Michael Kauffman - Chief Executive Officer Sharon Shacham - Founder, President and Chief Scientific Officer Justin Renz - Executive Vice President and Chief Financial Officer Christ Primiano - Vice President of Corporate Development and General Counsel.

Mike King - JMP Securities Michael Schmidt - Leerink Partners Arlinda Lee - MLV.

Good morning. My name is Andrew and I'll be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics First Quarter 2015 Financial Results Conference Call. Dr. Michael Kauffman, Chief Executive Officer of Karyopharm Therapeutics, please begin your conference..

Thank you and good morning. This is Michael Kauffman, the Chief Executive Officer of Karyopharm. I'm here with Dr. Sharon Shacham, our Founder, President and Chief Scientific Officer; Justin Renz, Executive Vice President and Chief Financial Officer; and Christ Primiano, our Vice President of Corporate Development and General Counsel.

Welcome to the first quarter 2015 earnings call, where we will provide a brief review of our finances, followed by a clinical and regulatory update. We will then have time for the questions. Earlier today, we issued a press release detailing Karyopharm's results for the first quarter ended March 31, 2015.

The release is available on our website at karyopharm.com. Various remarks we make may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

These include statements about our future expectations, clinical developments, and regulatory timelines, the potential success of our product candidates, financial projections, and our plans and prospects.

Actual results may differ materially from those indicated by these statements as a result of various important factors including those discussed in the "Risk Factors" section of our most recent Annual Report on Form 10-K, which is on file with the SEC and in any other filings we may make with the SEC.

Any forward-looking statements represent our views as of today only. We may update these statements in the future, but we disclaim any obligation to do so. Therefore, you should not relay on these forward-looking statements as representing our views as of any date subsequent to today.

Over the next 30 minutes, we will provide a brief review of our financial results to first quarter of 2015, and then provide a corporate update including our clinical development programs and business strategy. We are happy to take a few questions following the prepared comments. I will turn the call over to Justin to review the financials.

Justin?.

Thank you, Michael. Since we issued a press release earlier this today outlining our first quarter March 31, 2015 financial results, I'll just review the highlights and then speak to our cash balance and financial guidance.

The company reported a net loss of $26.1 million or $0.74 per share for the quarter ended March 31, 2015 that compares with a net loss of $13.7 million or $0.46 per share for the same period in 2014, including stock-based compensation expense of $3.7 million and $2.8 million for the quarters ended March 31, 2015 and 2014 respectively.

Our first quarter net cash burn from operating activities was $20.2 million. Research and development expense was $20.8 million in the first quarter of 2015, compared to $11 million for the same period in the previous year. And general and administration expenses were $5.4 million, compared to $2.9 million for the same period in 2014.

This increase in expenses is primarily related to the significantly expanded clinical development activities for our lead drug candidate Selinexor KPT-330.

And the increase in general and administration expense resulted primarily from increase in personnel costs, including headcount and stock-based compensation expense along with the cost of operating as a public company.

Cash, cash equivalents and investments, including long-term investments as of March 31, 2015, totaled $285.3 million, compared to $214.8 million as of December 31, 2014. As a reminder, Karyopharm raised approximately $91 million net of expenses in a common stock follow-on offering, which closed in January 2015.

Based on current operating plans, we expect our existing cash will fund our R&D programs and operations into 2018, including moving our registration-directed clinical studies to their next data inflection points. We expect to end 2015 with a cash balance greater than $200 million. With that, I'll turn the call back over to Dr. Kauffman..

Thank you, Justin. During the first quarter, Karyopharm and its collaborators presented a comprehensive body of data across our oncology pipeline, including a total of 21 presentations at the 2015 Annual Meeting of the American Association for Cancer Research, or AACR. Two of these were late breakers.

Sharon will tell you more about the content and importance of these data, as well as our clinical progress with selinexor. In sum, the data we presented at AACR further demonstrated the role of XPO1 inhibition in a broad set of difficult to treat cancers with limited treatment options. We have been granted a U.S.

patent for selinexor, which will expire in 2032 as is any patent term extensions. This patent covers the composition of matter of selinexor as well as certain other compositions and related methods.

Selinexor is being evaluated broadly in multiple registration-directed in other late stage trials in patients with relapsed or/and refectory hematological and solid tumor cancers. In addition, we received U.S.

patent allowance covering the composition of matter for KPT-350, an oral SINE compound being developed for the treatment of inflammatory and autoimmune diseases. Once issued, this patent is expected to provide patent protection for KPT-350 and pharmaceutical compositions comprising KPT-350 into 2033.

KPT-350 is expected to enter the clinic in healthy volunteers by Q1 2016. We also appointed Mikael Dolsten, President of Worldwide Research & Development at Pfizer to Karyopharm’s Board of Directors. Dr.

Dolsten brings significant pharmaceutical research and development expertise to carry upon drawing on over 25 years of clinical and regulatory experience including at Pfizer, Wyeth Research and Boehringer Ingelheim.

Mikael’s contributions will be significant as we continue to advance our product pipeline including selinexor for hematologic and solid tumor malignancies. I’ll now turn the call over to Dr. Sharon Shacham to provide an update on our clinical development plans for selinexor and our other SINE compounds.

Sharon?.

selinexor when combined with dexamethasone in multiple myeloma we presented preliminary evidence of anti-tumor activity with this combination at last year’s ASH meeting. Selinexor with bortezomib and dexamethasone in multiple myeloma in transparent induction has already begun.

In addition, the study of selinexor in combination with bortezomib and dexamethasone in patients with at least one pile therapy with myeloma is not refractory to bortezomib is expected to begin in the second half of 2015.

Selinexor with pomalidomide and dexamethasone in multiple myeloma which we anticipate will begin in the second half of 2015, selinexor and rituximab in combination with various chemotherapeutic and novel agents in non-Hodgkin lymphoma, including DLBCL, which we anticipate will begin in the second half of 2015.

Importantly, the result of this study will be used to design the Phase 3 randomized confirmatory study in patients with relapsed/refractory DLBCL. Selinexor with ibrutinib in CLL NHL [ph] and non-Hodgkin lymphoma, which we expect to begin shortly. Selinexor will decide to be in an AML, which began in 2014.

Selinexor is carboplatin and paclitaxel in patients with relapsed/refractory ovarian or in the mutual counsel, which has recently began. Additional combination studies in both solid and hematologic malignances have commenced or will begin shortly. A full list of ongoing and pending studies is available at clinical trial.gov.

Although our lead program is focused broadly in oncology, Exportin-1 the target of our sign compounds including selinexor is relevant in several other diseases settings. For example all strains of influenza a and b viruses regardless of species of origin require Exportin-1 in order to complete their life cycle.

Exportin-1 in addition with sign compounds importantly inhibit influenza application in vitro and in vivo.

In particular, administration of Verdinexor also called KPT-335 and all sign compound closely related to selinexor has shown reduction in viral titles, reduced cytokine levels, and improved survival in both [indiscernible] andSIRRTinfluenza models.

Based on these results Phase 1 healthy volunteer study of Verdinexor is expected to be initiated n the second quarter of 2015. Based on the result of the study we may move to evaluate the activity of Verdinexor as an antiviral agent.

This is just another exciting example of the birth of opportunity for sign compounds to help patients with limited treatment options. I’ll turn the call back to Michael now to provide a brief summary before we take questions. .

Thank you Sharon. In summary, our broad selinexor development program continues in 2015 with plans to initiate additional potential registration directed studies for selinexor and multiple myeloma and liposarcoma.

We look forward to the presentation of selinexor clinical data update in both solid and hematologic tumors at upcoming medical conferences later this year, including the presentation of selinexor single agent solid tumor data at the upcoming 2015 ASCO annual meeting being held May 29 through June 2, 2015 in Chicago.

Data to be presented include Phase 2 clinical updates in both gynecological cancers and recurrent glioblastoma, as well as Phase 1b clinical data in advanced sarcomas and Phase 1 clinical data in Asian patients with advanced solid and hematologic cancers. All of these data are with single-agent selinexor.

Finally, we anticipate that additional SINE compounds for non-oncology indications will enter the clinic over the next year. With that, operator, we are ready to take questions..

Thank you. [Operator Instructions] Our first question comes from the line Mike King from JMP Securities. Your line is open..

Good morning, guys. Thanks for taking my questions and congrats on all the progress. Couple of questions.

Regarding the combination study that you mentioned in the formal remarks, Sharon, both in myeloma as well as the other heme malignancies, I just want to be clear that all of those are going to be under a corporate IND rather than structured as ISTs or is there some mix of corporate and ISTs in there?.

It’s a mix of corporate and ISTs. The combination of selinexor with pomalidomide in myeloma will be a company-sponsored study. Combination of selinexor – one of the combination of selinexor with VELCADE in patient that are not refractory to bortezomib is also a company-sponsored study.

And the study investigating the combination of selinexor cetuximab and several chemotherapies in non-Hodgkin's lymphoma will also be a sponsored study. The rest of the studies are mostly ISTs..

Okay. Thank you for the clarification.

And then just wondering, Justin, if you could walk us through R&D spend, I don’t expect you to give us quarter-by-quarter, but should we think about increasing R&D spend as the year progresses and you guys will be starting a number of important registration-directed study with lots of patients and attendant [ph] costs?.

Yes, Michael, so as you suggested, our Q1 burn was approximately $20 million and I think it’s fair to ramp that up gradually over the course of the year for a burn target this year in the $95 million range, plus or minus $5 million depending on our enrollment..

Okay, great. And then just one more quick question, I will jump back in the queue. And that is with regard to STORM.

Are you guys going to push ahead aggressively on the combination studies, irrespective of the outcome of the STORM in the first 80-patient cohort or will that analysis drive another strategic decision sometime in 2016 regarding the further development of selinexor in myeloma? Thank you..

A combination of selinexor with pomalidomide or with VELCADE will be running parallel to the STORM study. So we will push this – the STORM – selinexor with that in the STORM study and then separately the combination cohort in parallel..

Thank you..

In addition, just keep in mind that we also have the study of carfilzomib and selinexor and that study was already initiated..

Thank you. Are we ready for the next question? The next question comes from the line Michael Schmidt from Leerink Partners. Your line is open..

All right. Good morning and thanks for taking my questions.

For the KING and SIGN studies, how many have you treated in those by now and could you help us frame expectations a little bit going into ASCO here?.

So, the SIGN study actually includes three different diseases – ovarian, endometrial, and cervical. Each one of them has a place to any patients or cohort and the results of that will be presented at ASCO. The KING Study has now over 20 patients across the surgical arm and the treatment arm and again we will present results from this study very soon..

Okay. And are those two studies – are those patients in those studies basically are they very late stage or solvage type patient similar to the studies that we’ve seen so far in the hematological settings..

Yes. So these are – in the science study, these are very heavily pretreated patients, especially in ovarian as there are more option in ovarian compared to endometrial disease or cervical cancer. In the KING Study, these patients have to come up temozolomide and radiation, and they may have received at least these two and potentially others..

I see. Great, thanks. And then I thought the AACR data in triple-negative breast cancer was pretty interesting.

Could you, I may have missed that on the call, what are your plans there for potential clinical studies?.

Yes, based on the results that we presented showing the synergy with PARP inhibitors, we are considering opening a study in combination of selinexor with PARP in either breast cancer or ovarian cancer..

Okay, great. Thanks so much and have a good ASCO coming up. Thanks..

Thank you. Our next question comes from the line of Arlinda Lee from MLV. Your line is open..

Hi, guys. Thanks for taking my question. Given the emerging data that you guys are putting out on other indications that are non-oncology, I am kind of curious about your prioritization between oncology and non-oncology and as well within oncology? Thanks. .

Let me be very clear about our priorities. Our number one priority is the registration directed studies for selinexor. That’s across the company, across all indications.

So the majority of the company resources and personnel effort are in the registration directed studies because our primary goal is to get selinexor to the patients who need them – who need it. Secondary priority is to further clarify the breadth of selinexor activity both alone and I think more broadly even in combination with lots of other drugs.

We’ve instituted a large IST mechanism to drive that since its cost prohibited to do it all as company sponsored. However, we and our Board have agreed that there is significant value that we could unleash taking advantage of well described biology involving XPO1.

We have utilized compounds that have different pharmacokinetic and toxical oncologic – toxicologic data to try to take advantage for instance the KPT-335 and influenza has shown significant in addition of influenza virus replication in both SINE and SIRRT models, and we want to push ahead with that.

It was much more potent than some of our other side compounds, and we’ve had KPT-350 being developed for autoimmune and inflammatory diseases, and that was the subject of a recent Nature Medicine publication as well. However, we showed both in inflammatory and our protective activity.

So each of our SINE compounds is of interest and could serve in significant on that medical needs, but the priority is on selinexor..

Great. Thank you very much..

Thank you. [Operator Instructions] And that looks like no other questions that we have in the queue for today. So I would like to turn the call back over to management for closing remarks..

Thank you very much. That concludes our first quarter 2015 conference call. Thank you all for participating and we hope to see you at our ASCO event in the next few weeks. Have a good day everyone..

Ladies and gentlemen, thank you again for your participation in today's conference. This now concludes the program and you may all disconnect your telephone lines. Everyone have a great day..