Syntis is advancing a pipeline of proprietary programs

Program

Discovery

Pre-Clinical

Ind-Enabling

Phase 1

Phase 2

Obesity

SYNT-101

SYNT-113

SYNT-115

SYNT-101

SYNT-101: Polymer Only

SYNT-113

SYNT-113: + Small Molecule (derisked molecule & target)

SYNT-115

SYNT-115: + Biologic (derisked target and mechanism

Rare Diseases

SYNT-212

SYNT-213

SYNT-212

SYNT-212: + Biologic (established mechanism)

SYNT-213

SYNT-213: + Biologic (established mechanism)

Other TAs

Multiple

Multiple: + Biologic and Small Molecules

‘Barrier’ Function

Local/Luminal Activity

Systemic Exposure

Obesity

Obesity is a global epidemic, impacting 100 million people in the U.S. and 800 million worldwide—with the latter figure projected to reach 1.5 billion by 2030.

GLP-1 drugs have achieved unprecedented weight loss efficacy and created new hope for patients living with obesity and related conditions. Issues related to accessibility, cost, tolerability and long-term therapeutic maintenance persist, however, creating growing demand for more diverse solutions. Our portfolio of obesity therapies may offer an alternative and/or complementary approach intended to provide patients with a more affordable and sustainable path forward.

SYNT-101

SYNT-101 is being developed as a once-daily pill for the treatment of obesity. SYNT-101 works by transiently blocking nutrient absorption in the duodenum, the upper part of the small intestine, and redirecting nutrients to the distal small intestine to stimulate the natural secretion of satiety and metabolism-regulating hormones, including GLP-1. This mechanism, known as duodenal nutrient exclusion, is a key contributor to the efficacy of gastric bypass surgery, which remains the gold standard for weight loss and metabolic disease management. Recent preclinical data demonstrated 100% preservation of lean muscle mass with consistent 1% weekly weight loss in rodent models, while first-in-human data showed that SYNT-101 demonstrated strong evidence of nutrient redirection and satiety hormone modulation.

Importantly, SYNT-101 displayed strong safety and tolerability across both studies, with no adverse events reported.

SYNT-101, currently under evaluation in Phase 1/1b studies, is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of SYNT-101 in healthy volunteers and in overweight or obese patients. The 28-day multi-ascending dose arm of the trial will also evaluate changes in relevant metabolic markers associated with weight management. SYNT-101 may be used in conjunction with GLP-1 agonists for potential additive/synergistic effects.

Obesity Portfolio

Beyond SYNT-101, we are advancing at least two distinct preclinical programs that pair the SYNT platform with proprietary therapeutics built on validated mechanisms of action. Each program is designed with the potential to be used as individually or to complement and act synergistically alongside GLP-1–based therapies.

Pediatric Rare Disease Portfolio

We are also developing a portfolio of gut-restricted enzyme replacement therapies to address rare metabolic disorders that lack approved treatments.

Our two leading enzyme programs are indicated in orphan pediatric diseases Homocystinuria (SYNT-212) and maple syrup urine disorder (SYNT-213). These enzymes were acquired from Codexis, Inc. in 2024 after eight years of optimization for GI stability through Codexis’ groundbreaking CodeEvolver™ platform that discovers and develops novel, high-performance enzymes. Both enzymes have been investigated in multiple pre-clinical studies, including in non-human primates. We are developing programs in combination with SYNT technology to sustain gut-restricted activity for maximum disease control.