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Post by ktim on Oct 3, 2024 1:52:12 GMT -5
prcgorman2I concur. Big issue is what is achieved vs expectations. If the expectation for 201 is simply to work, then very good tolerability results compared to oral might be an upside event. These Afrezza results will hopefully help getting the dosing sorted out on the label, but that will take some time and even then doesn't change the real hurdle of lack of formulary coverage... and peds, well the success of that I'd think is expected by everyone.
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Post by Clement on Oct 3, 2024 7:30:14 GMT -5
Re: nintedanib phase 1 readout from clinicaltrials.gov Official Title A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers Study Start (Actual) 2024-05-28 Primary Completion (Estimated) 2024-10-31 Study Completion (Estimated) 2024-10-31 Study completion date The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date. clinicaltrials.gov/study/NCT06532942?intr=inhaled%20nintedanib&rank=2 |
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Post by Clement on Oct 3, 2024 7:41:20 GMT -5
^ The safety and tolerability results should indicate how MNNKD-201 compares to OFEV concerning side effects in healthy volunteers. That's big.
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Post by ktim on Oct 3, 2024 8:56:05 GMT -5
I think the expectation is that it will have better tolerability than OFEV. Though there is risk it doesn't have any benefit. The derisking alone should give a bit of share price boost (meeting expectation), with possibility of bigger gain if the tolerability results are surprisingly good.
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Post by peppy on Oct 3, 2024 9:13:55 GMT -5
Is there news? Did India approve? What is going on?  |
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Post by lookforgrowth on Oct 3, 2024 9:18:14 GMT -5
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Post by tingtongtung on Oct 3, 2024 10:20:54 GMT -5
From seekingalpha:
"MannKind has large long-term liabilities, including $227.577 in senior convertible notes and $135.365 million in liability for sale of future royalties."
What is "liability for sale of future royalties"? Thanks.
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Post by peppy on Oct 3, 2024 10:25:55 GMT -5
From seekingalpha: "MannKind has large long-term liabilities, including $227.577 in senior convertible notes and $135.365 million in liability for sale of future royalties." What is "liability for sale of future royalties"? Thanks. 1% of the Tyvaso DPI royalty./year. |
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Post by prcgorman2 on Oct 3, 2024 10:27:37 GMT -5
From seekingalpha: "MannKind has large long-term liabilities, including $227.577 in senior convertible notes and $135.365 million in liability for sale of future royalties." What is "liability for sale of future royalties"? Thanks. I assume they're referring to a balance sheet accounting for the amount of cash MannKind received from Sagard in return for MannKind assigning 10% of their 10% (net 1%) of royalties from United Therapeutics for sale of Tyvaso DPI that was developed and is manufactured by MannKind. I want to say the Sagard infusion was around $200M in cash so the $135M referred to in the SA blog must be a portion of the larger total. It's worth mentioning there's an additional $50M in cash from Sagard if UTHR sales of Tyvaso DPI hit a milestone (whose details I don't remember). |
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Post by ktim on Oct 3, 2024 11:15:30 GMT -5
The Sagard deal probably had some contingency clauses that under some extremely unlikely scenarios (UTHR decides to stop selling it, for instance, or MNKD breaches their contract with UTHR in such a way that UTHR could legally stop paying royalty) then MNKD could owe Sagard unpaid portions of the money back. Maybe there would be accounting reason even if there weren't such a contingency, but that's what I'm guessing it's about.
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Post by BD on Oct 3, 2024 12:02:57 GMT -5
Is there news? Did India approve? What is going on? Is it my imagination, or are we sort of seeing a pattern here of a delayed reaction to good news? It's like the market reaction is "Meh' on initial news release, or even "sell the news"-ey, and then a few days later on no news there's a more serious bump. Weird. |
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Post by cppoly on Oct 19, 2024 6:56:45 GMT -5
Earnings call November 5th - 11th.
I'm under the impression we will have another one of these catalysts before the call.
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Post by Clement on Nov 6, 2024 13:49:08 GMT -5
Per the Q2 presentation, here's the upcoming milestones in 2024: 1) INHALE-1 top line data readout 2) INHALE-3 30 week readout 3) MNKD-201 (Nintedanib) phase 1 data readout and chronic tox results 4) MNKD-101 (Clofazamine) ICoN-1 trial expansion into international sites Which has the most impact to share price? So far, we have not heard about INHALE-1 top line data readout. Here's something from clinicaltrial.gov. Primary Completion (Actual) 2024-10-03 Primary Completion means: "The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures." clinicaltrials.gov/study/NCT04974528?cond=DIABETES&term=INHALE-1&rank=1 |
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Post by bthomas55ep on Nov 6, 2024 14:15:44 GMT -5
Per the Q2 presentation, here's the upcoming milestones in 2024: 1) INHALE-1 top line data readout 2) INHALE-3 30 week readout 3) MNKD-201 (Nintedanib) phase 1 data readout and chronic tox results 4) MNKD-101 (Clofazamine) ICoN-1 trial expansion into international sites Which has the most impact to share price? So far, we have not heard about INHALE-1 top line data readout. Here's something from clinicaltrial.gov. Primary Completion (Actual) 2024-10-03 Primary Completion means: "The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures." clinicaltrials.gov/study/NCT04974528?cond=DIABETES&term=INHALE-1&rank=1 Nice find. Also last update in the system 10/15/24. Maybe this is the next bit of news to come out. Obvious the study is over. GLTA |
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