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InflaRx N.V. (IFRX)

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2.7900+0.0700 (+2.57%)
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Previous Close2.7200
Open2.8500
Bid2.7000 x 1800
Ask2.7500 x 1300
Day's Range2.7500 - 2.8700
52 Week Range2.6600 - 9.6980
Volume246,607
Avg. Volume394,734
Market Cap123.28M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-1.3350
Earnings DateJul. 28, 2021 - Aug. 02, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est9.02
  • InflaRx Reports First Quarter 2021 Financial & Operating Results
    GlobeNewswire

    InflaRx Reports First Quarter 2021 Financial & Operating Results

    Severe COVID-19 trial enrollment reaches 178 patients; interim analysis expected in Q3 At the FDA’s suggestion, planning to request a Type A meeting to further discuss primary endpoint for the Phase III clinical development of vilobelimab in Hidradenitis SuppurativaVilobelimab proved safe and well tolerated as add-on therapy to standard of care in US ANCA-associated vasculitis safety trialCompleted target enrollment in Phase IIa Pyoderma Gangraenosum trialCash, cash equivalents and financial assets of approximately €137.8 million as of March 31, 2021 JENA, Germany, May 12, 2021 (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, 2021. “We have made significant progress with our vilobelimab clinical programs in the first few months of 2021,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “The team has worked tirelessly to progress the enrollment of our severe COVID-19 trial and we now expect the interim analysis to occur in the third quarter of this year. Despite the increase in vaccinations, patients remain in urgent need of better treatments for severe COVID-19. For HS, following feedback on the Special Protocol Assessment, we plan to continue our discussions with the FDA about the design of our Phase III trial in a Type A meeting. Following the positive safety data from our US ANCA-associated vasculitis trial, we are looking forward to data readouts in our European AAV trial by the end of the year. In our Pyoderma Gangraenosum trial we have reached target enrollment and expect additional data readouts in 2021.” Recent Highlights and R&D Update Issuance of Common Shares and WarrantsOn February 25, 2021, the Company sold an aggregate of 15,000,000 common shares through a public offering. The common shares were sold at a price of $5.00 per share. For each common share purchased, an investor also received a warrant to purchase a common share at an exercise price of $5.80. The warrants are exercisable immediately and have a term of up to one year. The shares and warrants were issued and the transaction closed on March 1, 2021 with gross offering proceeds to the Group (not including any potential proceeds from the exercise of warrants) of $75.0 million (€62.2 million), before deducting $4.5 million (€3.7 million) in underwriting discounts and other offering expenses of $0.4 million (€0.3 million). Vilobelimab for Hidradenitis Suppurativa (HS)In Q1, InflaRx submitted a Special Protocol Assessment (SPA) to the U.S. FDA for the Phase III HS program and in May the Company received an official response. The FDA agreed to the dosing regimen in the protocol but did not agree with the assessment of the primary endpoint using the International Hidradenitis Suppurativa Severity Score (IHS4). At the FDA’s suggestion, InflaRx plans to request a Type A meeting to discuss the primary endpoint measure in more detail. In Europe, as previously reported in 2020, InflaRx received scientific advice from the European Medicines Agency (EMA) about the European pathway for regulatory approval, including supporting the use of the IHS4 score as the primary endpoint. Once InflaRx receives final feedback from the FDA on the proposed Phase III primary endpoint, the Company will determine the best path forward for the global development program in HS. Vilobelimab for Severe COVID-19The Phase III part of the global Phase II/III trial evaluating vilobelimab in mechanically ventilated patients with COVID-19 was initiated in mid-September 2020, and recruitment has reached 178 patients, with 38 sites initiated across several countries in Europe and Latin America. Once 180 patients are enrolled and reach the 28-day endpoint, a blinded interim analysis will be conducted by an independent Data Safety Monitoring Board (DSMB) to continue the trial or stop for efficacy or futility. The recommendation of the DSMB based on the interim analysis is anticipated in Q3 of this year. Additional sites in other countries are expected to be added, including in the US. Topline data for all 360 enrolled patients at the 28-day mortality primary endpoint from the trial are expected to be available by the end of 2021. Vilobelimab for ANCA-associated Vasculitis (AAV)In the US IXPLORE clinical Phase II study of IFX-1 in AAV, all patients have completed treatment. In May 2021, InflaRx reported topline data for the study, indicating that vilobelimab, when given in addition to best standard of care proved to be safe and well tolerated. Furthermore, InflaRx previously reported that both Part 1 and Part 2 of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled. Data from the randomized, double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021. Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC) The Company has recently announced plans to initiate an open label, multicenter Phase II study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cSCC. The Phase II trial is expected to start enrolling patients in the second quarter of 2021 at sites in Europe, the US and other countries. The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess antitumor activity and safety of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm. Vilobelimab in Pyoderma Gangraenosum The Phase IIa open label trial has reached the target enrollment goal of 18 patients with moderate to severe PG at sites in the US, Canada and Europe. Promising initial data from the first five patients in the study were announced in 2020. A second interim analysis, including six patients treated at the second dose group until day 99, are expected to be available by the end of 2021. Final results from all patients, including the highest dose group, are expected in 2022. Financial highlights – Q1 2021 Research and development expenses incurred for the three months ended March 31, 2021 decreased over the corresponding period in 2020 by €2.4 million. This decline was primarily due to no contribution of expense in the period from the Phase IIb clinical development of vilobelimab in HS since this study was completed in 2020, with only limited residual activities thereafter. This was partly offset by the expenses in relation to the COVID-19 trial. These two factors led to €1.1 million of lower manufacturing costs which significantly contributed to an overall decline in third-party expenses of €2.6 million. The €0.4 million increase in personnel expenses was mainly related to equity-settled share-based compensation. General and administrative expenses increased by €0.5 million to €3.0 million for the three months ended March 31, 2021, from €2.6 million for the three months ended March 31, 2020. This increase is attributable to higher expenses from equity-settled share-based compensation recognized in personnel expenses (€0.5 million). Additionally, legal, consulting and other expenses decreased by €0.1 million to €1.0 million for the three months ended March 31, 2021, from €1.1 million for the three months ended March 31, 2020. Net financial result increased by €0.3 million to €1.8 million for the three months ended March 31, 2021, from €1.5 million for the three months ended March 31, 2020. This increase is mainly attributable to higher foreign exchange gains, which increased by €1.2 million and higher foreign exchange losses of €0.6 million while interest on marketable securities declined by €0.4 million. Other finance expenses for the three months ended March 31, 2021 include a €48 thousand gain from a reduction in the allowance for expected credit loss on marketable securities. Net loss for the three months ended March 31, 2021 was €6.1 million, compared to €8.2 million for the three month ended March 31, 2020. On March 31, 2021, the Company’s total funds available were approximately €137.8 million, composed of cash and cash equivalents (€78.7 million) and financial assets (€59.1 million). Net cash used in operating activities decreased to €10.4 million in the three months ended March 31, 2021, from €10.5 million in the three months ended March 31, 2020. Additional information regarding these results and other relevant information is included in the notes to the unaudited Condensed Consolidated Financial Statements as of March 31, 2021, as well as the financial statements as of December 31, 2020 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 subsidiariesUnaudited Condensed Consolidated Statements of Operations andComprehensive Loss for the three months ended March 31, 2021 and 2020 For the three months endedMarch 31,(in €, except for share data)2021(unaudited) 2020(unaudited) Operating Expenses Research and development expenses(4,906,885) (7,298,799)General and administrative expenses(3,022,339) (2,564,803)Total Operating Expenses(7,929,224) (9,863,601)Other income5,462 94,960Other expenses(565) (5,720)Operating Result(7,924,327) (9,774,362)Finance income22,962 401,435Finance expenses(3,684) (2,147)Foreign exchange result1,731,671 1,141,677Other financial result48,000 —Income Taxes— —Loss for the Period(6,125,378) (8,233,397) Share Information Weighted average number of shares outstanding33,807,774 26,105,255Loss per share (basic/diluted)(0.18) (0.32) Loss for the Period(6,125,378) (8,233,871)Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign currency3,504,699 1,713,868Total Comprehensive Loss(2,620,679) (6,519,529) InflaRx N.V. and subsidiariesUnaudited Condensed Consolidated Statements of Financial Positionas of March 31, 2021 and December 31, 2020 in €March 31,2021(unaudited) December 31,2020 ASSETS Non-current assets Property and equipment383,762 408,263Right-of-use assets457,513 546,694Intangible assets320,645 350,183Other assets358,767 353,522Financial assets272,443 272,268Total non-current assets1,793,130 1,930,930Current assets Current other assets6,527,973 3,734,700Current tax assets1,360,125 1,419,490Financial assets58,834,268 55,162,033Cash and cash equivalents78,734,662 25,968,681Total current assets145,457,028 86,284,904TOTAL ASSETS147,250,158 88,215,834 EQUITY AND LIABILITIES Equity Issued capital5,302,354 3,387,410Share premium280,261,994 220,289,876Other capital reserves27,980,274 26,259,004Accumulated deficit(174,470,998) (168,345,620)Other components of equity(222,091) (3,726,791)Total equity138,851,532 77,863,880Non-current liabilities Lease liabilities137,586 220,525Other liabilities34,352 33,323Total non-current liabilities171,938 253,847Current liabilities Trade and other payables7,107,880 8,258,133Lease liabilities330,969 338,516Employee benefits429,621 1,368,731Other financial liabilities358,217 117,727Provisions— 15,000Total current liabilities8,226,687 10,098,107Total Liabilities8,398,626 10,351,954TOTAL EQUITY AND LIABILITIES147,250,158 88,215,834 InflaRx N.V. and subsidiariesUnaudited Condensed Consolidated Statements of Changes in Shareholders’Equity for the three months ended March 31, 2021 and 2020 (in €, except for share data)Issuedcapital Sharepremium Othercapitalreserves Accumulateddeficit Othercomponentof equity Totalequity Balance as of January 1, 20213,387,410 220,289,876 26,259,004 (168,345,620) (3,726,790) 77,863,880Loss for the period— — — (6,125,378) — (6,125,378)Exchange differences on translation of foreign currency— — — — 3,504,699 3,504,699Total comprehensive loss— — — (6,125,378) 3,504,699 (2,620,679)Issuance of common shares and warrants1,873,203 63,269,346 — — — 65,142,549Transaction costs— (4,219,222) — — — (4.219.222)Equity-settled share-based payments— — 1,721,270 — — 1,721,270Share options exercised41,741 921,994 — — — 963,735Balance as of March 31, 20215,302,354 280,261,994 27,980,274 (174,470,998) (222,091) 138,851,532 Balance as of January 1, 20203,132,631 211,006,606 25,142,213 (134,362,006) 2,227,228 107,146,673Loss for the period— — — (8,233,397) — (8,233,397)Exchange differences on translation of foreign currency— — — — 1,713,868 1,713,868Total comprehensive loss— — — (8,233,397) 1,713,868 (6,519,529)Equity-settled share-based pay-ments— — 901,033 — — 901,033Balance as of March 31, 20203,132,631 211,006,606 26,043,246 (142,595,403) 3,941,097 101,528,177 InflaRx N.V. and subsidiariesUnaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020 in €For the three months ended March 31, 2021(unaudited) For the three months ended March 31, 2020(unaudited) Operating activities Loss for the period(6,125,378) (8,233,397)Adjustments for: Depreciation & amortization of property and equipment, right-of-use assets and intangible assets168,343 182,356Net finance income(1,798,949) (399,288)Share-based payment expense1,721,270 901,033Net foreign exchange differences193,847 (1,141,678)Other non-cash adjustments— (129,122)Changes in: Other assets(2,739,152) 188,476Employee benefits(952,820) (428,526)Other liabilities240,229 1,953Trade and other payables(1,150,252) (1,922,724)Interest received33,189 462,342Interest paid(3,780) (2,246)Net cash used in operating activities(10,413,453) (10,520,819)Investing activities Purchase of intangible assets, property and equipment(17,062) (27,686)Purchase of current financial assets(14,985,026) (23,412,469)Proceeds from the maturity of financial assets13,952,522 20,724,386Net cash from/ (used in) investing activities(1,049,566) (2,715,769)Financing activities Proceeds from issuance of common shares65,142,549 —Transaction costs from issuance of common shares(4,219,222) —Proceeds from exercise of share options963,735 —Repayment of lease liabilities(90,716) (88,339)Net cash from/ (used in) financing activities61,796,346 (88,339)Net increase/(decrease) in cash and cash equivalents50,333,328 (13,324,927)Effect of exchange rate changes on cash and cash equivalents2,432,654 1,277,255Cash and cash equivalents at beginning of period25,968,681 33,131,280Cash and cash equivalents at end of period78,734,662 21,083,608 About vilobelimab (IFX-1): Vilobelimab 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, vilobelimab 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. Vilobelimab 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. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab 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 OfficerEmail: IR@inflarx.deTel: +1 917-338-6523 MC Services AG Katja Arnold, Laurie Doyle, Andreas JungferEmail: inflarx@mc-services.euEurope: +49 89-210 2280US: +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.

  • InflaRx Announces Positive Topline Results for Vilobelimab from the U.S. Phase II ANCA-Associated Vasculitis IXPLORE Study
    GlobeNewswire

    InflaRx Announces Positive Topline Results for Vilobelimab from the U.S. Phase II ANCA-Associated Vasculitis IXPLORE Study

    U.S. IXPLORE Phase II trial achieved its objective; vilobelimab was shown to be safe and well tolerated in patients with ANCA-associated vasculitis when added to current standard of careEU IXCHANGE Phase II trial is fully enrolled with results expected by the end of 2021 JENA, Germany, May 11, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today positive topline results from its U.S. Phase II IXPLORE study with vilobelimab in patients with anti-neutrophil cytoplasmic auto-antibody (ANCA)-associated vasculitis, or AAV. “ANCA-associated vasculitis is an organ and life-threatening disease. Although current treatments for AAV are quite helpful in many patients, there are still unmet needs for fast-acting, effective, and safe treatments and alternatives to the regular use of high-dose glucocorticoids,” said Dr. Peter A. Merkel, Chief of Rheumatology and Professor of Medicine at the University of Pennsylvania. “Research suggests C5a has an important role in the pathogenesis of AAV, and blockade of C5a offers the opportunity to address several of these unmet needs. The results of the IXPLORE trial show C5a blockade by vilobelimab is safe and well tolerated when added to standard of care therapy for AAV. These results support the continued study of vilobelimab for the treatment of AAV.” “We are pleased to report that vilobelimab was safe and well tolerated in combination with standard of care for patients with ANCA-associated vasculitis in the U.S. IXPLORE Phase II trial,” said Dr. Korinna Pilz, Global Head of Clinical Research and Development. “We are looking forward to our EU IXCHANGE Phase II trial results later this year where we are further evaluating the potential efficacy of vilobelimab alone compared to a standard dose of glucocorticoids. The results from these two trials will provide us good insight to plan our next development steps in this important indication.” U.S. Phase II IXPLORE Study Design and Topline Results The randomized, double-blind, placebo-controlled Phase II study enrolled 19 patients in the U.S. (NCT 03712345). The study compared two different dose regimens of vilobelimab to placebo. All patients received current standard of care immunosuppressive therapy and high dose glucocorticoids (SOC). The primary endpoint of the study was to evaluate the safety of vilobelimab, as this was the first time the drug was being administered to patients with AAV in the U.S. Important efficacy parameters included response and remission rates based on the Birmingham Vasculitis Score (BVAS), a validated and well-established score in AAV. Patients were randomized into three groups: SOC plus placebo;SOC plus 400 mg vilobelimab q2w; andSOC plus 800 mg vilobelimab q2w Patients were treated for 16 weeks (including a fractionated loading dose at days 4 and 8) followed by an observation period of 8 weeks. The IXPLORE safety study met its primary objective: Across all groups, a similar number of patients experienced one or more treatment-emergent adverse events (TEAEs). TEAEs: 5 of 6 patients (SOC plus placebo)7 of 7 patients (SOC plus vilobelimab 400 mg)6 of 6 patients (SOC plus vilobelimab 800 mg) In addition, a similar number of patients experienced TEAEs rated as drug-related by investigators: Any drug-related TEAE: 3 of 6 patients (SOC plus placebo)3 of 7 patients (SOC plus vilobelimab 400 mg)2 of 6 patients (SOC plus vilobelimab 800 mg) Overall, no safety signal of concern could be detected in the study, as observed TEAEs are reflective of the disease and SOC treatment. At baseline, patients in the higher dose vilobelimab group (800 mg) showed a higher Birmingham Vasculitis Activity Score (BVAS) of 17.5 mean / 16.5 median, when compared to the baseline BVAS scores of the SOC group (13.8 mean / 13.5 median) and the 400 mg vilobelimab group (13.1 mean / 12.0 median). The IXPLORE study was not powered to show statistical significance on efficacy endpoints; however, clinical response and remission for each treatment group was measured at week 16 as secondary efficacy endpoints using the BVAS. The proportion of patients achieving a clinical response was defined as a 50% reduction in BVAS at week 16 (and no worsening in any body system) compared to baseline, and clinical remission was defined as BVAS=0. Although the sample size of the trial was small and it is difficult to interpret results not powered to show statistical significance, patients across all three treatment groups demonstrated a strong response at week 16, and more patients treated with SOC plus vilobelimab had clinical remissions at various timepoints throughout the study compared to SOC plus placebo: Clinical Response at Week 16: DoseSOC plus placeboN=6SOC plus 400 mg vilobelimabN=7SOC plus 800 mg vilobelimabN=5*Responders6 (100%)6 (85.7%)5 (100%) *one patient at week 16 did not attend the visit Clinical Remission at various timepoints: DoseSOC plus placeboN=6SOC plus 400 mg vilobelimab N=7SOC plus 800 mg vilobelimab N=6Combined vilobelimab groups N=13Remissions at Week 41 (16.7%)3 (42.9%)1 (20%)*4 (33.3%)*Remissions at Week 81 (16.7%)4 (57.1%)2 (33.3%)6 (46.2 %)Remissions at Week 123 (50%)5 (71.4 %)3 (50%)8 (61.5%)Remissions at Week 164 (66.7%)6 (85.7%)3 (60%)*9 (75%)*Remissions at Week 203 (50%)5 (71.4%)3 (75%)**8 (72.7%)**Remissions at Week 243 (50%)5 (71.4%)4 (80%)*9 (75%)* *one patient did not attend the visit at timepoint **two patients did not attend the visit at timepoint InflaRx plans to present more detailed trial results at a future medical meeting. As previously reported, both Part 1 and Part 2 of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled. Data from the randomized, double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021. About ANCA-associated vasculitis (AAV): AAV is a rare and life-threatening autoimmune disease in which activation of the complement system, and specifically the generation of larger amounts of C5a, is believed to play a key role in the neutrophil-driven vessel inflammation that defines the disease. AAV affects approximately 40,000 and 75,000 patients in the United States and Europe, respectively. About vilobelimab: Vilobelimab 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, vilobelimab 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. Vilobelimab 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. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, ANCA-associated vasculitis, pyoderma gangraenosum, cutaneous squamous cell carcinoma and severe COVID-19. 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 OfficerEmail: IR@inflarx.de Tel: +1 917-338-6523 MC Services AG Katja Arnold, Laurie Doyle, Andreas JungferEmail: inflarx@mc-services.eu Europe: +49 89-210 2280US: +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.

  • InflaRx Completes Enrollment of Vilobelimab Phase IIa Study in Pyoderma Gangraenosum
    GlobeNewswire

    InflaRx Completes Enrollment of Vilobelimab Phase IIa Study in Pyoderma Gangraenosum

    Target enrollment of 18 patients reached across three different dose groupsInterim results will be available by the end of 2021 with final results expected in 2022Initial positive data from the first 5 patients previously announced in Q1 2020 JENA, Germany, April 15, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the achievement of target enrollment of the Phase IIa open label study of vilobelimab in patients with Pyoderma Gangraenosum (PG). Dr. Korinna Pilz, Global Head of Clinical Research and Development of InflaRx, commented: “The full enrollment of our PG study is a significant milestone for the clinical development of vilobelimab as we continue to build the evidence that C5a is an important target for neutrophil-driven skin diseases. PG is a devastating autoimmune disease, and we hope our program can play a vital role in helping these patients.” This open-label Phase IIa proof-of-concept study has reached the target enrollment goal of 18 patients with moderate to severe PG at sites in the US, Canada and Europe. Patients in three different ascending dose groups are being treated with vilobelimab for 27 weeks with a two-month follow-up period. The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG. Efficacy will be evaluated by (i) a responder rate defined as Physician Global Assessment ≤3 of the target ulcer at various timepoints and (ii) time to complete closure of the target ulcer. Both endpoints will be compared with historical data. Additional clinical endpoints include a photographic documentation and analysis of the ulcer size and several patient-reported outcome parameters, such as pain score and Dermatology Life Quality Index (DLQI). In 2020, InflaRx announced positive initial data from the first five patients in the lowest dose group. Of these five initial patients, two patients achieved complete closure of the target ulcer and complete healing of all other PG ulcers. The drug was well tolerated and no drug-related severe adverse events (SAEs) have been recorded to date in the study. A second interim analysis, including six patients treated in the second dose group until day 99, will be available by the end of 2021. Final results from all patients, including the highest dose group, are expected in 2022. For more information about the study, visit www.clinicaltrials.gov (NCT03971643). About vilobelimab: Vilobelimab 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, vilobelimab 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. Vilobelimab 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. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, ANCA-associated vasculitis, pyoderma gangraenosum, cutaneous squamous cell carcinoma and severe COVID-19. About pyoderma gangraenosum (PG): PG is a rare and debilitating neutrophil-driven, autoinflammatory skin disease characterized by an acute, destructive ulcerating process of the skin, primarily occurring on the legs but also other regions of the body. It occurs in people in their 40s and 50s. The exact prevalence of PG is not yet known, but it is estimated that up to 50,000 people in the US and Europe are affected by this disease. Many PG patients also suffer from other autoimmune disorders, including inflammatory bowel diseases like ulcerative colitis, arthritides like rheumatoid arthritis, and hematological diseases such as multiple myeloma. Patients suffer from severe pain, long healing times, and frequent relapses. There are currently no FDA approved drugs for the treatment of PG. Current treatment options include the use of systemic immunosuppression in rapidly progressing cases. C5a is a key factor for neutrophil tissue infiltration and neutrophil activation, which are believed to play an important amplifying role in PG. Thus, C5a inhibition may be able to prevent neutrophil infiltration and activation in PG patients. Given the detected activity of C5a inhibition by vilobelimab in another neutrophil-driven skin disorder, hidradenitis suppurativa, InflaRx is currently conducting a Phase IIa clinical study to investigate the potential benefit of vilobelimab for patients suffering from PG. 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.de. Contacts: InflaRx N.V. Jordan Zwick – Chief Strategy OfficerEmail: IR@inflarx.deTel: +1 917-338-6523 MC Services AG Katja Arnold, Laurie Doyle, Andreas JungferEmail: inflarx@mc-services.euEurope: +49 89-210 2280US: +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.