H.C. Wainwright 22nd Annual Global Investment Conference

[mango]

Sept 15, 2020 7:47:31 GMT -5 peppy said:

Sept 15, 2020 7:21:57 GMT -5 mango said:

So I don't expect UT to be a single one and done product. I think you will see us continue to partner and find opportunities to help patients in that space. Plus, everything else we are doing in the orphan lung, looking at things like interstitial lung disease, ILD, what else we may helping idiopathic pulmonary fibrosis, there is whole bunch of different small lung disorders that we think our technology can make a huge difference. And so we are excited about those opportunities as well in the coming months and years that you will see in some of the work that we are doing.

• LNG01 (formerly SM04646) is a Phase I development-stage small-molecule inhibitor of the Wnt signaling pathway for the treatment of idiopathic pulmonary fibrosis (IPF). LNG01 is a nebulized therapy, which has been shown to be safe in healthy volunteers and subjects with IPF in single ascending dose (SAD) and multiple ascending dose (MAD) studies respectively. (UT in-licensed NA rights for SM04646 from Samumed in 2018).

pipeline.unither.com/product/lng01-formerly-sm04646-wnt-inhibitor/description/

pipeline.unither.com


Note: This molecule was specifically designed for inhalation. 

cystic fibrous? 

Idiopathic pulmonary fibrosis

rarediseases.org/rare-diseases/idiopathic-pulmonary-fibrosis/

[goyocafe]

“✅ Not all pipeline candidates are on the website”

The “too long” long group must be  getting hungry again, and too long on the tooth to remember the MNKD playbook. Doesn’t this sound eerily like RLS? Or Torrey Pines and the pain program?

mnkd.proboards.com/thread/4017/pain-management-plans

I used to prod MNKD for their prolific use of the carrot and stick approach to keeping hungry investors eager for a breakthrough announcement and none ever came. It seems we got a short reprieve from this earlier this year, and now it starts anew with “undisclosed pipeline candidates”. How quickly we forget and forgive the tactics we’ve fallen for before. I’ll believe it when I see it.

[hellodolly]

One of the better 'overall' presentations I've heard in a long while. I remain optimistic and look forward to the next few quarters.

[cretin11]

Sept 16, 2020 5:23:16 GMT -5 goyocafe said:

“✅ Not all pipeline candidates are on the website”

The “too long” long group must be  getting hungry again, and too long on the tooth to remember the MNKD playbook. Doesn’t this sound eerily like RLS? Or Torrey Pines and the pain program?

mnkd.proboards.com/thread/4017/pain-management-plans

I used to prod MNKD for their prolific use of the carrot and stick approach to keeping hungry investors eager for a breakthrough announcement and none ever came. It seems we got a short reprieve from this earlier this year, and now it starts anew with “undisclosed pipeline candidates”. How quickly we forget and forgive the tactics we’ve fallen for before. I’ll believe it when I see it.

Cafe you are so cynical. Clearly you’re blind to the fact that the very best pipeline candidates are NOT on the website. Veins of gold that are hidden but all shall be revealed when the time is right!

[LongMNKD]

Sept 16, 2020 9:12:06 GMT -5 cretin11 said:

Sept 16, 2020 5:23:16 GMT -5 goyocafe said:

Cafe you are so cynical. Clearly you’re blind to the fact that the very best pipeline candidates are NOT on the website. Veins of gold that are hidden but all shall be revealed when the time is right!

LOL! Veins of gold right? Is that like an embarrassment of riches?

I hope the undisclosed pipeline candidates are good.. but don't get your hopes up, especially for anything anytime soon. I wouldn't expect UTHR to push anything else until TreT is proven successful. 

[casualinvestor]

The migraine space, as you know, has been around a long time. It's really heated up lots of competition. But there is still an unmet need in the acute space, right. And that's where people try and fail multiple products. But sumatriptan has been the gold standard for, I don't know, 20-plus years now. And that, when you look at our profile, we released this data publicly in one of our investor decks, but you got like almost like an IV-like response in that first of couple minutes here soon as you inhale. But you don't have that lag effect that you get with the oral which you got that oral that's hanging in there for a little bit of time because it gets some time to get absorbed. So you get the fast throw and you get the fast ball, just like you see in our insulin.

Is MNKD able to do the phase 1 for Sumatriptan Technosphere® on it's own? I think this is the most likely non-UTHR molecule to get traction

[matt]

Sept 16, 2020 9:33:29 GMT -5 casualinvestor said:

The migraine space, as you know, has been around a long time. It's really heated up lots of competition. But there is still an unmet need in the acute space, right. And that's where people try and fail multiple products. But sumatriptan has been the gold standard for, I don't know, 20-plus years now. And that, when you look at our profile, we released this data publicly in one of our investor decks, but you got like almost like an IV-like response in that first of couple minutes here soon as you inhale. But you don't have that lag effect that you get with the oral which you got that oral that's hanging in there for a little bit of time because it gets some time to get absorbed. So you get the fast throw and you get the fast ball, just like you see in our insulin.

Is MNKD able to do the phase 1 for Sumatriptan Technosphere® on it's own? I think this is the most likely non-UTHR molecule to get traction

Phase I trials are generally limited to safety with no indication of efficacy at all.  Phase II trials are generally dose escalation protocols, which find the range(s) of dosages needed to create a therapeutic effect and sometimes provides limited efficacy data depending on how large the cohorts are.  Phase III is the largest where patients with the disease condition are treated for signs of efficacy and to reveal side effects not detectable in the Phase I population.

Phase I trials, especially with approved drugs, are often tiny or are skipped entirely.  Can MNKD afford a limited scope Phase I trial, which would only require 15-20 healthy subjects?  Almost certainly.  Would such a trial get anybody excited?  Unlikely, because that trial would be performed with a proven drug and a proven delivery system.  Indeed, it would be only be remarkable if Phase I failed miserably precisely because the risks involved are so minimal.  A more likely scenario would be to do a combined Phase I/II trial on a larger cohort, say 100 patients, which could provide insight into dosing requirements and some indication of efficacy.  That trial, while making a lot more economic sense, would be a fairly expensive exercise that would likely be too rich for MNKD to undertake without a partner.

What MNKD can afford to do on their own would provide such a limited amount of data that doing such a trial is not a good use of the money.  Conversely, if a trial has enough patients and collects enough data to provide meaningful results then it is probably more expensive than what MNKD itself can afford.  Rock meet hard place.

[goyocafe]

Sept 16, 2020 9:12:06 GMT -5 cretin11 said:

Sept 16, 2020 5:23:16 GMT -5 goyocafe said:

“✅ Not all pipeline candidates are on the website”

The “too long” long group must be  getting hungry again, and too long on the tooth to remember the MNKD playbook. Doesn’t this sound eerily like RLS? Or Torrey Pines and the pain program?

mnkd.proboards.com/thread/4017/pain-management-plans

I used to prod MNKD for their prolific use of the carrot and stick approach to keeping hungry investors eager for a breakthrough announcement and none ever came. It seems we got a short reprieve from this earlier this year, and now it starts anew with “undisclosed pipeline candidates”. How quickly we forget and forgive the tactics we’ve fallen for before. I’ll believe it when I see it.

Cafe you are so cynical. Clearly you’re blind to the fact that the very best pipeline candidates are NOT on the website. Veins of gold that are hidden but all shall be revealed when the time is right!

Cynical, yes. Blind? Hell no! Been here forever and seen it all. "The very best pipeline candidates are NOT on the website"? Really? Says who? That really doesn't make much sense to me.