EX-99.1 2 ea020490001ex99-1_inflarxnv.htm INFLARX N.V. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF AND FOR THE THREE MONTHS ENDED MARCH 31, 2024

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

 

Unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023 F-3
Unaudited condensed consolidated statements of financial position as of March 31, 2024 and December 31, 2023 F-4
Unaudited condensed consolidated statements of changes in shareholders’ equity for the three months ended March 31, 2024 and 2023 F-5
Unaudited condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 F-6
Notes to the unaudited condensed consolidated financial statements F-7
1. Summary of significant accounting policies and other disclosures F-7
a) Reporting entity and the Group’s structure F-7
b) Basis of preparation F-7
2. Revenues F-8
3. Cost of Sales F-8
4. Research and development expenses F-8
5. Other income F-8
6. Net financial result F-9
7. Inventory F-9
8. Other assets F-9
9. Tax receivable F-10
10. Financial assets and financial liabilities F-10
11. Other liabilities F-10
12. Cash and cash equivalents F-11
13. Share-based payments F-11
a) Equity settled share-based payment arrangements F-11
b) Share-based payment expense recognized F-12
c) Share options exercised F-12
14. Protective foundation F-12

 

F-2

 

 

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.

 

F-3

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.

 

F-4

 

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 

 

*unaudited

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

F-5

 

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.

 

F-6

 

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.

 

b)Basis of preparation

 

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

 

F-7

 

2.Revenues

 

   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.

 

3.Cost of Sales

 

   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).

 

5.Other income

 

   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.

 

F-8

 

6.Net financial result

 

   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.

 

7.Inventory

 

   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.

 

8.Other assets

 

   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 

 

F-9

 

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.

 

9.Tax receivable

 

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.

 

11.Other liabilities

 

   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 

 

F-10

 

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.

 

13.Share-based payments

 

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 

 

F-11

 

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).

 

14.Protective foundation

 

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