Galecto Highlights Key Strategic Priorities and Anticipated 2026 Milestones

Rhea-AI Summary

Galecto (NASDAQ: GLTO) outlined 2026 strategic priorities after acquiring Damora and expanding leadership. Key clinical milestones include an IND submission for DMR-001 (anti-mutCALR antibody) expected mid-2026 with first-in-human subcutaneous dosing and Phase 1 proof-of-concept data anticipated in 2027. A second anti-mutCALR candidate, DMR-002, is planned for IND submission in H2 2026, and GB3226 (ENL-YEATS/FLT3 inhibitor) targets an IND in Q1 2026. Management added a new COO and CMO with deep hematology/oncology experience. Financially, the company raised $285M in a November PIPE, providing runway into 2029 to support multiple data milestones.

Positive

• Raised $285M in November PIPE providing runway into 2029
• DMR-001 IND planned mid-2026 with subcutaneous first-in-human dosing
• Phase 1 proof-of-concept for DMR-001 anticipated in 2027
• DMR-002 IND planned H2 2026
• GB3226 IND planned Q1 2026
• Appointed experienced COO and CMO with hematology/oncology development track records

Negative

• None.

News Market Reaction

+6.44%

7 alerts

+6.44% News Effect

+8.5% Peak in 30 hr 20 min

+$2M Valuation Impact

$38M Market Cap

0.4x Rel. Volume

On the day this news was published, GLTO gained 6.44%, reflecting a notable positive market reaction. Argus tracked a peak move of +8.5% during that session. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $38M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

DMR-001 IND timing: mid-2026 DMR-001 Ph1 PoC: 2027 DMR-002 IND timing: second half of 2026 +5 more

8 metrics

DMR-001 IND timing mid-2026 Expected IND submission or equivalent for DMR-001

DMR-001 Ph1 PoC 2027 Anticipated Phase 1 clinical proof-of-concept data for DMR-001

DMR-002 IND timing second half of 2026 Planned IND submission or equivalent for DMR-002

GB3226 IND timing first quarter of 2026 Planned IND submission for GB3226 in AML

PIPE proceeds $285M Capital raised in November PIPE financing

Cash runway into 2029 Stated operational runway supported by November PIPE cash

LifeSci event dates January 12–14, 2026 15th Annual LifeSci Partners Corporate Access Event participation

COO experience over 20 years Industry experience of newly appointed Chief Operating Officer

Market Reality Check

Price: $24.98 Vol: Volume 13,770 is at 0.2x ...

low vol

$24.98 Last Close

Volume Volume 13,770 is at 0.2x the 20-day average volume of 67,320. low

Technical Shares at $20.50 are trading above the 200-day MA of $8.27.

Peers on Argus

GLTO is up 0.64% while close peers show mixed moves (e.g., QLGN +7.72%, ENTO -5....

GLTO is up 0.64% while close peers show mixed moves (e.g., QLGN +7.72%, ENTO -5.68%), suggesting a stock-specific reaction to the strategic and pipeline update rather than a broad biotech move.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Leadership additions	Positive	+2.7%	New COO and CMO plus reiteration of DMR-001 timeline and funding runway.
Dec 16	Equity inducement	Neutral	-5.1%	Inducement option grant with <b>312,535</b> options at <b>$32.00</b> strike to new hire.
Nov 10	Acquisition & funding	Positive	+248.5%	Damora acquisition and ~<b>$284.9M</b> private placement to fund mutCALR pipeline.
Nov 06	Q3 2025 earnings	Negative	-2.0%	Low cash of <b>$7.6M</b> and going-concern disclosure despite GB3226 progress.
Nov 03	Conference data	Positive	-8.5%	Positive preclinical GB3226 data ahead of ASH presentation for AML program.

Pattern Detected

Price has generally moved in the same direction as news tone, with one notable divergence on seemingly positive preclinical data.

Recent Company History

Over the last few months, Galecto reshaped its story around hematologic oncology. The Damora acquisition and a private placement raising about $284.9M repositioned the company around anti‑mutCALR antibodies and GB3226, with runway guided into 2029. Subsequent updates have reiterated IND timing for DMR-001 and GB3226 and detailed new leadership hires. Today’s announcement largely restates these timelines, emphasizes management expansion, and highlights anticipated 2026 milestones, reinforcing the strategic pivot described in prior releases.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-12-16

An effective S-3 dated 2025-12-16 registers 60,513,309 common shares for resale by existing holders from prior Damora and PIPE deals. Galecto will not sell shares or receive proceeds from these resales, but the registration enables existing investors to exit positions, which can influence secondary-market supply.

Market Pulse Summary

The stock moved +6.4% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +6.4% in the session following this news. A strong positive reaction aligns with the strategically important milestones outlined, including IND submissions for DMR-001, DMR-002, and GB3226, and a stated cash runway into 2029 after the $285M PIPE. Historically, large financing and acquisition updates have coincided with sizable moves. However, the presence of a resale shelf for over 60M shares and prior volatility suggest investors should weigh potential supply overhang and execution risks on upcoming clinical catalysts.

Key Terms

mutant calreticulin, monoclonal antibody, investigational new drug application, subcutaneous, +3 more

7 terms

mutant calreticulin medical

"DMR-001, a potentially best-in-class mutant calreticulin (“mutCALR”) targeting monoclonal antibody"

Mutant calreticulin is an abnormal version of a normal cellular protein caused by a change in the gene that makes it; think of it as a misprinted recipe that produces a different ingredient. It is important to investors because this abnormal protein is a known marker and driver in certain blood cancers, guiding diagnostic tests, prognosis, and the development or commercial potential of targeted therapies and companion diagnostics.

monoclonal antibody medical

"mutCALR targeting monoclonal antibody, on track for expected IND submission"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

investigational new drug application regulatory

"An Investigational New Drug application (“IND”), or equivalent, submission for DMR-001"

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

subcutaneous medical

"first-in-human dosing via subcutaneous administration is expected to occur in mid-2026"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

acute myeloid leukemia medical

"GB3226 is a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (AML)"

A fast‑moving blood cancer that starts in the bone marrow and crowd out healthy blood cell production, leaving the body short of normal red cells, white cells and platelets. It matters to investors because the disease creates urgent medical need, drives demand for new diagnostics and treatments, and so clinical trial results, regulatory decisions and drug pricing can rapidly change the commercial prospects and valuation of companies working on therapies.

PIPE financial

"cash balance, following $285M raised in the November PIPE, provides financial runway into 2029"

A "pipe" is a planned series of financial transactions or projects that companies intend to carry out over time, often involving the raising of funds or development of new assets. It matters to investors because it provides a clear picture of a company's future growth plans and potential revenue, helping them assess the company's upcoming opportunities and overall stability. Think of it as a detailed roadmap guiding a company's future steps.

FLT3 medical

"GB3226 is a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of AML"

FLT3 is a gene that makes a protein acting like a growth switch for blood-forming stem cells; when that switch is faulty or overactive it can drive certain blood cancers, most notably acute myeloid leukemia. Investors care because drugs that target FLT3 mutations can become important therapies, influencing clinical trial outcomes, regulatory approvals and the future revenues and valuations of biotech companies—think of it as a key control knob whose position can determine a treatment’s market value.

AI-generated analysis. Not financial advice.

• DMR-001, a potentially best-in-class mutant calreticulin (“mutCALR”) targeting monoclonal antibody, on track for expected IND submission, or equivalent, in mid-2026 with anticipated first-in-human dosing via subcutaneous administration
• Recent addition of deep hematology/oncology drug development experience with the appointment of a Chief Operating Officer and Chief Medical Officer
• Pipeline of additional candidates advancing to the clinic, with first IND submission of DMR-002 expected in second half of 2026
• Cash balance, following $285M raised in the November PIPE, provides financial runway into 2029 to support multiple data milestones, including Ph1 clinical proof-of-concept data for DMR-001 anticipated in 2027

BOSTON, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO) a biopharmaceutical company focused on developing novel therapeutics to redefine the treatment paradigm for people living with blood cancers, today highlighted its key strategic priorities and anticipated 2026 milestones. In addition, Galecto announced that management will participate in the 15^th Annual LifeSci Partners Corporate Access Event taking place in San Francisco, California, from January 12^th to 14^th, 2026.

“We are thrilled to start this new chapter for Galecto following the successful acquisition of Damora and the addition of exceptional leaders to our team”, said Hans Schambye, Ph.D., Chief Executive Officer of Galecto. “These milestones strengthen our position and accelerate our mission to deliver transformative therapies to patients. Looking ahead, 2026 will be a pivotal year as we prepare to submit an IND, or equivalent, for DMR-001 by mid-year and for DMR-002 in the second half of the year. With our expanded capabilities and growing talented team, we are well positioned to advance these programs and create meaningful impact for patients worldwide.”

Recent Management Team Expansion

• Sherwin Sattarzadeh appointed Chief Operating Officer. Mr. 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.
  
• Becker Hewes appointed Chief Medical Officer. Dr. 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 industry-leading 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 B.Sc. 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.
  

Anticipated 2026 milestones for Galecto’s pipeline

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.
  

Strong financial position

The Company anticipates that its cash balance, following $285 million raised in the November PIPE, provides operational runway into 2029.

In addition, management will participate in the 15^th Annual LifeSci Partners Corporate Access Event taking place in San Francisco, California, from January 12^th to 14^th, 2026. Galecto will be hosting 1x1 meetings during the event. Interested investors can request meetings with Galecto by registering here: https://cae.lifescipartners.com/2026.

About Galecto
Galecto, Inc. is a clinical-stage biotechnology company advancing a pipeline of antibody therapeutics to transform treatment of a broad spectrum of hematological cancers. Galecto’s pipeline includes a highly differentiated mutant calreticulin (mut-CALR)-driven myeloproliferative neoplasm portfolio targeting essential thrombocythemia and myelofibrosis. Galecto’s pipeline also includes GB3226, a first-in-class preclinical dual inhibitor of ENL-YEATS and FLT3 for the treatment of multiple genetic subsets of AML. For regular updates about Galecto, visit www.galecto.com.

Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of its assets, pipeline and business including, without limitation, the timing for IND submissions for DMR-001, DMR-002 and GB3226, the expected method of administration for DMR-001, the expected timing for Phase 1 data for DMR-001 and the length of time that the Company believes its existing cash resources will fund its operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the Company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the headings “Risk Factors,” “Cautionary Information Regarding Forward-Looking Statements” or “Cautionary Statement Regarding Forward-Looking Statements” in the Company’s most recent filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The Company does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

Media Contact:

Lia Dangelico
Deerfield Group
lia.dangelico@deerfieldgroup.com

Investor Contact:

Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

FAQ

When will Galecto (GLTO) submit the IND for DMR-001?

An IND, or equivalent, for DMR-001 is expected to be submitted by mid-2026.

What timeline does Galecto (GLTO) expect for DMR-001 Phase 1 data?

Galecto anticipates Phase 1 proof-of-concept data in 2027 for DMR-001.

How long is Galecto's (GLTO) cash runway after the November PIPE?

The company says the $285M November PIPE provides operational runway into 2029.

When is Galecto (GLTO) planning IND submissions for DMR-002 and GB3226?

DMR-002 is planned for an IND in the second half of 2026; GB3226 is planned for an IND in Q1 2026.

What administration route will Galecto (GLTO) use for first-in-human DMR-001 dosing?

The anticipated first-in-human dosing for DMR-001 is via subcutaneous administration.

What recent leadership hires did Galecto (GLTO) announce and why do they matter?

Galecto appointed a new COO and CMO with deep hematology/oncology drug development experience to support clinical advancement.