On November 20, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that its subsidiary, BriaPro Therapeutics Corp. ("BriaPro"), has initiated a research collaboration with Receptor.AI, an AI-driven drug discovery company, to design anti-cancer isoform-selective kinase inhibitors for multiple cancer indications.

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The collaboration will integrate AI-driven molecular design expertise and BriaPro’s proprietary technology to expand BriaPro’s small-molecule pipeline and accelerate the development of selective kinase inhibitors that may enhance immune-mediated tumor targeting and improve cancer patient outcomes.

"This partnership marks an important step in BriaCell’s strategic expansion beyond cell-based immunotherapy into small-molecule discovery, reinforcing its mission to deliver differentiated and complementary approaches to cancer treatment," stated Dr. William V. Williams, President and CEO of BriaCell and BriaPro.

"Kinase selectivity, down to the isoform level, remains one of the hardest optimization problems in oncology," said Dr. Alan Nafiev, CEO and Founder of Receptor.AI. "This collaboration is about bringing disciplined, AI-first molecular design and rigorous ADMET constraints to BriaCell’s oncology programs, enhancing precision and translational confidence from the earliest stages of discovery."

Receptor.AI has developed a multiplatform ecosystem for AI-enabled drug discovery, integrating small-molecule, peptide, and induced-proximity technologies into a unified framework that accelerates therapeutic innovation across modalities. Within the collaboration, Receptor.AI will harness its small-molecule discovery platform to drive target assessment, hit identification, and lead optimization, with a particular focus on achieving precise isoform selectivity among closely related kinases.

(Press release, BriaCell Therapeutics, NOV 20, 2025, View Source [SID1234660842])

On November 20, 2025 CrossBridge Bio, a biotechnology company pioneering next-generation dual-payload antibody-drug conjugates (ADCs) that have the potential to deliver safer, more durable responses for patients, including those resistant to approved ADC therapies, reported it has been awarded a $15 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). The award will support completion of IND-enabling activities and advancement of CBB-120, the company’s lead TROP-2 targeted TOP1i/ATRi dual-payload ADC, into first-in-human studies.

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CrossBridge Bio’s proprietary platform integrates branched tripeptide linkers (EGCit) with a dual-payload design that enables precise delivery of synergistic topoisomerase-1 inhibitor and ATR inhibitor payloads within a single ADC molecule. This architecture is engineered to deliver deeper, more durable responses and to overcome tumor resistance and heterogeneity – key limitations of earlier-generation ADCs.

CBB-120 has generated compelling preclinical data demonstrating potent and durable antitumor activity, including in models resistant to standard-of-care ADCs. The program was recently featured at the 2025 World ADC Conference, where it became the most attended non-plenary session in the event’s history, underscoring broad scientific interest in the platform and program.

The CPRIT award will enable CrossBridge Bio to complete GLP toxicology studies, scale up manufacturing, finalize analytical development, and prepare for an IND filing in 2026.

"We are honored to receive CPRIT’s support as we advance CBB-120 toward the clinic," said Michael Torres, Ph.D., Chief Executive Officer of CrossBridge Bio. "This grant is a strong validation of the innovation behind our dual-payload platform and reflects the importance of bringing new treatment options to patients facing difficult-to-treat cancers. CPRIT’s support allows us to accelerate development with the urgency this opportunity deserves."

"CBB-120 showcases the full strength of our scientific approach – dual-payload engineering, branched linker chemistry, and precision delivery," said Dan Pereira, Ph.D., Chief Scientific Officer of CrossBridge Bio. "We’re excited to build on the momentum from our World ADC recognition and move this program into clinical development, where we hope it will make a meaningful impact for patients with limited options."

(Press release, CrossBridge Bio, NOV 20, 2025, View Source [SID1234660859])

On November 20, 2025 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the third quarter ended September 30, 2025, and provided a corporate update.

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"In the third quarter of 2025 we focused on advancing preparations for the nebokitug Phase 3 trial in patients with primary sclerosing cholangitis (PSC), continuing our very productive discussions with the FDA and EMA," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "I am delighted to report that we have support from both agencies that a single Phase 3 registration trial would be sufficient for approval. In addition, both have agreed that a composite of clinically relevant events can be used for the study endpoint. In view of the general alignment of the two regulatory agencies and the advanced status of the Phase 3 design, we expect to launch the trial as soon as feasible."

Dr. Mor continued, "We are also encouraged that at the recent AASLD 2025 conference, the PSC community, including KOLs, global clinical centers and patient advocates, voiced their support for the nebokitug Phase 3 design, along with their interest in participating in the trial. With a clear regulatory pathway to approval in the US, international regulatory alignment on key aspects of the Phase 3 trial design and increasing market interest, we are seeing growing recognition of nebokitug’s potential to become the first disease-modifying therapy for this devastating condition. The limited number of ongoing PSC trials provides a unique opportunity to leverage our strong engagement with global PSC centers to advance our Phase 3 program rapidly and efficiently. In parallel, we are continuing discussions with potential strategic partners. We see this dual track as positioning Chemomab for maximum strength and flexibility as we work to launch the Phase 3 nebokitug trial as soon as the necessary financial resources are available."

Dr. Mor concluded, "This is an exciting time for Chemomab as we see more options for advancing nebokitug into a registrational trial that could enable us to be the first effective therapy in this large, unserved market, while providing hope to the tens of thousands of PSC patients seeking better options for managing their condition. We are continuing to lay the groundwork for rapidly launching the Phase 3 trial and look forward to reporting on our progress over the remainder of the year."

Third Quarter 2025 and Recent Highlights:

On November 6, 2025, Chemomab reported that data from the Phase 2 SPRING trial assessing nebokitug for the treatment of PSC was featured in three poster presentations at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting 2025. All three were designated by conference organizers as "posters of distinction." Data presented from the SPRING trial open label extension (OLE) showed the continued and consistent positive effects of nebokitug on key inflammatory and fibrotic biomarkers when administered to patients with PSC for up to 48 weeks, confirming its good safety profile and further reinforcing its disease-modifying potential. Two additional posters presented new clinical data that provided additional insights into the macrophage-related mechanism of action of nebokitug, a first-in-class antibody that inhibits the soluble protein CCL24, a key driver of disease processes in fibro-inflammatory diseases such as PSC. These results further confirm that nebokitug may halt or slow disease progression and improve clinical outcomes — the primary objectives of the proposed nebokitug Phase 3 study in PSC.

On August 14, 2025, Chemomab reported that it would change the ratio of its American Depositary Shares ("ADSs") to its Class A ordinary shares (the "ADS Ratio"), from the then current ADS Ratio of one ADS to 20 Class A ordinary shares to a new ADS Ratio of one ADS to 80 Class A ordinary shares, effective on August 26, 2025. This ratio adjustment essentially served as a one-for-four reverse ADS split for Chemomab ADS holders.
Third Quarter 2025 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $10.2 million as of September 30, 2025, compared to $9.5 million as of June 30, 2025 and $14.2 million as of December 31, 2024. This cash is expected to fund the company through the end of the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were approximately $1 million in the third quarter of 2025, compared to $2.8 million in the third quarter of 2024. The decrease in R&D expenses in the third quarter of 2025 compared to the third quarter of 2024 primarily resulted from the end of activities related to the nebokitug Phase 2 SPRING trial.

General and Administrative (G&A) Expenses: G&A expenses were approximately $0.9 million for the third quarter of 2025, generally equivalent to approximately $0.9 million in G&A expenses for the third quarter of 2024.

Net Loss: Net loss was $1.7 million, or a net loss of less than one-half of one cent per basic and diluted ordinary share for the third quarter of 2025, compared to a net loss of $3.5 million, or a net loss of approximately $0.01 per basic and diluted ordinary share, for the third quarter of 2024. The weighted average number of ordinary shares outstanding, basic and diluted, was 494,338,497 million (equal to approximately 6,179,231 million ADSs) for the third quarter of 2025.

Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of September 30th, 2025 will enable it to fund its operations through the end of the fourth quarter of 2026.

Number of Issued and Outstanding Shares:. As of September 30, 2025, the company had 492,409,320 Ordinary shares issued and outstanding (equal to 6,155,117 ADSs), compared to 377,132,220 Ordinary shares issued and outstanding (equal to 4,714,153 ADSs) as of December 31, 2024.

(Press release, Chemomab, NOV 20, 2025, View Source [SID1234660843])

On November 20, 2025 Amplia Therapeutics Limited (ASX: ATX; OTCQB: INNMF), referred to as "Amplia" or "the Company," reported it has received positive feedback from the US Food and Drug Administration (FDA) in response to questions posed by the Company as part of a recent Type D meeting.

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The Company received a positive response to the Type D questions around the dose optimisation strategy for narmafotinib in the proposed registration-enabling Phase 2b/3 trial which will investigate the combination of the Company’s lead compound, narmafotinib, in combination with gemcitabine and Abraxane in pancreatic cancer. The FDA’s response gives confidence in meeting current projected timelines for the Phase 2b/3 study planned to commence in late 2026. The full protocol will now be prepared for submission for FDA comment in H1 2026.

Dr Chris Burns, CEO and Managing Director of Amplia, commented, "FDA’s response supports the dose comparison design of the Phase 2b portion of this trial prior to the pivotal Phase 3 stage. We see this as a positive outcome as the changes proposed will have minimal impact to the trial timeline. This feedback also allows us to better plan the trial, and a full protocol will now be drafted for FDA comment in H1 2026."

A Type D meeting is a formal interaction with the FDA that allows companies to obtain focused feedback on specific regulatory questions outside of a standard review cycle.

(Press release, Amplia Therapeutics, NOV 20, 2025, View Source [SID1234660097])

On November 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Nippon Shinyaku Co., Ltd. (TOKYO: 4516) reported that the electronic package insert for the anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] has been revised to allow combination therapy with the anti-cancer agent/BCL-2 inhibitor Venclexta Tablets 10 mg, 50 mg, and 100 mg [generic name: venetoclax] for previously untreated CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma).

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This revision of the electronic package insert is based on the results of clinical studies evaluating the efficacy and safety of combination therapy with venetoclax and obinutuzumab for previously untreated chronic lymphocytic leukemia (including small lymphocytic lymphoma). These include a Japanese Phase II clinical study (M20-353) conducted by AbbVie GK and a global Phase III clinical study (CLL14/BO25323) conducted by Roche in cooperation with AbbVie Inc. and the German CLL Study Group from the University of Cologne.

Approval Information *Excerpt of relevant sections; underlined portions indicate changes

Before Revision After Revision
7. Precautions Concerning Dosage and Administration

7.1-7.2 (Omitted)

7.3-7.5 (Omitted)

7.6 Initiate administration of this product after 28 days of acalabrutinib treatment.

7.7-7.8 (Omitted) 7. Precautions Concerning Dosage and Administration

7.1-7.2 (Omitted)

7.3-7.5 (Omitted)

7.6 When used in combination with acalabrutinib, initiate administration of this product after 28 days of acalabrutinib treatment.
7.7-7.8 (Omitted)
7.9 For dosage and administration when used in combination with venetoclax, refer to the electronic package insert for venetoclax.
About the Japanese Phase II Clinical Study (M20-353)1
M20-353 study is an uncontrolled, open-label Japanese Phase II clinical study to evaluate the efficacy and safety of venetoclax in combination with obinutuzumab and venetoclax in combination with ibrutinib in Japanese patients with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The primary endpoint was the rate of complete response (CR) and complete response with incomplete bone marrow recovery (CRi) as assessed by an Independent Review Committee (IRC).

About the Global Phase III Clinical Study (CLL14 Study, BO25323)2
CLL14 Study (BO25323) is a multicenter, randomized, open-label global Phase III clinical study comparing venetoclax in combination with obinutuzumab versus obinutuzumab in combination with chlorambucil (not approved in Japan) in patients with treatment-naïve CLL. The primary endpoint was progression-free survival (PFS) as assessed by investigators.

About Gazyva (obinutuzumab)3
Gazyva is a glycoengineered type II anti-CD20 monoclonal antibody designed to bind to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva is designed to attack and destroy targeted B cells both directly and together with the body’s immune system. Chugai and Nippon Shinyaku jointly develop and market the product in Japan.

About Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
In CLL, blood stem cells in the bone marrow become excessive abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets4. This could result in anemia, infection, and bleeding. SLL is the same type of cancer as CLL. When lymphocytes are not located in the peripheral blood or bone marrow, the disease is called SLL5. CLL/SLL is a rare type of lymphoma accounting for less than one case in 100,000 population annually in Japan.

(Press release, Chugai, NOV 20, 2025, View Source [SID1234660844])