- Fast Track and Orphan Drug designation for vilobelimab in pyoderma gangrenosum (PG) granted by the FDA
- Plans to submit EUA with the FDA for vilobelimab in critically ill COVID-19 patients announced
- Grant income of €14.4 million realized during the second quarter
- Cash, cash equivalents and marketable securities of €91.8 million, expected to finance operations until year-end 2024
JENA, Germany, Aug. 05, 2022 (GLOBE NEWSWIRE) -- 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 three and six months ended June 30, 2022. “We have made strong progress in recent months in advancing our strategy for vilobelimab,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Following positive Phase IIa data and productive discussions with the FDA, we are finalizing the design of our Phase III trial in PG. Our discussions with the FDA related to vilobelimab for the treatment of critically ill, invasively mechanically ventilated COVID-19 patients following the results from our Phase III trial were encouraging. Based on this, we are preparing to apply for emergency use authorization in the U.S. and expect to complete the submission by the end of the third quarter this year. We are also looking forward to further discussing in greater detail our vilobelimab results in critically ill COVID-19 patients with the regulatory agencies in Europe to understand next steps towards a potential submission for marketing authorization. It is a busy time at InflaRx, and we are excited to be moving our programs forward with the goal of ultimately helping patients in need of more effective treatments." Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “We are well financed to follow through with the next steps of our development programs after sharpening our strategic focus, which we announced in May. We are also grateful for the grant of up to €43.7 million from the German federal government for the clinical development of vilobelimab in COVID-19 and the development of the manufacturing process of vilobelimab. Through this strong backing and our focused development strategy, we believe that we have been able to significantly extend our cash runway to YE 2024 in this challenging market environment.” Recent Corporate and R&D Highlights Development of Vilobelimab in Pyoderma Gangrenosum (PG):
InflaRx recently reported that vilobelimab was granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In addition, the Company had a productive End-of-Phase II meeting with the FDA related to its plans for a Phase III development program in PG. The FDA indicated its support for a randomized, controlled Phase III development program during the meeting and offered to review the study protocol, recognizing PG as a serious and rare condition. Based on the FDA’s feedback and recommendations, InflaRx is now finalizing the design for a Phase III trial and continues to be in dialogue with the FDA related to this. Moreover, the FDA has granted Fast Track designation for the development of vilobelimab for the treatment of ulcerative PG. The Company had submitted a request for Fast Track designation to the FDA on the basis of previously reported positive outcome data from its Phase IIa open-label dose-escalation study in PG. Development of Vilobelimab in Critically Ill COVID-19 Patients:
InflaRx recently announced its plans to submit a request for emergency use authorization (EUA) following encouraging interactions with the FDA at a recently held Type B meeting. As previously announced, the Company had requested the meeting to discuss a potential EUA submission and the development of its first-in-class anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients. In the meeting with the FDA, the Company discussed in detail the completed Phase III part of the PANAMO study and obtained guidance from the agency on deliverables related to its planned submission for EUA. InflaRx committed to submitting the request for an EUA by the end of the third quarter 2022 and is dedicated to achieving that ambitious goal. The Company had previously announced encouraging topline 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. The primary efficacy endpoint was 28-day all-cause mortality. In this trial, vilobelimab treatment resulted in a 23.9% relative reduction in 28-day all-cause mortality compared to the placebo arm in the global data set (n=368 patients). A pre-specified analysis of patients from Western European countries (n=209) showed a 43% relative reduction in 28-day all-cause mortality in the vilobelimab treatment arm compared to placebo. Development of Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC):
In 2021, InflaRx started treating patients in 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. To date, InflaRx has recruited nine patients in Arm A of this study (vilobelimab alone). Interim clinical data are expected in the second half of 2022. Arm B of this study (vilobelimab plus pembrolizumab) has enrolled nine patients so far in the first two dose groups. The interim analysis of Arm B is expected once ten patients treated at the dose level recommended by the independent Steering Committee are evaluable for response assessment. These data, which are required to move to the second stage of the Phase II trial, are expected to be available in the second half of 2023. INF904 – Small Molecule C5aR Inhibitor:
InflaRx expects to initiate a Phase I program in the second half of 2022 and plans to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients. Financial Highlights – Q2 2022 Research and Development Expenses Research and development expenses incurred for the six months ended June 30, 2022 increased compared to the corresponding period in 2021 by €5.4 million to €21.7 million. This increase was primarily due to higher expenses for the Phase III part of the COVID-19 trial as well as costs for manufacturing development activities and was driven by an overall increase in third-party expenses of €4.3 million. General and Administrative Expenses General and administrative expenses increased by €3.0 million to €8.7 million for the six months ended June 30, 2022, from €5.7 million for the six months ended June 30, 2021. This increase is primarily attributable to higher expenses associated with equity-settled share-based compensation recognized in personnel expenses. Furthermore, legal, consulting and other expenses increased by €2.0 million to €4.2 million for the six months ended June 30, 2022, from €2.2 million, mainly due to consulting, implementation and testing costs of the internal control over financial reporting (ICFR) environment. Other income Other income for the six months ended June 30, 2022 amounted to €14.4 million. This was attributable to income recognized 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 Net financial result increased by €1.4 million to €2.4 million for the six months ended June 30, 2022, from €1.0 million for the six months ended June 30, 2021. This increase was mainly attributable to lower foreign exchange losses which decreased by €1.4 million. Net Loss Net loss for the six months ended June 30, 2022 was €13.5 million, compared to €20.9 million for the six months ended June 30, 2021. Net Cash Used in Operating Activities Net cash used in operating activities increased by €7.1 million to €25.4 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021, during which net cash used in operating activities was €18.3 million. Cash, Cash Equivalents and Marketable Securities On June 30, 2022, the Company’s total funds available were approximately €91.8 million, composed of cash and cash equivalents of €15.4 million and marketable securities of €76.4 million. These funds are expected to finance operations until year-end 2024. Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of June 30, 2022, and the three and six months ended June 30, 2022 and 2021, as well as the consolidated financial statements as of and for the year ended December 31, 2021 in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2021 as filed with the U.S. Securities and Exchange Commission (SEC).
InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2022 and 2021 | | For the three months ended
June 30,
| | For the six months ended
June 30,
| | (in €, except for share data) | 2022
(unaudited)
| | 2021
(unaudited)
| | 2022
(unaudited)
| | 2021
(unaudited)
| | | | | | | | Operating Expenses | | | | | | 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 | | | Other expenses | (279 | ) | | (279 | ) | | (844 | ) | | (844 | ) | | Operating Result | (1,086,661 | ) | | (13,982,172 | ) | | (15,944,999 | ) | | (21,906,498 | ) | | Finance income | 82,401 | | | 35,622 | | | 110,362 | | | 58,584 | | | Finance expenses | (7,945 | ) | | (3,050 | ) | | (32,531 | ) | | (6,734 | ) | | Foreign exchange result | 1,563,580 | | | (826,303 | ) | | 2,291,513 | | | 905,367 | | | Other financial result | (86,000 | ) | | (5,000 | ) | | 39,000 | | | 43,000 | | | Income Taxes | — | | | — | | | — | | | — | | | Income (Loss) for the Period | 465,376 | | | (14,780,903 | ) | | (13,536,654 | ) | | (20,906,280 | ) | | | | | | | | Share Information | | | | | | Weighted average number of shares outstanding | 44,203,763 | | | 44,186,279 | | | 44,203,763 | | | 39,024,533 | | | Income (Loss) per share (basic/diluted) | 0.01 | | | (0.33 | ) | | (0.31 | ) | | (0.54 | ) | | | | | | | | Loss for the Period | 465,376 | | | (14.780.903 | ) | | (13,536,654 | ) | | (20,906,280 | ) | | Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | | | | | | Exchange differences on translation of foreign currency | 4,408,940 | | | (1,427,302 | ) | | 5,718,815 | | | 2,077,397 | | | Total Comprehensive Income (Loss) | 4,874,316 | | | (16,208,205 | ) | | (7,817,839 | ) | | (18,828,883 | ) | | | | | | |
InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2022 and December 31, 2021 | in € | June 30, 2022
(unaudited) | | | December 31, 2021
| | | | | | | ASSETS | | | | Non-current assets | | | | Property and equipment | 231,133 | | | 274,373 | | | Right-of-use assets | 1,506,039 | | | 1,408,078 | | | Intangible assets | 187,218 | | | 235,216 | | | Other assets | 341,666 | | | 336,566 | | | Financial assets | 237,412 | | | 27,206,990 | | | Total non-current assets | 2,503,468 | | | 29,461,224 | | | Current assets | | | | Current other assets | 10,130,597 | | | 10,983,458 | | | Current tax assets | 1,518,072 | | | 1,282,177 | | | Financial assets from government grants | 8,260,503 | | | — | | | Other financial assets | 76,804,249 | | | 57,162,266 | | | Cash and cash equivalents | 15,416,152 | | | 26,249,995 | | | Total current assets | 112,129,573 | | | 95,677,896 | | | TOTAL ASSETS | 114,633,041 | | | 125,139,120 | | | | | | | EQUITY AND LIABILITIES | | | | Equity | | | | Issued capital | 5,304,452 | | | 5,304,452 | | | Share premium | 280,310,744 | | | 280,310,744 | | | Other capital reserves | 35,259,689 | | | 30,591,209 | | | Accumulated deficit | (227,512,333 | ) | | (213,975,679 | ) | | Other components of equity | 8,769,086 | | | 3,050,270 | | | Total equity | 102,131,638 | | | 105,280,996 | | | Non-current liabilities | | | | Lease liabilities | 1,170,237 | | | 1,066,354 | | | Other liabilities | 37,733 | | | 35,019 | | | Total non-current liabilities | 1,207,970 | | | 1,101,373 | | | Current liabilities | | | | Trade and other payables | 7,912,503 | | | 8,574,244 | | | Liabilities from government grants received | 2,145,135 | | | 8,300,000 | | | Lease liabilities | 370,153 | | | 366,171 | | | Employee benefits | 735,304 | | | 1,378,130 | | | Other financial liabilities | 130,338 | | | 138,206 | | | 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 | | | | | |
InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2022 and 2021 | (in €, except for share data) | Issued
capital | | Share
premium | | | Other
capital
reserves | | Accumulated
deficit | | | Other
components
of equity | | | Total
equity | | | | | | | | | | | | | | | | | | | | Balance as of January 1, 2022 | 5,304,452 | | 280,310,744 | | | 30,591,209 | | (213,975,679 | ) | | 3,050,271 | | | 105,280,996 | | | Loss for the period | — | | — | | | — | | (13,536,654 | ) | | <
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