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Plus Therapeutics Announces Oral Presentation Highlighting REYOBIQ™ Clinical and Translational Data Demonstrating Favorable Safety, Survival, and Emerging Immunomodulation in Leptomeningeal Metastases

On May 8, 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 a plenary session reviewing key clinical and translational data, including the Phase 1 ReSPECT-LM trial of REYOBIQ (rhenium Re186 obisbemeda) was presented at the 2026 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting taking place May 1-4, 2026 in San Antonio, Texas.

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"This oral plenary session, which reviewed data collected to date, and included an overview of the ReSPECT-LM single dose escalation study, is an important validation of the clinical and translational evidence supporting REYOBIQ as a differentiated therapeutic approach for patients with leptomeningeal metastases, a devastating condition with no FDA-approved therapies. AANS is an important congress, and we are encouraged by these data being featured in such a prominent part of the conference," said Eric J. Daniels, M.D., M.B.A., Plus Therapeutics Chief Development Officer. "We continue to believe strongly in the potential of REYOBIQ in the clinical setting as we continue the ongoing multiple dose trial."

The oral presentation, titled, "¹⁸⁶Rhenium-Nanoliposomes (¹⁸⁶RNL) for the Treatment of Leptomeningeal Metastases: Translational Insights from Clinical and Preclinical Models," was delivered by Henriette U. Balinda, PhD, of UT Health San Antonio in a Plenary Session on Saturday, May 2, 2026.

Key Data Highlights

The Presentation highlighted the completed Phase 1 ReSPECT-LM study demonstrating:

Encouraging survival outcomes, with median overall survival of approximately 9 months in patients treated at the recommended Phase 2 dose, compared to historical survival of approximately 2–6 months
Robust anti-tumor activity, including high rates of circulating tumor cell (CTC) reduction and clinical benefit across evaluable patients
Favorable safety and tolerability profile, supporting advancement into later-stage clinical development
Highly targeted radiation delivery, with a target-to-off-target absorbed dose ratio exceeding 100:1, minimizing exposure to healthy tissue
In addition, translational analyses presented in the session demonstrate that REYOBIQ may induce immune remodeling within the tumor microenvironment, including activation of CD8+ T cells and enhancement of anti-tumor immune response, supporting potential future combination strategies with immunotherapies.

Currently, the ReSPECT-LM Phase 1 Multiple Dose trial is underway and enrolling patients at the University of Texas Health San Antonio. The primary objectives include characterizing safety and tolerability of multiple doses at defined intervals of REYOBIQ for patients of any primary solid tumor cancer with LM.

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, MAY 8, 2026, View Source [SID1234665390])

Soligenix Announces Recent Updates and First Quarter 2026 Financial Results

On May 8, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent updates and financial results for the quarter ended March 31, 2026.

"We remain disappointed with the unanticipated outcome of the FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Despite the fact that HyBryte (synthetic hypericin) demonstrated statistically significant reductions in cutaneous T-cell lymphoma (CTCL) lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)."

With approximately $6.0 million in cash at March 31, 2026, and cash runway into the 2nd quarter of 2027, we will evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities, and the potential of advancing SGX945 (dusquetide) for the treatment of Behçet’s Disease, which demonstrated promising biological efficacy in a Phase 2 study last year while most recently receiving orphan drug designation from EMA and Promising Innovative Medicine (PIM) designation from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). In December, we announced the extended results of the Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis where SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. With the completion of the pilot study, we have laid the groundwork for a more detailed evaluation in this large underserved market.

Soligenix Recent Updates

On April 28, 2026, the Company announced that the Data Monitoring Committee completed the interim efficacy analysis of its pivotal Phase 3 FLASH2 trial evaluating HyBryte in the treatment of CTCL and recommended the study halt for futility. To view this press release, please click here.
On April 2, 2026, the Company announced that the positive results of its comparability study evaluating HyBryte versus Valchlor (mechlorethamine) for the treatment of CTCL have been published in Oncology and Therapy. To view this press release, please click here.
Financial Results – Quarter Ended March 30, 2026

Soligenix had no revenue or related costs for the quarter ended March 31, 2026 and 2025, respectively.

Soligenix’s net loss was $2.8 million, or ($0.28) per share, for the quarter ended March 31, 2026, compared to $3.0 million, or ($0.97) per share, for the same prior year period. This decrease in net loss was primarily due to a decrease in operating expenses.

Research and development expenses were $1.8 million as compared to $1.9 million for the quarter ended March 31, 2026 and 2025, respectively. The decrease was primarily due to decreases in costs associated with third-party manufacturing, the completed Phase 2 study in BD and site initiation fees for the second confirmatory Phase 3 CTCL trial, partially offset by an increase in patient fees for the second confirmatory Phase 3 CTCL trial.

General and administrative expenses were $1.1 million for the quarter ended March 31, 2026 as compared to $1.1 million for the same period in 2025, relatively flat with a de minimis increase.

As of March 31, 2026, the Company’s cash position was approximately $6.0 million.

(Press release, Soligenix, MAY 8, 2026, View Source [SID1234665388])

Prokarium to present at the American Urology Association (AUA) Annual Meeting

On May 8, 2026 Prokarium reported that it will present at the American Urology Association (AUA) Annual Meeting.

Dr Michael Oefelein will be presenting on behalf of Prokarium at the American Urology Association (AUA) Annual Meeting, Washington, DC, 15-18th May 2026.

Presentation information:

Presentation Title: PD09-03: PARADIGM 1 – A multi-center Phase 1 study evaluating the safety and clinical effect of a novel microbial immunotherapeutic (ZH9) in patients with relapsed NMIBC – A first interim review
Session Title: PD09: Bladder Cancer: Non-invasive III
Session Date and Time: Saturday 16th May, 07:00 – 09:00

(Press release, Prokarium, MAY 8, 2026, View Source [SID1234665387])

Moleculin Biotech Secures Strategic Additional Patent, Strengthening Global Positioning of Annamycin

On May 8, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported a significant advancement in its intellectual property portfolio with the issuance of a Hong Kong patent covering its proprietary method of reconstituting liposomal Annamycin.

The newly granted patent (No. 40073244), titled "Method of Reconstituting Liposomal Annamycin," extends protection through June 25, 2040, further reinforcing Moleculin’s long-term global exclusivity strategy. The invention is jointly owned with The University of Texas System.

This patent represents an impactful layer of protection around Moleculin’s lead asset, Annamycin, at a time when the global oncology market continues to seek improved treatment options. By securing rights in Hong Kong, an influential gateway to broader Asian markets, Moleculin is strategically positioning itself in one of the fastest-growing regions for cancer therapeutics.

"This patent issuance is a meaningful step forward in fortifying the global intellectual property foundation for Annamycin," said Walter Klemp, President and Chief Executive Officer of Moleculin. "This level of patent protection is made all the more important given the expected timing of our first Phase 3 clinical data release later this quarter. As we continue advancing clinical development, protecting our formulation technology is essential to unlocking long-term value and supporting future commercialization efforts worldwide."

The Hong Kong patent approval builds on Moleculin’s expanding global intellectual property portfolio, which includes allowed, issued or granted patents in the United States, Australia, Canada, China, Europe, India, Israel, Japan, Mexico, Singapore, and Taiwan, further strengthening protection of Annamycin.

Annamycin is Moleculin’s lead product candidate designed to avoid cardiotoxicity, avoid multidrug resistance and cross-resistance, and improve tissue/organ distribution when compared with currently prescribed anthracyclines. Annamycin’s unique multilamellar lipid-based delivery system is intended to further enhance these characteristics.

(Press release, Moleculin, MAY 8, 2026, View Source [SID1234665386])

INOVIO to Participate in Upcoming Scientific Conferences

On May 8, 2026 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer and infectious diseases, reported that it will participate in the following scientific conferences:

American Society of Gene and Cell Therapy Annual Meeting (Boston)
Poster Presentation: Bleeding phenotype correction in hemophilia A mice following in vivo Factor VIII gene transfer by electroporation in skeletal muscle cells
Date: Tuesday, May 12
Time: 5 – 6:30 PM ET

American Society of Clinical Oncology Annual Meeting (Chicago)
Poster Presentation: B cell responses in Recurrent Respiratory Papillomatosis patients treated with DNA immunotherapy INO-3107
Date: Saturday, May 30
Time: 1:30 – 4:30 PM CDT

Available abstracts will be shared on INOVIO’s website following presentations.

(Press release, Inovio, MAY 8, 2026, View Source [SID1234665385])