Live nieuws • May 31
Fund Commits US$66 Million to Damora Therapeutics After 7x Share Price Move FCPM III Services B.V. has opened a new position in Damora Therapeutics, purchasing 2,441,000 shares valued at about US$65.63 million.
The investment follows a share price move of roughly 7x in Damora stock.
Damora has rebranded after acquiring mutant calreticulin-targeted therapies for rare blood cancers and plans a regulatory submission for lead candidate DMR-001 in mid-2026, supported by a cash runway the company expects to last into 2029.
This combination of fresh institutional capital, a focused rare-blood-cancer pipeline, and a cash runway that the company expects to support operations for several years puts attention squarely on Damora’s execution around the DMR-001 regulatory timeline.
Investors should weigh the concentration of value in a single lead candidate and the typical regulatory and clinical risks that come with early-stage oncology therapies when assessing how this stock fits their risk tolerance. Aankondiging • May 01
Damora Therapeutics, Inc., Annual General Meeting, Jun 17, 2026 Damora Therapeutics, Inc., Annual General Meeting, Jun 17, 2026. New Risk • Feb 12
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Over 44x increase in shares outstanding. This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 39% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 44x increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$166m net loss in 3 years). Aankondiging • Jan 13
Galecto, Inc. Announces Anticipated 2026 Milestones for Galecto’s Pipeline Galecto, Inc. announced 2026 is expected to be a foundational year for Galecto as the company initiates the clinical development of its anti-mutCALR pipeline candidates. DMR-001 is a potentially best-in-class anti-mutCALR monoclonal antibody demonstrated to have highly potent activity in both Type 1 and Type 2 mutCALR-driven preclinical models, supporting its potential to address the full spectrum of CALR mutations in both essential thrombocythemia (“ET”) and myelofibrosis (“MF”). DMR-001 is engineered with validated half-life extension technology to enable infrequent low-volume, subcutaneous dosing to maximize target coverage and patient convenience. An Investigational New Drug application (“IND”), or equivalent, submission for DMR-001, with anticipated first-in-human dosing via subcutaneous administration, is expected to occur in mid-2026, with Phase 1 proof-of-concept data anticipated in 2027; DMR-002 is an additional anti-mutCALR antibody. An IND, or equivalent, submission for DMR-002 is planned for the second half of 2026; GB3226 is a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (AML). An IND submission is planned for the first quarter of 2026. Aankondiging • Jan 07
Galecto, Inc. Appoints Sherwin Sattarzadeh as Chief Operating Officer and Becker Hewes as Chief Medical Officer, Effective January 5, 2026 Galecto, Inc. announced the appointment of Sherwin Sattarzadeh, former Chief Business Officer of Blueprint Medicines Corporation, as Chief Operating Officer and Dr. Becker Hewes, former Chief Medical Officer of Blueprint Medicines, as Chief Medical Officer, effective January 5, 2026. Sherwin Sattarzadeh brings over 20 years of industry experience across the many facets and stages of drug development and company lifecycle. Most recently, he served as Chief Business Officer at Blueprint Medicines. During his 10 years at Blueprint Medicines, Mr. Sattarzadeh held positions of increasing responsibility including Head of Regulatory Affairs, Chief of Staff, and SVP Strategic Operations. He has an extensive background in hematology/oncology and rare disease drug development, having led and contributed to the global approvals of AYVAKIT (avapritinib), GAVRETO (pralsetinib), CERDELGA (eliglustat) and MOZOBIL (plerixafor). Mr. Sattarzadeh received his M.B.A. from Boston University and holds a B.Sc. in Chemistry from the University of British Columbia. Dr. Becker Hewes brings over two decades of experience in drug development in public biotechnology companies. Most recently, he served as Chief Medical Officer at Blueprint Medicines. During his time at Blueprint Medicines, Dr. Hewes led the development of an pipeline across mast cell disorders and solid tumors, including the approval of AYVAKIT (avapritinib) for indolent and advanced systemic mastocytosis. Prior to joining Blueprint Medicines, Dr. Hewes had an illustrious career in hematology/oncology drug development, having led clinical development and translational medicine efforts for multiple early-stage oncology programs through clinical proof-of-concept, including Kisqali (ribociclib), as well as leading registration programs for Bosulif (bosutinib), and Torisel (temsirolimus). He received his BS from Vanderbilt University and an M.D. from Georgetown University. He completed his residency at New York Hospital/Cornell Medical Center and his fellowship training in Pediatric Oncology at Emory University. New Risk • Dec 22
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 21% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (59% average daily change). Earnings are forecast to decline by an average of 47% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$209m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (US$43.3m market cap). New Risk • Dec 01
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 47% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (59% average daily change). Earnings are forecast to decline by an average of 47% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$209m net loss in 3 years). Market cap is less than US$100m (US$23.6m market cap). New Risk • Sep 23
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 16% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Revenue is less than US$1m. Market cap is less than US$10m (US$3.97m market cap). Minor Risks Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (22% increase in shares outstanding). Aankondiging • Apr 19
Galecto, Inc., Annual General Meeting, Jun 18, 2025 Galecto, Inc., Annual General Meeting, Jun 18, 2025. New Risk • Mar 21
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 29% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$5.47m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$62m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). New Risk • Nov 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 21% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$25m free cash flow). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$9.21m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$67m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Aankondiging • Oct 16
Galecto, Inc Appoints Amy Wechsler to Its Board of Directors Galecto, Inc. announced the appointment of Dr. Amy Wechsler to its Board of Directors. Dr. Wechsler brings a unique combination of expertise and a proven track record of leadership in the healthcare industry. Dr. Wechsler is board-certified in both dermatology and psychiatry and has been a practicing dermatologist since 2005. Since 2016, she has served on the Board of Directors for Bausch Health where she played a key role in supporting the company through a successful IPO. Dr. Wechsler is also an adjunct clinical professor of psychiatry at Weill Cornell Medical College. She received a B.S. in psychology, magna cum laude, Phi Beta Kappa, from Duke University and earned her M.D., Alpha Omega Alpha, from Cornell University Medical College. Dr. Wechsler also received her M.B.A. from Columbia Business School in 2024. New Risk • Oct 08
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.19m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$30m free cash flow). Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$9.19m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$62m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). New Risk • Aug 29
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 279% a day. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$30m free cash flow). Share price has been highly volatile over the past 3 months (279% average daily change). Earnings are forecast to decline by an average of 25% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$59m net loss in 3 years). Market cap is less than US$100m (US$14.1m market cap). Aankondiging • Aug 29
Galecto Announces Reverse Stock Split to Regain Compliance with Nasdaq Minimum Bid Price Requirement Galecto, Inc. announced that it will implement a 1-for-25 Reverse Stock Split of its common stock (the “Reverse Stock Split”), effective at 5:00 p.m. Eastern Time on August 29, 2024. The Reverse Stock Split, which was approved by shareholders at the company’s Annual Meeting of Stockholders on June 20, 2024, is primarily intended to bring the company into compliance with the minimum bid price requirement for maintaining its listing on The Nasdaq Capital Market. Beginning with the opening of trading on August 30, 2024, the company’s common stock will trade on the Nasdaq Capital Market on a split-adjusted basis under the existing symbol “GLTO” and a new CUSIP number 36322Q 206. Aankondiging • May 02
Galecto, Inc. Announces First Patient Dosed in an Investigator-Initiated Phase 2 Trial of GB1211 in Combination with Pembrolizumab Galecto, Inc. announced that the first patient has been enrolled in an investigator-initiated Phase 2 trial to evaluate GB1211, Galecto’s first-in-class, oral small molecule galectin-3 inhibitor candidate, at the Earle A. Chiles Research Institute (EACRI), a division of Providence Cancer Institute in Portland, Oregon, USA. Under the direction of Providence investigators Dr. Brendan Curti and Dr. William Redmond, the study aims to evaluate the safety and efficacy of GB1211 at a dose of 100mg twice daily in combination with pembrolizumab for the treatment of metastatic malignant melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). Drs. Curti and Redmond received an R01 Research Project Grant award from the National Cancer Institute, National Institutes of Health, for their investigator-initiated Phase 2 trial. Galecto has committed to supply GB1211 for the trial. Galectin-3 is overexpressed in many cancers, including melanoma and HNSCC. Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. Furthermore, increased levels of galectin-3 in the tumor microenvironment can cause checkpoint inhibitor resistance by blocking the binding of the checkpoint inhibitor antibodies, pembrolizumab and atezolizumab (Tecentriq®), to their respective targets. Preclinical data has shown that GB1211 has the ability to reduce galectin-3 associated interference with immune checkpoint inhibition (ICI), thus alleviating galectin-3-specific ICI resistance. In the fourth quarter of 2023, Galecto reported topline results from its Phase 1b/2a GALLANT-1 clinical trial evaluating GB1211 twice daily in combination with atezolizumab for the first-line treatment of non-small cell lung cancer (NSCLC). Galecto reported that investigator-assessed objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received the recommended Phase 2 dose level of GB1211 100 mg for at least three weeks. Historically, response rates of only 22–38% have been observed with atezolizumab monotherapy in the first-line treatment of advanced NSCLC, suggesting a potential benefit of adding GB1211 to ICI. The randomized, double-blind placebo-controlled, investigator-initiated Phase 2 trial will evaluate whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. The study will employ a fixed dose of GB1211 in conjunction with the standard therapeutic dose of pembrolizumab in patients with unresectable or metastatic MM or recurrent or metastatic HNSCC progressing during or after platinum-containing chemotherapy. In addition to monitoring for toxicity and clinical response, biospecimens will be obtained to assess immunologic measures relevant to galectin biology and T-cell checkpoint inhibition. Tumor volume will be assessed by immune response RECIST criteria (iRECIST criteria 1.1). It is anticipated that early data from this trial could be available as early as 2025. Aankondiging • May 01
Galecto, Inc., Annual General Meeting, Jun 20, 2024 Galecto, Inc., Annual General Meeting, Jun 20, 2024, at 09:00 US Eastern Standard Time. Agenda: To elect Anne Prener, M.D., as a Class I member of the Board of Directors, to serve until the Company’s 2027 Annual Meeting of Stockholders and until her successor is duly elected and qualified, or until her earlier death, resignation or removal; to approve an amendment to the Company's Amended and Restated Certificate of Incorporation to effect a reverse stock split of the shares of the Company's common stock at a ratio of not less than 1-for-4 and not greater than 1-for-25with the exact ratio, effective time of and decision to implement the reverse stock split to be determined by the Board of Directors at any time within one year of the date of the Annual Meeting without further approval or authorization from the Company's stockholders; and to ratify the selection of EY God kendt Revisions partners elskab as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2024; and to consider other matters. New Risk • Mar 12
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$37m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$37m free cash flow). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$66m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (5.6% increase in shares outstanding). Market cap is less than US$100m (US$21.4m market cap). New Risk • Mar 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$62m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (6.0% increase in shares outstanding). Market cap is less than US$100m (US$21.8m market cap). Board Change • Dec 26
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Director Jayson Donald Dallas was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Dec 22
Galecto, Inc. Announces Positive Topline Results from A Phase 2A Trial of GB2064 for the Treatment of Myelofibrosis Galecto, Inc. announced positive topline results from a Phase 2a trial of GB2064 for the treatment of myelofibrosis. The MYLOX-1 trial dosed a total of 18 myelofibrosis patients, of which 11 (61%) patients had previously received janus kinase inhibitor (JAKi) therapy with ruxolitinib, with eight of those patients being refractory and three being intolerant to JAKi therapy. Six out of ten evaluable myelofibrosis patients who received GB2064 monotherapy for at least six months 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 be disease-modifying. Fibrosis is a key disease mechanism of myelofibrosis that destroys bone marrow function. Reducing fibrosis is required to slow the progression of the disease. Bone marrow biopsies taken during the study showed that GB2064 penetrated the bone marrow and could exert its anti-fibrotic effect directly in the disease compartment. Furthermore, GB2064 demonstrated target engagement systemically by binding to LOXL2 in plasma. All six patients who experienced a > 1-grade reduction in bone marrow fibrosis score also showed stable hematological parameters, including hemoglobin, white blood cell count and platelets. At six months of treatment, one patient obtained a =35% reduction in spleen volume, two patients reduced their Total Symptom Score (TSS) by more than 50% and one patient had an anemia response. Four of these patients have entered the extension phase of the study due to the clinical benefit derived from GB2064 as evaluated by the treating physician, with one patient receiving treatment for more than 30 months. GB2064 showed a generally acceptable tolerability profile in the MYLOX-1 trial. Eighteen patients were dosed with GB2064 monotherapy in the MYLOX-1 trial. Eight patients completed treatment in the core phase of the MYLOX-1 trial and ten patients discontinued treatment due to an adverse event or disease progression. The most commonly observed treatment-related adverse events were gastrointestinal in nature and were manageable in most patients with standard therapy. The only treatment-related serious adverse event was a case of fall, which was assessed as possibly related to GB2064 by the investigator. Aankondiging • Oct 24
Galecto, Inc. Presents Updated Clinical Data At ESMO Congress 2023 and Provides Update on Phase 1B/2A Gallant-1 Trial Galecto, Inc. presented a poster with new and encouraging clinical data, including two additional partial responders, from the dose-finding Part A of its Phase 1b/2a trial (NCT05240131) (the GALLANT-1 trial) at the European Society of Medical Oncology (ESMO) Congress 2023 in Madrid, Spain. The GALLANT-1 trial is designed to study the combination of atezolizumab (Tecentriq®?) and GB1211, Galecto's first-in-class, oral small-molecule galectin-3 inhibitor candidate, in the first-line treatment of patients with metastatic/advanced non-small cell lung cancer (NSCLC). At the recommended Phase 2 dose level of 100 mg GB1211 twice daily, investigator-assessed objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks. Response rates of only 22-38% have been observed with atezolizumab monotherapy in the first- line treatment of advanced NSCLC, suggesting a potential benefit of adding GB1211 to atezolizumab. The Company believes that GALLANT-1 is the first clinical trial to show that combining an oral galectin-3 inhibitor with a checkpoint inhibitor may enhance the effect of checkpoint inhibitors. In addition, insights from early biomarker analyses revealed a trend showing that responders had increased levels of galectin-3 at baseline, and stable or decreasing galectin-3 levels during treatment. In contrast, patients with progressive disease demonstrated increasing levels of galectin- 3 during treatment. Galecto will continue to supply GB1211 100 mg for the upcoming investigator-initiated Phase 2 trial at Providence Portland Medical Center's Earle A. Chiles Research Institute (EACRI). This trial, which is expected to be initiated in early 2024, will evaluate the safety and efficacy of GB1211 in combination with pembrolizumab (Keytruda®?). Galecto plans to explore external options for partnering and/or funding additional oncology-focused activities for GB1211 as part of its strategic alternative process. Aankondiging • Oct 05
Galecto Receives a Deficiency Letter from the Nasdaq Listing Qualifications Department of the Nasdaq Stock Market On September 27, 2023, Galecto, Inc. received a deficiency letter from the Nasdaq Listing Qualifications Department of The Nasdaq Stock Market LLC notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock has been below the minimum $1.00 per share required for continued listing on The Nasdaq Global Select Market pursuant to Nasdaq Listing Rule 5450(a)(1). The Nasdaq deficiency letter has no immediate effect on the listing of the Company’s common stock, and its common stock will continue to trade on The Nasdaq Global Select Market under the symbol “GLTO” at this time, subject to the Company’s compliance with the other continued listing requirements. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until March 25, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before March 25, 2024, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that the Company has achieved compliance. If the Company does not regain compliance with the Minimum Bid Price Requirement by March 25, 2024, the Company may be afforded a second 180 calendar day period to regain compliance. To qualify, the Company would be required to transfer to The Nasdaq Capital Market and meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the Minimum Bid Price Requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the deficiency during the second compliance period. Following a transfer to The Nasdaq Capital Market, the Company expects that it would be afforded the second 180 calendar day period to regain compliance, unless it does not appear to Nasdaq that it is possible for the Company to cure the deficiency. If the Company does not regain compliance with the Minimum Bid Price Requirement by the end of the compliance period (or the second compliance period, if applicable), the Company’s common stock will become subject to delisting. In the event that the Company receives notice that its common stock is being delisted, the Nasdaq listing rules permit the Company to appeal a delisting determination by the Staff to a hearings panel. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement, including initiating a reverse stock split. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq Listing Rules. Aankondiging • Aug 17
Galecto Announces Topline Results from Phase 2b GALACTIC-1 Trial of GB0139 for the Treatment of Idiopathic Pulmonary Fibrosis Galecto, Inc. announced topline results from its Phase 2b GALACTIC-1 trial evaluating the safety and efficacy of inhaled GB0139 for the treatment of idiopathic pulmonary fibrosis (IPF). The GALACTIC-1 trial did not meet its primary endpoint of change from baseline in rate of decline in forced vital capacity (FVC). Based on the results of the GALACTIC-1 trial, Galecto plans to discontinue development of GB0139. Going forward, Galecto will focus on development opportunities for the treatment of severe liver diseases. The GALACTIC-1 trial (NCT03832946) enrolled 173 patients who were not receiving pirfenidone or nintedanib, the current standard of care for IPF. The trial compared treatment with the inhaled 3 mg dose of GB0139 to placebo (randomized 2:1) over 52 weeks. The GALACTIC-1 trial did not meet its primary endpoint of change from baseline in rate of decline in forced vital capacity (FVC) at week 52. Levels of galectin-3 increased from day 0 to week 52 in both the placebo and active GB0139 3 mg arms, and thus there was no confirmation of target engagement in the trial. The mean change in FVC from baseline to week 52 was -316.6 ml in the GB0139 3 mg arm compared to -127.4 ml in the placebo arm (placebo-corrected difference of -189.2 ml; 95% CI -311.28 to -67.10 ml). The observed decrease in lung function in the placebo group was lower than similar placebo groups reported in previous IPF trials with other drugs. In the safety analysis, Galecto observed a significant amount of IPF-like treatment-emergent adverse events in the active GB0139 arm commensurate with FVC development. The most common adverse events included cough, dyspnea and COVID-19. Treatment-emergent serious adverse events, which included worsening of IPF, were observed in 7.8% of patients in the GB0139 group and 1.4% of patients in the placebo group. Adverse events leading to death were similar in both groups. Galecto intends to work in close collaboration with external experts to analyze the results observed in the placebo arm of the GALACTIC-1 trial. Additionally, Galecto plans to communicate the results of the GALACTIC-1 trial at an upcoming medical conference. Galecto previously announced that it had concluded a U.S. Food and Drug Administration (FDA) Type C meeting centered around the continued development of GB1211, Galecto’s oral galectin-3 inhibitor product candidate for the treatment of compensated and decompensated cirrhosis. As a result of this meeting and in accordance with guidance received from the FDA, Galecto’s next step in the development of GB1211 is to initiate a long-term, randomized, placebo-controlled, Phase 2a trial in patients with decompensated NASH cirrhosis, which will evaluate efficacy and tolerability at additional dose levels. This trial, referred to as the GULLIVER-3 trial, is expected to be initiated in early 2024, subject to obtaining additional financing. Galectin-3 and LOXL2 have been shown to be critical drivers of fibrotic disease pathogenesis and are associated with severe liver disease and poor outcomes. Galecto previously announced topline results from its Phase 1b/2a GULLIVER-2 trial of GB1211, its orally available galectin-3 inhibitor, for the treatment of decompensated cirrhosis. Topline results from the GULLIVER-2 trial showed statistically significant reductions in liver enzymes (AST, ALT and GGT) and other positive biomarker effects after 12 weeks of treatment, as well as a reduction in MELD score. GB1211 also exhibited a favorable tolerability profile in this trial. New Risk • Aug 03
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 6.8% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$38m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$132m net loss in 3 years). Shareholders have been diluted in the past year (6.8% increase in shares outstanding). Market cap is less than US$100m (US$72.0m market cap). New Risk • Jul 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$45m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$135m net loss in 3 years). Market cap is less than US$100m (US$78.3m market cap). New Risk • Jun 21
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$45m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$45m free cash flow). Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$135m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$69.3m market cap). Price Target Changed • Jun 15
Price target increased by 17% to US$12.00 Up from US$10.25, the current price target is an average from 4 analysts. New target price is 450% above last closing price of US$2.18. Stock is up 25% over the past year. The company is forecast to post a net loss per share of US$2.23 next year compared to a net loss per share of US$2.43 last year. Price Target Changed • Mar 20
Price target increased by 18% to US$10.25 Up from US$8.67, the current price target is an average from 4 analysts. New target price is 428% above last closing price of US$1.94. Stock is down 5.8% over the past year. The company is forecast to post a net loss per share of US$2.25 next year compared to a net loss per share of US$2.43 last year. Price Target Changed • Dec 15
Price target decreased to US$8.33 Down from US$9.00, the current price target is an average from 3 analysts. New target price is 491% above last closing price of US$1.41. Stock is down 39% over the past year. The company is forecast to post a net loss per share of US$2.45 next year compared to a net loss per share of US$2.05 last year. Board Change • Nov 16
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 5 experienced directors. No highly experienced directors. Independent Director Søren Møller is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Nov 01
Galecto to Present Topline Data from GULLIVER-2 Clinical Trial Showing GB1211 Reduced Signs of Liver Impairment at AASLD’s The Liver Meeting® 2022 Galecto, Inc. announced it will present data from its recently completed Phase 1b/2a GULLIVER-2 trial at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting 2022 being held in Washington, D.C. on November 4-8, 2022. GULLIVER-2 is a clinical trial designed to assess GB1211, an orally available and high-affinity small molecule carbohydrate-based galectin-3 inhibitor, for the treatment of severe liver diseases. Galectin-3 is a pro-fibrotic ß-galactoside binding protein highly expressed in fibrotic livers and implicated in severe liver diseases. In a late-breaking oral presentation, which was selected as Best of the Liver Meeting in the NASH/NAFLD category, Galecto will present topline data from Part 2 of its GULLIVER-2 trial (NCT05009680), an innovative, hybrid-design 3 part study investigating the safety, pharmacokinetics (PK), and exploratory efficacy of GB1211 in patients with decompensated cirrhosis. In this study, GB1211 was well-tolerated, had a predictable PK profile and showed encouraging signs of clinical efficacy (liver laboratory tests and FibroScan®). The observed reductions of liver enzyme values and measurements of liver fat indicate a decrease of liver inflammation and underlying steatosis, respectively. Overall, the data suggests a positive therapeutic effect in severe cirrhosis. This trial offers strong support for further development of GB1211 in severe liver diseases. Additional information and further analysis of these data relating to the GULLIVER-2 Part 2 trial findings will also be discussed in a webinar hosted by Galecto on Monday, November 8th at 8 a.m. ET. In a separate poster presentation, Galecto will highlight findings from Parts 1 and 3 of the GULLIVER-2 trial, where preliminary data indicates that liver impairment had moderate effects on the GB1211 PK profile compared to healthy participants. In patients with decompensated cirrhosis, GB1211 was observed to be well-tolerated with no treatment-related adverse events, supporting that it can be orally administered to patients with moderate and severe liver impairment in future trials. In support of the clinical data to be presented at The Liver Meeting 2022, Galecto will also present a late-breaking preclinical poster demonstrating GB1211’s ability to inhibit galectin-3 in severe liver diseases. In this study, the efficacy of GB1211 was investigated in a high fat diet rabbit model of non-alcoholic steatohepatitis (NASH)/fibrosis. GB1211 significantly reduced all measures of inflammation, fibrosis and fat compared to the control group. There were also trends for reduction in fibrotic and galectin-3 mechanistic genes (COL1A1, COL3A1, SNAI2, LGALS3, PAI-1), indicating positive effects of galectin-3 inhibition. Aankondiging • Oct 20
Galecto, Inc’s Galectin-3 Inhibitor GB1211 to Be Studied in Combination with Pembrolizumab in Patients with Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma by Providence Cancer Institute Galecto, Inc. announced that it has entered into a collaboration agreement for an investigator-initiated Phase 2 trial at Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI) to evaluate the safety and efficacy of GB1211, Galecto’s first-in-class, oral small molecule galectin-3 inhibitor candidate, in combination with pembrolizumab (Keytruda®). Galecto has committed to supply GB1211 for the Phase 2 trial. Galectin-3 is overexpressed in many cancers, including melanoma and head and neck squamous cell carcinoma (HNSCC). Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness, and metastatic potential. Furthermore, increased levels of galectin-3 in the tumor microenvironment can cause checkpoint inhibitor resistance by blocking the binding of the checkpoint inhibitor antibodies, pembrolizumab and atezolizumab (Tecentriq®), to their respective targets. Preclinical data has shown that GB1211 has the ability to reduce galectin-3-induced checkpoint inhibitor blockages, thus preventing galectin-3 from inducing checkpoint inhibitor resistance. The randomized, double-blind placebo controlled, investigator-initiated Phase 2 trial will evaluate whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. The study will employ a fixed dose of GB1211 in conjunction with the standard therapeutic dose of pembrolizumab in patients with unresectable or metastatic melanoma or recurrent or metastatic HNSCC progressing during or after platinum-containing chemotherapy. In addition to monitoring for toxicity and clinical response, blood and tumor samples will be obtained to assess immunologic measures relevant to galectin-3 biology and checkpoint inhibition. The Phase 2 trial is expected to begin in 2023 and top line results of the combination are expected to be reported as early as 2025. Aankondiging • Aug 30
Galecto Announces Publication Supporting the Predictive Role of Galectin-3 on Overall Survival of NSCLC Patients in Peer-Reviewed Scientific Journal Galecto, Inc. announced a recent publication in the Journal of Cancer Research and Clinical Oncology,1 a peer-reviewed scientific journal, supporting the Company’s ongoing clinical programs by reinforcing the foundational galectin-3 biology underlying Galecto’s approach to the inhibition of galectin-3 for the treatment of cancer. The journal article provides confirmation for the hypothesis that high levels of galectin-3 expression have a strong correlation with tumor resistance to checkpoint inhibitors. The publication includes study data from a group of patients with varying degrees of galectin-3 expression, with patients being categorized as having either “high” or “low” levels based on their blood galectin-3 levels. Patients in the high galectin-3 expression group showed significantly shorter overall survival (1.6 vs. 12.3 months, p?=?0.018) and trends toward reduced progression-free survival (0.9 vs. 3.7 months, p?=?0.196) when compared to patients in the low galectin-3 expression group. The Company believes that the inhibition of galectin-3 by GB1211, Galecto’s selective oral small molecule candidate, could lead to an increase in the efficacy of checkpoint inhibitors in cancer patients with high galectin-3 expression. Preclinical data presented at the 2022 American Society of Clinical Oncology Annual Meeting in May 2022 showed that galectin-3 may be a key cause of resistance to checkpoint inhibitors. Further, it was shown that GB1211 reversed the galectin-3 induced blockage of the checkpoint inhibitors atezolizumab and pembrolizumab and increased the effects of these checkpoint inhibitors. GB1211 is currently being evaluated in combination with atezolizumab in a Phase 2a trial for the first-line treatment of non-small cell lung cancer (NSCLC). Price Target Changed • Jul 31
Price target decreased to US$10.00 Down from US$11.00, the current price target is an average from 3 analysts. New target price is 521% above last closing price of US$1.61. Stock is down 62% over the past year. The company is forecast to post a net loss per share of US$2.34 next year compared to a net loss per share of US$2.05 last year. Aankondiging • Jun 17
Galecto Announces First Patient Enrolled in Phase 2 Trial of Gb1211 in Combination with Atezolizumab for First-Line Treatment of Nsclc Galecto, Inc. announced that the first patient has been enrolled in the Phase 2a GALLANT-1 trial. GALLANT-1 is designed to study the combination of GB1211, Galecto's oral small molecule galectin-3 inhibitor, with Roche's PD-L1 checkpoint inhibitor, atezolizumab, for the first-line treatment of non-small cell lung cancer. Galecto anticipates topline data from GALLANT-1 in mid-2023. The initiation of GALLANT-1 continues Galecto's strategy to treat cancer and fibrotic diseases through developing targeted therapeutics. Galectin-3, the target of GB1211, is elevated in many cancers. Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. Furthermore, increased levels of galectin-3 in the tumor microenvironment facilitates tumor escape from the immune response by suppressing essential T-cell functions and activating tumor-protecting macrophages. Clinical evidence from patients with NSCLC suggests that high levels of galectin-3 in tumors leads to resistance to treatment with checkpoint inhibitors. In multiple pre-clinical models, including NSCLC, GB1211 has been shown to reduce tumor growth and metastasis and increase efficacy of checkpoint inhibition. The Phase 2a trial of GB1211 in combination with Tecentriq(R) will be a 1:1 randomized, double blind, placebo-controlled trial in patients with NSCLC in the first line setting. Part A of GALLANT-1 will be an open-label stage in 8-12 patients to select the dose of GB1211 (200mg or 400mg twice daily) to be used with Tecentriq(R) . Part B will evaluate safety and tumor shrinkage in up to 75 patients; additionally, it will explore tumor response rate based on RECIST criteria, clinical activity and immune biomarkers. Galecto is the sponsor of the study and Roche will provide clinical supply of Tecentriq. Galecto retains all rights to GB1211 globally. About GB1211 and Galectin-3 Mechanisms in Cancer Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. In the tumor tissue, galectin-3 supports the creation of fibrosis, tumor proliferation, metastasis, and immune avoidance. Galectin-3 uses a host of mechanisms including, but not limited to, VEGF, TGF-<BETA>, TYRO3, and MER-TK to increase tumor growth and metastasis. Furthermore, increased levels of galectin-3 in the tumor microenvironment facilitates tumor escape from the immune response by suppressing essential T-cell functions and activating tumor-protecting macrophages. Galectin-3-mediated immune suppression is linked to the removal of the interferon-gamma gradient and immune exhaustion via binding to LAG3 and the T-cell receptor. Further, recent data announced at the 2022 ASCO Annual Meeting suggest that galectin-3 can enhance PD-1 and PD-L1 binding and avert the interference of anti-PD-1/anti-PD-L1 therapies by blocking the binding of the antibodies to their respective targets. GB1211 is designed to counter these effects. GB1211 demonstrated an anti-cancer effect and antifibrotic activity in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 was well-tolerated and exhibited dose-dependent pharmacokinetics. The mechanism of action is specific inhibition of the carbohydrate recognition domain of galectin-3. Price Target Changed • May 09
Price target decreased to US$11.00 Down from US$12.00, the current price target is an average from 3 analysts. New target price is 664% above last closing price of US$1.44. Stock is down 73% over the past year. The company is forecast to post a net loss per share of US$2.13 next year compared to a net loss per share of US$7.62 last year. Board Change • Apr 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Jayson Donald Dallas was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Apr 27
Galecto, Inc. Completes Enrollment in Global Phase 2B GALACTIC-1 Trial of GB0139 for the Treatment of IPF Galecto, Inc. announced it has completed enrollment of patients in its Phase 2b GALACTIC-1 trial of GB0139 for idiopathic pulmonary fibrosis (IPF). IPF is a life-threatening, rapidly progressing and irreversible disease causing scarring of the lungs and significantly impairing lung function. IPF affects approximately 100,000 people in the United States and is associated with significant morbidity and mortality, imposing substantial challenges for healthcare systems worldwide. The current standard of care treatment options for IPF have only been shown to have a modest impact on slowing the progression of the disease and have been associated with significant side effects, leading to poor therapeutic adherence. GALACTIC-1 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2b study being conducted across approximately 100 centers globally. The study is designed to investigate the safety and efficacy of Galecto’s most advanced compound, GB0139, in 141 patients with IPF. Patients in GALACTIC-1 are randomized (2:1) to either receive GB0139 or placebo. Patients in the GB0139 group receive a 3mg dose of GB0139 once daily for 52 weeks. The primary endpoint of the trial is to assess the annual rate of decline in forced vital capacity (FVC). Reduction in the decline of FVC was accepted by the U.S. Food and Drug Administration as primary endpoint for the approval of the current standard of care treatments for IPF: nintedanib, marketed as Ofev® by Boehringer Ingelheim, and pirfenidone, marketed as Esbriet® by Roche/Genentech. Aankondiging • Mar 30
Galecto Completes Enrollment in Phase 1b/2a GULLIVER-2 Trial of its Selective, Oral Galectin-3 Inhibitor GB1211 in Liver Cirrhosis Galecto, Inc. announced it has completed enrollment in Parts 2 and 3 of its ongoing 3-part Phase 1b/2a trial of GB1211, GULLIVER-2, in liver cirrhosis. GB1211 is a selective, oral small molecule inhibitor of galectin-3 being studied in liver cirrhosis, a severe, progressive disease that ultimately leads to liver failure, and for which there are limited treatment options. GULLIVER-2 is an innovative hybrid trial, combining a hepatic impairment trial of safety, tolerability and pharmacokinetics (Parts 1 and 3) and a Phase 2 trial to examine safety and demonstrate effects of GB1211 on hepatic function, inflammation, coagulation and fibrosis (Part 2). This novel trial design is intended to provide a holistic view of the safety, pharmacokinetics, liver function and liver-related parameters of GB1211 in this vulnerable patient population with significant unmet needs. Part 1 of the GULLIVER-2 trial, which was designed to measure the pharmacokinetics of GB1211 in patients with moderate hepatic impairment (Child-Pugh class B) as compared to healthy volunteers, was completed in December 2021. GB1211 was found to be well-tolerated with no drug-related serious adverse events. Part 2 of the trial is a randomized, double-blind, placebo-controlled cohort in 30 patients with liver cirrhosis and moderate hepatic impairment (Child-Pugh class B). This part of the trial is designed to observe the safety and tolerability of GB1211 over 12 weeks while also measuring fibrosis biomarkers, hepatic function, inflammation, and coagulation parameters, as well as detecting fibrosis using transient elastography ultrasound. Part 3 of the trial is an open-label cohort in 6 patients with severe hepatic impairment (Child-Pugh class C) and 6 matched healthy volunteers that is designed to examine the pharmacokinetics and safety and tolerability of GB1211. Galectin-3 plays a key role in fibrosis development through cellular activation and collagen production, and Galecto has demonstrated that inhibiting the galectin-3 target with GB1211 protects liver cells and reduces fibrosis in multiple animal models including models of liver fibrosis. Galectin-3 is elevated in cirrhosis patients and is a prognostic biomarker of hepatocellular carcinoma, a known complication of liver cirrhosis. Liver cirrhosis is associated with significant morbidity and mortality, and imposes a substantial health burden on many countries. It is estimated that more than 100 million patients suffer from liver cirrhosis worldwide. Currently, there are no approved disease-modifying therapies and liver transplantation remains the sole option for late-stage liver cirrhosis. Price Target Changed • Feb 25
Price target decreased to US$9.50 Down from US$12.00, the current price target is provided by 1 analyst. New target price is 395% above last closing price of US$1.92. Stock is down 84% over the past year. The company is forecast to post a net loss per share of US$2.13 next year compared to a net loss per share of US$7.62 last year. Price Target Changed • Feb 15
Price target decreased to US$11.67 Down from US$12.67, the current price target is an average from 2 analysts. New target price is 464% above last closing price of US$2.07. Stock is down 83% over the past year. The company is forecast to post a net loss per share of US$2.15 next year compared to a net loss per share of US$7.62 last year. Aankondiging • Jan 28
Galecto Publishes Results Showing Safety and Efficacy of the Gb0139 Inhaled Galectin-3 Inhibitor in Hospitalized Covid-19 Patients on Standard of Care Galecto, Inc. announced the publication of the full results of an investigator-initiated open and randomized trial to evaluate Galecto’s inhaled galectin-3 inhibitor, GB0139, in hospitalized patients with COVID-19 infection who required oxygen but not mechanical ventilation, compared to patients only on standard of care. Galectin-3 plays a key role in COVID-19-related acute lung injury, cytokine storm, T-cell exhaustion and organ micro-thrombosis, and the results from this trial suggest that GB0139 has the potential for treatment of viral induced acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). The study met its primary endpoint of safety as there were no observed treatment-related adverse events. Despite patients having a mean age of 65 years, mean BMI of 32, multiple comorbidities, and being breathless, all patients were able to effectively inhale GB0139 and achieve pharmacologically relevant plasma levels. Target engagement was confirmed with a statistically significant reduction (p<0.01) in serum galectin-3 levels. The study showed that GB0139 on top of standard of care may rapidly decrease markers of inflammation linked to the cytokine storm, inflammation-associated micro-thrombosis and those of short or long-term fibrosis. Patients treated with GB0139 had a significantly greater rate of decline in oxygen requirement versus standard of care alone and showed other signs of reduced organ damage. These effects were further accentuated in a subgroup of patients with moderate-to-severe disease who were at higher clinical risk. These patients showed multiple signs of improved immune-mediated viral responses as well as decreased lymphocyte exhaustion and decreased level of profibrotic macrophages. A 21% reduction of mortality was observed in this subgroup of patients at high clinical risk. The GALACTIC-1 trial is a Phase 2b, 52-week randomized, double-blind, multicenter, parallel, placebo-controlled trial investigating the safety and efficacy of GB0139 (3mg) in patients with IPF, with the rate of decline of forced vital capacity (FVC) as the primary endpoint. Based on blinded FVC (lung function) data from patients in this trial, the Company has determined that it may be possible to demonstrate a meaningful effect with fewer than the planned target of up to 210 randomized patients. As a result of this statistical analysis, the Company plans to seek regulatory approval of a protocol amendment to reduce the target patient population for the GALACTIC-1 trial, which would enable Galecto to maintain the cost structure of the trial and report topline results in mid-2023. In this open-label trial 41 patients were randomized to receive either standard of care, which included treatments such as steroids, heparin, remdesivir and tocilizumab (n=21), or inhaled GB0139 (dosed at 10 mg twice a day for 2 days and subsequently once a day for up to 14 days) plus standard of care (n=20), to evaluate the safety and tolerability of GB0139, pharmacokinetics, and its effects on clinical outcomes and biomarkers. Patients had a mean age of 65 years, mean BMI of 32, multiple comorbidities, and were hospitalized and needed oxygen therapy, but did not require mechanical ventilation. Aankondiging • Dec 21
Galecto Provides Enrollment Update on Phase 2a MYLOX-1 Trial and Reiterates Expected Timing of Multiple Data Readouts in 2022 Galecto, Inc. announced it has enrolled 10 of the anticipated 16 patients in its Phase 2a trial of its oral LOXL2 inhibitor GB2064 in myelofibrosis. The open label MYLOX-1 trial (NCT04679870) is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB2064 in 16 patients over 9 months. The trial will also assess the impact on fibrosis and quantification of the tissue targeting of GB2064, as well as other aspects of clinical response in myelofibrosis. Myelofibrosis is a type of bone marrow cancer that causes scarring in the bone marrow and disrupts the body’s normal production of blood cells, which can lead to multiple negative impacts and a significantly reduced quality of life and mortality. LOXL2 is an enzyme that plays a key role in myelofibrosis and contributes to the fibrotic progression in this disease. Galecto’s LOXL2 inhibitor, GB2064, has demonstrated potent inhibition of LOXL2 activity in cell-based assays and preclinical models and has successfully completed Phase 1 studies in healthy volunteers. Aankondiging • Dec 14
Galecto Announces Positive Preliminary Results for Oral Galectin-3 Inhibitor GB1211 in Part 1 of its Phase 1b/2a Liver Cirrhosis Trial Galecto, Inc. announced that it has successfully completed Part 1 of its Phase 1b/2a GULLIVER-2 trial, assessing the safety, tolerability and pharmacokinetics of the oral galectin-3 inhibitor GB1211 in patients with moderate hepatic impairment (Child-Pugh class B) as compared to healthy volunteers. GB1211 was observed to be well-tolerated, there were no drug-related serious adverse events, and exposure was only moderately increased in the Child-Pugh class B patients. Accordingly, no dose adjustment is required for Part 2 of the trial in patients with moderate hepatic impairment. Galecto has also initiated Part 2 of the trial, which is a randomized, double-blind placebo-controlled trial designed to assess the effect of 12-week dosing of GB1211 on a wide series of biological markers of hepatic function and structure in participants with moderate hepatic impairment. The Phase 1b/2a GULLIVER-2 trial is the first in Galecto’s clinical program for GB1211 in liver cirrhosis. Liver cirrhosis represents a significant unmet medical need for which there is no currently approved disease modifying therapy. The GULLIVER-2 trial (NCT05009680) is designed to assess the safety, tolerability, pharmacokinetics and potential activity of GB1211 in up to 54 participants, including liver cirrhosis patients with moderate or severe hepatic impairment (Child-Pugh classes B and C). In Part 2 of the trial, Child-Pugh class B liver cirrhosis patients of any etiology will be randomized to evaluate the impact of GB1211 on liver fibrosis and liver function. Galectin-3 plays a key role in fibrosis development through cellular activation and the production of collagen, and Galecto has demonstrated that inhibiting the galectin-3 target with GB1211 reduces fibrosis in multiple animal models including models of liver fibrosis. Galectin-3 is elevated in cirrhosis patients and is a prognostic biomarker of hepatocellular carcinoma, a known complication of liver cirrhosis. It is estimated that more than 100 million patients suffer from liver cirrhosis worldwide and the mortality rate is high. There are no approved disease modifying therapies and liver transplantation remains the sole option for late stage liver cirrhosis. Galecto is developing GB1211, a proprietary orally available potent small molecule galectin-3 inhibitor. GB1211 has the potential to treat multiple types of cancer and fibrotic diseases. Galecto’s initial target indications for GB1211 are NSCLC, a cancer indication with a high unmet need, and liver cirrhosis, a severe, progressive disease that ultimately leads to liver failure. GB1211 demonstrated an anti-cancer effect and antifibrotic activity in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 was well-tolerated and had dose-dependent pharmacokinetics. Galectin-3 has been shown to play a central role in fibrotic diseases, including liver cirrhosis. Preclinical evidence suggests that galectin-3 is required for TGF-beta-mediated activation of myofibroblasts and subsequent matrix production in liver fibrosis. Inhibition of galectin-3 reduces YKL-40, a chitin-like glycoprotein biomarker of liver fibrosis, and reduces the development of fibrosis. Aankondiging • Sep 14
Galecto Announces First Patient Treated in Phase 2 Trial of Oral Galectin-3 Inhibitor Gb1211 in Liver Cirrhosis Galecto, Inc. announced that the first patient has been treated with the galectin-3 inhibitor GB1211 in the Phase 1b/2a GULLIVER-2 trial. This trial marks the initiation of Galecto’s clinical program for GB1211 in liver cirrhosis. Top line data from the full trial is expected in the second half of 2022. The GULLIVER-2 trial (NCT05009680) will assess the safety, tolerability, pharmacokinetics and efficacy of GB1211 in up to 54 participants, including liver cirrhosis patients with moderate or severe hepatic impairment (Child Pugh classes B and C). The trial will randomize liver cirrhosis patients of any etiology and evaluate the impact of GB1211 on liver fibrosis and liver function. Galectin-3 plays a key role in fibrosis development through cellular activation and the production of collagen, and Galecto has demonstrated that inhibiting the galectin-3 target with GB1211 reduces fibrosis in multiple animal models. Galectin-3 is elevated in cirrhosis patients and is a prognostic biomarker of hepatocellular carcinoma, a known complication of liver cirrhosis. Aankondiging • Aug 19
Galecto, Inc. Announces First Patient Treated in Phase 2a Trial of the Oral LOXL2 Inhibitor Gb2064 in Myelofibrosis (The MYLOX-1 Trial) Galecto, Inc. announced the treatment of the first patient in a Phase 2a trial of its oral LOXL2 inhibitor GB2064 in myelofibrosis. Myelofibrosis, a form of chronic leukemia, is a rare type of blood cancer in which the normal bone marrow is destroyed by fibrous scar tissue that does not produce blood cells. The open label MYLOX-1 trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB2064 in 16 patients over 9 months. The trial will also assess impact on fibrosis and quantification of the tissue targeting of GB2064, as well as other aspects of clinical response in myelofibrosis. The current standard of care for myelofibrosis is JAK inhibitors, but questions remain regarding side effects caused by the mechanism of action. LOXL-2 is an attractive target, as it is upregulated in myelofibrosis fibrotic tissue and plays a key role in fibrosis and disease progression in the tumor micro-environment. Focused inhibition of LOXL-2 is believed to be inherently safer than pan-inhibition of all LOX enzymes because some of the iso-enzymes potentially carry important liabilities. Galecto successfully completed the Phase 1 SAD/MAD study of GB2064 in healthy volunteers without observing any safety issues. Aankondiging • Jul 15
Galecto Resumes Recruitment in Phase 2b Global GALACTIC-1 Trial of GB0139 for Idiopathic Pulmonary Fibrosis Galecto, Inc. announced that it has resumed recruitment in its Phase 2b GALACTIC-1 trial of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis under a revised protocol that was submitted to the U.S. Food and Drug Administration and other regulatory bodies, including those in Australia, Germany, Spain and the United Kingdom. Following the recommendation from an independent Data Safety Monitoring Board in March 2021 to modify the GALACTIC-1 trial protocol, 38 patients continued treatment in this Phase 2b trial. Under the revised protocol, the company is now recruiting additional patients who are not taking nintedanib or pirfenidone at screening, who will be randomized 2:1 to receive either GB0139 3 mg or placebo. GALACTIC-1 is a 52-week randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b trial being conducted across more than 100 centers globally, investigating the safety and efficacy of company’s lead inhaled compound, GB0139, in up to 210 patients with IPF. The revised trial design retains the same statistical powering to assess the primary endpoint of forced vital capacity decline over 52 weeks. The company anticipates that topline data from the GALACTIC-1 trial will be available by mid-2023. Aankondiging • Jun 23
Galecto, Inc. Announces Preliminary Topline Results from Galectin-3 Inhibitor GB0139 Galecto, Inc. announced preliminary topline results from an investigator-initiated trial examining Galecto’s inhaled galectin-3 inhibitor (GB0139). This trial included 41 hospitalized patients with COVID-19 infection who did not require mechanical ventilation, of which 20 were randomized to the GB0139 arm. GB0139, dosed at 10 mg twice a day for 2 days and subsequently once a day for up to 14 days, showed a favorable safety profile with no treatment-related serious adverse events reported. GB0139 had a positive trend on acute lung injury related to COVID-19, as patients who received GB0139 showed signs of improved lung function with a significant decline in oxygen flow requirements compared to patients only receiving standard of care (SOC), which included dexamethasone, remdesivir and anticoagulant therapy. GB0139 showed target engagement by reducing galectin-3 levels compared to SOC (p < 0.01). Patients with COVID-19 were able to inhale GB0139 and achieve consistent exposure of GB0139 at levels previously associated with systemic biomarker responses in IPF patients (including YKL-40 and PAI-1). Patients showed improved inflammation and coagulation biomarkers, including CXCL10, thrombocytes and reduced D-dimers, as well as improved biomarkers of liver function and tissue damage. While the severity of the disease at baseline was worse in patients receiving GB0139, these patients had similar outcomes to patients receiving only SOC. Aankondiging • Mar 16
Galecto, Inc. Announces Outcome of Data Safety Monitoring Board Interim Review of Phase 2b GALACTIC-1 Study of GB0139 for Idiopathic Pulmonary Fibrosis: DSMB Recommends Study to Continue with Modifications Galecto, Inc. announced that an independent Data Safety Monitoring Board (DSMB) has completed its interim review of the company’s Phase 2b GALACTIC-1 study of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). On March 12, the DSMB recommended that, based upon a safety analysis of the data, the company discontinue dosing and enrolling patients in the 10 mg arm along with patients in the 3 mg arm who are receiving combination treatment with the currently approved treatments of IPF, nintedanib and pirfenidone. GALACTIC-1 is a 52-week randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b study being conducted across more than 100 centers globally, investigating the safety and efficacy of Galecto’s lead compound, GB0139, in patients with IPF. Initial unblinded data readout is anticipated in 2022. The DSMB informed the company, based on unblinded safety and efficacy data, that there was an imbalance in the serious adverse experiences across the study groups, but not an imbalance between the groups in mortality. Galecto expects to continue recruiting patients who are not taking nintedanib or pirfenidone at screening and who would be randomized to receive GB0139 3 mg or placebo. The DSMB recommended the patients randomized to the 10mg group and all those taking nintedanib or pirfenidone should be discontinued from the study. Based on these recommendations, the Company plans to work with both the study investigators and the appropriate regulatory authorities to implement these changes promptly. Is New 90 Day High Low • Feb 13
New 90-day low: US$11.99 The company is down 28% from its price of US$16.71 on 13 November 2020. The American market is up 15% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 18% over the same period. Aankondiging • Jan 09
Galecto, Inc. Announces the Appointment of Dr. Anne Prener to Its Board of Directors Galecto, Inc. announced the appointment of Dr. Anne Prener to its Board of Directors. Dr. Anne Prener has more than 25 years of leadership experience within life sciences companies, and currently serves as Chief Executive Officer of Imbria Inc. and as venture partner at SV Health Investors. Dr. Prener previously served as CEO of Freeline Ltd.Dr. Prener has led companies and teams across several therapeutic areas, including a focus on rare diseases. Aankondiging • Nov 24
Galecto, Inc. Appoints Dr. Jayson Dallas to Board of Directors Galecto, Inc. appointed Dr. Jayson Dallas to board of directors, effective as of November 19, 2020. Dr. Dallas will serve as a Class III director until his term expires at the 2023 annual meeting of stockholders, at which time he is expected to stand for election by the Company’s stockholders. Dr. Dallas was also appointed to serve on the Nominating and Corporate Governance Committee of the Board. Jayson Dallas has extensive experience in both pharmaceutical and biotech industries in the U.S., Europe and globally, most recently as Chief Executive Officer of the California-based Aimmune Therapeutics, acquired by Nestlé Health Science this year. He is a member of the Board of Directors of Arena Pharmaceuticals and has previously served in senior roles for companies including Pfizer, Novartis, Roche and Ultragenyx Pharmaceuticals. His experience spans multiple therapeutic categories and covers new product launches, licensing and managing product portfolios. Aankondiging • Oct 30
Galecto, Inc. has completed an IPO in the amount of $85.000005 million. Galecto, Inc. has completed an IPO in the amount of $85.000005 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,666,667
Price\Range: $15
Transaction Features: Sponsor Backed Offering