Category Archives: RCH-01

Replicel Stock Price Trend and RCH-01 Update

Update: September 15, 2020 — For the past week, there has been a lot of online discussion about Replicel (Canada)’s collapsing stock price. REPCF is at 10 cents per share as of today, down from 30 cents just 6 months ago. A few days ago, Replicel’s Twitter account posted a comment that garnered a number of responses. My favorite interaction came today:

Replicel Reply

For several years, I have assumed that Replicel’s technology will only come to fruition if Shiseido decides to go through with it. The two semi-partners have had an ongoing dispute related to rights and clinical trials for several years. Shiseido is a cosmetics behemoth that is 100s of times as large as Replicel.

Replicel Update on Shiseido Partnership

Earlier today, Replicel also released a detailed update that included further elaboration on its Shiseido partnership problems:

“The disagreement regarding the status of the agreement between Shiseido and RepliCel remains unresolved, but is not the subject of any litigation or arbitration. RepliCel maintains the Agreement remains intact and is communicating with Shiseido its expectation that (a) they deliver to RepliCel the full clinical data set from the recently completed study of RCH-01 in Japan and (b) confirm that their license agreement remains intact without breach. RepliCel reserves the right to take the position that Shiseido’s failure to deliver the clinical data from the recently completed clinical study in Shiseido’s Territory constitutes a material breach of contract which, failing a cure, will warrant RepliCel’s termination of the agreement.”

Not very encouraging. It should be noted, however, that Shiseido has its own Japanese scientists and researchers that have been working on hair loss treatments for decades. I have written many posts on this company since this blog started. Hopefully, Shiseido can still produce a great treatment for androgenetic alopecia, even if unable to use Replicel’s technology. And vice versa of course.

RCH-01 Phase 2 Trials Status

Replicel also stated the following in its update:

“RepliCel will begin preparations for phase 2 human clinical trials of this product outside of Asia (Shiseido’s licensed territory).”

The company is in early stage discussions with potential partners outside of Asia. It seems like Replicel will always need to look for funding at each stage of trials. CEO Lee Buckler tends to post regular updates on Twitter regarding new partnerships.

March 23, 2020

RCH-01 Update

Replicel just published a slightly encouraging update on its RCH-01 product for hair loss. 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

Replicel 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. 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
Replicel Historical Stock Price Chart.

If Shiseido Decides to Do So

Update: March 27, 2020

Shiseido’s latest trial results are finally getting global publicity. Yesterday, lead researcher Dr. Ryoji Tsuboi was interviewed by the Asahi Shimbun. The title of the article clearly states that this technology entails transplantation of ones own cells. Not surprisingly, The Daily Mail has even more details.

Shiseido’s method involves autologous transplantation of dermal sheath cup cells. I am very optimistic that Japan’s favorable regulations will lead to this technology reaching the market in the next several years.

Shiseido Hair Research from Dr. Tsuboi
Shiseido lead researcher Dr. Ryoji Tsuboi. Source: Asahi Shimbun.

Dr. Tsuboi:

“The result of our study was very encouraging, We were able to show that the study could help develop a new treatment for hair loss.”


Update: March 6, 2020

Update: Fuji Maru sent me the following Japanese press release from Shiseido. The company plans to conduct further clinical trials that will administer DSC cells in multiple areas of the scalp.

Autologous Cell-Based Therapy Success

Reader “John Doe” just discovered this new study from Shiseido. As always, I am assuming that Shiseido uses both Replicel’s technology as well as its own-in house technology. Lead author is Dr. Ryoji Tsuboi from Tokyo Medical University. Toho University Ohashi Medical Center was also involved in the trial.

The treatment entails autologous cell–based therapy using dermal sheath cup (DSC) cells, which surround the dermal papilla (DP). Cell manufacturing was conducted at the Shiseido Cell-Processing and Expansion Center (SPEC) and Incubation Center. Both male pattern hair loss and female pattern hair loss patients were treated. 50 males and 15 females, all between the ages of 33-64.

The positive: Total hair density and cumulative hair diameter at injection site significantly increased at 6-months and at 9-months. They seem to imply that this was true for all patients, but maybe someone can access the full study and let us know. Side effects were limited to none in all participating volunteers.

The negative (possibly): The “positive effect was temporary until 9 months”. This statement does not make linguistical sense, and is likely a translation issue. Are they actually trying to say that hair growth was temporary for all of the first 9 months after injection?

Update: Thanks to reader “Left4Bald” for sending me the whole study. They state that the best results were at 6- and 9-months post injection. 12 months had “reduced hair growth”, which is still unclear wording. Further data in the full study indicates that there was a very slight average decline in hair count from 9 to 12 months. Interestingly, older men and women saw best results per phototrichogram before and after images.

Also of significance, 3.0×105 DSC cells was the lowest dose tested. It still elicited a significant increase in total hair density and cumulative hair diameter compared with the placebo. Higher doses did not translate to superior hair growth. The authors suggest that this could be due to an overload of cell debris and immune reactions. In effect causing a poorer environment for the remaining viable DSC cells.

In any case, we should prepare for an eventuality where we need once-a-year DSC injections. Hopefully, Shiseido succeeds in rapidly commercializing this autologous hair growth treatment in regulation friendly Japan.

Shiseido Replicel Hair Growth Treatment
Shiseido’s hair growth treatment with dermal sheath cup cells. Source: https://www.tokyo-med.ac.jp/news/media/docs/20200306pressrelease.pdf

Update: November 26, 2019

Shiseido Japanese Patent Published

Someone named “Paul” (thanks!) just posted a link to Shiseido’s official Japanese patent, which was released in Japan in May 2019. Paul found this link on an investing forum, and he also posted a bunch of information about stock prices. I deleted the latter, as I do not want to encourage blog readers to buy or sell Shiseido or Replicel stock.

Ultimately, whether “Shiseido decides to do so OR not to do so” will decide everything. The patent indicates optimism about the technology. However, nothing is set in stone for sure. The English translation of the patent is extremely informative if you expand each section and wait for it to load. Or you can open the whole Japanese pdf too and use translation software.

The big question I have is what portion of the technology comes from Replicel (licensing), versus from Shiseido in-house?

The inventors are listed as:

  • Tsutomu Soma
  • Jiro Kishimoto
  • Sayaka Koide
  • Hitoshi Okochi
  • Masahiro Kiso

Update: November 26, 2019

Replicel Year-End 2019 Update

RepliCel released its 2019 year-end update today. It includes discussion about its partnership with Shiseido. Regarding Replicel’s cellular therapy (RCH-01) for androgenetic alopecia, the key points are that:

  • Shiseido’s clinical study in Japan is now complete.
  • Shiseido will soon announce on whether it will commercially launch the product in Japan or conduct further clinical testing.
  • Replicel is holding off on Shiseido’s final decision before pursuing any further Phase 2 trials. The former’s Phase 1 trials in Europe were successful.
  • The Replicel and Shiseido dispute is still unresolved.

It seems like Shiseido could still launch the product in Japan soon. No doubt aided by the country’s new faster regulations for marketing when it comes to cellular therapy.

Replicel’s proprietary injection device, RCI-02, is on schedule to get approval and be used in much of the developed world in 2020.

Replicel-Shiseido Partnership

March 23, 2019

I used to cover Replicel (Canada) and its Japanese cosmetics behemoth partner Shiseido at least a few times per year until last year. At some point, I got skeptical about the RCH-01 autologous cell therapy hair loss product being released any time in the near future.

Shiseido LogoBesides typical delays, Replicel and Shiseido had some unclear conflicts regarding their partnership.

However, Replicel published two important updates this month, the second of which is of most interest to us:

Per the first link above, the disagreement regarding the agreement between Shiseido and Replicel remains unresolved. However, it is not subject to any litigation or arbitration at this time.

The key money quote is from the second link:

“While the Company’s RCH-01 product for hair loss due to androgenic alopecia may be launched in Japan much earlier if Shiseido decides to do so, current planning anticipates the potential for all four products to be on the market in Japan by 2022.”

The implication seems to be that:

  1. Shiseido could release the product well before 2022. See my past post on the company’s new research facility in Kobe, Japan.
  2. Even if Shiseido does not release the product earlier, it will quite possibly get released in 2022 in Japan by Replicel.

See my past post on Japan’s new laws fast-tracking stem cell therapies and clinical trials.

Another key quote:

“Unlike anywhere else in the world, one well-designed cell therapy trial in Japan, approved by their regulatory authorities, has the potential to lead to product market launch.”

Replicel is clearly focusing on a “First-in-Japan” strategy due the country’s favorable regulatory environment. Shiseido has rights to the Asian market when it comes to RCH-01. However, it seems like Replicel can still release the product in Japan in 2022 if Shiseido does not do so?

Hard to make this conclusion for certain without knowing much more about the two companies’ legal contract. In any case, this is a great development.

Further references:

— A discussion of Replicel’s technology in two videos.

— Shseido and Adenosine for hair loss.