Kent Hoover, Isabel Lippincott, Angel Pichardo, Katherine Anne

Rebholz, Beau Smith, Katrina Wiesner

Galecto Biotech

● Founded Nov 2011 by world leading Galectin and Fibrosis experts● Focus on Galectin Modulation◦ Galectins have been shown to be involved in several pathological

conditions◦ Founders have world class insight into Galectin biology and

pharmacology with dozens of publications● Target Indications: Fibrotic Diseases◦ IPF – a >$500 M IPF market opportunity with clear regulatory &

clinical path● Clinical development◦ IPF: First Human Dose completed Sept. 2014◦ Phase IIb in 24 IPF patients ongoing ◦ Three issued US composition of matter patents

Summary – Galecto Biotech

● IPF is a progressive, irreversible, ultimately fatal lung disease characterized by decline in lung function due to scarring◦ Respiratory failure◦ Median survival of 2 - 5

years◦ Cause is unknown, but

Galectin-3 is upregulated in the lung tissue of IPF patients.

Idiopathic Pulmonary Fibrosis

● US incidence of IPF: ~30,000/yr

● US prevalence: ~100,000, EU: ~120,000

◦ Increasing incidence and IPF-related deaths worldwide

● Most patients are ≥ 50 years-old at diagnosis

◦ Males more frequently affected than females

◦ In approx 10 % of cases there is a family history of IPF

IPF, an Orphan Indication

● Pirfinedone (Esbriet; Roche)

◦ Approved in EU and US

◦ Dose limiting side effects – upper GI symptoms and

skin sensitivity to light

● Nintedanib (BI)

◦ Tyrosine kinase inhibitor

◦ Just approved in EU and US

◦ Dose limiting side effects – diarrhea (> 60 %)

● Both only demonstrated to slow disease progression

IPF Drugs on Market

Lectins: Sugar binding proteins:

● Intra and Extracellular, often membrane bound. ● Mediate cellular, carbohydrate, and protein recognition● Involved in bacterial and viral binding● Can be toxic

Galectins: Non-Membrane bound

● Bind beta-galactoside sugars○ Found in Cytosol, nucleus, ECM, and Circulation○ Upregulation of Galectin-3 has been linked to fibrosis in the

lungs, kidneys and liver.

Galectins and IPF

● Affects signaling of cell surface receptors, including TGF-ß

● Galecto has developed a series of potent and specific Galectin-3 inhibitors, including TD139

TD139 Target: Galectin-3

Galectin-3

TD139

● Study design:○ Mice were treated with

bleomycin intratracheally day 0○ TD139 was instilled into the lungs

on days 18, 20, 22 and 24 ■ – well after the inflammation had

ceased

○ The level of fibrosis was evaluated at day 26■ Total collagen■ Fibrosis score (histological)■ β−catenin activation

In Vivo Study of TD139A Small Molecule Inhaled Galectin-3 Antagonist

● First in man study

completed, enabling

toxicology and safety

studies

◦ No dose limiting toxicity

observed

◦ 28 day studies conducted

◦ Highest dose tested 30

mg/kg in mice – 8 mg/kg

in dogs

Dry Powder Inhaled TD139

Plastiape monohaler

● Study design

◦ Combined healthy volunteer and patient study

● Healthy volunteer study completed:

◦ 6 dose groups (0.15, 1.5, 3, 10, 20 and 50 mg)

◦ 4 active, 2 placebo in each group

● Results

◦ Mild adverse effects only (cough & headache)

◦ All lab and other clinical parameters satisfactory

◦ Plastiape inhaler performing well

Clinical Data in Healthy Volunteers

● 20-24 patients in 2-3 dose groups

● Primary endpoint: Safety

● Secondary endpoints: Markers of efficacy

● Three centers in the UK

● Planned duration: Mar 2015 to Jun 2016

Patient StudyDaily Treatment for 14 Days

Day

0

Day

14

Examinations,Including lung lavage

Examinations,Including lung lavage

Daily inhalation of TD1390.3-10 mg

● Galectin-3 has been shown to play a central role in

fibrosis in many organs

● Development of an orally active Gal-3 inhibitor would

open up a plethora of new opportunities

● We have also identified new gal-3 inhibitors with

increased bioavailability

● Phase IIa trials for TD139 ending in June 2016

● Ca$h Money

Moving Forward...