Slides Are Up - Presentation This Morning

[centralcoastinvestor]

The slides are up for the presentation at 6:35 am this morning.  

Rodman & Renshaw 20th Annual Global Investment Conference

[centralcoastinvestor]

Really good presentation today.  What was new is that Mike had to spend half of his time on TreT and Technosphere as part of his presentation and the other half on Afrezza.  I think that will raise eyebrows in the investment community.  It was very apparent that MannKind has many many things in the pipeline and that is newsworthy.

[mnholdem]

Did you catch Mike’s comment that one application for the single-use Cricket could be erectile dysfunction?

[peppy]

Sept 5, 2018 9:41:17 GMT -5 mnholdem said:

Did you catch Mike’s comment that one application for the single-use Cricket could be erectile dysfunction?

"tada" 
Tadalafil, 
www.unither.com/products.html

[centralcoastinvestor]

Sept 5, 2018 9:41:17 GMT -5 mnholdem said:

Did you catch Mike’s comment that one application for the single-use Cricket could be erectile dysfunction?

I caught that.   RLS was mentioned again.  Mike also mentioned that they were farther along with Mexico and Canada which I thought was encouraging.  I will try and read the transcript when it comes out as Mike mentioned a lot of tidbits of news today.

[zumiker]

I heard from ST he mentioned RLS a couple of times. Does anyone know what he mentioned regarding RLS?

[wmdhunt]

Looks like we are finally turning that hard corner. First mention I have heard of ED applications. That would be huge with patents coming off of ED meds... no puns intended. lol

[therealisaching]

Very interesting and different presentation this morning. Mike was confidently pitching a drug development company today spending roughly half of his time on technosphere. We've all been frustrated with the pace of Afrezza sales, but management is working with a shoestring budget. Brilliant foresight to move forward with the TreT. In between last nights call and todays presentation it sounds like the bulk of the 2nd $50MM tranche from United is entirely within Mnkds control and attainable within 24 months. Certainly sounds from Mike's comments that the company will be looking to expand the pipeline with the "bucket 1" type drugs that are known compounds already being delivered to the lung while also attending to growing the Afrezza brand.

I have to say while its certainly been rocky Mike continues to deliver on his broad strokes. Continued good luck to all.

[ilovekauai]

Venite adoremus Dominum! (Good Morning!). Enjoying the climb again this morning and Michael C is indeed hitting his stride! Great to see and Onward!

[peppy]

Sept 5, 2018 11:40:38 GMT -5 therealisaching said:

Very interesting and different presentation this morning. Mike was confidently pitching a drug development company today spending roughly half of his time on technosphere. We've all been frustrated with the pace of Afrezza sales, but management is working with a shoestring budget. Brilliant foresight to move forward with the TreT. In between last nights call and todays presentation it sounds like the bulk of the 2nd $50MM tranche from United is entirely within Mnkds control and attainable within 24 months. Certainly sounds from Mike's comments that the company will be looking to expand the pipeline with the "bucket 1" type drugs that are known compounds already being delivered to the lung while also attending to growing the Afrezza brand.

I have to say while its certainly been rocky Mike continues to deliver on his broad strokes. Continued good luck to all.

Buckets

[mango]

Mike mentioned the cricket inhaler for an anxiety formulation. I need a Antixiety script please.

 Kindxiety. 

[mango]

Wonder if this product of United’s could use Technosphere

1. Unituxin

Unituxin is a monoclonal antibody and UT is currently doing studies evaluating for small cell lung cancer I think.

Currently, it is indicated in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.


Unituxin

Under our BLA approval for Unituxin, the FDA has imposed certain post-marketing requirements and post-marketing commitments on us. We are conducting additional clinical and non-clinical studies to satisfy these requirements and commitments. While we believe we will be able to complete these studies, any failure to satisfy these requirements or commitments could result in penalties, including fines or withdrawal of Unituxin from the market, unless we are able to demonstrate good cause for the failure.
In addition, we are conducting a study (DISTINCT) of Unituxin in adult patients with small cell lung cancer, which is another GD2-expressing cancer.

During the fourth quarter of 2017, we completed the phase II portion of the study, and commenced the phase III portion of the study following an interim safety review. We are also conducting preclinical research to determine Unituxin’s potential activity against other GD2-expressing tumor types. These research and development efforts into new indications for Unituxin have been substantially outsourced to a contract research organization called Precision Oncology, LLC.

Unituxin therapy is associated with severe side effects, including infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome. In post-approval use of Unituxin, the adverse reactions of prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome have been observed. Unituxin’s label also includes a boxed warning related to serious infusion reactions and neurotoxicity.

Finally, we are developing a fully humanized (non-chimeric) version of dinutuximab, the active ingredient in Unituxin. We expect this new version to reduce some of the side effects associated with Unituxin, which is a chimeric composed of a combination of mouse and human proteins.



ir.unither.com/static-files/30d54193-91ab-47d3-8c3d-438d04a68e2a

[peppy]

Sept 5, 2018 13:17:13 GMT -5 mango said:

Wonder if this product of United’s could use Technospere.

1. Unituxin

Unituxin is a monoclonal antibody and UT is currently doing studies evaluating for small cell lung cancer I think.

Currently, it is indicated in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.


Unituxin

Under our BLA approval for Unituxin, the FDA has imposed certain post-marketing requirements and post-marketing commitments on us. We are conducting additional clinical and non-clinical studies to satisfy these requirements and commitments. While we believe we will be able to complete these studies, any failure to satisfy these requirements or commitments could result in penalties, including fines or withdrawal of Unituxin from the market, unless we are able to demonstrate good cause for the failure.
In addition, we are conducting a study (DISTINCT) of Unituxin in adult patients with small cell lung cancer, which is another GD2-expressing cancer.

During the fourth quarter of 2017, we completed the phase II portion of the study, and commenced the phase III portion of the study following an interim safety review. We are also conducting preclinical research to determine Unituxin’s potential activity against other GD2-expressing tumor types. These research and development efforts into new indications for Unituxin have been substantially outsourced to a contract research organization called Precision Oncology, LLC.

Unituxin therapy is associated with severe side effects, including infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome. In post-approval use of Unituxin, the adverse reactions of prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome have been observed. Unituxin’s label also includes a boxed warning related to serious infusion reactions and neurotoxicity.

Finally, we are developing a fully humanized (non-chimeric) version of dinutuximab, the active ingredient in Unituxin. We expect this new version to reduce some of the side effects associated with Unituxin, which is a chimeric composed of a combination of mouse and human proteins.



ir.unither.com/static-files/30d54193-91ab-47d3-8c3d-438d04a68e2a

I know I have mentioned this prior. MNKD has some patents that include monoclonal antibodies. Technosphere can absorb then. UTHR has one monoclonal antibody on their product list.
dinutuximab. www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf
Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. (1)

[mango]

Sept 5, 2018 13:23:23 GMT -5 peppy said:

Sept 5, 2018 13:17:13 GMT -5 mango said:

Wonder if this product of United’s could use Technospere.

1. Unituxin

Unituxin is a monoclonal antibody and UT is currently doing studies evaluating for small cell lung cancer I think.

Currently, it is indicated in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.


Unituxin

Under our BLA approval for Unituxin, the FDA has imposed certain post-marketing requirements and post-marketing commitments on us. We are conducting additional clinical and non-clinical studies to satisfy these requirements and commitments. While we believe we will be able to complete these studies, any failure to satisfy these requirements or commitments could result in penalties, including fines or withdrawal of Unituxin from the market, unless we are able to demonstrate good cause for the failure.
In addition, we are conducting a study (DISTINCT) of Unituxin in adult patients with small cell lung cancer, which is another GD2-expressing cancer.

During the fourth quarter of 2017, we completed the phase II portion of the study, and commenced the phase III portion of the study following an interim safety review. We are also conducting preclinical research to determine Unituxin’s potential activity against other GD2-expressing tumor types. These research and development efforts into new indications for Unituxin have been substantially outsourced to a contract research organization called Precision Oncology, LLC.

Unituxin therapy is associated with severe side effects, including infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome. In post-approval use of Unituxin, the adverse reactions of prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome have been observed. Unituxin’s label also includes a boxed warning related to serious infusion reactions and neurotoxicity.

Finally, we are developing a fully humanized (non-chimeric) version of dinutuximab, the active ingredient in Unituxin. We expect this new version to reduce some of the side effects associated with Unituxin, which is a chimeric composed of a combination of mouse and human proteins.



ir.unither.com/static-files/30d54193-91ab-47d3-8c3d-438d04a68e2a

I know I have mentioned this prior. MNKD has some patents that include monoclonal antibodies. Technosphere can absorb then. UTHR has one monoclonal antibody on their product list.
dinutuximab. www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf

First thing I thought of when I read what Unituxin is. 

[mango]

MONOCLONAL ANTIBODIES AND DIAGNOSTIC USES THEREOF

patentscope.wipo.int/search/en/detail.jsf?docId=EP173338937&recNum=1&maxRec=755&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=FP%3A%28MANNKIND%29&tab=NationalBiblio