Full Press Release Details
Full Year 2017 Financial & Operating Results
Phase IIa data in Hidradenitis Suppurativa (HS) patients
US$136 million Series D & Nasdaq IPO financings
U.S. IND opened, international Phase IIb initiated for IFX-1 in HS patients
Strong cash position with approx. US$148 million ( 123 million) at end of 2017
Germany, 29 March 2018 - InflaRx (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, announced
today financial results for the year ended December 31, 2017.
has been a transformational year for InflaRx, highlighted by multiple achievements in our pipeline and completion of two important
financings that will fuel future development of our key therapeutic candidates," said Prof. Niels C. Riedemann, Chief Executive
Officer. "Specifically, we demonstrated efficacy with our lead product, IFX-1, in a phase IIa clinical trial to treat Hidradenitis
Suppurativa (HS), and completed a US$55 million private financing in October, followed by a successful US$106 million Nasdaq IPO
in November. These financings provide the resources we need to drive our pipeline forward."
2018, the U.S. Food and Drug Administration approved the IND application for IFX-1, a complement C5a inhibitor, in HS. Subsequently,
InflaRx initiated phase IIb clinical testing in HS patients, and top-line data from this trial are anticipated during the first
half of 2019. In 2018, the Company plans to initiate additional phase IIb clinical development of IFX-1 in antineutrophil cytoplasmic
autoantibodies (ANCA)-associated vasculitis (AAV) and in another autoimmune or inflammatory indication.
cash equivalents totaled 123.3 million as of December 31, 2017 compared to 29.1 million as of December 31, 2016.
This increase was primarily attributable to the completion of InflaRx' initial public offering of its common shares in November
2017 and the exercised green shoe in December 2017, as well as the primary portion of the Series D financing executed in October
used in operating activities increased from 5.0 million in the year ended December 31, 2016 to 12.2 million in
the year ended December 31, 2017, mainly due to the increase of 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.
and development expenses increased by 9.1 million to 14.4 million in the year ended December 31, 2017 from
5.3 million for the year ended December 31, 2016. This increase is primarily attributable to a 5.1 million increase in CRO
and CMO expenses for IFX-1 in connection with the preparation of the Phase IIb clinical trial in patients with HS and the Phase
II clinical trial in patients with AAV and to a 3.4 million increase in employee-related costs associated with salaries,
bonus, benefits and non-cash share-based compensation.
and administrative expenses increased by 3.3 million to 5.1 million for the year ended December 31, 2017, from
1.8 million for the year ended December 31, 2016. This increase is primarily attributable to a 1.8 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 1.0 million, which is mainly attributable to expenses incurred in connection
with the IPO and Nasdaq listing.
costs (net) increased by 2.8 million to 4.8 million for the year ended December 31, 2017, from 2.0 million
for the year ended December 31, 2016. This increase is mainly attributable to interest expense on outstanding preferred shares
issued in the Series C financing, which increased by 0.4 million to 2.2 million for the year ended December 31, 2017,
from 1.8 million for the year ended December 31, 2016; and unrealized foreign exchanges losses which increased by 2.4
million to 2.4 million for the year ended December 31, 2017.
for the year 2017 was 24.2 million or 2.6 per common share, compared to 8.9 million or 3.8 per common
share for the year 2016.
information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2017
and "Item 5. Operating and Financial Review and Prospects," which will be included in InflaRx's Annual Report
on Form 20-F as filed with the SEC.
statements of comprehensive loss for the years ended December 31,
| in thousand | 2016 | 2017 | ||||||
| Other income and expenses (net) | 231 | 108 | ||||||
| Research and development expenses | (5,278 | ) | (14,415 | ) | ||||
| General and administrative expenses | (1,844 | ) | (5,138 | ) | ||||
| Loss before interest and income taxes | (6,891 | ) | (19,445 | ) | ||||
| Finance income | 1 | 130 | ||||||
| Finance costs | (2,049 | ) | (4,923 | ) | ||||
| Finance costs (net) | (2,048 | ) | (4,793 | ) | ||||
| Loss before income taxes | (8,939 | ) | (24,238 | ) | ||||
| Income taxes | 0 | 0 | ||||||
| Loss for the period | (8,939 | ) | (24,238 | ) | ||||
| Other comprehensive income | ||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||
| Exchange differences on translating | ||||||||
| foreign operations | 1 | 0 | ||||||
| Other comprehensive income for the period | 1 | 0 | ||||||
| Total comprehensive loss | (8,938 | ) | (24,238 | ) | ||||
| Loss per common share in (basic/diluted) | (3.8 | ) | (2.6 | ) |
statements of financial position as of December 31,
| in thousand | 2016 | 2017 | ||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 5 | 41 | ||||||
| Laboratory and office equipment | 131 | 173 | ||||||
| Financial assets | 1 | 20 | ||||||
| Total non-current assets | 137 | 234 | ||||||
| Current assets | ||||||||
| Other assets | 264 | 696 | ||||||
| Cash and cash equivalents | 29,117 | 123,282 | ||||||
| Total current assets | 29,381 | 123,979 | ||||||
| Total assets | 29,518 | 124,213 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 31 | 2,858 | ||||||
| Other reserves | 1,685 | 167,864 | ||||||
| Accumulated deficit | (27,055 | ) | (51,293 | ) | ||||
| Own shares | (350 | ) | 0 | |||||
| Total equity | (25,689 | ) | 119,429 | |||||
| Non-current liabilities | ||||||||
| Preferred shares | 53,440 | 0 | ||||||
| Deferred income | 19 | 15 | ||||||
| Provisions | 2 | 2 | ||||||
| Total non-current liabilities | 53,461 | 17 | ||||||
| Current liabilities | ||||||||
| Trade payables | 1,534 | 4,464 | ||||||
| Other liabilities, provisions | 212 | 302 | ||||||
| Total current liabilities | 1,746 | 4,767 | ||||||
| Total equity and liabilities | 29,518 | 124,213 |
statements of changes in equity for the years ended December 31,
| Other reserves | |||||||||||||||||
| in thousand | Note | Issued capital | Capital reserve | currency translation | share-based payments | Accumulated deficit | Own shares | Total equity | |||||||||
| Balance as of January 1, 2016 | 31 | 0 | 9 | 807 | (18,116) | (350) | (17,619) | ||||||||||
| Comprehensive loss | |||||||||||||||||
| Loss for the period | 0 | 0 | 0 | 0 | (8,939) | 0 | (8,939) | ||||||||||
| Total comprehensive loss | 0 | 0 | 0 | 0 | (8,939) | 0 | (8,939) | ||||||||||
| Recognition of equity-settled share-based payments | 13 | 868 | 868 | ||||||||||||||
| Balance as of December 31, 2016 /January 1, 2017 | 12 | 31 | 0 | 9 | 1,675 | (27,055) | (350) | (25,690) | |||||||||
| Comprehensive loss | |||||||||||||||||
| Loss for the period | 0 | 0 | 0 | 0 | (24,238) | 0 | (24,238) | ||||||||||
| Total comprehensive loss | 0 | 0 | 0 | 0 | (24,238) | 0 | (24,238) | ||||||||||
| Recognition of equity-settled share-based payments | 13 | 0 | 0 | 0 | 4,550 | 0 | 0 | 4,550 | |||||||||
| Issue of share capital | |||||||||||||||||
| Issued shares | 12 | 848 | 90,055 | 90,904 | |||||||||||||
| Transaction costs | 12 | 0 | (9,115) | 0 | 0 | 0 | 0 | (9,115) | |||||||||
| Total issue of share capital | 848 | 80,941 | 0 | 0 | 0 | 0 | 81,789 | ||||||||||
| Liquidation of a subsidiary | (9) | (9) | |||||||||||||||
| Reorganization | 12 | 1,979 | 80,698 | 350 | 83,026 | ||||||||||||
| Balance as of December 31, 2017 | 12 | 2,858 | 161,639 | 0 | 6,226 | (51,293) | 0 | 119,429 |
statements of cash flows for the years ended December 31,
| in thousand | 2016 | 2017 | ||||||
| Cash flow from Operations | ||||||||
| Loss before income taxes | (8,939 | ) | (24,238 | ) | ||||
| Reconciliation from result before taxes to net cash flows | ||||||||
| Depreciation/amortization of intangible assets, laboratory and office equipment | 33 | 71 | ||||||
| Share based payment expense | 868 | 4,550 | ||||||
| Finance Income | (1 | ) | (130 | ) | ||||
| Finance costs | 2,049 | 4,923 | ||||||
| other non-cash adjustments | (2 | ) | 24 | |||||
| Change in Provisions and Government Grants | (136 | ) | (71 | ) | ||||
| Working capital adjustments | ||||||||
| Change in Trade payables and other liabilities | 1,442 | 3,086 | ||||||
| Change in other assets | (96 | ) | (433 | ) | ||||
| Interest received | (0 | ) | 66 | |||||
| Interest paid | (212 | ) | 0 | |||||
| Cash flow from Operations | (4,992 | ) | (12,152 | ) | ||||
| Cash flow from investing activities | ||||||||
| Cash outflow from the purchase of intangible assets, laboratory and office equipment | (53 | ) | (149 | ) | ||||
| Cash outflow for the investment in non-current financial assets | 0 | (19 | ) | |||||
| Net cash flows used in investing activities | (53 | ) | (167 | ) | ||||
| Financing activities | ||||||||
| Proceeds from issuance of stock | 0 | 90,904 | ||||||
| Transaction cost from issuance of stock | 0 | (9,115 | ) | |||||
| Proceeds from issuance of preferred shares | 30,993 | 27,069 | ||||||
| Share issue costs paid | (133 | ) | (56 | ) | ||||
| Net cash flows from/(used in) financing activities | 30,860 | 108,801 | ||||||
| Effect of exchange rate changes | 1 | (2,317 | ) | |||||
| Change in cash and cash equivalents | 25,815 | 94,165 | ||||||
| Net change in cash and cash equivalents | 25,815 | 94,165 | ||||||
| Cash and cash equivalents at beginning of period | 3,302 | 29,117 | ||||||
| Cash and cash equivalents at end of period | 29,117 | 123,282 |
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.
N.V. (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 in Munich, Germany. For further information please visit www.inflarx.com.
| 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 +49-89-4141897821 | |
| 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.