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XPOVIO™ Commercial Launch Underway Following July 3rd FDA Accelerated Approval −
− XPOVIO is the First and Only Prescription Medicine Approved in the U.S. for the Treatment of Patients with Multiple Myeloma whose Disease is Refractory to Proteasome Inhibitors, Immunomodulatory Agents, and an Anti-CD38 Monoclonal Antibody –
− Conference Call Scheduled for Today at 8:30 a.m. ET −
NEWTON, Mass., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today reported financial results for the second quarter 2019. In addition, Karyopharm highlighted select corporate milestones, including an update regarding the initial commercial launch of XPOVIO, and provided an overview of its key clinical development programs.
“Our second quarter progress was followed by a transformational milestone: the U.S. Food and Drug Administration (FDA) granting accelerated approval of oral XPOVIO™ (www.XPOVIO.com), indicated for patients with heavily pre-treated multiple myeloma,” said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. “The commercial launch of XPOVIO, our first approved product, is off to a strong start with encouraging early prescribing trends from both academic and community-based physicians throughout the U.S. While we are laser-focused on the success of the initial launch, we remain deeply committed to serving the future needs of patients well beyond those directly indicated in the U.S. accelerated approval. To that end, we eagerly await the clinical trial results from the ongoing Phase 3 BOSTON study and continue to support the evaluation of a Marketing Authorization Application (MAA) of selinexor currently under review by the European Medicines Agency (EMA). And finally, we expect to rapidly advance the regulatory filings for selinexor in both the U.S. and Europe requesting accelerated and conditional approval, respectively, for patients with relapsed or refractory diffuse large B-cell lymphoma.”
Second Quarter 2019 Highlights and Recent Progress
Selinexor in Multiple Myeloma
Selinexor in Diffuse Large B-Cell Lymphoma (DLBCL)
Selinexor in Solid Tumors
Second Quarter 2019 Financial Results
Cash, cash equivalents and investments as of June 30, 2019, including restricted cash, totaled $217.9 million, compared to $330.9 million as of December 31, 2018.
License and other revenue for the quarter ended June 30, 2019 was $9.5 million, compared to $19.9 million for the quarter ended June 30, 2018, both of which were primarily related to the Company’s license agreements with Antengene and Ono, respectively.
For the quarter ended June 30, 2019, research and development expense was $26.5 million, compared to $44.7 million for the quarter ended June 30, 2018. Karyopharm expects research and development expense to be relatively consistent for the remainder of 2019 compared to the second quarter of 2019. For the quarter ended June 30, 2019, general and administrative expense was $24.7 million compared to $9.5 million for the quarter ended June 30, 2018. The increase in general and administrative expenses compared to the prior year period was due primarily to the hiring of the Karyopharm commercial team and related commercial launch preparation activities to support the U.S. commercial launch of XPOVIO.
Karyopharm reported a net loss of $43.4 million, or $0.71 per share, for the quarter ended June 30, 2019, compared to a net loss of $33.7 million, or $0.60 per share, for the quarter ended June 30, 2018. Net loss includes non-cash stock-based compensation expense of $4.1 million and $4.4 million for the quarters ended June 30, 2019 and June 30, 2018, respectively.
2019 Financial Outlook
Based on its current operating plans, Karyopharm expects its non-GAAP operating expenses, which excludes stock-based compensation expense, for the full year 2019 to be in the range of $200 million to $215 million. The Company expects that its existing cash, cash equivalents and investments will be sufficient to fund its operations into the second half of 2020. Additional key activities expected in 2019 include supporting the ongoing multiple myeloma regulatory filing for selinexor in Europe, progressing the pivotal Phase 3 BOSTON study in multiple myeloma and potentially submitting an NDA and MAA, in the U.S. and Europe, respectively, in DLBCL.
Non-GAAP Financial Information and Other Disclosures
Karyopharm uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Karyopharm believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Karyopharm’s operating performance as it excludes non-cash stock compensation expense. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Karyopharm’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Karyopharm’s operating results as reported under GAAP. Karyopharm has not provided GAAP reconciliation for its forward-looking non-GAAP annual operating expense because Karyopharm cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure.
Conference Call Information
Karyopharm will host a conference call today, Tuesday, August 6, 2019, at 8:30 a.m. Eastern Time, to discuss the second quarter 2019 financial results, recent accomplishments, clinical developments and business plans. To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 5550468. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. An archived webcast will be available on the Company's website approximately two hours after the event.
Important Safety Information
The most common adverse reactions observed in patients treated with XPOVIO (incidence ≥20%) are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.
The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in the XPOVIO dose, and 65.3% had the dose of XPOVIO interrupted. The most frequent adverse reactions requiring permanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, and thrombocytopenia. The rate of fatal adverse reactions was 8.9%.
The full Prescribing Information for XPOVIO is available at www.XPOVIO.com.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is an oncology-focused pharmaceutical company dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export 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). Karyopharm’s lead compound, XPOVIO™ (selinexor), received accelerated approval from the FDA in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma. A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency. 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 has several 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 Karyopharm’s expectations relating to XPOVIO for the treatment of patients with heavily pretreated multiple myeloma, commercialization of XPOVIO or any of its drug candidates, submissions to, and the review and potential approval of selinexor by, regulatory authorities, including the anticipated timing of such submissions and actions and the potential availability of accelerated approval pathways, and the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, especially selinexor. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond Karyopharm's control, that may cause actual events or results to differ materially from Karyopharm's current expectations. For example, there can be no guarantee that Karyopharm will successfully commercialize XPOVIO; that regulators will agree that selinexor qualifies for conditional approval in the E.U. as a result of data from the STORM study or accelerated or conditional approval in the U.S. or EU, respectively, based on the SADAL study in patients with relapsed or refractory DLBCL, or that any of Karyopharm's drug candidates, including selinexor, will successfully complete necessary 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: the timing and costs involved in commercializing XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; 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, including with respect to the need for additional clinical studies; 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, 2019, which was filed with the Securities and Exchange Commission (SEC) on May 9, 2019, 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, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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Karyopharm Therapeutics Inc.
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Karyopharm Therapeutics Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
|Cash and cash equivalents||$||75,545||$||118,021|
|Prepaid expenses and other current assets||5,671||6,413|
|Total current assets||222,830||334,612|
|Property and equipment, net||3,375||3,863|
|Operating lease right-of-use assets||11,180||—|
|Liabilities and stockholders’ equity|
|Operating lease liabilities||1,522||—|
|Other current liabilities||453||327|
|Total current liabilities||32,174||46,904|
|Convertible senior notes||106,157||102,664|
|Operating lease liabilities, net of current portion||14,055||—|
|Deferred revenue, net of current portion||3,245||4,532|
|Deferred rent, net of current portion||—||3,922|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding||—||—|
|Common stock, $0.0001 par value; 200,000,000 shares authorized; 60,965,505 shares issued and outstanding at June 30, 2019; 100,000,000 shares authorized; 60,829,308 shares issued and outstanding at December 31, 2018||6||6|
|Additional paid-in capital||865,726||857,156|
|Accumulated other comprehensive income (loss)||61||(244||)|
|Total stockholders’ equity||82,469||183,170|
|Total liabilities and stockholders’ equity||$||238,100||$||341,192|
Karyopharm Therapeutics Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
Three Months Ended,
Six Months Ended
|License and other revenue||$||9,493||$||19,891||$||9,648||$||29,891|
|Research and development||26,517||44,734||64,491||86,055|
|General and administrative||24,662||9,489||51,765||17,110|
|Total operating expenses||51,179||54,223||116,256||103,165|
|Loss from operations||(41,686||)||(34,332||)||(106,608||)||(73,274||)|
|Other income (expense):|
|Other (expense) income||(44||)||7||(46||)||(7||)|
|Total other (expense) income, net||(1,721||)||660||(2,950||)||1,155|
|Loss before income taxes||(43,407||)||(33,672||)||(109,558||)||(72,119||)|
|Income tax (provision) benefit||(8||)||17||(18||)||5|
|Net loss per share—basic and diluted||$||(0.71||)||$||(0.60||)||$||(1.80||)||$||(1.36||)|
|Weighted-average number of common shares outstanding used in net loss per share—basic and diluted||60,929,024||56,089,159||60,892,860||52,862,194|