28 July 2016
Proceeds to finance development of NCX 4251 in blepharitis and NCX 470 in glaucoma and for general corporate purposes
Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced a reserved capital increase of ordinary shares of the Company to a specific category of investors. The proceeds from the financing will principally be used to drive the development of NCX 4251, a nanocrystalline formulation of fluticasone for blepharitis, and of NCX 470, a nitric oxide (NO)-donating bimatoprost for intraocular pressure lowering, through proof-of-concept clinical studies. The gross proceeds of the financing are approximately €18 million, for a total of 2,064,000 million new shares, which represents the maximum capital increase the Company could undertake without publishing a formal prospectus.
“This financing demonstrates the confidence experienced healthcare investors have in our company. We welcome the support and interest they have for our other highly promising pipeline assets and in our endeavor to build an innovative R&D-focussed ophthalmology company” commented Michele Garufi, Chairman and Chief Executive Officer of Nicox, adding: “With the potential approvals of latanoprostene bunod and AC-170, plus the anticipated completion of the collaboration agreement with GHO Capital involving our European commercial assets, Nicox is well placed to achieve this ambition. With this additional funding, we are also in an excellent financial position to continue to advance the rest of our promising proprietary ophthalmology pipeline”
The financing attracted significant investor interest which exceeded the maximum offering size.
Nicox’s key assets in this R&D strategy are:
• Partnership with Bausch + Lomb (a wholly‐owned subsidiary of Valeant Pharmaceuticals International, Inc.) on latanoprostene bunod in glaucoma, which has the potential to generate significant revenue through milestones (up to $132.5 million net, mainly on commercial sales targets) and royalties (potential net tiered royalties on sales from 6% to 11%). On July 21, 2016, the US Food and Drug Administration (FDA) issued a Complete Response Letter regarding the NDA for latanoprostene bunod citing some concerns pertaining to Current Good Manufacturing Practice (CGMP) at Bausch + Lomb’s manufacturing facility in Tampa, Florida. The FDA’s letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA.
• AC-170, a novel, proprietary formulation of cetirizine 0.24%, a widely-used antihistamine developed for topical application in the eye for the first time. The NDA for the treatment of ocular itching associated with allergic conjunctivitis was granted Priority Review with a Prescription Drug User Fee (PDUFA) date of October 18, 2016 (contingent upon the information and data provided by Nicox during the review period). Any approval of the NDA triggers a payment in Nicox shares to former Aciex shareholders. Nicox is currently in partnering discussions in the United States for this program.
• NCX 4251, a novel, proprietary formulation of nanocrystalline fluticasone propionate for blepharitis. This is currently in formulation development. Nicox currently plans to seek a pre- Investigational New Drug (IND) meeting, to be held by the end of Q1 2017, and also expects to start clinical studies directly at Phase 2 in 2017.
• NCX 470, a NO-donating bimatoprost for reduction of intraocular pressure based on our nitric oxide (NO)-donating research platform. This molecule is currently in pre- IND toxicology studies. Nicox currently plans to seek a pre-IND meeting, to be held by the end of Q1 2017, and also expects to start clinical studies directly at Phase 2 in H2 2017.
• Next generation standalone nitric oxide (NO)-donors in ophthalmology. This program, also from the nitric oxide (NO)-donating research platform, is at an earlier stage but we believe has significant promise. Nicox is planning to develop these candidates in collaboration with an ocular drug delivery technology company.
• Participation in new pan-European ophthalmology specialty company led by GHO Capital. Subject to completion, Nicox will become a minority shareholder of this new organisation to which it will have transferred its European and International commercial infrastructure and portfolio including some products in late‐stage development for Europe only (see Press Release dated July 5, 2016).
Main terms of the financing
The share capital increase, by issuance of 2,064,000 million new ordinary shares (the “New Shares”), was reserved for subscription by French or foreign companies or mutual funds investing in the pharmaceutical biotechnology sector (sociétés ou fonds gestionnaires d’épargne collective de droit français ou de droit étranger investissant dans le secteur pharmaceutique/biotechnologique).
The subscription price of the New Shares has been set at €8.75 per New Share. Following the completion of the capital increase, the 2,064,000 New Shares will represent approximately 9% of the issued share capital of the Company before the capital increase and 8.3% after the capital increase and is the maximum capital increase the Company could undertake without publishing a formal prospectus.
Directors and Executive Committee members of Nicox have agreed to certain customary lock-up arrangements with the Placement Agents on the shares they hold in Nicox for a 90-day period.
Use of proceeds
The net proceeds from the sale of the New Shares are intended to provide additional resources to the Company to finance its strategy, in particular:
• Clinical development of pipeline candidates as set out above
• Working capital and general corporate purposes
Listing of new shares
An application will be made for the admission to listing of the New Shares on Euronext Paris. The settlement-delivery of the New Shares is expected to take place on August 2, 2016.
Guggenheim Securities, LLC acted as lead placement agent for the offering, and Bryan, Garnier & Co and Needham & Company, LLC acted as placement agents.