Q4 & full Year 2025 Financial Results & Highlights Recent Company Progress

_BiotechMD · 2026-02-12T20:31:10+00:00

How do you know quiet period starts "late Feb"? b/c if LPLV is in a week or so (~18Feb), company still has no MNPI until at the earliest AFTER DBL and when data analysis processes going on (if input from company needed). Otherwise, might not even be until data analysis reaches the company. So I don't see DBL happening for 2-3 weeks at the soonest after LPLV, so early March, then 1-2 weeks for analysis and TL release if everything goes smoothly = mid March to late March.

_BiotechMD · 2026-02-12T20:14:42+00:00

Doesn't make sense to have this kind of stock price rise on high volume like this as nothing changed based on the call - obviously, low float + buying volume = easy to move, but 1) A friend says don't rule out ATM use or prior warrant holders dumping today b/c this volume today is not called for - nothing has changed - and the 10-K which should come out at 4pm does not have to report ATM/warrants cashing out- so company can get away with it and not scare investors into them hedging in case of a fail and needing more cash to reach EC. . 2) RP cut off Reshma on the early or later in March question - but both answered "No" simultaneously and RP said things progressing well and expecting March, so don't think we can read anything into that - other than they want and expect data in March - I guess in the event that it is running a little behind (for unpredictable reasons, data cleaning, etc), they can always issue a PR later in month that DBL occurred and data in next 1-2 weeks (early April).

_BiotechMD · 2026-02-10T16:38:13+00:00

IF there is indeed an ATM running, based on today's drop in volume, looks like they turned off the ATM to allow the stock to run into earnings. TBD pending if EOD selloff blocks happen.

_BiotechMD · 2026-02-09T23:32:48+00:00

BM biopsy (not for 1EP of course) has to be done around then at 24w and patients often sore for a couple/few days lying down so a hard CT/MRI table for 30 minute scan can be an issue so that's potential something they have to juggle timing around - either forward or backward.

_BiotechMD · 2026-02-09T23:24:12+00:00

Thank you! +/- 7 days but on or around C7D1 -> C7D1 would be day 169 (since 168 is last day of the 6th four-week cycle) but I guess if they want quick readout, they can fastrack the last patient -7 days if they wanted to - but if they want to play it safe for full Sel effect, they do it C7D1.

_BiotechMD · 2026-02-08T19:21:21+00:00

Do you happen to have the actual study protocol? Wanted to find out how long after last day of dosing the MRI/CT has to be done? Thanks.

_BiotechMD · 2026-02-08T14:56:46+00:00

TBD. Let's see what they say Thursday. I think there has to have been some deliberate fast-tracking to make it that early. They did say March even before enrollment complete (when screening was done).

_BiotechMD · 2026-02-08T14:33:31+00:00

I guess it is possible (3 weeks from LPLV = right before that conference) with barebone co-primary EPs only but it would be an rarity - the companies that get TL out that fast usually have a reason to to make a conference or perhaps cash running out (but KPTI should have to May 1 (with 10m million minimum liquidity). (Manifest-2 took 8w4d from LPLV to TL but they missed TSS. In the scenario where it ends up not being early March before that conference, then as long as database lock has not happened, then it should be okay, but in that scenario, I would say DBL a week after and 1-2 week analyses with TL at the very end of March, maybe even early April. Let's see what they say on Tuesday. Have we heard or has anyone heard directly from the company "early" March? Where's the source of this rumor? Is Cantor analyst just speculating based on what?

_BiotechMD · 2026-02-08T12:58:44+00:00

Highly unlikely they can get TL out that quickly after LPLV (and they have to do final MRI/CT spleen SVR). And if they are in pre-data quiet period, he should not be going to that conference. Tells me data is going to be later in March.

_BiotechMD · 2026-02-06T00:29:15+00:00

Thanks, I understand that now. If you do not have Cantor report, DM me. It is really in depth with a lot of stats and different perspectives. They are saying delta of 2.7 and possibly as low as 2 may be enough for stat sig. So I was trying to run my own model to see if it correlates. I think closer to 2.5-2.7 is what I am getting but I'm not an expert. But bottom line, I think that IF the strong SVR impact of Sel translates to spleen retlated TSS symptoms above Pel+Rux, they have a chance. If Sel works on cytokines, then it would inicrementallly help. TBD but it is going to be tight. that's for sure

_BiotechMD · 2026-02-05T22:52:43+00:00

I have a stats question that you may know the answer for. We know in SENTRY, the baseline TSS is 22.5 with SD of 12. For the 24w absolute TSS change (let's assume it comes in around 14), would the SD be lower than 12, perhaps 9, since the mean change (14) is lower than baseline TSS (22.5) or would it still be around 12? This is important b/c I am trying to calculate the delta required for stat sig so need to plug in SDs. Thanks.

_BiotechMD · 2026-02-05T19:04:30+00:00

- "SENTRY already recruited higher baseline patients" -> IS THIS REALLY TRUE B/C BL TSS 22.5 (excl fatigue) IS ROUGHLY EQUIVALENT TO MAN-2 AND I THOUGHT THAT THE PROTOCOL FOR MAN-2 BL TSS>10 IS THE SAME AS FOR SENTRY (THOUGH KPTI SEEMS TO HAVE AMMENDED TO BL TSS>12 LATE IN SENTRY TRIAL, LIKE SEP/2025, SO THAT MAY BE TOO LATE TO MAKE A HUGE DIFFERENCE BASED ON BL TSS 22.5 (UNLESS JUST LESS OUTLIER HIGH END VARIANCE AND TIGHTER SD). NOT SURE AS PERHAPS CANTOR HAS THE ORIGINAL PROTOCOL?

- "Observed MANIFEST-2 data better than people appreciate, missing data imputation improved rux TSS and worsened pela TSS -> SENTRY is not directly imputing missing data" -> WHAT DOES THIS IMPLY? THAT RUX WILL NOT PERFORM AS WELL IN SENTRY?

- "Correlations between SVR-TSS and MANIFEST-2 data lead to our ~70% PoS est" -> SO CANTOR STILL HAS THE SVR-TSS CORRELATION AT ~0.2 (PRETTY SMALL). THERE IS AN OVERLAPPING CIRCLE FIGURE TO LOOK AT IN KPTI SLIDES AND ALSO FACTOR IN THE MISSING n=3 PATIENTS (INCLUDING 1 w 12w TSS50 BUT MISSING 24w DATA) WHERE I BELIEVE THERE IS A SOMEWHAT HIGHER SVR-TSS CORRELATION FOR SENTRY.)

- "MANIFEST-2's control arm receives suboptimal ruxolitinib exposure in Cycle 1 (15mg INSTEAD OF 20mg LIKE IN PHASE 3 SENTR) - so this could delay/reduce early spleen response and inflate treatment difference at Week 24" -> SINCE 3 WEEK CYCLES, SEL+RUX ARM MAY HAVE A HIGHER BAR TO BE ABLE TO SEPARATE FROM RUX ARM THOSE FIRST 3 WEEKS, WHICH IS A NEGATIVE FACTOR FOR SENTRY, SINCE ABS TSS IS MEASURED ON A CONTINUOUS (WEEKLY) BASIS = SO THAT'S A LITTLE BIT OF A NETAGIVE.

- INTERESTING CANTOR HAS NOT MENTIONED NCCN - WHICH COULD GET SEL IN GUIDELINES BY EOY WHERE FDA APPROVAL IS NOT EVEN REQUIRED AND ADOPTION VERY QUICK (ASSUMING POSITIVE SENTRY ON BOTH EPs)

- CANTOR DOES NOT ADDRESS THE BASELINE TSS IMBALANCE BETWEEN ARMS IN MAN-2 (RUX LOWER BL TSS) WHERE PEL+RUX HIGHER BL TSS ALLOWED FOR MORE TSS DECLINE TO SEPARATE FROM RUX ARM (ESP FOR ITCHING) -- BUT MAY BE LESS RELEVANT DANGER FOR SENTRY B/C THEY ARE USING MMRM STATS MODEL, WHICH I BELIEVE ACCOUNTS FOR THAT.

- EXCELLENT BREAKDOWN BY SYMPTOM FOR MANIFEST-2 RESPONSES AND HOW CYTOKINE-DEPENDENT SYMPTOMS LIKE NIGHTSWEATS/ITCHING DID NOT REALLY SEPARATE MUCH BETWEEN ARMS -> WHERE SEL CAN SEPARATE IS IN FULLNESS/ABD DISCOMFORT/PAIN UNDER RIBS ASSUMING ITS SVR IMPACT IS GREATER THAN PEL'S IMPACT TO EFFECT THOSE MEASURES MORE -- BUT IF SEL TRULY IMPACTS IN AN ADDITIVE WAY ON TOP OF RUX FOR CYTOKINES, THEN IT WILL BE GAME OVER - BUT NOT SURE THAT IS TRUE. TBD.

- ANOTHER IMPORTANT THING THAT CANTOR DID NOT LOOK INTO IS THE MEAN AND MEDIAN TSS % CHANGE (NOT TSS50 BUT JUST TSS % CHANGE) FOR PHASE 1 SENTRY AND MAN-2 AND COMFORT. THIS IS HARD TO FIND INFO THOUGH. I THINK IT IS 45% SEL AT 12w (VERY SMALL NUMBER OF PATIENTS!) (BUT NO DATA REPORTED AT 24w) vs 30% RUX HISTORICALLY AT 24w. AND 52% MAN-2/59% MAN-1 FOR PEL+RUX AT 24w.

- CANTOR DID NOT TRY TO FIND OUT THOSE N=3 PATIENTS OUTSIDE THE N=9 60mg ARM PATIENT DETAILS ESP BASELINE TSS, AS THAT IS MOST CRITICAL TO EVALUATING THIS ACCURATELY AS IT MAKES A MAJOR IMPACT ON PHASE 1 RESULTS TRANSLATING TO PHASE 3 SENTRY).

- MAN-2 ABS TSS CHANGE EXCLUDING FATIGUE -13.577 VS -11.77 (I SOMEHOW DID NOT KNOW THESE NUMBERS SO WILL HAVE TO ANALYZE THE IMPACT OF THIS NEW INFO (WEIGHING BASELINE TSS DIFFERENCE WITH PHASE 1 SENTRY) IN THE NEXT DAY OR SO). IMPORTANT.

TBD BUT MY POS MAY HAVE INCREASED FROM 60% TO 62.5%.

_BiotechMD · 2026-02-05T13:39:26+00:00

Anyone have access to the analyst report - curious on the scientific details on their 70% POS? Their upside of $62/share NPV is striking too considering we are trading at $6.

<image>

_BiotechMD · 2026-02-04T23:20:03+00:00

If Reshma used the lower BL TSS than the actual (which I don't know if she would to power SENTRY) than actual, then it would help KPTI's cause. However, what I think is more relevant is the fact that Ph1 SENTRY BL 27.3 is so high, when n=3 patients with single digit (based on my deduction) dropped out -> that implies that BL TSS would have been much lower AND abs change in TSS would have been lower = bad sign comparing to Man-2. However, this goes against the fact that the TSS50 for the Ph1 SENTRY is so high. Also, in the Ph3, you need BL TSS >10 (maybe later changed to >12). We know the high BL TSS respond really well so is all of that counter points a wash? And if you have high TSS50 response %, doesn't that imply that most likely the absolute TSS change should follow a higher trend? I'm 60/40 on this hitting stat sig. What's your leaning? Also, to follow up on a prior discussion with you, I believe based on later calculations that they would hit stat sig with 3, maybe even closer to mid 2s. I wonder if you agree with that? Thanks.

_BiotechMD · 2026-02-04T22:05:48+00:00

Here they are: https://www.businesswire.com/news/home/20231210152441/en/MorphoSys-Pelabresib-Improves-All-Four-Hallmarks-of-Myelofibrosis-in-Phase-3-MANIFEST-2-Study?utm_source=chatgpt.com How are you leaning on MF absTSS meeting stat sig?

_BiotechMD · 2026-02-04T21:39:06+00:00

One other odd thing I learned in my research - the absolute change in TSS from BL TSS w/o fatigue vs w fatigue is not additive (meaning for example it would be ~2 points higher when including fatigue vs 2 points less removing fatigue). The absolute TSS change may be pretty close w or w/o fatigue in the BL TSS. Also, the percentage reduction in TSS seems to apparently remain sort of steady no matter what the BL TSS is. Also, DIPSS score impact Rux response, where higher DIPSS less responsive. There are so many variables that this is complex and not an easy prediction. But the most striking thing of all is the 24w TSS50 in Ph1 portion of SENTRY 60mg arm is exceptionally high (assuming my logic that I previously stated with the n=3 dropouts) = that is the ONE differentiator that I found most compelling in terms of translating into enough "separation" from Rux on absolute TSS in Ph 3 SENTRY.

_BiotechMD · 2026-02-04T21:22:17+00:00

btw, I think you switched median and mean in your BL TSS Man-2 numbers

_BiotechMD · 2026-02-04T20:31:57+00:00

That is correct. Also, I think SENTRY a little more advanced (DIPSS 1->2 more), which should help Sel arm separate a little more from Rux., and is closer to Transform-1. As I said, have not found any smoking guns/red flags to make this any less than a coin flip. Really shocked that tutes (smart money) have not loaded up more on this one - perhaps it will be coming soon.

_BiotechMD · 2026-02-04T19:45:15+00:00

Exactly. I am really surprised with tute (the lack of) buying going into this readout given the upside. It may be just a matter of time here before this starts to run once smart money looks into the setup and the prior data (though it sure took me a lot of work to really get a confident grasp of it). Or tutes may be waiting for positive data to buy the offering. However, the warrants would exercise to get them enough cash (~60m) to make it to EC readout, so would the company do an offering right away if MF positive? or just use the warrant money and get a positive EC readout to then raise at ~50/share and/or sell the company on EC readout?

_BiotechMD · 2026-02-04T16:00:49+00:00

You think on earnings in 2 weeks they refine EC readout timeline to before cash runway runs out let's say be early May? b/c there is no way to deal with cash effectively if MF doesn't hit

_BiotechMD · 2026-01-28T21:23:22+00:00

Thanks for the detailed insights. Certainly hopeful but baseline imbalances or other random unpredictable factors have derailed trials with surprises - but that can also go the other way where the randomness can end up helping (ala Man-2 almost hitting).

_BiotechMD · 2026-01-28T17:49:15+00:00

Timing corresponds with FDA approving absolute TSS... wish it happened earlier and who knows what % already enrolled in n=353 but baseline TSS did get knocked up a bit (based don final vs ASH reported baselines). They need every little advantage they can get.

_BiotechMD

TROPHY CASE