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]

Core Insights - Surrozen, Inc. is focused on developing targeted therapeutics that modulate the Wnt pathway for tissue repair and regeneration, particularly in severe eye diseases [1][2] Business Highlights - The company is concentrating on its ophthalmology pipeline, utilizing its expertise in Wnt biology and antibody technologies to create new treatments for severe eye diseases [2] Leadership Changes - Andrew Maleki has been appointed as Chief Financial Officer, bringing over a decade of biotech experience and a track record of raising over $500 million in capital [4][5] - Charles Williams will continue as Chief Operating Officer, focusing on strategic initiatives and corporate development [6][7] Financial Performance - As of September 30, 2025, cash and cash equivalents were $81.3 million, down from $90.4 million as of June 30, 2025 [8] - Collaboration and license revenue was zero for the quarter, compared to $10 million for the same period in 2024, due to the recognition of a milestone in September 2024 [8] - The net loss for the quarter was $71.6 million, or $8.36 per share, compared to a net loss of $1.4 million, or $0.44 per share, for the same period in 2024 [13][23] Ophthalmology Pipeline - Surrozen is advancing its lead candidates, SZN-8141 and SZN-8143, for retinal diseases and plans to submit an Investigational New Drug (IND) application for SZN-8141 in 2026 [9] - SZN-8141 combines Frizzled 4 (Fzd4) agonism and Vascular Endothelial Growth Factor (VEGF) antagonism, showing potential benefits over existing treatments for Diabetic Macular Edema (DME) and wet Age-Related Macular Degeneration [14] - SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism, which may offer advantages for treating DME, wet AMD, and uveitic macular edema [15] Strategic Partnerships - Surrozen has a partnership with Boehringer Ingelheim for SZN-413, a bi-specific antibody targeting Fzd4-mediated Wnt signaling, which has shown promise in preclinical models for retinal diseases [16][18]

Surrozen (NasdaqCM:SRZN) FY Conference Summary Company Overview - Surrozen is a biotechnology company focused on developing targeted antibodies to treat serious tissue injury diseases, particularly in the field of ophthalmology [1] - Founded in 2016, the company specializes in Wnt biology, a fundamental pathway in cell biology previously considered undruggable [2] Core Industry Insights - The company is innovating in the ophthalmology sector, specifically targeting diseases like wet age-related macular degeneration (AMD) and diabetic macular edema [3] - Surrozen's approach involves bispecific antibodies that activate the Wnt pathway, which has shown potential in improving retinal anatomy and function [3][4] Competitive Landscape - Merck acquired a direct competitor for $1.25 billion upfront, indicating significant strategic interest in the Wnt biology space [3] - Surrozen has a broad intellectual property portfolio, including an issued patent with claims that may infringe on competitors [4] Pipeline and Product Development - Surrozen has multiple candidates in its pipeline, including SCN-8141, SCN-8143, and SCN-113, which target various aspects of retinal diseases [6] - The first molecule licensed to Boehringer Ingelheim is expected to enter clinical trials in 2026 [10][20] Clinical Data and Efficacy - Preclinical data suggests that Surrozen's molecules can prevent vessel leakage and normalize retinal vessels, addressing underlying pathologies in diseases like diabetic macular edema [8][17] - The company aims to provide transformative clinical benefits, with a focus on restoring normal vessel formation rather than merely reducing leakage [18][20] Market Opportunity - The global market for VEGF inhibitors is approximately $20 billion and is expected to grow rapidly [12] - There is a significant unmet need for improved therapies in retinal diseases, particularly for patients seeking fewer injections and stable anatomy [18] Future Directions - Surrozen is exploring additional disease areas, including geographic atrophy and front-of-the-eye diseases, with promising preclinical results [25][26] - The company is positioned to rapidly advance its clinical programs, with expectations of data within six to eight months of starting phase one trials [21] Conclusion - Surrozen is at the forefront of innovation in the ophthalmology sector, leveraging its expertise in Wnt biology to develop therapies that address significant unmet needs in retinal diseases [2][3][10]

Core Viewpoint - Surrozen, Inc. has granted stock option awards to new employees as an inducement for their acceptance of employment, reflecting the company's commitment to attracting talent in the biotechnology sector focused on severe eye diseases [1][2][3] Group 1: Stock Option Awards - Surrozen granted a total of 45,710 stock option awards to four recently hired non-executive employees [1] - The stock options were issued under Surrozen's 2025 Equity Inducement Plan, complying with Nasdaq Listing Rule 5635(c)(4) [2] - Each stock option allows the purchase of shares at a price of $12.32 per share, which was the closing price on September 2, 2025 [2] Group 2: Vesting Schedule - The stock options will vest over a four-year period, with 25% vesting on the first anniversary of the vesting commencement date based on the employee's hire date [3] - The remaining shares will vest ratably each month thereafter, contingent on the employee's continuous service [3] Group 3: Company Overview - Surrozen is a biotechnology company focused on developing tissue-specific antibodies to modulate the Wnt pathway, particularly in the field of ophthalmology [4] - The company's proprietary technologies aim to leverage the body's biological repair mechanisms to address severe diseases [4]

Financial Data and Key Metrics Changes - The company completed a financing round of $175 million, which will support operations through the IND filing and into Phase 1b/2a trials for its lead candidates [11][54]. - The upfront financing amount was $76 million, with an additional $98 million expected in a second tranche [54]. Business Line Data and Key Metrics Changes - The company has pivoted its focus to ophthalmology, specifically targeting retinal vascular disorders, moving away from its previous lead molecule for severe alcoholic hepatitis due to treatment challenges [10][11]. - The lead candidates, 8141 and 8143, are currently in CMC development, with an IND filing expected next year for 8141 [25][26]. Market Data and Key Metrics Changes - The company is targeting diseases such as wet AMD and diabetic macular edema (DME), which are characterized by hematological angiogenesis and barrier function breakdown [21][22]. - Recent data from iBio indicated visual acuity gains of over 11 letters in a 12-week study, which is competitive with historical clinical trials [18][19]. Company Strategy and Development Direction - The company aims to leverage its proprietary Swaps technology platform to develop therapeutics that activate the Wnt signaling pathway, focusing on localized delivery to reduce side effects [7][9]. - The strategy includes combining multiple pathways to enhance therapeutic efficacy, particularly in treating rare diseases [17][29]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their ophthalmology pipeline, citing strong interest and validation from recent data [10][11]. - The management highlighted the importance of addressing unmet needs in the market, such as longer duration of therapy and alternative mechanisms of action [47]. Other Important Information - The company has secured broad intellectual property claims related to multivalent antibodies targeting the Wnt pathway, which could provide a competitive edge in the market [51][53]. - The company is also exploring additional programs beyond its lead candidates, including a FRIZZLED 127 molecule with promising preclinical results [48][50]. Q&A Session Summary Question: What is the current status of the IND filing for the lead programs? - The company plans to file an IND for 8141 next year and is currently working on the design of the clinical trial [42][43]. Question: How does the company differentiate its assets from competitors? - The company believes its candidates have higher potency and the ability to concentrate at higher levels compared to competitors, which may lead to better efficacy and durability [27][28]. Question: What are the key catalysts for investors to watch? - Investors should look for updates on the IND filing, progress in clinical trials for 8141 and 8143, and any new data from ongoing studies [54][57].

Summary of Surrozen (SRZN) FY Conference - August 13, 2025 Company Overview - Surrozen is a biotechnology company focused on modulating the Wnt pathway, which is clinically validated for large markets in ophthalmology [1][2] Core Industry Insights - The Wnt pathway has garnered significant interest from major pharmaceutical companies such as Merck, Roche, and Boehringer Ingelheim due to its potential in treating diabetic macular edema and improving visual acuity outcomes [2] - Surrozen has developed a broad pipeline of ophthalmology development candidates targeting prevalent retinal and corneal diseases with significant unmet needs [2][5] Key Developments and Innovations - Surrozen's approach involves using bispecific and multispecific antibody technologies to activate Wnt signaling, which was previously considered undruggable [4] - The company has established a strong intellectual property position in activating Wnt signaling with antibodies, with their patent cited as prior art in a withdrawn Merck patent [2] - The most advanced candidate, SCN413, targets Frizzled four and has shown superior effects in preclinical models compared to existing treatments like Eylea [12][13] Clinical Data and Pipeline - SCN413 demonstrated a compelling treatment effect in rabbit and rodent models, significantly reducing vessel leakage and normalizing retinal vascular anatomy [12][13] - Surrozen is advancing additional molecules, including SCN8141 and SCN8143, which incorporate VEGF and IL-6 inhibition, aiming to improve treatment efficacy and reduce the frequency of injections [15][16] - The company is also exploring treatments for Fuchs endothelial dystrophy, showing promising results in improving corneal clarity and thickness in preclinical models [17][19] Market Opportunities - The market for treating Fuchs endothelial dystrophy is significant, with a high unmet need for effective therapies beyond current transplant options [17] - Dry AMD and geographic atrophy represent another area of focus, with current therapies being limited and a strong need for new mechanisms to preserve vision [20][21] Future Outlook - Surrozen aims to report progress and clinical outcomes in 2025 and 2026, highlighting its commitment to addressing high-need areas in ophthalmology [23]