Galectin Therapeutics, Inc.

BOSTON, MASSACHUSETTS, January 10, 2025 -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat viral diseases, fibrosis, stroke, dementia, and Alzheimer's disease, announced its preprint article titled “Immune Checkpoint Inhibitors (ICI): Prospects for Galectin-3 Modulation to Increase Objective Response Rate (ORR) and Remission-free Survival in Oncology Patients” (the “Article”) authored by Dr. Adesuyi Ajayi, Dr. David Platt, and Andrew Blumenthal. The preprint reviews detailed theories regarding the resistance to ICI therapy and how galectin-3 contributes to resistance. Immune Checkpoint Inhibitors (ICI): Prospects for Galectin-3 Modulation to Increase Objective Response Rate (ORR) and Remission-free Survival in Oncology Patients http://dx.doi.org/10.13140/RG.2.2.31077.31202 The Article discusses the potential of immune checkpoint inhibitors (ICIs) in cancer treatment and explores how galectin-3 modulation might enhance ICI effectiveness. It highlights the importance of overcoming resistance to ICIs and improving patient outcomes by targeting galectin-3, which could increase the objective response rate (ORR) and remission-free survival in oncology patients. Galectin-3 is also a powerful predictive biomarker of ICI failure in Non-Small Cell Lung Cancer (NSCLC) where 90% of patients with high galectin-3 levels failed to see their cancer shrink after 3 treatments. The Article also determined that low to moderate galectin-3 expression in the tumor correlated strongly with a positive response to ICI therapy. ICI resistance due to galectin-3 in the tumor microenvironment is also due to the galectin-3 glycoprotein occupying the antibody’s PD-1 receptor binding site. This was confirmed by Surface Plasmon Resonance (a technique used to study the interactions between molecules by detecting changes in the refractive index near a sensor surface) - and cyrogenic electron microscopy. The galectin-3 protein binds in such a way that it prevents ICI’s from binding to PD-1. This leaves the receptor open to PD-L1 binding which switches off the T-Cells. In vitro tests show that galectin-3 antagonists could reverse this effect. The Company also published its cancer metastasis presentation titled “Galectin Antagonists in Cancer.” The presentation goes over the various ways that cancer tricks the immune system and the current modalities being used to fight cancer. The “Galectin Effect” was highlighted as cancers primary defense mechanism to downregulate and cloak the cancer from immune response. Shortcomings in current treatments are addressed as well as innovative approaches to address the deficiencies. The heart of the presentation shows that galectins play a key role in the tumor microenvironment, promoting tumor growth, metastasis, and immune suppression. Galectin antagonists may hold the key to overcoming these effects and improve efficacy of other cancer treatments. Galectin Antagonists in Cancer https://tinyurl.com/bdcth9j2 "The magnitude of this breakthrough in cancer research cannot be overstated," said Dr. David Platt, CEO of Bioxytran Inc. "Our findings herald a significant shift in cancer treatment paradigms. We've developed a robust theory of cancer and metastasis, identifying Galectin-3 as a pivotal driver of disease progression. This finding elucidates the variable responses in immunotherapy and the development of resistance in other cancer treatments. With over 4,000 peer-reviewed articles examining the role of galectins in cancer, one consensus is clear: they must be inhibited. Our team has synthesized this extensive body of research into the core insights presented in our preprint and cancer presentation. The data unequivocally supports the finding that combining galectin-3 antagonists can significantly enhance treatment response rates." About Bioxytran, Inc. Bioxytran, Inc. is a clinical stage biotechnology company pioneering a library of novel complex carbohydrate structures using artificial intelligence software that interprets the Nuclear Magnetic Resonance imaging of druggable targets like the galectin fold to create a rational drug design. The leading drug candidates vetted by in vitro testing, are capable of neutralizing viruses. The peer-reviewed discovery of the galectin fold located on the spike proteins of viruses such as COVID-19, RSV, and H1N1 demonstrate there exists a conserved region on the spike in which Bioxytran’s molecules achieve virus neutralization. The extent of the carbohydrate structure’s ability to neutralize untested viruses is unknown just like the initial discovery of antibiotics last century and its ability to treat a broad spectrum of bacterial infections. Applications of this platform technology extend to the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. The leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. Bioxytran’s other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at www.bioxytraninc.com Investor Relations Michael Sheikh 509-991-0245 mike.sheikh@bioxytraninc.com Forward-Looking Statements This press release includes forward-looking statements as defined under federal law, including those related to the performance of technology described in this press release. These forward-looking statements are generally identified by the words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements contain these identifying words. Such statements are subject to significant risks, assumptions and uncertainties. Known material factors that could cause Bioxytran’s actual results to differ materially from the results contemplated by such forward-looking statements are described in the forward-looking statements and risk factors in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and those risk factors set forth from time-to-time in other filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except to the extent required under federal securities laws. ‍

Since Galectin Therapeutics shared phase 3 data this morning, its stock has dropped 54% from $2 per share to 92 cents.\n Galectin Therapeutics’ stock has halved since the company revealed its investigational drug failed to significantly reduce enlarged veins for people with liver scarring.Since the biotech shared the phase 3 data this morning, the company’s stock has dropped 54%, from $2 per share to 92 cents.The data center around belapectin, a new chemical entity designed to target extracellular galectins, which are carbohydrate-binding proteins involved in many bodily functions. Galectin tested the candidate out in a late-stage trial, dubbed NAVIGATE, that enrolled 355 patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.Patients were randomized to one of three groups: In one arm, individuals received 2 mg of belapectin for each kilogram of lean body mass; another cohort of patients received 4 mg belapectin per kilogram; and the last arm received placebo. All received their assigned treatment every other week for 18 months.The trial’s primary endpoint was preventing varices, which are swollen veins in the esophagus. Galectin measured the endpoint as a combined clinical outcome that included patients with any varices, those with intercurrent events, or patients without an endoscopy or intercurrent events at 18 months. While Galectin found that esophageal varices incidence dropped for patients in both the 2-mg/kg and 4-mg/kg groups, the composite endpoint failed to hit statistical significance.    “I am encouraged by the results demonstrating an approximately 49% reduction in the development of varices in patients with MASH cirrhosis with the previously studied belapectin dose of 2 mg in such a large, global trial,” Naim Alkhouri, M.D., chief medical officer and director of the steatotic liver program at Arizona Liver Health, said in a Dec. 20 release. “I believe the results warrant further clinical development as belapectin could become a pivotal therapeutic option for these patients that currently do not have any treatment options.”Belapectin was overall well tolerated, with a similar rate of adverse events and serious adverse events across treatment and placebo groups, according to Galectin.“All enrolled subjects transitioned into a 36-month treatment period, with approximately 50 subjects completing the full 36 months to date,” Galectin Chief Medical Officer Khurram Jamil, M.D., said in the release. “We are still analyzing the extensive data from the trial and anticipate providing multiple clinical updates from the subjects completing 36-month therapy, as well as additional biomarker data in Q1 2025.”The company plans to speak with potential pharma partners and medical experts to figure out the next steps for the investigational drug, Galectin CEO Joel Lewis said in the release.

Plus, news about Pyxis, Epitopea and Genevant: Idorsia’s deal for blood pressure drug hits snag: The Swiss company said negotiations with an unnamed party for global rights to Tryvio are unlikely to end this year. Idorsia is looking at strategies to stretch its cash reserves until the deal is signed. Last month, the drugmaker announced plans for 270 potential layoffs. Its share price was down almost 50% on Friday. Galectin’s liver drug fails late-stage test: The biotech’s belapectin did not significantly reduce the development of enlarged blood vessels in people with cirrhosis and portal hypertension due to metabolic dysfunction-associated steatohepatitis, or MASH, in the placebo-controlled Phase 2/3 NAVIGATE trial. Galectin said it is analyzing the data to determine next steps. Its share price $GALT plummeted 47% at market open Friday. Pyxis doubles down on lead cancer program: The Boston biotech is stopping development of its monoclonal antibody PYX-106 to focus its resources on an ADC candidate dubbed PYX-201. This Phase 1 asset achieved a 50% objective response rate and a 100% disease control rate in a handful of head and neck cancer patients in November. Epitopea, Genevant ink cancer therapy pact: Epitopea will use Genevant’s lipid nanoparticle technology to develop RNA-based immunotherapies targeting certain proprietary tumor-specific antigens. The Canadian biotech could get up to $123.5 million in upfront and milestone fees for each product it makes with Epitopea.