InflaRx

InflaRx NV is a clinical-stage biopharmaceutical company, which engages in the discovery and development of inhibitors of the complement activation factor known as C5a and its receptor C5aR. Its primary product candidate is vilobelimab. The company was founded by Niels Christoph Riedemann, Renfeng Guo and Nicolas Fulpius in December 2007 and is headquartered in Jena, Germany.

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InflaRx NV is a clinical-stage biopharmaceutical company, which engages in the discovery and development of inhibitors of the complement activation factor known as C5a and its receptor C5aR. Its primary product candidate is Vilobelimab. The company was founded by Niels Christoph Riedemann, Renfeng Guo, and Nicolas Fulpius in December 2007 and is headquartered in Jena, Germany.

JENA, Germany, Nov. 09, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Initiates First-in-Human Study with Small Molecule C5aR Inhibitor INF904

JENA, Germany, Nov. 09, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Reports Third Quarter 2022 Financial & Operating Results

JENA, Germany, Sept. 29, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients

JENA, Germany, Sept. 09, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx to Present at Upcoming Scientific and Investor Conferences

JENA, Germany, Sept. 08, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Announces Vilobelimab Phase III Results in Critically Ill COVID-19 Patients Published in The Lancet Respiratory Medicine

Does InflaRx N.V. (IFRX) have what it takes to be a top stock pick for momentum investors?

Here's Why InflaRx N.V. (IFRX) is a Great Momentum Stock to Buy

InflaRx N.V. (IFRX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

InflaRx N.V. (IFRX) Upgraded to Buy: What Does It Mean for the Stock?

JENA, Germany, Aug. 05, 2022 (GLOBE NEWSWIRE) -- 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 six months ended June 30, 2022.

InflaRx Reports Second Quarter 2022 Financial & Operating Results

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InflaRx (NASDAQ: IFRX ), a maker of anti-inflammatory therapeutics, is up 40% today after announcing it's pursuing emergency-use authorization from the U.S. Food and Drug Administration for its Covid-19 treatment. Its Vilobelimab is the treatment InflaRx is targeting for FDA approval.

Why Is InflaRx (IFRX) Stock Up 40% Today?

JENA, Germany, July 26, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Announces Plans to Apply for Emergency Use Authorization from the US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients

JENA, Germany, July 06, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum

InflaRx N.V. (NASDAQ: IFRX) provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19.

InflaRx Provides Development Update For Vilobelimab In Skin Disorder, COVID-19

JENA, Germany, June 29, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Provides Development Update for Vilobelimab in Pyoderma Gangrenosum and Severe COVID-19

JENA, Germany, May 17, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx to Present at the H.C. Wainwright Global Investment Conference

JENA, Germany, May 12, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Reports First Quarter 2022 Financial and Operating Results and Provides Strategic Update

InflaRx N.V. (NASDAQ: IFRX) announced topline data from Phase 3 part of Phase 2/3 PANAMO study of vilobelimab in critically ill COVID-19 patients.

InflaRx Shares Plunge After Disappointing Results On Vilobelimab In Critically Ill COVID-19 Patients

JENA, Germany, March 31, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Announces Encouraging Phase III Topline Results from PANAMO Trial of Vilobelimab in Severe COVID-19 Patients

JENA, Germany, March 24, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Reports Full Year 2021 Financial and Operating Results

InflaRx N.V. (NASDAQ: IFRX) has received a corrected advice letter from the FDA regarding its Phase 3 vilobelimab program for hidradenitis suppurativa (HS).

FDA Issues Corrected Advice To InflaRx's Vilobelimab Study In Skin Disease

JENA, Germany, March 17, 2022 (GLOBE NEWSWIRE) -- 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).1 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.

InflaRx Receives Corrected Advice Letter from FDA Related to Phase III Program for Vilobelimab in Hidradenitis Suppurativa

JENA, Germany, March 08, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Announces Vilobelimab Trial in Pyoderma Gangrenosum Selected for Late-Breaker Oral Presentation at 2022 AAD Annual Meeting

JENA, Germany, Feb. 28, 2022 (GLOBE NEWSWIRE) -- 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.

InflaRx Provides Update on Development Plans for Vilobelimab in Hidradenitis Suppurativa

InflaRx N.V. (NASDAQ: IFRX) has received an advice letter from the FDA about the vilobelimab Phase 3 program for hidradenitis suppurativa (HS), a condition that causes small, painful lumps to form under the skin.

See Why Did InflaRx Pause Late-Stage Vilobelimab Trial In Chronic Skin Condition

JENA, Germany, Feb. 16, 2022 (GLOBE NEWSWIRE) -- 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).

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