Nicox — Animal data show favourable profile vs Lumigan

Nicox (Euronext Growth: ALCOX)

Last close As at 17/07/2024

EUR0.19

−0.01 (−3.08%)

Market capitalisation

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Research: Healthcare

Nicox — Animal data show favourable profile vs Lumigan

Nicox has reported that an in vivo study carried out in beagles found that NCX-470 (0.1%) treatment led to a greater degree of intraocular pressure (IOP) reduction compared to AbbVie’s Lumigan (bimatoprost 0.01%), the best-selling branded prostaglandin F2α analogue (PGA) drug, in both single and repeated (five-day) dosing. The newly reported data from the open-label cross-over study assessing NCX-470, Lumigan and vehicle were published in the peer-reviewed Journal of Ocular Pharmacology and Therapeutics. While we acknowledge the limitations in read-across from animal data and note the Mont Blanc study did not show statistical superiority against PGA drug latanoprost (although it did meet the non-inferiority primary efficacy endpoint), we believe the new findings add to the body of collective data suggesting a competitive commercial profile for NCX-470 versus standalone PGA drugs such as bimatoprost.

Written by

Pooya Hemami

Analyst - Healthcare

nicox01

Healthcare

Nicox

Animal data show favourable profile vs Lumigan

Study update

Pharma and biotech

18 December 2023

Price

€0.39

Market cap

€20m

$1.09/€

Net debt (€m) at 30 September 2023

6.5

Shares in issue

50.2m

Free float

90%

Code

ALCOX

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

Business description

France-based Nicox develops therapeutics for the treatment of ocular conditions. Its lead candidate NCX-470 is in Phase III studies for the treatment of glaucoma, and it is advancing NCX-4251 for dry eye disease. Nicox also receives licence revenue for its FDA-approved drugs Vyzulta and Zerviate.

Analysts

Pooya Hemami, OD MBA CFA

+1 643 653 7026

Soo Romanoff

+44 (0)20 3077 5700

Nicox is a research client of Edison Investment Research Limited.

Nicox has reported that an in vivo study carried out in beagles found that NCX-470 (0.1%) treatment led to a greater degree of intraocular pressure (IOP) reduction compared to AbbVie’s Lumigan (bimatoprost 0.01%), the best-selling branded prostaglandin F2α analogue (PGA) drug, in both single and repeated (five-day) dosing. The newly reported data from the open-label cross-over study assessing NCX-470, Lumigan and vehicle were published in the peer-reviewed Journal of Ocular Pharmacology and Therapeutics. While we acknowledge the limitations in read-across from animal data and note the Mont Blanc study did not show statistical superiority against PGA drug latanoprost (although it did meet the non-inferiority primary efficacy endpoint), we believe the new findings add to the body of collective data suggesting a competitive commercial profile for NCX-470 versus standalone PGA drugs such as bimatoprost.

Year end

Revenue**
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/21

8.6

(15.5)

(0.32)

0.0

N/A

N/A

12/22

5.2

(18.3)

(0.34)

0.0

N/A

N/A

12/23e

6.1

(15.6)

(0.31)

0.0

N/A

N/A

12/24e

7.6

(20.3)

(0.40)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. **Revenue figures reflect gross revenues.

Nicox’s lead candidate NCX-470 is a nitric oxide donating bimatoprost, in a second Phase III study (Denali) in the treatment of elevated IOP in patients with glaucoma or ocular hypertension. As recently disclosed by Nicox, the peer-reviewed article by Galli et al. found that after single dosing, NCX-470 showed stronger IOP reduction than Lumigan at most tested timepoints up to 24 hours post-dosing. In the repeat dosing study component, the effects of both Lumigan and NCX-470 were generally consistent and stable throughout the study evaluation period, with NCX-470 showing consistently stronger decreases in IOP compared to Lumigan at all the tested timepoints. We note that the tested 0.1% NCX-470 drug concentration is the same as what was selected for the two Phase III NCX-470 pivotal trials (the now-completed Mont Blanc study and the ongoing Denali trial).

Previously reported non-clinical data from another animal model, also discussed in the journal article, suggested NCX-470’s mechanisms for IOP reduction included both the uveoscleral pathway traditionally associated with PGA drugs, but also improvements in outflow through the trabecular meshwork (TM) and/or Schlemm’s canal, which we believe is likely due to the NO donating properties of NCX-470. Nicox plans to initiate the Whistler Phase IIIb trial in the coming weeks, which is designed to evaluate NCX-470’s effects on aqueous humour dynamics, including its outflow through TM, and may confirm NCX-470’s ability to lower IOP through the TM/SC pathway, potentially differentiating it from traditional PGA drugs. Nicox reiterated in October that the Denali trial is on track to report data in 2025, and we estimate it can potentially reach commercialisation in the US in 2027. Nicox maintains it remains funded until end-H124 based on the development of NCX-470 alone and it is seeking potential partnership arrangements (particularly for NCX-470), which could provide non-dilutive funding and extend its cash runway. It is also exploring multiple strategic options.

General disclaimer and copyright

This report has been commissioned by Nicox and prepared and issued by Edison, in consideration of a fee payable by Nicox. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

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United Kingdom

General disclaimer and copyright

This report has been commissioned by Nicox and prepared and issued by Edison, in consideration of a fee payable by Nicox. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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