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IFRX - Inflarx NV News Story

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Sector
Healthcare
Size
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Market Cap £115.7m
Enterprise Value £45.9m
Revenue £n/a
Position in Universe 4720th / 6850

InflaRx Reports Q3 2020 Financial & Operating Results

Thu 29th October, 2020 11:00am
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* Initiated Phase III part of the Phase II/III adaptive, randomized,
controlled trial in patients with severe COVID-19 induced pneumonia
* Published encouraging data from Phase II part of COVID-19 trial in The
Lancet Rheumatology
* Announced leadership team additions
* Cash, cash equivalents and financial assets of approximately €95.7 million
as of September 30, 2020
JENA, Germany, Oct. 29, 2020 (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 three and nine months ended September 30, 2020.

“With cases of COVID-19 on the rise throughout the world, there remains an
urgent need to find safe and efficacious treatments for critically ill
patients. Thus, we are highly focused on advancing our ongoing Phase III trial
with IFX-1 in patients with severe COVID-19 induced pneumonia,” said Prof.
Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “In
addition, we are continuing to move forward IFX-1 in development for important
inflammatory indications, including hidradenitis suppurativa, pyoderma
gangraenosum and ANCA-associated vasculitis, all disease areas where patients
are in need of better treatment options.”

Corporate and R&D Highlights
* Leadership appointments: In September 2020, InflaRx announced the
appointment of Thomas Taapken, Ph.D. as Chief Financial Officer, and Jordan
Zwick was promoted to the newly created position of Chief Strategy Officer.
* IFX-1 in COVID-19 induced pneumonia: In September 2020, InflaRx announced
the start of the global Phase III part of its Phase II/III trial with IFX-1 in
severe COVID-19 induced pneumonia with the initiation of the first clinical
site in the Netherlands. In parallel, the German regulatory authority, the
Paul-Ehrlich-Institut (PEI), approved the Phase III clinical trial in Germany.
The trial is currently enrolling, and patients are undergoing treatment. The
randomized, double-blinded and placebo-controlled Phase III part of the Phase
II/III trial is planned to enroll approximately 360 early intubated,
critically ill patients with COVID-19 induced pneumonia across sites in the
US, EU, South America and other regions. Patients are being randomized 1:1 to
receive either IFX-1 or placebo; all patients will receive standard of care.
The primary endpoint is 28-day all-cause mortality; key secondary endpoints
will include assessment of organ support and disease improvement. An interim
analysis is planned after enrollment of 180 patients, with a potential for an
early stop for efficacy or futility. Also in September, encouraging data from
the Phase II part of the study were published in the peer-reviewed journal,
The Lancet Rheumatology.
* IFX-1 in Hidradenitis Suppurativa (HS): The Company is assessing different
strategies for a potential pathway to regulatory approval for IFX-1 in the
United States and plans to engage with the Food & Drug Administration (FDA) on
next steps. In Europe, InflaRx is working diligently to address the feedback
received in Scientific Advice from the European Medicines Agency (EMA) and
analyzing the strategy for its Phase III development program for the use of
IFX-1 in the treatment of HS.
* IFX-1 in Pyoderma Gangraenosum (PG): The Phase IIa open label trial
continues to enroll patients in the higher dose groups. Additional clinical
trial sites continue to be opened to support enrollment. Results from the
higher dose groups are expected in 2021.
* IFX-1 in ANCA-associated vasculitis (AAV): In the US IXPLORE study, all
patients have completed treatment.  Data is expected in the first half of
2021. In the European Phase II IXCHANGE trial, Part 2 continues to enroll
patients, with approximately half of the targeted 25 patients enrolled. Final
results are expected in 2021.
* IFX-1 in oncology: Activities are ongoing for the Phase IIa oncology
program, with expected initiation in the first half of 2021.
Financial highlights – Q3 2020

Research and development expenses incurred for the nine months ended September
30, 2020 decreased over the corresponding period in 2019 by €13.7 million.
This decline was primarily due to lower contribution of expense in the period
from the Phase IIb clinical development of IFX-1 in HS since this study was
completed in 2019, offset by the COVID-19 trial expenses. These two factors
led to €6.6 million of lower manufacturing costs which contributed to an
overall decline in third-party expenses of €11.5 million. The €2.0 million
decrease in personnel expenses is mainly caused by equity-settled share-based
compensation.

General and administrative expenses decreased by €3.4 million to €6.1
million for the nine months ended September 30, 2020, from €9.4 million for
the nine months ended September 30, 2019. This decrease is largely
attributable to lower expenses associated with equity-settled share-based
compensation recognized in personnel expenses (€3.0 million). Furthermore,
legal, consulting and other expenses decreased by €0.4 million to €3.2
million for the nine months ended September 30, 2020, from €3.6 million for
the nine months ended September 30, 2019. In 2019, consulting expenses were
higher due to a one-time strategic project in June 2019. Other expenses in
2020 include increased D&O insurance costs compared to the respective nine
month period in 2019.

Net financial result decreased by €2.7 million to €0.6 million for the
nine months ended September 30, 2020, from €3.3 million for the nine months
ended September 30, 2019. This decrease is mainly attributable to higher
foreign exchange losses, which increased by €1.7 million partially
compensated with foreign exchange gains (€0.5 million) while interest on
marketable securities declined by €1.5 million.

Net loss for the nine months ended September 30, 2020 was €25.1 million ,
compared to €39.6 million for the nine months ended September 30, 2019. On
September 30, 2020, the Company’s total funds available were approximately
€95.7 million, composed of cash and cash equivalents (€44.8 million) and
financial assets (€50.8 million).

Net cash used in operating activities decreased to €26.8 million in the nine
months ended September 30, 2020, from €27.0 million in the nine months ended
September 30, 2019. The decrease of cash expenses, such as third-party
expenses for manufacturing and clinical trials for our lead program IFX-1 was
nearly offset by €12.3 million lower payments on trade liabilities in the
nine months ended September 30, 2019.

Additional information regarding these results and other relevant information
is included in the notes to the unaudited Condensed Consolidated Financial
Statements as of September 30, 2020, as well as the financial statements as of
December 31, 2019 in “ITEM 18. Financial statements,” which is included in
InflaRx’s Annual Report on Form 20-F as filed with the U.S. Securities and
Exchange Commission (SEC).

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

                                                                                                      For the three months ended September 30 ,                        For the nine months ended September 30 ,                   
 ( in € , except for share data)                                                                      2020 (unaudited)                201 9 (unaudited)                2020 (unaudited)                   201 9 (unaudited)       
                                                                                                                                                                                                                                  
 Operating Expenses                                                                                                                                                                                                               
 Research and development expenses                                                                    (5,246,536  )                   (13,405,646  )                   (19,901,661  )                     (33,598,018  )          
 General and administrative expenses                                                                  (1,166,070  )                   (2,490,245   )                   (6,057,767   )                     (9,439,080   )          
 Total Operating Expenses                                                                             (6,412,606  )                   (15,895,891  )                   (25,959,428  )                     (43,037,098  )          
 Other income                                                                                         3,471                           126,559                          200,763                            194,261                 
 Other expenses                                                                                       (13         )                   (838         )                   (9,184       )                     (83,907      )          
 Operating Result                                                                                     (6,409,148  )                   (15,770,170  )                   (25,767,849  )                     (42,926,744  )          
 Finance income                                                                                       1,325,367                       2,029,992                        3,593,803                          4,527,952               
 Finance expenses                                                                                     (1,775,183  )                   (761,268     )                   (2,951,147   )                     (1,211,366   )          
 Net F inancial Result                                                                                (449,816    )                   1,268,725                        642,656                            3,316,586               
 Loss for the P eriod                                                                                 (6,858,964  )                   (14,501,446  )                   (25,125,193  )                     (39,610,157  )          
                                                                                                                                                                                                                                  
 Share I nformation                                                                                                                                                                                                               
 Weighted average number of shares outstanding                                                        27,733,778                      25,982,754                       26,674,233                         25,970,571              
 Loss per share (basic/diluted)                                                                       (0.25       )                   € (0.56)                         (0.94        )                     € (1.53)                
                                                                                                                                                                                                                                  
 Loss for the P eriod                                                                                 (6,858,964  )                   (14,501,446  )                   (25,125,193  )                     (39,610,157  )          
 Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:                                                                                                                              
 Exchange differences on translation of foreign currency                                              (3,022,687  )                   4,988,141                        (2,761,792   )                     5,683,610               
 Total C omprehensive L oss                                                                           (9,881,651  )                   (9,513,305   )                   (27,886,985  )                     (33,926,548  )          
                                                                                                                                                                                                                                  



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Financial Position
as of September 30, 2020 and December 31, 2019

 in €                                                              September 30 , 2020 (unaudited)       December 31, 2019        
                                                                                                                                  
 ASSETS                                                                                                                           
 Non-current assets                                                                                                               
 Property, plant and equipment                                     467,937                               576,373                  
 Right-of-use assets                                               623,452                               836,924                  
 Intangible assets                                                 379,811                               452,400                  
 Other assets                                                      385,837                               452,217                  
 Financial assets                                                  272,448                               272,614                  
 Total non-current assets                                          2,129,485                             2,590,528                
 Current assets                                                                                                                   
 Other assets                                                      3,794,075                             3,500,884                
 Financial assets                                                  50,563,814                            82,353,867               
 Cash and cash equivalents                                         44,834,089                            33,131,280               
 Total current assets                                              99,191,977                            118,986,031              
 TOTAL ASSETS                                                      101,321,462                           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                                            26,039,651                            25,142,213               
 Accumulated deficit                                               (159,487,199      )                   (134,362,006  )          
 Other components of equity                                        (534,564          )                   2,227,228                
 Total equity                                                      89,695,174                            107,146,673              
                                                                                                                                  
 Non-current liabilities                                                                                                          
 Lease liabilities                                                 123,053                               330,745                  
 Other non-financial liabilities                                   35,488                                39,013                   
 Total non-current liabilities                                     158,541                               369,758                  
                                                                                                                                  
 Current liabilities                                                                                                              
 Trade and other payables                                          9,998,452                             12,413,662               
 Lease liabilities                                                 511,652                               515,203                  
 Employee benefits                                                 799,812                               975,629                  
 Social security, other taxes and other non-financial liabilities  121,830                               105,634                  
 Provisions                                                        36,000                                50,000                   
 Total current liabilities                                         11,467,747                            14,060,128               
 Total Liabilities                                                 11,626,288                            14,429,886               
 TOTAL EQUITY AND LIABILITIES                                      101,321,462                           121,576,558              
                                                                                                                                  



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Changes in Shareholders’
Equity for the nine months ended September 30, 2020 and 2019

 (in €, except for share data)                            Issued       Share                 Other         Ac cu mulated             Other                  Total              
                                                          capital      premium               capital       deficit                   compo nents            equity             
                                                                                             re serves                               of equity                                 
                                                                                                                                                                               
 Balance as of January 1, 2020                            3,132,631    211,006,606           25,142,213    (134,362,006  )           2,227,228              107,146,673        
 Loss for the period                                      —            —                     —             (25,125,193   )           —                      (25,125,193  )     
 Exchange differences on translation of foreign currency  —            —                     —             —                         (2,761,792  )          (2,761,792   )     
 Total comprehensive loss                                 —            —                     —             (25,125,193   )           (2,761,792  )          (27,886,985  )     
 Contributions                                                                                                                                                                 
 Issuance of common shares                                234,982      9,535,961             —             —                         —                      9,770,943          
 Transaction costs                                        —            (729,841     )        —             —                         —                      (729,841     )     
 Equity-settled share-based payments                      —            —                     897,438       —                         —                      897,438            
 Share options exercised                                  19,797       477,149               —             —                         —                      496,946            
 Total Contributions                                      254,779      9,283,269             897,438       —                         —                      10,435,486         
 Balance as of September 30 , 2020                        3,387,410    220,289,876           26,039,651    (159,487,199  )           (534,564    )          89,695,174         
                                                                                                                                                                               
 Balance as of January 1, 2019                            3,115,725    211,021,835           18,310,003    (81,107,188   )           50,196                 151,390,571        
 Loss for the period                                      —            —                     —             (39,610,157   )           —                      (39,610,157  )     
 Exchange differences on translation of foreign currency  —            —                     —             —                         5,683,610              5,683,610          
 Total comprehensive loss                                 —            —                     —             (39,610,157   )           5,683,610              (33,926,547  )     
 Contributions                                                                                                                                                                 
 Equity-settled share-based pay-ments                     —            —                     5,689,367     —                         —                      5,689,367          
 Share options exercised                                  16,905       (15,229      )        —             —                         —                      1,676              
 Total Contributions                                      16,905       (15,229      )        5,689,367     —                         —                      5,691,043          
 Balance as of September 30, 2019                         3,132,631    211,006,606           23,999,370    (120,717,345  )           5,733,805              123,155,067        
                                                                                                                                                                               



InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows for the nine months
ended September 30, 2020 and 2019

 in €                                                                                                  For the nine months ended September 30 , 2020 (unaudited)        For the nine months ended September 30 , 2019 (unaudited)     
                                                                                                                                                                                                                                      
 Operating activities                                                                                                                                                                                                                 
 Loss for the period                                                                                   (25,125,193                    )                                 (39,610,157                    )                              
 Adjustments for:                                                                                                                                                                                                                     
 Depreciation & amortization of property, plant, equipment, right-of-use assets and intangible assets  533,687                                                          485,822                                                       
 Net financial result                                                                                  (642,656                       )                                 (3,316,586                     )                              
 Share-based payment expense                                                                           897,438                                                          5,689,367                                                     
 Net foreign exchange differences                                                                      (869,402                       )                                 (345,347                       )                              
 Other non-cash adjustments                                                                            —                                                                59,958                                                        
 Changes in:                                                                                                                                                                                                                          
 Other assets                                                                                          (226,811                       )                                 (1,233,165                     )                              
 Employee benefits                                                                                     (191,042                       )                                 (14,316                        )                              
 Social security and other current non-financial liabilities                                           13,896                                                           (205,175                       )                              
 Trade and other payables                                                                              (2,415,210                     )                                 9,859,875                                                     
 Interest received                                                                                     1,238,643                                                        1,653,617                                                     
 Interest paid                                                                                         (15,546                        )                                 (19,822                        )                              
 Net cash used in operating activities                                                                 (26,802,196                    )                                 (26,995,930                    )                              
 Investing activities                                                                                                                                                                                                                 
 Purchase of intangible assets, laboratory and office equipment                                        (83,855                        )                                 (622,265                       )                              
 Purchase of non-current other financial assets                                                        —                                                                (75,543                        )                              
 Purchase of current financial assets                                                                  (68,169,518                    )                                 40,539,826                                                    
 Proceeds from the maturity of financial assets                                                        97,465,290                                                       (42,688,210                    )                              
 Net cash from / (used in) investing activities                                                        29,211,918                                                       (2,846,193                     )                              
 Financing activities                                                                                                                                                                                                                 
 Proceeds from issuance of common shares                                                               9,770,944                                                        —                                                             
 Transaction costs from issuance of common shares                                                      (729,841                       )                                 —                                                             
 Proceeds from exercise of share options                                                               496,946                                                          1,676                                                         
 Repayment of lease liabilities                                                                        (275,323                       )                                 (209,176                       )                              
 Net cash from/ (used in) financing activities                                                         9,262,726                                                        (207,500                       )                              
 Net increase/(decrease) in cash and cash equivalents                                                  11,672,447                                                       (30,049,623                    )                              
 Effect of exchange rate changes on cash and cash equivalents                                          30,362                                                           1,673,191                                                     
 Cash and cash equivalents at beginning of period                                                      33,131,280                                                       55,386,240                                                    
 Cash and cash equivalents at end of period                                                            44,834,089                                                       27,009,808                                                    
                                                                                                                                                                                                                                      

About IFX-1:

IFX-1 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,
IFX-1 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. IFX-1 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. IFX-1 is believed to
be the first monoclonal anti-C5a antibody introduced into clinical
development. Approximately 300 people have been treated with IFX-1 in clinical
trials, and the antibody has been shown to be well tolerated. IFX-1 is
currently being developed for various indications, including Hidradenitis
Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum and COVID-19
pneumonia.

About InflaRx N.V.:

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

Contacts:

InflaRx N.V.

Jordan Zwick – Chief Strategy Officer
Email: jordan.zwick@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/38d5f700-4678-4aa4-a293-4118e2b21998)



GlobeNewswire, Inc. 2020
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