- New identity unveiled, with the aim at developing innovative
therapies against cancer
- R&D efforts maintained for VIO-01 (formerly OX425) and
AsiDNATM
- Optimization of PlatONTM platform, targeting new assets in
combination with DNA decoys
- Cash position of €16.8 million as of June 30, 2023,
strengthened by a €12 million capital increase
- Financial visibility assured until Q2 2024
- Continue to evaluate opportunities for business
partnerships
Regulatory News:
Valerio Therapeutics S.A. (Euronext Growth Paris: ALVIO),
hereafter “Valerio Therapeutics” or the “Company”, a
clinical-stage biotechnology company specializing in the
development of innovative drugs targeting tumor DNA Damage Response
(DDR), today reports its consolidated half-year financial results
to June 30, 2023, and provides an update on its activities.
Dr. Shefali Agarwal, President and CEO of Valerio
Therapeutics, said: “The first half of 2023 was an important
phase for our Company. By renaming ourselves Valerio Therapeutics,
we highlighted our will to use innovative technologies such as DNA
decoys to advance new anti-cancer treatments.
AsiDNATM, our first-in-class drug candidate, is currently being
evaluated in an ongoing 1b/2 trial in the United State. This study
is in combination with Olaparib in recurrent ovarian, breast and
metastatic castration-resistant prostate cancer and the objective
is to assess the safety and tolerability of the combination as well
as to determine the recommended Phase 2 dose. Patient recruitment
is progressing, and Top-line results are expected this year.
In parallel, AsiDNATM has also continued to be evaluated in two
additional studies in collaboration with French academic research
centers, the first one by Gustave Roussy to combat PARP inhibitor
resistance in second-line maintenance treatment of recurrent
ovarian cancer, and the second one by the Institut Curie in
combination with radiotherapy in recurrent high-grade glioma in
children.
Finally, our R&D efforts have been focused on the
optimization of our PlatONTM platform and the development new
therapeutic agents in oncology and other therapeutic agents. We now
have a lead candidate from the OX400 compound family, VIO-01
(formerly OX425), a pan DNA repair decoy. This product works by
abrogating several DNA repair pathways, inducing a drug-driven
synthetic lethality without the need of a combined treatment. This
potentially is first of its kind product with a broad applicability
and thus represents a promising drug candidate to move forward to
clinical development. We continue to explore new therapeutic
pathways with PlatONTM and think that PROTACs
(PROteolysis-TArgeting Chimeras) technology and other tumor
specific targeting options may be a novel class presenting several
potential benefits when combined with our DNA decoy molecules.
By all these progresses, Valerio Therapeutics is well positioned
to rapidly advance breakthrough therapeutic candidates through
Phase 2 development and, eventually, to contribute to the treatment
of cancer patients globally. Additionally, we are also continuing
active evaluation of business partnerships that can be synergistic
to our pipeline and the team.”
FINANCIAL RESULTS FOR THE FIRST HALF OF 2023
Consolidated income statement
(IFRS)
In thousands of euros
June 30, 2023
June 30,2022
Revenues, of which:
0
0
Recurring revenues
0
0
Non-recurring revenues
0
0
Operating expenses, including:
(11,622)
(9,631)
R&D expenditure with third parties
(5,643)
(4,107)
Other current operating income
28
282
Current operating income
(11,594)
(9,348)
Other non-recurring operating
income
0
385
Income from companies accounted for by
the equity method
Operating income after share of profit
of associates
(11,593)
(8,963)
Financial income
(50)
(2,448)
Income tax expense
0
(59)
Net income
(11,644)
(11,471)
The half-year accounts as of June 30, 2023, drawn up according
to IFRS standards and approved by the Board of Directors on
September 28, 2023, have not been audited nor been the subject of a
limited review; being remembered that a new auditor was appointed
at the shareholders’ meeting held on 6 June 2023.
The Group did not record any consolidated revenues for
the period ended June 30, 2023.
Operating expenses amounted to €11.6 million. The
increase compared to €9.6 million in 2022 is related to the
strengthening of the scientific teams, and to the growth in R&D
expenses. The latter increased by €1.5 million in the first half of
2023 to reach €5.6 million, mainly due to industrial development
and manufacturing of clinical batches for AsiDNATM.
The financial loss as of June 30, 2023, amounted to €50k
compared to a loss of €2.4 million as of June 30, 2022, mainly due
to the cost of the bond issue with SWK Holdings.
The Group's total net loss was thus €11.6 million in the
first half of 2023, compared with a loss of €11.4 million for the
same period in 2022.
CASH POSITION AS OF JUNE 30, 2023
As of June 30, 2023, the Group's cash position was €16.8
million, compared to €14.6 million as of December 31, 2022. This
increase comes from a €12 million financing obtained on June 9,
2023, from the Company’s historical shareholders, Invus and
Financière de la Montagne and a new investor, Agenus Inc. The net
proceeds of this reserved share issue are intended for the
development of VIO-01 (formerly OX425), both clinically and
industrially, for ongoing and future clinical trials and more
generally, to finance the Company's current expenses.
Following the completion of the capital increase, Invus Public
Equities LP and Financière de la Montagne held 28.5% and 19% of the
Company's capital respectively, based on a total of 154,364,273
shares. Agenus held 11.5% of the Company’s capital.
These resources provide the Company with sufficient visibility
to carry out its projects, including the expansion of the clinical
development of AsiDNATM and the continuation of the preclinical
development of the platONTM compounds, including VIO-01, until the
second quarter of 2024.
HIGHLIGHTS OF THE FIRST HALF OF 2023 AND RECENT
DEVELOPMENTS
AsiDNATM
In the United States, the multi-center Phase 1b/2 study
evaluating the safety and efficacy of AsiDNATM in combination with
the PARP inhibitor Olaparib in patients with epithelial ovarian
cancer, breast cancer and metastatic castration-resistant prostate
cancer who have progressed despite initial treatment with PARP
inhibitors was initiated in December 2022, and is currently
ongoing, with 1 patient enrolled in the study. The plan is to
continue enrollment in the dose escalation phase until the third
quarter 2023, convene a Safety Monitoring Committee (SMC) to review
the data and identify dose for expansion.
In addition, during the first half of the year 2023, Valerio
Therapeutics continued supporting two investigator induced studies
conducted in collaboration with two academic research centers of
excellence in oncology:
- The Revocan phase 1b/2 trial evaluating the addition of
AsiDNA™ to combat PARP inhibitor resistance in second-line
maintenance treatment of recurrent ovarian cancer. Gustave Roussy
is the promoter of this study. The pace of recruitment has been
slower than expected and 15 patients have been enrolled in this
first part of the study. The first interim analysis of 10 patients
was conducted in the first half of 2023, showing a Disease Control
Rate (DCR) of 70 %, an overall reduction in the percentage of CA125
(tumor marker) in responding patients, which serves as a proof of
concept of the treatment with AsiDNATM.
- The Phase 1b/2 trial evaluating AsiDNATM in combination with
radiotherapy in recurrent high-grade glioma in children, an
indication with a particularly poor prognosis. The Institut Curie
is the sponsor of this study, which is supported by a grant from
the European Fight Kids Cancer program. The Company has announced
the treatment of a first patient in August 2022, 7 patients were
enrolled in this first part of the study, no data from the study
has been disclosed yet.
VIO-01 (formerly OX425)
During the first half of 2023, the Company continued to optimize
the OX400 pan-DDR DNA decoy family to improve its action on repair
proteins, involved in the tumor DNA repair cascade, and its
activation of the antitumor immune response via the cGAS-STING
pathway.
VIO-01, formerly OX425, is a Pan-DDR DNA Decoy Targeting
Multiple Proteins & Repair Pathways and represents the most
optimal drug candidate selected to enter preclinical development.
VIO-01 traps several DDR Proteins Inhibiting Different DNA Repair
Pathways. VIO-01 reaches the nucleus and acts as a decoy for
several DNA repair enzymes. It has an increased resistance to
nucleases and plasmatic stability.
Valerio Therapeutics presented new preclinical data confirming
the pan-DDR DNA decoy effect of VIO-01 and the high anti-tumor
activity in tumor models independently from the homologous
recombination repair status on April 19, 2023, at the American
Association for Cancer Research (AACR) Annual Meeting. Also, the
Company presented new preclinical data confirming VIO-01’s
capability to abrogate several DNA repair pathways and induce a
drug-driven synthetic lethality, without the need of a combined
treatment.
3rd generation of PlatONTM platform
Valerio Therapeutics continued to optimize the PlatON platform
to develop more potent assets coupled to innovative technologies,
with the objective to combine PlaTON platform’s DNA decoys with the
targeted protein degradation strategy offered by PROTACs
(PROteolysis-TArgeting Chimeras) technology. PROTACs technology and
other tumor specific targeting options may be a novel class of
heterobifunctional molecules that can selectively degrade target
proteins within cells. This approach offers several advantages over
the other molecules involved in modulating the DNA damage response,
such as increased selectivity and reduced toxicity. This specific
strategy involves generating DecoyTAC combining our vectorized DNA
decoy molecules capable of efficient cell penetration with a
linker+E3 ligand promoting the complete degradation of the target
proteins, thereby presenting a novel mechanism of action.
The exploration of the convergence of PROTACs and DNA Decoys
aims to not only propose new therapeutic modalities against DDR
proteins but also against transcription factor proteins that are
challenging to target. Through these efforts, the Company strive to
advance the field of oncology drug development and contribute to
the treatment of cancer patients.
Governance and Corporate
The Annual General Meeting of June 6, 2023, renewed the terms of
Financière de la Montagne, represented by Mr. Nicolas Trebouta, and
Robert Coleman as directors for three years. As of the date of this
report, the Board of Directors is composed of 7 members, 6 men and
1 woman, including 3 independent members.
The Annual General Meeting also approved the change of company
name to Valerio Therapeutics. This name change was accompanied by a
new identity designed to better represent Valerio Therapeutics'
ability to rapidly advance breakthrough therapeutic candidates
through Phase 2 development, and to collaborate with partners for
further development and commercialization. The ISIN code remained
unchanged.
OUTLOOK
In 2023, the Company will continue to pursue its value creation
strategy based on the development of its therapeutic innovations up
to proof-of-concept studies in humans, and then generate revenues
through agreements with other pharmaceutical companies capable of
pursuing their development.
AsiDNA™
- Enrollment to continue in the U.S. phase 1b/2 trial in
combination with Olaparib in ovarian, breast and prostate cancers
to identify the RP2D in combination with Olaparib.
- Clinical updates expected in the second half of 2023 from phase
1b/2 trials conducted in France and European Union under the
sponsorship of academic centers:
- REVOCAN trial with Gustave Roussy;
- Pediatric trial in High-Grade Glioma with Institut Curie;
- Submissions for publications in international scientific
journals of the results of preclinical or clinical studies as part
of the development plan to demonstrate the potential of
AsiDNA.
VIO-01 (formerly OX425)
- Finalization of the IND-enabling preclinical studies.
- Preparation of an IND application with the FDA in second
half-year 2023.
platON™
- Continued evaluation and optimization of PlatONTM platform and
potential new drug candidates.
The 2023 half-year financial report is available on the
Company's website.
***
About Valerio Therapeutics
Valerio Therapeutics (Euronext Growth Paris) 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 Valerio Therapeutics’s proprietary chemistry
platform of DNA decoy therapeutics, which generates new innovative
compounds and broaden the Company’s product pipeline.
AsiDNA, the first compound from platON, is a highly
differentiated, clinical-stage first-in-class candidate in the
field of DNA damage response (DDR) applied to oncology. Its DNA
decoy therapeutic mechanism acting upstream of multiple DDR
pathways results in distinctive antitumor properties, including the
ability to prevent or abrogate tumor resistance to targeted
therapies such as PARP inhibitors and strong synergy with tumor
DNA-damaging agents such as radio-chemotherapy. AsiDNA is currently
being studied in Europe and the US in combination with other
treatment modalities in difficult-to-treat solid tumors.
VIO-01 (formerly OX425), the second compound from platON,
is a novel pan-DDR Decoy with high antitumor activity. It also
mediates multiple immunostimulatory effects by activating the STING
pathway. OX425 is currently undergoing IND-enabling preclinical
development.
For further information, please visit
www.valeriotx.com.
Forward looking statements
This communication expressly or implicitly contains certain
forward-looking statements concerning Valerio Therapeutics 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
Valerio Therapeutics to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Valerio Therapeutics 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 Valerio Therapeutics 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
(https://valeriotx.com/) and/or the AMF (www.amf-france.org).
APPENDIX
CONSOLIDATED FINANCIAL STATEMENTS AT JUNE 30, 2023
Consolidated balance sheet
ASSETS (in thousands €)
June 30, 2023
December 31, 2022
Note
Non-current assets
Intangible assets
20,531
20,531
4
Property, plant and equipment
774
794
Rights of use
872
1,093
5
Other financial assets
240
90
Total non-current assets
22,417
22,507
Current assets
Trade receivables and related accounts
1,473
6.1
Other current receivables
4,777
4,521
6.2
Cash and cash equivalents
16,826
14,586
7
Total current assets
21,603
20,579
TOTAL ASSETS
44,020
43,086
LIABILITIES AND SHAREHOLDERS' EQUITY
(in thousands of €)
June 30, 2023
December 31, 2022
Note
Shareholders' equity
Capital
38,591
27,877
8.1
Less: Treasury shares
-97
-81
8.2
Additional paid-in capital
28,991
27,705
8.3
Retained earnings
-32,666
-13,669
Result
-11,644
-19,562
Total shareholders' equity
23,176
22,270
Non-current liabilities
Non-current provisions
764
869
9.1
Deferred tax liability
Non-current financial debts
7,547
8,104
9.2
Non-current lease liabilities
450
646
9.2
Other non-current liabilities
4,048
Total non-current liabilities
8,762
13,667
Current liabilities
Current provisions
20
Short-term borrowings and financial
liabilities
1,212
1,003
10.1
Current lease liabilities
327
335
Trade payables and related accounts
4,388
3,449
10.2
Other current liabilities
6,155
2,342
10.3
Total current liabilities
12,082
7,149
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
44,020
43,086
Consolidated statement of comprehensive income
In thousands of €
June 30, 2023
June 30, 2022
Note
Recurring revenue from license
agreements
Non-recurring revenue from license
agreements
Total revenues
0
0
11.1
Purchases consumed
-219
-242
Personnel expenses
-5,011
-4,258
11.2
External expenses
-6,128
-4,652
11.3
Taxes
-28
-25
Net depreciation and provisions
-111
-237
Other current operating expenses
-127
-217
Operating expenses
-11,622
-9,631
Other current operating income
28
282
Recurring operating income
-11,594
-9,348
Other operating income
0
385
Other operating expenses
-417
0
Share of profit from equity affiliates
Operating income after share of profit
from equity affiliates
-11,593
-8,963
Cost of net financial debt
-14
-2,154
Other financial income
10
122
Other financial expenses
-46
-416
Financial income
-50
-2,448
12
Income before tax
-11,644
-11,412
Income tax expense
0
-59
- of which deferred tax
Net income of all consolidated
accounts
-11,644
-11,471
Earnings per share
-0.08
-0.11
13
In thousands of €
June 30, 2023
June 30, 2022
Note
Earnings for the period
-11,644
-11,471
Translation differences
133
113
Other items that can be reclassified to
profit or loss
133
113
Actuarial gains and losses
93
Other items that cannot be reclassified
to profit or loss
93
Other comprehensive income for the
period, net of tax
133
207
Total comprehensive income for the
period
-11,511
-11,264
Total comprehensive income attributable
to:
- owners of parent
- non-controlling interests
-11,511
-11,264
Consolidated statement of net cash flows
In thousands of €
Note
June 30, 2023
December 31, 2022
June 30, 2022
Consolidated net income
-11,644
-19,562
-11,471
+/- Net depreciation and provisions
(excluding those related to current assets)
4, 5, 9.1
125
-167
48
-/+ Unrealized gains and losses related to
changes in fair value
174
+/- Income and expenses calculated in
relation to stock options and similar instruments
8.4
270
213
219
-/+ Other calculated income and
expenses
724
-/+ Capital gains and losses on
disposals
-/+ Dilution gains and losses
+/- Share of profit from equity
affiliates
+/- Other items with no impact on cash
Cash flow from operations after cost of
net financial debt and tax
-11,249
-18,792
-11,029
+ Cost of gross financial debt
12
42
2,189
2,157
+/- Tax expense (including deferred
taxes)
285
59
Cash flow from operations before cost
of net financial debt and tax
-11,207
-16,318
-8,813
- Tax paid
+/- Change in operating working capital
requirements (including employee benefit liabilities)
2,087
-6,875
7,368
NET CASH FLOW PROVIDED BY OPERATING
ACTIVITIES
-9,120
-9,443
-1,446
- Disbursements related to acquisitions of
property, plant and equipment and intangible assets
-97
-488
-71
+ Cash receipts related to disposals of
property, plant and equipment and intangible assets
- Disbursements related to acquisitions of
financial assets (non-consolidated shares)
+ Cash receipts related to disposals of
financial assets (non-consolidated shares)
80
3
+/- Impact of changes in the scope of
consolidation
+ Dividends received (equity affiliates,
non-consolidated shares)
+/- Change in loans and advances
granted
+ Investment grants received
+/- Other flows related to investment
operations
NET CASH FLOW USED IN INVESTING
ACTIVITIES
-97
-409
-68
+ Sums received from shareholders on
capital increases
. Paid by the shareholders of the parent
company
8.1
12,000
7,875
7,961
. Paid by minority shareholders of
consolidated companies
+ Amounts received on exercise of stock
options
-/+ Net repurchases and resales of own
shares
8.2
99
37
+ Cash inflow from new loans
- Loan repayments (including finance
leases)
9.2, 10.1
-550
1,513
2,343
Of which reimbursement of rights of use
(IFRS16)
-166
-405
-238
+/- Other flows related to financing
operations
-7
1
3
NET CASH FLOW USED IN FINANCING
ACTIVITIES
11,443
6,463
10,343
+/- Impact of foreign exchange rate
changes
12
87
144
CHANGE IN NET CASH FLOW
2,238
-3,301
8,974
INITIAL CASH FLOW
14,585
17,886
17,886
FINAL CASH FLOW
16,823
14,585
26,861
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version on businesswire.com: https://www.businesswire.com/news/home/20230928112317/en/
Valerio Therapeutics Investor Relations investors@valeriotx.com +33 1 45 58 76 00
Media Relations Arthur Rouillé NewCap valeriotx@newcap.eu +33 1 44 71 94 98
Investor Relations / Strategic Communication Dušan
Orešanský / Nicolas Fossiez NewCap valeriotx@newcap.eu +33 1 44 71 94 92
Valerio Therapeutics (EU:ALVIO)
Gráfica de Acción Histórica
De Dic 2024 a Ene 2025
Valerio Therapeutics (EU:ALVIO)
Gráfica de Acción Histórica
De Ene 2024 a Ene 2025
