Forum Topics CUV CUV Vitiligo Update - CUV105 Study

Pinned straw:

Added 3 months ago

CUV released an update on it's ongoing CUV105 Study of Vitiligo, due to be completed with full study results in 2026.

SCENESSE efficacy in vitiligo - new cases presented to EADV 

Having followed and been an investor in Clinuvel for a number of years, each update on the CUV105 study is promising. The clear visual impact Scenesse implants, along with NB-UVB (Narrowband UV-B) Phototherapy, has on re-pigmentation of the affected skin areas, increases the efficacy, safety and validity of this treatment which increased the probability of commercialisation for treatment of patients who suffer from Vitiligo.

I haven't gone through and updated my valuation after the FY25 results yet, which came in below expectations due to increased spending on a few areas including personnel. However with a warchest of cash ($224m as of June 30, 2025 *which is ~39% of the entire MC), you only have to factor in a small probability of Scenesse's success in the huge Vitiligo for the current SP to be undervalued.

Disc. Held in RL & on SM.

Nnyck777
Added 2 months ago

Hi I have watched CUV over several years but never invested. I note the upcoming NASDAQ listing? That CUV is deft free with a war chest of $224 million and reasonable revenue growth. My concern with Scenesse is the patent life and room for generics to move into the market. Anyone have more expertise and opinion on this. Thanks Nnyck

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BoredSaint
Added 2 months ago

Been following and am still currently a shareholder in CUV.

Listened into the results but haven't done a write-up yet (been busy with other things) but might do one down the track.

Interestingly they allowed for analyst's questions for the first time during the results webinar. In the past the questions were collated and the IR would prepare questions for management to answer but they allowed an open call for the first time which was encouraging.

Results a little bit mixed for this year IMO. Revenue growth was good but they are ramping up expenses to try and diversify out their portfolio. Vitiligo remains the main potential growth driver of this business with Scenesse for EPP having matured mostly in their current markets and the photocosmetics business being further delayed. Photocosmetics also being an area with huge competition unlike EPP and potentiall Vitiligo in which they are the only current treatment.

I think the NASDAQ listing makes sense given their large proportion of revenue coming from North America and would also increase the level of exposure and liquidity of the company. At the current share price I see it being fairly valued based only on the Scenesse business provided there is no incoming competition in the near future and with blue sky potential in Vitiligo and hence I remain a share holder.

Disc: Held IRL and on Strawman.

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Travisty
Added a month ago

Hi @Nnyck777,

I've been an LT investor in RL & on SM and have seen the company consistently grow revenue and earnings despite the less than ideal market returns. The 2 biggest risks I see in CUV are opportunity cost and it being a value trap. However, they do have some very promising avenues for significant growth which I highlight below.

@BoredSaint gave a great summary of the most recent financials and shift, finally, to allowing live analyst questions on their results call. I too believe that the company is fairly valued based on it's EPP growth outlook, with a slight boost in growth available if the regulators allow for Scenesse approval in other countries along with treatment in adolescent's. I don't think the market is really taking into account for the real potential of Vitiligo and also other areas of their "House of Melanocortins" which includes ACTH, Variegate Porphyria and PhotoCosmetics.

While there are clearly risks involved with any new drug in trial phase, the updates provided, especially around Vitiligo have been positive. Being the first mover in EPP makes patients sticky, as switching to a new drug takes time and risk, multiple doses over many months/years are required before any real difference in results would be seen for a superior drug. So, I can't see many switching away from Scenesse to a newly released drug when they've already seen their quality of life improving while taking Scenesse.

The biggest reason I remain a holder is the risk averse nature of the company, the ability to fund all trials and manufacturing in-house which preserves IP, all while building cash reserves to survive an economic downturn and fully fund over 4-years of projected expenses. Many see this slow build up of cash as a lazy balance sheet, but those are often short term focused and aren't willing to hold LT.

I would highly recommend reading the MD (Dr Wolgens) address at the AGM, here. He outlines the clear mindset the Executive team and Board have on how they manage the capital CUV has and the goals they have moving forward.

Lastly, they recently released a promising announcement regarding their Singapore based research lab, who have been working since 2014 on a next generation formulation for a slow release dosage that isn't via inserted capsule and can be injected in liquid form or possibly applied on the skin as a gel, allowing for variance in dosage all the while being slowly released into the patient. Philippe spoke briefly about this at the AGM and said the potential for this is huge as it can be applied by a number of other peptide & melanocortin based drugs. The potential being a far greater addressable market than that of Vitiligo. I would suggest taking the time to watch the AGM, especially Dr. Wolgen's address and his answers to shareholder questions.

I'll look to do an update on my valuation soon, trying to take into account the possibility of Vitiligo hitting commercialisation by the end of the decade.

Held in RL & on SM.

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