InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, announced today financial and operating results
for the three months ended March 31, 2022 and provided a business
update.
Prof. Niels C. Riedemann, Chief Executive
Officer and Founder of InflaRx, commented: “Following a recent
internal strategic review, we are announcing the Company’s updated
key priorities and strategy. With final data now available from our
Phase IIa study, we intend to move vilobelimab into a pivotal
program in pyoderma gangrenosum and advance INF-904, our small
molecule C5aR inhibitor, into first-in-human testing this year.
Additionally, with the encouraging topline Phase III results we saw
with vilobelimab in treating severe COVID-19 patients, we are now
discussing our data with regulatory authorities to assess a
potential path towards approval. With all of these important
activities, we decided to halt the Phase III program in
hidradenitis suppurativa and not to advance vilobelimab in AAV for
the time being to prioritize the best use of our resources. We are
excited about InflaRx’s potential to develop effective new
treatments to improve the lives of patients suffering from
neutrophil-driven inflammatory diseases.”
Recent Highlights
– Progress with Vilobelimab in Several
Indications
Severe COVID-19: On March 31,
2022, InflaRx announced topline results from the Phase III part of
the global Phase II/III PANAMO trial evaluating vilobelimab in
mechanically ventilated patients with COVID-19. A total of 369
patients were enrolled. Vilobelimab treatment resulted in a
relative reduction in 28-day all-cause mortality of 23.9% compared
to placebo (vilobelimab 31.7% versus placebo 41.6%, p=0.094), which
was not statistically significant using site-stratified Cox
regression analysis as pre-specified in the final statistical
analysis plan. At the recommendation of regulatory authorities,
during the course of the trial, the Company changed the statistical
analysis method for the primary endpoint. The original
protocol-specified analysis would have resulted in a statistically
significant p-value of 0.027. Additionally, logistic regression
analyses of 28-day all-cause mortality resulted in p-values of
<0.05 for 3 out of the 4 pre-specified analyses.
A pre-specified analysis of patients from
Western European countries showed a relative reduction in 28-day
all-cause mortality of 43% (p=0.014), suggesting an improvement in
mortality in line with the reported Phase II data from the PANAMO
trial.
Importantly, 60-day all-cause mortality, a key
secondary endpoint, showed a continued reduction of mortality in
the vilobelimab arm.
The Company is engaged in ongoing discussions
with regulatory authorities to determine next steps towards a
potential approval in this indication.
Pyoderma Gangrenosum (PG):
InflaRx presented final data from an open-label, multi-center Phase
IIa exploratory study evaluating the safety and efficacy of
vilobelimab in patients with moderate to severe PG at the American
Academy of Dermatology Association (AAD) Annual Meeting on March
26, 2022 in an oral late-breaker session by Afsaneh Alavi, MD,
Associate Professor of Dermatology, Mayo Clinic. The final results
showed a strong dose-dependent effect in the highest dose cohort of
2400 mg, with 6 out of 7 patients showing a clinical remission
(Physician Global Assessment (PGA) score ≤ 1) and closure of the
target ulcer. The seventh patient showed a slight improvement (PGA
score 4) with a decrease of the target ulcer area of over 50%.
During the follow-up period, ulcers remained closed two months
after treatment completion in all but one patient, and a sustained
suppression of C5a was observed for up to 20 days after the last
dosing. With these compelling results, an end-of-Phase II meeting
has been scheduled with the FDA for mid-2022 to discuss the pivotal
program in this indication.
Cutaneous Squamous Cell Carcinoma
(cSCC): InflaRx is developing vilobelimab for the
treatment of PD-1/PD-L1 inhibitor resistant/refractory locally
advanced or metastatic cSCC. An open-label, non-comparative,
two-stage, Phase II trial in cSCC is ongoing and has two
independent arms: vilobelimab alone (Arm A) and vilobelimab in
combination with pembrolizumab (Arm B).
Enrollment continues in the monotherapy Arm A.
Eight patients are now enrolled in this arm. Data are expected to
be available in the third quarter of 2022.
In February 2022, the Company announced the
start of the second dosing cohort of Arm B. The interim analysis in
this arm is expected after ten patients have been treated and are
evaluable for response assessment at the recommended Phase II dose
level, which will be selected based on data from the safety run-in
phase of the study. These Arm B interim data, which are a
prerequisite to move to the second stage of the trial, are expected
to be available in the second half of 2023.
Hidradenitis Suppurativa (HS) and
ANCA-Associated Vasculitis (AAV): In response to its
recent strategic pipeline review, the Company has decided to move
vilobelimab into pivotal testing in pyoderma gangrenosum and to
halt the development of vilobelimab in HS and not to advance
vilobelimab in AAV for the time being.
New Development Program
Introduced InflaRx announced in January 2022 a new
pipeline program, INF904, an oral small molecule inhibitor of C5aR.
InflaRx has been granted a composition of matter patent for INF904
and associated compounds by the U.S. Patent and Trademark Office
and has completed investigational new drug (IND)-enabling
(preclinical) studies that demonstrated no obvious toxicological
findings even in the highest dose groups in required GLP toxicity
analyses.
The Company expects to initiate a Phase I
program in the second half of 2022 and plans to study INF904 in
complement-mediated, chronic autoimmune and inflammatory diseases
where oral administration is the preferred choice for patients.
Financial
Highlights –
Q1
2022
Research and Development
Expenses
Research and development expenses for the three
months ended March 31, 2022 increased by €5.6 million to €10.5
million compared to the three months ended March 31, 2021. This
increase was primarily due to the completion of Phase III clinical
development of vilobelimab for the treatment of COVID-19. This led
to an increase of €3.1 million in manufacturing costs, which
significantly contributed to an overall increase of €5.1 million in
third-party expenses. The €0.5 million increase in personnel
expenses was mainly related to equity-settled share-based
compensation.
General and Administrative
Expenses
General and administrative expenses increased by
€1.4 million to €4.4 million for the three months ended March 31,
2022, from €3.0 million for the three months ended March 31, 2021.
This increase is attributable to higher personnel expenses from
equity-settled share-based compensation recognized in personnel
expenses of €0.4 million. Additionally, legal, consulting and other
expenses increased to €1.9 million for the three months ended March
31, 2022, from €1.0 million for the three months ended March 31,
2021.
Net Financial Result
Net financial result decreased by €0.9 million
to €0.9 million for the three months ended March 31, 2022, from
€1.8 million for the three months ended March 31, 2021. This
decrease is mainly attributable to lower foreign exchange gains,
which decreased by €1.3 million, and higher foreign exchange losses
of €0.3 million. Other finance expenses for the three months ended
March 31, 2022 included a €48 thousand gain from a reduction in the
allowance for expected credit loss on marketable securities.
Net Loss
Net loss for the three months ended March 31,
2022 was €14.0 million, compared to €6.1 million for the three
months ended March 31, 2021.
On March 31, 2022, the Company’s total funds
available were approximately €99.3 million, composed of cash and
cash equivalents of €40.1 million and financial assets of €59.2
million. With the Company’s adjusted strategy, these funds are
expected to finance operations well into the second half of
2024.
Net Cash Used in Operating
Activities
Net cash used in operating activities increased
to €12.9 million in the three months ended March 31, 2022, from
€10.4 million in the three months ended March 31, 2021.
Additional information regarding these results
and other relevant information is included in the notes to the
unaudited interim condensed consolidated financial statements as of
March 31, 2022 and the three months ended March 31, 2022 and 2021,
as well as the consolidated financial statements as of and for the
year ended December 31, 2021 in “ITEM 18. Financial Statements,” in
InflaRx’s Annual Report on Form 20-F for the year ended December
31, 2021 as filed with the U.S. Securities and Exchange
Commission.
InflaRx N.V. and
subsidiariesUnaudited Condensed Consolidated
Statements of Operations
and Comprehensive Loss for the three months
ended March 31,
2022 and
2021
|
For the three months endedMarch
31, |
(in €, except for share data) |
2022(unaudited) |
|
2021(unaudited) |
|
|
|
Operating Expenses |
|
|
Research and development expenses |
(10,471,923 |
) |
|
(4,906,885 |
) |
General and administrative expenses |
(4,387,443 |
) |
|
(3,022,338 |
) |
Total Operating Expenses |
(14,859,366 |
) |
|
(7,929,224 |
) |
Other income |
1,593 |
|
|
5,462 |
|
Other expenses |
(565 |
) |
|
(565 |
) |
Operating Result |
(14,858,338 |
) |
|
(7,924,327 |
) |
Finance income |
27,962 |
|
|
22,962 |
|
Finance expenses |
(24,586 |
) |
|
(3,684 |
) |
Foreign exchange result |
727,933 |
|
|
1,731,671 |
|
Other financial result |
125,000 |
|
|
48,000 |
|
Income Taxes |
— |
|
|
— |
|
Loss for the Period |
(14,002,030 |
) |
|
(6,125,378 |
) |
|
|
|
Share Information |
|
|
Weighted average number of shares outstanding |
44,203,763 |
|
|
33,807,774 |
|
Loss per share (basic/diluted) |
(0.32 |
) |
|
(0.18 |
) |
|
|
|
|
|
Loss for the Period |
(14,002,030 |
) |
|
(6,125,378 |
) |
|
|
|
|
|
|
Other comprehensive income (loss) that may be reclassified to
profit or loss in subsequent periods: |
|
|
|
|
Exchange differences on translation of foreign currency |
1,309,875 |
|
|
3,504,699 |
|
Total Comprehensive Loss |
(12,692,154 |
) |
|
(2,620,679 |
) |
|
|
|
InflaRx N.V. and
subsidiariesUnaudited Condensed
Consolidated Statements of Financial Positionas
of March 31,
2022 and
December 31,
2021
in € |
March31,2022(unaudited) |
|
December31,2021 |
|
|
|
ASSETS |
|
|
Non-current assets |
|
|
Property and equipment |
251,713 |
|
|
274,373 |
|
Right-of-use assets |
1,314,691 |
|
|
1,408,078 |
|
Intangible assets |
209,818 |
|
|
235,216 |
|
Other assets |
331,539 |
|
|
336,566 |
|
Financial assets |
9,272,352 |
|
|
27,206,990 |
|
Total non-current assets |
11,380,114 |
|
|
29,461,224 |
|
Current assets |
|
|
Current other assets |
12,521,363 |
|
|
10,983,458 |
|
Current tax assets |
1,154,604 |
|
|
1,282,177 |
|
Financial assets |
49,925,236 |
|
|
57,162,266 |
|
Cash and cash equivalents |
40,096,286 |
|
|
26,249,995 |
|
Total current assets |
103,697,489 |
|
|
95,677,896 |
|
TOTAL ASSETS |
115,077,603 |
|
|
125,139,120 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
Equity |
|
|
Issued capital |
5,304,452 |
|
|
5,304,452 |
|
Share premium |
280,310,744 |
|
|
280,310,744 |
|
Other capital reserves |
33,121,984 |
|
|
30,591,209 |
|
Accumulated deficit |
(227,977,709 |
) |
|
(213,975,679 |
) |
Other components of equity |
4,360,146 |
|
|
3,050,270 |
|
Total equity |
95,119,617 |
|
|
105,280,996 |
|
Non-current liabilities |
|
|
Lease liabilities |
973,905 |
|
|
1,066,354 |
|
Other liabilities |
35,628 |
|
|
35,019 |
|
Total non-current liabilities |
1,009,533 |
|
|
1,101,373 |
|
Current liabilities |
|
|
Trade and other payables |
9,502,770 |
|
|
8,574,244 |
|
Liabilities from government grants received |
8,300,000 |
|
|
8,300,000 |
|
Lease liabilities |
369,676 |
|
|
366,171 |
|
Employee benefits |
644,646 |
|
|
1,378,130 |
|
Other financial liabilities |
131,362 |
|
|
138,206 |
|
Total current liabilities |
18,948,452 |
|
|
18,756,751 |
|
Total Liabilities |
19,957,985 |
|
|
19,858,124 |
|
TOTAL EQUITY AND LIABILITIES |
115,077,603 |
|
|
125,139,120 |
|
|
|
|
InflaRx N.V. and
subsidiariesUnaudited
Condensed Consolidated Statements of Changes in
Shareholders’ Equity for the
three months ended March
31, 2022 and
2021
(in €, except for share data) |
Issuedcapital |
|
Sharepremium |
|
Othercapitalreserves |
|
Accumulateddeficit |
|
Othercomponentsof
equity |
|
Totalequity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balanceas ofJanuary 1,
2022 |
5,304,452 |
|
280,310,744 |
|
|
30,591,209 |
|
(213,975,679 |
) |
|
3,050,271 |
|
|
105,280,996 |
|
Loss for the period |
— |
|
— |
|
|
— |
|
(14,002,030 |
) |
|
— |
|
|
(14,002,030 |
) |
Exchange differences ontranslation of foreign currency |
— |
|
— |
|
|
— |
|
— |
|
|
1,309,875 |
|
|
1,309,875 |
|
Total comprehensive loss |
— |
|
— |
|
|
— |
|
(14,002,030 |
) |
|
1,309,875 |
|
|
(12,692,155 |
) |
Equity-settled share-based payments |
— |
|
— |
|
|
2,530,775 |
|
— |
|
|
— |
|
|
2,530,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balanceas ofMarch 31,
2022 |
5,304,452 |
|
280,310,744 |
|
|
33,121,984 |
|
(227,977,709 |
) |
|
4,360,146 |
|
|
95,119,617 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1,
2021 |
3,387,410 |
|
220,289,876 |
|
|
26,259,004 |
|
(168,345,620 |
) |
|
(3,726,790 |
) |
|
77,863,880 |
|
Loss for the period |
— |
|
— |
|
|
— |
|
(6,125,378 |
) |
|
— |
|
|
(6,125,378 |
) |
Exchange differenceson translation of foreign currency |
— |
|
— |
|
|
— |
|
— |
|
|
3,504,699 |
|
|
3,504,699 |
|
Total comprehensive loss |
— |
|
— |
|
|
— |
|
(6,125,378 |
) |
|
3,504,699 |
|
|
(2,620,679 |
) |
Issuance of common shares and warrants |
1,873,203 |
|
63,269,346 |
|
|
— |
|
— |
|
|
— |
|
|
65,142,549 |
|
Transaction costs |
— |
|
(4,219,222 |
) |
|
— |
|
— |
|
|
— |
|
|
(4,219,222 |
) |
Equity-settled share-based payments |
— |
|
— |
|
|
1,721,270 |
|
— |
|
|
— |
|
|
1,721,270 |
|
Share options exercised |
41,741 |
|
921,994 |
|
|
— |
|
— |
|
|
— |
|
|
963,735 |
|
Balance as of March 31, 2021 |
5,302,354 |
|
280,261,994 |
|
|
27,980,274 |
|
(174,470,998 |
) |
|
(222,091 |
) |
|
138,851,532 |
|
|
|
|
|
|
|
|
|
|
InflaRx N.V. and
subsidiariesUnaudited
Condensed Consolidated Statements of Cash Flows for
the three months ended
March 31, 2022
and 2021
in € |
For the threemonths
endedMarch 31,
2022(unaudited) |
|
For the threemonths
endedMarch31,
2021(unaudited) |
|
|
|
Operating activities |
|
|
Loss for the period |
(14,002,030 |
) |
|
(6,125,378 |
) |
Adjustments for: |
|
|
Depreciation & amortization of property and equipment,
right-of-use assets and intangible assets |
153,321 |
|
|
168,343 |
|
Net finance income |
(856,308 |
) |
|
(1,798,949 |
) |
Share-based payment expense |
2,530,775 |
|
|
1,721,270 |
|
Net foreign exchange differences |
135,826 |
|
|
193,847 |
|
Changes in: |
|
|
Other assets |
(1,405,328 |
) |
|
(2,739,152 |
) |
Employee benefits |
(732,876 |
) |
|
(952,820 |
) |
Other liabilities |
(6,844 |
) |
|
240,229 |
|
Trade and other payables |
928,526 |
|
|
(1,150,252 |
) |
Interest received |
420,916 |
|
|
33,189 |
|
Interest paid |
(24,641 |
) |
|
(3,780 |
) |
Net cash used in operating activities |
(12,858,662 |
) |
|
(10,413,453 |
) |
Investing activities |
|
|
Purchase of intangible assets, property and equipment |
(7,828 |
) |
|
(17,062 |
) |
Purchase of current financial assets |
— |
|
|
(14,985,026 |
) |
Proceeds from the maturity of financial assets |
26,488,950 |
|
|
13,952,522 |
|
Net cash from/ (used
in)investing activities |
26,481,122 |
|
|
(1,049,566 |
) |
Financing activities |
|
|
Proceeds from issuance of common shares |
— |
|
|
65,142,549 |
|
Transaction costs from issuance of common shares |
— |
|
|
(4,219,222 |
) |
Proceeds from exercise of share options |
— |
|
|
963,735 |
|
Repayment of lease liabilities |
(90,806 |
) |
|
(90,716 |
) |
Net cash from/ (used in) financing activities |
(90,806 |
) |
|
61,796,346 |
|
Net increase/(decrease) in cash and cash equivalents |
13,531,653 |
|
|
50,333,328 |
|
Effect of exchange rate changes on cash and cash equivalents |
314,639 |
|
|
2,432,654 |
|
Cash and cash equivalents at beginning of period |
26,249,995 |
|
|
25,968,681 |
|
Cash and cash equivalents at end of period |
40,096,286 |
|
|
78,734,662 |
|
|
|
|
About InflaRx N.V.:
InflaRx (Nasdaq: IFRX) is a clinical-stage
biopharmaceutical company focused on applying its proprietary
technology to discover and develop first-in-class or best-in-class,
potent and specific inhibitors of C5a and C5aR. Complement C5a and
its receptor C5aR are powerful inflammatory mediators 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.
The COVID-19 related work described herein is
partly funded by the German Federal Government through grant number
16LW0113 (Vilo-Covid). All responsibility for the content of this
work lies with InflaRx.
Contacts:
InflaRx N.V.
Jordan Zwick – Chief Strategy OfficerEmail:
IR@inflarx.deTel: +1 917-338-6523
MC Services AG
Katja Arnold, Laurie Doyle, Andreas
JungferEmail: inflarx@mc-services.euEurope: +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, development of vilobelimab for
mechanically ventilated COVID-19 patients; future analysis of our
Phase II/III PANAMO trial and interactions with regulators
regarding the results of the trial and potential regulatory
approval pathways; the impact of the COVID-19 pandemic on us; 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; decisions regarding the strategic direction of
our company; 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; our status as an emerging growth company
and/or foreign private issuer; 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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