On March 25, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported final clinical data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). The large randomized 112-patient study evaluated IMNN-001 in women with newly diagnosed advanced ovarian cancer. IMNN-001, the company’s lead drug candidate, utilizes its proprietary non-viral DNA delivery platform, TheraPlas, the only nucleic acid nanoparticle technology showing promise in treating cancer. This novel immunotherapy is designed to recruit the entirety of the immune system by enabling locoregional secretion of the powerful cancer-fighting cytokine interleukin 12 (IL-12), altering the tumor microenvironment.

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Based on prior data assessments, IMUNON previously reported a median 11.1-month increase in OS (40.5 vs. 29.4 months) in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent data assessment, the company is now reporting a median 14.7-month increase in OS (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in OS (3.6 delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in OS of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone.

"It is very encouraging to see results from the OVATION 2 trial indicating that treatment with IMNN-001 was associated with an overall survival benefit of more than a year in patients treated with IMNN-001 plus chemotherapy and more than two years in women also receiving PARP inhibitors as part of maintenance therapy. These new findings are especially exciting given that there have been no meaningful advances in standard of care in ovarian cancer in the last 30 years," said Premal H. Thaker, M.D., Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, OVATION 2 Study Chair and Study Chair of Phase 3 OVATION 3 trial. "Importantly, with these new efficacy results, IMNN-001 continues to maintain a highly favorable safety and tolerability profile, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment for women who are in desperate need of new and improved treatment options."

"With each new assessment of the findings from the OVATION 2 study, IMNN-001 has continued to show that it can improve overall survival in women with newly diagnosed advanced ovarian cancer while maintaining an advantageous safety profile," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "The strong response from our current trial investigators and the broader medical community supports our belief in the significant potential of IMNN-001 to make a meaningful difference in women’s lives. We remain focused on executing our Phase 3 trial and advancing this promising therapy to the final stage of regulatory review as quickly as possible."

The pivotal Phase 3 OVATION 3 trial is a robustly designed clinical study with the primary endpoint of OS. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for potential submission of a Biologics License Application (BLA) for full approval of IMNN-001 to the U.S. Food and Drug Administration (FDA) if the primary endpoint reaches statistical significance. OVATION 3 is currently enrolling patients at seven clinical sites with up to 43 additional sites being considered for activation. IMUNON anticipates enrolling approximately 80 patients (~20%) of the total target of 500 participants within the next year.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, MAR 25, 2026, View Source [SID1234663902])

On March 25, 2026 Exicure, Inc. (Nasdaq: XCUR, the "Company") reported the following financial results for the year ended December 31, 2025.

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2025 Financial Results

Cash Position: Cash and cash equivalents were $3.7 million as of December 31, 2025, compared to $12.5 million as of December 31, 2024. Our current liquidity may not be sufficient to fund operations for the next 12 months. Additional financing will be required to support ongoing operations, continue the exploration of strategic alternatives, and pursue any alternatives that we identify.

Research and Development (R&D) Expense: Research and development expenses were $3.3 million for the year ended December 31, 2025, as compared to $0 for the year ended December 31, 2024. The increase of $3.3 million reflects R&D activities incurred following the acquisition of GPCR Therapeutics USA Inc. ("GPCR USA"), which conducts research operations. Immediately prior to closing the acquisition of GPCR USA, the Company recorded no research or development expenses.

General and Administrative (G&A) Expense: General and administrative expenses were $6.8 million for the year ended December 31, 2025, as compared to $5.4 million for the year ended December 31, 2024. The increase in G&A expense of $1.4 million was primarily driven by additional expenses associated with the acquisition and integration of GPCR USA.

Loss from sale or disposal of property and equipment: The Company recognized a $90,000 loss from GPCR USA’s sale of fixed assets.

Gain on early lease termination: As a result of the early termination of the Company’s lease for its office in Chicago, effective January 31, 2025, the Company recognized a $6.0 million gain from the reversal of the remaining liability related to this lease.

Other Income and Expense: The Company recognized a $346,000 gain in the third quarter of 2025 upon satisfying its self‑insured retention with its insurer. The Company recorded a loss of $1,553,000 related to the change in fair value of its contingent liability. The Company recognized a loss of $275,000 associated with the sale of its subsidiary, KC Creation, along with additional currency translation losses related to this foreign subsidiary.

Net Loss: The Company had a net loss of $4.9 million for the year ended December 31, 2025, compared to a net loss of $9.7 million for the year ended December 31, 2024. The decrease in net loss of $4.8 million was primarily due to the $6.0 million gain resulting from the lease liability reversal, partially offset by increased operating expenses following the acquisition of GPCR USA.

Going Concern: Management believes that the Company’s existing cash and cash equivalents is not sufficient to continue to fund operations. The Company has already engaged in significant cost reductions, and its ability to further cut costs and extend the Company’s operating runway is limited. As a result, substantial additional financing is needed in the short term to pay expenses, fund the ongoing exploration of strategic alternatives and pursue any alternatives that may be identified. The Company also needs to raise capital to fund its operations. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.

(Press release, Exicure, MAR 25, 2026, View Source [SID1234663901])

On March 25, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported that the U.S. Food and Drug Administration (FDA) has approved Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA).

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Approval was based on the positive outcomes of Lifyorli’s pivotal ROSELLA trial, which enrolled 381 patients with platinum-resistant ovarian cancer who had received one to three prior lines of therapy, at least one of which included bevacizumab. Patients were randomized 1:1 to receive either Lifyorli plus nab-paclitaxel or nab-paclitaxel monotherapy. No biomarker selection was required.

ROSELLA met its dual primary endpoints of progression-free and overall survival. Patients treated with Lifyorli in addition to nab-paclitaxel experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004), with a median overall survival (OS) of 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months. Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30 percent reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.008), as assessed by blinded independent central review (PFS-BICR), compared to patients treated with nab-paclitaxel alone.

The combination of Lifyorli with nab-paclitaxel was well-tolerated and manageable. The safety of Lifyorli was assessed in a pooled analysis of patients from ROSELLA and Lifyorli’s Phase 2 trial. The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity. The most common adverse reactions experienced by more than 20 percent of patients (including laboratory abnormalities) were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash and decreased appetite.

Data from ROSELLA were first presented at ASCO (Free ASCO Whitepaper) 2025 (American Society of Clinical Oncology) with simultaneous publication in The Lancet. Complete results from ROSELLA will be presented at the Society of Gynecologic Oncology (SGO) meeting in April.

"Data demonstrate that Lifyorli plus nab-paclitaxel provides a clinically meaningful benefit in overall survival for patients with platinum-resistant ovarian cancer and is well tolerated. Lifyorli is positioned to become a new standard-of-care treatment," said Rob Coleman, M.D., Texas Oncology and special advisor to the president of the GOG Foundation. "Having a new treatment for this advanced, recurrent disease will provide clinicians with a compelling option to help patients with this extremely difficult-to-treat cancer."

"The FDA’s approval of Lifyorli in combination with nab-paclitaxel is welcome news to all of us in the ovarian cancer community," said Sarah DeFeo, Chief Program Officer at Ovarian Cancer Research Alliance (OCRA). "We are grateful to everyone who participated in the clinical trials, their families and the physicians who helped advance this urgently needed treatment option for patients with platinum-resistant ovarian cancer."

"It is a privilege to bring forward a new treatment for patients who historically have had few options," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "We have worked for years to demonstrate the potential of cortisol modulation in oncology. Today’s approval of Lifyorli is an important first step, but there is much more to explore with this new mode of treatment. We extend our deep appreciation to the patients and healthcare providers who participated in the clinical trials that made this approval possible."

ROSELLA enrolled patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia, and was conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Lifyorli

Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement for Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.

Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support at 1-85-LIFYORLI (1-855-439-6754).

LIFYORLI Indication & Usage

LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.

IMPORTANT SAFETY INFORMATION

Contraindications:

LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.

Warnings and Precautions:

Neutropenia and Severe Infections

LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.

Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.

Adrenal Insufficiency

LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.

Exacerbation of Conditions Treated with Glucocorticoids

Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.

Embryo-Fetal Toxicity

LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.

Adverse Reactions:

Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).

Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.

The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Drug Interactions:

Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.
Use in Specific Populations:

Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose.
Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.
Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).
Please see the full Prescribing Information for additional Important Safety Information.

(Press release, Corcept Therapeutics, MAR 25, 2026, https://ir.corcept.com/news-releases/news-release-details/fda-approves-corcepts-selective-glucocorticoid-receptor [SID1234663900])

On March 25, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that the first patient has been dosed with cemsidomide, an oral IKZF1/3 degrader, in a Phase 1b trial evaluating cemsidomide and dexamethasone in combination with elranatamab (ELREXFIO), an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody, for the treatment of relapsed/refractory multiple myeloma (RRMM).

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"Data from our Phase 1 trial support cemsidomide as a potential best-in-class, next-generation IKZF1/3 degrader and the initiation of this Phase 1b trial, along with our late-line Phase 2 MOMENTUM trial, enable an efficient path toward bringing cemsidomide to growing myeloma patient populations across multiple lines of therapy," said Len Reyno, M.D., chief medical officer of C4 Therapeutics. "Bispecific T-cell engagers have quickly become a critical treatment pillar in multiple myeloma while IKZF1/3 degraders remain foundational therapies across multiple lines and combination regimens in multiple myeloma. In this combination with elranatamab, we see an opportunity to leverage cemsidomide’s potent direct anti-myeloma effect and its ability to enhance the immune environment which has the potential to deliver a deeper and more durable therapeutic response for patients, including those in earlier lines of therapy."

The Phase 1b trial is an open-label, multicenter study to establish an optimal dose for cemsidomide in combination with elranatamab by evaluating the safety and tolerability as well as preliminary anti-myeloma activity of cemsidomide in combination with elranatamab in RRMM patients. The trial will enroll up to 54 patients to evaluate cemsidomide in combination with elranatamab, beginning at the 75 µg dose of cemsidomide with the opportunity to explore 50 µg and 100 µg doses of cemsidomide. The primary endpoint is to assess the safety and tolerability of cemsidomide in combination with elranatamab. Secondary endpoints will evaluate anti-myeloma activity per the International Myeloma Working Group (IMWG) response criteria, which will include the overall response rate, minimal-residual disease (MRD)-negative complete response rate, duration of response and other relevant measures. In October 2025, C4T and Pfizer entered into a clinical trial collaboration supply agreement under which Pfizer provides elranatamab at no cost while C4T sponsors and conducts the clinical trial. Phase 1b data from all cohorts evaluating cemsidomide in combination with elranatamab is anticipated in mid-2027.

The Phase 1b trial is part of a broader developmental strategy to support cemsidomide’s use across multiple lines of treatment. This strategy also includes the ongoing Phase 2 MOMENTUM Trial investigating the use of cemsidomide and dexamethasone in the fourth line of treatment or later. In addition to these two trials, C4T intends to evaluate cemsidomide in combination with other anti-myeloma agents, and remains on track to share these plans in mid-2026.

About Cemsidomide
Cemsidomide is an investigational, orally bioavailable molecular glue degrader (MonoDAC degrader) of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the Phase 1 trial, which has completed enrollment, show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.

About Cemsidomide in Combination with Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide and dexamethasone in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to deeper and more durable responses. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm, study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Multiple Myeloma
Multiple myeloma (MM) is a rare blood cancer affecting plasma cells. Approximately 36,000 people in the United States are diagnosed with MM each year. Approved IKZF1/3 degraders remain foundational therapies across lines of MM treatment. Despite advances, including immune-directed approaches, most patients ultimately relapse, underscoring a growing need for new therapeutics options that continue to leverage IKZF1/3 degradation to drive myeloma cell death and T-cell activation.

(Press release, C4 Therapeutics, MAR 25, 2026, View Source [SID1234663899])

On March 25, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the year ended December 31, 2025, and highlighted late-stage clinical progress for Plinabulin and strategic developments related to its equity interest in SEED Therapeutics ("SEED").

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2025: Clinical and Operational Progress
"2025 was a year of important clinical and operational progress for BeyondSpring and SEED Therapeutics," said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer of BeyondSpring. "We advanced our Phase 3 Plinabulin program, generated meaningful clinical data, and strengthened our strategic and financial position."

"BeyondSpring made meaningful progress advancing Plinabulin in Phase 3 NSCLC, while SEED Therapeutics reached a critical milestone — initiating its first clinical trial following IND clearance in both the U.S. and China — and strengthened its leadership team and capital resources."

Positioned for 2026 and Beyond
"With a solid scientific and clinical foundation and clear regulatory pathways, we believe BeyondSpring and SEED are well positioned for the next stage of development," Dr. Huang concluded. "As we enter 2026, we remain focused on advancing the DUBLIN-4 confirmatory trial for Plinabulin in non-squamous EGFR wild-type NSCLC post immune checkpoint inhibitors, supporting SEED’s Phase 1a clinical program for ST-01156 in solid tumors, and creating long-term value for our shareholders."

Recent Clinical and Business Updates
Plinabulin Demonstrates Overall Survival Benefit in Phase 3 NSCLC Study; Confirmatory Trial Planned
There is a significant unmet need in EGFR wild-type NSCLC following immune checkpoint inhibitor (ICI) therapy, where numerous Phase 3 studies have failed to improve overall survival over standard of care docetaxel.

BeyondSpring reported positive Phase 3 results from the DUBLIN-3 study evaluating plinabulin in combination with docetaxel in second- and third-line (2/3L) EGFR wild-type non-small cell lung cancer (NSCLC). The study demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to docetaxel alone (ITT, n=559), with results published in The Lancet Respiratory Medicine.

At IASLC North America and ESMO (Free ESMO Whitepaper) Asia in December 2025, BeyondSpring presented updated data from the mechanism-targeted non-squamous NSCLC population (n=332; 24-month after database lock), in which the combination achieved:

OS hazard ratio (HR) of 0.72 (p=0.0078)
Median OS improvement of 2.5 months vs. docetaxel
Doubling of 2-year and 3-year survival rates
Favorable safety profile, reducing grade 4 neutropenia from >30% to 5% (p<0.0001)
To date, over 700 patients have been treated with plinabulin across clinical studies, supporting the characterization of its safety and tolerability profile.

Based on these findings and discussions with the U.S. FDA, BeyondSpring plans to initiate the global Phase 3 DUBLIN-4 confirmatory study, focusing on a mechanism-enriched patient population of EGFR wild-type non-squamous NSCLC progressed on prior PD-1/L1 inhibitors with overall survival as the primary endpoint (NCT07361484).

Plinabulin Shows Potential to Overcome PD-1/PD-L1 Resistance
Emerging clinical data suggests plinabulin may help address acquired resistance to PD-1/PD-L1 therapies — a major challenge affecting approximately 60% of patients, with limited therapies for these progressed patients. With PD-1/PD-L1 therapies representing a multi-billion-dollar market, addressing resistance remains one of the most significant opportunities in oncology.

Presentations at ASCO (Free ASCO Whitepaper) 2025 and SITC (Free SITC Whitepaper) 2025 on multiple early-stage and investigator-initiated studies of Plinabulin combinations:

Plinabulin + pembrolizumab + docetaxel (303 study, NCT05599789): A Phase 2 study conducted at Peking Union Hospital in China in metastatic NSCLC patients progressing on PD-1/PD-L1 inhibitors (n=47) demonstrated:
Median progression-free survival (PFS) of 7.0 months
Disease control rate (DCR) of 85% and overall response rate (ORR) of 18.2%
Median OS not reached with 24-month overall survival rate of 66%
Whole blood analysis indicated higher proportions of activated CD4+/CD8+ T-cells post treatment

Plinabulin + PD-1 inhibitor + radiation (NCT04902040): A Phase 1 study conducted at MD Anderson Cancer Center across eight tumor types resistant to checkpoint inhibitors showed:
DCR of 54% and ORR of 23%
Mechanistic evidence of dendritic cell maturation and immune activation
Identification of a potential predictive biomarker (GEF-H1 immune signature)
These findings, published in Med 2025 (Cell Press), support plinabulin’s proposed immune-priming mechanism and its potential role in combination strategies to restore tumor sensitivity to immunotherapy
BeyondSpring Business Update

In January 2025, BeyondSpring entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED for gross proceeds of approximately $35.4 million to advance late-stage clinical development of Plinabulin. First closing of approximately $7.35 million was completed in February 2025.
SEED Therapeutics (Reported as Discontinued Operations) Advances First Clinical Program and Strengthens Organization
SEED Therapeutics continued to make progress in 2025 and early 2026, advancing its targeted protein degradation platform and pipeline.

Key highlights include:

ST-01156, a novel oral RBM39 degrader:
Received U.S. FDA Orphan Drug and Rare Pediatric Disease Designations
Achieved IND clearance in both the U.S. and China
Dosed first patient in a Phase 1a study in January 2026
ST-01156 Phase 1a enrolling at leading U.S. cancer centers: Dana-Farber, Massachusetts General Hospital, Memorial Sloan Kettering, MD Anderson Cancer Center, Hoag, and City of Hope
Presentation at AACR (Free AACR Whitepaper) 2025 on ST-01156 mechanism and preclinical studies including complete tumor regression in Ewing sarcoma and other cancer models; new degrader approaches in KRAS G12D degradation
SEED Business Update

Completed a $30 million Series A-3 financing
Appointed Dr. Bill Desmarais as Chief Financial Officer and Chief Business Officer
Named a finalist for the 2025 Prix Galien USA "Best Start-Up" Award
Full-Year 2025 Financial Resultsˆ
Continuing operations:

R&D expenses: $4.4 million (vs. $2.6 million in 2024), driven by increased drug manufacturing, NSCLC data management, Plinabulin combination research, regulatory consulting, and personnel costs
G&A expenses: $4.6 million (vs. $6.1 million in 2024), driven by lower personnel costs, reduced consulting expenses, and lower corporate overhead
Net loss: $8.7 million (vs. $8.9 million in 2024)
Cash, cash equivalents, and short-term investments: $12.6 million as of December 31, 2025
Discontinued operations:

Net loss: $5.5 million (vs. $7.8 million in 2024)
Current assets: $8.0 million as of December 31, 2025
Note 1. As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes.

(Press release, BeyondSpring Pharmaceuticals, MAR 25, 2026, View Source [SID1234663898])