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Galecto(GLTO) - 2025 Q4 - Annual Report
2026-03-19 20:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39655 DAMORA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 37-1957007 (State or other jurisdict ...
Galecto(GLTO) - 2025 Q4 - Annual Results
2026-03-10 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2026 DAMORA THERAPEUTICS, INC. (Registrant's telephone number, including area code) Galecto, Inc. (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the regi ...
Galecto (NasdaqCM:GLTO) 2026 Conference Transcript
2026-03-09 15:42
Summary of Damora Therapeutics Conference Call Company Overview - **Company Name**: Damora Therapeutics (formerly Galecto) [6] - **Focus**: Development of mutant CALR directed therapies for myeloproliferative neoplasms, specifically essential thrombocythemia (ET) and myelofibrosis (MF) [6] Market Opportunity - **Market Size**: The mutant CALR-driven populations in ET and MF account for approximately 25% to over 33% of the patient population, representing a potential market opportunity of $5 billion in the U.S. [6] Financial Position - **Funding**: Raised over $500 million from private and public offerings, providing sufficient capital to advance their lead asset, DMR-001, through proof of concept and towards registration [7] Product Development - **Lead Asset**: DMR-001, expected to enter clinical trials later this year [7] - **Clinical Strategy**: Aiming for a best-in-class efficacy, safety, and convenience profile with DMR-001, which is designed to address both Type 1 and Type 2 CALR mutations [16] Competitive Landscape - **Incyte Comparison**: Incyte has shown proof of concept in CALR pathway therapies, but Damora believes their DMR-001 can provide superior efficacy, particularly for Type 2 mutations, which have been less responsive to existing therapies [15][21] - **Antibody Potency**: DMR-001 is reported to be three times more potent against Type 1 and ten times more potent against Type 2 mutations compared to Incyte's antibody [20] Clinical Insights - **Disease Modification**: Emphasis on disease modification endpoints, with a focus on reducing symptoms, spleen volume, and bone marrow fibrosis [12][28] - **JAK Inhibition Concerns**: Discussion on the potential impact of JAK washout on clinical outcomes, with a belief that DMR-001 will show more consistent benefits than JAK inhibitors [22][24] Regulatory Considerations - **Endpoints for Approval**: Damora plans to engage with regulators on novel endpoints for their therapies, potentially moving beyond traditional measures used for JAK inhibitors [66][67] Future Developments - **IND Filing Timeline**: DMR-001 IND filing is expected by mid-year, with clinical proof of concept datasets anticipated by mid-next year [42][43] - **Second Asset**: DMR-002 is also in development, with an IND filing expected by the end of the year [42] Strategic Positioning - **Patient Population Targeting**: Damora aims to redefine the patient population eligible for treatment, potentially targeting a broader range of patients than current therapies [77] - **Convenience of Administration**: Plans for a more convenient dosing regimen with an auto-injector, contrasting with the infusion methods used by competitors [35] Leadership and Organizational Development - **CEO Search**: The board is actively prioritizing the search for a new CEO, with significant interest from potential candidates [89]
Galecto Announces Name Change to Damora Therapeutics with Mission to Fundamentally Redefine Care for Patients with Blood Disorders
Globenewswire· 2026-03-09 12:00
-- Company will trade on Nasdaq under trading symbol "DMRA" effective March 10, 2026 -- -- On track to submit IND or CTA for DMR-001 in mutant-calreticulin essential thrombocythemia and myelofibrosis in mid-2026, with two clinical proof-of-concept datasets expected mid-2027 -- -- Strong financial position with approximately $535 million of cash and cash equivalents as of February 28, 2026, with anticipated runway into Phase 3 development of DMR-001 -- BOSTON, March 09, 2026 (GLOBE NEWSWIRE) -- Galecto, Inc. ...
Galecto Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2026-03-04 13:00
BOSTON, March 04, 2026 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a biotechnology company working to redefine care for people with hematologic disorders, today announced that it granted equity awards on March 2, 2026, to four newly-hired, non-executive employees. The inducement grants were approved by Galecto’s independent Compensation Committee and were made as material inducements to such individuals’ acceptance of employment with Galecto in accordance with Nasdaq Listing Rule 5635(c)(4). The induc ...
Galecto to Participate in Leerink Partners 2026 Global Healthcare Conference
Globenewswire· 2026-03-02 13:00
BOSTON, March 02, 2026 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a biotechnology company working to redefine care for people with hematologic disorders, today announced that company management will participate in a fireside chat at the Leerink Partners 2026 Global Healthcare Conference on Monday, March 9, 2026 at 10:40 a.m. ET. A live webcast of the Company’s presentation will be available under the “News & Events” tab in the Investor Calendar section of the Company’s website at https://ir.galecto.c ...
Galecto Announces Closing of Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares for Gross Proceeds of $316.3 Million
Globenewswire· 2026-02-12 21:01
Company Overview - Galecto, Inc. is a clinical-stage biotechnology company focused on developing novel therapeutics for blood cancers, including a portfolio targeting essential thrombocythemia and myelofibrosis [5] - The company's pipeline features GB3226, a first-in-class preclinical dual inhibitor aimed at treating multiple genetic subsets of acute myeloid leukemia [5] Recent Financial Activity - Galecto announced the closing of an underwritten public offering of 16,644,737 shares of common stock at a public offering price of $19.00 per share, resulting in gross proceeds of approximately $316.3 million before expenses [1] - The offering included the full exercise of the underwriters' option to purchase an additional 2,171,052 shares [1] Underwriters and Registration - Jefferies, Leerink Partners, Evercore ISI, and Guggenheim Securities served as joint book-running managers for the offering [2] - An automatically effective shelf registration statement was filed with the SEC on February 10, 2026, and the offering was conducted via a written prospectus [3]
Galecto Announces Pricing of $275 Million Underwritten Public Offering - Galecto (NASDAQ:GLTO)
Benzinga· 2026-02-11 03:42
Group 1 - An automatically effective shelf registration statement was filed with the SEC on February 10, 2026, for the offering of certain securities [1] - The offering is being conducted through a written prospectus, including a prospectus supplement, which is part of the effective registration statement [1] - A preliminary prospectus supplement and accompanying prospectus have been filed with the SEC and are available on the SEC's website [1] Group 2 - The press release contains forward-looking statements regarding the company's expectations about the offering and its future business prospects [2] - These forward-looking statements are based on current expectations and beliefs, and actual results may differ due to various risks and uncertainties [2] - The company does not undertake any obligation to update or revise the forward-looking statements made in the press release [2]
Galecto Announces Pricing of $275 Million Underwritten Public Offering
Globenewswire· 2026-02-11 03:42
Core Viewpoint - Galecto, Inc. has announced a public offering of 14,473,685 shares of common stock at a price of $19.00 per share, aiming to raise approximately $275 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 2,171,052 shares at the same public offering price [1]. - The expected closing date for the offering is around February 12, 2026, subject to customary closing conditions [2]. Group 2: Company Overview - Galecto, Inc. is a clinical-stage biotechnology company focused on developing antibody therapeutics for hematological cancers [5]. - The company's pipeline includes a mutant calreticulin (mut-CALR)-driven myeloproliferative neoplasm portfolio and GB3226, a first-in-class preclinical dual inhibitor for acute myeloid leukemia [5].
Galecto Announces Proposed Underwritten Public Offering of Common Stock and Preferred Stock
Globenewswire· 2026-02-10 21:04
Core Viewpoint - Galecto, Inc. has initiated an underwritten public offering of its common stock and Series C non-voting convertible preferred stock to support its therapeutic development for blood cancers [1][2]. Group 1: Offering Details - The public offering includes common stock and Series C preferred stock, with the latter convertible into 1,000 shares of common stock at the holder's discretion [1]. - Galecto plans to grant underwriters a 30-day option to purchase additional shares of common stock [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1]. Group 2: Use of Proceeds - Proceeds from the offering will be utilized for preclinical studies, clinical trials, manufacturing for antibody programs, and additional research and development activities [2]. - Funds will also support working capital and general corporate purposes [2]. Group 3: Management and Registration - Jefferies, Leerink Partners, Evercore ISI, and Guggenheim Securities are acting as joint book-running managers for the offering [3]. - An automatically effective shelf registration statement was filed with the SEC on February 10, 2026, and the offering will be conducted via a written prospectus [4]. Group 4: Company Overview - Galecto, Inc. is a clinical-stage biotechnology company focused on developing antibody therapeutics for hematological cancers [6]. - The company's pipeline includes a mutant calreticulin-driven myeloproliferative neoplasm portfolio and GB3226, a preclinical dual inhibitor for acute myeloid leukemia [6].