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
- 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 | — | — | 2,097,780 | |||||||||
| Total transactions with owners of the Company | — | — | 2,097,780 | — | — | 2,097,780 | |||||||
| Balance at March 31, 2019* | 3,115,725 | 211,021,835 | 20,407,783 | (90,945,059 | ) | 2,367,742 | 145,968,026 | ||||||
| * unaudited | |||||||||||||
InflaRx N.V. and subsidiary
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2020 and 2019
| in € | 2020 (unaudited) | 2019 (unaudited) | |||
| Operating activities | |||||
| Loss for the period | (8,233,397 | ) | (9,837,871 | ) | |
| Adjustments for: | |||||
| Depreciation & Amortization of property, plant, equipment, right-of-use assets and intangible assets | 182,356 | 116,519 | |||
| Net financial result | (1,540,965 | ) | (1,097,495 | ) | |
| Share-based payment expense | 901,033 | 2,097,780 | |||
| Other non-cash adjustments | (129,122 | ) | 81,346 | ||
| Changes in: | |||||
| Other assets | 188,476 | (581,651 | ) | ||
| Employee benefits | (428,526 | ) | (333,864 | ) | |
| Social securities, other current non-financial liabilities | 1,953 | 457,497 | |||
| Trade and other payables | (1,922,724 | ) | 364,158 | ||
| Interest received | 462,342 | 241,817 | |||
| Interest paid | (2,246 | ) | (6,682 | ) | |
| Net cash flows from operating activities | (10,520,819 | ) | (8,498,447 | ) | |
| Investing activities | |||||
| Purchase of intangible assets, laboratory and office equipment | (27,686 | ) | (254,316 | ) | |
| Purchase of current financial assets | (23,412,469 | ) | (10,599 | ) | |
| Disposal of current financial assets | — | 3,088 | |||
| Securities matured | 20,724,386 | — | |||
| Net cash flows from investing activities | (2,715,769 | ) | (261,827 | ) | |
| Financing activities | |||||
| Repayment of leasing liabilities | (88,339 | ) | (54,781 | ) | |
| Net cash flows from financing activities | (88,339 | ) | (54,781 | ) | |
| Net (decrease)/increase in cash and cash equivalents | (13,324,927 | ) | (8,815,054 | ) | |
| Effect of exchange rate changes on cash and cash equivalents | 1,277,255 | 592,005 | |||
| Cash and cash equivalents at beginning of period | 33,131,280 | 55,386,240 | |||
| Cash and cash equivalents at end of period | 21,083,608 | 47,163,191 | |||
About IFX-1:
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.
About InflaRx N.V.:
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.
Contacts:
InflaRx N.V.
Jordan Zwick – Global Head of Business Development & Corporate Strategy
Email: jordan.zwick[at]inflarx.de
Tel: +1 917-338-6523
MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: inflarx[at]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 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 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.
