Full Press Release Details
Karyopharm Reports Fourth Quarter and Full Year 2015 Financial Results and Highlights Recent Progress
Company Continues to Expand its Leadership in SINETM-based Therapies with
Selinexor Clinical Advancement and Presentations of Encouraging Data for Earlier Stage Pipeline Programs
Cash Expected to Fund
Current R&D Plans into 2018
Several Data Readouts Expected over the Next 18 Months
Conference Call Scheduled for Today at 8:30 a.m. ET
Newton, Mass. March 14, 2016 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today reported
financial results for the fourth quarter and full year 2015 and commented on recent accomplishments and clinical development plans for its pipeline of several SINE-based therapeutics including selinexor, its lead product candidate.
During 2015, we continued to expand our leadership position in the development of oral SINE-based oncology and non-oncology therapies with clinical
advancement of selinexor across a number of hematologic and solid tumor indications and the presentation of encouraging data on our earlier-stage pipeline programs, said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm.
Our broad and aggressive oncology clinical development program continues in 2016 with both company- and investigator-sponsored trials underway or planned to evaluate selinexor both as a single-agent and in combination with other existing and
emerging oncology therapies. In addition, we made important progress with our non-oncology focused SINE compounds in a number of disease areas in which XPO1 is critically involved. We look forward to several potentially value-creating data readouts
over the next 18 months.
Conference Call Information:
Karyopharm will host a conference call today, Monday, March 14, 2016, at 8:30 a.m. Eastern Time, to discuss the fourth quarter and full-year 2015
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: 59463471. 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:
Scientific Presentations and Publications:
Fourth Quarter and Year Ended December 31, 2015 Financial Results
Cash, cash equivalents and investments as of December 31, 2015, including restricted cash, totaled $210.0 million, compared to $214.8 million as of
For the year ended December 31, 2015, research and development expense was $97.7 million compared to $60.1 million for the
year ended December 31, 2014. For the year ended December 31, 2015, general and administrative expense was $21.6 million compared to $15.9 million for the year ended December 31, 2014. The
increase in research and development expense 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 an increase in personnel costs, including stock-based compensation expense.
Karyopharm reported a net loss
of $118.2 million, or $3.32 per share, for the year ended December 31, 2015, compared to a net loss of $75.8 million, or $2.43 per share, for the year ended December 31, 2014. Net loss includes stock-based compensation expense of $17.1
million and $14.2 million for the years ended December 31, 2015 and 2014, respectively.
For the quarter ended December 31, 2015, research and
development expense was $24.1 million compared to $20.0 million for the quarter ended December 31, 2014. For the quarter ended December 31, 2015, general and administrative expense was $5.3 million compared to $5.9 million for the quarter
ended December 31, 2014. The increase in research and development expenses resulted primarily from the increase in expenses related to the continued clinical development of selinexor.
Karyopharm reported a net loss of $29.0 million, or $0.81 per share, for the quarter ended December 31, 2015, compared to a net loss of $25.9 million, or
$0.79 per share, for the quarter ended December 31, 2014. Net loss includes stock-based compensation expense of $5.4 million and $4.6 million for the quarters ended December 31, 2015 and December 31, 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 the middle of 2018, including advancing the four later-stage 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) , leading to the
accumulation of tumor suppressor proteins in the cell nucleus. Karyopharm s lead drug candidate, selinexor (KPT-330), is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. In addition to single-agent and combination
activity against a variety of different human cancers, SINE compounds have also shown biological activity in models of inflammation, autoimmune disease, neurological disorders, 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.
Forward-Looking Statements
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,
Karyopharm s first-in-class oral dual inhibitor of PAK4 and NAMPT, 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
September 30, 2015, which was filed with the Securities and Exchange Commission (SEC) on November 9, 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.
Consolidated Balance Sheets
thousands, except share and per share amounts)
| December 31, 2015 | December 31, 2014 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 58,358 | $ | 150,609 | ||||
| Short-term investments | 117,275 | 55,115 | ||||||
| Prepaid expenses and other current assets | 1,967 | 2,027 | ||||||
| Total current assets | 177,600 | 207,751 | ||||||
| Property and equipment, net | 3,483 | 2,754 | ||||||
| Long-term investments | 33,878 | 8,658 | ||||||
| Other assets | 774 | |||||||
| Restricted cash | 482 | 400 | ||||||
| Total assets | $ | 215,443 | $ | 220,337 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,808 | $ | 6,288 | ||||
| Accrued expenses | 11,023 | 5,825 | ||||||
| Deferred rent | 206 | 126 | ||||||
| Other current liabilities | 95 | 62 | ||||||
| Total current liabilities | 15,132 | 12,301 | ||||||
| Deferred rent, net of current portion | 1,946 | 1,242 | ||||||
| Total liabilities | 17,078 | 13,543 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| 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; 35,864,765 and 32,699,380 shares issued and outstanding at December 31, 2015 and 2014, respectively | 4 | 3 | ||||||
| Additional paid-in capital | 455,170 | 345,166 | ||||||
| Accumulated other comprehensive loss | (282 | ) | (29 | ) | ||||
| Accumulated deficit | (256,527 | ) | (138,346 | ) | ||||
| Total stockholders equity | 198,365 | 206,794 | ||||||
| Total liabilities and stockholders equity | $ | 215,443 | $ | 220,337 |
Karyopharm Therapeutics Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except share and per share amounts)
| For the Quarter Ended, December 31, | For the Year Ended December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Contract and grant revenue | $ | 25 | $ | 16 | $ | 250 | $ | 229 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 24,064 | 20,038 | 97,744 | 60,127 | ||||||||||||
| General and administrative | 5,264 | 5,920 | 21,582 | 15,948 | ||||||||||||
| Total operating expenses | 29,328 | 25,958 | 119,326 | 76,075 | ||||||||||||
| Loss from operations | (29,303 | ) | (25,942 | ) | (119,076 | ) | (75,846 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 250 | 42 | 897 | 97 | ||||||||||||
| Other expense | 7 | (28 | ) | (2 | ) | (28 | ) | |||||||||
| Total other income (expense), net | 257 | 14 | 895 | 69 | ||||||||||||
| Net loss | $ | (29,046 | ) | $ | (25,928 | ) | $ | (118,181 | ) | $ | (75,777 | ) | ||||
| Net loss per share basic and diluted | $ | (0.81 | ) | $ | (0.79 | ) | $ | (3.32 | ) | $ | (2.43 | ) | ||||
| Weighted-average number of common shares outstanding used in net loss per share basic and diluted | 35,749,362 | 32,668,705 | 35,619,506 | 31,135,694 |