- Acquisition of Emglev Therapeutics to focus on discovering
single-domain antibodies (sdAbs)
- The VIO-01 trial is currently in Phase 1 dose
escalation
- R&D efforts maintained for optimization of the PlatONTM
platform, targeting new assets in combination with DNA
decoys
- 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) and driver oncogenes, today announced the publication of the
Company’s 2024 half-year report. The 2024 half-year report is
available to the public on the Company’s website/investor
relations/financial information.
On September 29, 2024, Valerio portfolio was extended with the
acquisition of Emglev Therapeutics, bringing to the Company,
through its subsidiary Valour Bio, a unique proprietary platform of
fully synthetic single domain antibodies (sdAbs), Valour Bio has
been established as a wholly owned subsidiary of Valerio
Therapeutics to focus on discovering single domain antibodies
(sdAbs) as drug and radio conjugates, bispecific T-cell engagers,
blocking and binding sdAbs, or CAR-T sdAb drug candidates for
multiple therapeutic areas (see section “post-closing events”).
Dr. Shefali Agarwal, President and CEO of Valerio
Therapeutics, said: “The first half of 2024 was an important
phase for our Company. By initiating a Phase 1 clinical trial in
VIO-01 and continuing to develop our pipeline, we highlighted our
will to use innovative technologies, such as DNA decoys, to advance
new anti-cancer treatments. Additionally, we are also very excited
about the acquisition of Emglev Therapeutics through our newly
formed subsidiary Valour Bio, which highlights our vision to
develop innovative drugs using next-generation technology. Emglev’s
sdAb technology offers unique advantages in the conjugation of sdAb
in different modalities such asradio-conjugates, bispecific T-cell
engagers, blocking sdAbs and CAR-T sdAb drugs. Combining Emglev's
talent and expertise in sdAb with the knowledge and skills of
Valerio Therapeutics’ research and development teams will enhance
opportunities to improve the care of people living with
debilitating diseases.”
FINANCIAL RESULTS FOR THE FIRST HALF OF 2024
Consolidated income statement
(IFRS)
In thousands of euros
June 30, 2024
June 30, 2023
Revenues, of which:
0
0
Recurring revenues
0
0
Non-recurring revenues
89
0
Operating expenses, including:
(10,839)
(11,622)
R&D expenditure with third parties
(4,360)
(5,643)
Other current operating income
2
28
Current operating income
(10,837)
(11,594)
Other non-recurring operating
income
(88)
0
Income from companies accounted for by
the equity method
Operating income after share of profit
of associates
(10,925)
(11,593)
Financial income
(33)
(50)
Income tax expense
0
0
Net income
(10,958)
(11,644)
The half-year accounts as of June 30, 2024, drawn up according
to IFRS standards and approved by the Board of Directors on
September 30, 2024, have not been audited nor been the subject of a
limited review.
The Group did not record any consolidated revenues for the
period ended June 30, 2024.
Operating expenses amounted to €10.8 million. The decrease
compared to €11.6 million in first-half 2023 is mainly due to €700K
loss reduction due to a decrease in payroll.
The financial loss as of June 30, 2024, amounted to €33k
compared to a loss of €50k as of June 30, 2023.
The Group's total net loss was thus €11 million in the first
half of 2024, compared with a net loss of €11.6 million for the
same period in 2023.
CASH POSITION AS OF JUNE 30, 2024
The Group's cash balance on June 30, 2024, was €4 million,
compared with €6.8 million on December 31, 2023. The change in cash
is mainly due to the shareholders’ loans received from Artal and
Financière de la Montagne in May 2024, and the expenses incurred
for acquiring Emglev in cash and developing its research
programs.
The cash on hand as of June 30, 2024, along with the receipt of
the Research Tax Credit, the Clinical partnership, the Service
agreement with Valour Bio, and the optimization of the operational
expenses, provides Valerio Therapeutics with financial visibility
through the end of 2024.
HIGHLIGHTS OF THE FIRST HALF OF 2024 AND RECENT
DEVELOPMENTS
VIO-01
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. The Company
also 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 for a combined treatment.
VIO-01 underwent late-stage IND-enabling preclinical development
in 2023, with the execution of regulatory toxicology and ADME/PK
studies. This package allowed IND submission to FDA followed by
approval to start first-in-human clinical trial.
In clinical development
The Company gained IND clearance from the FDA in November 2023
to conduct a Phase1/2 trial evaluating VIO-01 in patients with
recurrent or metastatic homologous recombination repair mutated or
homologous repair deficient solid tumors. The trial is currently in
Phase 1 dose escalation which is evaluating the safety,
tolerability, dose-limiting toxicities and recommended phased 2
dose of VIO-01. Currently, the trial has enrolled 6 patients across
two dose levels. The VIO-01 trial is currently in Phase 1 dose
escalation, evaluating the safety, tolerability, dose-limiting
toxicities, and recommended Phase 2 doses of VIO-01. Currently, the
trial has enrolled 6 patients across two dose levels. VIO-01 has
shown an acceptable safety profile and plans to proceed through
dose escalation for the remainder of 2024. Once the recommended
dose is determined, the trial is planned to proceed to the Phase 2
expansion, which will evaluate the activity of VIO-01 in HRD+
ovarian cancer and in HRRm/HRD+ solid tumors. The Phase 2 expansion
is planned to assess the preliminary efficacy. Based on the
evidence generated in the Phase1/2 trial further development may
include additional combinations of chemotherapy or targeted
therapies with VIO-01 or development in additional solid
tumors.
3rd generation of PlatON platform – the DecoyTAC
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 strives
to advance the field of oncology drug development and contribute to
the treatment of cancer patients.
AsiDNA™
AsiDNA™ is a first-in-class DNA Decoy that traps and sequesters
DNA-PK, a complex of proteins involved in the DNA Damage Response.
AsiDNA™ thus induces inhibition of DNA-PK-dependent DNA repair in
tumor cells, which nevertheless continues its replication cycle but
with damaged DNA, thus leading to cell death. AsiDNA is used in
combination with other tumor DNA damaging agents such as
radiotherapy and chemotherapy, or in combination with inhibitors of
a specific repair pathway such as PARPi or other targeted
therapies, to increase their efficacy, notably by abrogating any
resistance to these treatments, without increasing toxicity.
AsiDNA™ specifically targets tumor cells and has a very favorable
safety profile in humans observed in four Phase 1/1b clinical
studies.
Given the limited efficacy observed during phase 1 clinical
trials especially as a monotherapy, it was not considered
beneficial for patients to further pursue clinical development of
AsiDNA™ or initiate a phase 2 study. Furthermore, AsiDNA™ is
assumed to generate no revenue and only have minor carrying costs
for company industrial property. For all these reasons, it was
decided to deprioritize AsiDNA™ clinical investigation to focus
efforts on the development of VIO-01, our second-generation drug
candidate.
GOVERNANCE AND CORPORATE
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.
OUTLOOK
In 2024, the Company will continue to pursue its value-creation
strategy based on developing its therapeutic innovations up to
proof-of-concept studies in human and then generate revenues
through agreements with other pharmaceutical companies capable of
pursuing their development.
The Company anticipates the following major events:
AsiDNA™
- The U.S. phase 1b/2 trial of AsiDNA in
combination with Olaparib in ovarian, breast, and prostate cancers
was discontinued before proceeding to Phase 2 as the company has
prioritized efforts and resources to the next-generation candidate
VIO-01. The development of AsiDNA has been deprioritized, and no
clinical studies investigating its use are ongoing.
VIO-01 (formerly OX425)
- Continuation of dose escalation throughout
2024. - Initiation of Phase 2 expansion 2H 2025.
platON™
- Continued evaluation and optimization of
PlatON platform and potential new drug candidates.
Emglev / proprietary platform of fully synthetic single
domain antibodies (sdAbs)
- Valour Bio has been established as a wholly
owned subsidiary of Valerio Therapeutics to focus on discovering
single domain antibodies (sdAbs) as drug and radio conjugates,
bispecific T-cell engagers, blocking and binding sdAbs, or CAR-T
sdAb drug candidates for multiple therapeutic areas. - Valerio
Therapeutics' R&D team will provide services to Valour Bio
throughout 2024 and beyond to develop the first proof-of-concept
bispecific nanobody for the treatment of autoimmune disease.
Additionally, Valerio Therapeutics is continuing to actively
evaluate business partnerships that can be synergistic with its
pipeline and team. Valerio Therapeutics believes that, given its
current activities, it has no further comments to make on trends
that would likely affect its recurring revenues and general
operating conditions from the end of the last fiscal year, which
ended December 31, 2023, until the date of publication of this
report.
The 2024 half-year financial report is available on the
Company's website.
About Valerio Therapeutics
ValerioTX (Euronext Growth Paris: ALVIO) 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 ValerioTX’s proprietary chemistry platform of
oligonucleotides acting as decoy agonists, which generates
new innovative compounds and broadens the Company’s product
pipeline.
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. The VIO-01 trial is currently in Phase 1 dose
escalation, evaluating the safety, tolerability, dose-limiting
toxicities, and recommended Phase 2 doses of VIO-01. Currently, the
trial has enrolled 6 patients across two dose levels. VIO-01 has
shown an acceptable safety profile and plans to proceed through
dose escalation for the remainder of 2024. Once the recommended
dose is determined, the trial is planned to proceed to the Phase 2
expansion, which will evaluate the activity of VIO-01 in HRD+
ovarian cancer and HRRm/HRD+ solid tumors. The Phase 2 expansion is
planned to assess the preliminary efficacy.
DecoyTAC: the 3rd generation platON™ platform,
leveraging the unique MOA of DNA decoy therapeutics coupled to
targeted protein degradation (PROTAC). This evolution expands the
activity of platON™ platform beyond DNA repair by targeting other
proteins such as transcription and epigenetic factors, in oncology
and outside oncology for other diseases like inflammatory and
muscular diseases.
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 financial report 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).
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Valerio Therapeutics Investor Relations ir@valeriotx.com
France: +33 (0) 1 70 38 33 99 U.S.: +1 617 366 1022
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