Jena, Germany, April 30, 2024 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will report its first quarter 2024 financial and operating results on May 8, 2024, before the market opens. No conference call is planned for the first quarter 2024 results.

InflaRx also announced it will host a virtual research and development event on June 5, 2024. Guided by internationally renowned thought leaders, this event will focus on the planned development of our new oral small molecule C5aR inhibitor, INF904, and the role of C5aR in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). Discussions will address underlying development rationales and expected Phase IIa trial design and provide insights into the commercial opportunity. In addition, we will discuss INF904's broader therapeutic potential in the immuno-inflammation field and recent advances in our understanding of the role of C5a/C5aR signaling as it relates to human inflammatory diseases.

Featured key opinion leaders will include Prof. Dr. Marcus Maurer (Professor of Dermatology and Allergology, Institute of Allergology, Charité – Universitätsmedizin Berlin, Germany), Christopher Sayed, MD (Prof. of Dermatology, University of North Carolina, Medical School; and Secretary of the HS Foundation) and Prof. Dr. Jörg Köhl (Director of the Institute for Systemic Inflammation Research, University of Lübeck, Lübeck, Germany).

The R&D event will take place on June 5, from 12:00 PM EDT / 6:00 PM CEST to 2:00 PM EDT / 8:00 PM CEST. To participate in the virtual event, participants may pre-register here to receive an invite link and dial-in details to access the R&D event. 

About the speakers

Prof Dr. Marcus Maurer

Professor of Dermatology and Allergology, Institute of Allergology, Charité – Universitätsmedizin Berlin, Germany

Dr. Maurer is a globally renowned key opinion leader in the area of allergy and urticaria research who has been instrumental in the global clinical development of numerous medical therapies.

Dr. Maurer has over 25 years of experience in the field of dermatology and allergology, with a research interest in the biology of mast cells, in inflammation and immunology. His clinical focus is on all areas of urticaria, allergic skin- and mast-cell diseases. He has supervised more than 60 clinical trials, Phase I through IV. and has contributed to more than 800 publications in peer-reviewed journals and 40 books and book chapters. Since 2005, he has held a full Professor position at Charité. He is a coordinator of the Global Allergy and Asthma European Networks of urticaria and angioedema centers of reference and excellence, UCARE and ACARE.

Dr. Maurer trained at Beth Israel Deaconess Hospital and Harvard Medical School in Boston (1995-1998) and is board certified for Dermatology (2000) and Allergology (2003).

Christopher Sayed, MD

Professor of Dermatology, University of North Carolina, Medical School, and Secretary of the HS Foundation

Dr. Sayed is an internationally recognized global key opinion leader in the field of hidradenitis suppurativa (HS) and has previously served as a board member of the US HS foundation.

Dr. Sayed has over 10 years of experience in the field of dermatology and clinical research with a special interest in the medical and surgical management of hidradenitis suppurativa (HS). He is the Medical Director of the HS clinic at University of North Carolina, Chapel Hill, NC, USA. He has performed clinical and basic science research in HS and other dermatologic conditions with more than 65 publications in the medical literature. He serves as a directing member of the Hidradenitis Suppurativa Foundation and is medical lead of a local HS support group. He is board certified in Dermatology and received his medical training at the University of North Carolina, USA.

Prof. Dr. Jörg Köhl

Director of the Institute for Systemic Inflammation Research, University of Lübeck, Lübeck, Germany

Dr. Köhl is an internationally leading translational complement scientist with a particular focus on the role of C5a/C5aR biology and its role in human disease.

He has over 30 years of medical and research experience and has published over 200 papers in the complement therapeutic landscape. His research has been continuously funded by the National Institutes of Health, the German Research Foundation, the Federal Ministry of Education and Research and the European Union since 1990. He has held several senior scientific positions, including a 20-year research appointment as Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center in the Divisions of Molecular Immunology and Immunobiology and his current position as the Founding Director of the Institute for Systemic Inflammation Research at the University of Lübeck, Germany. Dr. Köhl received his medical degree from the University of Mainz, Germany.

About InflaRx

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor.  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.

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FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. 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, the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations, our ability to successfully commercialize and the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including PG, and any other product candidates, including INF904, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of our product candidates and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our Marketing Authorization Application submission for vilobelimab and our biologics license application submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the U.S. Food and Drug Administration, the European Medicines Agency or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the  U.S. 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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