Spyre Therapeutics, Inc.

Aeglea reported a fourth-quarter 2018 net loss of $14.9 million, or $0.62 per share, versus a net loss of $6.5 million, or $0.39 per share, in Q4 2017. Fourth-quarter 2018 R&D expense was $11.8 million versus $5.8 million a year earlier, and G&A expense was $3.5 million versus $2.3 million. All 2018 and 2017 revenue came from a $19.8 million cancer research grant, with the full grant revenue recognized over the life of the award. The company said it completed a February financing for $69 million gross proceeds, resulting in pro forma cash of approximately $139 million at Dec. 31, 2018 and expected cash runway through the PEACE pivotal trial readout in 1Q21. Forward-looking guidance included first patient dosing in PEACE in Q2 2019, top-line SCLC combination data in 1H20, homocystinuria IND filing in 1Q20, and cystinuria IND filing in 2H20.

Anthony Quinn struck an upbeat tone, framing 2018 as a year of substantial progress and saying the company is well positioned for 2019. He emphasized three priorities: advancing pegzilarginase in arginase 1 deficiency, continuing oncology development, and pushing new pipeline assets toward the clinic. He also highlighted the February financing as a key balance-sheet step that supports execution into 2021.

Charles York focused on financing strength, liquidity, and spending plans. He said the February financing added $69 million gross proceeds and lifted pro forma cash to about $139 million at Dec. 31, 2018, with runway expected through the PEACE readout in 1Q21. He also quantified Q4 losses and expenses, with net loss of $14.9 million, R&D of $11.8 million, and G&A of $3.5 million, and guided to quarterly burn of $12 million to $15 million in 2019, except for Q1 at $15 million to $17 million due to pipeline and manufacturing ramp.

Analysts pressed on how the new cystinuria and homocystinuria programs will produce clinical proof of concept, and management said homocystinuria will likely show early readouts from homocystine lowering in patients, while cystinuria has the advantage of an FDA-listed surrogate endpoint. Questions also focused on the SCLC program and the rationale for moving to Phase 2 despite no objective responses; management said safety was consistent with prior experience, no dose-limiting toxicities were seen, and the selected 0.27 mg/kg dose was supported by the Phase 1 data. Another question addressed ARG1-D prevalence, where management said their estimate of at least 600 patients in major markets may be conservative because they have already identified more than 170 patients. The company also confirmed it has Rare Pediatric Disease designation, but said any pediatric voucher would only be available after approval.