Sensorion: 2016 First-Half Results

Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN / PEA-PME eligible), a biotech company specializing in the treatment of inner ear diseases, today announces its results for the first half of the year to June 30, 2016 as well as its recent developments.

Laurent Nguyen, CEO of Sensorion, comments: "The first half of 2016 was characterized by the intensive work undertaken by all of our teams on our drug candidates in the field of inner ear pathologies. This considerable effort resulted in substantial scientific newsflow from the start of the second half, illustrating the tangible progress made towards meeting our commitments. Our leading drug candidate, SENS-111, has a well-documented safety profile, and we are ready to assess its efficacy in acute severe vertigo during an international phase 2 clinical trial that will be carried out in the United States and Europe. The activity signals observed via the caloric test bode well for this key development stage. We have also strengthened our portfolio with a new drug candidate, SENS-401, which shows considerable potential in the treatment of inner ear lesions and could further expand our intellectual property. Lastly, we have a financial situation that will enable us to cope with the gradual ramping up of our programs.”

Financial results for the first half of 2016

The Company’s accounts for the six months to June 30, 2016, drawn up under IFRS, have been the subject of a limited review by its statutory auditors and were approved by the Board on October 12, 2016.

They are characterized by an increase in operating costs associated with Sensorion’s Research and Development activity, resulting in cash use consistent with the Company’s development objectives. The Company’s financial structure is sized to finance the development of its clinical programs.

The simplified income statement at June 30, 2016 is as follows:

At June 30, 2016, Sensorion’s operating income, essentially consisting of Research Tax Credit (€1,082 thousand), totaled €1,124 thousand, a significant increase of 239% compared with June 30, 2015.

Operating expenses increased from €2.0 million at June 30, 2015 to approximately €5.4 million at June 30, 2016, notably as a result of the scaling up of clinical programs concerning the Company’s drug candidates. R&D expenses accounted for approximately 77% of total operating expenses.

General and Administrative expenses increased from €0.4 million at June 30, 2015 to approximately €1.3 million at June 30, 2016, mainly due to structural costs associated with the Company’s listing on Alternext Paris and the strengthening of its team.

The operating loss at June 30, 2016 was -€4.3 million, compared with -€1.5 million at June 30, 2015.

After financial profit (€1.8 thousand), net loss amounts to €4.3 million at June 30, 2016, compared with a net loss of €1.5 million at June 30, 2015.

At June 30, the Company had a staff of 16.

Solid and flexible financial structure

At June 30, 2016, Sensorion had cash and cash equivalents of €8.5 million, versus €13.9 million at December 31, 2015. Cash used by operating and investment activities was €4.8 million and cash used by financing activities (essentially reimbursement of a loan and repayable advances) was €0.5 million.

Subsequent to June 30, 2016, the Company requested the exercise of a second tranche of €3 million of convertible notes with warrants within the framework of the original issuance contract signed on November 19, 2015 with Yorkville Global Advisors Ltd. In accordance with this flexible financing agreement, Sensorion still has the ability to strengthen shareholders’ equity, depending on its requirements, by up to approximately €14 million over the coming 25 months (plus €5 million, should all the associated warrants be exercised).

Key developments since January 1, 2016

Symptomatic treatment program (SENS-111)

Following the positive results obtained in the phase 1b clinical trial at the end of 2015, the Company continued to develop its leading drug candidate in the first half of 2016, with the aim of initiating a phase 2 trial in the treatment of severe bouts of vertigo by the end of 2016 with a new formulation adapted to its future market. Specifically, the Company has had interaction with various regulatory authorities, notably in Europe and the United States, and has been working on the production of the product’s pharmaceutical form. SENS-111 has since obtained IND (Investigational New Drug) status from the FDA (US Food and Drug Administration) enabling it to be administered in clinical trials in the United States.

Anti-lesion program (SENS-218 / SENS-401)

During the first half of 2016, the Company successfully undertook a phase 1 clinical trial in the United Kingdom with its second drug candidate, SENS-218, which aims to protect and preserve inner ear tissue when lesions are present. During this trial, which confirmed the molecule’s excellent clinical tolerance, Sensorion also assessed the compound’s two enantiomer forms.

Comparative preclinical experimental studies carried out on Sensorion’s screening platform have shown that one of these two enantiomers, named SENS-401, had a superior pharmacokinetic distribution profile and greater efficacy on animal models than those obtained with SENS-218 or the second enantiomer.

This improved profile, as well as the possibility of expanding Sensorion’s intellectual property thanks to this discovery, have led the Company to select SENS-401 as a drug candidate for the oral treatment of inner ear lesions.

Program for preventing the toxicity of chemotherapy (SENS-300)

The Company has also continued preclinical development with a view to selecting the drug candidate to develop to protect the inner ear from the toxicity resulting from chemotherapy using platinum salts.

Technological platform

The Company is continuing the development and use of its specialized screening platform in all inner ear pathologies.

Scientific communication

During the first half of this year, Sensorion submitted a number of papers for public presentation and participated in various professional congresses and conferences enabling it to present its research to the international scientific community:

• on February 20, 2016: the preclinical results obtained with SENS-218 were presented to the ARO (Association for Research in Otolaryngology) congress in San Diego, California;
• on September 19, 2016: Sensorion presented the results of two preclinical trials at the 2016 IEB (Inner Ear Biology) workshop in Montpellier, France:
  • SENS-111 reduces the symptoms of vestibular vertigo more than standard treatments (oral presentation);
  • An algorithm developed by Sensorion facilitates the study of inner ear tissue (poster);
• on September 21, 2016: Sensorion presented the initial good clinical tolerance results of the phase 1b trial with SENS-111 at the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) annual meeting & OTO EXPO in San Diego;
• on October 6, 2016: Sensorion presented the positive results of the caloric test on SENS-111 at the EACPT (European Association for Clinical Pharmacology and Therapeutics) conference in Opatija, Croatia.

French Tech Pass certification

In recognition of Sensorion’s innovation and internationalization potential, in February 2016 the Company obtained French Tech Pass certification giving it preferential access to the services provided by Bpifrance, Business France, DGE (Direction Générale des Entreprises, or Directorate-General for Enterprise), Coface and Inpi, and to the French Tech Pass regional partners and French Tech community networks.

Strategy and outlook

Over the second half of 2016, Sensorion intends to continue the buoyant development of its drug candidate programs and the research work on its screening platform. By the end of the year, the Company plans to:

• initiate an international phase 2 clinical trial with SENS-111 in acute severe vertigo, in accordance with the IND status granted for this drug candidate by the FDA;
• present the preclinical results obtained with SENS-401 in hearing loss resulting from acoustic trauma at the 46^th Annual Meeting of the Society for Neuroscience (SfN), Neuroscience 2016, on November 12-16 in San Diego;
• detail clinical strategy chosen for its program to treat inner ear lesions.

Upcoming events attended by the Company

• Participation in the MedStartup conference, October 27-28, 2016 (New York)
• Participation in the BIO Europe conference, November 7-9, 2016 (Cologne)
• Participation in the Actionaria trade fair, November 18-19, 2016 (Paris)

About Sensorion

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 candidate programs for treating hearing loss and the symptoms of vertigo and tinnitus, for preventing and treating complications associated with progressive lesions in the inner ear, and for preventing the toxicity of chemotherapy in the inner ear. Based in Montpellier, southern France, Sensorion received financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative.

Sensorion is listed on Alternext Paris since April 2015. www.sensorion-pharma.com

Name: SENSORION
ISIN code: FR0012596468
Ticker: 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 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.

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