Full Press Release Details
Karyopharm Reports First Quarter 2015 Financial Results and Highlights Recent Progress
Positive Data in Difficult to Treat Cancers with Significant Unmet Need Further Supports Broad Clinical
Development Campaign for Selinexor
Conference Call Scheduled for today at 8:30 a.m. ET
Newton, Mass. May 11, 2015 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today reported
financial results for the first quarter 2015 and commented on recent accomplishments and clinical development plans for selinexor, its lead product candidate.
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 American Association for Cancer Research, said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. These data further demonstrated the role XPO1 inhibition in difficult to treat cancers
with limited treatment options, including preclinical data describing the robust activity of selinexor alone and in combination with novel and standard of care therapies across a variety of hematologic and solid tumor cancers. Taken together, these
data further support our ongoing broad clinical development plans for selinexor.
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:
Scientific Presentations and Publications:
Regulatory and Intellectual Property Updates:
First Quarter March 31, 2015 Financial Results
Cash, cash equivalents and investments as of March 31, 2015, including restricted cash, totaled $285.3 million, compared to $214.8 million as of
December 31, 2014. Karyopharm raised $90.8 million in a common stock follow-on offering which closed in January 2015.
ended March 31, 2015, research and development expense was $20.8 million compared to $11.0 million for the quarter ended March 31, 2014. For the quarter ended March 31, 2015, general and administrative expense was $5.4 million
compared to $2.9 million for the quarter ended March 31, 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.
reported a net loss of $26.1 million, or $0.74 per share, for the quarter ended March 31, 2015, compared to a net loss of $13.7 million, or $0.46 per share, for the quarter ended March 31, 2014. Net loss includes stock-based compensation
expense of $3.7 million and $2.8 million for the quarters ended March 31, 2015 and March 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 2018, including moving registration-directed clinical studies to their next data inflection points. Karyopharm expects to end 2015 with greater than $200 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 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 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) 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 Annual Report on Form 10-K for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission (SEC) as of March 13, 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
thousands, except share and per share amounts)
| March 31, 2015 | December 31, 2014 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 51,453 | $ | 150,609 | ||||
| Short-term investments | 194,956 | 55,115 | ||||||
| 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 | ||||||
| Long-term investments | 38,539 | 8,658 | ||||||
| Other assets | 500 | 774 | ||||||
| Restricted cash | 400 | 400 | ||||||
| Total assets | $ | 292,040 | $ | 220,337 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,957 | $ | 6,288 | ||||
| Accrued expenses | 7,417 | 5,825 | ||||||
| Deferred rent | 200 | 126 | ||||||
| Other current liabilities | 128 | 62 | ||||||
| Total current liabilities | 14,702 | 12,301 | ||||||
| Deferred rent, net of current portion | 1,813 | 1,242 | ||||||
| Total liabilities | 16,515 | 13,543 | ||||||
| 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; 35,687,196 and 32,699,380 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively | 4 | 3 | ||||||
| Additional paid-in capital | 439,914 | 345,166 | ||||||
| Accumulated other comprehensive income (loss) | 19 | (29 | ) | |||||
| Accumulated deficit | (164,412 | ) | (138,346 | ) | ||||
| Total stockholders equity | 275,525 | 206,794 | ||||||
| Total liabilities and stockholders equity | $ | 292,040 | $ | 220,337 |
Karyopharm Therapeutics Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except share and per share amounts)
| Three Months Ended, March 31, | ||||||||
| 2015 | 2014 | |||||||
| Contract and grant revenue | $ | $ | 171 | |||||
| Operating expenses: | ||||||||
| 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): | ||||||||
| Interest income | 141 | 18 | ||||||
| Other expense | (58 | ) | ||||||
| Total other income (expense), net | 83 | 18 | ||||||
| Net loss | $ | (26,067 | ) | $ | (13,694 | ) | ||
| Net loss per share applicable to common stockholders basic and diluted | $ | (0.74 | ) | $ | (0.46 | ) | ||
| 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 |