CLINUVEL preparing upgrade of聽ADR program to Level II, Nasdaq uplist
CLINUVEL (CLVLY) has announced plans to upgrade its Level I American Depository Receipt (ADR) program to a Level II ADR and uplist to the Nasdaq Stock Market by the end of 2025. The company has initiated preparations to file Form 20-F with the SEC and has appointed U.S. legal counsel and an investment bank.
Currently, 28% of CLINUVEL's shares are held by U.S.-based investors, with the Level I ADR program representing approximately 7% of outstanding shares. The Bank of New York Mellon is proposed as the depositary. Importantly, the company's primary listing on the Australian Securities Exchange (ASX) will remain unchanged, and no capital raising is planned in connection with the uplisting.
CLINUVEL (CLVLY) ha annunciato l'intenzione di aggiornare il proprio programma di American Depositary Receipt (ADR) da Level I a Level II e di trasferire la quotazione al Nasdaq entro la fine del 2025. La societ脿 ha avviato le procedure per la presentazione del modulo 20-F alla SEC e ha nominato consulenti legali negli USA e una banca d'investimento.
Attualmente, il 28% delle azioni di CLINUVEL 猫 detenuto da investitori statunitensi, mentre il programma Level I ADR rappresenta circa il 7% delle azioni in circolazione. 脠 proposta la Bank of New York Mellon come depositary. La quotazione primaria rimarr脿 sull'Australian Securities Exchange (ASX) e non 猫 previsto alcun aumento di capitale in occasione dell'uplisting.
CLINUVEL (CLVLY) ha anunciado su plan para elevar su programa de American Depositary Receipts (ADR) de Level I a Level II y cotizar en Nasdaq antes de finales de 2025. La compa帽铆a ha comenzado los preparativos para presentar el Formulario 20-F ante la SEC y ha designado asesores legales en EE. UU. y un banco de inversi贸n.
Actualmente, el 28% de las acciones de CLINUVEL est谩n en manos de inversores con sede en Estados Unidos, y el programa Level I ADR representa aproximadamente el 7% de las acciones en circulaci贸n. Se propone a Bank of New York Mellon como depositaria. La cotizaci贸n principal permanecer谩 en la Australian Securities Exchange (ASX) y no se prev茅 una ampliaci贸n de capital vinculada al uplisting.
CLINUVEL (CLVLY)電� 鞛愳偓 氙戈淡鞓堩儊歃濎劀(ADR) 頂勲攴鸽灗鞚� Level I鞐愳劀 Level II ADR搿� 瓴╈儊頃橁碃 2025雲� 毵愱箤歆� 雮橃姢雼レ溂搿� 靸侅灔 鞚挫爠(uplist)頃� 瓿勴殟鞚� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� SEC 鞝滌稖鞖� Form 20-F 欷�牍勲ゼ 鞁滌瀾頄堨溂氅�, 氙戈淡 氩曤 鞛愲瓿� 韴瀽鞚�頄夓潉 靹犾瀯頄堨姷雼堧嫟.
顺勋灛 CLINUVEL 欤检嫕鞚� 28%電� 氙戈淡 韴瀽鞛愱皜 氤挫湢頃橁碃 鞛堨溂氅�, Level I ADR 頂勲攴鸽灗鞚� 鞝勳泊 氚滍枆 欤检嫕鞚� 鞎� 7%毳� 彀頃╇媹雼�. 鞓堩儊鞚�頄夓棎電� Bank of New York Mellon鞚� 瓯半霅橁碃 鞛堨姷雼堧嫟. 欤检殧 靸侅灔鞚� 順胳＜歃濌秾瓯半灅靻�(ASX)鞐� 鞙犾霅橂┌, uplisting瓿� 甏�霠暅 鞛愱笀 臁半嫭 瓿勴殟鞚� 鞐嗢姷雼堧嫟.
CLINUVEL (CLVLY) a annonc茅 son projet de faire passer son programme d'American Depositary Receipt (ADR) de Level I 脿 Level II ADR et de s'introduire sur le Nasdaq d'ici la fin 2025. La soci茅t茅 a entam茅 les d茅marches pour d茅poser le formulaire 20鈥慒 aupr猫s de la SEC et a d茅sign茅 un cabinet juridique aux 脡tats鈥慤nis ainsi qu'une banque d'investissement.
Actuellement, 28% des actions de CLINUVEL sont d茅tenues par des investisseurs bas茅s aux 脡tats鈥慤nis, et le programme Level I ADR repr茅sente environ 7% des actions en circulation. La Bank of New York Mellon est propos茅e comme d茅positaire. La cotation principale restera sur l'Australian Securities Exchange (ASX) et aucune lev茅e de capitaux n'est pr茅vue en lien avec cet uplisting.
CLINUVEL (CLVLY) hat angek眉ndigt, sein American Depositary Receipt (ADR)-Programm von Level I auf Level II ADR hochzustufen und bis Ende 2025 an die Nasdaq umzuziehen. Das Unternehmen hat die Vorbereitung zur Einreichung des Formulars 20-F bei der SEC begonnen und US-Rechtsbeistand sowie eine Investmentbank benannt.
Derzeit befinden sich 28% der CLINUVEL-Aktien im Besitz von US-Investoren, und das Level I ADR-Programm entspricht etwa 7% der ausstehenden Aktien. Als Depositary ist die Bank of New York Mellon vorgeschlagen. Die prim盲re Notierung bleibt an der Australian Securities Exchange (ASX) bestehen, und mit dem Uplisting ist keine Kapitalerh枚hung geplant.
- Strong U.S. investor base with 28% of shares held by U.S.-based investors
- No dilutive capital raising planned with the uplisting
- Company is one of few profitable biopharmaceutical companies
- Potential for increased U.S. visibility and trading access
- SEC review and Nasdaq listing requirements still pending approval
- Uncertainty about completion timeline and success of uplisting process
Executive summary
- plan to upgrade American Depository Receipt (ADR) program (CLVLY) to a Level II ADR listed on Nasdaq, expected before the end of 2025
- CLINUVEL鈥檚 primary listing on the ASX will remain unchanged as a result of the ADR uplist
- preparation of Form 20-F for submission to U.S. SEC
- Nasdaq listing to enhance U.S. visibility, trading access and investor engagement
- approximately
28% of CLINUVEL鈥檚 issued shares held by U.S.-based investors - no capital raising is proposed in connection with the ADR uplist
MELBOURNE, Australia, Aug. 22, 2025 (GLOBE NEWSWIRE) -- 聽CLINUVEL is undertaking preparatory steps to upgrade its Level I American Depository Receipts (CLVLY), currently trading over-the-counter in the United States, to a Level II program listed on the Nasdaq Stock Market (Nasdaq). CLINUVEL鈥檚 primary listing on the Australian Securities Exchange (ASX) will remain unchanged.
Work has commenced to file a Form 20-F registration statement with the U.S. Securities and Exchange Commission (SEC). CLINUVEL is currently undertaking legal, financial, and regulatory workstreams in support of this process, and has appointed U.S. legal counsel and an investment bank.
The planned upgrade is expected to occur before the end of 2025 (subject to the successful completion of the SEC review and satisfaction of listing requirements).
The Bank of New York Mellon is currently proposed to act as depositary, custodian and registrar of the upgraded Level II ADR program.
CLINUVEL鈥檚 current Level I ADR program constitutes approximately
Strategic Rationale
CLINUVEL鈥檚 intent to pursue a Level II ADR and Nasdaq listing is aligned with the Company鈥檚 existing shareholder base (approximately
鈥淲e believe this initiative will significantly broaden CLINUVEL鈥檚 visibility and trading access in the United States,鈥� CLINUVEL鈥檚 Managing Director, Dr Philippe Wolgen said. 鈥淩ecent engagement with U.S. institutional investors has confirmed growing interest in CLINUVEL鈥檚 profile as one of the very few profitable biopharmaceutical companies.鈥�
鈥淭he Board believes that this step will help in further realising the long-term value of the Company,鈥� Dr Wolgen concluded.
Risk statement聽
No final decision has been made in respect of the proposed ADR uplisting. The process also remains subject to SEC review and satisfaction of Nasdaq listing requirements. There is no guarantee that the uplisting will proceed, nor that it will occur within the expected timeframe. CLINUVEL will provide further updates to the market as material developments occur.
This announcement does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
About CLINUVEL PHARMACEUTICALS LIMITED
CLINUVEL (ASX: CUV; ADR LEVEL I: CLVLY; B枚rse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL鈥檚 research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives.
CLINUVEL鈥檚 lead therapy, SCENESSE庐 (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world鈥檚 first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to .
Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD.
Head of Investor Relations
Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD
Investor Enquiries
Forward-Looking Statements
This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL鈥檚 management. All statements other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements in this document by using words or phrases such as 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃onsider,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渇oresee,鈥� 鈥渋ntend,鈥� 鈥渓ikely,鈥� 鈥渕ay,鈥� 鈥渙bjective,鈥� 鈥減otential,鈥� 鈥減lan,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟eek,鈥� 鈥渟hould,鈥� 鈥渨ill鈥� and similar words or phrases and their negatives. Forward-looking statements reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products; competition for our products, especially SCENESSE庐 (afamelanotide 16mg), CYAC脢LLE, PR脡NUMBRA庐, NEURACTHEL庐 or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE庐, CYAC脢LLE, PR脡NUMBRA庐, NEURACTHEL庐 or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran鈥檚 Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology, cosmetic and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2024 Annual Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.
Contact:
Tel: +61 3 9660 4900
Fax: +61 3 9660 4909
贰尘补颈濒:听
Australia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia
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FAQ
What is CLINUVEL's plan for its ADR program (CLVLY) in 2025?
Will CLINUVEL raise capital as part of the Nasdaq uplisting?
What percentage of CLINUVEL shares are held by U.S. investors?
What is the current size of CLINUVEL's Level I ADR program?
Who will be the depositary bank for CLINUVEL's Level II ADR program?
