BDB-001

Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug Administration (FDA); clinical trial protocol submitted; first patient expected around mid-2023 Fast Track and Orphan Drug designations granted for treatment of pyoderma gangrenosum (PG) in the United States and Orphan Drug designation granted in Europe Encouraging results from Phase III study in critically ill COVID-19 patients published in The Lancet Respiratory Medicine Emergency Use Authorization (EUA) application for treatment of critically ill, invasively mechanically ventilated COVID-19 patients submitted to the FDA; review ongoing First-in-human clinical trial with oral C5aR inhibitor INF904 initiated in November 2022; first data expected in H2 2023 Amendment of co-development agreement with Staidson and incremental $2.5 million equity investment by Staidson HK for planned regulatory filing of BDB-001 for COVID-19 in China Total funds available approximately €83.7 million as of December 31, 2022, funding the company into H2 2025 JENA, Germany, March 22, 2023 (GLOBE NEWSWIRE) -- 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 have made in the past year with our lead drug candidate, vilobelimab, in several areas, as well as in advancing our pipeline with a new clinical asset, INF904, an orally available small molecule inhibitor of the C5a receptor. Upon detailed feedback from the FDA related to our development of vilobelimab for the treatment of PG, a rare debilitating and neutrophil driven skin disease, we have designed and submitted a Phase III protocol to the FDA while we are currently initiating the trial. We also submitted an EUA application to treat critically ill, mechanically ventilated patients with COVID-19, who today are still facing poor outcomes, and shortly await a decision from the FDA. Further, we expect first results from our ongoing Phase I clinical trial with INF904 and interim results from our Phase II clinical trial in cutaneous squamous cell carcinoma later this year. With these important milestones anticipated, 2023 promises to be an exciting year.” Recent Highlights and R&D Update InflaRx reported on key recent highlights and provided an update on its research and development activities. Vilobelimab in Pyoderma Gangrenosum (PG) Final data from an open-label, multi-center Phase IIa exploratory study evaluating the safety and efficacy of vilobelimab in patients with moderate to severe PG were presented in March 2022. The results showed a dose-dependent treatment effect. In the highest dose cohort of 2,400 mg, six out of seven patients demonstrated a clinical remission (Physician Global Assessment (PGA) score ≤ 1) and closure of the target ulcer. Based on these compelling results and a productive End-of-Phase II meeting with the FDA in Q3 2022, InflaRx is moving forward with a pivotal Phase III clinical development program in this indication. In January 2023, the Company announced details related to the design of its planned Phase III study, a multi-national, randomized, double-blind, placebo-controlled trial. The Company has submitted the clinical trial protocol to the FDA and plans to begin patient enrollment around mid-2023. Vilobelimab was granted Orphan Drug designation by both the FDA and the European Medicines Agency (EMA) for the treatment of ulcerative PG in June 2022, and in July was granted Fast Track designation for this indication by the FDA. Vilobelimab for the Treatment of Critically ill COVID-19 Patients InflaRx submitted an EUA application to the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients in September 2022. The Company continues to be in active dialogue with and has addressed several requests for information that it received from the FDA. There is no set timeline for a decision from the FDA related to the EUA. The Company will continue to interact closely with the FDA and will provide a timely update when appropriate. If EUA is granted, InflaRx plans to seek full marketing authorization in major markets, including the United States and Europe and, in parallel, intends to seek partners to support commercialization efforts. InflaRx also previously received Fast Track designation from the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients. In September 2022, results from the PANAMO Phase III study, an international, double-blind, placebo-controlled, randomized clinical trial investigating vilobelimab in invasively mechanically ventilated COVID-19 patients, were published in the peer-reviewed journal, The Lancet Respiratory Medicine, which included an in-depth statistical analysis supporting the robustness of the observed clinical survival benefit in the study. Based on current COVID-19 trends, the U.S. Department of Health and Human Services (HHS) expects the COVID-19 federal public health emergency to expire on May 11, 2023. However, HHS has stated that it expects that the FDA will provide continued access to pathways for EUAs for medical products. See . In 2021, InflaRx was awarded a grant from the German Ministry of Education and Research and the German Ministry of Health to support the development of vilobelimab for the treatment of COVID-19. As of December 31, 2022, the Company had received €25.6 million in grant funds and still has a maximum amount of €15.9 million available for claiming under the grant throughout the end of the grant term in June 2023. Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC) InflaRx is conducting an open-label, multicenter Phase II study, evaluating vilobelimab alone and in combination with pembrolizumab in patients with programmed cell death protein-1 (PD-1) or programmed cell death ligand-1 (PD-L1) inhibitor resistant/refractory, locally advanced or metastatic cSCC. Patients are being recruited into two independent arms - vilobelimab as monotherapy (Arm A) and in combination with pembrolizumab (Arm B). The main objectives of the trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm in this patient population. So far, 10 patients have been recruited into Arm A of the study. First data from an interim analysis in patients in Arm A is expected to be available in the first half of 2023. In Arm B of the study, as of today, 14 patients have been recruited into three dose cohorts (3+6+5). Data from an interim analysis in Arm B are expected to be available in the first half of 2024. C5aR Inhibitor INF904 In November 2022, the company announced that the first healthy volunteer had been dosed in a randomized, double-blind, placebo-controlled Phase I trial. This single and multiple ascending dose Phase I trial aims to evaluate the safety, tolerability and pharmacokinetics of INF904 in healthy volunteers. The effect of INF904 on C5a-induced downstream activity will also be explored. Results are expected in the second half of 2023. In the future, InflaRx plans to develop INF904 for complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients. Staidson Agreements In December 2022, InflaRx amended its existing co-development agreement with Staidson (Beijing) BioPharmaceuticals Co., Ltd. (Staidson) from 2015 to support Staidson in its regulatory approval efforts for its proprietary drug candidate BDB-001 in China. InflaRx will receive royalties of 10% on net sales of BDB-001 for the treatment of COVID-19 in China. InflaRx has granted Staidson an exclusive license for use in China to certain of InflaRx’s clinical, manufacturing and regulatory documentation regarding vilobelimab in order to support and facilitate the planned regulatory filing for BDB-001 for the treatment of severely ill COVID-19 patients with the Chinese National Medical Products Administration (NMPA). In parallel, InflaRx entered into a share purchase agreement with Staidson Hong Kong Investment Company Limited (Staidson HK), an affiliate of Staidson, pursuant to which Staidson HK purchased ordinary shares of InflaRx for an aggregate amount of $2.5 million at a price of $5.00 per share. The share purchase agreement also includes an option pursuant to which Staidson HK may in the future purchase, at InflaRx’s discretion, additional ordinary shares for an aggregate amount of $7.5 million. 2022 Financial Highlights Dr. Thomas Taapken, CFO of InflaRx, said: “We are well financed to bring vilobelimab to patients, should we receive EUA, as well as to continue our development programs, including initiating a Phase III study in PG later this year. The grant money we have received from the German government for our COVID-19 development work as well as the investment by Staidson further strengthen our financial position, and we have sufficient cash to fund operations into H2 2025.” Research and Development (R&D) Expenses InflaRx’s R&D expenses increased by €1.8 million to €37.5 million in 2022, from €35.7 million in 2021. R&D expenses are predominantly comprised of costs for external contract research organizations (CROs) for pre-clinical activities and the conduct of clinical trials, costs for external contract manufacturing organizations (CMOs) for product manufacturing-related activities, costs for professional consultants primarily in the areas of regulatory affairs and intellectual property, as well as personnel expenses. General and Administrative (G&A) Expenses InflaRx’s G&A expenses increased by €2.9 million to €14.9 million in 2022, from €12.0 million in 2021. The increase is partly attributable to higher consulting and legal costs incurred in enhancing InflaRx’s internal control environment as it is complying with the auditor attestation requirement of Section 404(b) of the Sarbanes-Oxley Act of 2002 for the first time due to the loss of its “emerging growth company” status. G&A expenses are predominantly comprised of professional fees for auditors, consulting expenses not related to R&D activities, professional fees for lawyers, cost of facilities, travel, communication and office expenses as well as personnel related expenses. Other Income In 2022, InflaRx recognized other income of €20.1 million from grant payments received from the German federal government for the development of vilobelimab in COVID-19, including expenses related to clinical development and manufacturing process development. Net Financial Result InflaRx’s net financial result increased by €0.7 million to €2.7 million in 2022, from €2.0 million in 2021. This is mainly attributable to a net increase of €0.5 million in foreign exchange income and expense and an increase of €0.5 million in interest income from marketable securities. Net Loss InflaRx incurred a net loss of €29.5 million, or €0.67 per common share, in 2022 compared to €45.6 million, or €1.10 per common share, in 2021. Liquidity and Capital Resources As of December 31, 2022, InflaRx’s total funds available amounted to approximately €83.7 million, comprised of €16.3 million of cash and cash equivalents and €67.4 million of marketable securities. Net Cash Used in Operating Activities InflaRx’s net cash used in operating activities decreased to €33.7 million in 2022, from €39.9 million in 2021, mainly due to the decrease of loss before income tax resulting mainly from income recognized from the grant received from the German federal government. Additional Financial Information Additional information regarding these results and other relevant information is included in the notes to the financial statements in “Item 18. Financial Statements,” which are included in InflaRx’s most recent annual report on Form 20-F as filed with the U.S. Securities and Exchange Commission. InflaRx N.V. and subsidiaries Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2022, 2021 and 2020 in €, except for share information 2022 2021 2020 Operating Expenses Research and development expenses (37,526,090 ) (35,697,935 ) (25,684,140 ) General and administrative expenses (14,869,564 ) (11,984,722 ) (8,467,203 ) Total Operating Expenses (52,395,654 ) (47,682,657 ) (34,151,343 ) Other income 20,159,169 54,221 221,748 Other expenses (1,381 ) (6,381 ) (13,209 ) Operating Result (32,237,866 ) (47,634,817 ) (33,942,804 ) Finance income 608,679 109,391 887,702 Finance expenses (45,250 ) (24,769 ) (26,000 ) Foreign exchange result 2,442,298 1,964,135 (776,512 ) Other financial result (252,471 ) (44,000 ) (126,000 ) Income Taxes — — — Loss for the Period (29,484,611 ) (45,630,059 ) (33,983,614 ) Share Information Weighted average number of shares outstanding 44,207,873 41,629,974 27,064,902 Loss per share (basic/diluted) (0.67 ) (1.10 ) (1.26 ) Loss for the Period (29,484,611 ) (45,630,059 ) (33,983,614 ) Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign currency 4,206,810 6,777,061 (5,954,019 ) Total Comprehensive Loss (25,277,801 ) (38,852,998 ) (39,937,633 ) InflaRx N.V. and subsidiaries Consolidated Statements of Financial Position as December 31, 2022 and 2021 in € 2022 2021 ASSETS Non-current assets Property and equipment 328,920 274,373 Right-of-use assets 1,311,809 1,408,078 Intangible assets 138,905 235,216 Other assets 308,066 336,566 Financial assets 2,900,902 27,206,990 Total non-current assets 4,988,602 29,461,223 Current assets Current other assets 14,170,510 10,983,458 Income tax receivable 1,432,087 1,282,177 Financial assets from government grants 732,971 — Other Financial assets 64,810,135 57,162,266 Cash and cash equivalents 16,265,355 26,249,995 Total current assets 97,411,058 95,677,896 TOTAL ASSETS 102,399,660 125,139,120 EQUITY AND LIABILITIES Equity Issued capital 5,364,452 5,304,452 Share premium 282,552,633 280,310,744 Other capital reserves 36,635,564 30,591,209 Accumulated deficit (243,460,290 ) (213,975,679 ) Other components of equity 7,257,081 3,050,270 Total equity 88,349,440 105,280,996 Non-current liabilities Lease liabilities 987,307 1,066,354 Other liabilities 36,877 35,019 Total non-current liabilities 1,024,184 1,101,373 Current liabilities Trade and other payables 4,987,538 8,574,244 Liabilities from government grants received 6,209,266 8,300,000 Lease liabilities 369,376 366,171 Employee benefits 1,312,248 1,378,130 Other liabilities 147,608 138,206 Total current liabilities 13,026,036 18,756,751 Total Liabilities 14,050,220 19,858,124 TOTAL EQUITY AND LIABILITIES 102,399,660 125,139,120 InflaRx N.V. and subsidiaries Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2022, 2021 and 2020 in € Issued capital Share premium Other capital reserves Accumulated deficit Other components of equity Total equity Balance as of January 1, 2020 3,132,631 211,006,606 25,142,213 (134,362,006 ) 2,227,228 107,146,673 Loss for the Period — — — (33,983,614 ) — (33,983,614 ) Exchange differences on translation of foreign currency — — — — (5,954,019 ) (5,954,019 ) Total Comprehensive Loss — — — (33,983,614 ) (5,954,019 ) (39,937,633 ) Issuance of common shares 234,982 9,535,961 — — — 9,770,943 Transaction costs — (729,840 ) — — — (729,840 ) Equity-settled share-based payments — — 1,116,791 — — 1,116,791 Share options exercised 19,797 477,149 — — — 496,946 Balance as of December 31, 2020 3,387,410 220,289,876 26,259,004 (168,345,620 ) (3,726,791 ) 77,863,880 Loss for the Period — — — (45,630,059 ) — (45,630,059 ) Exchange differences on translation of foreign currency — — — — 6,777,061 6,777,061 Total Comprehensive Loss — — — (45,630,059 ) 6,777,061 (38,852,998 ) Issuance of common shares 1,873,203 63,269,346 — — — 65,142,549 Transaction costs — (4,219,222 ) — — — (4,219,222 ) Equity-settled share-based payments — — 4,332,205 — — 4,332,205 Share options exercised 43,839 970,744 — — — 1,014,583 Balance as of December 31, 2021 5,304,452 280,310,744 30,591,209 (213,975,679 ) 3,050,270 105,280,996 Loss for the Period — — — (29,484,611 ) — (29,484,611 ) Exchange differences on translation of foreign currency — — — — 4,206,810 4,206,810 Total Comprehensive Loss — — — (29,484,611 ) 4,206,810 (25,277,801 ) Issuance of common shares 60,000 2,289,624 — — — 2,349,624 Transaction costs — (47,735 ) — — — (47,735 ) Equity-settled share-based payments — — 6,044,356 — — 6,044,356 Balance as of December 31, 2022 5,364,452 282,552,633 36,635,564 (243,460,290 ) 7,257,080 88,349,440 InflaRx N.V. and subsidiaries Consolidated Statements of Cash Flows for the Years ended December 31, 2022, 2021 and 2020 in € 2022 2021 2020 Operating activities Loss for the Period (29,484,611 ) (45,630,059 ) (33,983,614 ) Adjustments for: Depreciation & amortization of property and equipment, right-of-use assets and intangible assets 596,597 669,434 712,713 Net finance income (2,753,255 ) (2,004,757 ) 40,810 Share-based payment expense 6,044,356 4,332,205 1,116,791 Net foreign exchange differences 385.359 111,606 (247,322 ) Other non-cash adjustments — — 3,436 Changes in: Financial assets from government grants (732,971 ) — — Other assets (3,308,485 ) (7,094,467 ) (1,554,611 ) Employee benefits (64,024 ) (3,290 ) 355,545 Other liabilities 9,403 19,863 8,960 Liabilities from government grants received (2,090,734 ) 8,300,000 — Trade and other payables (3,586,706 ) 316,112 (4,155,529 ) Interest received 1,287,200 1,070,235 1,201,547 Interest paid (44,946 ) (23,633 ) (26,387 ) Net cash used in operating activities (33,742,817 ) (39,936,751 ) (36,527,661 ) Investing activities Purchase of intangible assets and property and equipment (162,391 ) (37,778 ) (94,189 ) Purchase of non-current other financial assets — — — Purchase of current and non-current financial assets (64,474,543 ) (97,516,417 ) (101,600,176 ) Proceeds from the maturity of current financial assets 83,995,029 71,603,310 123,056,347 Net cash from/ (used in) investing activities 19,358,095 (25,950,885 ) 21,361,982 Financing activities Proceeds from issuance of common shares 2,349,624 65,142,549 9,770,944 Transaction costs from issuance of common shares (47,735 ) (4,219,222 ) (729,841 ) Proceeds from exercise of share options — 1,014,583 496,946 Repayment of lease liabilities (364,430 ) (360,644 ) (366,156 ) Net cash from/ (used in) financing activities 1,937,459 61,577,266 9,171,893 Net increase/(decrease) in cash and cash equivalents (12,447,262 ) (4,310,369 ) (5,993,786 ) Effect of exchange rate changes on cash and cash equivalents 2,462,622 4,591,683 (1,168,813 ) Cash and cash equivalents at beginning of period 26,249,995 25,968,681 33,131,280 Cash and cash equivalents at end of period 16,265,355 26,249,995 25,968,681 About Vilobelimab: Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has controlled the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. Vilobelimab has been shown to be well tolerated within clinical trials in different disease settings. Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG), severe COVID-19 and cutaneous squamous cell carcinoma (cSCC). The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx. About InflaRx N.V.: InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a and C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit . Contacts: InflaRx N.V.: Email: IR@inflarx.de MC Services AG Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 US: +1-339-832-0752 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the status of the Company’s EUA application for vilobelimab to treat critical COVID-19 and the FDA’s review of such application; the Company’s ongoing and planned pre-clinical development and clinical trials, including the development of vilobelimab in several indications; the Company’s interactions with regulators regarding the results of clinical trials, clinical trial design and potential regulatory approval pathways; the impact of the COVID-19 pandemic on the Company; the timing and its ability to commence and conduct clinical trials; potential results from current or potential future collaborations; its ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for its product candidates; its intellectual property position; its ability to develop commercial functions; expectations regarding clinical trial data; decisions regarding the strategic direction of the Company; its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which the Company operates; the trends that may affect the industry or the Company’s business; and the risks, uncertainties and other factors described under the heading “Risk Factors” in Company’s periodic filings with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.