DISCLAIMER: This is a private undertaking by Reza Ganjavi, MBA. This page is not sponsored by Karyopharm. This page is not an investment advice. Do your own research.

I Got An Anti-Semite's KPTI Poster Account Permanently Closed

https://www.rezamusic.com/writings/essays-and-short-pieces/Got-Anti-Semitic-Mans-Account-Banned-And-Posting-History-Deleted

Patient Speaks

https://twitter.com/LindaMyeloma/status/1638140215033229315?s=20
Linda F Huguelet
@LindaMyeloma

Began Selinexor/Kyprolis/dex as 4th line of treatment a few weeks ago. Looking forward to first lab evaluation next week. Happily not experiencing any GI side effects.  #MYelomaSTORY #mmsm

https://twitter.com/JackMAiello/status/1637129370711261184
Jack Aiello
@JackMAiello

Selinexor (Xpovio) should be considered as a treatment option for #myeloma. Optimal timing and drug combination of selinexor in multiple myeloma: a systematic review and... - https://goo.gl/scholar/AK8sNB #ScholarAlerts

Valuation / $30 buyout

$3 billion valuation means $26 a share. Just to give you an idea how undervalued KPTI is, in my view. And Watson66 predicts $5 billion next year which is doable given how much data we're expecting. That would be $44 a share. A 10-bagger from here? I think it's realistic. But I think the company will get bought out before that for something like 3.5 billion ($30 a share) but I don't have confidence in the current team to be able to negotiate a deal effectively. We need a new CFO and Legal Counsel to start talking major league.I just don't see how Mike Mason and Mike Mano can be involved in getting a good deal for the company.

March 2023 Corporate Presentation

https://investors.karyopharm.com/download/KPTI+Q4+and+FY+2022+results_2.15.2023_FINAL.pdf

Optimal timing and drug combination of selinexor in multiple myeloma: a systematic review and meta-analysis

https://www.tandfonline.com/doi/pdf/10.1080/16078454.2023.2187972

ABSTRACT Objectives: Multiple myeloma (MM) remains an incurable disease despite advances in treatment options. Recently, selinexor has shown promising efficacy for relapsed/refractory multiple myeloma (RRMM), whereas its optimal timing and drug combination remain unclear. In order to assess the various regimens that incorporate selinexor, a systematic review and meta-analysis was conducted. Methods: Clinical trials and real-world studies involving MM patients treated with selinexor were included. Pooled risk ratio (RR) was calculated to compare the rates, along with a 95% confidence interval (CI) and concurrent p-value assessment. A random-effects model was employed to provide a more conservative evaluation. Results: A total of 16 studies enrolling 817 patients were reviewed. The usage of selinexor as the fifth-line or prior therapy achieved a higher objective response rate (ORR) (65.9% versus 23.4%, p < 0.01) and longer pooled progression-free survival (PFS) (median: 12.5 months versus 2.9 months, p < 0.01) than those after the fifth-line usage. In addition, early usage also resulted in a consistent trend of pooled overall survival (median: 22.7 months versus 8.9 months, p = 0.26), compared with post-fifth-line usage. Selinexor and dexamethasone (Xd) plus either protease inhibitors (PIs) or immunomodulatory drugs (IMiDs) achieved better ORRs than the Xd-only regimen for RRMM, with ORRs of 56.1%, 52.5% and 24.6%, respectively (p < 0.01). Conclusion: In conclusion, using selinexor as the fifth-line or prior therapy had a beneficial impact on RRMM. The regimen of Xd plus PIs or IMiDs was recommended.

short interest down by about 3 million shares.

Still way too hight (18.3m shares).

https://www.tandfonline.com/doi/pdf/10.1080/16078454.2023.2187972

Our Superstar Rocked The House Today At Barclays 

Thank you Reshma. 

WE LOVE YOU RESHMA

Keep up the great work.

God Bless

Reza

Don't miss the replay of Barclays Global Healthcare Conference: 

https://event.webcasts.com/viewer/event.jsp?ei=1603787&tp_key=b2caa015fe

Dr. Due Diligence's excellent notes: https://www.reddit.com/r/KPTI/comments/11san5t/dr_dds_quick_barclays_notes/

Hedge Fund Shill Attacks. Dr. Vig Puts Him In His Right Place

Given Karyopharm itself has no fighting bone with a Legal Counsel like Mike Mano (the company has said that online disparagement is not actionable -- that's how clueless the company is about this topic under direction of Mike Mano), attacks on the company's reputation is nothing new. Check out this article on Vinay Prasad, Aaron Goodman, Al-Ola A Abdallah, Manni Mohyuddin, Bijoy Telivala, etc. - some of whom have questionable affiliations and apparently even link to hedge funds:https://www.rezamusic.com/writings/law-ethics/Selinexor-bashers-and-link-to-hedge-funds

Yesterday, a party who appears to be a hedge fund shill wrote a garbage article spreading negativity, FUD (Fear Uncertainty Doubt), and the timing was not surprising, just as the stock and biotech sector had taken off, and Karyopharm outperformed all indices, and gained a nice 16% in about a day. 

Our good friend, Dr. Vig called out the sucker with this note: 

"If you go to xpovio.com and look at the prescribing information, go to section 2.5, table one through table 4, to look at "Dosage modifications for adverse reactions"... you will see that the physician has the option to go from twice weekly dosing to once weekly dosing of xpovio, and/or to decrease the milligrams given per dose, to help avoid side effects. A treating physician can monitor the patient and adjust the dose of xpovio if needed to minimize side effects. Karyopharm also is working to try to get additional indications approved for xpovio, including myelofibrosis and p53 wild type endometrial cancer. Karyopharm is also hoping for approval of eltanexor for myelodysplastic syndrome. Approval in any or all of these three areas could be a stimulus to the stock price."

Dr. Vig is absolutely right. Doctors have been successfully managing the side effects by lowering the dose that still works, and in other ways, and feedback from doctors have been very positive. The response from the author of the garbage article, Stephen Ayers, was mind blowing and confirmed again, in my view, that his trash piece was intentionally malicious, and apparently written for ulterior motives. The scum shamelessly replies to Dr. Vig with smart ass stupid cunning lines pointing to some statement in his garbage article as an excuse / disclaimer. Stephen Ayers is either a total idiot or compromised and gets a kickback from some short sellers to spread FUD, or both or none or I have no idea what his trip is but he showed himself in this article, in my view, to be a total idiot as a minimum! 

I commented to the scum: 

"@Stephen Ayers "Improvements in toxicity profile: If Karyopharm can successfully mitigate the toxic effects of selinexor, it could lead to improved patient outcomes, potentially driving increased adoption and usage." 

Are you serious? It's not a matter of "IF". It's already done. Doctors are doing it every day if you have any idea about MM treatment landscape. Dr. Vig correctly points out that you were wrong, and you turn around and try to justify your false assumptions that are contradictory to doctor practices every day, by pointing him to the above statement?! Unbelievable! 

And you say "The article specifically mentions everything he said.. "dose modifications""

Mentioning dose modifications when the entire (false) thesis of your article is based on non dose modification, is not a good excuse. I find your reasoning mind-boggling."

Karyopharm Announces Updated Selinexor Data in Patients with Treatment-Naïve Myelofibrosis to be Presented at AACR 2023

NEWTON, Mass., March 14, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that results from its Phase 1 study evaluating the safety and efficacy of once-weekly selinexor in combination with standard dose ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389) have been selected for a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, being held April 14-19, 2023 in Orlando, Florida.

Email to Karyopharm Management 

Thanks for the note Elhan.

I hope you realize my frustration because y'all have wholly failed to fulfill your duty you were hired to do, i.e., to build shareholder value, and have screwed up so many things. Investors who trusted Mike Mano, Mike Mason and Mike K., have lost almost 90% of their investment because this gang can't shoot straight. Add Richard to the mix. The buck stops at the top.

Spending money like crazy because that's what Mike Mason knows how to do: raise and spend and have an unsustainable cost structure that's losing a TON of money every single day, and look at shareholders as adversaries. How many shareholders Mike Mason has EVERY written to in his lifetime? A handful ? Or hardly even that? A CFO who can't wait for an investor conference to be over because investors are just ATM machines to fund his salary and spend spend spend mentality and fund the fun science lab that is still sick with the sick culture of ex-clueless CEO Mike Kauffman (great doctor/scientist) who felt entitled to shareholders funding his fun science lab indefinitely with everyone benefiting except shareholders who are funding the circus.

Richard Paulson has been a major disaster because he neglected to fix the big mess that Mike Kauffman left behind and kept the same person who have now proven to be utterly incompetent in building shareholder value.

And you screwed up SIENDO because the gang that can't shoot straight is clueless about politics of power -- with that level of short interest FDA negative nod was a given for a management team who is a perfect punching bag for shorts -- they adore Mike Mason and Mike Mano -- dream team for them, add to the mix Richard who's been too weak in shaking up the rotten status quo. I warned him a long time ago that the stock would go to $2-$3 range if he didn't take certain action and let the gang that couldn't shoot straight continue.

Let's be clear, shooting strait means only one thing: BUILDING SHAREHOLDER VALUE. But y'all I think have a different idea in mind. Your primary purpose if your salary and bonus, and that terrible Board is not any better. Deepa cashed in a ton of shares ahead of bad news and Mano tried to justify it with a terribly weak argument. They just care for their salary and bonuses. Shareholders have been getting flipped time and again. Just look at the way Mike Mason behaves in investor conferences "is it over yet?". What kind of message does that send from the head of IR??? Investor Relations reporting into Mike Mason has to be the biggest joke of the century. They guy can't even manage his own body language on investor conferences , and his terrible track record speaks for itself: how's 85% drop in stock price for those who bought in the 20's not long ago?

And you've messed up the sales, despite Sohanya who is a superstar. The very entities Mike Mano thinks as irrelevant have hurt your sales. The private placement was a disaster, with bad excuses to justify narrow thinking and inability to think outside the bod, e.g. that short position is not disclosed so we didn't even ask.

You have a hotshot CCO and CMO but the rest of the senior management are a gang who can't shoot straight. And as a result of this D minus management the company will probably get taken over by some sleazy hedge fund for far below fair value because this gang can't shoot straight, unless there's a significant change of management or awakening. But people who have proven to be incompetent in building shareholder value, can't suddenly become competent. We need new blood. Mike Mano and Mike Mason should quit. Nothing personal against them. They're just not at the caliber Karyopharm needs, and if Richard is going to continue being a disaster in driving shareholder value he should follow them out the door.

The same people can't do the same things and expect a different result.

Mike Mano doesn't like to hear this because you're a team blah blah -- a team funded by shareholders; just look at your financials and look at how much money Mr. Mason / Mr. Paulson are burning every single day. Shareholders invest and hire management to build value and not just to raise money and burn money and sustain an incompetent team because it's the status quo. The organization has memory which continues, and its way is lousy, incompetent, dysfunctional.

Just look at the share price and remember those who trusted Kauffman, Mano, Mason and paid over $20/share.  Even knowing this team has been a disaster, Mr. Paulson just joined the status quo because he didn't have the power to go against it and take the bull by the horn. He put up with a bean counter who apparently just knows how to raise and spend, as CFO and as a result the financial aspect of the company has been a disaster. Anytime you doubt me, look at the share price. Same story with Mike Kauffman's other hire. Mr. Mano. Nice man. Hedge fund shorts must love him.

All the above are my opinions. Again, nothing person against any of you. I send you all good wishes. But you have to call a spade a spade. Your gang has been a disaster for shareholders who gave you those jobs (those who have an MBA understand that). So get your act together Richard.

I am happy to talk about this any time. Maybe Richard believes me now because when I told him the stock will be taken to 2-3 range he didn't believe me. Experience counts.

Have a nice weekend.

Reza Ganjavi

Good For Karyopharm: Incyte's LIMBER lumbers to early end as analysis shows Jakafi cancer combo destined to fail

By Nick Paul Taylor Mar 6, 2023

https://www.fiercebiotech.com/biotech/incytes-limber-lumbers-early-end-analysis-shows-jakafi-cancer-combo-destined-fail

The Board Should Fire Mike Mason, Mike Mano, Richard Paulson For Failure of Their Duty of Building Shareholder Value. 

Hey management, how about fulfilling the mission you were hired to do: build shareholder value. Mike Mason and Mike Mano were part of the lousy senior management team who got investors to give them over 20 bucks a share, only to see almost 90% of their investment go up in smokes because this gang who can't shoot straight just raises money and spends money, constantly runs a deficit, has a cost structure that's not sustainable by anything but a "F U to shareholders" mentality. I'm tired of this incompetent senior management team including Mike Mano, Mike Mason, and their incompetent boss Richard Paulson, all of whom have been proven to be incompetent in building shareholder value. I was hoping Richard would perform but he's been proven to be just as incompetent as Mike Mano and Mike Mason in building shareholder value. With this great science if we had a gang who could shoot straight the stock would be a lot higher but instead we're stuck with this gang who can't shoot straight.

They have Fucked Up! They fucked up SIENDO because they are clueless about politics of power. They fucked up the private placement and didn't even require that the participants are not existing big shorts! They fucked up the sales because Mike Mano apparently wrongly thinks online disparagement is not actionable -- while the hedge fund shorts who hire rogue doctors have managed to hurt the sales via the very online forums the clueless gang doesn't think it matters. They fucked up expense control and are still spending like crazy because we have a  CFO who has proven to be incompetent in building shareholder value, and they feel they're entitled to endless investor funds to fund their fun science lab which splurges like crazy and spending money like it's an endless pit. 

They Board is just as bad -- Deepa cashed out a ton of shares before negative news came out which is absolutely unacceptable but Mike Mano tried to justify it using a weak argument.

They have a few great things going, i.e. their sales lead, their chief medical officer, and their science. Otherwise, the CEO, CFO and Legal Counsel are disastrously incompetent in building shareholder value, which means the company will get taken over by some sleazy hedge fund for far below fair value because this gang can't shoot straight, unless there's a significant change of management or awakening. But people who have proven to be incompetent in building shareholder value, can't suddenly become competent. We need new blood.

9 Questions For Karyopharm Management / Barclays Call

This list is a combination of a list made by Dr. Due Diligence and points that I added to it.

1. When are you meeting with FDA about MF Frontline Combination trial? Are you still planning on 1H2023 launch (less than 3 months)?

2. Does the November - 2nd line MF trial (Phase 2) have the potential to be registrational given the FDA FastTrack status?

3. MDS trial was slated for earlier interim readout, so the fact that it is taking longer is a good sign (event driven outcomes). Do you anticipate a SIENDO1 style readout (super responders vs not) or a traditional readout?

4. Have you talked to the FDA about submitting for tumor agnostic indication (Mount Sinai MM, SIENDO1 WTp53, previous gyn phase 1, etc)? Is this something the company will consider in the future?

5. Have you considered being more cost aware? Do you think a more disciplined organization would have a better share price right now? How about a better CFO who knows something about building shareholder value and can think outside the box, instead of just raising and spending money like a runaway train and a cost structure that's not sustainable based on the apparent false premise that the company's goal is to spend money to develop drugs and it's entitled to be permanently funded by shareholders? What about people who participated in CFO Mike Mason's arrangement and paid over $20 a share. Their shares are worth $3 today. Isn't it time for a new CFO given that disastrous performance?
   
   

6. How about a new legal counsel whom unlike Mike Mano can think outside the box, understand politics of power, and understand simple facts like online disparagement being legally actionable, so the company stops being a favorite punching bag for hedge funds engaged in "short and distort", with help from the doctors who have systemically managed to deter demand for your products and negatively impact your sales, for the benefit of their short-seller clients; and FDA's SIENDO decision was right along those lines, if you know anything about the well-documented fact that FDA is influenced by big money (think Provenge).
   
   

7. What do you think is an appropriate valuation for the company? If it's higher than today's value (which it should be), what is the disconnect other than weak financial and legal management?
   
   

8. SIENDO2 Enrollment is where? How many sites are active and enrolling?

9. Your former CEO told us the company had overtures from Pharma to buy the company and you told them "not yet". Barclays had Karyopharm at top of its list of acquisition prospects. Are you in any discussions with prospective buyers?
   
   

To Elhan Webb, Richard Paulson

From an investor I personally know and respect:

KPTI clinical missteps have mingled together with management shenanigans to inspire a highly complex, dysfunctional love-hate sentiment for the management among value investors. Under this increasingly sour layer brews a growing recognition that XPO1 compounds have a valuable future in combination with other compounds, many of which are coming off patent, for treatment of many blood and solid cancer targets.

~~~

Elhan, so you know, a long time ago I wrote to Richard a registered letter. I told him the stock would go to 2-3 range and it did exactly that. After you wrestle with Wall Street sharks long enough you know their games, and you know the kind of management team they like to have for lunch and y'all the love

The only way our of this hole is to change the people who got you into this hole but a non-working status quo's priority is to give itself continuity, and keep burning thought shareholder value. Very bad karma.

Best Regards

Reza

Upcoming Game-changer Data

"So the timing of the MDS in term analysis is very much dependent upon the overall survival data. And I say that partly because very high unmet need patient population in this very hard to relapsed refractory patient population. We know from the published literature that overall survival for these patients is less than a year at only 4 to 6 months. So being able to identify a robust overall survival signal allows us to identify the best path forward. So at this point, we're still following the OS data. It looks like it is going to occur in the first half of this year. But again, hard to project as we continue following these patient survival. We'll be opportunistic in terms of how we present those data, whether it's at a Medical Congress or through some kind of company forum. But the way I look at it, this is only a good thing for our patients." 

Selinexor Saves Lives

"Seli has potential. My good friend relapsed after 2 CAR-T cell infusions.  Her disease became EMD and non-secretory. Seli in combination with Bortezomob away her tumors within a month and kept her myeloma at bay for2 years.

https://twitter.com/MyelomaTeacher/status/1629602583487688710

20 Feb 2023 EMAIL TO MIKE MASON (AND MIKE MANO)

Dear Mr. Mason

Since you're so disinterested in investor conferences -- and you clearly don't want to be there -- and are not paying attention -- and making disruptive jerking move -- and apparently playing with your phone or whatever it is you're doing on the side -- and didn't even bother wearing something appropriate (like a basic collared shirt, a business casual, or more appropriately a formal business outfit that a CFO should wear on such an occasion) -- and given your terrible performance (remember those investors who believed your lines and bought the stock in the 20's)?

If the CEO, CMO, CCO can pay attention during the call why can't you? You obviously have no idea and are entirely clueless to how disruptive your absolutely disastrous investor facing presence is, and its impact to the quality of the entire event which you obviously don't give a damn about, and you seem clueless about what active listening is, and how it effects the quality of what is presented -- by your very listening and attention instead of saying with your body language you don't give a damn -- just give me money when I need to raise money, and I don't give a damn which shark gets in, and which short is bailed out, etc. etc. -- that's how it appears Mike.

Trust me, this is not just my impression. Other investors have called your dismal presence too -- and even commented about your outfit.

After years of this repeat disaster, it's very clear what you're about, what your weaknesses are. I'm sure you have strengths too -- I'm sure you're a nice guy to know and you're an honest guy -- but as a CFO you're a disaster, in my view for the above and more reasons.

Go ahead and block me if you want - like you've blocked so many other investors whose criticisms you couldn't handle. Nothing personally against you -- I swear -- I feel affection for you -- but I sincerely believe you're in the wrong role. Spare us please and quit -- there must be a ton of job for good bean counters out there.

Reminders:

CFO is arguably the most important role in a company.

CFO's investor facing role is crucial.

CFO having top notch communication, presentation, sales skills is essential.

Company value is a function of supply and demand. Aside from issuing so many shares to shark hedge funds as you guys did unfortunately, high quality investors need to have confidence their money is in good hands.Trust in management is essential. Demand is a function of promotion and other p's -- ask Sohanya. The attitude that we just run a science gig and investors will line up is outdated and proven to be false.

The attitude that investors are our ATM machines -- fund the company and screw you, is dysfunctional, as we are witnessing by shareholder value.

You have been a total disaster in building shareholder value -- that's a fact. Add to it, your performance in my view has been terrible, in controlling expenses, in running a lean organization, in investor relations which reports to you (Elhan is good but she's bound by your limitation), in thinking outside the box, and least of the problem is the damage you do to the company's image by your dismal performances at investor conferences.

Please look for another job Mike. We will celebrate it and will wish you all the best in your future endeavors. But don't get a CFO job. Get a controller or accountant job. But I don't care - get any job. As long as you go. Please. And take Mike Mano's hand out the door with you, who's had just as a dismal track record, in my view, based on company performance, and the disaster deals you entered. Those shark hedge funds love you.

Richard it's almost getting too late -- these shark hedge funds you apparently surrendered to will eat your two Mikes alive, and take over the company before your eyes while your financial and legal team apparently couldn't shoot straight.

Mike Mano, I'm sure you don't like this message -- you're a team right and nobody should be criticized, meanwhile your team's performance has meant hundreds of millions of dollars of erosion in shareholder value. This email is about Mike, not you, but I copied you because you were mentioned. Your performance has been a disaster as well.

Just look at change in shareholder value, look at the terrible disparagement the company and our life saving drugs has gone through on your watch while the company was falsely and wrongly believing online disparagement is not actionable (I assume as their L.C. they got that advice from you and am not surprised a bit). How about covering up for Deepa's dumping so many shares before the stock tanked?

Your response was unacceptable. How about the latest disastrous private placement which diluted the hell out of the stock and put shares in hands of so many sharks and very likely most of the big shorts -- and you didn't even bother asking, apparently, if they were short the stock -- it's nowhere in the contract -- the excuse I heard is that SEC doesn't require short disclosure. Right. But you can think outside the box sometimes (maybe not).  And you're not SEC. And if you know anything about contract law, anything is possible but it takes creative thinking which doesn't seem to be your cup of tea.

Likewise, nothing personally against you Mike Mano -- I feel affection for you and wish you the best, in your next job. Please. You are ready for a new challenge.

Best Regards

~~~

Picture below is Mike Mason at the latest investor conference -- he seemed:  totally dull, inattentive, jerky, doing other things, uninterested, insensitive to what's happening, etc. 

E3 ubiquitin ligase ASB8 promotes selinexor-induced proteasomal degradation of XPO1

• Identification of genes that modulate sensitivity to the XPO1 inhibitor selinexor.

• TGFβ-SMAD4 signaling may be a predictive biomarker for selinexor treatment.

• ASB8 is the host factor responsible for selinexor-induced degradation of XPO1.

https://www.sciencedirect.com/science/article/pii/S0753332223000938?via%3Dihub

BUYOUT BY AUGUST?

Most biotechs I watch have call and put options way past end of the year. KPTI's latest are August 2022. As such it's the only company in the biotech list I watch. Options market makers are probably closest to hedge funds. I wrestled with some at some point when I led a team that helped FINRA stop some shenanigans (story in link below). It might be that they're expecting a buyout by August. Also remember potential acquirers in biotech have been on record for sometimes manipulating stocks of companies they want to buy and that's done through brokers' market makers.   https://www.rezamusic.com/writings/law-ethics/reverse-conversions-scam 

BARCLAY'S LIKES KPTI

Not long ago Barclay's had KPTI on top of their acquisition target list with a buyout target price of $60. I just saw this under Yahoo news: Barclays PLC lifted its position in shares of Karyopharm Therapeutics Inc. (NASDAQ:KPTI - Get Rating) by 456.0% during the third quarter, according to the company in its most recent filing with the SEC. The institutional investor owned 455,464 shares of the company's stock after buying an additional 373,539 shares during the quarter. 

NEXPOVIO SECOND LINE+ IN FRANCE 

Drugs open for contribution (early access or access to reimbursement) or under review

Translated from French 

"NEXPOVIO is indicated :  

in combination with bortezomib and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.  

in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulators, and an anti-CD38 monoclonal antibody, and in whom the disease has progressed on the last therapy."

Médicaments ouverts à contribution (accès précoce ou accès au remboursement) ou en cours d'instruction

NEXPOVIO est indiqué : 

en association avec le bortézomib et la dexaméthasone pour le traitement du myélome multiple chez les patients adultes qui ont reçu au moins un traitement antérieur. 

en association avec la dexaméthasone pour le traitement du myélome multiple chez les patients adultes qui ont reçu au moins quatre traitements antérieurs et dont la maladie est réfractaire à au moins deux inhibiteurs du protéasome, deux immunomodulateurs et un anticorps monoclonal anti-CD38, et chez qui la maladie a progressé lors du dernier traitement.

18 March 2023 

https://www.has-sante.fr/jcms/p_3114053/fr/contribution-des-associations-de-patients-et-d-usagers-aux-evaluations-de-medicaments

MENARINI To Acquire KARYOPHARM?

"The CEO of Menarini is delighted to partner with $KPTI and through Stemline they are actively working towards commercialization milestones for MM. Next they’ll expand NEXPOVIO into the treatment of solid tumors, such as endometrial cancers. Given Menarini’s obligation of an additional $200+M in milestone payments + double digit royalties, and their existing $677M investment into XPO1 assets from Stemline it’s not unreasonable to think they could take out Karyopharm. They literally won an “M&A Award” in 2021 for the strategic move with Stemline, and they were just getting started. Also fwiw, here I called out the license deal between Menarini and Karyopharm months before it happened based entirely on public information."

And: 

Menarini receives the coveted M&A Award 2021 for the 2020 acquisition of US company Stemline Therapeutics

https://www.menarini.com/en-us/news/news-detail/menarini-receives-the-coveted-ma-award-2021-for-the-2020-acquisition-of-us-company-stemline-therapeutics

Swiss Big Pharma 

When it came to cross-border transactions meanwhile, Swiss firms were more involved in buying others out than being bought out. KPMG expert Timo Knak said he expected the boom in M&A activity to continue in 2023, despite problems in global supply chains, the war in Ukraine, and interest rate hikes.

https://www.swissinfo.ch/eng/company-takeovers-and-mergers-on-the-rise-in-switzerland/48232086

~~~

Bullish Thesis Intact, But Not For Fainthearted

Some Karyopharm retail investors are losing their minds. They couldn't stomach a 50% drop. Some pundit said if you can't stomach a 70% drop you shouldn't be in stocks. Stocks are manipulated in many ways by people who know investor psychology very well. That includes huge manipulated drops and huge rises (not that real ones don't happen) to influence investors to act in a way that profits the manipulators. Institutions are far less manipulated because they don't act on emotions as much as retail. I learned this the hard way. So KPTI being $3.32 doesn't bother me because my due diligence is solid and my vision for the future of the company is intact.

~~~

I agree. We don't know what their short position is and if they're short. I'm just assuming they are but as you know shorts are not disclosed, which is a gift SEC gives to short sellers and one of the key crooked parts of the US market as lobbied by hedge fund industry. I was involved in discussions with SEC on this as a member of public challenging them to stop this practice.  Based on my experience, these large hedge funds have an ultimate vision for companies and know up front if they'll make money on short or long side or both. In this case I think they knew they'd make money on the short side given the bozo who ran the company before and his bozos who ran it down and are still there. But hedge funds also know the drug is fantastic and will eventually succeed. This latest 50% haircut and huge increase in short position tells me they took the gloves off and we're at the end chapters for the hedgies profiting on the short position. Next chapter will be running it up, IMO.

Patience is Virtue

Change in short interest tells me the big drop was manipulated. Right now KPTI is a waiting game. If you have patience you'll get rewarded, in my opinion, because the manipulators are over extended. 20+mm shorted shares is not sustainable. One good data and this short volume can provide enough fuel to go to $15. So, I believe brokers are trying to buy as many shares as they can without significantly moving the price. But every time supply dries up they increase their bid. Turn clearly comfortable and buying around 7 million shares under $5 which I think is tough to do. It looks like they covered about 1 million yesterday. Some name of the game is waiting. 

Piper Sandler Initiated Bullish Coverage

Overweight Rating, Price Target $8. I guess they're done churning the shares following the pathetic private placement they orchestrated, and loading up on shares for their high-fee paying clients, hedge funds, short sellers. So up we should go from here.

Interesting Dynamics

Interesting dynamics with KPTI. I had contact with a medical doctor who prescribes Selinexor and likes it, and owns the stock. And The stock is attracting new biotech investors who are saying the company is a biotech candidate, undervalued, and the advanced pipeline is very attractive. 

KPTI Prediction

KPTI will turn on a dime. I got my front row seat tickets at hand. Be it data, sales, partnership, rating, leaked buyout speculation, one big buyer to trigger short squeeze, or good news if they get a new CFO, etc. But current price is not in equilibrium and it will change. The company's worth a lot more, in my view.

P53 Wild Type is Very Prevalent

Bashers were spreading FUD that P53 is only 25% of patients blah blah. Someone put them in their right place: "If you read the entire pub, the summary line says TP53 mutations are in about 25% of all endometrial cancer patients which would leave 75% with TP53 wild type. SIENDO enrollment was about 50% (77 of 160 treated, 33 of 80 placebo)."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5287061/

Short Interest Up 

The company didn't bother to demand that the participants in the private placement are not shorts. With a Legal Counsel like Mike Mano it's not surprising. The fact that SEC doesn't disclose short position doesn't mean the company couldn't have demanded and insisted on it from their partners.

Company Needs New CFO, Legal Counsel

Great data, hotshot CMO, CCO, weak CFO, LC. Get a couple of hotshots in the latter roles to take the bull by the horn and build shareholder value. CFO Mike Mason is a bean counter, and has had a terrible track record at the company of just raising and spending, and he's in charge of IR while he doesn't seem to have any talents in the direction of communications, sales, alliance management, relationship building, which are essential for a CFO and IR executive. Elhan is good but she reports to Mason who's calling the shots so IR is bound by the limited paradigm of Mason's mind. Mike Mano is also weak as Legal Counsel. That's CEO Paulson's fault for not building a top team despite the spending. It's ultimately Directors' fault as they're failing their duties by not bringing necessary change. Same people doing same things: same results. So we will initiate a formal notice to the Board and a derivative suite if necessary. If you want to help contact me here: https://www.rezamusic.com/about/contact

Coming up... 

• XPO is name of game in P53 wild-type subgroup treatment. 50% of patients are P53 and there's no current threapy for them.

• 21 months PFS. Still patients on therapy that have no progression event!!

• Eltanexor data this quarter. It's fast-tracked by FDA. Could even be registratioal (approval on P2 data). No other treatment option for relapsed/refractory MDS.

10 Jan 2023 - New Analyst Price Target for KPTI: $16

HC Wainwright new PT: $16.00. 

Anticipated Near-Term Catalysts and Operational Objectives in 2023

• Continue to grow our commercial foundation in the competitive multiple myeloma marketplace, driving increased XPOVIO sales.

• Additional global launches of selinexor by partners in ex-U.S. territories.

• Present data supporting optimization of selinexor dose in multiple myeloma and other key programs.

• Continue to generate data demonstrating selinexor's efficacy, combinability and tolerability in patients with multiple myeloma.

• Report interim data from the Phase 2 study evaluating eltanexor in relapsed/refractory MDS in 1Q.

• Report updated results from the Phase 1 study of selinexor in combination with ruxolitinib in patients with treatment-naïve MF in 1H. Initiate pivotal Phase 3 study in front-line myelofibrosis in 1H 2023, subject to regulatory feedback.

• Present updated subgroup analysis results in patients with TP53 wild-type endometrial cancer from the SIENDO study at a medical conference in 2023 further supporting rationale for EC-042 pivotal Phase 3 study.

• Further exploration of biomarker subsets to identify patient populations who best respond to SINE compounds.

Foundation Medicine Announces Collaboration with Karyopharm Therapeutics to Develop FoundationOne®CDx as a Companion Diagnostic for XPOVIO® (selinexor)

https://finance.yahoo.com/news/foundation-medicine-announces-collaboration-karyopharm-120500573.html?fr=sycsrp_catchall

CAMBRIDGE, Mass., January 10, 2023--(BUSINESS WIRE)--Today Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, announced a global collaboration with Karyopharm Therapeutics Inc. to develop FoundationOne®CDx as a companion diagnostic for selinexor, which is being evaluated as a front-line maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer.

Endometrial cancer is the most common cancer of the female reproductive organs in the U.S.1 Roughly 50% of patients with advanced or recurrent disease have p53 wild-type tumors.2 Karyopharm’s phase 3 study (EC-042; NCT03555422) is a multicenter, blinded, placebo-controlled, randomized study evaluating the efficacy and safety of selinexor as a maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer. The study is utilizing Foundation Medicine's tissue-based next generation sequencing test to identify and enroll patients whose tumors are TP53 wild-type.

"We’re looking forward to partnering with Karyopharm as they work to advance this exciting new treatment option for patients living with advanced endometrial cancer," said Sanket Agrawal, Chief Biopharma Business Officer, Foundation Medicine. "Our deep understanding of cancer biology and global regulatory expertise, combined with their innovative approach to developing cancer therapies puts us in a strong position to help more patients living with this devastating condition."

New Article: Founder's Syndrome

https://www.rezamusic.com/writings/law-ethics/Founders-Syndrome-Activist-Investors-Ousting-CEOs

New Video (off-topic): 

https://www.instagram.com/reel/Cm9syhFDDkW/

CFO Mike Mason and Legal Counsel Mike Mano Should Go. Activist Shareholder Team is Getting Active. Join us. 

The science is absolutely great and there's nothing wrong with the market. What's wrong is a couple of member of senior executives, Mike Mason and Mike Mano, hired by the last disaster CEO Mike Kauffman are not at the caliber the company needs and that has led to deterioration of company value for a number of reasons. But we're going to do something about it.

If instead of moaning and venting he that makes no difference to the company and its management and prospects, you want to actually do something that helps get rid of some bozo members of the management who seem to be behind this deterioration of shareholder value, contact me and join us in the legal action we will take on behalf of the company. We are going to notify the Board first (it's a legal requirement). We've had success in this before in ousting a couple of CEOs but in this case we don't want to oust the CEO but other members of the management team. You can contact me on contact page of https://www.rezamusic.com/various/kpti

Good reading about P53 and why Karyopharm is on to something really big.

https://www.nature.com/articles/s41573-022-00571-8 

Short Thesis is Flawed

Short argument is phase 3 costs money so any company that can't get FDA to approve its drug based on phase 1 or phase 2 data is a failure !! That's how lousy KPTI short rationale is.

New Presentation Deck

https://investors.karyopharm.com/download/KPTI+JPM+HC+Conference+2023.pdf

Amazing updated E.C. data: Median PFS Selinexor (n=77): 20.8 months - Placebo (n=36): 5.2 months

Karyopharm Announces Preliminary Unaudited Fourth Quarter and Full Year 2022 Revenue and Outlines 2023 Objectives

– Preliminary Unaudited Full Year 2022 Total Revenue and U.S. XPOVIO® (selinexor) Net Product Revenue Expected to be Approximately $157.7 Million and $120.4 Million, Respectively, Meeting Company's Guidance –

– Initiated Pivotal Phase 3 Study Evaluating Selinexor as a Maintenance Therapy in Women with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer; Encouraging Updated Exploratory Subgroup Analysis in Patients with TP53 Wild-Type Endometrial Cancer Continues to Support Study Rationale; Partnership with Foundation Medicine to Develop TP53 Companion Diagnostic –

– Planning to Initiate Pivotal Phase 3 Study in Front-Line Myelofibrosis in 1H 2023; Report Updated Results from the Phase 1 study of Selinexor in Combination with Ruxolitinib in Patients with Treatment-Naïve MF in 1H 2023 –

– Anticipate Multiple Data Catalysts and Progress Across Multiple Myeloma, Myelofibrosis, Endometrial Cancer and Myelodysplastic Neoplasms in 2023 – 

– Extended Cash Runway to Late 2025 –

My Response to Dr. Due Diligence About KPTI Management

Good writeup doc. Appreciate your thoughts. I agree with most, esp. the need to cut costs. But Richard's biggest mistake was not to replace the CFO and Legal Counsel given their past failures at the company and weak profiles.

CFO Mike Mason prides himself of knowing how to raise money. Look at the stock price since the raise they did in the 20s. IT also reports to him which is a pity. Relationships doesn't appear to be one of his strengths, let alone sales skills which is a must for a CFO who's in charge of IR too. CFO just doesn't seem capable of bringing costs down -- probably a competence issue and attitude issue and disregard to shareholders and thinking of shareholders as job security for himself.

The Legal Counsel Mike Meno is way off. I've been on zoom call with him, and I was not impressed at all. He clearly has competences but is not at a level that KPTI needs given. Oh and the company thinks online disparagement is not actionable (wrong).

Funny that both Mikes were hired by the disaster CEO Mike Kauffman (a great scientist/doctor but has always been a failure as a CEO). And low-grade CEOS are known to bring in people who are below them in terms of caliber. Great CEOs bring in star players. That's Steve Jobs' insight. One of the many horrible things about Kauffman which ran KPTI into the ground was the sick attitude that the company is entitled to shareholder funding their "fun science lab". Running a huge deficit and still givings away lots of money to this and that and spending like crazy -- they just don't seem to have a good grasp of the big picture that management is hired to build shareholder value. They work for shareholders but they think shareholders are ATM machines for them.

Richard Paulson is now criticized because he's been a total failure as a CEO as measured by shareholder value which is the ultimate measure for a CEO's performance.

I bet some of the hedge fund shorts participated in the one on ones and signed non disclosures and met the management and found out this management team is not one to be afraid of - it can't bark and it can't bite. It's a perfect punching bags.

I'm still holding my shares because of the science, but am very disappointed at Richard Paulson for not having top caliber people that KPTI needs at this juncture, despite millions they're spending. Mediocre and below-average caliber produces below-average results. Competence matters. Management matters.

The company value is being at cash value is absolutely ridiculous. I think we should see a double in the share price fairly soon. I believe in market equilibrium.

~~~

I don't think they are explicitly in bed with shorts but Mike Mason weakness as a CFO could transfer to an implicit helping of the shorts by unwise moves. Regarding the second possibility you mentioned I think that's more like it i.e. lack of sufficient competence on the part of the CFO and legal counsel and therefore CEO. I think Richard is very competent but he inherited a big mess from a very incompetent CEO who was a very good scientist and doctor but a disaster of a CEO. Him and his recruits ran the company down because of their incompetence. They just knew how to raise and spend money. And Richard's biggest mistake was to go along with that status quo. 

The science should save the day but it should never come to that. These guys should be garnering and much higher valuation but they failed at that because of competence issues, in my opinion. Despite all of that I think the stock is very undervalued. But I really wish to see a serious change in the management.  Investors should come together to put the company on notice and file a derivative lawsuit if the board doesn't react. If any of you are interested in helping out you can contact me on the contact page of https://www.rezamusic.com/various/kpti 

Dr. Due Diligence Good Writeup 

https://www.reddit.com/r/KPTI/comments/1069m3q/doctor_dds_thoughts_on_kpti_post_raise/

Scripts 

An investor with handle: "ProfOB" said his company gets script data  

• "$KPTI just load up guys… xpovio sales are up… users are up… this will be double digit before the first quarter… "

• "We have an open claim files as a company and gets update every week. Multiple Myeloma market grown to the advantage of KPTI with couple of products pulled out of market. Seeing these number we took a big long position but since then we see huge drop and kept buying more. I think this will be double digit by catching higher end of projected sales. Good luck… 2023 could be the year of leaving these single digits! Bullish."

• "I work with open insurance claims files. And the data is updated everyweek."

Short Interest

Short interest increased by 2.8 million shares. So now we know after the private placement shorts kicked the daylight out of the stock. Year end window dressing to maximize their fees? 

I don't believe it's so simple that after the private placement 2.8m shares were shorted randomly. 2.8m shares is a lot. Was it that the participants of the private placement are totally independent of the shorts and short hedgy funds just decided they really want a year end low price to boost their fees? If that's the case we should see a sharp move back to the pre-drop levels.   

Did shorts also participate in discussions and thought the future is bleak so they decided to up the ante?  I don't think anyone in their right mind would think that -- KPTI's future looks bright.  

Were some of the participants who went long shorted? Go long at 5.19 and go short at 4.19?  Not that simple.   

Did shorts get bailed out, pocketed a huge profit, then decided to dump 2.8m shares (see above).  

We just don't know... yet. Your views are welcome. Contact me here.

28 Dec 2022 - Talk with Company

I spoke with the company yesterday. Notes to follow.

Opportunity

"Have been watching EPZM for a few years as they are considered a peer of KPTI. Ultimately seems unlikely that KPTI could sell out at such low levels though, because of approved combo treatments paired with blockbuster compounds from big pharma. Also, KPTI holds the lead compound for Antengene and an important one for Menarini (~ $1B invested between Stemline acquisition and KPTI commitments). So I’d expect $BMY (Antengene investor via Celgene) or Menarini to make bids. Or $PFE could pick up KPTI novel small molecule oncology assets for cheap, even at $2B… which seems far fetched now, but is it?"

"So my takeaway - maybe $KPTI is delaying the interim analysis of its MDS trial to allow the secondary endpoint of overall survival (OS) to mature (more robust data for analysis) before the readout. The company may also be planning to discuss the data with the FDA to explore the possibility of an accelerated approval."

MDS

"After already getting orphan medicinal and Fast Track designation related to MDS indications in '22, the progress and possibilities look good so far. If the Q1 2023 interim analysis of the MDS clinical trial shows positive results for the overall survival (OS) endpoint, it is possible that $KPTI and the independent data monitoring committee (DMC) may decide to continue the trial as planned or even consider submitting the data for regulatory review. If the data are considered strong enough, $KPTI may consider seeking accelerated approval."

"In order to qualify for accelerated approval, the drug must demonstrate a "reasonably likely" clinical benefit based on the available data. If granted accelerated approval, $KPTI must conduct additional clinical trials to confirm the clinical benefit of the drug and to gather additional safety data.

Does this sound reasonable, especially considering there are currently no approved therapies for HMA- refractory MDS?"

"I recommend to keep a close eye on KPTI and to consider adding it to your portfolio. As always, it is important to do your own research and assess the risk before making any investment decisions."

More Countries Coming Aboard

Antengene Announces NDA Submission for XPOVIO® in Macau, Malaysia and Thailand for Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B-cell Lymphoma

https://finance.yahoo.com/news/antengene-announces-nda-submission-xpovio-003000484.html

28 Dec 2022 - Selinexor Heals The Nastiest, Incurable Cancer

Per this report: "My cousin has had multiple myeloma 11:14 for 7 years now. She failed everything. She enrolled in the REGN BCMA bispecific trial and was the top responder in the trial and still failed a few months later. Since June 2021 she's been on selinexor. 

She hasn't taken a drug in a month and just had blood work done and she's in complete remission. The side effects are horrific. Like the worst side effects imaginable ever for anything. The docs refused to give it to her because of them but I pushed it through. And now she's gone to her daughters wedding, her grandson is four, she's in complete remission. All because of Selinexor.  KPTI should get acquired or the stock should be $50 right now. It's just DUMB. She's literally the hardest type of MM to treat, she was bleeding out of her eyes; the dex gave her cataracts too. She's in CR. It's incredible."    [CR = Complete Response = The disappearance of all signs of cancer in response to treatment.]

https://mobile.twitter.com/wexcapital/status/1608135911761481729

MESSAGE TO SHARON SHACHAM 

Dear Sharon

Hope all is well.

I don't know if you saw the message on Selinexor curing someone. I posted it on

https://www.rezamusic.com/various/kpti

~~~

Also, FYI, I got an anti-Semite guy's history eliminated:

In honor of my Jewish friends, including the discoverer of Selinexor, Dr. Sharon Shacham, and for the sake of decency, I got the entire posting history of "Freddie Leone" (ID: JustBeers) removed, for having posted several anti-Semitic messages on this platform, Stocktwits.

If he continues with his hostile, prejudiced insults towards people of any religion, race, nationality, gender, ethnicity, Stocktwits will remove his account permanently. I encourage participants here to flag messages as inappropriate so Stocktwits admins are alerted immediately. When a posting gets flagged twice or more, ST intervenes manually.

~~~

KPTI is in the toilette -- I blame it squarely on the inept handling of the private placement by Mike Mason and MIke Mano, in my opinion. I predicted this will happen and wrote to Richard about it -- I said 2-3 dollar range. And I explained to him bombshells that Wall Street sharks can drop when you least expect it, will catch you dumbfounded, which is exactly the state of the company now, because Mike & Mike are dream come true for shorts.

~~~

Wishing you a great 2023

Reza

Selinexor in combination with weekly paclitaxel in patients with metastatic solid tumors

Results of an open label, single-center, multi-arm phase 1b study with expansion phase in ovarian cancer

https://www.sciencedirect.com/science/article/abs/pii/S0090825822019187

Highlights

• The combination of the selective inhibitor of nuclear export (SINE), selinexor, and weekly paclitaxel is tolerable.

• Selinexor and weekly paclitaxel yielded clinical benefit in heavily pre-treated platinum-resistant ovarian cancer.

27 Dec 2022

KTPI is trading under book value which happens for companies that are totally hopeless. Is Karyopharm hopeless? Approved in over 40 countries. Making over 150 million dollars a year in revenue. Rich pipeline. Not hopeless at all. I have a lot of hope for the company. So what gives? Year end cooking of the books for the short hedge funds who will earn bigger fees the lower the price is? Year-end tax loss selling? Churning the float to get the last of retail to throw in the towel by psychological torture and triggering margin calls and stop loss order? Order of potential acquirer of the company to brokers to kill the price by abusing their naked shorting ability? Force sale by tutes who had sale All of the above? None of the above? Any other ideas? 

OVERSOLD

If a biotech stock is experiencing a steep decline due to broader market conditions and technical sell indicators flashing red (as with KPTI), but the value-based factors such as the company's financial performance and product pipeline are healthy, it could potentially indicate that the stock is temporarily oversold (RSI @ 24 also indicates this). This could present an opportunity for value-based investors to buy the stock at a discounted price, with the expectation that the price will eventually return to a level that reflects the company's underlying value. 

XPOVIO FOOTPRINT

Xpovio's footprint now reaches 40 countries, growing revenue (~$160 million in 2022), experienced management, and partnership possibilities should accelerate with more efficacy and additional targets as this medicine in various combo treatments gets personalized with help from biomarkers (also biosimulation), enabling multiple product approvals over the next two to four years. The level of unrelenting short interest is a problem though. Until it's not.

https://www.medrxiv.org/content/10.1101/2022.12.15.22283531v1

Protein biomarkers for response to XPO1 inhibition in hematologic malignancies https://www.medrxiv.org/content/10.1101/2022.12.15.22283531v1

KPTI country approval info, revenue, and forecast of additional approvals in the next 2-3 years from Q3 2022 conference call transcript https://www.fool.com/earnings/call-transcripts/2022/11/04/karyopharm-therapeutics-kpti-q3-2022-earnings-call/

Selinexor/Ruxolitinib Combo Reduces Spleen Volume in Myelofibrosis

https://www.onclive.com/view/novel-selinexor-ruxolitinib-combo-reduces-spleen-volume-in-myelofibrosis

INCY & KPTI

Incyte seems to be actively promoting Xpovio (selinexor) and other compounds in clinical trials that work in combination with their Jakafi (ruxolitinib) treatment. This is presented and marketed in a compliant way. 🧐 Good for them.

Dr. Rampal on the Importance of Clinical Trial Enrollment in Myelofibrosis Raajit K. Rampal, MD, PhD, hematologic oncologist, associate attending physician, Memorial Sloan Kettering Cancer Center, discusses the importance of clinical trial enrollment in patients with myelofibrosis.

https://www.onclive.com/view/dr-rampal-on-the-importance-of-clinical-trial-enrollment-in-myelofibrosis

PROGNOSIS 

My hunch based on everything I know and have seen and believe, is that the shorts are repositioning themselves, after the gift our moronic CFO and Legal Counsel and CEO who listened to them, gave the shorts,  and are going to continue this through the 31st to cook their books to show huge profit for their funds so they can charge huge fees and get huge bonuses, and by JPM conference their books have gone from short to long and they'll drive this up. I'm pissed at management for being so naive as to put the gun in the hands of shorts like this, but I couldn't expect anything better than Mike Kauffman's lousy recruitment.

I don't see any reason to sell so am holding  and believe a month from now the share price may be a lot higher. I was stupid to hold after Paulson decided to keep Mano & Mason, but I'm not stupid to sell when there's no bad news; nothing in the thesis has changed since the stock was 16, and the story has just gotten better. The above is just my opinion.

INVESTOR NOTE

Note a thoughtful long-term KPTI investor sent me: "I have little visibility into what is happening with KPTI related to the recent private placement. I’d expect this involved more than just a capital raise, and offers strategic value related to one or more of the new investor partners. I’ll be glad if that value is related to dealing with shorts, positioning KPTI better as an acquisition target, or bringing suitors.

Meanwhile I think Menarini is a potential suitor and I just hope they don’t get too good of a deal.

Lots of other scenarios could happen, of course. On the bright side, not much downside from here."

NEW DATA: BETTER THAN EXPECTED

SVR35: 92% (92% chance of response, Seli taken in combo with Rux.

Expectation was a much lower number, so Karyopharm beat expectations. 

A Study of a Fully Human BCMA-targeting CAR (CT103A) Combined With Selinexor in Patients With Relapsed/Refractory Extramedullary Multiple Myeloma

https://www.clinicaltrials.gov/ct2/show/NCT05201118

STOCK ACTION

Data was released yesterday which was better than expected. Stock tanked for unknown reason. In my view, only thing that has changed is the capital raise they did last week for $5.xx and warrants at $6.xx which is the best we could expect from a CFO which I am not fond of. Both CFO and Legal Counsel were hired by Mike Kauffman, that previous CEO who was a great scientist / doctor but a terrible CEO (typical) and he hired these two Mikes who are both below average in my view. The new CEO decided to keep them which is mind boggling -- I think it was due to his confidence in the science that it will prevail and I still believe it will. So I'm holding on to my shares till buyout. 

It's difficult to read the minds of the hedge funds. Often they switch from short to long. My middle of February when institutional report is out, and some short reports are out, we will have a better idea of what's going on behind the scenes but I remain long and strong. If I hadn't seen such turmoil in biotech before I would be surprised, but it's business as usual especially for a stock with huge potential. 

Just my opinions and not an investment advice.

"In an aging population (such as ours) the incidence of myelofibrosis will keep up with treatment options and then some. JAK inhibitors are great (with black-box caveats) until better drugs take their place."

Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at ASH 2022

Key Opinion Leader: very compelling drug: higher efficacy than other agents, and good tolerability. 

Very good results 

– A 92% SVR35 and a 67% TSS50 were Observed in the Efficacy Evaluable Patients at Week 24 –

– 57% of Transfusion Independent Patients Achieved Hemoglobin Stabilization –

"In the Phase 1 portion of the study, encouraging efficacy was observed across the relevant efficacy endpoints of SVR35, TSS50, and hemoglobin stabilization and a generally manageable safety profile was observed regardless of dose. Furthermore, I find the rapid spleen reduction as early as week 12 especially notable, along with early signs of durability," said Dr. Haris Ali, City of Hope Comprehensive Cancer Center. "These data support the potential of an oral XPO1 inhibitor, in combination with a JAK inhibitor, to deliver significant benefits for patients with myelofibrosis."

https://investors.karyopharm.com/2022-12-12-Karyopharm-Announces-Presentation-of-Updated-Phase-1-Selinexor-Data-in-Patients-with-Treatment-Naive-Myelofibrosis-at-ASH-2022

FDA looks to pull approval for Oncopeptides' troubled multiple myeloma drug Pepaxto

Another positive for Karyopharm, in hands of financial management who can't shoot straight. 

https://www.fiercepharma.com/pharma/fda-seeks-withdrawal-marketing-authorization-oncopeptides-pepaxto

Karyopharm Announces Investor and Analyst Event at ASH 2022 on Selinexor Data in Patients with Treatment-Naïve Myelofibrosis

– Key Opinion Leaders to Review Highlights from Updated Phase 1 Data to be Presented at ASH 2022 at Company Sponsored Event on Monday, December 12 at 8:30 AM ET –

Great Talk By Karyopharm's Brilliant CMO Reshma Rangwala

https://www.youtube.com/watch?v=Qy_akVLNhh8

Galien Week of Innovation 2022 / Pharma: Hematologic Cancers & Gene-based “Tumor Agnostic” Therapies

Bad Companies Aren't Bashed On Stock Message Boards

Those who don't own the stock or are short cheer down days and make stupid claims like "shorts own this stock". They don't. Large majority of shares are owned by institutions and if you assume the entire short interest is the same institutions which is a stupid assumption, shorts still don't own the stock. Notice on days when KPTI beats the index hands down, these bashers go quiet.

The stock was 4.08 in August and now it's 4.98 and yesterday it was 5.30. Shorts wish they owned this stock but with all the upcoming catalysts and the pent-up demand, the doom and gloom antagonists are wasting their time if they think they can influence people to sell. Of course they could be nobodies looking for attention, which is a very common behavior on message boards about a topic people have interest on, and some bozo comes and attacks their interest with stupid nonsense, to get attention. Life goes on.  Good luck to KPTI longs.

--- 

An investor wrote: "These are all great points! I am also surprised more folks are not bullish about the fact Belantamab was pulled by the FDA last week. Yes, Teclistamab was added recently but still given the withdrawl of Blenrep its another opportunity. Add in Myelofibrosis and down the line someday Endometrial; this stock will eventually have its day in the sun. Why sell at $4 or $5?"

Upward Trend 

Most of the shares are in institutional hands who are not trading it. The few shares left are in our hands. So most of the volume is day trading and games market makers and hedge funds play. The bulk of the volume will come when buyers and shorts pull the trigger to buy/cover shares.

The trend seems to be for that to happen they have to bid up the price to get sellers to agree to sell. Institutions know the potential of the company and doubt would sell any time soon. So we should see bidding up the price as prospects continue to improve. Given the stock is undervalued, such move could come even without material news.

Piper Sandler Conference

Piper is a heavy weight in biotech M&A - so talks could be happening.

https://investors.karyopharm.com/events-presentations?item=60

Deck: https://investors.karyopharm.com/download/Piper+HC+Conference+KPTI+Presentation_+Final_+November+29+2022.pdf

Excellent presentation. CEO's emphasis on seniority of the team is important -- they're doing some very scientifically intense heavy lifting and they have the right team to do ti. 

MDS interim data not out yet which is a positive - the longer it takes the better.

Announcement in ASH (December 2022) about Myelofibrosis should be significant. 

Lot of new data expected in 2023 including phase 2/3. As saying goes, most money is made on phase 2 data. 

150 million revenue, drug approved in over 40 countries, rich pipeline.

Latest Presentation

https://investors.karyopharm.com/download/KPTI+Corp.+Pres+November+2022+11.15.22.pdf

Positive outlook for biotech 2023 Outlook 

Bio: It’s Time for Biotech Firms to Outshine S&P500 Healthcare Players www.businesskorea.co.kr/news/articleView.html?idxno=104629

2948 Selinexor in Combination with R-GDP for Patients with Relapsed/Refractory B-Cell Lymphoma: Final Results of 18 Patients Treated at RP2D of Selinexor in the Selinda Phase Ib Lysa Study

Program: Oral and Poster Abstracts

Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II

Hematology Disease Topics & Pathways:

Combination therapy, Therapies

Sunday, December 11, 2022, 6:00 PM-8:00 PM

https://ash.confex.com/ash/2022/webprogram/Paper157496.html

GSK Could Eye Karyopharm 

GSK plc (LSE/NYSE: GSK) has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf) following the request of the US Food and Drug Administration (FDA).

Belantamab Mafodotin to Be Withdrawn From US Market for Relapsed/Refractory Myeloma

https://www.onclive.com/view/belantamab-mafodotin-to-be-withdrawn-from-us-market-for-relapsed-refractory-myeloma

Good Companies Are Bought Not Sold

To all the people who write "sell the company", remember, good  companies are bought not sold. Mike Kauffman the last disaster CEO told me on a zoom call that they had overtures in the past but told the prospective buyer "not yet". And he said it's like sending your kid to university - and they want to send their kid to Ivy League. So that would be like Pfizer or Roche or something -- so we'll see.

Of course this idea of beiing bought not sold does not mean a company has to sit still and do nothing about promoting itself. Sharon Shacham the genius inventor of Selinexor told me on a Zoom call buyout discussions are like dating.

I told her, using another analogy, that the idea of standing there waiting to be asked to dance is outdated -- the company has to promote itself as well. The best example is ARIAD CEO Paris Panayiotopoulos who shrewdly got a great valuation for Ariad.

https://www.bizjournals.com/boston/news/2017/01/20/ariad-played-hardball-to-boost-takeda-buyout-price.html

3969 Novel Combination of Clinical Menin Inhibitor Ziftomenib and the Nuclear Export Inhibitor Selinexor Synergistically Inhibit MLL-r AML 

• Program: Oral and Poster Abstracts

• Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III

• Hematology Disease Topics & Pathways:

• Research, Acute Myeloid Malignancies, Translational Research, Combination therapy, Diseases, Therapies, Myeloid Malignancies

• Monday, December 12, 2022, 6:00 PM-8:00 PM

https://ash.confex.com/ash/2022/webprogram/Paper168151.html

Very Significant Buyout in KPTI Space; Barclays Issues Optimistic View on Karyopharm

Merck just acquired Imago Biosciences for $1.35 billion to boost Merck's hematology pipeline.  Barclays issued positive view on Karyopharm, noting he transaction will have a positive read-through to biotechs focused on hematological malignancies such as Karyopharm (KPTI).

Lisa A. DiPaolo, Chief Human Resource Officer of Karyopharm Named as 10 Most Influential HR Exec

https://twitter.com/CIOviews/status/1591089727897489408/photo/1

https://cioviews.com/digital/2022/november/the-10-most-influential-hr-executives-of-the-year-2022-nov-08/

Valuation

With KPTI current sales. Plus what they have going on in trials and pipeline. A 2 billion dollar market cap is very modest. That would be $25.00 per share

Upgrades, Nov 2022

RBC Capital analyst Brian Abrahams upgrades Karyopharm Therapeutics from Sector Perform to Outperform and raises the price target from $7 to $10.

SVB Leerink analyst Jonathan Chang maintains Karyopharm Therapeutics with a Market Perform and raises the price target from $5 to $6.

~~~

RBC Capital Markets has upgraded Karyopharm Therapeutics to outperform from market perform saying the company's opportunities are discounted in the stock price. The firm also upped its price target to $10 from $7. Analyst Brian Abrahams highlighted cancer treatment Xpovio (selinexor), which he said could achieve $700M in annual sales based on its activity across multiple tumor types. He added that Xpovio could see growth with potential approval in myelofibrosis and endometrial cancer. He sees ~$300M in peak sales for the former indication, and the latter adding ~$140M in revenue.

Ex-CEO Michael Kauffman 

Ex-disaster CEO Michael Kauffman (great doctor/scientist) used to sell regularly. He told me his financial consultants told him it's crazy to be so concentrated in one stock. The last 13G/A he filed was in Feb 2022. He hasn't sold since then. That's a good sign. He owns over 4 million shares. Also his wife, Sharon is a big holder.

KPTI back to $14

Not long ago the stock went from $10 to $14 because the company cancelled a meeting. Sounds crazy, and it is, when the short interest is so high, and the stock is so manipulated to such ridiculous valuation. I expect we'll see that happen again; perhaps not a cancelled meeting but the real nightmare of shorts: buyout discussions.

KPTI, the world leader in SINE technology at JEFF Biotech Conference in London

The whole gang is in London. I hope they're also meeting with Roche and other prospective acquirers in UK and Switzerland. 

https://wsw.com/webcast/jeff255/kpti/1866024

Our rock star, Sohanya, say 60 mg dose is used off label. Doctors are getting confident with the dose reduction which improves progression free survival.  

KPTI bashing by prospective buyers, to get in for cheap! 

I'm very pleased to see stupid bashing by KPTI prospective buyers (shorts who are getting margin calls to cover or otherwise see the writing on the wall and make the right decision to cover; or others who want to buy the shares). I sense a desperation in their bashing messages.

Usually bashers attack a company's science, market, prospects, etc. which requires solid arguments that can't get debunked. Since such arguments are impossible to make against Karyopharm, the bashers have resorted to stupid lies, like posting "CEO selling tons of shares". No he's not. That's a flat out lie. The CEO sold a few shares to pay options tax. That's very customary and happens in every company, and he is the beneficiary owner of hundreds of thousands of shares. Try again!

Institutional quarterly filings are coming in. Ally Bridge Group took on a new 1.5 million share position in KPTI worth $8.5 million!

More should be filed by end of day tomorrow. 

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma (XPORT-EC)

https://www.stockilluminati.com/kpti/display.php?url=https://clinicaltrials.gov/ct2/show/NCT05611931

Karyopharm holds company call after results of competitor drug failing (good news for Karyopharm)

• GSK's CAR-T rival Blenrep fails multiple myeloma trial, endangering its accelerated approval. GSK’s dream just turned into a nightmare.

• The company’s BCMA-targeted Blenrep has failed a phase 3 trial in relapsed or refractory multiple myeloma. The GSK antibody-drug conjugate didn’t outdo Bristol Myers Squibb’s Pomalyst and low-dose dexamethasone at slowing disease progression or death, the company said Monday.

• The DREAMM-3 trial flop is a blow to GSK’s oncology ambitions; the British pharma has projected Blenrep could reach more than 3 billion pounds sterling in peak sales. And it puts Blenrep’s accelerated approval in multiple myeloma in danger.

https://www.fiercepharma.com/pharma/gsks-car-t-rival-blenrep-fails-multiple-myeloma-trial-endangering-fda-accelerated-approval

https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-dreamm-3-phase-iii-trial-for-blenrep/

Preliminary Results from Two Clinical Studies of Selinexor to be Presented at 2022 ASH Annual Meeting

“The data to be presented at ASH 2022 highlights the broad clinical potential and manageable side effect profile of selinexor in patients with well-defined T-cell lymphomas and R/R MM,” said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. “It is our great pleasure to share these updates with the hematology/oncology community at ASH 2022.”

https://www.antengene.com/newsinfo/283

GETTING CLOSER TO BUYOUT? Piper Sandler connection is a hint? Barclay had predicted buyout price of $60 / share for KPTI.

I don't recall Karyopharm ever attending a Piper Sandler conference before. Mind you merger & aquisitions is a specialty of PS. At this stage in Karyopharm's history, getting aquired is a natural. Price tage? Barclay had a $60 aquisition price targer for KPTI and put KPTI on top of their buyout candidate list last year. Things have only gotten better. 

NEW CONFERENCES. NOTE: PIPER SANDLER is a specialist in capital markets and M&A advisory services.

Live webcast: http://investors.karyopharm.com/events-presentations

Jefferies 2022 London Healthcare Conference

Piper Sandler 34th Annual Healthcare Conference

Buyout prospects 

7 Nov 2022 -- Buyout prospects just increased with the last earnings report. Big Pharma could  make a move any time. I have a lot of faith in Richard Paulson. But don't know his negotiation skills. If he plays his cards right he can get competitive bids and we're talking mega buyout price.

Excellent 2022 Q3 Progress

Great earnings report; great sales numbers; great scientific progress; Richard Paulson sounded stronger and more confident than ever. I'm confident my investment is in right hands. I sent them a congrats note. It's just a matter of time before the company is bought by a big pharma for a luscious premium. 

KPTI had a good quarter - revenues increasing nicely - revenue guidance reiterated - and company has made a lot of important scientific progress. I continue to be very bullish on KPTI and believe the company will be bought by a big pharma early to mid 2023 at much higher value than today's stock price.

I'm planning to hold my shares till the company gets bought out. That's my exit strategy.

UPGRADES

§ Brokerage Firm:  RBC Capital Mkts  |  Action:  Upgrade  |  Ratings Change:  Sector Perform » Outperform  |  Price Tgt:  $7 » $10 

§ $KPTI SVB Leerink analyst Jonathan Chang maintains Karyopharm Therapeutics with a Market Perform and raises the price target

 Karyopharm Announces New Selinexor Data in Myelofibrosis and Multiple Myeloma to be Presented at ASH 2022

–  Encouraging Data Observed in Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Activity Across Three Key Efficacy Endpoints of Spleen Volume Reduction, Symptom Improvement, and Hemoglobin Stabilization, with a Generally Manageable Tolerability Profile and No Dose Limiting Toxicities–

– New Data on Triple Class Refractory Multiple Myeloma Patients Continue to Highlight the Efficacy and Tolerability of Selinexor in the Treatment of Multiple Myeloma –

https://www.prnewswire.com/news-releases/karyopharm-announces-new-selinexor-data-in-myelofibrosis-and-multiple-myeloma-to-be-presented-at-ash-2022-301667668.html

Selinexor demonstrates anti-tumor efficacy in paired patient-derived xenograft models and hydrogel-embedded histoculture drug sensitivity test of penile cancer

Conclusion:

The PDX model of penile cancer was a powerful tool for penile cancer research and new drug development. It showed that Selinexor can effectively inhibit penile cancer in vitro and in vivo. In addition, XPO1 may affect P53, P21, and Cyclin D1 expression to regulate the growth and apoptosis of penile carcinoma.

https://www.researchsquare.com/article/rs-2218336/v1

A novel anti-cancer therapy with nuclear export inhibitor Selinexor in combination with oncolytic myxoma virus

These results for the first time indicate that Selinexor in combination with oncolytic MYXV can be used as potential new anti-cancer therapy.

https://www.biorxiv.org/content/10.1101/2022.10.31.514585v1

A PHASE 1, OPEN-LABEL, DOSE-ESCALATION STUDY OF SELINEXOR PLUS RUXOLITINIB IN PATIENTS WITH TREATMENT-NAÏVE MYELOFIBROSIS

Conclusion

In pts with treatment-naïve MF, QW SEL in combination with RUX is well tolerated with a manageable side effect profile. Based on current data there have been no observed dose limiting toxicities in cohort 1 of QW oral SEL 40 and 60 mg with RUX.

https://library.ehaweb.org/eha/2022/eha2022-congress/357865/haris.ali.a.phase.1.open-label.dose-escalation.study.of.selinexor.plus.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Adate%3D2022-04-13+17%3A21%3A36%2C2022-05-13+17%3A21%3A40%2Asearch%3Dselinexor

Karyopharm and Menarini Group Announce Orphan Medicinal Product Designation from the European Commission for Selinexor for the Treatment of Myelofibrosis

https://investors.karyopharm.com/2022-10-31-Karyopharm-and-Menarini-Group-Announce-Orphan-Medicinal-Product-Designation-from-the-European-Commission-for-Selinexor-for-the-Treatment-of-Myelofibrosis

A Study to Evaluate Safety and Efficacy of Selinexor Versus Treatment of Physician's Choice in Participants With Previously Treated Myelofibrosis

https://clinicaltrials.gov/ct2/show/NCT04562870?term=Selinexor&recrs=a&cond=myelofibrosis&draw=2&rank=1

Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications

https://clinicaltrials.gov/ct2/show/NCT02649790?term=Eltanexor&draw=2&rank=1

A Study to Evaluate Safety and Efficacy of Selinexor in Combination With Ruxolitinib in Participants With Myelofibrosis

https://clinicaltrials.gov/ct2/show/NCT04562389?term=Selinexor&recrs=a&cond=myelofibrosis&draw=2&rank=2

Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors (ESSENTIAL)

This is a phase II, open label, prospective, single-arm study evaluating the efficacy and safety of selinexor in patients with PMF or secondary MF (PPV-MF or PET-MF) who are refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors.

https://clinicaltrials.gov/ct2/show/NCT03627403?term=Selinexor&recrs=a&cond=myelofibrosis&draw=2&rank=3

Antengene Announces XPOVIO® Regulatory Approval in Taiwan 

Antengene Announces XPOVIO® Regulatory Approval in Taiwan for the Treatment of Relapsed and/or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma. TFDA has approved XPOVIO® (selinexor) for three indications.

https://www.antengene.com/newsinfo/274

Ripe Buyout Target

Here's a stock I'm very excited about: KPTI. It has over 90% institutional interest. MS has been flip flopping on it and the short interest is very high, but shorts on the wrong side of science. It makes drugs for incurable diseases. The valuation is ridiculously low at the moment and manipulated by the short interest. It's a ripe buyout target. Barclays had a $60 buyout price target for KPTI. Since then there's only been positive developments. Biotechs have hiccups along the way, which are sometimes influences and orchestrated by short interest influence, but at the end of the day, Karyopharm will come out shining and will probably get bought out at a couple of billion dollars or more (current valuation: 390 million).

Selinexor: Rationale for Use in R/R MM Patients

https://www.cancernetwork.com/view/selinexor-rationale-for-use-in-r-r-mm-patients

Endometrial Cancer Edition with Dr Mansoor Raza Mirza

http://oncologytoday.researchtopractice.com/128

Conversations Around Selinexor: Best Nursing Practices in Multiple Myeloma

https://www.oncnursingnews.com/view/conversations-around-selinexor-best-nursing-practices-in-multiple-myeloma

Combination venetoclax and selinexor effective in relapsed refractory multiple myeloma with translocation t(11;14)

These data suggest that the combination of venetoclax and selinexor is effective and t(11;14) may serve as a therapeutic marker for response and target for future clinical trials.

https://www.nature.com/articles/s41698-022-00315-2

Karyopharm has an amazingly competent CMO: Dr. Reshma Rangwala, MD, PhD.

https://www.karyopharm.com/person/reshma-rangwala-md-phd/

I just listened to her talk at Morgan Stanley Healthcare Conference and was very impressed. She's totally on top of things, and had this rock star level of excellence about her -- despite an analyst whose attitude was questionable (not surprising given the huge short interest which is on the wrong side of science). Karyopharm is going after several incurable diseases and short interest and a team of scums,  Vinay Prasad, Aaron Goodman, Al-Ola A Abdallah, Manni Mohyuddin, Bijoy Telivala, some of whom have questionable affiliations and apparently even link to hedge funds, have tried to derail and badmouth our life saving drug. They're being proven wrong. Read more about it here:  https://www.rezamusic.com/writings/law-ethics/Selinexor-bashers-and-link-to-hedge-funds

Site Update

Management team page is finally sorted out (after several messages I sent them that it made no sense: it wasn't alphabetical, and it wasn't according to importance or position. It was just random which looked unprofessional. Now it's alphabetical. Also, management team is optimized -- a smaller, leaner team. Still a couple of B players among them but I trust in Richard's decisions. https://www.karyopharm.com/about/management-team/

Dr. Ali on Key Findings From the Phase 1 Study of Selinexor Plus Ruxolitinib in Myelofibrosis

https://www.onclive.com/view/dr-ali-on-key-findings-from-the-phase-1-study-of-selinexor-plus-ruxolitinib-in-myelofibrosis

"Data presented at the 2022 ASCO Annual Meeting demonstrated that the combination of selinexor and ruxolitinib was safe and tolerable in all patients"

Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients

https://www.clinicaltrials.gov/ct2/show/NCT05577364?cond=Diffuse+Large+B+Cell+Lymphoma&sfpd_s=09%2F30%2F2022&sfpd_d=14&sel_rss=new14

"Selinexor is Incredibly Helpful... It Performs Very Well" 

https://www.youtube.com/watch?v=3S1E-nqmTFY

In this video, Paul Richardson, MD, Dana-Farber Cancer Institute, Boston, MA, discusses the role of selinexor in the treatment of multiple myeloma, emphasizing its value in patients with del(17p)-positive relapsed/refractory (R/R) disease. Dr Richardson also highlights some of the challenges associated with the use of selinexor, and clinical trials evaluating the safety and efficacy of this agent. This interview took place at the 19th International Myeloma Society Meeting (IMS) held in Los Angeles, CA.

Big Data Coming Up 

It's well known that in pre-approval phases, phase 2 data is where the big money can be made. KPTI has a phase 2 data coming out by end of this year. The current valuation is ridiculously low however you look at it. The upcoming phase 2 data is worth the entire current market cap, let alone KPTI's multiple approvals in multiple markets that are currently revenue generating. 

Real-World Use of Selinexor, Daratumumab and Dexamethasone in Chinese Patients With Multiple Myeloma at First Relapse

https://www.clinicaltrials.gov/ct2/show/NCT05559788?cond=Multiple+Myeloma&sfpd_s=09%2F28%2F2022&sfpd_d=14&sel_rss=new14

Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma

https://clinicaltrials.gov/ct2/show/NCT04768881

Gasparetto Discusses Sequencing Selinexor in Relapsed/Refractory Multiple Myeloma

September 22, 2022

Targeted Oncology Staff

Case-Based Roundtable Meetings Spotlight, Case-Based Roundtable Meetings Spotlight: September 2022,

https://www.targetedonc.com/view/gasparetto-discusses-sequencing-selinexor-in-relapsed-refractory-multiple-myeloma

IMPORTANT EVENT WITH CEO RICHARD PAULSON

https://twitter.com/Karyopharm/status/1569712474135629829?cxt=HHwWisDUxbbL3sgrAAAA

Notes From Presentation At Morgan Stanley

12 Sep 2022

https://www.reddit.com/r/KPTI/comments/xctsqz/morgan_stanley_20th_annual_global_healthcare/

Manirini To Buy Karyopharm?

"ELZONRIS is their only FDA approved drug. They bought it from the developer. Both Stemline and Menarini are growth through licensing & buying. The breast cancer drug currently in front of FDA is licensed from Radius Health. Looks like Menarini is using Stemline to launch this breast cancer drug + Menarini is focusing on having their own oncology franchise and plans to break into the US. On the Menarini website, it also mentioned MDS and MF as their focuses..."

Some of the other possibilities are Sanofi and Roche. 

AARON GOODMAN, KPTI BASHER

25 July 2022 

When Aaron Goodman bashes KPTI you know it's time to buy. There's evidence of link between him and an agency hedge funds use to retain "consultant" doctors. Is Goodman a paid shill? We can't prove it but he looks like one.

Fact is #selinexor has an excellent safety profile and is well managed by a huge number of doctors and the drug saves lives and works wonders. Just a bunch of fringe bozos on Twitter get a kick out of trash talking a life saving drug. And some have been linked to hedge funds.

~~~

There's evidence that links Aaron Goodman to an agency that hedge funds use to hire "consultant" doctors. 

It's well known the shorts hire doctors to trash talk a drug they're short on. I was in elevator and heard conversation of one hedge fund manager with a puppet medical doctor. I also had exchanges with Shkreli (convicted criminal hedge fund manager) who paid doctors to trash talk stocks. If they hired Goodman or not we don't know but it happens.

Their goal is to weaken sales and dissuade doctors and ultimately debilitate the company. They especially do this to companies they know have no teeth or a weak legal department.

Selinexor inhibits growth of patient derived chordomas in vivo as a single agent and in combination with abemaciclib through diverse mechanisms

https://www.frontiersin.org/articles/10.3389/fonc.2022.808021/full

Good News: Court dismisses ambulance chasers' lawsuit against Karyopharm.

https://www.wilmerhale.com/insights/news/20220812-wilmerhale-achieves-first-circuit-victory-for-karyopharm-therapeutics

On August 5, WilmerHale scored a significant win for client Karyopharm Therapeutics when the First Circuit unanimously affirmed a decision from the District of Massachusetts dismissing a securities class action suit. The WilmerHale team representing Karyopharm includes Peter Spaeth, Allyson Slater, Jocelyn Keider and Mike Bongiorno, who argued the case on appeal.

I hope plaintiff was ordered to cover Karyopharm's legal costs.

CHECK OUT THE UPDATED BASHER FILE AND SOME AFFILIATIONS WITH HEDGE FUNDS:

https://www.rezamusic.com/writings/law-ethics/Selinexor-bashers-and-link-to-hedge-funds

Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

https://clinicaltrials.gov/ct2/show/NCT02227251

Big Pharm Interest in Karyopharm

KPTI co-founder, Sharon Shacham told me last year they had interest from big pharma but told them "not yet". And their kid has grown and they want it to go to Ivy League which in my view he meant a big top notch pharma like PFE Pfizer, MRK Merck.  His wife (co-founder) told me talking with pharma prospective buyers "is like dating" and that she was not good at it :-) Let's hope Richard is :-)

Karyopharm Granted Regulatory Designations for Eltanexor for the Treatment of Myelodysplastic Syndromes

https://investors.karyopharm.com/2022-07-20-Karyopharm-Granted-Regulatory-Designations-for-Eltanexor-for-the-Treatment-of-Myelodysplastic-Syndromes

“Wood and team found that a combination of Selinexor and an AKT inhibitor work much better than chemotherapy, which is the current standard of care for otherwise healthy patients.”

https://cagt.pratt.duke.edu/news/locking-leukemia-cellular-escape-hatch

P2RY2-AKT activation is a therapeutically actionable consequence of XPO1 inhibition in acute myeloid leukemia

https://www.nature.com/articles/s43018-022-00394-x

Selinexor Maintenance Improves PFS in Advanced or Recurrent Endometrial Cancer, Particularly p53 Wild-Type Subset

https://www.onclive.com/view/selinexor-maintenance-improves-pfs-in-advanced-or-recurrent-endometrial-cancer-particularly-p53-wild-type-subset

Selinexor in Patients from Argentina with Multiple Myeloma Treated with Multiple Prior Therapies: A Case Series

https://pubmed.ncbi.nlm.nih.gov/35834427/

A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

The purpose of this study is to evaluate the efficacy and safety of selinexor alone or with pembrolizumab in participants with advanced or metastatic colorectal cancer (CRC). Approximately 78 participants with advanced or metastatic CRC will be enrolled, and randomized (1:1:1) into three arms A (selinexor only), B (selinexor and pembrolizumab), and C (standard of care [Combination of trifluridine and tipiracil]). Randomization will be based on stratification factors: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 versus 2. The end of treatment (EoT) visit will occur less than or equal to (<=30) days post-treatment discontinuation. A survival follow-up visit will be performed every 3 months from EoT and will continue for 12 months.

https://clinicaltrials.gov/ct2/show/NCT04854434

Combination Venetoclax and Selinexor Effective in Relapsed Refractory Multiple Myeloma with Translocation t(11;14)

https://www.medrxiv.org/content/10.1101/2022.08.01.22278282v1

26 Jul 22 - A combination comprised of selinexor (Xpovio) and ruxolitinib (Jakafi) induced rapid spleen responses at week 12 and showcased a manageable toxicity profile in patients with treatment-naïve myelofibrosis.

https://www.onclive.com/view/selinexor-ruxolitinib-combo-shows-early-activity-tolerability-in-treatment-na-ve-myelofibrosis

The combination of selinexor and ruxolitinib has been well tolerated and with a manageable [adverse] effect [AE] profile,” lead study author, Haris Ali, MD, an associate professor in the Department of Hematology and Hematopoietic Cell Transplantation, of the Division of Leukemia, at City of Hope Comprehensive Cancer Center, and colleagues, wrote in a poster on the data. “No dose-limiting toxicities [DLTs] were observed in patients with treatment-naïve myelofibrosis who received once weekly oral selinexor at 40 mg or 60 mg in combination with standard-dose ruxolitinib.”

https://twitter.com/topcancercure/status/1551769315690459137

#selinexor saves lives. Excellent safety profile. Thanks Dr. Haris Ali @harisali_md. Well done. 

Don't let the sucker Aaron Goodman @AaronGoodman33 and hedge funds who are short #KPTI find out. #oncology #Xpovio #ruxolitinib #Jakafi #myelofibrosis

E.U. SECOND APPROVAL IS IN

21 July 2022 - Big News is out. This approval will boost revenues, makes Karyopharm even a more attractive buyout candidate, and changes valuation models. Analysts upgrades should come soon. Current valuation is ridiculously low. Last year an analyst assigned a $60 buyout price target. Things have only gotten better since then. A big victim of stock price manipulation, KPTI is set to rebound strongly in the months ahead as revenues increase and buyout prospects get better and better. I am critical of the CFO and Legal Counsel and think those departments can significantly improve with better leadership, but am very optimistic overall. Do your own research. Congrats to Richard Paulson and Karyopharm team for this important approval which seemed like Mission Impossible a few months ago.

Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO® (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy

– Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication –

– Approval Follows Positive Opinion by European Committee for Medicinal Products for Human Use (CHMP) in May 2022 –

European approval seems to be shoe in

7.19.2022 - DL/2022/5395 - C(2022) 5253 - COMMISSION IMPLEMENTING DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "NEXPOVIO - selinexor", a medicinal product for human use and repealing Decision C(2021)2299(final). Waiting for C(2022) 5253 Decision details to be published. But "granting" sounds positive., supposing it is replacing Decision C(2021)2299.

Karyopharm Granted Regulatory Designations for Eltanexor for the Treatment of Myelodysplastic Syndromes

– FDA Fast Track Designation and European Commission Orphan Medicinal Product Designation Underscore the Significant Need for New Treatment Options for MDS 

Locking Leukemia’s Cellular Escape Hatch

https://cagt.pratt.duke.edu/news/locking-leukemia-cellular-escape-hatch

“Wood and team found that a combination of Selinexor and an AKT inhibitor work much better than chemotherapy, which is the current standard of care for otherwise healthy patients.”

P2RY2-AKT activation is a therapeutically actionable consequence of XPO1 inhibition in acute myeloid leukemia

CEO HOLDING

CEO Richard Paulson beneficially owns about 660,000 shares. At a $30 buyout price he'll cash in $20 million. At $50 he'll cash in $33 million. But they urgently need a new CFO, in my view.

BASHERS ARE A GOOD SIGN 

Very bullish sign when bashers are resorting to outright lies to try to disparage the company. If the company. One such lowlife with a new ID and no prior posts  wrote today that Sohanya sold all her shares. She just sold a few bucks worth out of her around 90,000 shares to pay taxes on options which is very normal. I wish the company's legal arm had some balls to go after these bashers but Michael Kauffman hired average, passive people who were below him. Ace CEOs hire people better than themselves. C minus CEOs hire D people.

So let's see Richard shake up the company into a lean and mean place instead of being a punching bag for Wall Street crooks.

CALL WITH KPTI 

Yesterday, 7 July 2022, I had a 40 minute call with Karyopharm's IR director and their legal council.

I asked them things, I gave them tips / ideas which they said they appreciated.

I am not fond of their legal council.

Unfortunately the IR VP is reporting into the CFO.

The CFO and the legal council were hired by Mike Kauffman - and they're both called Mike. Dr.Kauffman was lousy CEO whom some people think I was instrumental in helping oust him. D-CEOs hire people below them. Ace CEOs hire people who are better than them. 

Both Mikes are weak links in my view, and still embody the weak management of Kauffman and the culture he set in.

I questioned them on the Delphi transaction. Upon scrutiny and analysis on my part and their statements, bottom line is they claim they didn't tell the Board on June 7 or June 8 when they got the notice from Biogen. How inept is that?! And Delphi's transaction the next day was therefore just a coincidence! Right! Mano got defensive and asked if I'm thinking he's a lying that Delphi didn't know. I don't know the facts but never assumed he was lying. I remained puzzled and didn't conclude "oh he must be lying". Something doesn't add up. SEC may investigate Delphi. Till will tell.

And then it took KPTI 8 days to release a PR. Mano said we're working on improving out timing! What?! They haven't even gotten timing of PRs handled? Why did it take 8 days? 

All this seems to fall in Mike Mano's department -- he was somewhat defensive which further confirms that. It's sloppy at best, IMO.

In my view, this screams of mismanagement. Great science but the IR/Legal side of the company still appears weak, and guess who's in charge of them: the two Mikes.

Elhan, the IR director is a nice, decent lady. Mano is also a nice guy and three of us had a good  contact. I even played her a Turkish song on the guitar at the end of the call (we talked about guitar earlier), which they liked. She even understood the words, though I sang them with Azeri accent.

She kept answering me with "investor calls" -- I gave her tips about a lot that can happen outside investor calls.

Argot is in the picture with a reduced role (good). Gave them some tips I got from other CFOs about need to actively manage these thin-spread external IR firms.

We established a reliable channel of communication (me emailing Elhan). Although I could choose to write to Richard directly esp. given Mike Mason is Elhan's boss and I don't believe he's been investor friendly. And I'm not happy with the cost structure and I have no confidence in him as CFO, esp. regarding him calling shorts on ATM (I relayed a message to him that use of ATM at these prices would be utterly irresponsible). But I'm not selling my shares because of that. I'm holding till buyout.

Regarding countering disparagement by short cartel, their hired doctors (consultants) - I don't see it in Mano's profile any "teeth".

At the end Mano was like this is a talk between me, Mike Mano and you (trying to persuade me not to relay anything to public). I reminded them these are formal discussions between the company and the public and there's no need for them to be confidential - since nothing private was told to me. Hello!

Also told Elhan about history / founder's syndrome - she hadn't heard about it. And that she needs to be disruptive to inherited status quo. But given she reports to Mason I'm not holding my breath.

Mano wanted more info on my statement that Kauffman was a terrible CEO in my view. I elaborated some reasons.

It felt I had to reiterate some basics for them: that public company's management is hired by shareholders to build shareholder value, and detailed the factors that go into it, e.g. confidence on demand channel - marketing of the security - etc. etc.

And other topics, like BP manipulating share price; notes on buyout prospects and what the founders told me on the two zoom calls I had with them.

It was more of a learning experience for them than for me. They got to tap into the intensity of the challenge they're faced and that us shareholders hold them accountable.

I will keep my shares till buyout.

____

Company is still bogged down by repercussions of Michael Kauffman's mismanagement, in particular a couple of people he hired, Mike Mason as CFO and Mike Mano as Legal Counsel. In my view, based on a number of observations. Shorts have upped their stake probably knowing the company's weakness in these areas (CFO and Legal). Great science, great medicine, in hands of people who have proven to be incapable of building shareholder value. But I'm still not selling my shares. If you want to contact the management contact me for their email addresses off contact page of https://www.rezamusic.com/various/kpti

____

6/7 $KPTI gets news from partner. No big deal, not part of valuation – but shorts would abuse it to pound the stock.  

6/8 Delphi/Deepa sells a lot of shares. Saves $1.3m in opp loss. 

6/10 Delphi files S4. 

6/15 Finally, KPTI makes public disclosure. 

Stock tanked from June 8 onwards and Delphi got a great price. Deepika as Director should have been informed on 6/7.  

KPTI's lawyer, Mano, told me the Board was not informed of the news prior to D’s sale. Why not?! He forgot to tell them?!  

Was 6/8 sale totally random? True D was long term venture cap but still, timing is very fishy.  Did D find out in another way than formally by Mano/co? Possibly.  

Mike Mano was hired by Mike Kauffman who was a terrible CEO. Mano told me they’re trying to improve their PR timing. Seriously? After all this time and money they still can't get that right? Insider sale +  legal dept screwup? I won’t be surprised SEC investigates Delphi’s sale. I’m not selling my shares till buyout, regardless.

M&A is down, but Big Pharma likely to line up 'multiple shots on goal' in 2nd half, PwC says

https://www.fiercebiotech.com/biotech/ma-down-big-pharma-likely-line-multiple-shots-goal-heading-2nd-half

Price Jolt Two Week Cycle

An experienced investor said when there are jolts it takes 2 weeks for it to settle. I agree. KPTI broke down after a non-event deal cancellation on something that was not even in the valuation picture, coupled by a director (hedge fund) selling a small fraction of her holding which some  speculated may have been related to crypto crash. Neither of these were justification for the price breakdown, so I'm on the side of those who think some market makers are manipulating KPTI. In that scenario, the stock falling under $5 triggered margin calls at some brokers. I know as a fact some brokers don't even let self-directed accounts to buy stocks under $5 and some major brokers don't provide margin buying power for stocks under $5. So these 3 factors created a jolt. I don't think there were any real, big sellers. But games including naked shorting by MMs. But these have a short cycle of about 2 weeks for dust to settle and start of buys that historically have caused sudden rebound. 

PS -- Add to the manipulation mix end of quarter window dressing by hedge fund shorts to maximize their performance and fees. 

New Positive Finding

Mount Sinai looked at the genomics of your super responders, found that cancers that don't respond to chemotherapy +- radiation respond to Selinexor with deep and durable responses.

https://www.reddit.com/r/KPTI/comments/vd684e/an_interesting_read/

Straight out of small biotech playbook. Next step: Buyout.

$ARNA was taken out of retail hand and sold to Pfizer ($PFE). I’ve seen many examples of biotechs where retail holds majority shares and supports the company for years, then professional investors get involved and play their tricks and get retail to sell and they get majority of the shares then the company gets sold for a big premium. ARNA was $15 before reverse split after their lousy Founder/CEO was fired by the board which many believe was due to our efforts (and me specifically as active investor group). That $15 share was bought by Pfizer for $100 a few years later. $KPTI (Karyopharm)’s founder/CEO was fired last year (again many think our/my efforts was the catalyst) – and institutional interest has been rising. Next in the play book is a buyout for a rich premium, in my opinion. So I just hold my shares. Heavy manipulation is expected as another 10% of the company is in retail hands and needs to shift to institutions. So games are played abundantly. I just hold and smile and wait it out. Experts believe 2nd half of 2022 will see many bio-pharma M&A's. KPTI was on top of Barclay's M&A list for $60 a share last year. Nothing has changed except manipulation to shift wealth from retail to institutional hands. Retails who hang in there win. In my opinion; not an investment advice.

Antengene Announces Clinical Trial Collaboration with BeiGene to Evaluate Selinexor in Combination with Tislelizumab in T and NK-Cell Lymphoma

https://www.prnewswire.com/news-releases/antengene-announces-clinical-trial-collaboration-with-beigene-to-evaluate-selinexor-in-combination-with-tislelizumab-in-t-and-nk-cell-lymphoma-301574822.html

Excellent New Presentation at Jefferies / Sales on track

https://wsw.com/webcast/jeff240/kpti/1858200

Management reiterated guidance for the year. Sales are on track, despite efforts of the hedge fund doctor puppets to derail sales.

Selinexor is Approved in 38 Countries

38 countries! More approvals coming.

Canada Approved Selinexor

FORUS Therapeutics Inc ("FORUS") Announces XPOVIO® (selinexor) Is Authorized for Sale by Health Canada

Selinexor and an AKT inhibitor work much better than chemotherapy

Locking Leukemia’s Cellular Escape Hatch

“Wood and team found that a combination of Selinexor and an AKT inhibitor work much better than chemotherapy, which is the current standard of care for otherwise healthy patients.” P2RY2-AKT activation is a therapeutically actionable consequence of XPO1 inhibition in acute myeloid leukemia

https://cagt.pratt.duke.edu/news/locking-leukemia-cellular-escape-hatch

Interview With CEO 

Q&A with Karyopharm Therapeutics

https://www.massbio.org/news/recent-news/member-spotlight-qa-with-karyopharm-therapeutics/

1 JUNE 2022 UPDATE

§ The stock has been on a roller coaster along with XBI.

§ Institutional interest is almost 90% again (89.19%). I really like this metric because it shows level of conviction of institutions who generally do a lot of due diligence before buying a stock. 

§ KPT Is more sensitive to XBI these days because also XBI increased its holding.

§ The company's founders should be rolling off the management page on the website any day. That's a good thing.

§ ASCO meeting starts this Friday. Karyopharm will be presenting new Selinexor data. 

§ Short interest is at 14.5 million shares. They rise in short interest corresponds with latest price drop but it is artificial supply given institutional interest has been going up, so that could increase chance of short squeeze.

§ The company's presenting at Jefferies' in NY on June 9.

§ The company is presenting at EHA in Austria on June 9-12.

§ Phase 3 trials are cool. They put the company one step closer to more revenue. A P3 Study Evaluating an All Oral Regimen of Selinexor in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma has started and it's paid for by a MM coalition. Can't beat that. 

§ EU approval will likely be granted this month. Menarini Group is ready to hit the ground running.

§ KPTI's investment thesis right now, in my book, is valuation, valuation, valuation. Any way I look at it the company ought to be three times current value currently. It'll get there, in my opinion. 

§ Buyout written all over this stock. The ex-founder told me it's effectively a matter of when not if. I can wait. Amgen and Pfizer are on top of my list.

§ Revamped my KPTI info page: https://www.rezamusic.com/various/kpti

Karyopharm to Present New Selinexor Data at the 2022 American Society of Clinical Oncology Annual Meeting

– Encouraging Initial Data Observed in Phase 1/2 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Favorable Tolerability with No Dose Limiting Toxicities and 75% of Evaluable Patients Demonstrating ≥35% Spleen Volume Reduction (SVR 35) at Week 12 –

– FDA Grants Orphan Drug Designation for Selinexor for the Treatment of Myelofibrosis –

– Exploratory Subgroup Analyses from SIENDO Trial in Patients with Endometrial Cancer Treated with Selinexor as Maintenance Therapy Identified p53 Wild-type as a Potentially Important Predictor of Efficacy, with 10-month PFS Improvement over Placebo; No Benefit Was Seen in Patients with p53 Mutant Tumors –

https://investors.karyopharm.com/2022-05-26-Karyopharm-to-Present-New-Selinexor-Data-at-the-2022-American-Society-of-Clinical-Oncology-Annual-Meeting

GREAT NEWS: Another Phase 3 trial and good phase 2 data and paid by an expert group!!

The European Myeloma Network and Karyopharm Announce Dosing of First Patient in Collaborative EMN29/XPORT-MM-031 Study

- Phase 3 Study Evaluating an All Oral Regimen of Selinexor in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma -

https://investors.karyopharm.com/2022-05-25-The-European-Myeloma-Network-and-Karyopharm-Announce-Dosing-of-First-Patient-in-Collaborative-EMN29-XPORT-MM-031-Study

FULL EMA SECOND APPROVAL COULD COME BY END OF JUNE

Full EMA approval could come before end of June. Kimmtrak was approved by EMA 38 days after CHMP approval. On 25 Feb Kimmtrak was recommended by CHMP. It was approved on April 4. 60 days is max. 38 days for Karyopharm means 26 June. 

POSITIVE CHMP OPINION FOR SECOND LINE PLUS - EU APPROVAL EXPECTED BY 19 JULY 2022 

Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma

European Commission Decision Anticipated within Approximately 60 Days

https://investors.karyopharm.com/2022-05-20-Karyopharm-and-Menarini-Group-Receive-Positive-CHMP-Opinion-for-NEXPOVIO-R-selinexor-for-the-Treatment-of-Patients-with-Refractory-Multiple-Myeloma

Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the European Hematology Association 2022 Hybrid Congress

Excellent presentation at RBC CAPITAL 

https://www.veracast.com/webcasts/rbc/healthcare2022/j34239.cfm  -- Management came across as extremely confident.

Antengene Announces Commercial Availability of XPOVIO® (Selinexor), for the Treatment of Relapsed/Refractory Multiple Myeloma, Prescribed for the First Time Across Mainland China 

https://www.prnewswire.com/news-releases/antengene-announces-commercial-availability-of-xpovio-selinexor-for-the-treatment-of-relapsedrefractory-multiple-myeloma-prescribed-for-the-first-time-across-mainland-china-301547596.html

Antengene Announces XPOVIO® (selinexor) Data to be Presented at the Upcoming 2022 European Hematology Association Hybrid Congress 

https://www.prnewswire.com/news-releases/antengene-announces-xpovio-selinexor-data-to-be-presented-at-the-upcoming-2022-european-hematology-association-hybrid-congress-301546874.html 

HIGH PROFILE DOCTOR JOINS THE TEAM

Karyopharm is pleased to give a warm welcome to Dr. Tomer Mark as our Senior Vice President of Medical Strategy! We are confident that his deep expertise within the hematology space will be invaluable as we continue to develop our core programs.

https://som.ucdenver.edu/Profiles/Faculty/Profile/24678

https://www.uchealth.org/provider/tomer-mark-md-msc-hematology/

https://som.ucdenver.edu/Profiles/Faculty/Profile/24678

We got some top notch sales reps

e.g.Tanya Rivers Granados

 https://www.linkedin.com/in/tanya-rivers-granados-%F0%9F%87%BA%F0%9F%87%A6-43156317/

Commodore Capital LP bought 4 million shares of KPTI. They're a young hotshot 5th Avenue biopharma investment firm.

 https://www.commodorecapital.com/team

'New paper is published "A Case Report of a 58-Year-Old Woman with a Diagnosis of High-Risk Myeloma Refractory to Multiple Line of Therapy and Treated with Selinexor, Bortezomib, and Dexamethasone Prior

to Allogeneic Stem Cell Transplantation."

In this paper, a case of a 58-year-old woman with high-risk MM who had received 8 prior treatment lines, and whose disease was refractory to ixazomib, bortezomib, and all immunomodulatory agents, is described. After everything stopped working, this patient was treated with selinexor, bortezomib, and dexamethasone (XVd). After 1 cycle of XVd, she achieved a partial response, and after 4 cycles, a very good partial response (VGPR). Therefore, stem cell transplantation was performed. She remained relapse-free for 13 months after initiating XVd. Good to see that Selinexor works well in patients which have no other options.'

KPTI Titles for Selinexor presentations at ASCO in June:

1. Phase Ib trial of selinexor (SEL) in combination with nivolumab (NIVO) alone or nivolumab plus ipilimumab (NIVO+IPI) in patients (pts) with advanced malignancies: The renal cell carcinoma (RCC) experience.

2. Phase 1b study of weekly split-dose selinexor in soft tissue sarcoma (STS).

3. Randomized phase III study of maintenance selinexor versus placebo in endometrial cancer (ENGOT-EN5/GOG-3055/SIENDO): Impact of subgroup analysis and molecular classification.

4. A phase 1, open-label, dose-escalation study of selinexor plus ruxolitinib in patients with treatment-naïve myelofibrosis.

5. Phase Ib study of selinexor and eribulin combination in advanced solid tumors and triple-negative breast cancer.

https://www.instagram.com/_the_ary/

Karyopharm Announces Selinexor Data to be Presented at the 2022 American Society of Clinical Oncology Annual Meeting

https://investors.karyopharm.com/2022-04-27-Karyopharm-Announces-Selinexor-Data-to-be-Presented-at-the-2022-American-Society-of-Clinical-Oncology-Annual-Meeting

Oral Presentation

Title: Randomized phase III study of maintenance selinexor versus placebo in endometrial cancer (ENGOT - EN5/GOG-3055/SIENDO): Impact of subgroup analysis and molecular classification

Presenter: Vicky Makker, Memorial Sloan Kettering Cancer Center

Abstract #: 5511

Date and time: Tuesday, June 7, 2022, 8:00 a.m. – 9:30 a.m. CDT

Session: Clinical Science Symposium/Molecular-Based Treatment for Endometrial Cancer

Poster Presentations

Title: A phase 1, open-label, dose-escalation study of selinexor plus ruxolitinib in patients with treatment-naïve myelofibrosis

Presenter: Haris Ali, City of Hope

Abstract #: 7060

Date and time: Saturday, June 4, 2022, 8:00 a.m. – 11:00 a.m. CDT

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Title: Phase 1b study of weekly split-dose selinexor in soft tissue sarcoma (STS)

Presenter: Abdulazeez Salawu, University Health Network

Abstract #: 11563

Date and time: Sunday, June 5, 2022, 8:00 a.m. – 11:00 a.m. CDT

Session: Sarcoma

Title: Digital monitoring and assessments in patients with glioblastoma

Presenter: Yasaman Damestani, Karyopharm Therapeutics, Inc.

Abstract #: 2045

Date and time: Sunday, June 5, 2022, 8:00 a.m. – 11:00 a.m. CDT

Session: Central Nervous System Tumors

CEO Richard Paulson has a very impressive background. Solid business and sales and management experience unlike the last CEO who was just a good doctor/scientist and ran the company into the ground by mismanagement. Turnaround in progress.

 https://www.linkedin.com/in/richard-paulson-462536/

Details of KPTI Presentations at American Association For Cancer Research April 8 to 13 

·      4067 / 21 - Combination venetoclax and selinexor effective in relapsed refractory multiple myeloma with translocation t(11;14) https://www.abstractsonline.com/pp8/#!/10517/presentation/15278

·      5455 - Nuclear export inhibitor selinexor synergizes with proteasome inhibitor marizomib in preclinical models of glioblastoma https://www.abstractsonline.com/pp8/#!/10517/presentation/17686

·      1122 / 12 - Selinexor synergizes with IL-12 to inhibit tumor growth in syngeneic mouse models of melanoma https://www.abstractsonline.com/pp8/#!/10517/presentation/16291

·      6022 - Synergistic anti-cancer effects of selinexor and bevacizumab in mouse xenograft models of glioblastoma https://www.abstractsonline.com/pp8/#!/10517/presentation/17979

·      6023 - Selinexor synergizes with temozolomide in preclinical models of glioblastoma independent of MGMT promoter methylation https://www.abstractsonline.com/pp8/#!/10517/presentation/17980

·      6025 - Baseline cytokine profiling in naïve and tumor-bearing Balb/c and C57BL/6 Charles River mice https://www.abstractsonline.com/pp8/#!/10517/presentation/17982

·      5832 - Utilizing small noncoding RNAs as biomarkers for selinexor treatment in gastric cancer https://www.abstractsonline.com/pp8/#!/10517/presentation/18815

·      4195 / 3 - Evaluation of the anti-myeloma effects of high and metronomic selinexor alone and in combination with duvelisib in vitro and in vivo https://www.abstractsonline.com/pp8/#!/10517/presentation/16809

·      5519 - Selinexor synergizes with anti-PD-1 antibody and inhibits tumor growth and metastasis in syngeneic mouse models of KRAS mutant colorectal cancer https://www.abstractsonline.com/pp8/#!/10517/presentation/17738

·      5536 - Selinexor inhibits lymphoma-leukemia tumor progression directly and through activation of anti-cancer immune response  https://www.abstractsonline.com/pp8/#!/10517/presentation/17755

·      5314 - Selinexor, a selective inhibitor of nuclear export (SINE) compound, enhances the anti-tumor activity of Eribulin in leiomyosarcoma  https://www.abstractsonline.com/pp8/#!/10517/presentation/18544

·      5330 - Nuclear protein export inhibitor selinexor chemotherapy combination for pancreatic cancer therapy  https://www.abstractsonline.com/pp8/#!/10517/presentation/18560

20 presentations with Selinexor at AACR meeting in April / "99% inhibition of tumor growth with two mice cured sounds remarkable"

Top expert is a big fan of KPTI's science 

Robert L. Coleman, M.D., FACOG, FACS

https://www.texasoncology.com/gynecologic-oncologist/robert-coleman

GOOD NEWS: MERCK KEYTRUDA BLOCKBUSTER EXECUTIVE JOINS KARYOPHARM AS CHIEF MEDICAL OFFICER

NEW SELINEXOR APPROVAL - Many more to come.

https://www.antengene.com/wp-content/uploads/2022/03/%E3%80%90VA-EN%E3%80%91Approval-of-NDA-by-the-Singapore-HSA-for-Xpovio%C2%AE-for-the-Treatment-of-Relapsed-or-Refractory-Multiple-Myeloma-and-Diffuse-Large-B-Cell-Lymphoma-in-Three-Indications.pdf

APPROVAL OF NDA BY THE SINGAPORE HSA FOR XPOVIO (SELINEXOR) FOR THE TREATMENT OF RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND DIFFUSE LARGE B-CELL LYMPHOMA IN THREE INDICATIONS

"I remember what Pfizer CEO said about buyouts. He wants to identify gems before they are fully developed, to maximise their investment return. Siendo is essentially that. Now is the time to buy for its potential in other solid tumors. Not later. Just a thought about the possibility of an imminent buyout."

~~~

Also see: Doctors With Questionable Affiliations: Vinay Prasad, Aaron Goodman, Al-Ola A Abdallah, Maha Hussain, Howard Scher

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