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 and Six Months Ended June 30, 2020
|
|
InflaRx N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
InflaRx N.V. Press Release dated July 30, 2020
|
Unaudited Condensed Consolidated Financial Statements
|
||||
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2020 and 2019
|
3
|
|||
Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2020 and December 31, 2019
|
4
|
|||
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2020 and 2019
|
5
|
|||
Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019
|
6
|
|||
Notes to the Unaudited Condensed Consolidated Financial Statements
|
7
|
|||
1. Net Financial Result
|
7
|
|||
2. Other non-financial assets
|
7
|
|||
3. Financial assets and financial liabilities
|
8
|
|||
4. Cash and cash equivalents
|
8
|
|||
5. Share-based payments
|
9
|
|||
6. Protective foundation
|
10
|
|||
7. Summary of significant accounting policies
|
10
|
|||
|
(a)
|
Reporting entity and Group’s structure
|
10
|
|
|
(b)
|
Basis of preparation
|
11
|
|
|
(c)
|
New and amended standards adopted by the Group
|
11
|
|
|
(d)
|
Significant events of the quarter and changes in circumstances
|
12
|
|
|
(e)
|
Significant events after the reporting date
|
12
|
For the three months
ended June 30,
|
For the six months
ended June 30,
|
|||||||||||||||||||
(in €, except for share data)
|
Note
|
2020
(unaudited)
|
2019
(unaudited)
|
2020
(unaudited)
|
2019
(unaudited)
|
|||||||||||||||
Operating Expenses
|
||||||||||||||||||||
Research and development expenses
|
(7,356,326
|
)
|
(12,497,222
|
)
|
(14,655,125
|
)
|
(20,192,372
|
)
|
||||||||||||
(2,326,895
|
)
|
(3,647,849
|
)
|
(4,891,698
|
)
|
(6,949,015
|
)
|
|||||||||||||
(9,683,221
|
)
|
(16,145,071
|
)
|
(19,546,822
|
)
|
(27,141,387
|
)
|
|||||||||||||
197,292
|
67,702
|
|||||||||||||||||||
(3,450
|
)
|
(79,183
|
)
|
(9,170
|
)
|
(83,068
|
)
|
|||||||||||||
(9,584,339
|
)
|
(16,221,387
|
)
|
(19,358,701
|
)
|
(27,156,753
|
)
|
|||||||||||||
2,268,436
|
2,497,960
|
|||||||||||||||||||
(1,057,937
|
)
|
(388,097
|
)
|
(1,175,964
|
)
|
(449,807
|
)
|
|||||||||||||
1
|
(448,493
|
)
|
1,092,472
|
2,048,153
|
||||||||||||||||
(10,032,832
|
)
|
(15,270,729
|
)
|
(18,266,229
|
)
|
(25,108,600
|
)
|
|||||||||||||
Share Information
|
||||||||||||||||||||
Weighted average number of shares outstanding
|
26,138,639
|
25,964,379
|
||||||||||||||||||
(0.38
|
)
|
(0.59
|
)
|
(0.70
|
)
|
(0.97
|
)
|
|||||||||||||
Loss for the Period
|
(10,032,832
|
)
|
(15,270,729
|
)
|
(18,266,229
|
)
|
(25,108,600
|
)
|
||||||||||||
Exchange differences on translation of foreign currency
|
(1,452,973
|
)
|
(1,622,079
|
)
|
260,895
|
695,468
|
||||||||||||||
(11,485,805
|
)
|
(16,892,807
|
)
|
(18,005,334
|
)
|
(24,413,132
|
)
|
(in €)
|
Note
|
June 30,
2020
(unaudited)
|
December 31,
2019
|
|||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
576,373
|
|||||||||||
Right-of-use assets
|
716,871
|
836,924
|
||||||||||
Intangible assets
|
452,400
|
|||||||||||
Other assets
|
2
|
452,217
|
||||||||||
Financial assets
|
3
|
272,614
|
||||||||||
Total non-current assets
|
2,590,528
|
|||||||||||
Current assets
|
||||||||||||
Other assets
|
2
|
3,500,884
|
||||||||||
Financial assets
|
3
|
82,353,867
|
||||||||||
Cash and cash equivalents
|
4
|
33,131,280
|
||||||||||
Total current assets
|
118,986,031
|
|||||||||||
TOTAL ASSETS
|
121,576,558
|
|||||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity
|
||||||||||||
Issued capital
|
3,132,631
|
|||||||||||
Share premium
|
211,006,606
|
|||||||||||
Other capital reserves
|
25,142,213
|
|||||||||||
Accumulated deficit
|
(152,628,234
|
)
|
(134,362,006
|
)
|
||||||||
Other components of equity
|
2,227,228
|
|||||||||||
Total equity
|
107,146,673
|
|||||||||||
Non-current liabilities
|
||||||||||||
Lease liabilities
|
330,745
|
|||||||||||
Other non-financial liabilities
|
37,644
|
39,013
|
||||||||||
Total non-current liabilities
|
369,758
|
|||||||||||
Current liabilities
|
||||||||||||
Trade and other payables
|
3
|
12,413,662
|
||||||||||
Lease liabilities
|
515,203
|
|||||||||||
Employee benefits
|
867,121
|
975,629
|
||||||||||
Social security, other taxes and other non-financial liabilities
|
105,634
|
|||||||||||
Provisions
|
50,000
|
|||||||||||
Total current liabilities
|
14,060,128
|
|||||||||||
Total Liabilities
|
14,429,886
|
|||||||||||
TOTAL EQUITY AND LIABILITIES
|
121,576,558
|
(in €, except for share data)
|
Note
|
Shares
outstanding
|
Issued
capital
|
Share
premium
|
Other
capital
reserves
|
Accumulated
deficit
|
Other com-
ponents of
equity
|
Total equity
|
||||||||||||||||||||||||
Balance as of January 1, 2020
|
26,105,255
|
(134,362,006
|
)
|
|||||||||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
(18,266,229
|
)
|
—
|
(18,266,229
|
)
|
|||||||||||||||||||||||
Exchange differences on
translation of foreign currency
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
—
|
(18,266,229
|
)
|
(18,005,334
|
)
|
||||||||||||||||||||||||
Contributions
|
||||||||||||||||||||||||||||||||
Equity-settled share-based payments
|
6
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Share options exercised
|
6
|
164,974
|
19,797
|
477,149
|
—
|
—
|
—
|
496,946
|
||||||||||||||||||||||||
Total Contributions
|
—
|
—
|
||||||||||||||||||||||||||||||
Balance as of June 30, 2020
|
(152,628,234
|
)
|
||||||||||||||||||||||||||||||
Balance as of January 1, 2019
|
(81,107,188
|
)
|
50,196
|
|||||||||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
(25,108,600
|
)
|
—
|
(25,108,600
|
)
|
|||||||||||||||||||||||
Exchange differences
on translation of foreign currency
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
—
|
(25,108,600
|
)
|
(24,413,132
|
)
|
||||||||||||||||||||||||
Contributions
|
||||||||||||||||||||||||||||||||
Equity-settled share-based pay-ments
|
6
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Total Contributions
|
—
|
—
|
||||||||||||||||||||||||||||||
Balance as of June 30, 2019
|
(106,215,788
|
)
|
(in €)
|
Note
|
For the six
months ended
June 30, 2020
(unaudited)
|
For the six
months ended
June 30, 2019
(unaudited)
|
|||||||||
Operating activities
|
||||||||||||
Loss for the period
|
(18,266,229
|
)
|
(25,108,600
|
)
|
||||||||
Adjustments for:
|
||||||||||||
Depreciation & amortization of property, plant, equipment, right-of-use assets and intangible assets
|
||||||||||||
Net financial result
|
1
|
(1,092,472
|
)
|
(2,048,153
|
)
|
|||||||
Share-based payment expense
|
6
|
|||||||||||
Net foreign exchange differences
|
(789,528
|
)
|
(205,103
|
)
|
||||||||
Changes in:
|
||||||||||||
Other assets
|
(2,063,491
|
)
|
||||||||||
Employee benefits
|
(122,411
|
)
|
(84,890
|
)
|
||||||||
Social security and other current non-financial liabilities
|
341,012
|
(184,120
|
)
|
|||||||||
Trade and other payables
|
(1,783,200
|
)
|
||||||||||
Interest received
|
||||||||||||
Interest paid
|
(5,455
|
)
|
(16,308
|
)
|
||||||||
Net cash used in operating activities
|
(18,222,235
|
)
|
(18,730,669
|
)
|
||||||||
Investing activities
|
||||||||||||
Purchase of intangible assets, laboratory and office equipment
|
(35,107
|
)
|
(503,881
|
)
|
||||||||
Purchase of non-current other financial assets
|
—
|
(75,543
|
)
|
|||||||||
Disposal of non-current other financial assets
|
||||||||||||
Purchase of current financial assets
|
(59,196,096
|
)
|
—
|
|||||||||
Proceeds from the maturity of financial assets
|
||||||||||||
Net cash from investing activities
|
||||||||||||
Financing activities
|
||||||||||||
Proceeds from exercise of share options
|
496,946
|
—
|
||||||||||
Repayment of lease liabilities
|
(183,970
|
)
|
(125,075
|
)
|
||||||||
Net cash from/ (used in) financing activities
|
(125,075
|
)
|
||||||||||
Net (decrease)/increase in cash and cash equivalents
|
(1,722,622
|
)
|
||||||||||
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
|
4
|
For the three months ended
June 30,
|
For the six months ended
June 30,
|
|||||||||||||||
(in €)
|
2020
(unaudited)
|
2019
(unaudited)
|
2020
(unaudited)
|
2019
(unaudited)
|
||||||||||||
Finance income
|
||||||||||||||||
Foreign exchange income
|
1,518,680
|
628,357
|
||||||||||||||
749,756
|
1,869,603
|
|||||||||||||||
2,268,436
|
2,497,960
|
|||||||||||||||
Foreign exchange expense
|
(854,826
|
)
|
(380,764
|
)
|
(970,706
|
)
|
(434,786
|
)
|
||||||||
(203,111
|
)
|
(7,333
|
)
|
(205,258
|
)
|
(15,021
|
)
|
|||||||||
(1,057,937
|
)
|
(388,097
|
)
|
(1,175,964
|
)
|
(449,807
|
)
|
|||||||||
(448,493
|
)
|
1,092,472
|
2,048,153
|
As of
June 30, 2020
(unaudited)
|
As of December
31, 2019
|
|||||||
Non-current other assets
|
||||||||
Prepaid expense
|
452,217
|
|||||||
Total
|
452,217
|
|||||||
Current other assets
|
||||||||
Current tax assets
|
1,134,968
|
|||||||
Prepayments on research & development projects
|
698,891
|
|||||||
Prepaid expense
|
1,467,936
|
|||||||
Costs directly attributable to a future equity transaction
|
281,668
|
—
|
||||||
Other
|
199,088
|
|||||||
Total
|
3,500,884
|
(in €)
|
As of
June 30, 2020
(unaudited)
|
As of December
31, 2019
|
||||||
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
|
203,636
|
330,745
|
||||||
Current lease liabilities
|
524,034
|
513,834
|
(in €)
|
As of
June 30, 2020
(unaudited)
|
As of December
31, 2019
|
||||||
Short-term deposits
|
||||||||
Deposits held in U.S. Dollars
|
||||||||
Deposits held in Euro
|
9,900,000
|
—
|
||||||
Total
|
||||||||
Cash at banks
|
||||||||
Cash held in Euro
|
||||||||
Cash held in U.S. Dollars
|
||||||||
Total
|
||||||||
Total cash and cash equivalents
|
Number of share options
|
2020
|
2019
|
||||||
Outstanding as of January 1,
|
148,433
|
533,820
|
||||||
Exercised during the six months ended June 30
|
—
|
—
|
||||||
Outstanding as of June 30,
|
148,433
|
533,820
|
||||||
thereof vested
|
148,433
|
533,820
|
Number of share options
|
2020
|
2019
|
||||||
Outstanding as of January 1,
|
1,181,484
|
1,181,484
|
||||||
Exercised during the six months ended June 30
|
86,632
|
—
|
||||||
Outstanding as of June 30,
|
1,094,852
|
1,181,484
|
||||||
thereof vested
|
1,094,852
|
1,181,484
|
Number of share options
|
2020
|
2019
|
||||||
Outstanding as of January 1,
|
2,181,105
|
2,051,009
|
||||||
Granted during the six months ended June 30
|
—
|
54,450
|
||||||
Exercised during the six months ended June 30
|
78,342
|
—
|
||||||
Forfeited during the six months ended June 30
|
7,686
|
—
|
||||||
Outstanding as of June 30,
|
2,095,077
|
2,105,459
|
||||||
thereof vested
|
1,557,157
|
994,879
|
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)
|
||||||||||||||||||||||||
2019
|
||||||||||||||||||||||||||||||||
January 1
|
—
|
$
|
14.45
|
0.88
|
€
|
12.69
|
$
|
26.02
|
*
|
0.65
|
4.8
|
3.00
|
%
|
|||||||||||||||||||
February 4
|
18,450
|
$
|
18.17
|
0.87
|
€
|
15.87
|
$
|
32.63
|
*
|
0.65
|
4.9
|
2.60
|
%
|
|||||||||||||||||||
May 14
|
36,000
|
$
|
22.54
|
0.89
|
€
|
20.08
|
$
|
41.39
|
*
|
0.65
|
4.7
|
2.30
|
%
|
|||||||||||||||||||
54,450
|
|
(a) |
Reporting entity and Group’s structure
|
|
(b) |
Basis of preparation
|
|
(c) |
New and amended standards adopted by the Group
|
|
• |
Conceptual Framework Amendments, References to the Conceptual Framework in IFRS Standards (IFRS 2 Share-Based Payment, IFRS 3 Business Combinations, IAS 1 Presentation of Financial Statements, IAS 8 Accounting Policies, IAS 34 Interim
Financial Reporting, IAS 37 Provisions, Contingent Liabilities and Contingent Assets, IFRIC 12 Service Concession Arrangements, IFRIC 19 Extinguishing Financial Liabilities with Equity Instruments IFRIC 22 Foreign Currency Transactions and
Advance Consideration, SIC 32 Intangible Assets — Web Site Costs,), effective as of January 1, 2020
|
|
• |
IFRS 3 Business Combinations, Definition of a business, effective January 1, 2020
|
|
• |
IAS 39 Financial Instruments: Recognition and Measurement, IFRS 7 Financial Instruments Disclosures, IFRS 9 Financial Instruments, Interest Rate Benchmark Reform, effective January 1, 2020
|
|
• |
|
(d) |
Significant events of the quarter and changes in circumstances
|
|
(e) |
Significant events after the reporting date
|
a) |
increasing the maximum annual number of ordinary 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 ordinary shares (determined as of December
31 of the immediately preceding year); and
|
b) |
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.
|
|
• |
continue to develop and conduct clinical trials with respect to our lead product candidate, IFX-1, including in connection with the evaluation of any additional clinical development in HS, in connection with the ongoing Phase II clinical
trials in AAV and PG as well as planned Phase II studies in oncology and a Phase III trial in severe COVID-19 induced pneumonia;
|
|
• |
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 IFX-1 and IFX-2;
|
|
• |
maintain, expand and protect our intellectual property portfolio;
|
|
• |
hire and retain additional personnel, such as 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, 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.
|
|
• |
IFX-1. We expect our expenses associated with IFX-1 will increase in the remainder of 2020 as we will initiate a Phase III study in COVID-19 and evaluate initiating a Phase III
study in HS, conduct our Phase II clinical program of IFX-1 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 cancer and potentially additional indications.
In addition, we are also incurring expenses related to the manufacturing of clinical trial material and 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 June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Operating Expenses
|
||||||||||||
Research and development expenses
|
(7,356,326
|
)
|
(12,497,222
|
)
|
(5,140,896
|
)
|
||||||
General and administrative expenses
|
(2,326,895
|
)
|
(3,647,849
|
)
|
(1,320,954
|
)
|
||||||
Total Operating Expenses
|
(9,683,221
|
)
|
(16,145,071
|
)
|
(6,461,850
|
)
|
||||||
Other income
|
102,332
|
2,866
|
(99,466
|
)
|
||||||||
Other expense
|
(3,450
|
)
|
(79,183
|
)
|
(75,733
|
)
|
||||||
Operating Result
|
(9,584,339
|
)
|
(16,221,387
|
)
|
(6,637,048
|
)
|
||||||
Finance income
|
609,444
|
1,338,755
|
729,311
|
|||||||||
Finance expenses
|
(1,057,937
|
)
|
(388,097
|
)
|
669,840
|
|||||||
Net Financial Result
|
(448,493
|
)
|
950,659
|
1,399,152
|
||||||||
Loss for the Period
|
(10,032,832
|
)
|
(15,270,729
|
)
|
(5,237,897
|
)
|
||||||
Exchange differences on translation of foreign currency
|
(1,452,973
|
)
|
(1,622,079
|
)
|
(169,106
|
)
|
||||||
Total Comprehensive Loss
|
(11,485,805
|
)
|
(16,892,807
|
)
|
(5,407,002
|
)
|
Three Months Ended June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Third-party expenses
|
5,990,439
|
10,398,711
|
(4,408,272
|
)
|
||||||||
Personnel expenses
|
1,124,546
|
1,724,813
|
(600,267
|
)
|
||||||||
Legal and consulting fees
|
161,964
|
90,871
|
71,093
|
|||||||||
Other expenses
|
79,377
|
282,827
|
(203,450
|
)
|
||||||||
Total Research and development expenses
|
7,356,326
|
12,497,222
|
(5,140,896
|
)
|
Three Months Ended June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Personnel expenses
|
1,298,990
|
1,894,581
|
(595,591
|
)
|
||||||||
Legal, consulting and audit fees
|
313,777
|
954,841
|
(641,064
|
)
|
||||||||
Other expenses
|
714,128
|
798,427
|
(84,299
|
)
|
||||||||
Total General and administrative expense
|
2,326,895
|
3,647,849
|
(1,320,954
|
)
|
Three Months Ended June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Finance income
|
||||||||||||
Foreign exchange gains
|
261,123
|
271,886
|
(10,763
|
)
|
||||||||
Interest income
|
348,321
|
1,066,869
|
(718,548
|
)
|
||||||||
Total
|
609,444
|
1,338,755
|
(729,311
|
)
|
||||||||
Finance expenses
|
||||||||||||
Foreign exchange losses
|
(854,826
|
)
|
(380,764
|
)
|
474,062
|
|||||||
Other
|
(203,111
|
)
|
(7,333
|
)
|
195,778
|
|||||||
Total
|
(1,057,937
|
)
|
(388,097
|
)
|
669,840
|
|||||||
Net Financial Result
|
(448,493
|
)
|
950,659
|
(1,399,152
|
)
|
Six Months Ended June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Operating Expenses
|
||||||||||||
Research and development expenses
|
(14,655,125
|
)
|
(20,192,372
|
)
|
(5,537,247
|
)
|
||||||
General and administrative expenses
|
(4,891,698
|
)
|
(6,949,015
|
)
|
(2,057,317
|
)
|
||||||
Total Operating Expenses
|
(19,546,822
|
)
|
(27,141,387
|
)
|
(7,594,565
|
)
|
||||||
Other income
|
(129,590
|
)
|
||||||||||
Other expense
|
(9,170
|
)
|
(83,068
|
)
|
(73,898
|
)
|
||||||
Operating Result
|
(19,358,701
|
)
|
(27,156,753
|
)
|
(7,798,052
|
)
|
||||||
Finance income
|
||||||||||||
Finance expenses
|
(1,175,964
|
)
|
(449,807
|
)
|
||||||||
Net Financial Result
|
||||||||||||
Loss for the Period
|
(18,266,229
|
)
|
(25,108,600
|
)
|
(6,842,371
|
)
|
||||||
Exchange differences on translation of foreign currency
|
||||||||||||
Total Comprehensive Loss
|
(18,005,334
|
)
|
(24,413,132
|
)
|
(6,407,798
|
)
|
Six Months Ended June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Third-party expenses
|
(4,497,730
|
)
|
||||||||||
Personnel expenses
|
(988,932
|
)
|
||||||||||
Legal and consulting fees
|
593,061
|
|||||||||||
Other expenses
|
(312,397
|
)
|
||||||||||
Total Research and development expenses
|
(5,537,247
|
)
|
Six Months Ended June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Personnel expenses
|
(1,390,377
|
)
|
||||||||||
Legal, consulting and audit fees
|
512,327
|
(884,700
|
)
|
|||||||||
Other expenses
|
||||||||||||
Total General and administrative expense
|
(2,057,317
|
)
|
Six Months Ended June 30,
|
||||||||||||
(in €)
|
2020
|
2019
|
Change
|
|||||||||
Finance income
|
||||||||||||
Foreign exchange gains
|
||||||||||||
Interest and other finance income
|
(1,119,847
|
)
|
||||||||||
Total
|
(229,524
|
)
|
||||||||||
Finance expenses
|
||||||||||||
Foreign exchange losses
|
(970,706
|
)
|
(434,786
|
)
|
||||||||
Other
|
(205,258
|
)
|
(15,021
|
)
|
||||||||
Total
|
(1,175,964
|
)
|
(449,807
|
)
|
||||||||
Net Financial Result
|
(955,681
|
)
|
Six Months Ended June 30,
|
||||||||
(in €)
|
2020
|
2019
|
||||||
Net Cash used in operating activities
|
(18,222,235
|
)
|
(18,730,669
|
)
|
||||
Net cash from investing activities
|
||||||||
Net cash from/ (used in) financing activities
|
(125,075
|
)
|
||||||
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 June 30, 2020, our accumulated deficit was €152.6 million;
|
|
• |
the timing, progress and results of clinical trials of IFX-1 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 of any submission of filings for regulatory approval of IFX-1 or any other product candidate, and the timing of and our ability to obtain and maintain regulatory approval of IFX-1 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 IFX-1 and any other product candidates, and the scope of such protection;
|
|
• |
whether the FDA, 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 IFX-1 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 IFX-1 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 for our planned future clinical trials;
|
|
• |
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 IFX-1;
|
|
• |
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 IFX-1 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;
|
|
• |
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act or a foreign private issuer; and
|
|
• |
other risk factors discussed under “Risk factors” in the Annual Report.
|
• |
Announced encouraging results from the Phase II portion of the Phase II/III adaptive, randomized, controlled trial in patients with COVID-19 induced pneumonia, showing a trend in lower 28-day all-cause mortality rate
|
• |
Completed end-of-Phase II meeting with the FDA for IFX-1 in hidradenitis suppurativa
|
• |
Received positive EMA scientific advice suggesting that IHS4 could be used as primary endpoint in InflaRx´s pivotal development in hidradenitis suppurativa
|
• |
Cash, cash equivalents and financial assets of approximately €98.9 million as of June 30, 2020
|
•
|
IFX-1 in COVID-19 induced pneumonia: In June 2020, InflaRx announced encouraging results from the first 30 patients treated in the adaptive randomized Phase II/III
trial in patients with severe COVID-19 induced pneumonia. Positive treatment trends were seen in the 28-day all-cause mortality rate and in various other endpoints. Twenty-eight-day all-cause mortality in the IFX-1 treatment group was 13%
(2 out of 15) versus 27% (4 out of 15) in the control group. In the best supportive care group, four patients died of COVID-19-induced multi-organ failure, and three of them had pulmonary embolisms reported as a serious adverse event. In
the IFX-1 treatment arm, one patient died after an acute ventilator tube complication (leakage) leading to hypoxia, and one patient who met an exclusion criterion with a history of severe chronic obstructive pulmonary disease, which was not
known at time point of enrollment, died of pulmonary failure. Additionally, fewer patients in the IFX-1 treatment arm experienced renal impairment assessed by estimated glomerular filtration rates, and more patients showed reversal of
blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations as a sign of reduction in tissue damage. A temporary significant increase of D-dimer levels in the first days following IFX-1 administration was noted, as
potentially an expression of induction of blood clot lysis. No statistically significant group differences on the chosen primary endpoint of relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were
detected. However, the exploratory first part of this study was not powered to show such differences. InflaRx is now planning an adequately powered, placebo-controlled, double blinded Phase III part using 28-day all-cause mortality as the
primary endpoint, an accepted regulatory primary endpoint for critical care studies.
|
•
|
IFX-1 in Hidradenitis Suppurativa (HS): In June 2020, InflaRx completed an end-of-Phase II meeting with the FDA to discuss a Phase III program for the use of IFX-1 for
the treatment of HS. The FDA agreed to key proposals to support a Biologics License Application (BLA) submission, including aspects of the Phase III trial design, IFX-1 dosing, target study population, and the nonclinical and clinical
pharmacology packages. While the FDA did not agree that the International Hidradenitis Suppurativa Severity Score (“IHS4”) is fit for purpose as a primary efficacy endpoint tool to support labeling, the FDA recommended that the Company
obtain HS patient input to help determine the validity of the IHS4 score. The Company is now assessing different strategies for a potential pathway to regulatory approval for IFX-1 in the United States and plans to engage with the FDA on
next steps.
|
•
|
IFX-1 in Pyoderma Gangraenosum (PG): The Phase IIa open label trial continues to enroll patients in the higher dose groups. Additional clinical trial sites continue to be opened to support
enrollment. Results from the higher dose groups are expected in 2021.
|
•
|
IFX-1 in ANCA-associated vasculitis (AAV): In the European Phase II IXCHANGE trial, Part 2 continues to enroll patients. Final results are expected in 2021.
|
•
|
IFX-1 in oncology: Activities are ongoing for the Phase IIa oncology program, with expected initiation in the first half of 2021.
|
For the three months ended
June 30,
|
For the six months ended
June 30,
|
|||||||||||||||
(in €, except for share data)
|
2020
(unaudited)
|
2019
(unaudited)
|
2020
(unaudited)
|
2019
(unaudited)
|
||||||||||||
Operating Expenses
|
||||||||||||||||
Research and development expenses
|
(7,356,326
|
)
|
(12,497,222
|
)
|
(14,655,125
|
)
|
(20,192,372
|
)
|
||||||||
General and administrative expenses
|
(2,326,895
|
)
|
(3,647,849
|
)
|
(4,891,698
|
)
|
(6,949,015
|
)
|
||||||||
Total Operating Expenses
|
(9,683,221
|
)
|
(16,145,071
|
)
|
(19,546,822
|
)
|
(27,141,387
|
)
|
||||||||
Other income
|
102,332
|
2,866
|
197,292
|
67,702
|
||||||||||||
Other expenses
|
(3,450
|
)
|
(79,183
|
)
|
(9,170
|
)
|
(83,068
|
)
|
||||||||
Operating Result
|
(9,584,339
|
)
|
(16,221,387
|
)
|
(19,358,701
|
)
|
(27,156,753
|
)
|
||||||||
Finance income
|
609,444
|
1,338,755
|
2,268,436
|
2,497,960
|
||||||||||||
Finance expenses
|
(1,057,937
|
)
|
(388,097
|
)
|
(1,175,964
|
)
|
(449,807
|
)
|
||||||||
Net Financial Result
|
(448,493
|
)
|
950,659
|
1,092,472
|
2,048,153
|
|||||||||||
Loss for the Period
|
(10,032,832
|
)
|
(15,270,729
|
)
|
(18,266,229
|
)
|
(25,108,600
|
)
|
||||||||
Share Information
|
||||||||||||||||
Weighted average number of shares outstanding
|
26,172,023
|
25,964,379
|
26,138,639
|
25,964,379
|
||||||||||||
Loss per share (basic/diluted)
|
(0.38
|
)
|
(0.59
|
)
|
(0.70
|
)
|
(0.97
|
)
|
||||||||
Loss for the Period
|
(10,032,832
|
)
|
(15,270,729
|
)
|
(18,266,229
|
)
|
(25,108,600
|
)
|
||||||||
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
(1,452,973
|
)
|
(1,622,079
|
)
|
260,895
|
695,468
|
||||||||||
Total Comprehensive Loss
|
(11,485,805
|
)
|
(16,892,807
|
)
|
(18,005,334
|
)
|
(24,413,132
|
)
|
in €
|
June 30,
2020
(unaudited)
|
December 31,
2019
|
||||||
ASSETS
|
||||||||
Non-current assets
|
||||||||
Property, plant and equipment
|
493,377
|
576,373
|
||||||
Right-of-use assets
|
716,871
|
836,924
|
||||||
Intangible assets
|
404,251
|
452,400
|
||||||
Other assets
|
419,424
|
452,217
|
||||||
Financial assets
|
272,627
|
272,614
|
||||||
Total non-current assets
|
2,306,550
|
2,590,528
|
||||||
Current assets
|
||||||||
Other assets
|
2,973,228
|
3,500,884
|
||||||
Financial assets
|
62,191,912
|
82,353,867
|
||||||
Cash and cash equivalents
|
36,398,578
|
33,131,280
|
||||||
Total current assets
|
101,563,718
|
118,986,031
|
||||||
TOTAL ASSETS
|
103,870,268
|
121,576,558
|
||||||
EQUITY AND LIABILITIES
|
||||||||
Equity
|
||||||||
Issued capital
|
3,152,427
|
3,132,631
|
||||||
Share premium
|
211,483,756
|
211,006,606
|
||||||
Other capital reserves
|
26,627,185
|
25,142,213
|
||||||
Accumulated deficit
|
(152,628,234
|
)
|
(134,362,006
|
)
|
||||
Other components of equity
|
2,488,124
|
2,227,228
|
||||||
Total equity
|
91,123,258
|
107,146,673
|
||||||
Non-current liabilities
|
||||||||
Lease liabilities
|
203,636
|
330,745
|
||||||
Other non-financial liabilities
|
37,644
|
39,013
|
||||||
Total non-current liabilities
|
241,280
|
369,758
|
||||||
Current liabilities
|
||||||||
Trade and other payables
|
10,630,462
|
12,413,662
|
||||||
Lease liabilities
|
524,034
|
515,203
|
||||||
Employee benefits
|
867,121
|
975,629
|
||||||
Social security, other tax and non-financial liabilities
|
448,113
|
105,634
|
||||||
Provisions
|
36,000
|
50,000
|
||||||
Total current liabilities
|
12,505,730
|
14,060,128
|
||||||
Total Liabilities
|
12,747,010
|
14,429,886
|
||||||
TOTAL EQUITY AND LIABILITIES
|
103,870,268
|
121,576,558
|
(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, 2020
|
3,132,631
|
211,006,606
|
25,142,213
|
(134,362,006
|
)
|
2,227,228
|
107,146,673
|
|||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(18,266,229
|
)
|
—
|
(18,266,229
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
260,895
|
260,895
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(18,266,229
|
)
|
260,895
|
(18,005,334
|
)
|
||||||||||||||||
Contributions
|
||||||||||||||||||||||||
Equity-settled share-based payment
|
—
|
—
|
1,484,972
|
—
|
—
|
1,484,972
|
||||||||||||||||||
Share options exercised
|
19,797
|
477,149
|
—
|
—
|
—
|
496,946
|
||||||||||||||||||
Total Contributions
|
19,797
|
477,149
|
1,484,972
|
—
|
—
|
1,981,918
|
||||||||||||||||||
Balance as of June 30, 2020
|
3,152,427
|
211,483,756
|
26,627,185
|
(152,628,234
|
)
|
2,488,124
|
91,123,258
|
|||||||||||||||||
Balance as of January 1, 2019
|
3,115,725
|
211,021,835
|
18,310,003
|
(81,107,188
|
)
|
50,196
|
151,390,571
|
|||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(25,108,600
|
)
|
—
|
(25,108,600
|
)
|
||||||||||||||||
Exchange differences on translation of foreign currency
|
—
|
—
|
—
|
—
|
695,468
|
695,468
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(25,108,600
|
)
|
695,468
|
(24,413,132
|
)
|
||||||||||||||||
Contributions
|
||||||||||||||||||||||||
Equity-settled share-based payment
|
—
|
—
|
3,889,767
|
—
|
—
|
3,889,767
|
||||||||||||||||||
Total Contributions
|
—
|
—
|
3,889,767
|
—
|
—
|
3,889,767
|
||||||||||||||||||
Balance as of June 30, 2019
|
3,115,725
|
211,021,835
|
22,199,770
|
(106,215,788
|
)
|
745,663
|
130,867,206
|
|||||||||||||||||
in €
|
For the six months ended June 30, 2020
(unaudited)
|
For the six months ended June 30, 2019
(unaudited)
|
||||||
Operating activities
|
||||||||
Loss for the period
|
(18,266,229
|
)
|
(25,108,600
|
)
|
||||
Adjustments for:
|
||||||||
Depreciation & amortization of property, plant, equipment, right-of-use assets and intangible assets
|
353,976
|
307,130
|
||||||
Net financial result
|
(1,092,472
|
)
|
(2,048,153
|
)
|
||||
Share-based payment expense
|
1,484,972
|
3,889,767
|
||||||
Net foreign exchange differences
|
(789,528
|
)
|
(205,103
|
)
|
||||
Changes in:
|
||||||||
Other assets
|
560,449
|
(2,063,491
|
)
|
|||||
Employee benefits
|
(122,411
|
)
|
(84,890
|
)
|
||||
Social security and other current non-financial liabilities
|
341,012
|
(184,120
|
)
|
|||||
Trade and other payables
|
(1,783,200
|
)
|
5,513,355
|
|||||
Interest received
|
1,096,651
|
1,269,745
|
||||||
Interest paid
|
(5,455
|
)
|
(16,308
|
)
|
||||
Net cash used in operating activities
|
(18,222,235
|
)
|
(18,730,669
|
)
|
||||
Investing activities
|
||||||||
Purchase of intangible assets, laboratory and office equipment
|
(35,107
|
)
|
(503,881
|
)
|
||||
Purchase of non-current other financial assets
|
—
|
(75,543
|
)
|
|||||
Disposal of non-current other financial assets
|
—
|
3,088
|
||||||
Purchase of current financial assets
|
(59,196,096
|
)
|
—
|
|||||
Proceeds from the maturity of financial assets
|
56,553,296
|
17,709,459
|
||||||
Net cash from investing activities
|
20,272,857
|
17,133,122
|
||||||
Financing activities
|
||||||||
Proceeds from exercise of share options
|
496,946
|
—
|
||||||
Repayment of lease liabilities
|
(183,970
|
)
|
(125,075
|
)
|
||||
Net cash from/ (used in) financing activities
|
312,976
|
(125,075
|
)
|
|||||
Net (decrease)/increase in cash and cash equivalents
|
2,363,597
|
(1,722,622
|
)
|
|||||
Effect of exchange rate changes on cash and cash equivalents
|
903,700
|
399,266
|
||||||
Cash and cash equivalents at beginning of period
|
33,131,280
|
55,386,240
|
||||||
Cash and cash equivalents at end of period
|
36,398,578
|
54,062,885
|