You can read all about it here, this is the breach @roger_that was talking about.
They haven’t even started phase 2 trial !!!
“Because of financial constraints, RepliCel has not been able to proceed with its previously announced plans to initiate a phase 2 clinical trial of RCH-01,”
Has anyone seen Replicel’s financial statements ?
Their year 2016 financials will not be available for another month or so, but the independent auditor’s report issued the following warning for their Dec 2015 year end:
"Without qualifying our opinion, we draw attention to Note 2(a) in the accompanying financial statements which indicates the Company has incurred operating losses since inception, has a working capital deficiency, and a deficiency in shareholder’s equity, which raises substantial doubt about the Company’s ability to continue as a going concern. "
The auditor’s report and financial statements are available at
It would be interesting to see how they fare when their year 2016 financials become available.
This is very distressing. Thanks for the heads up, @HairSite. I hope the 2016 financials are better, but not counting on it.
In their latest forecast, RepliCel’s CEO acknowledged that 2016 was a very tough year to raise capital. They did, however, manage to arrange a $4.2M financing in 4th quarter 2016. A little bit of good news in that respect but note that it is FINANCING, not capital; meaning they have to pay the $4.2M back.
IMO, the next 2 years will be critical. If RepliCel fails to bring in sufficient licensing and/or royalty revenues from RCT-01 (tendon injury) and RCH-01 (pattern baldness), this would have a huge impact on their cash flow.
When RepliCel’s 2016 financials become available, we should have more insights about the terms of the $4.2M financing arrangement and how big an impact this plays in the near future.
Correction. If I understand correctly, if turns out that the $4.2M is EQUITY financing and not DEBT financing. So good news for RepliCel.
“While 2016 has been a tough financial year for the Company,” stated RepliCel President & CEO, R. Lee Buckler, “we were very pleased with the eventual response to this financing. By the time of the closing, we had significantly more investment interest than capacity. A healthy mix of past investors, existing shareholders, and new investors participated in the placement. The coming months carry with them the potential to be very exciting for RepliCel and its shareholders with clinical data from two clinical trials expected before the end of first Quarter next year, completion of the manufacturing and testing of our medical device, and the positioning of assets for potential partnerships.”
“With the restructuring that was done and the financing complete, we are confident the strategy we are executing has put RepliCel on a pathway to realize its near-term clinical, commercial, and financial potential,” Buckler concluded.
The full press release here
I thought that Replicel had already started phase 2 studies. I guess I was wrong. It’s doubtful that their technology works since investors would be throwing money at Replicel if the technology works.
And since Shiseido is using the same technology as Replicel that means that Shiseido’s technology probably doesn’t work either.
Meanwhile back at Dr. Tsuji’s lab…
@HairSite $4M is not a lot of money these days, besides we still don’t know if Shiseido’s alleged breach will be a problem for Replicel or not.
What about Histogen, are they in better shape financially speaking? I guess whoever has the most money will see the finishing line.
True, $4M isn’t a lot. To put this in perspective, in 2015 RepliCel reported $2.7 in R&D and $2.3 in General & Admin, a total of over $5M in expenses. $4M isn’t even enough to last RepliCel a full year if they are to opearate at the same level of R&D and overheads in 2017.
As for the alleged breach, it appears that RepliCel’s responsibility with respect to the collaboration is limited to the transfer of technology to Shiseido and their obligation in that respect is considered completed (at least from RepliCel’s persepctive). According to RepliCel, Shiseido is responsible for all further development of the transferred technology.
If I interpret this correctly, Shiseido can develop, commercialize and market in territories with which they have rights whether with or without RepliCel.
The above are purely based on my very limited understanding of the situation. Please do not consider what I post here as accurate. They are strictly my opinions and speculations. When in doubt, please contact RepliCel and other sources directly.
As for Histogen, it is a private company (last I checked); they are not obligated to disclose their financials. I have no way of knowing how sound their finances are.
Very confusing indeed with respect to the status of their phase 2 trial.
In Sep 2016, RepliCel released the following statement:
“Because of financial constraints, RepliCel has not been able to proceed with its previously announced plans to initiate a phase 2 clinical trial of RCH-01,” stated RepliCel’s Buckler. “This has caused Shiseido to allege breach of our co-development obligations which we deny and vigorously oppose. While there is a clear obligation on our part to transfer data from such a trial when it is available, there is no express or implied obligations in the agreement as to when such a trial would have to be initiated or completed,” continued Buckler.
Here’s my guess as to what’s going on:
RepliCel still has not started phase 2 trial as of now. Meanwhile, Shiseido has continued to fund and conduct their own clinical trials (independent of RepliCel) in order to satisfy Japanese regulations. Once Shiseido has obtained government approval, they will proceed to commercialize RCH-01 whether with or without RepliCel.
RepliCel will not start phase 2 trial for markets outside Asia until after they have collected trial data from the Japanese, due 2018 according to RepliCel’s latest forecast. IMO, this was potentially the dispute between the two companies because Shiseido was probably expecting RepliCel to provide phase 2 data to complement or substantiate their own trials so that Shiseido can present a strong collective data package for the Japanese government. Instead, Shiseido has to go at it alone.
@HairSite I blame Shiseido’s attorney if what you speculate is true. An experienced attorney will specify a final deadline for Replicel to submit phase 2 trial results instead of leaving it open ended. There should also be a clause for damages if Replicel fails to submit phase 2 results by a certain date.
I agree with you on this. Since last summer when Replicel granted rights to their technology, Shiseido and Replicel are two different entities. Shiseido is working with Tokyo medical University Hospital and they are now conducting trials separately from Replicel. “As announced in July, RepliCel’s RCH-01 product, for the treatment of androgenetic alopecia, is now under clinical investigation at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama.”
Obviously, Replicel’s phase 2 data would have helped, but since there is no, Shiseido will have to figure that out themselves. The good thing is in Japan you don’t need phase 1-3. As soon as R&N is satisfactory, it can be filed for approval. Pretty much what Dr.P.Kemp described about U.K regulatory.
Would be interesting if we could contact Tokyo medical University team.