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)

JENA, Germany, Aug. 01, 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 report its second quarter 2024 financial and operating results on August 8, 2024, before the market opens. No conference call is planned. About InflaRx InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR ...

INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has shown antiinflammatory 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 ...

JENA, Germany, June 24, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced today that GOHIBIC (vilobelimab) has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as one of three investigational therapies to be assessed in a Phase 2 cli ...

Core Insights - InflaRx N.V. is advancing its oral small molecule C5aR inhibitor, INF904, targeting chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) as part of its immuno-dermatology development strategy [1][4][10] Company Overview - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary technologies to develop inhibitors of the complement activation factor C5a and its receptor C5aR [12] - The company was founded in 2007 and has operations in Germany and the USA [12] Product Development - INF904 is designed to inhibit C5a-induced signaling and has shown promise in pre-clinical models for its anti-inflammatory effects [11] - The company plans to initiate a Phase 2a basket trial for INF904 by the end of 2024, involving 75 patients with moderate-to-severe CSU and HS [5][6] - The trial will assess safety, pharmacokinetics (PK), and preliminary efficacy over a 4-week treatment period, with data expected in summer 2025 [6][8] Clinical Trial Design - The CSU group will include 45 patients randomized to receive INF904 at doses of 30 mg and 90 mg twice daily [7] - Efficacy measures for CSU will include changes in Urticaria Activity Score 7 (UAS7) and other patient-reported outcomes [7] - The HS group will consist of 30 patients receiving doses of 30 mg, 60 mg, or 90 mg twice daily, with similar efficacy measures [9] Market Potential - The commercial assessment indicates that CSU and HS represent multi-billion-dollar market opportunities, highlighting a significant unmet medical need for effective treatments [8][10] - INF904 is viewed as a "pipeline-in-a-product," with potential applications extending beyond immuno-dermatology to areas such as nephrology, neurology, and hematology [10] Financial Position - InflaRx's strong financial position is expected to support operations and clinical program advancements into 2026 [8]

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. P ...

JENA, Germany, May 21, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22, 2024 in San Diego. InflaRx is presenting a poster at the thematic poster session at the ATS conference today from 11:30 AM PT / 2:30 PM ET to 1:15 PM PT / 4:15 PM ET. The poster is titled, "Vilobelima ...

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 i ...

JENA, Germany, April 24, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a biotechnology company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will participate in the Capital One Securities 1st Annual Biotech/Biopharma Disrupters Event to be held in New York City. InflaRx will participate in a panel titled, New Potential Dermatology Treatments for Psoriasis, Urticaria, and Alopecia scheduled on May 14, 2024, at 2:30 PM EDT / 8:30 PM CEST. ...