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.

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"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])

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

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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])

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.

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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])

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:

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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])

On May 8, 2026 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported financial results and business highlights for the fiscal quarter ended March 31, 2026.

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"We are encouraged by the progress of the KOMODO-1 trial," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "We continue to expand the body of evidence supporting BBI-940’s kinesin degradation mechanism, with our recent AACR (Free AACR Whitepaper) poster demonstrating anti-tumor activity and tumor regression across multiple ecDNA+ cancer models. These findings further strengthen our confidence in the therapeutic potential of BBI-940 as we advance the program through a first-in-human clinical trial."

Business Highlights and Upcoming Milestones

BBI-940 Novel Kinesin Degrader Clinical Program

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Enrollment is ongoing in KOMODO-1 (Kinesin Oral Molecular Degrader for Oncology-1), a first-in-human clinical trial of BBI-940 in patients with estrogen receptor positive and human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer who have progressed following treatment with a cyclin-dependent kinase 4 and/or 6 (CDK4/6) inhibitor plus endocrine therapy, as well as patients with triple-negative breast cancer luminal androgen receptor subtype (TNBC-LAR).
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Initial safety and efficacy clinical proof-of-concept data are expected within the Company’s existing cash runway timeline.

Validating Kinesin Degradation Data Presented at 2026 AACR (Free AACR Whitepaper) Annual Meeting

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In vitro and in vivo study data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, which demonstrated that genetic depletion and pharmacologic degradation of a novel kinesin (Kinesin) cause ecDNA mis-segregation, ecDNA reduction, and reduced viability of ecDNA positive (ecDNA+) cancer cells.
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Further, selective degradation of Kinesin in a panel of tumor cell lines demonstrated sensitivity across multiple tumor types, including 32% of breast cancer cell lines, including those positive for ecDNA and FGFR1 gain. This molecularly defined subgroup for Kinesin degradation sensitivity was further validated in vivo with demonstrated monotherapy tumor regressions in an ecDNA+ TNBC-LAR model, and significant antitumor activity as monotherapy and in combination with fulvestrant in an ecDNA+/FGFR1+ ER+ breast cancer model.

First Quarter 2026 Financial Results

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Cash Position: Cash, cash equivalents, and short-term investments totaled $92.8 million as of March 31, 2026. The Company expects its cash to fund operations into the second half of 2028.
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Research and Development (R&D) Expenses: R&D expenses were $9.7 million for the first quarter of 2026 compared to $12.1 million for the same period in 2025.
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General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the first quarter of 2026 compared to $5.2 million for the same period in 2025.
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Net Loss: Net loss totaled $13.6 million for the first quarter of 2026 compared to $15.8 million for the same period in 2025.

(Press release, Boundless Bio, MAY 8, 2026, View Source [SID1234665384])