- Development milestone achieved for SENS-501 (OTOF-GT)
program with the submission of Clinical Trial Applications in the
UK and in Europe
- GJB2-GT advancing towards IND-enabling activities after
candidate selection
- Positive preliminary efficacy results of Proof-of-Concept
Phase 2a clinical trial of SENS-401 to prevent residual hearing
loss following cochlear implantation
- Completion of a private placement of €35million led by
US-based healthcare investor, Redmile Group, and renewed support
from existing shareholders, Invus and Sofinnova Partners; extended
cash runway until the end of September 2024
Regulatory News:
Sensorion (FR0012596468 – ALSEN) a pioneering
clinical-stage biotechnology company which specializes in the
development of novel therapies to restore, treat, and prevent
within the field of hearing loss disorders, announces its half-year
results as of June 30, 2023, alongside its outlook for the
remainder of 2023.
Nawal Ouzren, CEO of Sensorion, said: “Over the past few
months, Sensorion has achieved several decisive milestones on its
roadmap to develop solutions that will potentially improve the
quality of life of patients suffering from hearing disorders. In
August, in a difficult market environment, we succeeded in closing
a major round of financing from international investors with unique
gene therapy expertise. This deal strengthens our financial
visibility and our stable, committed, and ambitious shareholder
base. At the same time, we have made significant regulatory and
operational progress with our most innovative programs, in
particular SENS-501. We are positioned to bring our first gene
therapy drug candidate into the clinic by mid-2024 and to reaffirm
our ambition to rank among the leaders in a field which holds
immense promise for patients suffering from genetic hearing loss,
and which is attracting growing interest from the pharmaceutical
industry. In parallel, building on the very promising clinical
results unveiled in July, we are confidently pursuing the clinical
development of SENS-401, with the support of our Australian partner
Cochlear Limited. As we enter an extremely exciting period for
Sensorion, I would like to thank all our shareholders, both
individual and institutional, for their support and loyalty.”
Pipeline Highlights and Upcoming Milestones
During the first half of 2023, Sensorion continued to develop
innovative therapies to restore hearing, to treat and prevent
hearing loss to potentially transform the patients’ quality of life
suffering from hearing loss disorders.
Gene Therapies for Hereditary Monogenic Hearing Loss
Sensorion continues to advance its gene therapy programs,
developed as part of its collaboration with the Institut Pasteur.
The framework agreement with the Institut Pasteur grants Sensorion
an exclusive option to obtain exclusive licenses to develop and
commercialize drug candidates in gene therapy for the restoration
of hearing. The company has expanded its technical development
capabilities over the period along with pilot-scale non-GMP (Good
Manufacturing Practices) manufacturing capacity.
- SENS-501 (OTOF-GT): milestones achieved with Clinical Trial
Application submissions to the UK’s MHRA and in Europe. First
Patient Inclusion expected in H1 2024
Sensorion’s SENS-501 (OTOF-GT) dual AAV vector gene therapy
development program aims at restoring hearing in patients with
mutations in the OTOF gene, who suffer from severe to profound
sensorineural prelingual non syndromic hearing loss. Otoferlin, the
product of the OTOF gene, is a protein expressed in the inner hair
cells (IHC) present in the cochlea and is critical for the
transmission of the signal to the auditory nerve. Otoferlin
deficiency related hearing loss is responsible for up to 8% of all
cases of congenital hearing loss, with around 20,000 people
affected in the US and Europe1.
SENS-501 previously received Orphan Drug Designation from the US
Food and Drug Administration (FDA)2 and the European Medicines
Agency (EMA)3 and Rare Pediatric Disease Designation from the FDA
in Q4 2022, which support the medical plausibility and development
plan of the Company’s lead gene therapy program.
In the first half of 2023, Sensorion achieved a major
development milestone by completing the preclinical package, and
successfully producing the GMP dual AAV OTOF-GT batches at 200L
clinical scale. The production will enable the Company to cover the
needs for the envisioned Phase 1/2 gene therapy clinical trial.
Following the positive feedback from regulatory agencies EMA,
ANSM (French National Agency for Medicines and Health Products
Safety) and the UK’s MHRA (Medicines and Healthcare product
Regulatory Agency), Sensorion has submitted a Clinical Trial
Application (CTA) to initiate a Phase 1/2 clinical trial of
SENS-501 to the UK’s MHRA on July 10, 2023, and in Europe on July
19, 2023.
In parallel, Sensorion submitted a Medical Device Application
for the injection system. This injection device is intended at
administering gene therapy into the cochlea for the envisioned
Phase 1/2 clinical trial. In the framework of the medical device
development, Sensorion is collaborating with Eveon, a company
specialized in designing and manufacturing custom medical devices
for the preparation and delivery of drugs.
The Company expects the first CTA approval by end of 2023 and
subsequent CTA approvals as early as H1 2024. Inclusion of the
first patient is expected within H1 2024.
OTOCONEX, the Company’s Natural History Study to document the
natural course of disease progression in otoferlin deficiency
patients and in children with hearing loss related to GJB2
mutations, is running across Europe.
- GJB2-GT accelerating IND-enabling studies towards clinical
development
Sensorion's GJB2 gene therapy program, developed in
collaboration with the Institut Pasteur, has the potential to
address three pathologies related to GJB2 mutations: early onset of
presbycusis in adults, progressive forms of hearing loss in
children, and pediatric congenital deafness. Although the types of
GJB2 mutations in children and adults may differ, gene therapy
offers potential solutions for both.
In April 2023, Sensorion announced the candidate selection for
GJB2-GT during its R&D Day focusing on gene therapy. The
candidate designed with a specific adeno-associated virus (AAV)
capsid safely targets key cells in the ear that normally express
GJB2. A replay of the R&D Day is available in the “Past Events”
section of the Company’s website.
Sensorion has acquired bioreactors and has initiated the non-GMP
process development of the GJB2 candidate up to 50L scale. Process
and analytical methods will be transferred to the CDMO for the GMP
production of the clinical batch. Sensorion is advancing the
candidate into IND-enabling activities for future clinical
development.
SENS-401
Sensorion is developing SENS-401 (Arazasetron) in two Proof of
Concept Phase 2a clinical trials. The first one is designed to
assess SENS-401 for residual hearing preservation following
cochlear implantation in partnership with Cochlear Limited, and the
second one is a proof-of-concept trial to prevent Cisplatin-Induced
Ototoxicity (CIO).
SENS-401 is an orally available small molecule that aims to
protect and preserve inner ear tissue from damage responsible of
hearing impairment. SENS-401 has been granted Orphan Drug
Designation by the EMA in Europe for the treatment of sudden
sensorineural hearing loss (SSNHL), and by the FDA in the U.S. for
the prevention of platinum-induced ototoxicity in pediatric
population.
- Milestone achieved for SENS-401 to prevent residual hearing
loss after cochlear implantation with positive preliminary efficacy
data. Final data readout planned in H1 2024
Sensorion is advancing its small molecule SENS-401 in a
multicentric, randomized, controlled open label Phase 2a trial
aimed at evaluating the presence of SENS-401 in the cochlea
(perilymph) after 7 days of twice-daily oral administration in
adult patients prior to cochlear implantation due to moderately
severe to profound hearing impairment. Patients start treatment
with SENS-401 7 days before implantation and continue to receive
SENS-401 for a further 42 days.
In June 2023, Sensorion disclosed preliminary data from the
Phase 2a study showing SENS-401 presence in the perilymph of all 5
adult patients treated with the product. Levels of SENS-401 were
considered consistent with potential therapeutic effects after 7
days of repeated oral treatment.
In July 2023, Sensorion reported further analysis during its KOL
webinar suggesting that SENS-401 treated patients demonstrated a
clinically significant 21 dB improvement in the preservation of
their residual hearing compared to the control group 6 weeks after
cochlear implantation at 500 Hz. Indeed, in the SENS-401-treated
group (N=5), the loss of residual hearing was only 12 dB,
contrasting with a larger loss of 33 dB observed in the control
group of 4 participants not treated with SENS-401. These
preliminary and promising findings reinforce the hypothesis that
SENS-401, by crossing the labyrinthine barrier to reach the
cochlear compartment, has a positive effect on the preservation of
residual hearing.
Sensorion anticipates the publication of the POC Phase 2a
clinical trial of SENS-401 final data in H1 2024.
- Progressing on SENS-401 in Cisplatin-Induced Ototoxicity
(CIO)
Cisplatin and other platinum compounds are essential
chemotherapeutic agents for many malignancies. Unfortunately,
platinum-based therapies cause ototoxicity, or hearing loss, which
is permanent, irreversible, and particularly harmful to 50-60% of
adult patients and 90% of pediatric patients who survive
cancer.
The NOTOXIS clinical trial application was approved in 2022
following further analysis of the AUDIBLE-S study data, Sensorion’s
Phase 2 study of SENS-401 which was completed in Sudden
Sensorineural Hearing Loss (SSNHL) in January 2022.
The exploratory Phase 2a, multicenter, randomized, controlled,
open-label study, NOTOXIS, aims at evaluating the efficacy of
SENS-401 to prevent ototoxicity induced by cisplatin in adult
patients with a neoplastic disease. The trial also assesses several
outcome measures, including the rate and severity of ototoxicity,
the change in Pure Tone Audiometry (PTA) (dB) throughout the study
and the tolerance.
The first patient was enrolled in December 2022 and Sensorion
anticipates the publication of the preliminary results in H2
2023.
Expected future milestones
- H2 2023 – SENS-401 CIO: NOTOXIS Phase 2a preliminary
results
- H2 2023 – OTOF-GT: First CTA Approval
- H1 2024 – SENS-401 in combination with cochlear implantation:
Final proof-of-concept Phase 2a clinical data readout
- H1 2024 – OTOF-GT: First Patient Inclusion
- GJB2-GT: Ongoing IND-enabling preclinical activities
First-half 2023 financial highlights
Cash & Cash Equivalents amounted to €14.4million as of June
30, 2023, compared to €26.2 million as of December 31, 2022.
- Research And Development (R&D) Expenses
R&D expenses increased by 11% from €11.1 million in H1 2022
to €12.3m in H1 2023, primarily due to an increase in gene therapy
programs with OTOF-GT CTA-enabling activities.
- General And Administrative (G&A) Expenses
G&A expenses were €2.6 million for half-year 2023, compared
to €3.0 million for the same period in 2022.
Net loss was -€12.3 million for half-year 2023, at the same
level as for half-year 2022.
Based on its forecasted expenses, the cash position of €14.4
million as of June 30, 2023, together with the €35 million proceeds
received from the August private placement, the Company expects to
be able to fund its operations until end of Q3 2024.
Financial structure
The annual accounts on June 30, 2023, drawn up according to IFRS
standards and approved by the Board of Directors on September 18,
2023.
The simplified income statement as of June 30, 2023, is as
follows:
In Euros – IFRS standards
30.06.2023
30.06.2022
Operating income
2.647.410
1.901.426
Research & Development expenses
-12.271.319
-11.079.153
General & Administrative expenses
-2.572.414
-3.037.382
Total operating expenses
-14.843.733
-14.116.535
Operating loss
-12.196.324
-12.215.108
Financial result
130.452
-49.383
Net loss
-12.287.783
-12.264.491
The simplified balance sheet as of June 30, 2023, is as
follows:
In Euros – IFRS standards
30.06.2023
31.12.2022
Non-current Assets
3.188.770
3.175.915
Other Current Assets
9.900.707
9.565.307
Cash & cash equivalent
14.447.336
26.203.905
Total Assets
27.536.812
38.945.127
Equity
9.865.173
21.885.121
Non-current Liabilities
3.047.808
3.467.116
Current Liabilities
14.623.832
13.592.890
Total Liabilities
27.536.812
38.145.127
First-Half 2023 certified accounts On September 18th,
2023, the Board of Directors approved the Company’s first half-year
results as of June 30, 2023. The Half-Year Financial Report can be
found on Sensorion’s website (https://www.sensorion.com/en/home/)
in the investor section under financial information. The first-half
year accounts of 2023 have been subject to a limited review by the
Company’s statutory auditors and an unqualified report is being
issued.
About Sensorion Sensorion is a pioneering clinical-stage
biotech company, which specializes in the development of novel
therapies to restore, treat, and prevent hearing loss disorders, a
significant global unmet medical need. Sensorion has built a unique
R&D technology platform to expand its understanding of the
pathophysiology and etiology of inner ear related diseases,
enabling it to select the best targets and mechanisms of action for
drug candidates.
It has two gene therapy programs aimed at correcting hereditary
monogenic forms of deafness, developed in the framework of its
broad strategic collaboration focused on the genetics of hearing
with the Institut Pasteur. OTOF-GT targets deafness caused by
mutations of the gene encoding for otoferlin and GJB2-GT targets
hearing loss related to mutations in GJB2 gene to potentially
address important hearing loss segments in adults and children. The
Company is also working on the identification of biomarkers to
improve diagnosis of these underserved illnesses.
Sensorion’s portfolio also comprises clinical-stage small
molecule programs for the treatment and prevention of hearing loss
disorders.
Sensorion’s clinical-stage portfolio includes one Phase 2
product: SENS-401 (Arazasetron) progressing in a planned Phase 2
proof of concept clinical study of SENS-401 in Cisplatin-Induced
Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of
SENS-401 in patients scheduled for cochlear implantation. A Phase 2
study of SENS-401 was also completed in Sudden Sensorineural
Hearing Loss (SSNHL) in January 2022.
www.sensorion.com
Label: SENSORION ISIN: FR0012596468 Mnemonic:
ALSEN
Disclaimer This press release contains certain
forward-looking statements concerning Sensorion and its business.
Such forward looking statements are based on assumptions that
Sensorion considers to be reasonable. However, there can be no
assurance that such forward-looking statements will be verified,
which statements are subject to numerous risks, including the risks
set forth in the 2022 full year financial report published on March
30, 2023, and available on our website and to the development of
economic conditions, financial markets and the markets in which
Sensorion operates. The forward-looking statements contained in
this press release are also subject to risks not yet known to
Sensorion or not currently considered material by Sensorion. The
occurrence of all or part of such risks could cause actual results,
financial conditions, performance, or achievements of Sensorion to
be materially different from such forward-looking statements. This
press release and the information that it contains do not
constitute an offer to sell or subscribe for, or a solicitation of
an offer to purchase or subscribe for, Sensorion shares in any
country. The communication of this press release in certain
countries may constitute a violation of local laws and regulations.
Any recipient of this press release must inform oneself of any such
local restrictions and comply therewith.
1 Rodríguez-Ballesteros M, et al., . A multicenter study on the
prevalence and spectrum of mutations in the otoferlin gene (OTOF)
in subjects with nonsyndromic hearing impairment and auditory
neuropathy. Hum Mutat. 2008 Jun;29(6):823-31. doi:
10.1002/humu.20708. PMID: 18381613. 2 FDA Orphan Drug Designations
and Approvals
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm
3 EU Community Register of orphan medicinal products
https://ec.europa.eu/health/documents/community-register/html/o2698.htm
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version on businesswire.com: https://www.businesswire.com/news/home/20230919767340/en/
Investor Relations Noémie Djokovic, Investor Relations
and Communications Associate ir.contact@sensorion-pharma.com
Press Relations Ulysse Communication Pierre-Louis Germain
/ 00 33 (0)6 64 79 97 51 plgermain@ulysse-communication.com
Bruno Arabian / 00 00(0)6 87 88 47 26
barabian@ulysse-communication.com
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