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– Positive Selinexor Clinical Data Presented across Several Difficult to Treat Cancers –
– Provides Update to Certain Trials based on Expanding Clinical Experience –
Conference Call Scheduled for today at 8:30 a.m. ET
NEWTON, Mass., Aug. 10, 2015 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today reported financial results for the second quarter 2015 and commented on recent accomplishments and clinical development plans for selinexor, its lead product candidate.
"Important data describing the clinical benefit of selinexor across multiple solid and hematologic malignancies was presented during the quarter, including single agent anti-tumor activity and durable disease control in patients with recurrent glioblastoma, advanced sarcomas, ovarian and endometrial cancers. We also presented survival data in patients with relapsed/refractory diffuse large B-cell lymphoma treated with selinexor, along with combination data of selinexor with chemotherapy in patients with heavily pretreated acute myeloid leukemia," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "In addition, we continue to execute against the selinexor clinical development plan with the initiation of a Phase 2 study in patients with quad-refractory multiple myeloma and make steady progress enrolling patients in our other on-going later phase clinical trials in acute myeloid leukemia, diffuse large B cell lymphoma and Richter's transformation. Furthermore, we made some important changes to certain trials based on our growing experience with selinexor. Finally, we recently met with FDA and now have a path forward for a phase 2/3 study in liposarcoma. In the second half of 2016, we look forward to reporting preliminary top-line data from our later phase clinical trials in AML, DLBCL and Richter's transformation, as well as data from the first 80 patients in our later phase clinical trial in multiple myeloma in the middle of 2016."
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 98056569. 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.
Scientific Presentations and Publications:
Regulatory and Intellectual Property Updates:
Clinical Development Plans:
Second Quarter June 30, 2015 Financial Results
Cash, cash equivalents and investments as of June 30, 2015, including restricted cash, totaled $256.0 million, compared to $285.3 million as of March 31, 2015.
For the quarter ended June 30, 2015, research and development expense was $27.0 million compared to $13.2 million for the quarter ended June 30, 2014. For the quarter ended June 30, 2015, general and administrative expense was $6.2 million compared to $3.3 million for the quarter ended June 30, 2014. The increase in research and development expenses resulted primarily from the increase in expenses related to the continued clinical development of selinexor. The increase in general and administrative expense resulted primarily from the costs of being a public company and an increase in stock-based compensation.
Karyopharm reported a net loss of $32.7 million, or $0.92 per share, for the quarter ended June 30, 2015, compared to a net loss of $16.4 million, or $0.55 per share, for the quarter ended June 30, 2014. Net loss includes stock-based compensation expense of $4.5 million and $3.9 million for the quarters ended June 30, 2015 and June 30, 2014, 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 2018, including moving the four later-stage clinical studies to their next data inflection points. Karyopharm expects to end 2015 with greater than $200 million in cash, cash equivalents and investments.
"Karyopharm continues to maintain a very strong balance sheet, with approximately $256M in cash as of the end of the second quarter of 2015," said Justin Renz, Executive Vice President, Chief Financial Officer & Treasurer. "As for financial guidance this year, we remain on track to end 2015 with greater than $200M in cash."
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 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). 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 Newton, Massachusetts. 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) 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 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 June 30, 2015, which is on file with the Securities and Exchange Commission (SEC) as of August 10, 2015, 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||$ 24,231||$ 150,609|
|Prepaid expenses and other current assets||4,066||2,027|
|Total current assets||225,252||207,751|
|Property and equipment, net||3,234||2,754|
|Total assets||$ 263,293||$ 220,337|
|Liabilities and stockholders' equity|
|Accounts payable||$ 4,469||$ 6,288|
|Other current liabilities||97||62|
|Total current liabilities||14,099||12,301|
|Deferred rent, net of current portion||1,867||1,242|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized; 35,703,418 and 32,699,380 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively||4||3|
|Additional paid-in capital||444,574||345,166|
|Accumulated other comprehensive loss||(143)||(29)|
|Total stockholders' equity||247,327||206,794|
|Total liabilities and stockholders' equity||$ 263,293||$ 220,337|
|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||$ 150||$ 21||$ 150||$ 193|
|Research and development||27,006||13,159||47,757||24,138|
|General and administrative||6,157||3,310||11,556||6,214|
|Total operating expenses||33,163||16,469||59,313||30,352|
|Loss from operations||(33,013)||(16,448)||(59,163)||(30,159)|
|Other income (expense)||51||—||(7)||—|
|Total other income, net||318||17||401||34|
|Net loss||$ (32,695)||$ (16,431)||$ (58,762)||$ (30,125)|
|Net loss per share applicable to common stockholders—basic and diluted||$ (0.92)||$ (0.55)||$ (1.65)||$ (1.02)|
|Weighted-average number of common shares outstanding used in net loss per share applicable to common stockholders—basic and diluted||35,697,012||29,659,457||35,508,146||29,633,215|
CONTACT: Justin Renz (617) 658-0574 firstname.lastname@example.org Gina Nugent (617) 460-3579 email@example.comNEXT ARTICLE
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