Simtuzumab

BOSTON, April 28, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the quarter ended March 31, 2023. “Galecto continued to make strong progress with its clinical programs in the first quarter of 2023 and remains on target for several significant milestones this year. We reported exciting preliminary data from our clinical trials that are evaluating our oral galectin-3 inhibitor GB1211 plus atezolizumab for the first-line treatment of non-small cell lung cancer and our LOXL2 inhibitor GB2064 for the treatment of myelofibrosis, which further deepen our confidence in the potential of our pipeline,” said Hans Schambye, President and Chief Executive Officer of Galecto. “The Galecto team is delivering on development plans for our novel therapies, and we continue to expect top-line results from our Phase 2b GALACTIC-1 trial of our lead product GB0139 in idiopathic pulmonary fibrosis this August.” First Quarter and Other Recent Highlights Reported partial response in two patients in the open-label portion (Part A) of the Phase 1b/2a GALLANT-1 trial evaluating GB1211 in combination with atezolizumab for the treatment of non-small cell lung cancer (NSCLC). A partial response is defined by RECIST criteria to be shrinkage of at least 30% of the tumor. One of these patients has been treated with GB1211 200 mg twice daily for 23 weeks, while the other has been treated with GB1211 100 mg twice daily for 14 weeks, and both patients continue to receive active treatment in the trial. Recruitment in Part A of this trial is currently ongoing. Reported data from three additional evaluable myelofibrosis patients in the Phase 2a MYLOX-1 trial with GB2064 for the treatment of myelofibrosis that showed one patient experienced a 1-grade reduction in reticulin fibrosis at nine months and, following an initial increase of collagen fibrosis score of 1 grade at six months, experienced a 1-grade reduction of collagen fibrosis at nine months. In the third quarter of 2022, Galecto announced that four of five evaluable myelofibrosis patients in an intermediate assessment experienced a ≥ 1-grade reduction in collagen fibrosis of the bone marrow, an improvement suggesting that GB2064 could impact the progression of the disease and potentially be disease modifying. Because the trial has exceeded the pre-defined target of a ≥ 1 grade reduction in collagen fibrosis in at least three out of 16 evaluable patients, Galecto believes that MYLOX-1 has reached the dual goal of confirming LOXL2 as an attractive fibrosis target and demonstrating that GB2064 has clinically meaningful antifibrotic activity. Accordingly, Galecto has determined to stop enrolling additional patients in the trial and will continue following the remaining patients. Presented two posters at the American Association for Cancer Research (AACR) Annual Meeting 2023 showing anti-cancer activity in both our galectin-1 specific inhibitor and our dual acting galectin-1/3 inhibitor compounds, which could provide potential new cancer therapies. Expected Upcoming Milestones Top-line results from Phase 2b GALACTIC-1 trial (IPF) with GB0139 in August 2023 Top-line results from Phase 2a MYLOX-1 trial (myelofibrosis) with GB2064 in 2H 2023 Interim safety data from Phase 2a GALLANT-1 trial (NSCLC) with GB1211 in 2H 2023 Initiation of Phase 2 investigator-sponsored GB1211 oncology trial (melanoma and HNSCC) by Providence Cancer Institute in 2H 2023 First Quarter 2023 Financial Highlights Cash, cash equivalents, and investments as of March 31, 2023 were approximately $57.2 million. The company anticipates that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital requirements into the second half of 2024. Research and development expenses were $10.4 million for the period ended March 31, 2023, compared to $13.2 million for the period ended March 31, 2022. The decrease of $2.8 million was due primarily to lower clinical spending based on timing of clinical trial activities. General and administrative expenses were $3.1 million for the period ended March 31, 2023, compared to $3.7 million for the period ended March 31, 2022. The decrease of $0.6 million was primarily related to decreased insurance costs and other various general and administrative costs. Net loss attributable to common stockholders for the period ended March 31, 2023 was $13.0 million or $(0.51) per basic and diluted share, compared with $16.9 million, or $(0.67) per basic and diluted share, for the prior year period. About Galecto Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2a trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a recently completed Phase 1b/2a trial in liver cirrhosis; and (iv) an orally active galectin-3 inhibitor (GB1211) in combination with atezolizumab (Tecentriq®) in a separate Phase 2a trial for the treatment of NSCLC. 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 ability to make progress across its clinical pipeline of asset and Galecto’s expectation that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital requirements into the second half 2024. 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 9, 2023. 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.

Aug. 24, 2021 16:30 UTC The Enhanced Liver Fibrosis (ELF) is the first prognostic tool for patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH) to be granted De Novo marketing authorization. The blood test, for use in patients with advanced fibrosis due to NASH, helps assess the likelihood of progressing to cirrhosis and liver-related clinical events. There is a clinical need for a simple noninvasive test that is convenient, objective, reproducible, accurate, and widely accessible. This milestone follows the Breakthrough Device Designation FDA granted for the test in November 2018. TARRYTOWN, N.Y.--(BUSINESS WIRE)-- Siemens Healthineers announced today that its Enhanced Liver Fibrosis (ELF™) Test was granted marketing authorization under the De Novo review pathway.1 The ELF Test, for use with the ADVIA Centaur® XP Immunoassay System, provides a simple numeric score that is automatically generated via an algorithm and is used to improve patient care by assessing the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH). NASH is a type of non-alcoholic fatty liver disease (NAFLD) and is characterized by inflammation of the liver and liver cell damage, which can ultimately lead to cirrhosis and/or liver cancer. Minimally invasive testing is an important tool to help identify NASH patients at risk of progressing to cirrhosis and liver-related clinical events. The Journal of Hepatology states the global prevalence of NAFLD is approximately 25 percent and is increasing in line with rising prevalence of type 2 diabetes and obesity.2 In the U.S. alone, an estimated 80-90 million individuals currently have diagnosed or undiagnosed NAFLD, of which up to 20 million people could have NASH, with as many as 4-6 million people projected to have advanced fibrosis due to NASH.3 Prognostic risk assessments using the ELF Test may be useful to help identify patients who could benefit from additional examinations, from increased monitoring, and from potential lifestyle changes and treatment interventions. “If you just find fat in the liver by ultrasound or an imaging study, that by itself does not mean the patient is going to develop bad liver disease. What you must do is find those patients who have the highest chance of progression. So, who are those patients? Those are the patients who have some scarring of the liver. How do we do this today? By liver biopsy. However, things are changing,” said Zobair Younossi, MD, MPH, FACP, FACG, AGAF, and expert hepatologist.4 The Chronic Liver Disease Foundation's recent interim guidance, for example, proposes how the Siemens Healthineers' ELF Test, in combination with other clinical and laboratory assessments, may be used to identify patients with advanced fibrosis due to NASH at high risk of adverse outcomes.5 "In the United States, there is a need for a simple, noninvasive prognostic test that is convenient, objective, reproducible, accurate, and widely accessible," said Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers. "Our ELF Test, the only IVD assay granted marketing authorization by FDA, measures biomarkers directly involved in the active process of scarring. Available worldwide for more than 10 years, including in the European Union, this test combines three serum biomarkers to assess the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis due to NASH. Clinicians in the U.S. now have access to a convenient and minimally invasive tool that can enhance their prognostic patient management."4,6,7 The ELF Test’s marketing authorization in the U.S. results from a strong clinical and research partnership between Gilead Sciences, Inc. and Siemens Healthineers. Gilead Sciences, Inc. supported the ELF Test De Novo Classification Request throughout the FDA review by providing scientific expertise, clinical study data and resources. This marketing authorization of the ELF Test follows the Breakthrough Device Designation granted by FDA for the test in November 2018. The FDA’s Breakthrough Devices program is intended to facilitate the development and expedited review of breakthrough technologies to help patients gain more timely access to solutions that potentially provide for more effective treatment or diagnosis for life-threatening diseases for which no approved treatment exists. 1 The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed. 2 Younossi, Zobair. Non-alcoholic fatty liver disease – A global public health perspective. Journal of Hepatology. 3 Estes C, Razavi H, Loomba, R, et al. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018;67(1):123-3. 4 Liver biopsy is currently the gold standard for diagnosing NASH and assessing fibrosis. The ELF Test is not for use in the diagnosis of NASH or for the staging of fibrosis. The ELF Test provides prognostic information supplemental to biopsy to assess the likelihood of progression to cirrhosis and liver-related clinical events. 5 Younossi ZM, Noureddin M, Bernstein D, et al. Role of Noninvasive Tests in Clinical Gastroenterology Practices to Identify Patients With Nonalcoholic Steatohepatitis at High Risk of Adverse Outcomes: Expert Panel Recommendations. Am J Gastroenterol. 2021;116(2):254-262. 6 Sanyal AJ, Harrison SA, Ratziu V, et al. The Natural History of Advanced Fibrosis Due to Nonalcoholic Steatohepatitis: Data From the Simtuzumab Trials. Hepatology. 2019;70(6):1913-1927. 7 Younossi, Anstee QM, Wong VWW, et al. The Association of Histologic and Noninvasive Tests with Adverse Clinical and Patient-Reported Outcomes in Patients with Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021;160(5):1608-1619.e13. Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostics, image-guided therapy, in-vivo diagnostics, and innovative cancer care. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Following the acquisition of Varian Medical Systems, Inc. the company has approximately 66,000 employees worldwide. Further information is available at .