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Post by #NoMoreNeedles on Jan 14, 2021 17:38:34 GMT -5
A phase 3 trial for Peds will cost approximately $20M. Who will sponsor this trial? Shareholders via dilution?
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Post by Deleted on Jan 14, 2021 19:05:09 GMT -5
A phase 3 trial for Peds will cost approximately $20M. Who will sponsor this trial? Shareholders via dilution? If this is a 2 year trial I doubt the cost is $20M. I think it's higher.....much higher. |
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Post by cjm18 on Jan 14, 2021 20:52:08 GMT -5
Uhtr
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Post by boca1girl on Jan 15, 2021 7:59:03 GMT -5
Why would they fund the trial? |
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Post by markado on Jan 15, 2021 8:05:00 GMT -5
I could envision this possibility. An organization that's willing to pay $100M to accelerate a drug to market might just see the possibilities of providing world class, non-invasive, non-injurous (no shots) or less injurious (fewer shots) treatment for diabetics on a life long basis, and be willing to foot the bill. Not saying it is so, just saying I could see it. We also still don't know who the owner of the shares is from the great dilution of December '19, do we? |
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Post by cjm18 on Jan 15, 2021 8:50:57 GMT -5
Why would they fund the trial? Indirectly. From Tyvaso sales. Where would mnkd be without them. |
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Post by agedhippie on Jan 15, 2021 9:19:10 GMT -5
I could envision this possibility. An organization that's willing to pay $100M to accelerate a drug to market might just see the possibilities of providing world class, non-invasive, non-injurous (no shots) or less injurious (fewer shots) treatment for diabetics on a life long basis, and be willing to foot the bill. Not saying it is so, just saying I could see it. We also still don't know who the owner of the shares is from the great dilution of December '19, do we? UTHR paid $100M to buy a lead on Liquidia. Don't confuse commercial companies with charities. Occasionally they two coincide and doing the right thing is also doing the right commercial thing as well, but if they don't align the company will take the commercial route or get sued by angry shareholders. |
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Post by Deleted on Jan 15, 2021 9:55:04 GMT -5
Why would they fund the trial? Indirectly. From Tyvaso sales. Where would mnkd be without them. I doubt UTHR would step into the field of diabetes. Also you can ask...Where would UTHR be WITHOUT MNKD? Tyvaso DPI is a life changing drug for PAH Patients and this keeps Generics away from Tyvaso for a long time. Also what other drugs is UTHR planning to convert to the TS Platform? |
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Post by radgray68 on Jan 15, 2021 13:03:42 GMT -5
Don't we have $25 million left to borrow under the midcap loan agreement? I'm thinking that'll cover it.
On top of that, Martine seemed to imply that UTHR would be seeking indications for COPD. As I recall, Mannkind retained the rights for COPD in the original agreement. That could mean an additional Opt-In payment and milestones if I'm correct on the wording from the agreement. Or, a whole new agreement altogether. It's been a couple years since I read it, though.
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Post by sportsrancho on Jan 15, 2021 13:14:30 GMT -5
I could envision this possibility. An organization that's willing to pay $100M to accelerate a drug to market might just see the possibilities of providing world class, non-invasive, non-injurous (no shots) or less injurious (fewer shots) treatment for diabetics on a life long basis, and be willing to foot the bill. Not saying it is so, just saying I could see it. We also still don't know who the owner of the shares is from the great dilution of December '19, do we? Rumors it was the CEO of Dexcom. I cannot elaborate on those rumors:-) |
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Post by jlaw277 on Jan 15, 2021 13:37:31 GMT -5
I am struck by the common thread of Novartis/Sandoz running through MNKD's team and recent activity, and the fact that they seemed to have emphasized/strengthened their pediatric expertise. They looked to be well prepared for the pediatric trial and one has to wonder if Novartis might not be involved.
Qrum:
Thomas Hofmann - Pediatric Pulmonologist - Prior experience included Chief Scientific and Safety Officer for what was to become Novartis Germany - also member of the team that gained approval for inhaled tobramycin
Novartis owns Lamprene (clofazimine)
Co-promote with Vertice Pharma:
- Scott Meyers (CEO) - most recently as Vice President, General Manager, Dermatology of Fougera Inc., a Sandoz / Novartis company - Prior to Fougera, Scott led Strategic Planning & Market Analytics for Sandoz US
- Noel Grennberger (CCO) - most recently Executive Director of Respiratory at Sandoz U.S., the generics division of Novartis, and was responsible for building and commercializing Sandoz’ portfolio of respiratory medicines
MNKD:
James Shannon - prior global head of Pharma development for Novartis - recent assumption of chairman role
M Castagna - prior to Amgen, former VP and head of Biopharmaceuticals NA for Sandoz (generic arm of Novartis)
Plus:
Kevin Kaiserman - Pediatric Endocrinologist - MNKD VP Medical Affairs & Safety - leading pediatric initiatives
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Post by jlaw277 on Jan 15, 2021 15:11:16 GMT -5
I am struck by the common thread of Novartis/Sandoz running through MNKD's team and recent activity, and the fact that they seemed to have emphasized/strengthened their pediatric expertise. They looked to be well prepared for the pediatric trial and one has to wonder if Novartis might not be involved. Qrum: Thomas Hofmann - Pediatric Pulmonologist - Prior experience included Chief Scientific and Safety Officer for what was to become Novartis Germany - also member of the team that gained approval for inhaled tobramycin Novartis owns Lamprene (clofazimine) Co-promote with Vertice Pharma: - Scott Meyers (CEO) - most recently as Vice President, General Manager, Dermatology of Fougera Inc., a Sandoz / Novartis company - Prior to Fougera, Scott led Strategic Planning & Market Analytics for Sandoz US- Noel Grennberger (CCO) - most recently Executive Director of Respiratory at Sandoz U.S., the generics division of Novartis, and was responsible for building and commercializing Sandoz’ portfolio of respiratory medicines MNKD: James Shannon - prior global head of Pharma development for Novartis - recent assumption of chairman role M Castagna - prior to Amgen, former VP and head of Biopharmaceuticals NA for Sandoz (generic arm of Novartis)Plus: Kevin Kaiserman - Pediatric Endocrinologist - MNKD VP Medical Affairs & Safety - leading pediatric initiatives Article: Novartis' Sandoz sets sights on insulin (2/19/2019) "When you look at insulin, there are two things: barriers to entry, and there's also a big price issue. The big insulin manufacturers have been taking price increases continuously — that's not a criticism of them, [it] just means that market is very big — I also think it creates an access issue," Francis said. "So from an access point of view, that feels like an opportunity. From a market size, it is massive and there's no real innovation coming." The Sandoz CEO said he is looking at a time frame in the "early to mid-20s" to launch the first rival insulin." |
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Post by mnkdfann on Jan 15, 2021 16:28:21 GMT -5
I am struck by the common thread of Novartis/Sandoz running through MNKD's team and recent activity, and the fact that they seemed to have emphasized/strengthened their pediatric expertise. They looked to be well prepared for the pediatric trial and one has to wonder if Novartis might not be involved. Qrum: Thomas Hofmann - Pediatric Pulmonologist - Prior experience included Chief Scientific and Safety Officer for what was to become Novartis Germany - also member of the team that gained approval for inhaled tobramycin Novartis owns Lamprene (clofazimine) Co-promote with Vertice Pharma: - Scott Meyers (CEO) - most recently as Vice President, General Manager, Dermatology of Fougera Inc., a Sandoz / Novartis company - Prior to Fougera, Scott led Strategic Planning & Market Analytics for Sandoz US- Noel Grennberger (CCO) - most recently Executive Director of Respiratory at Sandoz U.S., the generics division of Novartis, and was responsible for building and commercializing Sandoz’ portfolio of respiratory medicines MNKD: James Shannon - prior global head of Pharma development for Novartis - recent assumption of chairman role M Castagna - prior to Amgen, former VP and head of Biopharmaceuticals NA for Sandoz (generic arm of Novartis)Is that game starting up again (big pharma connections to Mannkind, hinting at great things underway)? Is Novartis the new Amgen, this time around?  |
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Post by jlaw277 on Jan 15, 2021 17:55:17 GMT -5
I don’t mean to start that speculation (and certainly wouldn’t invest based on it) but I find it interesting that they are using cash in acquisitions and at the same time are planning for “peds” to be starting Q1/Q2 per MC at HCW. Cash as we know is king and I would be surprised if they were using cash in an acquisition if they didn’t feel confident of another incoming source. MNKD still need to get from today to whenever the first Tyvaso DPI royalties come in. I would think they would have to be partnered prior to engaging in the Phase III pediatric trial for multiple reasons. Only possible/likely additional sources of cash at this point without dilution are:
- announcement of another molecule candidate with UTHR or other
- possible partner on pediatric afrezza
- more debt
Of course MC may have been utilizing the ATM enthusiastically over recent weeks.
You mention Amgen. One difference here is that they never engaged in any transactions with Amgen. Here we have seen an acquisition and a compromote deal, both with the involvement of former Novartis/Sandoz execs. And Qrum clearly has an existing relationship with Novartis due to clofazimine aka Lamprene.
Does anyone know the approximate cash requirements of trial like the planned pediatric one?
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Post by casualinvestor on Jan 16, 2021 11:46:51 GMT -5
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