UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39635 Surrozen, Inc. (Exact name of registrant as specified in its charter) Table of Contents | | | Page | | --- | --- | --- | | PAR ...

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 Boehringer Ingelheim for SZN-413, triggering $5 million milestone payment Strengthened key leadership roles in 2025 to support long-term ophthalmology strategy SOUTH SAN FRANCISCO, Calif., March 23, 2026 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” o ...

© 2026 Surrozen, Inc. March 2026 Restoring Vision Through the Science of Renewal Legal Disclaimers This presentation 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-look ...

Summary of the Conference Call Company Overview - **Company**: Surrozen - **Industry**: Biotechnology, specifically focusing on retinal vascular diseases - **Key Products**: SZN-8141 and SZN-413, targeting Wnt biology and VEGF inhibition Core Points and Arguments Company Strengths - Surrozen combines expertise in Wnt biology with multivalent antibody technology, focusing on retinal vascular diseases [2][3] - Unique approach of combining Wnt, VEGF, and IL-6 inhibition in a single molecule, SZN-8141, which is currently the only known product to do so [2][3] Challenges - The company is in the execution phase, with an IND filing planned for 2026 [3] - Current therapies primarily slow disease progression rather than improve visual outcomes, highlighting the need for innovative solutions [3] Opportunities - Potential to improve visual and anatomic outcomes in diabetic macular edema and wet AMD [3] - The ability to stimulate normal vessel growth in the retina, which is a unique aspect of Wnt biology [4] Product Details - **SZN-8141**: An IgG-based multispecific molecule that activates Wnt signaling by binding to Fzd4 and LRP5 receptors, while also acting as a VEGF trap [9][10] - Preclinical data indicates that SZN-8141 shows synergistic benefits compared to existing therapies like EYLEA [12] Clinical Development - The first human trial design is still being finalized, with an emphasis on determining dosing and patient endpoints [18][19] - The company plans to conduct a phase 1b/2a study with ascending doses to evaluate visual acuity and retinal drying [19] Competitive Landscape - Merck's program, which is similar, has two phase 3 trials ongoing, with top-line data expected in September 2023 [26] - Surrozen aims to demonstrate that combining multiple mechanisms in one antibody will yield better outcomes than single-target therapies [27] Financial Aspects - Surrozen has a cash balance of approximately $80 million, with additional funding expected upon IND clearance [102] - The company is currently self-funding its clinical studies for SZN-8141 and SZN-8143, indicating a strong financial position for development [96] Safety and Risks - No theoretical risks associated with combining VEGF and Wnt inhibition have been identified, although immunogenicity risks are always a concern with large molecules [42][87] - Recent studies have shown some retinal vascular occlusions, but these are not deemed above the expected background rate [88] Future Directions - Surrozen plans to advance both SZN-8141 and SZN-8143, with SZN-8143 targeting more inflammatory-driven diseases [63][64] - The company is optimistic about the potential for IL-6 inhibition to provide additive benefits in retinal diseases [68][70] Additional Important Information - The market for retinal diseases is becoming increasingly attractive, with growing strategic interest from larger pharmaceutical companies [100][101] - Surrozen's strategy includes leveraging the small number of retinal specialists in the U.S. for commercialization, making it a tractable market for a small biotech firm [96][97]

Surrozen (NasdaqCM:SRZN) Conference Call Summary Company Overview - Surrozen is a biotech company founded in 2016, focusing on Wnt biology and antibody engineering, particularly in retinal diseases [3][4] Core Points and Arguments Wnt Pathway and Retinal Diseases - The Wnt pathway is critical for the development and maintenance of various tissues, including the eye [3] - Surrozen is targeting the Fzd4 receptor, which is essential for normal retinal vessel function [4] - Diseases associated with the loss of function of the Wnt pathway include rare conditions like Norrie Disease and FEVR, but the focus is on more prevalent retinal vascular diseases such as diabetic macular edema (DME) and wet age-related macular degeneration (AMD) [6][7] Competitive Landscape - Surrozen's lead molecule is positioned against competitors like Merck, which has a similar pharmacological approach and is currently in Phase III trials [6][7][29] - The current market is dominated by Roche's Vabysmo and Eylea, which are anti-VEGF therapies [29] Mechanism of Action - Surrozen's approach involves activating the Wnt pathway to restore normal vessel architecture and function, contrasting with existing therapies that inhibit pathological factors like VEGF [17][20] - Activation of the Wnt pathway is shown to upregulate tight junction proteins, which help seal leakage in retinal endothelial cells, particularly relevant in DME [19][20] Clinical Development - Surrozen has three programs: two internal molecules (8141 and 8143) and one partnered with Boehringer Ingelheim (SZN-413) [27][82] - The IND for molecule 8141 is expected to clear in 2026, with ongoing IND-enabling work [41][61] - Molecule 8141 is a bispecific tetravalent antibody targeting Wnt and VEGF, while 8143 adds IL-6 inhibition, making it trifunctional [71][72] Upcoming Milestones - The first Phase III trial data for Merck's molecule is expected in September 2026, which could validate the Wnt pathway's role in treating retinal diseases [75] - Surrozen anticipates updates on the IND timelines and further details on clinical trial designs soon [70][88] Intellectual Property and Financial Health - Surrozen has a robust patent estate with approximately 38 applications, focusing on multivalent Frizzled and LRP5/6 binding antibodies [89] - The company completed a PIPE in March 2025, raising $175 million, with $80 million in cash reported at the end of Q3 2025 [90] Other Important Information - The partnership with Boehringer Ingelheim has yielded $22.5 million, with hopes for clinical advancement of SZN-413 [82][85] - Roche's acquisition of Frizzled and LRP binders from University of Toronto is noted, but no updates on their progress have been provided [87] This summary encapsulates the key points discussed during the conference call, highlighting Surrozen's strategic focus, competitive positioning, and future milestones in the context of retinal disease treatment.

Summary of Surrozen Conference Call Company Overview - **Company**: Surrozen - **Focus**: Development of multifunctional antibodies targeting ophthalmologic conditions, particularly diabetic macular edema (DME) and wet age-related macular degeneration (AMD) Key Points Industry and Market Context - Surrozen is positioned in the ophthalmology space, particularly focusing on retinopathies and the competitive landscape influenced by recent acquisitions, such as Merck's acquisition of EyeBio [1][3] Product Pipeline and Development Plans - Surrozen plans to file an Investigational New Drug (IND) application for an ophthalmology candidate in 2026, focusing on a multifunctional antibody aimed at improving visual function and retinal health [2] - The company has a strong intellectual property portfolio around Wnt biology, which is foundational to its product development [3][4] - Surrozen has licensed its first product to Boehringer Ingelheim, which is expected to enter the clinic soon, representing a direct competitor to EyeBio's Restoret molecule [3] Mechanism of Action and Clinical Benefits - Surrozen's lead molecule, 8141, combines Wnt agonism and VEGF inhibition, targeting the two largest contributors to retinopathy pathologies [4] - A trifunctional molecule, 8143, is also in development, which includes IL-6 inhibition alongside Wnt and VEGF targeting, potentially addressing more inflammatory-driven diseases [5] - Preclinical data suggests that the bi-specific approach (Wnt and VEGF) shows synergy, outperforming separate injections or co-formulations in terms of efficacy [8][9] Unmet Needs and Treatment Efficacy - The primary unmet need in the market is retinal drying, which is crucial for preventing vision loss, rather than just reducing injection burden [13][24] - Surrozen aims to demonstrate significant improvements in the percentage of patients achieving complete retinal drying compared to existing treatments like Eylea and Vabysmo [14][15] Regulatory and Study Design Considerations - The company is considering various study designs for its clinical trials, including treatment-naive and treatment-experienced patient populations, with a focus on demonstrating clinical benefits in a timely manner [26][30] - There are challenges associated with including treatment-experienced patients due to the need for a run-in period to characterize their lack of response to existing therapies [32][36] Competitive Landscape - Surrozen's unique approach to Wnt biology and its proprietary technology differentiates it from competitors, including EyeBio, which may infringe on Surrozen's patents [44][45] - The company is aware of other players in the IL-6 space but believes its trifunctional approach offers distinct advantages in treating retinal diseases [42][43] Future Directions - Surrozen is also exploring opportunities in geographic atrophy, although this area presents challenges in demonstrating functional improvement due to longer timelines for clinical endpoints [46] - The company is excited about preclinical data showing protective effects on photoreceptors and other retinal cells, indicating potential for future development [47] Conclusion Surrozen is strategically positioned in the ophthalmology market with a focus on innovative therapies targeting retinal diseases. The company's emphasis on Wnt biology, combined with a robust pipeline and a clear understanding of market needs, positions it well for future growth and competitive advantage in the industry.

Summary of Surrozen Conference Call Company Overview - **Company**: Surrozen - **Focus**: Development of bispecific, multivalent antibodies targeting the Wnt pathway for tissue regeneration, particularly in ophthalmology and retinopathies [1][2] Key Points Pipeline and Product Development - **Lead Program**: SZN-8141, a bispecific antibody targeting Wnt and VEGF [3] - **Rationale for Bispecific Development**: Initial development of a Wnt-only agonist led to the realization that targeting multiple pathways (Wnt, VEGF, and IL-6) could provide additive benefits in treating retinopathies [5][6] - **Clinical Data**: Merck's acquisition of EyeBio was influenced by early data showing potential efficacy comparable to Eylea, with a visual acuity gain of about 10 letters and a reduction in macular thickness of approximately 150 microns [8][9] Clinical Trials and Efficacy - **Current Status**: Phase three data from Merck expected around mid-2026 [11] - **Comparison with Eylea**: Surrozen's molecule shows superior efficacy in animal models compared to Eylea alone, indicating a synergistic effect when combining Wnt activation with VEGF antagonism [22][23] - **Durability of Treatment**: While animal models may not fully predict long-term effects, the company is optimistic about achieving infrequent dosing based on drug concentration levels in the eye [29] Binding and Mechanism - **Wnt Pathway Activation**: The antibody binds specifically to LRP5 and Frizzled 4, with a focus on enhancing Wnt signaling [36][37] - **Comparison with Competitors**: Surrozen's Wnt component is reportedly more potent than Merck's, although clinical relevance remains to be established [41] Financial and Strategic Partnerships - **Collaboration with Boehringer Ingelheim**: Surrozen retains exclusivity on its bispecific and trispecific molecules, with a deal structure including $12.5 million upfront and potential milestones totaling $500 million to $600 million [43][44] - **Cash Position**: Surrozen ended the quarter with $80 million in cash, supported by a recent $175 million PIPE financing, allowing funding for both programs through proof of concept [55] Market Context - **Industry Trends**: The discussion highlighted the growing interest in targeting multiple pathways in ophthalmology, with IL-6 showing additive benefits in diabetic macular edema [52][54] Additional Insights - **Safety Profile**: Early data suggests a favorable safety profile for Surrozen's therapies, which is critical for ophthalmic treatments [9] - **Regulatory Considerations**: The company is preparing for an IND filing in 2026, with ongoing toxicology studies and trial design development [19][20][30] This summary encapsulates the key aspects of Surrozen's conference call, focusing on its innovative approach to treating retinal diseases through a combination of targeted therapies and strategic partnerships.

Core Insights - Surrozen, Inc. is a biotechnology company focused on developing targeted therapeutics that modulate the Wnt pathway, particularly for severe eye diseases [1][4] - The company granted inducement stock option awards covering 50,000 shares to its new Chief Financial Officer, Andrew P. Maleki, as part of his employment agreement [1][2] - The stock options were granted under the 2025 Equity Inducement Plan and were approved by the Board of Directors [2][3] Stock Option Details - The stock options allow the purchase of shares at a price of $12.94 per share, which is the closing price on November 12, 2025 [2] - The options vest over a four-year period, with 25% vesting on the first anniversary and the remainder vesting monthly [3] - The awards were granted as an inducement for the new CFO to accept employment, in compliance with Nasdaq Listing Rule 5635(c)(4) [3] Company Overview - Surrozen is pioneering a new class of Wnt-based therapeutics aimed at repairing and restoring tissue function, with a primary focus on ophthalmology [4] - The company utilizes a proprietary antibody-engineering platform to develop multifunctional biologics that activate Wnt signaling [4] - Surrozen aims to deliver durable therapies that can significantly improve patient outcomes and create long-term value [4]

Summary of Surrozen Conference Call Company Overview - **Company**: Surrozen - **Founded**: 2016 - **Focus**: Wnt biology and its therapeutic applications, particularly in ophthalmology [3][4] Industry Context - **Therapeutic Area**: Ophthalmology, specifically targeting retinal diseases such as diabetic macular edema (DME) and age-related macular degeneration (AMD) [4][16] - **Key Competitors**: Merck and Roche, both involved in Wnt biology and retinal disease treatments [9][16] Core Insights and Arguments - **Wnt Pathway**: - Critical for tissue regeneration, stem cell renewal, and response to injury [3][4] - Activation of the Wnt pathway has shown significant clinical benefits, comparable to VEGF inhibition [4][5] - Surrozen's approach involves multispecific antibodies that activate Wnt while inhibiting other pathways like VEGF and IL-6 [5][19] - **Clinical Proof of Concept**: - Merck's acquisition of a competitor's molecule demonstrated compelling clinical proof of concept in diabetic macular edema [4][5] - Surrozen's preclinical models show that their approach can normalize retinal vessels and prevent leakage, which is a significant advancement over existing therapies [9][10][12] - **Safety and Efficacy**: - Current Wnt agonists, such as Amgen's Evenity, have shown to be safe, with no notable safety issues reported in clinical trials [8] - Surrozen aims to leverage intravitreal injections to minimize systemic liabilities [8] - **Differentiation from Competitors**: - Surrozen's molecule 8141 combines Wnt activation with VEGF inhibition, showing greater potency than Merck's RESTRA molecule [18][19] - The company is also developing a trifunctional molecule (8143) that targets Wnt, VEGF, and IL-6 [26] Development Pipeline - **Current Assets**: - 8141: Expected IND filing in 2026, combining Wnt activation and VEGF inhibition [29] - 8143: Trifunctional molecule in development, behind 8141 in the pipeline [28][29] - **Clinical Strategy**: - Plans to target both DME and wet AMD in upcoming studies, with a focus on treatment-naive patients for clearer data interpretation [30][32] Financial Position - **Funding**: - Completed a $175 million PIPE financing, with the first tranche of $75 million supporting operations post-IND clearance [48] - The second tranche of $100 million will provide a cushion for data reporting from phase one studies [48] Intellectual Property - **Patents**: - Surrozen holds a broad patent for multivalent antibodies targeting Frizzled LRP5 or 6, which could infringe on competitors like Merck and Roche [47] Market Expectations - **Upcoming Data**: - Anticipation for results from Merck's studies (Brunello and Barolo) in Q3 next year, which may influence the Wnt biology space [50][52] Additional Considerations - **Expertise in Wnt Biology**: - Surrozen emphasizes its scientific credibility, founded by leading scientists in Wnt biology, to educate the market on the pathway's role in retinal health [41][42] - **Clinical Feedback**: - Retinal specialists express a need for improved retinal drying and visual acuity benefits, which Surrozen aims to address through its innovative mechanisms [41][42]

Financial Performance - For the three months ended September 30, 2025, total revenue decreased by $9.0 million, or 90%, to $0.983 million compared to $10.0 million in the same period of 2024[119] - The net loss for the three months ended September 30, 2025, was $71.6 million, compared to a net loss of $1.4 million in the same period of 2024, representing a decrease of $70.2 million[119] - Collaboration and license revenue dropped by $10.0 million, or 100%, for the three months ended September 30, 2025, due to the recognition of a milestone achieved in September 2024[120] - Total revenue for the nine months ended September 30, 2025, was $2.949 million, a decrease of $7.051 million, or 71%, from $10.0 million in 2024[127] - Net loss for the nine months ended September 30, 2025, was $58.867 million, an increase of $23.342 million, or 66%, compared to a net loss of $35.525 million in 2024[127] Expenses - Research and development expenses increased by $2.6 million, or 50%, to $7.8 million for the three months ended September 30, 2025, primarily due to increased manufacturing costs and lab expenses[122] - General and administrative expenses rose by $0.5 million, or 15%, to $4.1 million for the three months ended September 30, 2025, mainly due to higher professional service fees[123] - Research and development expenses increased by $4.6 million, or 29%, for the nine months ended September 30, 2025, primarily due to increased manufacturing costs and consulting fees[130] - General and administrative expenses rose by $0.9 million, or 8%, for the nine months ended September 30, 2025, mainly due to higher professional service fees[131] Cash and Financing Activities - As of September 30, 2025, the accumulated deficit was $344.1 million, with cash and cash equivalents of $81.3 million[115] - Cash used in operating activities was $24.432 million for the nine months ended September 30, 2025, compared to $21.109 million in 2024[148] - Cash provided by financing activities was $71.3 million for the nine months ended September 30, 2025, primarily from the issuance and sale of common stock, pre-funded warrants, and warrants in the 2025 PIPE[151] - The company entered into a sales agreement to issue and sell up to $50.0 million of shares of common stock under the 2025 ATM program, with no shares sold as of September 30, 2025[140] Future Outlook and Strategic Initiatives - The company expects to incur increased expenses as it expands its pipeline and advances product candidates through clinical development[116] - SZN-8141 and SZN-8143 were nominated as development candidates for retinal diseases, with clinical studies expected to commence in 2026[106][108] - The Research Collaboration Agreement with TCGFB, Inc. is set to terminate effective November 13, 2025, following TCGFB's notice of termination[141] Economic and Regulatory Considerations - Inflation is expected to continue increasing, potentially leading to higher labor and research costs, which may adversely affect the company's financial condition[157] - The company is currently evaluating the potential impact of tariffs imposed on imports, particularly as its contract manufacturing organization is located in the United Kingdom[158] - The company intends to rely on exemptions and reduced reporting requirements provided by the JOBS Act, which may affect the comparability of its financial statements[154] - The company remains an emerging growth company under the JOBS Act until the earliest of the last day of the fiscal year 2025 or when total annual gross revenue reaches at least $1.235 billion[155] Accounting and Compliance - The company is assessing the impact of recent accounting pronouncements on its financial statements[156] - Contractual obligations as of September 30, 2025, have not materially changed since December 31, 2024[152] Intellectual Property - The company is focused on maintaining and expanding its intellectual property portfolio, which includes costs associated with licensing and patent enforcement[150] Other Income and Expenses - Interest income increased by $0.5 million, or 111%, to $0.911 million for the three months ended September 30, 2025, attributed to a rise in cash and cash equivalents[124] - Other expense, net increased by $17.8 million for the three months ended September 30, 2025, primarily due to the noncash change in fair value of warrant liabilities[126] - Interest income increased by $1.9 million, or 71%, for the nine months ended September 30, 2025, attributed to a rise in cash and cash equivalents[132]