On May 14, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended March 31, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development program.

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"Our team’s exceptional clinical and operational execution in the first quarter of 2026, combined with growing investigator enthusiasm for MICVO’s potential to positively impact the lives of patients with cancer, has positioned us to deliver key milestones for the MICVO program this year," said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "We remain on track to share updated monotherapy data in mid-year 2026 and updated combination data in the second half of 2026. The mid-year 2026 monotherapy update will focus on 2L+ R/M HNSCC patients treated at or below a dose cap, which we implemented in December 2025. The goal of moving to a dose cap was to maintain MICVO’s strong efficacy profile while improving safety and tolerability. In the Phase 1/2 dose escalation combination study with pembrolizumab, we have refined our focus to 1L R/M HNSCC patients. We believe these two datasets will help establish MICVO’s broad potential as a novel ADC for patients with difficult-to-treat cancers and substantial unmet need."

Pipeline & Corporate Updates

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Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in mid-year 2026. The mid-year 2026 update will focus on participants who were treated at 5.4 mg/kg IV Q3W, with a dose equivalent to or below a dose cap. Results will include detailed analyses of the impact of a dose cap on safety, tolerability and efficacy.

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The ongoing MICVO Phase 1 monotherapy study is a multi-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2, a dose expansion study in 2L+ R/M HNSCC, is currently ongoing. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025.
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The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post platinum and anti-PD-(L)1 experienced patients (Arm 1) and post EGFRi and anti-PD-(L)1 experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20. Total study target enrollment was completed in 1Q26.
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In December 2025, a dose cap was implemented for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposures with dose capping and adjusted ideal bodyweight (AIBW) dosing are expected to be comparable, dose capping was prioritized due to its operational simplicity and speed of implementation.
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Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs[i].
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A protocol amendment permitting AIBW has been approved, and AIBW dosing has begun. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.
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Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for 1L R/M HNSCC patients in 2H26.
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The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA (pembrolizumab) is currently in dose escalation across multiple doses for the treatment of 1L R/M HNSCC. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025.
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The MICVO Phase 1/2 combination dose escalation study update in 2H26 will focus on 1L R/M HNSCC patients.
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In April 2026, Pyxis Oncology presented new preclinical data in a poster presentation at the 2026 AACR (Free AACR Whitepaper) Annual Meeting that showed treatment with a mouse analog of MICVO (maMICVO) in combination with anti-mouse PD-1 produced synergistic anti-tumor activity in an immune-refractory syngeneic preclinical model of HNSCC (MOC2). Additional key poster findings include:
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Monotherapy with maMICVO produced dose-dependent inhibition of tumor outgrowth.
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Monotherapy with maMICVO modulated the immune compartment toward a more favorable immune-permissive environment for immunotherapy. Treatment with maMICVO reduced the overall abundance of immune-suppressive regulatory T cells (Tregs) in MOC2 tumors, increased the CD8 T cell-to-Treg ratio and enhanced the abundance of a progenitor exhausted T cell subset that is highly responsive to anti-PD-1 therapy.
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Despite the MOC2 model being insensitive to anti-mouse PD-1 as a monotherapy, the combination of maMICVO and anti-mouse PD-1 resulted in greater tumor control and tumor growth inhibition than maMICVO monotherapy. Bliss independence analysis confirmed that maMICVO acted synergistically with anti-mouse PD-1 in a preclinical model unresponsive to anti-mouse PD-1 monotherapy.

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In May 2026, Pyxis Oncology announced the appointment of Nelson Azoulay as Chief Business Officer. Mr. Azoulay most recently served as Senior Vice President, Strategy and Business Development at Flagship Pioneering, where he spearheaded business development initiatives across select portfolio companies. Previously, he was Vice President of Corporate Development at ImmunoGen, where he helped shape the Company’s mid- to long-term strategy, led search and evaluation efforts, supported fundraising activities, and helped secure key transactions, including collaborations and partnerships with major pharmaceutical companies. He also played a role in ImmunoGen’s acquisition by AbbVie and subsequent integration in 2024. Earlier in his career, at PDL BioPharma, Mr. Azoulay led corporate restructuring and managed strategic divestitures. At Syneos Health Consulting, he advised global pharmaceutical and biotechnology companies on portfolio strategy, transactions and commercial planning. He holds an MBA from Columbia Business School, an MS in Neuroscience from McGill University and a BA from Wesleyan University.
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In February 2026, Pyxis Oncology announced the appointment of Thomas Civik as Interim Chief Executive Officer. Mr. Civik has been a member of Pyxis Oncology’s Board of Directors since October 2021 and is a highly experienced biotechnology executive with a proven track record in advancing cancer therapeutics. He most recently served as President and Chief Executive Officer of Five Prime Therapeutics, where he led the company through its acquisition by Amgen for $1.9 billion in April 2021. Mr. Civik previously served as Chairperson of the Board of ImCheck Therapeutics and Repare Therapeutics through their respective acquisitions by Ipsen and XOMA.

First Quarter 2026 Financial Results

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As of March 31, 2026, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $42.5 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the fourth quarter of 2026.
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Research and development expenses were $20.0 million for the quarter ended March 31, 2026, compared to $17.0 million for the quarter ended March 31, 2025. The increase was primarily due to a $5.5 million increase in clinical trial related expenses including CMC, related to monotherapy and combination therapy of MICVO, offset by reduction in employee-related costs and other costs.
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General and administrative expenses were $4.4 million for the quarter ended March 31, 2026, compared to $5.9 million for the quarter ended March 31, 2025. The decrease was primarily due to lower employee-related costs including stock-based compensation.
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Net loss was $23.3 million, or ($0.37) per common share, for the quarter ended March 31, 2026, compared to $21.2 million, or ($0.35) per common share, for the quarter ended March 31, 2025. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended March 31, 2026 was $22.1 million, compared to a net loss of $17.5 million for the quarter ended March 31, 2025.
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As of May 13, 2026, the outstanding number of shares of Common Stock of Pyxis Oncology was 63,355,482.

(Press release, Pyxis Oncology, MAY 14, 2026, View Source [SID1234665711])

On May 14, 2026 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported new preclinical data from its PBGENE-DMD program in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting in Boston, Massachusetts. The new data show that treatment with PBGENE-DMD in early-juvenile mice resulted in significantly higher efficacy across key skeletal and respiratory muscles than treatment in late-juvenile mice over a comparable timeframe. This new data further supports evaluating PBGENE-DMD in younger DMD patient populations, including the 2- to 3-year-old patients, who are a key demographic of the ongoing Phase 1/2 FUNCTION-DMD trial evaluating PBGENE-DMD in boys ages 2 to 7.

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The greater efficacy observed in early-juvenile mice is also expected to be an important point of differentiation for PBGENE-DMD versus microdystrophin approaches. With microdystrophin approaches the AAV dilution effect driven by muscle growth and turnover would be expected to be even more pronounced in younger DMD patients.

"These new data give us a clear preclinical rationale for treating DMD as early as possible. By directly comparing early- and late-juvenile mice, we showed that intervening earlier translated into substantially greater dystrophin restoration in the skeletal and respiratory muscles that matter most for long-term outcomes. This is important because the FUNCTION-DMD trial is designed to treat children between the ages of two and seven years," said Cassie Gorsuch, Ph.D., Chief Scientific Officer of Precision BioSciences. "These results also reinforce a meaningful point of differentiation for PBGENE-DMD. Because we are correcting the gene rather than delivering a synthetic transgene, the durability of effect would not be expected to be subject to the AAV dilution that affects microdystrophin approaches as young patients grow, a limitation that becomes more pronounced the younger the patient."

New preclinical data: strong efficacy in early-juvenile mice (age 2 weeks, equivalent to a patient population aged 2–3 years)

PBGENE-DMD in early-juvenile mice achieved up to 3x higher dystrophin protein restoration in skeletal muscle, and up to 12x higher dystrophin protein restoration in respiratory muscle, compared with late-juvenile mice at equivalent dose levels.
Strong efficacy which exceeded the expected dystrophin protein restoration therapeutic threshold of 5% was observed in respiratory muscle tissues, with mice achieving up to 12% dystrophin restoration in the diaphragm and up to 30% in the intercostals, muscles whose function is critical to preventing respiratory failure in patients with DMD.
PBGENE-DMD drove high levels of dystrophin-positive fibers in early-juvenile mice, with levels 2–3x higher in skeletal and respiratory muscle tissues than in late-juvenile mice after three months, reaching up to 70% dystrophin-positive fibers.
Similar therapeutic efficacy was achieved in cardiac muscle in both early- and late-juvenile mice.
Building on a growing body of preclinical evidence

These new data extend Precision’s previously reported preclinical findings supporting the safety, efficacy, and durability profile of PBGENE-DMD:

A toxicology study in a humanized DMD mouse model showed that PBGENE-DMD treatment led to greater than 45% reduction in serum creatine kinase across multiple dose levels, alongside improvements in muscle pathology relative to vehicle-treated controls, supporting the safety profile of the program.
Beyond safety, PBGENE-DMD has demonstrated sustained efficacy over time through dystrophin protein restoration and dystrophin-positive myofibers, translating into durable muscle function. Treated mice maintained up to 92% of the maximum force output of non-diseased animals, while untreated, diseased mice showed progressively declining force output.
Presentation details

Abstract title: PBGENE-DMD gene editing drives safe, efficacious, and durable functional improvement in a humanized Duchenne muscular dystrophy mouse model

Session: Emerging molecular therapeutic strategies for muscular dystrophies

Presenter: Adam Mischler, Ph.D., DMD Research Lead, Precision BioSciences

Date and time: Thursday, May 14, 2026, 8:45 A.M. ET

About PBGENE-DMD, A Muscle-Targeted Excision Program

PBGENE-DMD is Precision’s development program for the treatment of Duchenne Muscular Dystrophy (DMD), a devastating genetic disease caused by mutations in the dystrophin gene that prevents production of the dystrophin protein, which is essential for maintaining muscle structural integrity and function. DMD affects approximately 15,000 patients in the U.S. alone, and there are currently no approved therapies capable of driving significant, durable functional improvements over time.

PBGENE-DMD is designed to durably improve function for approximately 60% of patients with DMD by employing two complementary ARCUS nucleases, delivered using a single AAV, to excise exons 45-55 of the dystrophin gene, restoring expression of a near full-length dystrophin protein. Compared with DMD, deletion of exons 45-55 is often associated with a more mild prognosis for patients. This protein more closely resembles normal dystrophin than synthetic, truncated microdystrophin approaches, which currently offer minimal proven functional benefit. Precision’s Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations between exons 45 and 55, which impact approximately 60% of boys with DMD. The clinical trial will employ an appropriate immune modulation regimen and safety monitoring program to treat patients at world class specialized DMD clinical sites.

PBGENE-DMD was granted Orphan Drug Designation by the FDA in July 2025. The PBGENE-DMD program is eligible for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program, which was signed into law on February 3, 2026, as part of the Consolidated Appropriations Act of 2026. PBGENE-DMD received Fast Track designation from the FDA in February 2026.

Further details on the trial can be found on Precision’s website and clinicaltrials.gov identifier NCT07429240.

(Press release, Precision Biosciences, MAY 14, 2026, View Source [SID1234665710])

On May 14, 2026 Monopar Therapeutics Inc. ("Monopar" or the "Company") (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, reported first quarter 2026 financial results and provided business updates.

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Recent Program Developments

ALXN1840 for Wilson Disease – NDA Submission on Track for Mid-2026

In April 2026, Monopar presented new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC) at the American Academy of Neurology (AAN) Annual Meeting 2026. The late-breaker oral and poster presentation, titled "Greater clinical benefit with tiomolibdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial," demonstrated greater neurologic benefit of ALXN1840 versus standard of care ("SoC") in Wilson disease patients with neurologic symptoms at baseline.

These results from the FoCus trial will also be presented in a poster at the 12th Congress of the European Academy of Neurology (EAN) in Geneva, Switzerland, June 27-30, 2026. Dr. Aurélia Poujois, MD, PhD, of the Adolphe de Rothschild Foundation Hospital, a leading authority in Wilson disease, will present on June 28 at 12:50 CEST.

Monopar will also present at the European Association for the Study of the Liver (EASL) Congress 2026, a leading global forum for liver disease research. The presentation, titled "Tiomolibdate choline stabilizes liver disease and improves neurological symptoms as well as quality-of-life in treatment-experienced Wilson disease patients," will be presented by UC Davis Professor Dr. Valentina Medici, MD, MAS, FAASLD. EASL Congress 2026 will take place in Barcelona, Spain, from May 27-30, 2026, with Dr. Medici presenting on May 29 at 08:45 CEST.

The Company remains on track with its plans to submit the New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") in mid-2026. Susan Rodriguez, the Company’s Chief Commercial and Strategy Officer who joined in March 2026, is leading commercial readiness activities in preparation for a potential launch.

Financial Results for the First Quarter Ended March 31, 2026, Compared to the First Quarter Ended March 31, 2025

Cash and Net Loss

Cash, cash equivalents and investments as of March 31, 2026, were $137.5 million. Monopar expects its current funds to support operations at least through December 31, 2027, including: (1) regulatory and potential commercial activities for ALXN1840; (2) continued development of MNPR-101 programs; and (3) internal research and development.

Net loss for the first quarter of 2026 was $3.9 million, or $0.46 per share, compared to net loss of $2.6 million, or $0.38 per share, for the first quarter of 2025.

Research and Development ("R&D") Expenses

R&D expenses for the first quarter of 2026 were $3,487,247 compared to $1,643,375 for the first quarter of 2025. This represents an increase of $1,843,872 primarily attributed to (1) an $825,972 increase in R&D contractor and consulting expenses, (2) a $799,593 increase in R&D personnel expenses including stock-based compensation and (3) a net increase of $218,307 in other R&D expenses.

General and Administrative ("G&A") Expenses

G&A expenses for the first quarter of 2026 were $1,738,006 compared to $1,578,442 for the first quarter of 2025. This represents an increase of $159,564 primarily attributed to (1) a $134,599 increase in G&A personnel expenses including stock-based compensation and (2) a net increase of $24,965 in other G&A expenses.

Interest Income

Interest income for the first quarter of 2026 was $1,332,203 compared to $596,845 for the first quarter of 2025. The increase is attributed to interest earned on U.S. Treasury securities and commercial paper, and higher bank balances in 2026, due to the net proceeds of approximately $91.9 million from the September 2025 capital raise.

(Press release, Monopar Therapeutics, MAY 14, 2026, View Source [SID1234665709])

On May 14, 2026 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that Eric Risser, President and CEO of MacroGenics, will participate in a fireside chat at the Stifel 2026 Virtual Targeted Oncology Forum on Wednesday, May 20, 2026 at 10:30 a.m. ET.

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A webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcasts on its website for 30 days.

(Press release, MacroGenics, MAY 14, 2026, View Source [SID1234665708])

On May 14, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported financial results for the first quarter of 2026 and highlighted progress on key clinical development programs. These milestones reflect meaningful progress towards Karyopharm’s goal of advancing selinexor in late-stage indications and expanding the value of the franchise.

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"As we move through 2026, Karyopharm is in a pivotal period with meaningful clinical and regulatory milestones ahead," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Through the second and third quarters of 2026, we expect several important developments that have the potential to create significant value for the Company, while improving outcomes for patients. In endometrial cancer, we have completed enrollment in our Phase 3 XPORT-EC-042 trial and remain on track to report topline data in mid-2026. In myelofibrosis, the Phase 3 SENTRY results reinforced the potential of selinexor to meaningfully improve patient outcomes, including a statistically significant SVR35 benefit and a promising overall survival signal. With the endometrial cancer readout ahead and the myelofibrosis regulatory and guideline path coming into focus, we believe these programs could meaningfully expand the impact and long-term opportunity of the selinexor franchise."

First Quarter 2026 and Recent Company Highlights

XPOVIO Commercial Performance

U.S. net product revenue was $29.2 million for the quarter ended March 31, 2026 compared to $21.1 million for the quarter ended March 31, 2025.
Demand for XPOVIO was lower in the first quarter of 2026 compared to the first quarter of 2025, due to new competitive entrants. The community setting continued to represent approximately 60% of net product revenue.
Expanded global patient access for selinexor is translating into growth in royalty revenue from Menarini, Antengene and other international partners. Royalty revenue increased to $1.9 million in the first quarter of 2026 compared to $1.7 million in the first quarter of 2025, with selinexor now approved in more than 50 ex-U.S. countries and territories.
Research and Development (R&D) Highlights

Myelofibrosis

Results from the Phase 3 SENTRY trial in myelofibrosis were accepted for a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Reported topline results from the Phase 3 SENTRY trial, a randomized, double-blind trial evaluating 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis compared to ruxolitinib alone (n=353). The trial met the first co-primary endpoint of spleen volume reduction of 35% or more (SVR35) at week 24 and also demonstrated rapid, deep and sustained improvement in this endpoint over time. The trial did not meet its second co-primary endpoint of mean change in absolute total symptom score (Abs-TSS) at week 24 relative to baseline. Similar symptom improvement from baseline was observed in patients who received the combination of selinexor plus ruxolitinib compared to ruxolitinib alone. Importantly, a promising overall survival signal was also observed, which further reinforces the relevance of XPO1 inhibition in combination with ruxolitinib in frontline myelofibrosis. The combination of selinexor and ruxolitinib demonstrated a manageable safety and tolerability profile consistent with the known profile of each agent individually with no new safety signals observed.
Completed enrollment of the 60 mg cohort (n=29) of the Phase 2 SENTRY-2 trial (NCT05980806) and began enrolling patients into the 40 mg cohort.
Endometrial Cancer

Completed enrollment of the Phase 3 XPORT-EC-042 trial (NCT05611931), which is evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer. Approximately 220 patients enrolled in the modified intent-to-treat (mITT) population and 257 enrolled in the intent-to-treat (ITT) population. Enrollment in the mITT population was focused on patients with either proficient mismatch repair status (pMMR) tumors or patients with deficient mismatch repair status (dMMR) tumors who are medically ineligible for checkpoint inhibitors.
Multiple Myeloma

Patients enrolled in the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348) continued to be followed for progression-free survival events contributing towards the primary endpoint. The trial is being conducted in collaboration with the European Myeloma Network and is evaluating the all-oral combination of selinexor 40 mg, pomalidomide and dexamethasone (SPd40) in patients with previously treated multiple myeloma who received an anti-CD38 as their immediate prior line of therapy.
Anticipated Catalysts and Operational Objectives

Myelofibrosis

Present results from the Phase 3 SENTRY trial in myelofibrosis at ASCO (Free ASCO Whitepaper) as a late-breaking oral presentation on June 2 at 9:45 a.m. Central Time during the "Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant" oral abstract session. The Company expects that its abstract titled "Selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis: Phase 3 SENTRY trial" (abstract number LBA6500) will be available on ASCO (Free ASCO Whitepaper)’s website on June 2 at approximately 8:00 a.m. Eastern Time / 7:00 a.m. Central Time. A copy of the SENTRY presentation will be available following its presentation at ASCO (Free ASCO Whitepaper) under "Publications and Presentations" in the Investors & Media section of the Company’s website.
Engage with the U.S. Food and Drug Administration (FDA) on the data from the SENTRY trial and the Company’s supplemental new drug application (sNDA) filing plan; engage with other global regulatory agencies in collaboration with the Company’s partners.
The Company believes the potential inclusion of the combination in relevant compendia could occur in the second half of 2026.
Announce topline data from all patients in the 60 mg cohort of the Phase 2 SENTRY-2 trial with at least 24 weeks of follow-up, expected in the second half of 2026.
Endometrial Cancer

Announce topline data from the event-driven, Phase 3 XPORT-EC-042 trial, expected in mid-2026.
Multiple Myeloma

Maintain the Company’s commercial foundation in the increasingly competitive multiple myeloma marketplace and drive increased XPOVIO revenues.

Support global launches by our partners following regulatory and reimbursement approvals for selinexor in ex-U.S. countries and territories.

Announce topline data from the event-driven, Phase 3 XPORT-MM-031 (EMN29) trial, expected in the second half of 2026.
2026 Financial Outlook

Based on its current operating plans, Karyopharm expects the following for full year 2026:

Total revenue to be in the range of $130 million to $150 million. Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners.
U.S. XPOVIO net product revenue to be in the range of $115 million to $130 million.
R&D and selling, general and administrative (SG&A) expenses to be in the range of $230 million to $245 million.
The Company expects its existing liquidity, including cash and cash equivalents, as well as cash flow from net product revenue and license and other revenue, will enable it to fund its current operating plans into late in the third quarter of 2026.
First Quarter 2026 Financial Results

Total revenue: Total revenue for the first quarter of 2026 was $35.1 million, compared to $30.0 million for the first quarter of 2025.

Net product revenue: Net product revenue was $29.2 million for the first quarter of 2026, compared to $21.1 million for the first quarter of 2025. The increase was primarily driven by lower gross-to-net adjustments, which were 21.8% in the first quarter of 2026 versus 45.0% in the prior-year period. The gross-to-net adjustments were impacted by an atypical product return adjustment in the first quarter of 2025 and lower realized discounts and returns in the first quarter of 2026.

License and other revenue: License and other revenue was $5.9 million for the first quarter of 2026, compared to $9.0 million for the first quarter of 2025. License and other revenue for the first quarter of 2026 primarily consisted of $3.5 million in milestone revenue and $1.9 million in royalties. For the first quarter of 2025, license and other revenue primarily consisted of $7.0 million related to the reimbursement of development-related expenses and $1.7 million in royalties.

Cost of sales: Cost of sales was $1.3 million for both the first quarter of 2026 and 2025.

R&D expenses: R&D expenses were $33.8 million for the first quarter of 2026, compared to $34.6 million for the first quarter of 2025.

SG&A expenses: SG&A expenses were $26.7 million for the first quarter of 2026, compared to $27.4 million for the first quarter of 2025.

Loss from operations: Loss from operations was $26.8 million for the first quarter of 2026, compared to $33.3 million for the first quarter of 2025, representing a 20% improvement. The decrease reflects improved operating efficiency and disciplined cost management.

Interest income: Interest income was $0.5 million for the first quarter of 2026, compared to $1.0 million for the first quarter of 2025. The decrease reflects lower investment balances during 2026 compared to 2025.

Interest expense: Interest expense was $12.6 million for the first quarter of 2026, compared to $11.0 million for the first quarter of 2025. The increase reflects higher outstanding debt and higher interest rates following the Company’s financing transactions executed in October 2025.

Other income, net: Other income, net was $16.4 million in the first quarter of 2026, compared to $19.8 million in the first quarter of 2025. The amounts primarily reflect non-cash fair value remeasurements of embedded derivatives and liability-classified common stock warrants related to the refinancing transactions completed in the second quarter of 2024 and the fourth quarter of 2025.

Net loss: Net loss was $22.4 million, or $1.02 per basic share and $1.24 per diluted share, for the first quarter of 2026, compared to $23.5 million, or $2.77 per basic and diluted share, for the first quarter of 2025. Net loss included non-cash stock-based compensation expense of $3.0 million in the first quarter of 2026 compared to $3.6 million in the first quarter of 2025.

Cash position: Cash, cash equivalents, and restricted cash as of March 31, 2026 totaled $91.2 million, including approximately $50 million of gross proceeds raised from a private placement of common stock and warrants and sales of common stock under the Company’s Open Market Sale Agreement during the first quarter of 2026, compared to $64.1 million as of December 31, 2025.

Conference Call Information

Karyopharm will host a conference call today, May 14, 2026, at 8:00 a.m. Eastern Time, to discuss the first quarter 2026 financial results, the financial outlook for 2026 and to provide other business updates. To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (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, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website. An archived webcast will be available on the Company’s website approximately two hours after the event.

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 (N=353). Patients were 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.

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-only therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (N=257). Patients were 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: 1) a modified intent to treat population (mITT) that includes 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 includes all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status. The key secondary endpoint of overall survival will be evaluated in the ITT population. 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.

About Endometrial Cancer

Endometrial cancer (EC) is the most common gynecologic malignancy in the U.S.1 In 2026, approximately 68,000 uterine cancers (predominantly endometrial) are expected to be diagnosed, with approximately 14,000 deaths.1 Worldwide there were about 420,368 cases with 97,723 deaths in 2022.2 Both incidence and mortality have continued to rise.3,4 Key risk factors include obesity, type 2 diabetes, high-fat diets, tamoxifen or oral estrogen use, and delayed menopause.5 TP53 is a well-recognized prognostic marker for EC; >50% of advanced or recurrent EC tumors are TP53wt (gene for tumor protein P53; wild-type), and ~40%-55% are both TP53wt and mismatch repair-proficient (pMMR).6-8 While immune checkpoint inhibitors have shown benefit in patients with mismatch repair–deficient (dMMR) and pMMR, the magnitude of benefit is greater for patients with dMMR tumors versus pMMR tumors.9-10 There remains an unmet need for targeted therapies for patients with pMMR EC.11

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor compound for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved and marketed by Karyopharm in the U.S. in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; and (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in myelofibrosis and endometrial cancer.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

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).
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%.
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.

(Press release, Karyopharm, MAY 14, 2026, View Source [SID1234665707])