On November 3, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that results from its pivotal Phase 3 ARES trial evaluating Xervyteg (MaaT013) in patients with gastrointestinal acute Graft-versus-Host Disease refractory to steroids and refractory or intolerant to ruxolitinib (SR GI-aGvHD) will be presented in an oral session at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition that will take place December 6-9, 2025, in Orlando, Florida, USA. This marks the ninth consecutive year that MaaT Pharma’s clinical data has been selected for presentation at ASH (Free ASH Whitepaper) annual meeting, and the first time the Company will present its Phase 3 results at a medical congress.

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"For the ninth consecutive year, MaaT Pharma is proud to present data at ASH (Free ASH Whitepaper), reaffirming our position as the undisputed leader in microbiotherapy for hematology-oncology. The ARES study demonstrated a clinically meaningful and durable benefit in patients with gastrointestinal aGvHD, further validating our approach and its potential to redefine the standard of care in this high unmet need," said Hervé Affagard, CEO and co-founder of MaaT Pharma.

The ARES trial met its primary endpoint and topline results were announced in January 2025. At the upcoming ASH (Free ASH Whitepaper) annual meeting, the Company will detail secondary endpoints, such as GI-ORR at D56 and Month 3 (M3), and some safety data. Final results, including 1-year overall survival, are expected by the end of 2025.

In the single-arm ARES study, 66 adult patients with GI-aGvHD refractory to steroids and refractory to ruxolitinib were treated with Xervyteg (MaaT013) as third-line treatment across 50 European sites in 6 countries (Austria, Belgium, France, Germany, Italy and Spain). The vast majority of patients included in the study (91%, n=60) presented with severe gastrointestinal aGvHD, classified as grade III (58%, n=38) or grade IV (33%, n=22). Among them, 86% (n=57) were steroid-resistant and 14% (n=9) steroid-dependent; all were refractory to ruxolitinib.

Efficacy data to be presented at the ASH (Free ASH Whitepaper) annual meeting is summarized below (see here for full abstract) – (up to the data cut-off of November 11, 2024):

GI-Overall Response Rate at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (25/66 patients, 38%) and very good partial response (VGPR) (13/66 patients, 20%).
Overall Response Rate (all organs) at Day 28 occurred in 42/66 patients (64%) patients and was similarly driven by high rates of CR (24/66 patients, 36%) and VGPR (12/66 patients, 18%).
GI-ORR at Day 56 was maintained in 49% (31/ 63 patients) and prevalently consisted of CR (37%)
GI-ORR at 3 months was 44% (27/ 62 patients), with a prevalence of GI-CR (36%).
Average duration of response was 6.4 months
Probability of overall survival (OS) at 12 months:
The estimated OS was 54% with a median follow-up of 140.5 days (median survival not reached).
The estimated OS was significantly higher in patients who had a GI response at Day 28 than those who did not respond (67% vs 28% respectively, p <0.0001), demonstrating Xervyteg (MaaT013)’s significant survival benefit in refractory GI-aGvHD.
The median OS of responders was not reached while it was 54 days in non-responders.
Xervyteg (MaaT013) is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025, with a decision anticipated in the second half of 2026.

Details of the Oral Presentation:

Title: MaaT013 for ruxolitinib-refractory acute graft-versus-host disease with gastrointestinal involvement: Results from the ARES phase III trial
Publication Number: 817
Presenting Author: Prof. Malard, MD, hematology professor at Saint-Antoine Hospital and Sorbonne University, lead investigator for the Phase 3 ARES trial
Session Date: December 8, 2025
Presentation Time: 10:30 AM – 10:45 AM
Session Name: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Clinical and Translational Insights
Room: OCCC – Sunburst Room (W340)
Upcoming investor and medical conferences participation

November 5-9, 2025 – 40th SITC (Free SITC Whitepaper) annual meeting in National Harbor, MD, USA
November 19-21, 2025 – SFGM-TC annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event, Paris, France
December 6-9, 2025 – 67th ASH (Free ASH Whitepaper) annual meeting in Orlando, FL, USA

(Press release, MaaT Pharma, NOV 3, 2025, View Source [SID1234659267])

On November 3, 2025 Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a clinical stage oncology company, reported that data from the ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor, in participants with previously treated chronic myeloid leukemia (CML) has been selected for oral presentation on December 8, 2025 at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in Orlando, FL. The company will host a conference call and webcast for investors at 4:30pm ET following the ASH (Free ASH Whitepaper) presentation.

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The abstract is now available on the ASH (Free ASH Whitepaper) website and details are summarized below. A more expansive and updated dataset from the CARDINAL trial will be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December.

"We are pleased that data from our CARDINAL trial have been selected for oral presentation at ASH (Free ASH Whitepaper). These data further validate the potential of TERN-701 to be a new, game-changing therapy for CML. The 24 weeks MMR achievement rate with TERN-701 is unprecedented, trending at least two times higher than the rates reported in other Phase 1 studies of CML therapies that are approved or in development," said Amy Burroughs, chief executive officer of Terns.

"Importantly, TERN-701 also achieved consistently high overall (cumulative) MMR rates in key, difficult to treat patient subgroups while maintaining an encouraging safety profile. These emerging data strongly reinforce our conviction that TERN-701 has the potential to be a best-in-disease therapy, with broad opportunity across all CML treatment lines. We look forward to sharing additional data in December," added Ms. Burroughs.

The ASH (Free ASH Whitepaper) abstract published today reports data from the ongoing dose escalation and dose expansion parts of the CARDINAL study of TERN-701 in patients with previously treated CML. As of the June 30th, 2025, cutoff date, 55 patients were enrolled. Highlights include:

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  Of 32 efficacy-evaluable patients:

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Overall (cumulative) major molecular response (MMR) rate of 75% (24/32) by 24 weeks, with 64% (14/22) achieving MMR and 100% (10/10) maintaining MMR

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Overall (cumulative) MMR by 24 weeks in difficult to treat patient subgroups:

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  69% (11/16) in patients with lack of efficacy to last tyrosine kinase inhibitor (TKI)

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  60% (6/10) in patients who had prior asciminib

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  67% (8/12) in patients with prior asciminib / ponatinib / investigational TKI

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No patients had lost MMR at the time of data cutoff

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  Enrolled patients had heavily pretreated, refractory disease:

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Median of 3 prior TKIs

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35% had ≥4 prior TKIs

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56% and 44% had baseline BCR::ABL1 >1% and >10%, respectively

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64% discontinued their last TKI due to lack of efficacy

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36% had prior asciminib treatment, 25% had prior ponatinib and/or an investigational TKI (olverembatinib / ELVN-001)

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13% with BCR::ABL1 mutations (9% with T315I and 4% with F317L)

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  Encouraging safety profile:

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87% (48/55) patients remained on treatment as of the data cut-off; with discontinuations due to disease progression (n=4), adverse events (n=1), and consent withdrawal/lost to follow up (n=2)

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No dose-limiting toxicities (DLTs) were observed in dose escalation and a maximum tolerated dose (MTD) was not reached

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The majority (74%) of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship

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Most common TEAEs were diarrhea (22%), headache (18%) and nausea (16%), all Grade 1 or 2

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Grade 3 or higher TEAEs were all less than 10%, most commonly neutropenia (7%) and thrombocytopenia (4%)

•
TERN-701 exposures were approximately dose proportional across the dose range

Details for the ASH (Free ASH Whitepaper) oral presentation are as follows:

Title: CARDINAL: A Phase 1 study of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor for patients with previously treated CML

Presenter: Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center

Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes

Session Date: December 8, 2025

Session Time: 2:45 – 4:15pm ET

Presentation Time: 2:45 – 3:00pm ET

Following the full presentation at the ASH (Free ASH Whitepaper) Annual Meeting, the presentation materials will be made available on the Terns website.

Company Conference Call and Webcast Information

Terns will host a conference call and webcast for investors at 4:30pm ET on December 8, 2025 following the oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting. Members of the Terns management team will discuss the TERN-701 data from CARDINAL and next steps in the development of TERN-701.

Webcasts can be accessed in the investor relations section of the Company’s website. A replay of the event will be available for a limited time.

About TERN-701 and CARDINAL Clinical Trial

TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion clinical trial to assess safety, tolerability and efficacy in patients with previously treated chronic phase (CP) CML. The dose escalation portion of the CARDINAL trial completed in January 2025 with no dose limiting toxicities (DLTs) observed up to the maximum dose of 500 mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm.

(Press release, Terns Pharmaceuticals, NOV 3, 2025, View Source [SID1234659283])

On November 3, 2025 Matica Biotechnology, Inc. ("Matica Bio"), a leading viral vector CDMO specializing in advanced therapies, reported a strategic partnership with Calidi Biotherapeutics, Inc. ("Calidi"), a clinical-stage immuno-oncology company developing next-generation oncolytic virus-based therapies. Under the agreement, Matica Bio will provide analytical development (AD), process development (PD), and GMP manufacturing to support the IND submission for CLD-401, the first lead from Calidi’s RedTail platform a groundbreaking approach to genetic medicines. CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist in the tumor microenvironment, a potent cytokine that induces NK and T-cell responses to the tumor.

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This collaboration reinforces Matica Bio’s growing reputation as one of the few CDMOs globally with proven, end-to-end capabilities, especially in oncolytic virus manufacturing. The company has successfully executed multiple oncolytic virus programs at its state-of-the-art, purpose-built GMP facility in College Station, Texas—designed specifically to support complex viral vector modalities.

"Matica Bio has become a sought-after partner especially in the oncolytic virus space because of our technical expertise, regulatory readiness, and track record of delivering seamless development-to-GMP manufacturing programs," said Paul Kim, CEO of Matica Bio. "We’re excited to work with Calidi on this breakthrough program and continue advancing next-gen cancer immunotherapies."

Calidi’s CLD-401 is part of its differentiated RedTail platform. RedTail utilizes an engineered form of extracellular enveloped vaccinia virus that is resistant to immune clearance, can be administered systemically with tropism for metastatic sites, and can deliver genetic medicine payloads to the tumor microenvironment. CLD-401 has potent oncolytic and immune priming effects and also specifically delivers IL-15 superagonist at high levels to the tumor microenvironment.

"Matica Bio stood out as the clear CDMO of choice for Calidi project due to their deep experience with viral vector and their ability to handle complex viral programs with precision," said Eric Poma, CEO of Calidi Biotherapeutics. "The team and facility give us full confidence as we prepare for IND filing and clinical advancement."

With an increasing number of biotechs developing virotherapies, the demand for CDMOs capable of managing these highly specialized programs is growing. Matica Bio’s flexible manufacturing model, integrated process and analytical development, and deep viral vector expertise—including AAV, LVV, and oncolytic viruses—make it a preferred partner for innovative CGT developers worldwide.

(Press release, Calidi Biotherapeutics, NOV 3, 2025, View Source [SID1234659301])

On November 3, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that it has secured a $30 million funding commitment from Yorkville Advisors Global.

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Under the terms of the agreement, CytoDyn has the right to sell, and Yorkville has the obligation to purchase up to $30 million worth of CytoDyn’s common stock over the next 36 months. CytoDyn, at its sole discretion, will control the timing of all sales of common stock to Yorkville, and there are no warrants, derivatives, or other share classes associated with the funding arrangement. CytoDyn is not obligated to utilize any of the $30 million available, there are no minimum commitments or minimum use penalties, and the arrangement does not impose any restrictions on the Company’s operating activities.

"This funding commitment from Yorkville is a solid step in the right direction for CytoDyn," said Robert E. Hoffman, CFO of CytoDyn. "We will utilize this underlying commitment to further develop our program centered around the ability of leronlimab to upregulate PD-L1. This type of discretionary arrangement allows us continued flexibility as we look to bring in additional capital, whether it be through additional financings or strategic partnerships."

For more information on the funding commitment secured from Yorkville, including key terms and conditions of the agreement, please see CytoDyn’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed on November 3, 2025.

(Press release, CytoDyn, NOV 3, 2025, View Source [SID1234659252])

On November 3, 2025 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that Company management will participate in fireside chats at following conferences:

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UBS Global Healthcare Conference
Date: Monday, November 10, 2025
Time: 5pm ET / 11pm CET
Location: Palm Beach Gardens, FL
Presenter: Bart van Rhijn, Chief Financial & Business Officer of Nanobiotix

Guggenheim’s Annual Healthcare Innovation Conference
Date: Monday, November 10, 2025
Time: 4:30pm ET / 10:30pm CET
Location: Boston, MA
Presenter: Laurent Levy, Chief Executive Officer of Nanobiotix
Webcast link: Click here

Stifel Healthcare Conference
Date: Thursday, November 13, 2025
Time: 8am ET / 2pm CET
Location: New York, NY
Presenters: Laurent Levy, Chief Executive Officer of Nanobiotix and Bart van Rhijn, Chief Financial & Business Officer of Nanobiotix

The recorded fireside chats will be webcast live from the events page of the Investors section of the Company’s website. Replay of the webcast will be available following the event.

(Press release, Nanobiotix, NOV 3, 2025, View Source [SID1234659268])