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  • Strengthens financial position in advance of upcoming key value inflection points
  • Two clinical readouts in Q4 2021 – Mont Blanc Phase 3 for NCX 470 and Mississippi Phase 2b for NCX 4251
  • Long-term shareholder HBM Healthcare Investments participated in the financing alongside specialist institutional investors in the U.S. and Europe

Chennai, NFAPost: An international ophthalmology company Nicox has announced a financing through a private placement via the issuance of 3,529,565 new ordinary shares with gross proceeds of €15.0 million.

The Company was previously financed to complete both the Mont Blanc Phase 3 trial for NCX 470 and the Mississippi Phase 2b trial for NCX 4251. Proceeds from this financing extend the cash runway well beyond these key inflection points. Nicox’s principal shareholder HBM Healthcare Investments, a leading, publicly listed healthcare investment fund was joined by new US and Europeaninstitutional investors in this financing.

Nicox Chairman and Chief Executive Officer Michele Garufi said, “We are very pleased with the continued support from our long-term shareholder and would like to welcome the new specialist investors who participated in this financing. With a cash runway now well beyond the top-line results of two important trials of our lead product candidates, we are in the ideal position to capitalize optimally on the clinical results of both NCX 4251 and NCX 470 that are expected towards the end of next year.”

Proceeds from this financing are not planned to be used to make payments on any of the Company’s debts, which are expected to be covered by licensing revenue.

Cash Position

The Nicox Group had cash, cash equivalents and financial instruments of €39.0 million (excluding the proceeds of this financing) on November 30, 2020 and total financial debt of €18.7 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement with Société Générale and LCL, guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.

Status of Key Development Programs

NCX 470, Nicox’s lead clinical product candidate, a novel second-generation nitric oxide (NO)-donating bimatoprost analog, is being evaluated in the Mont Blanc and Denali Phase 3 clinical trials for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Top-line results from Mont Blanc are currently expected in Q4 2021 and top-line results from Denali in Q4 2022. The Denali trial is being jointly and equally financed by Nicox and Ocumension Therapeutics, our partner for the Chinese, Korean and South East Asian markets.  Together Mont Blanc and Denali will support regulatory submissions in the US and China.

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals and our second clinical program. The Mississippi Phase 2b clinical trial for the treatment of acute exacerbations of blepharitis is expected to be initiated later this month with top-line results currently expected in Q4 2021.

If successful in meeting the primary endpoint previously agreed with the US Food and Drug Administration (FDA), the Mississippi trial could represent the first of two pivotal trials needed to support the submission of a New Drug Application (NDA) in the US. NCX 4251 is the first product candidate developed as a targeted topical treatment of the eyelid margin in patients with acute exacerbations of blepharitis.  The Danube Phase 2 demonstrated a statistically significant reduction in the composite score of key signs and symptoms of blepharitis at day 14 and also showed encouraging results in dry eye disease endpoints.

“We continue to closely watch the spread and impact of the COVID-19 pandemic. Some of the clinical trials indicated above have just started or will start in the near future, and any potential impact of the pandemic on them cannot be fully assessed at this time. We do not currently anticipate major delays in our clinical timelines but we are monitoring the situation and will provide an update when needed,” the company said.

Main terms of the financing

The share capital increase without preferential rights, by issuance of 3,529,565 new ordinary shares, was reserved for subscription by French or foreign companies or mutual funds investing in the pharmaceutical biotechnology sector pursuant to the 7th resolution of the Extraordinary General Meeting of Nicox dated June 30, 2020.

The subscription price of the new shares has been set by the Board of directors on December 4 at €4.25 per new share representing a discount of 14.8% on the Volume Weighted Average Price (VWAP) over the last 3 trading days prior to pricing (equal to €4.99).  Following the completion of the capital increase, the 3,529,565 new shares will represent 10.5% of the issued share capital of the Company before the capital increase and 9.5% after the capital increase.  The financing is expected to close on or about December 8, 2020, 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, 2020, in each case calculated on a non-diluted and fully diluted basis, i.e. taking into account the issuance of a maximum of 1,733,048 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 3,529,565 new shares 1.00% €2.85
After issue of 3,529,565 new shares (non-diluted basis) 0.90% €2.95
After issue of 3,529,565 new shares and of 1,733,048 new shares resulting from outstanding dilutive instruments (fully diluted basis)* 0.86% €3.08

Use of proceeds

The net proceeds from the issuance of the new shares are intended for working capital purposes.

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