MNKD Corp to Present at NobleCon14 - Noble Capital Markets'
Jan 29, 2018 18:55:14 GMT -5
sportsrancho, pantaloons, and 3 more like this
Post by buyitonsale on Jan 29, 2018 18:55:14 GMT -5
In the Motley Fool interview Mike mentioned that they will most likely need to do Phase 1 study on their own to get better terms with potential partner.
www.fool.com/investing/2017/11/21/mannkind-ceo-michael-castagna-on-whats-ahead-for-t.aspx
Pipeline
Speights: You announced in June that you had engaged Lotus Walk to look for strategic partners on non-insulin pipeline candidates. Any progress?
Castagna: Nothing of significance that I want to speak to yet. I think it was good to go out and seek partners and to get some feedback on the pipeline. That helps me filter what I want to prioritize internally. I think the general comments I got back were they wanted to see a little bit more data. So I think that's a reasonable approach. We've tested 45 molecules; we know can make 43 of them. But in fairness to everybody, we've not put any of those compounds into human beings. So showing what a phase 1 study looks like for a PK/PD for $1 million will show that you have a real drug. I think if you want to get some good economic terms from partners, sometimes you have to spend a little bit of money to get better terms.
I went out on a fishing expedition. We weren't looking for bass or swordfish; we just said, "Hey, is there any interest in anything here sitting on the shelf?" If there's not, then what do we want to prioritize moving forward? That has staffing implications and everything else.
Speights: What about the rest of the pipeline?
Castagna: With Trepostinil -- we went to the FDA in June and we got phenomenal feedback on a very clear development pathway. So that's not that expensive and it's relatively straightforward. And what that means is that we'll be submitting our IND in January, and in the first six months of next year we'll be testing that. It will be our second drug ever put in patients. And sometime next year we'll know whether or not we have another molecule going forward into a larger phase 3 program. And that could be phenomenal. It's a huge category in need of dosing that we can believe we can dose higher levels in a more convenient administration method, so this will be another unmet need we're working on. So that's just something to watch out for.
A second part in the pipeline is a collaboration called Receptor Life Sciences. That market was focused on the cannabinoid medical-marijuana space, and they'll be looking at a strategy around the 505(b)s for an old product called Marinol. And really, looking at bringing out something going forward in that space for hopefully oncology is what I think the market focus is.
www.fool.com/investing/2017/11/21/mannkind-ceo-michael-castagna-on-whats-ahead-for-t.aspx
Pipeline
Speights: You announced in June that you had engaged Lotus Walk to look for strategic partners on non-insulin pipeline candidates. Any progress?
Castagna: Nothing of significance that I want to speak to yet. I think it was good to go out and seek partners and to get some feedback on the pipeline. That helps me filter what I want to prioritize internally. I think the general comments I got back were they wanted to see a little bit more data. So I think that's a reasonable approach. We've tested 45 molecules; we know can make 43 of them. But in fairness to everybody, we've not put any of those compounds into human beings. So showing what a phase 1 study looks like for a PK/PD for $1 million will show that you have a real drug. I think if you want to get some good economic terms from partners, sometimes you have to spend a little bit of money to get better terms.
I went out on a fishing expedition. We weren't looking for bass or swordfish; we just said, "Hey, is there any interest in anything here sitting on the shelf?" If there's not, then what do we want to prioritize moving forward? That has staffing implications and everything else.
Speights: What about the rest of the pipeline?
Castagna: With Trepostinil -- we went to the FDA in June and we got phenomenal feedback on a very clear development pathway. So that's not that expensive and it's relatively straightforward. And what that means is that we'll be submitting our IND in January, and in the first six months of next year we'll be testing that. It will be our second drug ever put in patients. And sometime next year we'll know whether or not we have another molecule going forward into a larger phase 3 program. And that could be phenomenal. It's a huge category in need of dosing that we can believe we can dose higher levels in a more convenient administration method, so this will be another unmet need we're working on. So that's just something to watch out for.
A second part in the pipeline is a collaboration called Receptor Life Sciences. That market was focused on the cannabinoid medical-marijuana space, and they'll be looking at a strategy around the 505(b)s for an old product called Marinol. And really, looking at bringing out something going forward in that space for hopefully oncology is what I think the market focus is.
