| • |
continue research, preclinical and clinical development efforts, as applicable, for any existing and future product candidates, including izicopan, vilobelimab and IFX002;
|
| • |
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 and expand sales, marketing, distribution and other commercial infrastructure now and in the future to commercialize various products for which we may obtain marketing authorization or approval, if any;
|
| • |
require the scale-up and validation of the manufacturing process and the manufacturing of larger quantities of product candidates for clinical development and, potentially, commercialization;
|
| • |
collaborate with strategic partners to optimize the manufacturing process for izicopan, vilobelimab, IFX002, and other pipeline products;
|
| • |
maintain, expand and protect our intellectual property portfolio;
|
| • |
hire and retain additional personnel, such as commercial, marketing, clinical, quality control and scientific personnel; and
|
| • |
add operational, financial and management information systems and personnel, including personnel to support our product development as well as commercialization and help us comply with our obligations as a public
company.
|
| • |
expenses incurred under agreements with CROs, contract manufacturing organizations, or CDMOs, 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 expense based upon employees’ role within the organization; and
|
| • |
professional fees for lawyers related to the protection and maintenance of our intellectual property.
|
| • |
Vilobelimab. Our expenses associated with vilobelimab have decreased significantly as a result of the January 2026 restructuring and the termination of our Phase 3 study in
PG. We expect vilobelimab-related expenses to continue to decrease in 2026 compared to 2025. However, we will still incur costs associated with the wind-down of the Phase 3 trial in PG, ongoing participation in the BARDA-sponsored Phase 2
clinical platform study in broader ARDS, maintaining our manufacturing infrastructure for GOHIBIC (vilobelimab) in compliance with regulatory standards, and continued FDA discussions regarding a potential BLA for full approval of GOHIBIC
(vilobelimab). Any future clinical development activities in PG or other indications would likely be conducted only in collaboration with a partner
|
| • |
Izicopan. We are developing izicopan, a product candidate that targets C5aR. We expect to incur additional costs by advancing the clinical and non-clinical development of
izicopan. Specifically, we expect to incur expenses during Phase 2 clinical development. We plan to continue studying izicopan in complement-mediated, chronic autoimmune and inflammatory conditions where an oral low molecular weight
compound might have advantages or is needed for patients and where oral delivery is the medically preferred route of administration.
|
| • |
IFX002. We are 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 PK properties compared to vilobelimab and is currently in pre-clinical 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.
|
| • |
employee-related expenses, including salaries, benefits and stock-based compensation expense based upon employees’ role within the organization;
|
| • |
professional fees for auditors and consulting expenses not related to research and development activities;
|
| • |
professional fees for lawyers not related to the filing, prosecution, protection and maintenance of our intellectual property;
|
| • |
insurance expenses including directors and officers liability insurance premiums; and
|
| • |
cost of facilities, travel, communication and office expenses.
|
|
three months ended March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in €)
|
||||||||||||
|
Revenues
|
—
|
—
|
—
|
|||||||||
|
Cost of sales
|
—
|
(9,291
|
)
|
9,291
|
||||||||
|
Gross profit
|
—
|
(9,291
|
)
|
9,291
|
||||||||
|
Operating expenses
|
||||||||||||
|
Sales and marketing expenses
|
(108,072
|
)
|
(1,457,978
|
)
|
1,349,906
|
|||||||
|
Research and development expenses
|
(4,170,546
|
)
|
(7,016,336
|
)
|
2,845,791
|
|||||||
|
General and administrative expenses
|
(3,177,444
|
)
|
(5,062,605
|
)
|
1,885,160
|
|||||||
|
Total operating expenses
|
(7,456,062
|
)
|
(13,536,919
|
)
|
6,080,857
|
|||||||
|
Other income
|
247,978
|
541,098
|
(293,119
|
)
|
||||||||
|
Other expenses
|
(66
|
)
|
(26
|
)
|
(40
|
)
|
||||||
|
Operating result
|
(7,208,150
|
)
|
(13,005,139
|
)
|
5,796,989
|
|||||||
|
Finance income
|
334,768
|
493,764
|
(158,996
|
)
|
||||||||
|
Finance expenses
|
(14,809
|
)
|
(4,086
|
)
|
(10,723
|
)
|
||||||
|
Foreign exchange result
|
492,382
|
(1,908,829
|
)
|
2,401,212
|
||||||||
|
Other financial result
|
803,160
|
6,110,264
|
(5,307,103
|
)
|
||||||||
|
Income taxes
|
—
|
—
|
—
|
|||||||||
|
Income (loss) for the period
|
(5,592,649
|
)
|
(8,314,027
|
)
|
2,721,378
|
|||||||
|
Exchange differences on translation of foreign currency
|
(15,026
|
)
|
(150,667
|
)
|
135,640
|
|||||||
|
Total comprehensive income (loss)
|
(5,607,675
|
)
|
(8,464,694
|
)
|
2,857,018
|
|||||||
|
three months ended March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in €)
|
||||||||||||
|
Cost of sales
|
—
|
9,291
|
(9,291
|
)
|
||||||||
|
Total
|
—
|
9,291
|
(9,291
|
)
|
||||||||
|
three months ended March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in €)
|
||||||||||||
|
Third-party expenses
|
36,610
|
207,811
|
(171,201
|
)
|
||||||||
|
Marketing expenses
|
3,082
|
205,078
|
(201,996
|
)
|
||||||||
|
Personnel expenses
|
54,247
|
644,216
|
(589,970
|
)
|
||||||||
|
Legal and consulting fees
|
10,155
|
261,332
|
(251,178
|
)
|
||||||||
|
Other expenses
|
3,978
|
139,541
|
(135,562
|
)
|
||||||||
|
Total sales and marketing expenses
|
108,072
|
1,457,978
|
(1,349,906
|
)
|
||||||||
|
three months ended March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in €)
|
||||||||||||
|
Third-party expenses
|
1,885,957
|
3,969,044
|
(2,083,087
|
)
|
||||||||
|
thereof vilobelimab
|
460,581
|
1,559,909
|
(1,099,328
|
)
|
||||||||
|
thereof izicopan
|
1,334,073
|
2,340,564
|
(1,006,491
|
)
|
||||||||
|
thereof non-allocated
|
91,303
|
68,571
|
22,732
|
|||||||||
|
Personnel expenses
|
1,964,384
|
2,678,658
|
(714,274
|
)
|
||||||||
|
Other expenses
|
320,205
|
368,634
|
(48,429
|
)
|
||||||||
|
thereof vilobelimab
|
113,822
|
120,189
|
(6,367
|
)
|
||||||||
|
thereof izicopan
|
173,404
|
46,367
|
127,037
|
|||||||||
|
thereof non-allocated
|
32,979
|
202,078
|
(169,099
|
)
|
||||||||
|
Total research and development expenses
|
4,170,546
|
7,016,336
|
(2,845,791
|
)
|
||||||||
|
three months ended March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in €)
|
||||||||||||
|
Personnel expenses
|
1,828,964
|
2,628,711
|
(799,747
|
)
|
||||||||
|
Legal, consulting and audit fees
|
588,528
|
969,883
|
(381,355
|
)
|
||||||||
|
Other expenses
|
759,952
|
1,464,011
|
(704,059
|
)
|
||||||||
|
Total general and administrative expenses
|
3,177,444
|
5,062,605
|
(1,885,160
|
)
|
||||||||
|
three months ended March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in €)
|
||||||||||||
|
Other income from government grants and research allowances
|
245,055
|
532,860
|
(287,805
|
)
|
||||||||
|
Further other income
|
2,924
|
8,238
|
(5,315
|
)
|
||||||||
|
Total other income
|
247,978
|
541,098
|
(293,120
|
)
|
||||||||
|
three months ended March 31,
|
||||||||||||
|
2026
|
2025
|
Change
|
||||||||||
|
(in €)
|
||||||||||||
|
Interest income
|
334,768
|
493,764
|
(158,996
|
)
|
||||||||
|
Interest expenses
|
—
|
(443
|
)
|
443
|
||||||||
|
Interest on lease liabilities
|
(14,809
|
)
|
(3,643
|
)
|
(11,166
|
)
|
||||||
|
Financial Result
|
319,959
|
489,678
|
(169,719
|
)
|
||||||||
|
Foreign exchange income
|
764,782
|
1,229,009
|
(464,227
|
)
|
||||||||
|
Foreign exchange expense
|
(272,400
|
)
|
(3,137,838
|
)
|
2,865,438
|
|||||||
|
Foreign exchange result
|
492,382
|
(1,908,829
|
)
|
2,401,212
|
||||||||
|
Result from the revaluation of pre-funded warrants at fair value
|
803,160
|
6,110,264
|
(5,307,103
|
)
|
||||||||
|
Other financial result
|
803,160
|
6,110,264
|
(5,307,103
|
)
|
||||||||
|
Net financial result
|
1,615,501
|
4,691,112
|
(3,075,611
|
)
|
||||||||
|
three months ended March 31,
|
||||||||
|
2026
|
2025
|
|||||||
|
(in €)
|
||||||||
|
Net cash used in operating activities
|
(7,392,345
|
)
|
(14,015,672
|
)
|
||||
|
Net cash from/ (used in) investing activities
|
6,138,480
|
17,655,632
|
||||||
|
Net cash from/ (used in) financing activities
|
(74,690
|
)
|
27,009,500
|
|||||
|
Cash and cash equivalents at the beginning of the period
|
16,022,171
|
18,375,979
|
||||||
|
Effect of Exchange gains/ (losses) on cash and cash equivalents
|
300,176
|
(1,738,808
|
)
|
|||||
|
Cash and cash equivalents at the end of the period
|
14,993,792
|
47,286,630
|
||||||
|
1.
|
Net cash from/used in operating activities
|
|
2.
|
Net cash from/used in investing activities
|
|
3.
|
Net cash from/used in financing activities
|
| • |
the success of our future clinical trials for vilobelimab’s treatment of other debilitating or life-threatening inflammatory indications, including ARDS;
|
| • |
the potential strategic transactions or collaborations, including a potential partnership of izicopan, or vilobelimab for PG;
|
| • |
the success of our future clinical trials for izicopan, and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials;
|
| • |
the timing, progress and results of preclinical studies and clinical trials of vilobelimab, izicopan and any other product candidates, including for the development of vilobelimab in several indications and other
virally induced ARDS, HS and CSU, 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 and the receptiveness and approval by regulators regarding the results of clinical trials and potential regulatory approval or authorization pathways, including our BLA submission for GOHIBIC
(vilobelimab);
|
| • |
the timing and outcome of any discussions or submission of filings for regulatory approval of vilobelimab, izicopan or any other product candidate, and the timing of and our ability to obtain and maintain full
regulatory approval and/or market authorization of vilobelimab or izicopan for any indication;
|
| • |
our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated immunological and inflammatory diseases;
|
| • |
our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection;
|
| • |
whether the FDA 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;
|
| • |
the success of our future clinical trials for vilobelimab, izicopan 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, the market opportunity for, the medical need for and clinical utility of vilobelimab, izicopan or any other product candidates, if approved or
authorized 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 for commercial supply of any development candidate in the United States
and Europe;
|
| • |
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 or authorized, any commercial sales;
|
| • |
if any of our product candidates obtain regulatory approval or authorization, our ability to comply with and satisfy ongoing drug regulatory obligations and continued regulatory overview;
|
| • |
our ability to comply with enacted and future legislation in seeking marketing approval or 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 and C5aR inhibitors and other therapeutic products being developed in similar medical
conditions in which vilobelimab, izicopan or any other of our product candidates is being developed or our industry; and
|
| • |
other risk factors discussed under the “ITEM 3. Key information––Risk factors” section of our Annual Report on Form 20-F.
|