InflaRx Reports Q1 2020 Financial & Operating Results
- End of Phase II meeting with the FDA scheduled to discuss the path forward for IFX-1 in Hidradenitis Suppurativa
- Initial promising results reported in Pyoderma Gangraenosum
- Part 1 of adaptive randomized trial in severe COVID-19 pneumonia fully enrolled
- Signed clinical collaboration agreement in oncology
- Cash, cash equivalents and financial assets of approximately €108.0 million as of March 31, 2020
JENA, Germany, May 21, 2020 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three months ended March 31, 2020.
“InflaRx continues to make progress with its clinical development programs for IFX-1 and recently reported encouraging initial results in Pyoderma Gangraenosum, the second neutrophil-driven devastating skin disease we are pursuing,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “With the upcoming scheduled FDA End of Phase II meeting for development in Hidradenitis Suppurativa, the Company is keeping a strong focus on potentially advancing into Phase III development in this disease.”
Prof. Riedemann continued, “We are currently analyzing results from the first 30 patients in our ongoing adaptive randomized COVID-19 pneumonia trial, which will serve as the basis for the decision to potentially continue into a confirmatory larger second part of the study.”
R&D highlights – Q1 2020
- IFX-1 in Hidradenitis Suppurativa (HS): In Q1 2020, the Company requested an End of Phase II meeting with the FDA to discuss the path forward for a pivotal program with IFX-1 in HS. The meeting has been scheduled for mid-year 2020.
- IFX-1 in Pyoderma Gangraenosum (PG): In February 2020, the Company announced positive initial data from the first 5 patients dosed in the ongoing Phase IIa open label study. Of these 5 initial patients dosed with IFX-1, 2 patients achieved complete closure of the target ulcer and complete healing of all other PG ulcers. Patients continue to enroll in higher dose groups.
- IFX-1 in ANCA-associated vasculitis (AAV): Part 1 of the European Phase II IXCHANGE study has been fully enrolled. After analyzing the impact of COVID-19 on the study, a blinded interim analysis of Part 1 has been completed. Based on the analysis, the Company intends to continue with Part 2 of the study but decrease the number of enrolled patients. Following a blinded interim analysis of the US Phase II IXPLORE study with IFX-1 in patients with AAV and an assessment of the potential impact of the COVID-19 pandemic, the Company has decided to stop the study and read out the existing results earlier than initially planned as part of a strategy to align and streamline the US and EU AAV development programs.
- IFX-1 in oncology: In Q1 2020, the Company entered into a clinical collaboration agreement (reported on April 29, 2020) to evaluate the combination of IFX-1 and a market leading anti-PD-1 therapy in patients with an undisclosed tumor type. Under the terms of the agreement, InflaRx will conduct a Phase IIa clinical study with two IFX-1 arms, including one with the anti-PD-1 therapy.
- IFX-1 in COVID-19 pneumonia: The Company initiated a Phase II clinical development program with IFX-1 in COVID-19 patients with severely progressed pneumonia. After all patients have been treated in the first part of the trial, an interim analysis will be performed to evaluate the clinical benefit of the treatment using the assessed clinical parameters in order to potentially initiate and adapt the confirmatory second part of the study. Part 1 was fully enrolled with 30 patients as of April 24, 2020.
Financial highlights - Q1 2020
Research and development expenses decreased by €0.4 million in the three months ended March 31, 2020 compared to the three months ended March 31, 2019. This decrease is primarily attributable to a €0.3 million decrease in expenses from non-cash share-based compensation.
General and administrative expenses decreased by €0.7 million to €2.6 million for the three months ended March 31, 2020, from €3.3 million for the three months ended March 31, 2019. This decrease is primarily attributable to a €0.9 million decrease in non-cash share-based compensation expense. Legal, consulting and other expenses increased by €0.1 million to €1.1 million for the three months ended March 31, 2020, from €1.0 million for the three months ended March 31, 2019.
Net financial result increased by €0.4 million to €1.5 million for the three months ended March 31, 2020, from €1.1 million for the three months ended March 31, 2019. This increase is mainly attributable to (a) higher foreign exchange gains, which increased by €0.8 million and (b) interest on marketable securities, which decreased by €0.4 million.
Net loss for the three months ended March 31, 2020 was €8.2 million or €(0.32) per common share, compared to €9.8 million or €(0.38) per common share for the three months ended March 31, 2019. On March 31, 2020, the Company’s total funds available were approximately €108.0 million, mostly composed of cash and cash equivalents (€21.1 million) and marketable securities (€86.3 million).
Net cash used in operating activities increased to €10.5 million for the three months ended March 31, 2020, from €8.5 million in the three months ended March 31, 2019, mainly due to the increase of cash expenses, such as third-party expenses for manufacturing and clinical trials for our lead program IFX-1 and higher personnel costs.
Additional information regarding these results is included in the notes to the consolidated financial statements as of March 31, 2020, as well as the financial statements as of December 31, 2019 in “ITEM 18. Financial statements,” which is included in InflaRx’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).
InflaRx N.V. and subsidiary
Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2020 and 2019
in € | 2020 (unaudited) | 2019 (unaudited) | |||
Operating Expenses | |||||
Research and development expenses | (7,298,799 | ) | (7,695,150 | ) | |
General and administrative expenses | (2,564,803 | ) | (3,301,166 | ) | |
Total Operating Expenses | (9,863,601 | ) | (10,996,316 | ) | |
Other income | 94,960 | 64,836 | |||
Other expenses | (5,720 | ) | (3,886 | ) | |
Operating Result | (9,774,362 | ) | (10,935,366 | ) | |
Finance income | 1,658,991 | 1,159,205 | |||
Finance expenses | (118,026 | ) | (61,710 | ) | |
Net Financial Result | 1,540,965 | 1,097,495 | |||
Loss for the Period | (8,233,397 | ) | (9,837,871 | ) | |
Share Information | |||||
Weighted average number of shares outstanding | 26,105,255 | 25,964,379 | |||
Loss per share (basic/diluted) | (0.32 | ) | (0.38 | ) | |
Loss for the Period | (8,233,397 | ) | (9,837,871 | ) | |
Other comprehensive income that may be reclassified to profit or loss in subsequent periods: | |||||
Exchange differences on translation of foreign currency | 1,713,868 | 2,317,546 | |||
Total Comprehensive Loss | (6,519,529 | ) | (7,520,325 | ) | |
InflaRx N.V. and subsidiary
Consolidated Statements of Financial Position as of March 31, 2020 and December 31, 2019
in € | 2020 (unaudited) | 2019 | |||
ASSETS | |||||
Non-current assets | |||||
Property, plant and equipment | 540,606 | 576,373 | |||
Right-of-use assets | 748,785 | 836,924 | |||
Intangible assets | 430,368 | 452,400 | |||
Non-current other assets | 445,403 | 452,217 | |||
Non-current financial assets | 272,718 | 272,614 | |||
Total non-current assets | 2,437,880 | 2,590,528 | |||
Current assets | |||||
Current other assets | 3,319,222 | 3,500,884 | |||
Current financial assets | 86,680,961 | 82,353,867 | |||
Cash and cash equivalents | 21,083,608 | 33,131,280 | |||
Total current assets | 111,083,791 | 118,986,031 | |||
TOTAL ASSETS | 113,521,671 | 121,576,558 | |||
EQUITY AND LIABILITIES | |||||
Equity | |||||
Issued capital | 3,132,631 | 3,132,631 | |||
Share premium | 211,006,606 | 211,006,606 | |||
Other capital reserves | 26,043,246 | 25,142,213 | |||
Accumulated deficit | (142,514,552 | ) | (134,362,006 | ) | |
Other components of equity | 3,860,246 | 2,227,228 | |||
Total equity | 101,528,177 | 107,146,673 | |||
Non-current liabilities | |||||
Lease liabilities | 245,478 | 330,745 | |||
Other non-financial liabilities | 39,148 | 39,013 | |||
Total non-current liabilities | 284,625 | 369,758 | |||
Current liabilities | |||||
Trade and other payables | 10,490,938 | 12,413,662 | |||
Lease liabilities | 513,374 | 515,203 | |||
Employee Benefits | 571,960 | 975,629 | |||
Social securities, other tax and non-financial liabilities | 108,221 | 105,634 | |||
Provisions | 24,374 | 50,000 | |||
Total current liabilities | 11,708,869 | 14,060,128 | |||
Total Liabilities | 11,993,494 | 14,429,886 | |||
TOTAL EQUITY AND LIABILITIES | 113,521,671 | 121,576,558 | |||
InflaRx N.V. and subsidiary
Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2020 and 2019
in € | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other components of equity | Total equity | |||||||
Balance at 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 | — | — | — | (8,233,397 | ) | — | (8,233,397 | ) | |||||
Exchange differences on translation of operations in foreign currency | — | — | — | — | 1,713,868 | 1,713,868 | |||||||
Total comprehensive loss | — | — | — | (8,233,397 | ) | 1,713,868 | (6,519,529 | ) | |||||
Transactions with owners of the Company | |||||||||||||
Contributions | |||||||||||||
Equity-settled share-based payment | — | — | 901,033 | — | — | 901,033 | |||||||
Total Contributions | — | — | 901,033 | — | — | 901,033 | |||||||
Total transactions with owners of the Company | — | — | 901,033 | — | — | 901,033 | |||||||
Balance at March 31, 2020* | 3,132,631 | 211,006,606 | 26,043,246 | (142,595,403 | ) | 3,941,097 | 101,528,177 | ||||||
Balance at January 1, 2019 | 3,115,725 | 211,021,835 | 18,310,003 | (81,107,188 | ) | 50,196 | 151,390,571 | ||||||
Loss for the period | — | — | — | (9,837,871 | ) | — | (9,837,871 | ) | |||||
Exchange differences on translation of operations in foreign currency | — | — | — | — | 2,317,546 | 2,317,546 | |||||||
Total comprehensive loss | — | — | — | (9,837,871 | ) | 2,317,546 | (7,520,325 | ) | |||||
Transactions with owners of the Company | |||||||||||||
Contributions | |||||||||||||
Equity-settled share-based payment | — | — | 2,097,780 | — | — | 2,097,780 | |||||||
Total Contributions | 2,097,780 |
By: GlobeNewswire
- 21 May 2020
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