IFRX InflaRx N.V.

5.04
+0.07  (+1%)
Previous Close 4.97
Open 5.07
52 Week Low 2.17
52 Week High 9.6979
Market Cap $131,570,485
Shares 26,270,229
Float 21,926,584
Enterprise Value $14,375,463
Volume 348,305
Av. Daily Volume 887,896
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Upcoming Catalysts

Drug Stage Catalyst Date
IFX-1
ANCA-associated vasculitis (AAV)
Phase 2
Phase 2
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IFX-1
Pyoderma Gangraenosum (PG)
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
IFX-1
COVID-19
Phase 3
Phase 3
Phase 3 trial to be initiated in the coming months - noted July 21, 2020.
IFX-1
Hidradenitis Suppurativa
Phase 2b
Phase 2b
Phase 2b data June 5, 2019 did not meet primary endpoint.

Latest News

  1. JENA, Germany, Aug. 06, 2020 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present at several upcoming virtual investor events in August and September as follows:

    BTIG Virtual Biotechnology Conference: August 10th – 11th

    A BTIG analyst will host a fireside chat with Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, to discuss the Company's pipeline and upcoming catalysts on Monday, August 10th at 12:30pm EST. The Company will also hold virtual 1X1 meetings.

    A live webcast of the fireside chat will be provided on the InflaRx website in the Investors section under Events & Presentations…

    JENA, Germany, Aug. 06, 2020 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present at several upcoming virtual investor events in August and September as follows:

    BTIG Virtual Biotechnology Conference: August 10th – 11th

    A BTIG analyst will host a fireside chat with Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, to discuss the Company's pipeline and upcoming catalysts on Monday, August 10th at 12:30pm EST. The Company will also hold virtual 1X1 meetings.

    A live webcast of the fireside chat will be provided on the InflaRx website in the Investors section under Events & Presentations. A replay will be available following the live event.

    H.C. Wainwright Annual Global Investment Conference: September 14th – 16th

    The Company will give a presentation and conduct virtual 1X1 meetings.

    A live webcast of the Company's presentation will be provided on the InflaRx website in the Investors section under Events & Presentations.

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: September 21st – 23rd

    The Company will give a presentation and conduct virtual 1X1 meetings.

    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  of 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.

    Primary Logo

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    • Announced encouraging results from the Phase II portion of the Phase II/III adaptive, randomized, controlled trial in patients with COVID-19 induced pneumonia, showing a trend in lower 28-day all-cause mortality rate
    • Completed end-of-Phase II meeting with the FDA for IFX-1 in hidradenitis suppurativa
    • Received positive EMA scientific advice suggesting that IHS4 could be used as primary endpoint in InflaRx´s pivotal development in hidradenitis suppurativa
    • Cash, cash equivalents and financial assets of approximately €98.9 million as of June 30, 2020

    JENA, Germany, July 30, 2020 (GLOBE NEWSWIRE) -- InflaRx (NASDAQ:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced…

    • Announced encouraging results from the Phase II portion of the Phase II/III adaptive, randomized, controlled trial in patients with COVID-19 induced pneumonia, showing a trend in lower 28-day all-cause mortality rate

    • Completed end-of-Phase II meeting with the FDA for IFX-1 in hidradenitis suppurativa
    • Received positive EMA scientific advice suggesting that IHS4 could be used as primary endpoint in InflaRx´s pivotal development in hidradenitis suppurativa
    • Cash, cash equivalents and financial assets of approximately €98.9 million as of June 30, 2020

    JENA, Germany, July 30, 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 six months ended June 30, 2020.

    "The encouraging data from the randomized exploratory first part of our study in COVID-19 are in line with the mode of action of IFX-1 and give hope that C5a inhibition with IFX-1 may be a life-saving treatment option. The results have been submitted for publication in a peer-reviewed medical journal and to a pre-print server, and we are planning an adequately controlled and powered Phase III part of the study in critically ill COVID-19 patients," said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx.

    Prof. Riedemann continued, "We just received the EMA scientific advice agreeing with our arguments on the limitations of the currently used score in hidradenitis suppurativa development (HiSCR) and suggesting that IHS4 could be used as the primary endpoint in our pivotal studies. Our initial interactions with both EMA and FDA related to a Phase III development program in hidradenitis suppurativa have shown us that IFX-1 is a Phase III ready drug candidate. We are working on a strategy to address the FDA´s concerns related to the suggested change in the primary endpoint and plan additional FDA interactions on this topic. Our other clinical programs with IFX-1 are moving forward in pyoderma gangraenosum and ANCA-associated vasculitis. Depending on the COVID-19 situation, we expect readouts in these indications in 2021."

    Recent R&D Highlights

    • IFX-1 in COVID-19 induced pneumonia: In June 2020, InflaRx announced encouraging results from the first 30 patients treated in the adaptive randomized Phase II/III trial in patients with severe COVID-19 induced pneumonia.  Positive treatment trends were seen in the 28-day all-cause mortality rate and in various other endpoints.  Twenty-eight-day all-cause mortality in the IFX-1 treatment group was 13% (2 out of 15) versus 27% (4 out of 15) in the control group. In the best supportive care group, four patients died of COVID-19-induced multi-organ failure, and three of them had pulmonary embolisms reported as a serious adverse event. In the IFX-1 treatment arm, one patient died after an acute ventilator tube complication (leakage) leading to hypoxia, and one patient who met an exclusion criterion with a history of severe chronic obstructive pulmonary disease, which was not known at time point of enrollment, died of pulmonary failure.  Additionally, fewer patients in the IFX-1 treatment arm experienced renal impairment assessed by estimated glomerular filtration rates, and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations as a sign of reduction in tissue damage. A temporary significant increase of D-dimer levels in the first days following IFX-1 administration was noted, as potentially an expression of induction of blood clot lysis. No statistically significant group differences on the chosen primary endpoint of relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were detected. However, the exploratory first part of this study was not powered to show such differences. InflaRx is now planning an adequately powered, placebo-controlled, double blinded Phase III part using 28-day all-cause mortality as the primary endpoint, an accepted regulatory primary endpoint for critical care studies.
    • IFX-1 in Hidradenitis Suppurativa (HS): In June 2020, InflaRx completed an end-of-Phase II meeting with the FDA to discuss a Phase III program for the use of IFX-1 for the treatment of HS. The FDA agreed to key proposals to support a Biologics License Application (BLA) submission, including aspects of the Phase III trial design, IFX-1 dosing, target study population, and the nonclinical and clinical pharmacology packages. While the FDA did not agree that the International Hidradenitis Suppurativa Severity Score ("IHS4") is fit for purpose as a primary efficacy endpoint tool to support labeling, the FDA recommended that the Company obtain HS patient input to help determine the validity of the IHS4 score. The Company is now assessing different strategies for a potential pathway to regulatory approval for IFX-1 in the United States and plans to engage with the FDA on next steps.

      Additionally, the Company requested scientific advice from the European Medicines Agency (EMA) about the European pathway for regulatory approval and received feedback in July 2020. Although the EMA noted certain considerations regarding the Company's proposal, the EMA acknowledged that HiSCR response does not account for the clinical relevance of a reduction in draining fistulas and the effort to construct a new endpoint that better captures these changes was endorsed in principle.  According to the EMA, although HiSCR was used as an endpoint in previous studies, IHS4 could be an appropriate tool to evaluate the efficacy of a novel compound in HS. The Company is working diligently to address the additional feedback received and analyzing the strategy for its Phase III development in 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 European Phase II IXCHANGE trial, Part 2 continues to enroll patients.  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 – H1 2020

    Research and development expenses incurred for the six months ended June 30, 2020

    decreased over the corresponding period in 2019 by €5.5 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 a net decline of €3.7 million in third-party expenses. Furthermore third-party manufacturing expenses also declined by €1.0 million. Additionally, equity-settled share-based compensation recognized in personnel expenses decreased by €0.9 million.

    General and administrative expenses decreased by €2.1 million to €4.9 million for the six months ended June 30, 2020, from €6.9 million for the six months ended June 30, 2019. This decrease is primarily attributable to decreasing expenses associated with equity-settled share-based compensation recognized in personnel expenses (€1.5 million). Furthermore, legal, consulting and other expenses decreased by €0.7 million to €2.1 million for the six months ended June 30, 2020, from €2.8 million for the six months ended June 30, 2019. In 2019, consulting costs were higher due to a onetime strategic project.

    Net financial result decreased by €1.0 million to €1.1 million for the six months ended June 30, 2020, from €2.0 million for the six months ended June 30, 2019. This decrease is mainly attributable to lower interest earned on marketable securities (€1.1 million), partially offset by a higher foreign exchange result (higher gains €0.9 million and €0.5 million higher losses).

    Net loss for the six months ended June 30, 2020 was €18.3 million or €(0.70) per common share, compared to €25.1 million or €(0.97) per common share for the six months ended June 30, 2019. On June 30, 2020, the Company's total funds available were approximately €98.9 million, composed of cash and cash equivalents (€36.4 million) and financial assets (€62.5 million).

    Net cash used in operating activities decreased to €18.2 million in the six months ended June 30, 2020, from €18.7 million in the six months ended June 30, 2019, mainly due to the decrease of cash expenses, such as third-party expenses for manufacturing and clinical trials for our lead program IFX-1, compensated by lower payments on trade liabilities in the six months ended June 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 June 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 six months ended June 30, 2020 and 2019

     For the three months ended

    June 30,
    For the six months ended

    June 30,
    (in €, except for share data)2020

    (unaudited)

     2019

    (unaudited)

     2020

    (unaudited)

     2019

    (unaudited)
         
    Operating Expenses    
    Research and development expenses(7,356,326) (12,497,222) (14,655,125) (20,192,372)
    General and administrative expenses(2,326,895) (3,647,849) (4,891,698) (6,949,015)
    Total Operating Expenses(9,683,221) (16,145,071) (19,546,822) (27,141,387)
    Other income102,332  2,866  197,292  67,702 
    Other expenses(3,450) (79,183) (9,170) (83,068)
    Operating Result(9,584,339) (16,221,387) (19,358,701) (27,156,753)
    Finance income609,444  1,338,755  2,268,436  2,497,960 
    Finance expenses(1,057,937) (388,097) (1,175,964) (449,807)
    Net Financial Result(448,493) 950,659  1,092,472  2,048,153 
    Loss for the Period(10,032,832) (15,270,729) (18,266,229) (25,108,600)
         
    Share Information    
    Weighted average number of shares outstanding26,172,023  25,964,379  26,138,639  25,964,379 
    Loss per share (basic/diluted)(0.38) (0.59) (0.70) (0.97)
         
    Loss for the Period(10,032,832) (15,270,729) (18,266,229) (25,108,600)
    Other comprehensive income that may be re­clas­si­fied to profit or loss in subsequent periods:    
    Exchange differences on translation of foreign currency(1,452,973) (1,622,079) 260,895  695,468 
    Total Comprehensive Loss(11,485,805) (16,892,807) (18,005,334) (24,413,132)
         

    InflaRx N.V. and subsidiary

    Unaudited Condensed Consolidated Statements of Financial Position

    as of June 30, 2020 and December 31, 2019

    in €June 30,

    2020

    (unaudited)
     December 31,

    2019
     
       
       
    ASSETS  
    Non-current assets  
    Property, plant and equipment493,377 576,373 
    Right-of-use assets716,871 836,924 
    Intangible assets404,251 452,400 
    Other assets419,424 452,217 
    Financial assets272,627 272,614 
    Total non-current assets2,306,550 2,590,528 
    Current assets  
    Other assets2,973,228 3,500,884 
    Financial assets62,191,912 82,353,867 
    Cash and cash equivalents36,398,578 33,131,280 
    Total current assets101,563,718 118,986,031 
    TOTAL ASSETS103,870,268 121,576,558 
       
       
    EQUITY AND LIABILITIES  
    Equity  
    Issued capital3,152,427 3,132,631 
    Share premium211,483,756 211,006,606 
    Other capital reserves26,627,185 25,142,213 
    Accumulated deficit(152,628,234)(134,362,006)
    Other components of equity2,488,124 2,227,228 
    Total equity91,123,258 107,146,673 
       
    Non-current liabilities  
    Lease liabilities203,636 330,745 
    Other non-financial liabilities37,644 39,013 
    Total non-current liabilities241,280 369,758 
    Current liabilities  
    Trade and other payables10,630,462 12,413,662 
    Lease liabilities524,034 515,203 
    Employee benefits867,121 975,629 
    Social security, other tax and non-financial liabilities448,113 105,634 
    Provisions36,000 50,000 
    Total current liabilities12,505,730 14,060,128 
    Total Liabilities12,747,010 14,429,886 
    TOTAL EQUITY AND LIABILITIES103,870,268 121,576,558 
       
       



    InflaRx N.V. and subsidiary

    Unaudited Condensed Consolidated Statements of Changes in Shareholders' Equity for the six months ended June 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, 20203,132,631 211,006,606 25,142,213 (134,362,006) 2,227,228 107,146,673 
    Loss for the period   (18,266,229)  (18,266,229)
    Exchange differences on

    translation of foreign currency
        —  260,895 260,895 
    Total comprehensive loss   (18,266,229) 260,895 (18,005,334)
    Contributions          
    Equity-settled share-based pay­ment  1,484,972    1,484,972 
    Share options exercised19,797 477,149     496,946 
    Total Contributions19,797 477,149 1,484,972    1,981,918 
    Balance as of June 30, 20203,152,427 211,483,756 26,627,185 (152,628,234) 2,488,124 91,123,258 
               
    Balance as of January 1, 20193,115,725 211,021,835 18,310,003 (81,107,188) 50,196 151,390,571 
    Loss for the period   (25,108,600)  — (25,108,600)
    Exchange differences

    on translation of foreign currency
        —  695,468 695,468 
    Total comprehensive loss   (25,108,600) 695,468 (24,413,132)
    Contributions          
    Equity-settled share-based pay­ment  3,889,767  —   — 3,889,767 
    Total Contributions  3,889,767  —   — 3,889,767 
    Balance as of June 30, 20193,115,725 211,021,835 22,199,770 (106,215,788) 745,663 130,867,206 
               

    InflaRx N.V. and subsidiary

    Unaudited Condensed Consolidated Statements of Cash Flows

    for the six months ended June 30, 2020 and 2019

    in €For the six

    months ended

    June 30, 2020


    (unaudited)
      For the six

    months ended

    June 30, 2019


    (unaudited)
       
    Operating activities  
    Loss for the period(18,266,229) (25,108,600)
    Adjustments for:  
    Depreciation & amortization of property, plant, equipment, right-of-use assets and intangible assets353,976  307,130 
    Net financial result(1,092,472) (2,048,153)
    Share-based payment expense1,484,972  3,889,767 
    Net foreign exchange differences(789,528) (205,103)
    Changes in:  
    Other assets560,449  (2,063,491)
    Employee benefits(122,411) (84,890)
    Social security and other current non-financial liabilities341,012  (184,120)
    Trade and other payables(1,783,200) 5,513,355 
    Interest received1,096,651  1,269,745 
    Interest paid(5,455) (16,308)
    Net cash used in operating activities(18,222,235) (18,730,669)
    Investing activities  
    Purchase of intangible assets, laboratory and office equipment(35,107) (503,881)
    Purchase of non-current other financial assets —  (75,543)
    Disposal of non-current other financial assets —  3,088 
    Purchase of current financial assets(59,196,096)  
    Proceeds from the maturity of financial assets56,553,296  17,709,459 
    Net cash from investing activities20,272,857  17,133,122 
    Financing activities  
    Proceeds from exercise of share options496,946   
    Repayment of lease liabilities(183,970) (125,075)
    Net cash from/ (used in) financing activities312,976  (125,075)
    Net (decrease)/increase in cash and cash equivalents2,363,597  (1,722,622)
    Effect of exchange rate changes on cash and cash equivalents903,700  399,266 
    Cash and cash equivalents at beginning of period33,131,280  55,386,240 
    Cash and cash equivalents at end of period36,398,578  54,062,885 
       

    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  of 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.

    Primary Logo

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    • 50% lower all-cause mortality rate and other efficacy trends were shown with IFX-1 in initial data from the randomized exploratory Phase II part of the Phase II/III trial
    • Subject to regulatory approval, a randomized, double-blinded, placebo-controlled, multinational Phase III part of the trial will be initiated
    • Primary endpoint of the planned Phase III part to be 28-day all-cause mortality       

    JENA, Germany, July 21, 2020 (GLOBE NEWSWIRE) -- InflaRx (NASDAQ:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that the Company has decided to continue development with IFX-1 in severe COVID-19 induced pneumonia.  The Company plans to initiate a double-blinded…

    • 50% lower all-cause mortality rate and other efficacy trends were shown with IFX-1 in initial data from the randomized exploratory Phase II part of the Phase II/III trial

    • Subject to regulatory approval, a randomized, double-blinded, placebo-controlled, multinational Phase III part of the trial will be initiated
    • Primary endpoint of the planned Phase III part to be 28-day all-cause mortality       

    JENA, Germany, July 21, 2020 (GLOBE NEWSWIRE) -- InflaRx (NASDAQ:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that the Company has decided to continue development with IFX-1 in severe COVID-19 induced pneumonia.  The Company plans to initiate a double-blinded, randomized, placebo-controlled Phase III trial that will be adequately powered for statistical analyses.

    In the Phase III part of the study, subject to regulatory approval, the Company plans to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia. InflaRx plans to conduct the study at sites in the US, Europe, South America and potentially other regions. An interim analysis is currently planned after enrollment of 180 patients, with the potential for an early stop for efficacy or futility. In addition to the primary endpoint of 28-day all-cause mortality, other planned key endpoints include assessments of organ support and assessment of disease improvement on the ordinal scale. 

    Dr. Korinna Pilz, Global Head of Clinical R&D at InflaRx, noted: "Data from the initial exploratory Phase II part of the study in patients with severe COVID-19 induced pneumonia suggested a positive impact of IFX-1 treatment on the all-cause mortality rate and other endpoints. Based on these encouraging results, we are excited to initiate the Phase III part of the trial, which we anticipate starting in the coming months."

    The Phase II part of the study evaluated IFX-1 treatment plus best supportive care compared to best supportive care alone for up to 28 days. The Phase II part was randomized and enrolled a total of 30 patients. The 28-day all-cause mortality rate was 13% (n = 2 out of 15) in the IFX-1 treatment arm compared to 27% (n = 4 out of 15) in the best supportive care arm. All deaths in the best supportive care arm occurred in COVID-19 induced multi-organ failure. In the IFX-1 treatment arm, one patient died after an acute ventilator tube complication (leakage) leading to hypoxia and one patient who met an exclusion criterion with a history of severe chronic obstructive pulmonary disease, which was not known at time point of enrollment, died of pulmonary failure. In the IFX‑1 treatment arm fewer patients experienced renal impairment assessed by estimated glomerular filtration rates and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations as a sign of reduction in tissue damage. A temporary, but statistically significant increase of D-dimer levels in the first days following IFX-1 administration was noted, as a potential signal for induction of blood clot lysis. No statistically significant group differences on the chosen primary endpoint of relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were detected.

    The Phase II results have been submitted for publication to a peer-reviewed medical journal along with a preprint server.

    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 induced 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, including the planned continuation into a Phase III part trial in patients with severe COVID-19 pneumonia; 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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    • IFX-1 treatment showed a trend in lower 28-day all-cause mortality rate, along with trends of maintained kidney function, faster normalization in lymphocyte counts and greater reduction in LDH in patients with severe COVID-19 pneumonia
    • InflaRx is now evaluating the continuation into a placebo-controlled Phase III part of the trial with 28-day all-cause mortality as the primary endpoint

    JENA, Germany, June 17, 2020 (GLOBE NEWSWIRE) -- InflaRx (NASDAQ:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today interim results from the first 30 patients treated in the adaptive randomized Phase II/III trial in patients with severe COVID-19 pneumonia.

    The Phase II…

    • IFX-1 treatment showed a trend in lower 28-day all-cause mortality rate, along with trends of maintained kidney function, faster normalization in lymphocyte counts and greater reduction in LDH in patients with severe COVID-19 pneumonia
    • InflaRx is now evaluating the continuation into a placebo-controlled Phase III part of the trial with 28-day all-cause mortality as the primary endpoint

    JENA, Germany, June 17, 2020 (GLOBE NEWSWIRE) -- InflaRx (NASDAQ:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today interim results from the first 30 patients treated in the adaptive randomized Phase II/III trial in patients with severe COVID-19 pneumonia.

    The Phase II part of the study evaluated IFX-1 treatment plus best supportive care compared to best supportive care alone for up to 28 days. Relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) was assessed as the primary endpoint along with additional clinical parameters until day 28. Relative change in the oxygenation index at day 5 showed no differences between treatment groups. However, IFX-1 treatment was associated with a lower 28-day all-cause mortality when compared to the best supportive care group, along with trends in disease improvement, as evidenced by fewer patients experiencing renal impairment assessed by estimated glomerular filtration rates, more patients showing reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations.  In IFX-1-treated patients, pulmonary embolisms reported as serious adverse events were lower compared to the best supportive care arm. Also, a temporary increase of D-dimer levels, as potential expression of induction of blood clot lysis, was detected in the first days after initiation of IFX-1 treatment. The data are being prepared for submission to a scientific journal1.

    Dr. Korinna Pilz, Global Head of Clinical R&D at InflaRx, commented: "These are encouraging preliminary data which suggest that C5a inhibition might be beneficial in treating critically ill COVID-19 patients."

    A total of 30 patients were randomized in the trial, and 15 patients were treated in each arm: IFX-1 plus best supportive care or best supportive care alone. Over a treatment period of 28 days, patients in the IFX-1 arm received a maximum of seven doses of 800 mg IFX-1 intravenously on separate days. At randomization, 18 patients were intubated (60%), and 12 patients (40%) had other oxygen supply. A higher number of patients with 2 or more comorbidities associated with increased COVID-19 mortality were reported in the IFX-1 treatment group compared to best supportive care group. Twenty-eight-day all-cause mortality in the IFX-1 treatment group was 13% (2 out of 15) versus 27% (4 out of 15) in the control group. In the best supportive care group, four patients died of COVID-19-induced multi-organ failure, and three of them had pulmonary embolisms reported as a serious adverse event. In the IFX-1 arm, one patient died after an acute ventilator tube complication (leakage) and one patient with a history of severe chronic obstructive pulmonary disease died of pulmonary failure.

    Prof. Niels Riedemann, CEO and co-founder of InflaRx, commented: "InflaRx's core expertise in the acute care field and our development work with IFX-1 in sepsis and viral lung injury put InflaRx in a scientifically strong position to develop IFX-1 in COVID-19. We are encouraged by these preliminary data."

    Serious adverse event (SAE) rates were comparable between groups, but the rate of pulmonary embolisms reported as SAEs was substantially lower in the IFX-1 treatment group. Upon review of the safety data, the independent data safety monitoring board recommended continuation of the trial into the Phase III part.

    This Phase II part of the trial was exploratory in nature and was not powered to show statistically significant differences in clinical endpoints. Relative change (%) from baseline to day 5 in the oxygenation index, chosen as the primary endpoint for the Phase II part, showed a large variability and dependency on patient positioning and intubation status which excludes this endpoint from being used in a confirmatory study.

    InflaRx is now evaluating continuing the study in an adequately powered, placebo-controlled, double blinded, Phase III part using 28-day all-cause mortality as the primary endpoint, an accepted regulatory primary endpoint for critical care studies.

    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, including a potential continuation into a Phase III part trial in patients with severe COVID-19 pneumonia; 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.

    ___________________

    1 Data and trends reflect the knowledge at the time of the press release, with ongoing data cleaning not fully completed. Data will be submitted for publication upon completion of data cleaning activities.

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    • 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, May 21, 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 months ended March 31, 2020.

    "InflaRx continues to make progress with its clinical development programs for…

    • 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, May 21, 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 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.

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