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IFRX - Inflarx NV News Story

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Last Trade - 11/05/21

Sector
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Market Cap £104.4m
Enterprise Value £35.2m
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Position in Universe 4792nd / 6852

InflaRx Reports Full Year 2020 Financial & Operating Results

Thu 25th March, 2021 10:30am
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* Submitted a Special Protocol Assessment to the FDA for Phase III program
evaluating vilobelimab in Hidradenitis Suppurativa (HS) in Q1 2021
* Phase III trial in Severe COVID-19 is ongoing and recruiting patients
* Topline data from Phase II US trial in ANCA-Associated Vasculitis expected
by mid-2021
* Cash, cash equivalents and financial assets of approximately
€81.4 million as of December 31, 2020
* Completed $75M public offering in Q1 2021
JENA, Germany, March 25, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a
clinical-stage biopharmaceutical company developing anti-inflammatory
therapeutics by targeting the complement system, announced today financial
results for the year ended December 31, 2020.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx,
commented: “The year 2020 was a challenging one for all of us dealing with a
pandemic. As a physician and scientist, it has been extremely rewarding to see
how quickly effective vaccines have been developed and are already in the arms
of thousands of people.  However, we continue to see a need for novel
treatments for COVID-19 and similar future viral diseases.  We are happy to
be evaluating vilobelimab as a potential treatment to help severe COVID-19
patients and look forward to seeing those results, as well as results from
ongoing trials in other disease areas, later this year.”

Prof. Riedemann continued: “We have submitted as planned a Special Protocol
Assessment to the FDA to reach agreement on the path forward for our phase III
plans with vilobelimab in hidradenitis suppurativa.  We were excited to
announce a new area of clinical development – oncology – and are on track
to start our first cancer trial with vilobelimab in cutaneous squamous cell
carcinoma in the second quarter of this year. I am also pleased that our team
recently completed a $75 million public offering, further strengthening our
cash position and putting us on a firm financial footing to advance
vilobelimab in a number of indications. We look forward to reporting our
progress in the months ahead.”

Recent Highlights and R&D Update

Issue of Share Capital
On March 1, 2021, InflaRx announced the closing of a public offering of common
shares pursuant to which the Company sold 15,000,000 common shares and
warrants to purchase up to 15,000,000 common shares. The common shares were
sold at a price to the public of $5.00 per share. For each common share
purchased, an investor also received a warrant to purchase a common share at
an exercise price of $5.80. The warrants are exercisable immediately and have
a term of up to one year. The gross proceeds from this offering were $75.0
million (€61.6 million), before deducting the $4.5 million (€3.7 million)
underwriting discount and other estimated offering expenses of approximately
$0.5 million (€0.5 million) and excluding the exercise of any warrants.

Vilobelimab for Hidradenitis Suppurativa (HS)
InflaRx has submitted a Special Protocol Assessment (SPA) to the Food & Drug
Administration (FDA) for the planned Phase III program in HS in the first
quarter of 2021. Details on the Phase III design will be provided once
agreement has been reached with the FDA. 

In Europe, as previously reported in 2020, InflaRx received scientific advice
from the European Medicines Agency (EMA) about the European pathway for
regulatory approval, including supporting the use of a new primary endpoint,
the International Hidradenitis Suppurativa Severity Score (“IHS4”). The
Company is working diligently to address the additional feedback received to
achieve alignment with the US strategy for a global Phase III development
program in HS.

New data supporting the continued development of vilobelimab in the treatment
of HS were presented in February 2021 at the 10th Conference of the European
Hidradenitis Suppurativa Foundation e.V. (EHSF).  The data from the SHINE
Phase II trial showed that significantly elevated baseline C5a levels occurred
in HS patients versus healthy volunteers.  Data also showed that vilobelimab
dose-dependently suppressed C5a levels over time accompanied by the previously
reported reduction in inflammatory lesion counts and scores. 

Vilobelimab for Severe COVID-19
The Phase III part of the global Phase II/III trial evaluating vilobelimab in
mechanically ventilated patients with COVID-19 was initiated in mid-September
2020, and recruitment is currently ongoing with sites open in several
countries in Europe and Latin America. Additional countries are in the process
of being added. The study is enrolling as planned with a total goal of 360
patients. A blinded interim analysis is planned after 180 patients, with a
potential early stop of the trial for efficacy or futility. Topline data from
the trial are expected to be available by the end 2021.

Vilobelimab for ANCA-associated Vasculitis (AAV)
InflaRx reported the completion of enrollment in the European Phase II
IXCHANGE study of vilobelimab in AAV in Q1 2021. Topline data from the
randomized, double-blind, placebo-controlled trial with 57 patients are
expected by the end of 2021.

Vilobelimab is also being studied in the US phase II IXPLORE study in patients
with AAV. The main objective of this randomized, double-blind,
placebo-controlled study is to evaluate the safety of vilobelimab, as this is
the first time the drug is being administered to patients with AAV in the US.
Topline results are expected by mid-2021.

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

The non-comparative two-stage multi-national Phase II trial is expected to
start enrolling patients in Q2 2021 with sites in Europe, the US and other
countries. The study will investigate two independent arms: vilobelimab alone
and vilobelimab in combination with pembrolizumab. The main objectives of the
trial are to assess antitumor activity and safety of vilobelimab monotherapy
and to determine the maximum tolerated or recommended dose, safety and
antitumor activity in the combination arm.

Vilobelimab in Pyoderma Gangraenosum 
The Phase IIa open label trial continues to enroll patients in the higher dose
groups. Promising initial data from the first five patients in the study were
announced in 2020. Results from the higher dose groups are expected by the end
of 2021.

Financial highlights 2020

Research and development expenses decreased by €18.9 million to €25.7
million in the year ended December 31, 2020 compared to the year ended
December 31, 2019.

This decrease is attributable to lower CRO and CMO costs from clinical trials
in the amount of  €16.9 million due to the conclusion of the Phase IIb for
HS in 2019, the expense of which was higher than 2020 costs associated with
the new Phase II/III clinical trial in patients with COVID (2020: €4.9
million, 2019: nil) or other running trials like Phase II clinical program in
patients with AAV, the Phase II clinical program in patients with PG, the
preparation of a Phase II clinical program in patients cSCC or ongoing
manufacturing activities for clinical trial related materials.

In addition there was a €1.8 million decrease in employee-related costs
mainly caused by a €2.0 million decrease in expenses from non-cash
share-based compensation.

General and administrative expenses decreased by €4.0 million to €8.5
million for the year ended December 31, 2020, from €12.5 million for the
year ended December 31, 2019. This decrease is primarily attributable to a
€3.8 million decrease in expenses from non-cash share-based compensation.
Legal, consulting and audit fees and other expenses decreased by €0.6
million to €1.6 million for the year ended December 31, 2020, from €2.2
million for the year ended December 31, 2019, which decrease is mainly
attributable to lower consulting and travel costs. The increase of other
expenses by €0.2 million is primarily related to higher D&O insurance cost.

Net financial result decreased by €3.6 million in the year ended December
31, 2020 compared to the year ended December 31, 2019. This decrease is mainly
attributable to (a) higher foreign exchange losses, which increased by €1.7
million and (b) lower interest on marketable securities, which decreased by
€2.0 million.

Net loss for the year 2020 was €34.0 million or €1.3 per common share,
compared to €53.3 million or €2.1 per common share for the year 2019. On
December 31, 2020, the Company’s total funds available were approximately
€81.4 million, composed of cash and cash equivalents (€26.0 million) and
financial assets (€55.4 million).

Net cash used in operating activities decreased to €36.5 million in the year
ended December 31, 2020, from €43.2 million in the year ended December 31,
2019, mainly due to the decrease of research and development expenditures and
lower personnel costs, excluding stock-based compensation.

Additional information regarding these results and other relevant information
is included in the notes to the financial statements as of December 31, 2020
in “ITEM 18. Financial statements,” which is included in InflaRx’s
Annual Report on Form 20-F as filed with the US Securities and Exchange
Commission.

InflaRx N.V. and subsidiaries
Consolidated Statements of Operations and Comprehensive Loss for the Years
Ended December 31, 2020, 2019 and 2018

 in €, except for share information                                                                         2020             2019             2018           
                                                                                                                                                             
 Operating Expenses                                                                                                                                          
 Research and development expenses                                                                          (25,684,140)     (44,582,136)     (25,028,554)   
 General and administrative expenses                                                                        (8,467,203)      (12,501,048)     (12,786,869)   
 Total Operating Expenses                                                                                   (34,151,343 )    (57,083,184 )    (37,815,422 )  
 Other income                                                                                               221,748          400,253          303,860        
 Other expenses                                                                                             (13,209)         (85,242)         (4,802)        
 Operating Result                                                                                           (33,942,804 )    (56,768,173 )    (37,516,364 )  
 Finance income                                                                                             887,702          2,840,676        2,182,842      
 Finance expenses                                                                                           (26,000)         (22,265)         —              
 Foreign exchange result                                                                                    (776,512)        694,944          5,626,071      
 Other financial result                                                                                     (126,000)        —                (107,182)      
 Income Taxes                                                                                               —                —                —              
 Loss for the Period                                                                                        (33,983,614 )    (53,254,817 )    (29,814,634 )  
                                                                                                                                                             
 Share Information                                                                                                                                           
 Weighted average number of shares outstanding                                                              27,064,902       26,004,519       25,095,027     
 Loss per share (basic/diluted)                                                                             (1.26)           (2.05)           (1.19)         
                                                                                                                                                             
 Loss for the Period                                                                                        (33,983,614 )    (53,254,817 )    (29,814,634 )  
 Other comprehensive income (loss) that may be re­clas­si­fied to profit or loss in subsequent periods:                                                      
 Exchange differences on translation of foreign currency                                                    (5,954,019)      2,177,033        50,196         
 Total Comprehensive Loss                                                                                   (39,937,633 )    (51,077,785 )    (29,764,438 )  
                                                                                                                                                             

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

 in €                           2020             2019           
                                                                
 ASSETS                                                         
 Non-current assets                                             
 Property and equipment*        408,263          576,373        
 Right-of-use assets*           546,694          836,924        
 Intangible assets              350,183          452,400        
 Other assets                   353,522          452,217        
 Financial assets               272,268          272,614        
 Total non-current assets       1,930,930        2,590,528      
 Current assets                                                 
 Current other assets*          3,734,700        2,365,916      
 Income tax receivable*         1,419,490        1,134,968      
 Financial assets               55,162,033       82,353,867     
 Cash and cash equivalents      25,968,681       33,131,280     
 Total current assets           86,284,904       118,986,031    
 TOTAL ASSETS                   88,215,834       121,576,558    
                                                                
 EQUITY AND LIABILITIES                                         
 Equity                                                         
 Issued capital                 3,387,410        3,132,631      
 Share premium                  220,289,876      211,006,606    
 Other capital reserves         26,259,004       25,142,213     
 Accumulated deficit            (168,345,620)    (134,362,006)  
 Other components of equity     (3,726,791)      2,227,228      
 Total equity                   77,863,880       107,146,673    
 Non-current liabilities                                        
 Lease liabilities              220,525          330,745        
 Other liabilities              33,323           39,013         
 Total non-current liabilities  253,847          369,758        
 Current liabilities                                            
 Trade and other payables       8,258,133        12,413,662     
 Lease liabilities              338,516          515,203        
 Employee benefits              1,368,731        975,629        
 Other liabilities              117,727          105,634        
 Provisions                     15,000           50,000         
 Total current liabilities      10,098,107       14,060,128     
 Total Liabilities              10,351,954       14,429,886     
 TOTAL EQUITY AND LIABILITIES   88,215,834       121,576,558    
                                                                

InflaRx N.V. and subsidiaries
Consolidated Statements of Changes in Shareholders’ Equity for the Years
Ended December 31, 2020, 2019 and 2018

 in €                                                     Issued       Share          Other         Ac­cu­mu­lated        Other com­-         Total          
                                                          capital      pre­mium       capital       deficit               ­po­nents of        equity         
                                                                                      reserves                            equity                             
                                                                                                                                                             
 Balance as of January 1, 2018                            2,857,452    161,638,566    6,225,353     (51,292,555 )         —                   119,428,816    
 Loss for the Period                                      —            —              —             (29,814,634)          —                   (29,814,634)   
 Exchange differences on translation of foreign currency  —            —              —             —                     50,196              50,196         
 Total Comprehensive Loss                                 —            —              —             (29,814,634 )         50,196              (29,764,438 )  
 Issuance of common shares                                222,000      52,768,733     —             —                     —                   52,990,733     
 Transaction costs                                        —            (3,801,265)    —             —                     —                   (3,801,265)    
 Equity-settled share-based pay­ments                     —            —              12,084,651    —                     —                   12,084,651     
 Share options exercised                                  36,273       415,801        —             —                     —                   452,075        
 Balance as of December 31, 2018                          3,115,725    211,021,835    18,310,003    (81,107,188 )         50,196              151,390,571    
 Loss for the Period                                      —            —              —             (53,254,817)          —                   (53,254,817)   
 Exchange differences on translation of foreign currency  —            —              —             —                     2,177,033           2,177,033      
 Total Comprehensive Loss                                 —            —              —             (53,254,817 )         2,177,033           (51,077,784 )  
 Equity-settled share-based pay­ments                     —            —              6,832,210     —                     —                   6,832,210      
 Share options exercised                                  16,905       (15,229)       —             —                     —                   1,676          
 Balance as of December 31, 2019                          3,132,631    211,006,606    25,142,213    (134,362,006 )        2,227,228           107,146,673    
 Loss for the Period                                      —            —              —             (33,983,614)          —                   (33,983,614)   
 Exchange differences on translation of foreign currency  —            —              —             —                     (5,954,019)         (5,954,019)    
 Total Comprehensive Loss                                 —            —              —             (33,983,614 )         (5,954,019 )        (39,937,633 )  
 Issuance of common shares                                234,982      9,535,961      —             —                     —                   9,770,943      
 Transaction costs                                        —            (729,840)      —             —                     —                   (729,840)      
 Equity-settled share-based pay­ments                     —            —              1,116,791     —                     —                   1,116,791      
 Share options exercised                                  19,797       477,149        —             —                     —                   496,946        
 Balance as of December 31, 2020                          3,387,410    220,289,876    26,259,004    (168,345,620 )        (3,726,791 )        77,863,880     
                                                                                                                                                             

InflaRx N.V. and subsidiaries
Consolidated Statements of Cash Flows for the Years ended December 31, 2020,
2019 and 2018

                                                                                                   2020             2019             2018           
                                                                                                                    (in €)                          
 Operating activities                                                                                                                               
 Loss for the Period                                                                               (33,983,614)     (53,254,817)     (29,814,634)   
 Adjustments for:                                                                                                                                   
 Depreciation & amortization of property and equipment, right-of-use assets and intangible assets  712,713          663,166          173,630        
 Net finance income                                                                                40,810           (3,513,355)      (7,701,731)    
 Share-based payment expense                                                                       1,116,791        6,832,210        12,084,651     
 Net foreign exchange differences                                                                  (247,322)        (368,477)        (17,257)       
 Other non-cash adjustments                                                                        3,436            60,628           213,956        
 Changes in:                                                                                                                                        
 Other assets                                                                                      (1,554,611)      (2,364,399)      (893,602)      
 Current financial assets                                                                          —                —                (316,112)      
 Employee benefits                                                                                 355,545          235,500          494,837        
 Other liabilities                                                                                 8,960            (209,948)        304,627        
 Trade and other payables                                                                          (4,155,529)      5,734,795        2,243,137      
 Interest received                                                                                 1,201,547        3,001,109        1,679,250      
 Interest paid                                                                                     (26,387)         (20,903)         —              
 Net cash used in operating activities                                                             (36,527,661 )    (43,204,492 )    (21,549,248 )  
 Investing activities                                                                                                                               
 Purchase of intangible assets and property and equipment                                          (94,189)         (594,889)        (806,531)      
 Purchase of non-current other financial assets                                                    —                (75,543)         (209,705)      
 Proceeds from the disposal of non-current other financial assets                                  —                —                21,811         
 Purchase of current financial assets                                                              (101,600,176)    (82,547,409)     (106,445,120)  
 Proceeds from the maturity of current financial assets                                            123,056,347      103,559,395      7,990,204      
 Net cash from/ (used in) investing activities                                                     21,361,982       20,341,554       (99,449,341 )  
 Financing activities                                                                                                                               
 Proceeds from issuance of common shares                                                           9,770,944        —                52,990,733     
 Transaction costs from issuance of common shares                                                  (729,841)        —                (3,801,265)    
 Proceeds from exercise of share options                                                           496,946          1,676            452,075        
 Repayment of lease liabilities                                                                    (366,156)        (296,020)        —              
 Net cash from/ (used in) financing activities                                                     9,171,893        (294,344 )       49,641,542     
 Net increase/(decrease) in cash and cash equivalents                                              (5,993,786 )     (23,157,282 )    (71,357,047 )  
 Effect of exchange rate changes on cash and cash equivalents                                      (1,168,813)      902,321          3,461,399      
 Cash and cash equivalents at beginning of period                                                  33,131,280       55,386,240       123,281,888    
 Cash and cash equivalents at end of period                                                        25,968,681       33,131,280       55,386,240     
                                                                                                                                                    

About vilobelimab:

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a
antibody, which highly and effectively blocks the biological activity of C5a
and demonstrates high selectivity towards its target in human blood. Thus,
vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact
as an important defense mechanism, which is not the case for molecules
blocking the cleavage of C5. Vilobelimab has been demonstrated to control the
inflammatory response driven tissue and organ damage by specifically blocking
C5a as a key “amplifier” of this response in pre-clinical studies.
Vilobelimab is believed to be the first monoclonal anti-C5a antibody
introduced into clinical development. Approximately 300 people have been
treated with vilobelimab in clinical trials, and the antibody has been shown
to be well tolerated. Vilobelimab is currently being developed for various
indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis,
Pyoderma Gangraenosum, Cutaneous Squamous Cell Carcinoma and severe
COVID‑19.

About InflaRx N.V.:

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused
on applying its proprietary anti-C5a technology to discover and develop
first-in-class, potent and specific inhibitors of C5a. Complement C5a is a
powerful inflammatory mediator involved in the progression of a wide variety
of autoimmune and other inflammatory diseases. InflaRx was founded in 2007,
and the group has offices and subsidiaries in Jena and Munich, Germany, as
well as Ann Arbor, MI, USA. For further information please visit
www.inflarx.de.

Contacts:

InflaRx N.V.
Jordan Zwick – Chief Strategy Officer
Email: IR@inflarx.de
Tel: +1 917-338-6523

MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer 
Email: inflarx@mc-services.eu 
Europe: +49 89-210 2280
US: +1-339-832-0752

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other
than statements of historical fact are forward-looking statements, which are
often indicated by terms such as “may,” “will,” “should,”
“expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “believe,” “estimate,” “predict,”
“potential” or “continue” and similar expressions. Forward-looking
statements appear in a number of places throughout this release and may
include statements regarding our intentions, beliefs, projections, outlook,
analyses and current expectations concerning, among other things, our ongoing
and planned preclinical development and clinical trials; the impact of the
COVID-19 pandemic on the Company; the timing and our ability to commence and
conduct clinical trials; potential results from current or potential future
collaborations; our ability to make regulatory filings, obtain positive
guidance from regulators, and obtain and maintain regulatory approvals for our
product candidates; our intellectual property position; our ability to develop
commercial functions; expectations regarding clinical trial data; our results
of operations, cash needs, financial condition, liquidity, prospects, future
transactions, growth and strategies; the industry in which we operate; the
trends that may affect the industry or us and the risks uncertainties and
other factors described under the heading “Risk Factors” in InflaRx’s
periodic filings with the Securities and Exchange Commission. These statements
speak only as of the date of this press release and involve known and unknown
risks, uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by the
forward-looking statements. Given these risks, uncertainties and other
factors, you should not place undue reliance on these forward-looking
statements, and we assume no obligation to update these forward-looking
statements, even if new information becomes available in the future, except as
required by law.

(https://www.globenewswire.com/NewsRoom/AttachmentNg/b865827c-d3ff-479b-90ea-5284ef1a1a8c)



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