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On Track to Report Top-Line Data from STORM and STOMP Studies in Relapsed/Refractory Multiple Myeloma and Updated Data from SIGN Study in Gynecologic Malignancies
Conference Call Scheduled for Today at 8:30 a.m. ET
NEWTON, Mass., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today reported financial results for the second quarter 2016 and commented on recent accomplishments and clinical development plans for its lead, novel, oral Selective Inhibitor of Nuclear Export (SINE™) compound selinexor (KPT-330), and other pipeline assets, including KPT-8602, its second-generation SINE™ compound, and KPT-9274, its oral, dual inhibitor of p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT).
“In the first half of 2016, we continued to drive rapid and meaningful progress across our development programs, including completion of enrollment in our Phase 2b STORM study in multiple myeloma (MM), the opening of a Phase 1b study arm evaluating selinexor in combination with the PD-1 inhibitor pembrolizumab in advanced solid tumors, and the advancement of KPT-9274 into the clinic,” said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. “At the 2016 European Hematology Association Annual Meeting, we presented exciting preliminary data from our Phase 1b STOMP study showing high response rates, along with durable activity and a favorable safety profile when selinexor is combined with standard-of-care agents in heavily pre-treated patients with MM.”
Dr. Kauffman continued, “We remain on track for data readouts from several of our ongoing selinexor studies, including top-line results from the STORM and STOMP studies in relapsed/refractory MM, updated data from the SIGN study in gynecologic malignancies at the European Society of Medical Oncology 2016 Annual Meeting, and an interim analysis from the ongoing Phase 2 SOPRA study in relapsed/refractory acute myeloid leukemia (AML) in late 2016. For KPT-8602, our second generation SINE™ compound, we look forward to reporting top-line safety and tolerability results from the Phase 1 portion of the ongoing study in patients with relapsed/refractory MM in late 2016. All of these efforts bring us ever closer to our goal of providing novel, first-in-class medicines to patients with cancer and other major diseases. We look forward to keeping you updated on our progress.”
Conference Call Information:
Karyopharm will host a conference call today, Thursday, August 4, 2016, at 8:30 a.m. Eastern Time, to discuss the second quarter 2016 financial results, recent accomplishments, clinical developments and business plans. 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: 51644582. An audio recording 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.
Clinical Development Plans and Timelines:
Second Quarter 2016 Financial Results
Cash, cash equivalents and investments as of June 30, 2016, including restricted cash, totaled $166.2 million, compared to $187.1 million as of March 31, 2016.
For the quarter ended June 30, 2016, research and development expense was $24.6 million compared to $27.0 million for the quarter ended June 30, 2015. For the quarter ended June 30, 2016, general and administrative expense was $6.0 million compared to $6.2 million for the quarter ended June 30, 2015. The decrease in research and development expenses resulted primarily from a decrease in costs associated with the completion of selinexor clinical trial supply manufacturing and toxicology studies in 2015.
Karyopharm reported a net loss of $30.2 million, or $0.84 per share, for the quarter ended June 30, 2016, compared to a net loss of $32.7 million, or $0.92 per share, for the quarter ended June 30, 2015. Net loss includes stock-based compensation expense of $6.4 million and $4.5 million for the quarters ended June 30, 2016 and June 30, 2015, respectively.
Based on current operating plans, Karyopharm expects that its existing cash and cash equivalents will fund its research and development programs and operations into the middle of 2018, including advancing the STORM, SOPRA, SADAL and SEAL clinical studies to their next data inflection points. Karyopharm expects to end 2016 with at least $120 million in cash, cash equivalents and investments.
About Karyopharm Therapeutics
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 and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). The Company's initial focus is on seeking regulatory approval and commercialization of its lead drug candidate, oral selinexor (KPT-330). To date, over 1,500 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-stage clinical trials across multiple cancer indications, including acute myeloid leukemia (SOPRA), diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL) and in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), among others. In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm, which was founded by Dr. Sharon Shacham, currently has five investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
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), KPT-8602, Karyopharm's next generation SINE™ compound, or KPT-9274, Karyopharm's first-in-class oral dual inhibitor of PAK4 and NAMPT, verdinexor (KPT-335), KPT-350, 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 U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on May 9, 2016, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
|Karyopharm Therapeutics Inc.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share amounts)|
|June 30,||December 31,|
|Cash and cash equivalents||$||37,717||$||58,358|
|Prepaid expenses and other current assets||1,464||1,967|
|Total current assets||124,200||177,600|
|Property and equipment, net||3,170||3,483|
|Liabilities and stockholders’ equity|
|Other current liabilities||79||95|
|Total current liabilities||15,523||15,132|
|Deferred rent, net of current portion||1,808||1,946|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized; 35,989,260 and 35,864,765 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively||4||4|
|Additional paid-in capital||467,168||455,170|
|Accumulated other comprehensive income (loss)||138||(282||)|
|Total stockholders’ equity||153,566||198,365|
|Total liabilities and stockholders’ equity||$||170,897||$||215,443|
|Karyopharm Therapeutics Inc.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share amounts)|
|Three Months Ended,||Six Months Ended|
|June 30,||June 30,|
|Contract and grant revenue||$||59||$||150||$||59||$||150|
|Research and development||24,579||27,006||46,374||47,757|
|General and administrative||5,956||6,157||11,510||11,556|
|Total operating expenses||30,535||33,163||57,884||59,313|
|Loss from operations||(30,476||)||(33,013||)||(57,825||)||(59,163||)|
|Other income (expense)||(11||)||51||(7||)||(7||)|
|Total other income, net||318||318||608||401|
|Net loss per share—basic and diluted||$||(0.84||)||$||(0.92||)||$||(1.59||)||$||(1.65||)|
|Weighted-average number of common shares outstanding used |
in net loss per share—basic and diluted
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