Full Press Release Details
InflaRx Reports Full Year 2019 Financial & Operating Results
Jena, Germany, 29 April 2020 - InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the
complement system, announced today financial results for the year ending December 31, 2019.
"The Company underwent significant changes in 2019 and has selected a compelling set of high unmet medical need indications for its lead drug candidate IFX-1," said Prof. Niels C. Riedemann, Chief
Executive Officer and Founder of InflaRx. "The Company has also provided new evidence supporting the activity of IFX-1 in neutrophil-driven skin diseases, which continue to be a clear focus. With our current cash position and future value inflection
points, we believe InflaRx is well positioned to weather the current global environment."
Prof. Riedemann continued, "With the recently initiated trial in severe progressed COVID-19 pneumonia, our Company is making a strong contribution to help identify potential treatment options for
patients during this global pandemic, which is based on several years of in-house research on the role of C5a-driven lung injury and viral pneumonia."
Corporate and R&D highlights - 2019 through early 2020
Lead product candidate, IFX-1, first-in-class anti-human complement factor C5a antibody
Hidradenitis Suppurativa (HS)
1 HiSCR response defined as: At least a 50% reduction in total AN count (abscesses & inflammatory nodules) with no increase in the number of abscesses from baseline and no increase in the number of
draining fistulas from baseline
ANCA-associated vasculitis (AAV)
Pyoderma Gangraenosum (PG)
2019 financial highlights
Research and development expenses increased by 19.6 million to 44.6 million in 2019, from 25.0 million in 2018. This increase was primarily attributable to a 20.9 million
increase in clinical research and manufacturing organizations (CRO and CMO) costs related to IFX-1 in connection with the Phase IIb clinical trial in patients with HS, the Phase II clinical program in patients with AAV,
the Phase II clinical program in patients with PG, the preparation of a Phase II clinical program in oncology as well as with the ongoing manufacturing activities for clinical trial-related material. In addition, there was a 1.8 million decrease in
employee-related costs mainly due to a 2.6 million anticipated decrease in expenses related to non-cash share-based compensation.
General and administrative expenses decreased by 0.3 million to 12.5 million in 2019, from 12.8 million in 2018. This decrease was primarily
attributable to a 1.6 million decrease in employee-related costs associated with a 2.6 million anticipated decrease in non-cash share-based compensation, partially offset by 1.0 million
higher personnel expense due to new hires. Legal, consulting and audit fees and other expenses increased by 0.2 million to 2.2 million in 2019, from 2.0 million in 2018, the increase being mainly attributable to higher consulting costs. The
increase in other expenses of 1.1 million is primarily related to higher D&O insurance costs, IT and office expenses.
Net financial result decreased by 4.2 million to 3.5 million in 2019, from 7.7 million in 2018. This change was mainly attributable to lower foreign exchange gains, which decreased by 4.8 million, partially offset by interest on marketable securities, which increased by 0.6 million.
Net loss for the year 2019 was 53.3 million or 2.05 per common share, compared to 29.8 million or 1.19 per common share for the year 2018. On December 31, 2019, the
Company's total funds available were 115.8 million, mostly composed of cash and cash equivalents ( 33.1 million) and marketable securities ( 81.9 million).
Net cash used in operating activities increased to 43.2 million in 2019, from 21.5 million in 2018, mainly due to the increase in research and development expenditures and
higher personnel costs, excluding stock-based compensation.
Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2019 and "ITEM 18. Financial statements," which will be included in InflaRx's Annual
Report on Form 20-F as filed with the U.S. Securities and Exchange Commission on April 29, 2020.
InflaRx N.V. and subsidiary
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2019, 2018 and 2017
| in | 2019 | 2018 | 2017 | |||||||||
| Operating Expenses | ||||||||||||
| Research and development expenses | (44,582,136 | ) | (25,028,554 | ) | (14,414,628 | ) | ||||||
| General and administrative expenses | (12,501,048 | ) | (12,786,869 | ) | (5,138,498 | ) | ||||||
| Total Operating Expenses | (57,083,184 | ) | (37,815,422 | ) | (19,553,126 | ) | ||||||
| Other income | 400,253 | 303,860 | 115,525 | |||||||||
| Other expenses | (85,242 | ) | (4,802 | ) | (7,644 | ) | ||||||
| Operating Result | (56,768,173 | ) | (37,516,364 | ) | (19,445,245 | ) | ||||||
| Finance income | 6,220,320 | 10,432,695 | 130,032 | |||||||||
| Finance expenses | (2,706,964 | ) | (2,730,964 | ) | (4,922,535 | ) | ||||||
| Net Financial Result | 3,513,355 | 7,701,731 | (4,792,503 | ) | ||||||||
| Loss for the Period | (53,254,817 | ) | (29,814,634 | ) | (24,237,748 | ) | ||||||
| Share Information | ||||||||||||
| Weighted average number of shares outstanding | 26,004,519 | 25,095,027 | 9,410,524 | |||||||||
| Loss per share in euro (basic/diluted) | (2.05 | ) | (1.19 | ) | (2.58 | ) | ||||||
| Loss for the Period | (53,254,817 | ) | (29,814,634 | ) | (24,237,748 | ) | ||||||
| Other comprehensive income that may be re-clas-si-fied to profit or loss in subsequent periods: | ||||||||||||
| Exchange differences on translation of operations in foreign currency | 2,177,033 | 50,196 | - | |||||||||
| Total Comprehensive Loss | (51,077,785 | ) | (29,764,438 | ) | (24,237,748 | ) |
InflaRx N.V. and subsidiary
Consolidated Statements of Financial Position as of December 31, 2019 and 2018
| in | 2019 | 2018 | ||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 1,413,297 | 624,668 | ||||||
| Intangible assets | 452,400 | 222,866 | ||||||
| Non-current other non-financial assets | 452,217 | - | ||||||
| Non-current financial assets | 272,614 | 207,444 | ||||||
| Total non-current assets | 2,590,528 | 1,054,979 | ||||||
| Current assets | ||||||||
| Current other non-financial assets | 3,500,884 | 1,588,702 | ||||||
| Current financial assets | 82,353,867 | 101,184,240 | ||||||
| Cash and cash equivalents | 33,131,280 | 55,386,240 | ||||||
| Total current assets | 118,986,031 | 158,159,183 | ||||||
| TOTAL ASSETS | 121,576,558 | 159,214,161 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 3,132,631 | 3,115,725 | ||||||
| Share premium | 211,006,606 | 211,021,835 | ||||||
| Other capital reserves | 25,142,213 | 18,310,003 | ||||||
| Accumulated deficit | (134,362,006 | ) | (81,107,188 | ) | ||||
| Other components of equity | 2,227,228 | 50,196 | ||||||
| Total equity | 107,146,673 | 151,390,571 | ||||||
| Non-current liabilities | ||||||||
| Lease liabilities | 330,745 | - | ||||||
| Provisions and Government grants | 39,013 | 67,945 | ||||||
| Total non-current liabilities | 369,758 | 67,945 | ||||||
| Current liabilities | ||||||||
| Lease liabilities | 515,203 | - | ||||||
| Employee Benefits | 975,629 | 789,800 | ||||||
| Social securities, other tax and non-financial liabilities | 105,634 | 308,533 | ||||||
| Trade and other payables | 12,413,662 | 6,657,312 | ||||||
| Provisions | 50,000 | - | ||||||
| Total current liabilities | 14,060,128 | 7,755,645 | ||||||
| Total Liabilities | 14,429,886 | 7,823,590 | ||||||
| TOTAL EQUITY AND LIABILITIES | 121,576,558 | 159,214,161 |
InflaRx N.V. and subsidiary
Consolidated Statements of Changes in Shareholders' Equity for the Years Ended December 31, 2019, 2018 and 2017
| in | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other components of equity | Total equity | ||||||||||||||||||
| Balance at January 1, 2017 | 31,428 | - | 1,325,006 | (27,054,806 | ) | 8,839 | (25,689,533 | ) | ||||||||||||||||
| Loss for the Period | - | - | - | (24,237,748 | ) | - | (24,237,748 | ) | ||||||||||||||||
| Exchange differences on translation of operations in foreign currency | - | - | - | - | - | - | ||||||||||||||||||
| Total Comprehensive Loss | - | - | - | (24,237,748 | ) | - | (24,237,748 | ) | ||||||||||||||||
| Transactions with owners of the Company | ||||||||||||||||||||||||
| Contributions | ||||||||||||||||||||||||
| Issue of common shares | 848,175 | 90,055,312 | - | - | - | 90,903,488 | ||||||||||||||||||
| Transaction costs | - | (9,114,770 | ) | - | - | - | (9,114,770 | ) | ||||||||||||||||
| Equity-settled share-based payment | - | - | 4,550,105 | - | - | 4,550,105 | ||||||||||||||||||
| Total Contributions | 848,175 | 80,940,542 | 4,550,105 | - | - | 86,338,823 | ||||||||||||||||||
| Changes in ownership interests | ||||||||||||||||||||||||
| Reorganization | 1,977,849 | 80,698,025 | 350,242 | - | - | 83,026,115 | ||||||||||||||||||
| Liquidation of a Subsidiary | - | - | - | - | (8,839 | ) | (8,839 | ) | ||||||||||||||||
| Total changes in ownership interests | 1,977,849 | 80,698,025 | 350,242 | - | (8,839 | ) | 83,017,276 | |||||||||||||||||
| Total transactions with owners of the Company | 2,826,024 | 161,638,566 | 4,900,347 | - | (8,839 | ) | 169,356,099 | |||||||||||||||||
| Balance at December 31, 2017 | 2,857,452 | 161,638,566 | 6,225,353 | (51,292,555 | ) | - | 119,428,816 | |||||||||||||||||
| Loss for the period | - | - | - | (29,814,634 | ) | - | (29,814,634 | ) | ||||||||||||||||
| Exchange differences on translation of operations in foreign currency | - | - | - | - | 50,196 | 50,196 | ||||||||||||||||||
| Total comprehensive loss | - | - | - | (29,814,634 | ) | 50,196 | (29,764,438 | ) | ||||||||||||||||
| Transactions with owners of the Company | ||||||||||||||||||||||||
| Contributions | ||||||||||||||||||||||||
| Issue of common shares | 222,000 | 52,768,733 | - | - | - | 52,990,733 | ||||||||||||||||||
| Transaction costs | - | (3,801,265 | ) | - | - | - | (3,801,265 | ) | ||||||||||||||||
| Equity-settled share-based pay-ment | - | - | 12,084,651 | - | - | 12,084,651 | ||||||||||||||||||
| Share options exercised | 36,273 | 415,801 | - | - | - | 452,074 | ||||||||||||||||||
| Total Contributions | 258,273 | 49,383,269 | 12,084,651 | - | - | 61,726,193 | ||||||||||||||||||
| Total transactions with own-ers of the Company | 258,273 | 49,383,269 | 12,084,651 | - | - | 61,726,193 | ||||||||||||||||||
| Balance at December 31, 2018 | 3,115,725 | 211,021,835 | 18,310,003 | (81,107,188 | ) | 50,196 | 151,390,571 | |||||||||||||||||
| Loss for the period | - | - | - | (53,254,817 | ) | - | (53,254,817 | ) | ||||||||||||||||
| Exchange differences on translation of operations in foreign currency | - | - | - | - | 2,177,033 | 2,177,033 | ||||||||||||||||||
| Total comprehensive loss | - | - | - | (53,254,817 | ) | 2,177,033 | (51,077,784 | ) | ||||||||||||||||
| Transactions with owners of the Company | ||||||||||||||||||||||||
| Contributions | ||||||||||||||||||||||||
| Equity-settled share-based pay-ment | - | - | 6,832,210 | - | - | 6,832,210 | ||||||||||||||||||
| Share options exercised | 16,905 | (15,229 | ) | - | - | - | 1,676 | |||||||||||||||||
| Total Contributions | 16,905 | (15,229 | ) | 6,832,210 | - | - | 6,833,886 | |||||||||||||||||
| Total transactions with owners of the Company | 16,905 | (15,229 | ) | 6,832,210 | - | - | 6,833,886 | |||||||||||||||||
| Balance at December 31, 2019 | 3,132,631 | 211,006,606 | 25,142,213 | (134,362,006 | ) | 2,227,228 | 107,146,673 |
InflaRx N.V. and subsidiary
Consolidated Statements of Cash Flows for the Years ended December 31, 2019, 2018 and 2017
| in | 2019 | 2018 | 2017 | |||||||||
| Operating activities | ||||||||||||
| Loss for the period | (53,254,817 | ) | (29,814,634 | ) | (24,237,748 | ) | ||||||
| Adjustments for: | ||||||||||||
| Depreciation & Amortization | 663,166 | 173,630 | 70,910 | |||||||||
| Net Financial Result | (3,513,355 | ) | (7,701,731 | ) | 4,792,503 | |||||||
| Share based payment expense | 6,832,210 | 12,084,651 | 4,550,105 | |||||||||
| Other non-cash adjustments | (307,849 | ) | 196,699 | 24,076 | ||||||||
| Changes in: | ||||||||||||
| Other non-financial assets | (2,364,399 | ) | (893,602 | ) | (522,818 | ) | ||||||
| Current financial assets | - | (316,112 | ) | 89,599 | ||||||||
| Employee benefits | 235,500 | 494,837 | 132,305 | |||||||||
| Social securities, other tax and non-financial liabilities | (209,948 | ) | 304,627 | (30,024 | ) | |||||||
| Trade and other payables | 5,734,795 | 2,243,137 | 2,912,740 | |||||||||
| Interest received | 3,001,109 | 1,679,250 | 66,391 | |||||||||
| Interest paid | (20,903 | ) | - | - | ||||||||
| Net cash flows from operating activities | (43,204,492 | ) | (21,549,248 | ) | (12,151,962 | ) | ||||||
| Investing activities | ||||||||||||
| Cash outflow from the purchase of intangible assets, laboratory and office equipment | (594,889 | ) | (806,531 | ) | (148,542 | ) | ||||||
| Cash outflow for the investment in non-current other financial assets | (75,543 | ) | (209,705 | ) | (18,481 | ) | ||||||
| Proceeds from the disposal of non-current other financial assets | - | 21,811 | - | |||||||||
| Proceeds from the disposal of current financial assets or repayment of maturing securities | 103,559,395 | 7,990,204 | - | |||||||||
| Purchase of current & non-current financial assets | (82,547,409 | ) | (106,445,120 | ) | - | |||||||
| Net cash flows from investing activities | 20,341,554 | (99,451,341 | ) | (167,023 | ) | |||||||
| Financing activities | ||||||||||||
| Proceeds from issuance of share capital | - | 52,990,733 | 90,903,488 | |||||||||
| Transaction cost from issuance of share capital | - | (3,801,265 | ) | (9,114,770 | ) | |||||||
| Proceeds from exercise of share options | 1,676 | 452,075 | - | |||||||||
| Proceeds from issuance of preferred shares | - | - | 27,012,050 | |||||||||
| Repayment of leasing debt | (296,020 | ) | - | - | ||||||||
| Net cash flows from financing activities | (294,344 | ) | 49,641,542 | 108,800,767 | ||||||||
| Effect of exchange rate changes | 902,321 | 3,461,399 | (2,316,631 | ) | ||||||||
| Net change in cash and cash equivalents | (22,254,960 | ) | (71,357,047 | ) | 94,165,152 | |||||||
| Cash and cash equivalents at beginning of period | 55,386,240 | 123,281,888 | 29,116,737 | |||||||||
| Cash and cash equivalents at end of period | 33,131,280 | 55,386,240 | 123,281,888 |
IFX-1 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, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response
driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people
have been treated with IFX-1 in clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum
and COVID-19 pneumonia.
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement
C5a is a powerful inflammatory mediator 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 www.inflarx.com.
Jordan Zwick - Global Head of Business Development & Corporate Strategy
Email: jordan.zwick[at]inflarx.de
Tel: +1 917-338-6523
Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: inflarx[at]mc-services.eu
Europe: +49 89-210 2280
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," "estimate," "believe," "predict," "potential" or "continue" and similar expressions. Forward-looking statements appear in a number of places throughout this release and may
include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the impact of the COVID-19 pandemic
on the Company, the timing and our ability to commence and conduct clinical trials, potential results from current or potential future collaborations, our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and
maintain regulatory approvals for our product candidates, our intellectual property position, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition,
liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading "Risk Factors" in InflaRx'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 our 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 we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.