BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer

On May 26, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the independent Data Safety Monitoring Board (DSMB) has issued its sixth consecutive positive recommendation following review of safety data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).

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Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.

"We are highly encouraged by the sixth consecutive positive recommendation of the DSMB for continuation of BriaCell’s pivotal Phase 3 Bria-ABC study," said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. "This important milestone represents another step forward in advancing BriaCell’s novel immunotherapy approaches for patients with urgent unmet medical needs."

(Press release, BriaCell Therapeutics, MAY 26, 2026, View Source [SID1234666084])

Bionano Announces Largest OGM Study of T-Cell Acute Lymphoblastic Leukemia

On May 26, 2026 Bionano Genomics, Inc. (Nasdaq: BNGO) reported publication of a peer-reviewed study in Modern Pathology showing that optical genome mapping (OGM) detected genomic abnormalities in 97.8% of T-cell acute lymphoblastic leukemia (T-ALL) cases — nearly double the 55% detection rate achieved by conventional cytogenetic analysis. Conducted by researchers at The University of Texas MD Anderson Cancer Center and Johns Hopkins University School of Medicine and representing one of the most comprehensive genomic analyses of T-ALL to date, the study underscores OGM’s potential to transform how this aggressive blood cancer is studied and understood.

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T-ALL is an aggressive form of pediatric and adult leukemia driven by a wide variety of complex genetic changes, many of which are too subtle or structurally complex to be detected by traditional methods. The disease is notoriously difficult to characterize fully, limiting the ability of researchers to study its biology, classify subtypes, and develop targeted therapies.

The 91-subject study compared OGM head-to-head against conventional karyotyping and next-generation sequencing (NGS) — the standard tools for evaluating T-ALL. Where karyotyping identified abnormalities in just 55% of cases, OGM found them in 97.8% of cases, and provided additional genomic insights beyond standard methods in approximately 70% of the cases — all from OGM’s single workflow.

Key Highlights:

91 cases: of T-ALL cases analyzed across three platforms — OGM, conventional karyotyping, and NGS — making this study the largest OGM study of T-ALL conducted to date.
High success rate for finding abnormalities: OGM identified chromosomal abnormalities in 97.8% of cases, compared to 55% by conventional karyotyping — a dramatic improvement in detection for a disease where missed findings can leave the biology incompletely understood.
Broader picture in 70% of cases: OGM delivered clinically relevant genomic information beyond karyotyping in approximately 70% of cases, uncovering abnormalities that standard methods missed — all without requiring additional testing.
24 known + 21 novel gene fusions identified: OGM detected gene rearrangements in 80% of cases, including 24 known recurrent fusions and 21 newly identified fusions, pointing to potential new targets for T-ALL research.
Comprehensive sequence variant and copy number profiling: OGM identified copy number changes in 93% of cases. NGS detected sequence variants in 92% of cases. The gene most frequently found to harbor variants was NOTCH1 (57% of cases).
Disease subtypes decoded: OGM uncovered distinct genomic patterns across T-ALL subtypes, supporting more precise biological classification of this heterogeneous disease.
OGM can streamline workflows for T-ALL. T-ALL presents particular challenges for standard genomic analysis: samples often yield poor-quality material for karyotyping, and many of the most biologically important genetic changes are subtle, small-scale, or driven by rearrangements in non-coding regions of the genome. Conventional approaches typically require multiple sequential analyses to piece together a complete picture — a process that is time-consuming, costly, and incomplete. OGM can address these limitations with a genome-wide approach that captures the full landscape of genetic variation in a single workflow.

"This publication further strengthens the growing body of evidence supporting OGM as a powerful tool for resolving the genomic complexity of challenging childhood and adult blood cancers like T-ALL, 50% of which remain unsolved by legacy methods, such as, karyotyping. This study, as one of the first and largest of its kind in T-ALL, demonstrates the complementarity that OGM and NGS can provide and shows how OGM can be particularly well-suited to T-ALL’s unique challenges — including poor sample quality, subtle rearrangements, and a wide range of genomic targets — capturing recurrent and novel alterations in a single pass that would otherwise require multiple sequential tests," said Alka Chaubey, PhD, FACMG, chief medical officer of Bionano. Dr. Chaubey continued, "the ability to uncover subtle and complex rearrangements in diseases like T-ALL can give researchers a far more complete picture of the biology — and reinforces why comprehensive structural variant analysis matters in blood cancer research."

(Press release, BioNano International Singapore Pte, MAY 26, 2026, View Source [SID1234666083])

Calidi Biotherapeutics Announces Online Abstract Acceptances at the 2026 ASCO Annual Meeting

On May 26, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or "the Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that two abstracts showcasing the Company’s RedTail platform have been accepted for online publication at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from May 29 to June 2, 2026 in Chicago, IL. The Company’s proprietary RedTail platform is a systemically delivered virotherapy platform engineered to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within tumors.

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The Company will present preclinical data on its lead program, CLD-401. CLD-401 is a systemically delivered virotherapy designed to selectively target tumors and enable high-level expression of IL-15 superagonist ("IL-15 SA"), a known T- and NK-cell activator, driving profound immune changes in the tumor microenvironment ("TME"), including the recruitment and activation of NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent animal models. The Company expects to file an IND for CLD-401 by the end of 2026.

The Company will also present preclinical data on CLD-501, the lead compound from its in situ T-cell engager ("TCE") approach. CLD-501 is a systemically delivered virotherapy designed to selectively target tumors and simultaneously enable the high-level in situ expression of a TROP-2 TCE and IL-15 SA.

"The data presented at ASCO (Free ASCO Whitepaper) demonstrate the potential for the RedTail platform as systemic virotherapy that can deliver genetic medicine to metastatic sites after systemic administration," said Antonio F. Santidrian, PhD, Chief Scientific Officer of Calidi. "The ability of CLD-401 to induce high levels of IL15-SA expression in the TME may drive activity in patients that have progressed on current IO therapies while the tandem expression of a TCE and a T-cell activator as seen with CLD-501 may overcome the barriers to TCE efficacy in solid tumors."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAY 26, 2026, View Source [SID1234666082])

RenovoRx Announces Promising Pharmacokinetic Data Using the TAMP™ Platform Presented at the 2026 ASCO Annual Meeting

On May 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that an abstract from a pharmacokinetic (PK) and pharmacodynamic sub-study of its ongoing Phase III TIGeR-PaC clinical trial has been published online in connection with the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 29 – June 2, 2026.

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The abstract, entitled "The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study," is a sub-study of the Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer. The abstract evaluates the TAMP (Trans-Arterial Micro-Perfusion) platform for targeted intra-arterial delivery of gemcitabine via RenovoCath, (the Company’s lead investigational product candidate, known as IAG) and its potential to reduce systemic levels of gemcitabine and increase levels of its inactive metabolite compared with IV gemcitabine.

Results showed that IAG administration was associated with a direct correlation between increased metabolite levels and reduced CA 19-9, a biomarker commonly used to assess potential chemotherapy response. By decreasing systemic levels of gemcitabine, through limited systemic exposure and rapid conversion to an inactive metabolite, this drug-delivery approach may both increase local drug potency and reduce the negative side effects common to patients receiving gemcitabine via IV delivery for the treatment of pancreatic cancer. The PK and pharmacodynamic analyses were performed from a total of 16 patients across six TIGeR-PaC trial sites.

"This study suggests that enhancing local drug potency while reducing systemic exposure with IAG may increase efficacy while minimizing toxicity, addressing a key limitation of many therapies," said co-author Dr. Reza Nazemzadeh of Atrium Health Levine Cancer Institute, Charlotte, NC. "By lowering circulating drug levels, the approach has the potential to reduce side effects and improve patient tolerability, representing a promising step toward more precise and patient-centered cancer care."

The 2026 ASCO (Free ASCO Whitepaper) Annual Meeting is being held May 29 – June 2, 2026, in Chicago, Illinois.

Abstract Details:
Online Publication Date & Time: May 21, 2026, at 5:00 P.M. ET
Location: Online
Number for Publication: E16463
Title: The TIGeR-PaC Phase 3 Clinical Trial Examining Intra-Arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic and Pharmacodynamic Sub-Study

(Press release, Renovorx, MAY 26, 2026, View Source [SID1234666081])

NANOBIOTIX Announces Closing of Global Offering

On May 26, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – "Nanobiotix" or the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the closing today (the "Closing") of its global offering (the "Global Offering"), including in respect of the earlier total exercise by the underwriters of their option (the "Option") to purchase additional new ordinary shares in the form of additional American Depositary Shares (the "Additional ADSs").

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Following the full exercise of the Option, the total number of ordinary shares (each an "Ordinary Share"), of the Company and pre-funded warrants to subscribe for one Ordinary Share each (the "PFW") issued in the Global Offering amounts to 2,218,467 Ordinary Shares, including 225,373 Ordinary Shares in the form of American Depositary Shares ("ADSs") and 33,805 Ordinary Shares in the form of Additional ADSs, and 345,099 PFW, resulting in aggregate gross proceeds for the Company of approximately $100 million (corresponding to approximately €86.1 million), before deducting underwriting commissions in respect of the Global Offering and estimated expenses related to the Global Offering.

The subscription price of €33.60 per Ordinary Share, corresponding to the offering price of $38.98 per ADS based on an exchange rate of €1.00 = $1.16 as published by the European Central Bank on May 20, 2026, is equal to the volume weighted average price of the Ordinary Shares on the regulated market of Euronext in Paris over the last three trading sessions preceding the pricing of the Global Offering (i.e. May 18, May 19 and May 20, 2026), less a discount of 14.92% and has been determined by the Company pursuant to the 29th resolution of the Company’s combined shareholders’ meeting held on May 19, 2025. The subscription price of each PFW is equal to the subscription price per Ordinary Share issued in the Global Offering minus their nominal value of €0.03 per Ordinary Share.

The Company intends to use the net proceeds from the Global Offering, including the net proceeds from the sale of the Additional ADSs, as follows:

less than 10% to support the development and advancement of JNJ-1900 (NBTXR3);
between 50-60% to advance our Nanoprimer and other platforms; and
between 30-40% for general corporate purposes.

The expected use of proceeds represents the Company’s intentions based upon its current plans and business conditions. The Company cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of Global Offering (including the Additional ADSs) or the amounts that the Company will actually spend on the uses set forth above. The amounts and timing of the Company’s actual expenditures and the extent of clinical development may vary significantly depending on numerous factors, including the progress of the development efforts, the status of and results from preclinical studies and any ongoing clinical trials or clinical trials the Company may commence in the future, as well as any collaborations that the Company may enter into with third parties for its product candidates and any unforeseen cash needs. As a result, the Company’s management will retain broad discretion over the allocation of the net proceeds.

The Company believes that the net proceeds from the Global Offering (including the Additional ADSs), together with its cash and cash equivalents, will be sufficient to meet its working capital requirements for operations into 2029, consistent with the Company’s currently contemplated cash burn rate.

Jefferies, TD Cowen and Stifel acted as global coordinators and joint bookrunners for the Global Offering.

Jefferies LLC, acting as the stabilizing agent on its own behalf and on behalf of the other Underwriters, reported that no stabilization activities had been carried out and the stabilization period is now closed.

The ADSs are listed on the Nasdaq Global Select Market under the symbol "NBTX" and the Company’s Ordinary Shares are listed on Euronext Paris under the symbol "NANO".

The ADSs (including the Additional ADSs) and Ordinary Shares issued in the Global Offering were offered pursuant to an effective shelf registration statement on Form F-3 (Registration No. 333-285604), which was filed with the Securities and Exchange Commission (the "SEC") on March 6, 2025 and subsequently declared effective on March 14, 2025. The Global Offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the Global Offering has been filed with the SEC on May 22, 2026 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the Global Offering (and accompanying prospectus) relating to the Global Offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388 or by email at [email protected]; from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected].

(Press release, Nanobiotix, MAY 26, 2026, View Source [SID1234666080])