EX-99.3 4 ex99_3.htm EXHIBIT 99.3
Exhibit 99.3


InflaRx Reports Third Quarter 2019 Financial & Operating Results


 •
Recently announced results of open label extension part of SHINE Phase IIb study confirm potential of IFX-1 in Hidradenitis Suppurativa and warrant evaluation of future development

•
Company announces updated strategy with focus on selected indications for its anti-C5a complement technology and on broadening the development pipeline

•
Cash and cash equivalents plus securities and other investments of €135.5 million (approx. US$151 million) as of September 30, 2019

•
Conference call to be held today at 8am EST / 2pm CET

Jena, Germany, 7 November 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported financial results for the third quarter and first nine months of 2019 and provided a business update, outlining its corporate strategy and plans.
 
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented: “Based on our firm belief in the potential of our anti-C5a technology, we have conducted an in-depth assessment of all currently pursued development efforts and decided to put a focus on inflammatory rare diseases with high unmet medical need as well as on a defined oncology space. With this, we aim to deliver several clinical proof-of-concept milestones. Our strong cash position will additionally allow us to pursue a strategy to broaden and diversify our pipeline beyond C5a inhibition.”
 
Corporate update

IFX-1 in Hidradenitis Suppurativa: Although the main part of the SHINE Phase IIb trial did not achieve its primary endpoint of a dose dependent drug effect on the Hidradenitis Suppurativa Clinical Response Score (HiSCR) at week 16, in July, the Company reported additional results from an in-depth post-hoc data analysis of the main part of the SHINE trial. This post-hoc analysis suggested a robust anti-inflammatory activity in the high dose IFX-1 treatment group across numerous efficacy measures which were not reflected by the HiSCR. Additionally, the Company very recently reported positive results from a snapshot analysis of the open label extension (OLE) part of the SHINE study: 70.6% of the HiSCR Responder Group maintained their response during the OLE, and 41.8% of the HiSCR Non-responder Group became responders at week 40, which represented the end of the treatment period.


Strategic update: As a result of a comprehensive review of all currently running clinical programs with IFX-1 and based on newly available data, Management has decided to continue these programs while broadening its R&D pipeline as part of its diversification strategy. IFX-1 will be developed in current and new indications, such as a defined oncology indication in which a clinical proof-of-concept study is planned to start enrollment in 2020. With the positive long-term results announced recently in the OLE part of the SHINE Phase IIb study in HS, InflaRx plans to discuss with regulatory authorities the data from the trial and next steps regarding the future development of IFX-1 in this indication.
 
In parallel, InflaRx is pursuing a diversification strategy to broaden its pipeline beyond C5a inhibition. In order to implement this strategy, InflaRx has hired an experienced head of global business development and strategy in the US with a pharmaceutical background who is expected to join the team within the course of November 2019.
 
The Company has decided to focus its development efforts on rare and inflammatory diseases with high unmet medical need and on the oncology space.
 
IFX-1 in Pyoderma Gangraenosum (PG): The ongoing open label Phase IIa trial in Pyoderma Gangraenosum (PG), a debilitating, rare autoimmune disease marked by large, painful ulcers, is continuing enrollment. The Company has decided to expand enrollment from 12 to 18 patients.
 
Management update:  The Company has unilaterally terminated the employment contract of the CMO of the Company, Othmar Zenker.
 
Q3 2019 financial highlights
 
Cash and cash equivalents plus securities and other investments totaled €135.5 million as of September 30, 2019, compared to €156.3 million as of December 31, 2018. Cash and cash equivalents amounted to €27.0 million as of September 30, 2019 (December 31, 2018: €55.4 million) and marketable securities €108.5 million (December 31, 2018: €100.9 million).
 
Net cash used in operating activities increased to €27.0 million in the first nine months of 2019, compared to €15.2 million in the first nine months of 2018, mainly due to higher cash expenses, such as third-party expenses for manufacturing and clinical trials for our lead program IFX-1 and personnel expenses at InflaRx.

 

Research and development expenses increased to €33.6 million for the first nine months of 2019 (2018: €16.0 million). The principal drivers of the increase were CRO expenses associated with preclinical studies and clinical trials conducted for IFX-1 as well as manufacturing costs.
 
General and administrative expenses amounted to €9.4 million in the first nine months of 2019, compared to €9.2 million in the first nine months of 2018.
 
Net financial result in the first nine months of 2019 of €3.3 million consisted of €2.3 million interest income and €1.0 million net exchange gain, compared to a net financial gain of €5.4 million in the first nine months of 2018, which mainly consisted of €4.1 million net foreign exchange gains and €1.5 million interest income.
 
Net loss for the first nine months of 2019 was €39.6 million or € (1.53) per common share (basic and diluted), compared to €19.5 million or € (0.79) per common share (basic and diluted) for the first nine months of 2018.
 
Net loss for the three months ended September 30, 2019 was €14.5 million or € (0.56) per common share (basic and diluted), compared to €6.8 million or € (0.26) per common share (basic and diluted) for the respective three months of 2018.
 
Additional information regarding these results is included in the notes to the consolidated financial statements as of and for the quarter ended September 30, 2019, which can be found on the InflaRx website in the Investors section.
 
Strategic update call

Today, the Company will host a conference call to provide details on the results of the OLE part of the SHINE study and a strategic update in conjunction with its quarterly results at 8am EST / 2pm CET.
 
Dial-in details:

From the US: +1 929 477 0402
From the UK: +44 (0) 330 336 9127
From Europe: +49 (0) 69 2222 25577
Conference Code: 3567762

Please dial in 10 minutes before the call to register. The webcast presentation for the conference call can be accessed at https://webcasts.eqs.com/inflarx20191107/no-audio.
 

InflaRx N.V. and subsidiary
Unaudited condensed consolidated statements of comprehensive loss
for the three and nine months ended September 30, 2019 and September 30, 2018

   
Three months ended
September 30,
    
Nine months ended
September 30,
  
   
2019
(unaudited)
    
2018
(unaudited)
    
2019
(unaudited)
    
2018
(unaudited)
  
   
(in €, except for per share data)
  
Operating Expenses
                        
Research and development expenses
    
(13,405,646
)
    
(5,450,544
)
    
(33,598,018
)
    
(15,954,005
)
General and administrative expenses
    
(2,490,245
)
    
(3,042,144
)
    
(9,439,080
)
    
(9,200,333
)
Total Operating Expenses
    
(15,895,891
)
    
(8,492,688
)
    
(43,037,098
)
    
(25,154,338
)
Other income
    
126,559
      
60,616
      
194,261
      
209,898
  
Other expenses
    
(838
)
    
(2,152
)
    
(83,907
)
    
(34,446
)
Operating Result
    
(15,770,170
)
    
(8,434,224
)
    
(42,926,744
)
    
(24,978,886
)
Finance income
    
2,029,992
      
2,100,634
      
4,527,952
      
8,107,285
  
Finance expenses
    
(761,268
)
    
(440,567
)
    
(1,211,366
)
    
(2,666,155
)
Net financial Result
    
1,268,725
      
1,660,067
      
3,316,586
      
5,441,130
  
Loss for the period
    
(14,501,446
)
    
(6,774,157
)
    
(39,610,157
)
    
(19,537,756
)
                                 
Share information
                                
Weighted average number of shares outstanding
    
25,982,754
      
25,662,100
      
25,970,571
      
24,804,184
  
Loss per share (basic/diluted)
  
€
(0.56
)
  
€
(0.26
)
  
€
(1.53
)
  
€
(0.79
)
                                 
Loss for the period
    
(14,501,446
)
    
(6,774,157
)
    
(39,610,157
)
    
(19,537,756
)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
                                
Exchange differences on translation of foreign currency
    
4,988,141
      
41,810
      
5,683,610
      
25,401
  
Total comprehensive loss
    
(9,513,305
)
    
(6,732,347
)
    
(33,926,548
)
    
(19,512,355
)


InflaRx N.V. and subsidiary
Condensed consolidated statements of financial position as of September 30, 2019 and December 31, 2018

   
Sep 30, 2019
(unaudited)
    
Dec 31, 2018
  
   
(in €)
  
ASSETS
            
Non-current assets
            
Property, plant and equipment
    
1,583,254
      
624,668
  
Intangible assets
    
470,995
      
222,866
  
Non-current other assets
    
528,329
      
—
  
Non-current financial assets
    
272,744
      
207,444
  
Total non-current assets
    
2,855,322
      
1,054,979
  
Current assets
                
Current other assets
    
2,293,538
      
1,588,702
  
Current financial assets
    
109,365,112
      
101,184,240
  
Cash and cash equivalents
    
27,009,808
      
55,386,240
  
Total current assets
    
138,668,459
      
158,159,183
  
TOTAL ASSETS
    
141,523,781
      
159,214,161
  
                 
EQUITY AND LIABILITIES
                
Equity
                
Issued capital
    
3,132,631
      
3,115,725
  
Share premium
    
211,006,606
      
211,021,835
  
Other capital reserves
    
23,999,370
      
18,310,003
  
Accumulated deficit
    
(120,717,345
)
    
(81,107,188
)
Other components of equity
    
5,733,805
      
50,196
  
Total equity
    
123,155,067
      
151,390,571
  
Non-current liabilities
                
Lease liabilities
    
563,993
      
—
  
Provisions
    
43,398
      
57,148
  
Government grants
    
8,044
      
10,797
  
Total non-current liabilities
    
615,435
      
67,945
  
Current liabilities
                
Lease liabilities
    
340,748
      
—
  
Employee benefits
    
775,484
      
788,405
  
Social securities and current other tax liabilities
    
106,111
      
309,928
  
Trade and other payables
    
16,530,937
      
6,657,312
  
Total current liabilities
    
17,753,280
      
7,755,645
  
Total liabilities
    
18,368,715
      
7,823,590
  
TOTAL EQUITY AND LIABILITIES
    
141,523,781
      
159,214,161
  


InflaRx N.V. and subsidiary
Unaudited condensed consolidated statements of changes in shareholders’ equity for the nine months ended September 30, 2019 and September 30, 2018

   
Shares out-standing
    
Issued capital
    
Share premium
    
Other capital
reserves
    
Accumulated deficit
    
Other components
of equity
    
Total equity
  
   
(in €, except for share data)
  
Balance as of January 1, 2019
    
25,964,379
      
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
)
Transactions with owners of the Company
                                                        
Contributions
                                                        
Issued shares
    
140,876
      
16,905
      
(15,229
)
    
—
      
—
      
—
      
1,676
  
Equity-settled share-based payment
    
—
      
—
      
—
      
5,689,367
      
—
      
—
      
5,689,367
  
Total contributions
    
140,876
      
16,905
      
(15,229
)
    
5,689,367
      
—
      
—
      
5,691,043
  
Total transactions with owners of the Company
    
140,876
      
16,905
      
(15,229
)
    
5,689,367
      
—
      
—
      
5,691,043
  
Balance as of September 30, 2019*
    
26,105,255
      
3,132,631
      
211,006,606
      
23,999,370
      
(120,717,345
)
    
5,733,805
      
123,155,067
  
                                                         
Balance as of January 1, 2018
    
23,812,100
      
2,857,452
      
161,638,566
      
6,225,353
      
(51,292,555
)
    
0
      
119,428,816
  
Loss for the period
    
—
      
—
      
—
      
—
      
(19,537,756
)
    
—
      
(19,537,756
)
Exchange differences on translation of foreign currency
    
—
      
—
      
—
      
—
      
—
      
25,401
      
25,401
  
Total comprehensive loss
    
—
      
—
      
—
      
—
      
(19,537,756
)
    
25,401
      
(19,512,355
)
Transactions with owners of the Company
                                                        
Contributions
                                                        
Issued shares
    
1,850,000
      
222,000
      
52,768,733
      
—
      
—
      
—
      
52,990,733
  
Transaction costs
    
—
      
—
      
(3,801,265
)
    
—
      
—
      
—
      
(3,801,265
)
Equity-settled share-based payment
    
—
      
—
      
—
      
9,003,725
      
—
      
—
      
9,003,725
  
Share options exercised
    
274,584
      
32,950
      
418,794
      
—
      
—
      
—
      
451,744
  
Total contributions
    
2,124,584
      
254,950
      
49,386,262
      
9,003,725
      
—
      
—
      
58,644,937
  
Total transactions with owners of the Company
    
2,124,584
      
254,950
      
49,386,262
      
9,003,725
      
—
      
—
      
58,644,937
  
Balance as of September 30, 2018*
    
25,936,684
      
3,112,402
      
211,024,828
      
15,229,077
      
(70,830,310
)
    
25,401
      
158,561,398
  

* unaudited


InflaRx N.V. and subsidiary
Unaudited condensed consolidated statement of cash flows for the nine months ended September 30, 2019 and 2018

   
2019
(unaudited)
    
2018
(unaudited)
  
   
(in €)
  
Operating activities
            
Loss for the period
    
(39,610,157
)
    
(19,537,756
)
Adjustments for:
                
Depreciation & Amortization
    
485,822
      
105,274
  
Net financial result
    
(3,316,586
)
    
(5,441,130
)
Share based payment expense
    
5,689,367
      
9,003,725
  
Other non-cash adjustments
    
(285,389
)
    
(688,866
)
Changes in:
                
Other assets
    
(1,233,165
)
    
(964,938
)
Current financial assets
    
—
      
217
  
Employee benefits
    
(14,316
)
    
353,185
  
Social securities and current other tax liabilities
    
(205,175
)
    
2,970,381
  
Trade and other payables
    
9,859,875
      
(2,016,987
)
Interest received
    
1,653,617
      
980,442
  
Interest paid
    
( 19,822
)
    
—
  
Net cash from operating activities
    
(26,995,930
)
    
(15,236,454
)
Investing activities
                
Cash outflow from the purchase of intangible assets, laboratory and office equipment
    
(622,265
)
    
(537,357
)
Cash outflow for the investment in non-current other financial assets
    
(75,543
)
    
(200,769
)
Proceeds from the disposal of current other financial assets
    
40,539,826
      
6,179,502
  
Purchase of current financial assets
    
(42,688,210
)
    
(110,851,660
)
Net cash used in investing activities
    
(2,846,193
)
    
(105,410,284
)
Financing activities
                
Proceeds from issuance of share capital
    
—
      
52,990,733
  
Transaction cost from issuance of share capital
    
—
      
(3,801,265
)
Proceeds from exercise of share options
    
1,676
      
451,744
  
Repayment of leasing debt
    
(209,176
)
    
—
  
Net cash from financing activities
    
(207,500
)
    
49,641,212
  
Effect of exchange rate changes
    
1,673,191
      
4,072,716
  
Change in cash and cash equivalents
    
(28,376,432
)
    
(66,932,810
)
Cash and cash equivalents at beginning of period
    
55,386,240
      
123,281,888
  
Cash and cash equivalents at end of period
    
27,009,808
      
56,349,080
  


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. More than 300 people have been treated with IFX-1 in completed clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various inflammatory indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum.
 
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.
Arnd Christ
Chief Financial Officer
info[at]inflarx.de
+49 89-4141 897 800

Media Relations
MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer
inflarx[at]mc-services.eu
+49 89-210 2280


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,” “estimate,” “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 timing of and our ability to make regulatory filings 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.