InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, announced today financial results for the three
months ended March 31, 2020.
“InflaRx continues to make progress with its
clinical development programs for IFX-1 and recently reported
encouraging initial results in Pyoderma Gangraenosum, the second
neutrophil-driven devastating skin disease we are pursuing,” said
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of
InflaRx. “With the upcoming scheduled FDA End of Phase II meeting
for development in Hidradenitis Suppurativa, the Company is keeping
a strong focus on potentially advancing into Phase III development
in this disease.”
Prof. Riedemann continued, “We are currently
analyzing results from the first 30 patients in our ongoing
adaptive randomized COVID-19 pneumonia trial, which will serve as
the basis for the decision to potentially continue into a
confirmatory larger second part of the study.”
R&D
highlights – Q1 2020
- IFX-1 in Hidradenitis
Suppurativa (HS): In Q1 2020, the Company requested an End
of Phase II meeting with the FDA to discuss the path forward for a
pivotal program with IFX-1 in HS. The meeting has been scheduled
for mid-year 2020.
- IFX-1 in Pyoderma
Gangraenosum (PG): In February 2020, the Company announced
positive initial data from the first 5 patients dosed in the
ongoing Phase IIa open label study. Of these 5 initial patients
dosed with IFX-1, 2 patients achieved complete closure of the
target ulcer and complete healing of all other PG ulcers. Patients
continue to enroll in higher dose groups.
- IFX-1 in ANCA-associated
vasculitis (AAV): Part 1 of the European Phase II IXCHANGE
study has been fully enrolled. After analyzing the impact of
COVID-19 on the study, a blinded interim analysis of Part 1 has
been completed. Based on the analysis, the Company intends to
continue with Part 2 of the study but decrease the number of
enrolled patients. Following a blinded interim analysis of the US
Phase II IXPLORE study with IFX-1 in patients with AAV and an
assessment of the potential impact of the COVID-19 pandemic, the
Company has decided to stop the study and read out the existing
results earlier than initially planned as part of a strategy to
align and streamline the US and EU AAV development programs.
- IFX-1 in oncology:
In Q1 2020, the Company entered into a clinical collaboration
agreement (reported on April 29, 2020) to evaluate the combination
of IFX-1 and a market leading anti-PD-1 therapy in patients with an
undisclosed tumor type. Under the terms of the agreement, InflaRx
will conduct a Phase IIa clinical study with two IFX-1 arms,
including one with the anti-PD-1 therapy.
- IFX-1 in COVID-19
pneumonia: The Company initiated a Phase II clinical
development program with IFX-1 in COVID-19 patients with severely
progressed pneumonia. After all patients have been treated in the
first part of the trial, an interim analysis will be performed to
evaluate the clinical benefit of the treatment using the assessed
clinical parameters in order to potentially initiate and adapt the
confirmatory second part of the study. Part 1 was fully enrolled
with 30 patients as of April 24, 2020.
Financial highlights - Q1
2020
Research and development
expenses decreased by €0.4 million in the three months
ended March 31, 2020 compared to the three months ended March 31,
2019. This decrease is primarily attributable to a €0.3 million
decrease in expenses from non-cash share-based compensation.
General and administrative
expenses decreased by €0.7 million to €2.6 million for the
three months ended March 31, 2020, from €3.3 million for the three
months ended March 31, 2019. This decrease is primarily
attributable to a €0.9 million decrease in non-cash share-based
compensation expense. Legal, consulting and other expenses
increased by €0.1 million to €1.1 million for the three months
ended March 31, 2020, from €1.0 million for the three months ended
March 31, 2019.
Net financial result increased
by €0.4 million to €1.5 million for the three months ended March
31, 2020, from €1.1 million for the three months ended March 31,
2019. This increase is mainly attributable to (a) higher foreign
exchange gains, which increased by €0.8 million and (b) interest on
marketable securities, which decreased by €0.4 million.
Net loss for the three months
ended March 31, 2020 was €8.2 million or €(0.32) per common share,
compared to €9.8 million or €(0.38) per common share for the three
months ended March 31, 2019. On March 31, 2020, the Company’s
total funds available were approximately €108.0
million, mostly composed of cash and cash equivalents (€21.1
million) and marketable securities (€86.3 million).
Net cash used in operating
activities increased to €10.5 million for the three months
ended March 31, 2020, from €8.5 million in the three months ended
March 31, 2019, 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 higher personnel costs.
Additional information regarding these results
is included in the notes to the consolidated financial statements
as of March 31, 2020, as well as the financial statements as of
December 31, 2019 in “ITEM 18. Financial statements,” which is
included in InflaRx’s Annual Report on Form 20-F as filed with the
U.S. Securities and Exchange Commission (SEC).
InflaRx N.V. and
subsidiaryConsolidated Statements of Comprehensive
Loss for the three months ended March 31, 2020 and
2019
in € |
2020(unaudited) |
|
2019(unaudited) |
|
|
|
|
Operating
Expenses |
|
|
Research and development expenses |
(7,298,799 |
) |
|
(7,695,150 |
) |
General and administrative
expenses |
(2,564,803 |
) |
|
(3,301,166 |
) |
Total Operating
Expenses |
(9,863,601 |
) |
|
(10,996,316 |
) |
Other income |
94,960 |
|
|
64,836 |
|
Other expenses |
(5,720 |
) |
|
(3,886 |
) |
Operating
Result |
(9,774,362 |
) |
|
(10,935,366 |
) |
Finance income |
1,658,991 |
|
|
1,159,205 |
|
Finance expenses |
(118,026 |
) |
|
(61,710 |
) |
Net Financial
Result |
1,540,965 |
|
|
1,097,495 |
|
Loss for the
Period |
(8,233,397 |
) |
|
(9,837,871 |
) |
|
|
|
Share
Information |
|
|
Weighted average number of
shares outstanding |
26,105,255 |
|
|
25,964,379 |
|
Loss per share
(basic/diluted) |
(0.32 |
) |
|
(0.38 |
) |
|
|
|
|
|
Loss for the
Period |
(8,233,397 |
) |
|
(9,837,871 |
) |
Other comprehensive income
that may be reclassified to profit or loss in subsequent
periods: |
|
|
|
|
|
Exchange differences on
translation of foreign currency |
1,713,868 |
|
|
2,317,546 |
|
Total Comprehensive
Loss |
(6,519,529 |
) |
|
(7,520,325 |
) |
|
|
|
|
|
|
InflaRx N.V. and subsidiaryConsolidated
Statements of Financial Position as of March 31, 2020 and December
31, 2019
in € |
2020(unaudited) |
|
2019 |
|
|
|
|
ASSETS |
|
|
Non-current
assets |
|
|
Property, plant and equipment |
540,606 |
|
|
576,373 |
|
Right-of-use assets |
748,785 |
|
|
836,924 |
|
Intangible assets |
430,368 |
|
|
452,400 |
|
Non-current other assets |
445,403 |
|
|
452,217 |
|
Non-current financial assets |
272,718 |
|
|
272,614 |
|
Total non-current
assets |
2,437,880 |
|
|
2,590,528 |
|
Current
assets |
|
|
Current other assets |
3,319,222 |
|
|
3,500,884 |
|
Current financial assets |
86,680,961 |
|
|
82,353,867 |
|
Cash and cash equivalents |
21,083,608 |
|
|
33,131,280 |
|
Total current
assets |
111,083,791 |
|
|
118,986,031 |
|
TOTAL
ASSETS |
113,521,671 |
|
|
121,576,558 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
Equity |
|
|
Issued capital |
3,132,631 |
|
|
3,132,631 |
|
Share premium |
211,006,606 |
|
|
211,006,606 |
|
Other capital reserves |
26,043,246 |
|
|
25,142,213 |
|
Accumulated deficit |
(142,514,552 |
) |
|
(134,362,006 |
) |
Other components of equity |
3,860,246 |
|
|
2,227,228 |
|
Total
equity |
101,528,177 |
|
|
107,146,673 |
|
Non-current
liabilities |
|
|
Lease liabilities |
245,478 |
|
|
330,745 |
|
Other non-financial
liabilities |
39,148 |
|
|
39,013 |
|
Total non-current
liabilities |
284,625 |
|
|
369,758 |
|
Current
liabilities |
|
|
Trade and other payables |
10,490,938 |
|
|
12,413,662 |
|
Lease liabilities |
513,374 |
|
|
515,203 |
|
Employee Benefits |
571,960 |
|
|
975,629 |
|
Social securities, other tax and
non-financial liabilities |
108,221 |
|
|
105,634 |
|
Provisions |
24,374 |
|
|
50,000 |
|
Total current
liabilities |
11,708,869 |
|
|
14,060,128 |
|
Total
Liabilities |
11,993,494 |
|
|
14,429,886 |
|
TOTAL EQUITY AND
LIABILITIES |
113,521,671 |
|
|
121,576,558 |
|
|
|
|
InflaRx N.V. and subsidiaryCondensed
Consolidated Statements of Changes in Shareholders’
Equity for the three months ended March 31,
2020 and 2019
in € |
Issuedcapital |
|
Sharepremium |
|
Othercapitalreserves |
|
Accumulateddeficit |
|
Othercomponentsof equity |
|
Totalequity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2020 |
3,132,631 |
|
211,006,606 |
|
25,142,213 |
|
(134,362,006 |
) |
|
2,227,228 |
|
107,146,673 |
|
Loss for the period |
— |
|
— |
|
— |
|
(8,233,397 |
) |
|
— |
|
(8,233,397 |
) |
Exchange differences on
translation of operations in foreign currency |
— |
|
— |
|
— |
|
— |
|
|
1,713,868 |
|
1,713,868 |
|
Total comprehensive
loss |
— |
|
— |
|
— |
|
(8,233,397 |
) |
|
1,713,868 |
|
(6,519,529 |
) |
Transactions with
owners of the Company |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contributions |
|
|
|
|
|
|
|
|
|
Equity-settled share-based
payment |
— |
|
— |
|
901,033 |
|
— |
|
|
— |
|
901,033 |
|
Total
Contributions |
— |
|
— |
|
901,033 |
|
— |
|
|
— |
|
901,033 |
|
Total transactions
with owners of the Company |
— |
|
— |
|
901,033 |
|
— |
|
|
— |
|
901,033 |
|
Balance at March 31,
2020* |
3,132,631 |
|
211,006,606 |
|
26,043,246 |
|
(142,595,403 |
) |
|
3,941,097 |
|
101,528,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1,
2019 |
3,115,725 |
|
211,021,835 |
|
18,310,003 |
|
(81,107,188 |
) |
|
50,196 |
|
151,390,571 |
|
Loss for the period |
— |
|
— |
|
— |
|
(9,837,871 |
) |
|
— |
|
(9,837,871 |
) |
Exchange differences on
translation of operations in foreign currency |
— |
|
— |
|
— |
|
— |
|
|
2,317,546 |
|
2,317,546 |
|
Total comprehensive
loss |
— |
|
— |
|
— |
|
(9,837,871 |
) |
|
2,317,546 |
|
(7,520,325 |
) |
Transactions with
owners of the Company |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contributions |
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity-settled share-based
payment |
— |
|
— |
|
2,097,780 |
|
— |
|
|
— |
|
2,097,780 |
|
Total
Contributions |
|
|
|
|
2,097,780 |
|
— |
|
|
— |
|
2,097,780 |
|
Total transactions
with owners of the Company |
— |
|
— |
|
2,097,780 |
|
— |
|
|
— |
|
2,097,780 |
|
Balance at March 31,
2019* |
3,115,725 |
|
211,021,835 |
|
20,407,783 |
|
(90,945,059 |
) |
|
2,367,742 |
|
145,968,026 |
|
*
unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
InflaRx N.V. and subsidiaryCondensed
Consolidated Statements of Cash Flows for the three months ended
March 31, 2020 and 2019
in € |
2020(unaudited) |
|
2019(unaudited) |
|
|
|
|
|
|
Operating
activities |
|
|
Loss for the period |
(8,233,397 |
) |
|
(9,837,871 |
) |
Adjustments for: |
|
|
Depreciation & Amortization of property, plant, equipment,
right-of-use assets and intangible assets |
182,356 |
|
|
116,519 |
|
Net financial result |
(1,540,965 |
) |
|
(1,097,495 |
) |
Share-based payment expense |
901,033 |
|
|
2,097,780 |
|
Other non-cash adjustments |
(129,122 |
) |
|
81,346 |
|
Changes in: |
|
|
Other assets |
188,476 |
|
|
(581,651 |
) |
Employee benefits |
(428,526 |
) |
|
(333,864 |
) |
Social securities, other current non-financial liabilities |
1,953 |
|
|
457,497 |
|
Trade and other payables |
(1,922,724 |
) |
|
364,158 |
|
Interest received |
462,342 |
|
|
241,817 |
|
Interest paid |
(2,246 |
) |
|
(6,682 |
) |
Net cash flows from
operating activities |
(10,520,819 |
) |
|
(8,498,447 |
) |
Investing
activities |
|
|
Purchase of intangible assets,
laboratory and office equipment |
(27,686 |
) |
|
(254,316 |
) |
Purchase of current financial
assets |
(23,412,469 |
) |
|
(10,599 |
) |
Disposal of current financial
assets |
— |
|
|
3,088 |
|
Securities matured |
20,724,386 |
|
|
— |
|
Net cash flows from
investing activities |
(2,715,769 |
) |
|
(261,827 |
) |
Financing
activities |
|
|
Repayment of leasing
liabilities |
(88,339 |
) |
|
(54,781 |
) |
Net cash flows from
financing activities |
(88,339 |
) |
|
(54,781 |
) |
Net (decrease)/increase in cash
and cash equivalents |
(13,324,927 |
) |
|
(8,815,054 |
) |
Effect of exchange rate changes
on cash and cash equivalents |
1,277,255 |
|
|
592,005 |
|
Cash and cash equivalents at
beginning of period |
33,131,280 |
|
|
55,386,240 |
|
Cash and cash equivalents
at end of period |
21,083,608 |
|
|
47,163,191 |
|
|
|
|
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.
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 indications, including
Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma
Gangraenosum and COVID-19 pneumonia.
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.Jordan Zwick –
Global Head of Business Development & Corporate StrategyEmail:
jordan.zwick[at]inflarx.deTel: +1 917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas Jungfer Email: inflarx[at]mc-services.eu
Europe: +49 89-210 2280US: +1-339-832-0752
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,” “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 impact of the COVID-19
pandemic on the Company; the timing and our ability to commence and
conduct clinical trials; potential results from current or
potential future collaborations; our ability to make regulatory
filings, obtain positive guidance from regulators, 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.
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