CLINUVEL PHARMACEUTICALS LTD

Melanocortins are a group of small protein hormones derived from proopiomelanocortin (POMC). They modulate physiological activity in the body by binding with specific melanocortin receptors (MCRs) on cells across the body. Five MCRs have been identified: MC1R-MC5R.

POMC, the precursor molecule to all naturally occurring melanocortins, is widely expressed throughout the body, although has very little biological activity. POMC is cleaved into smaller peptides, producing melanocortins that are able to bind to receptors on cells and exert their effects.

CLINUVEL is building a melanocortin house and has outlined the melanocortin technology being developed in its recently released Annual Report. Read more here: https://annualreport.clinuvel.com/

CLINUVEL’s Notice of Meeting for our Annual General Meeting is now live. Head to our website to view: https://www.clinuvel.com/2024/09/notice-of-annual-general-meeting-20240913/

Notice of Annual General Meeting - CLINUVEL Notice of Annual General Meeting

In addition to announcing its eighth consecutive year of profit, CLINUVEL also outlined its ambitions to build a melanocortin house in its recently released Annual Report.

These ambitions would see the Company become a sustainable, diversified pharmaceutical group of international significance.

Read more here: https://annualreport.clinuvel.com/

In a letter addressed to shareholders, CLINUVEL’s Chair, Prof Jeffrey Rosenfeld, discusses the Company’s refresh of the Board of Directors, market value, and its upcoming Annual General Meeting.

Read the letter here: https://www.clinuvel.com/2024/09/chairs-letter-to-shareholders-20240909/

Chair’s letter to shareholders - CLINUVEL CLINUVEL’s Chair, Professor Jeffrey Rosenfeld, released a letter addressed to shareholders today.

CLINUVEL’s three new directors bring extensive experience across corporate finance and governance, investment banking, and dermatology (with a focus on pigmentation disorders).

Read more here: https://www.clinuvel.com/2024/09/clinuvel-board-renewal-expansion-20240906/

CLINUVEL today announced renewal and expansion of its Board, with Brenda Shanahan to retire at the Annual General Meeting and three new Non-Executive Directors appointed.

Read more: https://www.clinuvel.com/2024/09/clinuvel-board-renewal-expansion-20240906/

CLINUVEL Board Renewal, Expansion - CLINUVEL CLINUVEL today announced that Non-Executive Director Brenda Shanahan has advised the Board that she will retire as a Director of the Company at the conclusion of the next Annual General Meeting, with three new Non-Executive Directors appointed today.

Our third day at the International Congress on started off with a session on new research and controversies on and , with a particularly enlightening presentation by Prof Henry on personalised photoprotection.

We concluded our day with the session on diseases and , where Prof Piergiacomo Calzavara-Pinton, Prof Henry Lim, Dr Sally Ibbotson, and Dr Yolanda Gilaberte shared their experiences and approaches on diagnosing and treatment photosensitivity diseases.

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The quality of life in children with erythropoietic protoporphyria (EPP), when compared to that of healthy children and adults with EPP, is especially affected in the social and physical domains.

Children with EPP showed a higher percentage of social inhibition than their unaffected peers.

CLINUVEL is working to expand its research to provide solutions for more EPP patients, to improve their quality of life.

Keep up to date with our latest news here: https://bit.ly/3SZN7HC

Source: Kluijver LG, Wensink D, Wagenmakers MAEM, Huidekoper HH, Witters P, Rymen D, Langendonk JG. Quality of life in children with erythropoietic protoporphyria: a case-control study. J Dermatol. 2024 Aug;51(8):1068-1078. doi: 10.1111/1346-8138.17348. Epub 2024 Jun 26. PMID: 38923596.

It’s a wrap for Day 2 of the 18th International Congress on ! Of particular interest today were sessions that delved into the science of (UV) exposure on the human skin and .

We heard from Louisa Collins on maintaining the balance of sun exposure and vitamin D levels; Prof Antony Young on use and the effects on synthesis, and the impact of on DNA photo damage; and from Dr Tasneem Mohammad on the impact of both visible and UV light on the human skin, and addressing challenges of photoprotection for skin of colour.

We are excited for the sessions over the next few days, covering more researching in the field of , and .

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The Presidential Lecture is happening now with Professor Scott Byrne, discussing the important work in the field of and in particular, the effects of exposure on the human body.

Read more about Prof Byrne here: https://www.icpworldcongress.com/scott-byrne

The 18th International Congress on Photobiology commences shortly in . Professor Janet Bornman, the President of International Union of Photobiology ( ), is kicking off proceedings. In welcoming delegates, Prof Borman is presenting on interconnections of and .

Read more about Prof Bornman here:
https://icpworldcongress.com/janet-bornman

A recent study has found that the quality of life in children with erythropoietic protoporphyria (EPP) is lower than that in both healthy children and adults with EPP.

This demonstrates a clear need for therapeutic solutions for younger patients with EPP. CLINUVEL is working to expand its research to provide solutions for more EPP patients.

Read more about our program here: https://bit.ly/3SZN7HC

Source: Kluijver LG, Wensink D, Wagenmakers MAEM, Huidekoper HH, Witters P, Rymen D, Langendonk JG. Quality of life in children with erythropoietic protoporphyria: a case-control study. J Dermatol. 2024 Aug;51(8):1068-1078. doi: 10.1111/1346-8138.17348. Epub 2024 Jun 26. PMID: 38923596.

The 18th International Congress on Photobiology kicks off this Sunday in Perth, Western Australia (25‒30 August 2024).

CLINUVEL is proud to be sponsoring this event, and we are looking forward to sessions on photoprotection and photomedicine.

Stay tuned for updates from the event.

CLINUVEL today announced updates on its vitiligo program and the restructure of its Clinical Affairs team.

Read more here: https://www.clinuvel.com/2024/08/vitiligo-and-operational-update-20240821/

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Vitiligo and Operational Update - CLINUVEL Phase III vitiligo study (CUV105) amended following expert clinician feedback

As the global authority on photomedicine, CLINUVEL is working to provide novel solutions to those with unmet needs.

CLINUVEL announced final results from our CUV151 study last month, evaluating the effects of afamelanotide and ultraviolet light exposure in healthy volunteers.

Read more about the results here: https://www.clinuvel.com/2024/07/afamelanotide-assists-dna-repair-response-following-uv-radiation-20240705/

CYACÊLLE Radiant is a mineral SPF50+ that delivers an unrivalled level of protection from three types of rays, while the skin-smoothing tint enhances your radiance.

Formulated with triple-light defence, the solar shield protects against ultraviolet B rays, which can cause sunburn and skin cancer; ultraviolet A, which leads to premature ageing; and skin-damaging blue light, which can lead to hyperpigmentation.

Learn more here: https://www.cyacelle.com/en-gb

Exposure to ultraviolet (UV) light not only increases your risk of skin cancer, but it can also cause premature ageing.

In fact, up to 90% of skin ageing is caused by UV light. Photoageing results in collagen depletion, loss of elasticity, fine lines and wrinkles, and hyperpigmentation such as age spots.

While you can’t stop time, using topical solar protection, and avoiding the sun during the hottest times of day, will help reduce your risk of photoageing.

The is in full swing, but did you know that participating in outdoor sports such as tennis, golf and surfing leaves you at a higher risk of photodamage?

A study from 2023 suggested that golfers are 2.4 times as likely to develop skin cancer than non-golfers.

Using a high factor polychromatic solar protection, along with protective clothing when on the golf course is essential.

Source:

Stenner B, Boyle T, Archibald D, Arden N, Hawkes R, Filbay S. Golf participants in Australia have a higher lifetime prevalence of skin cancer compared with the general population. BMJ Open Sport Exerc Med. 2023 Jul 20;9(3):e001597.

When it comes to solar protection it is helpful to understand how our skin might react to ultraviolet (UV) and visible light, in order to better protect it.

The Fitzpatrick scale for skin types is a useful tool to better understand your skin and how to protect it from light.

CLINUVEL advises that Ms Claire Newstead-Sinclair has been appointed Company Secretary, effective today, with Mr Peter Vaughan stepping down from the interim role.

Read more: https://www.clinuvel.com/2024/08/change-of-company-secretary-20240806/

Change of Company Secretary - CLINUVEL CLINUVEL advises Mr Peter Vaughan will be appointed Company Secretary, effective today until 6 August 2024 when a permanent Company’s Secretary is starting employment.

Does vitiligo make you more susceptible to skin cancer?
Despite the lack of protective melanin in depigmented skin, studies have indicated that the incidence of melanoma and non-melanoma skin cancers in vitiligo patients is actually lower than in the general population.

However, this does not mean that vitiligo patients do not experience photodamage. Many patients have reported severe sunburn on depigmented skin, along with itching and blistering following sun exposure.

Using a high factor polychromatic solar protection on every part of your skin ensures you are protected from ultraviolet (UV) induced DNA damage that could lead to skin cancer and premature ageing.

CLINUVEL published a Technical Note on the recently announced CUV151 results from the Company’s DNA Repair program. The Technical Note explores the RNA sequencing technique used and presents the results that demonstrate a broader role of afamelanotide in preventing and assisting repair in UV-induced skin damage than has been previously reported.

Read it here: https://www.clinuvel.com/2024/07/technical-note-cuv151-dna-repair-program-20240730/

Technical note: CUV151 — DNA Repair program - CLINUVEL HomeNews2024 AnnouncementsTechnical note: CUV151 — DNA Repair program 30.07.2024 2024 Announcements Clinical News Technical note: CUV151 — DNA Repair program Melbourne, Australia, 30 July 2024 Download PDF

The SF Derm Annual Meeting took place over the weekend at the Ritz-Carlton Half Moon Bay. CLINUVEL is proud to have sponsored the event, at which there was an in-depth discussion of vitiligo and emerging treatments. Dr Faranak Kamangar, Chair of SF Derm and Department Chair of the Palo Alto Medical Foundation, also presented on the design of CLINUVEL’s Phase III vitiligo study (CUV105).

CLINUVEL is a global leader in the research and commercialisation of melanocortins.

Melanocortin peptides are known for their neuroprotective, anti-inflammatory and repairing properties. By understanding these complex peptides, CLINUVEL is able to translate this expertise into finding novel solutions to protect the brain and skin.

Read more about our pioneering research here: https://www.clinuvel.com/pharmaceuticals/disease-entities/

Pol Dominquez is an 11-year-old boy with xeroderma pigmentosum (XP), the rare disease in which patients are unable to repair DNA damage incurred from exposure to ultraviolet (UV) light, putting them at a significantly higher risk of developing skin cancers.

Read his story (via Reuters): https://reuters.com/business/healthcare-pharmaceuticals/boy-lives-permanent-shade-survive-dangerous-sunlight-2024-07-18/.

CYACÊLLE Radiant is a highly protective solar shield that protects your skin from harmful UVB, UVA and high energy visible (HEV) light waves.

Formulated with 100% mineral UV filters, antioxidants and hydrating squalane, argan and jojoba oils, it enhances your skin’s natural radiance without leaving a white cast.

Click here to shop now: https://www.cyacelle.com/en-gb

Diagnoses of melanoma in the UK are rising faster than any other common cancer, but you can take measures to protect yourself:

- Seek shade when you can, especially between 10am and 4pm
- Wear UV protective clothing, a hat and sunglasses
- Use a high factor topical solar protection daily

CLINUVEL has recently launched CYACÊLLE Radiant, a polychromatic solar shield that offers the highest protection against UVB, UVA and high energy visible (HEV) light.

Click here to shop now: https://www.cyacelle.com

When looking for a treatment for vitiligo, 67% of patients report that repigmentation is the main treatment goal, with over 42% wanting a treatment they can use long-term.

Current therapies that fulfill both goals are limited. CLINUVEL is working to change that and to give those who seek treatment more effective options.

Read more about our ongoing vitiligo program here: https://www.clinuvel.com/pharmaceuticals/disease-entities/vitiligo/

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Source: Rosmarin, D., H. Lofland, J., Marwaha, S., Piercy, J., Anderson, P., & Liu, J. (2024). Patient burden of nonsegmental vitiligo: A US Real-World survey of dermatologists and their patients. Dermatology and Therapy. https://link.springer.com/article/10.1007/s13555-024-01165-5