Exhibit
|
Description of Exhibit
|
InflaRx N.V. Unaudited Condensed Consolidated Financial Statements as of and for the Three Months Ended March 31, 2023
|
|
InflaRx N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
InflaRx N.V. Press Release, dated May 11, 2023
|
INFLARX N.V.
|
|||
Date: May 11, 2023
|
By:
|
/s/ Niels Riedemann
|
|
Name:
|
Niels Riedemann
|
||
Title:
|
Chief Executive Officer
|
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2023 and 2022
|
3
|
Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2023 and December 31, 2022
|
4
|
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2023 and 2022
|
5
|
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022
|
6
|
Notes to the Unaudited Condensed Consolidated Financial Statements
|
7
|
1.
|
Summary of significant accounting policies and other disclosures
|
7
|
|
a)
|
Reporting entity and the Group’s structure
|
7
|
|
b)
|
Basis of preparation
|
7
|
|
2.
|
Other income
|
8
|
|
3.
|
Net financial result
|
8 | |
4.
|
Other assets
|
9 | |
5.
|
Financial assets and financial liabilities
|
9 | |
6.
|
Cash and cash equivalents
|
10
|
|
7.
|
Equity
|
10
|
|
8.
|
Share-based payments
|
10
|
|
a)
|
Equity settled share-based payment arrangements
|
10
|
|
b)
|
Share-based payment expense recognized
|
10
|
|
9.
|
Protective foundation
|
11 | |
10.
|
Subsequent events
|
12 |
For the three months ended March 31,
|
||||||||||||
Note
|
2023
(unaudited)
|
2022
(unaudited)
|
||||||||||
(in €, except for share data)
|
||||||||||||
Operating expenses
|
||||||||||||
Research and development expenses
|
(14,731,908
|
)
|
(10,471,923
|
)
|
||||||||
General and administrative expenses
|
(3,608,554
|
)
|
(4,387,443
|
)
|
||||||||
Total operating expenses
|
(18,340,462
|
)
|
(14,859,366
|
)
|
||||||||
Other income
|
2
|
1,593
|
||||||||||
Other expenses
|
(566
|
)
|
(565
|
)
|
||||||||
Operating result
|
(10,594,839
|
)
|
(14,858,338
|
)
|
||||||||
Finance income
|
3
|
27,962
|
||||||||||
Finance expenses
|
3
|
(5,528
|
)
|
(24,586
|
)
|
|||||||
Foreign exchange result
|
3
|
(1,137,310
|
)
|
727,933
|
||||||||
Other financial result
|
3
|
125,000
|
||||||||||
Income taxes
|
—
|
—
|
||||||||||
Loss for the period
|
(11,083,833
|
)
|
(14,002,030
|
)
|
||||||||
Share information
|
||||||||||||
Weighted average number of shares outstanding
|
44,203,763
|
|||||||||||
Loss per share (basic/diluted)
|
(0.25
|
)
|
(0.32
|
)
|
||||||||
Loss for the period
|
(11,083,833
|
)
|
(14,002,030
|
)
|
||||||||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:
|
||||||||||||
Exchange differences on translation of foreign currency
|
(16,785
|
)
|
1,309,875
|
|||||||||
Total comprehensive loss
|
(11,100,618
|
)
|
(12,692,154
|
)
|
Note
|
March 31, 2023
(unaudited)
|
December 31,
2022
|
||||||||||
(in €)
|
||||||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property and equipment
|
328,920
|
|||||||||||
Right-of-use assets
|
1,311,809
|
|||||||||||
Intangible assets
|
138,905
|
|||||||||||
Other assets
|
4
|
308,066
|
||||||||||
Financial assets
|
5
|
2,900,902
|
||||||||||
Total non-current assets
|
4,988,602
|
|||||||||||
Current assets
|
||||||||||||
Current other assets
|
5
|
14,170,510
|
||||||||||
Income tax receivable
|
1,432,087
|
|||||||||||
Financial assets from government grants
|
5
|
732,971
|
||||||||||
Other financial assets
|
5
|
64,810,135
|
||||||||||
Cash and cash equivalents
|
6
|
16,265,355
|
||||||||||
Total current assets
|
97,411,058
|
|||||||||||
TOTAL ASSETS
|
102,399,660
|
|||||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity
|
||||||||||||
Issued capital
|
7
|
5,364,452
|
||||||||||
Share premium
|
6
|
282,552,633
|
||||||||||
Other capital reserves
|
7
|
36,635,564
|
||||||||||
Accumulated deficit
|
(254,544,123
|
)
|
(243,460,290
|
)
|
||||||||
Other components of equity
|
7,257,081
|
|||||||||||
Total equity
|
88,349,440
|
|||||||||||
Non-current liabilities
|
||||||||||||
Lease liabilities
|
987,307
|
|||||||||||
Other liabilities
|
36,877
|
|||||||||||
Total non-current liabilities
|
1,024,184
|
|||||||||||
Current liabilities
|
||||||||||||
Trade and other payables
|
5
|
4,987,538
|
||||||||||
Liabilities from government grants received
|
5
|
6,209,266
|
||||||||||
Lease liabilities
|
369,376
|
|||||||||||
Employee benefits
|
1,312,248
|
|||||||||||
Other liabilities
|
147,608
|
|||||||||||
Total current liabilities
|
13,026,036
|
|||||||||||
Total liabilities
|
14,050,220
|
|||||||||||
TOTAL EQUITY AND LIABILITIES
|
102,399,660
|
Note
|
Shares
outstanding
|
Issued
capital
|
Share
premium
|
Other
capital
reserves
|
Accumulated
deficit
|
Other
com-
ponents of
equity
|
Total equity
|
|||||||||||||||||||||||||
Balance as of January 1, 2023
|
(243,460,290
|
)
|
||||||||||||||||||||||||||||||
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
|
7
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Share options exercised
|
—
|
—
|
—
|
|||||||||||||||||||||||||||||
Balance as of March 31, 2023*
|
(254,544,123
|
)
|
||||||||||||||||||||||||||||||
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
|
—
|
—
|
—
|
—
|
(14,002,030
|
)
|
—
|
(14,002,030
|
)
|
|||||||||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
—
|
1,309,875
|
1,309,875
|
|||||||||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
—
|
(14,002,030
|
)
|
1,309,875
|
(12,692,155
|
)
|
|||||||||||||||||||||||
Equity-settled share-based payments
|
7
|
—
|
—
|
—
|
2,530,775
|
—
|
—
|
2,530,775
|
||||||||||||||||||||||||
Balance as of March 31, 2022*
|
44,203,763
|
5,304,452
|
280,310,744
|
33,121,984
|
(227,977,709
|
)
|
4,360,146
|
95,119,617
|
For the three months ended March 31,
|
||||||||||||
Note
|
2023
(unaudited)
|
2022
(unaudited)
|
||||||||||
(in €)
|
||||||||||||
Operating activities
|
||||||||||||
Loss for the period
|
(11,083,833
|
)
|
(14,002,030
|
)
|
||||||||
Adjustments for:
|
||||||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
|
||||||||||||
Net finance income
|
3
|
(856,308
|
)
|
|||||||||
Share-based payment expense
|
8
|
|||||||||||
Net foreign exchange differences
|
3
|
(106,793
|
)
|
135,826
|
||||||||
Changes in:
|
||||||||||||
Financial assets from government grants
|
5
|
(2,701,076
|
)
|
—
|
||||||||
Other assets
|
(1,405,328
|
)
|
||||||||||
Employee benefits
|
(834,713
|
)
|
(732,876
|
)
|
||||||||
Other liabilities
|
(6,844
|
)
|
||||||||||
Liabilities from government grants received
|
5
|
(5,033,779
|
)
|
—
|
||||||||
Trade and other payables
|
(371,445
|
)
|
||||||||||
Interest received
|
3
|
|||||||||||
Interest paid
|
3
|
(5,627
|
)
|
(24,641
|
)
|
|||||||
Net cash used in operating activities
|
(10,516,193
|
)
|
(12,858,662
|
)
|
||||||||
Investing activities
|
||||||||||||
Purchase of intangible assets, property and equipment
|
(6,046
|
)
|
(7,828
|
)
|
||||||||
Purchase of current financial assets
|
(25,120,832
|
)
|
—
|
|||||||||
Proceeds from the maturity of financial assets
|
||||||||||||
Net cash from/(used in) investing activities
|
(3,586,300
|
)
|
||||||||||
Financing activities
|
||||||||||||
Proceeds from exercise of share options
|
8
|
—
|
||||||||||
Repayment of lease liabilities
|
(93,744
|
)
|
(90,806
|
)
|
||||||||
Net cash from/(used in) financing activities
|
(90,806
|
)
|
||||||||||
Net increase/(decrease) in cash and cash equivalents
|
(14,072,291
|
)
|
||||||||||
Effect of exchange rate changes on cash and cash equivalents
|
(95,814
|
)
|
||||||||||
Cash and cash equivalents at beginning of period
|
||||||||||||
Cash and cash equivalents at end of period
|
6
|
1. |
Summary of significant accounting policies and other disclosures
|
a) |
Reporting entity and the Group’s structure
|
b) |
Basis of preparation
|
• |
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
|
2. |
Other income
|
For the three months ended March 31,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €)
|
||||||||
Other income from government grants
|
—
|
|||||||
Further other income
|
1,593
|
|||||||
Total
|
1,593
|
3. |
Net financial result
|
For the three months ended March 31,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €)
|
||||||||
Finance income
|
||||||||
Interest income
|
27,962
|
|||||||
Finance expenses
|
||||||||
Interest expenses
|
(5,108
|
)
|
(19,859
|
)
|
||||
Interest on lease liabilities
|
(420
|
)
|
(4,727
|
)
|
||||
Total
|
3,376
|
For the three months ended March 31,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €)
|
||||||||
Foreign exchange result
|
||||||||
Foreign exchange income
|
1,110,408
|
|||||||
Foreign exchange expense
|
(1,427,835
|
)
|
(382,475
|
)
|
||||
Total
|
(1,137,310
|
)
|
727,933
|
|||||
For the three months ended March 31,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €)
|
||||||||
Other financial result
|
125,000
|
4. |
Other assets
|
As of March 31, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Non-current other assets
|
||||||||
Prepaid expense
|
308,066
|
|||||||
Total
|
308,066
|
|||||||
Current other assets
|
||||||||
Prepayments on research & development projects
|
9,776,505
|
|||||||
Prepaid expense
|
1,841,935
|
|||||||
Others
|
2,552,071
|
|||||||
Total
|
14,170,511
|
|||||||
Total other assets
|
14,478,577
|
5. |
Financial assets and financial liabilities
|
As of March 31, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Financial assets at amortized cost
|
||||||||
Non-current financial assets
|
2,900,902
|
|||||||
Financial assets from government grants
|
732,971
|
|||||||
Other current financial assets
|
64,791,088
|
|||||||
Financial liabilities at amortized cost
|
||||||||
Liabilities from government grants
|
6,209,266
|
|||||||
Trade and other payables
|
4,987,538
|
6. |
Cash and cash equivalents
|
As of March 31, 2023
(unaudited)
|
As of
December 31, 2022
|
|||||||
(in €)
|
||||||||
Short-term deposits
|
||||||||
Deposits held in U.S. dollars
|
3,422
|
|||||||
Total
|
3,422
|
|||||||
Cash at banks
|
||||||||
Cash held in U.S. dollars
|
8,645,014
|
|||||||
Cash held in Euro
|
7,616,918
|
|||||||
Total
|
16,261,932
|
|||||||
Total cash and cash equivalents
|
16,265,354
|
7. |
Equity
|
8. |
Share-based payments
|
a) |
Equity settled share-based payment arrangements
|
Number of share options
|
2023
|
2022
|
||||||
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
|
Number of share options
|
2023
|
2022
|
||||||
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
|
Number of share options
|
2023
|
2022
|
||||||
Outstanding as of January 1,
|
4,985,523
|
3,170,046
|
||||||
Granted during the three months ended March 31,
|
1,506,750
|
1,561,666
|
||||||
Exercised during the three months ended March 31,
|
56.304
|
—
|
||||||
Forfeited during the three months ended March 31,
|
—
|
(18,334
|
)
|
|||||
Outstanding as of March 31,
|
6,435,969
|
4,713,378
|
||||||
thereof vested
|
4,474,219
|
2,846,155
|
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
|
Expecte
d
volatility
|
Expec
ted life
(midp
oint
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
|
%
|
||||||||||||||||||||
1,506,750
|
b) |
Share-based payment expense recognized
|
c) |
Share options exercised
|
9. |
Protective foundation
|
10. |
Subsequent events
|
• |
continue to prepare for commercialization of Gohibic (vilobelimab) in the U.S. by investing in our commercial infrastructure and seek partners to support commercialization of our 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 IFX002 and INF904;
|
• |
invest in our working capital;
|
• |
generally actively seek to identify additional research programs and additional product candidates;
|
• |
pursue full BLA and MAA approvals for Gohibic (vilobelimab);
|
• |
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 the scale-up and validation of the manufacturing process for the commercialization of Gohibic (vilobelimab) including the manufacturing of larger quantities of product candidates for the completion of
the development activities towards the establishment of a commercial manufacturing process and for further 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.
|
•
|
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 and conducting our Phase II clinical program in cSCC. In addition, we are incurring, 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 approval for 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 by establishing a commercial scale production process.
|
•
|
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 oral 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.
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Operating expenses
|
||||||||||||
Research and development expenses
|
(14,731,908
|
)
|
(10,471,923
|
)
|
(4,259,985
|
)
|
||||||
General and administrative expenses
|
(3,608,554
|
)
|
(4,387,443
|
)
|
778,889
|
|||||||
Total operating expenses
|
(18,340,462
|
)
|
(14,859,366
|
)
|
(3,481,096
|
)
|
||||||
Other income
|
7,746,189
|
1,593
|
7,744,596
|
|||||||||
Other expenses
|
(566
|
)
|
(565
|
)
|
(1
|
)
|
||||||
Operating result
|
(10,594,839
|
)
|
(14,858,338
|
)
|
4,263,499
|
|||||||
Finance income
|
456,036
|
27,962
|
428,074
|
|||||||||
Finance expenses
|
(5,528
|
)
|
(24,586
|
)
|
19,058
|
|||||||
Foreign exchange result
|
(1,137,310
|
)
|
727,933
|
(1,865,243
|
)
|
|||||||
Other financial result
|
197,808
|
125,000
|
72,808
|
|||||||||
Income taxes
|
—
|
—
|
—
|
|||||||||
Loss for the period
|
(11,083,833
|
)
|
(14,002,030
|
)
|
2,918,197
|
|||||||
Exchange differences on translation of foreign currency
|
(16,785
|
)
|
1,309,875
|
(1,326,660
|
)
|
|||||||
Total comprehensive loss
|
(11,100,618
|
)
|
(12,692,154
|
)
|
1,591,536
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Third-party expenses
|
12,403,127
|
8,088,608
|
4,314,519
|
|||||||||
Personnel expenses
|
1,611,079
|
2,107,623
|
(496,544
|
)
|
||||||||
Legal and consulting fees
|
545,151
|
194,087
|
351,064
|
|||||||||
Other expenses
|
172,550
|
81,604
|
90,946
|
|||||||||
Total research and development expenses
|
14,731,908
|
10,471,923
|
4,259,985
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Personnel expenses
|
1,606,005
|
2,477,017
|
(871,012
|
)
|
||||||||
Legal, consulting and audit fees
|
985,912
|
770,291
|
215,621
|
|||||||||
Other expenses
|
1,016,638
|
1,140,136
|
(123,498
|
)
|
||||||||
Total general and administrative expense
|
3,608,554
|
4,387,443
|
(778,889
|
)
|
For the three months ended March 31,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €)
|
||||||||
Other income from government grants
|
7,734,855
|
—
|
||||||
Further other income
|
11,334
|
1,593
|
||||||
Total
|
7,746,189
|
1,593
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2022
|
Change
|
||||||||||
(in €)
|
||||||||||||
Interest income
|
456,036
|
27,962
|
428,074
|
|||||||||
Interest expenses
|
(420
|
)
|
(19,859
|
)
|
19,439
|
|||||||
Interest on lease liabilities
|
(5,108
|
)
|
(4,727
|
)
|
(381
|
)
|
||||||
Finance Result
|
450,508
|
3,376
|
447,132
|
|||||||||
Foreign exchange income
|
290,525
|
1,110,408
|
(819,883
|
)
|
||||||||
Foreign exchange expense
|
(1,427,835
|
)
|
(382,475
|
)
|
(1,045,360
|
)
|
||||||
Foreign exchange result
|
(1,137,310
|
)
|
727,933
|
(1,865,243
|
)
|
|||||||
Other financial result
|
197,808
|
125,000
|
72,808
|
|||||||||
Net financial result
|
(488,994
|
)
|
856,309
|
(1,345,303
|
)
|
Three Months Ended March 31,
|
||||||||
2023
|
2022
|
|||||||
(in €)
|
||||||||
Net cash used in operating activities
|
(10,516,193
|
)
|
(12,858,662
|
)
|
||||
Net cash from/(used in) investing activities
|
(3,586,300
|
)
|
26,481,122
|
|||||
Net cash from/(used in) financing activities
|
30,202
|
(90,806
|
)
|
|||||
Cash and cash equivalents at the beginning of the period
|
16,265,355
|
26,249,995
|
||||||
Exchange gains/losses on cash and cash equivalents
|
(95,814
|
)
|
314,639
|
|||||
Cash and cash equivalents at the end of the period
|
2,097,250
|
40,096,286
|
1. |
Net Cash used in Operating Activities
|
2. |
Net Cash from/used in Investing Activities
|
3. |
Net Cash from/used in Financing Activities
|
•
|
our ability to commercialize Gohibic (vilobelimab) or our other product candidates;
|
•
|
our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for and clinical utility of Gohibic (vilobelimab) in its approved or authorized
indication or for vilobelimab and any other product candidates, under the EUA and in the future if approved for commercial use in the U.S. or elsewhere;
|
•
|
the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and
clinical trials;
|
•
|
the timing, progress and results of clinical trials of our product candidates, and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the
period during which the results of the trials will become available, the costs of such trials and our research and development programs generally;
|
•
|
our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our biologics license application, or 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.
|
•
|
Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patients
|
•
|
Gohibic planned to be available to patients in the U.S. within the next few weeks
|
•
|
Phase III study with vilobelimab in pyoderma gangrenosum (PG) underway; first patient expected to be enrolled mid-2023
|
•
|
Cash, cash equivalents and marketable securities approximately €72.3 million as of March 31, 2023
|
•
|
Additional €53.5 million in aggregate proceeds subsequently raised under at-the-market (ATM) program and by an underwritten public offering of ordinary shares
|
For the three months ended March 31,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €, except for share data)
|
||||||||
Operating expenses
|
||||||||
Research and development expenses
|
(14,731,908
|
)
|
(10,471,923
|
)
|
||||
General and administrative expenses
|
(3,608,554
|
)
|
(4,387,443
|
)
|
||||
Total operating expenses
|
(18,340,462
|
)
|
(14,859,366
|
)
|
||||
Other income
|
7,746,189
|
1,593
|
||||||
Other expenses
|
(566
|
)
|
(565
|
)
|
||||
Operating result
|
(10,594,839
|
)
|
(14,858,338
|
)
|
||||
Finance income
|
456,036
|
27,962
|
||||||
Finance expenses
|
(5,528
|
)
|
(24,586
|
)
|
||||
Foreign exchange result
|
(1,137,310
|
)
|
727,933
|
|||||
Other financial result
|
197,808
|
125,000
|
||||||
Income taxes
|
—
|
—
|
||||||
Loss for the period
|
(11,083,833
|
)
|
(14,002,030
|
)
|
||||
Share information
|
||||||||
Weighted average number of shares outstanding
|
44,771,703
|
44,203,763
|
||||||
Loss per share (basic/diluted)
|
(0.25
|
)
|
(0.32
|
)
|
||||
Loss for the period
|
(11,083,833
|
)
|
(14,002,030
|
)
|
||||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:
|
||||||||
Exchange differences on translation of foreign currency
|
(16,785
|
)
|
1,309,875
|
|||||
Total comprehensive loss
|
(11,100,618
|
)
|
(12,692,154
|
)
|
March 31, 2023
(unaudited)
|
December 31, 2022
|
|||||||
(in €)
|
||||||||
ASSETS
|
||||||||
Non-current assets
|
||||||||
Property and equipment
|
306,371
|
328,920
|
||||||
Right-of-use assets
|
1,214,865
|
1,311,809
|
||||||
Intangible assets
|
114,847
|
138,905
|
||||||
Other assets
|
297,021
|
308,066
|
||||||
Financial assets
|
7,969,071
|
2,900,902
|
||||||
Total non-current assets
|
9,902,175
|
4,988,602
|
||||||
Current assets
|
||||||||
Current other assets
|
5,956,752
|
14,170,510
|
||||||
Income tax receivable
|
2,141,785
|
1,432,087
|
||||||
Financial assets from government grants
|
3,434,047
|
732,971
|
||||||
Other financial assets
|
62,779,179
|
64,810,135
|
||||||
Cash and cash equivalents
|
2,097,250
|
16,265,355
|
||||||
Total current assets
|
76,409,014
|
97,411,058
|
||||||
TOTAL ASSETS
|
86,311,189
|
102,399,660
|
||||||
EQUITY AND LIABILITIES
|
||||||||
Equity
|
||||||||
Issued capital
|
5,373,000
|
5,364,452
|
||||||
Share premium
|
282,668,032
|
282,552,633
|
||||||
Other capital reserves
|
37,842,612
|
36,635,564
|
||||||
Accumulated deficit
|
(254,544,123
|
)
|
(243,460,290
|
)
|
||||
Other components of equity
|
7,240,295
|
7,257,081
|
||||||
Total equity
|
78,579,816
|
88,349,440
|
||||||
Non-current liabilities
|
||||||||
Lease liabilities
|
896,331
|
987,307
|
||||||
Other liabilities
|
36,877
|
36,877
|
||||||
Total non-current liabilities
|
933,208
|
1,024,184
|
||||||
Current liabilities
|
||||||||
Trade and other payables
|
4,616,092
|
4,987,538
|
||||||
Liabilities from government grants received
|
1,175,487
|
6,209,266
|
||||||
Lease liabilities
|
365,457
|
369,376
|
||||||
Employee benefits
|
477,535
|
1,312,248
|
||||||
Other liabilities
|
163,594
|
147,608
|
||||||
Total current liabilities
|
6,798,165
|
13,026,036
|
||||||
Total liabilities
|
7,731,373
|
14,050,220
|
||||||
TOTAL EQUITY AND LIABILITIES
|
86,311,189
|
102,399,660
|
(in €)
|
Issued capital
|
Share premium
|
Other capital reserves
|
Accumulated deficit
|
Other components 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
|
—
|
—
|
—
|
(11,083,833
|
)
|
—
|
(11,083,833
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
(16,785
|
)
|
(16,785
|
)
|
||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(11,083,833
|
)
|
(16,785
|
)
|
(11,100,618
|
)
|
|||||||||||||||
Equity-settled share-based payments
|
—
|
—
|
1,207,048
|
—
|
—
|
1,207,048
|
||||||||||||||||||
Share options exercised
|
8,548
|
115,399
|
—
|
—
|
—
|
123,947
|
||||||||||||||||||
Balance as of March 31, 2023
|
5,373,000
|
282,668,032
|
37,842,612
|
(254,544,123
|
)
|
7,240,295
|
78,579,816
|
|||||||||||||||||
Balance as of January 1, 2022
|
5,304,452
|
280,310,744
|
30,591,209
|
(213,975,679
|
)
|
3,050,271
|
105,280,996
|
|||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(14,002,030
|
)
|
—
|
(14,002,030
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
1,309,875
|
1,309,875
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(14,002,030
|
)
|
1,309,875
|
(12,692,155
|
)
|
||||||||||||||||
Equity-settled share-based payments
|
—
|
—
|
2,530,775
|
—
|
—
|
2,530,775
|
||||||||||||||||||
Balance as of March 31, 2022
|
5,304,452
|
280,310,744
|
33,121,984
|
(227,977,709
|
)
|
4,360,146
|
95,119,617
|
For the three months ended March 31,
|
||||||||
2023
(unaudited)
|
2022
(unaudited)
|
|||||||
(in €)
|
||||||||
Operating activities
|
||||||||
Loss for the period
|
(11,083,833
|
)
|
(14,002,030
|
)
|
||||
Adjustments for:
|
||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
|
147,969
|
153,321
|
||||||
Net finance income
|
488,994
|
(856,308
|
)
|
|||||
Share-based payment expense
|
1,207,048
|
2,530,775
|
||||||
Net foreign exchange differences
|
(106,793
|
)
|
135,826
|
|||||
Changes in:
|
||||||||
Financial assets from government grants
|
(2,701,076
|
)
|
—
|
|||||
Other assets
|
7,515,105
|
(1,405,328
|
)
|
|||||
Employee benefits
|
(834,713
|
)
|
(732,876
|
)
|
||||
Other liabilities
|
15,986
|
(6,844
|
)
|
|||||
Liabilities from government grants received
|
(5,033,779
|
)
|
—
|
|||||
Trade and other payables
|
(371,445
|
)
|
928,526
|
|||||
Interest received
|
245,971
|
420,916
|
||||||
Interest paid
|
(5,627
|
)
|
(24,641
|
)
|
||||
Net cash used in operating activities
|
(10,516,193
|
)
|
(12,858,662
|
)
|
||||
Investing activities
|
||||||||
Purchase of intangible assets, property and equipment
|
(6,046
|
)
|
(7,828
|
)
|
||||
Purchase of current financial assets
|
(25,120,832
|
)
|
—
|
|||||
Proceeds from the maturity of financial assets
|
21,540,578
|
26,488,950
|
||||||
Net cash from/(used in) investing activities
|
(3,586,300
|
)
|
26,481,122
|
|||||
Financing activities
|
||||||||
Proceeds from exercise of share options
|
123,947
|
—
|
||||||
Repayment of lease liabilities
|
(93,744
|
)
|
(90,806
|
)
|
||||
Net cash from/(used in) financing activities
|
30,202
|
(90,806
|
)
|
|||||
Net increase/(decrease) in cash and cash equivalents
|
(14,072,291
|
)
|
13,531,653
|
|||||
Effect of exchange rate changes on cash and cash equivalents
|
(95,814
|
)
|
314,639
|
|||||
Cash and cash equivalents at beginning of period
|
16,265,355
|
26,249,995
|
||||||
Cash and cash equivalents at end of period
|
2,097,250
|
40,096,286
|