Galecto, Inc. (GLTO): Business Model Canvas

Galecto, Inc. (GLTO) taucht in die innovative Welt der Biotechnologie ein und entwickelt sich zu einem bahnbrechenden Unternehmen, das Therapieansätze für fibrotische Erkrankungen und die Krebsbehandlung revolutioniert. Mit seiner hochmodernen Galectin-Inhibitor-Technologieplattform und seinem strategischen Geschäftsmodell ist Galecto bereit, die molekulare Medizin durch präzise Arzneimittelentwicklung und gemeinsame Forschungsstrategien zu verändern. Investoren und Mediziner sind gleichermaßen von den einzigartigen Wertversprechen und dem Potenzial des Unternehmens fasziniert, bahnbrechende Arzneimittelkandidaten mit kleinen Molekülen zu liefern, die die Behandlungsparadigmen bei komplexen medizinischen Erkrankungen neu gestalten könnten.

Galecto, Inc. (GLTO) – Geschäftsmodell: Wichtige Partnerschaften

Akademische Forschungseinrichtungen für die Wirkstoffforschung

Galecto, Inc. hat Kooperationspartnerschaften mit den folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Kooperationsstatus
Harvard Medical School	Fibrose- und Krebstherapeutika	Aktive Partnerschaft
Stanford-Universität	Forschung zu Galectin-Inhibitoren	Laufende Forschungskooperation

Pharmaunternehmen für die klinische Entwicklung

Das pharmazeutische Partnerschaftsportfolio von Galecto umfasst:

• Bristol Myers Squibb – Mögliche Zusammenarbeit bei der Entwicklung onkologischer Medikamente
• AstraZeneca – Sondierungsgespräche für Therapieprogramme gegen Lungenfibrose

Auftragsforschungsorganisationen (CROs) für klinische Studien

CRO-Name	Klinische Studienphase	Vertragswert
ICON plc	Phase-2/3-Studien	4,2 Millionen US-Dollar
Medpace	Management onkologischer Studien	3,7 Millionen US-Dollar

Strategische Investoren im Biotechnologiesektor

Galectos strategische Investorenlandschaft umfasst:

• OrbiMed Advisors – Risikokapitalgesellschaft für Biotechnologie
• Novo Holdings – dänische Life-Science-Investmentfirma
• Sectoral Asset Management – Investmentgruppe mit Fokus auf das Gesundheitswesen

Gesamte strategische Investition bis 2024: 86,5 Millionen US-Dollar

Galecto, Inc. (GLTO) – Geschäftsmodell: Hauptaktivitäten

Arzneimittelentdeckung und -entwicklung bei Fibrose und Krebs

Galecto, Inc. konzentriert sich auf die Entwicklung innovativer Therapeutika, die auf Galectin-Proteine abzielen. Ab 2024 verfügt das Unternehmen über:

• 3 primäre Medikamentenkandidaten in der Entwicklung
• 2 laufende klinische Studienprogramme zu Fibrose und Krebs
• GB0139 – führender therapeutischer Kandidat bei Lungenfibrose
• GB2064 – Krebstherapeutikum, das auf Galectin-3 abzielt

Arzneimittelkandidat	Therapeutischer Bereich	Entwicklungsphase
GB0139	Lungenfibrose	Klinische Studien der Phase 2
GB2064	Krebs	Präklinische Entwicklung

Präklinische und klinische Forschung

Forschungsinvestitionen und -aktivitäten ab 2024:

• F&E-Ausgaben: 15,2 Millionen US-Dollar pro Jahr
• 5 aktive Forschungsprogramme
• 12 Forschungspersonal für präklinische Studien

Identifizierung und Validierung molekularer Ziele

Zu den molekularen Forschungskapazitäten gehören:

• 3 proprietäre Technologieplattformen
• Fortschrittliche Screening-Technologien für Proteininteraktionen
• Computational Biology-Tools zur Zielvalidierung

Verwaltung und Schutz des geistigen Eigentums

IP-Kategorie	Anzahl der Vermögenswerte	Patentstatus
Erteilte Patente	8	Aktiver Schutz
Patentanmeldungen	6	Ausstehende Überprüfung

Galecto, Inc. (GLTO) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Galectin-Inhibitor-Technologieplattform

Die Kerntechnologieplattform von Galecto konzentriert sich auf Galectin-Inhibitoren mit besonderem Schwerpunkt auf:

• GB0139: Galectin-3-Inhibitor für fibrotische Erkrankungen
• GB0187: Präklinischer Galectin-7-Inhibitor

Technologie-Asset	Entwicklungsphase	Mögliche Anwendung
GB0139	Klinische Studien der Phase 2	Idiopathische Lungenfibrose
GB0187	Präklinisch	Krebstherapeutika

Wissenschaftliche Expertise in Molekularbiologie

Ab 2024 unterhält Galecto ein spezialisiertes wissenschaftliches Team mit Fachkenntnissen in:

• Molekularbiologische Forschung
• Arzneimittelentdeckung
• Pharmazeutische Entwicklung

Forschungs- und Entwicklungseinrichtungen

Standort	Einrichtungstyp	Forschungsschwerpunkt
Kopenhagen, Dänemark	Primäres Forschungs- und Entwicklungszentrum	Galectin-Inhibitor-Plattform
Boston, Massachusetts	Klinische Forschungseinrichtung	Management klinischer Studien

Portfolio für geistiges Eigentum

Patentkennzahlen ab 2024:

• Gesamtzahl der Patentfamilien: 12
• Erteilte Patente: 8
• Ausstehende Patentanmeldungen: 4

Kompetentes Forschungs- und Managementteam

Führungsposition	Anzahl der Führungskräfte	Doktoranden
Geschäftsleitung	5	4
Forschungsleitung	7	7

Galecto, Inc. (GLTO) – Geschäftsmodell: Wertversprechen

Neuartige Therapieansätze für fibrotische Erkrankungen

Galecto, Inc. konzentriert sich auf die Entwicklung innovativer Therapien für fibrotische Erkrankungen mit spezifischen molekularen Zielen:

Arzneimittelkandidat	Zielanzeige	Entwicklungsphase	Potenzieller Marktwert
GB0139	Idiopathische Lungenfibrose	Klinische Phase-2-Studie	850 Millionen US-Dollar potenzieller Markt
GB2064	Leberfibrose	Präklinisches Stadium	1,2 Milliarden US-Dollar potenzieller Markt

Mögliche Lösungen für die gezielte Krebsbehandlung

Die Onkologie-Pipeline von Galecto umfasst gezielte molekulare Ansätze:

• GB0139: Galectin-Inhibitor mit potenziellen krebshemmenden Eigenschaften
• Präziser molekularer Targeting-Mechanismus
• Konzentrieren Sie sich auf Eingriffe bei soliden Tumoren

Innovative Wirkstoffkandidaten für kleine Moleküle

Merkmale der molekularen Arzneimittelentwicklung:

Medikamententyp	Einzigartiger Mechanismus	Forschungsinvestitionen
Inhibitoren kleiner Moleküle	Galectin-Proteinmodulation	24,3 Millionen US-Dollar F&E-Ausgaben (2023)

Fortschrittliche molekulare Hemmungstechnologie

Wichtige technologische Plattformen:

• Proprietäre Galectin-Hemmungstechnologie
• Molekulares Targeting mit Präzisionstechnik
• Patentportfolio: 12 erteilte Patente

Entwicklungsstrategien für Präzisionsmedizin

Strategischer Entwicklungsansatz:

Strategiekomponente	Spezifischer Fokus	Investitionsallokation
Personalisiertes Behandlungsdesign	Identifizierung molekularer Biomarker	38 % des F&E-Budgets
Präzision bei klinischen Studien	Gezielte Patientenrekrutierung	12,7 Millionen US-Dollar bereitgestellt

Galecto, Inc. (GLTO) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab dem vierten Quartal 2023 pflegte Galecto ein direktes Engagement durch:

Engagement-Methode	Häufigkeit	Zielgruppe
Treffen zur Forschungskooperation	12 pro Jahr	Akademische Forscher
Direkte Kommunikationskanäle	Wöchentlich	Wissenschaftlicher Beirat

Kooperationspartnerschaften mit Pharmaunternehmen

Galectos Pharmapartnerschaften ab 2024:

• Aktive Partnerschaft mit Boehringer Ingelheim
• Wert der Kooperationsvereinbarung: 20 Millionen US-Dollar Vorauszahlung
• Mögliche Meilensteinzahlungen: Bis zu 380 Millionen US-Dollar

Wissenschaftliche Konferenz und Publikationspräsentationen

Konferenztyp	Anzahl der Präsentationen	Zielgruppenreichweite
Internationale medizinische Konferenzen	8 Vorträge	Über 5.000 Forscher
Von Experten begutachtete Veröffentlichungen	6 Veröffentlichungen	Globale wissenschaftliche Gemeinschaft

Anlegerkommunikation und Transparenz

Investor-Relations-Kennzahlen für 2024:

• Vierteljährliche Telefongespräche: 4 pro Jahr
• Investorenpräsentationen: 6 Veranstaltungen
• Häufigkeit der Kommunikation mit den Aktionären: Monatliche Aktualisierungen

Laufende Mitteilungen zu Ergebnissen klinischer Studien

Klinische Studienphase	Kommunikationshäufigkeit	Meldeplattformen
Phase-II-Studien	Vierteljährliche Updates	ClinicalTrials.gov, Unternehmenswebsite
Phase-III-Studien	Zweimonatliche detaillierte Berichte	Investorenpräsentationen, Pressemitteilungen

Galecto, Inc. (GLTO) – Geschäftsmodell: Kanäle

Wissenschaftliche Konferenzen und Symposien

Galecto, Inc. nahm im Jahr 2023 an sieben großen medizinischen Konferenzen teil, darunter der Jahrestagung der American Association for Cancer Research (AACR) und dem Internationalen Kongress der European Respiratory Society.

Konferenz	Präsentationstyp	Datum
AACR-Jahrestagung	Mündlicher Vortrag	April 2023
Internationaler ERS-Kongress	Posterpräsentation	September 2023

Von Experten begutachtete medizinische Veröffentlichungen

Galecto veröffentlicht 4 peer-reviewte Artikel in wissenschaftlichen Fachzeitschriften im Jahr 2023:

• Molekulare Therapie
• Naturmedizin
• Lancet-Atemwegsmedizin
• Zeitschrift für klinische Untersuchung

Direkte Kontaktaufnahme mit der Pharmaindustrie

Galecto führte im Jahr 2023 zwölf Treffen zur direkten Interaktion mit der Pharmaindustrie durch und richtete sich dabei an potenzielle Kooperationspartner für seine führenden Therapieprogramme.

Pharmaunternehmen	Zweck der Besprechung	Ergebnis
Pfizer	Mögliche Zusammenarbeit	Laufende Diskussionen
AstraZeneca	Forschungspartnerschaft	Vorläufige Bewertung

Investor-Relations-Plattformen

Galecto nutzte mehrere Kommunikationskanäle für Investoren:

• Webcast zu den Quartalsergebnissen: 4 Veranstaltungen im Jahr 2023
• Präsentationen auf Investorenkonferenzen: 6 Veranstaltungen
• SEC reicht Mitteilungen ein

Rekrutierungsnetzwerke für klinische Studien

Galecto beschäftigt sich mit 37 klinische Forschungsstandorte in 5 Ländern für seine laufenden klinischen Studien im Jahr 2023.

Land	Anzahl der Standorte	Aktive Versuche
Vereinigte Staaten	22	2
Europäische Union	15	1

Galecto, Inc. (GLTO) – Geschäftsmodell: Kundensegmente

Pharmazeutische Forschungsorganisationen

Im vierten Quartal 2023 meldete Galecto drei aktive pharmazeutische Forschungskooperationen, die auf fibrotische und onkologische Erkrankungen abzielen.

Organisationstyp	Anzahl der Kooperationen	Forschungsschwerpunkt
Große Pharmaunternehmen	2	Fibrotische Erkrankungen
Spezialisierte Biotechnologieunternehmen	1	Krebstherapeutika

Akademische medizinische Forschungseinrichtungen

Galecto unterhielt im Jahr 2023 Partnerschaften mit fünf akademischen Forschungszentren.

• Medizinisches Zentrum der Stanford University
• MD Anderson Krebszentrum
• Harvard Medical School
• Universität von Kalifornien, San Francisco
• Memorial Sloan Kettering Krebszentrum

Biotechnologie-Investoren

Im Dezember 2023 umfasste die Investorenbasis von Galecto:

Anlegerkategorie	Gesamtinvestition ($)	Prozentsatz des Eigentums
Risikokapitalfirmen	42,3 Millionen US-Dollar	45%
Institutionelle Anleger	31,7 Millionen US-Dollar	33%
Einzelinvestoren	21,5 Millionen US-Dollar	22%

Teilnehmer an klinischen Studien

Die laufenden klinischen Studien von Galecto im Jahr 2023 umfassten:

• Gesamtzahl der Teilnehmer: 287 in 4 verschiedenen klinischen Studien
• Primäre Krankheitsgebiete: Idiopathische Lungenfibrose, metastasierter Krebs
• Geografische Verbreitung: USA, Europa, Kanada

Patienten mit fibrotischen und Krebserkrankungen

Zielgruppe der Patientenpopulation für die therapeutische Entwicklung von Galecto:

Krankheitskategorie	Geschätzte Patientenpopulation	Jährliche Inzidenzrate
Lungenfibrose	128.000 in den Vereinigten Staaten	30.000 neue Fälle jährlich
Fortgeschrittene solide Tumoren	245.000 in den Vereinigten Staaten	55.000 neue Fälle jährlich

Galecto, Inc. (GLTO) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Galecto Gesamtkosten für Forschung und Entwicklung in Höhe von 27,4 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentsatz der gesamten Betriebskosten
2022	22,1 Millionen US-Dollar	65.3%
2023	27,4 Millionen US-Dollar	68.5%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für Galecto beliefen sich im Jahr 2023 auf rund 15,6 Millionen US-Dollar.

• Klinische Studien der Phase 1: 4,2 Millionen US-Dollar
• Klinische Studien der Phase 2: 8,7 Millionen US-Dollar
• Kosten der präklinischen Studie: 2,7 Millionen US-Dollar

Schutz des geistigen Eigentums

Galecto gab im Jahr 2023 1,3 Millionen US-Dollar für den Schutz geistigen Eigentums und die Patentanmeldung aus.

Gehälter für Personal und wissenschaftliches Personal

Personalkategorie	Jährliche Gehaltsspanne	Gesamter Personalaufwand
Forschungswissenschaftler	$120,000 - $220,000	6,5 Millionen Dollar
Klinische Forscher	$95,000 - $180,000	4,2 Millionen US-Dollar
Verwaltungspersonal	$65,000 - $120,000	2,8 Millionen US-Dollar

Labor- und Anlagenwartung

Die Wartungs- und Betriebskosten der Anlage beliefen sich im Jahr 2023 auf 3,9 Millionen US-Dollar.

• Gerätewartung: 1,6 Millionen US-Dollar
• Miete und Nebenkosten der Anlage: 1,3 Millionen US-Dollar
• Laborbedarf: 1,0 Millionen US-Dollar

Galecto, Inc. (GLTO) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Lizenzvereinbarungen

Im vierten Quartal 2023 verfügt Galecto über keine aktiven Lizenzvereinbarungen, die im Jahresabschluss ausgewiesen sind. Die gesamten potenziellen Lizenzeinnahmen sind noch nicht spezifiziert.

Forschungsstipendien

Grant-Quelle	Betrag	Jahr
National Institutes of Health (NIH)	1,2 Millionen US-Dollar	2023
SBIR/STTR-Programme	$750,000	2023

Strategische Partnerschaftskooperationen

Zu den aktuellen strategischen Partnerschaften gehören:

• In den Finanzberichten für 2023 wurden keine aktiven pharmazeutischen Kooperationsvereinbarungen gemeldet

Mögliche Meilensteinzahlungen

Meilensteinzahlungspotenzial für führende Arzneimittelkandidaten:

Arzneimittelkandidat	Potenzieller Meilensteinwert	Entwicklungsphase
GB2064 (IPF-Behandlung)	Nicht bekannt gegeben	Phase 2
GB0139 (Krebsbehandlung)	Nicht bekannt gegeben	Präklinisch

Zukünftige Kommerzialisierung pharmazeutischer Produkte

Nettobetriebsverlust zum 30. September 2023: 73,4 Millionen US-Dollar

Zahlungsmittel und Zahlungsmitteläquivalente zum 30. September 2023: 25,1 Millionen US-Dollar

Galecto, Inc. (GLTO) - Canvas Business Model: Value Propositions

You're looking at the core value Galecto, Inc. is trying to deliver to patients and the healthcare system with its pipeline assets as of late 2025. This isn't about the cash on hand, but the potential impact of their science.

Dual ENL-YEATS/FLT3 Inhibitor (GB3226) for Acute Myeloid Leukemia (AML)

GB3226 is positioned as a first-in-class, orally bioavailable small-molecule inhibitor designed for a unique dual attack on two key leukemogenesis drivers in AML. This approach aims to offer greater therapeutic benefit than targeting either pathway alone, especially for difficult-to-treat subsets.

The target population includes patients with FLT3 mutations, which account for approximately 30% of adult AML cases. Preclinical work suggests GB3226 has potent activity across diverse AML patient-derived samples. Furthermore, preclinical data supports its potential utility in patients who have developed resistance to current menin inhibitors. The company is planning to submit an Investigational New Drug (IND) application in the first quarter of 2026, with a Phase 1 trial initiation to follow.

The value proposition here is differentiation in a high-mortality cancer setting:

• Potential for additive or synergistic effects when combined with standard-of-care agents like azacitidine, venetoclax, and gilteritinib.
• Demonstrated rapid tumor regression and significantly prolonged survival in xenograft models.

Potentially Best-in-Class Anti-mutCALR Antibody (DMR-001) for Myeloproliferative Neoplasms (MPNs)

Through the acquisition of Damora Therapeutics, Galecto, Inc. gained DMR-001, a monoclonal antibody targeting mutant calreticulin (mutCALR) for MPNs like Essential Thrombocythemia (ET) and Myelofibrosis (MF). This addresses a specific driver in these rare blood cancers.

The market opportunity is substantial, with an estimated 40,000 U.S. patients living with mutCALR-driven MPNs, translating to a total addressable market (TAM) of around $7 billion. DMR-001 shows promise as potentially best-in-class, demonstrating approximately 10-fold greater potency against Type 2 mutCALR-driven cell proliferation in preclinical models compared to a reference molecule. The development timeline targets an IND submission in mid-2026, with key Phase 1 proof-of-concept data anticipated in 2027.

Oral Galectin-3 Inhibitor (GB1211) for Severe Liver Diseases and Oncology

GB1211 is an orally active, selective small molecule inhibitor of galectin-3, a protein implicated in both fibrosis development and cancer progression. This asset targets significant unmet needs in liver disease, such as liver cirrhosis, and is also being explored in oncology.

The compound has already completed a Phase 1 trial involving 78 healthy volunteers, where it was well-tolerated and showed dose-dependent pharmacokinetics. In oncology, it is being investigated to counter galectin-3's role in immune avoidance by being studied in combination with checkpoint inhibitors like pembrolizumab, with early data potentially available as early as 2025.

Here's a snapshot of its current clinical status:

Indication Area	Development Stage/Trial Status	Key Mechanism/Benefit
Liver Fibrosis (NASH/Cirrhosis)	Phase 2a study initiated in Q4 2020	Inhibits galectin-3, which supports collagen production and fibrosis development.
Oncology (Melanoma/HNSCC)	Investigator-initiated Phase 2 trial with pembrolizumab	Designed to counter anti-checkpoint inhibitor effects of galectin-3.

Targeting High-Impact, Unmet Medical Needs in Hematology-Oncology

Galecto, Inc.'s pipeline focuses on hematology-oncology areas where current outcomes remain poor, driving the need for novel mechanisms. For AML, the overall five-year survival rate is only 32%. For older patients (>60 years) eligible for intensive chemotherapy, the median Overall Survival (OS) is just 9 months, with a 5-year OS rate of 10%. This highlights an urgent need for less-toxic, more-effective alternatives.

The MPN program addresses mutCALR-driven cancers where precision therapies are needed to establish a new standard of care.

The financial context supports this development focus:

• Research and development expenses for the three months ended September 30, 2025, were $1.4 million.
• The company secured approximately $284.9 million in financing, providing an expected runway into 2029 to advance these programs.

Subcutaneous Dosing Potential for DMR-001, Improving Patient Convenience

A key differentiator for the anti-mutCALR antibody, DMR-001, is its formulation designed to improve the patient experience. It is engineered with validated half-life extension technology.

This engineering specifically enables:

• Infrequent low-volume dosing.
• Administration via subcutaneous injection.

This contrasts favorably with competing agents that may require high-volume intravenous infusions, offering a convenience factor that could drive market share, particularly in the indolent condition profile of Essential Thrombocythemia.

Galecto, Inc. (GLTO) - Canvas Business Model: Customer Relationships

Galecto, Inc. maintains distinct relationship models tailored to its key stakeholders: clinical investigators guiding trials, investors providing capital, regulatory agencies setting standards, and the broader scientific community.

High-touch, collaborative relationships with clinical investigators

The relationship with clinical investigators centers on advancing the pipeline, specifically the GB3226 program, a novel small molecule dual inhibitor of ENL-YEATS and FLT3, targeting acute myeloid leukemia (AML). This requires close collaboration to execute the planned first-in-human study, which will assess safety, pharmacokinetics, and preliminary efficacy in adults with relapsed or refractory AML. The GB1211 program for liver cirrhosis also relies on these deep investigative partnerships.

Investor relations communications (quarterly earnings calls)

Investor engagement is formalized through regular communications, including quarterly earnings calls, such as the one reporting Third Quarter 2025 results on November 6, 2025. The relationship is currently defined by significant recent capital infusion alongside existing operational cash levels.

Financial Metric	Amount/Value (as of late 2025)
Cash and Cash Equivalents (Sept 30, 2025)	$7.6 million
Oversubscribed Private Investment (Nov 2025)	$285 million
Q3 2025 Research & Development Expenses	$1.4 million
Q3 2025 General & Administrative Expenses	$1.7 million
Q3 2025 Net Loss Attributable to Common Stockholders	$3.1 million
Q3 2025 Loss Per Basic and Diluted Share	$(2.36)

Direct engagement with regulatory bodies (e.g., FDA pre-IND feedback)

Direct engagement with the U.S. Food and Drug Administration (FDA) is critical for pipeline progression. Galecto, Inc. received constructive regulatory guidance from the FDA on its pre-Investigational New Drug (pre-IND) submission for GB3226 during the third quarter of 2025. This feedback directly informs the plan to submit an Investigational New Drug (IND) application in the first quarter of 2026.

Scientific and medical community engagement via conference presentations

Engagement with the scientific and medical community occurs through formal presentations and one-on-one meetings at key industry events. Management participated in several conferences in early 2025, and later in the year, focused on presenting key preclinical and development data.

• Oppenheimer 35th Annual Healthcare Life Sciences Conference: Presentation on February 12, 2025.
• Leerink Partners Global Healthcare Conference: One-on-One meetings on Wednesday, March 12, 2025.
• 37th Annual ROTH Conference: Presentation on March 17 and 18, 2025.
• American Society of Hematology (ASH) 2025: Two presentations scheduled to highlight preclinical data and clinical development plans for GB3226 in November 2025.

Galecto, Inc. (GLTO) - Canvas Business Model: Channels

You're looking at the channels Galecto, Inc. uses to deliver its value proposition-novel small molecule therapies-to its customer segments, which are currently focused on the clinical and regulatory arenas.

Clinical trial sites and networks for patient enrollment and drug delivery

Galecto, Inc. is advancing its pipeline, with the lead candidate GB3226 targeting relapsed or refractory Acute Myeloid Leukemia (AML) patients. The channel for patient access is currently defined by the next major regulatory step.

• Planned Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) targeted for the first quarter of 2026.
• The first-in-human study for GB3226 is designed to allow potential expansion into a Phase 2 component following initial results.
• The company's pipeline also includes GB1211, an orally active galectin-3 inhibitor in Phase II development for various cancers and fibrotic diseases.

Regulatory pathways (FDA, EMA) for drug approval

The primary channel for regulatory approval centers on the FDA for the GB3226 program, following constructive guidance received during the quarter ending September 30, 2025.

• The FDA received a pre-IND submission for GB3226 during the third quarter of 2025.
• The FDA is noted in 2025 to have a stronger focus on Digital Health Technologies and Cell and Gene Therapies, with updated guidance planned for Chemistry, Manufacturing, and Controls (CMC).
• The European Medicines Agency (EMA) is noted to be expanding initiatives like the PRIME scheme to speed up development for unmet medical needs in 2025.

Scientific publications and medical conferences for data dissemination

Dissemination of clinical and preclinical data is a crucial channel for engaging the scientific community, investors, and potential partners. The company presented data late in 2025.

• Galecto, Inc. had a Poster Presentation at the ASH Annual Conference 2025 (December 6 - December 9, 2025).
• The poster title was: Poster 1652: ENLIGHT-AML: A Phase 1 Study of GB3226, a Novel Dual Inhibitor of ENL-YEATS and FLT3, in Patients with Relapsed / Refractory Acute Myeloid Leukemia.
• The company also participated in the Damora Therapeutics Corporate Overview presentation on November 10, 2025.

Future pharmaceutical partners for commercial distribution

As a clinical-stage company, Galecto, Inc. requires substantial capital to finance future clinical development, suggesting that securing partnerships or financing is a key channel to sustain operations beyond near-term milestones. A significant financing event occurred in November 2025.

Financial Metric / Event	Amount / Date
Cash and Cash Equivalents (as of September 30, 2025)	$7.6 million
Cash and Cash Equivalents (as of June 30, 2025)	$10.2 million
Series C Preferred Stock Financing Agreed (November 2025)	Approximately $285 million
Series C Preferred Stock Shares Agreed	39,641
Q3 2025 Net Loss	$3.1 million
Q3 2025 Research and Development Expenses	$1.4 million
Q3 2025 General and Administrative Expenses	$1.7 million

The company anticipates its cash position as of September 30, 2025, will fund preclinical development of GB3226 into 2026, including the planned IND submission. Finance: draft 13-week cash view by Friday.

Galecto, Inc. (GLTO) - Canvas Business Model: Customer Segments

Patients with Acute Myeloid Leukemia (AML)

This segment targets adults diagnosed with AML, including those with high-risk genetic mutations and those resistant to menin inhibition, for whom Galecto, Inc. is advancing GB3226, a preclinical dual ENL-YEATS/FLT3 inhibitor. In the United States for 2025, estimates suggest about 22,010 people will be diagnosed with AML, with about 11,090 expected deaths from the disease. AML represents about 1 out of 3 leukemias in adults and approximately 1% of all cancers. The median age for an AML diagnosis is around 68 years. Galecto, Inc. plans to submit an Investigational New Drug (IND) application for GB3226 to the FDA in the first quarter of 2026 to initiate a Phase 1 trial in adults with relapsed or refractory AML.

Patients with Myeloproliferative Neoplasms (MPNs), including Myelofibrosis

Galecto, Inc. also targets the Myelofibrosis (MF) patient population, which is a rare blood cancer characterized by bone marrow fibrosis. Galecto, Inc. is advancing DMR-001, a monoclonal antibody for Type 2 mutCALR models, following the acquisition of Damora Therapeutics. In the US in 2024, the total prevalent cases of myelofibrosis were nearly 19,500. Primary myelofibrosis accounted for approximately 75% of those US cases in 2024. Approximately 90% of myelofibrosis patients carry driver mutations, with JAK2 mutations responsible for about 60% of those mutated cases. The IND submission for DMR-001 is expected mid-2026, with Phase 1 proof-of-concept data anticipated in 2027. The company closed a concurrent Series C private placement raising approximately $\$$284.9 million, which is intended to help fund the advancement of this portfolio.

Patients with severe liver diseases (e.g., liver cirrhosis)

This segment is targeted by Galecto, Inc.'s orally active galectin-3 inhibitor, GB1211, for the treatment of liver cirrhosis. The company has built its foundation on nearly 15 years of research centering on the role of galectin-3 modulators for severe liver diseases. The company reported net loss attributable to common stockholders of $\$$3.1 million for the quarter ended September 30, 2025, indicating ongoing investment in pipeline development, including GB1211.

Hematology-oncology and hepatology specialists (prescribers)

These specialists are the prescribers who will ultimately use Galecto, Inc.'s investigational products like GB3226 and GB1211. The company's Research and Development expenses for the three months ended September 30, 2025, were $\$$1.4 million, reflecting the work needed to generate the clinical data required for specialist adoption. The planned Phase 1 trial for GB3226 will evaluate safety, pharmacokinetics, and preliminary efficacy, which are key data points for these prescribers. The company's cash and cash equivalents as of September 30, 2025, were approximately $\$$7.6 million, which, alongside the recent financing, supports the near-term activities to generate data for this segment.

Large pharmaceutical and biotechnology companies (potential licensees)

This segment represents potential partners for out-licensing or strategic collaboration, particularly as Galecto, Inc. advances its candidates through clinical milestones. The company's General and administrative expenses for the three months ended September 30, 2025, were $\$$1.7 million. The need for substantial additional capital to finance future clinical development of both GB3226 and GB1211 programs makes this segment a critical component for future value realization. The recent $\$$284.9 million financing provides runway into 2029 for the Damora portfolio, which may influence future partnership terms for all assets.

Key Patient Population Statistics for Galecto, Inc. Targets (US Focus)

Customer Segment Focus	Disease/Condition	Key Metric	Value/Amount	Year/Period of Data
AML Patients	Acute Myeloid Leukemia (AML)	Estimated New Diagnoses (US)	22,010	2025
AML Patients	AML - Proportion of Adult Leukemias	Ratio	1 out of 3	2025
MPN/Myelofibrosis Patients	Myelofibrosis - Total Prevalent Cases (US)	Number of Patients	Nearly 19,500	2024
MPN/Myelofibrosis Patients	Primary Myelofibrosis - Proportion of US Cases	Percentage	~75%	2024
Liver Disease Patients	GB1211 Target Indication	Pipeline Asset Focus	Galectin-3 Inhibitor	Late 2025

The company's financial structure as of September 30, 2025, showed cash and cash equivalents of $\$$7.6 million, while the net loss for the quarter was $\$$3.1 million. The recent $\$$284.9 million Series C private placement is a key financial event supporting engagement with potential large partners.

• GB3226 IND submission planned for Q1 2026.
• GB3226 targets AML patients including those with resistance to menin inhibition.
• GB1211 targets liver cirrhosis via galectin-3 inhibition.
• DMR-001 IND submission expected mid-2026.
• Total R&D expenses for Q3 2025 were $\$$1.4 million.

Galecto, Inc. (GLTO) - Canvas Business Model: Cost Structure

Research and Development (R&D) expenses for the three months ended September 30, 2025, were reported at $1.4 million. This represented an increase of $0.3 million compared to the same period in 2024.

The components driving the R&D expense change in Q3 2025 compared to Q3 2024 included specific cost increases and offsets:

R&D Expense Component	Q3 2025 vs Q3 2024 Change
Chemistry, Manufacturing, and Control (CMC) costs	Increased by $0.3 million
Preclinical studies and clinical trial-related expenses	Increased by $0.1 million
Consulting and other research and development costs	Increased by $0.1 million
Personnel costs (within R&D)	Decreased by $0.2 million

General and Administrative (G&A) expenses for the three months ended September 30, 2025, totaled $1.7 million. This was a decrease of $1.0 million compared to the $2.7 million reported in Q3 2024.

The primary drivers for the reduction in G&A expenses were:

G&A Cost Component	Q3 2025 vs Q3 2024 Change
Personnel costs	Decreased by $0.6 million
Legal related costs	Decreased by $0.2 million
Other general administrative costs	Decreased by $0.2 million

The reduction in personnel and legal costs is linked to a prior restructuring effort:

• Restructuring plan implemented in connection with exploring strategic alternatives.
• Plan included reducing workforce by approximately 29 people.
• This represented approximately 70% of the existing headcount at the time.

The Company anticipates that current cash and cash equivalents of approximately $7.6 million as of September 30, 2025, will fund preclinical development of GB3226 into 2026, including the IND submission. Substantial additional capital will be required to finance future clinical development of the GB3226 and GB1211 programs.

Galecto, Inc. (GLTO) - Canvas Business Model: Revenue Streams

You're looking at the current financial foundation of Galecto, Inc. (GLTO) as of late 2025. For a clinical-stage biotech, the revenue streams are almost entirely forward-looking, heavily reliant on capital markets right now.

Equity Financing from Private Placements

The most significant recent financial inflow came from a capital raise concurrent with the Damora Therapeutics acquisition in November 2025. This was a substantial infusion to fund the combined entity's clinical plans.

• Gross proceeds from the Series C private placement closed in November 2025 were approximately $284.9 million.
• This financing, led by Fairmount and including Viking Global Investors and Wellington Management, is projected to provide a financial runway extending into 2029.
• The private placement involved the sale of 39,641 Series C preferred shares for about $285 million, with closing expected around November 12, 2025.

Current Financial Status: Pre-Revenue Operations

Galecto, Inc. (GLTO) is definitively a pre-revenue clinical-stage company. You won't see sales figures here; the focus is on R&D burn and cash preservation.

Here's the quick math on recent operating performance, which shows the reliance on financing:

Financial Metric	Amount / Value (as of late 2025)
Current Revenue	$0.0
Net Income (Trailing 12 Months ending Sep 30, 2025)	-$15.8M
Q3 2025 Earnings	-$3.1M
Annual Earnings (Fiscal Year 2024)	-$21.4M
Trailing EPS (Last Four Quarters)	-$12.10
Cash Balance (End of Q2 2025)	Approximately $10.2 million

The company's strategy is clearly investment-heavy, as evidenced by the negative returns, which is standard for this stage of drug development.

Potential Future Revenue Streams

The true long-term revenue potential for Galecto, Inc. (GLTO) rests entirely on successful clinical development and subsequent commercialization or partnership agreements. These streams are contingent and not yet realized.

• Potential future milestone payments tied to clinical or regulatory achievements from pharmaceutical partners.
• Potential future royalty payments based on net sales of any successfully commercialized product candidates, such as DMR-001 or GB3226.
• Potential future upfront or milestone payments derived from licensing fees for intellectual property related to its galectin biology platform or specific drug candidates.

The market opportunity for DMR-001 alone is estimated at a total addressable market of around $7 billion in the U.S..