Karyopharm Therapeutics

Karyopharm Therapeutics, Inc. is a commercial-stage pharmaceutical company, which engages in the discovery, development, and commercialization of drugs directed against nuclear export for the treatment of cancer and other diseases. Its Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s 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 pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. 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. The company was founded by Joseph Araujo, Ronald A. DePinho, Pamela A Silver, Giulio Draetta, Michael G. Kauffman, and Sharon Shacham on December 22, 2008 and is headquartered in Newton, MA.

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Karyopharm reports robust revenue growth and strategic clinical advancements

Karyopharm Therapeutics demonstrated strong performance in revenue growth and clinical pipeline advancements, positioning them for continued success in 2023.
Strategic strengths in product portfolio, leadership, and innovation align well with opportunities in accelerating growth and exploring novel treatment approaches.
Challenges in differentiation, data updates, and dose optimization require focused strategies to overcome obstacles and drive sustainable growth.
Overall, Karyopharm's focus on patient outcomes, strategic expansion, and upcoming milestones indicate a positive trajectory for the company.

Karyopharm Therapeutics navigates revenue challenges while advancing pipeline innovations

Karyopharm Therapeutics faced revenue challenges due to PAP usage and discounts but showcased strong demand for XPOVIO and promising pipeline progress.
The company's financial stability was supported by expense reductions and total revenue of $38.7 million for Q1 2023.
Opportunities lie in commercial expansions, Phase III data advancements, and strategic product development efforts, positioning Karyopharm for future growth and innovation.

Karyopharm Therapeutics excels in Q2, eyes $2B peak revenues

Karyopharm Therapeutics showcased strong financial performance, strategic workforce reductions, and progress in pivotal Phase III trials during the Q2 earnings call. The company's focus on advancing novel SINE compounds and maintaining financial strength positions them well for future growth and value creation.

Karyopharm Therapeutics reports robust Q3 earnings and highlights growth prospects

Karyopharm Therapeutics showcased strong financial performance with revenue of $36 million and emphasized growth potential.
Promising Phase III trial data for myelofibrosis and endometrial cancer positions selinexor as a treatment paradigm changer.
Challenges include PAP impact from foundation closures, but opportunities lie in novel drug combinations and growth strategies.

Karyopharm meets revenue targets, eyes transformative outcomes in trials

Karyopharm Therapeutics delivered on revenue targets, showcasing strong performance and promising trial results in key indications.
While facing challenges in academic settings and financial obligations, the company's strategic strengths and growth opportunities position it well for the future.
With a focus on advancing Phase III trials, leveraging IP advantages, and exploring new treatment avenues, Karyopharm aims for continued innovation and market expansion.
Overall, Karyopharm's Q4 2023 Earnings Call reflects a balanced outlook with a solid foundation for growth and value creation in the biopharmaceutical sector.

Karyopharm Therapeutics reports strong Q1 performance and strategic refinancing

Karyopharm Therapeutics' Q1 2024 earnings call highlighted robust performance, strategic refinancing, and promising late-stage pipeline developments. While facing challenges in financial clarity and trial progress, the company is well-positioned to capitalize on growth opportunities through biomarker-driven patient selection and combination therapies.

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Karyopharm Therapeutics, Inc. is a commercial-stage pharmaceutical company, which engages in the discovery, development, and commercialization of drugs directed against nuclear export for the treatment of cancer and other diseases. Its Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s 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 pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. 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. The company was founded by Joseph Araujo, Ronald A. DePinho, Pamela A, Silver, Giulio Draetta, Michael G. Kauffman, and Sharon Shacham on December 22, 2008 and is headquartered in Newton, MA.

Karyopharm Therapeutics Inc. (NASDAQ:KPTI ) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Elhan Webb - Senior Vice President of Investor Relations Richard Paulson - President & Chief Executive Officer Reshma Rangwala - Chief Medical Officer Sohanya Cheng - Chief Commercial Officer Michael Mason - Chief Financial Officer Conference Call Participants Chris Raymond - Piper Sandler Maurice Raycroft - Jefferies Colleen Kusy - Baird Brian Abrahams - RBC Capital Markets Ed White - H.C. Wainwright Jonathan Chang - Leerink Partners Operator Good morning.

Karyopharm Therapeutics Inc. (KPTI) Q1 2024 Earnings Call Transcript

– $148.0 Million (86%) of Existing Convertible Notes due in 2025 to be Exchanged for $111.0 Million of New Convertible Notes due in 2029 and Warrants – – Issues New $100.0 Million Senior Secured Term Loan due in 2028 – – Repays Principal Portion and Amends Royalty Agreement with HealthCare Royalty – NEWTON, Mass. , May 8, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, announced today that it has entered into a series of financing transactions that will extend the Company's debt maturities into 2028 and 2029, well beyond the Company's planned Phase 3 data readouts in 2025.

Karyopharm Announces Significant Refinancing Transactions and Amended Royalty Agreement Extending Vast Majority of Its Debt Maturities into 2028 and 2029

– Announces Significant Refinancing Transactions and Amends Royalty Agreement with HealthCare Royalty Extending Vast Majority of Its Debt Maturities into 2028 and 2029, Well Beyond Expected Data Readouts and Potential Approvals from the Company's Three Phase 3 Trials, Strengthening the Company for its Next Stage of Growth –  – Achieves First Quarter 2024 Total Revenue of $33.1 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $26.0 Million – –  Reaffirms Full Year 2024 Total Revenue Guidance of $140 .0  Million to $160 .0  Million, Including U.S. XPOVIO Net Product Revenue Guidance of $100 .0  Million to $120 .0  Million – –        Invited to Present Updated Data from a Pre-Specified Exploratory Subgroup Analysis of the Phase 3 SIENDO Trial of Selinexor Maintenance Treatment in Patients with TP53 Wild-type Advanced/Recurrent Endometrial Cancer at 2024 ASCO Annual Meeting – – Conference Call Scheduled for Today at 8:00 a.m. ET – NEWTON, Mass.

Karyopharm Reports First Quarter 2024 Financial Results and Highlights Recent Company Progress

-- Conference Call Scheduled for Wednesday, May 8, 2024, at 8:00 a.m. ET -- NEWTON, Mass.

Karyopharm to Report First Quarter 2024 Financial Results on May 8, 2024

Karyopharm Therapeutics Inc.'s selinexor is being featured in 7 presentations at ASCO. The company is also exploring selinexor's potential role in myelofibrosis, with two key trials planned. Karyopharm Therapeutics' cash position is a challenge, but success in any of their pivotal trials could be a game changer for selinexor's prospects.

Karyopharm Therapeutics: Spiraling Despite Upcoming Catalysts

Invited to Present Updated Endometrial Cancer Data During Special Session "ASCO Plenary Series: Rapid Abstract Updates" NEWTON, Mass. , April 24, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that several abstracts detailing new selinexor data have been selected for presentation at the 2024 American Society of Clinical Oncology Annual Meeting (2024 ASCO Annual Meeting) being held May 31 - June 4 in Chicago, IL.

Karyopharm Announces Presentations in Endometrial Cancer and Myelofibrosis at the 2024 American Society of Clinical Oncology Annual Meeting

NEWTON, Mass. , March 6, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Company's senior management team will participate in the Leerink Partners Global Biopharma Conference on Tuesday, March 12, 2024 and present at the Barclays 26th Annual Global Healthcare Conference in a fireside chat on Wednesday, March 13, 2024 at 9:00 a.m.

Karyopharm to Participate at Barclays 26th Annual Global Healthcare and Leerink Partners Global Biopharma Conferences

Karyopharm Therapeutics Inc. (KPTI) Q4 2023 Earnings Call Transcript

Karyopharm Therapeutics (KPTI) came out with a quarterly loss of $0.36 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to loss of $0.43 per share a year ago.

Karyopharm Therapeutics (KPTI) Reports Q4 Loss, Tops Revenue Estimates

–  Total Revenue of $146 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $112 Million for Full Year 2023, Meeting Company's Guidance – – Top-Line Data Readouts from Three Pivotal Phase 3 Trials Evaluating Selinexor in Endometrial Cancer, Myelofibrosis and Multiple Myeloma Expected in 2025 –  –  Company Provides Full-Year 2024 Total Revenue Guidance of $140 Million to $160 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $100 Million to $120 Million ; Cash Runway to Late 2025 –   –  Conference Call Scheduled for Today at 8:00 a.m. ET — NEWTON, Mass.

Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress

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-- Conference Call Scheduled for Thursday, February 29, 2024, at 8:00 a.m. ET -- NEWTON, Mass.

Karyopharm to Report Fourth Quarter and Full Year 2023 Financial Results on February 29, 2024

Karyopharm Therapeutics (KPTI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Will Karyopharm Therapeutics (KPTI) Report Negative Q4 Earnings? What You Should Know

Karyopharm Inc. has entered the realm of undervalued biotech stocks, making it a potential buying opportunity. The company's main drug, selinexor, is currently approved for the management of multiple myeloma and diffuse large B-cell lymphoma. Karyopharm is pursuing indications for myelofibrosis and endometrial cancer, with promising preliminary data and ongoing clinical trials.

Karyopharm: Approaching The Bottom Ahead Of Earnings And Topline Data (Rating Upgrade)

– Accelerating Innovation and Growth Strategy with Top-Line Data Readouts Expected in 2H 2024 and 2025 from Three Pivotal Phase 3 Studies Evaluating Selinexor in Multiple Myeloma, Endometrial Cancer and Myelofibrosis –  – Preliminary Unaudited Full Year 2023 Total Revenue and U.S. XPOVIO® (selinexor) Net Product Revenue Expected to be Approximately $146 Million and $112 Million, Respectively, Meeting Company's Guidance – – Potential for Selinexor to be a Novel Maintenance Treatment for Patients with TP53 Wild-Type Endometrial Cancer Further Strengthened with Long-Term Exploratory Subgroup Analyses from SIENDO Study; Recruitment Ongoing in the Company's Pivotal Phase 3 Study; Further Updates Planned to be Presented in 2024 – – Opportunity to Define a New Myelofibrosis Treatment Paradigm Based on the Encouraging Data Presented from the Phase 1 Study of Selinexor in Combination with Ruxolitinib in Patients with Treatment-Naïve Myelofibrosis; Recruitment Ongoing in the Company's Pivotal Phase 3 Study; Further Updates Planned to be Presented in 2024 – – Expect Cash Runway into Late 2025 Supporting Company Through Multiple Potentially Value Generating Milestones – NEWTON, Mass. , Jan. 8, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced preliminary unaudited fourth quarter and full year 2023 total revenue and U.S. XPOVIO net product revenue estimates and outlined its 2023 achievements and 2024 objectives.

Karyopharm Announces Preliminary Unaudited 2023 Revenue and 2024 Objectives

NEWTON, Mass. , Jan. 3, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Company's senior management team will participate at the 42nd Annual J.P.

Karyopharm to Present at 42nd Annual J.P. Morgan Healthcare Conference

SHANGHAI and HONG KONG , Dec. 13, 2023 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced that XPOVIO® (selinexor) has been added to the National Reimbursement Drug List (2023 Version) ("NRDL") for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) whose disease is refractory to at least one proteasome inhibitors (PIs), one immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody (mAb). The updated NRDL will officially take effect on January 1, 2024.

Antengene Announces Inclusion of XPOVIO® (selinexor) in 2023 China's National Reimbursement Drug List

Biomarker Data from Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis (MF) Suggestive of Disease Modification Data Reinforce the Potential for Selinexor in Combination with Ruxolitinib to Become a Novel, First-Line Treatment for JAKi-Naïve Patients with MF NEWTON, Mass. , Dec. 10, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced long-term follow up of treatment-naïve patients with myelofibrosis (MF) who participated in the Phase 1 portion of its study evaluating once-weekly selinexor in combination with ruxolitinib (NCT04562389).

Karyopharm Shares Data at ASH 2023 Showing Strong SVR and TSS Durability Observed from Phase 1 Study of Selinexor 60mg and Ruxolitinib in JAK Inhibitor (JAKi)-Naïve Myelofibrosis Patients, with no SVR or TSS Progressions Observed As of the Data Cutoff(1)

XPOVIO® (selinexor) is the first and only exportin 1 (XPO1) inhibitor approved in Macau.  XPOVIO® has received regulatory approvals in   42 countries and regions including Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia.

Antengene Announces XPOVIO® Regulatory Approval in Macau for the Treatment of Relapsed and/or Refractory Multiple Myeloma

Selinexor has received three approvals but has faced disappointing sales due to competition and toxicity. Nevertheless, an already established global commercial infrastructure will support the launch of additional indications. Selinexor is being evaluated in three phase 3 trials; (1) multiple myeloma, (2) endometrial cancer, (3) myelofibrosis. The probability of success is high based on prior data. Topline results are anticipated in 2H 2024, 1H 2025, and 2025, respectively. Each of the above trials, if successful, may add $1-2B in peak annual sales.

Karyopharm Therapeutics: Promising Potential With 3 Ongoing Phase 3 Studies But Risky

Long-Term Safety and Efficacy Data from SIENDO Study in the TP53 Wild-Type Exploratory Subgroup Showed Signals of Improvement in Overall Survival  (OS) Regardless of Mismatched Repair Status (MMR) Median OS Not Reached for Selinexor-Treated Patients Who are TP53 Wild-Type pMMR NEWTON, Mass., Nov. 6, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the presentation of updated long-term safety and efficacy data from a pre-specified exploratory subgroup analysis of the SIENDO study (NCT03555422) in patients with advanced or recurrent TP53 wild-type endometrial cancer at the International Gynecological Cancer Society (IGCS) Annual Global Meeting in Seoul, South Korea.

Karyopharm Announces New Preliminary Data in Overall Survival (OS) in Selinexor-Treated Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer as Part of Pre-Specified Exploratory Subgroup Analysis of the SIENDO Study

Karyopharm Therapeutics Inc. (NASDAQ:KPTI ) Q3 2023 Earnings Conference Call November 2, 2023 8:00 AM ET Company Participants Elhan Webb - SVP, IR Richard Paulson - President and CEO Reshma Rangwala - Chief Medical Officer Sohanya Cheng - Chief Commercial Officer Michael Mason - CFO Conference Call Participants Maury Raycroft - Jefferies Colleen Kusy - Baird Operator Good morning. My name is Guru and I will be your conference operator today.

Karyopharm Therapeutics Inc. (KPTI) Q3 2023 Earnings Conference Call Transcript

Long-Term Selinexor Data in Myelofibrosis will be Presented as Part of Oral Presentation NEWTON, Mass. , Nov. 2, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that several abstracts that include selinexor data in myelofibrosis (MF) have been selected for presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12, 2023, in San Diego, CA.

Karyopharm Announces Presentations at the 65th American Society of Hematology Annual Meeting and Exposition (ASH)

– Achieved Third Quarter 2023 Total Revenue of $36.0 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $30.2 Million – –  Maintains Full Year 2023 Total Revenue Guidance of $145 Million to $160 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $110 Million to $125 Million – –  Strong SVR and TSS Durability Observed from Phase 1 Study of Selinexor 60mg and Ruxolitinib in JAK Inhibitor (JAKi)-Naïve Myelofibrosis Patients, with No SVR or TSS Progressions Observed 1  – – Announced Clinical Trial Collaboration with Bristol Myers Squibb to Evaluate Novel CELMoD™ Agent CC- 92480, Mezigdomide in Combination with Selinexor in Patients with R/R Multiple Myeloma Progressing After T-cell Immunotherapies – – Conference Call Scheduled for Today at 8:00 a.m. ET – NEWTON, Mass.

Karyopharm Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

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—  Phase 1b/2 Trial Will Investigate Mezigdomide in Combination with  Selinexor  in Patients with Relapsed/Refractory Multiple Myeloma Progressing after T-cell Immunotherapies – — Expected to be Initiated 1H 2024 – NEWTON, Mass. , Oct. 30, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has entered into a clinical trial collaboration and supply agreement with Bristol-Myers Squibb (NYSE: BMY) to evaluate the company's proprietary investigational cereblon E3 ligase modulator (CELMoD™) agent mezigdomide in combination with Karyopharm's selinexor, an approved first-in-class inhibitor of Exportin 1 (XPO1), plus dexamethasone in patients with relapsed/refractory multiple myeloma.

Karyopharm Announces Clinical Trial Collaboration with Bristol Myers Squibb to Evaluate Novel CELMoD™ Agent CC- 92480 Mezigdomide in Combination with Selinexor in Patients with Relapsed/Refractory Multiple Myeloma

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