UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 6-K
REPORT OF FOREIGN
PRIVATE ISSUER
PURSUANT TO RULE
13A-16 OR 15D-16 UNDER
THE SECURITIES
EXCHANGE ACT OF 1934
For the month
of May 2024
Commission File
Number: 001-38283
InflaRx N.V.
(Translation of
registrant’s name into English)
Winzerlaer Str.
2
07745 Jena, Germany
(Address of principal
executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒
Form 40-F ☐
EXPLANATORY NOTE
Exhibits 99.1 and 99.2 to this Report on Form
6-K shall be deemed to be incorporated by reference into (i) the registration statement on Form S-8 (File No. 333-221656) and (ii) the
registration statement on Form F-3 (File No. 333-273058) of InflaRx N.V. and to be a part thereof from the date on which this report is
submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit 99.3 to this Report on Form 6-K shall
not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act.
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
INFLARX N.V. |
|
|
Date: May 8, 2024 |
By: |
/s/ Niels Riedemann |
|
Name: |
Niels Riedemann |
|
Title: |
Chief Executive Officer |
3
Exhibit 99.1
InflaRx N.V.
Unaudited Condensed
Consolidated
Financial Statements
– March 31, 2024
These unaudited condensed financial
statements are consolidated financial statements for the group consisting of InflaRx N.V. and its wholly-owned subsidiaries InflaRx GmbH,
Jena, Germany, and InflaRx Pharmaceuticals Inc., Ann Arbor, Michigan, United States (together, the “Group”). The financial
statements are presented in euros (€).
InflaRx N.V. is a company
limited by shares, incorporated and domiciled in Amsterdam, The Netherlands.
Its registered office and principal
place of business is in Germany, Jena, Winzerlaer Str. 2.
Index to Unaudited Condensed Consolidated Financial
Statements for the three months ended March 31, 2024
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of
operations and comprehensive loss for the three months ended March 31, 2024 and 2023
| |
| |
For the three months ended March 31, | |
| |
Note | |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
| |
(in €, except for share data) | |
| |
| |
| |
Revenues | |
2 | |
| 36,037 | | |
| — | |
Cost of sales | |
3 | |
| (220,521 | ) | |
| — | |
Gross profit | |
| |
| (184,484 | ) | |
| — | |
Sales and marketing expenses | |
| |
| (1,459,539 | ) | |
| — | |
Research and development expenses | |
4 | |
| (7,301,810 | ) | |
| (14,731,908 | ) |
General and administrative expenses | |
| |
| (3,579,150 | ) | |
| (3,608,554 | ) |
Other income | |
5 | |
| 36,323 | | |
| 7,746,189 | |
Other expenses | |
| |
| (30 | ) | |
| (566 | ) |
Operating result | |
| |
| (12,488,690 | ) | |
| (10,594,839 | ) |
Finance income | |
6 | |
| 908,426 | | |
| 456,036 | |
Finance expenses | |
6 | |
| (4,632 | ) | |
| (5,528 | ) |
Foreign exchange result | |
6 | |
| 1,824,375 | | |
| (1,137,310 | ) |
Other financial result | |
6 | |
| 103,285 | | |
| 197,808 | |
Income taxes | |
| |
| — | | |
| — | |
Income (loss) for the period | |
| |
| (9,657,236 | ) | |
| (11,083,833 | ) |
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |
| |
| | | |
| | |
Exchange differences on translation of foreign currency | |
| |
| (25,538 | ) | |
| (16,785 | ) |
Total comprehensive income (loss) | |
| |
| (9,682,774 | ) | |
| (11,100,618 | ) |
| |
| |
| | | |
| | |
Share information (based on income (loss) for the period) | |
| |
| | | |
| | |
Weighted average number of shares outstanding | |
| |
| 58,883,272 | | |
| 44,771,703 | |
Income (loss) per share (basic/diluted) | |
| |
| (0.17 | ) | |
| (0.25 | ) |
The accompanying notes
are an integral part of these condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements
of financial position as of March 31, 2024 and December 31, 2023
| |
Note | |
March 31, 2024 (unaudited) | | |
December 31, 2023 | |
| |
| |
(in €) | |
ASSETS | |
| |
| | |
| |
Non-current assets | |
| |
| | |
| |
Property and equipment | |
| |
| 284,043 | | |
| 289,577 | |
Right-of-use assets | |
| |
| 1,056,966 | | |
| 1,071,666 | |
Intangible assets | |
| |
| 52,145 | | |
| 68,818 | |
Other assets | |
8 | |
| 244,009 | | |
| 257,267 | |
Financial assets | |
10 | |
| 2,490,202 | | |
| 9,052,741 | |
Total non-current assets | |
| |
| 4,127,365 | | |
| 10,740,069 | |
Current assets | |
| |
| | | |
| | |
Inventories | |
7 | |
| 11,048,645 | | |
| 11,367,807 | |
Current other assets | |
8 | |
| 5,869,744 | | |
| 4,036,650 | |
Trade receivables | |
8 | |
| 35,242 | | |
| — | |
Tax receivable | |
9 | |
| 2,098,276 | | |
| 3,791,564 | |
Other financial assets | |
10 | |
| 58,812,905 | | |
| 77,504,518 | |
Cash and cash equivalents | |
12 | |
| 25,103,058 | | |
| 12,767,943 | |
Total current assets | |
| |
| 102,967,870 | | |
| 109,468,483 | |
TOTAL ASSETS | |
| |
| 107,095,235 | | |
| 120,208,552 | |
| |
| |
| | | |
| | |
EQUITY AND LIABILITIES | |
| |
| | | |
| | |
Equity | |
| |
| | | |
| | |
Issued capital | |
| |
| 7,065,993 | | |
| 7,065,993 | |
Share premium | |
| |
| 334,211,338 | | |
| 334,211,338 | |
Other capital reserves | |
| |
| 41,910,754 | | |
| 40,050,053 | |
Accumulated deficit | |
| |
| (295,785,055 | ) | |
| (286,127,819 | ) |
Other components of equity | |
| |
| 7,356,629 | | |
| 7,382,166 | |
Total equity | |
| |
| 94,759,658 | | |
| 102,581,730 | |
Non-current liabilities | |
| |
| | | |
| | |
Lease liabilities | |
| |
| 727,058 | | |
| 745,716 | |
Other liabilities | |
| |
| 36,877 | | |
| 36,877 | |
Total non-current liabilities | |
| |
| 763,935 | | |
| 782,593 | |
Current liabilities | |
| |
| | | |
| | |
Trade and other payables | |
10 | |
| 7,607,757 | | |
| 11,974,362 | |
Lease liabilities | |
| |
| 378,089 | | |
| 374,329 | |
Employee benefits | |
| |
| 637,607 | | |
| 1,609,766 | |
Other liabilities | |
11 | |
| 2,948,189 | | |
| 2,885,772 | |
Total current liabilities | |
| |
| 11,571,642 | | |
| 16,844,229 | |
Total liabilities | |
| |
| 12,335,577 | | |
| 17,626,822 | |
TOTAL EQUITY AND LIABILITIES | |
| |
| 107,095,235 | | |
| 120,208,552 | |
The accompanying notes are
an integral part of these condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of
changes in shareholders’ equity for the three months ended March 31, 2024 and 2023
(in €, except for share data) | |
Note | |
Shares outstanding | | |
Issued capital | | |
Share premium | | |
Other capital
reserves | | |
Accumulated
deficit | | |
Other components
of equity | | |
Total equity | |
| |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance as of January 1, 2024 | |
| |
| 58,883,272 | | |
| 7,065,993 | | |
| 334,211,338 | | |
| 40,050,053 | | |
| (286,127,819 | ) | |
| 7,382,166 | | |
| 102,581,730 | |
Loss for the period | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| (9,657,236 | ) | |
| — | | |
| (9,657,236 | ) |
Exchange differences on translation of foreign currency | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (25,538 | ) | |
| (25,538 | ) |
Total comprehensive loss | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| (9,657,236 | ) | |
| (25,538 | ) | |
| (9,682,774 | ) |
Equity-settled share-based payments | |
13 | |
| — | | |
| — | | |
| — | | |
| 1,860,701 | | |
| — | | |
| — | | |
| 1,860,701 | |
Balance as of March 31, 2024* | |
| |
| 58,883,272 | | |
| 7,065,993 | | |
| 334,211,338 | | |
| 41,910,754 | | |
| (295,785,055 | ) | |
| 7,356,629 | | |
| 94,759,658 | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as of January 1, 2023 | |
| |
| 44,703,763 | | |
| 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 on translation of foreign currency | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (16,785 | ) | |
| (16,785 | ) |
Total comprehensive loss | |
| |
| — | | |
| — | | |
| — | | |
| — | | |
| (11,083,833 | ) | |
| (16,785 | ) | |
| (11,100,618 | ) |
Equity-settled share-based payments | |
13 | |
| — | | |
| — | | |
| — | | |
| 1,207,048 | | |
| — | | |
| — | | |
| 1,207,048 | |
Share options exercised | |
| |
| 71,234 | | |
| 8,548 | | |
| 115,399 | | |
| — | | |
| — | | |
| — | | |
| 123,947 | |
Balance as of March 31, 2023* | |
| |
| 44,774,997 | | |
| 5,373,000 | | |
| 282,668,032 | | |
| 37,842,612 | | |
| (254,544,123 | ) | |
| 7,240,295 | | |
| 78,579,816 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of cash flows
for the three months ended March 31, 2024 and 2023
| |
| |
For the three months ended March 31, | |
| |
Note | |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
| |
(in €) | |
Operating activities | |
| |
| | |
| |
Loss for the period | |
| |
| (9,657,236 | ) | |
| (11,083,833 | ) |
Adjustments for: | |
| |
| | | |
| | |
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | |
| |
| 123,949 | | |
| 147,969 | |
Net finance income (expense) | |
6 | |
| (2,831,454 | ) | |
| 488,994 | |
Share-based payment expense | |
4 | |
| 1,860,701 | | |
| 1,207,048 | |
Net foreign exchange differences | |
6 | |
| (119,126 | ) | |
| (106,793 | ) |
Changes in: | |
| |
| | | |
| | |
Financial assets from government grants | |
10 | |
| — | | |
| (2,701,076 | ) |
Inventories | |
7 | |
| 319,162 | | |
| — | |
Trade receivables | |
10 | |
| (35,242 | ) | |
| — | |
Employee benefits | |
| |
| (972,159 | ) | |
| (834,713 | ) |
Other assets | |
| |
| (126,547 | ) | |
| 7,515,105 | |
Other liabilities | |
| |
| 62,417 | | |
| 15,986 | |
Liabilities from government grants received | |
10 | |
| — | | |
| (5,033,779 | ) |
Trade and other payables | |
| |
| (4,366,605 | ) | |
| (371,445 | ) |
Interest received | |
6 | |
| 875,990 | | |
| 245,971 | |
Interest paid | |
6 | |
| (2,214 | ) | |
| (5,627 | ) |
Net cash used in operating activities | |
| |
| (14,868,364 | ) | |
| (10,516,193 | ) |
Investing activities | |
| |
| | | |
| | |
Purchase of intangible assets, property and equipment | |
| |
| (16,069 | ) | |
| (6,046 | ) |
Purchase of current financial assets | |
| |
| (3,566,235 | ) | |
| (25,120,832 | ) |
Proceeds from the maturity of financial assets | |
| |
| 30,527,108 | | |
| 21,540,578 | |
Net cash from/(used in) investing activities | |
| |
| 26,944,804 | | |
| (3,586,300 | ) |
Financing activities | |
| |
| | | |
| | |
Proceeds from exercise of share options | |
| |
| — | | |
| 123,947 | |
Repayment of lease liabilities | |
| |
| (85,706 | ) | |
| (93,744 | ) |
Net cash from/(used in) financing activities | |
| |
| (85,706 | ) | |
| 30,202 | |
Net increase/(decrease) in cash and cash equivalents | |
| |
| 11,990,733 | | |
| (14,072,291 | ) |
Effect of exchange rate changes on cash and cash equivalents | |
| |
| 344,381 | | |
| (95,814 | ) |
Cash and cash equivalents at beginning of period | |
| |
| 12,767,943 | | |
| 16,265,355 | |
Cash and cash equivalents at end of period | |
2 | |
| 25,103,058 | | |
| 2,097,250 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Notes to the unaudited condensed consolidated financial
statements
| 1. | Summary of significant accounting policies and other disclosures |
| a) | Reporting entity and the Group’s structure |
InflaRx N.V. (the “Company” or “InflaRx”)
is a Dutch public company with limited liability (naamloze vennootschap) with its corporate seat in Amsterdam, the Netherlands,
and is registered in the Commercial Register of the Netherlands Chamber of Commerce Business Register under CCI number 68904312. The Company’s
registered office is at Winzerlaer Straße 2 in 07745 Jena, Germany. Since November 10, 2017, InflaRx N.V.’s ordinary shares
have been listed on the Nasdaq Global Select Market under the symbol IFRX.
InflaRx is a biopharmaceutical company focused
on applying its proprietary anti-C5a and C5aR technologies to discover, develop and commercialize first-in-class, potent and specific
inhibitors of the complement activation factor known as C5a and its receptor C5aR. On April 4, 2023, the U.S. Food and Drug Administration
issued an Emergency Use Authorization (EUA) for GOHIBIC (vilobelimab), for the treatment of COVID-19 in critically ill, invasively mechanically
ventilated hospitalized adults. These consolidated financial statements of InflaRx comprise the Company and the Group.
These interim condensed consolidated financial
statements for the three -month reporting period ended March 31, 2024, and 2023 have been prepared in accordance with IAS 34 Interim Financial
Reporting. These condensed consolidated financial statements do not include all the information and disclosures required in the annual
financial statements. Accordingly, this report is to be read in conjunction with the financial statements in the Company’s annual
report for the year ended December 31, 2023 on Form 20-F.
The interim condensed consolidated financial
statements were authorized for issue by the board of directors of the Company (the “Board of Directors”) on May 7, 2024.
The financial statements are presented in euros
(€). The euro is the functional currency of InflaRx N.V. and InflaRx GmbH. The functional currency of InflaRx Pharmaceuticals Inc.
is the U.S. dollar.
All financial information presented in euros
have been rounded. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that
precede them or may deviate from other tables.
The accounting policies adopted are consistent
with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December 31, 2023,
except for the adoption of new standards effective as of January 1, 2024, as set out below. The Group has not adopted any other standard,
interpretation or amendment that has been issued but is not yet effective early.
The following amendments were adopted effective
January 1, 2024, and do not have a material impact on the consolidated financial statements of the Group:
| ● | Amendments
to IFRS 16 Leases: Leases on Sale and Leaseback |
| ● | Amendments
to IAS 1 Presentation of Financial Statements: Classification of Liabilities as Current or
Non-current and Non-current Liabilities with Covenants |
| ● | Amendments
to IAS 7, Statement of Cash Flows and IFRS 7, Financial Instruments |
The
following standards issued will be adopted in a future period, and the potential impact, if any, they will have on the Group’s
consolidated financial statements is being assessed:
| ● | Amendments
to IAS 21 Effects of Changes in Foreign Exchange Rates: Lack of exchangeability |
| ● | IFRS
18 Presentation and Disclosure in Financial Statements |
| |
For the three months ended March 31, | |
| |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
(in €) | |
Revenues | |
| 36,037 | | |
| — | |
Total | |
| 36,037 | | |
| — | |
For the three months ended March 31, 2024, the
Company realized revenues from the product sales of GOHIBIC (vilobelimab) in the amount of €36 thousand. Revenues reported are sales
to end customers (hospitals). Sales to distributors do not constitute revenue for the Company under IFRS 15. All revenues are attributed
to sales made in the United States.
| |
For the three months ended March 31, | |
| |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
(in €) | |
| |
| | |
| |
Cost of Sales | |
| 220,521 | | |
| — | |
Total | |
| 220,521 | | |
| — | |
The cost of sales during the three months ended
March 31, 2024 mainly consists of write-downs of inventories that will expire prior to their expected sale.
| 4. | Research and development expenses |
Research and development expenses incurred for
the three months ended March 31, 2024 decreased by €7.4 million compared to the three months ended March 31, 2023. This decrease
is primarily due to the fact that we incurred high third-party expenses in the first quarter of 2023 in connection with our efforts to
develop the commercial manufacturing process and to obtain an EUA for GOHIBIC (vilobelimab).
| |
For the three months ended March, 31, | |
| |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
(in €) | |
Other income | |
| | |
| |
Income from government grants | |
| — | | |
| 7,734,855 | |
Other | |
| 36,323 | | |
| 11,334 | |
Total | |
| 36,323 | | |
| 7,746,189 | |
Other income for the three months ended March
31, 2024 amounted to €36 thousand (PY: €7.7 million). The decrease of €7.7 million in income from government grants is
due to the end of the grant period on June 30, 2023.
| |
For the three months ended March 31, 2024 | |
| |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
(in €) | |
| |
| | |
| |
Interest income | |
| 908,426 | | |
| 456,036 | |
Interest expenses | |
| (439 | ) | |
| (420 | ) |
Interest on lease liabilities | |
| (4,193 | ) | |
| (5,108 | ) |
Finance Result | |
| 903,794 | | |
| 450,508 | |
| |
| | | |
| | |
Foreign exchange income | |
| 2,049,582 | | |
| 290,525 | |
Foreign exchange expense | |
| (225,207 | ) | |
| (1,427,835 | ) |
Foreign exchange result | |
| 1,824,375 | | |
| (1,137,310 | ) |
| |
| | | |
| | |
Other financial result | |
| 103,285 | | |
| 197,808 | |
Net financial result | |
| 2,831,454 | | |
| (488,994 | ) |
Net financial result increased by €3.3 million
to a gain of €2.8 million for the three months ended March 31, 2024 from a loss of €0.5 million for the three months ended March
31, 2023. This increase is mainly attributable to an increase of interest income on marketable securities by €0.5 million and an
increase of the foreign exchange result of €3.0 million. Other financial result consists of an adjustment for expected credit losses
on marketable securities.
| |
As of March 31, 2024 (unaudited) | | |
As of December 31, 2023 | |
| |
(in €) | |
| |
| | |
| |
Raw material and supplies | |
| 423,560 | | |
| 423,560 | |
Unfinished goods | |
| 10,515,518 | | |
| 10,614,159 | |
Finished goods | |
| 109,566 | | |
| 330,087 | |
Total | |
| 11,048,645 | | |
| 11,367,807 | |
As of March 31, 2024, total write-downs on inventories
amounted to €0.7 million, €0.2 million for the three months ended March 31, 2024. These write-downs were set up due to the expected
expiry of the shelf life.
| |
As of March 31, 2024 (unaudited) | | |
As of December 31, 2023 | |
| |
(in €) | |
Non-current other assets | |
| | |
| |
Prepaid expenses | |
| 244,009 | | |
| 257,267 | |
Total | |
| 244,009 | | |
| 257,267 | |
Current other assets | |
| | | |
| | |
Prepayments on research & development projects | |
| 4,129,342 | | |
| 3,670,167 | |
Prepaid expenses | |
| 1,432,090 | | |
| 272,999 | |
Others | |
| 308,312 | | |
| 93,482 | |
Total | |
| 5,869,744 | | |
| 4,036,648 | |
Total other assets | |
| 6,113,753 | | |
| 4,293,915 | |
As of March 31, 2024, prepayments on research
and development projects amounted to €4.1 million compared to €3.7 million as of December 31, 2023, and consist of prepayments
on clinical contracts, especially for INF904.
Prepaid expenses mainly consist of prepaid D&O
insurance expense for the year 2024, which will be recognized into general and administrative expenses pro rata over the year.
The category “others” primarily relate
to prepayments on commercial production.
As of March 31, 2024, tax receivable amounted
to €2.1 million compared to €3.8 million as of December 31, 2023. The decrease is mainly attributable to VAT refunds for Q2
2023 and Q3 2023 received during the three months ended March 31, 2024.
| 10. | Financial assets and financial liabilities |
Set out below is an overview of financial assets
and liabilities, other than cash and cash equivalents, held by the Group as of March 31, 2024 and December 31, 2023.
| |
As of March 31, 2024 (unaudited) | | |
As of December 31, 2023 | |
| |
(in €) | |
Financial assets at amortized cost | |
| | |
| |
Trade receivables | |
| 35,242 | | |
| — | |
Non-current financial assets | |
| 2,490,202 | | |
| 9,052,741 | |
Other current financial assets | |
| 58,812,907 | | |
| 77,504,518 | |
Financial liabilities at amortized cost | |
| | | |
| | |
Trade and other payables | |
| 7,607,757 | | |
| 14,716,441 | |
As of March 31, 2024, the fair value of current
and non-current financial assets (primarily quoted debt securities) amounted to €60.9 million (Level 1). The Group’s debt instruments
at amortized cost consist solely of quoted securities that are graded highly by credit rating agencies such as S&P Global and, therefore,
are considered low credit risk investments.
As of March 31, 2024, current and non-current
financial assets decreased by €25.3 million to €61.3 million compared to €86.6 million as of December 31, 2023. For the
three months ended March 31, 2024 this decrease is mainly due to the maturity of financial assets, and their subsequent reinvestment into
interest bearing bank deposits, which are accounted for as part of cash and cash
equivalents.
As of March 31, 2024, trade and other payables
decreased by €7.1 million to €7.6 million compared to €14.7 million as of December 31, 2023. As of December 31, 2023 the
Company had high trade payables from CDMO’s, which arose in connection with the manufacturing of commercial products.
Trade receivables arose from GOHIBIC (vilobelimab)
product deliveries to end customers (hospitals) through a subsidiary of Cencora, which acts as a US distributor for the Company.
| |
As of March 31, 2024 (unaudited) | | |
As of December 31, 2023 | |
| |
(in €) | |
| |
| | |
| |
Liabilities to commercial partner | |
| 2,836,972 | | |
| 2,784,231 | |
Miscellaneous other liabilities | |
| 111,218 | | |
| 101,542 | |
Total | |
| 2,948,190 | | |
| 2,885,773 | |
In September 2023, the Company received €2.9
million for GOHIBIC (vilobelimab) product shipments from a subsidiary of Cencora which acts as a U.S. distributor for the Company, as
well as an additional €26 thousand in March 2024. The majority of this product will remain in stock at the distributor awaiting sale
to customers. In accordance with IFRS 15, InflaRx recognizes revenue when control of the products is transferred to the end customer (hospital).
For each unit sold to the end customer, this liability is reduced with a corresponding amount recognized in revenue. During April 2024,
the Company came to agreement with Cencora to pay back the amount due for the product shipments transferred in September 2023.
| 12. | Cash and cash equivalents |
| |
As of March 31, 2024 (unaudited) | | |
As of December 31, 2023 | |
| |
(in €) | |
Short-term deposits | |
| | |
| |
Deposits held in U.S. dollars | |
| 15,741,977 | | |
| 4,120,951 | |
Deposits held in euros | |
| 2,555,000 | | |
| 1,020,000 | |
Total | |
| 18,296,977 | | |
| 5,140,951 | |
Cash at banks | |
| | | |
| | |
Cash held in U.S. dollars | |
| 5,469,183 | | |
| 5,041,802 | |
Cash held in euros | |
| 1,336,898 | | |
| 2,585,190 | |
Total | |
| 6,806,081 | | |
| 7,626,991 | |
Total cash and cash equivalents | |
| 25,103,058 | | |
| 12,767,942 | |
As of March 31, 2024, cash and cash equivalents
increased by €12.3 million to €25.1 million compared to €12.8 million as of December 31, 2023. For the three months ended
March 31, 2024 this increase is mainly due to the maturity of financial assets, and their subsequent reinvestment into interest bearing
bank deposits.
| a) | Equity settled share-based payment arrangements |
InflaRx GmbH granted options under the 2012 Stock
Option Plan. Those InflaRx GmbH options were converted into options for ordinary shares of InflaRx N.V. at the time of its IPO in November
2017:
Number of share options | |
2024 | | |
2023 | |
Outstanding as of January 1, | |
| 148,433 | | |
| 148,433 | |
Exercised during the three months ended March 31, | |
| — | | |
| — | |
Outstanding as of March 31, | |
| 148,433 | | |
| 148,433 | |
thereof vested | |
| 148,433 | | |
| 148,433 | |
Under the terms and conditions of the share option
plan 2016, InflaRx GmbH granted rights to subscribe for InflaRx GmbH’s ordinary shares to directors, senior management, and key
employees. Those InflaRx GmbH options were converted into options for ordinary shares of InflaRx N.V. at the time of its IPO in November
2017:
Number of share options | |
2024 | | |
2023 | |
Outstanding as of January 1, | |
| 888,632 | | |
| 888,632 | |
Exercised during the three months ended March 31, | |
| — | | |
| — | |
Outstanding as of March 31, | |
| 888,632 | | |
| 888,632 | |
thereof vested | |
| 888,632 | | |
| 888,632 | |
InflaRx also granted share options under the
2017 LTIP subsequently to its IPO in November 2017. The total number of share options granted during the three months ended March 31,
2024 under the 2017 LTIP was as follows:
Number of share options | |
2024 | | |
2023 | |
Total number of options outstanding as of January 1, | |
| 6,584,946 | | |
| 4,985,523 | |
Granted during the three months ended March 31, | |
| 2,275,000 | | |
| 1,506,750 | |
Exercised during the three months ended March 31, | |
| - | | |
| 56,304 | |
Forfeited during the three months ended March 31, | |
| (7,000 | ) | |
| - | |
Outstanding as of March 31, | |
| 8,852,946 | | |
| 6,435,969 | |
thereof vested | |
| 5,986,946 | | |
| 4,474,219 | |
The number of share options granted during the
three months ended March 31, 2024 under the 2017 LTIP was as follows:
Share options granted 2024 | |
Number | | |
Fair value per option | | |
FX rate as of grant date | | |
Fair value per option | | |
Share price at grant date / Exercise price | | |
Expected volatility | | |
Expected life (midpoint based) | | |
Risk-free rate (interpolated, U.S. sovereign strips curve) | |
January 5 | |
| 2,245,000 | | |
$ | 1.65 | | |
| 0.916 | | |
€ | 1.51 | | |
$ | 1.79 | | |
| 1.47 | | |
| 5.30 - 5.50 | | |
| 4.023%- 4.025% | |
February 21 | |
| 30,000 | | |
$ | 1.40 | | |
| 0.925 | | |
€ | 1.30 | | |
$ | 1.51 | | |
| 1.47 | | |
| 5.50 | | |
| 4.308 | % |
| |
| 2,275,000 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Of the 2,275,000 options granted during
the three months ended March 31, 2024 (ended March 31, 2023: 1,506,750), 1,615,000 options (March 31, 2023: 1,223,500) were granted to
members of the executive management or Board of Directors.
Expected dividends are nil for all share
options listed above.
| b) | Share-based payment expense recognized |
For the three months ended March 31, 2024, the
Company has recognized €1.8 million (ended March 31, 2023: €1.2 million) of share-based payment expense in the statements of
operations and comprehensive loss.
None of the share-based payment awards were dilutive
in determining earnings per share due to the Group’s loss position.
| c) | Share options exercised |
During the three months ended March 31, 2024,
no shares (ended March 31, 2023: 56,304) were issued, because no share options were exercised, resulting in proceeds to the Company in
the amount of €0 thousand (ended March 31, 2023: €98 thousand).
According to the Articles of Association of the
Company, up to 110,000,000 ordinary shares and up to 110,000,000 preferred shares with a nominal value of €0.12 per share are authorized
to be issued. All shares are registered shares. No share certificates shall be issued.
In order to deter acquisition bids, the Company`s
general meeting of shareholders approved the right of an independent foundation under Dutch law, or protective foundation, to exercise
a call option pursuant to the call option agreement, upon which preferred shares will be issued by the Company to the protective foundation
of up to 100% of the Company’s issued capital held by others than the protective foundation, minus one share. The protective foundation
is expected to enter into a finance arrangement with a bank, or, subject to applicable restrictions under Dutch law, the protective foundation
may request the Company to provide, or cause the Company’s subsidiaries to provide, sufficient funding to the protective foundation
to enable it to satisfy its payment obligation under the call option agreement. These preferred shares will have both a liquidation and
dividend preference over the Company`s ordinary shares and will accrue cash dividends at a pre-determined rate. The protective foundation
would be expected to require the Company to cancel its preferred shares once the perceived threat to the Company and its stakeholders
has been removed or sufficiently mitigated or neutralized. The Company believes that the call option does not represent a significant
fair value based on a level 3 valuation, since the preference shares are restricted in use and can be canceled by the Company.
During the three months ended March 31, 2024,
the Company expensed €13 thousand (2023: €15 thousand) of ongoing costs to reimburse expenses incurred by the protective foundation.
F-12
Exhibit 99.2
MANAGEMENT’S
DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This management’s discussion and analysis
is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read
this discussion together with our unaudited interim condensed consolidated financial statements, including the notes thereto, for the
three months ended March 31, 2024 and 2023, respectively, included as Exhibit 99.1 to the report on Form 6-K to which this discussion
is attached as Exhibit 99.2. We also recommend that you read our “ITEM 5. Operating and financial review and prospects” and
our audited consolidated financial statements for fiscal year 2023, and the notes thereto, which appear in our Annual Report on Form 20-F
for the year ended December 31, 2023 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”).
In addition, we recommend that you read any public announcements made by InflaRx N.V.
The following discussion is based on our financial
information prepared in accordance with IFRS as issued by the IASB, which may differ in material respects from generally accepted accounting
principles in the United States and other jurisdictions. We maintain our books and records in euros. Unless otherwise indicated, all references
to currency amounts in this discussion are in euros. We have made rounding adjustments to some of the figures included in this discussion
and analysis. Accordingly, numerical figures shown as totals in some tables may not be arithmetic aggregations of the figures that precede
them.
The following discussion includes forward-looking
statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these
forward-looking statements as a result of many factors, including but not limited to those described under “ITEM 3. Key Information––Risk
factors” in the Annual Report and risks described in our subsequent SEC filings.
Unless otherwise indicated or the context otherwise
requires, all references to “InflaRx” or the “Company,” “we,” “our,” “ours,”
“us” or similar terms refer to InflaRx N.V. and its subsidiaries InflaRx GmbH and InflaRx Pharmaceuticals, Inc.
Overview
We are a biopharmaceutical company focused on
applying our proprietary anti-C5a and C5aR technologies to discover, develop and commercialize first-in-class, potent and specific inhibitors
of the complement activation factor known as C5a and its receptor known as C5aR. C5a is a powerful inflammatory mediator involved in the
progression of a wide variety of autoimmune and other inflammatory diseases. Our lead product candidate, vilobelimab, is a novel intravenously
delivered first-in-class anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical
activity and tolerability in multiple clinical settings.
Vilobelimab for the treatment of pyoderma
gangrenosum
We are developing vilobelimab for the treatment
of pyoderma gangrenosum, or PG. PG is a rare, chronic inflammatory form of neutrophilic dermatosis characterized by accumulation of neutrophils
in the affected skin areas. The exact pathophysiology is not fully understood, but it is postulated that inflammatory cytokine production
as well as neutrophil activation and dysfunction contribute to a sterile inflammation in the skin. PG often presents as painful pustule
or papule, mainly on the lower extremities, which can rapidly progress to an extremely painful enlarging ulcer. Associated symptoms include
fever, malaise, weight loss and myalgia. PG usually has a devastating effect on a patient’s life due to the severe pain and induction
of significant movement impairment depending on lesions’ location. The exact prevalence of PG is not yet known but is estimated
that up to 51,000 patients in the United States and Europe are affected by this disease.
Vilobelimab has been granted orphan drug designation
for the treatment of PG by both the FDA in the United States and the European Medicines Agency, or EMA, in Europe as well as fast-track
designation be the FDA. Furthermore, we announced that we had a productive end-of-phase II meeting with the FDA related to our plans for
a Phase III development program in PG in June 2022. In January 2023, we announced details related to the design of our planned Phase III
study with vilobelimab in ulcerative PG.
In November 2023, we announced the enrollment
of the first patient in the Phase III trial. The Phase III study is designed to enroll patients in the United States, Europe and selected
countries in other regions. The study design is based on detailed feedback and recommendations from the FDA Division of Dermatology and
Dentistry and was developed in close collaboration with the Company´s advisors from the United States, Europe and other regions.
The multi-national, randomized, double-blind, placebo-controlled Phase III trial has two arms: vilobelimab (2,400mg every other week)
plus a low dose of corticosteroids and placebo plus the same low dose of corticosteroids. In both arms, corticosteroid treatment will
be initiated on day one and will be tapered off within the first eight weeks of the treatment period. The primary endpoint of the study
will be complete closure of the target ulcer at any time up to 26 weeks after initiation of treatment. Treatment will be discontinued
for patients whose disease progresses or fails to improve at defined time points during the study. The study has an adaptive trial design
with an interim analysis blinded for the sponsor and investigators (but unblinded for the independent data safety monitoring committee),
which is planned upon enrollment of approximately 30 patients, divided equally between the two arms of the study. The interim analysis
with a set of predefined rules will take into account the then-observed difference in complete target ulcer closure between the two arms
and will then determine whether the trial sample size will be adapted or whether the trial should be stopped due to futility. The enrollment
period is projected to last at least two years, and its overall period will depend on the total trial size after sample size adaptation.
GOHIBIC (vilobelimab) for the treatment
of critically ill, invasively mechanically ventilated COVID-19 patients
In April 2023, we received an Emergency Use Authorization,
or the EUA, from the U.S. Food and Drug Administration, or FDA, for GOHIBIC (vilobelimab) for the treatment of critically ill, invasively
mechanically ventilated COVID-19 patients. Specifically, we received the EUA for the treatment of COVID-19 in hospitalized adults when
initiated within 48 hours of receiving invasive mechanical ventilation, or IMV, or extracorporeal membrane oxygenation, or ECMO. GOHIBIC
(vilobelimab) is not FDA-approved for any indication, including for the treatment of COVID-19 in critically ill, invasively mechanically
ventilated patients.
To achieve full commercial scale and successfully
reach the full market potential of the product in the United States in the future, we also aspire to obtain full market approval for GOHIBIC
(vilobelimab). We are therefore planning the submission of a Biologics License Applications, BLA, for full approval of GOHIBIC (vilobelimab)
in our COVID-19 indication and potentially, in the future, in similar indications that may apply to other virally induced acute respiratory
distress conditions. In October 2023, in furtherance of our continued efforts to obtain a BLA, we had an encouraging Type C meeting with
the FDA. In that meeting, the FDA indicated their willingness to collaborate with us in identifying a development pathway towards a BLA
for a broader acute respiratory distress syndrome (ARDS) label. To achieve this, we would need to conduct an additional well-controlled
and adequately powered study in a broader ARDS setting that demonstrates the safety and efficacy of vilobelimab.
We are actively evaluating and working towards
next steps to enable such a trial in a broader ARDS setting and are currently exploring different funding options, including government
grants as well as collaborations with third parties.
In June 2023, we began the commercialization
of GOHIBIC (vilobelimab) in the United States for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving
IMV or ECMO. We entered into agreements with certain subsidiaries of Cencora Inc. to act as our U.S. distributor and to make GOHIBIC (vilobelimab)
available for order by U.S. hospital customers under the EUA. Cencora provides cold storage, cold-chain distribution services, inventory
management and secondary labeling/packaging, among other services. To support our commercial efforts, we have hired and are continuing
to hire U.S. experts with relevant experience in the commercialization of medical products in the hospital market, including in the areas
of sales, sales operations, marketing, market access, distribution, medical affairs and others. In addition, we are expanding the necessary
infrastructure, including IT systems, supply chain, financial reporting systems and inventory management systems both, internally and
with the assistance of external service providers.
In July 2023, we also submitted a Marketing Authorization
Application, or MAA, for SARS-CoV-2 induced septic ARDS receiving IMV or ECMO to the EMA. In August 2023, the EMA validated the MAA. This
means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use, or CHMP, under
the centralized procedure, which applies to all 27 member states of the European Union, or EU.
C5aR inhibitor INF904
Inhibition of the C5a/C5aR axis provides strong
anti-inflammatory effects in a variety of diseases. Blockade of C5a using highly specific antibodies, such as vilobelimab, may offer a
fast, effective, and safe way to control C5a-induced inflammation. In addition to this approach, inhibition of C5aR by oral small molecules
may provide the ease of administration required for effective long-term treatment for more chronic inflammatory diseases. To expand the
breadth of our anti-C5a/C5aR technologies, we are also developing INF904, an oral, small molecule drug candidate that targets the C5aR
receptor. C5aR, a G-protein-coupled-receptor expressed primarily by granulocytes, mediates the pathophysiological effects of C5a. In INF904,
we discovered a small molecule C5aR inhibitor that in pre-clinical studies has shown potential for superior characteristics to the only
approved C5aR inhibitor, avacopan. INF904 has provided higher plasma exposure in animals, including non-human primates, and improved inhibitory
activity in a hamster neutropenia model compared to avacopan. Furthermore, in contrast to avacopan, in vitro experiments showed INF904
has substantially less inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a
variety of drugs, including glucocorticoids. No obvious toxicological findings, even in the highest dose groups tested in required GLP
toxicity analyses, were identified. INF904 demonstrated potential for anti-inflammatory therapeutic effects in several preclinical disease
models.
All IND-enabling studies, including certain GLP-toxicological
studies, have been completed, and we conducted a Phase I single and multiple ascending dose, or MAD, clinical study from November 2022
to January 2024.
In September 2023, we announced the topline results
from the single ascending dose, or SAD part of a randomized, double-blind, placebo-controlled Phase I trial with INF904, which enrolled
62 healthy volunteers within six different dosing groups from 3 mg to 240 mg who were randomly assigned to receive INF904 or a placebo.
Different drug concentrations were tested for the 60 mg dosing group. The main objectives were to assess safety and tolerability of the
SAD under fasting conditions. Secondary endpoints included several pharmacokinetic, or PK, parameters, and the effect of INF904 on C5a-induced
neutrophil activation in blood samples from treated volunteers ex vivo also was explored.
The results show that INF904 was well tolerated
in treated patients and resulted in no safety signals of concern in single doses ranging from 3 mg to 240 mg. The overall percentage of
adverse events (AEs) was lower in the INF904 treated patients compared to the placebo group, and no serious or severe AEs were observed
at any dosing level. No related AEs were reported in conjunction with INF904 dosing.
Analysis of INF904 PK in subject plasma samples
revealed sustained exposure to INF904 with six hours to maximum concentration, or tmax. INF904 plasma levels were dose proportional
for systemic exposure (AUClast) and nearly dose proportional for maximum concentration (Cmax) over the dose range
used in the study. With the 30 mg dose, INF904 reached a Cmax of 289 ng/ml with an AUClast of 5197 h.ng/ml, which
are approximately 3-fold and 10-fold, respectively, higher than the published Phase I data from the only marketed comparator, avacopan.
Single doses of 30 mg or higher of INF904 achieved
≥90% blocking of C5a induced up-regulation of the activation marker CD11b on neutrophils in plasma samples from subjects ex vivo
at 24 hours post dosing. This inhibition was achieved when 12.6 nM recombinant C5a was added as stimulus in this assay, a C5a concentration
which can be observed in patients with severe inflammatory conditions such as the immuno-dermatological disease, hidradenitis suppurativa,
or HS, or during life-threatening inflammation (e.g., in critically ill COVID-19 patients or septic patients). Thus, INF904 inhibition
of C5a-induced neutrophil activation in human plasma achieved the set goal for effective C5aR control at disease relevant C5a levels.
In January 2024, we announced topline results
from the MAD part a randomized, double-blind, placebo-controlled Phase I trial for INF904. The PK and pharmacodynamic, or PD parameters
confirm the favorable data we observed during the SAD part of the study, which provides support for the best-in-class potential of INF904.
INF904 was well tolerated and there were no adverse safety events of concern after repeated dosing in participants over the entire tested
dose range.
In the MAD part of the randomized, double-blind,
placebo-controlled Phase I trial, 24 participants received multiple doses of INF904 for 14 days of either 30 mg once per day, or QD, 30
mg twice per day, or BID, or 90 mg BID. The study’s primary objective was to evaluate the safety and tolerability of repeated dosing.
Several PK parameters were analyzed as secondary endpoints, and the effect of the dosing scheme on C5a-induced neutrophil activation in
blood samples from the participants was also explored in an ex vivo assay.
The safety analysis of INF904 in the MAD part
of the Phase I study demonstrated that it was well tolerated in participants over the entire dose range and resulted in no safety signals
of concern. The overall percentage of AEs in INF904 treated participants was 77.8%, which was lower than the 83.3% observed in the placebo
group. There were no serious or severe AEs observed at any dosing level.
Analysis of the PK profile showed that potential
target AUC0-12h, Cmax, and trough values were achieved rapidly within 14 days of 30 mg BID dosing. INF904 exposure
further increased proportionally with dosing up to 90 mg BID. These results were demonstrated even when participants ingested the drug
in a fasted state, suggesting that food is not required to achieve potentially therapeutic drug levels.
Analysis of the PD profile showed that the blocking
activity of C5a-induced neutrophil activation by INF904 reached equal to or above 90% over the 14-day dosing period for all tested doses
in an ex vivo challenge assay where physiological and disease- relevant levels of C5a were added to blood samples provided by the trial
participants.
In parallel, we have progressed with the development
of a commercially viable formulation of INF904 which we plan to introduce into Phase II development towards the end of 2024.
We are currently conducting additional required
pre-clinical studies, including long-term chronic toxicology studies, to enable longer-term dosing of INF904 for chronic inflammatory
diseases. We initially plan to develop INF904 for the treatment of two initial immuno-dermatology indications: HS and chronic spontaneous
urticaria, or CSU.
We plan to initiate an open-label Phase IIa “basket
study” before the end of 2024 to explore at least three different doses of INF904 for a duration of four weeks and to assess PK
and PD parameters in HS and CSU patients, as well as provide safety data and certain early efficacy readouts. Data from this Phase IIa
study is expected to be available in 2025. Depending on the results of this study, we expect to initiate a larger and longer-term Phase
IIb study in one or both indications in 2025 as well.
CSU and HS are chronic inflammatory skin conditions
in which C5a has been suggested to play a significant role and where a high unmet need exists. Being an oral drug with a mechanism of
action currently not addressed by other drugs in development for these indications, we see a unique opportunity to improve standard of
care for patients with these conditions.
CSU is a debilitating and unpredictable skin
disease characterized by intensely itchy hives / wheals and angioedema. The burden of this chronic disease is high and impacts sleep,
mental health, quality of life and productivity due to absences from school and work. CSU is estimated to affect around 40 million people
worldwide. CSU patients have been reported to show elevated C5a levels, a major activator of mast cells and basophils, which are thought
to be significant contributors to CSU pathogenesis. In addition, studies suggest that complement activation (including C5a) in CSU can
lead to histamine release. Current treatments are limited, and a significant unmet need exists in a sizable proportion of patients. As
an orally available agent with a favorable PK / PD profile that could drive a broad dose range for systemic exposure, INF904 could find
a differentiated position in the CSU market.
HS is a chronic, recurrent, debilitating neutrophil-driven
inflammatory disease that can persist for years and tremendously impacts quality of life; it is characterized by abscesses, nodules and
draining tunnels, or dTs, which can flare and cause scarring. INF904 inhibits the known C5a-induced effects on neutrophil activation and
tissue accumulation of immune cells, including generation of tissue damaging mechanisms (enzyme release and oxidative radical formation)
as well as induction of NETosis, which are mechanisms thought to be involved in HS progression and dT formation. Clinical evidence with
existing C5a/C5aR inhibitors also supports that blocking this pathway reduces lesion counts. Patients’ responses to treatment with
currently approved drugs are known to wane over time in a significant number of cases, and treatments with new mechanisms of action are
needed for these patients.
We announced to hold a virtual research and development
day highlighting our development plans for INF904 and to offer insights from key opinion leaders into the development and commercial rationales
of our pipeline. The meeting will take place on June 5, beginning at 12:00 PM ET / 6:00 PM CET and ending at 2:00 PM ET / 8:00 PM CET.
Our featured thought leaders will include Joerg Koehl, Ph.D., Marcus Maurer, M.D. and Chris Sayed M.D..
Anti-C5a antibody IFX002
We are also developing IFX002 for the treatment
of chronic inflammatory diseases. IFX002 is a highly potent anti- C5a antibody, which binds to the same domain of the C5a protein as vilobelimab,
but which has a higher humanization grade and altered PK properties compared to vilobelimab. IFX002 is currently in preclinical development.
We consider IFX002 to be a life-cycle management product to vilobelimab, given the long remaining patent life of IFX002.
Financial highlights
As of March 31, 2024, we had cash and cash equivalents
of €25.1 million and marketable securities of €60.7 million. We believe that our current funds on hand will be sufficient to
fund our planned operations into 2026.
We
anticipate that our expenses might increase if and as we:
| ● | continue
to develop and conduct clinical trials with respect to our lead product candidate, vilobelimab; |
| ● | continue
research, preclinical and clinical development efforts for any future product candidates, including INF904 and IFX002; |
| ● | actively
seek to identify additional research programs and additional product candidates; |
| ● | seek
regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any; |
| ● | establish
sales, marketing, distribution and other commercial infrastructure now and in the future to commercialize various products for which
we may obtain marketing authorization or approval, if any; |
| ● | require
the scale-up and validation of the manufacturing process and the manufacturing of larger quantities of product candidates for clinical
development and, potentially, commercialization; |
| ● | collaborate
with strategic partners to optimize the manufacturing process for vilobelimab, IFX002, INF904 and other pipeline products; |
| ● | maintain,
expand and protect our intellectual property portfolio; |
| ● | hire
and retain additional personnel, such as commercial, marketing, clinical, quality control and scientific personnel; and |
| ● | add
operational, financial and management information systems and personnel, including personnel to support our product development as well
as commercialization and help us comply with our obligations as a public company. |
Our ability to become and remain profitable depends
on our ability to generate revenue. We do not expect to generate significant revenue unless and until we are, or any future collaborator
is, able to obtain full marketing authorization or approval for, and successfully commercialize, one or more of our product candidates.
Successful commercialization will require achievement of key milestones, including completing clinical trials of vilobelimab, INF904 and
any other product candidates, obtaining marketing authorization or approval for these product candidates, manufacturing, marketing and
selling those products for which we, or any of our future collaborators, may obtain marketing authorization or approval, satisfying any
post-marketing requirements and obtaining reimbursement for our products from private insurance or government payors. Because of the uncertainties
and risks associated with these activities, we are unable to accurately predict the timing and amount of revenues, and if or when we might
achieve profitability. We and any future collaborators may never succeed in these activities and, even if we do, or any future collaborators
do, we may never generate revenue that is large enough for us to achieve profitability. Even if we do achieve profitability, we may not
be able to sustain or increase profitability on a quarterly or annual basis.
We expect our financial condition and operating
results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.
In order to succeed, we will need to transition from a company with a research and development focus to a company capable of undertaking
commercial activities. We may encounter unforeseen expenses, difficulties, complications and delays, and may not be successful in such
a transition.
Accordingly, we may seek to further fund our
operations through public or private equity or debt financings or other sources, including strategic collaborations. We may, however,
be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise
capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability
to develop vilobelimab or any additional product candidates.
Our failure to become and remain profitable could
depress the market price of our ordinary shares and could impair our ability to raise capital, pay dividends, expand our business, diversify
our product offerings or continue our operations. If we continue to suffer losses as we have in the past, investors may not receive any
return on their investment and may lose their entire investment.
Research and development expenses
Research and development expenses have consisted
principally of:
| ● | expenses incurred under agreements with CROs, contract manufacturing organizations,
or CDMOs, consultants and independent contractors that conduct research and development, preclinical and clinical activities on our behalf; |
| ● | employee-related expenses, including salaries, benefits and stock-based compensation
expense based upon employees’ role within the organization; and |
| ● | professional fees for lawyers related to the protection and maintenance of
our intellectual property. |
Our research and development expenses primarily
relate to the following key programs:
| ● | Vilobelimab. We expect our expenses associated with vilobelimab
will increase in 2024 compared to 2023, as we progress to conduct the Phase III clinical study in PG. In addition, we are incurring and
expect to further incur expenses in conjunction with the preparation and filing of full market authorizations for vilobelimab in the United
States, Europe and elsewhere. We might also potentially consider development of vilobelimab in additional indications. In addition, we
are also incurring expenses related to the manufacturing of clinical trial material and the completion of activities towards the final
establishment of commercial scale production. |
| ● | INF904. We are also developing INF904, a product candidate
that targets the C5aR receptor. We expect to incur additional costs by advancing the clinical and non-clinical development of INF904.
Specifically, we expect to incur expenses by developing a new formulation, conducting long-term toxicological studies in several animal
species and initiation Phase II clinical trials. We plan to study INF904 in complement-mediated, chronic autoimmune and inflammatory conditions
where an oral low molecular weight compound might have advantages or is needed for patients and where oral delivery is the medically preferred
route of administration. |
| ● | IFX002. We are also developing IFX002 for the treatment of chronic inflammatory indications. IFX002 is a highly potent anti-complement C5a antibody with a higher humanization grade and altered PK properties compared to vilobelimab and is currently in pre-clinical development. Expenses for this program mainly consist of salaries, costs for preclinical testing conducted by CROs and costs to produce preclinical material. |
| ● | Other development programs. Our other research and development
expenses relate to our preclinical studies of other product candidates and discovery activities, expenses for which mainly consist of
salaries, costs for production of preclinical compounds and costs paid to CROs. |
In 2023, we incurred €41.0 million in research and development expenses. For each of the three months ended March 31, 2024 and 2023, we incurred research and development expenses of €7.3 million and €14.7 million, respectively. The decrease in our research and development expenses was attributable to higher R&D expenses in the first three month of 2023 for the completion of the development activities for vilobelimab for the treatment of critically ill COVID-19 patients, for which the FDA granted the EUA in April 2023. The 2023 expenses comprised of costs 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.
Our research and development expenses may vary
substantially from period to period based on the timing of our research and development activities, including due to timing of clinical
trial initiation and conduct.
We expense research and development costs as
incurred. We recognize costs for certain development activities, such as preclinical studies and clinical trials, based on an evaluation
of the progress towards completion of specific tasks. We use information provided to us by our vendors such as patient enrollment or clinical
site activations for services received and efforts expended. Research and development activities are central to our business model.
The successful development and commercialization
of our product candidates is highly uncertain. We cannot reasonably and accurately predict the nature, timing and estimated costs of the
efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence
from, any of our product candidates. For a discussion of our other key financial statement line items, please see “ITEM 5. Operating
and Financial Review and Prospects—Operating results” in the Annual Report.
General and administrative expenses
We expect that our general and administrative
expenses will increase in the future as our business expands and we incur additional costs associated with operating as a public company.
These public company-related costs relate primarily to additional personnel, additional legal and consulting fees, audit fees, directors’
and officers’ liability insurance premiums and costs associated with investor relations activities.
In 2023, we incurred €12.6 million in general
and administrative expenses. For each of the three months ended March 31, 2024 and 2023, we incurred general and administrative expenses
of €3.6 million and €3.6 million, respectively.
Sales and marketing expenses
Sales and marketing expenses include costs for
commercial operations, distribution and logistics, sales, marketing and comparable activities. We incur these costs either directly through
the employment of own personnel and in-house activities or through commissioning third parties to assist in different aspects of commercializing
our products. These expenses amounted to €1.5 million in the three-months ended March 31, 2024. The Group started with its commercialization
activities when the EUA was granted in April 2023. Prior to that, no sales and marketing expenses had been incurred.
Results of operations
The information below was derived from our unaudited
interim condensed consolidated financial statements included elsewhere herein. The discussion below should be read along with these unaudited
interim condensed consolidated financial statements and our Annual Report.
Comparison of the three months ended March 31, 2024 and 2023
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
Revenues | |
| 36,037 | | |
| — | | |
| 36,037 | |
Cost of Sales | |
| (220,521 | ) | |
| — | | |
| (220,521 | ) |
Gross profit | |
| (184,484 | ) | |
| — | | |
| (184,484 | ) |
Operating expenses | |
| | | |
| | | |
| | |
Sales and marketing expenses | |
| (1,459,539 | ) | |
| — | | |
| (1,459,539 | ) |
Research and development expenses | |
| (7,301,810 | ) | |
| (14,731,908 | ) | |
| 7,430,098 | |
General and administrative expenses | |
| (3,579,150 | ) | |
| (3,608,554 | ) | |
| 29,404 | |
Total operating expenses | |
| (12,340,499 | ) | |
| (18,340,462 | ) | |
| 5,999,963 | |
Other income | |
| 36,323 | | |
| 7,746,189 | | |
| (7,709,866 | ) |
Other expenses | |
| (30 | ) | |
| (566 | ) | |
| 536 | |
Operating result | |
| (12,488,690 | ) | |
| (10,594,839 | ) | |
| (1,893,851 | ) |
Finance income | |
| 908,426 | | |
| 456,036 | | |
| 452,390 | |
Finance expenses | |
| (4,632 | ) | |
| (5,528 | ) | |
| 896 | |
Foreign exchange result | |
| 1,824,375 | | |
| (1,137,310 | ) | |
| 2,961,685 | |
Other financial result | |
| 103,285 | | |
| 197,808 | | |
| (94,523 | ) |
Income (loss) for the period | |
| (9,657,236 | ) | |
| (11,083,833 | ) | |
| 1,426,597 | |
Exchange differences on translation of foreign currency | |
| (25,538 | ) | |
| (16,785 | ) | |
| (8,753 | ) |
Total comprehensive income (loss) | |
| (9,682,774 | ) | |
| (11,100,618 | ) | |
| 1,417,844 | |
Revenues
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
Revenues | |
| 36,037 | | |
| — | | |
| 36,037 | |
Total | |
| 36,037 | | |
| — | | |
| 36,037 | |
For the three months ended March 31, 2024, we
realized revenues from the product sales of GOHIBIC (vilobelimab) in the amount of €36 thousand. Revenues reported are sales to end
customers (hospitals). Sales to distributors do not constitute revenue for the Company under IFRS 15. All revenues are attributed to sales
made in the United States.
Cost of sales
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
Cost of Sales | |
| (220,521 | ) | |
| — | | |
| (220,521 | ) |
Total | |
| (220,521 | ) | |
| — | | |
| (220,521 | ) |
The cost of sales during the three months ended
March 31, 2024 mainly consists of write-downs of inventories that will expire prior to their expected sale.
Sales and marketing expenses
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
Third-party expenses | |
| 709,763 | | |
| — | | |
| 709,763 | |
Personnel expenses | |
| 323,573 | | |
| — | | |
| 323,573 | |
Legal and consulting fees | |
| 315,243 | | |
| — | | |
| 315,243 | |
Other expenses | |
| 110,960 | | |
| — | | |
| 110,960 | |
Total sales and marketing expenses | |
| 1,459,539 | | |
| — | | |
| 1,459,539 | |
In the three-months ended March 31, 2024, we
incurred €1.5 million of sales and marketing expenses. These expenses are primarily comprised of €0.3 million in personnel costs
and €0.7 million in external services for distribution of GOHIBIC.
Research and development expenses
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
Third-party expenses | |
| 4,116,271 | | |
| 12,403,127 | | |
| (8,286,856 | ) |
Personnel expenses | |
| 2,446,620 | | |
| 1,611,079 | | |
| 835,541 | |
Legal and consulting fees | |
| 387,052 | | |
| 545,151 | | |
| (158,099 | ) |
Other expenses | |
| 351,867 | | |
| 172,550 | | |
| 179,317 | |
Total research and development expenses | |
| 7,301,810 | | |
| 14,731,908 | | |
| (7,430,098 | ) |
We use our employee and infrastructure resources
across multiple research and development programs directed toward developing our therapeutics in different indications and in our pre-clinical
and clinical programs. We manage certain activities such as contract research and manufacturing of therapeutics and our discovery programs
through our third-party vendors. Research and development expenses incurred for the three months ended March 31, 2024 decreased by €7.4
million compared to the three months ended March 31, 2023. This decrease is primarily due to the fact that we incurred high third-party
expenses in the first quarter of 2023 in connection with our efforts to develop the commercial manufacturing process and to obtain the
EUA for GOHIBIC (vilobelimab).
General and administrative expenses
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
Personnel expenses | |
| 2,020,375 | | |
| 1,606,005 | | |
| 414,370 | |
Legal, consulting and audit fees | |
| 570,126 | | |
| 985,912 | | |
| (415,786 | ) |
Other expenses | |
| 988,650 | | |
| 1,016,638 | | |
| (27,988 | ) |
Total general and administrative expense | |
| 3,579,150 | | |
| 3,608,554 | | |
| (29,404 | ) |
General and administrative expenses amounted
to €3.6 million for the three months ended March 31, 2024. For the three months ended March 31, 2023 general and administrative expenses
also amounted to €3.6 million.
Other income
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
Income from government grants | |
| — | | |
| 7,734,855 | | |
| (7,734,855 | ) |
Other | |
| 36,323 | | |
| 11,334 | | |
| 24,989 | |
Total other income | |
| 36,323 | | |
| 7,746,189 | | |
| (7,709,866 | ) |
Other income for the three months ended March
31, 2024 amounted to €36 thousand (PY: €7.7 million). The decrease of €7.7 million in income from government grants is
due to the end of the grant period that ended on June 30, 2023.
Net financial result
| |
three months ended March 31, | |
| |
2024 | | |
2023 | | |
Change | |
| |
(in €) | |
| |
| | |
| | |
| |
Interest income | |
| 908,426 | | |
| 456,036 | | |
| 452,390 | |
Interest expenses | |
| (439 | ) | |
| (420 | ) | |
| (19 | ) |
Interest on lease liabilities | |
| (4,193 | ) | |
| (5,108 | ) | |
| 915 | |
Finance result | |
| 903,794 | | |
| 450,508 | | |
| 453,286 | |
| |
| | | |
| | | |
| | |
Foreign exchange income | |
| 2,049,582 | | |
| 290,525 | | |
| 1,759,057 | |
Foreign exchange expense | |
| (225,207 | ) | |
| (1,427,835 | ) | |
| 1,202,628 | |
Foreign exchange result | |
| 1,824,375 | | |
| (1,137,310 | ) | |
| 2,961,685 | |
| |
| | | |
| | | |
| | |
Other financial result | |
| 103,285 | | |
| 197,808 | | |
| (94,523 | ) |
Net financial result | |
| 2,831,454 | | |
| (488,994 | ) | |
| 3,320,448 | |
Net financial result increased by €3.3 million
to a gain of €2.8 million for the three months ended March 31, 2024 from a loss of €0.5 million for the three months ended March
31, 2023. This increase is mainly attributable to an increase of interest income on marketable securities by €0.5 million and an
increase of foreign exchange result of €3.0 million. Other financial result consists of an adjustment for expected credit losses
on marketable securities.
Liquidity and capital resources
Since inception, we have incurred significant
operating losses. For the three months ended March 31, 2024, we incurred a net loss of €9.7 million. To date, we have financed our
operations primarily through the sale of our securities. As of March 31, 2024, we had cash, cash equivalents in the amount of €25.1
million and financial assets in the amount of €61.3 million, comprised of marketable securities in the amount of €60.7 million
and other financial assets amounting to €0.6 million. Our cash and cash equivalents primarily consist of bank deposit accounts and
fixed U.S. dollar term deposits.
Cash flows
The table below summarizes our consolidated statement
of cash flows for the three months ended March 31, 2024 and 2023:
| |
three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(in €) | |
Net cash used in operating activities | |
| (14,868,364 | ) | |
| (10,516,193 | ) |
Net cash from/ (used in) investing activities | |
| 26,944,804 | | |
| (3,586,300 | ) |
Net cash from/ (used in) financing activities | |
| (85,706 | ) | |
| 30,202 | |
Cash and cash equivalents at the beginning of the period | |
| 12,767,943 | | |
| 16,265,355 | |
Exchange gains/ (losses) on cash and cash equivalents | |
| 344,381 | | |
| (95,814 | ) |
Cash and cash equivalents at the end of the period | |
| 25,103,058 | | |
| 2,097,250 | |
1. Net
cash from/used in operating activities
The use of cash in all periods resulted primarily
from our net losses, adjusted for non-cash charges and changes in components of working capital.
Net cash used in operating activities increased
to €14.9 million in the three months ended March 31, 2024, from €10.5 million in the three months ended March 31, 2023.
2. Net
cash from/used in investing activities
Net cash from investing activities increased
by €30.5 million in the three months ended March 31, 2024, mainly due to higher proceeds from the maturity of marketable securities
in the three months ended March 31, 2024 compared to the three months ended March 31, 2023. These proceeds were reinvested into interest
bearing bank deposits, which are accounted for as part of cash and cash equivalents.
3. Net
cash from/used in financing activities
Net cash from financing activities decreased
by €0.1 million in the three months ended March 31, 2024, compared to the three months ended March 31, 2023.
Funding requirements
We expect our expenses associated with vilobelimab to
increase in 2024 compared to 2023, as we continue discussions with the FDA related to the planned submission of a BLA for
full approval of GOHIBIC (vilobelimab) to treat severe COVID-19 and potentially additional related indications, continue to pursue commercializing
of GOHIBIC (vilobelimab) under the EUA for emergency use as granted by the FDA, complete developing vilobelimab in other indications,
including PG in our Phase III trial, and wind down the Phase II clinical program in cSCC. In addition, we also incur expenses related
to the manufacturing of clinical trial material and in connection with further optimizing our manufacturing process for vilobelimab in
compliance with regulatory standards. Furthermore, we also have established commercial scale production options and have initiated manufacturing
campaigns to be able to serve the market needs in the United States under the granted EUA.
We also plan to advance the development of INF904
by the initiation of Phase II clinical development. In parallel, we are also continuing with non-clinical development activities in relation
to CMC and additional non-clinical animal studies in order to prepare for this future development.
If clinical data is supportive, we may seek marketing
approval for any product candidates that we successfully develop. Additionally, we will validate and further develop the manufacturing
process of our products to be able to apply for marketing authorization and to be able to provide a commercial-grade product. If we obtain
marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to establishing
sales, marketing, distribution, and other commercial infrastructure to commercialize such products. We will need to obtain substantial
additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms,
we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts. We believe
that our existing cash and cash equivalents and financial assets will enable us to fund our operating expenses and capital expenditure
requirements under our current business plan into 2026.
Until such time, if ever, that we can generate
substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, royalty-based
financings, future collaborations, strategic alliances, licensing arrangements and revenues from product sales. To the extent that we
raise additional capital through the sale of equity or convertible debt securities, the interest of our current shareholders will be diluted,
and the terms of these securities may include voting or other rights that adversely affect your rights as an ordinary shareholder. Debt
financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such
as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through additional collaborations,
strategic alliances or licensing arrangements with third parties, we may have to relinquish rights to our technologies, future revenue
streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.
For more information as to the risks associated
with our future funding needs, see “ITEM 3. Key Information––Risk factors” in our Annual Report.
Off-balance sheet arrangements
As of March 31, 2024, and during the periods
presented, we did not have any off-balance sheet arrangements other as described under “ITEM 5. Operating and financial review and
prospects—off-balance sheet arrangements” in our Annual Report.
Contractual obligations and commitments
We do not have any, and during the periods presented
we did not have any, contractual obligations and commitments other than as described under “ITEM 5. Operating and Financial Review
and Prospects—Liquidity and capital resources––Contractual obligations and commitments” in the Annual Report.
Quantitative and qualitative disclosures about market risk
During the three months ended March 31, 2024,
there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “ITEM
11. Quantitative and Qualitative Disclosures About Market Risk” in the Annual Report.
Critical judgments and accounting estimates
There have been no material changes to the significant
accounting policies and estimates described in “ITEM 5. Operating and Financial Review and Prospects—Critical judgments and
accounting estimates” in the Annual Report.
Critical Accounting Estimates
There have been no material changes to the significant
accounting policies and estimates described in Note B.2. to our consolidated financial statements in the Annual Report.
Cautionary statement regarding forward looking statements
This discussion contains forward-looking statements
that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “estimate,” “believe,” “predict,” “potential”
or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future.
These statements speak only as of the date of this discussion 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. We have based these forward-looking statements largely on our current expectations
and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations.
These forward-looking statements include, without limitation, statements about the following:
| ● | our ability to successfully commercialize and the receptiveness of GOHIBIC
(vilobelimab) as a treatment for COVID-19 patients by U.S. hospitals, our ability to positively influence treatment recommendations by
medical/healthcare institutes, guideline bodies and other third-party organizations; |
our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under the EUA, and in the future if approved for commercial use in the United States or elsewhere;
our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including PG, and any other product candidates, including INF904, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials;
the timing, progress and results of preclinical studies and clinical trials of vilobelimab, INF904 and any other product candidates, including for the development of vilobelimab in several indications, including to treat PG, HS and CSU 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 and the receptiveness and approval by regulators regarding
the results of clinical trials and potential regulatory approval or authorization pathways including related to our MAA submission for
vilobelimab and our BLA for GOHIBIC (vilobelimab); the timing and outcome of any discussions or submission of filings for regulatory approval
or authorization of vilobelimab, INF904 or any other product candidate, and the timing of and our ability to obtain and maintain full
regulatory approval or the EUA, of vilobelimab or GOHIBIC (vilobelimab) for any indication; our ability to leverage our proprietary anti-C5a
and anti-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, INF904 and any other product candidates, and the scope of such protection; |
whether the FDA, or 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;
| ● | the success of our future clinical trials for vilobelimab, INF904 and any
other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical
trials; |
| ● | our expectations regarding the size of the patient populations for, the market
opportunity for, the medical need for and clinical utility of vilobelimab, INF904 or any other product candidates, if approved or authorized
for commercial use; |
| ● | 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 expectations regarding the scope of any approved indication for vilobelimab; |
| ● | our ability to defend against liability claims resulting from the testing
of our product candidates in the clinic or, if, approved or authorized, any commercial sales; |
| ● | if any of our product candidates obtain regulatory approval or authorization,
our ability to comply with and satisfy ongoing drug regulatory obligations and continued regulatory overview; |
| ● | our ability to comply with enacted and future legislation in seeking marketing
approval or authorization 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 and other therapeutic products being developed in similar medical conditions
in which vilobelimab, INF904 or any other of our product candidates is being developed or our industry. |
Because forward-looking statements are inherently
subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should
not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking
statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.
You should refer to the “ITEM 3. Key Information––Risk factors” section of our Annual Report and risks described
in our subsequent SEC filings for a discussion of important factors that may cause our actual results to differ materially from those
expressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties
may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these
factors, we cannot assure you that the forward-looking statements in this discussion or in our Annual Report will prove to be accurate.
Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether
as a result of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risks
and other information we describe in the reports we will file from time to time with the SEC after the date of this discussion.
13
Exhibit 99.3
InflaRx Reports First Quarter 2024
Financial Results and Provides Business Update
| ● | Virtual R&D event to be held on June 5, 2024 from 12:00 to 2:00 PM
EDT – highlighting company plans for INF904 and the opportunity, the role of C5aR in chronic spontaneous urticaria (CSU) and hidradenitis
suppurativa (HS) and C5a/C5aR signaling in human inflammatory diseases |
| ● | INF904 multiple ascending dose (MAD) pharmacokinetic (PK) and pharmacodynamic
(PD) data supporting best-in-class potential announced, and plans to initiate Phase IIa in CSU and HS by the end of 2024, with data availability
anticipated in 2025 |
| ● | Phase III vilobelimab pyoderma gangrenosum (PG) trial expected to have
an interim analysis in 2025 |
| ● | Cash, cash equivalents and marketable securities of €85.8 million,
expected to fund operations at least into 2026 |
Jena, Germany, May 8, 2024 – InflaRx N.V. (Nasdaq: IFRX),
a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced financial results
for the three months ended March 31, 2024, and provided an operating update.
Prof. Niels C. Riedemann, Chief Executive
Officer and founder of InflaRx, commented: “InflaRx made tremendous progress during the early months of 2024, and is
well positioned to advance vilobelimab and INF904 toward meaningful clinical milestones. Our pivotal trial with vilobelimab in PG continues
to enroll patients, with an interim analysis expected next year. Patients suffering from PG have no approved treatment alternatives and
often experience tremendous suffering. Thus, PG remains an area of high unmet medical need and represents a significant market opportunity
for us. Phase I data for INF904 indicate best-in-class potential, and the possibility to address multiple sizable unmet needs, spurring
our plans to initiate Phase IIa in CSU and HS by the end of this year. With our clear strategic focus on immuno-dermatology, and the additional
potential of our drug candidates in the broader immunology inflammation field, we are excited about the path ahead of us”
Virtual R&D event on June 5, 2024
InflaRx will host a virtual research and development
event on June 5, 2024. Guided by internationally renowned thought leaders, this event will focus on the planned development of InflaRx’s
new orally administered, low molecular weight C5aR inhibitor, INF904, and the role of C5aR in CSU and HS. Discussions will address underlying
development rationales and expected Phase IIa trial design, and provide insights into the commercial opportunity. In addition, the event
will cover INF904’s broader therapeutic potential in the immuno-inflammation field and recent advances in our understanding of the role
of C5a/C5aR signaling as it relates to human inflammatory diseases.
Featured key opinion leaders will include Prof.
Dr. Marcus Maurer (Professor of Dermatology and Allergology, Institute of Allergology, Charité – Universitätsmedizin
Berlin, Germany), Christopher Sayed, MD (Prof. of Dermatology, University of North Carolina, Medical School; and Secretary of the
HS Foundation) and Prof. Dr. Jörg Köhl (Director of the Institute for Systemic Inflammation Research, University of Lübeck,
Lübeck, Germany). The meeting will take place on June 5, from 12:00 PM EDT / 6:00 PM CEST to 2:00 PM EDT / 8:00 PM CEST.
To participate in the virtual R&D event, participants
may pre-register here to receive a dedicated link and dial-in details to access the meeting.
Capital One Securities Dermatology Panel
on May 14, 2024
InflaRx will also participate in the Capital One
Securities 1st Annual Biotech/Biopharma Disrupters Event, as a panelist on a panel, titled “New Potential Dermatology Treatments
for Psoriasis, Urticaria, and Alopecia” on May 14, 2024, at 2:30 PM EDT / 8:30 PM CEST.
Recent Highlights and Business Update
INF904 – Initial focus on CSU and
HS, broader opportunities in I&I possible via partnering
In March 2024, InflaRx announced it had chosen
two initial immuno-dermatology indications it intends to pursue with INF904 and that it plans to initiate a Phase IIa “basket study”.
This open-label, 4-week, multi-dose trial enrolling CSU and HS patients is expected to begin by the end of 2024 and to assess safety,
as well as PK and PD parameters. InflaRx anticipates releasing data from this Phase IIa study in 2025. Similarly, the company expects to
initiate a Phase IIb study in 2025 as well. InflaRx is currently conducting additional pre-clinical studies, including chronic toxicology
studies, to enable longer-term dosing of INF904.
CSU and HS are two chronic inflammatory skin conditions
in which C5a has been suggested to play a significant role and where a high unmet need exists. In addition, as an oral drug with a mechanism
of action currently not addressed by other drugs in development for these indications, the company sees a unique opportunity for INF904
to improve the standard of care.
INF904 - Positive topline results from Phase
I trial support best-in-class potential
In January 2024, InflaRx reported results from
the MAD part of a randomized, double-blind, placebo-controlled Phase I trial in healthy volunteers to assess the safety, tolerability
and PK / PD properties of its orally administered, low molecular weight C5aR inhibitor, INF904.The safety analysis of INF904 in the Phase
I study demonstrated that it was well tolerated in participants over the entire dose range and resulted in no safety signals of concern.
There were no serious or severe adverse events observed at any dosing level. Both the single ascending dose and the MAD part of the study
showed favorable PK and PD profiles, including achieving the desired blocking activity (>90%) of C5a-induced neutrophil activation
in an ex vivo challenge assay using physiological and disease-relevant levels of C5a.
Vilobelimab in PG – Enrollment ongoing
in pivotal Phase III trial
InflaRx is conducting a multi-national, randomized,
double-blind, placebo-controlled pivotal Phase III study of vilobelimab for the treatment of ulcerative PG, a rare, chronic inflammatory
form of neutrophilic dermatosis characterized by accumulation of neutrophils in the affected skin areas. The trial has two arms: (1) vilobelimab
plus a low dose of corticosteroids and (2) placebo plus the same low dose of corticosteroids. The primary endpoint of the study is complete
closure of the target ulcer at any time up to 26 weeks after initiation of treatment.
The study has an adaptive design with an interim
analysis blinded for the sponsor and investigators planned upon enrollment of approximately 30 patients (15 per arm). Depending on the
results of the interim analysis, expected to occur in 2025, the trial sample size will be adapted, or the trial will be terminated due
to futility. The total enrollment period is projected to be at least two years, depending on the total trial size after sample size adaptation.
Vilobelimab has been granted orphan drug designation
for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as fast track
designation by the FDA.
Vilobelimab GOHIBIC (vilobelimab) for the
treatment of critically ill COVID-19 Patients – The InflaRx Commitment Program launched
In April, 2023, the FDA issued an Emergency Use
Authorization (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). In January 2024, InflaRx announced the launch of
The InflaRx Commitment Program, pursuant to which the cost of GOHIBIC (vilobelimab) will be refunded for up to six (6) administered inpatient
doses (the full treatment course) to institutions that meet the eligibility requirements*, for patients who were administered GOHIBIC
(vilobelimab) in line with its EUA and who died due to COVID-19 in the intensive care unit.
InflaRx continues to explore funding options for
vilobelimab as a treatment for acute respiratory distress syndrome (ARDS), including government grants as well as collaborations with
third parties.
The Marketing Authorization Application (MAA)
for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO is under regulatory review by the European
Committee for Medicinal Products for Human Use under the centralized procedure, which applies to all 27 member states of the European
Union.
Vilobelimab abstract presentation at ATS
2024
An InflaRx abstract titled “Vilobelimab
in Combination With Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients: A Subgroup Analysis”
has been accepted for presentation during a thematic poster session at the American Thoracic Society 2024 International Conference on
Tuesday, May 21, from 11:30 AM PT / 2:30 PM ET / 8:30 PM CEST to 1:15 PM PT / 4:15 PM ET / 10:15 PM CEST.
Dr. Thomas Taapken, Chief Financial Officer
of InflaRx, said: “In the first quarter of 2024, InflaRx strategically prioritized its efforts, focusing development
activities in a select number of immuno-dermatology indications. Sharpening our profile in this way has helped put us in a strong financial
position, allowing us to advance our clinical programs towards their next milestones and to fund operations at least into 2026.”
Financial Highlights – Q1 2024
Revenue
For the three months ended March 31, 2024, we
realized revenues from the product sales of GOHIBIC (vilobelimab) in the amount of €36 thousand. Revenues reported are sales to end
customers (hospitals). Sales to distributors do not constitute revenue for the InflaRx under IFRS 15. All revenues are attributed to sales
made in the United States.
Cost of sales
The cost of sales during the three months ended
March 31, 2024 mainly consists of write-downs of inventories that will expire prior to their expected sale.
Sales and marketing expenses
In the three-months ended March 31, 2024, we incurred
€1.5 million of sales and marketing expenses. These expenses are primarily comprised of €0.3 million in personnel costs and
€0.7 million in external services for distribution.
R&D expenses
R&D expenses incurred for the three months
ended March 31, 2024 decreased by €7.4 million compared to the three months ended March 31, 2023. This decrease is primarily due
to the fact that we incurred high third-party expenses in the first quarter of 2023 in connection with our efforts to develop the commercial
manufacturing process and to obtain an EUA for GOHIBIC (vilobelimab).
General and administrative expenses
General and administrative expenses amounted to
€3.6 million for each of the three months ended March 31, 2024 and March 31, 2023.
Other income
Other income for the three months ended March
31, 2024 amounted to €36 thousand (PY: €7.7 million). The decrease of €7.7 million in other income is due to the end of
the government grant period on June 30, 2023.
Net financial result
Net financial result increased by €3.3 million
to a gain of €2.8 million for the three months ended March 31, 2024 from a loss of €0.5 million for the three months ended March
31, 2023. This increase is mainly attributable to an increase of interest income on marketable securities by €0.5 million and an
increase of foreign exchange result of €3.0 million. Other financial result consists of an adjustment for expected credit losses
on marketable securities.
Net loss
Net loss for the first three months of 2024 amounted
to €9.7 million, compared to €11.1 million in the first three months of 2023.
Net cash used in operating activities
Net cash used in operating activities for the
first three months of 2024 increased to €14.9 million from €10.5 million for the comparable period in 2023.
Liquidity and capital resources
As of March 31, 2024, InflaRx’s total available
funds were approximately €85.8 million, composed of €25.1 million in cash and cash equivalents and €60.7 million in marketable
securities. These funds are expected to finance operations at least into 2026.
Additional financial information
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, 2024, as well as the consolidated financial statements as of and for the year ended December 31, 2023, in “ITEM 18. Financial
Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2023, as filed with the U.S. Securities
and Exchange Commission (SEC) on March 21, 2024.
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of operations
and comprehensive loss for the three months ended March 31, 2024 and 2023
| |
For the three months ended March 31, | |
| |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
(in €, except for share data) | |
| |
| |
Revenues | |
| 36,037 | | |
| — | |
Cost of sales | |
| (220,521 | ) | |
| — | |
Gross profit | |
| (184,484 | ) | |
| — | |
Sales and marketing expenses | |
| (1,459,539 | ) | |
| — | |
Research and development expenses | |
| (7,301,810 | ) | |
| (14,731,908 | ) |
General and administrative expenses | |
| (3,579,150 | ) | |
| (3,608,554 | ) |
Other income | |
| 36,323 | | |
| 7,746,189 | |
Other expenses | |
| (30 | ) | |
| (566 | ) |
Operating result | |
| (12,488,690 | ) | |
| (10,594,839 | ) |
Finance income | |
| 908,426 | | |
| 456,036 | |
Finance expenses | |
| (4,632 | ) | |
| (5,528 | ) |
Foreign exchange result | |
| 1,824,375 | | |
| (1,137,310 | ) |
Other financial result | |
| 103,285 | | |
| 197,808 | |
Income taxes | |
| — | | |
| — | |
Income (loss) for the period | |
| (9,657,236 | ) | |
| (11,083,833 | ) |
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |
| | | |
| | |
Exchange differences on translation of foreign currency | |
| (25,538 | ) | |
| (16,785 | ) |
Total comprehensive income (loss) | |
| (9,682,774 | ) | |
| (11,100,618 | ) |
| |
| | | |
| | |
Share information (based on income (loss) for the period) | |
| | | |
| | |
Weighted average number of shares outstanding | |
| 58,883,272 | | |
| 44,771,703 | |
Income (loss) per share (basic/diluted) | |
| (0.17 | ) | |
| (0.25 | ) |
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of financial
position as of March 31, 2024 and December 31, 2023
| |
March 31, 2024 (unaudited) | | |
December 31, 2023 | |
| |
(in €) | |
ASSETS | |
| | |
| |
Non-current assets | |
| | |
| |
Property and equipment | |
| 284,043 | | |
| 289,577 | |
Right-of-use assets | |
| 1,056,966 | | |
| 1,071,666 | |
Intangible assets | |
| 52,145 | | |
| 68,818 | |
Other assets | |
| 244,009 | | |
| 257,267 | |
Financial assets | |
| 2,490,202 | | |
| 9,052,741 | |
Total non-current assets | |
| 4,127,365 | | |
| 10,740,069 | |
Current assets | |
| | | |
| | |
Inventories | |
| 11,048,645 | | |
| 11,367,807 | |
Current other assets | |
| 5,869,744 | | |
| 4,036,650 | |
Trade receivables | |
| 35,242 | | |
| — | |
Tax receivable | |
| 2,098,276 | | |
| 3,791,564 | |
Other financial assets | |
| 58,812,905 | | |
| 77,504,518 | |
Cash and cash equivalents | |
| 25,103,058 | | |
| 12,767,943 | |
Total current assets | |
| 102,967,870 | | |
| 109,468,483 | |
TOTAL ASSETS | |
| 107,095,235 | | |
| 120,208,552 | |
| |
| | | |
| | |
EQUITY AND LIABILITIES | |
| | | |
| | |
Equity | |
| | | |
| | |
Issued capital | |
| 7,065,993 | | |
| 7,065,993 | |
Share premium | |
| 334,211,338 | | |
| 334,211,338 | |
Other capital reserves | |
| 41,910,754 | | |
| 40,050,053 | |
Accumulated deficit | |
| (295,785,055 | ) | |
| (286,127,819 | ) |
Other components of equity | |
| 7,356,629 | | |
| 7,382,166 | |
Total equity | |
| 94,759,658 | | |
| 102,581,730 | |
Non-current liabilities | |
| | | |
| | |
Lease liabilities | |
| 727,058 | | |
| 745,716 | |
Other liabilities | |
| 36,877 | | |
| 36,877 | |
Total non-current liabilities | |
| 763,935 | | |
| 782,593 | |
Current liabilities | |
| | | |
| | |
Trade and other payables | |
| 7,607,757 | | |
| 11,974,362 | |
Lease liabilities | |
| 378,089 | | |
| 374,329 | |
Employee benefits | |
| 637,607 | | |
| 1,609,766 | |
Other liabilities | |
| 2.948.189 | | |
| 2,885,772 | |
Total current liabilities | |
| 11,571,642 | | |
| 16,844,229 | |
Total liabilities | |
| 12,335,557 | | |
| 17,626,822 | |
TOTAL EQUITY AND LIABILITIES | |
| 107,095,235 | | |
| 120,208,552 | |
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of changes
in shareholders’ equity for the three months ended March 31, 2024 and 2023
(in €) | |
Issued capital | | |
Share premium | | |
Other capital reserves | | |
Accumulated deficit | | |
Other components of equity | | |
Total equity | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance as of January 1, 2024 | |
| 7,065,993 | | |
| 334,211,338 | | |
| 40,050,053 | | |
| (286,127,819 | ) | |
| 7,382,166 | | |
| 102,581,730 | |
Loss for the period | |
| — | | |
| — | | |
| — | | |
| (9,657,236 | ) | |
| — | | |
| (9,657,236 | ) |
Exchange differences on translation of foreign currency | |
| — | | |
| — | | |
| — | | |
| — | | |
| (25,538 | ) | |
| (25,538 | ) |
Total comprehensive loss | |
| — | | |
| — | | |
| — | | |
| (9,657,236 | ) | |
| (25,538 | ) | |
| (9,682,774 | ) |
Equity-settled share-based payments | |
| — | | |
| — | | |
| 1,860,701 | | |
| — | | |
| — | | |
| 1,860,701 | |
Balance as of March 31, 2024 | |
| 7,065,993 | | |
| 334,211,338 | | |
| 41,910,754 | | |
| (295,785,055 | ) | |
| 7,356,629 | | |
| 94,759,658 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
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 on translation of foreign currency | |
| — | | |
| — | | |
| — | | |
| — | | |
| (16,785 | ) | |
| (16,785 | ) |
Total comprehensive loss | |
| — | | |
| — | | |
| — | | |
| (11,083,833 | ) | |
| (16,785 | ) | |
| (11,100,618 | ) |
Equity-settled share-based payments | |
| — | | |
| — | | |
| 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 | |
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated
statements of cash flows for the three months ended March 31, 2024 and 2023
| |
For the three months ended March 31, | |
| |
2024 (unaudited) | | |
2023 (unaudited) | |
| |
(in €) | |
Operating activities | |
| | |
| |
Loss for the period | |
| (9,657,236 | ) | |
| (11,083,833 | ) |
Adjustments for: | |
| | | |
| | |
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | |
| 123,949 | | |
| 147,969 | |
Net finance income (expense) | |
| (2,831,454 | ) | |
| 488,994 | |
Share-based payment expense | |
| 1,860,701 | | |
| 1,207,048 | |
Net foreign exchange differences | |
| (119,126 | ) | |
| (106,793 | ) |
Changes in: | |
| | | |
| | |
Financial assets from government grants | |
| — | | |
| (2,701,076 | ) |
Inventories | |
| 319,162 | | |
| — | |
Trade receivables | |
| (35,242 | ) | |
| — | |
Employee benefits | |
| (972,159 | ) | |
| (834,713 | ) |
Other assets | |
| (126,547 | ) | |
| 7,515,105 | |
Other liabilities | |
| 62,417 | | |
| 15,986 | |
Liabilities from government grants received | |
| — | | |
| (5,033,779 | ) |
Trade and other payables | |
| (4,366,605 | ) | |
| (371,445 | ) |
Interest received | |
| 875,990 | | |
| 245,971 | |
Interest paid | |
| (2,214 | ) | |
| (5,627 | ) |
Net cash used in operating activities | |
| (14,868,364 | ) | |
| (10,516,193 | ) |
Investing activities | |
| | | |
| | |
Purchase of intangible assets, property and equipment | |
| (16,069 | ) | |
| (6,046 | ) |
Purchase of current financial assets | |
| (3,566,235 | ) | |
| (25,120,832 | ) |
Proceeds from the maturity of financial assets | |
| 30,527,108 | | |
| 21,540,578 | |
Net cash from/(used in) investing activities | |
| 26,944,804 | | |
| (3,586,300 | ) |
Financing activities | |
| | | |
| | |
Proceeds from exercise of share options | |
| — | | |
| 123,947 | |
Repayment of lease liabilities | |
| (85,706 | ) | |
| (93,744 | ) |
Net cash from/(used in) financing activities | |
| (85,706 | ) | |
| 30,202 | |
Net increase/(decrease) in cash and cash equivalents | |
| 11,990,733 | | |
| (14,072,291 | ) |
Effect of exchange rate changes on cash and cash equivalents | |
| 344,381 | | |
| (95,814 | ) |
Cash and cash equivalents at beginning of period | |
| 12,767,943 | | |
| 16,265,355 | |
Cash and cash equivalents at end of period | |
| 25,103,058 | | |
| 2,097,250 | |
About InflaRx
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals
Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
InflaRx (Nasdaq: IFRX) is a biopharmaceutical
company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop
and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful
inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate,
vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and
has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is
also developing INF904, an orally administered, small molecule inhibitor of the C5a receptor. 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.
Jan Medina, CFA |
MC Services AG |
Vice President, Head of Investor Relations |
Katja Arnold, Laurie Doyle, Dr. Regina Lutz |
Email: IR@inflarx.de |
Email: inflarx@mc-services.eu |
|
Europe: +49 89-210 2280 |
|
U.S.: +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,” “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,
the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations
by medical/healthcare institutes and other third-party organizations, our ability to successfully commercialize and the receptiveness
of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations
regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return
accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimab and any other
product candidates, under an EUA and in the future if approved for commercial use in the United States or elsewhere; our ability to successfully
implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of COVID-19 and
other debilitating or life-threatening inflammatory indications, including PG, and any other product candidates including INF904, and
whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing,
progress and results of pre-clinical studies and 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 MAA submission for vilobelimab and 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 our 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.
11
InflaRx NV (NASDAQ:IFRX)
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From Apr 2024 to May 2024
InflaRx NV (NASDAQ:IFRX)
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From May 2023 to May 2024