Histogen 02-20-2016 (never Seen This Document Before)

[pegasus2]

I would think they would open up in several places, and continually add more. They will try to get it into as many clinics as possible if they are smart.

 

[thomps1523]

Xaser did you notice that this forum will pay people for bringing new topics to the forum? You seem to do this weekly... Get your compensation for all the work homie!

 

[thomps1523]

I can't agree with that.

They state what each treatment is in a pretty neutral manner.

Also in other pages of the document they go into a whole laundry list of negative reasons to invest in Histogen - some of those reasons being stiff competition.

Edit - Investment Risk Factors start on page 40. Pretty honest and straight forward if you ask me.

For some reason I assumed the risk factors would be for the treatment, and not the investment risk. Is anyone worried about the risks these injected cells may cause, or is it a pretty safe treatment? For some reason or another I feel like in the past I had heard the cells histogen would be using carry significantly more risk than replicell's... Am I remembering wrong?

 

[Breyfogle]

I can't agree with that.

They state what each treatment is in a pretty neutral manner.

Also in other pages of the document they go into a whole laundry list of negative reasons to invest in Histogen - some of those reasons being stiff competition.

Edit - Investment Risk Factors start on page 40. Pretty honest and straight forward if you ask me.

Here’s their curt, dismissive take on Follica. No mention of proprietary device, wounding, announcement of going to market soon….

‘The company conducted a European based phase 1 clinical trial in 2010, and no results have been announced to date. It is currently being run as a virtual company with no reports of pending clinical trials.’

I look forward to not reading the investment risk section. Not my kind of Thursday night.

 

[That Guy]

Here’s their curt, dismissive take on Follica. No mention of proprietary device, wounding, announcement of going to market soon….

‘The company conducted a European based phase 1 clinical trial in 2010, and no results have been announced to date. It is currently being run as a virtual company with no reports of pending clinical trials.’

I look forward to not reading the investment risk section. Not my kind of Thursday night.

It surprises me that you're surprised a company looking for investors would highlight the failures of their competition.

 

[mr_robot]

Why do you have to apply minoxidil twice a day? If one treatment was enough it would be called a cure.

Sure, but if you need to spend large $$$ every six months forever then even their "conservative" projections are too optimistic. If for example replicel costs twice as much but the results last for years then they are screwed. As an investor I would think twice and it's probably why they have n't been able to get the money for the FDA trials and why they are trialing in less expensive countries.

Personally, I could afford it for a few years whilst I waiting for something better.

 

[That Guy]

I'll get both Histogened multiple times and then RepliSeidoed if that's what it takes.

 

[mr_robot]

For some reason I assumed the risk factors would be for the treatment, and not the investment risk. Is anyone worried about the risks these injected cells may cause, or is it a pretty safe treatment? For some reason or another I feel like in the past I had heard the cells histogen would be using carry significantly more risk than replicell's... Am I remembering wrong?

Well the main risk with histogen is that they are basically injecting growth factors (no cells) that could encourage cancerous as well as hair growth (same issues with WNT agonists) where as Replicel is basically inkeced cultured DP cells that they hope will migrate back to the follicles. From a safety profile Replicel is probably safer but a more difficult process to industrialise.

 

[Blackber]

Here’s their curt, dismissive take on Follica. No mention of proprietary device, wounding, announcement of going to market soon….

‘The company conducted a European based phase 1 clinical trial in 2010, and no results have been announced to date. It is currently being run as a virtual company with no reports of pending clinical trials.’

I look forward to not reading the investment risk section. Not my kind of Thursday night.

Again, you're reading into this way too much and jumping to conclusions. All their statements about other companies are neutral. The investment memorandum for Histogen that @Xaser94 found and posted in the OP is dated in February '16 which means it was put together in the months prior to February. Follica has been notorious for a lack of communication not to mention @hellouser couldn't get any information regarding them at the '15 Hair Congress and was met with a brick wall every time he inquired. Furthermore, Xaser94 was able to finally dig deep and get us some info on them which he posted in this thread https://www.gourmetstylewellness.com/interact/threads/lots-of-new-info-on-follica.98226/ in March which was AFTER Histogen released their memo in February.

It surprises me that you're surprised a company looking for investors would highlight the failures of their competition.

Agreed, but they weren't even bad mouthing anyone.

Sure, but if you need to spend large $$$ every six months forever then even their "conservative" projections are too optimistic. If for example replicel costs twice as much but the results last for years then they are screwed. As an investor I would think twice and it's probably why they have n't been able to get the money for the FDA trials and why they are trialing in less expensive countries.

Personally, I could afford it for a few years whilst I waiting for something better.

As stated previously in this thread you need multiple injections to target the right growth stages of all the follicles on your head - they are not synchronized. Their clinical trials have shown that there is still an increase in hair after one injection a year past baseline. If you don't want to spend the money I can understand that but don't assume their "projections are too optimistic".

Every investor should always think twice and all these companies have been trialing in countries outside the US because the FDA is a dinosaur and doesn't have the proper regulations in place for this new wave of regenerative medicine.

You also state "trialing in less expensive countries"... Let's suppose your assumption is right and it is cheaper in other countries. Business 101 would say its a no-brainer to trial your product for less in a country that will possibly let you bring it to market sooner and make money faster. Why wouldn't you pursue that? Especially as a start-up company.

I'll get both Histogened multiple times and then RepliSeidoed if that's what it takes.

I'm right there with you man lol desperate times call for desperate measures.

Well the main risk with histogen is that they are basically injecting growth factors (no cells) that could encourage cancerous as well as hair growth (same issues with WNT agonists) where as Replicel is basically inkeced cultured DP cells that they hope will migrate back to the follicles. From a safety profile Replicel is probably safer but a more difficult process to industrialise.

Histogen has stated multiple times that they are not injecting cells in an effort to specifically avoid any cancerous side effects, that they have an excellent safety profile, and have performed additional testing in regards to cancer monitoring. The Phase III testing in Mexico will include a class of 330 patients. This is a large trial which will give us further details on efficacy and safety.

I'm not trying to promote any of these companies, all I'm trying to do is present the information that already has been given to us and not make assumptions - take the information how you want.

 

[farkhairloss]

Sure, but if you need to spend large $$$ every six months forever then even their "conservative" projections are too optimistic. If for example replicel costs twice as much but the results last for years then they are screwed. As an investor I would think twice and it's probably why they have n't been able to get the money for the FDA trials and why they are trialing in less expensive countries.

Personally, I could afford it for a few years whilst I waiting for something better.

Not sure why they havnt been able to get money for trials, but they seem to have now if they are starting or about to start stage 3 trials. Regarding how long it lasts, well plenty of people pay for botox injection every 3 to 6 months, so id be quite happy to pay for top up treatments if it worked and i could avoid getting into limited donor transplants with unnaturally thick haired hairlines.

 

[Noisette]

I'm sorry my eye couldn't catch where it specified "$2,000".

You can hear that : (listen this at 17mn)

 

[mr_robot]

Not sure why they havnt been able to get money for trials, but they seem to have now if they are starting or about to start stage 3 trials. Regarding how long it lasts, well plenty of people pay for botox injection every 3 to 6 months, so id be quite happy to pay for top up treatments if it worked and i could avoid getting into limited donor transplants with unnaturally thick haired hairlines.

Sure, I never said people wont go every 3 months, but the number of people willing to pay at $1000 a pop every 3 months is not going to be large as they are projecting and that was my point. Look at it this way if you had to invest between Histogen and Replicel which one would you choose?

 

[Blackber]

Sure, I never said people wont go every 3 months, but the number of people willing to pay at $1000 a pop every 3 months is not going to be large as they are projecting and that was my point. Look at it this way if you had to invest between Histogen and Replicel which one would you choose?

How do you know that?

What do you honestly expect them to charge for this? $100? $200? $300? If it works well I think $1,000 1-3 times a year is extremely reasonable if you have an established career (obviously recent graduates out of college may have a tougher time). If your hair loss means that much to you that you're on this forum - not talking about you specifically, people in general - and you can't afford $1k injections 1-3 times a year to get what we hope turns out to be a substantial amount of hair back you have bigger problems than male pattern baldness.

Obviously until it's available in your market the added plane tickets could be a heavier burden but that's presumably only temporary.

 

[mr_robot]

As stated previously in this thread you need multiple injections to target the right growth stages of all the follicles on your head - they are not synchronized. Their clinical trials have shown that there is still an increase in hair after one injection a year past baseline. If you don't want to spend the money I can understand that but don't assume their "projections are too optimistic".

I know they are not all synchronized, 10% of your hair are in the resting phase at one point. They don't have enough data to say one way or another how well it works. My point was that if you need regular top ups, and they want to charge the physician $500 a pop then they're projects are too optimistic.
[/QUOTE]

Every investor should always think twice and all these companies have been trialing in countries outside the US because the FDA is a dinosaur and doesn't have the proper regulations in place for this new wave of regenerative medicine.

You also state "trialing in less expensive countries"... Let's suppose your assumption is right and it is cheaper in other countries. Business 101 would say its a no-brainer to trial your product for less in a country that will possibly let you bring it to market sooner and make money faster. Why wouldn't you pursue that? Especially as a start-up company.

It's not an assumption at all, it's a fact you even elude to the fact yourself by calling the FDA a dinosaur. At the moment it takes a long time and a lot of money. Do you think they are paying the people who are taking part in the trial in Mexico the same amount as if they were in the US?

Launching it in Mexico does not bring the product to market any sooner in the US or any other advanced economy because neither the trial data or approval will not be transferable. It will take the same amount of time and money to get it approved in the US regardless. What Mexico lets them do is basically get some more data without having to spend any money and hope that the trial is conclusive enough to get entice investors so they can get FDA approval for launch in the US. If they had people willing to invest now to get the trials in the US they would be doing them now.

Business 101 would actually be getting to market first and in markets where you would make the most money. Their strategy is not the optimum one considering there are potential competitors around the counter, it's only optimum based on the fact they have problems raising money.

 

[That Guy]

I think you underestimate the popularity of medical tourism.

If this treatment costs 1,000 USD in Mexico, when it finally comes to the USA it will cost way more. Again, mentioning Los Algodones, and I can honestly see them opening a clinic there as it would not be a huge undertaking for people living in the southwestern USA to simply drive into Mexico a few times a year to pay for a treatment that would cost a fraction of what they'd charge back home. This is assuming Emperor Trump doesn't get his wall =P

Many people won't care where they have to go or how often to restore their hair.

 

[Blackber]

I know they are not all synchronized, 10% of your hair are in the resting phase at one point. They don't have enough data to say one way or another how well it works. My point was that if you need regular top ups, and they want to charge the physician $500 a pop then they're projects are too optimistic.

Agreed that they don't have enough data that's obviously why they need to do more trials. I don't mean this in a disrespectful way but how are you qualified to determine whether they are being too optimistic if they charge a doctor $500? I have female family members that fly all over the US for Botox injections because it's cheaper than getting it done where I live (NYC). A couple thousand dollars a year for hair (if it works) is not expensive at all.

It's not an assumption at all, it's a fact you even elude to the fact yourself by calling the FDA a dinosaur. At the moment it takes a long time and a lot of money. Do you think they are paying the people who are taking part in the trial in Mexico the same amount as if they were in the US?

Launching it in Mexico does not bring the product to market any sooner in the US or any other advanced economy because neither the trial data or approval will not be transferable. It will take the same amount of time and money to get it approved in the US regardless. What Mexico lets them do is basically get some more data without having to spend any money and hope that the trial is conclusive enough to get entice investors so they can get FDA approval for launch in the US. If they had people willing to invest now to get the trials in the US they would be doing them now.

Business 101 would actually be getting to market first and in markets where you would make the most money. Their strategy is not the optimum one considering there are potential competitors around the counter, it's only optimum based on the fact they have problems raising money.

I agree that longer trials cost more money - time = money. If you were trying to say trials in Mexico vs the US cost less over the same period of time, I can't say I agree with that and I think that would be an assumption unless you have sourced data that shows otherwise.

Do you honestly think Histogen cares where they bring it to market first? I'm sure they'd love to hit the US market first but as a start-up company trying to "make it" you want to focus on establishing yourself because any new business is always on shaky ground in the beginning. You would want to bring your product to market as fast as possible even if it's not your preferred market in order to make some cash and bide your time so you have enough money to survive the LONGER trials in a country like the US. You're more likely to get investors if you can show progress.

Hypothetical situation: Histogen doesn't have enough money to last through the longer and more expensive US trials. Are they supposed to just close up shop or should they try to get their product approved in a smaller market that costs them less to do so because of the shorter trial time so they can start making SOME money to hold them over and allow them to complete trials in the larger market they prefer to be in?

You mention they have competitors around the corner yet most of those competitorsare running trials outside the US.

I respect your opinion but do not agree with your logic.

 

[Swoop]

Ask your questions here;

https://www.gourmetstylewellness.com/interact/threads/gathering-questions-for-histogen-interview.100552/

There will be a interview done shortly.

 

[farkhairloss]

Ask your questions here;

https://www.gourmetstylewellness.com/interact/threads/gathering-questions-for-histogen-interview.100552/

There will be a interview done shortly.

Yeh boy, this is the shiz nitz!

 

[g.i joey]

Is this too early to get excited for or are we actually looking at the most solid male pattern baldness treatment ever?

 

[Mister_you]

On page 22, histogen claims permanent hair growth