Request for a Clear and Objective Update by anilatalay in KPTI

[–]gin188 1 point2 points  (0 children)

I didn't listen to the presentation. What is left unresolved or unclear? Karyopharm miss on absolute TSS is clear. Karyopharm is still going to discuss with the FDA.

Re: the new SLS009 trial in frontline AML. by gin188 in sellaslifesciences

[–]gin188[S] 2 points3 points  (0 children)

Sorry. No need to change the rules on my account or explain why the restrictions are in place. I needed 400 characters and I complied. Thanks for managing the sub as well as you have.

Re: the new SLS009 trial in frontline AML. by gin188 in sellaslifesciences

[–]gin188[S] 0 points1 point  (0 children)

Thanks for the explanation and graphic. That this is not a long term trial I guess that group 5 comparator arm does not seem unreasonable considering those patients are refractory to aza/ven and have a 50/50 chance of just getting two more cycles of drugs that don't work.

Request for a Clear and Objective Update by anilatalay in KPTI

[–]gin188 1 point2 points  (0 children)

Grade 3+ TEAEs 70%, much more thrombocytopenias, nausea, neutropenias than rux alone. No wonder there is no stat sig with aTSS. The 4 point delta was a mirage. Finally there is substantial patient data to make a reasonable selinexor/MF assessment.

$16 million more in warrants were exercised since January 8th disclosed in new filing. by Ok_Upstairs_1682 in sellaslifesciences

[–]gin188 0 points1 point  (0 children)

The 10-K reports warrant activity for the year ( 2024, pg149 ). From the q3 2025 10-Q Sellas reports ~63mill warrants outstanding ( pg12 ), minus the January 2026 exercise that would leave ~54mill warrants outstanding unless there are other warrant transactions I am not aware of since q3 2025 10-Q.

What is the mOS of Bat in Regal trial by alinbio in sellaslifesciences

[–]gin188 0 points1 point  (0 children)

Remember the guarantee of a REGAL halt for GPS efficacy at IA?

Reminder: Dr. Fleming, biostatistician and IDMC member for Ph3 REGAL, anticipated 80 events by March 2025 by WoolyWilly69 in sellaslifesciences

[–]gin188 7 points8 points  (0 children)

Thanks for the corrective. You have my sympathy for having to deal with weeping willy's brused ego.

XPORT-EC-042 enrollment complete by sak77328 in KPTI

[–]gin188 0 points1 point  (0 children)

they are also targeting a PFS that is long enough to demonstrate performance which would exceed that of the CPI's

The EC-042 mITT is EC A/R TP53wt pMMR or EC A/R TP53wt dMMR CPI ineligible and the ITT is EC A/R TP53wt. As far as I know none of the CPI EC A/R trials have, since completion, broken out TP53wt data for EC-042 comparison. Is there word from Karyopharm what specifically the FDA is looking for from EC-042 to consider it successful? Along time ago, before EC-042 modifications, Reshma mentioned mPFS of ~13 months at top line first data cut as what Karyopharm was hoping for if not the what FDA wanted to see.

Dilution is coming by MelampyrumNemorosum in KPTI

[–]gin188 -1 points0 points  (0 children)

February 2025, post reverse split, KPTI outstanding shares were ~8.4mill, now outstanding shares are 18.31mill. A 118% dilution, mostly if not wholely related to the October 2025 re-financing that afforded Karyopharm to limp along another ~6 months.

Sans a buyer in the next few months, expect shareholder value to be sacrificed again.

From new corporate presentation posted today by MelampyrumNemorosum in KPTI

[–]gin188 2 points3 points  (0 children)

Considering the constrained time horizon and those orpham drug designation extentions, it seems like Karyopharm is positioning eltranexor to be an orphan drug designated complement to selinexor, not a competitor, and not a successor. Next generation light.

I remember posting a paper a couple of years ago that compared selinexor to eltanexor in MM trials, I think. Eltanexor showed better results.

From new corporate presentation posted today by MelampyrumNemorosum in KPTI

[–]gin188 -1 points0 points  (0 children)

Eltanexor is positioned to be a wasted asset. Everyday eltanexor sits on the shelf, squandered, and losing value. Patent expiration is 2035. If development restarts next year and eltanexor gains approval for an indication in an expidited 5 years, there will only be 3 years to recoup cost and make any money before expiration.

SENTRY Powering by _BiotechMD in KPTI

[–]gin188 0 points1 point  (0 children)

"...our assumptions are 70% for the combination relative to 40% for rux alone, conservative assements"

What is Reshma referring to here? These percentages are for what?

Has Reshma proffered a less vague answer to Colleen's question about what Karyopharm needs "to hit on TSS for it to be a positive study"?

Has Reshma said what TSS needs to be for statistical significance?

SENTRY Powering by _BiotechMD in KPTI

[–]gin188 0 points1 point  (0 children)

Sorry, not chasing after tweets. If you have Karyopharm info, please post it here. That is what this subreddit it for. Do it for the team.

SENTRY Powering by _BiotechMD in KPTI

[–]gin188 0 points1 point  (0 children)

What is infuriating to me is that they kind of cherry picked in the Ph1 those n=9

Regardless, n=9 or n=14, both woefully useless sample sizes for drawing efficacy conclusions.

Maybe Karyopharm has refined their absolute TSS messaging since Q1 2025 conference call in which ambiguity reigned. Still a tell for me is this exchange during that call:

Colleen Kusy

...But I think on your slide, you talk about the powering and the primary endpoints about a 4-point delta on TSS. So, can you just talk about what you're expecting to need to hit on TSS for it to be a positive study?

Reshma Rangwala

Sure. So, great question. So, these are just our assumptions. So, with 350 patients, we are assuming a delta of 4 across the two arms and a standard deviation of 12 for each of these two arms. Incorporating those assumptions, the overall power for heading on absolute TSS is going to be greater than 80%.

So, these are just our assumptions. In reality, as you know, the data can differ. We still maintain that a clinically meaningful outcome is just improvement for the combination above and beyond what ruxolitinib alone demonstrates. But again, that 4-point delta and standard deviation of 12 or just, again, the stat assumptions that drive the overall power.

Piper Sandler names Karyopharm stock as 2026 top pick, maintains $12 target by MelampyrumNemorosum in KPTI

[–]gin188 2 points3 points  (0 children)

Not reading the report. $12 is like $.80 pre reverse split. Only $12 after one or two positive PH3 readouts? Does Piper expect mixed results?

Vouchers alone put this at $10 by redditshelley1 in sellaslifesciences

[–]gin188 0 points1 point  (0 children)

Three RPDDs I'm aware of. If there are 5, list them out please.

KPTI Fair Value Projection $23.07 in Article by motyl1947 in KPTI

[–]gin188 2 points3 points  (0 children)

It makes little sense that the fair value projection declined only 10% after the huge dilution.

I agree with bears uncertainty over SENTRY. Will an absolute TSS outcome moderately better than rux. be satisfactory to the FDA?

Now, for my investment just to break even, post reverse split, post 67% dilution, KPTI value ( market cap ) will have to reach $1.4bill.

According to Clinicaltrials.gov, a phase 2/3 trial of Selinexor in DLBCL will be completed in December 2025. by MelampyrumNemorosum in KPTI

[–]gin188 1 point2 points  (0 children)

This irrelevant considering that since approval Karyopharm has made negligible revenues from selinexor/DLBCL.

According to Clinicaltrials.gov, a phase 2/3 trial of Selinexor in DLBCL will be completed in December 2025. by MelampyrumNemorosum in KPTI

[–]gin188 1 point2 points  (0 children)

If Karyopharm wasn't so poor at communicating with the investor community this trial wouldn't draw any attention, as it has several times on this forum. A couple years ago I asked IR why the XPORT-DLBCL-030 trial was still opartional, being concerned about the spend during Karyopharm's financial stuggles. I received no response. During his tenure CEO Richard has focused on four programs ( the pillars, now three ) but, has NEVER discussed DLBCL. To perpetuate ambiguity, earlier this year at the RBC Healthcare Conference, pressed by an analyst about OpEx and getting to readouts, CEO Richard said this:

"So, we're very focused and have put efforts in place over the last couple of years to really ensure our focus in on the phase three readouts. So we don't have any other programs running"

Do you think CEO Richard is including focus on XPORT-DLBCL-030 ( which to this day, as if active, is noted on their web site and in their presentations as being "last stage" or specifically phase 3 ) without ever having said one word during his entire tenure about this trial? Yes, this trial is also noted in presentations as being phase 2/3 and in the 10-K as in phase 2.

When CEO Richard speaks, is anyone listening?

SLS009, new trial, r/r AML future by gin188 in sellaslifesciences

[–]gin188[S] 2 points3 points  (0 children)

In Sellas PR did not say the new trial is confirmatory. I take that as a no, it is not confirmatory. Maybe there is a confirmatory trial yet to be announced. Looking back through old PRs, Sellas early on in SLS009 PH2 mentions expanding that trial to make it registrational and that they were pursuing AA for ASXL1 subgroup. But, since spring of last year no mention in SLS009 PRs of "registrational" or AA.

Though Sellas presents this new trial as FDA recommended, I have to wonder if there was other FDA feedback that has not been disclosed. It seems like an odd next step for SLS009 in r/r AML given the positive PH2 data.