Oxurion NV Business & Financial Update – H1 2021
Developing Next generation Standard of
Care Ophthalmic Therapies
Addressing Unmet Medical Needs in Retinal
Vascular Disorders
Highlights
Pipeline
- Patient recruitment initiated in Phase 2 trial evaluating
THR-687 for first line DME
- Part A data from Phase 2 study evaluating THR-149 in second
line DME fully recruited, with data expected end of September,
early October 2021
Corporate
- Tom Graney, CFA, promoted to CEO in orderly transition
- Patrik De Haes, M.D., appointed non-executive Chairman
- Organization adapted to focus resources on developing THR-149
and THR-687
- Cash position of €10 million as of end June 2021
- Negma Group and others made capital commitments for the next 12
months for the amount of €23.4 million under certain conditions,
which, together with other possible sources of funding not
committed as of today and/or reductions in investments, have the
potential to extend Company’s cash runway to August 2022
Science
- Multiple conference presentations and publications
demonstrating the strong retinal science underpinning Oxurion’s
clinical pipeline
Leuven, BE, Boston, MA, US – September
9, 2021 – 06.00 PM CET – Oxurion NV (Euronext Brussels:
OXUR), a biopharmaceutical company developing next generation
standard of care ophthalmic therapies, with a clinical stage
portfolio in retinal vascular disorders, today issues its business
and financial update for the six month period ending June 30,
2021.
Oxurion is advancing its pipeline of innovative
clinical drug candidates targeting the treatment of retinal
disorders.
The Company’s clinical development pipeline,
initially focusing on diabetic macular edema (DME), consists of two
novel product candidates with different and complementary modes of
action:
- THR-149 is a potential first in class plasma
kallikrein inhibitor with the possibility to become the second line
treatment of choice for DME patients showing suboptimal response to
anti-VEGF therapy.
- THR-687 is a potential best in class small
molecule pan-RGD integrin antagonist being developed to treat DME
with the possibility to become a first line therapy for most DME
patients. Beyond DME, THR-687 also has development possibilities in
additional vascular retinal disorders including for wet age-related
macular degeneration (wet AMD) and retinal vein occlusion (RVO),
potentially allowing the Company to tap into a broader therapeutic
market with a current combined estimated annual value of $12
billion.
Tom Graney, CFA, CEO of
Oxurion, commented: “Oxurion has made
excellent progress during 2021 as we have taken steps to focus our
resources on the clinical development of THR-149 and THR-687. We
expect to report the first data from Part A of our Phase 2 study of
THR-149 in patients with DME at the end of this month or the
beginning of October. If successful, this milestone will allow us
to demonstrate proof of concept and initiate Part B of this study,
which will compare THR-149 to current standard of care aflibercept,
immediately thereafter.
We recently started recruitment of patients in
our Phase 2 DME trial with THR-687, a drug candidate for which we
have very high hopes given its potential to become a first line
treatment option for this sight threatening eye disease. We are
also looking to expand the market opportunity for THR-687 by
potentially developing it for both wet AMD and RVO.
Taken together, successfully developing these
two exciting, novel and differentiated back of the eye drug
candidates would allow Oxurion to generate significant value given
they are targeting potential market opportunities of over $12
billion combined.
We look forward to reporting on our progress as
we deliver further value inflection points for both THR-149 and
THR-687, including very important THR-149 Part A data in the near
future.”
Pipeline Update
THR-149 – Part A data from Phase 2 study
in DME expected end September/ begin October
In June, Oxurion announced the completion of
patient enrollment into Part A of its Phase 2 study (“KALAHARI”)
evaluating multiple injections of THR-149 for the treatment of DME
patients previously showing suboptimal response to anti-VEGF
therapy.
Dose selection based on the data from Part A of
the study is expected end September, early October.
The Phase 2 KALAHARI study is a two-part,
randomized, prospective, multicenter study assessing multiple (3)
injections of THR-149 in DME patients previously showing suboptimal
response to anti-VEGF therapy.
In Part A of the study, three dose levels of
THR-149, each administered in 3 monthly intravitreal injections,
are being tested in at least 18 patients to select the optimal dose
for Part B.
Part B is the double-masked, active-controlled
part of the study with the dose selected from Part A studied
against aflibercept as the active comparator.
Final topline results from this statistically
powered Part B of the study are expected in the first half of
2023.
THR-687 – Patient Recruitment ongoing in
Phase 2 study in DME
In August, Oxurion started recruitment of
patients in its Phase 2 clinical study evaluating THR-687 in
patients with DME (“INTEGRAL”). The INTEGRAL study is a
Phase 2, randomized, multicenter trial and is the first study in
which multiple intravitreal injections of THR-687 will be
administered in humans.
The two-part study will assess different dose
levels of multiple THR-687 injections (Part A) and go on to
evaluate the efficacy and safety of THR-687 versus aflibercept (the
current standard of care) for the treatment of DME (Part B).
Part A is being conducted in treatment naïve
subjects to select the THR-687 dose level to be assessed in Part
B.
Part B, the statistically powered part of this
phase 2 study, will be conducted in both treatment naïve and
treatment experienced subjects to evaluate the efficacy and safety
of the dose level selected from Part A when compared to
aflibercept.
The Part B primary endpoint is the change in
best corrected visual acuity (BCVA) from baseline at month 3.
The dose selection decision, following Part A,
is anticipated in the first half of 2022 with top line data from
Part B expected in the second half of 2023.
Beyond DME, THR-687 has the potential to be
developed for additional vascular retinal disorders including wet
AMD and RVO.
Corporate Update
Tom Graney, CFA promoted to Chief
Executive Officer
In May, Oxurion announced the promotion of Tom
Graney, CFA from Chief Financial Officer (CFO) to Chief Executive
Officer (CEO) in a planned succession and he was appointed to the
Board in July. He took over from Patrik De Haes, M.D., who after 14
years as CEO, decided to move away from day-to-day management of
the Company to become the non-executive Chairman. Thomas Clay, the
outgoing Chairman of Oxurion, remains on the Board as a
non-executive Director of the Company and Chairman of the
Nominations and Remuneration Committee.
Mr. Graney has extensive capital markets and
business development experience in biotech as the CFO of several
successful public companies, including Vertex. This includes having
raised more than $500M in capital for highly innovative companies
like Oxurion and executing a number of value creating business
development transactions. The Company intends to rely on Tom’s
extensive capital markets experience to explore a dual listing in
the United States in addition to other sources of funding. Tom also
has a track record of developing high performing teams and talent
everywhere he has worked both in the United States and Europe.
Organizational Changes to Focus
Resources on Clinical Assets THR-687 and THR-149
In June, Oxurion announced a plan to better
align its organizational resources towards its key priority -
executing its clinical development strategy for its two novel
programs, THR-687 and THR-149. As a result, Oxurion will no longer
make direct investments in non-core activities, including research
in dry AMD and oncology (Oncurious).
As a result of the focus on its clinical assets,
Oxurion decided to reduce its headcount by 10 people in June.
After undertaking further discussions with third parties about the
possibility of exploiting the non-core assets, a decision was taken
in August to further reduce the workforce by four positions. All of
individuals impacted are receiving the Company’s support in finding
a next position outside of the Company.
The Company also made key additions to its
leadership team in order to further strengthen its capability to
execute its ongoing clinical development. This included the
appointment of Hanne Callewaert, PhD, as Chief Operating Officer,
and Vincent Baeyens, PhD, to Head of Clinical Operations. Grace
Chang, M.D., has departed her position as Chief Medical Officer to
pursue other opportunities.
Hanne Callewaert,
PhD. Prior to being appointed Chief
Operations Officer of Oxurion NV, Hanne Callewaert was heading up
the Regulatory Affairs team and was involved in Business
Development and Alliance Management. Before joining Oxurion, Hanne
gained extensive drug development expertise at GlaxoSmithKline
Vaccines by occupying several roles in Regulatory Affairs as well
as serving as Vaccine Development Leader. Hanne holds a PhD in
Medical Sciences from the University of Leuven, a master’s degree
in Biomedical Sciences from the University of Leuven, as well as a
master’s degree in Intellectual Property Law from the University of
Leuven and Brussels.
Vincent Baeyens, PhD.
Vincent Baeyens joined Oxurion in June with over 25 years’ global
R&D and clinical operations leadership experience in the
ophthalmic space. Most recently, he served as Senior Director
Global Clinical Operations EMEA at Santen. Prior to that, he worked
13 years for TRB Chemedica International as Associate Director
Ophthalmology R&D where he led the global Research and
Development division of Ophthalmology and as Senior Project
Development Director. Vincent is also a trainer at ECCRT (Brussels)
on CRO management and oversight. Vincent holds a master’s degree in
Pharmacy, from the University of Louvain, Louvain-la-Neuve and a
PhD in Pharmaceutical Science, Ophthalmology from the University of
Geneva, Switzerland.
These changes followed a detailed review of the
Company’s operations and growth opportunities and are designed to
maximize value creation in the most capital efficient way, whilst
safeguarding Oxurion’s scientific and clinical leadership position
in the global retina community.
Scientific Update
Conference presentations and
publications highlight Oxurion’s retinal science
During 2021, Oxurion has continued to
demonstrate the quality of the science that underpins its R&D
activities via a number of conference presentations and
publications.
In May, the Company presented novel scientific
data at the Association for Research in Vision and Ophthalmology
(ARVO) 2021 Annual Meeting. The presentation entitled, “The Mouse
Sodium Iodate Model Exhibits Acute Retinal Inflammation,” covered
data supporting the use of this model for the investigation of
age-related macular degeneration (AMD) hallmarks.
In August, Oxurion announced that the results of
the positive Phase 1 study with THR-687, had been published in
Ophthalmology Science, the prestigious journal of the American
Academy of Ophthalmology.
Also in August, Oxurion announced the
publication of two related papers in the Journal of
Pharmacokinetics and Pharmacodynamics entitled “Systemic exposure
following intravitreal administration of therapeutic agents: an
integrated pharmacokinetic approach.”
These papers described the pharmacokinetic
properties of THR-149 and THR-687 following intravitreal injection
in animals and utilize novel pharmacokinetic models developed by
Oxurion to accurately describe systemic levels of these drug
candidates.
As intravitreally delivered drugs become more
widely used, achieving an accurate understanding of their systemic
exposure as enabled by these new pharmacokinetic models is crucial
in the evaluation and development of novel drugs administered into
the eye.
Chief Scientific Officer, Professor Alan Stitt,
also gave a presentation entitled “Targeting RGD-Binding Integrins
as an Integrative Therapy for Diabetic Retinopathy &
Neovascular Age-Related Macular Degeneration,” at the virtual
Integrin Drug Discovery event in August. In his presentation,
he discussed the potential of a pan-RGD integrin antagonist, such
as THR-687, to limit the progress of these important retinal
vascular disorders.
Andy De Deene, M.D., Chief Development Officer,
was part of a panel discussion at the Clinical Trials at the
Summit, which was held at the end of August. This event brought
together a diverse group of experts from around the world to
discuss ongoing clinical trials and the latest data, all with the
goal of achieving advances in vitreoretinal care. This
conference program also explored the partnerships and strategies
required to design and execute effective vitreoretinal clinical
trials.
Financial Update
Total revenue amounted to €0.3 million in the
first six months of 2021 compared to €1.3 million in the
corresponding period in 2020.
The Company reported a gross profit of €0.1
million during the period compared to €0.9 million in the same
period in 2020.
R&D expenses in the first half of 2021 were
€11.1 million compared to €10.0 million in 2020. The expenses are
mainly investments in trials for Oxurion’s two clinical compounds
THR-149 and THR-687.
Selling and marketing expenses were €0.7 million
in 2021, compared to €1.8 million in the corresponding period in
2020.
General and administrative expenses were €3.7
million. This compares to €2.7 million reported in H1 2020.
In H1 2021, Oxurion reported a net loss of €16.2
million (or -€0.42 per share), compared to a loss of €13.3 million
(or -€0.35 per share), in the same period in 2020.
Oxurion’s cash position (including investments)
at the end of June 2021 amounted to €10.0 million. This compares to
€24.8 million at the end of December 2020.
As reported in the Company’s 2020 Annual
Accounts, in April the Company entered into a binding term sheet
whereby the Negma Group committed to subscribe to up to €30 million
in Oxurion equity through mandatory convertible bonds (the “Funding
Program”).
Under the Issuance and Subscription Agreement
(the ISA) entered into between the Company and Negma, Negma agrees
to subscribe to up to €30 million in mandatory convertible bonds in
tranches of up to €2.5 million with an initial term of 12 months,
which is automatically extendable by another 24 months. The right
for the Company to draw a tranche of convertible
bonds is subject to certain conditions precedent
(including with respect to average daily trading volume) and the
expiry of a cool down period of 22 trading days since the previous
tranche.
During the negotiation of the ISA, it was also
agreed that the total tranches during the first six months of the
Program would not exceed €5 million, with the remainder of the €30
million being available at the discretion of the Company thereafter
in tranches of up to €2.5 million every 22 business days provided
the conditions established in the agreement are met. This means
that over the 12-month period starting from the date of the first
tranche call, the Company will have access to up to maximum €20
million under the Negma Funding Program provided the Company can
and does draw the maximum tranche on a monthly basis, with the
remainder of the €30 million being available thereafter at the
discretion of Oxurion over another 24 months subject to the terms
of the agreement.
In addition, the Company has also secured
conditional pre-commitments for equity financing of €3.4 million
from others provided certain conditions are met ultimately on
September 30, 2021. These conditionally committed and pre-committed
fundings may not be sufficient to fund full operations during the
next twelve months without cost reductions. Therefore, the Company
is actively exploring the possibility for additional funding
through debt/equity, and/or alternatively will reduce its costs and
investments to the extent that there is at all times sufficient
cash to continue its operations during the next twelve months.
END
For further information please
contact:
Oxurion NVWouter Piepers, Global Head of Corporate Communications
& Investor RelationsTel: +32 16 75 13 10 / +32 478 33 56
32wouter.piepers@oxurion.com |
EU MEDiSTRAVA ConsultingDavid Dible/ Sylvie Berrebi/Frazer HallTel:
+44 20 7638 9571oxurion@medistrava.com USWestwicke, an ICR
CompanyChristopher BrinzeyTel: +1 617 835
9304chris.brinzey@westwicke.com |
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
(AMD) and retinal vein occlusion (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-687 is a pan-RGD integrin antagonist that is initially
being developed as a potential first line therapy for DME patients.
Positive topline results in a Phase 1 clinical study assessing
THR-687 as a treatment for DME were announced in 2020. Oxurion is
currently conducting a Phase 2 clinical trial evaluating THR-687
for first line therapy in patients with DME. THR-687 also has the
potential to deliver improved treatment outcomes for patients with
wet AMD and RVO.
- THR-149 is a 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-149 has shown
positive topline Phase 1 results for the treatment of DME. The
Company is currently conducting a Phase 2 clinical trial evaluating
multiple injections of THR-149 in DME patients previously showing
suboptimal response to anti-VEGF therapy. Dose selection data from
Part A of the study, which is fully enrolled, is expected in the
second half of 2021.
Oxurion is headquartered in Leuven, Belgium, and
is listed on the Euronext Brussels exchange under the symbol OXUR.
More information is available at www.oxurion.com.
Important information about
forward-looking statementsCertain 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 an
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. 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.
Unaudited consolidated statement of profit and
loss
In '000 euro (for the period ended on June
30) |
2021 |
2020 |
|
|
|
Income |
333 |
1,259 |
Sales |
250 |
1,249 |
Income from royalties |
83 |
10 |
Cost of sales |
-252 |
-315 |
Gross profit |
81 |
944 |
Research and development expenses |
-11,077 |
-9,905 |
General and administrative expenses |
-3,705 |
-2,745 |
Selling expenses |
-702 |
-1,774 |
Other operating income |
317 |
250 |
Impairment losses |
-1,127 |
0 |
Operating result |
-16,213 |
-13,230 |
Finance income |
19 |
50 |
Finance expense |
-25 |
-139 |
Result before income tax |
-16,219 |
-13,319 |
Taxes |
-1 |
0 |
Loss for the period |
-16,220 |
-13,319 |
|
|
|
Attributable to: |
|
|
Equity holders of the company |
-15,858 |
-13,139 |
Non-controlling interest |
-362 |
-180 |
|
|
|
Result per share |
|
|
Basic earnings/(loss) per share (euro) |
-0.42 |
-0.35 |
Diluted earnings/(loss) per share (euro) |
-0.42 |
-0.35 |
Unaudited consolidated statements of
other comprehensive income
In '000 euro (for the period ended on June
30) |
2021 |
2020 |
Loss for the period |
-16,220 |
-13,319 |
Exchange differences on translation of foreign operations |
-6 |
48 |
Other comprehensive income, net of income tax |
-6 |
48 |
Other comprehensive income that will not be reclassified to profit
or loss |
-6 |
48 |
Total comprehensive income for the period |
-16,226 |
-13,271 |
Attributable to: |
|
|
Equity holders of the company |
-15,864 |
-13,091 |
Non-controlling interest |
-362 |
-180 |
Unaudited consolidated
statement of financial position
In '000 euro (as at) |
30-jun-21 |
31-dec-20 |
|
|
|
ASSETS |
|
|
Property, plant and equipment |
191 |
230 |
Right-of-use assets |
710 |
1,069 |
Intangible assets |
999 |
2,127 |
Other non-current assets |
95 |
96 |
Non-current tax credit |
3,438 |
3,708 |
Non-current assets |
5,433 |
7,230 |
Inventories |
85 |
85 |
Trade and other receivables |
2,568 |
1,451 |
Current tax receivables |
913 |
719 |
Investments |
248 |
288 |
Cash and cash equivalents |
9,759 |
24,511 |
Current assets |
13,573 |
27,054 |
Total assets |
19,006 |
34,284 |
|
|
|
EQUITY AND LIABILITIES |
|
|
Share capital |
44,913 |
44,913 |
Share premium |
0 |
0 |
Cumulative translation differences |
-1,045 |
-1,039 |
Other reserves |
-5,896 |
-6,133 |
Retained earnings |
-28,419 |
-12,561 |
Equity attributable to equity holders of the
company |
9,553 |
25,180 |
Non-controlling interest |
45 |
-132 |
Total equity |
9,598 |
25,048 |
Lease liabilities |
151 |
447 |
Employee benefit liabilities |
1,096 |
1,096 |
Non-current liabilities |
1,247 |
1,543 |
Trade payables |
3,932 |
4,377 |
Lease liabilities |
584 |
649 |
Other short-term liabilities |
3,645 |
2,667 |
Current liabilities |
8,161 |
7,693 |
Total equity and liabilities |
19,006 |
34,284 |
Unaudited consolidated statement of cash
flows
In '000 euro (for the period ended on June
30) |
2021 |
2020 |
|
|
|
Cash flows from operating activities |
|
|
Loss for the period |
-16,220 |
-13,319 |
Finance expense |
25 |
139 |
Finance income |
-19 |
-50 |
Depreciation of property, plant and equipment |
51 |
126 |
Amortization and impairment of intangible assets |
1,127 |
0 |
Amortization of right-of-use assets |
359 |
459 |
Equity settled share-based payment transactions |
690 |
249 |
Increase/decrease in trade and other receivables including tax
receivables and inventories |
-1,041 |
1,214 |
Increase/decrease in short-term liabilities |
533 |
-3,061 |
Net cash flows used (-) / generated in operating
activities |
-14,495 |
-14,243 |
|
|
|
Cash flows from investing activities |
|
|
Disposal of property, plant and equipment (following a sale) |
1 |
22 |
Decrease / increase (-) in investments |
40 |
95 |
Interest received and similar income |
-7 |
0 |
Acquisition of intangible assets |
0 |
-270 |
Purchase of property, plant and equipment |
-13 |
-92 |
Purchase / divestment (-) of other non-current assets |
1 |
0 |
Net cash flows used (-) / generated in investing
activities |
22 |
-245 |
|
|
|
Cash flows from financing activities |
|
|
Principal paid on lease liabilities |
-361 |
-454 |
Interest paid on lease liabilities |
-3 |
-9 |
Proceeds from capital and share premium increases from exercise of
warrants |
86 |
0 |
Paid interests |
-5 |
-5 |
Net cash flows used (-) / generated in financing
activities |
-283 |
-468 |
|
|
|
Net change in cash and cash equivalents |
-14,756 |
-14,956 |
Net cash and cash equivalents at the beginning of the period |
24,511 |
42,492 |
Effect of exchange rate fluctuations |
4 |
-27 |
Net cash and cash equivalents at the end of the
period |
9,759 |
27,509 |
Unaudited consolidated statement of
changes in equity
|
Share capital |
Share premium |
Cumulative translation differences |
Other reserves |
Retained earnings |
Attributable to equity holders of the company |
Non-controlling interest |
Total |
As at January 1, 2020 |
100,644 |
0 |
-615 |
-12,122 |
-34,747 |
53,160 |
146 |
53,306 |
Loss for the period 2020 |
0 |
0 |
0 |
0 |
-13,139 |
-13,139 |
-180 |
-13,319 |
Change to foreign currency translation difference and revaluation
reserve |
0 |
0 |
48 |
0 |
0 |
48 |
0 |
48 |
Share-based payment transactions |
0 |
0 |
0 |
249 |
0 |
249 |
0 |
249 |
As at June 30, 2020 |
100,644 |
0 |
-567 |
-11,873 |
-47,886 |
40,318 |
-34 |
40,284 |
|
|
|
|
|
|
|
|
|
As at January 1, 2021 |
44,913 |
0 |
-1,039 |
-6,133 |
-12,561 |
25,180 |
-132 |
25,048 |
Loss for the period 2021 |
0 |
0 |
0 |
0 |
-15,858 |
-15,858 |
-362 |
-16,220 |
Change to foreign currency translation difference and revaluation
reserve |
0 |
0 |
-6 |
0 |
0 |
-6 |
0 |
-6 |
Transactions with non-controlling interests |
0 |
0 |
0 |
-453 |
0 |
-453 |
539 |
86 |
Share-based payment transactions |
0 |
0 |
0 |
690 |
0 |
690 |
0 |
690 |
As at June 30, 2021 |
44,913 |
0 |
-1,045 |
-5,896 |
-28,419 |
9,553 |
45 |
9,598 |
- OXUR HY BU 2021 (EN) 09092021 FINAL
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