Follica, Jason Bhardwaj, Peter Diamandis

Jason Bhardwaj and Peter Diamandis

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Summary of Jason Bhardwaj’s video at the bottom of this post:

  • Follica FDA approval targeted for 2023.
  • Seems like Phase 3 trials should start shortly. They were supposed to start in 2019-2020, but got delayed.
  • 6 brief in-office treatments.
  • Cost = $3,000.
  • 75% chance of strong hair growth effect. 25% chance of modest effect.

Follica

Of all the companies that I have covered on this blog, Follica (majority owned by PureTech) is by far the most frustrating. The company was founded in 2005 and its CEO is Jason Bhardwaj. I have covered Follica regularly since this blog was incepted in August 2013.

Regular readers (and myself) expected Phase 3 clinical trials of Follica’s drug-device to have been completed at least 2-3 years ago. Yet here we are in 2022, getting a poster instead. The company’s invention (a scalp wounding device) is relatively straightforward in concept.

The purposeful scalp wounding and injury phenomenon has been proven to grow hair in numerous studies (see my post on at-home microneedling). Not entirely surprising, since even friction from long-term cast use has often grown hair in people.

Follica’s device is unlikely to require any kind of hurdles in being approved by the US FDA, as the potential for side effects seems negligible. Moreover, all signs are that the company will initially only use Minoxidil in combination with the device. Minoxidil was already approved by the FDA to treat male pattern hair loss in 1988. In fact, people are now increasingly taking off-label oral Minoxidil to treat their hair loss.

Jason Bhardwaj Presentation

Yet I keep covering Follica and giving them the benefit of doubt. Future hair cloning and hair multiplication related hair loss cures will always have the potential of major side effects. Not to mention major cost in the initial years. New medications will also be met with some trepidation when in comes to long-term side effects. In contrast, wounding related side effects will most likely be limited to minor scalp bleeding. And some scalp skin deterioration in the worst cases.

Recently, I discovered the below (see bottom of post) video presentation from Follica CEO Jason Bhardwaj. It is on Peter Diamandis’s YouTube channel. The presentation happened fairly recently and it is the first time that I have seen Mr. Bhardwaj talk. I am assuming that Mr. Diamandis arranged the conference where the below video was filmed.

Peter Diamandis Needs my Money

A funny story. In 2008, I flew across the country to attend the Singularity Summit (initiated by Ray Kurzweil) in San Jose, California. After the event was over, one of the younger guys that I befriended invited me to a mini-conference and dinner that he was organizing in a large private room in a restaurant.

Little did I know that just 20 or so people would be in that room. As soon as I entered, Mr. Peter Diamandis (at the head of the table ) approached me and shook my hand vigorously and gave me a huge smile. Within a few minutes, it became clear to me that this was a major donor meeting based on Mr. Diamandis’ intro. I was totally out of place with my lower middle class living standard.

I immediately left the restaurant after telling my organizer friend that I knew no-one in the room. Even he seemed a bit uncertain and had the deer-in-headlights look after witnessing the list of accomplished attendees. To this day, I have no idea why he invited me in the first place.

Having said that, Mr. Diamandis is known as Mr. Optimism. He is always smiling and overly optimistic about everything. You never read or hear even one pessimistic statement from him on Twitter or in his numerous YouTube video appearances.

 

Cellular Reprogramming, dNovo, Ernesto Lujan

dNovo: De Novo Hair Regeneration

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A new biotech startup named dNovo is all over the news this week when it comes to the hair loss world. They have already grown reprogrammed human hair on mice.

Update: They raised $2.7 million in seed funding.

dNovo stem cell hair loss cure
Stem cell hair loss cure from dNovo. Proven in mice so far.

I am no longer keen to cover startup hair loss cure related companies that have yet to even commence pre-clinical trials. In all past such cases, we have always been left with major disappointment. Such companies waste years of our time before ending up in situations such as the below:

  • Fail or see minimal results during Phase 2 or Phase 3 clinical trials (e.g., Follicum) despite significant hopes after Phase 1. Then they discontinue further product development. In the case of Histogen and Samumed (Biosplice), 10 plus years of false hopes culminating in the end of their hair loss operations.
  • Cannot raise sufficient funds at some point very late in the process. (e.g., Riken/Tsuji and Intercytex/Aderans).
  • Close down their hair loss program abruptly with no clear explanation (e.g., Aclaris). In many cases, despite decent hair growth results.
  • Keep announcing minor new developments even ten plus years after inception, with no end in sight. e.g., Follica just released a poster.
  • Get involved in licensing and other partnership disputes (e.g., Shiseido/Replicel).

I increasingly feel that most new companies are all money-making schemes to raise investor funds or boost share prices. But the hope for someone legitimate never ends (at least not till I finally shave my head).

dNovo: Hair Growth with Stem Cells

However, for the past three days, dNovo has been in the news every day and several readers commented and e-mailed about the company. “De novo” stands for “anew” or “from the beginning”. i.e., brand new hair follicle formation in this case. Note that there is another company named “denovo hair” (but their site suggests it is no longer in business).

The initial detailed article on dNovo was published in MIT Technology Review. Then came Fortune. Followed by BoingBoing. Today, I finally gave in after Slashdot also got in on the game. The comments underneath their article are funny.

I am covering dNovo despite major reservations. Assuming they even succeed in humans, I do not think that dNovo’s hair cell regeneration product can come to market before 2030. And Stemson will likely beat them to the game.

dNovo Cell Reprogramming Process

dNovos’s lab-grown hair process is outlined on their site in five steps:

  1. Collect human hair cells at their facility. Per several articles, they might even use skin cells and convert them to hair cells.
  2. Add proprietary reprogramming factors.
  3. General hair producing cells.
  4. Seed these cells into the balding recipient’s scalp.
  5. See visible hair growth in 1-3 months post implantation.

As of second quarter 2021, dNovo had successfully developed the reprogramming system to generate human dermal papilla cells (patent pending). These reprogrammed dermal papilla cells perform biochemically as expected of human dermal papilla cells.

At the end of 2020, the company successfully transplanted reprogrammed human hair stem cells onto mice. These then turned into actual human hair (image at the top of this post).

Dr. Ernesto Lujan

dNovo was founded in 2018 by Stanford University educated biologist Dr. Ernesto Lujan. He has a PhD in genetics, and has many other accomplishments per his bio on YCombinator. dNovo’s team consist of PhDs and MDs trained at Stanford, Harvard, and Caltech.

Dr. Lujan was a co-author of a 2012 paper in which his team  converted mouse skin cells into cells that become the three main parts of the nervous system. So it seems like he has been interested in this type of cell reprogramming work for at least ten years.

I love this quote on YCombinator:

“After hair, we envision using our cellular reprogramming technique to make any cell, any tissue or any organ on demand to replace what is lost as we age.”

Per Dr. Lujan (in Fortune magazine):

“We are currently in the preclinical stage of development. We have shown the results in laboratory mice and are very excited with those. We hope to eventually demonstrate the efficacy in human trials and make our product commercially available, but at the moment we are in the early stages of the whole process.”