KPTI Karyopharm Therapeutics Inc.

5.25
-0.13  -2%
Previous Close 5.38
Open 5.3
52 Week Low 4.42
52 Week High 18
Market Cap $396,360,610
Shares 75,497,259
Float 71,743,134
Enterprise Value $346,177,445
Volume 684,612
Av. Daily Volume 1,362,390
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Upcoming Catalysts

Drug Stage Catalyst Date
XPOVIO (selinexor) - SIENDO
Endometrial cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Eltanexor (KPT-8602)
Myelodysplastic syndrome (MDS), hypomethylating agents (HMA) refractory.
Phase 1/2
Phase 1/2
Phase 1 portion of the study demonstrated a 53% ORR and a median 9.9 months OS, comparing favorably to historical controls. Phase 2 expansion initiated, noted October 21, 2021.
XPOVIO (selinexor) and JAKAFI (ruxolitinib) - (XPORT-MF-034)
Myelofibrosis
Phase 1/2
Phase 1/2
Phase 1/2 initiation of dosing announced July 28, 2021.
XPOVIO (selinexor) and KEYTRUDA (pembrolizumab) - (XPORT-MEL-033)
Melanoma
Phase 2
Phase 2
Phase 2 initiation of dosing announced July 28, 2021.
KPT-9274
Non-Hodgkin Lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 ongoing.
XPOVIO (selinexor)
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Phase 2
Phase 2
Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.
XPOVIO (selinexor)
COVID-19 Coronavirus
Phase 2
Phase 2
Phase 2 data noted unlikely to demonstrate efficacy benefit across entire patient population with benefit in a clearly defined subpopulation of patients.
XPOVIO (selinexor)
Diffuse Large B-Cell Lymphoma (DLBCL)
Approved
Approved
FDA Approval announced June 22, 2020.
XPOVIO (selinexor)
Glioblastoma
Phase 1/2
Phase 1/2
Phase 1/2 commencement of dosing announced June 9, 2020.
XPOVIO (selinexor)
Multiple myeloma
Approved
Approved
FDA approval announced December 18, 2020.
XPOVIO (selinexor)
Dedifferentiated liposarcoma
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 2, 2020.
XPOVIO (selinexor)
Quadruple Refractory Multiple Myeloma
Approved
Approved
FDA Approval announced July 3, 2019.

Latest News

  1. NEWTON, Mass., Oct. 21, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced dosing of the first patient in the Phase 2 expansion of an ongoing open-label Phase 1/2 study investigating eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) compound, as a single-agent or in combination with approved and investigational agents in patients with several types of hematologic and solid tumor cancers (KCP-8602-801; NCT02649790). The Phase 2 expansion is designed to evaluate eltanexor monotherapy in patients with hypomethylating agents (HMA) refractory, intermediate or high-risk myelodysplastic syndrome (MDS). The primary endpoint…

    NEWTON, Mass., Oct. 21, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced dosing of the first patient in the Phase 2 expansion of an ongoing open-label Phase 1/2 study investigating eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) compound, as a single-agent or in combination with approved and investigational agents in patients with several types of hematologic and solid tumor cancers (KCP-8602-801; NCT02649790). The Phase 2 expansion is designed to evaluate eltanexor monotherapy in patients with hypomethylating agents (HMA) refractory, intermediate or high-risk myelodysplastic syndrome (MDS). The primary endpoint for this Phase 2 expansion is overall response rate (ORR) with the secondary endpoints of determining progression-free and overall survival.

    Initiation of the Phase 2 expansion follows encouraging results from the Phase 1 portion of the study where single-agent eltanexor showed activity in patients with high-risk, relapsed MDS that was refractory to HMAs.  In that study (Sangmin, et al. EHA 2021), eltanexor demonstrated a 53% ORR and a median overall survival of 9.9 months, comparing favorably to historical controls. At the recommended Phase 2 dose of 10 mg, eltanexor monotherapy was well tolerated with low incidence and grade of gastrointestinal events. Exacerbation of cytopenias occurred in 20-40% of patients. Based on these promising signals, the study has been expanded to include an additional 83 patients with the first patient recently dosed. 

    "MDS is a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function, leading to a high risk of transformation into acute leukemia. HMAs are the current standard of care for patients with newly diagnosed, higher-risk MDS, however only 40-60% patients respond, with these responses typically lasting less than two years. As such, prognosis in HMA refractory disease is poor, with a median overall survival of four to six months. With no agents currently approved for primary HMA refractory MDS, the need for novel, efficacious agents is critical.  Based on the promising signal observed in the prior Phase 1 study, we are pleased to initiate dosing in the Phase 2 expansion and look forward to updating you on the progress of this important study in the future," said Sharon Shacham, PhD, MBA, Co-Founder and Chief Scientific Officer of Karyopharm.

    About Eltanexor

    Eltanexor (KPT-8602) is an investigational novel SINE compound that, like selinexor, functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.

    In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure at higher levels than is possible with selinexor. As a result, we believe that eltanexor represents another novel SINE compound and we are evaluating its safety, tolerability and efficacy in ongoing clinical studies.

    Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration, Health Canada, the European Medicines Agency, or any other regulatory agency.

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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.

    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 Karyopharm's expectations and plans relating to XPOVIO and eltanexor for the treatment of hematologic malignancies or certain solid tumors; the expected design of the Company's clinical trials; and the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, especially selinexor and eltanexor. 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 any of Karyopharm's drug candidates, including selinexor and eltanexor, 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 the development or commercialization of 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 risk that the COVID-19 pandemic could disrupt Karyopharm's business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO in the commercial marketplace, 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; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development or regulatory approval of drug candidates by Karyopharm's competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. 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, 2021, which was filed with the Securities and Exchange Commission (SEC) on August 5, 2021, 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.

    XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this press release are the property of their respective owners.

     

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    SOURCE Karyopharm Therapeutics Inc.

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  2. NEWTON, Mass., Sept. 7, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that Richard Paulson, President and Chief Executive Officer, will participate in the following virtual investor conferences in September:

    H.C. Wainwright 23rd Annual Global Investment Conference
    Format: Podium presentation
    Date: Monday, September 13, 2021
    Time: 7:00 AM Eastern Time

    Morgan Stanley 19th Annual Global Healthcare Conference
    Format: Fireside chat
    Date: Monday, September 13, 2021
    Time: 11:00 AM Eastern Time

    Baird 2021 Global Healthcare Conference
    Format: Fireside chat
    Date: Tuesday, September 14, 2021
    Time: 2:00 PM Eastern Time

    A live webcast of the fireside…

    NEWTON, Mass., Sept. 7, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that Richard Paulson, President and Chief Executive Officer, will participate in the following virtual investor conferences in September:

    H.C. Wainwright 23rd Annual Global Investment Conference

    Format: Podium presentation

    Date: Monday, September 13, 2021

    Time: 7:00 AM Eastern Time

    Morgan Stanley 19th Annual Global Healthcare Conference

    Format: Fireside chat

    Date: Monday, September 13, 2021

    Time: 11:00 AM Eastern Time

    Baird 2021 Global Healthcare Conference

    Format: Fireside chat

    Date: Tuesday, September 14, 2021

    Time: 2:00 PM Eastern Time

    A live webcast of the fireside chats and a replay of the H.C. Wainwright presentation can be accessed under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. A replay of the webcasts will be archived on the Company's website for 30 days following the presentation and fireside chats.

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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.

    Cision View original content:https://www.prnewswire.com/news-releases/karyopharm-announces-upcoming-virtual-investor-conference-participation-301369142.html

    SOURCE Karyopharm Therapeutics Inc.

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  3. NEWTON, Mass., Sept. 1, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that in connection with the hiring of Eleonora Goldberg, Senior Vice President of Global Medical & Scientific Affairs,  the Compensation Committee of Karyopharm's Board of Directors granted a stock option to purchase 100,000 shares of Karyopharm's common stock to Dr. Goldberg, with a grant date of August 31, 2021. The stock option was granted as an inducement material to Dr. Goldberg entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Compensation Committee also granted stock options to purchase an aggregate of 76,700…

    NEWTON, Mass., Sept. 1, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that in connection with the hiring of Eleonora Goldberg, Senior Vice President of Global Medical & Scientific Affairs,  the Compensation Committee of Karyopharm's Board of Directors granted a stock option to purchase 100,000 shares of Karyopharm's common stock to Dr. Goldberg, with a grant date of August 31, 2021. The stock option was granted as an inducement material to Dr. Goldberg entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Compensation Committee also granted stock options to purchase an aggregate of 76,700 shares of Karyopharm's common stock to 16 newly-hired employees, with a grant date of August 31, 2021. The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each of the stock options has an exercise price of $5.80 per share, the closing price of Karyopharm's common stock on August 31, 2021. Each stock option vests over four years, with 25% of the total number of shares underlying the stock option vesting on the one-year anniversary of the applicable employee's employment commencement date and 1/48th of the total number of shares vesting monthly thereafter, subject to the employee's continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each stock option will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee's employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable stock option agreement).

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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.

    XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this release are the property of their respective owners.

    Contacts:

    Investors: Argot Partners, Joe Rayne/Matthew DeYoung, 212.600.1902 | karyopharm@argotpartners.com

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    SOURCE Karyopharm Therapeutics Inc.

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  4. SHANGHAI and HONG KONG, Aug. 23, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that China's National Medical Products Administration has approved a Phase II study of selinexor (XPOVIO®) for the treatment of patients with myelofibrosis (MF).

    MF is a clonal bone narrow neoplasm which can emerge either as primary MF (PMF), polycythemia vera (PV) or essential thrombocythemia (ET). The disease is primarily characterized by fibrosis in the bone marrow, extramedullary hematopoiesis, anemia, splenomegaly, constitutional symptoms, and possible progression to leukemia that would shorten patients' survival. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is currently the only curative treatment for MF. However, such treatment is commonly associated with a high rate of complications and treatment-related deaths. According to the National Comprehensive Cancer Network (NCCN®) Guidelines for the Treatment of MF, patients with intermediate-2 or high-risk MF ineligible for allo-HSCT and with a platelet count of ≥50×109/L should be treated with JAK inhibitors ruxolitinib or fedratinib (2020 NCCN® Guidelines). Due to the poor prognosis of patients who have failed or developed resistance to these targeted therapies, MF still represents an urgent unmet medical need.

    This randomized, open-label, global multicenter Phase II study will be conducted at 15 centers across China, including the primary trial center the First Affiliated Hospital Soochow University, and enroll approximately 20 patients in total. The study is designed to evaluate the safety and efficacy of selinexor versus physician's choice (PC) in patients with MF who had received at least six months of treatment with a JAK1/2 inhibitor. Enrolled patients will be randomized in a 1:1 ratio into one of the two treatment arms, to receive either single agent selinexor or PC treatment. The primary endpoint of the study is the proportion of patients with a ≥35% spleen volume reduction from baseline (SVR35), as assessed by the independent radiographic review committee (IRC).

    Prof. Depei Wu, Director of Hematology Department at the First Affiliated Hospital Soochow University, and the principal investigator of the study, noted: "MF is a relatively rare form of proliferative neoplasm in the bone narrow that has long lacked effective treatment options before the emergence of targeted therapies. Allo-HSCT is currently the only curative treatment for patients with MF, yet not all patients with MF are eligible to or tolerant of the treatment. Although ruxolitinib has already been approved in China for the treatment of MF, patients who have failed on or developed resistance to the therapy still have very limited treatment options. This randomized, open-label, global multicenter Phase II study is designed to assess the safety and efficacy of selinexor versus physician's choice (PC) in patients with MF who had received at least six months of treatment with a JAK1/2 inhibitor. We are very hopeful that this study will provide additional evidence supporting the exploration of effective treatments for MF and ultimately provide a new treatment option to patients with MF in China."

    Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "The NMPA's approval for this clinical trial of selinexor in patients with MF marks another major milestone in our effort in developing selinexor in a broad range of diseases, and a big step towards expanding potential indications for this candidate drug. We are confident that selinexor will demonstrate its clinical utility in the treatment of MF as we progress with this clinical development program. We look forward to advancing this study under the oversight of the NMPA, and aim to achieve a clinical breakthrough for patients with MF in China."

    About Selinexor (XPOVIO®)

    Selinexor is a first-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ:KPTI), Selinexor is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, Korea, Australia, New Zealand and the ASEAN countries, and already obtained an NDA approval in South Korea through a priority review process.

    In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (RR DLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with RRMM or RR DLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.

    Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene's partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

    Antengene is currently conducting multiple clinical trials of selinexor for the treatment of MM, DLBCL, endometrial cancer, and peripheral T and NK/T-cell lymphoma, and five of these trials are at late-stages (Phase II/III).

    About Antengene

    Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D- driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has obtained 16 investigational new drug (IND) approvals, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor in South Korea already approved through a priority review process. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 13 clinical and pre-clinical assets, comprising 8 global rights assets and 5 assets with rights for Asia Pacific markets including the Greater China region. Driven by its vision of "Treating Patients Beyond Borders", Antengene is committed to addressing significant unmet medical needs by discovering, developing, manufacturing and commercializing first-in-class/best-in-class therapeutics.

    Forward-looking statements

    The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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    SOURCE Antengene Corporation Limited

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  5. NEWTON, Mass., Aug. 5, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported business highlights and financial results for the quarter ended June 30, 2021.

    Richard Paulson, President and Chief Executive Officer of Karyopharm, commented, "We are encouraged by the commercial performance of XPOVIO during the first half of 2021, which reflected meaningful year-over-year growth, up 21% compared to the first half of 2020, driven by rising confidence and demand from both academic and community-based oncologists. XPOVIO continues to move earlier in the treatment paradigm following U.S. Food and Drug Administration (FDA) approval in the second-line…

    NEWTON, Mass., Aug. 5, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported business highlights and financial results for the quarter ended June 30, 2021.

    Richard Paulson, President and Chief Executive Officer of Karyopharm, commented, "We are encouraged by the commercial performance of XPOVIO during the first half of 2021, which reflected meaningful year-over-year growth, up 21% compared to the first half of 2020, driven by rising confidence and demand from both academic and community-based oncologists. XPOVIO continues to move earlier in the treatment paradigm following U.S. Food and Drug Administration (FDA) approval in the second-line plus treatment setting for multiple myeloma in December 2020. In my first 100 days as CEO, my top priorities have been executional excellence in our multiple myeloma launch and prioritizing and advancing our pipeline. With respect to the launch, we've strengthened our organization and execution while solidifying our positioning in the multiple myeloma treatment landscape. XPOVIO is a new and effective modality that can become a standard of care in second-line plus, where utilizing new mechanisms is critical to continue improving patient outcomes. With respect to the pipeline, we have initiated a comprehensive portfolio review and continue to move forward with key new trials."

    "Looking ahead to the remainder of 2021, there are several important events and milestones on the horizon. First, we plan to host an investor day in the fourth quarter to outline Karyopharm's commercial and pipeline priorities and objectives for the upcoming quarters and years. Next, along with continued commercial growth in hematologic cancers, we are expecting top-line data from the Phase 3 SIENDO study in endometrial cancer, also around the end of this year. Endometrial cancer is the most common gynecologic cancer and has the potential to be our first XPOVIO approval in solid tumors. And finally, we expect to initiate or expand several key clinical studies across our pipeline, including in myelodysplastic syndrome, myelofibrosis, multiple myeloma and colorectal cancer," concluded Mr. Paulson.

    Second Quarter 2021 & Recent Highlights

    XPOVIO® Commercial Performance

    • Achieved U.S. net product revenue for the second quarter of 2021 of $20.2 million and $41.9 million year to date, representing 8% growth compared to the second quarter of 2020 and 21% growth compared to the first half of 2020.
    • Achieved the following across both multiple myeloma and diffuse large B-cell lymphoma (DLBCL):
      • Over 7,600 prescriptions filled as of June 30, 2021; and
      • Added 142 new unique accounts during the second quarter of 2021, an increase of 11% compared to the first quarter of 2021.
    • Payer coverage remains strong at 97%.
    • Launched three new strength oral XPOVIO tablets (40mg, 50mg and 60mg), versus only 20mg available previously, to simplify regimens and reduce pill burden for patients.
    • Intent to prescribe metrics show a rising confidence in physicians' overall perception of XPOVIO and that physicians are choosing it for earlier lines of treatment; discontinuation rates remain low (approximately 13%).
    • Strengthened the commercial team with the appointment of Sohanya Cheng, former sales and marketing lead for Kyprolis® (carfilzomib) at Amgen, as Head of Sales and Commercial Operations.
    • Expanded global access to XPOVIO through the conditional approval for XPOVIO plus dexamethasone in the United Kingdom for the treatment of penta-refractory multiple myeloma, and Karyopharm's partner Antengene securing marketing approval for XPOVIO for the treatment of penta-refractory multiple myeloma and DLBCL in South Korea.

    R&D Highlights

    Hematologic Malignancies: Karyopharm is actively building its hematologic oncology franchise through several key initiatives, including pursuing NEXPOVIO marketing approval in Europe in the second-line plus treatment setting for multiple myeloma, expanding approved multiple myeloma indications in the U.S. to include combinations with certain approved therapies, and pursuing additional high unmet need indications beyond multiple myeloma, such as myelofibrosis and myelodysplastic syndrome.

    • European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for NEXPOVIO® in combination with Velcade® (bortezomib) and low-dose dexamethasone for the treatment of multiple myeloma following at least one prior therapy. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), which will issue an opinion to the European Commission regarding the potential approval for the expanded indication. Karyopharm expects this review to be completed in the first half of 2022.
    • Presented positive results for near-term and longer-term multiple myeloma expansion programs at the European Hematology Association 2021 Congress, including:
      • The arm of the Phase 1b/2 STOMP study evaluating the all oral combination of XPOVIO, Pomalyst® (pomalidomide) and dexamethasone (XPd) in previously treated multiple myeloma. Karyopharm remains on track to initiate a randomized Phase 3 study with this combination by the end of 2021.
      • A subset analysis demonstrating that two STOMP triplet regimens XPOVIO, Kyprolis® and dexamethasone (XKd) and XPd achieved high response rates of 67% and 58%, respectively, in multiple myeloma patients with disease refractory to an anti-CD38 monoclonal antibody. These response rates compare favorably to the ~45% response rates seen with other combo regimens.
    • Commenced dosing in a new Phase 1/2 study evaluating XPOVIO in combination with Jakafi® (ruxolitinib) in patients with treatment-naïve myelofibrosis (XPORT-MF-034; NCT04562389).

    XPOVIO in Solid Tumors: In 2020, Karyopharm established proof-of-concept for XPOVIO in solid tumors in advanced liposarcoma. The Company is actively pursuing additional solid tumor indications for XPOVIO, either alone or in combination with other agents, including in endometrial cancer, glioblastoma, melanoma, colorectal cancer and non-small cell lung cancer.

    • Continued enrollment and dosing in the Phase 3 SIENDO study. Remain on track to report top-line results during the fourth quarter of 2021.
    • Commenced dosing in a new Phase 2 study evaluating XPOVIO in combination with Keytruda® (pembrolizumab) in patients with locally advanced or metastatic melanoma (XPORT-MEL-033; NCT04768881).

    Corporate & Business Highlights

    • Richard Paulson, formerly of Ipsen North American and Amgen, named President and Chief Executive Officer.
    • Received $60 million in expanded royalty agreement with entities managed by HealthCare Royalty Management, LLC (HCR), with up to another $40 million in potential financing available.
    • Acquired investigational Interleukin-12 (IL-12) program from Neumedicines Inc. for $7.4 million in cash and equity and certain other contingent consideration upon the satisfaction of certain development milestones. Karyopharm is evaluating potential opportunities to combine IL-12 asset with XPOVIO and/or other therapies for cancer and other diseases.
    • Karyopharm to host an investor day during the fourth quarter of 2021 to outline commercial and pipeline priorities and objectives.

    Second Quarter 2021 Financial Results

    "Our balance sheet remains strong, and based on our current operating plans, we believe our cash, cash equivalents and investments, together with growing XPOVIO revenues, license revenues and the recent capital secured through our amended agreement with HCR, provide us with a cash runway into mid-2023," said Michael P. Mason, Chief Financial Officer of Karyopharm. "Through steady topline growth, driven by both increased physician adoption as well as adding new patient groups and indications over time, our goal is to become a self-sustaining organization for our stakeholders."

    Net product revenue: Net product revenue for the second quarter of 2021 was $20.2 million, compared to $18.6 million for the second quarter of 2020.

    License and other revenue: License and other revenue for the second quarter of 2021 was $2.4 million, compared to $14.9 million for the second quarter of 2020. During the three months ended June 30, 2021, Karyopharm recognized $1.0 million pursuant to its license agreement with Anivive Lifesciences, Inc. and $1.4 million of revenue associated with named patient programs. During the three months ended June 30, 2020, Karyopharm recognized $12.7 million pursuant to its license agreement with Antengene Therapeutics Limited and $2.2 million upon reacquisition of the exclusive development and commercial rights from Ono Pharmaceutical Co., Ltd.

    Cost of sales: Cost of sales for the second quarter of 2021 were $1.1 million, compared to $0.4 million for the second quarter of 2020. Cost of sales reflects the costs of XPOVIO units sold and third-party royalties on net product revenue.

    Research and development (R&D) expenses: R&D expenses for the second quarter of 2021 were $34.0 million, compared to $42.6 million for the second quarter of 2020. The decrease in R&D expenses in the second quarter of 2021 compared to the second quarter of 2020 was primarily attributable to the COVID-19 trial activity in the second quarter of 2020 that did not occur in 2021.

    Selling, general and administrative (SG&A) expenses:  SG&A expenses for the second quarter of 2021 were $36.5 million, compared to $30.8 million for the second quarter of 2020. The increase in SG&A expenses in the second quarter of 2021 compared to the second quarter of 2020 was due primarily to activities to support the U.S. commercialization of XPOVIO, including the launch of XPOVIO in combination with once-weekly Velcade® and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 

    Interest expense: Interest expense for the second quarter of 2021 was $5.0 million, compared to $6.8 million for the second quarter of 2020. The decrease in interest expense was primarily attributable to the decrease in non-cash interest expense related to Karyopharm's 3.00% senior convertible notes due 2025, as a result of the January 1, 2021 adoption of ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity's Own Equity. Post adoption, Karyopharm is no longer required to amortize the debt discount to non-cash interest expense, as the debt discount component of $50.6 million has now been reclassified out of equity into the convertible senior notes line on its balance sheet.

    Net loss: Karyopharm reported a net loss of $53.6 million, or $0.71 per share, for the second quarter of 2021, compared to a net loss of $46.4 million, or $0.63 per share, for the second quarter of 2020. Net loss included non-cash stock-based compensation expense of $8.1 million and $6.4 million for the second quarters of 2021 and 2020, respectively.

    Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2021 totaled $239.3 million, compared to $276.7 million as of December 31, 2020.

    2021 Financial Outlook

    Based on its current operating plans, Karyopharm expects the following for full year 2021:

    • Non-GAAP R&D and SG&A expenses, excluding stock-based compensation expense, are expected to be in the range of $270 million to $290 million. Karyopharm has not reconciled the full year 2021 outlook for non-GAAP R&D and SG&A expenses to full year 2021 outlook for GAAP R&D and SG&A expenses 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 full year 2021 outlook for non-GAAP R&D and SG&A expenses.
    • The Company expects that its existing cash, cash equivalents and investments, together with the revenue it expects to generate from XPOVIO product sales, as well as revenue generated from its license agreements, will be sufficient to fund its planned operations into the middle of 2023.

    Non-GAAP Financial Information

    Karyopharm uses a non-GAAP financial measure, including R&D and SG&A expenses, to provide operating expense guidance. Non-GAAP R&D and SG&A expenses exclude stock-based compensation expense. 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 R&D and SG&A expenses and should not be considered a measure of Karyopharm's liquidity. Instead, non-GAAP R&D and SG&A expenses should only be used to supplement an understanding of Karyopharm's operating results as reported under GAAP.

    Conference Call Information

    Karyopharm will host a conference call today, Thursday, August 5, 2021, at 8:30 a.m. Eastern Time, to discuss the second quarter 2021 financial results and other company updates. To access the conference call, please dial (888) 437-3179 (local) or (862) 298-0702 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. 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.

    About XPOVIO® (selinexor)

    XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm's supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

    For more information about Karyopharm's products or clinical trials, please contact the Medical Information department at:

    Tel: +1 (888) 209-9326

    Email: medicalinformation@karyopharm.com

    XPOVIO® (selinexor) is a prescription medicine approved:

    • In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
    • In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
    • For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

    SELECT IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    • Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
    • Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
    • Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
    • Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
    • Serious Infection: Monitor for infection and treat promptly.
    • Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
    • Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
    • Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.

    Adverse Reactions

    • The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
    • The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
    • The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.

    Use In Specific Populations

    Lactation: Advise not to breastfeed.

    For additional product information, including full prescribing information, please visit www.XPOVIO.com.

    To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1–888–209–9326 or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch. 

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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.

    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 Karyopharm's guidance on its 2021 non-GAAP research and development and selling, general and administrative expenses; expectations and plans relating to XPOVIO for the treatment of adult patients with relapsed or refractory multiple myeloma or relapsed or refractory diffuse large B-cell lymphoma and other hematologic malignancies and solid tumors; commercialization of XPOVIO or any of its drug candidates and the commercial performance of XPOVIO; submissions to, and the review and potential approval of selinexor by, regulatory authorities, including the Company's regulatory strategy, the anticipated availability of data to support such submissions, timing of such submissions and actions by regulatory authorities and the potential availability of accelerated approval pathways; the expected design of the Company's clinical trials; 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 grant confirmatory approval in the European Union based on the BOSTON study in adult patients with multiple myeloma; 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 the development or commercialization of 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 risk that the COVID-19 pandemic could disrupt Karyopharm's business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; the ability to obtain and 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; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development or regulatory approval of drug candidates by Karyopharm's competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. 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, 2021, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2021, 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.

    XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this release are the property of their respective owners.





    KARYOPHARM THERAPEUTICS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited)

    (in thousands, except per share amounts)







    Three Months Ended

    June 30,





    Six Months Ended

    June 30,







    2021





    2020





    2021





    2020



    Revenues:

































    Product revenue, net



    $

    20,179





    $

    18,601





    $

    41,910





    $

    34,662



    License and other revenue





    2,422







    14,913







    3,951







    16,990



    Total revenues





    22,601







    33,514







    45,861







    51,652



    Operating expenses:

































    Cost of sales





    1,138







    396







    2,071







    1,215



    Research and development





    33,981







    42,594







    71,031







    76,591



    Selling, general and administrative





    36,530







    30,843







    74,180







    61,521



    Total operating expenses





    71,649







    73,833







    147,282







    139,327



    Loss from operations





    (49,048)







    (40,319)







    (101,421)







    (87,675)



    Other income (expense):

































    Interest income





    165







    849







    429







    1,824



    Interest expense





    (5,001)







    (6,758)







    (10,096)







    (13,267)



    Other income (expense), net





    436







    (61)







    375







    (36)



    Total other expense, net





    (4,400)







    (5,970)







    (9,292)







    (11,479)



    Loss before income taxes





    (53,448)







    (46,289)







    (110,713)







    (99,154)



    Income tax provision





    (134)







    (137)







    (283)







    (203)



    Net loss



    $

    (53,582)





    $

    (46,426)





    $

    (110,996)





    $

    (99,357)



    Net loss per share—basic and diluted



    $

    (0.71)





    $

    (0.63)





    $

    (1.48)





    $

    (1.41)



    Weighted-average number of common shares outstanding used in net loss per share—basic and diluted





    75,189







    73,237







    74,863







    70,475









    KARYOPHARM THERAPEUTICS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited)

    (in thousands)











    June 30, 2021



    December 31,

    2020

    Assets







    Cash, cash equivalents and investments

    $   237,896



    $     273,455

    Restricted cash

    1,401



    3,203

    Accounts receivable

    17,887



    12,881

    Other assets

    29,383



    23,511

    Total assets

    $   286,567



    $     313,050

    Liabilities and stockholders' (deficit) equity







    Convertible senior notes

    168,899



    117,928

    Deferred royalty obligation

    132,478



    73,088

    Other liabilities

    68,322



    71,488

    Total liabilities

    369,699



    262,504

    Total stockholders' (deficit) equity

    (83,132)



    50,546

    Total liabilities and stockholders' (deficit) equity; 75,334 and 73,923 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

    $   286,567



    $     313,050









     

     

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