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INFLARX N.V. UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - SEPTEMBER 30, 2021 These unaudited interim condensed financial statements are consolidated financial statements for the group consisting of Inf

Key Takeaway: UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - SEPTEMBER 30, 2021 These unaudited interim condensed financial statements are consolidated financial statements for the group consisting of InflaRx N.V. and its wholly-owned subsidiaries InflaRx GmbH, Jena, Germany

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UNAUDITED INTERIM CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS - SEPTEMBER 30, 2021
These unaudited interim 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 Euro ( ).
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 INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2021
Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2021 and 2020 3
Unaudited Interim Condensed Consolidated Statements of Financial Position as of September 30, 2021 and December 31, 2020 4
Unaudited Interim Condensed Consolidated Statements of Changes in Shareholders' Equity for the nine months ended September 30, 2021 and 2020 5
Unaudited Interim Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2021 and 2020 6
Notes to the Unaudited Interim Condensed Consolidated Financial Statements 7
1. Summary of significant accounting policies and other disclosures 7
(a) Reporting entity and Group's structure 7
(b) Basis of preparation 7
(c) New and amended standards adopted by the Group 7
(d) Significant events of the quarter and changes in circumstances 8
2. Net Financial Result 10
3. Other assets 11
4. Financial assets and financial liabilities 11
5. Cash and cash equivalents 12
6. Equity 12
7. Share-based payments 13
(e) Equity settled share-based payment arrangements 13
(f) Share options exercised 14
(g) Share-based payment expense recognized 14
8. Protective foundation 14
9. Contractual Obligations and Commitments 15
10. Subsequent Events 15
InflaRx N.V. and subsidiaries
Unaudited Interim Condensed Consolidated Statements of Operations and
Comprehensive Loss for the three and nine months ended September 30, 2021 and 2020
For the three months ended September 30, For the nine months ended September 30,
(in , except for share data) Note 2021 (unaudited ) 2020 (unaudited) 2021 (unaudited) 2020 (unaudited)
Operating Expenses
Research and development expenses (9,359,850 ) (5,246,536 ) (25,566,005 ) (19,901,661 )
General and administrative expenses (3,395,606 ) (1,166,070 ) (9,115,783 ) (6,057,767 )
Total Operating Expenses (12,755,456 ) (6,412,606 ) (34,681,788 ) (25,959,428 )
Other income 22,850 3,471 43,529 200,763
Other expenses - (13 ) (844 ) (9,184 )
Operating Result (12,732,606 ) (6,409,148 ) (34,639,103 ) (25,767,849 )
Finance income 2 27,380 95,086 85,964 844,842
Finance expenses 2 (9,527 ) (9,995 ) (16,261 ) (15,253 )
Foreign exchange result 2 715,799 (660,907 ) 1,621,165 (112,933 )
Other financial result (56,000 ) 126,000 (13,000 ) (74,000 )
Income Taxes - - - -
Loss for the Period (12,054,955 ) (6,858,964 ) (32,961,235 ) (25,125,193 )
Share Information
Weighted average number of shares outstanding 44,186,279 27,733,778 40,740,353 26,674,233
Loss per share (basic/diluted) (0.27 ) (0.25 ) (0.81 ) (0.94 )
Loss for the Period (12,054,955 ) (6,858,964 ) (32,961,235 ) (25,125,193 )
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:
Exchange differences on translation of foreign currency 2,536,278 (3,022,687 ) 4,613,675 (2,761,792 )
Total Comprehensive Loss (9,518,677 ) (9,881,651 ) (28,347,560 ) (27,886,985 )
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Unaudited Interim Condensed Consolidated Statements of Financial
Position as of September 30, 2021 and December 31, 2020
(in ) Note September 30, 2021 (unaudited) December 31, 2020
ASSETS
Non-current assets
Property and equipment 299,896 408,263
Right-of-use assets 4 1,500,865 546,694
Intangible assets 262,641 350,183
Other assets 3 340,572 353,522
Financial assets 4 26,716,011 272,268
Total non-current assets 29,119,985 1,930,930
Current assets
Current other assets 3 5,409,078 3,734,700
Current tax assets 918,021 1,419,490
Financial assets 4 23,957,605 55,162,033
Cash and cash equivalents 5 69,967,424 25,968,681
Total current assets 100,252,128 86,284,904
TOTAL ASSETS 129,372,113 88,215,834
EQUITY AND LIABILITIES
Equity
Issued capital 6 5,302,354 3,387,410
Share premium 6 280,261,994 220,289,876
Other capital reserves 30,082,596 26,259,004
Accumulated deficit (201,306,855 ) (168,345,620 )
Other components of equity 886,884 (3,726,791 )
Total equity 115,226,973 77,863,880
Non-current liabilities
Lease liabilities 4 1,155,432 220,525
Other liabilities 34,770 33,323
Total non-current liabilities 1,190,202 253,847
Current liabilities
Trade and other payables 4 11,517,356 8,258,133
Lease liabilities 4 363,876 338,516
Employee benefits 943,640 1,368,731
Other liabilities 130,066 117,727
Provisions - 15,000
Total current liabilities 12,954,938 10,098,107
Total Liabilities 14,145,140 10,351,954
TOTAL EQUITY AND LIABILITIES 129,372,113 88,215,834
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Unaudited Interim Condensed Consolidated Statements of Changes in
Shareholders' Equity for the nine months ended September 30, 2021 and 2020
(in , except for share data) Note Shares outstanding Issued capital Share premium Other capital reserves Accumulated deficit Other compo-nents of equity Total equity
Balance as of January 1, 2021 28,228,415 3,387,410 220,289,876 26,259,004 (168,345,620 ) (3,726,790 ) 77,863,880
Loss for the period - - - - (32,961,235 ) - (32,961,235 )
Exchange differences on translation of foreign currency - - - - - 4,613,675 4,613,675
Total comprehensive loss - - - - (32,961,235 ) 4,613,675 (28,347,560 )
Issuance of common shares and warrants 6 15,610,022 1,873,203 63,269,346 - - - 65,142,549
Transaction costs 6 - - (4,219,222 ) - - - (4,219,222 )
Share-based payment expense 7 - - - 3,823,592 - - 3,823,592
Share options exercised 7 347,842 41,741 921,994 - - - 963,735
Balance as of September 30, 2021 (unaudited) 44,186,279 5,302,354 280,261,994 30,082,596 (201,306,855 ) 886,884 115,226,973
Balance as of January 1, 2020 26,105,255 3,132,631 211,006,606 25,142,213 (134,362,006 ) 2,227,228 107,146,673
Loss for the period - - - - (25,125,193 ) - (25,125,193 )
Exchange differences on translation of foreign currency - - - - - (2,761,792 ) (2,761,792 )
Total comprehensive loss - - - - (25,125,193 ) (2,761,792 ) (27,886,985 )
Issuance of common shares and warrants 1,958,186 234,982 9,535,961
Transaction costs (729,841 )
Share-based payment expense 7 - - - 897,438 - - 897,438
Share options exercised 7 164,974 19,797 477,149 - - - 496,946
Balance as of September 30, 2020 (unaudited) 28,228,415 3,387,410 220,289,876 26,039,651 (159,487,199 ) (534,564 ) 89,695,174
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Unaudited Interim Condensed Consolidated Statements of Cash Flows for the
nine months ended September 30, 2021 and 2020
(in ) Note For the nine months ended September 30, 2021 (unaudited) For the nine months ended September 30, 2020 (unaudited)
Operating activities
Loss for the period (32,961,235 ) (25,125,193 )
Adjustments for:
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets 502,605 533,687
Net finance income 2 (1,677,868 ) (642,656 )
Share-based payment expense 7 3,823,592 897,438
Net foreign exchange differences (3,185 ) (869,402 )
Changes in:
Other assets (1,159,960 ) (226,811 )
Employee benefits (438,436 ) (191,042 )
Other liabilities 12,130 13,896
Trade and other payables 3,259,223 (2,415,210 )
Interest received 443,531 1,238,643
Interest paid (15,072 ) (15,546 )
Net cash used in operating activities (28,214,674 ) (26,802,196 )
Investing activities
Purchase of intangible assets, property and equipment (21,691 ) (83,855 )
Purchase of financial assets (40,512,715 ) (68,169,518 )
Proceeds from the maturity of financial assets 48,250,724 97,465,290
Net cash from investing activities 7,716,318 29,211,918
Financing activities
Proceeds from issuance of common shares 6 65,142,549 9,770,944
Transaction costs from issuance of common shares 6 (4,219,222 ) (729,841 )
Proceeds from exercise of share options 7 963,735 496,946
Repayment of lease liabilities (271,608 ) (275,323 )
Net cash from financing activities 61,615,454 9,262,726
Net increase in cash and cash equivalents 41,117,098 11,672,447
Effect of exchange rate changes on cash and cash equivalents 2,881,645 30,362
Cash and cash equivalents at beginning of period 25,968,681 33,131,280
Cash and cash equivalents at end of period 5 69,967,424 44,834,089
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.
InflaRx N.V. and subsidiaries
Notes to the Unaudited Interim Condensed Consolidated Financial Statements
InflaRx N.V. 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 Stra e 2 in 07745 Jena, Germany. Since November 10, 2017, InflaRx N.V.'s common shares have been listed on The NASDAQ Global Select Market under
InflaRx is a clinical-stage biopharmaceutical Group focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of the complement activation factor
These consolidated financial statements of InflaRx comprise the Company and its wholly-owned subsidiaries InflaRx GmbH, Jena, Germany and InflaRx Pharmaceuticals Inc., Ann Arbor, Michigan, United States (together
referred to as "the Group").
InflaRx GmbH is a clinical-stage biopharmaceutical company founded in 2008. In 2017, InflaRx N.V. became the sole shareholder of InflaRx GmbH through the contribution of the subsidiary's shares to InflaRx N.V. by its
existing shareholders in exchange of new shares issued by InflaRx N.V.
These interim condensed consolidated financial statements for the three- and nine-month reporting periods ended September 30, 2021 and 2020 have been prepared in accordance with IAS 34 Interim Financial Reporting.
These interim 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 our
annual report for the year ended December 31, 2020 on Form 20-F.
The interim condensed consolidated financial statements were authorized for issue by the board of directors on November 4, 2021.
The financial statements are presented in Euro ( ). Euro is the functional currency of InflaRx GmbH. The functional currency of InflaRx N.V. and InflaRx Pharmaceuticals Inc. is U.S. Dollars. All financial information
presented in Euro has 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, 2020, except for the adoption of new
standards effective as of January 1, 2021 as set out below. The Group has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective.
The below listed amendments and interpretations were adopted effective January 1, 2021, but did not have a material impact on the consolidated financial statements of the Group:
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:
Vilobelimab in pyoderma gangraenosum (PG)
In April 2021, the Company announced the completion of enrollment in its Phase IIa proof-of-concept clinical study with vilobelimab in PG. This open-label trial enrolled 19 patients with moderate to severe PG, with 12
in the first two dose cohorts, at sites in the U.S., Canada and Europe. Data from the second dose cohort was announced on August 10, 2021. Ten patients were evaluable for the efficacy assessment on day 99 because two out of the 12 patients withdrew
from the study before reaching day 99 of the treatment. Out of the 10 patients evaluable for efficacy at day 99, four patients met the response criteria, with three of them achieving complete closure of the target ulcer. The three patients who
showed clinical response with a PGA score of 3 with complete target ulcer closure had elevated C5a levels at baseline. InflaRx previously reported the clinical response for two of these three patients in February 2020. The third patient
demonstrating complete target ulcer closure had been increased from the 1600mg dose group to the highest dose of 2400mg dose on day 57 of the study and closed the ulcer after the dose escalation. The other six patients (three patients of which the
results had been previously disclosed in February 2020) all showed slight improvement in their condition according to the PGA definition (PGA score = 4). Data from the third cohort was released on October 27, 2021. In the third dosing cohort at
2400mg biweekly, six of the seven patients achieved clinical remission with a PGA score of 1, which reflects a closure of the target ulcer. All patients in cohort 3 had elevated C5a levels at baseline that were continuously suppressed after
initiation of vilobelimab. From all cohorts, two patients had related SAEs that were reported: One patient experienced an erysipelas leading to hospitalization (judged as non-related by sponsor), another developed a rash due to a delayed
hypersensitivity reaction and withdrew from the study (which had been previously disclosed from cohort 2). No dose-related AEs were found. Overall, the observed AE profile was in line with the underlying diseases. Final results from this study are
expected in the first half of 2022.
Vilobelimab for hidradenitis suppurativa (HS)
InflaRx submitted a Type A meeting request to the U.S. Food & Drug Administration (FDA) in July 2021 to align on the Phase III HS study design. At the meeting, the discussion focused on reaching consensus on the
overall study population and the primary endpoint measure. On September 8, 2021, InflaRx announced the outcome of this meeting in which the FDA was supportive of the proposed pivotal study program focusing on patients with active draining tunnels.
The FDA also supported a new primary efficacy endpoint that will include measuring the reduction of all three lesions associated with HS - inflammatory nodules, abscesses and draining tunnels. InflaRx is still in active dialogue with the FDA on the
final details of the pivotal Phase III study design. The Company plans to submit the clinical study protocol in Q4 2021 and start the study activities upon agreement with the FDA. The Company plans to include various secondary and exploratory
endpoints to validate the newly proposed primary efficacy measure, which thus far has not been used in prospective randomized trials. Once the protocol is accepted by the FDA, the Company will provide more details about the study, including the
Vilobelimab in ANCA-associated vasculitis (AAV)
In May 2021, the Company announced results from its US Phase IIa clinical study in AAV patients (IXPLORE). The results of the IXPLORE trial show vilobelimab is safe and well tolerated when added to standard of care
therapy for AAV. These results support the continued study of vilobelimab for the treatment of AAV.
Furthermore, InflaRx previously reported that both Part 1 and Part 2 of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled and have now finished the treatment period. Data from this randomized,
double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021.
Vilobelimab in cutaneous squamous cell carcinoma (cSCC)
The open label, multicenter Phase II study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cSCC is
currently enrolling. So far, a total of five patients have been enrolled in the monotherapy arm and one in the combination arm. After five weeks of treatment with the first three patients in the monotherapy arm, a safety assessment was completed,
and enrollment in the combination arm was opened.
The Phase II clinical trial is expected to enroll approximately 70 patients at sites in Europe, the U.S. and elsewhere. The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination
with pembrolizumab. The main objectives of the trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm.
The COVID-19 pandemic, which began in December 2019 has spread worldwide and continues to cause many governments to maintain measures to slow the spread of the outbreak through quarantines, travel restrictions, closure
of borders and requiring maintenance of physical distance between individuals.
During the first nine months of 2021, the Company`s employees have continued to be able to work from their home offices and partially return to the Company's offices. Our service providers also continued at regular
operational levels and the recruitment of patients and new clinical trial sites likewise continued in the first nine month of 2021 through the date of issuance of these interim financial statements.
The Phase III part of the global Phase II/III trial evaluating vilobelimab in mechanically ventilated patients with COVID-19 was initiated in mid-September 2020, and recruitment has finished, enrolling 369 patients
with sites initiated across several countries, including the EU, South America and other regions.
An interim analysis by an independent data monitoring committee took place in July 2020 analyzed the data of the first 180 patients evaluable for the 28-day mortality endpoint that completed the study and led to the
recommendation to continue the study as planned.
Topline data at the 28-day mortality primary endpoint are expected to be available in the first quarter of 2022.
On October 19, 2021, InflaRx announced that it was awarded a grant of up to EUR 43.7 million from the German Ministry of Education and Research and the German Ministry of Health to support the Company's development of
vilobelimab for the treatment for severe COVID-19 patients. The initial tranche amounts to EUR 25.8 million (approximately USD 29.9 million) and is structured as reimbursement of 80% of certain pre-specified expenses related to the clinical
development and manufacturing of vilobelimab. The remainder of the grant will be awarded in three additional subsequent tranches, each conditional on reaching agreed-upon development and manufacturing-related milestones for the preceding tranche
and structured as reimbursement for Company expenses. Individual tranches will not be paid if the preceding milestone of a tranche is not met. Payments from this grant to the Company are expected to begin in the fourth quarter of 2021.
Changes to the Board and Management
On September 13, 2021, Ms. Lina Ma resigned as Member of the Board. Ms. Ma's resignation from the Board was not due to any disagreement with the Company.
The net financial result is comprised of the following items for the three and nine months ended September 30:
For the three months ended September 30, For the nine months ended September 30,
(in ) 2021 (unaudited) 2020 (unaudited) 2021 (unaudited) 2020 (unaudited)
Financial income
Interest income 27,380 95,086 85,964 844,842
Financial expenses
Interest expenses (4,305 ) (8,321 ) (7,190 ) (9,384 )
Interest on lease liabilities (5,222 ) (1,674 ) (9,071 ) (5,869 )
Total 17,853 85,091 69,703 829,589
Interest income results from marketable securities and short-term deposits in U.S. Dollars held by the Company and its subsidiaries.
For the three months ended September 30, For the nine months ended September 30,
(in ) 2021 (unaudited) 2020 (unaudited) 2021 (unaudited) 2020 (unaudited)
Foreign exchange result
Foreign exchange income 910,411 1,230,281 5,002,650 2,748,961
Foreign exchange expense (194,612 ) (1,891,188 ) (3,381,485 ) (2,861,894 )
Total 715,799 (660,907 ) 1,621,165 (112,933 )
Foreign exchange income and expense is mainly derived from the translation of the U.S. Dollar cash, cash equivalents and securities held by the Company and its subsidiaries.
(in ) As of September 30, 2021 (unaudited) As of December 31, 2020
Non-current other assets
Prepaid expense 340,572 353,522
Total 340,572 353,522
Current other assets
Prepayments on research & development projects 4,896,075 2,340,643
Current tax assets 918,021 1,419,490
Prepaid expense 513,004 1,295,682
Other - 98,374
Total 6,327,100 5,154,190
Prepaid expense mainly consists of prepaid insurance expense.
Prepayments on research & development projects consists of prepayments on clinical and production contracts. Mainly due to higher expense for the phase III part of our COVID-19 trial and the payments made under the
related CRO contract, prepayments have increased as of September 30, 2021 compared to December 31, 2020.
Last updated: Nov 5, 2021