InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, announced today financial results for the three
and six months ended June 30, 2020.
“The encouraging data from the randomized
exploratory first part of our study in COVID-19 are in line with
the mode of action of IFX-1 and give hope that C5a inhibition with
IFX-1 may be a life-saving treatment option. The results have been
submitted for publication in a peer-reviewed medical journal and to
a pre-print server, and we are planning an adequately controlled
and powered Phase III part of the study in critically ill COVID-19
patients,” said Prof. Niels C. Riedemann, Chief Executive Officer
and Founder of InflaRx.
Prof. Riedemann continued, “We just received the
EMA scientific advice agreeing with our arguments on the
limitations of the currently used score in hidradenitis suppurativa
development (HiSCR) and suggesting that IHS4 could be used as the
primary endpoint in our pivotal studies. Our initial interactions
with both EMA and FDA related to a Phase III development program in
hidradenitis suppurativa have shown us that IFX-1 is a Phase III
ready drug candidate. We are working on a strategy to address the
FDA´s concerns related to the suggested change in the primary
endpoint and plan additional FDA interactions on this topic. Our
other clinical programs with IFX-1 are moving forward in pyoderma
gangraenosum and ANCA-associated vasculitis. Depending on the
COVID-19 situation, we expect readouts in these indications in
2021.”
Recent R&D Highlights
- IFX-1 in COVID-19 induced pneumonia: In June
2020, InflaRx announced encouraging results from the first 30
patients treated in the adaptive randomized Phase II/III trial in
patients with severe COVID-19 induced pneumonia. Positive
treatment trends were seen in the 28-day all-cause mortality rate
and in various other endpoints. Twenty-eight-day all-cause
mortality in the IFX-1 treatment group was 13% (2 out of 15) versus
27% (4 out of 15) in the control group. In the best supportive care
group, four patients died of COVID-19-induced multi-organ failure,
and three of them had pulmonary embolisms reported as a serious
adverse event. In the IFX-1 treatment arm, one patient died after
an acute ventilator tube complication (leakage) leading to hypoxia,
and one patient who met an exclusion criterion with a history of
severe chronic obstructive pulmonary disease, which was not known
at time point of enrollment, died of pulmonary failure.
Additionally, fewer patients in the IFX-1 treatment arm experienced
renal impairment assessed by estimated glomerular filtration rates,
and more patients showed reversal of blood lymphocytopenia and a
greater lowering of lactate dehydrogenase concentrations as a sign
of reduction in tissue damage. A temporary significant increase of
D-dimer levels in the first days following IFX-1 administration was
noted, as potentially an expression of induction of blood clot
lysis. No statistically significant group differences on the chosen
primary endpoint of relative change (%) from baseline to day 5 in
oxygenation index (defined as PaO2/FiO2 ratio) were detected.
However, the exploratory first part of this study was not powered
to show such differences. InflaRx is now planning an adequately
powered, placebo-controlled, double blinded Phase III part using
28-day all-cause mortality as the primary endpoint, an accepted
regulatory primary endpoint for critical care studies.
- IFX-1 in Hidradenitis Suppurativa (HS): In
June 2020, InflaRx completed an end-of-Phase II meeting with the
FDA to discuss a Phase III program for the use of IFX-1 for the
treatment of HS. The FDA agreed to key proposals to support a
Biologics License Application (BLA) submission, including aspects
of the Phase III trial design, IFX-1 dosing, target study
population, and the nonclinical and clinical pharmacology packages.
While the FDA did not agree that the International Hidradenitis
Suppurativa Severity Score (“IHS4”) is fit for purpose as a primary
efficacy endpoint tool to support labeling, the FDA recommended
that the Company obtain HS patient input to help determine the
validity of the IHS4 score. The Company is now assessing different
strategies for a potential pathway to regulatory approval for IFX-1
in the United States and plans to engage with the FDA on next
steps.Additionally, the Company requested scientific advice from
the European Medicines Agency (EMA) about the European pathway for
regulatory approval and received feedback in July 2020. Although
the EMA noted certain considerations regarding the Company’s
proposal, the EMA acknowledged that HiSCR response does not account
for the clinical relevance of a reduction in draining fistulas and
the effort to construct a new endpoint that better captures these
changes was endorsed in principle. According to the EMA,
although HiSCR was used as an endpoint in previous studies, IHS4
could be an appropriate tool to evaluate the efficacy of a novel
compound in HS. The Company is working diligently to address the
additional feedback received and analyzing the strategy for its
Phase III development in HS.
- IFX-1 in Pyoderma Gangraenosum (PG): The Phase
IIa open label trial continues to enroll patients in the higher
dose groups. Additional clinical trial sites continue to be opened
to support enrollment. Results from the higher dose groups are
expected in 2021.
- IFX-1 in ANCA-associated vasculitis (AAV): In
the European Phase II IXCHANGE trial, Part 2 continues to enroll
patients. Final results are expected in 2021.
- IFX-1 in oncology: Activities are ongoing for
the Phase IIa oncology program, with expected initiation in the
first half of 2021.
Financial highlights – H1
2020
Research and development
expenses incurred for the six months ended June 30, 2020
decreased over the corresponding period in 2019 by €5.5 million.
This decline was primarily due to lower contribution of expense in
the period from the Phase IIb clinical development of IFX-1 in HS
since this study was completed in 2019, offset by the COVID-19
trial expenses. These two factors led to a net decline of €3.7
million in third-party expenses. Furthermore third-party
manufacturing expenses also declined by €1.0 million. Additionally,
equity-settled share-based compensation recognized in personnel
expenses decreased by €0.9 million.
General and administrative
expenses decreased by €2.1 million to €4.9 million for the
six months ended June 30, 2020, from €6.9 million for the six
months ended June 30, 2019. This decrease is primarily attributable
to decreasing expenses associated with equity-settled share-based
compensation recognized in personnel expenses (€1.5 million).
Furthermore, legal, consulting and other expenses decreased by €0.7
million to €2.1 million for the six months ended June 30, 2020,
from €2.8 million for the six months ended June 30, 2019. In 2019,
consulting costs were higher due to a onetime strategic
project.
Net financial result decreased
by €1.0 million to €1.1 million for the six months ended June 30,
2020, from €2.0 million for the six months ended June 30, 2019.
This decrease is mainly attributable to lower interest earned on
marketable securities (€1.1 million), partially offset by a higher
foreign exchange result (higher gains €0.9 million and €0.5 million
higher losses).
Net loss for the six months
ended June 30, 2020 was €18.3 million or €(0.70) per common share,
compared to €25.1 million or €(0.97) per common share for the six
months ended June 30, 2019. On June 30, 2020, the Company’s
total funds available were approximately €98.9
million, composed of cash and cash equivalents (€36.4 million)
and financial assets (€62.5 million).
Net cash used in operating
activities decreased to €18.2 million in the six months
ended June 30, 2020, from €18.7 million in the six months ended
June 30, 2019, mainly due to the decrease of cash expenses, such as
third-party expenses for manufacturing and clinical trials for our
lead program IFX-1, compensated by lower payments on trade
liabilities in the six months ended June 30, 2019.Additional
information regarding these results and other relevant information
is included in the notes to the unaudited Condensed Consolidated
Financial Statements as of June 30, 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
subsidiariesUnaudited Condensed Consolidated
Statements of Operations andComprehensive Loss for
the three and six months ended June 30, 2020 and 2019
|
For the three months endedJune
30, |
For the six months endedJune
30, |
(in €, except for
share data) |
2020(unaudited) |
|
2019(unaudited) |
|
2020(unaudited) |
|
2019(unaudited) |
|
|
|
|
|
Operating
Expenses |
|
|
|
|
Research and development expenses |
(7,356,326 |
) |
|
(12,497,222 |
) |
|
(14,655,125 |
) |
|
(20,192,372 |
) |
General and administrative
expenses |
(2,326,895 |
) |
|
(3,647,849 |
) |
|
(4,891,698 |
) |
|
(6,949,015 |
) |
Total Operating
Expenses |
(9,683,221 |
) |
|
(16,145,071 |
) |
|
(19,546,822 |
) |
|
(27,141,387 |
) |
Other income |
102,332 |
|
|
2,866 |
|
|
197,292 |
|
|
67,702 |
|
Other expenses |
(3,450 |
) |
|
(79,183 |
) |
|
(9,170 |
) |
|
(83,068 |
) |
Operating
Result |
(9,584,339 |
) |
|
(16,221,387 |
) |
|
(19,358,701 |
) |
|
(27,156,753 |
) |
Finance income |
609,444 |
|
|
1,338,755 |
|
|
2,268,436 |
|
|
2,497,960 |
|
Finance expenses |
(1,057,937 |
) |
|
(388,097 |
) |
|
(1,175,964 |
) |
|
(449,807 |
) |
Net Financial
Result |
(448,493 |
) |
|
950,659 |
|
|
1,092,472 |
|
|
2,048,153 |
|
Loss for the
Period |
(10,032,832 |
) |
|
(15,270,729 |
) |
|
(18,266,229 |
) |
|
(25,108,600 |
) |
|
|
|
|
|
Share
Information |
|
|
|
|
Weighted average number of
shares outstanding |
26,172,023 |
|
|
25,964,379 |
|
|
26,138,639 |
|
|
25,964,379 |
|
Loss per share
(basic/diluted) |
(0.38 |
) |
|
(0.59 |
) |
|
(0.70 |
) |
|
(0.97 |
) |
|
|
|
|
|
Loss for the
Period |
(10,032,832 |
) |
|
(15,270,729 |
) |
|
(18,266,229 |
) |
|
(25,108,600 |
) |
Other comprehensive income
that may be reclassified to profit or loss in subsequent
periods: |
|
|
|
|
Exchange differences on
translation of foreign currency |
(1,452,973 |
) |
|
(1,622,079 |
) |
|
260,895 |
|
|
695,468 |
|
Total Comprehensive
Loss |
(11,485,805 |
) |
|
(16,892,807 |
) |
|
(18,005,334 |
) |
|
(24,413,132 |
) |
|
|
|
|
|
InflaRx N.V. and
subsidiaryUnaudited Condensed Consolidated
Statements of Financial Positionas of June 30,
2020 and December 31, 2019
in € |
June 30,
2020(unaudited) |
|
December 31, 2019 |
|
|
|
|
|
|
|
ASSETS |
|
|
Non-current
assets |
|
|
Property, plant and
equipment |
493,377 |
|
576,373 |
|
Right-of-use assets |
716,871 |
|
836,924 |
|
Intangible assets |
404,251 |
|
452,400 |
|
Other assets |
419,424 |
|
452,217 |
|
Financial assets |
272,627 |
|
272,614 |
|
Total non-current
assets |
2,306,550 |
|
2,590,528 |
|
Current
assets |
|
|
Other assets |
2,973,228 |
|
3,500,884 |
|
Financial assets |
62,191,912 |
|
82,353,867 |
|
Cash and cash equivalents |
36,398,578 |
|
33,131,280 |
|
Total current
assets |
101,563,718 |
|
118,986,031 |
|
TOTAL
ASSETS |
103,870,268 |
|
121,576,558 |
|
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
Equity |
|
|
Issued capital |
3,152,427 |
|
3,132,631 |
|
Share premium |
211,483,756 |
|
211,006,606 |
|
Other capital reserves |
26,627,185 |
|
25,142,213 |
|
Accumulated deficit |
(152,628,234 |
) |
(134,362,006 |
) |
Other components of equity |
2,488,124 |
|
2,227,228 |
|
Total
equity |
91,123,258 |
|
107,146,673 |
|
|
|
|
Non-current
liabilities |
|
|
Lease liabilities |
203,636 |
|
330,745 |
|
Other non-financial
liabilities |
37,644 |
|
39,013 |
|
Total non-current
liabilities |
241,280 |
|
369,758 |
|
Current
liabilities |
|
|
Trade and other payables |
10,630,462 |
|
12,413,662 |
|
Lease liabilities |
524,034 |
|
515,203 |
|
Employee benefits |
867,121 |
|
975,629 |
|
Social security, other tax and
non-financial liabilities |
448,113 |
|
105,634 |
|
Provisions |
36,000 |
|
50,000 |
|
Total current
liabilities |
12,505,730 |
|
14,060,128 |
|
Total
Liabilities |
12,747,010 |
|
14,429,886 |
|
TOTAL EQUITY AND
LIABILITIES |
103,870,268 |
|
121,576,558 |
|
|
|
|
|
|
|
InflaRx N.V. and
subsidiaryUnaudited Condensed Consolidated
Statements of Changes in Shareholders’ Equity for the six months
ended June 30, 2020 and 2019
(in €, except for share data) |
Issued capital |
|
Share premium |
|
Other capital reserves |
|
Accumulated deficit |
|
|
Other components of equity |
|
Total equity |
|
|
|
|
|
|
|
|
|
|
|
Balance as of 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 |
— |
|
— |
|
— |
|
(18,266,229 |
) |
|
— |
|
(18,266,229 |
) |
Exchange differences on
translation of foreign currency |
— |
|
— |
|
— |
|
— |
|
|
260,895 |
|
260,895 |
|
Total comprehensive
loss |
— |
|
— |
|
— |
|
(18,266,229 |
) |
|
260,895 |
|
(18,005,334 |
) |
Contributions |
|
|
|
|
|
|
|
|
|
|
Equity-settled share-based
payment |
— |
|
— |
|
1,484,972 |
|
— |
|
|
— |
|
1,484,972 |
|
Share options exercised |
19,797 |
|
477,149 |
|
— |
|
— |
|
|
— |
|
496,946 |
|
Total
Contributions |
19,797 |
|
477,149 |
|
1,484,972 |
|
— |
|
|
— |
|
1,981,918 |
|
Balance as of June 30,
2020 |
3,152,427 |
|
211,483,756 |
|
26,627,185 |
|
(152,628,234 |
) |
|
2,488,124 |
|
91,123,258 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1,
2019 |
3,115,725 |
|
211,021,835 |
|
18,310,003 |
|
(81,107,188 |
) |
|
50,196 |
|
151,390,571 |
|
Loss for the period |
— |
|
— |
|
— |
|
(25,108,600 |
) |
|
— |
|
(25,108,600 |
) |
Exchange differences on
translation of foreign currency |
— |
|
— |
|
— |
|
— |
|
|
695,468 |
|
695,468 |
|
Total comprehensive
loss |
— |
|
— |
|
— |
|
(25,108,600 |
) |
|
695,468 |
|
(24,413,132 |
) |
Contributions |
|
|
|
|
|
|
|
|
|
|
Equity-settled share-based
payment |
— |
|
— |
|
3,889,767 |
|
— |
|
|
— |
|
3,889,767 |
|
Total
Contributions |
— |
|
— |
|
3,889,767 |
|
— |
|
|
— |
|
3,889,767 |
|
Balance as of June 30,
2019 |
3,115,725 |
|
211,021,835 |
|
22,199,770 |
|
(106,215,788 |
) |
|
745,663 |
|
130,867,206 |
|
|
|
|
|
|
|
|
|
|
|
|
InflaRx N.V. and
subsidiaryUnaudited Condensed Consolidated
Statements of Cash Flowsfor the six months ended
June 30, 2020 and 2019
in € |
For the six months ended June 30,
2020(unaudited) |
|
|
For the six months ended June 30,
2019(unaudited) |
|
|
|
Operating
activities |
|
|
Loss for the period |
(18,266,229 |
) |
|
(25,108,600 |
) |
Adjustments for: |
|
|
Depreciation & amortization of property, plant, equipment,
right-of-use assets and intangible assets |
353,976 |
|
|
307,130 |
|
Net financial result |
(1,092,472 |
) |
|
(2,048,153 |
) |
Share-based payment expense |
1,484,972 |
|
|
3,889,767 |
|
Net foreign exchange differences |
(789,528 |
) |
|
(205,103 |
) |
Changes in: |
|
|
Other assets |
560,449 |
|
|
(2,063,491 |
) |
Employee benefits |
(122,411 |
) |
|
(84,890 |
) |
Social security and other current non-financial liabilities |
341,012 |
|
|
(184,120 |
) |
Trade and other payables |
(1,783,200 |
) |
|
5,513,355 |
|
Interest received |
1,096,651 |
|
|
1,269,745 |
|
Interest paid |
(5,455 |
) |
|
(16,308 |
) |
Net cash used in
operating activities |
(18,222,235 |
) |
|
(18,730,669 |
) |
Investing
activities |
|
|
Purchase of intangible assets,
laboratory and office equipment |
(35,107 |
) |
|
(503,881 |
) |
Purchase of non-current other
financial assets |
— |
|
|
(75,543 |
) |
Disposal of non-current other
financial assets |
— |
|
|
3,088 |
|
Purchase of current financial
assets |
(59,196,096 |
) |
|
— |
|
Proceeds from the maturity of
financial assets |
56,553,296 |
|
|
17,709,459 |
|
Net cash from investing
activities |
20,272,857 |
|
|
17,133,122 |
|
Financing
activities |
|
|
Proceeds from exercise of share
options |
496,946 |
|
|
— |
|
Repayment of lease
liabilities |
(183,970 |
) |
|
(125,075 |
) |
Net cash from/ (used in)
financing activities |
312,976 |
|
|
(125,075 |
) |
Net (decrease)/increase in cash
and cash equivalents |
2,363,597 |
|
|
(1,722,622 |
) |
Effect of exchange rate changes
on cash and cash equivalents |
903,700 |
|
|
399,266 |
|
Cash and cash equivalents at
beginning of period |
33,131,280 |
|
|
55,386,240 |
|
Cash and cash equivalents
at end of period |
36,398,578 |
|
|
54,062,885 |
|
|
|
|
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 of 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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