INFLARX N.V.
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By:
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/s/ Niels Riedemann
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Name:
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Niels Riedemann
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Title:
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Chief Executive Officer
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Exhibit
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Description of Exhibit
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InflaRx N.V. Press Release dated March 28, 2019
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· |
$62.9 million (€53.0 million) raised in a follow-on offering to advance clinical programs for IFX-1
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· |
Start of three Phase II trials for IFX-1 in two serious inflammatory diseases
|
· |
Expansion of our operations along a number of fronts
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· |
Cash and cash equivalents and current financial assets of €156.6 million as of December 31, 2018
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· |
Closed a primary and secondary offering in May 2018 for total gross proceeds of $117.3 million ($62.9 million to InflaRx and $54.4 million to selling shareholders),
including the full exercise of the underwriters’ option to purchase additional shares.
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· |
Appointed highly experienced executives to the Board of Directors: Tony Gibney, CBO of Achillion Pharmaceuticals, Inc. and Jens Holstein, CFO of MorphoSys AG. Richard
Brudnick, CBO of Codiak BioSciences, appointed as Non-Executive Director, subject to shareholder approval at our annual general meeting (currently serving as a Non-Voting Observer).
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· |
Expanded U.S. operations with opening of two U.S. sites – R&D facility in Ann Arbor, Michigan and corporate offices in New York City.
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· |
Hired senior executives for key positions – Jason Marks (formerly of Bausch Health) as Chief Legal Officer/General Counsel and Jordan Silverstein (formerly of Advanced
Accelerator Applications) as Head of Corporate Strategy/Development.
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· |
Expanding research and development activities supported by growth in number of employees to 38 as of December 31, 2018 (2017: 21).
|
· |
First patient enrolled in March 2018 in Phase IIb SHINE trial in moderate or severe HS and enrollment completed in November 2018. The randomized, double-blind,
placebo-controlled, multicenter study is being conducted at 38 sites in North America and Europe. Topline results are expected in the second quarter of 2019.
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· |
New long-term retrospective data from completed Phase IIa trial presented in February 2019 at the 8th Conference of the European Hidradenitis Suppurativa
Foundation. The data showed sustained remissions and median time to first flare of almost seven months, after only eight weeks of treatment.
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· |
Received FDA clearance of an IND application for U.S. Phase II study in
patients with AAV in June 2018 and dosed the first patient in October 2018. The randomized, double-blind, placebo-controlled Phase II
study is planned to enroll approximately 36 patients at approximately 20 sites in the U.S.
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· |
Investigational Medicinal Product Dossier (IMPD) approved in December 2018 by European regulatory authorities, to initiate a Phase II study in Europe in patients with AAV.
The randomized, double-blind, placebo-controlled study is planned to enroll approximately 80 patients at about 60 sites in Europe.
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2017
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2018
|
|||||||
(in thousands of €, except for per share data)
|
||||||||
Operating Expenses
|
||||||||
Research and development expenses
|
(14,415
|
)
|
(25,028
|
)
|
||||
General and administrative expenses
|
(5,138
|
)
|
(12,787
|
)
|
||||
Total Operating Expenses
|
(19,553
|
)
|
(37,815
|
)
|
||||
Other income
|
116
|
304
|
||||||
Other expenses
|
(8
|
)
|
(5
|
)
|
||||
Operating Result
|
(19,445
|
)
|
(37,516
|
)
|
||||
Finance income
|
130
|
10,433
|
||||||
Finance expenses
|
(4,923
|
)
|
(2,731
|
)
|
||||
Net financial Result
|
(4,793
|
)
|
7,702
|
|||||
Loss for the period
|
(24,238
|
)
|
(29,815
|
)
|
||||
Share information
|
||||||||
Weighted average number of shares outstanding
|
9,411
|
25,095
|
||||||
Loss per share in euro (basic/diluted)
|
€
|
(2.60
|
)
|
€
|
(1.19
|
)
|
||
Loss for the period
|
(24,238
|
)
|
(29,815
|
)
|
||||
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:
|
||||||||
Exchange differences on translation of foreign operations
|
0
|
51
|
||||||
Total comprehensive loss
|
(24,238
|
)
|
(29,764
|
)
|
2017
|
2018
|
|||||||
(in thousands of €)
|
||||||||
ASSETS
|
||||||||
Non-current assets
|
||||||||
Property, plant and equipment
|
173
|
625
|
||||||
Intangible assets
|
41
|
223
|
||||||
Non-current financial assets
|
20
|
207
|
||||||
Total non-current assets
|
234
|
1,055
|
||||||
Current assets
|
||||||||
Current other assets
|
696
|
1,589
|
||||||
Current financial assets
|
0
|
101,184
|
||||||
Cash and cash equivalents
|
123,282
|
55,386
|
||||||
Total current assets
|
123,979
|
158,159
|
||||||
TOTAL ASSETS
|
124,213
|
159,214
|
||||||
EQUITY AND LIABILITIES
|
||||||||
Equity
|
||||||||
Issued capital
|
2,858
|
3,116
|
||||||
Share premium
|
161,639
|
211,022
|
||||||
Other capital reserves
|
6,225
|
18,310
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||||||
Accumulated deficit
|
(51,293
|
)
|
(81,107
|
)
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||||
Other components of equity
|
0
|
50
|
||||||
Total equity
|
119,429
|
151,391
|
||||||
Non-current liabilities
|
||||||||
Provisions
|
2
|
57
|
||||||
Government grants
|
15
|
11
|
||||||
Total non-current liabilities
|
17
|
68
|
||||||
Current liabilities
|
||||||||
Employee Benefits
|
295
|
788
|
||||||
Social securities and other current tax liabilities
|
2
|
310
|
||||||
Trade and other payables
|
4,469
|
6,657
|
||||||
Total current liabilities
|
4,766
|
7,756
|
||||||
Total Liabilities
|
4,783
|
7,824
|
||||||
TOTAL EQUITY AND LIABILITIES
|
124,213
|
159,214
|
Issued capital
|
Share premium
|
Other capital reserves
|
Accumulated deficit
|
Other components of equity
|
Total equity
|
|||||||||||||||||||
(in thousands of €, except for share data)
|
||||||||||||||||||||||||
Balance January 1, 2017
|
31
|
0
|
1,325
|
(27,055
|
)
|
9
|
(25,690
|
)
|
||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(24,238
|
)
|
—
|
(24,238
|
)
|
||||||||||||||||
Exchange differences on translation of foreign operations
|
—
|
—
|
—
|
—
|
0
|
2
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(24,238
|
)
|
0
|
(24,238
|
)
|
||||||||||||||||
Transactions with owners of InflaRx
|
||||||||||||||||||||||||
Contributions
|
||||||||||||||||||||||||
Issue of common shares
|
848
|
90,055
|
—
|
—
|
—
|
90,903
|
||||||||||||||||||
Transaction costs
|
—
|
(9,115
|
)
|
—
|
—
|
—
|
(9,115
|
)
|
||||||||||||||||
Equity-settled share-based payment
|
—
|
—
|
4,550
|
—
|
—
|
4,550
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||||||||||||||||||
Total Contributions
|
848
|
80,940
|
4,550
|
—
|
—
|
86,338
|
||||||||||||||||||
Changes in ownership interests
|
||||||||||||||||||||||||
Reorganization
|
1,978
|
80,698
|
350
|
—
|
—
|
83,026
|
||||||||||||||||||
Liquidation of a Subsidiary
|
—
|
—
|
—
|
—
|
(9
|
)
|
(9
|
)
|
||||||||||||||||
Total changes in ownership interests
|
1,978
|
80,698
|
350
|
—
|
(9
|
)
|
83,017
|
|||||||||||||||||
Total transactions with owners of InflaRx
|
2,826
|
161,638
|
4,900
|
—
|
(9
|
)
|
169,355
|
|||||||||||||||||
Balance at December 31, 2017
|
2,857
|
161,639
|
6,225
|
(51,293
|
)
|
0
|
119,429
|
|||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
(29,815
|
)
|
—
|
(29,815
|
)
|
||||||||||||||||
Exchange differences on translation of foreign operations
|
—
|
—
|
—
|
—
|
51
|
51
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(29,815
|
)
|
51
|
(29,764
|
)
|
||||||||||||||||
Transactions with owners of InflaRx
|
||||||||||||||||||||||||
Contributions
|
||||||||||||||||||||||||
Issue of common shares
|
222
|
52,769
|
—
|
—
|
—
|
52,991
|
||||||||||||||||||
Transaction costs
|
—
|
(3,801
|
)
|
—
|
—
|
—
|
(3,801
|
)
|
||||||||||||||||
Equity-settled share-based payment
|
—
|
—
|
12,085
|
—
|
—
|
12,085
|
||||||||||||||||||
Share options exercised
|
36
|
416
|
—
|
—
|
—
|
452
|
||||||||||||||||||
Total Contributions
|
258
|
49,384
|
12,085
|
—
|
—
|
61,727
|
||||||||||||||||||
Total transactions with owners of InflaRx
|
258
|
49,384
|
12,085
|
—
|
—
|
61,727
|
||||||||||||||||||
Balance at December 31, 2018
|
3,116
|
211,022
|
18,310
|
(81,107
|
)
|
50
|
151,391
|
2017
|
2018
|
|||||||
(in thousands of €)
|
||||||||
Operating activities
|
||||||||
Loss for the period
|
(24,238
|
)
|
(29,815
|
)
|
||||
Adjustments for:
|
||||||||
Depreciation & Amortization
|
71
|
174
|
||||||
Net financial result
|
4,793
|
(7,702
|
)
|
|||||
Share based payment expense
|
4,550
|
12,085
|
||||||
Effects of exchange rate changes on financial assets
|
(61
|
)
|
(2,387
|
)
|
||||
other non-cash adjustments
|
24
|
(83
|
)
|
|||||
Changes in:
|
||||||||
Current other assets
|
(523
|
)
|
(894
|
)
|
||||
Current financial assets
|
154
|
(316
|
)
|
|||||
Provisions
|
55
|
|||||||
Government grants
|
(4
|
)
|
(4
|
)
|
||||
Employee benefits
|
129
|
493
|
||||||
Social securities and other current tax liabilities
|
(30
|
)
|
310
|
|||||
Trade and other payables
|
2,917
|
2,188
|
||||||
Interest received
|
66
|
504
|
||||||
Interest paid
|
0
|
0
|
||||||
Net cash flows from operating activities
|
(12,152
|
)
|
(23,712
|
)
|
||||
Investing activities
|
||||||||
Cash outflow from the purchase of intangible assets, laboratory and office equipment
|
(149
|
)
|
(806
|
)
|
||||
Cash outflow for the investment in non-current other financial assets
|
(19
|
)
|
(210
|
)
|
||||
Proceeds from the disposal of non-current other financial assets
|
0
|
22
|
||||||
Proceeds from the disposal of current financial assets
|
0
|
7,990
|
||||||
Purchase of current & non-current financial assets
|
0
|
(106,445
|
)
|
|||||
Net cash flows used in investing activities
|
(167
|
)
|
(99,451
|
)
|
||||
Financing activities
|
||||||||
Proceeds from issuance of share capital
|
90,904
|
53,443
|
||||||
Transaction cost from issuance of share capital
|
(9,115
|
)
|
(3,801
|
)
|
||||
Proceeds from issuance of preferred shares
|
27,012
|
—
|
||||||
Net cash flows from financing activities
|
108,801
|
49,642
|
||||||
Effect of exchange rate changes
|
(2,317
|
)
|
5,626
|
|||||
Change in cash and cash equivalents
|
94,165
|
(67,896
|
)
|
|||||
Cash and cash equivalents at beginning of period
|
29,117
|
123,282
|
||||||
Cash and cash equivalents at end of period
|
123,282
|
55,386
|