On May 30, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the first quarter ended March 31, 2025, and provides an overview of recent and upcoming business highlights (Press release, Cytori Therapeutics, MAY 30, 2025, View Source [SID1234653516]).

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"We improved our cash position in the first quarter as a result of both a financing and grant support," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "With the additional cash and further anticipated grant support in 2025, we are well positioned to make solid progress in our 2 key business goals: enrollment in our REYOBIQ CNS cancer radiotherapeutic clinical trials and the planned launch of the CNSide cerebral spinal fluid (CSF) assay platform."

Q1 2025 & RECENT HIGHLIGHTS AND MILESTONES

Corporate

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Raised gross proceeds of $15 million in a private placement financing – along with a $2.0 million grant award advance from the Company’s existing grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to accelerate development of REYOBIQ for our leptomeningeal metastases (LM) program.
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Added industry veteran Kyle Guse to the Board of Directors – Mr. Guse brings 30 years of professional experience in multiple executive roles, including as a Chief Financial Officer and a General Counsel of innovative companies.
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Strengthened management team with addition of Dr. Michael Rosol as Chief Development Officer – Dr. Rosol will lead the Company’s clinical, pre-clinical, and biomarker development activities.

REYOBIQ Clinical Trials

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Presented updated interim data on its lead compound REYOBIQ at the Nuclear Medicine and Neuro-oncology conference held May 9-10, 2025 in Vienna, Austria that highlighted the safety and clinical benefit of REYOBIQ in patients with LM.
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Published Phase 1 clinical trial results for REYOBIQ in peer-reviewed publication Nature Communications, demonstrating safety and potential efficacy in treating recurrent glioblastoma (GBM), with patients receiving a radiation dose >100 Gy achieving a median overall survival of 17 months, more than double the standard of care. Additional details can be found here.
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Completed ReSPECT-LM Phase 1 single dose administration trial and determined the maximum tolerated and recommended Phase 2 dose. Additional details can be found here.
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Granted U.S. FDA Orphan Drug Designation for REYOBIQ for the treatment of LM in patients with lung cancer.
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Received U.S. FDA conditional agreement for the proprietary name REYOBIQ for the Company’s lead radiotherapeutic, rhenium Re186 obisbemeda.

CNSide CSF Assay Platform

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Strengthened management team with key leadership appointments:
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Russell Bradley as President and General Manager of Plus Therapeutics’ wholly owned subsidiary, CNSide Diagnostics, LLC ("CNSide Diagnostics") – Mr. Bradley provides leadership to CNSide Diagnostics with an immediate focus on commercialization of the CSF assay platform.
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Dr. Jonathan Stein as Medical Director, CNSide Diagnostics – Dr. Stein provides technical leadership to support the CNSide CSF assay platform.

Q1 2025 FINANCIAL RESULTS

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The Company’s cash balance was $9.9 million at March 31, 2025 compared to $0.1 million at December 31, 2024.
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The Company recognized $1.1 million in grant revenue in the first quarter of 2025 compared to $1.7 million in in the first quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM.
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Total operating loss for the first quarter of 2025 was $3.5 million compared to $3.3 million in the same period of 2024. The increase is primarily due to increased legal fees.
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Net loss for first quarter of 2025 was $17.4 million, or $(1.19) per share, compared to a net loss of $3.3 million, or $(0.75) per share, for the same period the prior year.

On May 30, 2025 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that it will be participating in the Jefferies Global Healthcare Conference, taking place in New York on June 3 – 5, 2025 (Press release, CorMedix, MAY 30, 2025, View Source [SID1234653515]).

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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

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Jefferies Global Healthcare Conference
Date: Thursday, June 5, 2025
Time: 3:45p.m. EDT
Format: Presentation
Webcast: Link

On May 30, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that management will participate in the Jefferies 2025 Global Healthcare Conference (Press release, ALX Oncology, MAY 30, 2025, View Source [SID1234653514]). Details are as follows:

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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

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Format: Fireside Chat
Date: Thursday, June 5, 2025
Time: 1:25 PM ET
Location: New York, NY
Webcast link: Available here

The live webcast of the Jefferies fireside chat can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date.

On May 30, 2025 Coherus Oncology, Inc. (Coherus Oncology, Nasdaq: CHRS), a commercial-stage innovative oncology company, formerly named Coherus BioSciences Inc., reported its name change, to better align with its exclusive focus on proprietary innovative immuno-oncology medicines (Press release, Coherus Biosciences, MAY 30, 2025, View Source [SID1234653513]).

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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

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"The field of cancer immunotherapy has been reinvigorated by the promise and power of combination therapies. Coherus Oncology has the expertise and pipeline to become a significant player in this dynamic space and unlock the potential of these next-generation therapeutic approaches," said Jill O’Donnell-Tormey, Ph.D., Coherus Oncology board member. Dr. O’Donnell-Tormey is a Senior Advisor to the Cancer Research Institute and its former CEO.

"The next wave of breakthroughs in cancer immunotherapy will come from new mechanistic orthogonal approaches that synergize for optimal clinical efficacy. CCR8+ Tregs represent one of the most promising targets in cancers, enabling selective depletion of tumor immune suppression while mitigating the risk of breaking tolerance and leading to severe autoimmunity," said Alexander Rudensky, Ph.D., Coherus Scientific Advisory Board Co-Chair, Chairman and Member, Immunology Program, Sloan Kettering Institute, Lloyd Old Chair in Clinical Investigation Investigator, Howard Hughes Medical Institute Director, Ludwig Center for Cancer Immunotherapy Tri-Institutional Professor at MSKCC, The Rockefeller University and Cornell University.

"Coherus Oncology is firmly committed to the oncology community and developing the next generation of therapies focused on extending survival of cancer patients and improving their quality of life," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer of Coherus Oncology. "Our objective is to set new standards of cancer care with novel combinations that broadly target the immune system and resistance."

Our Novel Oncology Pipeline

Coherus Oncology is developing a portfolio of novel combination therapies with the aim of unlocking immune resistance to current therapies.

LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor, is the foundation of our immuno-oncology franchise. LOQTORZI is the only available FDA-approved treatment indicated in combination with chemotherapy for recurrent or metastatic nasopharyngeal carcinoma (NPC), and it is in development for the treatment of additional tumor types with the goal of being the PD-1/ICI backbone of future treatment combinations that may extend survival for patients.

CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. CHS-114 is currently being evaluated in combination with toripalimab in Phase 1b studies in patients with advanced solid tumors, including second-line head and neck squamous cell carcinoma and second-line gastric cancer.

Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory NSCLC and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC). A randomized Phase 2 study is underway evaluating casdozokitug in combination with toripalimab and bevacizumab, versus toripalimab and bevacizumab, in patients with first-line advanced metastatic HCC. Squamous NSCLC continues as an area of clinical focus and future development.

Our Oncology Team & Board

Coherus Oncology is led and advised by a world-class team with deep expertise in oncology drug development and commercialization. The Scientific Advisory Board includes pioneers in the fields of Treg immunology, T cell exhaustion, and cytokine biology. The Board of Directors is comprised of industry leaders from the Cancer Research Institute, Merck, United Healthcare, Bristol Myers Squibb, as well as others. The breadth and depth of these perspectives provide Coherus Oncology with valuable insights to navigate the rapidly evolving oncology landscape and drive innovation to advance patient benefit and shareholder value.

Learn more about our executive team, Board of Directors, Scientific Advisory Board, and Strategic Advisors: View Source

On May 30, 2025 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare disease, reported that a poster including new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination clinical trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois (Press release, BioLineRx, MAY 30, 2025, View Source [SID1234653512]).

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The CheMo4METPANC trial is evaluating the company’s CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

Updated results from the pilot phase indicate that four of eleven patients remained progression free after more than one year. Two patients underwent definitive treatment for mPDAC: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response. An analysis of pre- and on-treatment biopsies and peripheral blood mononuclear cells (PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. In addition, patients achieving a partial response were found to have higher pre-treatment proportions of CXCL12-producing cancer associated fibroblasts, a potential marker of response.

"The data that continue to emerge from the pilot phase of the CheMo4METPANC Phase 2 study are extremely encouraging, with four of eleven patients remaining progression free after more than one year, as well as two patients that underwent definitive treatment, in what has historically been among the most challenging tumor types to treat," stated Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "Notably, these results further suggest that the combination of motixafortide, cemiplimab and standard-of-care chemotherapy can overcome the immunosuppressive mechanisms of the tumor microenvironment (TME) and increase intratumoral CD8+ T-cell infiltration, resulting in improved patient outcomes. We look forward to results from the ongoing randomized portion of this important study."

The pilot clinical trial of motixafortide, cemiplimab, gemcitabine and nab-paclitaxel (N=11) demonstrated an overall response rate (ORR) of 64% (7/11) and a disease control rate (DCR) of 91% (10/11), compared to historical ORR and DCR of 23% and 48%, respectively, with gemcitabine and nab-paclitaxel. Based on these encouraging results, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients. The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. The trial is planned to be fully enrolled in 2027, and a prespecified interim analysis is planned for when 40% of PFS events are observed.

Poster Presentation at ASCO (Free ASCO Whitepaper) 2025
McCormick Place, Chicago, Illinois

Poster Session Details

Primary Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic and Hepatobiliary

Title: CheMo4METPANC: Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (Motixafortide), and Immune Checkpoint Blockade (Cemiplimab) in Metastatic Treatment-Naïve Pancreatic Adenocarcinoma

Presenter: Gulam Abbas Manji, MD, PhD, Columbia University Herbert Irving Comprehensive Cancer Center
Abstract: 4167
Poster Bd #: 457
Date: May 31, 2025
Time: 9:00am CDT
Location: Hall A

About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04543071) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 108 patients. The trial’s primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.

About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.1 Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.2 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.

About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.