Jena, Germany, September 11, 2023 – InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today its topline results from the single ascending dose (SAD) part of its randomized, double-blind, placebo-controlled Phase I trial of the orally administered, low molecular weight C5aR inhibitor INF904. In the SAD part of the study, INF904 demonstrated an excellent safety and tolerability profile as well as a very favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile, confirming INF904´s best-in-class potential.
Jena, Germany, August 30, 2023 – InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today that the Company has submitted a Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) and that the European Medicines Agency (EMA) has validated the MAA. This means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 member states of the European Union (EU).
Jena, Germany, August 10, 2023 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharma-ceutical company developing and commercializing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three and six months ended June 30, 2023 and provided an operating update.
Jena, Germany, June 28, 2023 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company commercializing and developing anti-inflammatory therapeutics that target the complement system, today announced the appointment of Dr. Camilla Chong as Chief Medical Officer (CMO) of InflaRx, effective July 1, 2023. Dr. Chong is a medical doctor with extensive experience in the pharmaceutical industry, including leadership roles in clinical development, medical affairs and overseeing the launch of new drugs across multiple geographies. She will be responsible for all clinical developments related to InflaRx’s portfolio as she joins the C-suite of the company.
Jena, Germany, June 21, 2023 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the commercial launch of Gohibic (vilobelimab) in the U.S. In April 2023, Gohibic was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
Jena, Germany, May 11, 2023 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three months ended March 31, 2023, and provided a business update.
Jena, Germany, April 18, 2023 – InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that, in connection with its previously announced completion of its underwritten public offering of 9,411,765 ordinary shares, the underwriters have fully exercised their option to purchase an additional 1,411,764 ordinary shares at a public offering price of $4.25 per ordinary share. Including the option exercise, the aggregate gross proceeds from the offering after the exercise of the greenshoe option now amount to approximately $46 million, before deducting the underwriting discount and offering expenses.
Jena, Germany, April 14, 2023 – InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that it has completed its underwritten public offering of 9,411,765 ordinary shares at a public offering price of $4.25 per ordinary share. The aggregate gross proceeds from the offering were approximately $40 million, before deducting the underwriting discount and offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to 1,411,764 additional ordinary shares at the public offering price, less the underwriting discount.
Jena, Germany, April 11, 2023 – InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the pricing of its underwritten public offering of 9,411,765 ordinary shares at an offering price of $4.25 per ordinary share. The offering is expected to close on April 14, 2023, subject to the satisfaction of customary closing conditions.
Jena, Germany, April 11, 2023 – InflaRx N.V. (Nasdaq: IFRX) (the “Company”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that it has commenced an underwritten public offering of ordinary shares of the Company. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.
Jena, Germany, April 04, 2023 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Jena, Germany, March 22, 2023 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced financial and operating results for the year ended December 31, 2022.
Jena, Germany, January 5, 2023 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced details related to the design of its planned Phase III study with vilobelimab in ulcerative PG, a rare neutrophilic and inflammatory skin disease with destructive, painful cutaneous ulcers.
Jena, Germany, December 21, 2022 – InflaRx N.V. (Nasdaq: IFRX) (the “Company” or “InflaRx”), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that the Company has amended its existing co-development agreement with Staidson (Beijing) BioPharmaceuticals Co., Ltd. (together with its affiliates, “STS”) to support STS in its regulatory approval efforts for its proprietary drug candidate BDB-001 in China. Through the amendment of the existing co-development agreement, InflaRx will receive royalties of 10% on net sales of BDB-001 for the treatment of COVID-19 in China. InflaRx has granted STS an exclusive license for use in China to certain of InflaRx’s clinical, manufacturing and regulatory documentation regarding vilobelimab in order to support and facilitate the regulatory filing for BDB-001 for the treatment of severely ill COVID-19 patients with the Chinese National Medical Products Administration (NMPA).
Jena, Germany, November 9, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that it has dosed its first healthy volunteer in a randomized, double-blind, placebo-controlled Phase I trial of orally administered, small molecule C5aR inhibitor INF904. This single ascending dose Phase I trial aims to evaluate the safety, tolerability and pharmacokinetics of INF904 in healthy volunteers.
Jena, Germany, November 9, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and nine months ended September 30, 2022.
Jena, Germany, September 29, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today submitted a request for Emergency Use Authorization (EUA) following encouraging interactions with the US Food and Drug Administration (FDA) at a Type B meeting held this summer. Additionally, InflaRx has been granted Fast Track designation from the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients.
Jena, Germany, September 9, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced its participation at several conferences.
Jena, Germany, September 08, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that the previously reported results from its Phase III trial of vilobelimab to treat critically ill, invasively mechanically ventilated COVID-19 patients have been published in the peer-reviewed journal, The Lancet Respiratory Medicine. The publication can be accessed free of charge on The Lancet’s website.
Jena, Germany, August 5, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharma-ceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and six months ended June 30, 2022.
Jena, Germany, July 26, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced plans to submit a request for Emergency Use Authorization (EUA) following encouraging interactions with the US Food and Drug Administration (FDA) at a recently held Type B meeting. As previously announced, the company had requested the meeting to discuss a potential EUA submission and the development of its first-in-class anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients.
Jena, Germany, July 6, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that the US Food and Drug Administration (FDA) granted a Fast Track designation to the development of its first-in-class anti-C5a monoclonal antibody vilobelimab for the treatment of ulcerative pyoderma gangrenosum (PG). The Company had submitted a request for Fast Track designation to the FDA on the positive outcome data in PG from its Phase IIa open-label dose-escalation study.
Jena, Germany, June 29, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, provided a development update today for its first-in-class monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19.
Jena, Germany, May 17, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that management will give a company presentation at the upcoming H.C. Wainwright Global Investment Conference.
Jena, Germany, May 12, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three months ended March 31, 2022 and provided a business update.
Jena, Germany, March 31, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that the Phase III part of the Phase II/III PANAMO study with mechanically ventilated COVID-19 patients showed a relative reduction in 28-day all-cause mortality of 23.9% (vilobelimab 31.7% versus placebo 41.6%, p=0.094), which was not statistically significant using site-stratified Cox regression analysis as pre-specified in the final statistical analysis plan of the study. All patients in the study received standard of care.
Jena, Germany, March 24, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the year ended December 31, 2021.
Jena, Germany, March 17, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported that the Company has received a corrected advice letter from the U.S. Food and Drug Administration (FDA) related to its Phase III program with vilobelimab for the treatment of hidradenitis suppurativa (HS). In this corrected letter, FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the primary endpoint for the chosen patient population but gives recommendations related to implementation of the modified HiSCR (m-HiSCR).* The written advice letter received in February 2022 had stated that the Agency recommended using the HiSCR as the primary endpoint in the Phase III trial, which was inconsistent with the minutes from a Type A advice meeting held between InflaRx and the FDA in the third quarter of 2021.
Jena, Germany, March 8, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced that final data from the Company’s Phase IIa open-label study with vilobelimab in patients with pyoderma gangrenosum (PG) will be presented at the 2022 American Academy of Dermatology Association (AAD) Annual Meeting, being held March 25-29 in Boston, MA USA.
Jena, Germany, February 28, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported that the Company has received an advice letter from the U.S. Food and Drug Administration (FDA) related to its Phase III program with vilobelimab for the treatment of hidradenitis suppurativa (HS). The feedback indicates that the FDA recommends using the Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the primary endpoint in the Phase III trial. The FDA advice was provided nearly three months after the Company’s protocol submission and contrasts with the FDA advice provided to the Company in a Type A meeting held in Q3 2021. In the minutes of that meeting, FDA provided advice on how to implement, name and validate the meaningfulness of the modified HiSCR, a new primary endpoint suggested by the Company, that would measure the reduction of all three types of inflammatory lesions in HS – inflammatory nodules, abscesses and draining tunnels. A reduction in draining tunnels is not captured by the HiSCR. Within the Type A written response, FDA did not recommend the traditional HiSCR as the primary endpoint measure. Following the advice received in the Type A meeting, earlier this year, InflaRx announced the initiation of a Phase III trial, designed to study patients with moderate to severe HS disease suffering from actively draining tunnels.
Jena, Germany, February 16, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the start of the second dosing cohort of the vilobelimab and PD-1 checkpoint inhibitor, pembrolizumab, combination arm of the Phase II clinical trial in cutaneous squamous cell carcinoma (cSCC).
Jena, Germany, February 8, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present at the 11th Annual SVB Leerink Healthcare Conference being held virtually February 14-18, 2022.
Jena, Germany, January 10, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced a new pipeline program, INF904, an oral small molecule inhibitor of C5aR.
Jena, Germany, January 5, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced its participation at several investor events.
Jena, Germany, January 4, 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the initiation of the Phase III program with vilobelimab in hidradenitis suppurativa (HS) patients with active draining tunnels. The new primary endpoint, called modified HiSCR (Hidradenitis Suppurativa Clinical Response), will include measuring the reduction of all three lesions – inflammatory nodules, abscesses and draining tunnels.
Jena, Germany, November 15, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced positive data from the European Phase II IXCHANGE study of vilobelimab, a first-in-class anti-C5a antibody, in patients with ANCA-associated vasculitis (AAV). The study achieved its principal objective, demonstrating comparable clinical response of vilobelimab to standard of care, while significantly reducing the need for glucocorticoid (GC) treatment in this life-threatening indication.
Jena, Germany, November 11, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, will present a corporate overview at the H.C. Wainwright 7th Annual Israel Conference.
Jena, Germany, November 5, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and nine months ended September 30, 2021.
Jena, Germany, November 3, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, will present a corporate overview during a fireside chat at the Credit Suisse 30th Annual Healthcare Conference.
Jena, Germany, October 27, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum (PG).
Jena, Germany, October 19, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that the German Ministry of Education and Research (“Bundesministerium für Bildung und Forschung“ or “BMBF“) and the German Ministry of Health (“Bundesministerium für Gesundheit” or “BMG”) have notified InflaRx that the Company has been awarded a grant of up to EUR 43.7 million to support the development of vilobelimab for the treatment of severely ill, mechanically ventilated COVID-19 patients.
Jena, Germany, October 12, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.
Jena, Germany, September 9, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces that Prof. Niels C. Riedemann, Chief Executive Officer and Founder, will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference, which is being held virtually. The presentation will be available on demand starting at 7:00 AM EDT / 1:00 PM CET on Monday, September 13, 2021.
Jena, Germany, September 8, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces its plan to proceed with a pivotal development program for vilobelimab in Hidradenitis Suppurativa (HS) after a successful Type A meeting with the US Food and Drug Administration (FDA) and receipt of the official meeting minutes.
Jena, Germany, August 10, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the first 10 evaluable patients in the ongoing Phase IIa open label study with vilobelimab in Pyoderma Gangraenosum (PG).
Jena, Germany, August 6, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present at the BTIG Virtual Biotechnology Conference on August 10. 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 Tuesday, August 10 at 9:00am EDT. The Company will also hold virtual 1X1 meetings.
Jena, Germany, August 5, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and six months ended June 30, 2021.
Jena, Germany, June 17, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present virtually at the Raymond James Human Health Innovation Conference being held June 21-23, 2021.
Jena, Germany, June 8, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the enrollment of the first patient in an open-label, multicenter Phase II clinical study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC).
Jena, Germany, May 21, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced Mr. Tony Gibney has been appointed as a Non-Executive Director to the Board of Directors at InflaRx. Mr. Gibney is a highly experienced life sciences-focused biotech executive and former investment banker who has executed over 150 financings and M&A advisory transactions for US and European clients. Mr. Gibney's appointment was approved by InflaRx's shareholders at the 2021 annual shareholder meeting. Mr. Mark Kübler and Ms. Lina Ma were re-appointed as Non-Executive Directors to the Board of Directors.
Jena, Germany, May 12, 2021 – 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.
Jena, Germany, May 11, 2021 – 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.
Jena, Germany, April 15, 2021 – 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).
Jena, Germany, March 25, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the year ended December 31, 2020.
Jena, Germany, March 3, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that management will present at two upcoming virtual investor conferences.
Jena, Germany, March 1, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that it has completed its underwritten public offering of 15,000,000 common shares at a price of $5.00 per share. For each common share purchased, an investor received a warrant to purchase a common share at an exercise price of $5.80. The gross proceeds to InflaRx from the offering were approximately $75 million, before deducting the underwriting discount and other offering expenses and excluding the exercise of any warrants. The Company intends to use the net proceeds from the offering primarily to fund research and development expenses for its clinical and preclinical research and development activities and for working capital and general corporate purposes.
Jena, Germany, February 25, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the pricing of its underwritten public offering of 15,000,000 common shares and warrants. The shares are being sold at a public offering price of $5.00 per share. For each common share purchased, an investor will also receive 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 gross offering proceeds to InflaRx from this offering are expected to be approximately $75 million, before deducting the underwriting discount and other estimated offering expenses and excluding the exercise of any warrants. The Company intends to use the net proceeds from the offering primarily to fund research and development expenses for its clinical and preclinical research and development activities and for working capital and general corporate purposes.
Jena, Germany, February 24, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today that it has commenced an underwritten public offering of common shares of the Company. For each common share purchased, an investor will also receive a warrant to purchase a common share of the Company. The Company intends to use the net proceeds from the offering primarily to fund research and development expenses for its clinical and preclinical research and development activities and for working capital and general corporate purposes. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.
Jena, Germany, February 11, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the presentation of new data with vilobelimab (IFX-1), a first-in-class anti-C5a antibody, demonstrating significantly elevated baseline C5a levels in moderate and severe Hurley Stage II and III hidradenitis suppurativa (HS) patients compared to healthy volunteers. Data will be presented at the 10th Conference of the European Hidradenitis Suppurativa Foundation e.V. (EHSF) by Prof. Giamarellos-Bourboulis, from the ATTIKON University, Athens, Greece. The presentation, entitled, Complement split product C5a is elevated in moderate and severe hidradenitis suppurativa: clinical improvement by targeted therapy coming from the SHINE Study, will take place on February 11, 2021 at 11:30 am EST (5:30 pm CET).
Jena, Germany, January 11, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today provided an update on the ongoing development of vilobelimab (IFX-1), a first-in-class anti-C5a antibody.
Jena, Germany, January 7, 2021 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present virtually at the 39th Annual J.P. Morgan Healthcare Conference being held January 11-14, 2021.
Jena, Germany, January 5, 2021 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the European phase II IXCHANGE study of vilobelimab (IFX-1), a first-in-class anti-C5a antibody, in ANCA-associated vasculitis (AAV) has completed enrollment.
Jena, Germany, October 29, 2020 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three and nine months ended September 30, 2020.
Jena, Germany, 17 September 2020 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced two management appointments. Effective October 1, 2020, Thomas Taapken, Ph.D. will join InflaRx as Chief Financial Officer. Jordan Zwick has been promoted to Chief Strategy Officer, effective immediately.
Jena, Germany, 14 September 2020 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the start of the global Phase III part of its Phase II/III trial with IFX-1 in severe COVID-19 induced pneumonia with the initiation of the first clinical site in the Netherlands. In parallel, the German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved the Phase III clinical trial in Germany.
Jena, Germany, August 6, 2020 – 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.
Jena, Germany, 30 July 2020 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three and six months ended June 30, 2020.
Jena, Germany, 21 July 2020 – 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.
Jena, Germany, 17 June 2020 – 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.
Jena, Germany, 21 May 2020 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three months ended March 31, 2020.
Jena, Germany, 29 April 2020 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the year ended December 31, 2019.
Jena, Germany, March 31, 2020 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the enrollment of the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, the company´s monoclonal anti-C5a antibody, in patients with severe COVID-19-induced pneumonia. The company has received initial positive human data from two initial patients suffering from COVID-19-induced severe pneumonia who were treated with BDB-001, an anti-C5a antibody produced by BDB from the IFX-1 cell line, in China. Data from the two patients are part of a larger investigation on the role of complement activation in COVID-19 which have been made publicly available through a pre-print server and have not been independently validated by InflaRx.
Jena, Germany, February 26, 2020 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive initial data from the first 5 patients in the Phase IIa open label study with IFX-1 in patients suffering from Pyoderma Gangraenosum (PG).
Jena, Germany, February 19, 2020 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present at the 9th Annual SVB Leerink Global Healthcare Conference February 25-27, 2020 at the Lotte New York Palace in New York, NY, USA.
Jena, Germany, January 9, 2020 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present at the J.P. Morgan 38th Annual Healthcare Conference being held January 13-16, 2020 at the Westin St. Francis Hotel in San Francisco, CA, USA.
Jena, Germany, 7 November 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported financial results for the third quarter and first nine months of 2019 and provided a business update, outlining its corporate strategy and plans.
Jena, Germany, 6 November 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported results of the open label extension (OLE) part of the international SHINE Phase IIb study investigating the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody, in patients with moderate to severe Hidradenitis Suppurativa (HS), a painful and debilitating chronic inflammatory skin disease with limited treatment options. The data announced today are from a snapshot analysis at the end of the overall 9-month study treatment period (week 40).
Jena, Germany, 14 August 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported financial and operating results for the second quarter ended June 30, 2019.
Jena, Germany, July 18, 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported additional in-depth analysis of the completed double blind, placebo controlled part of the ongoing international SHINE Phase IIb study to supplement InflaRx’s top line disclosure of results reported on June 5, 2019. The purpose of this study is to investigate the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody, in patients suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful and debilitating chronic inflammatory skin disease with limited treatment options.
Jena, Germany, June 13, 2019 – InflaRx N.V. (Nasdaq: IFRX), an innovative biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the treatment of the first patient in a phase IIa clinical trial evaluating the Company’s lead product candidate, IFX-1, in Pyoderma Gangraenosum.
Jena, Germany, June 5th, 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics targeting the complement system, today reported the top-line results of the international SHINE Phase IIb study, investigating the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody, in patients suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful and debilitating chronic inflammatory skin disease with limited treatment options.
Jena, Germany, 23 May 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported financial and operating results for the first quarter ended March 31, 2019.
Jena, Germany, 14 May 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the treatment of the first patient in IXchange, a Phase II study with IFX-1 in patients with ANCA-associated vasculitis (AAV) (NCT03895801).
Jena, Germany, 28 March 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the year ended December 31, 2018.
Jena, Germany, February 27, 2019 – InflaRx N.V. (Nasdaq: IFRX), an innovative biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the approval of a Clinical Trial Application by Health Canada for a phase IIa clinical trial evaluating the Company’s lead product candidate, IFX-1, in Pyoderma Gangraenosum. This is the third autoimmune disease for which InflaRx is developing IFX-1.
Jena, Germany, February 14, 2019 – InflaRx N.V. (Nasdaq: IFRX), an innovative biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced that Mr. Richard Brudnick has been appointed, as interim Non-Executive Director to the Board of Directors of InflaRx N.V. Mr. Brudnick has substantial experience in the biotechnology and healthcare industry and is currently serving as Chief Business Officer and Head of Strategy for Codiak BioSciences. He brings extensive commercial and business development expertise to InflaRx as the Company’s pipeline progresses towards commercialization. The confirmed appointment of Mr. Brudnick as a Non-Executive Director of the Board is subject to the approval at the Annual General Meeting of Shareholders in May 2019. Prior to such time, Mr. Brudnick will attend board meetings as a non-voting observer.
Jena, Germany, February 6, 2019 – InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced that new clinical data with IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with moderate to severe Hidradenitis Suppurativa (HS) are to be presented this week at the 8th Conference of the European Hidradenitis Suppurativa Foundation in Wrocław, Poland. HS is a painful and debilitating chronic inflammatory skin disease with limited treatment options.
Jena, Germany and New York, NY, USA, January 3, 2019 – InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced the opening of the company’s second U.S.-based location and the addition of new management members.
Jena, Germany, December 19, 2018 – InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced the approval of an Investigational Medicinal Product Dossier (IMPD) from the European regulatory authorities, allowing InflaRx to initiate a phase II study with IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis (AAV).
Jena, Germany, 21 November 2018 – InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, reported financial and operating results for the third quarter and nine months ended September 30, 2018.
Jena, Germany, November 08, 2018 – InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced that patient enrollment has been completed in the phase IIb study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients suffering from moderate or severe Hidradenitis Suppurativa (HS). HS is a painful and debilitating chronic inflammatory skin disease with limited treatment options.
Jena, Germany October 30, 2018 – InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced that the first patient has been dosed in a phase II study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis (AAV).
Jena, Germany, September 21, 2018 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening and devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, announced today that Jens Holstein has been appointed as a new board member of InflaRx, serving as Non-Executive Director. The appointment was approved by the Extraordinary General Meeting of shareholders held today in Amsterdam, the Netherlands. Mr. Holstein has extensive management experience in the biotechnology and healthcare industry and currently serves as CFO of MorphoSys AG.
Jena, Germany, 28 August 2018 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, will host an R&D Day on Hidradenitis Suppurativa (HS) and its clinical experience with its breakthrough anti-C5a monoclonal antibody IFX-1, on Friday, September 7 in New York City.
Jena, Germany, 9 August 2018 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, reported financial and operating results for the second quarter ended June 30, 2018.
Jena, Germany, June 28, 2018 – InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced the approval of their Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). The open IND will allow InflaRx to start their planned phase II study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA associated vasculitis (AAV).
Jena, Germany, 5 June 2018 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, announced they have opened a new research facility in Ann Arbor, Michigan, in the United States. The facility will be part of InflaRx Pharmaceuticals Inc., a wholly owned US subsidiary of the InflaRx N.V. group, and operations will serve to further develop and extend the Company’s unique complement system-based therapeutics.
Jena, Germany, 17 May 2018 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, reported financial and operating results for the first quarter ended March 31, 2018.
Jena, Germany, May 8, 2018—InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat inflammatory diseases by targeting the complement system, a key component of the innate immune system, announced today the closing of its primary and secondary public offering of 3,450,000 common shares of the Company, consisting of 1,850,000 common shares offered by the Company and 1,600,000 common shares offered by the selling shareholders at price to the public of $34.00 per common share for total gross proceeds of $117.3 million, consisting of total gross proceeds to the Company of $62.9 million and total gross proceeds to the selling shareholders of $54.4 million, which includes the full exercise of the underwriters’ option to purchase additional shares.
Jena, Germany, May 3, 2018—InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat inflammatory diseases by targeting the complement system, a key component of the innate immune system, announced today the pricing of its primary and secondary public offering of 3,000,000 common shares of the Company, consisting of 1,500,000 common shares offered by the Company and 1,500,000 common shares offered by the selling shareholders at price to the public of $34.00 per common share for total gross proceeds of approximately $102 million, consisting of total gross proceeds to the Company of approximately $51 million and total gross proceeds to the selling shareholders of approximately $51 million. In addition, InflaRx and the selling shareholders have granted the underwriters a 30-day option to purchase up to an additional 450,000 common shares at the public offering price, less underwriting discounts and commissions.
