MONTPELLIER, France - Sensorion (FR0012596468 - ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced a EUR50.5 million offering reserved to specific categories of investors through the issuance of 88,594,737 new ordinary shares of the Company at a price per New Share of EUR0.57 to the benefit of Redmile Group, Invus and Sofinnova Partners, existing shareholders, and leading US Healthcare Specialists funds including Aquilo Capital, as well as two large investment management firms.
The settlement-delivery of the Reserved Offering is expected to take place around February 13, 2024, subject to customary conditions.
Nawal Ouzren, Chief Executive Officer of Sensorion, said: 'We are delighted to announce today's successful capital raise of EUR 50.5 million. We are very thankful to the top tier new investors who joined us and express our gratitude to our existing shareholders who have reaffirmed their support in this transaction, Redmile Group, Invus and Sofinnova Partners. This strengthened shareholder base reinforces Sensorion's ambition to advance its pipeline of innovative therapies intended to improve the quality of life of patients suffering from hearing disorders. The capital increase will enable the Company to pursue its relentless efforts in moving forward its gene therapy programs developed in the framework of the renewed collaboration with the Institut Pasteur. Firstly, SENS-501, our lead program, which has recently received approval from competent authorities to initiate its Phase 1/2 clinical study, Audiogene, in some European countries with France as first country. We are now entirely focused on the patients recruitment. The proceeds will also benefit our second gene therapy program, GJB2-GT, allowing us to complete the preclinical IND/CTA enabling activities in order to target Clinical Trial Applications submission in H1 2025.'
Khalil Barrage, ad interim Chair, Sensorion, said: 'We extend a warm welcome to the new investors who joined us. Their arrival in Sensorion's capital not only strengthens our financial foundation but also propels us forward on our path to innovation and scientific breakthrough for patients suffering from hearing disorders. We are excited about the opportunities that lie ahead and look forward to achieving new heights together.'
Expected next clinical milestones: H1 2024 - SENS-401 in combination with cochlear implantation: Primary endpoint readout
H2 2024, World Congress of Audiology - SENS-401 in Cisplatin-Induced Ototoxicity: Preliminary safety and efficacy data
H2 2024 - SENS-501: First patient communication
H1 2025 - SENS-501: Enrollment of the first two cohorts of Phase 1/2 Audiogene trial completed
H1 2025 - GJB2-GT: Clinical Trial Applications Submission
Impact on cash flow and use of proceeds
The Company intends to use the net proceeds from the Reserved Offering, which amount to circa EUR47 million (based on the aggregate Subscription Price), to fund the company's R&D activities through the end of Q2 2025, covering GJB2 CTA submission and the first two cohorts of the Audiogene Phase 1/2 clinical trial, which was approved in Europe in January 2024 as well as for other R&D and corporate overhead expenses.
Based on its forecasted expenses, cash balance as of December 31st, 2023, which amounts to c. EUR36.5 million (unaudited), as well as the net proceeds from the Reserved Offering, the Company believes that it will be able to finance its operations through the end of Q2 2025. The company continues to pursue non-dilutive financing for the other assets.
Main terms of the Reserved Offering
Sensorion's board of directors and Chief Executive Officer using the delegation of powers granted by the 8th resolution of the extraordinary shareholders' general meeting held on December 20th, 2023 (capital increase with cancellation of preferential subscription rights in favor of categories of persons with specific characteristics) and in accordance with article L. 225-138 et seq. of the French Commercial Code (Code de commerce), have decided on February 8, 2024, to complete the issuance of the New Shares. The New Shares were issued at a price of EUR0.57, which represents a 0,96 % discount to the weighted average share price on the five days preceding the date on which the issuance price is set, in accordance with the 8th resolution of the extraordinary shareholders' meeting of the Company held on December 20th, 2023.
The issuance of the 88,594,737 New Shares will result in an immediate capital increase of EUR50,499,000.09 (i.e., a nominal amount of EUR8,859,473.70 and a total issuance premium of EUR41,639,526.39 and corresponding to a nominal value of 10 cents (EUR0.10) plus an issuance premium of EUR0.47 per New Share), representing approximately 47% of the Company's share capital and voting rights outstanding before the Reserved Offering.
Redmile Group, Invus and Sofinnova Partners who are existing shareholders and are also represented on the Board of Directors of the Company, will participate in the Reserved Offering for subscription amounts of EUR9.6 million, EUR9.2 million and EUR7.0 million, respectively, representing 19%, 18% and 14% of the aggregate gross amount of the Reserved Offering, respectively. It is specified that Redmile Group, Invus and Sofinnova Partners, who are also members of Sensorion's Board of Directors, did not take part in the vote of the Reserved Offering at the Board of Directors' meeting held on February 8, 2024.
Following the settlement-delivery expected to occur on February 13, 2024, the Company's total share capital will be EUR27,567,553.10 divided into 275,675,531 ordinary shares, each with a par value of EUR0.10. The New Shares will be fungible with the existing ordinary shares of the Company and will be admitted to trading on Euronext Growth in Paris under the ISIN FR0012596468.
Leerink Partners LLC ('Leerink Partners') and Stifel Europe AG ('Stifel') are acting as lead agents in connection with the Reserved Offering. Chardan Capital Markets LLC ('Chardan') is acting as placement agent in connection with the Reserved Offering (Leerink Partners together with Stifel and Chardan, the 'Placing Agents'). Stifel is acting as Centralizing Agent. Namsen Capital is acting as equity capital markets advisor.
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. SENS-501 (OTOF-GT) targets deafness caused by mutations of the gene encoding for otoferlin and is currently developed in a Phase 1/2 clinical study, 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 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.
Forward-looking statements
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 Sensorion's 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.
Contact:
Bruno Arabian
Tel: 33 (0)6 64799751
Noemie Djokovic
Email: noemie.djokovic@sensorion-pharma.com
SENSORION 
