Replicel Stock Price Trend and RCH-01 Update

Update: March 23, 2020

Replicel just published a slightly encouraging update (h/t “Bekoo”). Well known dermatologist Dr. Jerry Shapiro has high praise for the recent Shiseido trial in Japan. He makes an astute point that most of the patients in the trial were at advanced stages of hair loss. This makes the results even more encouraging for those with recent hair loss. For transparency, the update does mention that Dr. Shapiro was a founding shareholder of Replicel.

The autologous cell-based therapy with dermal sheath cup cells that was used in the Shiseido study is the same product that RepliCel refers to as RCH-01:

Shiseido has licensed the co-development and commercial rights in Asia. RepliCel maintains the complete and unrestricted rights to this product outside of Asia.

Also of interest and something that I missed before: the Shiseido trial proved that the RCH-01 dermal sheath cup cell product can be used after cryopreservation and thawing.

March 11, 2020

In my last post on Shiseido, someone pointed out that Replicel has updated its Twitter feed. It seems like the latest Shiseido trials used Replicel’s RCH-01 technology. A bit strange that Shiseido does not mention Replicel in its latest communications. Perhaps indicating that the two companies’ partnership issues are not yet close to being resolved.

Replicel News Update
Replicel Update via Twitter.

Yesterday, Replicel also got good news from the Japanese regulatory agency PMDA. This was in regards to the issuance of several non-hair loss product related patents. And Replicel got a final consultation go-ahead today regarding the company’s skin and tendon regeneration products.

Replicel’s stock price is even more volatile than usual this week. It dropped 33 percent on Monday. Then increased 71 percent on Tuesday. Down 10 percent so far today.

Replicel Stock Price

May 26, 2019

For those who are in the finance sector, why has Replicel’s stock price declined so drastically and continuously during the past five years? Earlier today, the company made yet another positive press release. This time regarding its YOFOTO licensee in China and its decent growth prospects.

This comes on top of the two announcements that they already made earlier this month. I covered those in my post on Shiseido and Replicel. If any of this blog’s readers is investing in REPCF stock, please update us regularly on any developments. Including insider transactions, earnings announcements, P/E ratios and more.

Replicel Stock Price

 

Breezula Phase II Results Positive, Phase III Delayed

Update March 19, 2020: How things can change in just a few weeks. Breezula Phase 3 trials have now been delayed till 4th quarter 2020 or 1st quarter 2021. All due to COVID-19 (Coronavirus), which has hit Italy particularly hard. More information can be found in Cassiopea’s 2019 Annual Results presentation, which was released today.

The Clascoterone female pattern hair loss Phase 2 trials are on track to finish enrollment in 2Q 2020. Trials should be completed by year-end 2020. However, delays are still possible depending on progression and recurrence of the current pandemic.

Quote from the accompanying pdf:

“As part of the process in the NDA review, the FDA amongst other, also inspects the facility in which Clascoterone cream 1% is manufactured. Clascoterone cream 1% is planned to be manufactured at Cosmo Pharmaceuticals plant in Lainate in Italy. Given restrictions currently in place because of the COVID-19, the FDA had to postpone the inspection planned for March.”

Nevertheless, Cassiopea is still planning to  release its Winlevi acne cream product by the end of this year.

Update January 19, 2020: A new article in labiotech suggests Breezula sales to total 350 million Euros. Quite impressive.

Update November 13, 2019: Cassiopea’s women’s hair loss clascoterone solution Phase II trials starting soon in Germany.


April 16, 2019

I have covered Italian company Cassiopea since 2014 (when it was called Cosmo Pharmaceuticals). The company is developing a topical anti-androgen hair loss product named Breezula (originally called CB-03-01). The chemical name for this product is Clascoterone.

Breezula will be available for both men and women. Several of my well known physician contacts in the hair loss world have told me great things about this product. Their feedback is based on what they saw at conferences or heard from colleagues.

Breezula Phase II Trials Very Successful

In July of last year, Cassiopea stated that the interim Phase II clinical trial results for Breezula were very positive. Today, they released twelve month Phase II trial results with the same conclusion:

Cassiopea announces very positive Phase II Twelve Months Results for Breezula® (Clascoterone) in treating androgenetic alopecia.

The presentation of the results is confusing, detailed, full of acronyms and somewhat open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they release before and after photos at some point.

Also note that the previous 6-month interim report had 375 subjects, and the 12-month report has 344 subjects. The trial was conducted in Germany.

Breezula Target Area Hair Count Increase

Breezula Hair Count Increase
Breezula Hair Count Increase.

Best case result highlighted in yellow (14.3 new hairs per square centimeter, after 12 months of 7.5% BID clascoterone solution dosage). BID means twice per day.

Breezula Target Area Hair Width Increase

Breezula Hair Width Increase
Breezula Hair Width Increase.

Best case result highlighted in yellow (762.5 um width increase, after 12 months of 7.5% BID dosage).

My gut feeling is that Breezula will be at least as effective as Finasteride and Minoxidil.

Clascoterone Summary

Some key points from the above linked article from Cassiopea:

  • If approved, Breezula (Clascoterone) will be the first FDA-approved topical anti-androgen for the treatment of androgenetic alopecia.
  • Moreover, it would also be the first new drug approved for treating androgenetic alopecia since 1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods last won the Master’s before this past weekend’s surprise.
  • Based on these great results, Cassiopea plans to proceed with 6-month Phase III trials in men in the fourth quarter of 2019, after consultation with the FDA. The company is also going to start proof-of-concept trials in women.
  • Breezula works by blocking dihydrotestosterone (DHT) interaction with hair follicle androgen receptors.
  • Clascoterone does not interfere with testosterone and other hormones in male subjects. Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.

In the past, I used to often state that perhaps an initial cure for hair loss would entail the usage of a cocktail of products. Each working via different mechanisms and chemical or biological reactions.

It is looking likely that Breezula will be one of the main products in this cocktail.

Note that Clascoterone 1% cream to treat acne will be released by Cassiopea before Breezula. The acne product is called Winlevi.

Hair Loss Cure News Blog. Hair Cloning, Regrowth and Multiplication for Baldness.