-
SENS-111 phase 2 AUV trial: major progress with 75% of patients
enrolled in the clinical trial assessing the efficacy of SENS-111 on
vertigo intensity -
SENS-111 phase 2a trial: the phase 2a trial has achieved its
tolerance primary end point; SENS-111 affects neither the vigilance
nor the cognitive performance of patients during a motion stimulus -
SENS 401: entry in phase 2 strengthens the pipeline with the
treatment of sudden sensorineural hearing loss -
€2.7m in cash at 31 December 2018 and a bond issue offering the
company gross income of €4.7m on 11 March 2019
MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering
clinical-stage biopharmaceutical company which specializes in the
development of novel therapies to restore, treat and prevent inner ear
diseases such as hearing loss, tinnitus and vertigo, today announces its
annual results at 31 December 2018 and its outlook for 2019.
‘The repositioning of our AUV phase 2 clinical trial for SENS-111 has
borne fruit, we have obtained the necessary regulatory approval and are
now proud to announce that we have enrolled 75% of the patients. We
confirm that the results of the proof of concept trial will be announced
in the second half. Following the bond issue in March 2019, we believe
that cash in hand will carry us through until the middle of the second
half. 2019 will be a turnaround year for Sensorion. We expect two major
clinical phase 2 results in the second half for our two drugs SENS-111
and SENS-401. Sensorion now has a promising pipeline enabling it to
offer therapeutic solutions to Prevent and Treat inner ear disorders’,
states Nawal Ouzren, Sensorion CEO.
2018 financial results
The annual accounts at 31 December 2018, drawn up according to IFRS
standards and approved by the Board of Directors on 26 March 2019, have
been duly reviewed by statutory auditors and the certification report is
being issued.
They show an increase in Research & Development spending, linked to the
launch of a phase 2 clinical trial for SENS-401 in the second half of
2018.
The simplified income statement at 31 December 2018 is as follows:
| In Euros – IFRS standards | 31.12.2018 | 31.12.2017 | ||||
| Operating income | 2,309,859 | 2,025,413 | ||||
| Research & Development expenses | 11,907,943 | 7,872,735 | ||||
| General & Administrative expenses | 2,627,684 | 3,668,464 | ||||
| Total operating expenses | 14,535,677 | 11,541,199 | ||||
| Operating profit/loss | -12,225,767 | -9,515,785 | ||||
| Financial profit/loss | -124,254 | -170,379 | ||||
| Net profit/loss | -12,350,021 | -9,686,164 | ||||
At 31 December 2018, Sensorion operating income, mainly the
research tax credit, amounted to €2.2m, i.e. +18.9% compared with 31
December 2017.
Operating expenses rose 26%, moving up from €11.5m at 31 December
2017 to €14.5m at 31 December 2018, mainly owing to the preparation of
the launch of the phase 2 clinical trial with SENS-401 in the treatment
of sudden hearing sensorineural loss and execution of the SENS-401
toxicology programme.
G&A expenses are down 28%; they amounted to some €2.6m at 31 December
2018 compared with €3.7m at 31 December 2017.
Operating loss at 31 December 2018 thus came to -€12.2m, compared
with -€9.5m at 31 December 2017.
Net loss came to -€12.3m at 31 December 2018 versus a net
loss of -€9.7m at 31 December 2017.
At 31 December 2018, the company employed 18 persons.
Financial structure
Total equity came to €3.5m at 31 December 2018 versus €7.4m at 31
December 2017 In May 2018, the company undertook a €8.65m share issue,
broadening the shareholder base, notably with the entry into the capital
of US investors such as Novalis LifeSciences (created by Marijn Dekkers).
Financial debt was reduced to €1.7m versus 2.2m at December 2017,
following the conversion of the Yorkville bond (40 convertible bonds
were converted in Q1 2018). The contract signed with Yorkville for
financing via convertible bonds with share warrants (‘OCABSA’) was done
on 18 November 2018.
At 31 December 2018, Sensorion cash and cash equivalents amounted to
€2.7m versus €8.8m at 30 June 2018. Cash flow linked to operating
activities and investment amounted to €12.5m.
At 31 December 2018, the company lacked sufficient net working capital
to meet its cash requirements for the coming 12 months. Following the
bond issue generating €4.7m in gross income, and as of today, the
company has requisite cash to ensure coverage of its day-to-day expenses
and its development out till the middle of the second half of 2019.
Hence the company has led and continue to lead the search for financing
solutions mainly industrial partnership contracts or licence agreements
on one or several of its product candidates but also the search for
non-dilutive financing (grants and/or repayable advances) specifically
to fund the company’s research programs. Those financing solutions could
comprise
-
the search for financing via debt, simple or bond debt, convertible or
not; - further cash call with historic shareholders;
-
the search for investors as part of fund raising that may take the
form of an immediate share issue (reserved or not).
In addition, the company may re-dimension its operational plans by
postponing or limiting the extent of its research and development
programmes.
Capital breakdown
The company’s capital breakdown at 31 December 2018 is as follows. The
two last columns include the impact of any conversion of the entirety of
the convertible bonds issued in March 2019 (the ‘CBs’).
| Shareholders | Number of shares |
% capital and |
Number of shares |
% capital and |
|||||||||
| Bpifrance Investissements (Innobio) | 3,499,874 | 26.79% | 3,499,874 | 20.83% | |||||||||
| Inserm Transfert Initiative | 982,911 | 7.52% | 982,911 | 5.85% | |||||||||
| Cochlear | 533,755 | 4.09% | 533,755 | 3.18% | |||||||||
| Free float | 7,878,886 | 60.3% | 7,878,886 | 46.90% | |||||||||
| Management | 170,506 | 1.30% | 170,506 | 1.02% | |||||||||
| CB holders | – | – | 3,733,574 | 22.22% | |||||||||
| Total | 13,065,932 | 100.00% | 16,799,506 | 100.00% | |||||||||
|
Convertible bonds converted on the basis of the Sensorion share |
|||||||||||||
Key developments in 2018
Research and development
-
SENS-111 drug candidate:
enrolment of 75% of the patients in the phase 2 proof of concept
Sensorion has undertaken clinical phase 2 tests with SENS-111 in acute
unilateral vestibulopathy (AUV). AUV has been chosen as the first
indication to initiate the SENS-111 clinical programme as it is a pure
disease for which the patient phenotype is quite homogenous. Two phase
2s were conducted in 2018, the positive results of the first were
published in December, the second is ongoing.
The results of the phase 2a trial reported in December 2018 were aimed
at comparing the tolerance of SENS-111 versus meclizine. Meclizine was
chosen as it belongs to the histamine receptor antagonist class H1 and
constitutes the first line treatment of vertigo in the US.
The results of the SENS-111 phase 2a trial met the main tolerance
primary end point to a statistically significant degree. The trial
confirms the initial postulate whereby the SENS-111 drug candidate
impacts neither the vigilance nor the cognitive performance of patients
during a motion stimulus.
The trial has shown that SENS-111, in contrast to meclizine, has no
negative CNS side effects such as sedation, impairment of memory and of
cognitive performance.
The study protocol of the ongoing Phase 2 clinical trial in acute
unilateral vestibulopathy (AUV) has been amended as announced in 2018.
Sensorion has received the necessary regulatory approvals for the
continuation of the modified trial. Some 100 patients are now expected
in centers opened in the United-States, Europe, Israel, and South Korea.
The trial has proceeded with success as we have enrolled 75% of the
forecast patients. Sensorion is progressing well in this trial and we
confirm that the trial results will be released in the second half of
2019, to assess efficacy of the drug candidate.
These items will allow the company to build a strong data package
covering the scientific, clinical and commercial strengths of SENS-111,
thereby to crystallize a SENS-111 licence partnership.
-
SENS-401 drug candidate: start
of the phase 2 trial in the treatment of sudden sensorineural hearing
loss (SSNHL) and ongoing collaboration with Cochlear
Sensorion launched a phase 2 clinical trial for SENS-401 in the
treatment of SSNHL in adults. This randomised, double-blind and
placebo-controlled phase 2 trial will unfold in 12 countries to enrol
some 260 patients and has already started in fifteen or so sites in
Europe and Canada. Interim results are expected in the second half of
2019.
Following the agreement initiated in December 2017, Sensorion and
Cochlear (world leader in cochlear implants) pursued their
collaboration. Based on the otoprotective properties demonstrated in
several preclinical models, SENS-401 could potentially save the residual
hearing of patients receiving cochlear implants. In 2018 we successfully
performed additional safety studies to assess the feasibility of long
duration treatment with SENS-401, which may be required in the cochlear
implant indication. Supported by these results, studies were carried out
to assess the different potential treatment modalities for cochlear
implantation and to validate the local exposure levels of SENS-401 in
the inner ear in preclinical models appropriate for cochlear implants
(results jointly presented jointly with Cochlear at the 2018 ARO
MidWinter Meeting).
- Technological platform
The company is accelerating the development and utilisation of its
screening platform in all inner ear pathologies. We have
increased throughput of the High Content Screening platform.
Collaboration has been initiated with internationally renowned experts
for the validation of translational, quantitative endpoint measures in
tinnitus. We have also implemented robust models of chronic noise
exposure and age-related hearing loss.
Regular scientific communication
At various scientific congresses in 2018, Sensorion presented major
preclinical results underpinning the development of its drug candidates,
and in particular:
-
The results presented to the ARO MidWinter Meeting concerning SENS-401
supplied key information on the treatment mode and the dosage to use
in a clinical context for this drug candidate.
Indeed, the
comparison of administration of a dose of SENS-401 once per day and
twice per day over a period of 28 days reveals an impact of the
administration duration of the treatment, leading to a reduction in
severe hearing loss caused by acoustic trauma in mouse models. -
Moreover, the data presented in an oral presentation, at the
53rd American Neurotology Society (ANS) Annual Spring Meeting, confirm
the potential efficacy of SENS-401 in a preclinical in vivo model in
the treatment of SSNHL, even if the treatment starts several days
after acoustic trauma (up to 96 hours). In a separate presentation at
the same event, new preclinical study findings revealed the first
potential biomarker for noise-induced hearing loss (prestin). -
SENS-401 demonstrated protective effects in two preclinical models of
hearing loss, in studies that were presented at the 15th International
Conference on Cochlear Implants and Other Implantable Auditory
Technologies (Ci2018). -
The results presented to the Annual Congress of the Society for
Neuroscience in San Diego in November suggest that the otoprotective
efficacy of the treatment with SENS-401 is not affected by
simultaneous administration of a corticoid following dosages
equivalent to the doses recommended for the treatment of patients.
Ongoing negotiation for an exclusive
collaboration with the Institut Pasteur on
Gene Therapy programmes targeting hearing loss
On 23 November 2018, Sensorion announced the signature of a letter of
intent with the Institut Pasteur (Paris, France) in order to collaborate
exclusively on several research programs to co-develop and commercialize
gene therapy product candidates for restoration, treatment and
prevention of hearing loss disorders.
The Pasteur Institute Unit of Genetics and Physiology of Hearing, headed
by Professor Christine Petit, has developed world-class expertise over
the last 25 years in hearing development, molecular physiology and
physiopathology leading to gene therapy programmes for inner ear
disorders. Sensorion and the Institut Pasteur should collaborate in the
future on several programs to correct monogenic forms of hereditary
hearing loss including, amongst others, the Usher Syndrome type1 and
otoferlin-deficiency.
The negotiations are ongoing.
Strategy and outlook: 2019 a turnaround year
Sensorion announced on March 11 a €4.7 million nominal bond issue,
consisting of one (i) convertible bond issue1 for a nominal
amount of €3.4 million subscribed by several new European investors as
well as (ii) a bond issue2 for a nominal amount of €1.3
million subscribed by these same European investors for an amount of €1
million and the balance by the Company’s management, Mr. Patrick
Langlois, Chairman of the Board of Directors and Ms. Nawal Ouzren, Chief
Executive Officer3.
At the same time, in order to promote the company’s development,
Bpifrance has included Sensorion in the “Hub Health Tech”, a highly
selective growth accelerator program designed for only five technology
leaders in BPI’s portfolio for the current promotion. This program also
provides preparation for internationalization. Bpifrance thus confirms
its interest and willingness to continue to actively support Sensorion
in its development.
Sensorion will continue to actively develop its drug candidates which
are in clinical trials, while undertaking research work in its
technological screening platform. As mentioned above, the results of the
phase 2 trial on the efficacy of SENS-111 in acute unilateral
vestibulopathy are expected during the second half of 2019 and the phase
2 of the SENS-401, in sudden hearing loss (SSNHL), is commencing with
intermediary results expected at the end of the year.
Next publication
- 2019 interim results: 17 October 2019
About Sensorion
Sensorion is a pioneering clinical-stage biopharmaceutical company,
which specializes in the development of novel therapies to restore,
treat and prevent inner ear diseases such as hearing loss, vertigo and
tinnitus. Our clinical-stage portfolio includes two phase 2 products:
Seliforant (SENS-111) in acute unilateral vestibulopathy and Arazasetron
(SENS-401) for sudden sensorineural hearing loss (SSNHL). We have built
a unique R&D technology platform to expand our understanding of the
pathophysiology and etiology of inner ear diseases enabling us to select
the best targets and modalities for drug candidates. We also identify
biomarkers to improve diagnosis and treatment of these underserved
illnesses.
We are uniquely placed through our platforms and pipeline of potential
therapeutics to make a lasting positive impact on hundreds of thousands
of people with inner ear related disorders; a significant global unmet
need in medicine today.
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
‘Document de référence’ registration document filed with the ‘Autorité
des Marchés Financiers’ (AMF French Financial Market Authority) on
September 7th, 2017 under n°R.17-062 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 i.e. 3,440,862 convertible bonds with a nominal value of €1
each
2 i.e. 1,290,325 bonds with a nominal value of €1
each
3 Mr. Patrick Langlois, Chairman of the Company’s
Board of Directors, has subscribed, through his family holding company,
for bonds, up to €50,000. Ms. Nawal Ouzren, Chief Executive Officer, has
subscribed for bonds, up to €200,000
Contacts
Sensorion
Nawal Ouzren
CEO
contact@sensorion-pharma.com
Tel:
+33 467 207 730
Catherine Leveau
Financial communication
catherine.leveau@sensorion-pharma.com
Tel:
+33 467 207 730