InflaRx Reports Q3 2020 Financial & Operating Results

Nachrichtenquelle: globenewswire
29.10.2020, 12:00  |  435   |   |   
  • 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)
  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 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. 


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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 pneumoniaPublished encouraging data from Phase II part of COVID-19 trial in The Lancet RheumatologyAnnounced leadership team …

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