Surrozen Doses First DUET Patient, Expands Phase 2a
Pro forma cash reached about $220.3 million after October financings that the company said extend the runway into 2029.
Surrozen, Inc. (SRZN), a biotechnology company developing Wnt-based ophthalmic therapeutics, dosed its first patient in the Phase 1b portion of DUET, a Phase 1b/2a study of SZN-8141 in diabetic macular edema, and said it plans to expand the randomized Phase 2a portion from about 60 patients to about 150.
The company had planned in August to submit an IND for SZN-8141 by the end of the third quarter of 2026 and to start DUET by year-end, with Part 2 then described as about 60 treatment-naïve patients. The U.S. Food and Drug Administration cleared the IND on October 2, 2026, triggering the second closing of the March 2025 private placement.
President and Chief Executive Officer Craig Parker said the first patient had been dosed in the open-label, single-ascending-dose Phase 1b portion, which is designed to evaluate safety, tolerability, pharmacokinetics, immunogenicity and exploratory measures of biological and clinical activity. The expanded Phase 2a is expected to compare two dose levels of SZN-8141 with Vabysmo (faricimab-svoa) in both treatment-naïve and treatment-experienced DME patients. Topline data from Phase 1b are expected in the second half of 2027; Phase 2a topline data are expected in 2028.
For the quarter ended September 30, 2026, research service revenue from a related party was zero, compared with $1.0 million a year earlier, after termination of the TCGFB collaboration effective November 2025.
Research and development expenses were $10.8 million, up from $7.8 million a year earlier, primarily reflecting a $2.1 million increase in research and manufacturing costs for ophthalmology programs and a $0.9 million increase in employee-related expenses, mainly stock-based compensation. General and administrative expenses were $6.8 million, compared with $4.1 million a year earlier, due to a $1.7 million increase in employee-related expenses, primarily stock-based compensation, and a $0.9 million increase in professional service fees, primarily intellectual property legal fees.
The net loss was $129.7 million, or $11.02 a share, including a $113.0 million non-cash loss on changes in fair value of tranche and warrant liabilities, compared with a net loss of $71.6 million, or $8.36 a share, a year earlier. Loss on change in fair value of the tranche liability was $73.9 million, versus $40.7 million a year earlier, which the company attributed to the non-cash fair-value change tied to a higher stock price. Other expense, net was $39.1 million, versus $20.9 million a year earlier, primarily from the non-cash change in fair value of warrant liabilities. Interest income was $0.9 million.
Cash and cash equivalents were $100.4 million as of September 30, 2026, compared with $102.0 million as of June 30, 2026. Subsequent to quarter-end, Surrozen closed the second and final tranche of the March 2025 private placement for approximately $95.1 million in gross proceeds, raised approximately $29.8 million in net proceeds through its at-the-market program and $1.1 million in net proceeds from warrant exercises, bringing pro forma cash and cash equivalents to approximately $220.3 million.
The company said it anticipates cash, cash equivalents and marketable securities will provide runway into 2029, including funding for completion of the expanded DUET study and initial Phase 1b clinical development of SZN-8143.