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Share Name | Share Symbol | Market | Type |
---|---|---|---|
InflaRx NV | NASDAQ:IFRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.19 | 1.19 | 1.50 | 0 | 09:40:15 |
Exhibit No.
|
Description
|
99.1
|
|
99.2
|
|
99.3
|
INFLARX N.V.
|
|||
Date: November 1, 2023
|
By:
|
/s/ Niels Riedemann
|
|
Name:
|
Niels Riedemann
|
||
Title:
|
Chief Executive Officer
|
3
|
||||
4 | ||||
5 | ||||
7 | ||||
|
1.
|
7 | ||
|
a)
|
7 | ||
|
b)
|
7 | ||
|
2.
|
8 | ||
|
3.
|
9 | ||
|
4.
|
9 | ||
|
5.
|
10 | ||
|
6.
|
10 | ||
|
7.
|
11 | ||
|
8.
|
11 | ||
|
9.
|
12 | ||
|
10.
|
12 | ||
|
11.
|
12 | ||
|
12.
|
12 | ||
|
a)
|
12 | ||
|
b)
|
13 | ||
|
c)
|
13 | ||
|
13.
|
14 |
For the three months
ended September 30,
|
For the nine months
ended September 30
|
|||||||||||||||||||
Note
|
2023
(unaudited)
|
2022
(unaudited)
|
2023
(unaudited)
|
2022
(unaudited)
|
||||||||||||||||
(in €, except for share data)
|
||||||||||||||||||||
Revenues
|
2
|
60,803
|
—
|
60,803
|
—
|
|||||||||||||||
Cost of Sales
|
3
|
(255,116
|
)
|
—
|
(255,116
|
)
|
—
|
|||||||||||||
Gross profit
|
(194,313
|
)
|
—
|
(194,313
|
)
|
—
|
||||||||||||||
Sales and marketing expenses
|
(1,562,473
|
)
|
—
|
(1,838,524
|
)
|
—
|
||||||||||||||
Research and development expenses
|
(7,305,541
|
)
|
(7,537,350
|
)
|
(32,957,044
|
)
|
(29,190,231
|
)
|
||||||||||||
General and administrative expenses
|
(2,897,732
|
)
|
(3,087,285
|
)
|
(10,047,091
|
)
|
(11,821,694
|
)
|
||||||||||||
Other income
|
4
|
808,866
|
2,030,406
|
13,437,963
|
16,473,540
|
|||||||||||||||
Other expenses
|
339
|
—
|
(2,851
|
)
|
(844
|
)
|
||||||||||||||
Operating Result
|
(11,150,854
|
)
|
(8,594,230
|
)
|
(31,601,861
|
)
|
(24,539,229
|
)
|
||||||||||||
Finance income
|
5
|
1,189,826
|
199,758
|
2,732,873
|
310,121
|
|||||||||||||||
Finance expenses
|
5
|
(4,897
|
)
|
(6,845
|
)
|
(15,476
|
)
|
(39,376
|
)
|
|||||||||||
Foreign exchange result
|
5
|
2,292,938
|
882,370
|
1,923,274
|
3,173,883
|
|||||||||||||||
Other financial result
|
5
|
221,577
|
(402,724
|
)
|
223,818
|
(363,724
|
)
|
|||||||||||||
Income Taxes
|
—
|
—
|
—
|
—
|
||||||||||||||||
Income (Loss) for the Period
|
(7,451,410
|
)
|
(7,921,671
|
)
|
(26,737,373
|
)
|
(21,458,325
|
)
|
||||||||||||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:
|
||||||||||||||||||||
Exchange differences on translation of foreign currency
|
73,574
|
4,317,134
|
56,459
|
10,035,949
|
||||||||||||||||
Total Comprehensive Income (Loss)
|
(7,377,836
|
)
|
(3,604,538
|
)
|
(26,680,914
|
)
|
(11,422,376
|
)
|
||||||||||||
Share Information (based on Income (Loss) for the Period)
|
||||||||||||||||||||
Weighted average number of shares outstanding
|
58,883,272
|
44,203,763
|
53,598,594
|
44,203,763
|
||||||||||||||||
Income (Loss) per share (basic/diluted)
|
(0.13
|
)
|
(0.18
|
)
|
(0.50
|
)
|
(0.49
|
)
|
Note
|
September 30, 2023
(unaudited)
|
December 31, 2022
|
||||||||||
(in €)
|
||||||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property and equipment
|
298,344
|
328,920
|
||||||||||
Right-of-use assets
|
1,076,402
|
1,311,809
|
||||||||||
Intangible assets
|
66,734
|
138,905
|
||||||||||
Other assets
|
7
|
270,526
|
308,066
|
|||||||||
Financial assets
|
8
|
237,564
|
2,900,902
|
|||||||||
Total non-current assets
|
1,949,570
|
4,988,602
|
||||||||||
Current assets
|
||||||||||||
Inventories
|
6
|
1,639,490
|
—
|
|||||||||
Current other assets
|
7
|
7,779,994
|
14,170,510
|
|||||||||
Current tax assets
|
3,398,481
|
1,432,087
|
||||||||||
Financial assets from government grants
|
8
|
1,164,217
|
732,971
|
|||||||||
Other financial assets
|
8
|
91,857,945
|
64,810,135
|
|||||||||
Cash and cash equivalents
|
10
|
21,695,607
|
16,265,355
|
|||||||||
Total current assets
|
127,535,734
|
97,411,058
|
||||||||||
TOTAL ASSETS
|
129,485,304
|
102,399,660
|
||||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity
|
||||||||||||
Issued capital
|
11
|
7,065,993
|
5,364,452
|
|||||||||
Share premium
|
334,211,338
|
282,552,633
|
||||||||||
Other capital reserves
|
39,597,055
|
36,635,564
|
||||||||||
Accumulated deficit
|
(270,197,663
|
)
|
(243,460,290
|
)
|
||||||||
Other components of equity
|
7,313,540
|
7,257,081
|
||||||||||
Total equity
|
117,990,262
|
88,349,440
|
||||||||||
Non-current liabilities
|
||||||||||||
Lease liabilities
|
8
|
771,814
|
987,307
|
|||||||||
Other liabilities
|
36,877
|
36,877
|
||||||||||
Total non-current liabilities
|
808,691
|
1,024,184
|
||||||||||
Current liabilities
|
||||||||||||
Trade and other payables
|
8
|
5,999,200
|
4,987,538
|
|||||||||
Liabilities from government grants
|
8
|
—
|
6,209,266
|
|||||||||
Lease liabilities
|
8
|
354,151
|
369,376
|
|||||||||
Employee benefits
|
1,285,355
|
1,312,248
|
||||||||||
Other liabilities
|
9
|
3,047,646
|
147,608
|
|||||||||
Total current liabilities
|
10,686,351
|
13,026,036
|
||||||||||
Total Liabilities
|
11,495,042
|
14,050,220
|
||||||||||
TOTAL EQUITY AND LIABILITIES
|
129,485,304
|
102,399,660
|
(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, 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
|
—
|
—
|
—
|
—
|
(26,737,373
|
)
|
—
|
(26,737,373
|
)
|
|||||||||||||||||||||||
Exchange differences on
translation of foreign currency
|
—
|
—
|
—
|
—
|
—
|
56,459
|
56,459
|
|||||||||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
—
|
(26,737,373
|
)
|
56,459
|
(26,680,914
|
)
|
|||||||||||||||||||||||
Issuance of common shares
|
10
|
14,059,252
|
1,687,110
|
54,796,819
|
—
|
—
|
—
|
56,483,929
|
||||||||||||||||||||||||
Transaction costs
|
10
|
—
|
—
|
(3,360,626
|
)
|
—
|
—
|
—
|
(3,360,626
|
)
|
||||||||||||||||||||||
Equity-settled share-based payments
|
11
|
—
|
—
|
—
|
2,961,491
|
—
|
—
|
2,961,491
|
||||||||||||||||||||||||
Share options exercised
|
11
|
120,257
|
14,431
|
222,512
|
—
|
—
|
—
|
236,943
|
||||||||||||||||||||||||
Balance as of September 30, 2023*
|
58,883,272
|
7,065,993
|
334,211,338
|
39,597,055
|
(270,197,663
|
)
|
7,313,540
|
117,990,262
|
||||||||||||||||||||||||
Balance as of January 1, 2022
|
44,203,763
|
5,304,452
|
280,310,744
|
30,591,209
|
(213,975,679
|
)
|
3,050,271
|
105,280,996
|
||||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
(21,458,325
|
)
|
—
|
(21,458,325
|
)
|
|||||||||||||||||||||||
Exchange differences on
translation of foreign currency
|
—
|
—
|
—
|
—
|
—
|
10,035,949
|
10,035,949
|
|||||||||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
—
|
(21,458,325
|
)
|
10,035,949
|
(11,422,376
|
)
|
|||||||||||||||||||||||
Equity-settled share-based payments
|
11
|
—
|
—
|
—
|
5,581,021
|
—
|
—
|
5,581,021
|
||||||||||||||||||||||||
Balance as of September 30, 2022*
|
44,203,763
|
5,304,452
|
280,310,744
|
36,172,229
|
(235,434,004
|
)
|
13,086,220
|
99,439,640
|
For the nine months ended September 30,
|
||||||||||||
Note
|
2023
(unaudited)
|
2022
(unaudited)
|
||||||||||
(in €)
|
||||||||||||
Operating activities
|
||||||||||||
Loss for the period
|
(26,737,373
|
)
|
(21,458,325
|
)
|
||||||||
Adjustments for:
|
||||||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
|
432,248
|
448,323
|
||||||||||
Net finance income
|
5
|
(4,864,488
|
)
|
(3,080,904
|
)
|
|||||||
Share-based payment expense
|
11
|
2,961,491
|
5,581,021
|
|||||||||
Net foreign exchange differences
|
5
|
(82,574
|
)
|
189,088
|
||||||||
Changes in:
|
||||||||||||
Financial assets from government grants
|
8
|
(431,246
|
)
|
(5,954,754
|
)
|
|||||||
Other assets
|
4,468,239
|
3,087,177
|
||||||||||
Employee benefits
|
(26,893
|
)
|
(221,982
|
)
|
||||||||
Other liabilities
|
2,893,461
|
5,061
|
||||||||||
Liabilities from government grants received
|
8
|
(6,209,266
|
)
|
(6,849,415
|
)
|
|||||||
Trade and other payables
|
1,011,662
|
(1,135,817
|
)
|
|||||||||
Inventories
|
6
|
(1,639,490
|
)
|
—
|
||||||||
Interest received
|
5
|
1,302,391
|
903,647
|
|||||||||
Interest paid
|
5
|
(15,773
|
)
|
(38,978
|
)
|
|||||||
Net cash used in operating activities
|
(26,937,611
|
)
|
(28,525,857
|
)
|
||||||||
Investing activities
|
||||||||||||
Purchase of intangible assets, property and equipment
|
(45,942
|
)
|
(17,908
|
)
|
||||||||
Purchase of current financial assets
|
(91,590,134
|
)
|
(47,031,216
|
)
|
||||||||
Proceeds from the maturity of financial assets
|
71,113,455
|
64,600,049
|
||||||||||
Net cash from/(used in) investing activities
|
(20,522,621
|
)
|
17,550,925
|
|||||||||
Financing activities
|
||||||||||||
Proceeds from issuance of common shares
|
10
|
56,483,929
|
—
|
|||||||||
Transaction costs from issuance of common shares
|
10
|
(3,360,626
|
)
|
—
|
||||||||
Proceeds from exercise of share options
|
11
|
236,943
|
—
|
|||||||||
Repayment of lease liabilities
|
(279,075
|
)
|
(273,092
|
)
|
||||||||
Net cash from/(used in) financing activities
|
53,081,170
|
(273,092
|
)
|
|||||||||
Net increase/(decrease) in cash and cash equivalents
|
5,620,938
|
(11,248,024
|
)
|
|||||||||
Effect of exchange rate changes on cash and cash equivalents
|
(190,686
|
)
|
2,976,033
|
|||||||||
Cash and cash equivalents at beginning of period
|
16,265,355
|
26,249,995
|
||||||||||
Cash and cash equivalents at end of period
|
9
|
21,695,607
|
17,978,003
|
1. |
a) |
b) |
• |
IAS 2 Inventories
|
• |
IFRS 15 Revenue from contracts with customers
|
• |
IFRS 17 Insurance Contracts
|
• |
Amendments to IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates
|
• |
Amendments to IAS 12 Deferred Tax related to Assets and Liabilities arising from a Single Transaction
|
• |
Amendments to IAS 1 and IFRS Practice Statement 2 - Disclosure of Accounting Policies -
|
• |
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 21 Effects of Changes in Foreign Exchange Rates: Lack of exchangeability
|
2. |
For the three months
ended September 30,
|
For the nine months
ended September 30
|
|||||||||||||||
2023
(unaudited)
|
2022
(unaudited)
|
2023
(unaudited)
|
2022
(unaudited)
|
|||||||||||||
(in €)
|
||||||||||||||||
Revenues
|
60,803
|
—
|
60,803
|
—
|
||||||||||||
Total
|
60,803
|
—
|
60,803
|
—
|
3. |
For the three months
ended June 30,
|
For the nine months
ended June 30
|
|||||||||||||||
2023
(unaudited)
|
2022
(unaudited)
|
2023
(unaudited)
|
2022
(unaudited)
|
|||||||||||||
(in €)
|
||||||||||||||||
Cost of Sales
|
(255,116
|
)
|
—
|
(255,116
|
)
|
—
|
||||||||||
Total
|
(255,116
|
)
|
—
|
(255,116
|
)
|
—
|
4. |
For the three months
ended September 30,
|
For the nine months
ended September 30
|
|||||||||||||||
2023
(unaudited)
|
2022
(unaudited)
|
2023
(unaudited)
|
2022
(unaudited)
|
|||||||||||||
(in €)
|
||||||||||||||||
Other income
|
||||||||||||||||
Income from government grants
|
772,604
|
2,019,684
|
13,382,393
|
16,435,051
|
||||||||||||
Other
|
36,262
|
10,722
|
55,570
|
38,489
|
||||||||||||
Total
|
808,866
|
2,030,406
|
13,437,963
|
16,473,540
|
5. |
For the three months
ended September 30,
|
For the nine months
ended September 30
|
|||||||||||||||
2023
(unaudited)
|
2022
(unaudited)
|
2023
(unaudited)
|
2022
(unaudited)
|
|||||||||||||
(in €)
|
||||||||||||||||
Interest income
|
1,189,826
|
199,758
|
2,732,873
|
310,121
|
||||||||||||
Interest expenses
|
(327
|
)
|
(878
|
)
|
(1,108
|
)
|
(22,980
|
)
|
||||||||
Interest on lease liabilities
|
(4,570
|
)
|
(5,967
|
)
|
(14,368
|
)
|
(16,396
|
)
|
||||||||
Finance Result
|
1,184,929
|
192,913
|
2,717,397
|
270,745
|
||||||||||||
Foreign exchange income
|
4,007,995
|
1,634,121
|
6,389,514
|
5,691,750
|
||||||||||||
Foreign exchange expense
|
(1,715,057
|
)
|
(751,751
|
)
|
(4,466,240
|
)
|
(2,517,867
|
)
|
||||||||
Foreign exchange result
|
2,292,938
|
882,370
|
1,923,274
|
3,173,883
|
||||||||||||
Other financial result
|
221,577
|
(402,724
|
)
|
223,818
|
(363,724
|
)
|
||||||||||
Net financial result
|
3,699,444
|
672,559
|
4,864,488
|
3,080,904
|
6. |
As of
September 30, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Raw material and supplies
|
1,115,243
|
—
|
||||||
Unfinished goods
|
261,124
|
—
|
||||||
Finished goods
|
263,123
|
—
|
||||||
Total
|
1,639,490
|
—
|
7. |
As of
September 30, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Non-current other assets
|
||||||||
Prepaid expenses
|
270,526
|
308,066
|
||||||
Total
|
270,526
|
308,066
|
||||||
Current other assets
|
||||||||
Prepayments on research & development projects
|
3,414,177
|
9,776,505
|
||||||
Prepayments on commercial production
|
3,636,868
|
—
|
||||||
Prepaid expenses
|
703,898
|
1,841,935
|
||||||
Others
|
25,052
|
2,552,071
|
||||||
Total
|
7,779,995
|
14,170,511
|
||||||
Total other assets
|
8,050,521
|
14,478,577
|
8. |
As of
September 30, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Financial assets at amortized cost
|
||||||||
Non-current financial assets
|
237,564
|
2,900,902
|
||||||
Financial assets from government grants
|
1,164,217
|
732,971
|
||||||
Other current financial assets
|
91,857,945
|
64,791,088
|
||||||
Financial liabilities at amortized cost
|
||||||||
Liabilities from government grants
|
—
|
6,209,266
|
||||||
Trade and other payables
|
5,999,200
|
4,987,538
|
9. |
As of
September 30, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Liabilities from commercial partner
|
2,875,722
|
—
|
||||||
Miscellaneous other liabilities
|
171,924
|
147,608
|
||||||
Total
|
3,047,646
|
147,608
|
10. |
As of
September 30, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Short-term deposits
|
||||||||
Deposits held in U.S. dollars
|
3,637,579
|
3,422
|
||||||
Deposits held in euros
|
4,450,000
|
—
|
||||||
Total
|
8,087,579
|
3,422
|
||||||
Cash at banks
|
||||||||
Cash held in U.S. dollars
|
10,030,927
|
8,645,014
|
||||||
Cash held in euros
|
3,577,101
|
7,616,918
|
||||||
Total
|
13,608,027
|
16,261,932
|
||||||
Total cash and cash equivalents
|
21,695,606
|
6,265,354
|
11. |
12. |
a) |
Number of share options
|
2023
|
2022
|
||||||
Outstanding as of January 1,
|
148,433
|
148,433
|
||||||
Exercised during the nine months ended September 30
|
—
|
—
|
||||||
Outstanding as of September 30,
|
148,433
|
148,433
|
||||||
thereof vested
|
148,433
|
148,433
|
Number of share options
|
2023
|
2022
|
||||||
Outstanding as of January 1,
|
888,632
|
888,632
|
||||||
Exercised during the nine months ended September 30
|
—
|
—
|
||||||
Outstanding as of September 30,
|
888,632
|
888,632
|
||||||
thereof vested
|
888,632
|
888,632
|
Number of share options
|
2023
|
2022
|
||||||
Total number of options outstanding as of January 1,
|
4,985,523
|
3,170,046
|
||||||
Granted during the nine months ended September 30,
|
1,735,750
|
1,561,666
|
||||||
Exercised during the nine months ended September 30,
|
(105,327
|
)
|
—
|
|||||
Forfeited during the nine months ended September 30,
|
(26.000
|
)
|
(136,259
|
)
|
||||
Outstanding as of September 30,
|
6,589,946
|
4,595,453
|
||||||
thereof vested
|
5,170,321
|
3,762,203
|
Share options
granted 2023
|
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 24
|
1,454,250
|
$
|
2.11
|
0.9008
|
€
|
1.90
|
$
|
2.37
|
1.35
|
5.30
|
3.571
|
%
|
||||||||||||||||||||
January 24
|
52,500
|
$
|
2.13
|
0.9008
|
€
|
1.92
|
$
|
2.37
|
1.35
|
5.50
|
3.565
|
%
|
||||||||||||||||||||
May 31
|
60,500
|
$
|
3.61
|
0.9361
|
€
|
3.38
|
$
|
4.19
|
1.35
|
4.50
|
3.820
|
%
|
||||||||||||||||||||
July 7
July 7
|
57,000
100,000
|
$
|
3.59
$3.64
|
0.9184
0.9184
|
€
|
3.30
€3.34
|
$
|
3,89
$3,89
|
1.46
1.46
|
5.50
6.10
|
4.320%
4.286
|
%
|
||||||||||||||||||||
July 19
|
4,000
|
$
|
3.55
|
0.8911
|
€
|
3.16
|
$
|
3,99
|
1.46
|
5.50
|
4.320
|
%
|
||||||||||||||||||||
September 18
|
7,500
|
$
|
3.15
|
0.9378
|
€
|
2.95
|
$
|
3,54
|
1.46
|
5.50
|
4.320
|
%
|
||||||||||||||||||||
1,735,750
|
b) |
c) |
13. |
• |
continue to expand the commercialization of Gohibic (vilobelimab) in the United States by investing in our commercial infrastructure and seek partners to support commercialization of our other products;
|
• |
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;
|
• |
invest in our working capital;
|
• |
actively seek to identify additional research programs and additional product candidates;
|
• |
pursue full BLA and centralized MAA approvals for Gohibic (vilobelimab), especially after the EMA's validation of our MAA in August 2023;
|
• |
seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any;
|
• |
establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize various products for which we may obtain marketing approval, if any;
|
• |
require further scale-up, transfer, validation or other activities for our manufacturing process for vilobelimab, including the manufacturing of larger quantities for further commercial needs and for clinical
development;
|
• |
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, administrative, clinical, quality control and scientific personnel; and
|
• |
add operational, financial and management information systems and personnel, including personnel to support our product development and help us comply with our obligations as a public company.
|
• |
expenses incurred under agreements with contract research organizations, or CROs, and contract manufacturing organizations, or CMOs, 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 expenses based upon employees’ roles within the organization; and
|
• |
professional fees for lawyers related to the protection and maintenance of our intellectual property and consulting fees for the support of our regulatory, medical affairs and related activities.
|
• |
Vilobelimab. We expect our expenses associated with vilobelimab to increase in 2023 compared to 2022, as we are initiating the
Phase III clinical study in PG. In addition, although we are winding down our Phase II clinical program in cSCC, we expect to continue incurring expenses in connection with such program until we complete the winding down process. We
also incurred expenses with the submission of an EUA with the FDA and a MAA with the EMA for the treatment of adult
patients with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving IMV or ECMO and expect to further incur expenses in conjunction with filing market authorizations for vilobelimab in the United States and
elsewhere, including expenses to obtain full BLA and MAA approval for Gohibic (vilobelimab). 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 establishing a commercial scale production process for vilobelimab.
|
• |
INF904. We are also developing INF904, a product candidate that targets
the C5aR receptor. We have been conducting a Phase I single and multiple ascending dose clinical study since November 2022 and expect to incur additional costs by advancing the development of INF904. We plan to study INF904 in
complement-mediated, chronic autoimmune and inflammatory conditions for which an orally administered low molecular weight compound might have advantages or is needed for patients and for which 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 pharmacokinetic properties compared to vilobelimab and is currently in preclinical 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.
|
1. |
Comparison of the three months ended September 30, 2023 and 2022
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Revenues
|
60,803
|
—
|
60,803
|
|||||||||
Cost of Sales
|
(255,116
|
)
|
—
|
(255,116
|
)
|
|||||||
Gross profit
|
(194,313
|
)
|
—
|
(194,313
|
)
|
|||||||
Operating expenses
|
||||||||||||
Sales and marketing expenses
|
(1,562,473
|
)
|
—
|
(1,562,473
|
)
|
|||||||
Research and development expenses
|
(7,305,541
|
)
|
(7,537,350
|
)
|
231,809
|
|||||||
General and administrative expenses
|
(2,897,732
|
)
|
(3,087,285
|
)
|
189,553
|
|||||||
Total operating expenses
|
(11,765,746
|
)
|
(10,624,636
|
)
|
(1,141,110
|
)
|
||||||
Other income
|
808,866
|
2,030,406
|
(1,221,540
|
)
|
||||||||
Other expenses
|
339
|
—
|
339
|
|||||||||
Operating result
|
(11,150,854
|
)
|
8,594,230
|
(19,745,084
|
)
|
|||||||
Finance income
|
1,189,826
|
199,758
|
990,068
|
|||||||||
Finance expenses
|
(4,897
|
)
|
(6,845
|
)
|
1,948
|
|||||||
Foreign exchange result
|
2,292,938
|
882,370
|
1,410,568
|
|||||||||
Other financial result
|
221,577
|
(402,724
|
)
|
624,301
|
||||||||
Income (loss) for the period
|
(7,451,410
|
)
|
(7,921,671
|
)
|
470,261
|
|||||||
Exchange differences on translation of foreign currency
|
73,574
|
4,317,134
|
(4,243,560
|
)
|
||||||||
Total comprehensive income (loss)
|
(7,377,836
|
)
|
(3,604,538
|
)
|
(3,773,298
|
)
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Revenues
|
60,803
|
—
|
60,803
|
|||||||||
Total
|
60,803
|
—
|
60,803
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Cost of Sales
|
(255,116
|
)
|
—
|
(255,116
|
)
|
|||||||
Total
|
(255,116
|
)
|
—
|
(255,116
|
)
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Third-party expenses
|
974,500
|
—
|
974,500
|
|||||||||
Personnel expenses
|
500,010
|
—
|
500,010
|
|||||||||
Legal and consulting fees
|
81,355
|
—
|
81,355
|
|||||||||
Other expenses
|
6,608
|
—
|
6,608
|
|||||||||
Total sales and marketing expenses
|
1,562,473
|
—
|
1,562,473
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Third-party expenses
|
4,224,875
|
5,164,843
|
(939,968
|
)
|
||||||||
Personnel expenses
|
1,780,148
|
1,599,452
|
180,696
|
|||||||||
Legal and consulting fees
|
372,788
|
668,408
|
(295,620
|
)
|
||||||||
Other expenses
|
927,730
|
104,646
|
823,084
|
|||||||||
Total research and development expenses
|
7,305,541
|
7,537,350
|
(231,809
|
)
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Personnel expenses
|
1,206,958
|
1,413,560
|
(206,602
|
)
|
||||||||
Legal, consulting and audit fees
|
751,086
|
533,648
|
217,438
|
|||||||||
Other expenses
|
939,688
|
1,140,078
|
(200,390
|
)
|
||||||||
Total general and administrative expense
|
2,897,732
|
3,087,286
|
(189,554
|
)
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Income from government grants
|
772,604
|
2,019,684
|
(1,247,080
|
)
|
||||||||
Other
|
36,262
|
10,722
|
25,540
|
|||||||||
Total other income
|
808,866
|
2,030,406
|
(1,221,540
|
)
|
three months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Interest income
|
1,189,826
|
199,758
|
990,068
|
|||||||||
Interest expenses
|
(327
|
)
|
(878
|
)
|
551
|
|||||||
Interest on lease liabilities
|
(4,570
|
)
|
(5,967
|
)
|
1,397
|
|||||||
Finance result
|
1,184,929
|
192,913
|
992,016
|
|||||||||
Foreign exchange income
|
4,007,995
|
1,634,121
|
2,373,874
|
|||||||||
Foreign exchange expense
|
(1,715,057
|
)
|
(751,751
|
)
|
(963,306
|
)
|
||||||
Foreign exchange result
|
2,292,938
|
882,370
|
1,410,568
|
|||||||||
Other financial result
|
221,577
|
(402,724
|
)
|
624,301
|
||||||||
Net financial result
|
3,699,444
|
672,559
|
3,026,885
|
2. |
Comparison of the nine months ended September 30, 2023 and 2022
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Revenue
|
60,803
|
—
|
60,803
|
|||||||||
Cost of Sales
|
(255,116
|
)
|
—
|
(255,116
|
)
|
|||||||
Gross profit
|
(194,313
|
)
|
—
|
(194,313
|
)
|
|||||||
Operating expenses
|
||||||||||||
Sales and marketing expenses
|
(1,838,524
|
)
|
—
|
(1,838,524
|
)
|
|||||||
Research and development expenses
|
(32,957,044
|
)
|
(29,190,231
|
)
|
(3,766,813
|
)
|
||||||
General and administrative expenses
|
(10,047,091
|
)
|
(11,821,694
|
)
|
1,774,603
|
|||||||
Total operating expenses
|
(44,842,659
|
)
|
(41,011,925
|
)
|
(3,830,734
|
)
|
||||||
Other income
|
13,437,963
|
16,473,540
|
(3,035,577
|
)
|
||||||||
Other expenses
|
(2,851
|
)
|
(844
|
)
|
(2,007
|
)
|
||||||
Operating result
|
(31,601,861
|
)
|
(24,539,229
|
)
|
(7,062,632
|
)
|
||||||
Finance income
|
2,732,873
|
310,121
|
2,422,752
|
|||||||||
Finance expenses
|
(15,476
|
)
|
(39,376
|
)
|
23,900
|
|||||||
Foreign exchange result
|
1,923,274
|
3,173,883
|
(1,250,609
|
)
|
||||||||
Other financial result
|
223,818
|
(363,724
|
)
|
587,542
|
||||||||
Income (loss) for the period
|
(26,737,373
|
)
|
(21,458,325
|
)
|
(5,279,048
|
)
|
||||||
Exchange differences on translation of foreign currency
|
56,459
|
10,035,949
|
(9,979,490
|
)
|
||||||||
Total comprehensive income (Loss)
|
(26,680,914
|
)
|
(11,422,376
|
)
|
(15,258,538
|
)
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Revenues
|
60,803
|
—
|
60,803
|
|||||||||
Total
|
60,803
|
—
|
60,803
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Cost of Sales
|
255,116
|
)
|
—
|
(255,116
|
)
|
|||||||
Total
|
(255,116
|
—
|
255,116
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Third-party expenses
|
1,099,430
|
—
|
1,099,430
|
|||||||||
Personnel expenses
|
604,894
|
—
|
604,894
|
|||||||||
Legal and consulting fees
|
124,247
|
—
|
124,247
|
|||||||||
Other expenses
|
9,954
|
—
|
9,954
|
|||||||||
Total sales and marketing expenses
|
1,838,524
|
—
|
1,838,524
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Third-party expenses
|
24,724,877
|
21,947,799
|
2,777,078
|
|||||||||
Personnel expenses
|
5,190,156
|
5,825,051
|
(634,895
|
)
|
||||||||
Legal and consulting fees
|
1,459,954
|
1,139,769
|
320,185
|
|||||||||
Other expenses
|
1,582,057
|
277,613
|
1,304,444
|
|||||||||
Total research and development expenses
|
32,957,044
|
29,190,231
|
3,766,813
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Personnel expenses
|
4,199,908
|
5,943,286
|
(1,743,378
|
)
|
||||||||
Legal, consulting and audit fees
|
2,822,519
|
2,445,355
|
377,164
|
|||||||||
Other expenses
|
3,024,665
|
3,433,052
|
(408,387
|
)
|
||||||||
Total general and administrative expense
|
10,047,091
|
11,821,694
|
(1,774,603
|
)
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Income from government grants
|
13,382,393
|
16,435,051
|
(3,052,658
|
)
|
||||||||
Other
|
55,570
|
38,489
|
17,081
|
|||||||||
Total other income
|
13,437,963
|
16,473,540
|
(3,035,577
|
)
|
nine months ended September 30,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Interest income
|
2,732,873
|
310,121
|
2,422,752
|
|||||||||
Interest expenses
|
(1,108
|
)
|
(22,980
|
)
|
21,872
|
|||||||
Interest on lease liabilities
|
(14,368
|
)
|
(16,396
|
)
|
2,028
|
|||||||
Finance Result
|
2,717,397
|
270,745
|
2,446,652
|
|||||||||
Foreign exchange income
|
6,389,514
|
5,691,750
|
697,764
|
|||||||||
Foreign exchange expense
|
(4,466,240
|
)
|
(2,517,867
|
)
|
(1,948,373
|
)
|
||||||
Foreign exchange result
|
1,923,274
|
3,173,883
|
(1,250,609
|
)
|
||||||||
Other financial result
|
223,818
|
(363,724
|
)
|
587,542
|
||||||||
Net financial result
|
4,864,488
|
3,080,904
|
1,783,584
|
nine months ended September 30,
|
||||||||
2023
|
2022
|
|||||||
(in €)
|
||||||||
Net cash used in operating activities
|
(26,937,611
|
)
|
(28,525,857
|
)
|
||||
Net cash from/ (used in) investing activities
|
(20,522,621
|
)
|
17,550,925
|
|||||
Net cash from/ (used in) financing activities
|
53,081,170
|
(273,092
|
)
|
|||||
Cash and cash equivalents at the beginning of the period
|
16,265,355
|
26,249,995
|
||||||
Exchange gains/ (losses) on cash and cash equivalents
|
(190,686
|
)
|
2,976,033
|
|||||
Cash and cash equivalents at the end of the period
|
21,695,607
|
17,978,003
|
3. |
Net cash used in operating activities
|
4. |
Net cash from/used in investing activities
|
5. |
Net cash from/used in financing activities
|
• |
Manufacturing: The manufacturing processes of Gohibic (vilobelimab) is complex. We may encounter manufacturing difficulties, including difficulties related to product storage and shelf-life. Such difficulties could result from the
complexities of manufacturing product batches at a larger scale, equipment failure, availability of excipients and other product components/ingredients (including related to choice and quality of raw materials), analytical testing
technology and product instability. Specifically, insufficient product stability or shelf-life of Gohibic (vilobelimab) or its components could materially limit or delay our or our collaborators’ ability to distribute and commercialize
Gohibic (vilobelimab) at the current price or at all. Further, if Gohibic (vilobelimab) becomes subject to a product recall, including as the result of manufacturing errors, design/labeling defects or other deficiencies, our reputation
would be adversely affected.
|
• |
Distribution: Gohibic (vilobelimab) is a “cold-chain product” that must be shipped and stored at cold temperatures. We could lose supply of Gohibic (vilobelimab) due to distribution difficulties, including generally related supply chain
management (e.g., shelf-life expiration) and specifically related to shipping and storing Gohibic (vilobelimab) at cold temperatures. If so, we could incur additional manufacturing costs in order to supply required quantities to U.S.
hospitals under the EUA.
|
• |
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 Gohibic (vilobelimab) and our other product candidates;
|
• |
our expectations regarding the size of the patient populations for, market opportunity for, estimated returns and return accruals for, coverage and reimbursement for and clinical utility of Gohibic
(vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under the EUA and in the future if approved for commercial use in the United States or elsewhere;
|
• |
the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical
trials;
|
• |
the timing, progress and results of pre-clinical studies and clinical trials of our product candidates, including the MAD part of the Phase I trial with C5aR inhibitor INF904, 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.
|
• |
Single ascending dose (SAD) Phase I data confirm best-in-class potential of orally available C5aR inhibitor INF904; multiple ascending dose (MAD) part ongoing
|
• |
Six clinical sites initiated; first patients screened in Phase III trial of vilobelimab in pyoderma gangrenosum (PG)
|
• |
FDA regulatory pathway towards BLA in broader acute respiratory distress syndrome (ARDS) indication discussed in encouraging FDA Type C meeting
|
• |
MAA for vilobelimab for treatment of SARS-CoV-2 induced septic ARDS in critically ill COVID-19 patients submitted and validated by EMA
|
• |
Update on development of vilobelimab in cutaneous squamous cell carcinoma (cSCC)
|
• |
First commercial sales for Gohibic (vilobelimab) recorded in the third quarter 2023
|
• |
Cash, cash equivalents and marketable securities of €113 million, expected to fund operations at least into 2026
|
For the three months
ended September 30,
|
For the nine months
ended September 30
|
|||||||||||||||
2023
(unaudited)
|
2022
(unaudited)
|
2023
(unaudited)
|
2022
(unaudited)
|
|||||||||||||
(in €, except for share data)
|
||||||||||||||||
Revenues
|
60,803
|
—
|
60,803
|
—
|
||||||||||||
Cost of Sales
|
(255,116
|
)
|
—
|
(255,116
|
)
|
—
|
||||||||||
Gross profit
|
(194,313
|
)
|
—
|
(194,313
|
)
|
—
|
||||||||||
Sales and marketing expenses
|
(1,562,473
|
)
|
—
|
(1,838,524
|
)
|
—
|
||||||||||
Research and development expenses
|
(7,305,541
|
)
|
(7,537,350
|
)
|
(32,957,044
|
)
|
(29,190,231
|
)
|
||||||||
General and administrative expenses
|
(2,897,732
|
)
|
(3,087,285
|
)
|
(10,047,091
|
)
|
(11,821,694
|
)
|
||||||||
Other income
|
808,866
|
2,030,406
|
13,437,963
|
16,473,540
|
||||||||||||
Other expenses
|
339
|
—
|
(2,851
|
)
|
(844
|
)
|
||||||||||
Operating Result
|
(11,150,854
|
)
|
(8,594,230
|
)
|
(31,601,861
|
)
|
(24,539,229
|
)
|
||||||||
Finance income
|
1,189,826
|
199,758
|
2,732,873
|
310,121
|
||||||||||||
Finance expenses
|
(4,897
|
)
|
(6,845
|
)
|
(15,476
|
)
|
(39,376
|
)
|
||||||||
Foreign exchange result
|
2,292,938
|
882,370
|
1,923,274
|
3,173,883
|
||||||||||||
Other financial result
|
221,577
|
(402,724
|
)
|
223,818
|
(363,724
|
)
|
||||||||||
Income Taxes
|
—
|
—
|
—
|
—
|
||||||||||||
Income (Loss) for the Period
|
(7,451,410
|
)
|
(7,921,671
|
)
|
(26,737,373
|
)
|
(21,458,325
|
)
|
||||||||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
73,574
|
4,317,134
|
56,459
|
10,035,949
|
||||||||||||
Total Comprehensive Income (Loss)
|
(7,377,836
|
)
|
(3,604,538
|
)
|
(26,680,914
|
)
|
(11,422,376
|
)
|
||||||||
Share Information (based on Income (Loss) for the Period)
|
||||||||||||||||
Weighted average number of shares outstanding
|
58,883,272
|
44,203,763
|
53,598,594
|
44,203,763
|
||||||||||||
Income (Loss) per share (basic/diluted)
|
(0.13
|
)
|
(0.18
|
)
|
(0.50
|
)
|
(0.49
|
)
|
September 30, 2023
(unaudited)
|
December 31, 2022
|
|||||||
(in €)
|
||||||||
ASSETS
|
||||||||
Non-current assets
|
||||||||
Property and equipment
|
298,344
|
328,920
|
||||||
Right-of-use assets
|
1,076,402
|
1,311,809
|
||||||
Intangible assets
|
66,734
|
138,905
|
||||||
Other assets
|
270,526
|
308,066
|
||||||
Financial assets
|
237,564
|
2,900,902
|
||||||
Total non-current assets
|
1,949,570
|
4,988,602
|
||||||
Current assets
|
||||||||
Inventories
|
1,639,490
|
—
|
||||||
Current other assets
|
7,779,994
|
14,170,510
|
||||||
Current tax assets
|
3,398,481
|
1,432,087
|
||||||
Financial assets from government grants
|
1,164,217
|
732,971
|
||||||
Other financial assets
|
91,857,945
|
64,810,135
|
||||||
Cash and cash equivalents
|
21,695,607
|
16,265,355
|
||||||
Total current assets
|
127,535,734
|
97,411,058
|
||||||
TOTAL ASSETS
|
129,485,304
|
102,399,660
|
||||||
EQUITY AND LIABILITIES
|
||||||||
Equity
|
||||||||
Issued capital
|
7,065,993
|
5,364,452
|
||||||
Share premium
|
334,211,338
|
282,552,633
|
||||||
Other capital reserves
|
39,597,055
|
36,635,564
|
||||||
Accumulated deficit
|
(270,197,663
|
)
|
(243,460,290
|
)
|
||||
Other components of equity
|
7,313,540
|
7,257,081
|
||||||
Total equity
|
117,990,262
|
88,349,440
|
||||||
Non-current liabilities
|
||||||||
Lease liabilities
|
771,814
|
987,307
|
||||||
Other liabilities
|
36,877
|
36,877
|
||||||
Total non-current liabilities
|
808,691
|
1,024,184
|
||||||
Current liabilities
|
||||||||
Trade and other payables
|
5,999,200
|
4,987,538
|
||||||
Liabilities from government grants
|
—
|
6,209,266
|
||||||
Lease liabilities
|
354,151
|
369,376
|
||||||
Employee benefits
|
1,285,355
|
1,312,248
|
||||||
Other liabilities
|
3,047,646
|
147,608
|
||||||
Total current liabilities
|
10,686,351
|
13,026,036
|
||||||
Total Liabilities
|
11,495,042
|
14,050,220
|
||||||
TOTAL EQUITY AND LIABILITIES
|
129,485,304
|
102,399,660
|
(in €)
|
Issued
capital
|
Share
premium
|
Other
capital
reserves
|
Accumulated deficit
|
Other
compo-
nents of
equity |
Total equity
|
||||||||||||||||||
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
|
—
|
—
|
—
|
(26,737,373
|
)
|
—
|
(26,737,373
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
56,459
|
56,459
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(26,737,373
|
)
|
56,459
|
(26,680,914
|
)
|
||||||||||||||||
Issuance of common shares
|
1,687,110
|
54,796,819
|
—
|
—
|
—
|
56,483,929
|
||||||||||||||||||
Transaction costs
|
—
|
(3,360,626
|
)
|
—
|
—
|
—
|
(3,360,626
|
)
|
||||||||||||||||
Equity-settled share-based payments
|
—
|
—
|
2,961,491
|
—
|
—
|
2,961,491
|
||||||||||||||||||
Share options exercised
|
14,431
|
222,512
|
—
|
—
|
—
|
236,943
|
||||||||||||||||||
Balance as of September 30, 2023
|
7,065,993
|
334,211,338
|
39,597,055
|
(270,197,663
|
)
|
7,313,540
|
117,990,262
|
|||||||||||||||||
Balance as of January 1, 2022
|
5,304,452
|
280,310,744
|
30,591,209
|
(213,975,679
|
)
|
3,050,271
|
105,280,996
|
|||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(21,458,325
|
)
|
—
|
(21,458,325
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
10,035,949
|
10,035,949
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(21,458,325
|
)
|
10,035,949
|
(11,422,376
|
)
|
||||||||||||||||
Equity-settled share-based payments
|
—
|
—
|
5,581,021
|
—
|
—
|
5,581,021
|
||||||||||||||||||
Balance as of September 30, 2022
|
5,304,452
|
280,310,744
|
36,172,229
|
(235,434,004
|
)
|
13,086,220
|
99,439,640
|
For the nine months ended September 30,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €)
|
||||||||
Operating activities
|
||||||||
Loss for the period
|
(26,737,373
|
)
|
(21,458,325
|
)
|
||||
Adjustments for:
|
||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
|
432,248
|
448,323
|
||||||
Net finance income
|
(4,864,488
|
)
|
(3,080,904
|
)
|
||||
Share-based payment expense
|
2,961,491
|
5,581,021
|
||||||
Net foreign exchange differences
|
(82,574
|
)
|
189,088
|
|||||
Changes in:
|
||||||||
Financial assets from government grants
|
(431,246
|
)
|
(5,954,754
|
)
|
||||
Other assets
|
4,468,239
|
3,087,177
|
||||||
Employee benefits
|
(26,893
|
)
|
(221,982
|
)
|
||||
Other liabilities
|
2,893,461
|
5,061
|
||||||
Liabilities from government grants received
|
(6,209,266
|
)
|
(6,849,415
|
)
|
||||
Trade and other payables
|
1,011,662
|
(1,135,817
|
)
|
|||||
Inventories
|
(1,639,490
|
)
|
—
|
|||||
Interest received
|
1,302,391
|
903,647
|
||||||
Interest paid
|
(15,773
|
)
|
(38,978
|
)
|
||||
Net cash used in operating activities
|
(26,937,611
|
)
|
(28,525,857
|
)
|
||||
Investing activities
|
||||||||
Purchase of intangible assets, property and equipment
|
(45,942
|
)
|
(17,908
|
)
|
||||
Purchase of current financial assets
|
(91,590,134
|
)
|
(47,031,216
|
)
|
||||
Proceeds from the maturity of financial assets
|
71,113,455
|
64,600,049
|
||||||
Net cash from/(used in) investing activities
|
(20,522,621
|
)
|
17,550,925
|
|||||
Financing activities
|
||||||||
Proceeds from issuance of common shares
|
56,483,929
|
—
|
||||||
Transaction costs from issuance of common shares
|
(3,360,626
|
)
|
—
|
|||||
Proceeds from exercise of share options
|
236,943
|
—
|
||||||
Repayment of lease liabilities
|
(279,075
|
)
|
(273,092
|
)
|
||||
Net cash from/(used in) financing activities
|
53,081,170
|
(273,092
|
)
|
|||||
Net increase/(decrease) in cash and cash equivalents
|
5,620,938
|
(11,248,024
|
)
|
|||||
Effect of exchange rate changes on cash and cash equivalents
|
(190,686
|
)
|
2,976,033
|
|||||
Cash and cash equivalents at beginning of period
|
16,265,355
|
26,249,995
|
||||||
Cash and cash equivalents at end of period
|
21,695,607
|
17,978,003
|
InflaRx N.V.
|
MC Services AG
|
Email: IR@inflarx.de
|
Katja Arnold, Laurie Doyle, Dr. Regina Lutz
|
Email: inflarx@mc-services.eu
|
|
Europe: +49 89-210 2280
|
|
U.S.: +1-339-832-0752
|
1 Year InflaRx NV Chart |
1 Month InflaRx NV Chart |
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