On March 31, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the year ended December 31, 2025.

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"We are entering a pivotal year with several high-impact clinical and regulatory milestones across our rare disease pipeline," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Key among these milestones is the interim analysis from the confirmatory Phase 3 FLASH2 (Fluorescent Light And Synthetic Hypericin 2) clinical trial of HyBryte (SGX301 or synthetic hypericin) for the treatment of early-stage cutaneous T-cell lymphoma (CTCL) slated for the second quarter and the release of top-line results from this trial expected in the second half of 2026. The overall blinded aggregate response rate in this trial remains consistent with what was previously reported and is higher than the estimated overall response rate used to design the study, increasing our confidence in the interim analysis and final study results. Additionally, we are advancing our inflammatory disease programs, with plans to initiate a placebo-controlled Phase 2 study of SGX945 (dusquetide) for Behçet’s Disease once formulation work for home-use administration is complete in the second half of 2026. We recently reported top-line results for the last cohort of four patients in the Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where SGX302 gel therapy demonstrated clincial benefit in improving psoriasis lesions and was well tolerated by all patients with no drug related adverse events identified."

Dr. Schaber continued, "Ending 2025 with approximately $7.9 million in cash, we remain focused on disciplined capital management to drive our strategic objectives. While our current cash balance provides operating runway into Q4 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On March 26, 2026, the Company announced that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), granted orphan drug designation to dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet’s Disease. To view this press release, please click here.
On March 23, 2026, the Company announced that findings from recent supportive trials with HyBryte in the treatment of CTCL are being presented at the United States Cutaneous Lymphoma Consortium Workshop. To view this press release, please click here.
On March 19, 2026, the Company announced that a summary of clinical trials completed to date evaluating HyBryte as a treatment for CTCL has been published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs. To view the publication, please click here. To view this press release, please click here.
On March 10, 2026, the Company announced that SGX945 has been granted Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of Behçet’s Disease. To view this press release, please click here.
On February 26, 2026, the Company announced that the EMA COMP provided a positive recommendation on the Company’s request for orphan drug designation for dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet’s Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. To view this press release, please click here.
On February 12, 2026, the Company issued an update letter detailing recent progress and upcoming milestones. To view this press release, please click here.
On December 18, 2025, the Company announced that the results from its Phase 2a proof of concept study evaluating SGX945 in the treatment of Behçet’s Disease have been published in Rheumatology (Oxford), in an article entitled "Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome". To view this press release, please click here.
On December 17, 2025, the Company announced extended results of its ongoing Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis. To view this press release, please click here.
On November 19, 2025, the Company announced it had completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte in the treatment of CTCL. To view this press release, please click here.
Financial Results – Quarter Ended December 31, 2025

Soligenix reported no revenues for the year ended December 31, 2025, compared to $0.1 million for the prior year. The decrease in revenues was primarily a result of the conclusion of the zero-margin grant for the HyBryte investigator-initiated study.

Soligenix’s net loss was $11.1 million, or ($2.14) per share, for the year ended December 31, 2025, compared to $8.3 million, or ($4.98) per share, for the prior year. The increase in net loss is primarily attributed to increases in research and development costs associated with the Phase 2 study in Behçet’s Disease, the ongoing second confirmatory Phase 3 CTCL study; a decrease in other income relating to tax credits; and the change in the fair value of debt.

Research and development expenses were $7.5 million as compared to $5.2 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily related to costs associated with the Phase 2 study in Behçet’s Disease and the ongoing second confirmatory Phase 3 CTCL study.

General and administrative expenses were $4.4 million and $4.2 million for the years ended December 31, 2025 and 2024, respectively. This increase is primarily attributable to increases in various taxes and stock related expenses offset by a decrease in professional fees.

As of December 31, 2025, the Company’s cash position was approximately $7.9 million.

(Press release, Soligenix, MAR 31, 2026, View Source [SID1234664085])

On march 31, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported publication of the final data from the Phase 1/2 ARROW study evaluating pralsetinib for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) in the Journal of Clinical Oncology. The final data includes an additional 42 months of follow-up from previously published data. Pralsetinib is the only once daily, oral RET-inhibitor therapy that is designed to selectively target RET in metastatic NSCLC and advanced or metastatic thyroid carcinoma.

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"The final data from the ARROW study shows robust and durable responses with a manageable safety profile in patients with RET fusion-positive NSCLC, emphasizing the importance of early biomarker testing and suggesting that pralsetinib may be a valuable tool in the treatment armamentarium," said Justin F. Gainor, M.D., Phase 1/2 trial investigator and Director of the Center for Thoracic Cancers at Mass General Brigham Cancer Institute. "In addition, the responses observed in the subset of patients with measurable CNS metastases at baseline further expand the potential clinical value of pralsetinib in everyday practice."

"The results published in the Journal of Clinical Oncology demonstrate the positive impact pralsetinib can have for patients with RET fusion-positive NSCLC," said Lisa Rojkjaer, M.D, Rigel’s chief medical officer. "These longer-term data further support pralsetinib’s role as a first-line treatment option for RET fusion-positive NSCLC patients."

Additional key points from the paper include:

Consistent with previous reports from the ARROW study NSCLC cohort, pralsetinib was generally well tolerated with a manageable toxicity profile. Three treatment-related deaths occurred in treatment-naive patients in Asia (pneumonia, n=2; interstitial lung disease and rhabdomyolysis, n=1 each), no new safety signals were observed and no hypersensitivity reactions were reported in patients receiving prior immunotherapies.
Among patients with measurable disease (n=259), the overall response rate (ORR) was 70%, including 7% complete responses and 63% partial responses.
ORR was 78% among treatment-naïve patients and 63% among patients receiving prior platinum-based chemotherapy.
At final data lock, median treatment duration was 15.0 months.
Median overall survival (OS) was 44.3 months in the overall measurable disease patient population, 50.1 months in treatment-naïve patients, and 39.7 months in prior-platinum patients, with median follow-ups of 47.6, 43.7, and 49.7 months, respectively. Longer median OS in the overall measurable disease patient population was seen in patients treated in the United States (62.4 months) vs. Asia (44.5 months) or Europe (29.6 months).
Median overall progression-free survival (PFS) was 13.1 months in the overall measurable disease patient population, but was longer in patients in the United States (25.9 months) vs. Asia (12.6 months) or Europe (12.8 months).
ORR remained high in subgroups bearing the RET fusion partners KI5FB and CCDC6 among both treatment-naive and prior platinum-based chemotherapy patients. Among all patients, median duration of response (DOR) was longer in patients with CCDC6 (47.9 months) vs. KIF5B (13.1 months).
Fifteen patients had measurable central nervous system (CNS) metastases at baseline. The intracranial response rate (CNS ORR) among these patients was 53%. In the 11 response-evaluable patients with CNS metastases, CNS ORR was 73%.
The publication, titled "Final Efficacy and Safety Data From the Phase 1/2 ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)," was published online and can be found here.

About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.1 RET fusions are implicated in approximately 1-2% of patients with NSCLC.2

About GAVRETO (pralsetinib)

INDICATIONS

GAVRETO (pralsetinib) is indicated for the treatment of:

Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)*
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS, INCLUDING OPPPORTUNISTIC INFECTIONS

GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity.

WARNINGS AND PRECAUTIONS

Serious Infections, Including Opportunistic Infections: GAVRETO may increase the risk for serious infections, including fatal and opportunistic infections. In the AcceleRET-Lung trial, infections occurred in 72% of patients who received GAVRETO, including 18% with Grade 3 and 3.7% with Grade 4 and 7% with fatal outcomes. Among the patients who received chemotherapy/immunotherapy, infections occurred in 52%, including 10% with Grade 3. Infections in the GAVRETO arm included pneumonia, urinary tract infection, opportunistic infections (such as pneumocystis jirovecii pneumonia and fungal infections) and others. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue GAVRETO based on severity.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.
Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.
Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.
Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.
Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.
Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.
Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.
ADVERSE REACTIONS

Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.
DRUG INTERACTIONS

Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.
Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.

Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.

Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

GAVRETO is a registered trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, MAR 31, 2026, View Source [SID1234664084])

On March 31, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported a rinzimetostat (ORIC-944) program update and potential best-in-disease efficacy and safety data from the Phase 1b trial of once daily rinzimetostat in combination with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate (abiraterone).

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"The combination dose optimization data announced today provide confirmatory evidence that support rinzimetostat’s potential best-in-disease clinical profile, reinforcing its path towards becoming a practice-changing therapy for patients with prostate cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "The durability observed to date is consistent with the competitor PRC2 inhibitor currently in Phase 3 in mCRPC and appears meaningfully improved relative to other approved standard of care therapies. Notably, rinzimetostat demonstrated this impressive durability with a markedly cleaner safety profile than competitor regimens."

"These data provide compelling validation for advancing rinzimetostat in combination with darolutamide into Phase 3 registrational trials in patients with prostate cancer," said Pratik S. Multani, M.D., chief medical officer. "We expect our first Phase 3 trial, Himalayas-1, in patients with mCRPC previously treated with abiraterone, to initiate in the first half of 2026 while we continue to evaluate rinzimetostat in additional indications in prostate cancer and beyond."

Rinzimetostat Phase 1b Dose Optimization Data in Combination with Darolutamide
Patients were previously treated with a median of two prior lines of therapy, including abiraterone, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median excludes background androgen deprivation therapy or first-generation androgen receptor (AR) inhibitors that the patients may have received. 18 patients were treated with 400 mg of rinzimetostat once daily and 15 patients were treated with 600 mg of rinzimetostat once daily, both in combination with the standard dose of darolutamide at 600 mg twice daily.

Rationale for Selection of the Recommended Phase 3 Dose (RP3D)
At the 400 mg dose, rinzimetostat in combination with darolutamide continues to be well tolerated and demonstrates a safety profile supportive of long-term administration and sustained patient adherence. As of the January 16, 2026 data cutoff, the vast majority of treatment-related adverse events (TRAEs) were Grade 1 in severity and consistent with PRC2 and AR inhibition. The most common TRAEs were fatigue (39%; 17% Grade 1 and 22% Grade 2), diarrhea (22%; 17% Grade 1 and 6% Grade 2) and nausea (22%; all Grade 1). A single Grade 3 TRAE was observed, and no Grade 4 or 5 AEs were attributed to rinzimetostat or darolutamide. Dose modifications were rare (one interruption and one discontinuation), with no dose reductions required. The 600 mg dose of rinzimetostat in combination with darolutamide was associated with a modestly higher rate of adverse events and dose modifications. In a broader dataset of post-ARPI (androgen receptor pathway inhibitor) patients (n=72, inclusive of the post-abiraterone patients), the safety and tolerability profile was consistent with the post-abiraterone cohort.

To support the selection of the recommended Phase 3 dose in accordance with the FDA’s Project Optimus initiative, the company conducted a comprehensive exposure-response (E-R) analysis in over 100 patients across both the single-agent and combination data evaluating the relationship between rinzimetostat drug exposure versus efficacy and safety outcomes. The analysis demonstrated that 400 mg and 600 mg once daily provided comparable efficacy. In contrast, the E-R analysis identified statistically significant relationships between higher drug exposure and toxicities as well as increased rates of treatment modifications, clearly favoring the 400 mg dose on the basis of safety. Based on these findings 400 mg once daily in combination with darolutamide has been selected as the RP3D for rinzimetostat.

Preliminary Efficacy Analysis at RP3D
As of March 6, 2026, radiographic progression-free survival (rPFS) was assessed in 18 efficacy-evaluable patients. PSA responses were assessed in a subset of 15 patients with at least one post-baseline assessment as of the January 16, 2026 clinical cutoff. ctDNA molecular response was evaluated in 14 patients with detectable ctDNA at baseline.

Early efficacy data, including landmark rPFS rates, PSA reductions and ctDNA responses, are suggestive of meaningful and durable clinical benefit for rinzimetostat in combination with darolutamide compared to competitor data and historical outcomes with approved therapies. Rinzimetostat 400 mg once daily in combination with darolutamide demonstrated compelling efficacy across multiple endpoints:

With a median follow up of 4.9 months, landmark rPFS rates of 93%, 84%, and 84% at 3, 4, and 5 months, respectively, are consistent with the competitor PRC2 inhibitor currently in Phase 3 in post-abiraterone mCRPC patients and superior to available standard-of-care therapies, including Xtandi, Jevtana, Taxotere, and Pluvicto. For reference, the 5-month landmark rPFS for these approved therapies ranges from approximately 60% to 75%.
47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed.
Impressive ctDNA reductions observed across a range of AR mutations, with 71% of patients (10/14) achieving >50% ctDNA reduction.
Himalayas-1 Phase 3 Trial
The company expects to initiate the Himalayas-1 global Phase 3 registrational trial in mCRPC patients previously treated with abiraterone in the first half of 2026. This proposed trial will enroll approximately 600 patients from over 250 sites in over 20 countries, randomized 1:1 to receive the RP3D of 400 mg QD rinzimetostat in combination with darolutamide versus physician’s choice of an AR inhibitor or chemotherapy. The primary endpoint is rPFS, the key secondary endpoint is overall survival, and additional secondary endpoints include PSA response rate, objective response rate and patient reported outcomes.

In the US, the annual incidence of mCRPC patients previously treated with abiraterone is approximately 17,000, with an estimated addressable market of greater than $3.5 billion and total global addressable market of $7 billion. This market lacks oral, well-tolerated therapies with meaningful efficacy.

Next Steps
Rinzimetostat 400 mg QD plus darolutamide is currently being evaluated in a food effect cohort. Thus far, there does not appear to be a significant food effect, consistent with previous single agent studies. Furthermore, as of March 6, 2026, early efficacy and safety are consistent with fasted results, with two confirmed PSA50 responses and one confirmed PSA90 response in the first five patients dosed, and all TRAEs reported being Grade 1 with a single Grade 2 TRAE.

The company is also evaluating additional prostate cancer populations for future potential Phase 3 trials in mCRPC and mCSPC. Early data from rinzimetostat in 19 patients with mCRPC previously treated with AR inhibitors demonstrated compelling landmark rPFS rates of 93%, 85%, and 85% at 3, 4, and 5 months, respectively, with a median follow-up of 4.8 months.

Rinzimetostat Phase 1b Trial Design
Rinzimetostat is being evaluated in a Phase 1b dose optimization trial in combination with ERLEADA (apalutamide), Johnson & Johnson’s AR inhibitor, and NUBEQA (darolutamide), Bayer’s AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an ARPI and up to one prior chemotherapy. The primary objective of the trial is to determine the RP3D, and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity.

Conference Call and Webcast Details
ORIC will host a conference call and webcast today at 4:30 p.m. ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

(Press release, ORIC Pharmaceuticals, MAR 31, 2026, View Source [SID1234664083])

On March 31, 2026 Omeros Corporation (Nasdaq: OMER) reported recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2025, which include:

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● Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share, for the fourth quarter of 2024. For the year ended December 31, 2025, net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share, in the prior year.

● Fourth quarter results include a net gain of $237.6 million tied to the zaltenibart transaction with Novo Nordisk. The fourth quarter also includes a $136.0 million non-cash charge associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 Notes and Term Loan. Excluding the non-cash charge associated with the embedded derivatives, non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively.

● At December 31, 2025, we had $171.8 million of cash and short-term investments. We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 47%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024.

Fourth Quarter and Recent Highlights

● On November 25, 2025, we closed the previously announced transaction with Novo Nordisk Health Care AG ("Novo Nordisk"). Pursuant to the Asset Purchase and License Agreement ("APLA"), Novo Nordisk received exclusive global rights in all indications to develop and commercialize zaltenibart (formerly OMS906), our lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 ("MASP-3") and certain related antibodies and products. Omeros retains rights to its MASP-3 small-molecule program unrelated to zaltenibart, including the ability to develop and commercialize small-molecule MASP-3 inhibitors with limited restrictions on indications. Omeros also retains rights to its "grandfathered" MASP-3 antibodies, with temporal and indication restrictions on commercialization and for use in advancing its small-molecule therapeutics.

At closing, we received an upfront cash payment of $240.0 million. In addition, we are eligible to receive:

● Up to $100.0 million in near-term milestone payments and an additional $410.0 million in one-time milestone payments upon the first achievement by Novo Nordisk or its affiliates or sublicensees of each of the development and approval milestone events as set forth in the APLA;

● Up to $1.3 billion in one-time milestone payments upon the achievement by Novo Nordisk or its affiliates or sublicensees of certain sales-based and commercial milestone events; plus

● Tiered royalties on annual global net sales of applicable products at rates ranging from a high single-digit to high-teens.

● Omeros used a portion of the cash received at closing of the Novo Nordisk transaction to repay the entire $67.1 million principal amount outstanding under its senior secured term loan, along with a related prepayment premium, accrued and unpaid interest, and expenses. The prepayment resulted in the termination of the corresponding credit agreement and the release in full of all liens and covenants thereunder. Another portion of the cash was subsequently used to repay the remaining $17.1 million aggregate principal amount outstanding of our 2026 convertible notes at maturity in February 2026.

● On December 23, 2025, the U.S. Food and Drug Administration ("FDA") approved YARTEMLEA (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy ("TA-TMA") in adults and in children ages two years and older. YARTEMLEA is the first and only approved therapy for TA-TMA, an often-fatal complication of stem cell transplantation driven by activation of the lectin pathway of complement. YARTEMLEA selectively inhibits MASP-2, the effector enzyme of the lectin pathway, blocking pathway activation while preserving classical and alternative complement functions important for host defense against infection.

● Commercial distribution and sales of YARTEMLEA began in January 2026. Both adult and pediatric patients with TA-TMA are now receiving YARTEMLEA, including patients who have recently failed prior off-label C5- and C3-inhibitor regimens, in both hospital and outpatient settings.

● We are commercializing YARTEMLEA in the U.S. market and have deployed our field force of account managers and directors, market development managers, access leads, and medical science liaisons to engage directly with transplant centers across the United States.

● A marketing authorization application ("MAA") for YARTEMLEA for the treatment of TA-TMA is currently under review by EMA with a decision expected in mid-2026. If approved, the MAA authorizes the product to be marketed in all EU member states and European Economic Area countries.

"In the fourth quarter of 2025, Omeros delivered transformative achievements for our shareholders," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "Following FDA approval of YARTEMLEA with a broad label and no boxed warning, REMS, or required vaccinations, our commercial launch is well underway, and patients who urgently need the drug are now able to access it. Our partnership with Novo Nordisk expands the breadth of indications being pursued for zaltenibart and has provided — and should continue to provide — substantial operating capital while underscoring the value of our science. These successes are expected to fuel the development of a growing portfolio of commercial products from our robust pipeline as we target positive cash flow in 2027."

Recent Developments

● Recent developments in other programs include the following:

● We were previously awarded a three-year, $6.24 million grant from the National Institute on Drug Abuse ("NIDA"), part of the National Institutes of Health, to develop, at NIDA’s request, our lead orally administered phosphodiesterase 7 ("PDE7") inhibitor for the treatment of cocaine use disorder. The grant is intended to support (i) preclinical cocaine interaction/toxicology studies to assess safety of the therapeutic candidate in the presence of concomitant cocaine administration and (ii) an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adult cocaine users who receive concurrent intravenous cocaine. The preclinical studies, designed with NIDA toxicologists, were completed and showed no drug-interaction or safety issues, supporting the scheduled in-patient human study of OMS527 in cocaine users. FDA subsequently requested additional preclinical information prior to initiating the clinical in-patient study in cocaine users. Together with our collaborators at NIDA, we are scheduled to meet with FDA in the coming quarter to discuss that request.

● We continue to progress preclinical studies within our novel oncology program, which is focused on developing novel, proprietary large-molecule therapeutics designed to selectively target and kill dividing cancer cells. The lead indication for development is acute myeloid leukemia ("AML"), an aggressive and highly fatal bone marrow and blood cancer. We have completed selection of a drug development candidate, and IND-enabling studies are underway for this program, which we refer to as OncotoX-AML.

o OncotoX-AML shows broad application across AML regardless of genetic mutation, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients. In human tumor-bearing animal and in vitro human AML cell-line studies, our AML therapeutic candidate has demonstrated superior efficacy to current AML standard of care treatments.

o In February 2026, we announced the successful completion of our initial study in nonhuman primates evaluating the efficacy and safety of OncotoX-AML. Administration of only one course of OncotoX-AML treatment to immunocompetent primates demonstrated the desired pharmacologic response, specifically marked, selective, reversible, and dose-related reduction in myeloid progenitor cells — the cells that can mutate and lead to AML — by up to 99%. OncotoX-AML was well tolerated. There were no observed safety signals or meaningful changes in blood chemistry values.

● Our Targeted Complement Activating Therapy ("T-CAT") platform — a new class of recombinant antibodies designed to target and directly kill bacteria, fungi, viruses, and parasites — continues to amass animal data across multiple pathogen classes and species. Our initial focus is on multidrug-resistant organisms ("MDROs"), widely recognized as one of the most critical unmet needs in medicine. In well-established in vivo animal models considered predictive of efficacy in humans, T-CAT recombinant antibodies demonstrated effectiveness in treating life-threatening infections caused by Gram-negative and Gram-positive bacteria, including those designated by the World Health Organization as priority pathogens. A publication on our T-CAT platform is expected in the coming weeks.

Financial Results

During the fourth quarter, we recognized $237.6 million in net proceeds from the sale of zaltenibart to Novo Nordisk. This represents $240.0 million in upfront cash from Novo Nordisk net of transaction related costs of $2.4 million.

With funds received from Novo Nordisk, we fully repaid $67.1 million in principal outstanding under our senior secured credit agreement in November 2025.

At December 31, 2025, we had $171.8 million of cash and short-term investments. We used available cash on hand to repay the remaining $17.1 million aggregate principal amount outstanding of our 2026 convertible notes at maturity in February 2026.

We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 46.7%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024.

Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share for the fourth quarter of 2024. For the year ended December 31, 2025, our net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share in the prior year.

The change in fair value of financial instruments as shown in our statement of operations and comprehensive loss reflects marking to market the embedded derivative on our 2029 Notes under GAAP. Excluding the net loss on change in fair value of financial instruments which is non-cash, our non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively.

For the fourth quarter of 2025, we earned OMIDRIA royalties of $9.2 million from Rayner Surgical Inc. on U.S. net sales of $30.7 million. This compares to earned OMIDRIA royalties of $10.1 million during the fourth quarter of 2024 on U.S. net sales of $33.6 million. Per the terms of our original 2022 and amended 2024 agreements with DRI Health Acquisition LP, ("DRI"), all U.S.-based royalties through 2031 are remitted from Rayner to DRI through an escrow agent.

Total operating expenses for the year ended December 31, 2025 were $122.8 million compared to $167.0 million for the year ended December 31, 2024. The $44.2 million decrease was primarily due to timing of manufacturing batches, as Omeros released approximately $21.9 million of drug substance in the prior year as well as completed work on the Phase 1 OMS1029 and IgA nephropathy studies. In addition, we reduced expenditures on certain activities in the current year to conserve capital in anticipation of our expected commercial launch of YARTEMLEA.

Interest expense decreased $25.6 million in 2025 compared to 2024. The decrease primarily relates to a $27.8 million change in non-cash remeasurement costs on the OMIDRIA royalty obligation to reflect a change in forecasted OMIDRIA cash flows from Rayner. Excluding any non-cash remeasurement adjustments of the DRI royalty obligation and any amortization of debt discount, premium, or issuance costs, contractual interest expense remained relatively unchanged from the prior year.

Interest and other income was $4.1 million in 2025 compared to $11.3 million in 2024. The difference is primarily due to lower average cash and investments balances available to invest in the current year.

Net income from discontinued operations, net of tax, was $1.5 million, or $0.02 net income per share, in 2025 compared to net income from discontinued operations, net of tax of $25.8 million, or $0.44 net income per share, in 2024. The decrease was primarily attributable to non-cash remeasurements.

Conference Call Details

Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.

For online access to the live webcast of the conference call, please register at the following URL View Source or go to Omeros’ website at View Source

A replay of the call will be made accessible online for 90 days at View Source

(Press release, Omeros, MAR 31, 2026, View Source [SID1234664082])

On March 31, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported financial results for the year ended December 31, 2025, and highlighted recent business updates including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer.

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"IMUNON continues to make significant progress in advancing IMNN-001, a potential breakthrough for women with newly diagnosed advanced ovarian cancer," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "A final data assessment of the Phase 2 OVATION 2 Study indicates 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."

"Unprecedented survival data results from the Phase 2 OVATION 2 Study, coupled with compelling interim results from our MRD study and a clear regulatory path in Phase 3, position IMNN-001 with the potential to deliver transformative impact on ovarian cancer treatment. These new results showing continued improvements in overall survival are especially exciting given that there have been virtually no advances in frontline standard of care for women newly diagnosed with ovarian cancer in the last 35 years," Dr. Lindborg continued.

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

Final Phase 2 OVATION 2 Study Data Show Continued Overall Survival Improvement with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer – On March 25, 2026, the Company announced final 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) in 112 women with newly diagnosed advanced ovarian cancer. IMUNON previously reported a median 11.1 month increase in overall survival (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 reported a median 14.7 month increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in overall survival (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 overall survival of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone.

Importantly, with these new efficacy results, IMNN-001 continued to show a highly favorable safety and tolerability profile, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment of this disease.

R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer – On November 10, 2025, the Company hosted an R&D Day, providing updates on new IMNN-001 data and discussing progress with the Phase 3 OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. Highlights from the R&D Day are summarized below.

Data from the Phase 2 OVATION 2 clinical trial:

Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.

Safety, tolerability and translational insights from the Phase 2 minimal residual disease (MRD) study of IMNN-001:

Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab, and in the maintenance setting.

Phase 2 and ongoing Phase 3 trial designs, and the strength of evidence for IMNN-001 from a statistical perspective:

The well-precedented nature of the Phase 3 trial design, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by the U.S. Food and Drug Administration (FDA) based on an interim analysis of overall survival.
This foundation, supported by conservative power assumptions drawn from Phase 2 clinical data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

New data further demonstrating IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis.

The presentations from the R&D Day are available on the "Scientific Presentations" page of the IMUNON website at View Source

Translational Data from Phase 2 OVATION 2 Study of IMNN-001 at SITC (Free SITC Whitepaper) 40th Annual Meeting – On November 7, 2025, the Company presented translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, held on November 5-9, 2025, in National Harbor, Maryland.

New data from recently analyzed OVATION 2 Study patient samples demonstrated that IMNN-001 creates a "hot" anti-tumor microenvironment in epithelial ovarian cancer by (i) increasing the recruitment of anti-tumor CD8+, myeloid dendritic cells and M1 macrophages in patient tumors; and (ii) decreasing immunosuppressive markers (IDO, T regulatory [Treg] cells, exhausted CD8, M2 macrophages). These results, including induction of favorable ratios of CD8+/Tregs and CD8+/CD4+ cells, which are both associated with improved patient outcomes, are consistent with the results of the previous OVATION 1 study and with the efficacy seen in the clinic in the OVATION 2 study. This biomarker research confirms local immune activation at the tumor site by IMNN-001.

The SITC (Free SITC Whitepaper) poster presentation is available on the "Scientific Presentations" page of the IMUNON website at View Source

Phase 3 OVATION 3 Study of IMNN-001 in Advanced Ovarian Cancer at the ESMO (Free ESMO Whitepaper) Congress and the IGCS 2025 Annual Global Meeting – On October 14, 2025, the Company announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001 were being presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, held on October 17-21, 2025, in Berlin, Germany with an encore presentation following at the 2025 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), held on November 5-7, 2025, in Cape Town, South Africa. The poster presentations are available on the "Scientific Presentations" page of the IMUNON website at View Source

PlaCCine DNA Vaccine Technology

PlaCCine DNA Technology Proof-of-Concept Data Presented in Platform Presentations at Leading Vaccine Conferences – On October 17, 2025, the Company announced oral presentations highlighting IMNN-101, its proof-of-concept DNA plasmid vaccine based on the Company’s proprietary PlaCCine technology platform, including proof-of-concept clinical trial results at the following vaccine conferences:

5th Edition of International Vaccines Congress (IVC) Keynote Oral Presentation: A promising novel approach to DNA vaccines, presented on October 23, 2025
10th International Conference on Vaccine Research and Development Oral Presentation: Development of a PlaCCine DNA Technology for Safe, Effective and Durable Vaccines, presented on November 6, 2025

These presentations described the unique design and composition of the PlaCCine technology and its differentiating features including a longer duration of antigen expression, safety, and user compliance, and storage stability at workable temperatures (up to one year at 4°C and one month at 37°C) in comparison to mRNA vaccines and other DNA vaccines requiring viruses or devices for delivery. The immunogenicity of the PlaCCine technology was demonstrated against various pathogens in multiple species and animal models. These presentations also demonstrated safety and immunogenicity of a PlaCCine based vaccine (IMNN-101) targeting a SARS-CoV-2 spike variant in healthy human participants following intramuscular administration. Durable neutralizing antibody (Nab) responses from baseline at six months demonstrating vaccine immunogenicity following a single dose in previously vaccinated or infected individuals with the SARS-CoV-2 underscore the significance of the PlaCCine approach and support continued development in both naive populations using a prime and boost vaccination to determine optimal benefits and in other infectious diseases.

IMNN-101 has been shown to be safe and well tolerated, with no serious adverse effects reported. To advance the development and commercialization of the PlaCCine platform in the prophylactic vaccine competitive landscape, IMUNON will require a strategic partnership(s) with a pharmaceutical or biotechnology company.

CORPORATE DEVELOPMENTS

IMUNON Sharpens Focus on its Promising Pivotal Phase 3 Ovarian Cancer Study – On February 5, 2026, the Company announced a strategic reorganization, the goal of which was to reduce operating expenses while supporting the Company’s focused strategy to rapidly advance the pivotal Phase 3 OVATION 3 clinical trial.

$7.0 Million Registered Direct Offering Priced At-The-Market Under NASDAQ Rules – On December 30, 2025, the Company announced that it entered into a securities purchase agreement for the purchase and sale of 1,939,114 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate of 1,939,114 shares of common stock. Each share of common stock (or pre-funded warrant in-lieu thereof) was sold together with one warrant to purchase one share of common stock at a combined purchase price of $3.61 (or $3.6099 per pre-funded warrant and warrant). The warrants have an exercise price of $3.482 per share, and became exercisable immediately upon issuance, and will expire five years from the date of issuance. The offering closed on December 31, 2025.

FINANCIAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2025

Cash Management Continues to Focus on the Phase 3 OVATION 3 Study –
IMUNON reported a net loss for 2025 of $14.5 million, or $6.83 per share, compared with a net loss of $18.6 million, or $16.94 per share, for 2024. Operating expenses were $14.7 million for 2025; a 23% decrease compared to 2024.

Research and development (R&D) expenses were $7.8 million for 2025; a 33% decrease compared to 2024. The decrease was due primarily to lower costs associated with the OVATION 2 Study, the Phase 1 proof-of-concept PlaCCine DNA vaccine trial, and development of the PlaCCine DNA vaccine technology platform, partially offset by start-up costs associated with the pivotal Phase 3 OVATION 3 Study.

General and administrative (G&A) expenses were $6.9 million for 2025, a decrease of 8% compared to 2024. This decrease was primarily attributable to headcount reductions and lower employee-related expenses.

Net cash used for operating activities was $13.9 million for full year 2025 compared with $18.9 million for full year 2024. Cash provided by financing activities of $17.1 million for 2025 resulted from two offerings in May 2025 and December 2025 ($13.6 million) and sales under the Company’s at-the-market equity facility ($3.5 million).

As of December 31, 2025, cash and cash equivalents were $8.8 million.

Conference Call and Webcast

The Company will be hosting a conference call to review 2025 financial results and provide a business update today, March 31, 2026, at 11:00 a.m. EDT. To participate in the call, please dial 800-715-9871 (North America/Toll Free) or 646-307-1963 (U.S./Toll) and ask for the IMUNON Year End 2025 Financial Results Call (Conference ID 4157104). A live webcast of the call will also be available here.

An audio replay of the call will be available for 90 days and can be accessed at 800-770-2030 (U.S. and Canada/Toll Free), 609-800-9909 (U.S./Toll) or 647-362-9199 (Canada/Toll) using replay access code 4157104#.

(Press release, IMUNON, MAR 31, 2026, View Source [SID1234664081])