Jena, Germany, 14 August 2019 – InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported financial and operating results for the second quarter ended June 30, 2019.
On June 5, 2019, InflaRx had announced the top-line results of their SHINE phase IIb trial of IFX-1 in Hidradenitis Suppurativa (HS). Unfortunately, the primary endpoint of the trial, a dose-dependent effect of IFX-1 on the HiSCR, a binary score for evaluating HS clinical response, was not met. Moreover, an unusually high placebo response rate was present. A more detailed analysis (published on July 18, 2019) showed, however, that high-dose treatment with IFX-1 resulted in multiple efficacy signals which were not reflected by the HiSCR. The number of draining fistulas was significantly reduced by week 16 in the high-dose group when compared to the placebo group. Further, using the International HS Severity Score System, IHS-4, which takes into account all lesions, a statistically significant reduction was seen in the high-dose group, when compared to the placebo group. The company is continuing the open label extension part of the SHINE trial as planned and will discuss the data with the regulatory authorities in an end of phase II meeting.
“While we are all disappointed about the failed primary endpoint for IFX-1 in the SHINE study in HS, our ongoing analysis and findings indicate that the high-dose IFX-1 treatment resulted in meaningful anti-inflammatory efficacy, which gives us reason for optimism as we plan the next steps,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Based on our strong current balance sheet, dedicated team with confidence in our technology, and support from the medical communities, we are well positioned to continue development in HS and in our other indications. I look forward to reporting on our further progress in the coming months.”
Further corporate update
Q2 2019 financial highlights
Cash and cash equivalents plus securities and other investments totaled €138.3 million as of June 30, 2019, compared to €156.4 million as of December 31, 2018. Cash and cash equivalents amounted to €54.1 million as of June 30, 2019 (December 31, 2018: €55.4 million) and marketable securities were €84.2 million (December 31, 2018: €100.9 million).
Net cash used in operating activities increased to €18.7 million in HY1 2019, compared to €11.1 million in HY1 2018, 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 personnel expenses at InflaRx.
Research and development expenses increased to €20.2 million for HY1 2019 (HY1 2018: €10.5 million). The principal drivers of the increase were CRO expenses associated with preclinical studies and clinical trials conducted for IFX-1 as well as manufacturing costs.
General and administrative expenses amounted to €6.9 million in HY1 2019, compared to €6.2 million in HY1 2018. This increase is primarily attributable to increased overall headcount and related cost.
Net financial result in HY1 2019 (€2.0 million) consisted of €1.9 million interest income and €0.2 million net exchange gain, compared to a net financial gain of €3.8 million in HY1 2018. This was mainly due to higher foreign exchange gains (€2.9 million) but lower interest income (€1.2 million).
Net loss for the first two quarters of 2019 was €25.1 million or € 0.97 per common share (basic and diluted), compared to €12.8 million or €0.51 per common share (basic and diluted) in HY1 2018.
Additional information regarding these results is included in the notes to the consolidated financial statements as of and for the quarter ended June 30, 2019, which can be found on the InflaRx website in the Investors section.
Unaudited condensed consolidated statements of comprehensive loss
for the three and six months ended June 30, 2019 and June 30, 2018
(in thousands of €, except for per share data)
Research and development expenses
General and administrative expenses
Total Operating Expenses
Net financial Result
Loss for the period
Weighted average number of shares outstanding
Loss per share in Euro (basic/diluted)
Loss for the period
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
Exchange differences on translation of foreign currency
Total comprehensive loss
Condensed consolidated statements of financial position as of June 30, 2019 and December 31, 2018
Unaudited condensed consolidated statements of changes in shareholders’ equity for the three months ended June 30, 2019 and June 30, 2018
Unaudited condensed consolidated statement of cash flows for the six months ended June 30 2019 and 2018
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. 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 inflammatory indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum.
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.
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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.