SYNlogic, Inc. (NASDAQ: SYBX) is a late-stage biopharmaceutical company advancing novel, orally-administered, non-systemically absorbed therapeutics for serious diseases based on the company's Synthetic Biotic product platform. The company's pipeline is focused on rare metabolic diseases, led by labafenogene marselecobac (previously referred to as SYNB1934), currently being studied as a potential treatment for phenylketonuria (PKU) in Synpheny-3, a global, pivotal Phase 3 study.
Business Overview
SYNlogic is a clinical-stage biotechnology company focused on developing Synthetic Biotics, which are generated from the company's proprietary platform, leveraging a reproducible, modular approach to the generation of novel drug candidates that perform or deliver critical therapeutic functions. The company's Synthetic Biotics are designed to metabolize toxic substances, compensate for missing or damaged metabolic pathways, or deliver combinations of therapeutic factors. SYNlogic's goal is to discover, develop, and ultimately commercialize Synthetic Biotics for the treatment of serious diseases.The company's pipeline is primarily focused on advancing late-stage drug candidates for rare metabolic diseases, which present a strong biological fit with Synthetic Biotics and also provide synergies in clinical trial execution and commercialization. Metabolic diseases result from alterations in how bodies break down or produce important metabolites or molecules needed for normal function. SYNlogic's approach enables the design of GI-restricted, oral medicines designed to consume or modify disease-specific metabolites – an approach well suited for PKU and homocystinuria (HCU), as well as other disorders in which the disease-specific metabolites transit through the GI tract, providing validated targets for these Synthetic Biotics.
Late-Stage Programs Focused on Rare Metabolic Diseases
SYNlogic's pipeline is led by labafenogene marselecobac, an orally administered, non-systemically absorbed, potential treatment for PKU. PKU is a rare metabolic disease caused by inherited mutations that impair the breakdown of phenylalanine (Phe), an amino acid found in all protein-containing foods. The goal of PKU management is to reduce plasma Phe below neurotoxic levels, reducing the risk of neurocognitive complications. Current treatment options for PKU are limited due to safety and efficacy, leaving the majority of people living with PKU without medical management and with uncontrolled Phe. SYNlogic designed labafenogene marselecobac to target and consume Phe in the GI tract by applying precision genetic engineering to a well-characterized probiotic. Results to date indicate the potential for labafenogene marselecobac to be the first and only orally administered, non-systemically absorbed medical treatment option for FDA available for patients to take alone, or as an adjunct to other medications for PKU.Following successful Phase 2 results, labafenogene marselecobac is currently being evaluated in Synpheny-3, a global, pivotal Phase 3 study. Labafenogene marselecobac has received Orphan Drug Designation, Fast Track designation, and Rare Pediatric Disease Designation (RPDD) from the FDA in addition to orphan designation from the European Medicines Agency (EMA).
SYNlogic's pipeline also includes SYNB1353, the company's drug candidate for HCU. HCU is a rare inherited metabolic disorder caused by a genetic defect that causes homocysteine and other toxic chemicals and their byproducts to build up in the blood and urine. SYNB1353 was designed to consume methionine in the GI tract as a means of reducing systemic levels of total homocysteine (tHcy). Like labafenogene marselecobac, SYNB1353 is an orally-administered, non-systemically absorbed investigational biotherapeutic. In November 2022, the company announced that proof of mechanism was achieved based on the positive findings from a Phase 1 study in healthy volunteers using a dietary model of homocystinuria, which showed that SYNB1353 reduced plasma methionine by metabolizing methionine and preventing its absorption in the GI tract. The FDA has granted SYNB1353 Fast Track, Orphan Drug, and Rare Pediatric Disease designations as a potential treatment for HCU.
Additional Clinical Pipeline & Preclinical Research Programs
In 2022, SYNlogic achieved proof of concept for SYNB8802, in development for enteric hyperoxaluria, a well-recognized cause of recurrent kidney stones. The company also announced the naming of SYNB2081, a Synthetic Biotic designed to metabolize uric acid as a potential biotherapeutic for gout, which is currently in IND-enabling studies. SYNlogic believes that both of these product candidates present compelling opportunities to help patients in significant need of new treatment options.The company also has ongoing preclinical research activities to advance a Synthetic Biotic for cystinuria, a rare, genetic cause of recurrent kidney stones which is also caused by an underlying metabolic disorder. In addition, SYNlogic has continued its preclinical research collaboration with Roche, focused on inflammatory bowel disease (IBD), which began in June of 2021.
Financials
For the full year 2022, SYNlogic reported annual net loss of $57.3 million, annual revenue of $3.4 million, annual operating cash flow of -$51.6 million, and annual free cash flow of -$51.8 million.For the third quarter of 2023, the company reported revenue of $0.4 million, compared to $0.7 million in the prior year period. The decrease in revenue was primarily due to lower collaboration revenue associated with the Roche Collaboration and Option Agreement.
Research and development expenses for the third quarter of 2023 were $9.6 million, compared to $14.6 million in the prior year period, a decrease of $5.0 million. The decrease was primarily driven by lower clinical, manufacturing, and professional costs associated with earlier generation product candidates, partially offset by an increase in costs for the company's lead program, labafenogene marselecobac.
General and administrative expenses for the third quarter of 2023 were $3.4 million, compared to $4.4 million in the prior year period, a decrease of $1.0 million. The decrease was primarily attributable to lower professional services costs and reduced compensation, benefits, and other employee-related expenses due to lower headcount.
Net loss for the third quarter of 2023 was $12.1 million, compared to a net loss of $17.9 million in the prior year period. The decrease in net loss was primarily due to the lower operating expenses.
As of September 30, 2023, SYNlogic had approximately $33.4 million in cash and cash equivalents. Inclusive of the net cash proceeds of $19.6 million received in October 2023 from the sale of the company's common stock, management believes that the company has sufficient cash and other sources of liquidity to fund its operations through at least the next 12 months.