12.02.2016 07:30:00

STENTYS Launches a €12.6 Million Rights Issue

Regulatory News:

STENTYS (the « Company » — FR0010949404 — STNT) (Paris:STNT), announces today the terms of its capital increase with shareholders’ preferential subscription rights for a gross amount of approximately €12.6 million.

The proceeds of this issue will enable STENTYS to continue its development and its geographic expansion, firstly in European centers by extending its network of distributors and, secondly, through obtaining approvals in countries outside of the CE Marking (initially in Russia and India, then in Brazil, China, Korea and Japan).

Stentys also intends to strengthen its position in France1, one of the main European markets, and will use part of the funds raised to finance two clinical studies in order to obtain the reimbursement of the stent XPosition S:

  • GAIN, a randomized study comparing Xposition S to a conventional drug-eluting stent already reimbursed in France. This study would enroll 300 patients from 30 European centers (including a minimum of 5 in France). The endpoints of the study would be the artery diameter narrowing at 9 months (Late Lumen Loss), as measured by angiography, and major adverse cardiac events.
  • WIN, a study designed to complement the randomized GAIN study in assessing the safety and the performance of the Xposition S stent in routine clinical practice. WIN would recruit 760 patients in 30 sites across Europe (with a minimum of 5 sites in France). Patient follow up would be after a 12 months period.

In addition, the proceeds of the transaction will also finance a clinical study to evaluate the efficacy of the Xposition S stent in treating lesions of the Left Main (main artery of the human heart) with a study enrolling 200 patients treated with Xposition S and recruited from 20 European clinical sites. The primary endpoint would be the rate of major adverse cardiac events at 12 months.

The Company intends to spend approximately one third of the proceeds on studies described above. In case of partial completion of the issue, the Company may decide not to realize all of these studies.

Subscription commitments

Six qualified investors have committed to subscribe to the shares that would not be subscribed at the end of the subscription period for a maximum amount of €10.65 million representing 84.4% of the capital increase (excluding the exercise before February 19, 2016 of rights giving access to share capital exercisable at the date hereof as described below).

Main terms of the share capital increase

The share capital increase will be carried out with shareholders’ preferential rights (Rights) by the issuance of 5,608,332 new shares at a price of €2.25 per new share, representing gross proceeds of €12,618,747, including issue premium. The number of new shares may be increased to a maximum of 5,858,316 new shares, representing maximum gross proceeds of €13,181,211 including issue premium, in the event that all the outstanding rights giving access to share capital exercisable at the date hereof (excluding those whose beneficiaries are committed not to exercise and the equity warrants issued by the Company as part of the equity line with Société Générale exercisable exclusively at the company’s request) were exercised prior to February 19, 2016 and that Rights allocated to the holders of these rights were also exercised.

Each shareholder of the Company will receive one Right for each share held as of the close of trading on February 12, 2016. 13 Rights will entitle the holder to subscribe on an irreducible basis to 6 new shares. On the basis of the closing price of STENTYS’ shares on February 10, 2016 (i.e. €4.05) the theoretical value of each Right is €0.58.

The subscription price represents a 44.44% discount to the closing price of the Company’s shares on February 10, 2016 and a 35.16% discount to the theoretical ex-right price.

Société Générale Corporate & Investment Banking is acting as Lead Manager and Sole Bookrunner of the issue.

Indicative timetable

The subscription period for the new shares will run from February 15, 2016 to the close of trading on February 26, 2016. During this period, the Rights will be listed and traded on the regulated market of Euronext in Paris under ISIN code FR0013114204. Any Rights not exercised before the end of the subscription period, i.e., the close of business on February 26, 2016, will be void.

The settlement-delivery and the listing of the new shares are expected to occur on March 8, 2016. The new shares will carry full rights (jouissance courante). They will be immediately fungible with the Company’s existing shares and will be traded on the same listing line under the same ISIN code FR0010949404.

Recent events and outlook

On January 13, 2016 the company announced revenues of €1.9M for the last quarter of the 2015 fiscal year, representing a growth of 81% over the same period last year. Revenues for the FY2015 increased by 59% to reach €6.1M.

On January 28, 2016 the Company announced the first interventions with the STENTYS self-apposing drug-eluting stent to treat arterial disease below the knee (BTK) were performed during two live case sessions at the LINC congress (The Leipzig Interventional Course).

On February 8, 2016 the Company announced the first distribution agreements for its drug-eluting stent for treating BTK arteries in Germany and Belgium, making it the first self-expanding drug eluting stent commercialized for this indication in Europe.

Information available to the public

The prospectus, filed with the French financial markets authority (Autorité des marchés financiers - "AMF”) under number 16-045 dated February 11, 2016 consisting of the registration document (the "Registration Document”) of STENTYS registered with the AMF on July 29, 2015 under number D.15-0807, the update to the Registration Document of STENTYS filed with the AMF on February 11, 2016 under number D.15-0807-A01 (the "Registration Document Update”), a securities note (the "Securities Note”) including the summary of the prospectus may be obtained free of charge from STENTYS’s registered office (29-31 Rue Saint-Augustin, 75002 Paris) and is also available on STENTY’s website (www.stentys.com) and the AMF’s website (www.amf-france.org).

STENTYS draws investors’ attention to the risk factors described in chapter 4 of the Registration Document as updated in section 4.1 of the Registration Document Update, as well as in section 2 of the Securities Note.

Upcoming events

FY 2015 Results, on March 16, 2016

About STENTYS

STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex coronary artery disease. STENTYS’ Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. The APPOSITION clinical trials in the treatment of acute myocardial infarction showed a very low one year mortality rate and a faster arterial healing compared to conventional stents. The company’s product portfolio also includes MiStent SES®, a coronary DES whose new drug delivery mechanism is designed to match vessel response, and is marketed through STENTYS’ commercial network in Europe, Middle East, Asia and Latin America. More information on www.stentys.com.

Disclaimer

The offer is open to the public in France following the delivery of the visa on the Prospectus by the French Autorité des marchés financiers (the « AMF »).

With respect to Member States of the European Economic Area that have transposed European Directive 2003/71/EC of the European Parliament and European Council (as amended in particular by Directive 2010/73/EU to the extent that the said Directive has been transposed into each Member State of the European Economic Area) (the "Prospectus Directive”), no action has been taken or will be taken to permit a public offering of the securities referred to in this press release requiring the publication of a prospectus in any Member State other than France. Therefore, such securities may not be and shall not be offered in any Member State (other than in France) other than in accordance with the exemptions of Article 3(2) of the Prospective Directive to the extent they have been transposed by the relevant Member State or, otherwise, in cases not requiring the publication of a prospectus by Stentys under Article 3(2) of the Prospective Directive and/or the applicable regulations in such Member State.

This press release and the information it contains are being distributed to and are only intended for persons who are (i) outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order”), (iii) high net worth entities and other such persons falling within Article 49(2)(a) to (d) of the Order ("high net worth companies”, "unincorporated associations”, etc.) or (iv) other persons to whom an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the Financial Services and Market Act 2000) may otherwise lawfully be communicated or caused to be communicated (all such persons in (i), (ii), (iii) and (iv) together being referred to as "Relevant Persons”). Any invitation, offer or agreement to subscribe, purchase or otherwise acquire securities to which this press release relates will only be engaged with Relevant Persons. Any person who is not a Relevant Person should not act or rely on this press release or any of its contents.

This press release and the information it contains do not, and will not, constitute an offer to subscribe for or sell, nor the solicitation of an offer to subscribe for or buy, securities of Stentys in the United States of America or any other jurisdiction where restrictions may apply. Securities may not be offered or sold in the United States of America absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act”), it being specified that the securities of Stentys have not been and will not be registered within the US Securities Act. Stentys does not intend to register securities or conduct a public offering in the United States of America.

The 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.

Any decision to subscribe for or purchase the shares or other securities of Stentys must be made solely based on information publicly available about Stentys. Such information is not the responsibility of Société Générale and has not been independently verified by Société Générale.

STENTYS is listed on Comp. C of the Euronext Paris market
ISIN: FR0010949404 – Ticker: STNT

1 In France, drug-eluting stents (or "Drug Eluting Stent" - DES) represented about 75% of stents market in 2014 (source: Prof. Blanchard, High Tech Congress 2015).

NOT FOR DISTRIBUTION IN THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA AND JAPAN

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