Synlogic, Inc. (Nasdaq: SYBX), a leading biopharmaceutical firm dedicated to advancing the treatment of severe diseases, disclosed its resolution to terminate Synpheny-3, an ongoing pivotal investigation of labafenogene marselecobac (SYNB1934) as a potential remedy for phenylketonuria (PKU). Consequently, Synlogic's leadership and Board of Directors have opted to scrutinize strategic options for the Company's future.

The determination to conclude Synpheny-3 stemmed from an internal assessment preceding an imminent independent evaluation by the Data Monitoring Committee (DMC), indicating that the trial was unlikely to achieve its primary objective. The resolution did not arise from apprehensions regarding safety or tolerability. Synlogic will collaborate with the Synpheny-3 clinical trial sites to effectuate the discontinuation.

"It is with a heavy heart that we share this news, and our resulting decision to end Synpheny-3. Based on the program’s progress and data to date, we had expected the study to demonstrate the potential for SYNB1934 to provide an important new treatment option for those affected by PKU," said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. "We express our deep gratitude for the support and partnership we have received from the PKU community, including the clinical trial site investigators and staff."

Synlogic's Board of Directors intends to evaluate strategic alternatives to enhance shareholder value, encompassing acquisition, merger, reverse merger, other business amalgamations, asset sales, dissolution, or other strategic transactions. The exploration of strategic alternatives does not guarantee agreements or transactions, nor does it assure successful completion or favorable terms.

The Company has not set a timeline for the strategic review's conclusion and does not plan to provide further updates on its progress unless the Board of Directors approves a definitive course of action or deems additional disclosure necessary.

Synlogic will wind down operations and downsize its workforce by over 90%, retaining select employees to facilitate the strategic review and manage the trial's discontinuation. Most affected positions will be terminated by February 2024. As of December 31, 2023, the unaudited balance of cash, cash equivalents, and short-term investments stood at $47.7 million. Dr. Brennan will also step down as President and Chief Executive Officer as part of the reduction and resign from the Board of Directors.

"I want to express my deepest thanks and appreciation to every person who has been part of Synlogic, and in so doing contributed to the science we have advanced and special company we have built," said Dr. Brennan.

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