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])

On March 31, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated, commercial-stage immunotherapy company, reported it has secured $75 million in non-dilutive financing under its existing Royalty Interest Purchase Agreement (RIPA) with Oberland Capital, increasing the total committed capital under the Agreement to $375 million. The amended agreement maintains existing terms, with a modest increase in the royalty payback rate while maintaining the royalty cap.

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"This additional non-dilutive financing gives us the capacity to continue scaling our commercial efforts and expanding globally following recent ANKTIVA approvals, while positioning us to take full advantage of the growth opportunities ahead," said Richard Adcock, President and CEO of ImmunityBio. "The strengthening of the company’s balance sheet through non-dilutive financing from Oberland, combined with the Founder’s reduction of debt, supports our global expansion following recent approvals and the advancement of our immunotherapy pipeline."

Simultaneous with the closing of the amendment to the RIPA, Nant Capital, LLC, an entity affiliated with our Executive Chairman, converted $25 million principal amount with the issuance of 4.6 million shares of the company’s common stock to Nant Capital, LLC and the reduction of debt under the $505 million December 2024 Promissory Note.

"The non-dilutive financing from Oberland and the conversion of debt to equity by Nant Capital, reflect strong confidence in ImmunityBio’s strategy and growth potential as a leading immunotherapy company paving the way for next-generation immunotherapy treatments," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.

Global Regulatory Approvals

ANKTIVA in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors, is now approved or authorized across five regulatory jurisdictions, representing approximately 34 countries:

United States: U.S. Food and Drug Administration (FDA) approval (April 2024)
United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA) authorization (July 2025)
Kingdom of Saudi Arabia: Saudi Food and Drug Authority (SFDA) accelerated approval for BCG-unresponsive NMIBC CIS (January 2026) and conditional accelerated approval for metastatic non-small cell lung cancer (NSCLC) in combination with checkpoint inhibitors (January 2026), the first jurisdiction globally to authorize ANKTIVA for lung cancer
European Union: European Commission conditional marketing authorization covering all 27 EU member states plus Iceland, Norway, and Liechtenstein (February 2026)
Macau Special Administrative Region (SAR): Pharmaceutical Administration Bureau authorization (March 2026)
This global regulatory footprint of 34 countries was established in under two years from initial U.S. FDA approval in 2024, reflecting rapid international expansion.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, MAR 31, 2026, View Source [SID1234664080])

On March 31, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, reported financial results and recent business highlights for its three months ended December 31, 2025.

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On November 17, 2025, the Company initiated its first-in-human clinical trial to evaluate HCW9302, the lead product candidate for the Company’s program to develop treatments for autoimmune disorders and proinflammatory diseases, in patients with areata alopecia. HCW9302 is a subcutaneously injectable, first-in-kind interleukin-2 ("IL-2") fusion immunotherapeutic. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of Treg cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases.

The Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding regulatory T cells ("Treg") cells. There are no curative FDA approved treatments of this indication. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime.

The Phase 1 multi-center dose-escalation study of HCW9302 is designed to treat up to 30 patients. The primary objectives of the study are to evaluate the safety of HCW9302, injected under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. A preliminary human data read out is expected in the first half of 2026.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, "We are excited to be the sponsor of this clinical study to evaluate this promising new treatment for alopecia areata. We will be conducting additional ancillary studies to provide further insights into disease responses and the effects of HCW9302 on proliferation and function of immune cells, particularly Treg cells."

Dr. Wong continued, "Based the results of our preclinical studies including non-human primates, we believe the human data read out will show that HCW9302 has superior IL-2Rα affinity and will sustain serum exposure, which could potentially make it favorable for the expansion and in increasing the functionality of Treg for autoimmune disease treatments. HCW9302 was well tolerated in non-human primate studies. If this remains the case in human studies, this would be a significant improvement over conventional IL-2 therapies that have low tolerability profiles. We believe the data will confirm that HCW9302 can achieve strong biological activity at lower therapeutic dose levels, and as a result, will have a favorable tolerability and at the same time can potentially enhance receptor selectivity and reduce off-target effects."

Business Highlights

Upfront License Fee Received for Exclusive Worldwide License for HCW11-006

As of March 16, 2026, we received the full payment of the upfront licensing fee for the exclusive worldwide license for HCW11-006, a preclinical molecule licensed to Beijing Trimmune Biotech Co., Ltd. ("Trimmune"). The Company received $3.5 million in gross proceeds, and $2.9 million net after taxes. In addition to the cash portion of the upfront license fee, the Company received a transferable minority equity interest in Trimmune.

HCW Biologics is eligible to receive additional payments under the license, including development milestone payments and double-digit royalties on future product sales, as well as a portion of the proceeds from certain future transaction(s) involving the licensed molecule, if and when such transaction(s) occur. Upon completion of Phase 1 by the licensee, the Company may exercise its Opt-In Rights to reclaim the rights to the Americas market. For an additional fee, Trimmune may exercise an option to license the China rights to HCW9302, the Company’s clinical-stage molecule, currently being evaluated in a Phase 1 trial in an autoimmune disorder.

Commercial-Ready Molecules Used as Reagents

During the year ended December 31, 2025, the Company launched two of its proprietary fusion protein molecules as commercial-ready molecules used as reagents to be used to support the production of cell-based immunotherapeutics to treat infectious diseases and cancer. While the Company’s focus remains on the development of fusion immunotherapeutics for the treatment of diseases promoted by chronic inflammation, the Company intends to market these reagents directly or through a corporate partnership to generate revenue which could offset development costs for its other immunotherapeutic treatments.

On March 13, 2026, Science Advances, a peer-reviewed, high-impact journal, released a publication with the Company’s data that showed the Company’s proprietary, commercial-ready compound, HCW9206, could fundamentally change how CAR-T cell therapies are manufactured and potential improve their clinical efficacy against diseases such as cancer and HIV. These findings support the Company’s belief that HCW9206 is a leap forward in both clinical potential and manufacturing efficiency.

Fourth Quarter 2025 Financial Results

Revenues: Revenues for the three months ended December 31, 2024 and 2025 were $394,804 and $27,010, respectively. Revenues for the years ended December 31, 2024 and 2025 were $2.6 million and $54,232, respectively. Historically, revenues have been derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the year ended December 31, 2025, the Company agreed to a one-year suspension of the Wugen License Agreement in exchange for the exclusive right to market HCW9206 and HCW9201 as reagents and potentially identify a new corporate partner during this period.

Research and development (R&D) expenses: R&D expenses for the three months ended December 31, 2024 and 2025 were $1.0 million and $1.3 million, respectively, an increase of $283,491, or 27%. R&D expenses for the years ended December 31, 2024 and 2025 were $6.4 million and $5.4 million, respectively, a decrease of $1.0 million, or 15%. R&D expenses in the year ended December 31, 2024 were higher than in the comparable period in 2025, due to higher expenses incurred for manufacturing and materials.

General and administrative (G&A) expenses: G&A expenses for the three months ended December 31, 2024 and 2025 were $2.0 million and $1.5 million, respectively, a decrease of $526,175, or 26%. G&A expenses for the years ended December 31, 2024 and 2025 were $6.8 million and $7.7 million, respectively, an increase of $884,832 or 13%. The increase in G&A expenses in 2025 was primarily due to salaries and benefits and professional fees related to audit services, tax and other advisory services, as well as required activities to remain in compliance with SEC regulations and Nasdaq listing rules.

Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration which held its hearing in May 2024, was settled on July 13, 2024, and was dismissed on December 24, 2024. Legal expenses (recoveries), net for the three months ended December 31, 2024 and 2025 were $148,949 and $120,136, respectively. Legal expenses (recoveries), net for the years ended December 31, 2024 and 2025 were $15.9 million and a contra expense of ($1.5) million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company and Dr. Wong reached a settlement agreement in 2025 for the full balance of $7.5 million which was owed for legal fees incurred in connection with the defense for Dr. Wong, resulting in a gain of $5.5 million for the year ended December 31, 2025.

Net (loss) gain: Net (loss) gain for the three months ended December 31, 2024 and 2025 was ($3.4) million and $2.2 million, respectively. Net loss for the years ended December 31, 2024 and 2025 was ($30.0) million and ($6.5) million, respectively.

(Press release, HCW Biologics, MAR 31, 2026, View Source [SID1234664079])