Universität zu Lübeck

BARCELONA, Spain--( BUSINESS WIRE )-- Almirall, S.A. (ALM) , a global pharmaceutical company dedicated to medical dermatology, today announced its participation in the 33rd Congress of the European Academy of Dermatology and Venereology (EADV) , taking place in Amsterdam from September 25 to 28, 2024. This year, Almirall marks its 80th anniversary, celebrating eight decades of innovation and commitment to delivering products positively impacting people’s health and lives. At the congress, Almirall will present 34 abstracts detailing the latest research on lebrikizumab for moderate-to-severe atopic dermatitis in adolescents and adults, tildrakizumab and Almirall’s CAL/BDP cream for moderate-to-severe plaque psoriasis in adults, as well as tirbanibulin for actinic keratosis. The company will also host two symposia, providing a platform for experts to discuss current data, share insights, and facilitate discussions about the treatment of these chronic conditions with advanced biologics. Impact of the treatment of psoriasis on patient wellbeing: new data from the POSITIVE study Almirall will unveil new interim data on the treatment of adults with moderate-to-severe plaque psoriasis with tidrakizumab at 52 weeks from the POSITIVE clinical study. The POSITIVE study is the first clinical trial in dermatology to use the WHO-5 Wellbeing Index as a primary endpoint. The 5-item World Health Organization Wellbeing Index is a validated questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The different sub-analyses presented during the congress reinforce the effectiveness of tildrakizumab on signs and symptoms in skin and beyond. Almirall will host the symposium "Advancing Psoriasis Management for Long-Term Patient Outcomes", featuring experts such as Prof. Dr. Diamant Thaçi from the University of Lübeck, Prof. Dr. Ulrich Mrowietz from the University Medical Center Schleswig-Holstein, and Prof. Anna López Ferrer from the Hospital de la Santa Creu i Sant Pau in Barcelona. The discussion will emphasize on the importance of tailoring treatments to individual patients , the latest real-world evidence, and practical strategies for clinical success managing psoriasis, with opportunities for interactive discussion with leading experts. Advancing atopic dermatitis disease management Almirall will also present new data on lebrikizumab, a biologic approved for the treatment of moderate-to-severe atopic dermatitis. The late-breaking presentation will report lebrikizumab’s data over three years of continuous treatment, alongside new data on the rates of absolute endpoints and its effectiveness in patients inadequately controlled or ineligible for cyclosporine. The Almirall symposium entitled "Precision in AD: How Lebrikizumab is Changing the Treatment Paradigm" will feature the experts Marjolein Bruin-Weller, from the National Expertise Center for Atopic Dermatitis at the Department of Dermatology and Allergology of the University Medical Center Utrecht; Andrew Blauvelt from Portland, US, and Sascha Gerdes from the Center for Inflammatory Skin Diseases of the University Medical Center Schleswig-Holstein Campus Kiel. Discussions will focus on the clinical impact of lebrikizumab and offer a chance for participants to engage with leading specialists in this field. Almirall celebrating 80 years of innovation 2024 marks a significant milestone for Almirall as the company celebrates 80 years of innovation and commitment to delivering impactful solutions to help improve patients’ lives. With a rich history in the pharmaceutical industry and a strong focus on medical dermatology, Almirall has built a robust pipeline addressing various diseases and using different therapeutic modalities. Leading innovating in medical dermatology is enabled by Almirall's close collaboration with the dermatology community and patient-centric mindset. Celebrating its 80 th anniversary, Almirall reaffirms its dedication to advancing skin science and developing novel treatments to benefit patients and the dermatology community around the world. For more information about Almirall’s 80th-anniversary celebrations, visit almirall80years.com ANNEX: 33 rd EADV Congress presentations and poster details: Satellite Symposium on psoriasis: Advancing Psoriasis Management for Long-Term Patient Outcomes - Chair, Prof. Dr. Diamant Thaçi, Lübeck, Germany - Prof. Dr. Anna López-Ferrer, Barcelona, Spain - Prof. Dr. Ulrich Mrowietz, Kiel, Germany Thursday 26th September at 17:45 (CEST) / Room G104-G105 (SAT 11.04). Satellite Symposium on atopic dermatitis : Precision in AD: how lebrikizumab is changing the treatment paradigm - Chair, Prof. Dr. Marjolein de Bruin-Weller, Utrecht, The Netherlands - Dr. Andrew Blauvelt, Lake Oswego, US - Prof. Dr. Sascha Gerdes, Kiel, Germany Friday 27th September at 13:00 (CEST) / Room G104-G105 (SAT 11.06). A total of 37 abstracts have been accepted by the EADV for their annual meeting. Ebglyss® (lebrikizumab ) 1. Late breaking news: Efficacy and safety of lebrikizumab is maintained up to 3 years in patients with moderate-to-severe atopic dermatitis: ADvocate 1 and ADvocate 2 to ADjoin long-term extension trial 2. Absolute EASI response achieved by lebrikizumab over 16 weeks in patients with moderate-to-severe atopic dermatitis 3. Absolute itch and quality of life response with lebrikizumab through 52 weeks 4. Absolute EASI response achieved with lebrikizumab over 52 weeks in patients with moderate-to-severe atopic dermatitis 5. Absolute response of lebrikizumab at Week 52 in patients with moderate-to-severe atopic dermatitis who did not achieve protocol-defined response after initial 16 weeks of treatment 6. Improvement across disease dimensions with lebrikizumab in combination with topical corticosteroids in atopic dermatitis inadequately controlled or ineligible to cyclosporine: results from the ADvantage study 7. Lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients inadequately controlled or ineligible for cyclosporine: week 52 results of a phase 3 clinical study (ADvantage) 8. Lebrikizumab in monotherapy improves the signs of moderate-to-severe atopic dermatitis across different body regions including the head and neck over one year of treatment 9. Number needed to treat with lebrikizumab in monotherapy at Week 16 in patients with moderate-to-severe atopic dermatitis Ilumetri® (tildrakizumab) 1. Improving the well-being of patients with moderate to severe plaque psoriasis and involvement of impactful areas with Tildrakizumab 2. Effectiveness and Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) of tildrakizumab patients with nail psoriasis: 52-week results from the phase IV POSITIVE Austrian subset. 3. Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis located in special areas: 52-week results from the POSITIVE study 4. High effectiveness of tildrakizumab in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study 5. High effectiveness of tildrakizumab regardless of baseline characteristics in patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study 6. Patient-reported well-being using tildrakizumab for psoriasis in a real-world setting: 52-week interim data of the phase IV POSITIVE study 7. Safety of tildrakizumab in patients with moderate-to-severe psoriasis: 52-week data from the phase IV POSITIVE study 8. Effectiveness of tildrakizumab for itch, pain, and fatigue in patients with moderate-to-severe psoriasis: 52-week results from the real-world POSITIVE study 9. Quality of life, work productivity and treatment satisfaction with tildrakizumab in moderate-to-severe psoriasis patients: 52-week interim data of the real-world POSITIVE study 10. Impact of patient psoriasis on partner well-being in a real-world setting: 52-week interim data of the phase IV POSITIVE study 11. Efficacy and safety of tildrakizumab through Week 28 in patients with early vs late-onset moderate-to-severe plaque psoriasis: A post hoc analysis of reSURFACE 1 and reSURFACE 2 Wynzora® (CAL/BDP) 1. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on scalp-PGA success, S-mPASI and clinician satisfaction among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 2. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on patient symptoms, functioning, emotions, level of itching, and sleep quality among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 3. Patient preference over other topicals, perception of cream usability, treatment adherence and satisfaction among patients with mild-to-moderate scalp psoriasis using calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 4. Best responders to calcipotriol and betamethasone dipropionate PAD-cream: post-hoc analysis from pooled MC2-01-C2 and MC2-01-C7 phase III trials at week 4 and week 8. 5. Cost per responder analysis of calcipotriol plus betamethasone dipropionate cutaneous PAD cream for the topical treatment of mild to moderate plaque psoriasis in Italy. 6. Patient benefit assessment of topical treatment in psoriasis: Validation of the PBI-TOP questionnaire in a longitudinal study. Klisyri® (tirbanibulin) and actinic keratosis 1. Lack of correlation between number of baseline actinic keratoses and local tolerability signs severity in patients treated with tirbanibulin over a 100 cm2 area: results from a Phase 3 study 2. Real-world evidence of tirbanibulin for actinic keratosis in Germany. Insights into patient-reported outcomes, safety and effectiveness 3. Efficacy and safety of tirbanibulin 1% ointment for the treatment of actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) 4. Patient and physician-reported outcomes with tirbanibulin 1% ointment for actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) 5. Enhancement of sun-damaged skin qualities with tirbanibulin (SunDamage Study) 6. Actinic cheilitis: Diagnosis and monitoring after treatment with Tirbanibulin using optical coherence tomography 7. Diagnosis and treatment of patients with actinic keratosis in France: REAKT study Actinic keratosis in France: an avoidable risk of skin cancer, unexpectedly also for people aged under 65 years (REAKT study) 8. Actinic keratosis in France: disease perceptions, expectations, and behaviors of patients (REAKT study). Poster availability date and time : From 25 September 2024 (07.00 CEST) until 3 months post congress. Location : https://eadv.org/congress/ , and e-poster area About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life . We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2023: €898.8 MM, 1900 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit https://www.almirall.com/ Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law.

Thought leaders in complement inhibition, chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) provide compelling new insights into the strong development rationales, potential differentiation and medical role of INF904 in initially targeted indications and inflammation & immunology (I&I) more broadly Additional details provided on INF904 Phase 2a trial design in moderate-to-severe CSU and HS, with study initiation expected by the calendar year-end of 2024 and a goal of generating additional safety and pharmacokinetic (PK) data, and showing meaningful clinical benefit INF904 Phase 2a data expected in summer 2025, with Phase 2b trial initiation expected in 2025 Commercial assessment indicates CSU and HS both represent multi-billion-dollar market opportunities, with tremendous patient need for effective new mechanisms of action InflaRx’s strong financial position is expected to fund company operations into 2026, allowing for advancement of clinical programs towards next milestones JENA, Germany, June 05, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today hosted a virtual R&D event focused on the company's oral small molecule C5aR inhibitor, INF904. Speakers provided additional details on development rationales and plans for INF904, as well as additional insight into its potential role in CSU and HS and its broader therapeutic potential in the immuno-inflammation field. Presenting key opinion leaders (KOLs) included: 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). Supplemental information related to today’s event, including presentations conducted by the KOLs and InflaRx management can be found in the accompanying slide deck here. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “InflaRx has been eager to provide additional details of its development plans for INF904 and to further showcase the tremendous promise of our approach to C5aR inhibition, initially in CSU and HS, and more broadly in I&I. We see the immense potential of INF904 in its ability to address multiple significant unmet medical needs not addressed by drugs currently in development, as well as the ability for this potentially best-in-class compound to find market acceptance in a number of sizable patient settings. We expect to progress expeditiously in our two initially selected immuno-derm indications, CSU and HS, and look forward to achieving additional milestones with INF904 in 2025.” INF904 CSU and HS clinical development program As previously disclosed, InflaRx will pursue two initial immuno-dermatology indications with INF904 in a single Phase 2a basket trial that is expected to begin by the end of 2024. The Phase 2a trial will be a multi-center, open-label study dosing 75 patients and evaluating multiple INF904 dosing regimens over 4 weeks of treatment in patients with moderate-to-severe CSU and moderate-to-severe HS. Outcome measures will be assessed via weekly visits to evaluate safety, PK and preliminary signs of efficacy. After the 4-week treatment period, patients will be followed for an additional 4 weeks. Data from this study are expected in the summer of 2025, with the subsequent initiation of a larger Phase 2b study anticipated in 2025 as well. In the CSU group, patients in Study Arms 1 and 2 will be dosed with INF904 at 30 mg and 90 mg BID (twice daily), respectively. Patients in Study Arm 3 will be comprised of anti-IgE non-responders and dosed at 90 mg BID. In total, the CSU group will dose 45 patients randomized at a 1:1:1 ratio. In addition to safety and PK parameters, assessed CSU efficacy measures will include change of the Urticaria Activity Score 7 (UAS7), Hives Severity Score (HSS7) and Itch Severity Score (ISS7) from baseline to the end of week 4. Biomarkers and Patient-Reported Outcome (PRO) endpoints related to urticaria control and quality of life will also be assessed. In the HS group, 30 patients will be randomized at a 1:1:1 ratio to 3 doses of INF904 at 30 mg, 60 mg or 90 mg BID. In addition to safety and PK parameters, assessed HS efficacy measures will include change in total abscess, inflammatory nodule and draining tunnel (dT) count, HS lesions-related scores and Clinician’s Global Impression of Change (CGI-C) at 4 weeks. PRO endpoints related to HS disease control and quality of life will also be assessed. As previously disclosed, the company is currently conducting additional pre-clinical studies with INF904, including chronic toxicology studies, as part of its effort to enable longer-term dosing of INF904 in future clinical trials. INF904 as a “pipeline-in-a-product" Given the potential of INF904 to have a broad commercial footprint, InflaRx believes INF904 could address meaningful markets in immuno-dermatology and in immuno-inflammation, including in nephrology, neurology and hematology. While InflaRx intends to focus its resources on its immediate goals addressing CSU and HS, we continue to assess and monitor the value of pursuing additional areas and applications via potential future collaborations with partners. About INF904 INF904 is an orally administered small molecule inhibitor of C5a-induced signaling via the receptor C5aR. INF904 showed anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that INF904 is well tolerated in treated subjects and exhibits no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days. Pharmacokinetic / pharmacodynamic data support best-in-class potential of INF904 with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. About InflaRx N.V. 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 . Contacts: InflaRx N.V. MC Services AG Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +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,” “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 FDA, 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 SEC. 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.

Virtual R&D event to be held on June 5, 2024 from 12:00 to 2:00 PM EDT – highlighting company plans for INF904 and the opportunity, the role of C5aR in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) and C5a/C5aR signaling in human inflammatory diseases INF904 multiple ascending dose (MAD) pharmacokinetic (PK) and pharmacodynamic (PD) data supporting best-in-class potential announced, and plans to initiate Phase IIa in CSU and HS by the end of 2024, with data availability anticipated in 2025Phase III vilobelimab pyoderma gangrenosum (PG) trial expected to have an interim analysis in 2025Cash, cash equivalents and marketable securities of €85.8 million, expected to fund operations at least into 2026 JENA, Germany, May 08, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced financial results for the three months ended March 31, 2024, and provided an operating update. Prof. Niels C. Riedemann, Chief Executive Officer and founder of InflaRx, commented: “InflaRx made tremendous progress during the early months of 2024, and is well positioned to advance vilobelimab and INF904 toward meaningful clinical milestones. Our pivotal trial with vilobelimab in PG continues to enroll patients, with an interim analysis expected next year. Patients suffering from PG have no approved treatment alternatives and often experience tremendous suffering. Thus, PG remains an area of high unmet medical need and represents a significant market opportunity for us. Phase I data for INF904 indicate best-in-class potential, and the possibility to address multiple sizable unmet needs, spurring our plans to initiate Phase IIa in CSU and HS by the end of this year. With our clear strategic focus on immuno-dermatology, and the additional potential of our drug candidates in the broader immunology inflammation field, we are excited about the path ahead of us." Virtual R&D event on June 5, 2024InflaRx 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 InflaRx’s new orally administered, low molecular weight C5aR inhibitor, INF904, and the role of C5aR in CSU and HS. Discussions will address underlying development rationales and expected Phase IIa trial design, and provide insights into the commercial opportunity. In addition, the event will cover 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 meeting 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 R&D event, participants may pre-register here to receive a dedicated link and dial-in details to access the meeting. Capital One Securities Dermatology Panel on May 14, 2024InflaRx will also participate in the Capital One Securities 1st Annual Biotech/Biopharma Disrupters Event, as a panelist on a panel, titled “New Potential Dermatology Treatments for Psoriasis, Urticaria, and Alopecia” on May 14, 2024, at 2:30 PM EDT / 8:30 PM CEST. Recent Highlights and Business Update INF904 – Initial focus on CSU and HS, broader opportunities in I&I possible via partneringIn March 2024, InflaRx announced it had chosen two initial immuno-dermatology indications it intends to pursue with INF904 and that it plans to initiate a Phase IIa “basket study”. This open-label, 4-week, multi-dose trial enrolling CSU and HS patients is expected to begin by the end of 2024 and to assess safety, as well as PK and PD parameters. InflaRx anticipates releasing data from this Phase IIa study in 2025. Similarly, the company expects to initiate a Phase IIb study in 2025 as well. InflaRx is currently conducting additional pre-clinical studies, including chronic toxicology studies, to enable longer-term dosing of INF904. CSU and HS are two chronic inflammatory skin conditions in which C5a has been suggested to play a significant role and where a high unmet need exists. In addition, as an oral drug with a mechanism of action currently not addressed by other drugs in development for these indications, the company sees a unique opportunity for INF904 to improve the standard of care. INF904 - Positive topline results from Phase I trial support best-in-class potentialIn January 2024, InflaRx reported results from the MAD part of a randomized, double-blind, placebo-controlled Phase I trial in healthy volunteers to assess the safety, tolerability and PK / PD properties of its orally administered, low molecular weight C5aR inhibitor, INF904. The safety analysis of INF904 in the Phase I study demonstrated that it was well tolerated in participants over the entire dose range and resulted in no safety signals of concern. There were no serious or severe adverse events observed at any dosing level. Both the single ascending dose and the MAD part of the study showed favorable PK and PD profiles, including achieving the desired blocking activity (>90%) of C5a-induced neutrophil activation in an ex vivo challenge assay using physiological and disease-relevant levels of C5a. Vilobelimab in PG – Enrollment ongoing in pivotal Phase III trialInflaRx is conducting a multi-national, randomized, double-blind, placebo-controlled pivotal Phase III study of vilobelimab for the treatment of ulcerative PG, a rare, chronic inflammatory form of neutrophilic dermatosis characterized by accumulation of neutrophils in the affected skin areas. The trial has two arms: (1) vilobelimab plus a low dose of corticosteroids and (2) placebo plus the same low dose of corticosteroids. The primary endpoint of the study is complete closure of the target ulcer at any time up to 26 weeks after initiation of treatment. The study has an adaptive design with an interim analysis blinded for the sponsor and investigators planned upon enrollment of approximately 30 patients (15 per arm). Depending on the results of the interim analysis, expected to occur in 2025, the trial sample size will be adapted, or the trial will be terminated due to futility. The total enrollment period is projected to be at least two years, depending on the total trial size after sample size adaptation. Vilobelimab has been granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as fast track designation by the FDA. GOHIBIC (vilobelimab) for the treatment of critically ill COVID-19 patients – The InflaRx Commitment Program launchedIn April, 2023, the FDA issued an Emergency Use Authorization (EUA) for GOHIBIC (vilobelimab) 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). In January 2024, InflaRx announced the launch of The InflaRx Commitment Program, pursuant to which the cost of GOHIBIC (vilobelimab) will be refunded for up to six (6) administered inpatient doses (the full treatment course) to institutions that meet the eligibility requirements*, for patients who were administered GOHIBIC (vilobelimab) in line with its EUA and who died due to COVID-19 in the intensive care unit. InflaRx continues to explore funding options for vilobelimab as a treatment for acute respiratory distress syndrome (ARDS), including government grants as well as collaborations with third parties. The Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO is under regulatory review by the European Committee for Medicinal Products for Human Use under the centralized procedure, which applies to all 27 member states of the European Union. Vilobelimab abstract presentation at ATS 2024An InflaRx abstract titled “Vilobelimab in Combination With Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients: A Subgroup Analysis” has been accepted for presentation during a thematic poster session at the American Thoracic Society 2024 International Conference on Tuesday, May 21, from 11:30 AM PT / 2:30 PM ET / 8:30 PM CEST to 1:15 PM PT / 4:15 PM ET / 10:15 PM CEST. Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “In the first quarter of 2024, InflaRx strategically prioritized its efforts, focusing development activities in a select number of immuno-dermatology indications. Sharpening our profile in this way has helped put us in a strong financial position, allowing us to advance our clinical programs towards their next milestones and to fund operations at least into 2026.” Financial Highlights – Q1 2024 RevenueFor the three months ended March 31, 2024, we realized revenues from the product sales of GOHIBIC (vilobelimab) in the amount of €36 thousand. Revenues reported are sales to end customers (hospitals). Sales to distributors do not constitute revenue for the InflaRx under IFRS 15. All revenues are attributed to sales made in the United States. Cost of salesThe cost of sales during the three months ended March 31, 2024 mainly consists of write-downs of inventories that will expire prior to their expected sale. Sales and marketing expenses In the three months ended March 31, 2024, we incurred €1.5 million of sales and marketing expenses. These expenses are primarily comprised of €0.3 million in personnel costs and €0.7 million in external services for distribution. R&D expenses R&D expenses incurred for the three months ended March 31, 2024 decreased by €7.4 million compared to the three months ended March 31, 2023. This decrease is primarily due to the fact that we incurred high third-party expenses in the first quarter of 2023 in connection with our efforts to develop the commercial manufacturing process and to obtain an EUA for GOHIBIC (vilobelimab). General and administrative expenses General and administrative expenses amounted to €3.6 million for each of the three months ended March 31, 2024 and March 31, 2023. Other incomeOther income for the three months ended March 31, 2024 amounted to €36 thousand (PY: €7.7 million). The decrease of €7.7 million in other income is due to the end of the government grant period on June 30, 2023. Net financial result Net financial result increased by €3.3 million to a gain of €2.8 million for the three months ended March 31, 2024 from a loss of €0.5 million for the three months ended March 31, 2023. This increase is mainly attributable to an increase of interest income on marketable securities by €0.5 million and an increase of foreign exchange result of €3.0 million. Other financial result consists of an adjustment for expected credit losses on marketable securities. Net lossNet loss for the first three months of 2024 amounted to €9.7 million, compared to €11.1 million in the first three months of 2023. Net cash used in operating activitiesNet cash used in operating activities for the first three months of 2024 increased to €14.9 million from €10.5 million for the comparable period in 2023. Liquidity and capital resourcesAs of March 31, 2024, InflaRx’s total available funds were approximately €85.8 million, composed of €25.1 million in cash and cash equivalents and €60.7 million in marketable securities. These funds are expected to finance operations at least into 2026. Additional financial informationAdditional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of March 31, 2024, as well as the consolidated financial statements as of and for the year ended December 31, 2023, in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2023, as filed with the U.S. Securities and Exchange Commission (SEC) on March 21, 2024. InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023 For the three months ended March 31, 2024(unaudited) 2023(unaudited) (in €, except for share data) Revenues36,037 — Cost of sales(220,521) — Gross profit(184,484) — Sales and marketing expenses(1,459,539) — Research and development expenses(7,301,810) (14,731,908)General and administrative expenses(3,579,150) (3,608,554)Other income36,323 7,746,189 Other expenses(30) (566)Operating result(12,488,690) (10,594,839)Finance income908,426 456,036 Finance expenses(4,632) (5,528)Foreign exchange result1,824,375 (1,137,310)Other financial result103,285 197,808 Income taxes— — Income (loss) for the period(9,657,236) (11,083,833)Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign currency(25,538) (16,785)Total comprehensive income (loss)(9,682,774) (11,100,618) Share information (based on income (loss) for the period) Weighted average number of shares outstanding58,883,272 44,771,703 Income (loss) per share (basic/diluted)(0.17) (0.25) InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of financial position as of March 31, 2024 and December 31, 2023 March 31, 2024(unaudited) December 31, 2023 (in €)ASSETS Non-current assets Property and equipment284,043 289,577 Right-of-use assets1,056,966 1,071,666 Intangible assets52,145 68,818 Other assets244,009 257,267 Financial assets2,490,202 9,052,741 Total non-current assets4,127,365 10,740,069 Current assets Inventories11,048,645 11,367,807 Current other assets5,869,744 4,036,650 Trade receivables35,242 — Tax receivable2,098,276 3,791,564 Other financial assets58,812,905 77,504,518 Cash and cash equivalents25,103,058 12,767,943 Total current assets102,967,870 109,468,483 TOTAL ASSETS107,095,235 120,208,552 EQUITY AND LIABILITIES Equity Issued capital7,065,993 7,065,993 Share premium334,211,338 334,211,338 Other capital reserves41,910,754 40,050,053 Accumulated deficit(295,785,055) (286,127,819)Other components of equity7,356,629 7,382,166 Total equity94,759,658 102,581,730 Non-current liabilities Lease liabilities727,058 745,716 Other liabilities36,877 36,877 Total non-current liabilities763,935 782,593 Current liabilities Trade and other payables7,607,757 11,974,362 Lease liabilities378,089 374,329 Employee benefits637,607 1,609,766 Other liabilities2,948,189 2,885,772 Total current liabilities11,571,642 16,844,229 Total liabilities12,335,557 17,626,822 TOTAL EQUITY AND LIABILITIES107,095,235 120,208,552 InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of changes in shareholders’ equity for the three months ended March 31, 2024 and 2023 (in €)Issuedcapital Sharepremium Othercapitalreserves Accumulateddeficit Other componentsof equity Total equity Balance as of January 1, 20247,065,993 334,211,338 40,050,053 (286,127,819) 7,382,166 102,581,730 Loss for the period— — — (9,657,236) — (9,657,236)Exchange differences on translation of foreign currency— — — — (25,538) (25,538)Total comprehensive loss— — — (9,657,236) (25,538) (9,682,774)Equity-settled share-based payments— — 1,860,701 — — 1,860,701 Balance as of March 31, 20247,065,993 334,211,338 41,910,754 (295,785,055) 7,356,629 94,759,658 Balance as of January 1, 20235,364,452 282,552,633 36,635,564 (243,460,290) 7,257,081 88,349,440 Loss for the period— — — (11,083,833) — (11,083,833)Exchange differences ontranslation of foreign currency— — — — (16,785) (16,785)Total comprehensive loss— — — (11,083,833) (16,785) (11,100,618)Equity-settled share-based payments— — 1,207,048 — — 1,207,048 Share options exercised8,548 115,399 — — — 123,947 Balance as of March 31, 20235,373,000 282,668,032 37,842,612 (254,544,123) 7,240,295 78,579,816 InflaRx N.V. and subsidiariesUnaudited condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 For the three months ended March 31, 2024(unaudited) 2023(unaudited) (in €)Operating activities Loss for the period(9,657,236) (11,083,833)Adjustments for: Depreciation & amortization of property and equipment, right-of-use assets and intangible assets123,949 147,969 Net finance income (expense)(2,831,454) 488,994 Share-based payment expense1,860,701 1,207,048 Net foreign exchange differences(119,126) (106,793)Changes in: Financial assets from government grants— (2,701,076)Inventories319,162 — Trade receivables(35,242) — Employee benefits(972,159) (834,713)Other assets(126,547) 7,515,105 Other liabilities62,417 15,986 Liabilities from government grants received— (5,033,779)Trade and other payables(4,366,605) (371,445)Interest received875,990 245,971 Interest paid(2,214) (5,627)Net cash used in operating activities(14,868,364) (10,516,193)Investing activities Purchase of intangible assets, property and equipment(16,069) (6,046)Purchase of current financial assets(3,566,235) (25,120,832)Proceeds from the maturity of financial assets30,527,108 21,540,578 Net cash from/(used in) investing activities26,944,804 (3,586,300)Financing activities Proceeds from exercise of share options— 123,947 Repayment of lease liabilities(85,706) (93,744)Net cash from/(used in) financing activities(85,706) 30,202 Net increase/(decrease) in cash and cash equivalents11,990,733 (14,072,291)Effect of exchange rate changes on cash and cash equivalents344,381 (95,814)Cash and cash equivalents at beginning of period12,767,943 16,265,355 Cash and cash equivalents at end of period25,103,058 2,097,250 About InflaRxInflaRx 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 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.com. Contacts: InflaRx N.V.MC Services AGJan Medina, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.deKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTSThis 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 United States 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 MAA submission for vilobelimab and our BLA submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, the EMA 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 SEC. 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.