On March 21, 2025 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 accomplishments and financial results for the year ended December 31, 2024 (Press release, Soligenix, MAR 21, 2025, View Source [SID1234651346]).

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"We remain highly focused on advancing our multiple clinical programs as we work towards achieving a number of important and potentially transformational development milestones, including top-line results in 2026 for our actively enrolling confirmatory Phase 3 placebo-controlled study evaluating HyBryte (synthetic hypericin) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. In the second half of this year, we also anticipate reporting top-line results from our ongoing Phase 2 studies for SGX945 (dusquetide) in Behçet’s disease and SGX302 (synthetic hypericin) in mild-to-moderate psoriasis."

Dr. Schaber continued, "With approximately $7.8 million in cash at December 31, 2024, we are committed to disciplined resource allocation to achieve our strategic goals. While this cash balance provides operating runway through 2025, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On January 14, 2025, the Company reported positive outcomes observed from the interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 12 months in patients with early-stage CTCL. To view this press release, please click here.
On December 16, 2024, the Company announced that it had opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL. To view this press release, please click here.
On December 2, 2024, the Company announced analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte to Valchlor (mechlorethamine) demonstrating continued improvement in HyBryte treated patients and their individual lesions even after stopping treatment. To view this press release, please click here.
On November 19, 2024, the Company announced the formation of a European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte in the treatment of CTCL patients with early-stage disease. To view this press release, please click here.
On November 14, 2024, the Company announced it had opened patient enrollment for its Phase 2 study (protocol number DUS-AUBD-01) evaluating SGX945 (dusquetide) in the treatment of Behçet’s Disease. To view this press release, please click here.
Financial Results – Quarter Ended December 31, 2024

Soligenix reported revenues of $0.1 million for the year ended December 31, 2024, compared to $0.8 million for the prior year. The decrease was primarily due to the timing of government grant funding and contracts supporting the development of SGX943 for emerging infectious diseases, as well as the development of CiVax and HyBryte. While we continue to receive government funding, fluctuations in grant timing may impact quarterly and annual revenues.

Soligenix’s net loss was $8.3 million, or ($4.98) per share, for the year ended December 31, 2024, compared to $6.1 million, or ($12.66) per share, for the prior year. The change in net loss per share reflects the Company’s one-for-sixteen reverse stock split, which was completed in June 2024. The overall increase in net loss was primarily due to lower revenue, higher research and development expenses associated with clinical trial activities, and changes in tax benefits, partially offset by increased interest income, tax credits and the change in the fair value of debt.

Research and development expenses were $5.2 million as compared to $3.3 million for the years ended December 31, 2024 and 2023, respectively. The increase was primarily related to preliminary costs associated with the initiation of our Phase 2 study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.

General and administrative expenses were $4.2 million and $4.5 million for the years ended December 31, 2024 and 2023, respectively. The decrease in general and administrative expenses for the three months ended December 31, 2024 was primarily attributable to decreases in legal and consulting expenses.

As of December 31, 2024, the Company’s cash position was approximately $7.8 million.

On March 20, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of the BriaCell clinical study to determine if the study should continue, be modified, or be halted, has completed its second safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612 ) and recommended continuation of the ongoing study without any modifications (Press release, BriaCell Therapeutics, MAR 20, 2025, View Source [SID1234651956]). BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).

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"We are very pleased with the safety and tolerability profile of Bria-IMT plus immune checkpoint inhibitor (CPI) combination in metastatic breast cancer to date," stated Dr. William V. Williams, BriaCell’s President & CEO. "The DSMB’s second positive data review and recommendation to continue with patient enrollment in BriaCell’s pivotal Phase 3 study clinical trial is highly encouraging and further highlights the potential of our groundbreaking novel immunotherapy to treat this urgent medical need."

"Metastatic breast cancer is a devastating disease for patients and their families, and the DSMB’s positive review represents an important step forward towards our goal of transforming cancer care, and improving patients’ survival and quality of life outcomes," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We look forward to sharing additional updates from BriaCell’s pivotal Phase 3 trial in the coming months."

On March 20, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that it will host a fireside chat with Shaun Bagai, Chief Executive Officer, on Thursday, April 3, 2025, at 12:00 p.m. ET (Press release, Renovorx, MAR 20, 2025, View Source [SID1234651335]).

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Mr. Bagai will discuss RenovoRx’s continued momentum of its RenovoCath commercial efforts, including new purchase orders and reorders received from cancer center customers, and the realization of initial revenues.

Mr. Bagai will also discuss progress on RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating the Company’s lead drug-device combination product candidate (intra-arterial delivery of gemcitabine via the RenovoCath catheter), known as IAG which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). The combination product candidate (IAG), which is enabled by the FDA-cleared RenovoCath device, is currently under investigation and has not been approved for commercial sale.

Fireside Chat Details:
Date: Thursday, April 3, 2025
Time: 12:00 p.m. ET
Webcast: View Source

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

On March 20, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, reported a peer-reviewed publication highlighting a potentially significant breakthrough in addressing drug resistance to EGFR-targeted therapies for non-small cell lung cancer (NSCLC) patients (Press release, Kairos Pharma, MAR 20, 2025, View Source [SID1234651334]). Recent findings published in Drug Resistance Updates highlight the critical role of CD105 (endoglin) in mediating resistance to osimertinib, a frontline treatment for EGFR-mutant NSCLC. The study, titled, "CD105 blockade restores osimertinib sensitivity in drug-resistant EGFR-mutant non-small cell lung cancer," demonstrated that CD105 expression is upregulated as a mechanism of therapy resistance, correlating with poor prognosis in patients.

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"We believe our latest findings represent a paradigm shift in overcoming resistance to EGFR-targeted therapies in NSCLC," said Neil Bhowmick, Ph.D., Kairos Pharma Chief Scientific Officer. "Revealing this mechanism-of-action underscores our commitment to advancing precision oncology and bringing innovative therapies to patients in need."

In preclinical models, targeting CD105 with ENV105 (carotuximab), a CD105-neutralizing antibody successfully restored treatment sensitivity to EGFR-targeted therapies. Notably, combining osimertinib with ENV105 reinstated susceptibility to EGFR inhibition through metabolic reprogramming and enhanced chromatin accessibility. These findings confirm the efficacy of this novel combination therapy strategy in overcoming drug resistance in this model of non-small cell lung cancer.

Dr. John Yu, CEO, stated, "These findings in lung cancer corroborate data in prostate cancer, breast cancer and colon cancer, that point to CD105 being a central mechanism of cancer drug resistance. We believe ENV105 can reverse this resistance in cancer models, and our clinical trials are designed to definitively demonstrate its potential impact."

The global NSCLC treatment market is projected to reach $45 billion by 2030, driven by advancements in targeted therapies. However, drug resistance remains a major challenge. The ability of ENV105 to enhance EGFR-targeted therapy effectiveness positions it as a high-value asset in next-generation oncology treatment. Kairos Pharma is currently evaluating this transformative cancer therapy in ongoing clinical trials for EGFR-driven lung cancer patients. The study can be accessed here.

On March 20, 2025 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, reported its participation in the 5th Annual TPD and Induced Proximity Summit, taking place March 25-27, 2025, in London, UK (Press release, BPGbio, MAR 20, 2025, View Source [SID1234651333]). BPGbio executive Vivek K. Vishnudas, Ph.D., Chief Technology Officer and R&D Site Head, will present a session titled "Pioneering a Differentiated Approach to Targeted Protein Degradation Using the Ubiquitin Conjugating Enzyme (E2) Family." Dr. Vishnudas will speak on March 26 as part of the conference’s Pre-Clinical and Translation track, highlighting the latest advancements in BPGbio’s protein homeostasis program and the potential of E2-based therapeutics in oncology and neurology.

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"Our innovative approach to targeted protein degradation via the ubiquitin-conjugating enzyme (E2) family represents a breakthrough in drug development, allowing us to address previously undruggable targets and overcome resistance mechanisms inherent in traditional E3-based strategies," said Dr. Vishnudas. "We look forward to sharing our progress in developing E2-based bifunctional and glue degraders for oncology and neurodegenerative disorders."

In addition to its E2-focused approach, BPGbio’s protein homeostasis program incorporates a proprietary library of over 1,000 Ro3 fragments identified as potential ligands and seed compounds for E2 targets. The program also features proprietary ternary structures, a computational toolkit for E2 ligand design, and advanced assays designed to optimize selectivity and specificity.

BPGbio’s therapeutic pipeline includes drug candidates for glioblastoma (orphan drug), pancreatic cancer (orphan drug), primary CoQ10 deficiency (rare pediatric disease designated), epidermolysis bullosa (EB, orphan drug), squamous cell carcinoma (SCC, orphan drug), sarcopenia, solid and liquid tumors, Huntington’s disease (orphan drug), and Parkinson’s disease. The company’s diagnostic pipeline includes its prostate diagnostic test (pstateDx), as well as tests in development for the detection of Parkinson’s disease (parkinsonDx), pancreatic cancer (pancDx), breast cancer, and liver disease.