On July 8, 2025 LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, reported that it has entered into a share and warrant purchase agreement (the "Purchase Agreement") with an institutional investor for the issuance and sale of 16,987,542 ordinary shares of the Company, par value US$0.0002 per share, at US$0.883 per share, and 16,987,542 warrants, each entitling the institutional investor to purchase one ordinary share at an exercise price of US$1.079 at any time and from time to time during a 36-month period, in a private placement of US$15 million exempt from registration pursuant to Regulation S under the Securities Act of 1933, as amended (Press release, LakeShore Biopharma, JUL 8, 2025, View Source [SID1234654288]). The closing of the private placement is expected to take place as soon as possible upon agreement by the parties to the Purchase Agreement, subject to customary conditions precedent stipulated thereunder.

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This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation, or sale of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 8, 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 the treatment of its initial patients in the Company’s ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM) (Press release, Plus Therapeutics, JUL 8, 2025, View Source [SID1234654287]). The dose optimization trial builds on promising results from the Company’s completed Phase 1 single-dose escalation study, which demonstrated the feasibility of REYOBIQ for treating LM. The trial is designed in alignment with the FDA’s Project Optimus to identify the optimal dosing regimen that maximizes efficacy and safety.

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"Based on the promising, recently completed Phase 1 single-dose escalation study and lack of FDA approved therapies for LM, we expect trial enrollment to proceed rapidly in accordance with the trial protocol," said Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio. "Furthermore, assuming REYOBIQ continues its attractive safety profile, we expect that we will enroll all required patients and doses in Cohort 1 by the end of this year."

Patients and family members interested in enrolling in the ReSPECT-LM Dose Optimization Trial can learn more here.

ReSPECT-LM Dose Optimization Trial
The study aims to optimize treatment dosing for maximum efficacy and safety, with the primary objectives of determining the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter at defined intervals in patients with LM from any primary solid tumor cancer, and to identify both the maximum tolerated dose and minimum effective dose. Previously announced details of the study, including primary, secondary, and exploratory endpoints, can be found here.

The dose optimization study builds on encouraging results from the Company’s previously announced Phase 1 trial, which showed a single dose of REYOBIQ delivered up to an average absorbed dose of >250 Gy to the cranial subarachnoid space. It also demonstrated that 5 of 7 patients achieving an over 80% reduction in LM tumor cells in the cerebrospinal fluid survived at least one year post-treatment. Additional details can be found here.

The Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial.

The ReSPECT-LM dose optimization trial benefits from a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), the second largest public funding source for cancer research in the world.

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

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.

About Cancer Prevention & Research Institute of Texas (CPRIT)
The Cancer Prevention & Research Institute of Texas (CPRIT) is a $6 billion cancer research and prevention initiative legislated in Texas. CPRIT accepts applications and award grants for a wide variety of innovative cancer-related research and product development and for the delivery of evidence-based cancer prevention programs and services by public and private entities located in Texas. CPRIT is the largest state cancer research investment in the history of the United States and the second largest cancer research and prevention program in the world with a three-part mission, established by the Texas Legislature, to invest in the research prowess of Texas universities and research organizations; create and expand life science infrastructure across the state; and expedite innovation in research and enhance the potential of breakthroughs in prevention and cures.

On July 8, 2025 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the "Company"), a clinical stage pharmaceutical company, reported the closing of a registered direct offering with accredited investors for the purchase and sale of approximately $1.5 million of shares of Common Stock (or Pre-Funded Warrants) (Press release, Lixte Biotechnology, JUL 8, 2025, View Source [SID1234654286]).

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The offering consisted of the sale of an aggregate of 974,026 shares of Common Stock (or Pre-funded Warrants in lieu thereof). The public offering price per share of Common Stock was $1.54 (or $1.53999 for each Pre-Funded Warrant, which is equal to the offering price per share of Common Stock sold in the offering minus an exercise price of $0.00001). The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until exercised in full.

Aggregate gross proceeds to the Company were approximately $1.5 million. The transaction closed on July 8, 2025. The Company expects to use the net proceeds from the offering, together with its existing cash, for general corporate purposes and working capital.

Spartan Capital Securities, LLC acted as exclusive placement agent for the offering. TroyGould PC acted as counsel to the Company. Kaufman & Canoles, P.C. acted as counsel to Spartan Capital Securities, LLC.

The registered direct offering was made pursuant to an effective shelf registration statement on Form S-3 (No. 333-278874) previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on May 2, 2024. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, by contacting Spartan Capital Securities, LLC, Attention: Prospectus Department, 45 Broadway, 19th Floor, New York, NY 10006, by e-mail at [email protected]. Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

On July 8, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its collaboration partner, PeriNess Ltd. (PeriNess), has informed the Company that Bnei Zion Medical Center has commenced patient dosing in an exploratory clinical study of systemic DNase I in combination with FOLFIRINOX for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer (Press release, Xenetic Biosciences, JUL 8, 2025, View Source [SID1234654285]).

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Dr. Abed Agbabrya, head of Oncology at the Bnei Zion Hospital, will act as the principal investigator and all work will be conducted at The Fund for Medical Research, Development of Infrastructure and Health services – Bnei Zion Medical Center in Israel.

Dr. Dmitry Genkin, Xenetic Chairman stated, "We are very pleased with the update provided by PeriNess and for the start of patient dosing in this exploratory study. We remain committed to advancing our systemic recombinant human DNase I technology into the clinical stage. The ability of DNase I to degrade neutrophil extracellular traps (NETs) in the pancreatic cancer tumor microenvironment holds promise to improve clinical responses in a critically underserved patient population. We look forward to further exploring the full potential of DNase I."

PeriNess has informed the Company that the exploratory study is evaluating the safety, biomarker response, pharmacokinetics (PK) and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer. All patients will receive intravenous infusions of DNase I on Days 1 and 8 of consecutive 14-day cycles. Safety will be continuously evaluated until the end of the study. DNase I pharmacokinetics will be evaluated on Days 1 and 2 of the first FOLFIRINOX cycle and Days 1 and 2 of the third FOLFIRINOX cycle. Neutrophil extracellular traps biomarkers will be evaluated on Day 1 of the first FOLFIRINOX cycle and every 4 weeks thereafter. Clinical activity will be evaluated by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Progression-Free Survival (PFS).

As previously announced, in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.

On July 8, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company’s intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies (Press release, Oncolytics Biotech, JUL 8, 2025, View Source [SID1234654284]).

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"We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, Chief Executive Officer of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology."

Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer. Currently, there are no approved immunotherapies for first-line treatment of mPDAC.

Clinical results of pelareorep in first-line mPDAC studies
Company
(Study)
Description
(Patients) 1-Year Survival 2-Year Survival Notes
Oncolytics
(REO 017)
Pelareorep+ Gemcitabine
(34 patients)
45% vs. 22% 24% vs. 4%
Disease Control Rate (DCR): 83% vs. 33%
Single arm vs. gemcitabine benchmark

Oncolytics
(NCI 8601)
Paclitaxel/Carboplatin + Pelareorep
(36 patients) vs.
Paclitaxel/Carboplatin
(37 patients)
34% vs. 28% 20% vs. 6%
Randomized study vs. control arm
(excluding crossover)
Oncolytics
(REO 029)
Pelareorep+ Gemcitabine/
Nab-Paclitaxel+ Atezolizumab
(13 patients)
45% vs. 35% N/A
ORR: 62% vs. 23%
Single arm vs. gemcitabine/
nab-paclitaxel benchmark

Pelareorep’s clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm.

"Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies like mPDAC and unresectable HR+/HER2- breast cancer, creating new oncology entry points for immune-based combination therapies."

Data from more than 1,100 patients enrolled in multiple studies across several tumor types affirm that pelareorep has a favorable, well-understood safety profile. The most common treatment-related adverse events (TRAEs) are "flu-like" symptoms, such as fever, chills, headache, fatigue, myalgia, cough, anorexia, nausea, diarrhea, or vomiting, and rarely resulted in clinically significant grade ≥3 TRAEs. Adverse events are typically transient and manageable with over-the-counter medications.

Pelareorep received Fast Track designations from the U.S. Food and Drug Administration (FDA) in 2017 for metastatic breast cancer and in 2022 for mPDAC in combination with chemotherapy and atezolizumab. In 2015, pelareorep also received Orphan Drug Designations from the FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer.

The Company released a new corporate presentation, available on its website, that provides detailed clinical and translational data.