- Cash position of €24.5 million as of June 30, 2021,
providing financial visibility until the end of 2022 and enabling
the Company to accelerate its development and its
portfolio
- Preparing an ambitious clinical plan for AsiDNA™, with
implementation to be initiated in the fall of 2021
Regulatory News:
Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First
North: ONXEO), « Onxeo », a clinical-stage biotechnology company
specializing in the development of innovative drugs targeting tumor
DNA Damage response (DDR) in oncology, today announced its
consolidated half-yearly financial results to June 30, 2021 and
provides an update on its activities.
Judith Greciet, Chief Executive Officer of Onxeo, said:
“Building upon the advances achieved in 2020, the first half of
2021 was marked by the strengthening of our financial resources and
the furtherance of several preclinical and clinical programs, in
particular those aimed at AsiDNA™.
With regard to AsiDNA™, the data obtained during the first half
of the year confirm the exceptional properties of this drug
candidate and will give rise to a wider range of clinical
prospects.
AsiDNA™’s highly novel mechanism of action hijacking DNA repair
functions is the basis of its novel antitumor properties, such as
the ability to fight tumor resistance to several important classes
of targeted therapies1, to induce a deficiency of the HR
repair pathway, necessary for PARPi to be fully effective2,
to increase the efficacy of reference treatments such as
chemotherapy3. Other properties such as action on tumor
metabolism and antitumor immune response are also under
investigation.
Over the past few weeks, we have assembled a Scientific Advisory
Committee composed of eminent members of the international medical
and scientific community in the fields of DDR, resistance to
treatment and, more generally, drug development in oncology. The
appointment of Dr. Shefali Agarwal, a global clinical development
expert, as Chairwoman of our Board of Directors, is also a strong
signal of a new strategic focus in the Company's development.
With their support and expert advice, we are currently
revisiting the opportunities and priorities for the development of
AsiDNA™, with the aim of implementing, starting this fall, an
ambitious global clinical plan that will aim to maximize its worth
by targeting the indications and combinations creating the most
value.
In the meantime, the REVOCAN study of AsiDNA™ in combination
with PARP inhibitors is continuing under the guidance of its
sponsor, Gustave Roussy, and the AsiDNA™ Children study, sponsored
by the Institut Curie to evaluate AsiDNA™ in combination with
radiotherapy in recurrent high-grade glioma (HGG) in children, is
also expected to begin this year.
In addition, we have secured Onxeo's financial visibility until
the end of 2022, notably through a rights issue widely supported by
our shareholders, and in particular by our core shareholders, Invus
and Financière de la Montagne.
Lastly, the first half of 2021 has still been largely subject to
the uncertainties of the global pandemic, and I would like to
warmly thank the Onxeo teams, our partners and our shareholders for
their involvement and unfailing support, which will enable us to
approach the major strategic steps that will be taken in the next
18 months with confidence and self-assurance.“
FINANCIAL RESULTS FOR THE FIRST HALF OF 2021
Consolidated income statement (IFRS)
In thousands of euros
30/06/2021
30/06/2020
Revenues, including:
Recurring revenues
Non-recurring revenues
589
0
589
1,082
1,076
6
Operating expenses
(5,367)
(2,390)
(5,067)
(1,916)
Other current operating income
33
34
Current operating income
(4,745)
(3,951)
Other non-current operating income and
expenses
198
10,040
Share of profit (loss) of companies
accounted for by the equity method
-
-
Operating profit after equity method
income (loss)
(4,547)
6,089
Financial result
(238)
(224)
Pre-tax income
(4,785)
5,065
Income tax
15
(823)
Net income
(4,770)
5,042
Consolidated revenues for the period ended June 30, 2021,
amounted to 0.6 million euros and consisted exclusively of
contractual licensing fees for a non-strategic product, whereas
revenues for the first half of 2020, amounting to 1.1 million
euros, corresponded to revenues from the commercialization of
Beleodaq, which have been recognized in the Group's accounts until
the date of signature of the licensing agreement with Acrotech
Biopharma in April 2020.
Operating expenses increased slightly as a result of the
evolution of R&D expenses, which went from 1.9 million euros at
June 30, 2020 to 2.4 million euros at June 30, 2021, in line with
the progress of AsiDNA™ and OX401 programs.
The strong variation in other non-current operating income
and expenses, which went from a net amount of 10 million euros
in the first half of 2020 to a net amount of 0.2 million, is due to
the recognition in 2020 of the effects of the license agreement
with Acrotech Biopharma, and notably
- an income of 5,7 million euros in net proceeds from the
transaction,
- an expense of 2,8 million euros corresponding to the net book
value of the R&D assets related to Beleodaq,
- an income of 7,1 million euros corresponding to the amount of
royalties, evaluated by management, that the group expected to
receive after the date of signature of the agreement and through
which it will repay the balance of the SWK loan.
The financial result at June 30, 2021, is a loss of 0.2
million euro, mainly due to the cost of the bond loan with SWK
Holdings.
As a result of the changes in business activity reflected by the
income and expense items described above, the net result for
the six months ended June 30, 2021, is a loss of 4.8 million euros,
compared with a profit of 5 million euros for the first half of
2020.
CASH AND CASH EQUIVALENTS AT JUNE 30, 2021
The Group's cash position on June 30, 2021, was 24.5 million
euros, compared with 14.5 million euros at December 31, 2020. The
change in cash and cash equivalents is mainly due to the financing
implemented during the first half of the year, State-backed loans
and a capital increase, which provided Onxeo with net proceeds of
14.4 million euros and enabled it to meet operating expenses of 5.4
million euros.
The cash available on June 30, 2021, provides Onxeo with
visibility until at least the end of 2022.
HIGHLIGHTS OF THE 1ST
HALF-YEAR 2021, RECENT DEVELOPMENTS AND OUTLOOK
CORPORATE &
GOVERNANCE
- On January 28, 2021, the Company announced that it had
obtained non-dilutive financing of 5 million euros in the form of
State Guaranteed Loans.
- On March 10, 2021, the Company announced the launch of a
capital increase with preferential subscription rights for
shareholders in France and Denmark, based on the seventeenth and
twentieth resolutions adopted by the extraordinary shareholders'
meeting of June 19, 2020.
- On April 12, 2021, the Company announced the success of this
capital increase, with a subscription rate of approximately 104.8%,
corresponding to 13,677,125 New Shares, of which 7,565,328 were
requested on an unrestricted basis, fully allocated through the
exercise of the extension clause. The gross amount of the capital
increase, including issue premium, amounts to 9,710,758.75 euros.
At the end of the capital increase, the Company's share capital
amounted to 22,998,733.75 euros, divided into 91,994,935 shares
with a nominal value of 0.25 euro each.
- On May 27, 2021, Onxeo announced the formation of a Scientific
Advisory Committee composed of leading scientific and clinical
experts in the fields of DNA Damage Response, immunology and
oncology drug development. This committee will advise and guide the
Company in advancing its PlatON™ platform and developing innovative
therapies that address unmet medical needs and improve the outlook
for cancer patients.
- On June 10, 2021, the General Meeting of Shareholders renewed
the term of office of Walter Thomas Hofstaetter as Director for
three years and ratified the appointment of two new Directors: Mr.
Julien Miara, representing Invus, and Dr. Shefali Agarwal, an
independent Director. Jean-Pierre Bizzari, an independent member of
the Board of Directors, has resigned from his position for personal
reasons at the end of June 2021.
- On July 29, 2021, the Company announced the appointment of Dr.
Shefali Agarwal as Chairperson of the Board of Directors, replacing
Ms. Danièle Guyot-Caparros, who remains an independent member of
the Board and Chairperson of the Audit committee (please refer to
the press release published today).
To date, the Board of Directors is thus composed of 7 members, 3
men and 4 women, including 4 independent members.
AsiDNA™
- In February 2021, Onxeo entered into a clinical research
agreement with Institut Curie, France's leading cancer center, to
conduct a Phase 1b/2 study to evaluate the effect of AsiDNA™ in
combination with radiotherapy in children with recurrent high-grade
glioma (HGG) eligible for re-irradiation. This study is supported
by a grant from the European Fight Kids Cancer program and is being
conducted as part of the European Innovative Therapies for Children
with Cancer (ITCC) consortium. The Institut Curie, as sponsor of
the study, will submit the request for authorization to the health
authorities and ethics committees, with the aim of initiating this
study in 2021.
- Onxeo completed the DRIIV-1b study of AsiDNA™ in combination
with reference chemotherapies (carboplatin and paclitaxel) in
patients with advanced solid tumors during the first half of 2021.
The very favorable safety profile of AsiDNA™ was confirmed and
significantly longer control times were observed than with previous
treatment lines. These results were published in the scientific
journal Oncology & Cancer Case Reports in March 2021.
- The Company presented new preclinical data at the American
Association for Cancer Research (AACR) meeting in April 2021
showing that acquired resistance to KRASG12C inhibitors (a new
class of targeted therapies), evolves from persistent drug-tolerant
cells vulnerable to AsiDNA™.
- The REVOCAN study evaluating the combination of AsiDNA™ with
PARP inhibitors (PARPi) in relapsed ovarian cancer also continued
in the first half of 2021. Results from Part 1b of the study, which
will focus on the safety of this combination, are now expected from
Gustave Roussy, the sponsor, in the second half of 2021.
- In addition, Onxeo has continued its active policy of
industrial protection of its compounds and their applications and
announced in June 2021 the authorization of a new patent in the
United States that extends the protection of AsiDNA™ associated
with PARP inhibitors. This new patent protects both AsiDNA™ in
combination with any PARP inhibitor, and a method of treating
cancers with a so-called "HR proficient" genetic profile with this
combination. This patent is based on preclinical data showing that
AsiDNA™ is able, through its novel mechanism of action, to
interfere with DNA repair pathways, including the homologous
recombination (HR) pathway. AsiDNA™ thus produces a "HR-deficient"
background, which is necessary for PARPi to be fully effective,
regardless of the initial genetic background of the tumor.
The work undertaken with our experts, especially those of our
newly formed Scientific Advisory Committee, to establish an
ambitious and robust clinical plan for AsiDNA™ will of course rely
on these programs to determine the new directions of its
development, which will be implemented from the fall of 2021.
As part of the acceleration of the development of AsiDNA™, the
Company could also file an IND application to extend its clinical
program to the United States.
OX400
Based on Onxeo's decoy agonist technology, OX400 compounds are
positioned as potent PARP agonists, acting on both the DNA damage
response and the activation of the immune response.
New preclinical results presented at the American Association
for Cancer Research (AACR) meeting in April 2021 showed that by
specifically trapping and hyper-activating PARP, OX400 compounds
have the potential to modulate the immune response and deplete
tumor cell metabolism. Ongoing in-vitro and in-vivo studies of
OX400 compounds aim to validate their action, alone and in
combination with immunotherapies, and to optimize their efficacy
profile. These translational studies will help optimize the entry
into the clinic, which could occur within 12 to 18 months.
COVID-19 PANDEMIC CONTEXT
To date, the Company considers that it has experienced only a
limited impact from the health crisis and has limited exposure to
risks on its operations due to the Covid-19 epidemic. The impact
has mainly been a slowdown in the pace of recruitment for the
REVOCAN study, leading to a delay in obtaining the first
results.
However, Onxeo does not exclude that a resumption of containment
measures could affect the smooth running of its subcontracted
activities, in particular the conduct of clinical trials, and thus
lead to delays in the development of its products and a greater
consumption of cash. In addition, the effect of this epidemic on
the global economy and financial markets could impact the Company's
ability to obtain financing in the capital markets and,
consequently, the conduct of its business. The Company has put in
place appropriate measures to protect its employees and to ensure
the continuity of its operations and will adapt these measures as
circumstances require.
The 2021 half-year financial report is available on the
Company's website.
About Onxeo
Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a
clinical-stage biotechnology company developing innovative oncology
drugs targeting tumor DNA-binding functions through unique
mechanisms of action in the sought-after field of DNA Damage
Response (DDR). The Company is focused on bringing early-stage
first-in-class or disruptive compounds from translational research
to clinical proof-of-concept, a value-creating inflection point
appealing to potential partners.
platON™ is Onxeo’s chemistry platform of oligonucleotides
acting as decoy agonists, which generates new innovative compounds
and broaden the Company’s product pipeline.
AsiDNA™, the first compound from platON™, is a
first-in-class, highly differentiated clinical stage candidate in
the field of DNA Damage Response (DDR). Its decoy and agonist
mechanism acting upstream of multiple DDR pathways results in
distinctive antitumoral properties, notably the ability to prevent
or abrogate tumor resistance to targeted therapies such as PARP
inhibitors and a strong synergy with tumor DNA-damaging agents such
as radio/chemotherapy. AsiDNA™ is currently in combination clinical
studies in hard-to-treat solid tumors.
OX401 is a new drug candidate from platON™, optimized to
be a potent PARP agonist acting on both the DNA Damage Response and
the activation of immune response, without inducing resistance.
OX401 is undergoing preclinical proof-of-concept studies, alone and
in combination with immunotherapies.
For more information, please visit www.onxeo.com.
Forward looking statements
This communication expressly or implicitly contains certain
forward-looking statements concerning Onxeo and its business. Such
statements involve certain known and unknown risks, uncertainties
and other factors, which could cause the actual results, financial
condition, performance or achievements of Onxeo to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Onxeo is
providing this communication as of this date and does not undertake
to update any forward-looking statements contained herein as a
result of new information, future events or otherwise. For a
discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of Onxeo
to differ from those contained in the forward-looking statements,
please refer to the risk factors described in the most recent
Company’s registration document or in any other periodic financial
report and in any other press release, which are available free of
charge on the websites of the Company Group (www.onxeo.com) and/or
the AMF (www.amf-france.org).
APPENDIX
INTERIM CONSOLIDATED FINANCIAL STATEMENTS AT JUNE 30,
2021
Consolidated balance sheet
ASSETS (in thousands €)
6/30/2021
12/31/2020
Non-current assets
Intangible assets
20,532
20,534
Tangible assets
58
83
Rights of use
2,334
2,479
Other financial fixed assets
224
233
Total non-current assets
23,148
23,329
Current assets
Trade receivables and related accounts
5,959
6,654
Other receivables
2,501
2,000
Cash and cash equivalents
24,462
14,523
Total current assets
32,922
23,177
TOTAL ASSETS
56,070
46,506
LIABILITIES AND SHAREHOLDERS' EQUITY
(in thousands of €)
6/30/2021
12/31/2020
Shareholders' equity
Capital
22,999
19,579
Less: treasury shares
-188
-182
Share premium
24,588
18,577
Reserves
-8,792
-10,027
Earnings
-4,770
1,089
Total shareholders’ equity
33,837
29,036
Non-current liabilities
Provisions
1,719
1,640
Deferred tax liability
393
415
Non-current financial debts
6,727
4,278
Other non-current liabilities
4,831
5,089
Total non-current liabilities
13,670
11,423
Current liabilities
Short-term borrowings and financial
debts
3,812
1,979
Trade payables and related accounts
3,220
2,762
Other current liabilities
1,531
1,306
Total current liabilities
8,563
6,047
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY
56,070
46,506
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
In thousands of €
6/30/2021
6/30/2020
Recurring revenues from licensing
agreements
1,076
Non-recurring revenues from licensing
agreements
589
6
Total revenues
589
1,082
Purchases
-194
-188
Personnel expenses
-2,128
-2,026
External expenses
-2,298
-2,228
Taxes and duties
-75
-95
Net depreciation, amortization and
provisions
-421
-327
Other current operating expenses
-251
-202
Operating expenses
-5,367
-5,067
Other current operating income
33
34
Current operating income
-4,745
-3,951
Other non-current operating income
332
12,857
Other non-current operating expenses
-134
-2,817
Share of income from equity affiliates
Operating result after share of income
from equity affiliates
-4,547
6,089
Net cost of financial debt
-381
-515
Other financial income
291
316
Other financial expenses
-148
-25
Financial income/loss
-238
-224
Income before tax
-4,785
1,560
Income tax expense
15
-823
- of which deferred tax
-565
Consolidated net income/loss
-4,770
5,042
Earnings per share
-0.06
0.08
Diluted earnings per share
-0.06
0.08
In thousands of €
6/30/2021
6/30/2020
Result for the period
-4,770
5,042
Currency translation adjustments
23
-8
Other items recyclable as a
result
23
-8
Actuarial gains and losses
50
17
Other items not recyclable as a
result
50
17
Other comprehensive income for the
period, net of tax
73
9
Total comprehensive income for the
period
-4,697
5,051
Total comprehensive income attributable
to:
- owners of the parent company
- minority interests
-4,697
5,051
Statement of changes in consolidated shareholders'
equity
Change in reserves and
earnings
In thousands of €
Capital
Treasury shares
Share premium
Translation reserves
Gains and losses recognized in
equity
Consolidated reserves and
earnings
Total Differences
TOTAL
Shareholders' equity as of
1/1/2019
13,344
-97
41,824
-109
-97
-9,462
-9,669
45,402
Total comprehensive income for
the period
75
-54
-33,728
-33,707
-33,707
Capital increase
1,986
3,100
0
5,086
Treasury shares
-92
-71
-71
-163
Other movements
138
138
138
Share-based payments
441
441
441
Shareholders' equity as of
12/31/2019
15,329
-189
44,924
-34
-151
-42,682
-42,868
17,197
Total comprehensive income for
the period
-8
17
5,042
5,051
5,051
Capital increase
4,250
6,186
10,436
Treasury shares
39
39
Other movements
-32,577
32,772
32,772
195
Share-based payments
18
18
18
Shareholders' equity as of
6/30/2020
19,579
-150
18,533
-42
-134
-4,850
-5,026
32,936
Total comprehensive income for
the period
-63
-39
-3953
-4055
-4055
Capital increase
44
188
188
232
Treasury shares
-32
89
89
56
Other movements
14
-210
-195
-195
Share-based payments
61
61
61
Shareholders' equity at
12/31/2020
19,579
-182
18,577
-91
-173
-8,674
-8,938
29,036
Total comprehensive income for
the period
23
50
-4,770
-4,697
-4,697
Capital increase
3,419
6,011
9,430
Treasury shares
-6
-2
-2
-8
Other movements
Share-based payments
75
75
75
Shareholders' equity as of
6/30/2021
22,999
-188
24,588
-68
-123
-13,371
-13,562
33,837
Consolidated statement of net cash flows
In thousands of €
Note
6/30/2021
12/31/2020
6/30/2020
Consolidated net
result
-4,770
1,089
5,042
+/- Net depreciation,
amortization and provisions (excluding those related to current
assets)
4, 5, 9.1
438
-8,215
-9,149
-/+ Unrealized gains and losses
related to changes in fair value
-148
-290
9
+/- Calculated income and
expenses related to stock options and similar instruments
8.4
75
79
18
-/+ Other calculated income and
expenses
-/+ Capital gains and losses on
disposals
57
57
-/+ Dilution gains and losses
+/- Share of profit/(loss) of
equity affiliates
+/- Other items with no impact on
cash
114
Cash flow from operations
after cost of net financial debt and taxes
4,291
-7,280
-4,023
+ Cost of gross financial
debt
12
385
959
515
+/- Tax expense (including
deferred taxes)
-15
757
823
Cash flow from operations
before cost of net financial debt and tax
-3,921
-5,564
-2,685
- Taxes paid
+/- Change in operating working
capital requirements (including employee benefit liabilities)
634
886
1,459
NET CASH FLOW FROM OPERATING
ACTIVITIES
-3,289
-4,678
-1,226
- Disbursements related to
acquisitions of property, plant and equipment and intangible
assets
-8
-119
-109
+ Proceeds from disposals of
property, plant and equipment and intangible assets
6,116
6,116
- Disbursements related to
acquisitions of financial assets (non-consolidated investments)
+ Proceeds from disposals of
financial assets (non-consolidated investments)
9
4
4
+/- Impact of changes in
perimeter
14
14
+ Dividends received (equity
affiliates, non-consolidated investments)
+/- Change in loans and advances
granted
+ Investment grants received
+/- Other cash flows from
investment activities
NET CASH FLOW FROM INVESTMENT
ACTIVITIES
1
6,015
6,025
+ Amounts received from
shareholders in connection with capital increases
. Paid by the shareholders of the
parent company
8.1
9,428
10,568
10,436
. Paid by minority shareholders
of consolidated companies
+ Amounts received upon exercise
of stock options
-/+ Net purchases and resales of
treasury shares
8.2
-6
8
97
+ Proceeds from new
borrowings
5,000
- Repayment of loans (including
finance leases)
9.3, 10.1
-1,199
-3,094
-1,422
Of which repayment of rights of
use (IFRS16)
-244
-475
-226
+/- Other cash flows from
financing activities
3
-1
2
NET CASH FLOW FROM FINANCING
ACTIVITIES
13,226
7,481
9,113
+/- Impact of changes in foreign
exchange rates
1
-3
-1
CHANGE IN NET CASH AND CASH
EQUIVALENTS
9,939
8,815
13,911
INITIAL CASH POSITION
14,523
5,708
5,708
FINAL CASH POSITION
24,462
14,523
19,619
1 Data presented at AACR 2020 et 2021 2 Press
release on June 9, 2021 3 Long Stabilization and Disease
Control with AsiDNA™, a first-in-class DNA Repair Inhibitor in
Combination with Carboplatin Oncology & Cancer Case Reports
2021, Vol.07, Issue 2, 001-007 – Dr Nuria Kotecki – March 2021
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210729005912/en/
Onxeo Valerie Leroy, Investor Relations investors@onxeo.com +33 1 45 58 76 00 Media
Relations Nicolas Merigeau NewCap onxeo@newcap.eu +33 1 44 71 94 98 Investor
Relations / Strategic Communication Dušan Orešanský / Emmanuel
Huynh NewCap onxeo@newcap.eu +33 1 44
71 94 92 Certified Adviser for Nasdaq First North Kapital
Partner www.kapitalpartner.dk info@kapitalpartner.dk +45 89 88 78
46