On June 26, 2025 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that it intends to offer and sell $85.0 million of shares of its common stock in an underwritten public offering (Press release, CorMedix, JUN 26, 2025, View Source [SID1234654157]). All of the shares to be sold in the offering will be offered by CorMedix. In addition, CorMedix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RBC Capital Markets is acting as sole bookrunner for the offering.

CorMedix intends to use the net proceeds from the offering for general corporate purposes, which may include working capital, expenses related to research and the development of product candidates, and potential strategic transactions, including acquisitions, joint ventures or collaborations, involving companies, products or assets that complement CorMedix’s business.

The securities described above are being offered by CorMedix pursuant to a shelf registration statement on Form S-3 which was initially filed by CorMedix with the Securities and Exchange Commission (the "SEC") May 6, 2024, and was declared effective by the SEC on May 22, 2024.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering, as well as copies of the final prospectus supplement, when available, may be obtained from RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer or sale will be made only by means of CorMedix’s prospectus supplement and prospectus forming part of the effective registration statement relating to these securities.

On June 26, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported it will announce major advancements to its industry-leading oncology pipeline during today’s investor R&D Day (Press release, BeOne Medicines, JUN 26, 2025, View Source [SID1234654142]). The event comes at a pivotal moment for the Company, which has more than 40 clinical and commercial stage assets in development, a signal of both scale and ambition.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At BeOne, our mission is simple yet bold: to create the world’s first next-generation oncology company," said John V. Oyler, Co-Founder, Chairman, and CEO. "What we will unveil demonstrates our progress towards this goal today, and the promise for tomorrow. From our innovative discovery engine to one of the broadest pipelines in oncology, we are well-positioned to bring transformative medicines to patients worldwide—and to do so with speed, quality, and purpose."

BeOne’s integrated, end-to-end R&D model is engineered for efficiency without compromise. The Company’s differentiated approach—combining in-house discovery targeting unmet patient needs, parallel early-stage exploration at low incremental cost, and rapid proof-of-concept generation—enables swift progression from bench to clinic. Our in-house manufacturing around the world, including our flagship facility in Hopewell, NJ, means we have a sustainable business model, purpose built with competitive advantages. This rigorous model has fueled a pipeline of more than 40 clinical and commercial-stage assets, making it one of the most productive in the industry. To complement this research engine, BeOne has built a robust global clinical development platform, with more than 170 trials conducted across 40 countries and more than 25,000 patients enrolled to date.

In hematologic cancers, the Company’s program is driven by its wholly-owned assets including BRUKINSA (zanubrutinib), a second-generation covalent BTK inhibitor and the backbone of the hematology franchise, sonrotoclax, a potential best-in-class next-generation BCL2 inhibitor, and BGB-16673, a BTK CDAC. New clinical data from CaDAnCe-101 highlight the promise of BGB-16673, a potential first-in-class BTK degrader, for patients with relapsed or refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL). Meanwhile, early data show the combination of sonrotoclax and BRUKINSA has demonstrated compelling efficacy and the potential to offer a best-in-class fixed-duration treatment in CLL, setting the stage for a possible new standard of care.

In solid tumors, the Company is advancing multiple targeted modalities beyond its foundational PD-1 inhibitor TEVIMBRA (tislelizumab-jsgr), including CDK4 inhibitor BGB-43395, which has shown clear pharmacodynamic activity and is expected to enter registration-enabling studies for the treatment of breast cancer within the next six to 12 months.

Promising new data for the B7-H4 ADC (BG-C9074) point to a potential first-in-class therapeutic option for patients with B7-H4 expressing tumors, including those without selection criteria. Additionally, early data from the novel PRMT5 inhibitor suggest a favorable safety profile and promising efficacy, supporting its potential for differentiation in the competitive lung cancer field.

"Our R&D team is running at full speed," said Lai Wang, Ph.D., Global Head of R&D. "With more than 1,200 scientists and more than 3,700 clinical development and medical affairs colleagues dedicated to pushing the boundaries of oncology, we have built the infrastructure, mindset, and capabilities to deliver sustained innovation. The volume of clinical milestones we anticipate over the next few years is extraordinary, and our agility in moving from idea to execution sets us apart."

Speakers at today’s event include BeOne’s executive leadership team, senior R&D leaders, and distinguished key opinion leaders, offering a multi-faceted view of the Company’s scientific strategy and execution momentum. The live webcast begins at 8:30 a.m. U.S. Eastern Time and is available on the investor relations section of BeOne’s website, where an archived version will also be accessible.

On June 25, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("Oncotelic" or the "Company"), a clinical-stage biopharmaceutical company focused on RNA-based therapeutics, reported the publication of a peer-reviewed research article highlighting TGFB2 gene methylation as a positive prognostic biomarker for pancreatic ductal adenocarcinoma (PDAC) (Press release, Oncotelic, JUN 25, 2025, View Source [SID1234654112]). The paper, published in collaboration with Sapu Biosciences, LLC ("Sapu"), a wholly owned subsidiary of GMP Biotechnology Limited ("GMP Bio"), in which Oncotelic owns a 45% stake, appears in the journal International Journal of Molecular Sciences and is entitled: "TGFB2 Gene Methylation in Tumors with Low CD8+ T-Cell Infiltration Drives Positive Prognostic Overall Survival Responses in Pancreatic Ductal Adenocarcinoma."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Access the publication online at: View Source

The study was co-authored by Dr. Sanjive Qazi, Dr. Michael Potts, Scott Myers, Dr. Stephen Richardson, and Dr. Vuong Trieu.

Key Findings

PDAC remains one of the most lethal malignancies with limited treatment options, typically restricted to cytotoxic regimens like FOLFIRINOX. This study identifies DNA methylation signatures of the TGFB2 gene as a novel biomarker for improved overall survival, particularly in immunosuppressed tumor microenvironments characterized by low CD8+ T-cell infiltration.

Notably, patients exhibiting high TGFB2 methylation along with low expression of immune markers such as CD3D, LCK, and HLA-DRA demonstrated a highly significant median overall survival exceeding 50 months. The data suggest that TGFB2 methylation is a favorable prognostic indicator and may inform patient stratification for therapies targeting TGFB2 mRNA-such as OT-101, Oncotelic’s investigational antisense oligonucleotide.

In addition, the study underscores the importance of profiling TGFB1, TGFB2, and TGFB3 methylation to better characterize tumor immune status and select candidates for immunotherapy in otherwise resistant "cold" tumors.

Leadership Commentary

"Our latest discovery significantly enhances our understanding of the TGFB gene complex in PDAC, particularly in immunologically cold tumors," said Dr. Sanjive Qazi, lead author. "These results support further clinical development of OT-101 in PDAC, especially among patients with low T-cell infiltration and high TGFB2 methylation."

"PDAOAI, our AI-powered chatbot platform, played a pivotal role in the literature mining and analysis for this paper," added Scott Myers, Product Manager. "The integration of AI into the scientific process is accelerating discovery."

"Large language models like PDAOAI are transforming how we identify, extract, and interpret biomedical insights," said Dr. Michael Potts, VP of Data Science at Oncotelic.

The underlying source data and referenced literature used in the manuscript are accessible via Oncotelic’s proprietary AI platform, PDAOAI. Engage with the research on the public PDAOAI Discord community.

On June 25, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQTM (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma (Press release, Plus Therapeutics, JUN 25, 2025, View Source [SID1234654113]). The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very excited for the opportunity to study the novel radiotherapeutic, REYOBIQ, in difficult-to-treat pediatric brain tumors. Surgery and external beam radiation have been the mainstays of treatment for pediatric high-grade glioma and, sadly, outcomes have not improved for many decades. We believe this novel therapy that may allow higher doses of radiation while limiting the exposure to normal developing brain and delivering this agent via convection enhanced delivery (CED) directly into the tumor has the potential to make a big difference in our patients’ lives and improve outcomes," said Dr. Ashley S. Plant, M.D., Principal Investigator for the trial, attending physician in Hematology, Oncology, Neuro-oncology, and Stem Cell Transplantation at Ann & Robert H. Lurie Children’s Hospital of Chicago, A.M. Khokhar Research Scholar and Associate Professor of Pediatrics at Feinberg School of Medicine Northwestern University. "I am extremely passionate about bringing this therapy into the pediatric space and hopeful about the benefits to my patients."

Phase 1/2a Trial Design Highlights:

The Phase 1/2a trial is a two-part, single-arm, prospective study aimed at determining the maximum tolerated dose (MTD), safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years (with consideration for patients up to 25 years on a case-by-case basis).

Key elements of the trial design include:

Phase 1a/b (Dose Escalation): This phase will enroll an estimated 24 patients using a modified 3+3 dose escalation scheme to establish the MTD and recommended Phase 2 dose (RP2D). Safety assessment and alignment with the FDA will occur at defined intervals.

Phase 2a: This phase will enroll approximately 32 patients (12 with ependymoma and 20 with HGG) at the RP2D to assess efficacy.

Pediatric HGG including ependymoma are rare (approximately 3.3 cases per 100,000 persons) but aggressive brain tumors with limited treatment options and poor prognosis, particularly in recurrent settings. Standard treatments, including surgical resection and external beam radiation therapy, often fail to prevent recurrence, with 5-year survival rates as low as 22% for HGG, depending on tumor grade and resection extent. REYOBIQ’s targeted delivery via CED bypasses the blood-brain barrier, offering a novel approach to potentially improve outcomes for these patients.

"This pediatric FDA clearance builds on our successful track record in the safe administration and promising efficacy signals observed in adult patients with more common central nervous cancers," said Marc Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We expect REYOBIQ will offer much needed hope to children with aggressive and difficult-to-treat brain cancers and their families."

REYOBIQ is a novel radiotherapeutic designed to deliver high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue. The ReSPECT-PBC (pediatric brain cancer) trial builds on promising preclinical data and clinical results from the Company’s adult recurrent glioblastoma trial (ReSPECT-GBM). As recently published in Nature Communications, ReSPECT-GBM demonstrated favorable safety and clinical response with a doubling of overall survival for those patients receiving a therapeutic dose of radiation defined as > 100 Gy.

For more information, please contact @plustherapeutics.com or visit www.clinicaltrials.gov (identifier to be assigned upon registration).

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 and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM 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 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.

On June 25, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of intratumoral (IT) PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma (Press release, Phio Pharmaceuticals, JUN 25, 2025, View Source [SID1234654114]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Five patients were enrolled in the fourth cohort of the Phase 1b clinical trial (NCT 06014086). Four of the enrolled patients were diagnosed with cSCC and one patient with Merkel cell carcinoma. As with the previous three cohorts, injections were well-tolerated and there were no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions reported.

Pathology results related to the efficacy of PH-762 in the fourth cohort will be forthcoming.

"We are encouraged by the continuing safety profile of PH-762 having now progressed through four escalating dose concentrations, and we anticipate that IT administration of the highest dose concentration of PH-762 in cohort 5 will result in a similar safety profile," said Mary Spellman, MD, Phio’s acting Chief Medical Officer.

To date, a total of 15 patients with cutaneous carcinomas have been treated with PH-762 in Cohorts 1 through 4. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma, and one patient with Merkel cell carcinoma.

Pathological response at Day 36 (planned tumor excision) in the previous three cohorts demonstrated complete response (100% tumor clearance) in 4 of 9 patients with cSCC. One cSCC patient had a near complete response (>90% clearance) and one cSCC patient had a partial response (>50% clearance). The other three patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients exhibited clinical progression of disease. Patients with a pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection.

Phio expects to complete enrollment in the expected final cohort in this trial in the third quarter of 2025.

"The continuing favorable safety profile of PH-762 through the fourth cohort provides promise of a well-tolerated treatment for skin cancer," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.