BOSTON, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Galecto, Inc. (the “Company” or “Galecto”) (Nasdaq: GLTO) today announced that the Company’s Board of Directors approved the grant of non-qualified stock options to purchase 312,535 shares of the Company’s common stock to one new employee (the “Inducement Grant”) on December 15, 2025 (the “Grant Date”). The Inducement Grant has been granted pursuant to the Company’s 2022 Inducement Plan, as amended from time to time. The Inducement Grant was granted as an inducement ...

Core Insights - Galecto Inc. (NASDAQ:GLTO) stock experienced a significant increase, tripling in value on Monday with a trading volume of 23.26 million shares, compared to the average volume of 2.41 million shares [1] - The company acquired Damora Therapeutics, which specializes in antibody therapeutics for mutant calreticulin-driven myeloproliferative neoplasms, enhancing its pipeline in hematological cancers [1][2] Company Developments - The acquisition of Damora Therapeutics broadens Galecto's pipeline, allowing it to advance complementary assets targeting blood cancers [2] - A private placement led by Fairmount raised approximately $284.9 million for Galecto, expected to fund operations through 2029 and support the advancement of Damora's lead program, DMR-001, with key Phase 1 proof-of-concept data anticipated in 2027 [3] Pipeline and Regulatory Updates - An Investigational New Drug (IND) submission for DMR-001 is expected in mid-2026, with plans for first-in-human subcutaneous administration [4] - Galecto aims to combine the newly acquired assets with its investigational candidate GB3226, a dual ENL-YEATS and FLT3 inhibitor for acute myeloid leukemia (AML) [4] - The company received constructive feedback from the U.S. FDA on its pre-IND submission and plans to submit an IND application for GB3226 in the first quarter of 2026 [5] Stock Performance - Following these developments, GLTO stock rose by 293.33%, reaching $19.40 [5]

Summary of Conference Call Regarding Galecto's Acquisition of Demora Therapeutics Industry and Company Involved - **Industry**: Biotechnology, specifically focusing on hematological cancers and myeloproliferative neoplasms (MPNs) - **Companies**: Galecto Incorporated and Demora Therapeutics Core Points and Arguments 1. **Acquisition Announcement**: Galecto has announced the acquisition of Demora Therapeutics, which is expected to create significant value and expand Galecto's pipeline with Demora's anti-mutant calreticulin targeted therapies [4][5] 2. **Pipeline Expansion**: The acquisition will enhance Galecto's existing programs, particularly in the treatment of hematological cancers, by integrating Demora's portfolio of potentially best-in-class antibodies [4][5] 3. **Financial Backing**: Over $285 million was raised in an oversubscribed private financing, which is anticipated to fund the combined company's lead programs, including DMR 001, extending the cash runway beyond key phase one proof of concept data expected in 2027 [5] 4. **Market Opportunity**: There are over 42,000 patients with calreticulin mutant MPNs in the U.S., representing a potential market opportunity exceeding $5 billion [9] 5. **Lead Asset - DMR 001**: DMR 001 is designed to target mutant calreticulin and is expected to enter first-in-human trials by mid-2026, with clinical proof of concept readouts anticipated in mid-2027 [8][10] 6. **Clinical Development**: DMR 001 has shown increased binding affinity and inhibition of calreticulin-driven cell proliferation in preclinical studies, with a tenfold increase in potency against type 2 mutant cells [10] 7. **Convenience of Administration**: DMR 001 is engineered for low-volume subcutaneous administration, which is crucial for patients requiring long-term therapy [10] 8. **Future Developments**: Additional assets in the pipeline include DMR 002 and DMR 003, with IND filings expected in the second half of 2026 [11] Other Important Content 1. **Management's Forward-Looking Statements**: The call included forward-looking statements regarding the potential benefits of the acquisition and future expectations for the combined company, emphasizing the inherent risks and uncertainties [2][3] 2. **Board Expansion**: New board members Julie Bruno, Chris Kane, and Peter Howan were welcomed, indicating a strengthening of governance and expertise as the company enters a new phase [5] 3. **Clinical Focus**: The focus on MPNs, particularly essential thrombocythemia and myelofibrosis, highlights the unmet medical need in this area, as there are currently no available disease-modifying therapies [4][8]

Core Insights - Galecto, Inc. has completed the acquisition of Damora Therapeutics, enhancing its portfolio of therapies targeting mutant calreticulin (mutCALR) for Myeloproliferative Neoplasms (MPNs) [2][6] - The acquisition is supported by a concurrent oversubscribed private placement that raised approximately $284.9 million, providing financial runway into 2029 for advancing clinical programs [3][6] - DMR-001, the lead program from Damora, is a potentially best-in-class monoclonal antibody with significant potency against mutCALR-driven cell proliferation, expected to enter first-in-human trials by mid-2026 [5][6] Company Overview - Galecto is a clinical-stage biopharmaceutical company focused on novel treatments for cancer and liver diseases, with a pipeline that includes first-in-class small molecule drug candidates [11] - Damora Therapeutics specializes in disease-modifying biologics for MPNs, particularly those driven by mutCALR, aiming to redefine treatment standards for these chronic hematologic cancers [12] Financial Aspects - The private placement involved participation from notable institutional investors, ensuring a strong financial position for Galecto to support its expanded pipeline [3][6] - The acquisition and funding are expected to facilitate the advancement of multiple data milestones, including Phase 1 clinical proof-of-concept data for DMR-001 anticipated in 2027 [2][3] Pipeline and Development - The combined company will leverage complementary assets, including Galecto's investigational candidate GB3226 for acute myeloid leukemia (AML), enhancing its overall therapeutic offerings [7] - DMR-001 has shown approximately 10-fold greater potency against Type 2 mutCALR-driven cell proliferation compared to reference molecules, indicating its potential effectiveness in treating MPNs [5] Market Context - MPNs are rare, chronic blood cancers affecting approximately 42,000 patients in the United States, with mutCALR mutations driving a significant portion of these cases [4]

Core Insights - Galecto, Inc. reported its operating and financial results for Q3 2025, highlighting progress in its clinical development pipeline, particularly for GB3226, a novel treatment for acute myeloid leukemia (AML) [1][2]. Financial Performance - As of September 30, 2025, cash and cash equivalents were approximately $7.6 million, which is expected to fund preclinical development into 2026, but additional capital will be needed for future clinical development [3]. - Research and development expenses increased to $1.4 million in Q3 2025 from $1.1 million in Q3 2024, primarily due to higher costs in chemistry, manufacturing, and control, as well as preclinical studies [4]. - General and administrative expenses decreased to $1.7 million in Q3 2025 from $2.7 million in Q3 2024, mainly due to reduced personnel and legal costs [5]. - The net loss attributable to common stockholders for Q3 2025 was $3.1 million, or $(2.36) per share, compared to a net loss of $3.9 million, or $(3.39) per share, in the prior year [6]. Development Pipeline - The company received positive regulatory feedback from the FDA regarding its pre-IND submission for GB3226, which is aimed at treating a broad range of AML patients, including those with high-risk genetic mutations [2]. - Preclinical data supports the potential of GB3226 to treat AML, either as a monotherapy or in combination with existing treatments, with plans for a Phase 1 trial to assess safety and efficacy [2]. Company Overview - Galecto is focused on developing novel treatments for oncology and liver diseases, with a pipeline that includes GB1211 for liver cirrhosis and GB3226 for AML [7].

Core Insights - Galecto, Inc. is presenting preclinical data and clinical development plans for GB3226, a novel dual ENL-YEATS and FLT3 inhibitor for acute myeloid leukemia (AML), at the ASH Annual Meeting in December 2025 [1][2] Group 1: Product Overview - GB3226 is a first-in-class, orally bioavailable small-molecule inhibitor targeting ENL-YEATS and FLT3, which is mutated in approximately 30% of adult AML patients [2][4] - The dual inhibition of ENL-YEATS and FLT3 may provide greater therapeutic benefits compared to existing treatments [2] - Preclinical studies show GB3226's potent activity across diverse AML patient-derived samples, leading to rapid tumor regression and significantly prolonged survival in xenograft models [2][4] Group 2: Clinical Development - Two poster presentations will detail the Phase 1 study of GB3226 in patients with relapsed/refractory AML, scheduled for December 6 and December 8, 2025 [3] - The presentations will be held at the Orange County Convention Center in Orlando, Florida, during the ASH Annual Meeting [3] Group 3: Efficacy and Safety - GB3226 demonstrated favorable pharmacokinetics and tolerability in animal studies, with potential additive or synergistic effects when combined with current standard-of-care agents [2][5] - The investigational candidate showed superior efficacy compared to both FLT3 and menin inhibitors in preclinical models [4] Group 4: Company Background - Galecto is a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer and liver diseases, with a pipeline that includes GB3226 and other first-in-class small molecule drug candidates [6]

Market Overview - Major U.S. indices closed lower, with the Dow Jones Industrial Average down 0.2% to 46,602.98, the S&P 500 down nearly 0.4% to 6,714.59, and the Nasdaq down about 0.7% to 22,788.36 [1] POET Technologies Inc. - POET Technologies shares increased by 23.51%, closing at $7.88, with an intraday high of $8.13 and a low of $6.47, within a 52-week range of $3.10 to $8.13 [2] - The company announced a non-brokered private placement, raising US$75 million through the sale of 13.6 million shares and accompanying warrants, marking the largest investment in its history. The funds will be used for corporate development, R&D expansion, and scaling its AI-related light source business [3] Oracle Corp - Oracle's stock fell by 2.52%, ending at $284.24, with fluctuations between $293.22 and $271, and a 52-week range from $118.86 to $345.72. The decline was attributed to financial challenges related to renting Nvidia chips, resulting in a nearly $100 million loss last quarter, with a gross profit margin from these rentals averaging around 16% over the past year [4] NUBURU Inc. - NUBURU's stock surged by 86.27%, closing at $0.48, with an intraday range of $0.50 to $0.30, and a 52-week high of $1.60 and low of $0.12. In after-hours trading, the stock spiked 24.5% to $0.59, following the announcement of its defense subsidiary's acquisition of Orbit S.r.l., enhancing its capabilities in defense software [5] Galecto Inc. - Galecto's stock skyrocketed by 383.02%, closing at $17.92, with an intraday high of $31.70 and a low of $16.40, within a 52-week range of $2.01 to $31.70. However, shares declined by 25.6% in after-hours trading to $13.33 [6] - The surge in Galecto's shares occurred despite the absence of company news, indicating speculative activity. The company reported having $10.2 million in cash at the end of June 2025 and anticipates needing additional capital for its cancer and liver disease programs [7] TMC The Metals Company - TMC The Metals Company shares rose by 20.21%, closing at $9.28, with an intraday high of $9.55 and a low of $7.96, and a 52-week range from $0.72 to $9.55. The rally was driven by investments in the metals sector by the Trump administration, increasing interest in rare earths and battery metals [8]

Core Viewpoint - Galecto Inc. has experienced a significant stock price increase without any news to justify the rally, indicating speculative trading activity [1][4]. Financial Position - As of June 30, 2025, the company reported cash and cash equivalents of approximately $10.2 million, which is expected to cover operating expenses and capital requirements through 2026 [1][2]. - The company anticipates needing substantial additional capital for future clinical development of its GB3226 and GB1211 programs [2]. Strategic Focus - In 2024, Galecto completed a strategic review and decided to concentrate on cancer and liver disease, utilizing its clinical-stage asset GB1211, which has shown positive results in non-small cell lung cancer and decompensated cirrhosis studies [3]. - The company has enhanced its pipeline by acquiring global rights to BRM-1420, a novel asset developed by Bridge Medicines, co-founded by Takeda Pharmaceutical Co Ltd [3].

Core Insights - Galecto, Inc. is focused on advancing its lead program, GB3226, a dual ENL-YEATS and FLT3 inhibitor for acute myeloid leukemia (AML), with plans to submit an Investigational New Drug (IND) application to the FDA in Q1 2026 [2] - The company reported a net loss of $3.4 million for Q2 2025, a decrease from $5.3 million in the same period last year, indicating improved financial performance [6][12] - As of June 30, 2025, Galecto had approximately $10.2 million in cash and cash equivalents, which is expected to fund operations into 2026, although additional capital will be needed for future clinical developments [3][11] Financial Performance - Research and development expenses for Q2 2025 were $1.5 million, down from $1.8 million in Q2 2024, primarily due to reduced preclinical studies and clinical trial-related expenses [4] - General and administrative expenses decreased to $2.0 million in Q2 2025 from $2.8 million in Q2 2024, attributed to lower personnel and legal-related costs [5] - Total operating expenses for Q2 2025 were $3.4 million, compared to $5.6 million in Q2 2024, reflecting a significant reduction in overall costs [12] Balance Sheet Overview - Total assets as of June 30, 2025, were $13.7 million, down from $17.1 million at the end of 2024, with a notable decrease in total stockholders' equity from $15.8 million to $11.0 million [11] - Current liabilities increased to $2.6 million from $1.2 million, indicating a rise in short-term obligations [11]

Core Viewpoint - Galecto, Inc. reported its operating and financial results for Q1 2025, highlighting advancements in its drug development pipeline, particularly GB3226 for AML, and a significant reduction in operating expenses compared to the previous year [1][2]. Financial Performance - Cash and cash equivalents as of March 31, 2025, were approximately $11.9 million, down from $14.2 million as of December 31, 2024 [3][11]. - Research and development expenses decreased to $0.7 million in Q1 2025 from $2.5 million in Q1 2024, a reduction of $1.8 million attributed to lower preclinical studies and personnel costs [4]. - General and administrative expenses also fell to $1.9 million in Q1 2025 from $3.3 million in Q1 2024, a decrease of $1.4 million primarily due to reduced personnel and legal costs [5]. - The net loss attributable to common stockholders for Q1 2025 was $2.5 million, or $(1.92) per share, compared to a net loss of $5.5 million, or $(5.05) per share, in the prior year [6][12]. Drug Development Progress - The company is advancing GB3226, a dual ENL-YEATS and FLT3 inhibitor for AML, with preclinical studies showing significant efficacy improvements over current treatments [2]. - The planned IND submission for GB3226 is on track for Q1 2026, with expectations for the drug to serve as both a monotherapy and a combination therapy [2]. Company Overview - Galecto is focused on developing novel treatments for oncology and liver diseases, with a pipeline that includes first-in-class small molecule drug candidates targeting cancer and fibrosis [7].