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, 2021.
“We have made significant progress with our
vilobelimab clinical programs in the first few months of 2021,”
said Prof. Niels C. Riedemann, Chief Executive Officer and Founder
of InflaRx. “The team has worked tirelessly to progress the
enrollment of our severe COVID-19 trial and we now expect the
interim analysis to occur in the third quarter of this year.
Despite the increase in vaccinations, patients remain in urgent
need of better treatments for severe COVID-19. For HS, following
feedback on the Special Protocol Assessment, we plan to continue
our discussions with the FDA about the design of our Phase III
trial in a Type A meeting. Following the positive safety data from
our US ANCA-associated vasculitis trial, we are looking forward to
data readouts in our European AAV trial by the end of the year. In
our Pyoderma Gangraenosum trial we have reached target enrollment
and expect additional data readouts in 2021.”
Recent Highlights and R&D
Update
Issuance of Common Shares and
WarrantsOn February 25, 2021, the Company sold an
aggregate of 15,000,000 common shares through a public offering.
The common shares were sold at a price of $5.00 per share. For each
common share purchased, an investor also received a warrant to
purchase a common share at an exercise price of $5.80. The warrants
are exercisable immediately and have a term of up to one year. The
shares and warrants were issued and the transaction closed on March
1, 2021 with gross offering proceeds to the Group (not including
any potential proceeds from the exercise of warrants) of $75.0
million (€62.2 million), before deducting $4.5 million (€3.7
million) in underwriting discounts and other offering expenses of
$0.4 million (€0.3 million).
Vilobelimab for Hidradenitis Suppurativa
(HS)In Q1, InflaRx submitted a Special Protocol Assessment
(SPA) to the U.S. FDA for the Phase III HS program and in May the
Company received an official response. The FDA agreed to the dosing
regimen in the protocol but did not agree with the assessment of
the primary endpoint using the International Hidradenitis
Suppurativa Severity Score (IHS4). At the FDA’s suggestion, InflaRx
plans to request a Type A meeting to discuss the primary endpoint
measure in more detail.
In Europe, as previously reported in 2020,
InflaRx received scientific advice from the European Medicines
Agency (EMA) about the European pathway for regulatory approval,
including supporting the use of the IHS4 score as the primary
endpoint.
Once InflaRx receives final feedback from the
FDA on the proposed Phase III primary endpoint, the Company will
determine the best path forward for the global development program
in HS.
Vilobelimab for Severe
COVID-19The Phase III part of the global Phase II/III
trial evaluating vilobelimab in mechanically ventilated patients
with COVID-19 was initiated in mid-September 2020, and recruitment
has reached 178 patients, with 38 sites initiated across several
countries in Europe and Latin America. Once 180 patients are
enrolled and reach the 28-day endpoint, a blinded interim analysis
will be conducted by an independent Data Safety Monitoring Board
(DSMB) to continue the trial or stop for efficacy or futility. The
recommendation of the DSMB based on the interim analysis is
anticipated in Q3 of this year. Additional sites in other countries
are expected to be added, including in the US. Topline data for all
360 enrolled patients at the 28-day mortality primary endpoint from
the trial are expected to be available by the end of 2021.
Vilobelimab for ANCA-associated
Vasculitis (AAV)In the US IXPLORE clinical Phase II study
of IFX-1 in AAV, all patients have completed treatment. In May
2021, InflaRx reported topline data for the study, indicating that
vilobelimab, when given in addition to best standard of care proved
to be safe and well tolerated. Furthermore, InflaRx previously
reported that both Part 1 and Part 2 of the AAV Phase II study in
Europe (IXCHANGE) are fully enrolled. Data from the randomized,
double-blind, placebo-controlled trial with 57 patients are
expected by the end of 2021.
Vilobelimab in Cutaneous Squamous Cell
Carcinoma (cSCC) The Company has recently announced plans
to initiate an open label, multicenter Phase II study evaluating
vilobelimab alone and in combination with pembrolizumab in patients
with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced
or metastatic cSCC.
The Phase II trial is expected to start
enrolling patients in the second quarter of 2021 at sites in
Europe, the US and other countries. The study will investigate two
independent arms: vilobelimab alone and vilobelimab in combination
with pembrolizumab. The main objectives of the trial are to assess
antitumor activity and safety of vilobelimab monotherapy and to
determine the maximum tolerated or recommended dose, safety and
antitumor activity in the combination arm.
Vilobelimab in Pyoderma
Gangraenosum The Phase IIa open label trial has reached
the target enrollment goal of 18 patients with moderate to severe
PG at sites in the US, Canada and Europe. Promising initial data
from the first five patients in the study were announced in 2020. A
second interim analysis, including six patients treated at the
second dose group until day 99, are expected to be available by the
end of 2021. Final results from all patients, including the highest
dose group, are expected in 2022.
Financial highlights – Q1
2021
Research and development
expenses incurred for the three months ended March 31,
2021 decreased over the corresponding period in 2020 by €2.4
million. This decline was primarily due to no contribution of
expense in the period from the Phase IIb clinical development of
vilobelimab in HS since this study was completed in 2020, with only
limited residual activities thereafter. This was partly offset by
the expenses in relation to the COVID-19 trial. These two factors
led to €1.1 million of lower manufacturing costs which
significantly contributed to an overall decline in third-party
expenses of €2.6 million. The €0.4 million increase in personnel
expenses was mainly related to equity-settled share-based
compensation.
General and administrative
expenses increased by €0.5 million to €3.0 million for the
three months ended March 31, 2021, from €2.6 million for the three
months ended March 31, 2020. This increase is attributable to
higher expenses from equity-settled share-based compensation
recognized in personnel expenses (€0.5 million). Additionally,
legal, consulting and other expenses decreased by €0.1 million to
€1.0 million for the three months ended March 31, 2021, from €1.1
million for the three months ended March 31, 2020.
Net financial result increased
by €0.3 million to €1.8 million for the three months ended March
31, 2021, from €1.5 million for the three months ended March 31,
2020. This increase is mainly attributable to higher foreign
exchange gains, which increased by €1.2 million and higher foreign
exchange losses of €0.6 million while interest on marketable
securities declined by €0.4 million. Other finance expenses for the
three months ended March 31, 2021 include a €48 thousand gain from
a reduction in the allowance for expected credit loss on marketable
securities.
Net loss for the three months
ended March 31, 2021 was €6.1 million, compared to €8.2 million for
the three month ended March 31, 2020. On March 31, 2021, the
Company’s total funds available were approximately
€137.8 million, composed of cash and cash equivalents (€78.7
million) and financial assets (€59.1 million).
Net cash used in operating
activities decreased to €10.4 million in the three months
ended March 31, 2021, from €10.5 million in the three months ended
March 31, 2020.
Additional information regarding these results
and other relevant information is included in the notes to the
unaudited Condensed Consolidated Financial Statements as of March
31, 2021, as well as the financial statements as of December 31,
2020 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 months ended March 31, 2021 and 2020
|
For the three months endedMarch
31, |
(in €, except for share data) |
2021(unaudited) |
|
2020(unaudited) |
|
|
|
|
Operating Expenses |
|
|
|
Research and development expenses |
(4,906,885) |
|
(7,298,799) |
General and administrative expenses |
(3,022,339) |
|
(2,564,803) |
Total Operating Expenses |
(7,929,224) |
|
(9,863,601) |
Other income |
5,462 |
|
94,960 |
Other expenses |
(565) |
|
(5,720) |
Operating Result |
(7,924,327) |
|
(9,774,362) |
Finance income |
22,962 |
|
401,435 |
Finance expenses |
(3,684) |
|
(2,147) |
Foreign exchange result |
1,731,671 |
|
1,141,677 |
Other financial result |
48,000 |
|
— |
Income Taxes |
— |
|
— |
Loss for the Period |
(6,125,378) |
|
(8,233,397) |
|
|
|
|
Share Information |
|
|
|
Weighted average number of shares outstanding |
33,807,774 |
|
26,105,255 |
Loss per share (basic/diluted) |
(0.18) |
|
(0.32) |
|
|
|
|
Loss for the Period |
(6,125,378) |
|
(8,233,871) |
Other comprehensive income (loss) that may be reclassified to
profit or loss in subsequent periods: |
|
|
|
Exchange differences on translation of foreign currency |
3,504,699 |
|
1,713,868 |
Total Comprehensive Loss |
(2,620,679) |
|
(6,519,529) |
InflaRx N.V. and
subsidiariesUnaudited Condensed Consolidated
Statements of Financial Positionas of March 31,
2021 and December 31, 2020
in € |
March
31,2021(unaudited) |
|
December
31,2020 |
|
|
|
|
ASSETS |
|
|
|
Non-current assets |
|
|
|
Property and equipment |
383,762 |
|
408,263 |
Right-of-use assets |
457,513 |
|
546,694 |
Intangible assets |
320,645 |
|
350,183 |
Other assets |
358,767 |
|
353,522 |
Financial assets |
272,443 |
|
272,268 |
Total non-current assets |
1,793,130 |
|
1,930,930 |
Current assets |
|
|
|
Current other assets |
6,527,973 |
|
3,734,700 |
Current tax assets |
1,360,125 |
|
1,419,490 |
Financial assets |
58,834,268 |
|
55,162,033 |
Cash and cash equivalents |
78,734,662 |
|
25,968,681 |
Total current assets |
145,457,028 |
|
86,284,904 |
TOTAL ASSETS |
147,250,158 |
|
88,215,834 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
5,302,354 |
|
3,387,410 |
Share premium |
280,261,994 |
|
220,289,876 |
Other capital reserves |
27,980,274 |
|
26,259,004 |
Accumulated deficit |
(174,470,998) |
|
(168,345,620) |
Other components of equity |
(222,091) |
|
(3,726,791) |
Total equity |
138,851,532 |
|
77,863,880 |
Non-current liabilities |
|
|
|
Lease liabilities |
137,586 |
|
220,525 |
Other liabilities |
34,352 |
|
33,323 |
Total non-current liabilities |
171,938 |
|
253,847 |
Current liabilities |
|
|
|
Trade and other payables |
7,107,880 |
|
8,258,133 |
Lease liabilities |
330,969 |
|
338,516 |
Employee benefits |
429,621 |
|
1,368,731 |
Other financial liabilities |
358,217 |
|
117,727 |
Provisions |
— |
|
15,000 |
Total current liabilities |
8,226,687 |
|
10,098,107 |
Total Liabilities |
8,398,626 |
|
10,351,954 |
TOTAL EQUITY AND LIABILITIES |
147,250,158 |
|
88,215,834 |
InflaRx N.V. and
subsidiariesUnaudited Condensed Consolidated
Statements of Changes in Shareholders’Equity for
the three months ended March 31, 2021 and 2020
(in €, except for share data) |
Issuedcapital |
|
Sharepremium |
|
Othercapitalreserves |
|
Accumulateddeficit |
|
Othercomponentof
equity |
|
Totalequity |
|
|
|
|
|
|
|
|
|
|
|
|
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 differences on 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 |
|
|
|
|
|
|
|
|
|
|
|
|
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 |
— |
|
— |
|
— |
|
(8,233,397) |
|
— |
|
(8,233,397) |
Exchange differences on translation of foreign currency |
— |
|
— |
|
— |
|
— |
|
1,713,868 |
|
1,713,868 |
Total comprehensive loss |
— |
|
— |
|
— |
|
(8,233,397) |
|
1,713,868 |
|
(6,519,529) |
Equity-settled share-based pay-ments |
— |
|
— |
|
901,033 |
|
— |
|
— |
|
901,033 |
Balance as of March 31, 2020 |
3,132,631 |
|
211,006,606 |
|
26,043,246 |
|
(142,595,403) |
|
3,941,097 |
|
101,528,177 |
InflaRx N.V. and
subsidiariesUnaudited Condensed Consolidated
Statements of Cash Flows for the three months ended March 31, 2021
and 2020
in € |
For the three months ended March 31,
2021(unaudited) |
|
For the three months ended March 31,
2020(unaudited) |
|
|
|
|
Operating activities |
|
|
|
Loss for the period |
(6,125,378) |
|
(8,233,397) |
Adjustments for: |
|
|
|
Depreciation & amortization of property and equipment,
right-of-use assets and intangible assets |
168,343 |
|
182,356 |
Net finance income |
(1,798,949) |
|
(399,288) |
Share-based payment expense |
1,721,270 |
|
901,033 |
Net foreign exchange differences |
193,847 |
|
(1,141,678) |
Other non-cash adjustments |
— |
|
(129,122) |
Changes in: |
|
|
|
Other assets |
(2,739,152) |
|
188,476 |
Employee benefits |
(952,820) |
|
(428,526) |
Other liabilities |
240,229 |
|
1,953 |
Trade and other payables |
(1,150,252) |
|
(1,922,724) |
Interest received |
33,189 |
|
462,342 |
Interest paid |
(3,780) |
|
(2,246) |
Net cash used in operating activities |
(10,413,453) |
|
(10,520,819) |
Investing activities |
|
|
|
Purchase of intangible assets, property and equipment |
(17,062) |
|
(27,686) |
Purchase of current financial assets |
(14,985,026) |
|
(23,412,469) |
Proceeds from the maturity of financial assets |
13,952,522 |
|
20,724,386 |
Net cash from/ (used in) investing activities |
(1,049,566) |
|
(2,715,769) |
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 |
(90,716) |
|
(88,339) |
Net cash from/ (used in) financing activities |
61,796,346 |
|
(88,339) |
Net increase/(decrease) in cash and cash equivalents |
50,333,328 |
|
(13,324,927) |
Effect of exchange rate changes on cash and cash equivalents |
2,432,654 |
|
1,277,255 |
Cash and cash equivalents at beginning of period |
25,968,681 |
|
33,131,280 |
Cash and cash equivalents at end of period |
78,734,662 |
|
21,083,608 |
About vilobelimab (IFX-1):
Vilobelimab 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,
vilobelimab 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. Vilobelimab 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. Vilobelimab
is believed to be the first monoclonal anti-C5a antibody introduced
into clinical development. Approximately 300 people have been
treated with vilobelimab in clinical trials, and the antibody has
been shown to be well tolerated. Vilobelimab 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 – 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, 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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