MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotechnology company specializing in the treatment of inner ear diseases, today announces its results for the year to December 31, 2016 and its outlook for 2017.
Laurent Nguyen, CEO of Sensorion, comments: “Our 2016 financial results reflect the scaling up of the clinical development of both SENS-111, which has begun phase II of its clinical development for the symptomatic treatment of acute unilateral vestibulopathy, and SENS-401, which has begun phase I and aims to treat sudden sensorineural hearing loss. This progress has notably been made possible thanks to the strengthening of our clinical teams, but also to the quality of our screening platform. Indeed, the latter has proven its ability to identify drug candidates that meet the requirements of clinical development in inner ear disorders and generate results replicable in humans. In 2017, we intend to continue this momentum, with the aim of strengthening our portfolio of products in phase 2 clinical trials and selecting a drug candidate for clinical trials aimed at preventing ototoxicity resulting from the use of cisplatin.”
2016 financial results
Annual accounts to December 31, 2016, drawn up under IFRS and approved by the Board on March 10, 2017, have been reviewed by the statutory auditors, whose report is currently being prepared.
These accounts were characterized by an increase in operating costs consistent with Sensorion’s Research & Development activity.
The simplified income statement at December 31, 2016 was as follows:
|In euros - IFRS||31.12.2016||31.12.2015|
|Research & Development costs||7,817,751||4,506,695|
|Total operating costs||10,191,135||6,055,226|
At December 31, 2016, Sensorion’s operating income – consisting mainly of Research Tax Credit (€1.7 million) and subsidies (€0.1 million) – totaled €1.8 million, up 36% compared with the figure at December 31, 2015 (€1.3 million).
Operating costs increased by 68% from €6.1 million at December 31, 2015 to €10.2 million at December 31, 2016, essentially driven by the clinical development of the Company’s two drug candidates, SENS-111 for treating acute severe vertigo and SENS-401 for treating sudden sensorineural hearing loss, and by the preclinical development efforts undertaken in particular to facilitate the selection, in 2017, of a drug candidate to treat ototoxicity resulting from the use of cisplatin. Furthermore, the Company strengthened its team via the recruitment of a Clinical Research Director and a Clinical Research Associate. R&D costs accounted for 77% of total operating costs, compared with 74% in 2015.
The operating loss at December 31, 2016 was -€8.4 million, versus -€4.8 million at December 31, 2015.
Once the financial loss (-€0.4 million) is taken into account, there was a net loss of -€8.8 million over the year to December 31, 2016, versus a loss of -€4.8 million the previous year.
The Company’s workforce increased from 16 staff at December 31, 2015 to 17 at December 31, 2016.
Solid financial structure
At December 31, 2016, Sensorion had cash and cash equivalents of €8.5 million, versus €13.9 million a year earlier. This decrease was the result of cash burn associated with operating activities of €7.7 million (versus €5.4 million in 2015) and the raising of €3 million within the framework of the exercising of a second tranche of OCABSA financing (convertible bonds coupled with equity warrants) with Yorkville Advisors Global, LP, a US investment company. Of the 300 equity warrants issued for this second tranche, 200 were converted into ordinary shares in 2016.
Of the 100 remaining equity warrants not converted into ordinary shares by their holder at December 31, 2016, 30 were converted in January 2017, leaving 70 still to be converted. Within the framework of this flexible financing line put in place in November 2015, Sensorion has the option of strengthening its shareholders’ equity by up to approximately €14 million over the next 20 months (plus €5 million should all the associated equity warrants be exercised) to support its development.
At the beginning of 2017, Sensorion received innovation support of €950 thousand from Bpifrance and the Occitania region of Southern France, in the form of an interest-free innovation loan, to strengthen its platform’s high-content screening capacity.
During the current financial year, Sensorion expects to receive €1.7 million in Research Tax Credit reimbursement, booked at December 31, 2016.
Research & Development:
- SENS-111: the positive results of the phase Ib clinical trial showing the compound’s effects on vertigo induced in healthy volunteers (similar to the results obtained in experimental animal models) and the development of regulatory dossiers with Sensorion’s leading drug candidate have enabled the Company to obtain approval to initiate a clinical trial in the United States (IND status) and establish an international phase II clinical trial in AUV (acute unilateral vestibulopathy) at the end of 2016.
- SENS-401: the successful execution of a phase I study with the Company’s SENS-218 drug candidate and the production of conclusive preclinical data with its enantiomer, SENS-401, have led Sensorion to select the latter as the clinical candidate in the treatment of SSNHL (sudden sensorineural hearing loss). In November 2016, SENS-401 received Orphan Drug Designation status in Europe, which provides Sensorion with a number of strategic advantages during its development cycle in the form of various incentives and a 10-year marketing exclusivity period once European marketing approval is granted.
- SENS-300 program: preclinical work continued throughout the year in the prevention of auditory toxicity resulting from the use of platinum salts (cisplatin) in chemotherapy.
In 2016, Sensorion’s R&D work was presented at a number of major scientific conferences:
- February 20: the preclinical results obtained with SENS-218 were presented at the ARO (Association for Research in Otolaryngology) congress in San Diego, California;
- September 19: the results of two preclinical studies were presented at the 2016 IEB congress in Montpellier, in the form of an oral presentation (“SENS-111 outperforms standard treatments in reducing the symptoms of vestibular vertigo”) and a poster presentation (“An algorithm developed by Sensorion facilitates the study of inner ear tissue”);
- September 21: the initial clinical tolerance results of the phase 1b study with SENS-111 were presented at the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) annual meeting & OTO EXPO, held in San Diego, California;
- October 6: the positive results of the caloric test on SENS-111 were presented at the EACPT (European Association for Clinical Pharmacology and Therapeutics) conference in Opatija, Croatia;
- November 17: the preclinical results obtained with SENS-401 were presented at the Annual Meeting of the Society for Neuroscience (SfN), Neuroscience 2016, in San Diego, California.
Recent events and 2017 outlook
Since the start of 2017, Sensorion has vigorously pursued the development of all its drug candidate programs, whose progress should mark this year:
- SENS-111: Sensorion has been granted authorization to undertake its phase II clinical trial with SENS-111 Europe-wide via the Voluntary Harmonization Procedure (VHP), confirming the solid regulatory framework enabling the first patient with acute unilateral vestibulopathy to be enrolled in the coming weeks. This trial, which should involve 207 patients, should last between 18 and 24 months and will be the subject of an interim analysis once at least half of the patients are enrolled.
- SENS-401: in the first half of 2017, Sensorion is planning to complete a phase 1 clinical trial with SENS-401 aimed at treating lesions of the inner ear, and in particular sudden sensorineural hearing loss. The Company is talking with the regulatory authorities, notably American and European, to define, this year, the next stages of its phase II clinical development.
- SENS-300: based on current preclinical development, Sensorion is aiming to select a drug candidate for clinical trials aimed at preventing ototoxicity resulting from the use of cisplatin in 2017.
Pierre Attali, Sensorion’s Chief Medical Officer, comments: “During 2016, we made significant clinical and regulatory progress with all our drug candidate programs. There has been great interest shown in our work by the international scientific community. We are entering a crucial phase in the undertaking of proof-of-concept phase II clinical trials, prior to confirmatory phase III studies. The greater screening capacity of our technological platform dedicated to the search for new drug candidates will enable us to explore in an even more efficient manner all inner ear disorders that result in vertigo, hearing loss and tinnitus.”
- BIO Europe Spring, March 20 to 22, 2017 in Barcelona
- Portzamparc Small & Midcap Seminar, March 21 and 22, 2017 in Paris
- Small Cap Event, April 12, 2017 in Paris
- SFAF financial analysts’ MidCap Day, April 18, 2017 in Paris
- Shareholders’ Meeting, May 30, 2017 in Paris
Sensorion specializes in the treatment of pathologies of the inner ear such as acute vertigo, tinnitus and hearing loss. The company was founded by Inserm (the French Institute of Health and Medical Research) and is utilizing its pharmaceutical R&D experience and comprehensive technology platform to develop first-in-class, easy-to-administer, notably orally active, drug candidates for treating and preventing hearing loss and the symptoms of bouts of vertigo and tinnitus. The first two programs are, respectively, in phase I (SENS-401) and phase II (SENS-111) clinical testing. Based in Montpellier, Southern France, Sensorion has received financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative.
Sensorion has been listed on the Euronext Alternext Paris exchange since April 2015.
ISIN code: FR0012596468
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 July 28, 2016 under n°R.16-069 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.