Earle Chiles Research Institute

Completed strategic review to focus on oncology and liver diseases with the acquisition of global rights to GB3226 (formerly BRM-1420), a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of AML from Bridge Medicines GB3226 on track for IND submission in Q1 2026 Phase 2 investigator-initiated trial (IIT) of GB1211 in combination with pembrolizumab (Keytruda®) in metastatic melanoma and head and neck squamous cell carcinoma continues to enroll patients BOSTON, March 19, 2025 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced its operating and financial results for the quarter and year ended December 31, 2024. “A significant moment for Galecto in 2024 was the completion of our strategic review, which solidified our commitment to advancing innovative oncology therapies,” said Dr. Hans Schambye, CEO of Galecto. “The acquisition of global rights to GB3226 provides us with an opportunity to develop a unique approach to AML that has the potential to significantly improve outcomes for the AML patient population. GB3226 has shown strong potential in preclinical studies, showing activity against a range of AML-driving mutations, including those commonly associated with resistance and relapse. With its dual mechanism of action, GB3226 has the potential to provide rapid therapeutic effect via inhibition of FLT3 and promote sustained response through inhibition of ENL-YEATS.” Dr. Schambye continued, “We are focused on moving GB3226 into clinical development as quickly as possible while maintaining our commitment to advancing transformative treatments for cancer and liver diseases. With a strengthened pipeline and a clear strategic focus, we look forward to advancing these promising therapies for patients in need.” 2024 Corporate Highlights Acquired global rights to Bridge Medicines’ BRM-1420 program, now GB3226, a novel dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (AML). GB3226 is a potent and selective inhibitor designed to disrupt key oncogenic pathway signaling. Preclinical data showed GB3226’s superior efficacy to both FLT3 and menin inhibitors in animal models, as well as additive or synergistic activity in combination with standard-of-care treatments. Providence Portland Medical Center’s Earle A. Chiles Research Institute initiated a Phase 2 trial of GB1211 in combination with pembrolizumab (Keytruda®) in metastatic melanoma and head and neck squamous cell carcinoma. Appointed Dr. Amy Wechsler to the Board of Directors. Dr. Wechsler brings strong biotech leadership experience to the Galecto board. Matthew Kronmiller, Bridge Medicine’s Chief Executive Officer, joined Galecto’s management team as the Executive Vice President of Strategy and Chief Business Officer. Full-Year 2024 Financial Results Cash and cash equivalents as of December 31, 2024 were approximately $14.2 million. The Company anticipates that its cash and cash equivalents will be sufficient to fund operating expenses and capital requirements into 2026, including the submission of an investigational new drug application for GB3226 to the FDA. However, the Company will require substantial additional capital to finance its operations, including future clinical development of its GB3226 and GB1211 programs. Research and development expenses were $6.4 million for the year ended December 31, 2024, compared to $23.8 million for the year ended December 31, 2023. The decrease was primarily related to decreased clinical trial-related expenses due to discontinued clinical trial activities, decreased chemistry, manufacturing, and control ("CMC") activities, decreased personnel costs, and decreased consulting related costs and other research and development costs. Acquired in-process research and development costs were $4.4 million for the year ended December 31, 2024. These costs related to an asset purchase with Bridge Medicines pursuant to which we acquired global rights to Bridge Medicines’ BRM-1420 program. There were no acquired in-process research and development costs for the year ended December 31, 2023. General and administrative expenses were $10.5 million for the year ended December 31, 2024, compared to $12.7 million for the year ended December 31, 2023. The decrease was primarily related to decreased personnel costs and decreased other general and administrative costs. Net loss attributable to common stockholders for the year ended December 31, 2024, was $21.4 million or $(18.53) per basic and diluted share, compared with $38.3 million, or $(36.08) per basic and diluted share, for the prior year period. About Galecto Galecto is a clinical-stage biopharmaceutical company committed to realizing the promise of novel treatments for cancer and liver diseases. The Company’s pipeline consists of first-in-class small molecule drug candidates that target cancer and fibrosis signaling pathways, including (i) a preclinical dual inhibitor of ENL-YEATS and FLT3 (BRM-1420) for multiple genetic subsets of AML; (ii) an orally active galectin-3 inhibitor (GB1211) in combination with a checkpoint inhibitor for various oncology indications; and (iii) an orally active galectin-3 inhibitor (GB1211) for the treatment of liver cirrhosis. Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com. Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Galecto’s preclinical and clinical development plans for GB3226 (formerly BRM-1420) and GB1211; that GB3226 could be additive or synergistic when used in combination with current standard of care therapies; the potential of Galecto’s product candidates to address or transform significant areas of unmet need and improve outcomes for patients; and Galecto’s expectation that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital requirements into 2026. Such forward-looking statements include statements about Galecto’s focus and plans for preclinical and clinical development of its product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on March [19], 2025. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law. For more information, contact: Investors/US Sandya von der Weid svonderweid@lifesciadvisors.com +41 78 680 0538 Source: Galecto, Inc.

- Data demonstrates potential for IO-108 to enhance immune activation and overcome resistance in advanced solid tumors as a monotherapy and in combination with pembrolizumab - PALO ALTO, CA, November 21, 2024 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced the publication of Phase 1 dose-escalation study results of IO-108, its first-in-class antibody targeting LILRB2 (also known as ILT4), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society for Immunotherapy of Cancer (SITC). The paper, entitled “Phase 1 Dose Escalation Study of IO-108, an Anti-LILRB2 Antibody, in Patients with Advanced Solid Tumors,” details the safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamic biomarker results from 25 patients with advanced solid tumors enrolled in a first-in-human study of IO-108 as a monotherapy and in combination with pembrolizumab, an anti-PD-1 antibody. In the IO-108 monotherapy cohort, the overall response rate was 9%, with one patient achieving a durable complete response (CR) for over two years. The CR was observed in a patient with treatment-refractory Merkel cell carcinoma whose prior treatment included two lines of immunotherapy (pembrolizumab, followed by a combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4)). Among 13 efficacy-evaluable patients treated with the combination of IO-108 plus pembrolizumab, 3 patients (2 cholangiocarcinoma and 1 colon cancer, all microsatellite-stable cancer types that typically do not respond to T-cell checkpoint inhibitors) had a partial response (23%). Biomarker analysis revealed pharmacodynamic changes consistent with increased T-cell infiltration in tumors, indicating an activated tumor microenvironment in patients with clinical benefit in both monotherapy and combination therapy. Results also demonstrated that IO-108 was well-tolerated at all dose levels, with no dose-limiting toxicities observed. “The durable responses observed in this heavily pretreated patient population underscore the therapeutic potential of IO-108 as both a monotherapy and in combination with T-cell immune checkpoint inhibitors,” said IO-108 Phase 1 investigator and first author of the paper, Matthew H. Taylor, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. “These findings provide compelling evidence that targeting myeloid-cell immune checkpoint LILRB2 offers a novel and promising approach to cancer treatment.” “We are very proud of our positive data published in the Journal for ImmunoTherapy of Cancer (JITC),” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “Our data suggest that IO-108 could play a pivotal role as a monotherapy and combination therapy with T-cell immune checkpoint inhibitors and support the broader clinical exploration of IO-108 as a versatile therapeutic option for patients with advanced solid tumors.” Immune-Onc is advancing the development of IO-108 in a Phase 1b/2 global, randomized study that is part of Roche’s Morpheus-Liver program. The study will evaluate IO-108 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab, the standard of care in patients with locally advanced, metastatic and/or unresectable liver cancer with no prior systemic treatment. The study’s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival. ABOUT IO-108 IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards the myeloid checkpoint, LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Clinical data from the U.S. Phase 1 dose escalation study of IO-108 (NCT05054348) was presented at the 2023 American Association for Cancer Research annual meeting and demonstrated a favorable safety profile and encouraging clinical benefit utilizing IO-108 as a monotherapy and in combination with anti-PD-1 across multiple tumor types. IO-108 is being studied in several expansion cohorts in adult cancer patients as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab, cemiplimab or tislelizumab). A global, randomized Phase 1b/2 study is underway to evaluate IO-108 in combination with atezolizumab and bevacizumab as a potential first-line therapy for hepatocellular carcinoma (HCC). ABOUT IMMUNE-ONC THERAPEUTICS, INC. Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors. Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs. Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn. MEDIA CONTACT Tara Cooper The Grace Group tara@gracegroup.us media@immuneonc.com 650-303-7306

ST. PAUL, Minn., Oct. 8, 2024 /PRNewswire/ -- ScaleReady™, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady™, today announced that Eric Tran, Ph.D, Associate Member of the Earle A. Chiles Research Institute, a division of the Providence Cancer Institute, has been awarded a G-Rex Grant. Dr. Tran's $200,000 G-Rex Grant will enable process development and IND enabling studies of a novel KRAS-targeted TCR-T cell therapy. "We have utilized G-Rex devices for a long time for our adoptive cell therapy efforts. This G-Rex Grant will substantially defray the costs associated with bringing our next generation TCR-T cell therapy into the clinic and advance the state of our manufacturing," said Dr. Tran "Dr. Tran has been contributing to the field of cell and gene therapy for nearly 15 years and we are grateful for the opportunity to award a G-Rex Grant to Dr. Tran and the Providence Cancer Institute. Providence's G-Rex Grant will help expedite an IND application of their novel KRAS-targeted TCR T-cell therapy to treat a variety of solid tumors in a Phase 1/1b clinical trial," said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. As part of the G-Rex Grant, Dr. Tran plans to optimize their manufacturing process by reducing the process duration and implementing fully-closed system G-Rex bioreactors. Dr. Tran will make use of Bio-Techne's new GMP cytokines that have been right-sized for one-touch G-Rex close process manufacturing, setting the stage for simple and efficient scale out. ScaleReady's G-Rex® Grant Program is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards worth up to $300,000. G-Rex Grant Recipients also gain access to exclusive support from ScaleReady's growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more. About ScaleReady ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 5 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact [email protected]. About Wilson Wolf Manufacturing Wilson Wolf () is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to create hope for cancer patients, one G-Rex® device at a time. About Bio-Techne Corporation Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube. Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 About CellReady LLC CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO) specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies. CellReady's mission is to create hope for cancer patients, one G-Rex® process at a time. About Providence Cancer Institute of Oregon Providence Cancer Institute of Oregon, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnosis, treatment, prevention, education and support. Providence is home to the Earle A. Chiles Research Institute, an internationally renowned leader in the field of cancer immunotherapy since 1993, where investigators lead numerous clinical trials for patients with cancers of the breast, colon, prostate, lung, esophagus, liver, pancreas, head and neck, ovary, skin, blood and other conditions. Learn more at Providence.org/ORcancer. SOURCE Bio-Techne Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED