InflaRx N.V. Reports Second Quarter 2018 Financial & Operating Results

• Received FDA clearance of IND for Phase II trial of IFX-1 in ANCA-associated vasculitis
• Established U.S. research facility to continue advancing complement-based research
• Completion of follow-on offering raising $62.9 million in primary proceeds
• Cash position approximately €156.1 million (US$182.2 million) as of June 30, 2018

JENA, Germany, Aug. 09, 2018 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, reported financial and operating results for the second quarter ended June 30, 2018.

“In the second quarter of 2018 we received FDA clearance of our IND application for a Phase II clinical trial with our lead product, IFX-1, in ANCA-associated vasculitis and expanded our presence in the United States with the opening of a new research facility in Ann Arbor, Michigan, where InflaRx’s founders began their pioneering research on anti-C5a technology,” said Arnd Christ, Chief Financial Officer of InflaRx.

“InflaRx is delivering on its operating plan and these achievements, in addition to the successful follow-on financing completed in May 2018, will allow the Company to continue advancing its proprietary complement-based therapies through clinical development, and evaluate their potential to bring clinical benefit to patients in additional indications.”

Q2 2018 Corporate Highlights

• On May 8^th, InflaRx closed a primary and secondary offering of 3,450,000 common shares, consisting of 1,850,000 common shares offered by InflaRx and 1,600,000 common shares offered by the selling shareholders at price to the public of $34.00 per common share for total gross proceeds of $117.3 million (€98.8 million) ($62.9 million to InflaRx and $54.4 million to the selling shareholders), including the full exercise of the underwriters’ option to purchase additional shares.
• On May 15^th, InflaRx opened a research facility in Ann Arbor, Michigan to further develop and extend the Company’s unique complement system-based therapeutics. Operations will be overseen by Chief Scientific Officer, Prof. Renfeng Guo, M.D. 
• On June 28^th, InflaRx received FDA clearance of an IND application from the FDA. This second open IND in 2018 allows InflaRx to start a phase II study to determine the safety and efficacy of IFX-1 in patients with ANCA-associated vasculitis (AAV), a life-threatening autoimmune disease.             

H1/Q2 2018 Financial Highlights

The figures for the second quarter (Q2, three months ended June 30, 2018) and six months of 2018 (H1, six months ended June 30, 2018) and 2017 represent unaudited figures.

Cash and cash equivalents totalled €156.1 million as of June 30, 2018 compared to €123.3 million as of December 31, 2017. This increase was due to the completion of InflaRx’s follow-on offering in May 2018.

Net cash used in operating activities increased by €5.9 million to €11.1 million in the first half of 2018 compared to €5.2 million in the six months ended June 30, 2017, due to a loss for the first half of €12.8 million (H1 2017: €8.5 million).

Research and development expenses amounted to €5.0 million in Q2 2018, an increase by €1.9 million from €3.1 million in Q2 2017, primarily due to higher CMO and CRO expenses for manufacturing and clinical trials for IFX-1 as well as an increase in employee-related costs associated with non-cash share-based compensation.

General and administrative expenses increased by €2.4 million to €3.2 million in Q2 2018, compared to €0.7 in Q2 2017 primarily due to employee-related costs associated with non-cash share-based compensation (€1.4 million) and legal and consulting fees for being a publicly listed company (€0.5 million).

Finance result amounted to a net gain of €5.7 million in Q2 2018, compared to a net loss of €0.8 million in Q2 2017. The increase is mainly attributable to unrealized foreign exchange gains of the USD term deposits (€5.3 million). In the previous year period, a loss of €0.8 million was attributable to interest expenses in connection with preferred shares, which were converted into common shares at the IPO in Q4 2017.

Net loss for the second quarter of 2018 totalled €2.5 million or €0.1 per common share, compared to €4.7 million or €2.0 per common share for the second quarter of 2017.

Additional information regarding these results is included in the notes to the consolidated financial statements as of June 30, 2018.

InflaRx N.V. and subsidiaries

Unaudited condensed consolidated statements of comprehensive loss
for the three months ended June 30, 2018

		For the three months ended June 30, 2018						For the six months ended June 30, 2018
in € thousand		Q2 2017			Q2 2018			H1 2017			H1 2018
Other income and expenses (net)		2			44			30			117
Research and development expenses		(3,101	)		(5.031	)		(5,502	)		(10,505	)
General and administrative expenses		(731	)		(3,161	)		(1,346	)		(6,158	)
Loss before interest and income taxes		(3,831	)		(8.148	)		(6,817	)		(16,545	)
Finance income		0			5,742			0			6,007
Finance costs		(843	)		(37	)		(1,655	)		(2,226	)
Finance result		(842	)		5,705			(1,655	)		3,781
Loss for the period		(4,673	)		(2,443	)		(8,473	)		(12,764	)
Other comprehensive loss for the period		(2	)		(17	)		(1	)		(16	)
Total comprehensive loss		(4,675	)		(2,460	)		(8,473	)		(12,780	)
Loss per common share in € (basic/diluted)		(2.0	)		(0.1	)		(3.6	)		(0.5	)

InflaRx N.V. and subsidiaries

Condensed consolidated statements of financial position

in € thousand				December 31, 2017			June 30, 2018
							unaudited
ASSETS
Non-current assets
	Intangible assets			41			47
	Laboratory and office equipment			173			478
	Financial assets			20			39
	Total non-current assets			233			565
Current assets
	Other assets			697			944
	Other financial assets			0			8,017
	Cash and cash equivalents			123,282			156,069
	Total current assets			123,979			165,030
Total assets				124,212			165,595
EQUITY AND LIABILITIES
Equity
	Issued capital			2,858			3,080
	Other reserves			167,864			222,753
	Accumulated deficit			(51,293	)		(64,056	)
	Total equity			119,429			161,776
Non-current liabilities
	Deferred income			15			13
	Provisions			2			54
	Total non-current liabilities			17			67
Current liabilities
	Trade payables			4,464			2,226
	Other liabilities, provisions			302			1,526
	Total current liabilities			4,766			3,752
Total equity and liabilities				124,212			165,595

InflaRx N.V. and subsidiaries

Unaudited Condensed consolidated statements of changes in equity

								Other reserves
in € thousand			Issued capital		Capital reserve			currency translation			share-based payments		Accumulated deficit			Own shares			Total equity
Balance as of January 1, 2017			31		0			9			1,675		(27,055	)		(350	)		(25,690		)
Comprehensive loss
Loss for the period													(8,473	)					(8,473		)
Other comprehensive income / Exchange differences			0		0			(1	)		0		0			0			(1		)
Total comprehensive loss			0		0			(1	)		0		(8,473	)		0			(8,473		)
Recognition of equity-settled share-based payments											1,489								1,489
Balance as of June 30, 2017			31		0			8			3,164		(35,527	)		(350	)		(32,674		)
Balance as of January 1, 2018			2,858		161,639			0			6,225		(51,293	)		0			119,429
Comprehensive loss
Loss for the period													(12,764	)					(12,764		)
Exchange differences								(16	)										(16		)
Total comprehensive loss			0		0			(16	)		0		(12,764	)		0			(12,780		)
Recognition of equity-settled share-based payments											5,938								5,938
Issue of share capital
	Issued shares		222		52,769														52,991
	Transaction costs				(3,801	)													(3,801		)
Total issue of share capital			222		48,967			0			0		0			0			49,189
Balance as of June 30, 2018			3,080		210,606			(16	)		12,163		(64,056	)		0			161,776

InflaRx N.V. and subsidiaries

Unaudited Condensed consolidated statement of cash flows for the six months ended June 30, 2018

in € thousand			H1 2017			H1 2018
Cash flow from Operations
Loss before income taxes			(8,473	)		(12,764	)
Reconciliation from result before taxes to net cash flows
	Depreciation/amortization of intangible assets, laboratory and office equipment		22			50
	Share based payment expense		1,489			5,938
	Finance Income		(0	)		(6,007	)
	Finance costs		1,655			2,247
	Other non-cash adjustments		(11	)		(58	)
	Change in Provisions and Government Grants		1,821			1,494
Working capital adjustments
	Change in trade payables and other liabilities		(927	)		(2,458	)
	Change in other assets		(806	)		(271	)
	Interest received		0			681
Cash flow from Operations			(5,230	)		(11,148	)
Cash flow from investing activities
	Cash outflow from the purchase of intangible assets, laboratory and office equipment		(38	)		(361	)
	Cash outflow for the investment in non-current financial assets		(19	)		(33	)
	Proceeds from the disposal of long-term financial assets		0			14
	Purchase of quoted debt securities		0			(8,014	)
Net cash flows used in investing activities			(57	)		(8,396	)
Financing activities
	Proceeds from issuance of stock		0			52,991
	Transaction cost from issuance of stock		0			(3,801	)
	Proceeds from issuance of preferred shares		1,500			0
Net cash flows from financing activities			1,500			49,189
Effect of exchange rate changes			0			3,142
Change in cash and cash equivalents			(3,787	)		32,787
Net change in cash and cash equivalents			(3,787	)		32,787
	Cash and cash equivalents at beginning of period		29,117			123,282
Cash and cash equivalents at end of period			25,330			156,069

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 has offices in Jena and Munich, Germany as well as Ann Arbor, Michigan, USA. InflaRx is listed on the Nasdaq Global Select Market in the United States under the trading symbol “IFRX”. For further information please visit www.inflarx.com.

About IFX-1:

IFX-1 is a first-in-class monoclonal anti-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 demonstrated control of 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 the first monoclonal anti-C5a antibody introduced into clinical development that has, to date, successfully completed three clinical Phase II studies. In total, more than 150 patients have so far been treated with IFX-1, which was well tolerated. IFX-1 is currently being developed for different inflammatory indications.

Contacts:

InflaRx N.V. Prof. Dr. Niels C. Riedemann Chief Executive Officer info[at]inflarx.de +49-3641-508180		Arnd Christ Chief Financial Officer info[at]inflarx.de +49-89-4141897800
Investor Relations LifeSci Advisors Hans Herklots hherklots[at]lifesciadvisors.com +41 79 598 7149
Media US LifeSci Public Relations Matt Middleman, M.D. matt[at]lifescipublicrelations.com +1 646 627 8384		Media Europe MC Services AG Katja Arnold katja.arnold[at]mc-services.eu +49 89 210 228 40

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.