Karyopharm Reports First Quarter 2015 Financial Results and Highlights Recent Progress
Positive Data in Difficult to Treat Cancers With
Conference Call Scheduled for Today at
"Karyopharm and its collaborators presented a comprehensive body of data across its oncology pipeline, including a total of twenty-one presentations at the 2015 Annual Meeting of the
Conference Call Information:
To access the conference call, please dial (855) 437-4406 (US) or (484) 756-4292 (international) at least five minutes prior to the start time and refer to conference ID 41661952. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of Karyopharm's website, http://www.karyopharm.com/, approximately two hours after the event.
Recent Corporate Accomplishments:
Mikael Dolsten, MD, PhD, President of Worldwide Researchand Development of Pfizer Inc., to Karyopharm's board of directors.
Scientific Presentations and Publications:
Presented positive data on Karyopharm's oncology pipeline at the 2015 Annual Meeting of the
American Association for Cancer Research(AACR) including 21 presentations with preclinical data for selinexor (KPT-330) and the role of XPO1 in cancer and on Karyopharm's novel oral PAK4 allosteric modulators (PAMs).
- Data presented for selinexor included mechanisms of drug action, specificity and molecular mechanisms leading to tumor radio-sensitization and to selective tumor and cancer stem cell killing. Data that expanded upon the understanding of selinexor's activity in hematologic malignances including non-Hodgkin's lymphoma, acute myeloid leukemia and multiple myeloma, and in solid tumors including sarcoma, mesothelioma, ovarian and non-small cell lung cancers, as well as in pediatric tumors including neuroblastoma, were also presented.
- Two late-breaking abstracts representing company and investigator-sponsored preclinical studies were presented demonstrating the potential role of XPO1 inhibition in two difficult to treat tumor types for which current therapies provide minimal benefit. These data included potent anti-cancer effects of selinexor both alone and in combination with chemotherapy in double- and triple-hit diffuse large B-cell lymphoma, or DLBCL, patient cell lines consistent with selinexor's activity in Karyopharm's ongoing Phase 1 clinical trial in hematologic malignancies. In addition, the combination of selinexor and olaparib, an approved PARP inhibitor, showed synergistic activity in models of triple-negative breast cancer, supporting further investigation of selinexor in solid tumors.
- Data related to the intercellular effects of PAMs on K-Ras and WNT/ß-catenin signaling pathways and the characterization of single-agent antitumor activity were also presented.
Karyopharm plans to present solid tumor data on single agent selinexor at the upcoming 2015
American Society of Clinical Oncology(ASCO) annual meeting being held May 29 to June 2, 2015in Chicago. Data to be presented include Phase 2 clinical updates in both gynecologic 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 hematological cancers.
Regulatory and Intellectual Property Updates:
- Granted U.S. patent for Karyopharm's lead product candidate, selinexor (KPT-330), a first-in-class, oral SINE™ compound. This patent, which will expire in 2032 absent any patent term extensions, covers the composition-of-matter of selinexor, as well as certain other compositions and related methods.
- Received U.S. patent allowance covering composition of matter for KPT-350, an oral SINE™ compound being developed for the treatment of inflammatory and autoimmune diseases. Once issued, this patent will provide patent protection for KPT-350 and pharmaceutical compositions comprising KPT-350 through 2033.
Clinical Development Plans:
- Karyopharm is actively enrolling patients in three registration-directed clinical studies evaluating selinexor: one in older patients with relapsed/refractory AML (SOPRA study), the second in patients with relapsed/refractory DLBCL (SADAL study) and the third in patients with relapsed/refractory Richter's transformation (SIRRT study). Preliminary top-line data from all three studies are anticipated in the second half of 2016.
- Karyopharm plans to initiate a single-arm trial in multiple myeloma called STORM, for Selinexor Treatment of Refractory Myeloma, in the second quarter of 2015, which will initially include 80 patients. If the data from the initial 80 patients is promising, the study may be expanded to potentially support accelerated approval.
- Karyopharm is also actively enrolling patients in four Phase 2 solid tumor studies evaluating selinexor in gynecologic malignancies (SIGN Study), glioblastoma multiforme (KING Study), metastatic prostate cancer (SHIP Study) and squamous head and neck, lung and esophageal cancers (STARRS Study). Karyopharm will present interim data from SIGN and KING at ASCO.
- Karyopharm plans to initiate a registration-directed clinical trial of selinexor to treat liposarcoma in the second half of 2015. Accrual to Karyopharm's Phase 1b clinical trial in sarcomas, including liposarcoma, is nearly complete.
- In addition, a number of investigator-sponsored (ISTs) or company-sponsored clinical studies evaluating the potential of selinexor in combination with either chemotherapy or targeted agents are currently ongoing or planned.
Karyopharm also plans to initiate a Phase 1 clinical study of verdinexor (KPT-335), an oral SINE™ compound closely related to selinexor that is being studied as a potential therapy for viral indications. This randomized, double-blind, placebo-controlled, dose-escalating trial, which has been designed to evaluate the safety and tolerability of verdinexor in healthy adult subjects, is expected to initiate in the second quarter of 2015 and will be conducted in
Cash, cash equivalents and investments as of
For the quarter ended
Karyopharm reported a net loss of
Based on current operating plans, Karyopharm expects that its existing cash and cash equivalents will fund its research and development programs and operations into 2018, including moving registration-directed clinical studies to their next data inflection points. Karyopharm expects to end 2015 with greater than
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding to and inhibiting the nuclear export protein XPO1 (or CRM1). In addition to single-agent activity against a variety of different human cancers, SINE™ compounds have also shown biological activity in models of cancer, inflammation, autoimmune disease, certain viruses, and wound-healing. Karyopharm was founded by Dr. Sharon Shacham and is located in
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that any of Karyopharm's SINE™ compounds, including selinexor (KPT-330) or any PAK4 inhibitor, or any other drug candidate that Karyopharm is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's
drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share amounts)|
|Cash and cash equivalents||$ 51,453||$ 150,609|
|Prepaid expenses and other current assets||2,910||2,027|
|Total current assets||249,319||207,751|
|Property and equipment, net||3,282||2,754|
|Total assets||$ 292,040||$ 220,337|
|Liabilities and stockholders' equity|
|Accounts payable||$ 6,957||$ 6,288|
|Other current liabilities||128||62|
|Total current liabilities||14,702||12,301|
|Deferred rent, net of current portion||1,813||1,242|
|Additional paid-in capital||439,914||345,166|
|Accumulated other comprehensive income (loss)||19||(29)|
|Total stockholders' equity||275,525||206,794|
|Total liabilities and stockholders' equity||$ 292,040||$ 220,337|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share amounts)|
|Three Months Ended,|
|Contract and grant revenue||$ —||$ 171|
|Research and development||20,751||10,979|
|General and administrative||5,399||2,904|
|Total operating expenses||26,150||13,883|
|Loss from operations||(26,150)||(13,712)|
|Other income (expense):|
|Total other income (expense), net||83||18|
|Net loss per share applicable to common stockholders—basic and diluted||
|Weighted-average number of common shares outstanding used in net loss per share applicable to common stockholders—basic and diluted||35,317,181||29,606,683|
Justin Renz(617) 658-0574 email@example.com Gina Nugent(617) 460-3579 firstname.lastname@example.org
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