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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 ...
InflaRx N.V.(IFRX) - 2022 Q2 - Quarterly Report
2022-08-05 10:07
[Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=1&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202022%20and%202021.) The statements detail operating expenses, other income, and the resulting net loss and comprehensive loss for the periods Statements of Operations and Comprehensive Loss (in €) | Metric | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :---------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development expenses | (11,180,958) | (11,299,270) | (21,652,881) | (16,206,155) | | General and administrative expenses | (4,346,965) | (2,697,839) | (8,734,408) | (5,720,177) | | Total Operating Expenses | (15,527,923) | (13,997,109) | (30,387,289) | (21,926,332) | | Other income | 14,441,541 | 15,216 | 14,443,135 | 20,678 | | Operating Result | (1,086,661) | (13,982,172) | (15,944,999) | (21,906,498) | | Income (Loss) for the Period | 465,376 | (14,780,903) | (13,536,654) | (20,906,280) | | Income (Loss) per share (basic/diluted) | 0.01 | (0.33) | (0.31) | (0.54) | | Total Comprehensive Income (Loss) | 4,874,316 | (16,208,205) | (7,817,839) | (18,828,883) | [Unaudited Condensed Consolidated Statements of Financial Position](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Financial%20Position%20as%20of%20June%2030%2C%202022%20and%20December%2031%2C%202021.) This statement presents the company's assets, equity, and liabilities as of June 30, 2022, and December 31, 2021 Statements of Financial Position (in €) | Metric | June 30, 2022 (unaudited) | December 31, 2021 | | :---------------------------------- | :-------------------------- | :-------------------------- | | Total non-current assets | 2,503,468 | 29,461,224 | | Total current assets | 112,129,573 | 95,677,896 | | TOTAL ASSETS | 114,633,041 | 125,139,120 | | Total equity | 102,131,638 | 105,280,996 | | Total non-current liabilities | 1,207,970 | 1,101,373 | | Total current liabilities | 11,293,433 | 18,756,751 | | Total Liabilities | 12,501,404 | 19,858,124 | | TOTAL EQUITY AND LIABILITIES | 114,633,041 | 125,139,120 | [Unaudited Condensed Consolidated Statements of Changes in Shareholders' Equity](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity%20for%20the%20six%20months%20ended%20June%2030%2C%202022%20and%202021.) This statement outlines the changes in total equity, including loss, exchange differences, and share-based payments, for the six-month periods Statements of Changes in Shareholders' Equity (in €) | Metric | Balance as of Jan 1, 2022 | Loss for the period | Exchange differences | Equity-settled share-based payments | Balance as of June 30, 2022 | | :---------------------------------- | :------------------------ | :------------------ | :------------------- | :---------------------------------- | :-------------------------- | | Total equity | 105,280,996 | (13,536,654) | 5,718,815 | 4,668,481 | 102,131,638 | | Metric | Balance as of Jan 1, 2021 | Loss for the period | Exchange differences | Issuance of common shares and warrants | Transaction costs | Equity-settled share-based payments | Share options exercised | Balance as of June 30, 2021 | | :---------------------------------- | :------------------------ | :------------------ | :------------------- | :------------------------------------- | :---------------- | :---------------------------------- | :---------------------- | :-------------------------- | | Total equity | 77,863,880 | (20,906,280) | 2,077,397 | 65,142,549 | (4,219,222) | 2,687,779 | 963,735 | 123,609,838 | [Unaudited Condensed Consolidated Statements of Cash Flows](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202022%20and%202021.) This statement summarizes cash flows from operating, investing, and financing activities, showing the net change in cash and equivalents Statements of Cash Flows (in €) | Metric | 6 Months Ended June 30, 2022 (unaudited) | 6 Months Ended June 30, 2021 (unaudited) | | :---------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net cash used in operating activities | (25,359,081) | (18,254,553) | | Net cash from investing activities | 12,554,101 | (1,942,546) | | Net cash from (used in) financing activities | (182,014) | 61,703,934 | | Net decrease increase in cash and cash equivalents | (12,986,995) | 45,391,927 | | Cash and cash equivalents at end of period | 15,416,152 | 72,360,428 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements.) These notes provide detailed explanations and additional disclosures for the interim condensed consolidated financial statements [Summary of Significant Accounting Policies and Other Disclosures](index=4&type=section&id=Summary%20of%20significant%20accounting%20policies%20and%20other%20disclosures.) This section details the basis of financial statement preparation, accounting policies, and the Group's structure [Reporting Entity and Group's Structure](index=4&type=section&id=Reporting%20entity%20and%20Group%27s%20structure.) InflaRx N.V. is a NASDAQ-listed biopharmaceutical company focused on anti-C5a technologies, operating with its German and US subsidiaries - InflaRx N.V. is a Dutch public company listed on The NASDAQ Global Select Market under the symbol IFRX since November 10, 2017[12](index=12&type=chunk) - The Group is a clinical-stage biopharmaceutical company focused on proprietary anti-C5a and C5aR technologies for developing inhibitors of complement activation factor C5a and its receptor C5aR[13](index=13&type=chunk) - The Group comprises InflaRx N.V. and its wholly-owned subsidiaries InflaRx GmbH (Germany) and InflaRx Pharmaceutical Inc. (United States)[13](index=13&type=chunk) [Basis of Preparation](index=5&type=section&id=Basis%20of%20preparation.) Interim financial statements adhere to IAS 34, presented in Euro, with consistent accounting policies and no material impact from new standards - The interim condensed consolidated financial statements for the three- and six-month periods ended June 30, 2022 and 2021, were prepared in accordance with IAS 34 Interim Financial Reporting[15](index=15&type=chunk) - The financial statements are presented in Euro (€), which is the functional currency of InflaRx GmbH, while InflaRx N.V. and InflaRx Pharmaceutical Inc. use U.S. Dollars as their functional currency[17](index=17&type=chunk) - The accounting policies adopted are consistent with those followed in the preparation of the Group's annual consolidated financial statements for the year ended December 31, 2021, except for the adoption of new standards effective as of January 1, 2022, which did not have a material impact[18](index=18&type=chunk)[19](index=19&type=chunk) [Significant Events of the Quarter and Changes in Circumstances](index=5&type=section&id=Significant%20events%20of%20the%20quarter%20and%20changes%20in%20circumstances.) This section covers the assessment of external impacts, strategic shifts in development programs, and key management personnel changes [Russian-Ukraine Conflict](index=5&type=section&id=Russian-Ukraine%20Conflict) The company anticipates no direct near-term operational impact from the Russian-Ukraine conflict - The Company does not expect the ongoing Russian-Ukraine war to have a direct impact on its operations in the near term, as it is not conducting business or receiving services from vendors in Russia or Ukraine[19](index=19&type=chunk)[22](index=22&type=chunk) [COVID-19 Pandemic](index=6&type=section&id=COVID-19%20Pandemic) The pandemic continues to influence operations with a hybrid work model, yet patient recruitment remains at regular levels - The COVID-19 pandemic continues to impact operations, with the Company using a hybrid working model and significantly reducing business travel[23](index=23&type=chunk)[24](index=24&type=chunk) - Patient recruitment and new clinical trial sites continued at regular operational levels during the first six months of 2022[24](index=24&type=chunk) [Development Programs](index=6&type=section&id=Development%20programs) Strategic focus shifted to vilobelimab in PG and severe COVID-19, and INF904, with key regulatory designations obtained - The Company decided to halt clinical development of vilobelimab in HS and AAV to focus resources on Phase III development of vilobelimab in PG, gaining regulatory approval for severe COVID-19, and starting clinical development of INF904[25](index=25&type=chunk) - Vilobelimab was granted Orphan Drug Designation for PG by FDA and EMA, and Fast Track designation by FDA for PG[26](index=26&type=chunk) - Following encouraging Phase III results for severe COVID-19, InflaRx plans to submit a request for Emergency Use Authorization (EUA) by end of Q3 2022[27](index=27&type=chunk) [Management Changes](index=6&type=section&id=Management%20changes.) The Chief Strategy Officer and Chief Clinical Development Officer departed, transitioning to advisory roles - Mr. Jordan Zwick, Chief Strategy Officer, departed on June 29, 2022, but will continue to serve as an advisor to the Company[28](index=28&type=chunk) - Dr. Korinna Pilz, Chief Clinical Development Officer, informed the Company of her intention to leave and will continue to provide services until October 28, 2022, followed by an advisory role[29](index=29&type=chunk) [Other Income](index=6&type=section&id=Other%20income.) Other income significantly increased due to the recognition of deferred government grant payments and reimbursable costs Other Income (in €) | Metric | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :---------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Other income from government grants | 14,415,368 | - | 14,415,368 | - | | Further other incomes | 26,173 | 15,216 | 27,767 | 20,678 | | Total | 14,441,541 | 15,216 | 14,443,135 | 20,678 | - The **€14.4 million** increase in other income was due to the recognition of **€7.1 million** in previously deferred grant payments and **€7.3 million** in reimbursable costs incurred in Q1 and Q2 2022, following written confirmation of grant conditions from the German government[31](index=31&type=chunk)[32](index=32&type=chunk) [Net Financial Result](index=7&type=section&id=Net%20financial%20result.) The net financial result was positively impacted by foreign exchange income from U.S. Dollar holdings and increased interest income Net Financial Result (in €) | Metric | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :---------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Financial income (Interest income) | 82,401 | 35,622 | 110,362 | 58,584 | | Financial expenses (Interest expenses) | (2,243) | (305) | (22,102) | (2,885) | | Financial expenses (Interest on lease liabilities) | (5,702) | (2,745) | (10,429) | (3,849) | | Total Financial Result (excluding FX) | 74,456 | 32,572 | 77,831 | 51,850 | | Foreign exchange result | 1,563,580 | (826,303) | 2,291,513 | 905,367 | | Other financial result | (86,000) | (5,000) | 39,000 | 43,000 | - Foreign exchange income and expense are mainly derived from the translation of U.S. Dollar cash, cash equivalents, and securities held by the Company and its subsidiaries[34](index=34&type=chunk) [Other Assets](index=8&type=section&id=Other%20assets.) Total other assets decreased, primarily driven by a reduction in prepayments for research and development projects Other Assets (in €) | Metric | June 30, 2022 (unaudited) | December 31, 2021 | | :---------------------------------- | :-------------------------- | :-------------------------- | | Non-current other assets (Prepaid expense) | 341,666 | 336,566 | | Current other assets (Prepayments on R&D projects) | 8,785,786 | 10,649,174 | | Current other assets (Current tax assets) | 1,518,072 | 1,282,177 | | Current other assets (Prepaid expense) | 1,343,166 | 334,284 | | Total Current Other Assets | 11,648,669 | 12,265,635 | - Prepayments on research & development (R&D) projects decreased from **€10.6 million** as of December 31, 2021, to **€8.8 million** as of June 30, 2022, consisting of prepayments on clinical and R&D material production contracts[37](index=37&type=chunk) [Financial Assets and Financial Liabilities](index=8&type=section&id=Financial%20assets%20and%20financial%20liabilities.) Non-current financial assets decreased, while current financial assets, including government grants, increased, and liabilities decreased Financial Assets and Liabilities (in €) | Metric | June 30, 2022 (unaudited) | December 31, 2021 | | :---------------------------------- | :-------------------------- | :-------------------------- | | Non-current financial assets | 237,412 | 27,206,990 | | Financial assets from government grants | 8,260,503 | - | | Other current financial assets | 76,804,249 | 57,162,266 | | Liabilities from government grants | 2,145,135 | 8,300,000 | | Trade and other payables | 7,912,503 | 16,874,244 | - Financial assets from government grants amounted to **€8.3 million** as of June 30, 2022, including **€1.6 million** in claims submitted and **€6.7 million** for eligible costs incurred but not yet claimed[38](index=38&type=chunk) - The fair value of current and non-current financial assets (primarily quoted debt securities) was **€84.3 million** (Level 1) as of June 30, 2022, and are considered low credit risk investments[39](index=39&type=chunk) [Cash and Cash Equivalents](index=9&type=section&id=Cash%20and%20cash%20equivalents.) Cash and cash equivalents significantly decreased, mainly due to a reduction in short-term deposits Cash and Cash Equivalents (in €) | Metric | June 30, 2022 (unaudited) | December 31, 2021 | | :---------------------------------- | :-------------------------- | :-------------------------- | | Short-term deposits (U.S Dollars) | 3,514 | 12,584,892 | | Cash at banks (U.S. Dollars) | 13,336,087 | 7,612,467 | | Cash at banks (Euro) | 2,076,551 | 6,052,636 | | Total cash and cash equivalents | 15,416,152 | 26,249,995 | [Equity](index=9&type=section&id=Equity.) The company maintains an at-the-market program and previously completed a public offering, with warrants expiring unexercised - The Company has a remaining authorized value of **$35.2 million** for sale under its at-the-market program[42](index=42&type=chunk) - In February 2021, the Company sold **15,000,000** common shares and warrants in a public offering, generating **$75.0 million** (**€62.2 million**) in gross proceeds; however, no warrants were exercised before their expiration on March 1, 2022[43](index=43&type=chunk) [Share-based Payments](index=9&type=section&id=Share-based%20payments.) This section details share option plans, including grants, exercises, forfeitures, and the repricing of options resulting in additional expense [Equity Settled Share-based Payment Arrangements](index=9&type=section&id=Equity%20settled%20share-based%20payment%20arrangements.) The company's share option plans saw grants, forfeitures, and a significant repricing of outstanding options in April 2022 Share Options Outstanding (2012 Plan) | Metric | 2022 | 2021 | | :---------------------------------- | :--- | :--- | | Outstanding as of January 1, | 148,433 | 148,433 | | Outstanding as of June 30, | 148,433 | 148,433 | | thereof vested | 148,433 | 148,433 | Share Options Outstanding (2016 Plan) | Metric | 2022 | 2021 | | :---------------------------------- | :--- | :--- | | Outstanding as of January 1, | 888,632 | 1,094,852 | | Exercised during the six months ended June 30 | - | (202,020) | | Outstanding as of June 30, | 888,632 | 892,832 | | thereof vested | 888,632 | 892,832 | Share Options Outstanding (2017 LTIP) | Metric | 2022 | 2021 | | :---------------------------------- | :-------- | :-------- | | Outstanding as of January 1, | 3,170,046 | 2,146,478 | | Granted during the six months ended June 30 | 1,561,666 | 870,928 | | Exercised during the six months ended June 30 | - | (145,822) | | Forfeited during the six months ended June 30 | (117,259) | (15,000) | | Outstanding as of June 30, | 4,614,453 | 2,856,584 | | thereof vested | 3,306,162 | 1,954,858 | - On April 13, 2022, the Board of Directors adjusted the exercise price of all outstanding and unexercised options under the 2016 Plan and LTIP to **$1.86** per share due to a significant stock price decrease, affecting **888,632** options from the 2016 Plan and **4,544,248** options from the LTIP[47](index=47&type=chunk)[48](index=48&type=chunk) - The repricing decision resulted in incremental fair values of the outstanding options, requiring additional compensation expense recognition[48](index=48&type=chunk) [Share-based Payment Expense Recognized](index=11&type=section&id=Share-based%20payment%20expense%20recognized.) The company recognized **€4.67 million** in share-based payment expense, including **€0.65 million** from option repricing - For the six months ended June 30, 2022, the Company recognized **€4,668 thousand** of share-based payment expense, which included an expense of **€651 thousand** for the valuation of past grants with the new exercise price as a result of the repricing of options[53](index=53&type=chunk) [Protective Foundation](index=11&type=section&id=Protective%20foundation.) The company maintains a protective foundation with a call option on preferred shares to deter acquisition bids, incurring ongoing costs - The Company's articles of association authorize the issuance of up to **110,000,000** common shares and up to **110,000,000** preferred shares, each with a nominal value of **€0.12**[54](index=54&type=chunk) - An independent protective foundation has a call option to acquire preferred shares up to **100%** of the Company's issued capital (excluding shares held by the foundation) to deter acquisition bids[55](index=55&type=chunk) - The Company expensed **€30 thousand** in ongoing costs to reimburse expenses incurred by the protective foundation for the six months ended June 30, 2022[57](index=57&type=chunk)
InflaRx (IFRX) presents at H.C. Wainwright Global Investment Conference - Slideshow
2022-05-24 18:59
CORPORATE PRESENTATION MAY 2022 IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by InflaRx N.V. ("InflaRx" or the "Company"). This presentation is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. This presentation may not be relied upon in connection with the purchase or sale of any security and should not be construed as investment advice. Forward-Looking Statements This presentation contains forward-looking s ...
InflaRx N.V.(IFRX) - 2021 Q4 - Annual Report
2022-03-24 13:17
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, 2021 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) - 2022 Q1 - Quarterly Report
2022-03-24 12:40
Exhibit 99.1 InflaRx Reports Full Year 2021 Financial and Operating Results Jena, Germany, March 24, 2022 – 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. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: "We have made important progress in broadening and advancing our development activ ...
InflaRx (IFRX) Presents At Annual SVB Leerink Global Health Conference
2022-02-24 19:02
Vilobelimab Clinical Development - Vilobelimab's pivotal Phase III study for Hidradenitis Suppurativa (HS) was initiated in Q1 2022, based on FDA feedback[5] - Phase III trial enrollment for severe COVID-19 was completed, with topline data expected in Q1 2022[5] - Positive Phase IIa data for Pyoderma Gangraenosum (PG) was achieved, prompting the company to seek regulatory advice for a pivotal program[5] - In a Phase II study of PG, 9 out of 17 evaluable patients (53%) achieved clinical remission (PGA ≤ 1) at the end of the treatment visit or day of last drug administration, and an additional 1 patient (6%) achieved clinical response (PGA ≤ 3)[42] - The high dose group in the PG Phase IIa study showed the highest rate of target ulcer closure and clinical remission at 857%[42] Pipeline and Technology - InflaRx has proprietary anti-C5a technology with patent protection until the end of 2030/2035 with extension[5] - A new program, INF904, an oral C5aR inhibitor, is planned to enter the clinic in H2 2022[5] - INF904 shows a high in vitro potency with a desired IC50 (<1nM) in calcium mobilization assay[58] Hidradenitis Suppurativa (HS) Program - The Phase III study in HS targets moderate to severe Hurley stage II-III patients with at least one active draining tunnel, estimated to be approximately 70-75% of Hurley stage II-III moderate to severe study patients[14] - In a subgroup of moderate to severe Hurley stage II-III patients with at least 1 draining tunnel at baseline, 545% of the 1200mg Q2W vilobelimab group achieved m-HiSCR response at Week 16, compared to 261% in the placebo group (p=00424)[23] Financial Status - The company reported a strong cash balance of €1206 million as of September 30, 2021[59]
Inflarx (IFRX) Investor Presentation - Slideshow
2022-01-15 21:14
Clinical Programs & Pipeline - Vilobelimab's clinical efficacy and safety profile enable advancement in multiple indications, including Hidradenitis Suppurativa (HS), Pyoderma Gangraenosum (PG), Severe COVID-19, ANCA-associated vasculitis (AAV), and Cutaneous squamous cell carcinoma (cSCC)[5] - A pivotal study program in HS was initiated in Q1 2022 after receiving no comments from the FDA in the 30-day review period[5] - Positive Phase IIa data was reported for PG, and the company is gathering regulatory input on next steps for a pivotal program[5] - Phase III enrollment for Severe COVID-19 was completed, with topline data expected in Q1 2022[5] - A new program involving the oral C5aR inhibitor INF904 is expected to enter the clinic in H2 2022[5] Hidradenitis Suppurativa (HS) - Likely more than 200,000 moderate to severe (Hurley II+III) HS patients in the US, with higher prevalence reported in Europe at >1% total HS prevalence[11] - Approximately 50% of patients with moderate to severe HS do not respond, and about 50% of responder patients lose response to Humira[11] - The FDA provided feedback supportive of a new primary endpoint measuring reductions in all three inflammatory HS lesions, including Draining Tunnels[14] Pyoderma Gangraenosum (PG) - An estimated 50,000 patients in the US and Europe are affected by PG[15] - In a Phase IIa study, out of 17 evaluable patients, 9 patients (53%) achieved clinical remission (PGA ≤ 1), and 1 additional patient (6%) achieved a clinical response (PGA ≤ 3)[24] - The high dose group in the PG Phase IIa study showed the highest rate of target ulcer closure and clinical remission (857%)[24] Financial Status - The company had a strong cash balance of €1206 million as of September 30, 2021, to pursue strategic activities[41]