ABL Bio, Inc.

The ESMO Gastrointestinal Cancers Congress to be held July 2-5 in BarcelonaROCKVILLE, Md., April 30, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that an abstract for a combination study of givastomig plus nivolumab and chemotherapy has been accepted for a mini-oral presentation at the ESMO Gastrointestinal Cancers Congress 2025, which will be held July 2-5 in Barcelona, Spain. “We are very pleased to receive confirmation that new clinical data for givastomig has been accepted as an oral presentation at the upcoming ESMO Gastrointestinal Cancers Congress 2025. As more information becomes available from the conference, we look forward to providing further details about the presentation,” said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (“CLDN18.2”)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (“1L”) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential combined effect of proximal interaction between CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. The Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment is progressing well in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data. 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. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. I-Mab has established operations in the U.S. in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn and X. I-Mab Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company’s pipeline and clinical development of I-Mab’s drug candidates, including givastomig; the projected advancement of the Company’s portfolio and anticipated milestones and related timing; the Company’s expectations regarding the impact of data from ongoing and future clinical trials the timing and progress of studies and trials (including with respect to patient enrollment); the potential benefits of givastomig; and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the “Risk Factors” section in I-Mab’s annual report on Form 20-F filed with the SEC on April 3, 2025, as well as the discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media Contacts PJ KelleherLifeSci Advisors+1-617-430-7579pkelleher@lifesciadvisors.comIR@imabbio.com

The recommendation builds on the committee’s June 2024 vote for the use of RSV vaccines for people aged 60 to 74 at high risk. Credit: MargJohnsonVA/Shutterstock. The US Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of respiratory syncytial virus (RSV) vaccines, including GSK’s adjuvanted Arexvy, for use in the adult population between the ages of 50 and 59 who are at higher risk for severe disease. This group includes individuals with asthma, heart disease, diabetes and chronic obstructive pulmonary disease (COPD) and those in residential care. People with these conditions are more susceptible to severe outcomes from RSV, which can lead to hospitalisation, pneumonia and even mortality. The recommendation builds on the committee’s June 2024 vote for the use of RSV vaccines for people aged 60 to 74 at high risk and all those aged 75 and above. ACIP’s decision was influenced by the outcomes from a Phase III trial that assessed the safety and immune response of the RSV vaccine in the 50 to 59 age group, particularly in those with high risk for RSV lower respiratory tract disease (RSV-LRTD) due to certain medical conditions. The vaccine has shown efficacy from a single dose in those aged 60 and above. Once approved, the committee’s recommendations will guide healthcare providers on the vaccine’s appropriate usage and notify insurance coverage decisions. GSK chief scientific officer Tony Wood stated: “We are pleased with ACIP’s recommendation to expand the benefits of RSV immunisation to more than 13 million adults aged 50 to 59 who are at increased risk for the severe consequences of this virus. “RSV can have a significant impact on those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination.” The adjuvanted RSV vaccine combines recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3) with the company’s AS01 E adjuvant. It is already approved to prevent RSV-LRTD in individuals aged 60 and older in 61 countries and regions, including the US, Japan and Europe. ABL Bio previously entered into a global licensing agreement with GSK to develop treatments for neurodegenerative diseases.

Welcome back to Endpoints Weekly! This week’s recap kicks off with Andrew Dunn’s examination of the biotech playbook for surviving market turmoil. As former Alnylam CEO John Maraganore put it, recent events have “put biotech CEOs in a very difficult set of shoes compared to what we’ve had to deal with in the past.” See below for more details on how companies might handle the uncertainty. Meanwhile, our reporters tracked news on potential pharma-specific tariffs, which President Donald Trump said would be arriving “very shortly.” And a congressional commission is pushing for a big investment in the biotechnology sector to keep up with Chinese competition. If you’ve got a bit of downtime this weekend, grab a cup of tea and peruse our handful of Q&As out this week, including conversations with GLP-1 co-discoverer Jens Juul Holst, gene editing pioneer David Liu and Leerink Partners senior managing director David Risinger. See you on Monday! — Nicole DeFeudis It’s a tough market for biotech companies, but the sector has been here before. Endpoints News’ Andrew Dunn reports that the playbook remains largely the same. Take a look here at the 10 moves Dunn said biotech CEOs are likely considering, including: 🪓 Buckle down and extend the cash runway: Drug programs on the chopping block can be out-licensed or spun into new subsidiaries. Or they may be ultimately shut down. The goal is to extend cash to make it through to catalysts for the most promising drug programs, Dunn reports. 💰 Selling royalty rights: For biopharmas with a potential approved drug in sight, royalty deals can raise capital without diluting shareholders. But they give away a chunk of future upside. 🤝 Pharma partnerships: They bring in cash, keep research going, and provide a credibility boost. But as former Vertex Pharmaceuticals CEO Joshua Boger told Dunn over a year ago: “Realize they’re going to be painful, it’s going to be horrible, and you need to do it.” Read the whole playbook here. And click here for more insight from Drew Armstrong and Max Bayer’s Q&A this week with Leerink Partners senior managing director David Risinger. “In a typical financial crisis, corporations have to think about their cash flows and balance sheets,” Risinger said. “But then the FDA-specific turmoil that is happening really makes it difficult for corporations to plan for the future.” 🌎 Much of the world got a reprieve from President Donald Trump’s tariffs this week. But the president said earlier in the week that pharma-specific tariffs would be arriving “very shortly.” Analysts weighed in on what a potential rollout could look like here. “We’re going to tariff our pharmaceuticals and once we do that, they’re going to come rushing back into our country,” Trump said at a National Republican Congressional Committee event. Trump has previously praised companies like Eli Lilly , Johnson & Johnson and Merck for boosting their US footprint. All three companies have announced multibillion-dollar investments to build or expand US factories. On Thursday, Swiss-based Novartis said it would invest $23 billion in American manufacturing and R&D over the next five years. A Novartis spokesperson declined to clarify how much of the $23 billion investment had already been planned or disclosed. Meanwhile, the European Federation of Pharmaceutical Industries and Associations warned of a potential “exodus” to the US. The group said in a statement on Tuesday that “unless Europe delivers rapid, radical policy change then pharmaceutical research, development and manufacturing is increasingly likely to be directed towards the US.” It called for “immediate action” on several fronts, including strengthening intellectual property provisions and “adopting a world leading regulatory framework conducive to innovation.” 💸 Amid the burgeoning trade war with China, a Congressional commission is looking to find a way for American biotechs to remain competitive. This week, the National Security Commission on Emerging Biotechnology — which is made up of members from both chambers of Congress as well as civilian experts — urged a $15 billion investment in the sector to keep up with Chinese competition. The timing comes amid cuts across the federal government, including at HHS, which laid out plans last month to cut thousands of employees. Sen. Todd Young (R-IN) recognized “the fiscal challenges associated with persuading colleagues to add new priorities to the list.” But he said the focus should be on setting the right priorities without needing to “fund everything.” This week’s recommendation echoes efforts of the Biosecure Act, a bill introduced last year. The legislation sought to ban US reliance on suppliers like WuXi AppTec, but didn’t eventually become law. Unlike the Biosecure Act, the commission’s report does not name specific Chinese companies. 💰 Merida Biosciences emerged from stealth this week with $121 million in its pockets . Their goal? Create and develop new medications for autoimmune diseases and allergies, with an initial focus in experimental drugs for a thyroid condition called Graves disease, food allergy and primary membranous nephropathy, an autoimmune kidney disease. Beating Xolair will be a challenge and may take years. Last year, the Roche and Novartis drug racked up $4.4 billion in sales, and other companies have tried to crack food allergy before. But CEO Adam Townsend thinks food allergy can be Merida’s “gateway into showing our science and how it works there.” 💬 Q&As with industry and academic thought leaders filled Endpoints’ newsletters this week, and what better way to start your weekend than by reading what they had to say? Elizabeth Cairns sat down with GLP-1 co-discoverer Jens Juul Holst to discuss the future of incretin-based drugs, and Ryan Cross had a conversation with gene editing pioneer David Liu about the economic and political turmoil in science. Both came from the sidelines of the Breakthrough Prizes in Life Sciences, also known as the “Oscars of Science.” We hope you enjoy.