On March 12, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported financial results for the fourth quarter and year ended December 31, 2025 and provides an overview of recent and upcoming business highlights.

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"Our team remains highly focused on achieving our 2026 targets," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Specifically, our top priority goals are CNSide commercial scale-up and REYOBIQ pivotal trial readiness; we also are looking aggressively for ways to over achieve where possible."

Q4 2025 AND RECENT HIGHLIGHTS

Corporate

Completed an upsized public offering generating $15 million in gross proceeds, extending the Company’s projected cash runway and supporting CNSide commercialization and advancement of two ongoing Phase 2 clinical programs
REYOBIQ Development

Secured American Medical Association Category III CPT reimbursement code for convection-enhanced delivery with REYOBIQ, unlocking market access and growth potential of REYOBIQ therapy in recurrent glioblastoma and pediatric brain cancer
Incorporating constructive Type B meeting feedback from the FDA to help accelerate clinical development timelines and facilitate submission of application for the approval of REYOBIQ for patients with leptomeningeal metastases (LM)
Highlighted three REYOBIQ clinical data presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO), building upon body of real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers that continue to show promising safety profile and signs of efficacy
CNSide CSF Assay Platform

Expanded CNSide laboratory licensing to 49 of 50 U.S. states, having recently added Pennsylvania and California; enables access to CNSide Tumor Cell Enumeration (TCE) test to approximately 95% of the U.S. population
Continued to expand the CNSide Diagnostics team to support national test adoption
Announced second of planned national coverage agreements with Humana effective October 29, 2025. Combined with UnitedHealthcare national coverage agreement, CNSide CSF laboratory test policy coverage now reaches approximately 67 million people throughout the U.S.
Full Year 2025 FINANCIAL RESULTS

The Company’s cash and investments balance was $13.1 million on December 31, 2025 compared to $3.6 million on December 31, 2024
Recognized $5.2 million in grant revenue in the year ending December 31, 2025 and $5.8 million for the year ending December 31, 2024, which in both periods represents CPRIT’s share of the costs incurred for the advancement of our REYOBIQ development for the treatment of patients with LM
Total operating loss for the year ending December 31, 2025 was $15.3 million versus $14.7 million for the year ending December 31, 2024, with the increase primarily attributed to expansion of the CNSide operations team
Net loss for the year ending December 31, 2025 was $22.4 million, or $(0.29) per basic share versus $13.0 million, or $(1.95) per basic share, for the year ending December 31, 2024. The change in the net loss for the year ended December 31 was primarily due to change in fair value of derivative instruments from the Q1 2025 financings
Anticipated MILESTONES and OUTLOOK for 2026

REYOBIQ clinical program:

Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial; anticipate reporting data in Q3 2026
Completing enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an End of Phase meeting with FDA with the goal of aligning on pivotal trial design. Data expected in Q4 2026
Complete commercial manufacturing scale up for REYOBIQ
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
The Company expects research and development expenditures to increase in 2026 compared to 2025, due to increased costs for the ReSPECT-LM clinical trial, manufacturing scale up for REYOBIQ commercial and approval trial drug availability, and initial patient enrollments in the ReSPECT-PBC clinical trial, together with expansion of CNSide research and development teams.

CNSide commercial roll out:

Expand U.S. commercial payer coverage to >150 million covered lives
Secure Medicare coverage pathway
Achieve > 1,250 annualized test orders
Launch additional CSF tumor characterization assays to expand the CNSide platform
The Company expects general and administrative expenditures to increase in 2026 as compared to 2025 due to expanded CNSide commercial operations team (including sales, customer service and laboratory operations), such that the goal is for CNSide Diagnostics to breakeven by 2027.

About Leptomeningeal metastases (LM)
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, MAR 12, 2026, View Source [SID1234663512])

On March 12, 2026 20/20 BioLabs (Nasdaq: AIDX), an early market entrant in cutting-edge, AI powered laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, reported an update on its patented protein tumor marker (PTM) based, machine learning (ML) derived multi-cancer early detection (MCED) methodology in the wake of several recent studies suggesting the expected value of this approach for earlier stage detection compared to stand-alone circulating tumor DNA (ctDNA) based MCEDs.

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As population-scale cancer screening studies continue to generate trial data and real-world evidence, the medical community, consumers, investment community, and scientific experts are increasingly focused on which MCEDs and biomarker modalities are best suited to detect cancers early enough to meaningfully change patient outcomes. Results reported in February 2026 from a large-scale ctDNA-based MCED study conducted in the U.K. has prompted broader discussion about the biological limitations of circulating tumor DNA as first-line screening tests for early-stage disease.

Generally, for MCED tests to be clinically meaningful, they must detect cancer early enough to change outcomes. Among other things, this requires biomarkers that are present and detectable before tumors shed sufficient DNA into the bloodstream. Circulating tumor DNA (ctDNA)-based tests, while valuable in detecting advanced disease, face a fundamental biological constraint: in early-stage cancers, where tumor burden is low, DNA shedding is often intermittent or absent. As a result, ctDNA signals may only become reliably detectable after disease has progressed beyond the window of greatest clinical impact.

"The U.K. trial confirms that MCED blood testing can meaningfully shift the stage of cancer diagnosis. However, it also underscores that detecting the earliest cancers remains a fundamental biological challenge for ctDNA-based tests, as cancer biology does not begin with DNA fragment release in the bloodstream," said Michael Lebowitz, Ph.D., Chief Scientific Officer of 20/20 BioLabs. "A scalable future for population screening will likely combine technologies, with sensitive protein biomarkers identifying risk earlier and genomic assays providing confirmatory precision."

Studies published by 20/20 Biolabs and several independent research groups in the U.S. and Asia over the past 10 months add to the growing body of evidence that our company’s patented multi-cancer testing approach may help overcome many of the limitations of ctDNA for earlier stage detection:

In May 2025 20/20 Biolabs presented data on the sensitivity of its OneTest for Cancer (Premium version) at the annual meeting of the U.S. National Cancer Institute’s (NCI) Early Detection Research Network (EDRN), demonstrating detection rates for early-stage cancers as high as 50% for some tumor types — including pancreatic and ovarian cancers — from a pre-diagnostic (asymptomatic) population using a blinded cohort supplied by the NCI. (EDRN Poster May 2025)
Additional support for using protein tumor markers comes from a large, multicenter validation study published in Nature’s Precision Oncology in October 2025, which evaluated an AI enhanced blood test integrating seven well established protein tumor markers (6 of which are part of OneTest) across more than 15,000 participants from seven centers in three countries (USA, China, and Brazil). The study demonstrated consistent cancer signal detection across diverse populations, with measurable sensitivity even in Stage I disease and progressively higher detection rates as cancers advanced.
In a blinded validation study published in November 2025, investigators at MD Anderson Cancer Center reported that a protein based multicancer test—with most of the same biomarkers measured in OneTest (Standard version)—identified nearly 90% of early stage lung cancers and flagged multiple other cancers a median of 12–21 months prior to diagnosis, supporting the sensitivity of protein tumor markers during early oncogenesis.

These recent reports build upon hundreds of studies over several decades showing the sensitivity of PTMs for early-stage detection of many different tumor types, especially following repeat (serial) testing. This evolving evidence reinforces the scientific and commercial rationale for large scale screening first with its protein biomarker-based OneTest for Cancer test prior to considering the more costly ctDNA tests or advanced imaging platforms.

"Given the higher sensitivity of protein-based tests for Stage I and II cancers, a tiered approach in which protein-based tests like OneTest serve as the initial screening step makes sense," suggests Dr. Lebowitz. "Individuals identified by protein-based tests to be at mild risk can then be directed into ctDNA-based testing within a 3–6-month window, when ctDNA signals are more likely to be present. We believe those deemed at higher risk by protein–based tests are likely better served by moving directly to imaging studies. This tiered, or multi-step, approach is likely to yield the best outcomes and the lowest costs."

Results from the ctDNA MCED trails in the U.K. come shortly after Congress passed legislation in February 2026 to create a pathway for Medicare coverage of MCEDs beginning in 2028.

"The reimbursement opportunity created by the new legislation is an important step forward for cancer screening access," said Jonathan Cohen, CEO of 20/20 BioLabs. "As coverage decisions are made, we believe the science supports a broader view of MCED — one that includes protein-based technologies that have demonstrated meaningful early-stage detection. We are committed to continuing to build the evidence base and to working with policymakers, regulators, and payers to ensure that the most meaningful and cost-effective screening tools are readily available to Americans."

(Press release, 20/20 GeneSystems, MAR 12, 2026, View Source [SID1234663528])

On March 12, 2026 Pamplona Therapeutics and Coherent Biopharma reported a strategic collaboration to combine Pamplona’s AI-driven targeted protein degradation (TPD) molecular design capabilities with Coherent’s dual-target conjugation technologies, Bi-XDC and C-PROTAC.

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Through this partnership, the two companies will jointly explore a new class of degrader–conjugate therapeutics, integrating precision degrader design with advanced targeted delivery technologies. The collaboration aims to expand the therapeutic potential of targeted protein degradation, particularly in chronic diseases and other areas with significant unmet medical needs.

"We are excited to initiate this collaboration with Pamplona and Dr. Liu’s team. Our Bi-XDC technology platform is designed to address key limitations in drug delivery and conventional antibody-drug conjugates. By combining our delivery capabilities with Pamplona’s AI-driven degrader design, we believe this partnership can unlock new opportunities for innovative therapeutics."

Dr. Jinsong Liu, CEO of Pamplona Therapeutics, commented:

"Pamplona’s first First-in-Class molecule received FDA clearance for clinical investigation within three years, validating the engineering capability of our ASTRIDE platform in the TPD field. This collaboration brings together AI-enabled molecular design and next-generation delivery technologies, enabling us to accelerate the development of degrader–conjugate therapeutics and expand the boundaries of targeted protein degradation."

By integrating AI-powered degrader discovery with precision tissue/cell-targeting Bi-XDC delivery technologies, the collaboration seeks to enhance both the efficacy and targeting capabilities of protein degradation therapeutics. The combined approach aims to enable more effective elimination of disease-driving proteins while improving tissue targeting and pharmacological performance.

(Press release, Pamplona Therapeutics, MAR 12, 2026, View Source [SID1234663494])

On March 12, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the fourth quarter and year ended December 31, 2025.

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"We believe the recent cohort 4 data from our Phase 1 atopic dermatitis trial demonstrate that soquelitinib has the potential to be an important new medicine for a broad range of patients with atopic dermatitis and other immune diseases," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "The data also highlight the unique mechanism of action with ITK inhibition, regulating multiple T cell functional pathways that leads to an immune system resetting that may be effective in treating many diseases. Our near-term focus is the ongoing enrollment of our registration Phase 3 peripheral T cell lymphoma (PTCL) trial, getting off to a strong start with our recently initiated Phase 2 atopic dermatitis trial, and reporting additional data from the Phase 1 trial at the Society of Investigative Dermatology (SID) meeting. We are also advancing our plans to initiate two additional Phase 2 trials in asthma and hidradenitis suppurativa later this year. Our recent financing will enable us to advance all of these programs through key data readouts, providing significant opportunity to further demonstrate the value of soquelitinib’s pipeline-in-a-product potential."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

On January 20, 2026, Corvus reported data from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis (data as of January 15, 2026). Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment.
Efficacy highlights:
75% of soquelitinib patients in cohort 4 achieved EASI 75, 25% achieved EASI 90 and 33% achieved IGA 0/1. This compares to 20%, 0% and 0%, respectively, for the placebo group.
Across cohorts 1-4 of the Phase 1 trial, positive efficacy results were achieved in patients who have received prior systemic therapy, including patients who are treatment resistant to approved therapies such as dupilumab and JAK inhibitors.
New long-term data for cohort 3 show maintenance or improvement in EASI out to three months beyond the treatment period associated with an increase of circulating Treg cells.
Safety highlights:
No new safety signals were observed. No severe or serious adverse events were reported. No significant lab abnormalities were seen.
Soquelitinib has now been administered to over 150 patients with T cell lymphoma, autoimmune lymphoproliferative syndrome and atopic dermatitis involving over 14,000 patient treatment days. No patient has required dose modification or treatment related drug discontinuation in any of these clinical trials.
Corvus initiated its Phase 2 randomized placebo-controlled atopic dermatitis clinical trial during Q1 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment.
Angel Pharmaceuticals, Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will be enrolled in the Phase 2 portion of the study. The trial is open at several leading dermatology centers in China who have been involved in global registration trials. The study is conducted in close collaboration with Corvus. Results from the initial cohorts are anticipated late this year.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation that is designed for specific immunology and oncology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

Patient enrollment continues in the Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial, which is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.
Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy.
In December, Corvus presented the final data from the Company’s Phase 1/1b clinical trial evaluating soquelitinib in patients with T cell lymphoma in an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The data showed that patients in the 200 mg BID cohort had median progression free survival of 6.2 months and median overall survival of 28.1 months, comparing favorably to results with other therapies. The data support Corvus’ ongoing registration Phase 3 trial in relapsed/refractory PTCL and soquelitinib’s potential in immune and inflammatory diseases, including atopic dermatitis. Soquelitinib has been well tolerated with no patient requiring dose modification or discontinuation of the drug. Some of these patients have been on therapy for over 2 years. Over 30 lymphoma patients had Epstein Barr Virus (EBV) detected in blood at baseline prior to soquelitinib administration. No patient, including those with EBV at baseline, experienced viral reactivation or associated illness.
Financial Results
As of December 31, 2025, Corvus had cash, cash equivalents and marketable securities of $56.8 million as compared to $52.0 million as of December 31, 2024. Cash, cash equivalents and marketable securities as of December 31, 2025 does not include approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. Based on its current plans, Corvus expects its cash to fund operations into the second quarter of 2028.

Research and development expenses for the three months and year ended December 31, 2025 totaled $9.9 million and $33.7 million, respectively, compared to $6.0 million and $19.4 million for the same periods in 2024. The increase in research and development expenses of $3.9 million and $14.3 million for the three months and year ended December 31, 2025, respectively, was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended December 31, 2025 was $12.3 million compared to a net loss of $12.1 million for the same period in 2024. Included in net loss for the three months ended December 31, 2025 and 2024 were non-cash losses of $0.7 million and $2.2 million, respectively, from Corvus’ equity method investment in Angel Pharmaceuticals and a non-cash loss of $2.3 million in the three months ended December 31, 2024 associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended December 31, 2025 was $1.6 million compared to $0.8 million for the same period in 2024.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, March 12, 2026, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2025 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

(Press release, Corvus Pharmaceuticals, MAR 12, 2026, View Source [SID1234663495])

On March 12, 2026 Aminex Therapeutics, Inc., a clinical-stage biotechnology company focused on developing a novel metabolic-targeted therapy to treat adult and pediatric cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AMXT 1501 in combination with difluoromethylornithine (DFMO) for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG). This is the company’s second Orphan Drug Designation, following the ODD granted in October 2025 for neuroblastoma.

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"This second Orphan Drug Designation is a powerful validation of AMXT 1501’s potential to make a meaningful difference for patients facing some of the most devastating cancers," said Mark Burns, PhD, Chief Scientific Officer and President of Aminex Therapeutics. "DIPG is heartbreaking — children diagnosed with this brain tumor have virtually no effective treatment options and very little time. We are committed to changing that."

DIPG is an aggressive brainstem tumor that primarily strikes children aged 5 to 10, with a median survival of less than 12 months from diagnosis. There is currently no cure.

For Families of Children with DIPG and Other High-Risk Cancers: A Trial Is Now Enrolling

The Beat Childhood Cancer Research Consortium at Penn State College of Medicine, in partnership with Aminex, is actively enrolling patients in a national Phase 1/2 clinical trial of AMXT 1501 plus DFMO in pediatric patients with DIPG, neuroblastoma, sarcomas and other high-risk childhood cancers. The trial is planned to open at 50 clinics nationwide and enroll patients. For more information, visit ClinicalTrials.gov (NCT06465199) to learn more.

AMXT 1501 is also being evaluated in adults with solid tumors including breast cancer and metastatic melanoma in an active Phase 1b/2 multicenter trial (NCT07287917.)

The FDA’s Orphan Drug Designation provides Aminex with development incentives including tax credits, fee waivers, and seven years of market exclusivity upon potential approval.

(Press release, Aminex Therapeutics, MAR 12, 2026, View Source;a-highly-aggressive-childhood-brain-cancer-302711779.html [SID1234663514])