Karyopharm Announces Strategic Financing Transactions to Support Growth; Extends Cash Runway Into Second Quarter of 2026, Beyond Expected Top-Line Readout of Phase 3 SENTRY Trial in Myelofibrosis

On October 8, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that it has entered into comprehensive financing and capital structure transactions expected to provide the Company with $100 million of financial flexibility and additional capital, extending the Company’s cash runway into the second quarter of 2026 based on the Company’s current operating plans (Press release, Karyopharm, OCT 8, 2025, View Source,-Beyond-Expected-Top-Line-Readout-of-Phase-3-SENTRY-Trial-in-Myelofibrosis [SID1234656510]).

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"Following the recent completion of enrollment of our Phase 3 SENTRY trial in myelofibrosis, we are excited to announce this strategic financing which is expected to provide us with the resources needed to deliver top-line data from this pivotal trial," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "I would like to thank our lenders, noteholders and equity investors for their ongoing support to strengthen our balance sheet, equitize near-term debt maturities and support our potentially transformational Phase 3 myelofibrosis program. We believe that selinexor plus ruxolitinib has the potential to be the first combination therapy approved for the treatment of myelofibrosis. By combining selinexor with the current standard of care, we have the potential to redefine the way people living with myelofibrosis are treated."

Each of the financing and capital structure transactions is expected to close on or around October 10, 2025 (Closing Date), subject to the satisfaction of customary closing conditions. The Company’s existing senior lenders have agreed to multi-faceted financing transactions with the following key components:

$67.5 million in financial flexibility and new capital consisting of $27.5 million in new term loan borrowings and new convertible notes, $25 million of near-term deferrals of interest and royalty payments, and a $15 million temporary reduction in the Company’s minimum liquidity covenant. In addition, holders of the Company’s convertible notes due 2029 have agreed to exchange $15 million of their notes for newly issued shares of common stock or pre-funded warrants in lieu thereof.
Holders of approximately $24.25 million aggregate principal amount of the Company’s senior unsecured convertible notes due October 15, 2025 have agreed to exchange their notes and accrued interest due thereon at a discount to par value for newly issued shares of common stock, or pre-funded warrants in lieu thereof, plus warrants to purchase shares of common stock.
In addition, the Company has entered into a securities purchase agreement for a private placement in which the Company agreed to sell 1,487,917 shares of common stock and accompanying warrants to purchase 1,317,771 shares of common stock with an exercise price of $6.64 per share. The warrants issued in the private placement will be exercisable on or before the 30th day following the public announcement of top-line results from the Company’s XPORT-EC-042 trial in endometrial cancer, which is anticipated in mid-2026. The private placement is expected to result in gross proceeds of approximately $8.75 million before deducting any offering expenses.

The Company intends to use the proceeds of the financing transactions to pay transaction expenses and for general corporate purposes, including to support the Company’s ongoing and planned clinical trial activities.

At closing of the financing transactions, the Company will issue an aggregate of 7,223,982 newly issued shares of common stock, newly issued pre-funded warrants to purchase an aggregate of 2,913,136 shares of common stock, and newly issued warrants to purchase an aggregate of 5,918,358 shares of common stock with an exercise price of $6.64 per share, a 15% premium to the Nasdaq minimum price. In addition, the Company will reduce the exercise price of outstanding warrants to purchase 3,068,417 shares from $16.50 per share to $6.64 per share. The financing transactions are intended to comply with Nasdaq rules, including being priced at the "minimum price" (as defined in the Nasdaq rules). Following consummation of the transactions, the Company expects to have an aggregate of 15,926,939 shares of common stock outstanding (assuming no exercise of any pre-funded warrants or warrants or conversions of any outstanding convertible notes).

Additional details on the financing transactions will be available in a Form 8-K that the Company will file with the United States Securities and Exchange Commission.

Preliminary Third Quarter 2025 Financial Results

Based on preliminary financial information, the Company expects total revenue, which includes license and royalty revenue from partners, to be in the range of $42 to $44 million and U.S. XPOVIO net product revenue to be approximately $32 million for the three months ended September 30, 2025.

Prior to the receipt of approximately $36 million of gross proceeds from the financing transactions, the Company expects to report that it had cash, cash equivalents, restricted cash and investments as of September 30, 2025 of approximately $46 million.

The financial information presented in this press release reflects the Company’s estimates with respect to total revenue, U.S. XPOVIO net product revenue and its cash balance and is based on currently available information, which is preliminary. The Company’s final results may vary from these preliminary estimates as a result of the completion of customary quarterly review procedures, including those conducted by the Company’s external auditors.

Endometrial Cancer Program

Enrollment continues in the Phase 3 XPORT-EC-042 (NCT05611931) trial evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer. The Company continues to expect to report top-line data from this event-driven trial in mid-2026.

Ongoing Efforts to Further Enhance Liquidity and Maximize Value

The Company expects to continue exploring potential financing and strategic alternatives to enhance liquidity and maximize value with the assistance of its advisors, including its financial advisor Centerview Partners LLC.

Centerview Partners LLC and J. Wood Capital Advisors LLC acted as financial advisors to Karyopharm and Sidley Austin LLP acted as legal counsel to Karyopharm in connection with these transactions.

The offer and sale of the shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities (including the shares of common stock issuable upon conversion of the New 2028 Notes, the New 2029 Notes and the shares of common stock issuable upon exercise of the warrants and pre-funded warrants issued in the financing transactions) are not being registered under the Securities Act, or any state securities laws. The shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities (including the shares of common stock issuable upon conversion of the New 2028 Notes, the New 2029 Notes and the shares of common stock issuable upon exercise of the warrants and pre-funded warrants issued in the financing transactions) may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities, nor shall there be any offer, solicitation or sale of shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities (including the shares of common stock issuable upon conversion of the New 2028 Notes, the New 2029 Notes and the shares of common stock issuable upon exercise of the warrants and pre-funded warrants issued in the financing transactions) in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About the Phase 3 SENTRY Trial

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L. Patients are randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.

About Myelofibrosis

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib. Patients treated with the most commonly prescribed JAK inhibitor often require blood transfusions, and more than 30% will discontinue treatment due to anemia.2 Anemia and transfusion dependence are strongly correlated with poor prognosis and shortened survival.3

1. Clarivate/DRG (2023)
2.. Palandri, F., Palumbo, G.A., Elli, E.M. et al. Ruxolitinib discontinuation syndrome: incidence, risk factors, and management in 251 patients with myelofibrosis. Blood Cancer J. 11, 4 (2021).
3. Pardanani, A., & Tefferi, A. (2011). Prognostic relevance of anemia and transfusion dependency in myelodysplastic syndromes and primary myelofibrosis. Haematologica, 96(1), 8–10.

About the Phase 3 XPORT-EC-042 Trial

EC-042 (XPORT-EC-042; NCT05611931) is a global, Phase 3, randomized, double-blind clinical trial evaluating selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer. The EC-042 trial is expected to enroll approximately 276 patients who will be randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial includes two patient populations, for which, the primary endpoint of progression free survival will be tested sequentially and the key secondary endpoint of overall survival will be evaluated: 1) a modified intent to treat population (mITT) that will include patients with either, a) TP53 wild-type tumors with proficient mismatch repair status (pMMR); or, b) TP53 wild-type tumors with deficient mismatch repair status (dMMR), who are medically ineligible to receive checkpoint inhibitors; and, 2) the trial’s original intent to treat (ITT) population, which will include all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status. The mITT population is expected to include approximately 220 patients. In connection with the EC-042 trial, Karyopharm entered into a global collaboration with Foundation Medicine, Inc. to develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test to identify and enroll patients whose tumors are TP53 wild-type.

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin® to Treat Ovarian Cancer

On October 8, 2025 Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, reported positive final 24-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis (Press release, Oncoinvent, OCT 8, 2025, View Source [SID1234656526]). Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

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In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq). The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point[1],[2],[3].

"These highly encouraging results conclude our Phase 1 program for Radspherin and fuel our determination to advance Radspherin as an innovative treatment for patients with peritoneal metastases as quickly as possible," said Oystein Soug, CEO of Oncoinvent. "We are profoundly grateful to the patients, investigators, and the team for their invaluable contributions and look forward to interim results from our Phase 2 study next year."

"Peritoneal metastases remain a defining challenge in ovarian cancer, often driving recurrence," said Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "These final results are truly encouraging, suggesting that Radspherin could help delay disease progression and offer patients hope for longer, healthier lives. It is particularly promising to see that the new recurrences were limited to lymph nodes, which are typically associated with longer survival compared to peritoneal relapses.

About RAD-18-001

RAD-18-001 was an open label Phase 1 trial conducted in patients with peritoneal metastases in platinum-sensitive recurrent ovarian cancer. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection. A total of 21 patients were enrolled across sites in Norway, Belgium and Spain.

Bayer and Kumquat Biosciences initiate Phase I study with KRAS G12D inhibitor in patients with KRAS-mutated tumors

On October 8, 2025 Bayer and Kumquat Biosciences Inc., a clinical-stage biotech company founded by pioneers of targeting the KRAS pathway, reported the initiation of a Phase I clinical trial with KQB548 (BAY 3771249), an investigational inhibitor designed to treat KRAS G12D-mutated tumors, such as pancreatic, colorectal and lung cancer (Press release, Kumquat Biosciences, OCT 8, 2025, View Source [SID1234656511]). The first-in-human, dose-escalation study (NCT07207707) will evaluate the safety and preliminary efficacy of KQB548 (BAY 3771249) as a monotherapy in patients with KRAS G12D mutated tumors. KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent and oncogenic KRAS variant (G12D) still lacks effective treatment options.

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"Initiating clinical development of investigational KRAS G12D inhibitor KQB548 (BAY 3771249) marks an important milestone in our commitment to develop new medicines targeting highly relevant signaling pathways that promote tumor growth and survival," said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "Targeting KRAS has been considered quite challenging. We aim to deliver treatment options for patients with cancers driven by the KRAS G12D mutation. Through continued research innovation we can unlock the potential of precision oncology and improve the lives of people living with cancer."

KRAS G12D mutations are found most frequently in approximately 37 percent of pancreatic ductal adenocarcinoma (PDAC), 13 percent of colorectal cancer and 4 percent of non-small cell lung cancers. These mutations are often recognized as important targets for cancer treatment, and their detection paves the way for the creation of tailored therapies.

Despite recent scientific advancements, there are currently no effective treatments available that provide durable therapeutic benefits for most patients with KRAS-G12D-mutated cancers. Introducing the KRAS G12D inhibitor into clinical trials aims to address the long-standing unmet need.

"We are excited to initiate the clinical trial of our KRAS G12D inhibitor KQB548, which holds the prospect of transforming the KRAS G12D treatments for the deadly malignancies such as pancreatic, lung and colorectal cancers," said Dr. Nicolas Acquavella, Senior Vice President of Clinical Development and Corporate Alliance Management of Kumquat. "The speedy enrollment highlights our team’s execution capabilities and Kumquat’s long-standing commitment to delivering potentially life-changing medicines to cancer patients."

About KRAS G12D inhibitor (KQB548 – BAY 3771249)
KQB548 (BAY 3771249) is an investigational KRAS G12D inhibitor being developed to treat KRAS-mutated tumors, such as pancreatic, colorectal and lung cancer. KQB548 (BAY 3771249) is the lead program from the Bayer and Kumquat global exclusive license and collaboration in precision oncology. Kumquat received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 2025.

Aarvik Therapeutics Announces Investment by Laurus Labs in Aarvik Series Seed 2 Round

On October 8, 2025 Aarvik Therapeutics, an innovative, ADC-focused biotechnology company dedicated to engineering precision medicines for cancer therapy, reported an investment by Laurus Labs, India in Aarvik’s recently-concluded Series Seed 2 financing round (Press release, Aarvik Therapeutics, OCT 8, 2025, View Source [SID1234656527]).

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Since launching in 2021, Aarvik has developed its proprietary MUTTA (MUlti-epitope Targeting Tetravalent Antibody) plaform with a focus on developing next generation antibody drug conjugates (ADCs) that can expand the success of ADCs beyond a limited number of targets. Aarvik’s comprehensive approach facilitiates the lowering of the minimum effective dose (MED) while maintaining or improving the maximum tolerated dose (MTD) thereby significantly improving the therapeutic window. The Series Seed 2 round, which had investments from multiple investors including Laurus, is an acknowledgement of the substantial progress made by Aarvik on the MUTTA platform and will allow Aarvik to further advance its exciting pipeline of ADC assets.

"As part of our global support of innovation and progress in healthcare, we are delighted to invest in Aarvik’s efforts to pursue breakthroughs in oncology therapies," said Dr. Satyanarayana Chava, Founder & CEO of Laurus Labs. "We look forward to a highly productive collaboration that results in tangible benefits for patients across the globe."

"Aarvik is delighted to welcome Laurus Labs as an investor and a partner in our efforts to pursue improved therapies for hard-to-treat indications in cancer," said Jagath Reddy Junutula, PhD, Co-founder, President and CEO of Aarvik Therapeutics. "Our mission to provide transformational benefits for cancer patients is greatly strengthened by our ability to work with outstanding companies like Laurus Labs."

NUCLIDIUM Presents Positive Phase I/II Results for First Copper-based PET Diagnostic in Neuroendocrine Tumors at EANM Congress 2025

On October 8, 2025 NUCLIDIUM AG a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported positive clinical data from the ongoing Phase I/II trial (NCT06455358) evaluating its novel copper-radiolabeled PET tracer, 61Cu-TraceNetTM ([61Cu]Cu-NODAGA-LM3) in patients with SSTR-positive gastroenteropancreatic and bronchopulmonary neuroendocrine tumors (GEP & BP-NETS) (Press release, NUCLIDIUM, OCT 8, 2025, https://nuclidium.com/nuclidium-presents-positive-phase-1-2-results-for-first-copper-based-pet-diagostic-in-neuroendocrine-tumors-at-eanm-congress-2025/ [SID1234656513]). Principal investigator Dr. Guillaume Nicolas, Deputy Head of Nuclear Medicine at the Department of Theragnostics at University Hospital Basel, Switzerland, presented the results in an oral session during the European Association of Nuclear Medicine (EANM) Congress in Barcelona, Spain.

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The first-in-human, open-label, randomized, reader-blinded, Phase I/II study compared the safety, biodistribution, tumor uptake, and image quality of NUCLIDIUM’s copper-61-radiolabeled somatostatin receptor subtype 2 (SSTR2) antagonist, 61Cu-TraceNetTM with the standard of care gallium-68-labelled SSTR2 agonist, [68Ga]Ga-DOTA-TOC. In the first 22 patients with well-differentiated GEP and BP-NETs evaluated at the University Hospital Basel, 61Cu-TraceNET was well tolerated with no clinically significant adverse events reported. 61Cu-TraceNET showed a higher tumor uptake and tumor-to-background ratio and detected additional lesions in the liver and lungs. In a blinded analysis, independent readers rated the 61Cu-TraceNET image quality as superior compared to 68Ga-DOTATOC at both 1- and 3-hour imaging post-injection, supported by its 5.6-hour half-life, which enables broader distribution and delayed imaging. The image quality of 61Cu-TraceNET at 1- and 3-hours post-injection was assessed as equally good.

"Next-generation radiopharmaceuticals have the potential to transform the diagnosis and management of difficult-to-treat cancers. The first-in-human data with NUCLIDIUM’s novel copper-based diagnostic, 61Cu-TraceNETTM, show its excellent tumor specificity, improved image quality, and its ability to detect additional metastases," said Guillaume Nicolas, MD, PhD, Principal Investigator of the trial. "I am also encouraged by the safety, pharmacokinetic data, and the strong potential for 61Cu-TraceNETTM to support clinicians in the diagnosis in a range of SSTR2-positive tumors, including metastatic breast cancer, where better diagnostic approaches are urgently needed to improve treatment strategies."

Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM added "This rapidly generated first clinical data with 61Cu-TraceNETTM validates the potential of our copper-based platform and our ability to radiolabel an SSTR2 antagonist with high yield at room temperature for convenient patient diagnosis. With high specificity, low toxicity, and the potential to detect even the smallest primary and metastatic tumors early, 61Cu-TraceNET is well positioned to become a best-in-class diagnostic. We remain committed to rapidly advancing our copper-based theranostic pipeline to improve outcomes for patients across multiple cancer types with a focus on women’s health."

61Cu-TraceNETTM is the diagnostic component of NUCLIDIUM’s TraceNETTM program, targeting NETs and other SSTR-positive tumors such as metastatic breast cancer. A clinical trial of the corresponding therapeutic, 67Cu-TraceNET, is expected to start enrolling patients in 2026.