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InflaRx Hosts R&D Event Highlighting the Promise of INF904
GlobeNewswire News Room· 2024-06-05 16:00
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 ...
InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators
Newsfilter· 2024-05-21 18:30
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 ...
InflaRx Reports First Quarter 2024 Financial Results and Provides Business Update
Newsfilter· 2024-05-08 11:30
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 ...
InflaRx to Participate in Capital One Securities 1st Annual Biotech/Biopharma Disrupters Event
Newsfilter· 2024-04-24 11:30
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. ...
InflaRx N.V.(IFRX) - 2023 Q4 - Annual Report
2024-03-21 11:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) ...
InflaRx N.V.(IFRX) - 2023 Q4 - Annual Report
2024-03-21 11:05
Exhibit 99.1 InflaRx Reports Full Year 2023 Results and Announces INF904 Development Plans InflaRx will host a virtual pipeline update call today, beginning at 8:00 AM ET / 1:00 PM CET to discuss its focus on immuno- dermatology. The company will provide details on the development rationales for its chosen indications for its oral C5aR inhibitor INF904 and provide an update on the development of vilobelimab in PG. To participate in the conference call, participants may pre-register at https://us06web.zoom.u ...
InflaRx N.V.(IFRX) - 2023 Q3 - Quarterly Report
2023-11-01 12:04
Revenue and Profitability - Revenues for the three months ended September 30, 2023, were €60,803, compared to €0 in the same period of 2022, marking a significant increase[5]. - Gross profit for the three months ended September 30, 2023, was a loss of €194,313, with total cost of sales amounting to €255,116[5]. - The company reported a loss of €7,451,410 for the three months ended September 30, 2023, compared to a loss of €7,921,671 in the same period of 2022[5]. - For the nine months ended September 30, 2023, the company reported a loss of €26,737,373, compared to a loss of €21,458,325 for the same period in 2022, representing an increase in loss of approximately 24%[11]. - Other income for the nine months ended September 30, 2023, amounted to €13,437,963, a decrease from €16,473,540 in the same period of 2022, primarily due to the end of the grant period on June 30, 2023[26]. Research and Development - Research and development expenses for the nine months ended September 30, 2023, were €32,957,044, an increase from €29,190,231 in the same period of 2022[5]. - Prepayments on research and development projects decreased to €3.4 million as of September 30, 2023, down from €9.8 million as of December 31, 2022[33]. - Share-based payment expense recognized for the nine months ended September 30, 2023, was €3.0 million, down from €5.6 million in the same period of 2022[46]. Cash and Financial Position - Cash and cash equivalents as of September 30, 2023, were €21,695,607, an increase from €16,265,355 as of December 31, 2022[7]. - Total assets as of September 30, 2023, were €129,485,304, compared to €102,399,660 as of December 31, 2022[7]. - Total equity as of September 30, 2023, was €117,990,262, up from €88,349,440 as of December 31, 2022[7]. - Cash and cash equivalents at the end of the period increased to €21,695,607 as of September 30, 2023, compared to €17,978,003 at the end of the same period in 2022[11]. - The company’s cash flow from financing activities for the nine months ended September 30, 2023, was €53,081,170, compared to a cash outflow of €273,092 in the same period of 2022[11]. Shareholder Information - The weighted average number of shares outstanding increased to 58,883,272 as of September 30, 2023, from 44,203,763 in the same period of 2022[5]. - Issued capital increased to €7,065,993 as of September 30, 2023, from €5,364,452 as of January 1, 2023[9]. - The company issued 3,235,723 ordinary shares under its at-the-market program in April 2023, resulting in net proceeds of €14.4 million[41]. - Through a public offering in April 2023, the company raised €38.7 million in net proceeds after deducting underwriting discounts[42]. - During the nine months ended September 30, 2023, the company issued 105,327 shares upon the exercise of share options, generating proceeds of €98,000[48]. Inventory and Costs - As of September 30, 2023, total inventory amounted to €1,639,490, with raw materials and supplies at €1,115,243, unfinished goods at €261,124, and finished goods at €263,123[30]. - Inventory write-downs of €0.3 million were recognized due to expected expiry of shelf-life during the three and nine months ended September 30, 2023[31]. - The company incurred costs of sales of €255,116 during the nine months ended September 30, 2023, related to Gohibic (vilobelimab) revenues[24]. Financial Results - The company reported a net financial result of €4,864,488 for the nine months ended September 30, 2023, an increase of €1,783,584 from €3,080,904 in the same period of 2022[29]. - The company recognized interest income of €2,732,873 for the nine months ended September 30, 2023, compared to €310,121 in the same period of 2022, reflecting a significant increase[28]. - The company reported a foreign exchange result of €1,923,274 for the nine months ended September 30, 2023, a decrease from €3,173,883 in the same period of 2022[29]. Commercialization - The company began the commercialization of Gohibic (vilobelimab) in the United States in June 2023, generating revenues of €60,803 for the nine months ended September 30, 2023, marking the first revenue since inception[22][23]. - Liabilities from commercial partners reached €2.9 million in September 2023, related to product shipments for Gohibic (vilobelimab)[39].
InflaRx N.V.(IFRX) - 2023 Q2 - Quarterly Report
2023-05-11 12:00
FINANCIAL STATEMENTS – MARCH 31, 2023 These unaudited condensed financial statements are consolidated financial statements for the group consisting of InflaRx N.V. and its wholly-owned subsidiaries InflaRx GmbH, Jena, Germany, and InflaRx Pharmaceuticals Inc., Ann Arbor, Michigan, United States (together, the "Group"). The financial statements are presented in Euro (€). InflaRx N.V. is a company limited by shares, incorporated and domiciled in Amsterdam, The Netherlands. Its registered office and principal ...
InflaRx N.V.(IFRX) - 2022 Q4 - Annual Report
2023-03-22 12:41
Financial Performance and Projections - The company incurred net losses of €29.5 million, €45.6 million, and €34.0 million for the years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of €243.5 million as of December 31, 2022[59]. - The company expects net losses to increase as it advances vilobelimab and other product candidates into larger and later-stage clinical trials[60]. - The company used €33.7 million and €39.9 million in net cash for operating activities in 2022 and 2021, respectively, primarily related to research and development[64]. - The company believes existing cash, cash equivalents, and marketable securities will fund operating expenses for at least the next 24 months[67]. - The company has no committed external source of funds, except for a grant from the German federal government awarded in October 2021[66]. - The company may need to seek additional funds sooner than planned due to changing circumstances that could cause capital consumption to accelerate[67]. - A grant of up to €41.4 million from the German federal government is not expected to allow the company to achieve profitability, and the timing and amount of grant-related income are uncertain[73]. Clinical Development and Regulatory Risks - The company is at a clinical development stage, and the potential therapeutic benefit of its lead product candidate, vilobelimab, remains unproven[75]. - The company submitted an application for Emergency Use Authorization (EUA) for vilobelimab for critically ill COVID-19 patients to the FDA in September 2022, but there is no set timeline for a decision[80]. - The company announced a planned Phase III study for vilobelimab in ulcerative PG in January 2023, based on FDA feedback, but risks exist regarding regulatory approval[81]. - The company may face delays or reductions in product discovery and development programs if it is unable to raise capital when needed[64]. - The marketing approval process is lengthy and uncertain, with no prior history of regulatory approval for product candidates targeting C5a inhibition[95]. - The company has not submitted an application for marketing approval for any product candidate in the United States or other jurisdictions[95]. - The company may incur additional costs or experience delays if clinical trials fail to demonstrate safety and efficacy necessary for regulatory approval[83]. - The company faces potential delays in regulatory approval due to undesirable side effects from product candidates, which could result in significant negative consequences following marketing approval[87]. - Clinical trials may be suspended or terminated if unacceptable side effects arise, impacting patient recruitment and increasing costs[88]. - The company has observed several adverse events in clinical trials of vilobelimab, which may create a negative safety perception and affect market acceptance[87]. Market Acceptance and Commercialization Challenges - Even if vilobelimab receives marketing approval, it may fail to achieve market acceptance necessary for commercial success[107]. - The company faces significant challenges in achieving market acceptance for its product candidates, which could impact revenue generation and profitability[108]. - The efficacy, safety, and competitive advantages of the product candidates are critical factors for market acceptance, along with pricing and reimbursement considerations[109]. - Uncertainty exists regarding third-party payor coverage and reimbursement for newly approved drugs, which could limit the company's ability to generate revenue[110]. - The healthcare industry's focus on cost containment may hinder the company's ability to sell its products profitably, as payors may not view them as cost-effective[113]. - The company lacks marketing, sales, and distribution capabilities, which could impede the successful commercialization of its product candidates[116]. - Collaborations with third parties for sales and distribution may result in lower product revenue compared to direct marketing efforts[117]. Intellectual Property and Legal Risks - The company’s success relies on obtaining and maintaining intellectual property protection for its product candidates, including vilobelimab[169]. - The patent application process is expensive and time-consuming, with no guarantee of obtaining broad patent protection necessary to compete effectively[170]. - The company faces risks related to potential challenges and litigation regarding its patents, which could adversely affect its competitive position[175]. - The company faces challenges in protecting its intellectual property and proprietary anti-C5a and anti-C5aR technologies, which may impact its commercial success[180]. - The company owns six families of patents and patent applications related to C5a and C5aR inhibitors, but the breadth of claims that may be allowed or enforced is uncertain[181]. - Non-compliance with patent application requirements could lead to abandonment or loss of patent rights, allowing competitors to enter the market earlier[181]. - The company cannot assure that any of its patent applications will be found patentable, which could limit patent protection for its product candidates[182]. - The company may face claims from third parties asserting ownership of its intellectual property, which could lead to litigation and significant resource diversion[189]. Operational and Workforce Considerations - As of December 31, 2022, the company had 48 full-time or part-time employees, indicating a limited workforce to manage operations and develop vilobelimab[211]. - The company is highly dependent on key executive officers, including the CEO, CFO, and Chief Scientific Officer, for its success in the biotechnology and pharmaceuticals industries[212]. - The company faces intense competition for hiring qualified personnel, which may hinder its ability to attract and retain necessary talent[214]. - The company relies on consultants and advisors for its research and development strategy, which may limit its ability to develop and commercialize product candidates if these individuals are not retained[215]. Financial and Tax Considerations - As of December 31, 2022, the company had €16.3 million in cash and cash equivalents and €67.6 million in marketable securities as of December 31, 2022, providing a total of €83.9 million in liquid assets[223]. - The company lost its "emerging growth company" status as of December 31, 2022, which may lead to increased costs and challenges in refining internal control processes over financial reporting[226]. - The company does not anticipate paying any cash dividends on its share capital in the foreseeable future, relying instead on capital appreciation for returns[227]. - The company may face increased future cash tax liability if it earns net taxable income and is unable to utilize pre-change NOL carryforwards[233]. - The company intends to maintain its place of effective management in Germany, which affects its tax residency status[236]. - Changes in applicable tax laws or interpretations may result in the company becoming a tax resident in a jurisdiction other than Germany, increasing its overall effective income tax rate[238].
InflaRx N.V.(IFRX) - 2023 Q1 - Quarterly Report
2023-03-22 11:37
Exhibit 99.1 InflaRx Reports Full Year 2022 Financial and Operating Results ● Major progress in development of vilobelimab Jena, Germany, March 22, 2023 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti- inflammatory therapeutics by targeting the complement system, today announced financial and operating results for the year ended December 31, 2022. Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented: "We are very pleased with the exceptional progress we h ...