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It's not new but I haven't seen / heard this interview.
- Phase 3 pivotal trial in Mexico : spring 2017. Early 2018, for the approval of their product (Mexico). Two years after the approval in Mexico, HSC would be available on US and Canada markets.
- Expected a phase 3 in China too.
Interview : http://www.onemednews.com/2016/11/19/dr-gail-naughton-histogen/
BJ: Can you first tell us, what does Histogen do?
GN: As you said, Histogen is a regenerative medicine company. We made a discovery that if you grow newborn skin cells under embryonic conditions of low oxygen and suspension, they rapidly become multi-potent stem cells. They secrete soluble and insoluble materials that are very embryonic that are able to stimulate stem cells throughout the body. We collect both of the products simultaneously. Our lead product is an injectable, and we’ve done two company-sponsored trials with excellent safety and efficacy, and one physician-sponsored trial. We are looking to get that product on the market in the next few years, to bring us to profitability, so that we can build our pipeline for other therapeutic indications.
BJ: So Histogen has essentially discovered a way to create embryonic stem cells without dealing with the ethical issues of embryos?
GN: Yes. It is completely noncontroversial. This work has been duplicated by others and we have very strong patent positions. Basically, these newborn cells will be brought back to have the same characteristics in terms of gene expressions and what proteins they make, the same as multi-potent, or even embryonic stem cells.
BJ: Does it solve the ethical debate that began several years ago?
GN: I don’t know that it solves it. In term of our cell byproducts that we use, we certainly have a very non-controversial, ethical way to produce them. The cells themselves have not been used therapeutically, but if we find that they can be used instead of embryonic stems cells for therapeutic uses, that would really be wonderful thing.
BJ: Your first product is a treatment for hair loss. How does it work?
GN: The growth factors that are made by the product are purified. We inject them into the mid-dermis. We have special needles that go 2MM – where the hair follicle stem cells are. So when you have a miniaturized hair follicle, and the hair follicle is starting to die, and you have very fine hair or no hair, the growth factors basically stimulates the stem cells and the hair follicles that start dividing, cause the keratinocyte in the hair follicle to migrate into the hair shaft, and either convert a baby fine vellus hair to a terminal hair to make brand new hair. So it’s really just waking up the hair follicles. It’s replacement therapy, we are just giving you back what you had when your scalp was functioning normally, and your hair was growing at a normal pace.
BJ: In what stage is this product?
GN: We have done both proof of concept and Phase I, two clinical trials in men. We are starting a pilot next year for women. Five women under a physician-supervised IND, with phenomenal results. So we are going to do a women-only trial. We are also going to be starting a Phase III trial, along with our partner in Mexico , and in March or April 2017 time frame, that will allow us to get the product approved, first in Mexico, and most likely, in the early 2018. We will also begin a Phase II dosing study in men early next year in the United States.
BJ: When might the product become approved and on the market in the U.S.?
GN: Probably two years after we receive the approval in Mexico, so 2020 for the U.S. and Canada.
BJ: Do you have a sense of the cost, and how it compares to the cost of other hair treatments?
GN: It will be far more affordable than the traditional hair transplant. Remember the current products on the market, such as Propecia, have to be used either once or twice every day. Once you stop using it, within a couple of weeks, you have massive shedding. Those products are not good at generating new hair, they are just preventing hair loss.
Our product will consist of a three-treatment regime. Injections, six weeks apart (Week 0, Week 6 and Week 12). The effects will last for at least two years, and experts are telling us it will probably last as long as your hair cycle lasts, which is between two to five years, before needing another treatment. It is transformational in terms of approaching hair growth.
The cost itself, of course, will depend on our marketing partner. Because we make both products, the soluble and insoluble, simultaneously, the margins can be spread evenly, over the products themselves in way that will be most beneficial to pricing. We are looking at $1500 per treatment, compared to a hair transplant which costs roughly $12,000-$15,000.
BJ: So, someone will go back for another treatment after two or three years?
GN: It can be compared to the Botox model. Botox shows that even as an injectable, people are willing to come back, every four to six months for an aesthetic improvement. This is more like two to five years, and it would be more of a “touch-up”, rather than a full scalp treatment at that point.
BJ: I would imagine that people would be happy to go back for the treatment, since it’s inspiring hair growth, correct?
GN: The results are quite dramatic, with cosmetically-relevant new hair growth as early as 12 weeks after the first set of injections.
BJ: Let’s talk about your international initiatives. You recently put together an investment relationship with a Chinese company. That was your Series D. Can you tell us a bit about it?
GN: Yes. Our lead investor in our Series D was Huapont Pharmaceuticals. Huapont is the leading dermatology company in mainland China. To be able to have them not only lead an investment, but in addition, take an exclusive license for the hair product for mainland China is a tremendous endorsement for us.
BJ: What was the nature of the agreement?
GN: Sure. In addition to the investment, the license will bring us about $5M in milestones, escalations in royalties that are very favorable, and about 180% margin on products that we manufacture. They will be our exclusive marketing partner in China, with connections to all of the top dermatology hospitals in China. They are tremendously suited to do an excellent job with this product. We will maintain the manufacturing rights, and they will be our promoter, sales and marketing, as well as getting it CFDA (China Food and Drug Administration) approved.
BJ: Do you have a sense of how long that will take to get it through the CFDA in China?
GN: Right now, we are assuming that, like in Mexico, we will be able to go straight into a Phase III trial. They are going to wait until we get our Phase II B dosing approved here in North America, and then we will be visiting the CFDA together. It takes about a year in China, from when you submit the IND-equivalent in China, to when you can start the clinical trial. Probably within eighteen to twenty months after we get the IND approvals, we hope to be on the market.
BJ: How did you come across Huapont?
GN: I attended the OneMed Forum in San Francisco, during JP Morgan, this past January. One of the days was dedicated to China. It was a phenomenal day. There were excellent panelists from China discussing the partnerships in China and what Chinese companies are looking for. Two of the executives from Huapont were there, and because of the OneMed Forum I was able to meet with them that same day. We had a really productive discussion, and a few days later, they flew to San Diego to visit Histogen and by March, we had a binding term sheet. It was probably one of the most efficient and effective meetings I have ever had in my life, and I am very grateful to OneMed Forum for helping to make it happen.
BJ: Glad to hear that. What insights would you have for companies looking to do business in China?
GN: We had spoken to many companies in China over the last three years, and of course, none of them panned out. To be able to continually present yourself to investors in China is important, particularly when the companies are coming here, to the U.S. to actively look at new investments. That is key, you can never go to enough meetings, or present at enough conferences, because you never know when your ideal partner is going to be in the audience.
The Huapont has executives were trained in Australia, completing their undergrad/grad education there, which meant that they were fluent in English and understood Western culture, and were very entrepreneurial. That made for a perfect partnership. There are other Huaponts out there. There are tremendous amounts of interest out there from many medical device and pharmaceutical companies in China, who are looking to invest in cutting-edge technologies in the U.S. right now. I think we will see an increased interest in these companies coming to the United States, to try and get some innovation license for their portfolio. It’s a very exciting time.
BJ: It certainly is. Let’s shift now and discuss the milestones for Histogen. What are some of the major events that you see happening in the next few years?
GN: In the short-term, before the end of this year, we will be announcing our license partner in Mexico. We’ve been working very effectively under an LLI for the last year, but we are going to finalize that. It will be exciting to start the Phase III pivotal trial in Mexico in the spring of next year. We have three amazing dermatologists who will be the PIs in that study. Of course, the clinical trials, one dedicated to women with hair loss, and the other dealing with Phase II dosing with men. Both will be starting in early to mid 2017.
We also have an orthopedic joint venture, which is separately funded, that is looking to start a clinical trial in the first part of 2017 for cartilage defects in the knee. We have done rabbit and goat studies with beautiful results, and have asked the FDA for a pre-IDE meeting, to be able to go and talk about the clinical protocols and start of that trials. So, lots of clinical data coming up, and hopefully lots of new investors as well.
Ever since Huapont has invested in us, we have had a number of groups in China come talk to us, and discuss the possibility of an investment in Histogen. To be able to close our Series D, another $12-$15M in the coming months, and get all our clinical data is going to be great. Our plan is, that once we get additional clinical data in the U.S. and Mexico, to file for an IPO, around early 2018.
BJ: Wow, seems like there are lots of exciting things happening at Histogen. Thanks again, Gail for joining us.
GN: Always a pleasure, Brett. Thank you again for the wonderful Huapont introduction.
It's not new but I haven't seen / heard this interview.
- Phase 3 pivotal trial in Mexico : spring 2017. Early 2018, for the approval of their product (Mexico). Two years after the approval in Mexico, HSC would be available on US and Canada markets.
- Expected a phase 3 in China too.
Interview : http://www.onemednews.com/2016/11/19/dr-gail-naughton-histogen/
BJ: Can you first tell us, what does Histogen do?
GN: As you said, Histogen is a regenerative medicine company. We made a discovery that if you grow newborn skin cells under embryonic conditions of low oxygen and suspension, they rapidly become multi-potent stem cells. They secrete soluble and insoluble materials that are very embryonic that are able to stimulate stem cells throughout the body. We collect both of the products simultaneously. Our lead product is an injectable, and we’ve done two company-sponsored trials with excellent safety and efficacy, and one physician-sponsored trial. We are looking to get that product on the market in the next few years, to bring us to profitability, so that we can build our pipeline for other therapeutic indications.
BJ: So Histogen has essentially discovered a way to create embryonic stem cells without dealing with the ethical issues of embryos?
GN: Yes. It is completely noncontroversial. This work has been duplicated by others and we have very strong patent positions. Basically, these newborn cells will be brought back to have the same characteristics in terms of gene expressions and what proteins they make, the same as multi-potent, or even embryonic stem cells.
BJ: Does it solve the ethical debate that began several years ago?
GN: I don’t know that it solves it. In term of our cell byproducts that we use, we certainly have a very non-controversial, ethical way to produce them. The cells themselves have not been used therapeutically, but if we find that they can be used instead of embryonic stems cells for therapeutic uses, that would really be wonderful thing.
BJ: Your first product is a treatment for hair loss. How does it work?
GN: The growth factors that are made by the product are purified. We inject them into the mid-dermis. We have special needles that go 2MM – where the hair follicle stem cells are. So when you have a miniaturized hair follicle, and the hair follicle is starting to die, and you have very fine hair or no hair, the growth factors basically stimulates the stem cells and the hair follicles that start dividing, cause the keratinocyte in the hair follicle to migrate into the hair shaft, and either convert a baby fine vellus hair to a terminal hair to make brand new hair. So it’s really just waking up the hair follicles. It’s replacement therapy, we are just giving you back what you had when your scalp was functioning normally, and your hair was growing at a normal pace.
BJ: In what stage is this product?
GN: We have done both proof of concept and Phase I, two clinical trials in men. We are starting a pilot next year for women. Five women under a physician-supervised IND, with phenomenal results. So we are going to do a women-only trial. We are also going to be starting a Phase III trial, along with our partner in Mexico , and in March or April 2017 time frame, that will allow us to get the product approved, first in Mexico, and most likely, in the early 2018. We will also begin a Phase II dosing study in men early next year in the United States.
BJ: When might the product become approved and on the market in the U.S.?
GN: Probably two years after we receive the approval in Mexico, so 2020 for the U.S. and Canada.
BJ: Do you have a sense of the cost, and how it compares to the cost of other hair treatments?
GN: It will be far more affordable than the traditional hair transplant. Remember the current products on the market, such as Propecia, have to be used either once or twice every day. Once you stop using it, within a couple of weeks, you have massive shedding. Those products are not good at generating new hair, they are just preventing hair loss.
Our product will consist of a three-treatment regime. Injections, six weeks apart (Week 0, Week 6 and Week 12). The effects will last for at least two years, and experts are telling us it will probably last as long as your hair cycle lasts, which is between two to five years, before needing another treatment. It is transformational in terms of approaching hair growth.
The cost itself, of course, will depend on our marketing partner. Because we make both products, the soluble and insoluble, simultaneously, the margins can be spread evenly, over the products themselves in way that will be most beneficial to pricing. We are looking at $1500 per treatment, compared to a hair transplant which costs roughly $12,000-$15,000.
BJ: So, someone will go back for another treatment after two or three years?
GN: It can be compared to the Botox model. Botox shows that even as an injectable, people are willing to come back, every four to six months for an aesthetic improvement. This is more like two to five years, and it would be more of a “touch-up”, rather than a full scalp treatment at that point.
BJ: I would imagine that people would be happy to go back for the treatment, since it’s inspiring hair growth, correct?
GN: The results are quite dramatic, with cosmetically-relevant new hair growth as early as 12 weeks after the first set of injections.
BJ: Let’s talk about your international initiatives. You recently put together an investment relationship with a Chinese company. That was your Series D. Can you tell us a bit about it?
GN: Yes. Our lead investor in our Series D was Huapont Pharmaceuticals. Huapont is the leading dermatology company in mainland China. To be able to have them not only lead an investment, but in addition, take an exclusive license for the hair product for mainland China is a tremendous endorsement for us.
BJ: What was the nature of the agreement?
GN: Sure. In addition to the investment, the license will bring us about $5M in milestones, escalations in royalties that are very favorable, and about 180% margin on products that we manufacture. They will be our exclusive marketing partner in China, with connections to all of the top dermatology hospitals in China. They are tremendously suited to do an excellent job with this product. We will maintain the manufacturing rights, and they will be our promoter, sales and marketing, as well as getting it CFDA (China Food and Drug Administration) approved.
BJ: Do you have a sense of how long that will take to get it through the CFDA in China?
GN: Right now, we are assuming that, like in Mexico, we will be able to go straight into a Phase III trial. They are going to wait until we get our Phase II B dosing approved here in North America, and then we will be visiting the CFDA together. It takes about a year in China, from when you submit the IND-equivalent in China, to when you can start the clinical trial. Probably within eighteen to twenty months after we get the IND approvals, we hope to be on the market.
BJ: How did you come across Huapont?
GN: I attended the OneMed Forum in San Francisco, during JP Morgan, this past January. One of the days was dedicated to China. It was a phenomenal day. There were excellent panelists from China discussing the partnerships in China and what Chinese companies are looking for. Two of the executives from Huapont were there, and because of the OneMed Forum I was able to meet with them that same day. We had a really productive discussion, and a few days later, they flew to San Diego to visit Histogen and by March, we had a binding term sheet. It was probably one of the most efficient and effective meetings I have ever had in my life, and I am very grateful to OneMed Forum for helping to make it happen.
BJ: Glad to hear that. What insights would you have for companies looking to do business in China?
GN: We had spoken to many companies in China over the last three years, and of course, none of them panned out. To be able to continually present yourself to investors in China is important, particularly when the companies are coming here, to the U.S. to actively look at new investments. That is key, you can never go to enough meetings, or present at enough conferences, because you never know when your ideal partner is going to be in the audience.
The Huapont has executives were trained in Australia, completing their undergrad/grad education there, which meant that they were fluent in English and understood Western culture, and were very entrepreneurial. That made for a perfect partnership. There are other Huaponts out there. There are tremendous amounts of interest out there from many medical device and pharmaceutical companies in China, who are looking to invest in cutting-edge technologies in the U.S. right now. I think we will see an increased interest in these companies coming to the United States, to try and get some innovation license for their portfolio. It’s a very exciting time.
BJ: It certainly is. Let’s shift now and discuss the milestones for Histogen. What are some of the major events that you see happening in the next few years?
GN: In the short-term, before the end of this year, we will be announcing our license partner in Mexico. We’ve been working very effectively under an LLI for the last year, but we are going to finalize that. It will be exciting to start the Phase III pivotal trial in Mexico in the spring of next year. We have three amazing dermatologists who will be the PIs in that study. Of course, the clinical trials, one dedicated to women with hair loss, and the other dealing with Phase II dosing with men. Both will be starting in early to mid 2017.
We also have an orthopedic joint venture, which is separately funded, that is looking to start a clinical trial in the first part of 2017 for cartilage defects in the knee. We have done rabbit and goat studies with beautiful results, and have asked the FDA for a pre-IDE meeting, to be able to go and talk about the clinical protocols and start of that trials. So, lots of clinical data coming up, and hopefully lots of new investors as well.
Ever since Huapont has invested in us, we have had a number of groups in China come talk to us, and discuss the possibility of an investment in Histogen. To be able to close our Series D, another $12-$15M in the coming months, and get all our clinical data is going to be great. Our plan is, that once we get additional clinical data in the U.S. and Mexico, to file for an IPO, around early 2018.
BJ: Wow, seems like there are lots of exciting things happening at Histogen. Thanks again, Gail for joining us.
GN: Always a pleasure, Brett. Thank you again for the wonderful Huapont introduction.
