Company Overview - InflaRx is a biopharmaceutical company specializing in anti-inflammatory therapeutics by targeting the complement system, particularly focusing on the C5a and C5aR pathways [2] - The company's lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody delivered intravenously, showing disease-modifying clinical activity and tolerability in multiple studies [2] - InflaRx is also developing INF904, an orally administered small molecule inhibitor of the C5a receptor [2] - Founded in 2007, the company has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [2] - InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc (USA) are wholly owned subsidiaries of InflaRx NV [3] Upcoming Events - InflaRx will participate in the Guggenheim SMID Cap Biotech Conference, scheduled for February 5-6, 2025, in New York, NY [1] Contact Information - Jan Medina, CFA, serves as Vice President and Head of Investor Relations at InflaRx NV [4] - MC Services AG handles media and investor relations for InflaRx, with contacts including Katja Arnold, Laurie Doyle, and Dr Regina Lutz [4]

InflaRx N.V. (IFRX) shares gained 7.7% on Wednesday following the European Commission's (EC) approval of marketing authorization, under exceptional circumstances, for Gohibic (vilobelimab) to treat adult patients with acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2. The targeted patient population in the EU comprises individuals receiving systemic corticosteroids as standard-of-care therapy and undergoing invasive mechanical ventilation, with or without extracorporeal membrane oxygenation.Th ...

JENA, Germany, Jan. 15, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receivin ...

JENA, Germany, Jan. 07, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will participate in multiple events the week of January 13, 2025, in San Francisco, CA. This activity will take place during the week of the 43rd Annual J.P. Morgan Healthcare Conference. LifeSci Partners Corporate Access Event1-on-1 meetings on January 14 and 15, 2025 Biotech Showcase 2025Works ...

JENA, Germany, Dec. 20, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company's oral C5aR inhibitor, INF904. Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: "We are pleased to have started our Phase 2a trial fo ...

InflaRx N.V. (IFRX) came out with a quarterly loss of $0.33 per share versus the Zacks Consensus Estimate of a loss of $0.27. This compares to loss of $0.14 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -22.22%. A quarter ago, it was expected that this company would post a loss of $0.21 per share when it actually produced a loss of $0.26, delivering a surprise of -23.81%.Over the last four quarters, the company has surpassed ...

INFLARX N.V. FINANCIAL STATEMENTS – SEPTEMBER 30, 2024 InflaRx N.V. is a company limited by shares, incorporated and domiciled in Amsterdam, The Netherlands. Its registered office and principal place of business is in Germany, Jena, Winzerlaer Str. 2. | --- | --- | --- | |------------|------------------------------------------------------------------------------------------------------------------------------------------|-------| | Unaudited | condensed consolidated statements of operations and comprehensiv ...

JENA, Germany, Aug. 27, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will participate in two investor conferences in September 2024. Details are as follows: H.C. Wainwright 26th Annual Global Investment Conference September 9-11, 2024 in New York, NY InflaRx's on-demand virtual presentation for the conference will be available beginning on September 9th. InflaRx will als ...

分组1 - InflaRx N.V. reported a quarterly loss of $0.26 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.21, and compared to a loss of $0.15 per share a year ago, indicating an earnings surprise of -23.81% [1] - The company posted revenues of $0.01 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 83%, while revenues were zero a year ago [2] - InflaRx shares have declined approximately 13.5% since the beginning of the year, contrasting with the S&P 500's gain of 9% [3] 分组2 - The earnings outlook for InflaRx is mixed, with the current consensus EPS estimate for the coming quarter at -$0.22 on $0.06 million in revenues, and -$0.81 on $0.37 million in revenues for the current fiscal year [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 37% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [8] 分组3 - Fortrea Holdings Inc., another company in the same industry, is expected to report quarterly earnings of $0.07 per share, reflecting a year-over-year change of -86.5%, with revenues anticipated to be $686.08 million, down 13.5% from the previous year [9][10]

[Unaudited Condensed Consolidated Financial Statements](index=1&type=section&id=Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Statements of Operations and Comprehensive Loss](index=3&type=section&id=Unaudited%20condensed%20consolidated%20statements%20of%20operations%20and%20comprehensive%20loss%20for%20the%20three%20months%20ended%20March%2031%2C%202024%20and%202023) The company's Q1 2024 net loss improved to €9.7 million, driven by lower R&D costs and a positive financial result **Q1 2024 vs. Q1 2023 Operating Results (€ thousands)** | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Revenues | 36 | 0 | | Research and development expenses | (7,302) | (14,732) | | Operating result | (12,489) | (10,595) | | Income (loss) for the period | (9,657) | (11,084) | | Income (loss) per share (basic/diluted) | (€0.17) | (€0.25) | - Research and development expenses decreased by **€7.4 million** year-over-year, mainly because high third-party expenses for developing the commercial manufacturing process for GOHIBIC were incurred in Q1 2023[20](index=20&type=chunk) - The net financial result improved to a gain of **€2.8 million** from a loss of €0.5 million in Q1 2023, largely due to a €3.0 million increase in the foreign exchange result and higher interest income[21](index=21&type=chunk) [Statements of Financial Position](index=4&type=section&id=Unaudited%20condensed%20consolidated%20statements%20of%20financial%20position%20as%20of%20March%2031%2C%202024%20and%20December%2031%2C%202023) Total assets decreased to €107.1 million while cash nearly doubled, reflecting a shift from financial assets to cash **Financial Position (€ thousands)** | Metric | Mar 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Total Assets | 107,095 | 120,209 | | Cash and cash equivalents | 25,103 | 12,768 | | Total Equity | 94,760 | 102,582 | | Total Liabilities | 12,336 | 17,627 | - The decrease in total assets is primarily linked to a **€25.3 million reduction** in current and non-current financial assets, which were subsequently reinvested into cash and cash equivalents[28](index=28&type=chunk)[30](index=30&type=chunk) - Total liabilities decreased significantly, driven by a **€7.1 million reduction** in trade and other payables, which were high at year-end 2023 due to manufacturing costs for commercial products[28](index=28&type=chunk) [Statements of Changes in Shareholders' Equity](index=5&type=section&id=Unaudited%20condensed%20consolidated%20statements%20of%20changes%20in%20shareholders%27%20equity%20for%20the%20three%20months%20ended%20March%2031%2C%202024%20and%202023) Shareholders' equity decreased by €7.8 million to €94.8 million, mainly due to the period's net loss **Reconciliation of Shareholders' Equity for Q1 2024 (€ thousands)** | Description | Amount | | :--- | :--- | | Balance as of January 1, 2024 | 102,582 | | Loss for the period | (9,657) | | Other comprehensive loss | (26) | | Equity-settled share-based payments | 1,861 | | **Balance as of March 31, 2024** | **94,760** | - In Q1 2023, equity was also impacted by the exercise of **71,234 share options**, which did not occur in Q1 2024[10](index=10&type=chunk) [Statements of Cash Flows](index=6&type=section&id=Unaudited%20condensed%20consolidated%20statements%20of%20cash%20flows%20for%20the%20three%20months%20ended%20March%2031%2C%202024%20and%202023) Net cash increased by €12.0 million, as positive investing cash flow offset negative operating cash flow **Cash Flow Summary for Q1 (€ thousands)** | Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | (14,868) | (10,516) | | Net cash from/(used in) investing activities | 26,945 | (3,586) | | Net cash from/(used in) financing activities | (86) | 30 | | **Net increase/(decrease) in cash** | **11,991** | **(14,072)** | - The positive cash flow from investing activities was primarily due to receiving **€30.5 million** from the maturity of financial assets, which significantly outweighed purchases of new assets[12](index=12&type=chunk) - The increase in cash used in operating activities was influenced by a **€4.4 million outflow** for trade and other payables[12](index=12&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20unaudited%20condensed%20consolidated%20financial%20statements) This section details GOHIBIC's first revenues, R&D cost changes, and other key financial statement disclosures [1. Summary of significant accounting policies and other disclosures](index=7&type=section&id=1.%20Summary%20of%20significant%20accounting%20policies%20and%20other%20disclosures) The company focuses on anti-C5a/C5aR inhibitors, with GOHIBIC receiving EUA for COVID-19 treatment - The company's focus is on its proprietary anti-C5a and C5aR technologies to discover, develop and commercialize inhibitors of the complement activation factor C5a[15](index=15&type=chunk) - GOHIBIC (vilobelimab) received an **Emergency Use Authorization (EUA)** from the U.S. FDA on April 4, 2023, for treating critically ill, invasively mechanically ventilated adult COVID-19 patients[15](index=15&type=chunk) - The financial statements are prepared in accordance with **IAS 34 Interim Financial Reporting** and should be read in conjunction with the 2023 annual report on Form 20-F[16](index=16&type=chunk) [2. Revenues](index=8&type=section&id=2.%20Revenues) The company recognized its first-ever revenues of €36,037 in Q1 2024 from GOHIBIC sales in the U.S **Revenues by Period** | Period | Revenues (€) | | :--- | :--- | | Q1 2024 | 36,037 | | Q1 2023 | 0 | - All revenues are from GOHIBIC product sales in the United States to end customers (hospitals); sales to distributors are not recognized as revenue under **IFRS 15**[18](index=18&type=chunk) [3. Cost of Sales](index=8&type=section&id=3.%20Cost%20of%20Sales) Q1 2024 cost of sales was €220,521, primarily from write-downs of expiring inventory - Cost of sales in Q1 2024 amounted to **€220,521**, mainly due to write-downs of inventories nearing their expiration date[19](index=19&type=chunk) [4. Research and development expenses](index=8&type=section&id=4.%20Research%20and%20development%20expenses) R&D expenses decreased by €7.4 million year-over-year due to lower one-time GOHIBIC manufacturing costs - R&D expenses fell to **€7.3 million** in Q1 2024 from €14.7 million in Q1 2023[5](index=5&type=chunk)[20](index=20&type=chunk) - The decrease is primarily due to high third-party expenses in Q1 2023 for the GOHIBIC commercial manufacturing process and EUA efforts[20](index=20&type=chunk) [5. Other income](index=8&type=section&id=5.%20Other%20income) Other income dropped by €7.7 million year-over-year following the conclusion of a government grant **Other Income Breakdown** | Income Source | Q1 2024 (€) | Q1 2023 (€) | | :--- | :--- | :--- | | Income from government grants | 0 | 7,734,855 | | Other | 36,323 | 11,334 | | **Total** | **36,323** | **7,746,189** | - The significant drop in other income is due to the end of the government grant period on June 30, 2023[20](index=20&type=chunk) [6. Net financial result](index=9&type=section&id=6.%20Net%20financial%20result) The net financial result improved by €3.3 million to a €2.8 million gain, driven by foreign exchange gains **Net Financial Result Breakdown (€ thousands)** | Financial Item | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Finance Result | 904 | 451 | | Foreign exchange result | 1,824 | (1,137) | | Other financial result | 103 | 198 | | **Net financial result** | **2,831** | **(489)** | - The improvement is mainly attributable to a **€0.5 million increase** in interest income and a **€3.0 million increase** in the foreign exchange result[21](index=21&type=chunk) [7. Inventory](index=9&type=section&id=7.%20Inventory) Total inventory value decreased slightly to €11.0 million after a €0.2 million write-down for expected expiry **Inventory Breakdown (€ thousands)** | Inventory Type | Mar 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Raw material and supplies | 424 | 424 | | Unfinished goods | 10,516 | 10,614 | | Finished goods | 110 | 330 | | **Total** | **11,049** | **11,368** | - Total inventory write-downs amounted to **€0.7 million** as of March 31, 2024, with €0.2 million recorded in Q1 2024 due to expected expiry[22](index=22&type=chunk) [8. Other assets](index=9&type=section&id=8.%20Other%20assets) Other assets increased to €6.1 million, driven by higher prepayments for R&D and D&O insurance - Prepayments on research and development projects increased to **€4.1 million** as of March 31, 2024, from €3.7 million as of December 31, 2023, mainly for clinical contracts related to INF904[24](index=24&type=chunk) - Prepaid expenses mainly consist of prepaid D&O insurance expense for the year 2024[24](index=24&type=chunk) [9. Tax receivable](index=10&type=section&id=9.%20Tax%20receivable) The tax receivable balance decreased to €2.1 million following the receipt of prior-period VAT refunds - Tax receivable decreased by **€1.7 million to €2.1 million** due to the receipt of VAT refunds for Q2 2023 and Q3 2023[25](index=25&type=chunk) [10. Financial assets and financial liabilities](index=10&type=section&id=10.%20Financial%20assets%20and%20financial%20liabilities) Financial assets decreased as funds moved to cash, while payables fell and first trade receivables were recorded - Financial assets (current and non-current) decreased by **€25.3 million**, as matured assets were moved to cash and cash equivalents[28](index=28&type=chunk) - Trade and other payables decreased by **€7.1 million** as high payables from CDMOs related to commercial product manufacturing were settled[28](index=28&type=chunk) - The company recorded its first trade receivables of **€35,242** from GOHIBIC product deliveries[28](index=28&type=chunk) [11. Other liabilities](index=10&type=section&id=11.%20Other%20liabilities) Other liabilities of €2.9 million primarily consist of payments from a distributor held as a liability - The company holds a liability to its commercial partner of **€2.8 million**, related to payments received for GOHIBIC product shipments from its U.S. distributor, Cencora[28](index=28&type=chunk)[29](index=29&type=chunk) - In accordance with **IFRS 15**, revenue is recognized only when control of the products is transferred to the end customer (hospital), at which point this liability is reduced[29](index=29&type=chunk) - In April 2024, the Company agreed with Cencora to repay the amount for product shipments transferred in September 2023[29](index=29&type=chunk) [12. Cash and cash equivalents](index=11&type=section&id=12.%20Cash%20and%20cash%20equivalents) Cash and cash equivalents increased by €12.3 million to €25.1 million due to reinvestment of matured financial assets **Cash and Cash Equivalents Breakdown (€ thousands)** | Category | Mar 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Short-term deposits | 18,297 | 5,141 | | Cash at banks | 6,806 | 7,627 | | **Total** | **25,103** | **12,768** | - The **€12.3 million increase** is mainly due to the maturity of financial assets and their subsequent reinvestment into interest-bearing bank deposits[30](index=30&type=chunk) [13. Share-based payments](index=11&type=section&id=13.%20Share-based%20payments) Share-based payment expenses rose to €1.8 million in Q1 2024, with 2.3 million new options granted - Share-based payment expense recognized in Q1 2024 was **€1.8 million**, compared to €1.2 million in Q1 2023[37](index=37&type=chunk) - A total of **2,275,000 share options** were granted during Q1 2024 under the 2017 LTIP[34](index=34&type=chunk)[35](index=35&type=chunk) - No share options were exercised in Q1 2024, whereas **56,304 were exercised in Q1 2023**, generating proceeds of €98 thousand in the prior year period[38](index=38&type=chunk) [14. Protective foundation](index=12&type=section&id=14.%20Protective%20foundation) The company utilizes a protective foundation with a call option as an anti-takeover defense mechanism - The company has a protective foundation under Dutch law as an **anti-takeover measure**[40](index=40&type=chunk) - The foundation can exercise a call option to be issued preferred shares up to **100% of the Company's issued capital** held by others (minus one share) to deter acquisition bids[40](index=40&type=chunk)