On March 29, 2023 Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, reported financial results for the fourth quarter and full year ending December 31, 2022 and provided a business update (Press release, Synlogic, MAR 29, 2023, View Source [SID1234629504]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Last year was a tremendous year for Synlogic and our Synthetic Biotic platform given our three positive clinical readouts in three different diseases in the fourth quarter alone," said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. "We are on track to initiate Synpheny-3, the pivotal Phase 3 study for SYNB1934 in PKU, our lead program, and we were thrilled to present three data presentations – including Phase 2 PKU data as a platform presentation – at the SIMD Annual Meeting."

Fourth Quarter 2022 and Recent Highlights

Received positive opinion on orphan designation from the European Medicines Agency (EMA) for SYNB1934 for PKU
Presentation of data from both the Phase 2 Synpheny-1 study in PKU and the Phase 1 study with SYNB1353 for HCU at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting
Received Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA) for both:
SYNB1934 for PKU
SYNB1353 for HCU
Announced positive top-line Phase 2 data for PKU; advancing SYNB1934 to Phase 3
Demonstrated proof of mechanism for SYNB1353 for HCU, based on a top-line data from a Phase 1 study using a methionine meal challenge in healthy volunteers
Proof of concept achieved with Phase 1b top-line data for SYNB8802 for enteric hyperoxaluria
Anticipated Upcoming Milestones

Initiation of Phase 3 clinical trial of SYNB1934 for PKU in the first half of 2023
Advancing SYNB1353 to Phase 2 study in patients with HCU
Presentation of data from Phase 1b studies of SYNB8802, in development for enteric hyperoxaluria
Progression of preclinical pipeline programs, including partnerships
Corporate Updates

In January 2023, the company announced the appointment of Dr. Dave Hava as Head of Research and Development. Through the integration of the company’s research and development teams, Dr. Hava oversees the advancement of clinical stage programs in addition to progressing our collaboration with Roche and select preclinical programs. Dr. Hava joined Synlogic in 2020, as Chief Scientific Officer, and continues to assume this position within the company.

Fourth Quarter 2022 Financial Results

As of December 31, 2022, Synlogic had cash, cash equivalents, and short-term marketable securities of $77.6 million.

Revenue was $0.1 million for the three months ended December 31, 2022, compared to $0.6 million for the corresponding period in 2021. Revenue in both periods was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD.

Research and development expenses were $13.6 million for the three months ended December 31, 2022, compared to $11.9 million for the corresponding period in 2021.

General and administrative expenses for the three months ended December 31, 2022 were $3.8 million compared to $3.9 million for the corresponding period in 2021.

For the three months ended December 31, 2022, Synlogic reported a consolidated net loss of $16.7 million, or $0.24 per share, compared to a consolidated net loss of $15.1 million, or $0.21 per share, for the corresponding period in 2021.

Full Year 2022 Financial Results

Revenues were $1.2 million for the year ended December 31, 2022, compared to $1.8 million for the same period in 2021. Revenue in both periods was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD. Operating expenses were $68.6 million for the year ended December 31, 2022, compared to $62.5 million for the same period in 2021. For the year ended December 31, 2022, consolidated net loss was $66.1 million, or $0.92 per share, compared to a consolidated net loss of $60.6 million, or $1.09 per share, for the year ended December 31, 2021.

Financial Outlook

Based upon its current operating plan and balance sheet as of December 31, 2022, Synlogic expects to have sufficient cash to be able to fund operations into the second half of 2024.