EX-99.3 4 brhc10016328_ex99-3.htm EXHIBIT 99.3
Exhibit 99.3


InflaRx Reports Q3 2020 Financial & Operating Results
 
•
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, October 29, 2020 – 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)
    
2019
(unaudited)
    
2020
(unaudited)
    
2019
(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 Financial Result
    
(449,816
)
    
1,268,725
      
642,656
      
3,316,586
  
Loss for the Period
    
(6,858,964
)
    
(14,501,446
)
    
(25,125,193
)
    
(39,610,157
)
                                 
Share Information
                                
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 Period
    
(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 Comprehensive Loss
    
(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
capital
    
Share
premium
    
Other
capital
reserves
    
Accumulated
deficit
    
Other
components
of equity
    
Total
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 payments
    
—
      
—
      
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.