InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing
anti-inflammatory therapeutics by targeting the complement system,
announced today financial and operating results for the three
months ended March 31, 2023, and provided a business update.
Prof. Niels C. Riedemann, Chief Executive
Officer and Founder of InflaRx, commented: “These last months have
been truly transformative for InflaRx. Upon receiving the EUA for
Gohibic (vilobelimab) for the treatment of critically ill patients
with COVID-19 last month, we became the first company worldwide
with a drug authorized for emergency use for the control of
complement factor C5a. We are working diligently to enable
physicians to access this treatment option in the U.S. and plan to
make the product available to patients within the next few weeks.
At the same time, we continue to diligently advance our development
pipeline. We expect to treat the first patient in a Phase III trial
with vilobelimab in pyoderma gangrenosum, a severe
neutrophil-mediated skin disease, around mid-year and are also
further developing our small molecule C5aR inhibitor, INF904, which
is currently in Phase I testing. The EUA for Gohibic is a great
recognition of our scientific approach, and we are excited to
continue developing our product candidates to provide patients with
other diseases driven by the complement system with new therapeutic
options.”
Recent Highlights and
Business Update
Gohibic (vilobelimab): EUA Granted for
Treatment of Critically Ill COVID-19 PatientsIn April
2023, the FDA issued an EUA for Gohibic (vilobelimab) for the
treatment of COVID-19 in hospitalized adults when initiated within
48 hours of receiving invasive mechanical ventilation (IMV) or
extracorporeal membrane oxygenation (ECMO).
InflaRx has an initial supply of Gohibic
(vilobelimab) available and is currently ramping up production at
its third-party manufacturer to be able to further supply the U.S.
as soon as possible. InflaRx expects to make the product available
in the U.S. for the treatment of hospitalized patients within the
next weeks. Therefore, the Company is expecting to be able to
record first revenues from sales of Gohibic already in Q3 2023.
InflaRx is continuing discussions with the FDA related to the
submission of a Biologics License Application (BLA) for the full
approval of Gohibic (vilobelimab). InflaRx has also completed
encouraging meetings with the rapporteur and co-rapporteur member
state teams of the European Committee for Medicinal Products for
Human Use (CHMP) related to a planned Marketing Authorization
Application with the European Medicines Agency (EMA). The Company
will provide updates on the status of regulatory submissions in the
U.S. and elsewhere once available.
Vilobelimab in Pyoderma Gangrenosum
(PG)In January 2023, InflaRx presented details related to
the design of its planned pivotal Phase III study with
vilobelimab in ulcerative PG, following compelling Phase II results
for the treatment of this rare neutrophilic and inflammatory skin
disease with destructive, painful cutaneous ulcers. The
multi-national, randomized, double-blind, placebo-controlled trial
has an adaptive design with an interim analysis that will determine
the planned total patient number. The Company has submitted the
clinical trial protocol to the FDA. InflaRx expects the first
patient to be enrolled in this study around mid-2023.
Vilobelimab in Cutaneous Squamous Cell
Carcinoma (cSCC) InflaRx is conducting an open-label,
multicenter Phase II study, evaluating vilobelimab in two study
arms - as stand-alone therapy and in combination with pembrolizumab
- in patients with programmed cell death protein 1 (PD1) or
programmed cell death ligand 1 (PDL1) inhibitor
resistant/refractory, locally advanced or metastatic cSCC. The main
objectives of this trial are to assess the safety and antitumor
activity of vilobelimab in the monotherapy arm and to assess the
maximum tolerated or recommended dose of vilobelimab and the safety
and antitumor activity of this drug pair in the combination arm.
First data from the monotherapy arm are expected to be available in
Q2 2023, and data from an interim analysis of the combination arm
are expected in H1 2024.
INF904 InflaRx is currently
conducting a Phase I trial in healthy volunteers to assess the
safety, tolerability and pharmacokinetic / pharmacodynamic
properties of this new and proprietary low molecular weight C5aR
inhibitor. The Company will explore the effect of INF904 on
C5a-induced downstream activity and generate data in a format
comparable with other published data on C5aR inhibitory molecules.
Results are expected in H2 2023. In the future, InflaRx plans to
develop INF904 for complement-mediated, chronic autoimmune and
inflammatory diseases where oral administration is the preferred
choice for patients.
Post-Period Financing
ActivitiesIn April 2023, the Company issued 3,235,723
ordinary shares under its ATM program, resulting in €14.4 million
in net proceeds. Also in April 2023, the Company completed an
underwritten public offering of an aggregate of 10,823,529 ordinary
shares, which included the full exercise of an overallotment option
granted to the underwriters to purchase 1,411,764 additional
ordinary shares, resulting in €39.1 million in net proceeds.
Aggregate proceeds from these equity offerings amounted to €53.5
million after deducting underwriting discounts.
Dr. Thomas Taapken, Chief Financial Officer of
InflaRx, said: “Our recent successful financing activities have put
us on an even firmer footing, not only to fund our development
activities and advance our pipeline, including the Phase III trial
with vilobelimab in pyoderma gangrenosum, but also to invest into
the required commercial, manufacturing and logistical
infrastructure in the U.S. for making Gohibic available to
physicians and patients in the U.S. very soon. Despite a financial
market environment that continues to be challenging, we are now
well funded to support operations into 2026.”
Financial Highlights – Q1
2023
Research and Development
ExpensesResearch and development expenses in Q1 2023
increased by €4.3 million to €14.7 million compared to Q1 2022.
This increase was primarily attributable to the establishment of a
commercial-scale manufacturing process for vilobelimab and
regulatory expenses in conjunction with the EUA filing and other
regulatory activities, as well as for the manufacturing of clinical
trial-related material.
General and Administrative
ExpensesGeneral and administrative expenses decreased by
€0.8 million to €3.6 million, from €4.4 million in Q1 2022. This
decrease was attributable to lower expenses associated with
equity-settled share-based compensation recognized in personnel
expenses of €0.8 million.
Other IncomeOther income
amounted to €7.7 million, which was primarily attributable to
income recognized from the grant payments received from the German
federal government for the development of vilobelimab for
critically ill COVID-19 patients.
In 2021, InflaRx was awarded a grant from the
German Ministry of Education and Research and the German Ministry
of Health to support the development of vilobelimab for the
treatment of COVID-19. As of March 31, 2023, the Company had
received €25.6 million in grant funds and still has a maximum
amount of €13.2 million available to claim through the end of the
grant term in June 2023. The grant is structured as a reimbursement
of 80% of certain pre-specified expenses related to the clinical
development and manufacturing of vilobelimab.
Net Financial ResultNet
financial result decreased by €1.3 million to net financial expense
of €0.5 million in Q1 2023, from net financial result of €0.9
million in Q1 2022. This decrease is attributable to an
aggregation of different factors, including higher interest income
on investments of €0.4 million due to higher interest rates,
lower foreign exchange gains, which decreased by €0.8 million, and
higher foreign exchange losses of €1.0 million.
Net LossNet loss in
Q1 2023, amounted to €11.1 million, compared to €14.0 million
in Q1 2022.
Liquidity and Capital
ResourcesAs of March 31, 2023, the Company had cash and
cash equivalents and marketable securities amounting to
€72.3 million. In addition, during April 2023, InflaRx raised
proceeds of €53.5 million through the utilization of the
Company’s established ATM program and through an underwritten
public share offering after deducting underwriting discounts. The
Company’s current funds on hand are expected to be sufficient to
fund operations into 2026.
Net Cash Used in Operating
ActivitiesNet cash used in operating activities decreased
to €10.5 million in Q1 2023, from €12.9 million in
Q1 2022.
Additional Financial
InformationAdditional 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, 2023, 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, 2022, in “ITEM 18. Financial
Statements,” in InflaRx’s Annual Report on Form 20-F for the year
ended December 31, 2022, as filed with the U.S. Securities and
Exchange Commission (SEC).
InflaRx N.V. and subsidiaries |
Unaudited Condensed Consolidated Statements of Operations
and |
Comprehensive Loss for the three months ended March 31,
2023 and 2022 |
|
|
|
For the three months ended March 31, |
|
2023(unaudited) |
|
2022(unaudited) |
|
(in €, except for share data) |
Operating expenses |
|
|
|
|
Research and development expenses |
(14,731,908 |
) |
|
(10,471,923 |
) |
General and administrative expenses |
(3,608,554 |
) |
|
(4,387,443 |
) |
Total operating expenses |
(18,340,462 |
) |
|
(14,859,366 |
) |
Other income |
7,746,189 |
|
|
1,593 |
|
Other expenses |
(566 |
) |
|
(565 |
) |
Operating result |
(10,594,839 |
) |
|
(14,858,338 |
) |
Finance income |
456,036 |
|
|
27,962 |
|
Finance expenses |
(5,528 |
) |
|
(24,586 |
) |
Foreign exchange result |
(1,137,310 |
) |
|
727,933 |
|
Other financial result |
197,808 |
|
|
125,000 |
|
Income taxes |
— |
|
|
— |
|
Loss for the period |
(11,083,833 |
) |
|
(14,002,030 |
) |
|
|
|
Share information |
|
|
Weighted average number of shares outstanding |
44,771,703 |
|
|
44,203,763 |
|
Loss per share (basic/diluted) |
(0.25 |
) |
|
(0.32 |
) |
|
|
|
Loss for the period |
(11,083,833 |
) |
|
(14,002,030 |
) |
Other comprehensive income (loss) that may be reclassified to
profit or loss in subsequent periods: |
|
|
Exchange differences on translation of foreign currency |
(16,785 |
) |
|
1,309,875 |
|
Total comprehensive loss |
(11,100,618 |
) |
|
(12,692,154 |
) |
|
|
|
InflaRx N.V. and subsidiaries |
Unaudited Condensed Consolidated Statements of Financial
Position |
as of March 31, 2023 and December 31, 2022 |
|
March 31, 2023(unaudited) |
|
|
December 31, 2022 |
|
(in €) |
|
|
|
|
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Property and equipment |
306,371 |
|
|
328,920 |
|
Right-of-use assets |
1,214,865 |
|
|
1,311,809 |
|
Intangible assets |
114,847 |
|
|
138,905 |
|
Other assets |
297,021 |
|
|
308,066 |
|
Financial assets |
7,969,071 |
|
|
2,900,902 |
|
Total non-current assets |
9,902,175 |
|
|
4,988,602 |
|
Current assets |
|
|
Current other assets |
5,956,752 |
|
|
14,170,510 |
|
Income tax receivable |
2,141,785 |
|
|
1,432,087 |
|
Financial assets from government grants |
3,434,047 |
|
|
732,971 |
|
Other financial assets |
62,779,179 |
|
|
64,810,135 |
|
Cash and cash equivalents |
2,097,250 |
|
|
16,265,355 |
|
Total current assets |
76,409,014 |
|
|
97,411,058 |
|
TOTAL ASSETS |
86,311,189 |
|
|
102,399,660 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
Equity |
|
|
Issued capital |
5,373,000 |
|
|
5,364,452 |
|
Share premium |
282,668,032 |
|
|
282,552,633 |
|
Other capital reserves |
37,842,612 |
|
|
36,635,564 |
|
Accumulated deficit |
(254,544,123 |
) |
|
(243,460,290 |
) |
Other components of equity |
7,240,295 |
|
|
7,257,081 |
|
Total equity |
78,579,816 |
|
|
88,349,440 |
|
Non-current liabilities |
|
|
Lease liabilities |
896,331 |
|
|
987,307 |
|
Other liabilities |
36,877 |
|
|
36,877 |
|
Total non-current liabilities |
933,208 |
|
|
1,024,184 |
|
Current liabilities |
|
|
Trade and other payables |
4,616,092 |
|
|
4,987,538 |
|
Liabilities from government grants received |
1,175,487 |
|
|
6,209,266 |
|
Lease liabilities |
365,457 |
|
|
369,376 |
|
Employee benefits |
477,535 |
|
|
1,312,248 |
|
Other liabilities |
163,594 |
|
|
147,608 |
|
Total current liabilities |
6,798,165 |
|
|
13,026,036 |
|
Total liabilities |
7,731,373 |
|
|
14,050,220 |
|
TOTAL EQUITY AND LIABILITIES |
86,311,189 |
|
|
102,399,660 |
|
|
|
|
|
|
|
InflaRx N.V. and subsidiaries |
Unaudited Condensed Consolidated Statements of Changes in
Shareholders’ Equity for the three months ended March 31, 2023 and
2022 |
|
(in €) |
Issuedcapital |
|
Sharepremium |
|
Othercapitalreserves |
|
Accumulated deficit |
|
|
Othercomponentsof equity |
|
|
Totalequity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2023 |
5,364,452 |
|
282,552,633 |
|
36,635,564 |
|
(243,460,290 |
) |
|
7,257,081 |
|
|
88,349,440 |
|
Loss for the period |
— |
|
— |
|
— |
|
(11,083,833 |
) |
|
— |
|
|
(11,083,833 |
) |
Exchange differences ontranslation of foreign currency |
— |
|
— |
|
— |
|
— |
|
|
(16,785 |
) |
|
(16,785 |
) |
Total comprehensive loss |
— |
|
— |
|
— |
|
(11,083,833 |
) |
|
(16,785 |
) |
|
(11,100,618 |
) |
Equity-settled share-basedpayments |
— |
|
— |
|
1,207,048 |
|
— |
|
|
— |
|
|
1,207,048 |
|
Share options exercised |
8,548 |
|
115,399 |
|
— |
|
— |
|
|
— |
|
|
123,947 |
|
Balance as of March 31, 2023 |
5,373,000 |
|
282,668,032 |
|
37,842,612 |
|
(254,544,123 |
) |
|
7,240,295 |
|
|
78,579,816 |
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 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 differenceson translation of foreign currency |
— |
|
— |
|
— |
|
— |
|
|
1,309,875 |
|
|
1,309,875 |
|
Total comprehensive loss |
— |
|
— |
|
— |
|
(14,002,030 |
) |
|
1,309,875 |
|
|
(12,692,155 |
) |
Equity-settled share-basedpayments |
— |
|
— |
|
2,530,775 |
|
— |
|
|
— |
|
|
2,530,775 |
|
Balance as of March 31, 2022 |
5,304,452 |
|
280,310,744 |
|
33,121,984 |
|
(227,977,709 |
) |
|
4,360,146 |
|
|
95,119,617 |
|
|
|
|
|
|
|
|
|
|
|
InflaRx N.V. and subsidiaries |
Unaudited Condensed Consolidated Statements of Cash Flows
for the three months ended March 31, 2023 and 2022 |
|
|
For the three months ended March 31, |
|
2023(unaudited) |
|
|
2022(unaudited) |
|
(in €) |
Operating activities |
|
|
|
|
Loss for the period |
(11,083,833 |
) |
|
(14,002,030 |
) |
Adjustments for: |
|
|
Depreciation & amortization of property and equipment,
right-of-use assets and intangible assets |
147,969 |
|
|
153,321 |
|
Net finance income |
488,994 |
|
|
(856,308 |
) |
Share-based payment expense |
1,207,048 |
|
|
2,530,775 |
|
Net foreign exchange differences |
(106,793 |
) |
|
135,826 |
|
Changes in: |
|
|
Financial assets from government grants |
(2,701,076 |
) |
|
— |
|
Other assets |
7,515,105 |
|
|
(1,405,328 |
) |
Employee benefits |
(834,713 |
) |
|
(732,876 |
) |
Other liabilities |
15,986 |
|
|
(6,844 |
) |
Liabilities from government grants received |
(5,033,779 |
) |
|
— |
|
Trade and other payables |
(371,445 |
) |
|
928,526 |
|
Interest received |
245,971 |
|
|
420,916 |
|
Interest paid |
(5,627 |
) |
|
(24,641 |
) |
Net cash used in operating activities |
(10,516,193 |
) |
|
(12,858,662 |
) |
Investing activities |
|
|
Purchase of intangible assets, property and equipment |
(6,046 |
) |
|
(7,828 |
) |
Purchase of current financial assets |
(25,120,832 |
) |
|
— |
|
Proceeds from the maturity of financial assets |
21,540,578 |
|
|
26,488,950 |
|
Net cash from/(used in) investing activities |
(3,586,300 |
) |
|
26,481,122 |
|
Financing activities |
|
|
Proceeds from exercise of share options |
123,947 |
|
|
— |
|
Repayment of lease liabilities |
(93,744 |
) |
|
(90,806 |
) |
Net cash from/(used in) financing activities |
30,202 |
|
|
(90,806 |
) |
Net increase/(decrease) in cash and cash equivalents |
(14,072,291 |
) |
|
13,531,653 |
|
Effect of exchange rate changes on cash and cash equivalents |
(95,814 |
) |
|
314,639 |
|
Cash and cash equivalents at beginning of period |
16,265,355 |
|
|
26,249,995 |
|
Cash and cash equivalents at end of period |
2,097,250 |
|
|
40,096,286 |
|
|
|
|
About InflaRxInflaRx GmbH
(Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned
subsidiaries of InflaRx N.V. (together, InflaRx).
InflaRx (Nasdaq: IFRX) is a biopharmaceutical
company focused on applying its proprietary anti-C5a / C5aR
technologies 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.de.
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.Email:
IR@inflarx.de
MC Services AGKatja Arnold,
Laurie Doyle, Regina LutzEmail: inflarx@mc-services.euEurope: +49
89-210 2280U.S.: +1-339-832-0752
FORWARD-LOOKING STATEMENTSThis
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,” “estimate,” “believe,” “predict,”
“potential” or “continue,” among others. 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 ability to commercialize Gohibic (vilobelimab) or our
other product candidates; our expectations regarding the size of
the patient populations for, market opportunity for, coverage and
reimbursement for and clinical utility of Gohibic (vilobelimab) in
its approved or authorized indication or for vilobelimab and any
other product candidates, under EUA and in the future if approved
for commercial use in the U.S. or elsewhere; the success of our
future clinical trials for vilobelimab and any other product
candidates and whether such clinical results will reflect results
seen in previously conducted preclinical studies and clinical
trials; the timing, progress and results of clinical trials of our
product candidates, and statements regarding the timing of
initiation and completion of studies or trials and related
preparatory work, the period during which the results of the trials
will become available, the costs of such trials and our research
and development programs generally; our interactions with
regulators regarding the results of clinical trials and potential
regulatory approval pathways, including related to our BLA
submission for Gohibic (vilobelimab), and our ability to obtain and
maintain full regulatory approval of vilobelimab or Gohibic
(vilobelimab) for any indication; whether the FDA, the EMA, or any
comparable foreign regulatory authority will accept or agree with
the number, design, size, conduct or implementation of our clinical
trials, including any proposed primary or secondary endpoints for
such trials; our expectations regarding the scope of any approved
indication for vilobelimab; our ability to leverage our proprietary
anti-C5a and C5aR technologies to discover and develop therapies to
treat complement-mediated autoimmune and inflammatory diseases; our
ability to protect, maintain and enforce our intellectual property
protection for vilobelimab and any other product candidates, and
the scope of such protection;; our manufacturing capabilities and
strategy, including the scalability and cost of our manufacturing
methods and processes and the optimization of our manufacturing
methods and processes, and our ability to continue to rely on our
existing third-party manufacturers and our ability to engage
additional third-party manufacturers for our planned future
clinical trials and for commercial supply of vilobelimab and for
the finished product Gohibic (vilobelimab); our estimates of our
expenses, ongoing losses, future revenue, capital requirements and
our needs for or ability to obtain additional financing; our
ability to defend against liability claims resulting from the
testing of our product candidates in the clinic or, if, approved,
any commercial sales; if any of our product candidates obtain
regulatory approval, our ability to comply with and satisfy ongoing
obligations and continued regulatory overview; our ability to
comply with enacted and future legislation in seeking marketing
approval and commercialization; our future growth and ability to
compete, which depends on our retaining key personnel and
recruiting additional qualified personnel; and our competitive
position and the development of and projections relating to our
competitors in the development of C5a and C5aR inhibitors or our
industry; and the risks, uncertainties and other factors described
under the heading “Risk Factors” in InflaRx’s periodic filings with
the SEC. 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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