InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company
developing anti-inflammatory therapeutics by targeting the
complement system, announced today financial results for the year
ended December 31, 2020.
Prof. Niels C. Riedemann, Chief Executive
Officer and Founder of InflaRx, commented: “The year 2020 was a
challenging one for all of us dealing with a pandemic. As a
physician and scientist, it has been extremely rewarding to see how
quickly effective vaccines have been developed and are already in
the arms of thousands of people. However, we continue to see
a need for novel treatments for COVID-19 and similar future viral
diseases. We are happy to be evaluating vilobelimab as a
potential treatment to help severe COVID-19 patients and look
forward to seeing those results, as well as results from ongoing
trials in other disease areas, later this year.”
Prof. Riedemann continued: “We have submitted as
planned a Special Protocol Assessment to the FDA to reach agreement
on the path forward for our phase III plans with vilobelimab in
hidradenitis suppurativa. We were excited to announce a new
area of clinical development – oncology – and are on track to start
our first cancer trial with vilobelimab in cutaneous squamous cell
carcinoma in the second quarter of this year. I am also pleased
that our team recently completed a $75 million public offering,
further strengthening our cash position and putting us on a firm
financial footing to advance vilobelimab in a number of
indications. We look forward to reporting our progress in the
months ahead.”
Recent Highlights and R&D
Update
Issue of Share CapitalOn March
1, 2021, InflaRx announced the closing of a public offering of
common shares pursuant to which the Company sold 15,000,000
common shares and warrants to purchase up to 15,000,000 common
shares. The common shares were sold at a price to the public 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 gross proceeds from this offering were $75.0
million (€61.6 million), before deducting the $4.5 million (€3.7
million) underwriting discount and other estimated offering
expenses of approximately $0.5 million (€0.5 million) and excluding
the exercise of any warrants.
Vilobelimab for Hidradenitis Suppurativa
(HS)InflaRx has submitted a Special Protocol Assessment
(SPA) to the Food & Drug Administration (FDA) for the planned
Phase III program in HS in the first quarter of 2021. Details on
the Phase III design will be provided once agreement has been
reached with the FDA.
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 a new primary endpoint, the
International Hidradenitis Suppurativa Severity Score (“IHS4”). The
Company is working diligently to address the additional feedback
received to achieve alignment with the US strategy for a global
Phase III development program in HS.
New data supporting the continued development of
vilobelimab in the treatment of HS were presented in February 2021
at the 10th Conference of the European Hidradenitis Suppurativa
Foundation e.V. (EHSF). The data from the SHINE Phase II
trial showed that significantly elevated baseline C5a levels
occurred in HS patients versus healthy volunteers. Data also
showed that vilobelimab dose-dependently suppressed C5a levels over
time accompanied by the previously reported reduction in
inflammatory lesion counts and scores.
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
is currently ongoing with sites open in several countries in Europe
and Latin America. Additional countries are in the process of being
added. The study is enrolling as planned with a total goal of 360
patients. A blinded interim analysis is planned after 180 patients,
with a potential early stop of the trial for efficacy or futility.
Topline data from the trial are expected to be available by the end
2021.
Vilobelimab for ANCA-associated
Vasculitis (AAV)InflaRx reported the completion of
enrollment in the European Phase II IXCHANGE study of vilobelimab
in AAV in Q1 2021. Topline data from the randomized, double-blind,
placebo-controlled trial with 57 patients are expected by the end
of 2021.
Vilobelimab is also being studied in the US
phase II IXPLORE study in patients with AAV. The main objective of
this randomized, double-blind, placebo-controlled study is to
evaluate the safety of vilobelimab, as this is the first time the
drug is being administered to patients with AAV in the US. Topline
results are expected by mid-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 non-comparative two-stage multi-national
Phase II trial is expected to start enrolling patients in Q2 2021
with 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 continues to
enroll patients in the higher dose groups. Promising initial data
from the first five patients in the study were announced in 2020.
Results from the higher dose groups are expected by the end of
2021.
Financial highlights 2020
Research and development
expenses decreased by €18.9 million to €25.7 million in
the year ended December 31, 2020 compared to the year ended
December 31, 2019.
This decrease is attributable to lower CRO and
CMO costs from clinical trials in the amount of €16.9 million
due to the conclusion of the Phase IIb for HS in 2019, the expense
of which was higher than 2020 costs associated with the new Phase
II/III clinical trial in patients with COVID (2020: €4.9 million,
2019: nil) or other running trials like Phase II clinical program
in patients with AAV, the Phase II clinical program in patients
with PG, the preparation of a Phase II clinical program in patients
cSCC or ongoing manufacturing activities for clinical trial related
materials.
In addition there was a €1.8 million decrease in
employee-related costs mainly caused by a €2.0 million decrease in
expenses from non-cash share-based compensation.
General and administrative
expenses decreased by €4.0 million to €8.5 million for the
year ended December 31, 2020, from €12.5 million for the year ended
December 31, 2019. This decrease is primarily attributable to a
€3.8 million decrease in expenses from non-cash share-based
compensation. Legal, consulting and audit fees and other expenses
decreased by €0.6 million to €1.6 million for the year ended
December 31, 2020, from €2.2 million for the year ended December
31, 2019, which decrease is mainly attributable to lower consulting
and travel costs. The increase of other expenses by €0.2 million is
primarily related to higher D&O insurance cost.
Net financial result decreased
by €3.6 million in the year ended December 31, 2020 compared to the
year ended December 31, 2019. This decrease is mainly attributable
to (a) higher foreign exchange losses, which increased by €1.7
million and (b) lower interest on marketable securities, which
decreased by €2.0 million.
Net loss for the year 2020 was
€34.0 million or €1.3 per common share, compared to €53.3
million or €2.1 per common share for the year 2019. On December 31,
2020, the Company’s total funds available were
approximately €81.4 million, composed of cash and cash
equivalents (€26.0 million) and financial assets
(€55.4 million).
Net cash used in operating
activities decreased to €36.5 million in the year ended
December 31, 2020, from €43.2 million in the year ended December
31, 2019, mainly due to the decrease of research and development
expenditures and lower personnel costs, excluding stock-based
compensation.
Additional information regarding these results
and other relevant information is included in the notes to 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 US Securities and Exchange Commission.
InflaRx N.V. and
subsidiariesConsolidated Statements of Operations
and Comprehensive Loss for the YearsEnded December 31, 2020, 2019
and 2018
in €, except for share information |
2020 |
|
2019 |
|
2018 |
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Research and development expenses |
(25,684,140) |
|
(44,582,136) |
|
(25,028,554) |
General and administrative expenses |
(8,467,203) |
|
(12,501,048) |
|
(12,786,869) |
Total Operating Expenses |
(34,151,343) |
|
(57,083,184) |
|
(37,815,422) |
Other income |
221,748 |
|
400,253 |
|
303,860 |
Other expenses |
(13,209) |
|
(85,242) |
|
(4,802) |
Operating Result |
(33,942,804) |
|
(56,768,173) |
|
(37,516,364) |
Finance income |
887,702 |
|
2,840,676 |
|
2,182,842 |
Finance expenses |
(26,000) |
|
(22,265) |
|
— |
Foreign exchange result |
(776,512) |
|
694,944 |
|
5,626,071 |
Other financial result |
(126,000) |
|
— |
|
(107,182) |
Income Taxes |
— |
|
— |
|
— |
Loss for the Period |
(33,983,614) |
|
(53,254,817) |
|
(29,814,634) |
|
|
|
|
|
|
Share Information |
|
|
|
|
|
Weighted average number of shares outstanding |
27,064,902 |
|
26,004,519 |
|
25,095,027 |
Loss per share (basic/diluted) |
(1.26) |
|
(2.05) |
|
(1.19) |
|
|
|
|
|
|
Loss for the Period |
(33,983,614) |
|
(53,254,817) |
|
(29,814,634) |
Other comprehensive income (loss) that may be reclassified to
profit or loss in subsequent periods: |
|
|
|
|
|
Exchange differences on translation of foreign currency |
(5,954,019) |
|
2,177,033 |
|
50,196 |
Total Comprehensive Loss |
(39,937,633) |
|
(51,077,785) |
|
(29,764,438) |
|
|
|
|
|
|
InflaRx N.V. and
subsidiariesConsolidated Statements of Financial
Position as December 31, 2020 and 2019
in € |
2020 |
|
2019 |
|
|
|
|
ASSETS |
|
|
|
Non-current assets |
|
|
|
Property and equipment* |
408,263 |
|
576,373 |
Right-of-use assets* |
546,694 |
|
836,924 |
Intangible assets |
350,183 |
|
452,400 |
Other assets |
353,522 |
|
452,217 |
Financial assets |
272,268 |
|
272,614 |
Total non-current assets |
1,930,930 |
|
2,590,528 |
Current assets |
|
|
|
Current other assets* |
3,734,700 |
|
2,365,916 |
Income tax receivable* |
1,419,490 |
|
1,134,968 |
Financial assets |
55,162,033 |
|
82,353,867 |
Cash and cash equivalents |
25,968,681 |
|
33,131,280 |
Total current assets |
86,284,904 |
|
118,986,031 |
TOTAL ASSETS |
88,215,834 |
|
121,576,558 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
3,387,410 |
|
3,132,631 |
Share premium |
220,289,876 |
|
211,006,606 |
Other capital reserves |
26,259,004 |
|
25,142,213 |
Accumulated deficit |
(168,345,620) |
|
(134,362,006) |
Other components of equity |
(3,726,791) |
|
2,227,228 |
Total equity |
77,863,880 |
|
107,146,673 |
Non-current liabilities |
|
|
|
Lease liabilities |
220,525 |
|
330,745 |
Other liabilities |
33,323 |
|
39,013 |
Total non-current liabilities |
253,847 |
|
369,758 |
Current liabilities |
|
|
|
Trade and other payables |
8,258,133 |
|
12,413,662 |
Lease liabilities |
338,516 |
|
515,203 |
Employee benefits |
1,368,731 |
|
975,629 |
Other liabilities |
117,727 |
|
105,634 |
Provisions |
15,000 |
|
50,000 |
Total current liabilities |
10,098,107 |
|
14,060,128 |
Total Liabilities |
10,351,954 |
|
14,429,886 |
TOTAL EQUITY AND LIABILITIES |
88,215,834 |
|
121,576,558 |
|
|
|
|
InflaRx N.V. and
subsidiariesConsolidated Statements of Changes in
Shareholders’ Equity for the YearsEnded December
31, 2020, 2019 and 2018
in € |
Issuedcapital |
|
Sharepremium |
|
Othercapitalreserves |
|
Accumulateddeficit |
|
Other com-ponents ofequity |
|
Totalequity |
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2018 |
2,857,452 |
|
161,638,566 |
|
6,225,353 |
|
(51,292,555) |
|
— |
|
119,428,816 |
Loss for the Period |
— |
|
— |
|
— |
|
(29,814,634) |
|
— |
|
(29,814,634) |
Exchange differences on translation of foreign currency |
— |
|
— |
|
— |
|
— |
|
50,196 |
|
50,196 |
Total Comprehensive Loss |
— |
|
— |
|
— |
|
(29,814,634) |
|
50,196 |
|
(29,764,438) |
Issuance of common shares |
222,000 |
|
52,768,733 |
|
— |
|
— |
|
— |
|
52,990,733 |
Transaction costs |
— |
|
(3,801,265) |
|
— |
|
— |
|
— |
|
(3,801,265) |
Equity-settled share-based payments |
— |
|
— |
|
12,084,651 |
|
— |
|
— |
|
12,084,651 |
Share options exercised |
36,273 |
|
415,801 |
|
— |
|
— |
|
— |
|
452,075 |
Balance as of December 31, 2018 |
3,115,725 |
|
211,021,835 |
|
18,310,003 |
|
(81,107,188) |
|
50,196 |
|
151,390,571 |
Loss for the Period |
— |
|
— |
|
— |
|
(53,254,817) |
|
— |
|
(53,254,817) |
Exchange differences on translation of foreign currency |
— |
|
— |
|
— |
|
— |
|
2,177,033 |
|
2,177,033 |
Total Comprehensive Loss |
— |
|
— |
|
— |
|
(53,254,817) |
|
2,177,033 |
|
(51,077,784) |
Equity-settled share-based payments |
— |
|
— |
|
6,832,210 |
|
— |
|
— |
|
6,832,210 |
Share options exercised |
16,905 |
|
(15,229) |
|
— |
|
— |
|
— |
|
1,676 |
Balance as of December 31, 2019 |
3,132,631 |
|
211,006,606 |
|
25,142,213 |
|
(134,362,006) |
|
2,227,228 |
|
107,146,673 |
Loss for the Period |
— |
|
— |
|
— |
|
(33,983,614) |
|
— |
|
(33,983,614) |
Exchange differences on translation of foreign currency |
— |
|
— |
|
— |
|
— |
|
(5,954,019) |
|
(5,954,019) |
Total Comprehensive Loss |
— |
|
— |
|
— |
|
(33,983,614) |
|
(5,954,019) |
|
(39,937,633) |
Issuance of common shares |
234,982 |
|
9,535,961 |
|
— |
|
— |
|
— |
|
9,770,943 |
Transaction costs |
— |
|
(729,840) |
|
— |
|
— |
|
— |
|
(729,840) |
Equity-settled share-based payments |
— |
|
— |
|
1,116,791 |
|
— |
|
— |
|
1,116,791 |
Share options exercised |
19,797 |
|
477,149 |
|
— |
|
— |
|
— |
|
496,946 |
Balance as of December 31, 2020 |
3,387,410 |
|
220,289,876 |
|
26,259,004 |
|
(168,345,620) |
|
(3,726,791) |
|
77,863,880 |
|
|
|
|
|
|
|
|
|
|
|
|
InflaRx N.V. and
subsidiariesConsolidated Statements of Cash Flows
for the Years ended December 31, 2020,2019 and
2018
|
2020 |
|
2019 |
|
2018 |
|
|
|
(in €) |
|
|
Operating activities |
|
|
|
|
|
Loss for the Period |
(33,983,614) |
|
(53,254,817) |
|
(29,814,634) |
Adjustments for: |
|
|
|
|
|
Depreciation & amortization of property and equipment,
right-of-use assets and intangible assets |
712,713 |
|
663,166 |
|
173,630 |
Net finance income |
40,810 |
|
(3,513,355) |
|
(7,701,731) |
Share-based payment expense |
1,116,791 |
|
6,832,210 |
|
12,084,651 |
Net foreign exchange differences |
(247,322) |
|
(368,477) |
|
(17,257) |
Other non-cash adjustments |
3,436 |
|
60,628 |
|
213,956 |
Changes in: |
|
|
|
|
|
Other assets |
(1,554,611) |
|
(2,364,399) |
|
(893,602) |
Current financial assets |
— |
|
— |
|
(316,112) |
Employee benefits |
355,545 |
|
235,500 |
|
494,837 |
Other liabilities |
8,960 |
|
(209,948) |
|
304,627 |
Trade and other payables |
(4,155,529) |
|
5,734,795 |
|
2,243,137 |
Interest received |
1,201,547 |
|
3,001,109 |
|
1,679,250 |
Interest paid |
(26,387) |
|
(20,903) |
|
— |
Net cash used in operating activities |
(36,527,661) |
|
(43,204,492) |
|
(21,549,248) |
Investing activities |
|
|
|
|
|
Purchase of intangible assets and property and equipment |
(94,189) |
|
(594,889) |
|
(806,531) |
Purchase of non-current other financial assets |
— |
|
(75,543) |
|
(209,705) |
Proceeds from the disposal of non-current other financial
assets |
— |
|
— |
|
21,811 |
Purchase of current financial assets |
(101,600,176) |
|
(82,547,409) |
|
(106,445,120) |
Proceeds from the maturity of current financial assets |
123,056,347 |
|
103,559,395 |
|
7,990,204 |
Net cash from/ (used in) investing activities |
21,361,982 |
|
20,341,554 |
|
(99,449,341) |
Financing activities |
|
|
|
|
|
Proceeds from issuance of common shares |
9,770,944 |
|
— |
|
52,990,733 |
Transaction costs from issuance of common shares |
(729,841) |
|
— |
|
(3,801,265) |
Proceeds from exercise of share options |
496,946 |
|
1,676 |
|
452,075 |
Repayment of lease liabilities |
(366,156) |
|
(296,020) |
|
— |
Net cash from/ (used in) financing activities |
9,171,893 |
|
(294,344) |
|
49,641,542 |
Net increase/(decrease) in cash and cash equivalents |
(5,993,786) |
|
(23,157,282) |
|
(71,357,047) |
Effect of exchange rate changes on cash and cash equivalents |
(1,168,813) |
|
902,321 |
|
3,461,399 |
Cash and cash equivalents at beginning of period |
33,131,280 |
|
55,386,240 |
|
123,281,888 |
Cash and cash equivalents at end of period |
25,968,681 |
|
33,131,280 |
|
55,386,240 |
|
|
|
|
|
|
About vilobelimab:
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,
Cutaneous Squamous Cell Carcinoma and severe COVID‑19.
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.de.
Contacts:
InflaRx N.V.Jordan Zwick –
Chief Strategy OfficerEmail: IR@inflarx.deTel: +1 917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas Jungfer Email: inflarx@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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