Histogen Upcoming Events

[Jasari]

While I hope Histogen can provide dramatic regrowth; I hope as a minimum it halts the progression of hair loss indefinitely. At least if that was the case, you wouldn't have to worry about further hair loss following a transplant to fix your current condition.

[hellouser]

While I hope Histogen can provide dramatic regrowth; I hope as a minimum it halts the progression of hair loss indefinitely. At least if that was the case, you wouldn't have to worry about further hair loss following a transplant to fix your current condition.

Only way it will halt it is if the growth stimulants from Histogen can continually cause growth where DHT's effects on the follicles will be rendered useless. Otherwise, DHT is still there furthering hair miniaturization.

[The Alchemist]

While I hope Histogen can provide dramatic regrowth; I hope as a minimum it halts the progression of hair loss indefinitely. At least if that was the case, you wouldn't have to worry about further hair loss following a transplant to fix your current condition.

I would be thrilled if it was shown to halt hairloss. Could throw away minoxidil, transplant the hairline and be done with these forums for good.

Can't believe how much the lawsuit with skinmedica delayed this. It's just unfcuking believable when you think how close they could be to market if it wasn't for those greedy, litigious SOBS.

Hopefully Histogen can get into an eastern market after they complete phase II. My hair is fading fast and i'm not sure how much longer i can hold on.

[Thinning87]

Despite the early promise, I've got this horrible feeling that they will present something underwhelming and we will be back to square one come May, and we will all be saying ' how come they are back to stage X when they presented such promising initial results '

God, I hope I'm wrong. Come on Histogen, don't let me down!!!

I don't know man, I tend to be cautious when it comes to this but I don't see how they can be bad. They obviously have something good, the only question now is durability of the results in the long run IMHO.

If I have to pay 10k a year I will, as long as it can keep my hair in a natural nw1 as I am only 25 and thinning. I would even accept finasteride if I had the guarantee of a well functioning histogen growth factor.

IMHO we shouldn't panick if we don't hear great news and announcements soon, especially the first ones when they'll obviously focus on facial skin rejuvination

[FearTheLoss]

In the trials we know so far they are testing on subjects using this as a stand alone treatment...subjects are still showing positive growth and hair count 2 years after the first injection...without dht inhibiting drug like propecia being taking...so they have not only shown maintenance, but unprecedented regrowth. Hopefully this next update is what we are all looking to hear and this forum will be a brighter place

[hellouser]

In the trials we know so far they are testing on subjects using this as a stand alone treatment...subjects are still showing positive growth and hair count 2 years after the first injection...without dht inhibiting drug like propecia being taking...so they have not only shown maintenance, but unprecedented regrowth. Hopefully this next update is what we are all looking to hear and this forum will be a brighter place

Combine that with a combination of FIN/Keratene/RU/CB/Minox or even HST from Gho and you should be cured.

[FearTheLoss]

Combine that with a combination of FIN/Keratene/RU/CB/Minox or even HST from Gho and you should be cured.

with the results they are having you wouldn't need anything other than a Gho HST and the injections and you are golden

[drybone]

I just went to read up a bit on it. If this process can actually regenerate our skin, never mind the hair.

If it regenerates our skin, it will be worth TRILLIONS of dollars. Being in your twenties will become irrelevant. Guys in their 50 60s and even 70s will be scoring all the women because they have so much money, power and wisdom and patience with women. Wow.

Imagine if you could regenerate your skin to a 21 year old level? Super cool

As for hair, yes then most forms of baldness would now be cured. I am so excited . If phase two goes well on the skin portion only I am going to invest in the company.

[rdawg]

In the trials we know so far they are testing on subjects using this as a stand alone treatment...subjects are still showing positive growth and hair count 2 years after the first injection...without dht inhibiting drug like propecia being taking...so they have not only shown maintenance, but unprecedented regrowth. Hopefully this next update is what we are all looking to hear and this forum will be a brighter place

Going on what Ziering said he mentioned injecting it for himself and noted that he was still maintaining for the most part 2 years later, didn't see much growth(but his hairloss is not aggressive at all and I'm not sure how much he injected).

I think this needs a combination, fin/DHT inhibitor to build the defense and histogen to come in and give your hair a huge boost. But there's nothing wrong with that if you don't have any side-effects. It will be really interesting to see how well they work together.

standalone we'll find out in one month!

[FearTheLoss]

Going on what Ziering said he mentioned injecting it for himself and noted that he was still maintaining for the most part 2 years later, didn't see much growth(but his hairloss is not aggressive at all and I'm not sure how much he injected).

I think this needs a combination, fin/DHT inhibitor to build the defense and histogen to come in and give your hair a huge boost. But there's nothing wrong with that if you don't have any side-effects. It will be really interesting to see how well they work together.

standalone we'll find out in one month!

True, I'm hoping we don't still need propecia in 5 years because I had terrible sides with it...

On another note, the results we have seen so far were from what was supposed to be the safety trials, not even testing the efficiency of HSC...so logically the next results should be even better.

[rdawg]

True, I'm hoping we don't still need propecia in 5 years because I had terrible sides with it...

On another note, the results we have seen so far were from what was supposed to be the safety trials, not even testing the efficiency of HSC...so logically the next results should be even better.

There's always alternatives(BIM and Aderans for example).

You are very correct on that, it's my understanding the 2A trial only did certain section while the 2B will do ALOT more and more frequently repeated(which might be crucial for say hair cycles).

Maybe it needs to be injected every 3-4 months instead of 6 to get the full effect, who knows! but I'm excited for possibilities!

[FearTheLoss]

speaking of aderans..what is their deal? I haven't heard of them for months...thought we were supposed to get an update on them and if they went to phase 3 this spring..

[Thinning87]

I found this online this morning and thought everyone should think of the implications of the section of the interview that I am highlighting below:

Q&A with Dr. Gail Naughton

Posted on October 31, 2012 by dbeal

The San Diego chapter of the MIT Enterprise Forum launched a new meeting format for its October event, “Creating Your Own Big Bang: How 3 CEOS Are Doing It.” The panel forum featured 3 CEOS of San Diego-based life sciences companies: Mark McWilliams – CEO, Medipacs, Craig Misrach – Chairman & CEO, Freedom Meditech, and Keith Murphy – CEO & President, Organovo. With the help of Dr. Gail Naughton, Chairman and CEO of Histogen, Inc., the panelists discussed the challenges they have encountered and successes they have achieved in launching and growing their companies. An advisor was assigned to each company from San Diego-based funding ventures. These advisors provided further dialog with the panelists at the conclusion of the forum. At the end of the meeting, the CEO panelists met with members of the audience in an open networking environment.

We caught up with Dr. Naughton after the event to get her views on the difficulties faced by emerging technology companies when they seek funding.

SDMITEF: You’ve overcome numerous funding challenges throughout your career. What are the challenges that you have experienced for Series A and Series B funding rounds?

Dr. Naughton: Funding for biotech and medtech start ups has changed dramatically over the past 20 years. I took my first company public in 1988 based on data from a few rats that looked good. The late 1980s and early ‘90s were filled with euphoria for anything bio related. Investors hit huge home runs with back to back blockbusters from Amgen, Genentech, and Biogen. The combination of the dot com bust, increased cost of drug and device development, increased time to approval, and product failures during development have made life science investors extremely cautious. Series A funding is particularly challenging because investors know that they will be diluted in subsequent funding rounds, and because there is usually more “promise” than “results” at this seed funding stage. Because of this, certain sweeteners, such as warrants, are often involved. Pre and post funding valuation is difficult, since actual time to market (and FDA approval, where necessary) can be very difficult to predict. Much of Series A funding is based on the confidence that investors have in the management team and their ability to deliver on the business plan. Many of us turn to friends and family for initial investment. Having many smaller investors, as well as financially non-qualified investors, complicates the Cap table and can lead to problems in future funding. At the Series B level, investors should be able to see tangible progress since the Series A funding, with certain key milestones having been met that can translate into inflection points for the Company and an “up” round.

SDMITEF: Can you comment on the different routes you’ve taken at Histogen for business development and considerations that were given in developing these avenues for growth?

Dr. Naughton: Partnering for programs in early clinical development: In order to maximize the value of each deal, we have chosen not to partner our products requiring regulatory approval until we have at least successful clinical Proof-of-Concept data. Our business plan focuses first on products that are based on our core technology, but that do not require FDA approval. Skincare is one example. We have licensed anti-aging skin creams and a post-resurfacing gel containing Histogen’s growth factor composition to Suneva Medical, and these products are currently in the physician’s market. Although clinical trials are not required before marketing, we did complete clinical studies prior to the license in order to have strong scientific support for each product. This license allows us to capture some manufacturing costs and a royalty, and has supported partnership discussions for skincare and beauty products in the non-medical spa and high-end retail markets.

Licensing after proof of concept stage: After we had strong safety and efficacy data from our Proof of Concept clinical study on hair growth with our lead therapeutic product, Hair Stimulating Complex (HSC), we began speaking to leading dermatology companies about licensing. Now that we have initial data from our Phase I/II trial, as well as data in both men and women from a Physician sponsored IND, we are in late-stage due diligence with three leading dermatology companies, with our goal being to consummate a license and have the partner fund future clinical trials and manufacturing upscaling.

SDMITEF: What has been your biggest roadblock to growth in your business in the past year and how are you solving this problem?

Dr. Naughton: Although it didn’t start in the past year, the biggest roadblock I have ever faced in fundraising was the patent lawsuit filed against Histogen by SkinMedica in 2009. The lawsuit paralyzed our funding, as investors understandably wanted their funds to be used for product development, not for litigation. We were forced to have a layoff of the entire staff, many of whom continued to volunteer until we were able to finally secure funding in May of 2010. That funding, because of the uncertainty around the lawsuit, had many investor perks and untraditional conditions. In November 2011, the Court granted summary judgment in favor of Histogen. The special conditions that were part of the 2010 funding have complicated additional funding. Luckily our major investor understands this and has agreed to a restructuring that will simplify securing future rounds of funding from new investors.

We thank Dr. Naughton for the insights into the challenges in the road to entrepreneurship. We encourage our readers to join us on November 13 for further discussions as we celebrate entrepreneurship for Global MIT Enterprise Forum Entrepreneurship Week!

Feel free to post comments and feedback on our Big Bang event through our LinkedIn Group at MIT Enterprise Forum San Diego.

Now, with that in mind, we know that Histogen just announced a JV agreement and is gonna sell some products with it. LINK

I don't understand if PUR will also include HSC in its product offering, because reading the article I see it mentions other type of applications, but it then also mentions growth factors in a very general way. However, reading at the end, it sounds like PUR is not going to do HSC.

The bottom line is I think what we should look for in the news is not so much an update on clinical trials, but that they reach a similar licensing agreement to fund marketing and sales of HSC, because from the interview it seems like they need this type of backing to continue to develop HSC in the first place.

[Kirby_]

True, I'm hoping we don't still need propecia in 5 years because I had terrible sides with it...

I hope fin is the first treatment to become totally obsolete. I don't care how, whether it's PGD2 blocking topicals, CB-03-01, Aderans, anything. It's just too risky in the long term for anyone, the regrowth is weak, the maintenance questionable over too many years, and sourcing a legit prescription is a nightmare...

[rdawg]

I hope fin is the first treatment to become totally obsolete. I don't care how, whether it's PGD2 blocking topicals, CB-03-01, Aderans, anything. It's just too risky in the long term for anyone, the regrowth is weak, the maintenance questionable over too many years, and sourcing a legit prescription is a nightmare...

The problem is the localizing of it IMO or at least from what I've read.

Fin is a system wide inhibitor, but all we need is something localized to the hair follicles(so far less system absorbsion)

We have weak versions of that in S5 cream and nizoral, but they are very very weak in comparison to what fin can do.

Also RU and CB but those are experimental.

I definitely think one is coming, just might be a few years.