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InflaRx N.V., corporate

InflaRx N.V.,

07.11.2019 - 13:02:27

InflaRx Reports Third Quarter 2019 Financial & Operating Results

InflaRx Reports Third Quarter 2019 Financial & Operating Results

Recently announced results of open label extension part of SHINE Phase IIb study confirm potential of IFX-1 in Hidradenitis Suppurativa and warrant evaluation of future development Company announces updated strategy with focus on selected indications for its anti-C5a complement technology and on broadening the development pipeline Cash and cash equivalents plus securities and other investments of EUR135.5 million (approx. US$151 million) as of September 30, 2019 Conference call to be held today at 8am EST / 2pm CET

Jena, Germany, 7 November 2019 - InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported financial results for the third quarter and first nine months of 2019 and provided a business update, outlining its corporate strategy and plans.

Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented: "Based on our firm belief in the potential of our anti-C5a technology, we have conducted an in-depth assessment of all currently pursued development efforts and decided to put a focus on inflammatory rare diseases with high unmet medical need as well as on a defined oncology space. With this, we aim to deliver several clinical proof-of-concept milestones. Our strong cash position will additionally allow us to pursue a strategy to broaden and diversify our pipeline beyond C5a inhibition."

Corporate update

IFX-1 in Hidradenitis Suppurativa: Although the main part of the SHINE Phase IIb trial did not achieve its primary endpoint of a dose dependent drug effect on the Hidradenitis Suppurativa Clinical Response Score (HiSCR) at week 16, in July, the Company reported additional results from an in-depth post-hoc data analysis of the main part of the SHINE trial. This post-hoc analysis suggested a robust anti-inflammatory activity in the high dose IFX-1 treatment group across numerous efficacy measures which were not reflected by the HiSCR. Additionally, the Company very recently reported positive results from a snapshot analysis of the open label extension (OLE) part of the SHINE study: 70.6% of the HiSCR Responder Group maintained their response during the OLE, and 41.8% of the HiSCR Non-responder Group became responders at week 40, which represented the end of the treatment period.

Strategic update: As a result of a comprehensive review of all currently running clinical programs with IFX-1 and based on newly available data, Management has decided to continue these programs while broadening its R&D pipeline as part of its diversification strategy. IFX-1 will be developed in current and new indications, such as a defined oncology indication in which a clinical proof-of-concept study is planned to start enrollment in 2020. With the positive long-term results announced recently in the OLE part of the SHINE Phase IIb study in HS, InflaRx plans to discuss with regulatory authorities the data from the trial and next steps regarding the future development of IFX-1 in this indication.

In parallel, InflaRx is pursuing a diversification strategy to broaden its pipeline beyond C5a inhibition. In order to implement this strategy, InflaRx has hired an experienced head of global business development and strategy in the US with a pharmaceutical background who is expected to join the team within the course of November 2019.

The Company has decided to focus its development efforts on rare and inflammatory diseases with high unmet medical need and on the oncology space.

IFX-1 in Pyoderma Gangraenosum (PG): The ongoing open label Phase IIa trial in Pyoderma Gangraenosum (PG), a debilitating, rare autoimmune disease marked by large, painful ulcers, is continuing enrollment. The Company has decided to expand enrollment from 12 to 18 patients.

Management update: The Company has unilaterally terminated the employment contract of the CMO of the Company, Othmar Zenker.

Q3 2019 financial highlights

Cash and cash equivalents plus securities and other investments totaled EUR135.5 million as of September 30, 2019, compared to EUR156.3 million as of December 31, 2018. Cash and cash equivalents amounted to EUR27.0 million as of September 30, 2019 (December 31, 2018: EUR55.4 million) and marketable securities EUR108.5 million (December 31, 2018: EUR100.9 million).

Net cash used in operating activities increased to EUR27.0 million in the first nine months of 2019, compared to EUR15.2 million in the first nine months of 2018, mainly due to higher 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 EUR33.6 million for the first nine months of 2019 (2018: EUR16.0 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 EUR9.4 million in the first nine months of 2019, compared to EUR9.2 million in the first nine months of 2018.

Net financial result in the first nine months of 2019 of EUR3.3 million consisted of EUR2.3 million interest income and EUR1.0 million net exchange gain, compared to a net financial gain of EUR5.4 million in the first nine months of 2018, which mainly consisted of EUR4.1 million net foreign exchange gains and EUR1.5 million interest income.

Net loss for the first nine months of 2019 was EUR39.6 million or EUR (1.53) per common share (basic and diluted), compared to EUR19.5 million or EUR (0.79) per common share (basic and diluted) for the first nine months of 2018.

Net loss for the three months ended September 30, 2019 was EUR14.5 million or EUR (0.56) per common share (basic and diluted), compared to EUR6.8 million or EUR (0.26) per common share (basic and diluted) for the respective three months of 2018.

Additional information regarding these results is included in the notes to the consolidated financial statements as of and for the quarter ended September 30, 2019, which can be found on the InflaRx website in the Investors section.

Strategic update call

Today, the Company will host a conference call to provide details on the results of the OLE part of the SHINE study and a strategic update in conjunction with its quarterly results at 8am EST / 2pm CET.

Dial-in details:

From the US: +1 929 477 0402 From the UK: +44 (0) 330 336 9127 From Europe: +49 (0) 69 2222 25577 Conference Code: 3567762

Please dial in 10 minutes before the call to register. The webcast presentation for the conference call can be accessed here

InflaRx N.V. and subsidiary Unaudited condensed consolidated statements of comprehensive lossfor the three and nine months ended September 30, 2019 and September 30, 2018

 

  Three months ended September 30, Nine months ended September 30,   2019 (unaudited) 2018 (unaudited) 2019 (unaudited) 2018 (unaudited)   (in EUR, except for per share data) Operating Expenses         Research and development expenses (13,405,646) (5,450,544) (33,598,018) (15,954,005) General and administrative expenses (2,490,245) (3,042,144) (9,439,080) (9,200,333) Total Operating Expenses (15,895,891) (8,492,688) (43,037,098) (25,154,338) Other income 126,559 60,616 194,261 209,898 Other expenses (838) (2,152) (83,907) (34,446) Operating Result (15,770,170) (8,434,224) (42,926,744) (24,978,886) Finance income 2,029,992 2,100,634 4,527,952 8,107,285 Finance expenses (761,268) (440,567) (1,211,366) (2,666,155) Net financial Result 1,268,725 1,660,067 3,316,586 5,441,130 Loss for the period (14,501,446) (6,774,157) (39,610,157) (19,537,756)           Share information         Weighted average number of shares outstanding 25,982,754 25,662,100 25,970,571 24,804,184 Loss per share (basic/diluted) EUR (0.56) EUR (0.26) EUR (1.53) EUR (0.79)           Loss for the period (14,501,446) (6,774,157) (39,610,157) (19,537,756) Other comprehensive income that may be reclassified to profit or loss in subsequent periods:         Exchange differences on translation of foreign currency 4,988,141 41,810 5,683,610 25,401 Total comprehensive loss (9,513,305) (6,732,347) (33,926,548) (19,512,355)            

InflaRx N.V. and subsidiary Condensed consolidated statements of financial position as of September 30, 2019 and December 31, 2018

  Sep.30, 2019 (unaudited) Dec 31, 2018   (in EUR) ASSETS     Non-current assets     Property, plant and equipment 1,583,254 624,668 Intangible assets 470,995 222,866 Non-current other assets 528,329 - Non-current financial assets 272,744 207,444 Total non-current assets 2,855,322 1,054,979 Current assets     Current other assets 2,293,538 1,588,702 Current financial assets 109,365,112 101,184,240 Cash and cash equivalents 27,009,808 55,386,240 Total current assets 138,668,459 158,159,183 TOTAL ASSETS 141,523,781 159,214,161       EQUITY AND LIABILITIES     Equity     Issued capital 3,132,631 3,115,725 Share premium 211,006,606 211,021,835 Other capital reserves 23,999,370 18,310,003 Accumulated deficit (120,717,345) (81,107,188) Other components of equity 5,733,805 50,196 Total equity 123,155,067 151,390,571 Non-current liabilities     Lease liabilities 563,993 - Provisions 43,398 57,148 Government grants 8,044 10,797 Total non-current liabilities 615,435 67,945 Current liabilities     Lease liabilities 340,748 - Employee benefits 775,484 788,405 Social securities and current other tax liabilities 106,111 309,928 Trade and other payables 16,530,937 6,657,312 Total current liabilities 17,753,280 7,755,645 Total liabilities 18,368,715 7,823,590 TOTAL EQUITY AND LIABILITIES 141,523,781 159,214,161       InflaRx N.V. and subsidiary

Unaudited condensed consolidated statements of changes in shareholders' equity for the nine months ended September 30, 2019 and September 30, 2018

  Shares outstanding Issued capital Share premium Other capital reserves Accumulated deficit Other components of equity Total equity   (in EUR, except for share data) Balance as of January 1, 2019 25,964,379 3,115,725 211,021,835 18,310,003 (81,107,188) 50,196 151,390,571 Loss for the period - - - - (39,610,157) - (39,610,157) Exchange differences on translation of foreign currency - - - - - 5,683,610 5,683,610 Total comprehensive loss - - - - (39,610,157) 5,683,610 (33,926,547) Transactions with owners of the Company               Contributions               Issued shares 140,876 16,905 (15,229) - - - 1,676 Equity-settled share-based payment - - - 5,689,367 - - 5,689,367 Total contributions 140,876 16,905 (15,229) 5,689,367 - - 5,691,043 Total transactions with owners of the Company 140,876 16,905 (15,229) 5,689,367 - - 5,691,043 Balance as of September 30, 2019* 26,105,255 3,132,631 211,006,606 23,999,370 (120,717,345) 5,733,805 123,155,067                 Balance as of January 1, 2018 23,812,100 2,857,452 161,638,566 6,225,353 (51,292,555) 0 119,428,816 Loss for the period - - - - (19,537,756) - (19,537,756) Exchange differences on translation of foreign currency - - - - - 25,401 25,401 Total comprehensive loss - - - - (19,537,756) 25,401 (19,512,355) Transactions with owners of the Company               Contributions               Issued shares 1,850,000 222,000 52,768,733 - - - 52,990,733 Transaction costs - - (3,801,265) - - - (3,801,265) Equity-settled share-based payment - - - 9,003,725 - - 9,003,725 Share options exercised 274,584 32,950 418,794 - - - 451,744 Total contributions 2,124,584 254,950 49,386,262 9,003,725 - - 58,644,937 Total transactions with owners of the Company 2,124,584 254,950 49,386,262 9,003,725 - - 58,644,937 Balance as of September 30, 2018* 25,936,684 3,112,402 211,024,828 15,229,077 (70,830,310) 25,401 158,561,398 * unaudited                

InflaRx N.V. and subsidiary Unaudited condensed consolidated statement of cash flows for the nine months ended September 30, 2019 and 2018

  2019 (unaudited) 2018 (unaudited)   (in EUR) Operating activities     Loss for the period (39,610,157) (19,537,756) Adjustments for:     Depreciation & Amortization 485,822 105,274 Net financial result (3,316,586) (5,441,130) Share based payment expense 5,689,367 9,003,725 Other non-cash adjustments (285,389) (688,866) Changes in:     Other assets (1,233,165) (964,938) Current financial assets - 217 Employee benefits (14,316) 353,185 Social securities and current other tax liabilities (205,175) 2,970,381 Trade and other payables 9,859,875 (2,016,987) Interest received 1,653,617 980,442 Interest paid (19,822) - Net cash from operating activities (26,995,930) (15,236,454) Investing activities     Cash outflow from the purchase of intangible assets, laboratory and office equipment (622,265) (537,357) Cash outflow for the investment in non-current other financial assets (75,543) (200,769) Proceeds from the disposal of current other financial assets 40,539,826 6,179,502 Purchase of current financial assets (42,688,210) (110,851,660) Net cash used in investing activities (2,846,193) (105,410,284) Financing activities     Proceeds from issuance of share capital - 52,990,733 Transaction cost from issuance of share capital - (3,801,265) Proceeds from exercise of share options 1,676 451,744 Repayment of leasing debt (209,176) - Net cash from financing activities (207,500) 49,641,212 Effect of exchange rate changes 1,673,191 4,072,716 Change in cash and cash equivalents (28,376,432) (66,932,810) Cash and cash equivalents at beginning of period 55,386,240 123,281,888 Cash and cash equivalents at end of period 27,009,808 56,349,080        

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. More than 300 people have been treated with IFX-1 in 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, USA. For further information please visit www.inflarx.com.

Contacts: InflaRx N.V. Arnd Christ Chief Financial Officer info[at]inflarx.de +49 89-4141 897 800Media Relations MC Services AG Katja Arnold, Laurie Doyle, Andreas Jungfer inflarx[at]mc-services.eu +49 89-210 2280

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.

07.11.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de

907489  07.11.2019 

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