> Several major clinical milestones achieved in 2020 by
AsiDNA™, including promising initial results in combination with
chemotherapy and the launch of a new study to evaluate the
abrogation of resistance to a targeted therapy
> Cash position of €14.5 million at December 31, 2020
supplemented by €14.7 million in new financing obtained in early
2021
> Extended financial visibility through the end of 2022,
enabling the expansion of clinical and industrial development of
AsiDNA™
Regulatory News:
Management live webcast today at 6.30 pm
CEST - to participate:
https://us02web.zoom.us/webinar/register/WN_T6v8Hc8TRU67rKXPrz2nXw
Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First
North Copenhagen: ONXEO) (Paris:ALONX) (NASDAQ OMX:ALONX), a
clinical-stage biotechnology company specializing in the
development of innovative drugs targeting tumor DNA Damage response
(DDR) in oncology, today reported its consolidated financial
results for the fiscal ending December 31, 2020, and provided a
business update.
Judith Greciet, Chief Executive Officer of Onxeo,
declared: “2020 was marked for all by an unprecedented
health crisis. Yet it will have allowed Onxeo to demonstrate the
resilience of its teams and strategy. The clinical program for
AsiDNA™, our lead candidate, made very significant progress in 2020
on its two development axes, synergy of efficacy with DNA breakers
as radio or chemotherapy, and the fight against tumor resistance to
targeted therapies.
On the first axis, the positive efficacy signals obtained in
DRIIV-1b, combining AsiDNA™ with reference chemotherapies, have
enabled the preparation of a randomized phase 2 trial in lung
cancer. Its adaptive design would allow it to be converted into a
pivotal study based on initial positive results. Enrolment will
start in the second half of 2021, as soon as regulatory approval is
obtained. We have also initiated a Phase 1b/2 pediatric program
with the Curie Institute in recurrent high-grade glioma, a brain
cancer with a poor prognosis, against which the combination of
AsiDNA™ with radiotherapy could offer an efficacy gain.
In the fight against resistance to targeted therapies, the Phase
1b/2 Revocan study, which is evaluating the effect of AsiDNA™ on
resistance to a PARP inhibitor in ovarian cancer, began in late
2020 and patient enrollment is ongoing. This study is sponsored by
Gustave Roussy who leads its management and we expect to receive
preliminary results from the first group of patients during the
second half of the year. In addition, recent results presented at
AACR 2021 confirm the effect of AsiDNA™ on drug-tolerant cells, one
of the causes of resistance to targeted therapies such as PARP,
KRAS or tyrosine kinase inhibitors. These results provide a strong
rationale to consider an expansion of the clinical development of
AsiDNA™ in other very high potential combinations.
Finally, the OX400 candidates have confirmed in preclinical
studies their action on tumor metabolism and the immune system,
presaging promising clinical combinations with immunotherapies.
This extensive and ambitious R&D program reflects the
significant potential of our candidates in multiple combinations
and therapeutic areas.
Over the past twelve months, we have also significantly
strengthened Onxeo's financial and shareholder structure. Invus, an
international investor specializing in biotechnology, has joined
Financière de la Montagne in the capital and on the Board of
Directors of the Company. Their support has contributed to extend
our financial horizon to the end of 2022 - well beyond the major
clinical milestones expected in the next 18 months - and validates
our strategy to expand the clinical and industrial development of
our candidates.”
FINANCIAL HIGHLIGHTS FOR 2020
Consolidated income statement
(IFRS)
In thousands of euros
12/31/2020
12/31/2019
Revenues, of which:
1,776
4,289
Recurring revenues
Non-recurring revenues
1,077
699
3,455
833
Operating expenses, of
which:
(9,803)
(14,178)
R&D expenses
(3,946)
(7,718)
Other current operating income
213
95
Current operating income /
(loss)
(7,814)
(9,794)
Other operating income and
expenses
10,008
(24,543)
Share of profit from equity
affiliates
(39)
Operating income/(loss) after share of
profit from equity affiliates
2,194
(34,376)
Financial income/(loss)
(347)
(1,677)
Income tax
(757)
2,324
Net profit/loss
1,089
(33,728)
The 2020 consolidated accounts were approved by the board of
directors on April 21, 2021. The audit procedures on the
consolidated accounts have been carried out. The certification
report is in the process of being issued.
Revenues for the year 2020 amounted to €1.8 million and
include:
- €1.1 million in recurring revenue
corresponding to sales of Beleodaq® under the European Named
Patient Program (NPP) and royalties on sales of Beleodaq® in the
United States by the partner Acrotech Biopharma. Its decrease from
€3.5 million in 2019 is explained by the transfer of this activity
to Acrotech as part of the licensing agreement signed in early
April 2020.
- €0.7 million in non-recurring revenue,
comprising contractual lump-sum royalties under the business
transfer agreement signed in 2017 with Vectans Pharma.
Operating expenses amounted to €9.8 million, compared to
€14.1 million in 2019. The 31% decrease is mainly related to lower
R&D expenses, notably manufacturing operations of AsiDNA™ for
clinical trials in 2019, as well as strict management of all the
Company's expenses.
Other operating income (non-current) amounted to €10.0
million and included the impacts of the agreement with Acrotech
Biopharma in April 2020, namely:
- a net income of 5.7 million euros
corresponding to the transaction price of €6.1 million less
payments to be made to Acrotech Biopharma for future product
development costs estimated at €0.4 million;
- a charge of 2.8 million euros corresponding
to the net book value of the R&D assets related to
Beleodaq®/belinostat, reflecting the treatment of the contract with
Acrotech under IFRS as a sale agreement;
- 7.1 million euros of proceeds, evaluated on
the basis of the financing plan established by management,
corresponding to the royalties that the Company expects to receive
after the date of signature of the agreement and that are intended
to repay the balance of the loan contracted with SWK Holdings
Corporation. This amount includes 1.6 million euros of royalties
recorded for 2020 after the transaction.
The financial result of €-0.3 million is mainly explained
by the interest expense related to the bond debt with SWK.
The tax charge is €0.8 million and includes deferred
taxes of €0.4 million, relating to the royalties the Company
expects to receive after December 31, 2020, through which it will
repay the balance of the SWK loan.
Net income for the year ended December 31, 2020 was a
profit of €1.1 million, resulting mainly from the Acrotech
transaction and its accounting treatment under IFRS, compared with
a loss of €33.7 million for the year ended December 31, 2019 that
was linked with a €12.9 million impairment of belinostat-related
R&D assets as well as the impacts of the settlement agreement
signed with SpePharm early 2020 (-€9.6 million).
STRENGTHENED FINANCIAL STRUCTURE
As of December 31, 2020, the Company had consolidated cash and
cash equivalents of €14.5 million, compared to €5.7 million at the
end of fiscal 2019. This sharp increase stems from financing
obtained during the year; in particular, the Company completed a
private placement in June 2020 with a new investor, Invus Public
Equities LP, and Financière de la Montagne, the historical
shareholder, for €7.3 million, and it also used the balance of its
equity financing line for €3.2 million. The Company also received a
payment of $6.6 million in consideration for the granting of
additional exclusive rights to belinostat to Acrotech Biopharma LLC
in April 2020.
The Company's cash position has since been strengthened by
obtaining, at the end of January 2021, a €5 million financing in
the form of State Guaranteed Loans (SGL) and by the proceeds of the
capital increase with shareholders' preferential subscription
rights (PSR) finalized on April 12, for a gross amount of €9.7
million. The Company's financial visibility has thus been extended
to the end of 2022.
FULL-YEAR 2020 HIGHLIGHTS, RECENT DEVELOPMENTS AND
OUTLOOK FOR 2021
AsiDNA™
- Revocan study
At the beginning of 2020, Onxeo launched the Revocan study to
evaluate the effect of AsiDNA™ on acquired resistance to a PARP
inhibitor (PARPi), in 2nd line recurrent ovarian cancer. This Phase
1b/2 study is sponsored by Gustave Roussy. Enrollment in the study
began at the end of 2020 and is continuing, albeit at a slower pace
than anticipated, notably due to the epidemic situation. However,
it should be noted that as study sponsor, GR is managing the
project. Preliminary results of part 1b, initially expected in the
first half of the year, are now expected from Gustave Roussy in the
second half of the year. The study aims to confirm preclinical data
presented at the American Association for Cancer Research (AACR)
Annual Meeting in June 2020, which showed the ability of AsiDNA™ to
reverse PARPi resistance, notably by preventing the regrowth of
drug-tolerant cells.
- DRIIV1-b study - Upcoming phase 2 study
Onxeo published favorable interim results from the DRIIV-1b
study of AsiDNA™ in combination with standard of care
chemotherapies in patients with progressing metastatic tumors in
November 2020. Exceptionally long disease control times were
observed and are particularly encouraging signals of efficacy. As a
result, the Company plans to continue development in this
combination in 2021 with a randomized Phase 2 study of AsiDNA™ in
non-small cell lung cancer. The adaptive design of this
international multicenter study, currently under development, would
allow its transformation into a pivotal study.
- New clinical developments
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.
As part of the acceleration of its development, the Company may
also file an IND application to expand the clinical program of
AsiDNA™ in the United States.
INTELLECTUAL PROPERTY
In 2020, Onxeo pursued an active policy of industrial
protection. The Company received a notice of allowance from the
U.S. Patent and Trademark Office for a new patent enhancing the
protection of AsiDNA™, which will be valid in the United States
until 2037. A notice of intent to issue a new patent enhancing
protection in Europe for AsiDNA™ combined with PARP inhibitors was
also announced in late October 2020. Onxeo's portfolio of
candidates is now protected by several patent families in all
territories of interest until 2040.
OX400
Onxeo continued preclinical studies of new OX400 candidates,
next-generation PARP agonists from its proprietary platON™
platform, in 2020. New results presented at AACR 2021 confirm that
by specifically trapping and hyperactivating PARP, OX400 compounds
have the potential to modulate the immune response and deplete
tumor cell metabolism. The preclinical proof of concept of one or
more OX400 compounds, expected in 2021, will be the starting point
for the activities necessary for entry into the clinic, potentially
in combination with immunotherapy, within 12 to 18 months.
CORPORATE & GOVERNANCE
- In February 2020, Onxeo announced that it
had reached an out-of-court settlement agreement with SpePharm and
SpeBio. As part of this agreement, Onxeo will pay SpePharm 15 to
20% of the net amounts to be received under future commercial
agreements relating to Onxeo's R&D assets, for a total
cumulative amount of 6 million euros within a period of 4 years,
i.e. at the latest on January 31, 2024. The balance of this debt
amounts to 5.1 million euros at December 31, 2020;
- At its meeting on September 17, 2020, the
Board of Directors of Onxeo co-opted Invus Public Equities LP,
represented by Mr. Julien Miara, as a director of the Company to
replace Mr. Jean-Pierre Kinet, who resigned;
- In December 2020, Onxeo transferred the
listing of its shares from the regulated market of Euronext Paris
(compartment C) to the multilateral trading system Euronext Growth
Paris. By coherence, Onxeo shares listed in Denmark on the Nasdaq
Copenhagen regulated market have been transferred to the Nasdaq
First North Growth multilateral trading facility.
CONTEXT OF THE COVID-19 PANDEMIC
The continuation of the global health crisis linked to the
Covid-19 epidemic creates an uncertain situation. Even if Onxeo has
been little impacted in 2020, it is difficult to measure the
repercussions on the Company's activity and financial situation,
which will depend on the intensity and duration of this crisis. The
Company has put in place appropriate measures to protect its
employees and to ensure the continuity of its operations. It will
adapt these measures to the circumstances.
The 2020 Financial Report will be available on the Company's
website as of April 23, 2021.
About Onxeo
Onxeo (Euronext Growth Paris: ALONX, Nasdaq First North
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 proprietary 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 DNA Damage Response (DDR)
inhibitor based on a decoy and agonist mechanism acting upstream of
multiple DDR pathways. Translational research has highlighted the
distinctive properties of AsiDNA™, notably its ability to abrogate
tumor resistance to PARP inhibitors regardless of the genetic
mutation status. AsiDNA™ has also shown a strong synergy with other
tumor DNA-damaging agents such as chemotherapy and PARP inhibitors.
The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase
I study has evaluated AsiDNA™ by systemic administration (IV) in
advanced solid tumors and confirmed the active doses as well as a
favorable human safety profile. The ongoing DRIIV-1b extension
study is evaluating the safety and efficacy of AsiDNA™ at a dose of
600 mg in combination with the reference chemotherapy, carboplatin
-/+ paclitaxel, in advanced metastatic tumors. Preliminary results
from both cohorts showed good tolerability, stabilization of the
disease and an increase in treatment duration compared to previous
treatments. The ongoing REVOCAN phase 1b/2 study evaluates the
effect of AsiDNA™ on the acquired resistance to PARP inhibitor
niraparib in relapsed ovarian cancer (sponsored by Gustave Roussy).
A phase 1b/2 study, AsiDNA™ Children, will be initiated in 2021 to
evaluate the association of AsiDNA™ with radiotherapy in children
with relapsed high-grade glioma (sponsored by Institut Curie).
OX401 is a new drug candidate from platON™, optimized to
be a next-generation PARP inhibitor 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 further 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
FULL YEAR CONSOLIDATED ACCOUNTS AT DECEMBER 31, 2020
Consolidated balance sheet
ASSETS in €K
12/31/2020
12/31/2019
Note
Non-current assets
Intangible assets
20,534
23,358
6
Tangible assets
83
109
7.1
Rights of use
2,479
2,718
7.2
Investments in equity
affiliates
20
Other financial fixed assets
233
141
8
Total non-current
assets
23,329
26,345
Current assets
Inventories and work in
progress
64
Trade receivables
6,654
3,353
9.1
Other receivables
2,000
2,159
9.2
Cash and cash equivalents
14,523
5,708
9.3
Total current assets
23,177
11,284
TOTAL ASSETS
46,506
37,629
LIABILITIES AND SHAREHOLDERS’
EQUITY K€
12/31/2020
12/31/2019
Note
Shareholders' equity
Capital
19,579
15,329
10.1
Less: Treasury shares
-182
-189
10.2
Share premium
18,577
44,924
10.3
Reserves
-10,024
-9,139
10.3
Earnings
1,089
-33,728
Total shareholders'
equity
29,036
17,197
Non-current
liabilities
Provisions
1,640
6,821
11.1
Deferred tax liability
415
16
Non-current financial debts
4,278
7,412
11.2
Other non-current liabilities
5,089
11.3
Total non-current
liabilities
11,423
14,233
Current liabilities
Short-term borrowings and
financial debts
1,979
1,170
12.1
Trade payables
2,762
3,672
12.2
Other current liabilities
1,306
1,358
12.3
Total current
liabilities
6,047
6,199
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY
46,506
37,629
Consolidated statement of comprehensive income
In K€
12/31/2020
12/31/2019
Note
Recurring revenue from license
agreements
1,077
3,455
Non-recurring revenues from license
agreements
699
833
Total revenues
1,776
4,289
14.1
Purchases
-347
-350
Personnel expenses
-4,265
-4,808
14.2
External expenses
-3,882
-7,857
14.3
Taxes and duties
-176
-127
Net depreciation, amortization and
provisions
-618
-671
Other current operating expenses
-515
-365
Operating expenses
-9,803
-14,178
Other current operating income
213
95
Current operating income
-7,814
-9,794
Other non-current operating income
13,500
14.4
Other non-current operating expenses
-3,492
-24,543
14.4
Share of profit from equity affiliates
-39
Operating income after share of profit
of associates
2,194
-34,376
Cost of net financial debt
-958
-1,018
Other financial income
1,006
Other financial expenses
-395
-659
Financial income
-347
-1,677
15
Tax expenses
-757
2,324
16
- of which deferred taxes
-415
2,330
Consolidated net income
1,089
-33,728
Earnings per share
0.01
(0.55)
17
Diluted earnings per share
0.01
(0.55)
17
In K€
12/31/2020
12/31/2019
Note
Result for the period
1,089
-33,728
Currency translation differences
-71
75
Other items recyclable as a
result
-71
75
Actuarial gains and losses
-22
-54
Other items not recyclable as a
result
-22
-54
Other comprehensive income for the
period, net of tax
-93
21
Total comprehensive income for the
period
996
-33,707
Total comprehensive income attributable
to
the the parent company owners
996
-33,707
Minority interests
Consolidated statement of changes in equity
Changes in reserves and
results
In K€
Capital
Treasury shares
Share premium
Translation reserves
Gains and losses recognized in
equity
Reserves and consolidated
results
Total Differences
TOTAL
Shareholders' equity as of
1/01/2019
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
-71
-22
1,089
996
996
Capital increase
4,250
6,230
188
188
10,668
Treasury shares
7
89
89
95
Other movements
-32,577
14
32,562
32,577
Share-based payments
79
79
79
Shareholders' equity as of
12/31/2020
19,579
-182
18,577
-91
-173
-8,674
-8,938
29,036
Consolidated statement of net cash flows
K€
12/31/2020
12/31/2019
Note
Consolidated net loss
1,089
-33,728
+/- Depreciation, amortization
and provisions, net
-8,215
25,394
6/7/11
(excluding provisions against
working capital)
+/- Unrealized gain and losses
associated with changes in fair value
-290
484
+/- Non-cash income and expenses
on stock options and similar items
79
441
+/- Other calculated income and
expenses
+/- Capital gains and losses on
disposal
57
+/- Dilution gains and losses
+/- Share of equity
affiliates
39
Gross operating cash flow
after cost of net debt and taxes
-7,280
-7,371
+ Cost of net debt
959
1,037
15
+/- Tax expenses (including
deferred taxes)
757
-2,324
16
Gross Operating cash flow
before cost of net debt and taxes
-5,564
-8,658
- Taxes paid
+/- Changes in operating WCR
(including debt related to employee benefits)
886
959
NET CASH FLOW FROM OPERATING
ACTIVITIES
-4,678
-7,699
- Expenditures on acquisition of
tangible and intangible assets
-119
-26
+ Proceeds of disposal of
tangible and intangible assets
6,116
- Expenditures on acquisition of
financial assets
+ Proceeds of disposal of
financial assets
4
163
+/- Effect on changes in scope of
consolidation
14
+ Dividends received (equity
affiliates, unconsolidated investments)
+/- Change in loans and advances
granted
+ Capital grants received
+/- Other changes from investment
transactions
NET CASH FLOW FROM INVESTING
ACTIVITIES
6,015
137
+ Net amount received from
shareholders on capital increase
. Paid by shareholders of
the parent company
10,568
4,743
10
. Paid by minority
interest in consolidated companies
+ Amount received on exercise of
stock options
-/+ Purchase and Sale of treasury
shares
8
+ Amounts received on issuances
of new loans
- Reimbursements of loans
(including lease debts)
-3,094
-2,729
11/12/15
o/w repayment of lease debts
(IFRS16)
-475
-452
+/- Others flows related to
financing activities
-1
-1
NET CASH FLOW FROM FINANCING
ACTIVITIES
7,481
2,014
+/- Effects of fluctuations in
foreign exchange rates
-3
3
CHANGE IN CASH AND CASH
EQUIVALENTS
8,815
-5,545
CASH AND CASH EQUIVALENTS AT
START OF YEAR
5,708
11,253
CASH AND CASH EQUIVALENTS AT
YEAR END
14,523
5,708
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210421005875/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