INFLARX N.V.
|
|||
By:
|
/s/ Niels Riedemann
|
||
Name:
|
Niels Riedemann
|
||
Title:
|
Chief Executive Officer
|
Exhibit
|
Description of Exhibit
|
InflaRx N.V. Unaudited Condensed Consolidated Financial Statements as of and for the Three Months Ended March 31, 2021
|
|
InflaRx N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
InflaRx N.V. Press Release dated May 12, 2021
|
Unaudited Condensed Consolidated Financial Statements
|
||
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2021 and 2020
|
3
|
|
Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 2021 and December 31, 2020
|
4
|
|
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2021 and 2020
|
5
|
|
Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020
|
6
|
|
Notes to the Unaudited Condensed Consolidated Financial Statements
|
7
|
|
1.
|
Summary of significant accounting policies and other disclosures
|
7
|
(a)
|
Reporting entity and Group’s structure
|
7
|
(b)
|
Basis of preparation
|
7
|
(c)
|
New and amended standards adopted by the Group
|
7
|
(d)
|
Significant events of the quarter and changes in circumstances
|
8
|
2.
|
Net Financial Result
|
8
|
3.
|
Other assets
|
10
|
4.
|
Financial assets and financial liabilities
|
10
|
5.
|
Cash and cash equivalents
|
11
|
6.
|
Equity
|
11
|
7.
|
Share-based payments
|
12
|
(e)
|
Equity settled share-based payment arrangements
|
12
|
(f)
|
Share options exercised
|
13
|
(g)
|
Share-based payment expense recognized
|
13
|
8.
|
Protective foundation
|
13
|
9.
|
Contractual Obligations and Commitments
|
14 |
For the three months ended March 31,
|
||||||||||||
(in €, except for share data)
|
Note
|
2021
(unaudited)
|
2020
(unaudited)
|
|||||||||
Operating Expenses
|
||||||||||||
Research and development expenses
|
(4,906,885
|
)
|
(7,298,799
|
)
|
||||||||
(3,022,338
|
)
|
(2,564,803
|
)
|
|||||||||
(7,929,224
|
)
|
(9,863,601
|
)
|
|||||||||
(565
|
)
|
(5,720
|
)
|
|||||||||
(7,924,327
|
)
|
(9,774,362
|
)
|
|||||||||
(3,684
|
)
|
(2,147
|
)
|
|||||||||
1,731,671
|
1,141,677
|
|||||||||||
Other financial result
|
2
|
48,000
|
—
|
|||||||||
Income Taxes
|
||||||||||||
(6,125,378
|
)
|
(8,233,397
|
)
|
|||||||||
Share Information
|
||||||||||||
Weighted average number of shares outstanding
|
33,807,774
|
|||||||||||
(0.18
|
)
|
(0.32
|
)
|
|||||||||
Loss for the Period
|
(6,125,378
|
)
|
(8,233,871
|
)
|
||||||||
Exchange differences on translation of foreign currency
|
||||||||||||
(2,620,679
|
)
|
(6,519,529
|
)
|
(in €)
|
Note
|
March 31,
2021
(unaudited)
|
December 31,
2020
|
|||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property and equipment
|
408,263
|
|||||||||||
Right-of-use assets
|
457,513
|
546,694
|
||||||||||
Intangible assets
|
350,183
|
|||||||||||
Other assets
|
3
|
353,522
|
||||||||||
Financial assets
|
4
|
272,268
|
||||||||||
Total non-current assets
|
1,930,930
|
|||||||||||
Current assets
|
||||||||||||
Current other assets
|
3
|
3,734,700
|
||||||||||
Current tax assets
|
1,360,125
|
1,419,490
|
||||||||||
Financial assets
|
4
|
55,162,033
|
||||||||||
Cash and cash equivalents
|
5
|
25,968,681
|
||||||||||
Total current assets
|
86,284,904
|
|||||||||||
TOTAL ASSETS
|
88,215,834
|
|||||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity
|
||||||||||||
Issued capital
|
6
|
3,387,410
|
||||||||||
Share premium
|
6
|
220,289,876
|
||||||||||
Other capital reserves
|
7
|
26,259,004
|
||||||||||
Accumulated deficit
|
(174,470,998
|
)
|
(168,345,620
|
)
|
||||||||
Other components of equity
|
(222,091
|
)
|
(3,726,791
|
)
|
||||||||
Total equity
|
77,863,880
|
|||||||||||
Non-current liabilities
|
||||||||||||
Lease liabilities
|
220,525
|
|||||||||||
Other liabilities
|
34,352
|
33,323
|
||||||||||
Total non-current liabilities
|
253,847
|
|||||||||||
Current liabilities
|
||||||||||||
Trade and other payables
|
4
|
8,258,133
|
||||||||||
Lease liabilities
|
338,516
|
|||||||||||
Employee benefits
|
429,621
|
1,368,731
|
||||||||||
Other liabilities
|
117,727
|
|||||||||||
Provisions
|
15,000
|
|||||||||||
Total current liabilities
|
10,098,107
|
|||||||||||
Total Liabilities
|
10,351,954
|
|||||||||||
TOTAL EQUITY AND LIABILITIES
|
88,215,834
|
(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, 2021
|
28,228,415
|
(168,345,620
|
)
|
(3,726,790
|
)
|
|||||||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
(6,125,378
|
)
|
—
|
(6,125,378
|
)
|
|||||||||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
—
|
(6,125,378
|
)
|
(2,620,679
|
)
|
||||||||||||||||||||||||
Issuance of common shares and warrants
|
6
|
15,610,022
|
1,873,203
|
63,269,346
|
—
|
—
|
—
|
65,142,549
|
||||||||||||||||||||||||
Transaction costs
|
6
|
—
|
—
|
(4,219,222
|
)
|
—
|
—
|
—
|
(4,219,222
|
)
|
||||||||||||||||||||||
Equity-settled share-based payments
|
7
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Share options exercised
|
7
|
347,842
|
41,741
|
921,994
|
—
|
—
|
—
|
963,735
|
||||||||||||||||||||||||
Balance as of March 31, 2021*
|
(174,470,998
|
)
|
(222,091
|
)
|
||||||||||||||||||||||||||||
Balance as of January 1, 2020
|
(134,362,006
|
)
|
2,227,228
|
|||||||||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
(8,233,397
|
)
|
—
|
(8,233,397
|
)
|
|||||||||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
—
|
(8,233,397
|
)
|
(6,519,529
|
)
|
||||||||||||||||||||||||
Equity-settled share-based payments
|
7
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Balance as of March 31, 2020*
|
(142,595,403
|
)
|
(in €)
|
Note
|
For the three months ended March 31, 2021
(unaudited)
|
For the three months ended March 31, 2020
(unaudited)
|
|||||||||
Operating activities
|
||||||||||||
Loss for the period
|
(6,125,378
|
)
|
(8,233,397
|
)
|
||||||||
Adjustments for:
|
||||||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
|
||||||||||||
Net finance income
|
2
|
(1,798,949
|
)
|
(399,288
|
)
|
|||||||
Share-based payment expense
|
7
|
|||||||||||
Net foreign exchange differences
|
193,847
|
(1,141,678
|
)
|
|||||||||
Other non-cash adjustments
|
—
|
(129,122
|
)
|
|||||||||
Changes in:
|
||||||||||||
Other assets
|
(2,739,152
|
)
|
||||||||||
Employee benefits
|
(952,820
|
)
|
(428,526
|
)
|
||||||||
Other liabilities
|
240,229
|
|||||||||||
Trade and other payables
|
(1,150,252
|
)
|
(1,922,724
|
)
|
||||||||
Interest received
|
||||||||||||
Interest paid
|
(3,780
|
)
|
(2,246
|
)
|
||||||||
Net cash used in operating activities
|
(10,413,453
|
)
|
(10,520,819
|
)
|
||||||||
Investing activities
|
||||||||||||
Purchase of intangible assets, property and equipment
|
(17,062
|
)
|
(27,686
|
)
|
||||||||
Purchase of current financial assets
|
(14,985,026
|
)
|
(23,412,469
|
)
|
||||||||
Proceeds from the maturity of financial assets
|
||||||||||||
Net cash used in investing activities
|
(1,049,566
|
)
|
(2,715,769
|
)
|
||||||||
Financing activities
|
||||||||||||
Proceeds from issuance of common shares
|
6
|
65,142,549
|
—
|
|||||||||
Transaction costs from issuance of common shares
|
6
|
(4,219,222
|
)
|
—
|
||||||||
Proceeds from exercise of share options
|
7
|
963,735
|
—
|
|||||||||
Repayment of lease liabilities
|
(90,716
|
)
|
(88,339
|
)
|
||||||||
Net cash from/(used in) financing activities
|
(88,339
|
)
|
||||||||||
Net increase/(decrease) in cash and cash equivalents
|
(13,324,927
|
)
|
||||||||||
Effect of exchange rate changes on cash and cash equivalents
|
||||||||||||
Cash and cash equivalents at beginning of period
|
||||||||||||
Cash and cash equivalents at end of period
|
5
|
1.
|
Summary of significant accounting policies and other disclosures
|
(a) |
Reporting entity and Group’s structure
|
(b) |
Basis of preparation
|
(c) |
New and amended standards adopted by the Group
|
• |
Interest Rate Benchmark Reform — Phase 2, Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16
|
• |
COVID-19-related Rent Concessions, Amendment to IFRS 16
|
• |
IFRS 17 Insurance Contracts, including Amendments to IFRS 17
|
• |
Amendments to IAS 1 Presentation of Financial Statements: Classification of Liabilities as Current or Non-current and Classification of Liabilities as Current or Non-current
|
• |
Amendments to IFRS 3 Business Combinations; IAS 16 Property, Plant and Equipment; IAS 37 Provisions, Contingent Liabilities and Contingent Assets; Annual Improvements 2018-2020
|
• |
Amendments to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of Accounting policies
|
• |
Amendments to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates
|
(d) |
Significant events of the quarter and changes in circumstances
|
2.
|
Net Financial Result
|
For the three months ended March 31,
|
||||||||
(in €)
|
2021
(unaudited)
|
2020
(unaudited)
|
||||||
Finance income
|
||||||||
Interest income
|
||||||||
Interest expenses
|
(2,580
|
)
|
||||||
(1,104
|
)
|
(2,147
|
)
|
|||||
For the three months ended March 31,
|
||||||||
(in €)
|
2021
(unaudited)
|
2020
(unaudited)
|
||||||
Foreign exchange result
|
||||||||
Foreign exchange income
|
2,457,039
|
1,257,557
|
||||||
Foreign exchange expense
|
(725,368
|
)
|
(115,879
|
)
|
||||
Total
|
1,731,671
|
1,141,678
|
For the three months ended March 31,
|
||||||||
(in €)
|
2021
(unaudited)
|
2020
(unaudited)
|
||||||
Other financial result
|
48,000
|
—
|
3.
|
Other assets
|
As of
March 31, 2021
(unaudited)
|
As of
December 31,
2020
|
|||||||
Non-current other assets
|
||||||||
Prepaid expense
|
353,522
|
|||||||
Total
|
353,522
|
|||||||
Current other assets
|
||||||||
Prepayments on research & development projects
|
2,340,643
|
|||||||
Current tax assets
|
1,360,125
|
1,419,490
|
||||||
Prepaid expense
|
1,295,682
|
|||||||
Other
|
98,374
|
|||||||
Total
|
5,154,190
|
4.
|
Financial assets and financial liabilities
|
(in €)
|
As of
March 31, 2021
(unaudited)
|
As of
December 31,
2020
|
||||||
Financial assets at amortized cost
|
||||||||
Non-current financial assets
|
||||||||
Current financial assets
|
||||||||
Financial liabilities at amortized cost
|
||||||||
Trade and other payables
|
||||||||
Interest bearing loans and borrowings
|
||||||||
Non-current lease liabilities
|
137,586
|
220,525
|
||||||
Current lease liabilities
|
330,969
|
338,516
|
5.
|
Cash and cash equivalents
|
(in €)
|
As of
March 31, 2021
(unaudited)
|
As of
December 31,
2020
|
||||||
Short-term deposits
|
||||||||
Deposits held in U.S. Dollars
|
||||||||
Deposits held in Euro
|
—
|
1,800,000
|
||||||
Total
|
||||||||
Cash at banks
|
||||||||
Cash held in U.S. Dollars
|
||||||||
Cash held in Euro
|
||||||||
Total
|
||||||||
Total cash and cash equivalents
|
6.
|
Equity
|
7.
|
Share-based payments
|
(e) |
Equity settled share-based payment arrangements
|
Number of share options
|
2021
|
2020
|
||||||
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
|
2021
|
2020
|
||||||
Outstanding as of January 1,
|
1,094,852
|
1,181,484
|
||||||
Exercised during the three months ended March 31
|
(202,020
|
)
|
—
|
|||||
Outstanding as of March 31,
|
892,832
|
1,181,484
|
||||||
thereof vested
|
892,832
|
1,181,484
|
Number of share options
|
2021
|
2020
|
||||||
Outstanding as of January 1,
|
2,146,478
|
2,181,105
|
||||||
Granted during the three months ended March 31
|
870,928
|
—
|
||||||
Exercised during the three months ended March 31
|
(145,822
|
)
|
—
|
|||||
Forfeited during the three months ended March 31
|
—
|
—
|
||||||
Outstanding as of March 31,
|
2,871,584
|
2,181,105
|
||||||
thereof vested
|
1,731,506
|
697,482
|
Share options
granted
|
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)
|
||||||||||||||||||||||||
2021
|
||||||||||||||||||||||||||||||||
January 4
|
839,260
|
$
|
4.53
|
0.8133
|
€
|
3.68
|
$
|
5.14
|
1.35
|
5.31
|
0.5
|
%
|
||||||||||||||||||||
January 4
|
31,668
|
$
|
4.57
|
0.8133
|
€
|
3.72
|
$
|
5.14
|
1.35
|
5.50
|
0.5
|
%
|
||||||||||||||||||||
870,928
|
• |
increasing the maximum annual number of common shares in the Company’s capital available for issuance under the LTIP, starting on January 1, 2021, to 4% (from 3%) of the Company’s outstanding common shares (determined as of December 31
of the immediately preceding year); and
|
• |
removing certain restrictions from the LTIP, which will allow the committee administering the LTIP and the Board to (i) lower the exercise price per share of any options and/or share appreciation rights issued under the LTIP or take any
other action treated as a ‘repricing’ of an award and (ii) cancel any option and/or share appreciation rights in exchange for cash or another award granted under the LTIP, in either case, without prior approval of the Company’s
shareholders.
|
(f) |
Share options exercised
|
(g) |
Share-based payment expense recognized
|
8.
|
Protective foundation
|
9.
|
Contractual Obligations and Commitments
|
• |
continue to develop and conduct clinical trials with respect to our lead product candidate, vilobelimab, including in connection with the evaluation of any additional clinical development in HS, the ongoing Phase III trial in severe
COVID-19, the ongoing Phase II clinical trials in AAV and PG as well as the planned Phase II study in cSCC;
|
• |
initiate and continue research, preclinical and clinical development efforts for any future product candidates, including IFX-2;
|
• |
actively seek to identify additional research programs and additional product candidates;
|
• |
seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any;
|
• |
establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize various products for which we may obtain marketing approval, if any;
|
• |
require the manufacture of larger quantities of product candidates for clinical development and, potentially, commercialization;
|
• |
collaborate with strategic partners to optimize the manufacturing process for vilobelimab and IFX-2;
|
• |
maintain, expand and protect our intellectual property portfolio;
|
• |
hire and retain additional personnel, such as clinical, quality control and scientific personnel;
|
• |
our use of share-based employee retention instruments that may involve significant future expense; 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, 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 share-based compensation expense based upon employees’ role within the organization; and
|
• |
professional legal fees related to the protection and maintenance of our intellectual property.
|
• |
vilobelimab (IFX-1). We expect our expenses associated with vilobelimab will further increase in the remainder of 2021, compared to the level on March 31, 2020, as we are
conducting the Phase III part of the clinical study in severe COVID-19, evaluate initiating a Phase III study in HS, conduct our Phase II clinical program of vilobelimab in patients with AAV and our Phase II clinical trial program in
patients with PG and plan to initiate a Phase II clinical program in cSCC along with potentially additional indications. In addition, we are also incurring expenses related to the manufacturing of clinical trial material and by
investigating commercial scale production options.
|
• |
IFX-2. We are continuing preclinical development of IFX-2, expenses for which mainly consist of salaries, costs for preclinical testing conducted by CROs and costs for the
production of 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,
|
||||||||||||
(in €)
|
2021
|
2020
|
Change
|
|||||||||
Operating Expenses
|
||||||||||||
Research and development expenses
|
(4,906,885
|
)
|
(7,298,799
|
)
|
2,391,914
|
|||||||
General and administrative expenses
|
(3,022,339
|
)
|
(2,564,803
|
)
|
(457,535
|
)
|
||||||
Total Operating Expenses
|
(7,929,224
|
)
|
(9,863,601
|
)
|
1,934,377
|
|||||||
Other income
|
5,462
|
94,960
|
(89,498
|
)
|
||||||||
Other expenses
|
(565
|
)
|
(5,720
|
)
|
5,155
|
|||||||
Operating Result
|
(7,924,327
|
)
|
(9,774,362
|
)
|
1,850,035
|
|||||||
Finance income
|
22,962
|
401,435
|
(378,473
|
)
|
||||||||
Finance expenses
|
(3,684
|
)
|
(2,147
|
)
|
(1,537
|
)
|
||||||
Foreign exchange result
|
1,731,671
|
1,141,678
|
589,993
|
|||||||||
Other financial result
|
48,000
|
—
|
48,000
|
|||||||||
Income Taxes
|
—
|
—
|
—
|
|||||||||
Loss for the Period
|
(6,125,378
|
)
|
(8,233,397
|
)
|
2,108,019
|
|||||||
Exchange differences on translation of foreign currency
|
3,504,699
|
1,713,868
|
1,790,831
|
|||||||||
Total Comprehensive Loss
|
(2,620,679
|
)
|
(6,519,529
|
)
|
3,898,850
|
Three Months Ended March 31,
|
||||||||||||
(in €)
|
2021
|
2020
|
Change
|
|||||||||
Third-party expenses
|
2,989,062
|
5,548,990
|
2,559,928
|
|||||||||
Personnel expenses
|
1,590,678
|
1,183,002
|
(407,676
|
)
|
||||||||
Legal and consulting fees
|
220,120
|
431,097
|
210,977
|
|||||||||
Other expenses
|
107,025
|
135,709
|
28,684
|
|||||||||
Total Research and development expenses
|
4,906,885
|
7,298,798
|
2,391,913
|
Three Months Ended March 31,
|
||||||||||||
(in €)
|
2021
|
2020
|
Change
|
|||||||||
Personnel expenses
|
2,000,459
|
1,509,593
|
(490,866
|
)
|
||||||||
Legal, consulting and audit fees
|
341,148
|
198,550
|
(142,598
|
)
|
||||||||
Other expenses
|
680,731
|
856,660
|
175,929
|
|||||||||
Total General and administrative expense
|
3,022,339
|
2,564,802
|
(457,537
|
)
|
Financial Result
|
Three Months Ended March 31,
|
|||||||||||
(in €)
|
2021
|
2020
|
Change
|
|||||||||
Finance income
|
||||||||||||
Interest income
|
22,962
|
401,435
|
(378,473
|
)
|
||||||||
Finance expenses
|
||||||||||||
Interest expenses
|
(2,580
|
)
|
—
|
(2,580
|
)
|
|||||||
Interest on lease liabilities
|
(1,104
|
)
|
(2,147
|
)
|
1,043
|
|||||||
Total
|
19,278
|
399,288
|
(380,010
|
)
|
||||||||
Foreign exchange result
|
Three Months Ended March 31,
|
|||||||||||
(in €)
|
2021
|
2020
|
Change
|
|||||||||
Foreign exchange result
|
||||||||||||
Foreign exchange income
|
2,457,039
|
1,257,557
|
1,199,482
|
|||||||||
Foreign exchange expense
|
(725,368
|
)
|
(115,879
|
)
|
(609,489
|
)
|
||||||
Total
|
1,731,671
|
1,141,678
|
589,993
|
|||||||||
Other financial result
|
Three Months Ended March 31,
|
|||||||||||
(in €)
|
2021
|
2020
|
Change
|
|||||||||
Other financial result
|
48,000
|
—
|
48,000
|
Three Months Ended March 31,
|
||||||||
(in €)
|
2021
|
2020
|
||||||
Net cash used in operating activities
|
(10,413,453
|
)
|
(10,520,819
|
)
|
||||
Net cash used in investing activities
|
(1,049,566
|
)
|
(2,715,769
|
)
|
||||
Net cash from/ (used in) financing activities
|
(88,339
|
)
|
||||||
Cash and cash equivalents at the beginning of the period
|
||||||||
Exchange gains on cash and cash equivalents
|
||||||||
Cash and cash equivalents at the end of the period
|
• |
our operation as a development stage company with limited operating history and a history of operating losses; as of March 31, 2021, our accumulated deficit was €(174.5) million;
|
• |
the timing, progress and results of clinical trials of vilobelimab and any other product candidates, including 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;
|
• |
the timing and outcome of any discussions or submission of filings for regulatory approval of vilobelimab or any other product candidate, and the timing of and our ability to obtain and maintain regulatory approval of vilobelimab for any
indication;
|
• |
our ability to leverage our proprietary anti-C5a technology 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;
|
• |
whether the Food and Drug Administration (FDA), European Medicines Agency (EMA) or comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including
any proposed primary or secondary endpoints for such trials;
|
• |
the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials;
|
• |
our expectations regarding the size of the patient populations for, market opportunity for and clinical utility of vilobelimab or any other product candidates, if approved for commercial use;
|
• |
our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our
existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and potentially for commercial supply of vilobelimab;
|
• |
our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;
|
• |
our expectations regarding the scope of any approved indication for vilobelimab;
|
• |
our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales;
|
• |
our ability to commercialize vilobelimab or our other product candidates;
|
• |
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;
|
• |
our competitive position and the development of and projections relating to our competitors in the development of C5a inhibitors or our industry; and
|
• |
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act or a foreign private issuer;
|
• |
Severe COVID-19 trial enrollment reaches 178 patients; interim analysis expected in Q3
|
• |
At the FDA’s suggestion, planning to request a Type A meeting to further discuss primary endpoint for the Phase III clinical development of
vilobelimab in Hidradenitis Suppurativa
|
• |
Vilobelimab proved safe and well tolerated as add-on therapy to standard of care in US ANCA-associated vasculitis safety trial
|
• |
Completed target enrollment in Phase IIa Pyoderma Gangraenosum trial
|
• |
Cash, cash equivalents and financial assets of approximately €137.8 million as of March 31, 2021
|
For the three months ended
March 31,
|
||||||||
(in €, except for share data)
|
2021
(unaudited)
|
2020
(unaudited)
|
||||||
Operating Expenses
|
||||||||
Research and development expenses
|
(4,906,885
|
)
|
(7,298,799
|
)
|
||||
General and administrative expenses
|
(3,022,339
|
)
|
(2,564,803
|
)
|
||||
Total Operating Expenses
|
(7,929,224
|
)
|
(9,863,601
|
)
|
||||
Other income
|
5,462
|
94,960
|
||||||
Other expenses
|
(565
|
)
|
(5,720
|
)
|
||||
Operating Result
|
(7,924,327
|
)
|
(9,774,362
|
)
|
||||
Finance income
|
22,962
|
401,435
|
||||||
Finance expenses
|
(3,684
|
)
|
(2,147
|
)
|
||||
Foreign exchange result
|
1,731,671
|
1,141,677
|
||||||
Other financial result
|
48,000
|
—
|
||||||
Income Taxes
|
—
|
—
|
||||||
Loss for the Period
|
(6,125,378
|
)
|
(8,233,397
|
)
|
||||
Share Information
|
||||||||
Weighted average number of shares outstanding
|
33,807,774
|
26,105,255
|
||||||
Loss per share (basic/diluted)
|
(0.18
|
)
|
(0.32
|
)
|
||||
Loss for the Period
|
(6,125,378
|
)
|
(8,233,871
|
)
|
||||
Other comprehensive income (loss) that may be reclas-sified to profit or loss in subsequent periods:
|
||||||||
Exchange differences on translation of foreign currency
|
3,504,699
|
1,713,868
|
||||||
Total Comprehensive Loss
|
(2,620,679
|
)
|
(6,519,529
|
)
|
in €
|
March 31,
2021
(unaudited)
|
December 31,
2020
|
||||||
ASSETS
|
||||||||
Non-current assets
|
||||||||
Property and equipment
|
383,762
|
408,263
|
||||||
Right-of-use assets
|
457,513
|
546,694
|
||||||
Intangible assets
|
320,645
|
350,183
|
||||||
Other assets
|
358,767
|
353,522
|
||||||
Financial assets
|
272,443
|
272,268
|
||||||
Total non-current assets
|
1,793,130
|
1,930,930
|
||||||
Current assets
|
||||||||
Current other assets
|
6,527,973
|
3,734,700
|
||||||
Current tax assets
|
1,360,125
|
1,419,490
|
||||||
Financial assets
|
58,834,268
|
55,162,033
|
||||||
Cash and cash equivalents
|
78,734,662
|
25,968,681
|
||||||
Total current assets
|
145,457,028
|
86,284,904
|
||||||
TOTAL ASSETS
|
147,250,158
|
88,215,834
|
||||||
EQUITY AND LIABILITIES
|
||||||||
Equity
|
||||||||
Issued capital
|
5,302,354
|
3,387,410
|
||||||
Share premium
|
280,261,994
|
220,289,876
|
||||||
Other capital reserves
|
27,980,274
|
26,259,004
|
||||||
Accumulated deficit
|
(174,470,998
|
)
|
(168,345,620
|
)
|
||||
Other components of equity
|
(222,091
|
)
|
(3,726,791
|
)
|
||||
Total equity
|
138,851,532
|
77,863,880
|
||||||
Non-current liabilities
|
||||||||
Lease liabilities
|
137,586
|
220,525
|
||||||
Other liabilities
|
34,352
|
33,323
|
||||||
Total non-current liabilities
|
171,938
|
253,847
|
||||||
Current liabilities
|
||||||||
Trade and other payables
|
7,107,880
|
8,258,133
|
||||||
Lease liabilities
|
330,969
|
338,516
|
||||||
Employee benefits
|
429,621
|
1,368,731
|
||||||
Other financial liabilities
|
358,217
|
117,727
|
||||||
Provisions
|
—
|
15,000
|
||||||
Total current liabilities
|
8,226,687
|
10,098,107
|
||||||
Total Liabilities
|
8,398,626
|
10,351,954
|
||||||
TOTAL EQUITY AND LIABILITIES
|
147,250,158
|
88,215,834
|
(in €, except for share data)
|
Issued capital
|
Share premium
|
Other capital reserves
|
Accumulated deficit
|
Other components of equity
|
Total equity
|
||||||||||||||||||
Balance as of January 1, 2021
|
3,387,410
|
220,289,876
|
26,259,004
|
(168,345,620
|
)
|
(3,726,790
|
)
|
77,863,880
|
||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(6,125,378
|
)
|
—
|
(6,125,378
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
3,504,699
|
3,504,699
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(6,125,378
|
)
|
3,504,699
|
(2,620,679
|
)
|
||||||||||||||||
Issuance of common shares and warrants
|
1,873,203
|
63,269,346
|
—
|
—
|
—
|
65,142,549
|
||||||||||||||||||
Transaction costs
|
—
|
(4,219,222
|
)
|
—
|
—
|
—
|
(4.219.222
|
)
|
||||||||||||||||
Equity-settled share-based pay-ments
|
—
|
—
|
1,721,270
|
—
|
—
|
1,721,270
|
||||||||||||||||||
Share options exercised
|
41,741
|
921,994
|
—
|
—
|
—
|
963,735
|
||||||||||||||||||
Balance as of March 31, 2021
|
5,302,354
|
280,261,994
|
27,980,274
|
(174,470,998
|
)
|
(222,091
|
)
|
138,851,532
|
||||||||||||||||
Balance as of January 1, 2020
|
3,132,631
|
211,006,606
|
25,142,213
|
(134,362,006
|
)
|
2,227,228
|
107,146,673
|
|||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(8,233,397
|
)
|
—
|
(8,233,397
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
1,713,868
|
1,713,868
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(8,233,397
|
)
|
1,713,868
|
(6,519,529
|
)
|
||||||||||||||||
Equity-settled share-based pay-ments
|
—
|
—
|
901,033
|
—
|
—
|
901,033
|
||||||||||||||||||
Balance as of March 31, 2020
|
3,132,631
|
211,006,606
|
26,043,246
|
(142,595,403
|
)
|
3,941,097
|
101,528,177
|
in €
|
For the three months ended March 31, 2021
(unaudited)
|
For the three months ended March 31, 2020
(unaudited)
|
||||||
Operating activities
|
||||||||
Loss for the period
|
(6,125,378
|
)
|
(8,233,397
|
)
|
||||
Adjustments for:
|
||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
|
168,343
|
182,356
|
||||||
Net finance income
|
(1,798,949
|
)
|
(399,288
|
)
|
||||
Share-based payment expense
|
1,721,270
|
901,033
|
||||||
Net foreign exchange differences
|
193,847
|
(1,141,678
|
)
|
|||||
Other non-cash adjustments
|
—
|
(129,122
|
)
|
|||||
Changes in:
|
||||||||
Other assets
|
(2,739,152
|
)
|
188,476
|
|||||
Employee benefits
|
(952,820
|
)
|
(428,526
|
)
|
||||
Other liabilities
|
240,229
|
1,953
|
||||||
Trade and other payables
|
(1,150,252
|
)
|
(1,922,724
|
)
|
||||
Interest received
|
33,189
|
462,342
|
||||||
Interest paid
|
(3,780
|
)
|
(2,246
|
)
|
||||
Net cash used in operating activities
|
(10,413,453
|
)
|
(10,520,819
|
)
|
||||
Investing activities
|
||||||||
Purchase of intangible assets, property and equipment
|
(17,062
|
)
|
(27,686
|
)
|
||||
Purchase of current financial assets
|
(14,985,026
|
)
|
(23,412,469
|
)
|
||||
Proceeds from the maturity of financial assets
|
13,952,522
|
20,724,386
|
||||||
Net cash from/ (used in) investing activities
|
(1,049,566
|
)
|
(2,715,769
|
)
|
||||
Financing activities
|
||||||||
Proceeds from issuance of common shares
|
65,142,549
|
—
|
||||||
Transaction costs from issuance of common shares
|
(4,219,222
|
)
|
—
|
|||||
Proceeds from exercise of share options
|
963,735
|
—
|
||||||
Repayment of lease liabilities
|
(90,716
|
)
|
(88,339
|
)
|
||||
Net cash from/ (used in) financing activities
|
61,796,346
|
(88,339
|
)
|
|||||
Net increase/(decrease) in cash and cash equivalents
|
50,333,328
|
(13,324,927
|
)
|
|||||
Effect of exchange rate changes on cash and cash equivalents
|
2,432,654
|
1,277,255
|
||||||
Cash and cash equivalents at beginning of period
|
25,968,681
|
33,131,280
|
||||||
Cash and cash equivalents at end of period
|
78,734,662
|
21,083,608
|