On May 13, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that it is approaching the first unblinding of data from its pivotal Phase 2B/3 "MIRACLE" trial evaluating Annamycin in combination with cytarabine for the treatment of subjects that have been relapsed or refractory to their primary line of treatment for acute myeloid leukemia (R/R AML). The trial incorporates two arms of Annamycin at different doses plus cytarabine compared to the control arm of cytarabine plus a placebo. The Company continues to expect this unblinding to occur prior to June 30, 2026, as previously communicated.

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The Company also reported that preliminary blinded efficacy data for the 45 subjects continue to approximate previously disclosed results, including a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. These results compare favorably to historical CR rates from two major trials of approximately 17-18% observed with cytarabine alone in similar patient populations. Cytarabine is a currently approved standard of care for second line treatment of AML. Based on preliminary data, the median age for subjects enrolled is in the mid-60’s, with over 30% entering the trial after becoming relapsed from or refractory (R/R) to a prior venetoclax regimen as first line therapy, which is considered a particularly challenging patient group. As of May 1st, a total of 56 subjects have been recruited in the MIRACLE trial to date keeping the Company on track to recruit the 90th subject in Part A in Q3 2026.

"The data coming from MIRACLE is encouraging" said Walter Klemp, Chairman and CEO of Moleculin. "For decades, cytarabine monotherapy regimens, although one of the current standards of care, have set a relatively low bar in relapsed or refractory AML, with historical complete remission rates hovering around 17-18% in previously referenced clinical trials. With our trial comparing two arms of Annamycin in combination with cytarabine compared to cytarabine with a placebo, we are looking forward to the opportunity of showing Annamycin is additive to cytarabine alone in a head to head trial. Against this backdrop, the data emerging from MIRACLE highlight what could be a substantial advancement, suggesting that we may finally be moving beyond the limitations that have defined standard-of-care outcomes."

MIRACLE Trial Progress and Next Steps

The MIRACLE study (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a Phase 2B/3, global multi-center, randomized, double-blind, placebo-controlled, adaptive designed clinical trial whereby data from the 2B (Part A) portion will be combined with the Phase 3 (Part B) portion for purposes of measuring its primary efficacy endpoint. Part A of the MIRACLE trial is designed to evaluate the effectiveness of Annamycin in two dosing arms (190 mg/m² and 230 mg/m²) in combination with cytarabine (also referred to as Ara-C) as compared to a control arm of cytarabine plus placebo. The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data of the three arms at 45 subjects in Part A, in addition to the conclusion of Part A (at 90 total subjects). The first early unblinding should yield approximately 30 subjects treated with Annamycin (190 mg/m2 and 230 mg/m2) in combination with cytarabine and 15 subjects treated with just cytarabine plus placebo. The MIRACLE trial is being offered only to AML patients who have had a single prior induction therapy (2nd line patients or 2L) including subjects that were treated with a Venetoclax regimen.

The unblinding of the first 45 subjects is on track to occur in late Q2 2026, as the data are subject to final data entry and audit. The second group of 45 subjects in Part A are expected to be fully recruited in the third quarter of 2026 with unblinding expected late in the second half of 2026. Recruitment of the second group of 45 subjects in Part A will continue uninterrupted while the first 45 subjects with efficacy are being unblinded. Unblinding for the full 90 subjects in Part A may require more time than for the first 45 as it involves more data to support the transition from Part A to Part B.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU can be found on euclinicaltrials.eu and the reference identifier is 2024-518359-47-00.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Annamycin also benefits from composition of matter patent protection through 2040 with the potential to extend that protection as far as 2045. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

(Press release, Moleculin, MAY 13, 2026, View Source [SID1234665635])

On May 13, 2026 BeOne Medicines Ltd. ("BeOne") (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BEQALZI was designed to enhance BCL2 inhibition—with greater potency, selectivity, and a pharmacologic profile with potential to improve efficacy, tolerability, and convenience over others in the class.

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Michael Wang, M.D., Global Principal Investigator, the Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, said:

"The data supporting the approval of sonrotoclax in the U.S. confirm its role as a foundational therapy for mantle cell lymphoma in the post-BTK inhibitor setting, and demonstrate that it can deliver robust disease control when treatment choices are limited and outcomes are poor. From a clinical perspective, this provides physicians with an important new option grounded in both efficacy and tolerability, fundamentally changing how we think about sequencing therapy in this disease."

Data supporting approval

The accelerated approval of BEQALZI is supported by efficacy and safety data from the Phase 1/2 study, BGB-11417-201 (NCT05471843), which was presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. The study included an independent review of efficacy data and demonstrated:

Overall response rate (ORR): 52% (95% CI, 42-62)
Complete response (CR) rate: 16% (95% CI, 9.1-24.0)
Median time to response (TTR): 1.9 months
Median duration of response (DOR): 15.8 months (95% CI, 7.4 months-NE) at a median response follow-up of 11.9 months (has yet to reach full maturity)
Safety: treatment with sonrotoclax monotherapy was generally well tolerated
Continued approval for this indication is contingent upon confirmation of clinical benefit in the confirmatory CELESTIAL-RRMCL trial (NCT06742996), which is underway. The U.S. FDA granted Breakthrough Therapy Designation (BTD) for sonrotoclax in this indication, as well as Fast Track Designation and Orphan Drug Designation.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:

"BeOne is leading the advancement and enhancement of BCL2 inhibition to revolutionize how we treat patients living with B-cell malignancies. Today’s approval of BEQALZI represents critical progress for patients with mantle cell lymphoma and reinforces our strategy of building foundational medicines designed to raise the standard of care in B-cell malignancies."

A new BCL2 option for a challenging R/R MCL post–BTK inhibitor setting

MCL is a rare and often aggressive subtype of non-Hodgkin lymphoma. In the United States, approximately 3,300 new cases of MCL are diagnosed each year.1 While many patients respond to initial therapy, relapse is common, and outcomes after progression can be poor, particularly after prior treatment with a BTK inhibitor. The accelerated approval of BEQALZI introduces a new targeted mechanism to the MCL treatment landscape and reinforces the importance of expanding therapeutic choices for patients as the disease evolves.

Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation, said:

"For people living with relapsed or refractory mantle cell lymphoma, each progression can bring uncertainty and questions regarding remaining treatment options. The FDA approval of sonrotoclax represents significant progress for the U.S. mantle cell lymphoma community, offering renewed hope for patients and families who have exhausted other available therapies. Advances like this underscore why continued research and innovation in this disease remain so critical."

Additional regulatory and development updates

BEQALZI is also approved in China for the treatment of R/R MCL, as well as adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor. Data from the Phase 1/2 study of sonrotoclax in R/R MCL is also under review by the European Medicines Agency and other regulatory agencies.

The U.S. FDA also granted sonrotoclax Fast Track Designation for Waldenström macroglobulinemia (WM), as well as Orphan Drug Designation for the treatment of adult patients with WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

Additionally, sonrotoclax is currently being studied in combination with other therapeutics, including zanubrutinib, as a potential treatment for CLL, with updated data expected to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

About BEQALZI (sonrotoclax)

BEQALZI (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program.

INDICATION

BEQALZI (sonrotoclax) is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome (TLS).

WARNINGS & PRECAUTIONS

Tumor Lysis Syndrome (TLS): BEQALZI can cause rapid tumor reduction and changes in blood chemistries consistent with TLS, which may be serious or life-threatening and require prompt management. TLS may occur as early as 4 hours after the first dose, with dose increases, or upon reinitiation following treatment interruption. Laboratory or clinical TLS occurred in 7% of patients who followed the recommended dose ramp-up. Assess all patients for TLS risk and initiate prophylaxis, including adequate hydration and antihyperuricemics. For patients at high risk of TLS, consider hospitalization with intravenous hydration and employ frequent monitoring. Monitor blood chemistries closely and manage abnormalities promptly. Interrupt BEQALZI for TLS; upon reinitiation, follow dose modification guidance in the Prescribing Information.
Serious Infections: BEQALZI can cause fatal or serious infections. Serious infections occurred in 14% of patients; Grade 3-4 occurred in 17% (fatal: 2.6%). The most common Grade 3 or greater infection was pneumonia (10%). Monitor for signs and symptoms of infection and treat appropriately. Consider prophylactic antimicrobials and immunoglobulins. Interrupt, reduce dose, or permanently discontinue BEQALZI based on severity.
Neutropenia: BEQALZI can cause serious or severe cytopenias, including neutropenia. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%); febrile neutropenia occurred in 1.7% of all patients. Monitor complete blood counts throughout treatment. Interrupt treatment, reduce the dose, or permanently discontinue BEQALZI based on severity.
Embryo-Fetal Toxicity: BEQALZI can cause fetal harm when administered to pregnant women. Advise patients of the potential risk to a fetus. Verify pregnancy status prior to initiation. Advise females to use effective contraception and males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.
ADVERSE REACTIONS

The most common adverse reactions (≥15%) are pneumonia (16%) and fatigue (16%). The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes (29%) and neutrophils (18%).

DRUG INTERACTIONS

Strong or Moderate CYP3A Inhibitors: Concomitant use increases BEQALZI exposure. Avoid use of strong CYP3A inhibitors during BEQALZI initiation and ramp-up. Avoid use of moderate CYP3A inhibitors at the 1 mg and 2 mg doses; for all other doses, reduce the BEQALZI dose with concomitant use. See approved labeling for dose modifications.
Strong or Moderate CYP3A Inducers: Concomitant use decreases BEQALZI exposure. Avoid use.
SPECIAL POPULATIONS

Lactation: Advise women not to breastfeed during treatment with BEQALZI and for 1 week after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full U.S. Prescribing Information.

(Press release, BeOne Medicines, MAY 13, 2026, View Source [SID1234665651])

On May 13, 2026 Omeros Corporation (Nasdaq: OMER) reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2026, which include:

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First Quarter and Recent Highlights

● In January 2026, we launched YARTEMLEA in the U.S. market. During the quarter, gross product sales were $11.1 million and associated net sales, after deduction of wholesaler distribution fees and chargebacks, were $9.9 million.

● Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share, for the first quarter of 2025.

● First quarter results include a $73.1 million non-cash gain associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 unsecured convertible notes (the "2029 Notes"). Excluding the non-cash change in our embedded derivatives, non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share.

● At March 31, 2026, we had $135.3 million of cash and short-term investments. This balance includes the February 2026 repayment at maturity of the remaining $17.1 million aggregate principal amount of our 2026 unsecured convertible notes (the "2026 Notes"). Following that repayment, our only remaining debt outstanding is $70.8 million aggregate principal amount of our 2029 Notes, which mature in June 2029.

● In April, the U.S. Centers for Medicare & Medicaid Services ("CMS") assigned a permanent Healthcare Common Procedure Coding System J-code specific for YARTEMLEA. This simplifies billing and reimbursement across payors. The J-code becomes effective on July 1, 2026. Also in April, CMS, in its Inpatient Prospective Payment System proposed rule, recommended approval of the New Technology Add-On Payment ("NTAP") for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost, innovative technologies, helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August, with NTAP expected to be effective October 1, 2026.

"The launch of YARTEMLEA has changed the trajectory of Omeros, both operationally and financially," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "We are seeing strong early adoption across transplant centers, expanding formulary access, favorable reimbursement support, and growing physician experience with the first and only approved treatment for TA-TMA. At the same time, our Novo Nordisk transaction has strengthened our balance sheet and accelerated advancement of our pipeline, including next-generation MASP-2 programs, OncotoX-AML, OMS527 for cocaine use disorder under NIDA funding, and our T-CAT platform targeting multidrug-resistant pathogens. The progress achieved this quarter further demonstrates the strength of our science and the value we are creating across Omeros."

Recent Developments

● YARTEMLEA and our other MASP-2 inhibitor programs

o A marketing authorization application ("MAA") for YARTEMLEA for the treatment of TA-TMA is currently under review by the European Medicines Agency ("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.

o We are assessing opportunities for YARTEMLEA across indications involving lectin pathway activation, including acute respiratory distress syndrome (ARDS), sickle cell disease, acute kidney injury, solid organ transplant-related TMA, and delayed graft function.

o In parallel, we are finalizing selection of an indication for a Phase 2 clinical program for OMS1029, our long-acting antibody targeting MASP-2. In our MASP-2 small-molecule inhibitor program, we have selected a drug development candidate and are advancing to IND-enabling studies.

● OMS527 for the treatment of addiction — cocaine use disorder program funded by the National Institute on Drug Abuse ("NIDA")

o We are developing, at NIDA’s request, our lead orally administered phosphodiesterase 7 ("PDE7") inhibitor for the treatment of cocaine use disorder. 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.

o Following FDA’s request for additional nonclinical information and a subsequent meeting with FDA to discuss that request, we are working with FDA to streamline the path to initiate the in-patient clinical trial, targeted for initiation by year-end 2026.

● Oncology platform — OncotoX-AML

o We continue to progress preclinical studies within our novel oncology program. 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 in the OncotoX-AML program, and IND-enabling studies are underway.

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, selectively reducing myeloid progenitor cells, which 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.

● Targeted Complement Activating Therapy ("T-CAT") platform

o Our T-CAT platform is a new class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on multidrug-resistant organisms ("MDROs"), one of the most critical unmet needs in medicine.

o Data from our T-CAT platform were recently featured in a podium presentation at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases.

o The seminal manuscript describing our T-CAT technology was accepted for publication in Science Translational Medicine.

Financial Results

Commercial distribution and sales of YARTEMLEA commenced in January 2026. Gross product sales for the three months ended March 31, 2026 were $11.1 million, with net sales of $9.9 million. Revenue for the period reflects sales of YARTEMLEA to U.S. wholesalers.

Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share for the first quarter of 2025.

The change in fair value of financial instruments as shown in our statement of operations and comprehensive income (loss) reflects marking to market the embedded derivative on our 2029 Notes under GAAP. Excluding the net gain on the change in the fair value of our financial instruments, which is non-cash, our non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share.

At March 31, 2026, we had $135.3 million of cash and short-term investments. Upon their maturity in February 2026, we repaid the remaining $17.1 million outstanding principal balance of our 2026 Notes and currently have only $70.8 million aggregate principal amount outstanding of our 2029 Notes, which mature in June 2029.

Total operating expenses for the three months ended March 31, 2026 were $27.3 million compared to $35.0 million for the three months ended March 31, 2025. The $7.7 million decrease was primarily due to reduced OMS906-related research and development work as a result of the zaltenibart asset sale and licensing agreement with Novo Nordisk in November 2025.

Interest expense increased $2.2 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The increase primarily relates to interest incurred on the 2029 Notes and, to a lesser extent, a non-cash remeasurement charge taken on our OMIDRIA royalty obligation in the prior year, offset by decreased interest incurred on our 2026 Notes, which were repaid in February 2026.

Interest and other income was $1.5 million for the three months ended March 31, 2026 compared to $1.1 million for the three months ended March 31, 2025 due to holding higher cash and investment balances in the current period.

Net income from discontinued operations, net of tax, was $4.8 million, or $0.07 per share, for the three months ended March 31, 2026 compared to $4.1 million, or $0.07 per share, in the prior year period.

During the three months ended March 31, 2026, we repurchased and retired approximately 0.4 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $4.2 million.

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, MAY 13, 2026, View Source [SID1234665636])

On May 13, 2026 AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, reported two-year results from the PRESERVE pivotal trial (NCT04972097) demonstrating durable oncologic control and a sustained safety profile for the NanoKnife System in the focal ablation of intermediate-risk prostate cancer. The data will be discussed by Izak Faiena, M.D., of Columbia University at the 2026 American Urological Association (AUA) Annual Meeting on Sunday, May 17 in Washington, D.C.

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The PRESERVE trial is a prospective, single-arm pivotal IDE study evaluating focal irreversible electroporation (IRE) using the NanoKnife System in 121 patients with Gleason Grade Group 2–3 intermediate-risk prostate cancer, conducted across 17 U.S. clinical centers in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). Primary 12-month results, published in European Urology in July 2025, demonstrated an 80% freedom-from-treatment-failure rate among protocol-biopsied patients.1

At 24 months, the updated findings confirm durability of outcomes:

94.4% of analysis-eligible patients (68 of 72) completed the 24-month assessment, reflecting strong cohort retention
No new treatment failures were identified among patients with available follow-up at 24 months
One patient (1.5%) underwent a clinically indicated biopsy, which was negative for any cancer
97% of patients (66 of 68) had a PSA at 24 months below their baseline value
No new device- or procedure-related adverse events were reported between the 12- and 24-month assessments
The 24-month PRESERVE data complement an international long-term evidence base for focal IRE, including median five-year outcomes from a 2023 international multi-institutional cohort demonstrating sustained oncologic control and preservation of functional outcomes.2

PRESERVE Trial — 24-Month Results Summary

Focal IRE Ablation Using the NanoKnife System for Intermediate-Risk Prostate Cancer

Study Design

Parameter

Detail

Trial Name

PRESERVE (NCT04972097)

Study Type

Prospective, single-arm, pivotal IDE study

Technology

NanoKnife System — Focal Irreversible Electroporation (IRE)

Population

Gleason Grade Group 2–3 (Gleason 3+4 or 4+3), clinical stage ≤T2c intermediate-risk prostate cancer

Sites

17 U.S. clinical centers

Partner

Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC)

Sponsor

AngioDynamics, Inc.

Key 24-Month Results

Endpoint

Result

Total Enrolled

121 patients

24-Month Analysis-Eligible

72 patients

24-Month Completers

68 of 72 (94.4%)

New Treatment Failures (12–24 mo)

0

Clinically Triggered Biopsies

1 (negative for any cancer)

PSA Below Baseline at 24 Months

66 of 68 (97%)

New Device/Procedure-Related AEs (12–24 mo)

0

12-Month Primary Endpoint (Reference)

Endpoint

Result

Freedom from Treatment Failure

80% among protocol-biopsied patients

Publication

European Urology, July 2025 (George et al.)

"Two years of prospective pivotal data in the United States, combined with more than five years of international follow-up evidence, paints a coherent and compelling picture of sustained efficacy," said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. "These results reinforce that the NanoKnife System is a clinically meaningful focal therapy option that physicians across care settings are actively incorporating into practice."

With a growing body of prospective U.S. pivotal data and long-term international evidence supporting the safety and efficacy of focal IRE, the NanoKnife System continues to gain traction as a meaningful treatment option for men with intermediate-risk prostate cancer who seek durable oncologic control while preserving quality of life. AngioDynamics is advancing the NanoKnife IRE System evidence base and the reimbursement infrastructure needed to bring this option to more patients and physicians across care settings.

(Press release, AngioDynamics, MAY 13, 2026, View Source [SID1234665652])

On May 13, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported business and clinical programs update and announced financial results for the quarter ended March 31, 2026.

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"During the first quarter, we made meaningful clinical and regulatory progress across our clinical pipeline," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "We work towards restarting enrollment in the amended VERSATILE-003 Phase 3 trial. With regards to PDS01ADC, we have completed enrollment in the metastatic colorectal cancer trial, and the advanced castration resistant prostate cancer trial continues to recruit well".

Dr. Bedu-Addo continued: "We believe the progress achieved during the quarter reflects the continued advancement and maturation of our clinical portfolio. We remain focused on advancing potentially differentiated immunotherapy candidates designed to address significant unmet medical needs for patients with difficult-to-treat cancers".

Clinical and Corporate Update

•
Amended VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.

•
Announced publication of positive clinical and immunological biomarker data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) trial evaluating PDS01ADC, the Company’s tumor-targeted IL-12 immunocytokine. The results, published in the March issue of Journal of Clinical Oncology (JCO) Oncology Advances, included:

o
Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20)

o
24-month survival rate approximately 85%; in the parallel trial without PDS01ADC, the 24-month survival rate was approximately 40%

o
Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS01ADC, the PFS was 8.1 months

•
Presented encouraging early results from an NCI-led trial investigating PDS01ADC at the AACR (Free AACR Whitepaper) special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer (mCRPC) the majority of whom received third-line treatment options — the combination of PDS01ADC and docetaxel demonstrated encouraging median PFS of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% decline.

•
Strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. and Japan. The new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.

First Quarter 2026 Financial Results

Reported net loss for the quarter ended March 31, 2026, was approximately $7.3 million, or $0.13 per basic and diluted share, compared to a net loss of $8.5 million, or $0.21 per basic and diluted share for the quarter ended March 31, 2025.

Research and development expenses for the quarter ended March 31, 2026, were $3.5 million, compared to $5.8 million for the quarter ended March 31, 2025. The decrease was primarily due to lower clinical and manufacturing costs.

General and administrative expenses for the year ended March 31, 2026, were $3.1 million, compared to $3.3 million for the year ended March 31, 2025. The decrease was primarily due to lower professional fees.

Total operating expenses for the year ended March 31, 2026, were $6.5 million compared to $9.1 million for the quarter ended March 31, 2025.

Net interest expense was $0.8 million for the quarter ended March 31, 2026, compared to $0.6 million for the quarter ended March 31, 2025.

The Company’s cash balance as of March 31, 2026, was $21.7 million.

Conference Call Details

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Date: May 13, 2026

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Time: 8:00 a.m. Eastern Time

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Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)

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Conference I.D.: 13760368

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Webcast: Click Here

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CallMeTM: Click Here (available 15 minutes prior to the call)

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

(Press release, PDS Biotechnology, MAY 13, 2026, View Source [SID1234665637])