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Jena, Germany, 23 May 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 first quarter ended March 31, 2019.
“It is an exciting time for InflaRx, as we await top-line results from our Phase IIb trial with IFX-1 in Hidradenitis Suppurativa, our lead indication,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “While we look forward to these HS results, we have also continued to execute within our other clinical development programs. We now have Phase II trials in ANCA-associated vasculitis ongoing in both Europe and the US, and expect to initiate the Phase IIa trial in Pyoderma Gangraenosum in short order. I am pleased with the company’s continued development, and with the addition of key new hires, and the steadfast support of our shareholders. I believe that we are well positioned to exploit the potential of our anti-C5a antibody technology to pursue additional high-value pipeline opportunities going forward.”
Q1 2019 corporate highlights
Q1 2019 financial highlights
Cash and cash equivalents plus securities and other investments totaled €150.1 million as of March 31, 2019, compared to €156.4 million as of December 31, 2018. Cash and cash equivalents amounted to €47.2 million as of March 31, 2019 (December 31, 2018: €55.4 million) and marketable securities €102.9 million (December 31, 2018: €100.9 million).
Net cash used in operating activities increased to €8.5 million in Q1 2019, compared to €5.7 million in Q1 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 €7.7 million for Q1 2019 (Q1 2018: €5.5 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 €3.3 million in Q1 2019, compared to €3.0 million in Q1 2018. This increase is primarily attributable to an increase in employee-related costs.
Net financial result in Q1 2019 (€1.1 million) consisted of €0.8 million interest income and €0.3 million net exchange gain, compared to a net financial loss of €1.9 million in Q1 2018. This was mainly due to lower foreign exchange losses of our U.S. Dollar term deposits (€2.1 million) and higher interest income (€0.5 million).
Net loss for the first quarter of 2019 was €9.8 million or €0.38 per common share (basic and diluted), compared to €10.3 million or €0.43 per common share (basic and diluted) in Q1 2018.
Additional information regarding these results is included in the notes to the consolidated financial statements as of and for the quarter ended March 31, 2019, which can be found on the InflaRx website in the Investors section.
Unaudited condensed consolidated statements of comprehensive loss
for the three months ended March 31,2018 and March 31, 2019
March 31,
2019
March 31,
2018
(unaudited)
(unaudited)
(in thousands of €, except for per share data)
Operating Expenses
Research and development expenses
(7,695)
(5,474)
General and administrative expenses
(3,301)
(3,005)
Total Operating Expenses
(10,996)
(8,479)
Other income
65
82
Other expenses
(4)
(12)
Operating Result
(10,935)
(8,409)
Finance income
1,159
265
Finance expenses
(62)
(2,188)
Net financial Result
1,097
(1,924)
Loss for the period
(9,838)
(10,333)
Share information
Weighted average number of shares outstanding
25,964
23,812
Loss per share in euro (basic/diluted)
€ (0.38)
€ (0.43)
Loss for the period
(9,838)
(10,333)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
Exchange differences on translation of foreign operations
2,318
0
Total comprehensive loss
(7,520)
(10,332)
Condensed consolidated statements of financial position as of March 31, 2019 and December 31, 2018
March 31, 2019
(unaudited)
December 31, 2018
(in thousands of €)
Unaudited condensed consolidated statements of changes in shareholders’ equity for the three months ended March 31, 2018 and March 31, 2019
* unaudited
Unaudited condensed consolidated statement of cash flows for the three months ended March 31 2018 and 2019
March 31,
2019
unaudited
March 31,
2018
unaudited
(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, 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.
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.