Sensorion Announces a €50.5 Million Financing With Participation From New and Existing US and European Healthcare Specialist Investors

2024-02-09

临床2期

Support from existing investors Redmile Group, Invus and Sofinnova Partners Participation from leading US Healthcare Specialists funds including Aquilo Capital, as well as two large investment management firms Financing will enable the Company to extend its cash runway through the end of Q2 2025 MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: 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 €50.5 million offering reserved to specific categories of investors (the “Reserved Offering”) through the issuance of 88,594,737 new ordinary shares of the Company (the “New Shares”) at a price per New Share of €0.57 (the “Subscription Price”) 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 €47 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. €36.5 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 €0.57, 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 €50,499,000.09 (i.e., a nominal amount of €8,859,473.70 and a total issuance premium of €41,639,526.39 and corresponding to a nominal value of 10 cents (€0.10) plus an issuance premium of €0.47 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 €9.6 million, €9.2 million and €7.0 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 €27,567,553.10 divided into 275,675,531 ordinary shares, each with a par value of €0.10. 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. Shareholding Structure after the Reserved Offering On an illustrative basis, a shareholder holding 1% of the Company's share capital before the Reserved Offering and who did not participate in the Reserved Offering will hold 0.68% of the Company's share capital after the issuance of the New Shares. To the Company's knowledge, the shareholding structure, on a non-diluted base, before and after the Reserved Offering, breaks down as follows: Shareholding Structure as of February 1st, 2024 (non diluted) Shareholding Structure POST FINANCING (non diluted) Shareholding Structure POST FINANCING (fully diluted) Number of shares Number of shares (%) Number of Voting Rights Number of Voting Rights (%) Number of shares Number of shares (%) Number of Voting Rights Number of Voting Rights (%) Number of shares Number of shares (%) Number of Voting Rights Number of Voting Rights (%) Redmile Group LLC 46 428 571 24,82% 46 428 571 24,84% 63 270 676 23,0% 63 270 676 23,0% 81 127 819 26,9% 81 127 819 26,9% Invus / Artal Group 62 204 700 33,25% 62 204 700 33,28% 78 345 050 28,4% 78 345 050 28,4% 78 345 050 26,0% 78 345 050 26,0% Sofinnova Partners 40 469 458 21,63% 40 469 458 21,65% 52 750 159 19,1% 52 750 159 19,1% 52 750 159 17,5% 52 750 159 17,5% WuXi App Tec 5 249 608 2,81% 5 249 608 2,81% 5 249 608 1,9% 5 249 608 1,9% 5 249 608 1,7% 5 249 608 1,7% 3SBio 4 055 150 2,17% 4 055 150 2,17% 4 055 150 1,5% 4 055 150 1,5% 4 055 150 1,3% 4 055 150 1,3% Innobio 3 499 874 1,87% 3 499 874 1,87% 3 499 874 1,3% 3 499 874 1,3% 3 499 874 1,2% 3 499 874 1,2% SONOVA AG 2 941 176 1,57% 2 941 176 1,57% 2 941 176 1,1% 2 941 176 1,1% 2 941 176 1,0% 2 941 176 1,0% Cochlear 533 755 0,29% 533 755 0,29% 533 755 0,2% 533 755 0,2% 533 755 0,2% 533 755 0,2% New investors 0 0,00% 0 0,00% 43 331 581 15,7% 43 331 581 15,7% 43 331 581 14,4% 43 331 581 14,4% Sub Total Institutional Shareholders 165 382 292 88,40% 165 382 292 88,47% 253 977 029 92,1% 253 977 029 92,2% 271 834 172 90,2% 271 834 172 90,2% Officers 160 000 0,09% 160 000 0,09% 160 000 0,1% 160 000 0% 4 010 355 1,3% 4 010 355 1,3% Directors - - - - - 0,0% - 0% 1 365 290 0,5% 1 365 290 0,5% Employees & consulting - - - - - 0,0% - 0% 2 352 020 0,8% 2 352 020 0,8% Treasury shares 151 162 0,08% 151 162 0,1% - 0,0% 151 162 0,1% - 0,0% Free Float 21 387 340 11,43% 21 387 340 11,44% 21 387 340 7,8% 21 387 340 7,8% 21 683 340 7,2% 21 683 340 7,2% TOTAL 187 080 794 186 929 632 100,00% 275 675 531 100,0% 275 524 369 100,0% 301 396 339 100,0% 301 245 177 100,0% Lock-up agreements In connection with the Reserved Offering, the Company has entered into a lock-up agreement restricting the issuance of additional ordinary shares for a period ending 90 days following the execution of the securities purchase agreement entered into with the investors, subject to customary exceptions. The Company’s management, Board members and shareholders represented at the Board of Directors who hold ordinary shares of the Company are also subject to a lock-up for a period of 90 days following the execution of the securities purchase agreement entered into with the investors, subject to customary exceptions. Settlement-delivery of the Reserved Offering The admission of the New Shares to trading on the Euronext Growth market in Paris is scheduled for the time of settlement and delivery, which is expected to take place on February 13, 2024. The New Shares will be immediately assimilated to the Company's existing shares already traded on Euronext Growth in Paris, and will be able to be traded, from their issuance, on the same listing line (ISIN code: FR0012596468). The Reserved Offering has not given rise to a prospectus submitted for approval by the AMF. Risk Factors The Company draws the public’s attention to the risk factors related to the Company and its activities presented in section I.3 of the Rapport financier annuel for the year ended December 31st, 2022, which is available free of charge on the website of the Company ( ). In addition, investors are invited to consider the following risks: (i) shareholders stake in the Company will be diluted further to the issuance of the New Shares for the shareholders who did not participate to the Reserved Offering, (ii) the market price for the Company's shares may fluctuate and fall below the subscription price of the shares issued pursuant to the Reserved Offering, (iii) the volatility and liquidity of the Company's shares may fluctuate significantly, (iv) sales of the Company’s shares may occur on the market and have a negative impact on the market price of the shares, and (v) the Company’s shareholders could undergo a potentially material dilution resulting from any future capital increases that are needed to finance the Company. 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. Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN 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. Disclaimer This press release does not constitute an offer to sell or the solicitation of an offer to buy ordinary shares of the Company, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. This announcement is an advertisement and not a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the “Prospectus Regulation”). In France, the Reserved Offering described above is exclusively carried out in the form of a placement to a category of institutional investors, in accordance with Article L. 225-138 of the Code de commerce and applicable regulations. With respect to Member States of the European Economic Area (including France), no action has been taken or will be taken to permit a public offering of the securities referred to in this press release which would require the publication of a prospectus (pursuant to article 3 of the Prospectus Regulation) in any Member State. This press release and the information it contains is not an offer to sell, nor the solicitation of an offer to subscribe for or buy the New Shares in the United States or any other jurisdiction where restrictions may apply including notably Canada, Australia or Japan. Securities may not be offered or sold in the United States absent registration under the Securities Act or an exemption from registration thereunder. Sensorion does not intend to register the New Shares under the Securities Act or conduct a public offering of the New Shares in France, the United States, or in any other jurisdiction. This communication is being distributed only to, and is directed only at (a) persons outside the United Kingdom, (b) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"), and (c) high net worth entities, and other persons to whom it may otherwise lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "relevant persons"). Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents. This distribution of this press release may be subject to legal or regulatory restrictions in certain jurisdictions. Any person who comes into possession of this press release must inform him or herself of and comply with any such restrictions. View source version on businesswire.com: Contacts 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 Source: Sensorion View this news release online at: