I-Mab Announces Intention to Undertake Strategic Transformation to Global Biotech Platform, to Pursue Hong Kong IPO, and Rebrand as NovaBridge Biosciences

On October 16, 2025 I-Mab (NASDAQ: IMAB) (I-Mab or the Company), is a global biotechnology platform company committed to accelerating access to innovative medicines for patients worldwide, reported its new business model, focused on its global capabilities built to accelerate access to innovative medicines and to enable broad strategic growth. The Company announced its intention to pursue a Hong Kong IPO through dual listing on NASDAQ and Hong Kong Stock Exchange (HKEX). The Company intends to operate under the new name of NovaBridge Biosciences.

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The Company also announced the pending acquisition of VIS-101, a novel bifunctional biologic targeting VEGF-A and ANG2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) than current standard of care. The pending acquisition will be made by a newly formed subsidiary, Visara, Inc. (Visara), a clinical-stage biopharmaceutical company focused on developing ophthalmic therapeutics for serious eye disorders, and is expected to be completed later this month.

In addition, the Company reaffirmed its previously announced givastomig investment plans as part of its new strategy.

Mr. Kyler Lei has been named Chief Financial Officer (CFO) of I-Mab, bringing significant expertise in the Hong Kong and global capital markets.

The Company sees a significant growth potential from the Asia Pacific originated biopharma innovations. Confidence in this opportunity comes from emerging trends showing that the Asia Pacific region has generated more than 30% of global biopharma assets under development, and has achieved more than $80B in deal value through collaborations with leading multi-national pharmaceutical organizations. In addition, the Asia Pacific biopharmaceutical ecosystem has become increasingly agile and efficient, with significantly lower clinical trial costs and faster patient enrollment than the global median, while maintaining high quality standards1.

"We believe we are entering a new era of rapid growth in the global biotech economy, driven by greater innovation capability in China and Asia and a resurgence of investment in high growth international markets across Asia. With our new business model, we are uniquely positioned to strategically create significant value for patients and investors," said Mr. Fu Wei, Executive Chairman of I-Mab. "Through the strategic insight of our expanded Board, backing by CBC Group,

Asia’s largest dedicated healthcare asset management firm, and our dual listing strategy, I-Mab is ideally placed to partner with leading global innovators to identify and accelerate high-value assets. The proposed dual listing on both NASDAQ and HKEX is a key element of our global growth strategy. This move will enable us to broaden and diversify our investor base, and enhance trading liquidity and access to capital, while strengthening our presence with key stakeholders in the rapidly growing Asian market."

"2025 has been a time of significant progress for I-Mab. Presentation of compelling Phase 1b givastomig combination data reinforced our confidence in its potential to be a best-in-class Claudin 18.2-directed therapy for gastric cancer and drove our plans to initiate a global randomized Phase 2 study, expected to begin in Q1 2026. In addition, the Company recently secured additional capital, and has attracted seasoned biotech executives to the Board of Directors and Scientific Advisory Board," said Sean Fu, PhD, Chief Executive Officer (CEO) of I-Mab. "With the strong foundation from our work on givastomig, and excellent progress this year, we are optimistic about moving forward with our new strategy. Our new global platform allows us to uphold our commitment to value creation by realizing the full potential of innovative medicines and improving the lives of patients."

The NovaBridge Business Model and Pipeline

The Company intends to partner with leading innovators to identify and accelerate high-value assets. Our model integrates rigorous asset selection, bespoke translational strategies, and efficient clinical execution. With the backing of CBC Group, we leverage deep local insights and global capabilities to develop the most promising drug candidates across a range of therapeutic categories.

The Company will utilize a "hub-and-spoke" model to create and advance specialized subsidiary companies (spokes) which maintain operational focus and agility. By focusing each spoke on a specific asset or therapeutic area, the Company can optimally manage risk and create value through potential partnering transactions.

Pipeline:


Givastomig, a potential best-in-class Claudin 18.2 X 4-1BB bispecific antibody, is in Phase 1b clinical trials for the potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. A global, randomized Phase 2 study is planned, with the enrollment of the first patient targeted in Q1 2026. Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

Ragistomig is an anti-PD-L1 X 4-1BB bispecific antibody. Built on Phase 1 clinical data, an ongoing Phase 1b study designed to expand the therapeutic index is expected to yield results in 2H 2026. The program is being jointly developed with ABL Bio.

Uliledlimab targets CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Progression free survival (PFS) data are expected in 2H 2026 from an ongoing randomized Phase 2 trial evaluating uliledlimab + toripalimab compared to pembrolizumab alone or toripalimab alone. I-Mab owns worldwide rights to uliledlimab outside of Greater China.
VIS-101, to be acquired by Visara, a newly formed I-Mab subsidiary, under the new business model, is a bifunctional biologic targeting VEGF-A and ANG2, currently in Phase 2 development


VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet AMD, DME, and retinal vein occlusion (RVO) than current standard of care. VIS-101 has completed initial safety and dose-escalation studies in both the US and China, and is currently completing a randomized, dose-ranging Phase 2 study in China. VIS-101 is anticipated to be Phase 3-ready in 2026.

Acquisition will be completed by a newly formed subsidiary, Visara. Visara, a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics, will be launched with an approximately $37M capital infusion from I-Mab and the contribution of certain rights by AffaMed Therapeutics (HK) Limited. The capital contributions to Visara and its acquisition of VS-101 (collectively, the Transactions) are cross-conditioned, and are expected to close later this month. The Company has also signed a separate termsheet with Everest Medicines (HKEX 1952.HK) to potentially out-license greater China rights for VIS-101 and collaborate on global clinical development. Following completion of the Transactions, I-Mab will be the majority shareholder of Visara, and Visara will control global rights to VS-101.

Visara is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH. Dr. Cunningham has been a physician, innovator, entrepreneur, and investor for more than 25 years, formerly serving as Senior Managing Director at Blackstone Group L.P. and Managing Director at Clarus Ventures, LLC. Dr. Cunningham is also an internationally recognized specialist in infectious and inflammatory eye disease with over 450 co-authored publications.
"VIS-101 is anticipated to be second-in-class with best-in-class potential, based on bioengineered, superior target neutralizing capabilities," said Dr. Cunningham, Co-Founder and Executive Chairman of Visara. "Leveraging the speed, quality, and unique advantages of dedicated teams in North America and Asia, Visara will seek accelerated global clinical development and regulatory approvals."

Organizational Overview

The Company will build on the strength of the I-Mab Board, led by Mr. Fu Wei, Executive Chairman, including the expanded Scientific Advisory Board and new Research and Development Committee. The Executive Leadership Team will include Sean Fu, PhD, Chief Executive Officer; Phillip Dennis, MD, PhD, Chief Medical Officer; Kyler Lei, Chief Financial Officer; and Claire Xu, MD, PhD, Senior Vice President, Clinical Development.

Kyler Lei has been appointed as the Chief Financial Officer of I-Mab, effective October 16, 2025. Kyler is a global capital markets and investor relations professional with extensive experience in healthcare, equity research, corporate communications, corporate finance and strategy. Kyler will be primarily responsible for overseeing overall financial strategy and management, corporate finance and capital markets, corporate development and operations. Prior to joining I-Mab, Kyler served as Deputy General Manager and Head of Capital Markets at Sino Biopharmaceutical Limited (HKEX: 1177.HK).

"I am enthusiastic about starting on this new chapter with Kyler, and leveraging his expertise in global capital markets and financial strategy to make our new business model a resounding success," said Dr. Fu, CEO.

Dr. Fu added, "I would like to extend our gratitude to Joseph Skelton for his tremendous contributions in shaping I-Mab’s success. We wish him all the best in his future endeavors."

Business Update Webinar

The Company will review its new business model, strategic focus and upcoming milestones by webcast on Thursday, October 16, 2025, and Friday, October 17, 2025

Webcast and Conference Call Details:

In English:


Date: Thursday, October 16, 2025

Time: 5:00 PM ET

Dial-in number (US): 1-877-407-0784

Dial-in number (International): 1-201-689-8560

Webcast info: please click here
In Chinese:


Date: Friday, October 17, 2025

Time: 5:00 PM HKT/5:00 AM ET


Webcast info: please click here, and note Kyler Lei as the CLSA contact
A replay of the webinar will be accessible on the Events page of the Company website for 90 days.

(Press release, I-Mab Biopharma, OCT 16, 2025, View Source [SID1234656702])

Tempus Announces Collaboration with Whitehawk Therapeutics to Advance Biomarker-Driven Oncology Research

On October 16, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported a multi-year collaboration with Whitehawk Therapeutics, Inc. (NASDAQ: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugates (ADC) cancer treatments. The collaboration aims to leverage Tempus’ proprietary real-world dataset to advance biomarker-driven research and support the development of Whitehawk Therapeutics’ oncology pipeline.

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Under the agreement, Whitehawk Therapeutics will apply Tempus’ de-identified multimodal database to support the biotech’s clinical trial designs by focusing on the right patient population(s) with the highest level of demonstrated real-world unmet need. The collaboration will center on powering research spanning Whitehawk Therapeutics’ ADC portfolio, which includes three assets designed to target clinically validated proteins (PTK7, MUC16 and SEZ6) that are broadly expressed in high-potential cancer indications, such as lung and gynecological cancers.

"Tempus’ comprehensive, multimodal data, paired with Whitehawk’s ADC drug development expertise, create a powerful foundation to validate the potential of their portfolio in a promising class of targeted cancer therapeutics," said Ryan Fukushima, Chief Operating Officer at Tempus. "We’re committed to working in tandem with our biotech collaborators to uncover actionable insights from our AI platform so they can make smarter, faster decisions throughout the drug development process."

"A proactive approach to our biomarker strategy ensures our programs are guided by data-driven insights," said Dave Lennon, PhD, President and CEO, Whitehawk Therapeutics. "By partnering with Tempus, our goal is to better understand the expression of our ADC protein targets to inform indication prioritization for our clinical development programs and better exploit the full potential of our pipeline. An important aspect of this partnership will be continuing to establish the concordance between RNA and IHC expression of our targets. Because RNA testing is objective, reproducible and scalable, establishing it as a reliable alternative to the more subjective IHC methods could enhance our ability to readily identify appropriate patients for our ADC therapies."

(Press release, Tempus, OCT 16, 2025, View Source [SID1234656721])

Iterion to present at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 16, 2025 Iterion reported to present new data on Tegavivint at the upcoming AACR (Free AACR Whitepaper)–NCI–EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), October 22–25 in Boston.

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Our Chief Scientific Officer, Stephen Horrigan, and Senior Director of Translational Research and Non-Clinical Development, Aundrietta Duncan, will share findings highlighting Tegavivint’s first-in-class mechanism and activity in advanced hepatocellular carcinoma (aHCC).

Tegavivint, the most advanced Wnt/β-catenin inhibitor in clinical development, targets TBL1, leading to degradation of nuclear β-catenin and inhibition of Wnt-driven oncogenic transcription. This novel approach has shown excellent tolerability and encouraging clinical activity in an ongoing Phase 1/2 aHCC trial.

📍 Poster Details
Title: Activity of Tegavivint in Hepatocellular Carcinoma with Aberrant Wnt/β-catenin Signaling and Evaluation of Biomarker Response
Date & Time: Friday, October 24, 2025 | 12:30 – 4:00 PM
Session: Poster Session B
Poster #: B135

(Press release, Iterion Therapeutics, OCT 16, 2025, View Source [SID1234656703])

bioAffinity Technologies Announces Notification of Allowance for U.S. Patent Application for Its Diagnostic Algorithm and Test Method for Lung Cancer

On October 16, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported it has received a notification of allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the AI-built algorithm and flow cytometry platform that analyzes cell populations in sputum leading to detection of lung cancer.

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"Artificial intelligence was integral to the development of our CyPath Lung test and has resulted in the detection of lung cancer at its earliest Stage 1A, a potentially curative stage," said Maria Zannes, President and CEO of bioAffinity Technologies. "A quarter of a million Americans are expected to receive a lung cancer diagnosis in 2025, representing the leading cause of cancer death. Harnessing AI with our novel flow cytometry platform has resulted in a diagnostic that produces high-precision, standardized, data-driven results."

The patent, titled "Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning," covers a system and method for predicting the likelihood of lung cancer by analyzing patient sputum samples. CyPath Lung’s advanced flow cytometry process detects changes in the lung linked to cancer, including populations of immune cells, apoptotic cells and cancer and cancer-related cells labeled by the Company’s proprietary TCPP porphyrin. CyPath Lung’s AI-driven analysis combines these variables with patient age to predict cancer in the lung.

CyPath Lung can be utilized by physicians to determine next steps for patients with pulmonary nodules requiring follow-up. The noninvasive test is designed to perform with high sensitivity and specificity and seeks to deliver valuable diagnostic insight while alleviating patient anxiety, preventing unnecessary invasive procedures and reducing costs to the healthcare system.

This newly allowed U.S. patent complements bioAffinity’s expanding global patent estate, which now includes 18 awarded and 33 pending patents. bioAffinity Technologies holds patents in the U.S., Canada, China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden, and the United Kingdom.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

(Press release, BioAffinity Technologies, OCT 16, 2025, View Source [SID1234656722])

ME THERAPEUTICS GRANTED LICENCE FOR CD22 NANOBODY ASSET TO EXPAND NEXT-GEN IN VIVO CAR CELL THERAPY PROGRAM

On October 16, 2025 ME Therapeutics Holdings Inc. ("ME Therapeutics" or the "Company") (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company working on novel cancer-fighting drugs in the field of immuno-oncology, reported its subsidiary, ME Therapeutics Inc., has entered into a technology license agreement dated October 15, 2025 (the "License Agreement") with the National Research Council of Canada (NRC) to license the NRC’s proprietary nanobody-based CD22 binder pursuant to the terms and conditions of the License Agreement (the "License").

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The licence gives ME Therapeutics exclusive commercial rights to the nanobody-based CD22 binder for use in Chimeric Antigen Receptor (CAR) therapy, including in vivo CAR-T and myeloid CAR (CAR-M) approaches.

"As a Canadian-owned company, we are honoured to advance this home-grown nanobody asset as part of our in vivo CAR cell therapy program," said Salim Dhanji, CEO of ME Therapeutics. "This milestone strengthens our commitment to develop innovative immuno-oncology candidates, including next-generation CAR therapies that can reprogram immune cells in the tumour microenvironment using advanced nanobody technology. We look forward to working with partners to bring these potentially life-saving treatments to cancer patients with currently limited options."

CD22 expression is often maintained in relapsed B-cell cancers following CD19 CAR-T therapy. By leveraging nanobody technology, the NRC’s CD22 binder offers potential advantages in stability, synthesis, and design flexibility compared to traditional antibody formats. Through in vivo CAR-M and CAR-T approaches, the binder provides an opportunity for novel approaches to treat patients with relapsed/refractory disease or as part of a first-line treatment.

"We are pleased to license this Canadian-made, publicly-owned nanobody-based CD22 binder to a Canadian company for use in next-generation CAR applications," says Sue Twine, Director General of the NRC’s Human Health Therapeutics Research Centre. "This technology was developed through years of dedicated NRC research, with support from our Cell and Gene Therapy Challenge program. It is a compelling example of publicly funded research enabling innovative next generation tools that can support development of affordable, cutting-edge treatments for Canadian patients."

The nanobody-based CD22 binder is currently being evaluated as part of an autologous CAR-T therapy in an investigator-driven Phase 1 clinical trial (NCT06208735) to assess safety and efficacy in pediatric and adult patients.

The Licence has been granted to the Company pursuant to the terms of the Licence Agreement in Australia, Brazil, Canada, China, Europe, India, Israel, Japan, New Zealand, Singapore, South Korea, and the United States (collectively the "Territory") for applications of the technology in these regions within the authorized field of use, which is CAR therapy. The rights granted to the Company are exclusive within the field of use for autologous CAR cell therapy products in the Territory (except in Canada) and exclusive in all jurisdictions of the Territory for any CAR cell therapies other than autologous CAR cell therapy products. The Licence Agreement provides, among other things, that the Company may sub-license its rights under the License Agreement. In consideration for the grant of the Licence, the Company shall pay the NRC an upfront licence fee within 12 months of entry into the License Agreement, and shall pay the NRC the certain royalties as more particularly described in the License Agreement relating to the sale of autologous CAR cell therapy products and sales revenue from the sale of allogeneic or in-vivo CAR cell therapy products, in all cases subject to a minimum yearly royalty subject to the terms and conditions of the License Agreement. In addition, the Company has agreed to make certain milestone payments to the NRC for each product on initiation of dosing in Phase 1 Trials, on initiation of dosing in Phase 2 clinical trials, on initiation of dosing in a registration trial, and on six months after the first regulatory approval of the first product anywhere in the Territory. The Licence shall expire upon the expiry of the last claim of the last patent pursuant to the terms of the License Agreement.

(Press release, ME Therapeutics, OCT 16, 2025, View Source [SID1234656705])