Oxurion NV announces 2021 Full Year Results and 2022 Outlook
- THR-149 – Positive
results from Part A of the Phase 2 clinical trial assessing THR-149
for the treatment of Diabetic Macular Edema (DME) (“KALAHARI”), and
first patient dosed in Part B evaluating THR-149 versus aflibercept
for the second line treatment of DME for the 40-50% of patients
that suboptimally respond to standard of care anti-VEGF
therapy.
- THR-687 – First
patient dosed in Part A of Phase 2 clinical trial evaluating
THR-687 for the treatment of DME in treatment naïve subjects
(“INTEGRAL”), and enrollment completed post-closing.
- Financing –
Capital commitment entered into with Negma Group (Negma) pursuant
to which Negma has committed to subscribe to up to EUR 30 million
in mandatory convertible bonds to be issued in tranches and subject
to certain conditions, and EUR 10 million convertible bond
financing secured from Kreos Capital and Pontifax Ventures.
- Cash position –
Available cash of EUR 10 million (including investments) at the end
of December 2021.
Leuven, BE,
Boston, MA, US
– February
22,
2022 –
08.00 AM
CET – Oxurion NV (Euronext Brussels: OXUR) (the
“Company” or “Oxurion”), a
biopharmaceutical company developing next generation standard of
care ophthalmic therapies, with a clinical stage portfolio in
vascular retinal disorders today announces its unaudited full year
results for the twelve-month period ending December 31, 2021, and
provides an operational update and an outlook for the remainder of
2022.
The Company has two novel therapeutics in
clinical development. THR-149 is a potent plasma kallikrein
inhibitor being developed as a potential new standard of care for
the 40-50% of DME patients showing suboptimal response to anti-VEGF
therapy. THR-687 is a highly selective pan-RGD integrin antagonist
that is being developed as a potential first line therapy for DME
patients as well as potentially wet age-related macular
degeneration (wet AMD) and macular edema following retinal vein
occlusion (ME-RVO).
Tom Graney,
CFA, CEO of
Oxurion, commented:
“During 2021, Oxurion made excellent progress by
focusing our resources on the clinical development of THR-149 and
THR-687, which if successfully developed together would serve a
market exceeding USD 12 billion. In addition, we secured sources of
capital to enable us to further invest behind both of our exciting
programs.
Earlier this month we were pleased to report
positive results from Part A of our Phase 2 trial of THR-149 in
patients with DME. The Part A results included post-hoc analysis by
a masked reading center revealing that by excluding two patients
with certain abnormalities at baseline, a >9 letter gain in mean
BCVA was achieved during Part A. This >9 letter gain was
maintained for the remaining four months of the trial after the
last THR-149 injection with no rescue treatment required. As a
result, patients with these abnormalities will be excluded from
Part B of the trial, which compares THR-149 to current standard of
care aflibercept for the 40-50% of patients that suboptimally
respond to anti-VEGF therapy and currently have limited treatment
options. Part B of the KALAHARI trial is recruiting with these
protocol amendments in place with topline data expected
mid-2023.
We are also delighted that Part A of our Phase 2
DME trial of THR-687 is fully enrolled with results expected in the
second quarter of this year. THR-687 has the potential to become a
first line treatment for DME, and we are also planning to develop
THR-687 for wet AMD and potentially ME-RVO assuming Part A of the
DME trial is successful.
We look forward to reporting on our progress as
we continue to deliver further value inflection points for both
THR-149 and THR-687, including very important THR-687 Part A data
in the near future.”
2021
Highlights
Operational
- Positive results from Part A of
Phase 2 KALAHARI trial evaluating THR-149 for treatment of DME.
THR-149 acts through inhibition of the plasma kallikrein-kinin
(PKaI-Kinin) system, a validated VEGF-independent target for DME
treatment. Three IVT injections of THR-149 (0.13mg) delivered a
clinically meaning improvement in Best Corrected Visual Acuity
(BCVA), the primary endpoint for registration in DME, and also
stabilized Central Subfield Thickness (CST), a promising result in
a population which, if left untreated, CST would be expected to
deteriorate. Based on these data, Oxurion decided to move THR-149
(0.13mg) into Part B of the trial. Further characterization of the
BCVA data was shared at the American Society for Retinal
Specialists (ASRS) Annual Scientific Meeting.
- First patient dosed in Part B of
Phase 2 KALAHARI trial evaluating multiple administrations of
THR-149 versus aflibercept for treatment of DME. The primary
objective of Part B of the trial is to assess the difference in
treatment effect between THR-149 (0.13mg) and aflibercept from
baseline to Month 3, in terms of increase in BCVA, the primary
endpoint, in the 40-50% of patients that suboptimally respond to
standard of care anti-VEGF therapy.
- Institutional Review Board (IRB)
approval received to initiate a Phase 2 clinical trial of THR-687
in patients with DME. Together with its earlier submission to the
U.S. Food and Drug Administration (FDA) of the final protocol to
the Investigational New Drug (IND) application, the approval was an
important step forward for the Phase 2 INTEGRAL trial.
- The first patient has been dosed in
Oxurion’s Phase 2 INTEGRAL trial evaluating THR-687 in patients
with DME. Enrollment was completed post-closing.
- The Journal of Pharmacokinetics and
Pharmacodynamics published two papers describing the
pharmacokinetic properties of THR-149 and THR-687 following
intravitreal (IVT) injection in animals utilizing novel
pharmacokinetic models developed by Oxurion.
- The 'Progress in Retinal and Eye
Research' journal published an article highlighting the
cutting-edge science and rationale for the design and development
of THR-687 and described the potential of pan-RGD integrin
antagonists to improve the treatment of diabetic retinopathy and
wet AMD.
- Positive Phase 1 clinical data
evaluating THR-687 for treatment of DME were published in
Ophthalmology Science, the American Academy of Ophthalmology
Journal.
- Appointment of Tom Graney, CFA as
Oxurion’s Chief Executive Officer and Dr. Patrik De Haes, M.D. as
non-executive Chairman.
- Appointment of Hanne Callewaert as
Chief Operating Officer and Professor Alan Stitt as Chief
Scientific Officer.
- Refined focus and resources towards
executing Oxurion’s clinical development strategy, including
advancing the THR-687 and THR-149 programs. The Company reduced its
head count by approximately one-third and will no longer make
direct investments in non-core activities, including research in
dry AMD and oncology (Oncurious NV).
Financial
- Entered into a capital commitment
with Negma pursuant to which Negma has committed to subscribe to up
to EUR 30 million in mandatory convertible bonds to be issued in
tranches and subject to certain conditions.
- 1,210 convertible bonds issued to
Negma (representing an aggregate amount of EUR 3,025,000) of which
540 convertible bonds were converted into 775,334 shares at the end
of December 2021.
- Secured a EUR 10 million
convertible bond financing from Kreos Capital and Pontifax
Ventures.
- Cash position (including
investments) of EUR 10 million at the end of December 2021.
Post-closing events
- Announcement at the Angiogenesis,
Exudation, and Degeneration 2022 Conference that post-hoc analysis
by the masked reading center from Part A of the KALAHARI trial
revealed that by excluding two patients with certain abnormalities
at baseline from Part A, a >9 letter gain in mean BCVA was
achieved and maintained for the remaining four months of the trial
after the last THR-149 injection with no rescue treatment
required.
- Protocol amendment approved to
reflect the post-hoc analysis of the Part A data by excluding
patients with these abnormalities at baseline from Part B of the
KALAHARI trial.
- Enrollment completed in Part A of
the INTEGRAL trial for THR-687.
2022 outlook
-
THR-149. Part B of the KALAHARI
trial is ongoing, assessing three monthly injections of THR-149,
compared to three monthly injections of aflibercept, up to Month 3.
As from Month 3, the safety and efficacy of a switched fourth
injection (THR-149 to aflibercept or aflibercept to THR-149) will
be evaluated in about half of the subjects whereas in the other
half of the subjects the durability of three monthly injections
(THR-149 or aflibercept) will be assessed through a single sham
injection until Month 6. Enrollment of approximately 108 patients
in Part B in over 50 sites in several European countries and the
U.S. will continue during 2022, with topline results expected in
mid-2023.
- THR-687. Topline
data is expected from Part A of the INTEGRAL trial in the second
quarter of this year. Assuming Part A is successful, the Company
plans to immediately start Part B of the INTEGRAL trial with
topline data expected in the second half of 2023. The Company is
also planning to start an additional Phase 2 trial of THR-687 in
wet AMD during 2022 if Part A is successful.
Details 2021
Full Year Financial
Results (unaudited)
Total income amounted to EUR 1.1 million in
2021, compared to EUR 2.1 million in 2020.
Gross profit of EUR 0.5 million in 2021,
compared to EUR 1.5 million in 2020.
R&D expenses in 2021 were EUR 20.7 million
compared to EUR 22.1 million in 2020. R&D expenses were mainly
related to clinical activities in THR-687 and THR-149. The 2020
figure included a milestone payment of EUR 2.0 million related to
the development of THR-149. Government grants and income from
recharge of costs are deducted from the research and development
expenses.
Selling and marketing expenses of EUR 1.3
million in 2021, compared to EUR 3.3 million in 2020.
General and administrative expenses of EUR 7.2
million in 2021, compared to EUR 5.5 million in 2020.
In 2021, Oxurion made a loss for the year of EUR
29.6 million, compared to a loss for the year in 2020 of EUR 28.6
million resulting in negative diluted earnings per share of EUR
0.77 in 2021 versus EUR 0.75 in 2020.
The financial results included in this press
release were prepared on the basis of continuation. On December 31,
2021, the Company had cash and cash equivalents of EUR 10 million
(including investments), compared with EUR 24.8 million (including
investments) at December 31, 2020. In addition to available cash,
the Company expects to meet its working capital requirements
through a combination of debt and equity, including drawing future
tranches from the Negma funding program described above, accessing
the debt markets through Kreos/Pontifax and/or other debt
providers, raising additional equity capital, and/or attracting
potential non-dilutive funding, all of which is uncertain. Under
the funding program with Negma described above, the Company will
have access to up to EUR 27.5 million in the twelve-month period
starting from this press release provided the Company can and does
draw the maximum tranche on a monthly basis, which is subject to
certain conditions that may not be met.
Considering the current available cash position,
the budgets for 2022 and 2023, the funding possibilities
potentially available to the Company from Negma and others, and the
possibility the Company has to reduce its working capital
requirements if necessary, the board of directors considers that it
is appropriate for the Company to continue to account on the basis
of continuation based on the information available on the date of
this press release.
When approving the Company’s 2020 annual report
and its 2021 HY report, the board of directors considered that
there was a material uncertainty with respect to the Company’s
ability to continue as a going concern. In the opinion of the board
of directors, there continues to be a material uncertainty with
respect to the Company’s ability to continue as a going concern on
the date of this press release. A more complete description of the
Company’s risks can be found in the latest PDF-version of the
Company’s presentation, which can be found here.
The financial results contained in this press
release are unaudited. Audited financial results and the 2021
annual report for the period ending December 31, 2021, will be
published on the Company’s website by March 25, 2022.
Unaudited consolidated statement of
profit and loss
In '000 euro (for the year ended 31 December) |
2021 |
2020 |
|
|
|
Income |
1.128 |
2.078 |
Sales |
967 |
2.000 |
Income from royalties |
161 |
78 |
Cost of sales |
-612 |
-550 |
Gross profit |
516 |
1.528 |
Research and development expenses |
-20.696 |
-22.053 |
General and administrative expenses |
-7.150 |
-5.489 |
Selling expenses |
-1.274 |
-3.252 |
Other operating income |
1.245 |
777 |
Other operating expense |
-9 |
-6 |
Impairment losses |
-1.127 |
-125 |
Operating result |
-28.495 |
-28.620 |
Finance income |
171 |
468 |
Finance expense |
-1.268 |
-408 |
Result before income tax |
-29.592 |
-28.560 |
Taxes |
-3 |
0 |
Result of the year |
-29.595 |
-28.560 |
|
|
|
Attributable to: |
|
|
Equity holders of the company |
-29.158 |
-28.012 |
Non-controlling interest |
-437 |
-548 |
|
|
|
Result per share |
|
|
Basic earnings / loss (-) per share (euro) |
-0,77 |
-0,75 |
Diluted earnings / loss (-) per share (euro) |
-0,77 |
-0,75 |
In '000 euro (as at 31 December) |
2021 |
2020 |
Result of the year |
-29.595 |
-28.560 |
Other comprehensive income: |
|
|
Remeasurement of defined benefit pension schemes |
566 |
-297 |
Fair value gain/(loss) on investments designated as at FVTOCI |
-5 |
0 |
Other comprehensive income that will not be reclassified to profit
or loss |
561 |
-297 |
Exchange differences arising on translation of foreign
operations |
122 |
-127 |
Other comprehensive income that will or may be reclassified to
profit or loss |
122 |
-127 |
Other comprehensive income, net of income tax |
683 |
-424 |
Total comprehensive loss (-) / income for the
year |
-28.912 |
-28.984 |
Attributable to: |
|
|
Equity holders of the company |
-28.475 |
-28.436 |
Non-controlling interest |
-437 |
-548 |
Unaudited consolidated statement of
financial position
In '000 euro (as at 31 December) |
2021 |
2020 |
|
|
|
ASSETS |
|
|
Property, plant and equipment |
120 |
230 |
Right-of-use assets |
252 |
1.069 |
Intangible assets |
1.000 |
2.127 |
Other non-current assets |
95 |
96 |
Non-current tax credit |
4.000 |
3.708 |
Non-current assets |
5.467 |
7.230 |
Inventories |
60 |
85 |
Trade and other receivables |
2.517 |
1.451 |
Current tax receivables |
845 |
719 |
Investments |
247 |
288 |
Cash and cash equivalents |
9.740 |
24.511 |
Current assets |
13.409 |
27.054 |
Total assets |
18.876 |
34.284 |
|
|
|
EQUITY AND LIABILITIES |
|
|
Share capital |
46.029 |
44.913 |
Share premium |
234 |
0 |
Other comprehensive income |
-356 |
-1.039 |
Other reserves |
-5.266 |
-6.133 |
Retained earnings |
-41.719 |
-12.561 |
Equity attributable to equity holders of the
company |
-1.078 |
25.180 |
Non-controlling interest |
-30 |
-132 |
Total equity |
-1.108 |
25.048 |
Lease liabilities |
44 |
447 |
Employee benefit liabilities |
594 |
1.096 |
Convertible loans |
8.433 |
0 |
Non-current liabilities |
9.071 |
1.543 |
Trade payables |
4.979 |
4.377 |
Lease liabilities |
221 |
649 |
Convertible loans |
3.401 |
0 |
Other short-term liabilities |
2.312 |
2.667 |
Current liabilities |
10.913 |
7.693 |
Total equity and liabilities |
18.876 |
34.284 |
Unaudited consolidated statement of cash
flows
In '000 euro (for the year ended 31 December) |
2021 |
2020 |
|
|
|
Cash flows from operating activities |
|
|
Loss for the period |
-29.595 |
-28.560 |
Finance expense |
896 |
408 |
Finance income |
-171 |
-468 |
Depreciation of property, plant and equipment |
77 |
194 |
Amortization and impairment of intangible assets |
1.127 |
125 |
Amortization of right-of-use assets |
600 |
916 |
Gain on sale of property, plant and equipment |
-344 |
-7 |
Fair value adjustments of financial instruments |
372 |
0 |
(Reversal of) impairment losses on current assets |
629 |
801 |
Increase / Decrease (-) in provisions |
64 |
0 |
Equity settled share-based payment transactions |
1.107 |
458 |
Increase (-) / Decrease in trade and other receivables and
inventories |
-2.037 |
700 |
Increase / Decrease (-) in short-term liabilities |
297 |
-1.646 |
Net cash flows generated / used (-) in operating
activities |
-26.978 |
-27.079 |
|
|
|
Cash flows from investing activities |
|
|
Disposal of property, plant and equipment (following a sale) |
394 |
35 |
Decrease / Increase (-) in investments |
36 |
10.154 |
Interest received and similar income |
9 |
-6 |
Purchase of property, plant and equipment |
-32 |
-119 |
Net cash flows generated / used (-) in investing
activities |
407 |
10.064 |
|
|
|
Cash flows from financing activities |
|
|
Principal paid on lease liabilities |
-599 |
-903 |
Proceeds from loans and borrowings |
11.150 |
0 |
Other financial income / expense (-) |
-20 |
0 |
Interest paid on lease liabilities |
-3 |
-16 |
Proceeds from capital increases in subsidiaries from
non-controlling interest |
86 |
0 |
Proceeds from capital and share premium increases, gross
amount |
1.350 |
0 |
Paid interests and other bank charges |
-186 |
-12 |
Net cash flows used (-) / generated in financing
activities |
11.778 |
-931 |
|
|
|
Net change in cash and cash equivalents |
-14.793 |
-17.946 |
Net cash and cash equivalents at the beginning of the period |
24.511 |
42.492 |
Effect of exchange rate fluctuations |
22 |
-35 |
Net cash and cash equivalents at the end of the
period |
9.740 |
24.511 |
Unaudited consolidated statement of
changes in equity
|
Share capital |
Share premium |
Other comprehensive income reserve |
Other reserves |
Retained earnings |
Attributable to equity holders of the company |
Non-controlling interest |
Total |
Balance as at 1 January 2020 |
100.644 |
0 |
-615 |
-12.122 |
-34.747 |
53.160 |
146 |
53.306 |
Total comprehensive income of the
year |
|
|
|
|
|
|
|
|
Result of the year |
0 |
0 |
0 |
0 |
-28.012 |
-28.012 |
-548 |
-28.560 |
Change to foreign currency translation difference |
0 |
0 |
-127 |
0 |
0 |
-127 |
0 |
-127 |
Remeasurement of DBO |
0 |
0 |
-297 |
0 |
0 |
-297 |
0 |
-297 |
Net change in fair value of investments |
0 |
0 |
0 |
-2 |
0 |
-2 |
0 |
-2 |
Contributions by and distributions to owners |
|
|
|
|
|
|
|
|
Issue of ordinary shares |
0 |
0 |
0 |
0 |
0 |
0 |
270 |
270 |
Capital decrease |
-55.731 |
0 |
0 |
5.533 |
50.198 |
0 |
0 |
0 |
Share-based payment transactions |
0 |
0 |
0 |
458 |
0 |
458 |
0 |
458 |
Balance as at 31 December 2020 |
44.913 |
0 |
-1.039 |
-6.133 |
-12.561 |
25.180 |
-132 |
25.048 |
|
Share capital |
Share premium |
Other comprehensive income reserve |
Other reserves |
Retained earnings |
Attributable to equity holders of the company |
Non-controlling interest |
Total |
Balance as at 1 January 2021 |
44.913 |
0 |
-1.039 |
-6.133 |
-12.561 |
25.180 |
-132 |
25.048 |
Total comprehensive income of the
year |
|
|
|
|
|
|
|
|
Result of the year |
0 |
0 |
0 |
0 |
-29.158 |
-29.158 |
-437 |
-29.595 |
Change to foreign currency translation difference |
0 |
0 |
122 |
0 |
0 |
122 |
0 |
122 |
Remeasurement of DBO |
0 |
0 |
566 |
0 |
0 |
566 |
0 |
566 |
Net change in fair value of investments |
0 |
0 |
-5 |
0 |
0 |
-5 |
0 |
-5 |
Total comprehensive income for the year |
0 |
0 |
683 |
0 |
-29.158 |
-28.475 |
-437 |
-28.912 |
Contributions by and distributions to owners |
|
|
|
|
|
|
|
|
Issue of ordinary shares |
1.116 |
234 |
0 |
213 |
0 |
1.563 |
0 |
1.563 |
Share-based payment transactions |
0 |
0 |
0 |
1.107 |
0 |
1.107 |
0 |
1.107 |
Total contributions by and distributions to
owners |
1.116 |
234 |
0 |
1.320 |
0 |
2.670 |
0 |
2.670 |
Transactions with non-controlling interests |
0 |
0 |
0 |
-453 |
0 |
-453 |
539 |
86 |
Balance as at 31 December 2021 |
46.029 |
234 |
-356 |
-5.266 |
-41.719 |
-1.078 |
-30 |
-1.108 |
About
Oxurion
Oxurion (Euronext Brussels: OXUR) is a
biopharmaceutical company developing next generation standard of
care ophthalmic therapies, which are designed to better preserve
vision in patients with retinal vascular disorders including
diabetic macular edema (DME), the leading cause of vision loss in
diabetic patients worldwide as well as other conditions, including
wet age-related macular degeneration (wet AMD) and macular edema
following retinal vein occlusion (ME-RVO).
Oxurion is aiming to build a leading global
franchise in the treatment of retinal vascular disorders based on
the successful development of its two novel therapeutics. THR-149
is a potent plasma kallikrein inhibitor being developed as a
potential new standard of care for the 40-50% of DME patients
showing suboptimal response to anti-VEGF therapy. THR-687 is a
highly selective pan-RGD integrin antagonist that is being
developed as a potential first line therapy for DME patients as
well as wet AMD and potentially ME-RVO. Oxurion is headquartered in
Leuven, Belgium, with corporate operations in Boston, MA. More
information is available at www.oxurion.com.
Important
information about
forward-looking statements
Certain statements in this press release may be
considered “forward-looking”. Such forward-looking statements are
based on current expectations, and, accordingly, entail and are
influenced by various risks and uncertainties. The Company
therefore cannot provide any assurance that such forward-looking
statements will materialize and does not assume any obligation to
update or revise any forward-looking statement, whether as a result
of new information, future events, or any other reason. Additional
information concerning risks and uncertainties affecting the
business and other factors that could cause actual results to
differ materially from any forward-looking statement is contained
in the Company’s Annual Report and in the latest PDF-version of the
Company’s presentation; which can be found here. This press release
does not constitute an offer or invitation for the sale or purchase
of securities or assets of Oxurion in any jurisdiction. No
securities of Oxurion may be offered or sold within the United
States without registration under the U.S. Securities Act of 1933,
as amended, or in compliance with an exemption therefrom, and in
accordance with any applicable U.S. state securities laws.
For further information please
contact:
Oxurion NV Tom GraneyChief Executive OfficerTel: +32 16 75
13 10tom.graney@oxurion.com Michaël DillenChief Business
OfficerTel: +32 479 783 583michael.dillen@oxurion.com |
EU MEDiSTRAVA ConsultingDavid Dible/Sylvie Berrebi/Frazer
HallTel: +44 203 928 6900oxurion@medistrava.com
USWestwicke, an ICR companyChristopher BrinzeyTel: +1 617 835
9304chris.brinzey@westwicke.com |
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