EX-99.3 4 ex99_3.htm EXHIBIT 99.3
Exhibit 99.3
 

InflaRx Reports Q1 2020 Financial & Operating Results
 
•
End of Phase II meeting with the FDA scheduled to discuss the path forward for IFX-1 in Hidradenitis Suppurativa
•
Initial promising results reported in Pyoderma Gangraenosum
•
Part 1 of adaptive randomized trial in severe COVID-19 pneumonia fully enrolled
•
Signed clinical collaboration agreement in oncology
•
Cash, cash equivalents and financial assets of approximately €108.0 million as of March 31, 2020
 
Jena, Germany, 21 May 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 months ended March 31, 2020.
 
“InflaRx continues to make progress with its clinical development programs for IFX-1 and recently reported encouraging initial results in Pyoderma Gangraenosum, the second neutrophil-driven devastating skin disease we are pursuing,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “With the upcoming scheduled FDA End of Phase II meeting for development in Hidradenitis Suppurativa, the Company is keeping a strong focus on potentially advancing into Phase III development in this disease.”
 
Prof. Riedemann continued, “We are currently analyzing results from the first 30 patients in our ongoing adaptive randomized COVID-19 pneumonia trial, which will serve as the basis for the decision to potentially continue into a confirmatory larger second part of the study.”
 
R&D highlights – Q1 2020
 
•
IFX-1 in Hidradenitis Suppurativa (HS): In Q1 2020, the Company requested an End of Phase II meeting with the FDA to discuss the path forward for a pivotal program with IFX-1 in HS. The meeting has been scheduled for mid-year 2020.
•
IFX-1 in Pyoderma Gangraenosum (PG): In February 2020, the Company announced positive initial data from the first 5 patients dosed in the ongoing Phase IIa open label study. Of these 5 initial patients dosed with IFX-1, 2 patients achieved complete closure of the target ulcer and complete healing of all other PG ulcers. Patients continue to enroll in higher dose groups.


•
IFX-1 in ANCA-associated vasculitis (AAV): Part 1 of the European Phase II IXCHANGE study has been fully enrolled. After analyzing the impact of COVID-19 on the study, a blinded interim analysis of Part 1 has been completed. Based on the analysis, the Company intends to continue with Part 2 of the study but decrease the number of enrolled patients. Following a blinded interim analysis of the US Phase II IXPLORE study with IFX-1 in patients with AAV and an assessment of the potential impact of the COVID-19 pandemic, the Company has decided to stop the study and read out the existing results earlier than initially planned as part of a strategy to align and streamline the US and EU AAV development programs.
•
IFX-1 in oncology: In Q1 2020, the Company entered into a clinical collaboration agreement (reported on April 29, 2020) to evaluate the combination of IFX-1 and a market leading anti-PD-1 therapy in patients with an undisclosed tumor type. Under the terms of the agreement, InflaRx will conduct a Phase IIa clinical study with two IFX-1 arms, including one with the anti-PD-1 therapy.
•
IFX-1 in COVID-19 pneumonia: The Company initiated a Phase II clinical development program with IFX-1 in COVID-19 patients with severely progressed pneumonia. After all patients have been treated in the first part of the trial, an interim analysis will be performed to evaluate the clinical benefit of the treatment using the assessed clinical parameters in order to potentially initiate and adapt the confirmatory second part of the study. Part 1 was fully enrolled with 30 patients as of April 24, 2020.

Financial highlights - Q1 2020
 
Research and development expenses decreased by €0.4 million in the three months ended March 31, 2020 compared to the three months ended March 31, 2019. This decrease is primarily attributable to a €0.3 million decrease in expenses from non-cash share-based compensation.
 
General and administrative expenses decreased by €0.7 million to €2.6 million for the three months ended March 31, 2020, from €3.3 million for the three months ended March 31, 2019. This decrease is primarily attributable to a €0.9 million decrease in non-cash share-based compensation expense.  Legal, consulting and other expenses increased by €0.1 million to €1.1 million for the three months ended March 31, 2020, from €1.0 million for the three months ended March 31, 2019.


Net financial result increased by €0.4 million to €1.5 million for the three months ended March 31, 2020, from €1.1 million for the three months ended March 31, 2019. This increase is mainly attributable to (a) higher foreign exchange gains, which increased by €0.8 million and (b) interest on marketable securities, which decreased by €0.4 million.
 
Net loss for the three months ended March 31, 2020 was €8.2 million or €(0.32) per common share, compared to €9.8 million or €(0.38) per common share for the three months ended March 31, 2019. On March 31, 2020, the Company’s total funds available were approximately €108.0 million, mostly composed of cash and cash equivalents (€21.1 million) and marketable securities (€86.3 million).
 
Net cash used in operating activities increased to €10.5 million for the three months ended March 31, 2020, from €8.5 million in the three months ended March 31, 2019, mainly due to the increase of cash expenses, such as third-party expenses for manufacturing and clinical trials for our lead program IFX-1 and higher personnel costs.
 
Additional information regarding these results is included in the notes to the consolidated financial statements as of March 31, 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 subsidiary
Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2020 and 2019
 
in €
  
2020
(unaudited)
    
2019
(unaudited)
  
             
Operating Expenses
            
Research and development expenses
    
(7,298,799
)
    
(7,695,150
)
General and administrative expenses
    
(2,564,803
)
    
(3,301,166
)
Total Operating Expenses
    
(9,863,601
)
    
(10,996,316
)
Other income
    
94,960
      
64,836
  
Other expenses
    
(5,720
)
    
(3,886
)
Operating Result
    
(9,774,362
)
    
(10,935,366
)
Finance income
    
1,658,991
      
1,159,205
  
Finance expenses
    
(118,026
)
    
(61,710
)
Net Financial Result
    
1,540,965
      
1,097,495
  
Loss for the Period
    
(8,233,397
)
    
(9,837,871
)
                 
Share Information
                
Weighted average number of shares outstanding
    
26,105,255
      
25,964,379
  
Loss per share (basic/diluted)
    
(0.32
)
    
(0.38
)
                 
Loss for the Period
    
(8,233,397
)
    
(9,837,871
)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
                
Exchange differences on translation of foreign currency
    
1,713,868
      
2,317,546
  
Total Comprehensive Loss
    
(6,519,529
)
    
(7,520,325
)


InflaRx N.V. and subsidiary
Consolidated Statements of Financial Position as of March 31, 2020 and December 31, 2019
 
in €
  
2020
(unaudited)
    
2019
  
             
ASSETS
            
Non-current assets
            
Property, plant and equipment
    
540,606
      
576,373
  
Right-of-use assets
    
748,785
      
836,924
  
Intangible assets
    
430,368
      
452,400
  
Non-current other assets
    
445,403
      
452,217
  
Non-current financial assets
    
272,718
      
272,614
  
Total non-current assets
    
2,437,880
      
2,590,528
  
Current assets
                
Current other assets
    
3,319,222
      
3,500,884
  
Current financial assets
    
86,680,961
      
82,353,867
  
Cash and cash equivalents
    
21,083,608
      
33,131,280
  
Total current assets
    
111,083,791
      
118,986,031
  
TOTAL ASSETS
    
113,521,671
      
121,576,558
  
                 
EQUITY AND LIABILITIES
                
Equity
                
Issued capital
    
3,132,631
      
3,132,631
  
Share premium
    
211,006,606
      
211,006,606
  
Other capital reserves
    
26,043,246
      
25,142,213
  
Accumulated deficit
    
(142,514,552
)
    
(134,362,006
)
Other components of equity
    
3,860,246
      
2,227,228
  
Total equity
    
101,528,177
      
107,146,673
  
Non-current liabilities
                
Lease liabilities
    
245,478
      
330,745
  
Other non-financial liabilities
    
39,148
      
39,013
  
Total non-current liabilities
    
284,625
      
369,758
  
Current liabilities
                
Trade and other payables
    
10,490,938
      
12,413,662
  
Lease liabilities
    
513,374
      
515,203
  
Employee Benefits
    
571,960
      
975,629
  
Social securities, other tax and non-financial liabilities
    
108,221
      
105,634
  
Provisions
    
24,374
      
50,000
  
Total current liabilities
    
11,708,869
      
14,060,128
  
Total Liabilities
    
11,993,494
      
14,429,886
  
TOTAL EQUITY AND LIABILITIES
    
113,521,671
      
121,576,558
  


InflaRx N.V. and subsidiary
Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2020 and 2019
 
in €
  
Issued
capital
    
Share
premium
    
Other
capital
reserves
    
Accumulated
deficit
    
Other
components
of equity
    
Total
equity
  
                                     
Balance at January 1, 2020
    
3,132,631
      
211,006,606
      
25,142,213
      
(134,362,006
)
    
2,227,228
      
107,146,673
  
Loss for the period
    
—
      
—
      
—
      
(8,233,397
)
    
—
      
(8,233,397
)
Exchange differences on translation of operations in foreign currency
    
—
      
—
      
—
      
—
      
1,713,868
      
1,713,868
  
Total comprehensive loss
    
—
      
—
      
—
      
(8,233,397
)
    
1,713,868
      
(6,519,529
)
Transactions with owners of the Company
                                                
Contributions
                                                
Equity-settled share-based payment
    
—
      
—
      
901,033
      
—
      
—
      
901,033
  
Total Contributions
    
—
      
—
      
901,033
      
—
      
—
      
901,033
  
Total transactions with owners of the Company
    
—
      
—
      
901,033
      
—
      
—
      
901,033
  
Balance at March 31, 2020*
    
3,132,631
      
211,006,606
      
26,043,246
      
(142,595,403
)
    
3,941,097
      
101,528,177
  
                                                 
Balance at January 1, 2019
    
3,115,725
      
211,021,835
      
18,310,003
      
(81,107,188
)
    
50,196
      
151,390,571
  
Loss for the period
    
—
      
—
      
—
      
(9,837,871
)
    
—
      
(9,837,871
)
Exchange differences on translation of operations in foreign currency
    
—
      
—
      
—
      
—
      
2,317,546
      
2,317,546
  
Total comprehensive loss
    
—
      
—
      
—
      
(9,837,871
)
    
2,317,546
      
(7,520,325
)
Transactions with owners of the Company
                                                
Contributions
                                                
Equity-settled share-based payment
    
—
      
—
      
2,097,780
      
—
      
—
      
2,097,780
  
Total Contributions
                    
2,097,780
      
—
      
—
      
2,097,780
  
Total transactions with owners of the Company
    
—
      
—
      
2,097,780
      
—
      
—
      
2,097,780
  
Balance at March 31, 2019*
    
3,115,725
      
211,021,835
      
20,407,783
      
(90,945,059
)
    
2,367,742
      
145,968,026
  
* unaudited
                                                


InflaRx N.V. and subsidiary
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2020 and 2019
 
in €
  
2020
(unaudited)
    
2019
(unaudited)
  
             
Operating activities
            
Loss for the period
    
(8,233,397
)
    
(9,837,871
)
Adjustments for:
                
Depreciation & Amortization of property, plant, equipment, right-of-use assets and intangible assets
    
182,356
      
116,519
  
Net financial result
    
(1,540,965
)
    
(1,097,495
)
Share-based payment expense
    
901,033
      
2,097,780
  
Other non-cash adjustments
    
(129,122
)
    
81,346
  
Changes in:
                
Other assets
    
188,476
      
(581,651
)
Employee benefits
    
(428,526
)
    
(333,864
)
Social securities, other current non-financial liabilities
    
1,953
      
457,497
  
Trade and other payables
    
(1,922,724
)
    
364,158
  
Interest received
    
462,342
      
241,817
  
Interest paid
    
(2,246
)
    
(6,682
)
Net cash flows from operating activities
    
(10,520,819
)
    
(8,498,447
)
Investing activities
                
Purchase of intangible assets, laboratory and office equipment
    
(27,686
)
    
(254,316
)
Purchase of current financial assets
    
(23,412,469
)
    
(10,599
)
Disposal of current financial assets
    
—
      
3,088
  
Securities matured
    
20,724,386
      
—
  
Net cash flows from investing activities
    
(2,715,769
)
    
(261,827
)
Financing activities
                
Repayment of leasing liabilities
    
(88,339
)
    
(54,781
)
Net cash flows from financing activities
    
(88,339
)
    
(54,781
)
Net (decrease)/increase in cash and cash equivalents
    
(13,324,927
)
    
(8,815,054
)
Effect of exchange rate changes on cash and cash equivalents
    
1,277,255
      
592,005
  
Cash and cash equivalents at beginning of period
    
33,131,280
      
55,386,240
  
Cash and cash equivalents at end of period
    
21,083,608
      
47,163,191
  


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 – Global Head of Business Development & Corporate Strategy
Email: jordan.zwick[at]inflarx.de
Tel: +1 917-338-6523
 
MC Services AG

Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: inflarx[at]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.