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Jena, Germany, 28 March 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the year ended December 31, 2018.
“2018 was marked by significant progress for InflaRx in both our business and clinical operations,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Importantly, we completed enrollment of our Phase IIb trial with IFX-1 in Hidradenitis Suppurativa, from which we will report top-line results in the second quarter of 2019, and also initiated a Phase II trial in ANCA-associated vasculitis. We are continuing to execute our clinical development plans in 2019 as well, as evidenced by the recent initiation of our Phase IIa study in Pyoderma Gangraenosum.”
Prof. Riedemann continued, “In addition to our pipeline progress, the Company experienced significant corporate growth in the past year by recruiting highly qualified directors to our board, opening our new R&D facility in the U.S. to support future innovation, and recruiting experienced executives to help us take InflaRx forward through 2019 and beyond. I am quite pleased with our team’s ability to execute on our core milestones of the past year and look forward to reporting on this continued progress in the months to come.”
Corporate and drug development highlights – 2018 through early 2019
Corporate
Lead product candidate, IFX-1, first-in-class anti-human complement factor C5a antibody
Hidradenitis Suppurativa (HS)
ANCA-associated vasculitis (AAV).
2018 financial highlights
Cash and cash equivalents plus securities and other investments. As of December 31, 2018, InflaRx had cash and cash equivalents and securities and other investments of €156.6 million, compared to €123.3 million at the end of 2017. This increase in funds of approximately €33.3 million was primarily attributable to the completion of InflaRx’s follow-on offering of common shares in May 2018. Cash and cash equivalents totaled €55.4 million as of December 31, 2018 (December 31, 2017: €123.3 million). Additionally, current financial assets totaled €101.2 million compared to €0 as of December 31, 2017.
Net cash used in operating activities increased to €23.7 million in 2018, from €12.2 million in 2017, mainly due to higher cash expenses for research and development, such as third-party expenses for manufacturing and clinical trials attributable to InflaRx’ lead program IFX-1 and personnel expenses.
Research and development expenses increased by €10.6 million to €25.0 million in 2018, compared to €14.4 million in 2017. This increase is primarily attributable to a €7.1 million increase in CRO and CMO expenses for IFX-1 in connection with preparation to commence the clinical trial Phase IIb in patients with HS and the Phase II clinical program in patients with AAV, as well as with the ongoing manufacturing activities for clinical trial material for these clinical trials with IFRX-1 and to a €3.4 million increase in employee-related costs associated with salaries, bonus, benefits and non-cash share-based compensation.
General and administrative expenses amounted to €12.8 million in 2018, an increase of €7.7 million from €5.1 million in 2017. This was primarily attributable to a €6.2 million increase in employee-related costs associated with salaries, bonus, benefits and non-cash share-based compensation. Legal, consulting and audit fees and other expenses increased by €0.5 million, which is mainly attributable to expenses incurred in connection with the follow on offering of common shares in May 2018.
Net financial result was €7.7 million, up by €12.5 million compared to a net financial loss of €4.8 million in 2017, mainly due to net foreign exchange gains. Large portions of InflaRx’ funds are held in U.S. dollars and the dollar improved compared to the euro during 2018.
Loss for the period 2018 was €29.8 million or €1.2 per common share (basic and diluted), compared to €24.2 million or €2.6 per common share (basic and diluted) for 2017.
Additional information regarding these results is included in the notes to the consolidated financial statements as of and for the year ended December 31, 2018 and “ITEM 18. Financial statements”, which will be included in InflaRx’ Annual Report on Form 20-F as filed with the SEC.
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2018 and 2017
(in thousands of €, except for per share data)
Operating Expenses
Research and development expenses
(14,415)
(25,028)
General and administrative expenses
(5,138)
(12,787)
Total Operating Expenses
(19,553)
(37,815)
Other income
116
304
Other expenses
(8)
(5)
Operating Result
(19,445)
(37,516)
Finance income
130
10,433
Finance expenses
(4,923)
(2,731)
Net financial Result
(4,793)
7,702
Loss for the period
(24,238)
(29,815)
Share information
Weighted average number of shares outstanding
9,411
25,095
Loss per share in euro (basic/diluted)
€ (2.60)
€ (1.19)
Loss for the period
(24,238)
(29,815)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
Exchange differences on translation of foreign operations
0
51
Total comprehensive loss
(24,238)
(29,764)
Consolidated Statements of Financial Position as of December 31, 2018 and 2017
(in thousands of €)
Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2018 and 2017
Consolidated Statements of Cash Flows for the Years ended December 31, 2018 and 2017
(in thousands of €)
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 and has, to date, successfully completed three clinical Phase II studies. More than 150 people have been treated with IFX-1 in these completed clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various inflammatory indications, including Hidradenitis Suppurativa and ANCA-associated vasculitis.
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 and New York, NY, USA. For further information please visit www.inflarx.com.
Contacts:
Investor Relations
InflaRx N.V.
Jordan Silverstein
Head of Corporate Development and Strategy
jordan.silverstein[at]inflarx.de
+1 917-837-1709
Media Relations
MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer
inflarx[at]mc-services.eu
+49 89 210 228 0
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,” “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 timing of and our ability to make regulatory filings 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.