Not for distribution in or into the United States of America, Canada, Japan or Australia, except as permitted by applicable law                                                             

  • Initiation of the first U.S. Phase 3 clinical trial for NCX 470 planned for Q2 2020

  • Company expects to be financed to reach the top-line results from the first U.S. Phase 3 clinical trial for NCX 470

  • Institutional investors participating in the financing include U.S.-based specialist healthcare investors and long-term Nicox shareholder HBM Healthcare Investments

Sophia Antipolis, France

Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced a financing through a private placement via the issuance of 3,315,650 new ordinary shares with gross proceeds of €12.5 million.

Proceeds from the financing will support the first U.S. Phase 3 “Mont Blanc” clinical trial of Nicox’s lead product candidate, NCX 470, in glaucoma. A number of funds are participating in the financing, including U.S.-based specialist healthcare investors and Nicox’s leading shareholder HBM Healthcare Investments (SIX:HBMN), a leading, publicly listed healthcare investment fund, as well as a number of other existing European shareholders.

Cantor and H.C. Wainwright & Co. are acting as joint lead placement agents for the financing and Bryan, Garnier is acting as co-placement agent.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “We are pleased with the support of leading U.S. and European funds in this transaction, and eagerly anticipate the start of the first U.S. Phase 3 Mont Blanc clinical trial for NCX 470, expected by the end of the second quarter of 2020. In addition to this financing we will be further supported by revenue from our existing partners for VYZULTA, ZERVIATE and NCX 470 and from other potential business and corporate development activities.

Nicox expects 2020 revenue to include royalties on sales of VYZULTA® and ZERVIATETM, following ZERVIATE’s planned commercial launch in the $400 million U.S. ocular allergy market by partner Eyevance Pharmaceuticals in H1 2020, plus up to €5.5 million in milestone payments from partner Ocumension Therapeutics related to the initiation of the U.S. NCX 470 Phase 3 Mont Blanc clinical trial by Nicox, and Ocumension’s planned NCX 470 Phase 3 clinical trial in China.

With the net proceeds from this financing together with current cash and cash equivalents, the €8 million of debt available from the bond financing with Kreos Capital and the expected revenue detailed above, the Company expects to be financed to reach the announcement of top-line results from the first of the two U.S. Phase 3 clinical trials for NCX 470 (the “Mont Blanc” clinical trial) which are expected in the third quarter of 2021. Should there be any delay in these timelines or should the revenues received be less than expected, additional capital may be needed in order to complete this first Phase 3 Mont Blanc clinical trial, and will be needed in order to accelerate other programs. The company is evaluating various additional financing options, including non-dilutive opportunities.

Cash Position

The Nicox Group had cash and cash equivalents of €17.6 million (excluding the proceeds of this financing) as at October 31, 2019. Nicox drew down a sub-tranche of €4 million in October 2019, received in November 2019, under its bond financing agreement with Kreos Capital and may draw down a further €8 million, without need to meet any pre-conditions or criteria, until December 16, 2019.

NCX 470 Financed into first Phase 3 trial

NCX 470, Nicox’s lead proprietary clinical development stage product candidate, is a novel, second generation nitric oxide (NO) donating bimatoprost analog. Positive results from the Dolomites Phase 2 clinical trial in patients with open angle glaucoma or ocular hypertension demonstrated statistical superiority of NCX 470 0.065% over the current standard of care, latanoprost 0.005%. The intraocular pressure (IOP) reduction from baseline at the three time points (8 AM, 10 AM and 4 PM) was up to 9.8mmHg, the highest IOP reduction ever demonstrated in an eye drop glaucoma clinical trial. Subject to an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which the company is requesting for early 2020, Nicox expects to start the first of the two U.S Phase 3 clinical trials (the “Mont Blanc” trial), with 0.065% and 0.1% doses of NCX 470 compared to latanoprost 0.005% in Q2 2020.

A U.S. market survey commissioned by Nicox indicated that there is a potential for net peak sales of NCX 470 of at least $230 million in the U.S. based on the Phase 2 data at the 0.065% dose, growing to over $500 million should the 0.1% dose enhance the IOP lowering efficacy to ~2mmHg superior to latanoprost 0.005%. In 2018, the glaucoma market was approximately $3 billion in the U.S. and over $5 billion worldwide.

Update on NCX 4251

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. It is the first product candidate developed as a targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis and also has a potential for future application in dry eye. While there are no approved treatments solely indicated for blepharitis, we estimate that the market potential for treatment of acute exacerbations of blepharitis could reach over $1 billion by 2024 in the U.S. alone. NCX 4251 is in a Phase 2 clinical trial with top-line data expected in December 2019. Nicox announced the completion of enrolment in this trial on September 27, 2019. Following analysis of the results of this trial, the Company plans a meeting with the U.S. FDA to discuss next development steps.

Main terms of the financing

The share capital increase without preferential rights, by issuance of 3,315,650 new ordinary 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) pursuant to the 8th resolution of the Extraordinary General Meeting of Nicox dated May 24, 2018.

The subscription price of the new shares has been set by the Board of directors on November 15, 2019 at €3.77 per new share representing a discount of 14.9% on the closing price of the shares on the last trading day prior to pricing (equal to €4.43 on November 15, 2019). Following the completion of the capital increase, the 3,315,650 new shares will represent 11.1% of the issued share capital of the Company before the capital increase and 10.0% after the capital increase. The financing is expected to close on or about November 20, 2019, subject to the satisfaction of customary closing conditions.

The impact of this share capital increase on (i) the stake held in the Company’s share capital by a shareholder holding 1%, and (ii) the share of equity (on a consolidated and per-share basis) as at June 30, 2019 , in each case calculated on a non-diluted and fully diluted basis, i.e. taking into account the issuance of a maximum of 1,334,948 new shares upon (x) exercise of all outstanding warrants and stock options, and (y) the definitive acquisition of all free shares outstanding is as follows:

Shareholder’s interest

Share of equity (consolidated and per-share basis)

Before issue of 3,315,650 new shares 1.00% €3.82
After issue of 3,315,650 new shares (non-diluted basis) 0.90% €3.78
After issue of 3,315,650 new shares and of 1,334,948 new shares resulting from outstanding dilutive instruments (fully diluted basis)* 0.87% €3.87

*The shares issuable from the additional contingent consideration payable to Aciex’s former shareholders are not included in the above table as the Company considers it improbable that the conditions for the payment of this additional remuneration will be met.

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 from the settlement date (subject to certain customary exemptions).

Use of proceeds

The net proceeds from the issuance of the new shares are intended to provide additional resources to the Company to prepare and initiate the first of the two U.S. Phase 3 clinical trials for NCX 470 (the “Mont Blanc” clinical trial).

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 November 20, 2019.

This financing does not require a listing prospectus submitted to the approval of the French Autorité des Marchés Financier (AMF).

Risks factors which are likely to have a material effect on Nicox’s business are presented in the 4th chapter of the ‘Document de référence, rapport financier annuel et rapport de gestion 2018’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2019, which is available on Nicox’s website (www.nicox.com). The half yearly financial report as of June 30, 2019 is also available on Nicox’s website.

Cantor and H.C. Wainwright & Co. are acting as joint lead placement agents for the financing and Bryan, Garnier is acting as co-placement agent.

Composition of Nicox’s Share Capital

As of October 2, 2019

Number of shares and % of share capital

After share capital increase

Number of shares and % of share capital

HBM Healthcare Investments 1,853,304 / 6.20% 2,383, 808 / 7.17%
Banque Publique d’Investissement 384,300 / 1.28% 384,300 / 1.16%
Michele Garufi 447,051 / 1.49% 447,051 / 1.35%
Elizabeth Robinson 74,060 / 0.25% 74,060 / 0.22%
Public 27,156,205 / 90.78% 29,941,351 / 90.10%
Total 29,914,920 / 100% 33,230,570 / 100%

 

HBM Healthcare Investments, which held 1,853,304 shares as of October 2, 2019, representing 6.20% of the share capital, subscribed 530,504 shares as part of this transaction.