Expect to submit an Investigational New Drug application for SZN-8141 to FDA in the second half of 2026
Scheduled to present retinal vascular research on SZN-8141 at the upcoming 2026 ARVO Annual Meeting
Received notice of achievement of research milestone by
Strengthened key leadership roles in 2025 to support long-term ophthalmology strategy
Business Highlights
Recent Events and Upcoming 2026 Milestones
- Ophthalmology Pipeline Advancement:
- The Company continues to progress its lead candidates, SZN-8141 and SZN-8143, in retinal diseases and remains on track to submit an Investigational New Drug (IND) application for SZN-8141 in the second half of 2026
- In
March 2026 ,Boehringer Ingelheim achieved a research milestone under the agreement for SZN-413, reflecting a positive outcome of the IND-enabling GLP toxicology study. The research milestone entitlesSurrozen to receive a$5.0 million payment fromBoehringer Ingelheim . - Scientific Presentations Highlighting Next Generation Surrozen Wnt Therapeutics for Retinal Diseases
- The Company presented an overview of Next Generation Wnt Therapeutics in Retinal Diseases at Eyecelerator (
American Academy of Ophthalmology ) Meeting and at the Ophthalmology Innovation Source (OIS) conference in fourth quarter 2025 - The Company plans to present at the 2026
Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting onMay 4, 2026 : Poster presentation titled “Wnt signaling activation synergizing with VEGF inhibition in preclinical models of retinal vascular disease”
- The Company presented an overview of Next Generation Wnt Therapeutics in Retinal Diseases at Eyecelerator (
- In 2025, the Company significantly strengthened its strategic leadership and ophthalmology expertise by forming a
Clinical Advisory Board composed of retinal disease experts and appointing two industry veterans:Daniel Chao , M.D., Ph.D., as Vice President and Head of Clinical Development andAndrew Maleki as Chief Financial Officer.
“2025 was a year of significant momentum as we progressed two lead product candidates in retinal vascular disease, advanced our platform for developing multifunctional biologic candidates that selectively activate Wnt signaling in combination with other key disease pathways and further strengthened our management team to drive our long-term growth strategy,” said
Fourth Quarter and Full Year 2025 Financial Highlights
- Cash Position: Cash and cash equivalents were
- Revenue:
- Collaboration and License Revenue: The company did not have any collaboration and license revenue during the year ended
December 31, 2025 , compared to$10.0 million in 2024, attributable to the recognition of a milestone achieved under a collaboration and license agreement withBoehringer Ingelheim International GmbH inSeptember 2024 . - Research Service Revenue –
Related Party : Research service revenue from a related party was$0.5 million and$3.5 million for the quarter and year endedDecember 31, 2025 , compared to$0.7 million for the same periods in 2024, driven by the collaboration withTCGFB, Inc. for TGF-ß antibodies research. The collaboration was terminated inNovember 2025 .
- Operating Expenses:
- Research and Development Expenses: R&D expenses were
$9.0 million and$29.4 million for the quarter and year endedDecember 31, 2025 , compared to$5.4 million and$21.1 million for the same periods in 2024, primarily reflecting the increase in manufacturing costs, lab expenses and consulting fees for our ophthalmology programs, offset by the decrease in clinical expenses as a result of the discontinuation of clinical development of SZN-043. - General and Administrative Expenses: G&A expenses were
$4.2 million and$16.2 million for the quarter and year endedDecember 31, 2025 , compared to$3.9 million and$15.1 million for the same periods in 2024, primarily due to the increase in professional service fees.
- Other Income and Expenses:
- Interest Income: Interest income was
$0.8 million and$3.0 million for the quarter and year endedDecember 31, 2025 , compared to$0.4 million and$1.7 million for the same periods in 2024, as a result of an increase in cash and cash equivalents. - Loss on Issuance of Common Stock, Pre-funded Warrants and Warrants in the 2024 PIPE: The Company recorded a non-cash
$20.4 million loss during the year endedDecember 31, 2024 , due to the fair value of warrants issued being greater than the proceeds received in a private placement that was closed inApril 2024 . There was no such corresponding loss in 2025. - Loss on Amendment and Cancellation of Warrants: Loss on amendment and cancellation of warrants originally issued in the 2024 PIPE was zero and
$2.1 million for the quarter and year endedDecember 31, 2025 , due to the non-cash change in fair value of warrant liabilities as a result of the amendment and cancellation of warrants inMarch 2025 . - Loss on Execution of the 2025 PIPE: Loss on execution of the 2025 PIPE was zero and
$71.1 million for the quarter and year endedDecember 31, 2025 , reflecting the non-cash loss recognized upon the initial execution of the private placement inMarch 2025 (2025 PIPE) as committed proceeds from the 2025 PIPE were less than the fair value of the tranche liability recognized at contract execution date. - Loss on Change in Fair Value of Tranche Liability: Loss on change in fair value of tranche liability related to the 2025 PIPE was
$112.0 million and$104.8 million for the quarter and year endedDecember 31, 2025 , driven by the non-cash change in fair value of tranche liability, which was primarily driven by the increase in our stock price from the initial measurement date. - Gain on Settlement of Tranche Liability: Gain on settlement of tranche liability related to the 2025 PIPE was
$0.2 million and$1.4 million for the quarter and year endedDecember 31, 2025 related to the proceeds from the sale of securities in the 2025 PIPE being greater than the net value of securities issued on settlement date. - Other Expense, Net: Other expense, net was
$59.6 million and$26.3 million for the quarter and year endedDecember 31, 2025 , compared to$19.8 million and$19.3 million for the same periods in 2024, primarily driven by the non-cash change in fair value of warrant liabilities.
- Net Loss: Net loss was
Surrozen’s Ophthalmology Portfolio
About SZN-8141 for Retinal Diseases
About SZN-8143 for Retinal Diseases
Partnership with
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen’s SWAP™ technology. It is currently being developed for the treatment of retinal diseases by
Under the terms of the agreement, BI received an exclusive, worldwide license to develop SZN-413 and other Fzd4-specific Wnt-modulating molecules for all purposes, including as a treatment for retinal diseases, in exchange for an upfront payment to
About
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease or address unmet needs in serious eye diseases, as well as the potential benefits and potential differentiation from existing therapies of such product candidates); Surrozen’s intention to submit an IND application for SZN-8141 in 2026; and expectations regarding Surrozen’s partnership with
Investor/Media Contact:
Email:?Investorinfo@surrozen.com
Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share amounts) | ||||||||
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Collaboration and license revenue | $ | — | $ | 10,000 | ||||
| Research service revenue - related party | 3,477 | 655 | ||||||
| Total revenue | 3,477 | 10,655 | ||||||
| Operating expenses: | ||||||||
| Research and development | 29,365 | 21,132 | ||||||
| General and administrative | 16,204 | 15,062 | ||||||
| Total operating expenses | 45,569 | 36,194 | ||||||
| Loss from operations | (42,092 | ) | (25,539 | ) | ||||
| Interest income | 3,020 | 1,693 | ||||||
| Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE | — | (20,397 | ) | |||||
| Loss on amendment and cancellation of warrants | (2,073 | ) | — | |||||
| Loss on execution of the 2025 PIPE | (71,084 | ) | — | |||||
| Loss on change in fair value of tranche liability | (104,847 | ) | — | |||||
| Gain on settlement of tranche liability | 1,362 | — | ||||||
| Other expense, net | (26,312 | ) | (19,321 | ) | ||||
| Net loss and comprehensive loss | $ | (242,026 | ) | $ | (63,564 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (32.37 | ) | $ | (21.67 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 7,478 | 2,933 | ||||||
Consolidated Balance Sheets (In thousands) | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 89,245 | $ | 34,565 | ||||
| Accounts receivable | — | 2,039 | ||||||
| Accounts receivable - related party | 208 | 502 | ||||||
| Prepaid expenses and other current assets | 2,106 | 1,826 | ||||||
| Total current assets | 91,559 | 38,932 | ||||||
| Property and equipment, net | 433 | 562 | ||||||
| Operating lease right-of-use assets | 6,000 | 7,801 | ||||||
| Restricted cash | 688 | 688 | ||||||
| Warrant asset | — | 153 | ||||||
| Other assets | 46 | 331 | ||||||
| Total assets | $ | 98,726 | $ | 48,467 | ||||
| Liabilities and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 728 | $ | 306 | ||||
| Accrued and other liabilities | 7,912 | 5,180 | ||||||
| Lease liabilities, current portion | 1,290 | 1,829 | ||||||
| Total current liabilities | 9,930 | 7,315 | ||||||
| Lease liabilities, noncurrent portion | 5,349 | 6,640 | ||||||
| Tranche liability | 158,662 | — | ||||||
| Warrant liabilities | 112,547 | 55,892 | ||||||
| Total liabilities | 286,488 | 69,847 | ||||||
| Stockholders’ deficit: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 1 | — | ||||||
| Additional paid-in-capital | 339,522 | 263,879 | ||||||
| Accumulated deficit | (527,285 | ) | (285,259 | ) | ||||
| Total stockholders’ deficit | (187,762 | ) | (21,380 | ) | ||||
| Total liabilities and stockholders’ deficit | $ | 98,726 | $ | 48,467 | ||||
Source: 