable for chronic therapy. IFX002 is in pre-clinical development.
 
Financial Highlights
 
As of March 31, 2022, we had cash and cash equivalents of €40.1 million and financial assets of €59.2 million. In April 2022, we conducted a strategic review of our programs and decided to halt development of vilobelimab for HS and AAV until if and when we have sufficient funds to run Phase III trials for the respective programs.  As a result of this prioritization, we believe that our current funds on hand will be sufficient to fund our planned operations into the second half of 2024.
 
We anticipate that the level of our expenses will be affected if and as we:
 

engage with regulators with respect to potential approval paths for vilobelimab in COVID-19 and PG and determine and execute on next steps for the clinical development of, and regulatory approval for, vilobelimab in severe COVID-19 and/or PG;

further develop vilobelimab for cSCC, depending on the results of the ongoing trial in that indication;

initiate and continue research programs and development activities, including development of IFX002 and INF904; and

manufacture clinical trial material and continue to validate our manufacturing process for vilobelimab to meet regulatory standards for approval as a commercial grade manufacturing process.

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 regulatory approval of vilobelimab in severe COVID-19 patients, PG, cSCC and additional indications as well as any potential addition of a technology platform or assets.
 
II-4

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 to be 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.
 
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, manufacturing 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.
 
Our research and development expenses primarily relate to the following key programs:
 

Vilobelimab. We expect our expenses associated with vilobelimab will increase in 2022 compared to 2021, as we complete the outstanding clinical trial activities in COVID-19, explore the regulatory approval submission for vilobelimab in severe COVID-19, complete outstanding activities in our Phase II clinical program of vilobelimab in patients with AAV and our Phase II clinical trial program in patients with PG, potentially start a Phase III study in PG, and continue the Phase II clinical program in cSCC. In addition, we are also incurring expenses related to the manufacturing of clinical trial material and by validating our manufacturing process for vilobelimab to meet regulatory standards for approval as a commercial grade manufacturing process. Furthermore, we are investigating commercial scale production options.
 

IFX002. We are continuing preclinical development of IFX002, expenses for which mainly consist of salaries, costs for preclinical testing conducted by CROs and costs for the production of preclinical material.
 

INF904. We are developing an oral, small molecule drug candidate that targets the C5aR receptor. All IND-enabling studies have been completed and we plan to initiate the Phase I program in the second half of 2022.
 

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 2021, we incurred €35.7 million of research and development expenses. For the three months ended March 31, 2022 and 2021, we incurred research and development expenses of €10.5 million and €4.9 million, respectively. The principal driver of the increase in our research and development expenses was the completion of the Phase III clinical trial of vilobelimab in severe COVID-19. 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.
 
II-5

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 “ITEM 5. Operating and Financial Review and Prospects—Operating results” 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 2021, we incurred €12.0 million in general and administrative expenses. For the three months ended March 31, 2022 and 2021, we incurred general and administrative expenses of €4.4 million and €3.0 million, respectively. The principal driver of the increase in our general and administrative expenses is attributable to higher personnel expenses from equity-settled share-based compensation recognized in personnel expenses of €0.4 million. Additionally, legal, consulting and other expenses increased to €1.9 million for the three months ended March 31, 2022, from €1.0 million for the three months ended March 31, 2021.
 
II-6

Results of Operations
 
The information below was derived from our unaudited interim condensed consolidated financial statements included elsewhere herein. The discussion below should be read along with these unaudited interim condensed consolidated financial statements and our Annual Report.
 
Comparison of the Three Months Ended March 31, 2022 and 2021
 
   
Three Months Ended March 31,
 
(in €)
 
2022
   
2021
   
Change
 
Operating Expenses
                 
Research and development expenses
   
(10,471,923
)
   
(4,906,885
     
(5,565,038
)
General and administrative expenses
   
(4,387,443
)
   
(3,022,338
)
   
(1,365,105
)
Total Operating Expenses
   
(14,859,366
)
   
(7,929,224
)
   
(6,930,142
)
Other income
   
1,593
     
5,462
     
(3,869
)
Other expenses
   
(565
)
   
(565
)
   
 
Operating Result
   
(14,858,338
)
   
(7,924,327
)
   
(6,934,011
)
Finance income
   
27,962
     
22,962
     
5,000
 
Finance expenses
   
(24,586
)
   
(3,684
)
   
(20,902
)
Foreign exchange result
   
727,933
     
1,731,671
     
(1,003,738
)
Other financial result
   
125,000
     
48,000
     
77,000
 
Income Taxes
   
     
     
 
Loss for the Period
   
(14,002,030
)
   
(6,125,378
)
   
(7,876,652
)
Exchange differences on translation of foreign currency
   
1,309,875
     
3,504,699
     
(2,194,824
)
Total Comprehensive Loss
   
(12,692,154
)
   
(2,620,679
)
   
(10,071,476
)

Research and Development Expenses
 
   
Three Months Ended March 31,
 
(in €)
 
2022
   
2021
   
Change
 
Third-party expenses
   
8,088,608
     
2,989,062
     
5,099,546
 
Personnel expenses
   
2,107,623
     
1,590,678
     
516,945
 
Legal and consulting fees
   
194,087
     
220,120
     
(26,033
)
Other expenses
   
81,604
     
107,025
     
(25,421
)
Total Research and development expenses
   
10,471,923
     
4,906,885
     
5,565,038
 

We use our employee and infrastructure resources across multiple research and development programs directed towards developing vilobelimab in different indications and in 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, 2022 increased by €5.6 million compared to the three months ended March 31, 2021. This increase was primarily due to completion of the Phase III clinical development of vilobelimab for the treatment of severe COVID-19. This led to an increase of €3.1 million manufacturing costs, which significantly contributed to an overall increase of €5.1 million in third-party expenses. The €0.5 million increase in personnel expenses was mainly related to equity-settled share-based compensation.
 
II-7

General and Administrative Expenses
 
   
Three Months Ended March 31,
 
(in €)
 
2022
   
2021
   
Change
 
Personnel expenses
   
2,477,017
     
2,000,459
     
476,558
 
Legal, consulting and audit fees
   
770,291
     
341,148
     
429,143
 
Other expenses
   
1,140,136
     
680,731
     
459,405
 
Total General and administrative expense
   
4,387,443
     
3,022,339
     
1,365,105
 

General and administrative expenses increased by €1.4 million to €4.4 million for the three months ended March 31, 2022, from €3.0 million for the three months ended March 31, 2021. This increase is attributable to higher personal expenses from equity-settled share-based compensation recognized in personnel expenses of €0.4 million. Additionally, legal, consulting and other expenses increased to €1.9 million for the three months ended March 31, 2022, from €1.0 million for the three months ended March 31, 2021.
 
Net financial result
 
Financial Result
 
Three Months Ended March 31,
 
(in €)
 
2022
   
2021
   
Change
 
Finance income
                 
Interest income
   
27,962
     
22,962
     
5,000
 
Finance expenses
                       
Interest expenses
   
(19,859
)
   
(2,580
)
   
(17,279
)
Interest on lease liabilities
   
(4,727
)
   
(1,104
)
   
(3,623
)
Total
   
3,376
     
19,278
     
(15,902
)

Foreign exchange result
 
Three Months Ended March 31,
 
(in €)
 
2022
   
2021
   
Change
 
Foreign exchange result
                 
Foreign exchange income
   
1,110,408
     
2,457,039
     
(1,346,631
)
Foreign exchange expense
   
(382,475
)
   
(725,368
)
   
342,893
 
Total
   
727,933
     
1,731,671
     
(1,003,738
)

Other financial result
 
Three Months Ended March 31,
 
(in €)
 
2022
   
2021
   
Change
 
Other financial result
   
125,000
     
48,000
     
77,000
 

Net financial result decreased by €0.9 million to €0.9 million for the three months ended March 31, 2022, from €1.8 million for the three months ended March 31, 2021. This decrease is mainly attributable to lower foreign exchange gains, which decreased by €1.3 million and lower foreign exchange losses of €0.3 million. Other finance expenses for the three months ended March 31, 2022 include a €125 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, 2022, we incurred a net loss of €14.0 million. To date, we have financed our operations primarily through the sale of our securities. As of March 31, 2022, we had cash and cash equivalents of €40.1 million, plus financial assets of €59.2 million. Our cash and cash equivalents primarily consist of bank deposit accounts and fixed U.S. Dollar term deposits. Our quoted debt securities have BBB+ to AAA credit ratings.
 
II-8

Cash Flows
 
The table below summarizes our consolidated statement of cash flows for the three months ended March 31, 2022 and 2021:
 
   
Three Months Ended March 31,
 
(in €)
 
2022
   
2021
 
Net cash used in operating activities
   
(12,858,662
)
   
(10,413,453
)
Net cash from / (used in) investing activities
   
26,481,122
     
(1,049,566
)
Net cash from/ (used in) financing activities
   
(90,806
)
   
61,796,346
 
Cash and cash equivalents at the beginning of the period
   
26,249,995
     
25,968,681
 
Exchange gains on cash and cash equivalents
   
314,639
     
2,432,654
 
Cash and cash equivalents at the end of the period
   
40,096,286
     
78,734,662
 

As of March 31, 2022, we had received €8.3 million in cash from the German Federal Government grant, which is presented in “Liabilities from government grants received”; our right to retain these funds is contingent on meeting all grant conditions.
 
Net Cash from/(used in) 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 €12.9 million in the three months ended March 31, 2022, from €10.5 million in the three months ended March 31, 2021.
 
Net Cash used in Investing Activities
 
Net cash from investing activities increased by €27.5 million in the three months ended March 31, 2022 mainly due to higher proceeds from the maturing of marketable securities in the three months ended March 31, 2022 compared to the three months ended March 31, 2021.
 
Net Cash from/(used in) Financing Activities
 
Net cash from financing activities decreased by €61.9 million in the three months ended March 31, 2022 compared to the three months ended March 31, 2021, primarily due to the financing having completed in March 2021.
 
Funding Requirements
 
 We expect our expenses associated with vilobelimab will increase in 2022 compared to 2021, as we complete the outstanding clinical trial activities in COVID-19, explore the regulatory approval submission for vilobelimab in severe COVID-19, complete outstanding activities in our Phase II clinical program of vilobelimab in patients with AAV and our Phase II clinical trial program in patients with PG, potentially start a Phase III study in PG, and continue the Phase II clinical program in cSCC. In addition, we are also incurring expenses related to the manufacturing of clinical trial material and by validating our manufacturing process for vilobelimab to meet regulatory standards for approval as a commercial grade manufacturing process. Furthermore, we are investigating commercial scale production options. We also plan to complete preclinical development of INF904 and to initiate a Phase I clinical trial in H2 2022. We also plan to continue preclinical development of IFX002. If clinical data is supportive, we may seek marketing approval for any product candidates that we successfully develop. Additionally, we will validate and further develop our manufacturing process to be able to apply for marketing authorization and to be able to provide a commercial grade product. 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. 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 until the second half of 2024.
 
II-9

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 “ITEM 3. Key Information––Risk factors” in our Annual Report.
 
Off-Balance Sheet Arrangements
 
As of March 31, 2022, and during the periods presented, we did not have any off-balance sheet arrangements other as described under “ITEM 5. Operating and Financial Review and Prospects—Off-balance sheet arrangements” in the Annual Report.
 
Contractual Obligations and Commitments
 
As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, contractual obligations and commitments other than as described under “ITEM 5. Operating and Financial Review and Prospects—Liquidity and capital resources––Contractual obligations and commitments” in the Annual Report.
 
Quantitative and Qualitative Disclosures about Market Risk
 
During the three months ended March 31, 2022, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “ITEM 11. Quantitative and Qualitative Disclosures About Market Risk” in the Annual Report.
 
Critical Judgments and Accounting Estimates
 
There have been no material changes to the significant accounting policies and estimates described in “ITEM 5. Operating and Financial Review and Prospects—Critical judgments and accounting estimates” in the Annual Report.
 
JOBS Act Exemptions
 
On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. As of December 31, 2022, we will no longer qualify as an emerging growth company. Accordingly, in our Annual Report on Form 20-F for the year ended December 31, 2022, we will no longer be subject to the reduced reporting requirements applicable to emerging growth companies and we will be required to adhere to, among other things, the auditor attestation requirement in the assessment of internal controls over financial reporting and compliance with the requirement that the Public Company Accounting Oversight Board has adopted regarding a supplement to the auditor’s report providing additional information about the audit and the financial statements. As a result of losing our emerging growth company status at the end of 2022, we will incur additional costs that may continue as we refine our financial reporting processes and expand our operations.
 
II-10

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:
 

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 and C5aR 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;
 

our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales and the costs of responding to, and defending against, any government investigations or other actions;
 

our ability to commercialize vilobelimab or our other product candidates;
 
II-11


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 and C5aR inhibitors or our industry; and
 

our expectations regarding the time during in which we will no longer be an emerging growth company under the JOBS Act and/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––Risk factors” section of our 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 or in our Annual Report 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-12

EX-99.3 4 brhc10037458_ex99-3.htm EXHIBIT 99.3

Exhibit 99.3

 
InflaRx Reports First Quarter 2022
Financial and Operating Results and Provides Strategic Update
 
Quarter highlighted by progress with vilobelimab in several indications:

o
Encouraging Phase III topline results reported in patients with severe COVID-19; discussions with regulatory authorities already underway

o
Final data from Phase IIa open-label study in patients with pyoderma gangrenosum presented at 2022 AAD Annual Meeting; end-of-Phase II meeting with FDA scheduled for mid-2022

o
In Phase II trial in cutaneous squamous cell carcinoma, second dosing cohort of combination arm started; enrollment in monotherapy arm continuing with 8 patients enrolled with data expected in Q3 2022

o
Clinical development in hidradenitis suppurativa and ANCA-associated vasculitis halted for the time being
Introduced new pipeline program, INF904, an oral small molecule inhibitor of C5aR; planned to enter the clinic later this year
Cash, cash equivalents and financial assets of approximately €99.3 million as of   March 31, 2022, expected to fund operations well into H2 2024
 
Jena, Germany, May 12, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three months ended March 31, 2022 and provided a business update.
 
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “Following a recent internal strategic review, we are announcing the Company’s updated key priorities and strategy. With final data now available from our Phase IIa study, we intend to move vilobelimab into a pivotal program in pyoderma gangrenosum and advance INF-904, our small molecule C5aR inhibitor, into first-in-human testing this year. Additionally, with the encouraging topline Phase III results we saw with vilobelimab in treating severe COVID-19 patients, we are now discussing our data with regulatory authorities to assess a potential path towards approval. With all of these important activities, we decided to halt the Phase III program in hidradenitis suppurativa and not to advance vilobelimab in AAV for the time being to prioritize the best use of our resources. We are excited about InflaRx’s potential to develop effective new treatments to improve the lives of patients suffering from neutrophil-driven inflammatory diseases.”
 


Recent Highlights – Progress with Vilobelimab in Several Indications

Severe COVID-19: On March 31, 2022, InflaRx announced topline results from the Phase III part of the global Phase II/III PANAMO trial evaluating vilobelimab in mechanically ventilated patients with COVID-19. A total of 369 patients were enrolled. Vilobelimab treatment resulted in a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (vilobelimab 31.7% versus placebo 41.6%, p=0.094), which was not statistically significant using site-stratified Cox regression analysis as pre-specified in the final statistical analysis plan. At the recommendation of regulatory authorities, during the course of the trial, the Company changed the statistical analysis method for the primary endpoint. The original protocol-specified analysis would have resulted in a statistically significant p-value of 0.027. Additionally, logistic regression analyses of 28-day all-cause mortality resulted in p-values of <0.05 for 3 out of the 4 pre-specified analyses.

A pre-specified analysis of patients from Western European countries showed a relative reduction in 28-day all-cause mortality of 43% (p=0.014), suggesting an improvement in mortality in line with the reported Phase II data from the PANAMO trial.

Importantly, 60-day all-cause mortality, a key secondary endpoint, showed a continued reduction of mortality in the vilobelimab arm.

The Company is engaged in ongoing discussions with regulatory authorities to determine next steps towards a potential approval in this indication.



Pyoderma Gangrenosum (PG): InflaRx presented final data from an open-label, multi-center Phase IIa exploratory study evaluating the safety and efficacy of vilobelimab in patients with moderate to severe PG at the American Academy of Dermatology Association (AAD) Annual Meeting on March 26, 2022 in an oral late-breaker session by Afsaneh Alavi, MD, Associate Professor of Dermatology, Mayo Clinic. The final results showed a strong dose-dependent effect in the highest dose cohort of 2400 mg, with 6 out of 7 patients showing a clinical remission (Physician Global Assessment (PGA) score ≤ 1) and closure of the target ulcer. The seventh patient showed a slight improvement (PGA score 4) with a decrease of the target ulcer area of over 50%. During the follow-up period, ulcers remained closed two months after treatment completion in all but one patient, and a sustained suppression of C5a was observed for up to 20 days after the last dosing. With these compelling results, an end-of-Phase II meeting has been scheduled with the FDA for mid-2022 to discuss the pivotal program in this indication. 
 
Cutaneous Squamous Cell Carcinoma (cSCC): InflaRx is developing vilobelimab for the treatment of PD-1/PD-L1 inhibitor resistant/refractory locally advanced or metastatic cSCC. An open-label, non-comparative, two-stage, Phase II trial in cSCC is ongoing and has two independent arms: vilobelimab alone (Arm A) and vilobelimab in combination with pembrolizumab (Arm B).

Enrollment continues in the monotherapy Arm A. Eight patients are now enrolled in this arm. Data are expected to be available in the third quarter of 2022.

In February 2022, the Company announced the start of the second dosing cohort of Arm B. The interim analysis in this arm is expected after ten patients have been treated and are evaluable for response assessment at the recommended Phase II dose level, which will be selected based on data from the safety run-in phase of the study. These Arm B interim data, which are a prerequisite to move to the second stage of the trial, are expected to be available in the second half of 2023.



Hidradenitis Suppurativa (HS) and ANCA-Associated Vasculitis (AAV): In response to its recent strategic pipeline review, the Company has decided to move vilobelimab into pivotal testing in pyoderma gangrenosum and to halt the development of vilobelimab in HS and not to advance vilobelimab in AAV for the time being.
 
New Development Program Introduced
InflaRx announced in January 2022 a new pipeline program, INF904, an oral small molecule inhibitor of C5aR. InflaRx has been granted a composition of matter patent for INF904 and associated compounds by the U.S. Patent and Trademark Office and has completed investigational new drug (IND)-enabling (preclinical) studies that demonstrated no obvious toxicological findings even in the highest dose groups in required GLP toxicity analyses.

The Company expects to initiate a Phase I program in the second half of 2022 and plans to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.

Financial Highlights – Q1 2022
 
Research and Development Expenses
 
Research and development expenses for the three months ended March 31, 2022 increased by €5.6 million to €10.5 million compared to the three months ended March 31, 2021. This increase was primarily due to the completion of Phase III clinical development of vilobelimab for the treatment of COVID-19. This led to an increase of €3.1 million in manufacturing costs, which significantly contributed to an overall increase of €5.1 million in third-party expenses. The €0.5 million increase in personnel expenses was mainly related to equity-settled share-based compensation.
 


General and Administrative Expenses
 
General and administrative expenses increased by €1.4 million to €4.4 million for the three months ended March 31, 2022, from €3.0 million for the three months ended March 31, 2021. This increase is attributable to higher personnel expenses from equity-settled share-based compensation recognized in personnel expenses of €0.4 million. Additionally, legal, consulting and other expenses increased to €1.9 million for the three months ended March 31, 2022, from €1.0 million for the three months ended March 31, 2021.
 
Net Financial Result
 
Net financial result decreased by €0.9 million to €0.9 million for the three months ended March 31, 2022, from €1.8 million for the three months ended March 31, 2021. This decrease is mainly attributable to lower foreign exchange gains, which decreased by €1.3 million, and higher foreign exchange losses of €0.3 million. Other finance expenses for the three months ended March 31, 2022 included a €48 thousand gain from a reduction in the allowance for expected credit loss on marketable securities.
 
Net Loss
 
Net loss for the three months ended March 31, 2022 was €14.0 million, compared to €6.1 million for the three months ended March 31, 2021.
 
On March 31, 2022, the Company’s total funds available were approximately €99.3 million, composed of cash and cash equivalents of €40.1 million and financial assets of €59.2 million. With the Company’s adjusted strategy, these funds are expected to finance operations well into the second half of 2024.
 
Net Cash Used in Operating Activities
 
Net cash used in operating activities increased to €12.9 million in the three months ended March 31, 2022, from €10.4 million in the three months ended March 31, 2021.
 
Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and the three months ended March 31, 2022 and 2021, as well as the consolidated financial statements as of and for the year ended December 31, 2021 in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2021 as filed with the U.S. Securities and Exchange Commission.
 


InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss for the three months ended March 31, 2022 and 2021
 
   
For the three months ended
March 31,
 
(in €, except for share data)
 
2022
(unaudited)
   
2021
(unaudited)
 
             
Operating Expenses
           
Research and development expenses
   
(10,471,923
)
   
(4,906,885
)
General and administrative expenses
   
(4,387,443
)
   
(3,022,338
)
Total Operating Expenses
   
(14,859,366
)
   
(7,929,224
)
Other income
   
1,593
     
5,462
 
Other expenses
   
(565
)
   
(565
)
Operating Result
   
(14,858,338
)
   
(7,924,327
)
Finance income
   
27,962
     
22,962
 
Finance expenses
   
(24,586
)
   
(3,684
)
Foreign exchange result
   
727,933
     
1,731,671
 
Other financial result
   
125,000
     
48,000
 
Income Taxes
   
     
 
Loss for the Period
   
(14,002,030
)
   
(6,125,378
)
                 
Share Information
               
Weighted average number of shares outstanding
   
44,203,763
     
33,807,774
 
Loss per share (basic/diluted)
   
(0.32
)
   
(0.18
)
                 
Loss for the Period
   
(14,002,030
)
   
(6,125,378
)
Other comprehensive income (loss) that may be reclas-sified to profit or loss in subsequent periods:
               
Exchange differences on translation of foreign currency
   
1,309,875
     
3,504,699
 
Total Comprehensive Loss
   
(12,692,154
)
   
(2,620,679
)



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Financial Position
as of March 31, 2022 and December 31, 2021
 
in €
 
March 31,
2022
(unaudited)
   
December 31,
2021
 
             
ASSETS
           
Non-current assets
           
Property and equipment
   
251,713
     
274,373
 
Right-of-use assets
   
1,314,691
     
1,408,078
 
Intangible assets
   
209,818
     
235,216
 
Other assets
   
331,539
     
336,566
 
Financial assets
   
9,272,352
     
27,206,990
 
Total non-current assets
   
11,380,114
     
29,461,224
 
Current assets
               
Current other assets
   
12,521,363
     
10,983,458
 
Current tax assets
   
1,154,604
     
1,282,177
 
Financial assets
   
49,925,236
     
57,162,266
 
Cash and cash equivalents
   
40,096,286
     
26,249,995
 
Total current assets
   
103,697,489
     
95,677,896
 
TOTAL ASSETS
   
115,077,603
     
125,139,120
 
                 
EQUITY AND LIABILITIES
               
Equity
               
Issued capital
   
5,304,452
     
5,304,452
 
Share premium
   
280,310,744
     
280,310,744
 
Other capital reserves
   
33,121,984
     
30,591,209
 
Accumulated deficit
   
(227,977,709
)
   
(213,975,679
)
Other components of equity
   
4,360,146
     
3,050,270
 
Total equity
   
95,119,617
     
105,280,996
 
Non-current liabilities
               
Lease liabilities
   
973,905
     
1,066,354
 
Other liabilities
   
35,628
     
35,019
 
Total non-current liabilities
   
1,009,533
     
1,101,373
 
Current liabilities
               
Trade and other payables
   
9,502,770
     
8,574,244
 
Liabilities from government grants received
   
8,300,000
     
8,300,000
 
Lease liabilities
   
369,676
     
366,171
 
Employee benefits
   
644,646
     
1,378,130
 
Other financial liabilities
   
131,362
     
138,206
 
Total current liabilities
   
18,948,452
     
18,756,751
 
Total Liabilities
   
19,957,985
     
19,858,124
 
TOTAL EQUITY AND LIABILITIES
   
115,077,603
     
125,139,120
 



InflaRx N.V. and subsidiaries
 
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2022 and 2021
 
(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, 2022
   
5,304,452
     
280,310,744
     
30,591,209
     
(213,975,679
)
   
3,050,271
     
105,280,996
 
Loss for the period
   
     
     
     
(14,002,030
)
   
     
(14,002,030
)
Exchange differences on
translation of foreign currency
   
     
     
     
     
1,309,875
     
1,309,875
 
Total comprehensive loss
   
     
     
     
(14,002,030
)
   
1,309,875
     
(12,692,155
)
Equity-settled share-based
pay-ments
   
     
     
2,530,775
     
     
     
2,530,775
 
                                                 
Balance as of March 31, 2022
   
5,304,452
     
280,310,744
     
33,121,984
     
(227,977,709
)
   
4,360,146
     
95,119,617
 
                                                 
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
payments
   
     
     
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
 



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2022 and 2021
 
in €
 
For the three
months ended
March 31, 2022
(unaudited)
   
For the three
months ended
March 31, 2021
(unaudited)
 
             
Operating activities
           
Loss for the period
   
(14,002,030
)
   
(6,125,378
)
Adjustments for:
               
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
   
153,321
     
168,343
 
Net finance income
   
(856,308
)
   
(1,798,949
)
Share-based payment expense
   
2,530,775
     
1,721,270
 
Net foreign exchange differences
   
135,826
     
193,847
 
Changes in:
               
Other assets
   
(1,405,328
)
   
(2,739,152
)
Employee benefits
   
(732,876
)
   
(952,820
)
Other liabilities
   
(6,844
)
   
240,229
 
Trade and other payables
   
928,526
     
(1,150,252
)
Interest received
   
420,916
     
33,189
 
Interest paid
   
(24,641
)
   
(3,780
)
Net cash used in operating activities
   
(12,858,662
)
   
(10,413,453
)
Investing activities
               
Purchase of intangible assets, property and equipment
   
(7,828
)
   
(17,062
)
Purchase of current financial assets
   
     
(14,985,026
)
Proceeds from the maturity of financial assets
   
26,488,950
     
13,952,522
 
Net cash from/ (used in) investing activities
   
26,481,122
     
(1,049,566
)
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
   
(90,806
)
   
(90,716
)
Net cash from/ (used in) financing activities
   
(90,806
)
   
61,796,346
 
Net increase/(decrease) in cash and cash equivalents
   
13,531,653
     
50,333,328
 
Effect of exchange rate changes on cash and cash equivalents
   
314,639
     
2,432,654
 
Cash and cash equivalents at beginning of period
   
26,249,995
     
25,968,681
 
Cash and cash equivalents at end of period
   
40,096,286
     
78,734,662
 



About InflaRx N.V.:
 
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary technology to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators 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.
 
The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (Vilo-Covid). All responsibility for the content of this work lies with InflaRx.
 
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, development of vilobelimab for mechanically ventilated COVID-19 patients; future analysis of our Phase II/III PANAMO trial and interactions with regulators regarding the results of the trial and potential regulatory approval pathways; the impact of the COVID-19 pandemic on us; 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; decisions regarding the strategic direction of our company; 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;  our status as an emerging growth company and/or foreign private issuer; and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.
 


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