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Surrozen (NasdaqCM:SRZN) FY Conference Transcript
2025-09-10 16:32
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]
Surrozen Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-09-04 20:15
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]
Surrozen (SRZN) 2025 Conference Transcript
2025-09-04 13:00
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].
Surrozen (SRZN) FY Conference Transcript
2025-08-13 12:00
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]
Surrozen Reports Q2 Profit on Gains
The Motley Fool· 2025-08-08 21:21
Core Insights - Surrozen reported a significant turnaround from a net loss in Q2 2024 to a net income of $39.7 million in Q2 2025, with GAAP EPS of $2.55, surpassing analyst expectations of a loss of $1.11 per share [1][2][5] - The positive financial results were primarily driven by non-operating gains, including a $31.5 million gain from the change in fair value of its tranche liability and $16.2 million in net other income, while core business performance remained typical of a pre-commercial biotech [5][11] - The company recorded its first meaningful research service revenue of $1.0 million, attributed to a collaboration with TCGFB, Inc., with no product sales reported [6][11] Financial Performance - Q2 2025 GAAP EPS was $2.55, a significant improvement from $(7.99) in Q2 2024 [2] - Total revenue for Q2 2025 was $1.0 million, compared to $0.0 million in Q2 2024 [2] - Research and development expenses increased to $6.0 million, up 13.2% from Q2 2024, while general and administrative expenses rose to $4.0 million, an 8.1% increase [2][6] Company Overview - Surrozen focuses on therapies that modulate the Wnt pathway, crucial for tissue repair and regeneration, with a proprietary SWAP platform aimed at creating Wnt mimetics for treating retinal diseases [3][4] - The company is advancing drug candidates SZN-8141 and SZN-8143, targeting retinal diseases through Wnt pathway stimulation [4][9] Pipeline and Development - Progress in the pipeline includes continued preclinical advancement of SZN-8141 and SZN-8143, with plans to submit an IND application for SZN-8141 in 2026 [8][9] - The company expanded its intellectual property portfolio, securing U.S. Patent No. 12,297,278 for its SWAP technology [9] Strategic Partnerships and Leadership - Strategic partnerships, particularly with larger pharmaceutical firms, are essential for revenue and expertise [4][10] - The company strengthened its clinical leadership by appointing Daniel Chao, M.D. Ph.D, as Vice President and Head of Clinical Development, and established a Clinical Advisory Board [10] Cash Position and Future Outlook - As of June 30, 2025, Surrozen had cash and cash equivalents of $90.4 million, an increase from $34.6 million at the end of 2024, reflecting earlier capital raises [7] - The company did not provide formal revenue or profitability guidance but emphasized its focus on advancing the ophthalmology pipeline and submitting the SZN-8141 IND application in 2026 [12][13]
Surrozen(SRZN) - 2025 Q2 - Quarterly Report
2025-08-08 20:14
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Surrozen, Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents Surrozen, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed explanatory notes [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This table provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates | Metric | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------- | :--------------------------------------- | :----------------------------------- | | **Assets:** | | | | Cash and cash equivalents | $90,390 | $34,565 | | Total current assets | $94,235 | $38,932 | | Total assets | $102,696 | $48,467 | | **Liabilities and Stockholders' Equity (Deficit):** | | | | Total current liabilities | $5,743 | $7,315 | | Tranche liability | $10,903 | — | | Warrant liabilities | $32,620 | $55,892 | | Total liabilities | $55,582 | $69,847 | | Total stockholders' equity (deficit) | $47,114 | $(21,380) | | Total liabilities and stockholders' equity | $102,696 | $48,467 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) This table presents the company's financial performance over specific periods, including revenue, expenses, and net income or loss | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :---------------------------------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research service revenue – related party | $983 | $— | $1,966 | $— | | Research and development expenses | $6,042 | $5,335 | $12,600 | $10,582 | | General and administrative expenses | $3,958 | $3,714 | $7,934 | $7,597 | | Loss from operations | $(9,017) | $(9,049) | $(18,568) | $(18,179) | | Interest income | $1,025 | $490 | $1,321 | $875 | | Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE | $— | $(20,397) | $— | $(20,397) | | Loss on amendment and cancellation of warrants | $— | $— | $(2,073) | $— | | Loss on execution of the 2025 PIPE | $— | $— | $(71,084) | $— | | Gain on change in fair value of tranche liability | $31,520 | $— | $47,860 | $— | | Gain on settlement of tranche liability | $— | $— | $1,117 | $— | | Other income, net | $16,218 | $3,695 | $54,203 | $3,610 | | Net income (loss) | $39,746 | $(25,261) | $12,776 | $(34,091) | | Net income (loss) per share, basic and diluted | $2.55 | $(7.99) | $0.85 | $(13.00) | [Unaudited Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) This table details changes in the company's equity over time, reflecting common stock, additional paid-in capital, and accumulated deficit | Metric | December 31, 2024 (in thousands) | June 30, 2025 (in thousands) | | :--------------------------------------- | :------------------------------- | :----------------------------- | | Common stock (shares) | 3,262 | 8,570 | | Common stock (amount) | $0 | $1 | | Additional paid-in capital | $263,879 | $319,596 | | Accumulated deficit | $(285,259) | $(272,483) | | Total stockholders' equity (deficit) | $(21,380) | $47,114 | - Issuance of common stock in 2025 PIPE: **5,213 shares**, **$53,189** in APIC[19](index=19&type=chunk) - Stock-based compensation expense: **$1,828**[19](index=19&type=chunk) - Net income: **$12,776**[19](index=19&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This table summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods | Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(15,392) | $(14,357) | | Net cash used in investing activities | $(45) | $(7) | | Net cash provided by financing activities | $71,262 | $16,086 | | Net increase in cash, cash equivalents and restricted cash | $55,825 | $1,722 | | Cash, cash equivalents and restricted cash at end of period | $91,078 | $38,453 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements [Note 1. Organization and Business](index=9&type=section&id=Note%201.%20Organization%20and%20Business) This note describes Surrozen, Inc.'s biotechnology focus on the Wnt pathway, its financial performance, and liquidity outlook - Surrozen, Inc. is a biotechnology company focused on modulating the Wnt pathway for tissue repair, with a current emphasis on ophthalmology[24](index=24&type=chunk) Financial Performance and Liquidity (in millions) | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) | $39.7 | $12.8 | $(34.1) | | Noncash gains (tranche & warrant liabilities) | $47.6 | $104.6 | — | | Cash used in operations | — | $(15.4) | $(14.4) | | Cash and cash equivalents (as of June 30, 2025) | $90.4 | $90.4 | — | | Accumulated deficit (as of June 30, 2025) | $(272.5) | $(272.5) | — | - Management believes existing cash and cash equivalents are sufficient for at least the next 12 months, but additional capital will be needed for future operations and clinical studies[26](index=26&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=9&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note details the basis of financial statement presentation, key accounting policies, and evaluation of recent accounting pronouncements - The financial statements are prepared under U.S. GAAP, with estimates for R&D accruals, tranche liability, and warrant fair values[27](index=27&type=chunk)[30](index=30&type=chunk) - Tranche liability from the 2025 PIPE and warrant liabilities are classified as liabilities and remeasured at fair value each reporting period, with changes recognized in the statements of operations[34](index=34&type=chunk)[35](index=35&type=chunk) - Basic and diluted net income (loss) per share are computed using the two-class method, considering pre-funded and certain PIPE warrants as participating securities[37](index=37&type=chunk)[38](index=38&type=chunk) - The company is evaluating the impact of new FASB Accounting Standards Updates 2024-03 (Expense Disaggregation Disclosures) and 2023-09 (Income Tax Disclosures), effective for annual periods beginning after December 15, 2026 and 2024, respectively[39](index=39&type=chunk)[40](index=40&type=chunk) [Note 3. Fair Value Measurement](index=15&type=section&id=Note%203.%20Fair%20Value%20Measurement) This note explains the fair value measurements of financial assets and liabilities, including valuation methodologies for warrants and tranche liability Financial Assets and Liabilities Measured at Fair Value (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | **Assets:** | | | | Money market funds (Level 1) | $80,155 | $25,495 | | **Liabilities:** | | | | Tranche liability (Level 3) | $10,903 | — | | 2021 Public Warrants (Level 1) | $96 | $109 | | 2021 PIPE Warrants (Level 2) | $11 | $17 | | 2024 Pre-Funded Warrants (Level 2) | $358 | $574 | | 2024 PIPE Warrants (Level 3) | $7,856 | $55,192 | | 2025 Pre-Funded Warrants (Level 2) | $11,667 | — | | 2025 PIPE Warrants (Level 3) | $12,632 | — | | Total financial liabilities at fair value | $43,523 | $55,892 | - Level 3 liabilities (tranche liability, 2024 PIPE Warrants, 2025 PIPE Warrants) are valued using the Black-Scholes model with unobservable inputs like expected term, volatility, risk-free rate, dividend yield, and for some, milestone timing/probability[44](index=44&type=chunk)[45](index=45&type=chunk) - The discontinuation of SZN-043 clinical development in Q1 2025 resulted in the fair value of Series C and D 2024 PIPE Warrants becoming zero. Amendments to Series A and B 2024 PIPE Warrants and their cancellation in connection with the 2025 PIPE led to a **$2.1 million loss**[48](index=48&type=chunk) [Note 4. Balance Sheet Components](index=18&type=section&id=Note%204.%20Balance%20Sheet%20Components) This note provides a detailed breakdown of the company's accrued and other liabilities at specific reporting dates Accrued and Other Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Accrued payroll and related expenses | $2,114 | $2,929 | | Accrued research and development expenses | $1,652 | $1,904 | | Accrued professional service fees | $193 | $156 | | Other | $232 | $191 | | **Total Accrued and other liabilities** | **$4,191** | **$5,180** | [Note 5. Collaboration and License Agreements](index=18&type=section&id=Note%205.%20Collaboration%20and%20License%20Agreements) This note details the collaboration and license agreement with Boehringer Ingelheim for Fzd4 bi-specific antibodies, including milestone and royalty terms - The company has a Collaboration and License Agreement (CLA) with Boehringer Ingelheim (BI) for Fzd4 bi-specific antibodies, including SZN-413[51](index=51&type=chunk) - Under the CLA, BI paid a non-refundable upfront payment of **$12.5 million** (received **$10.5 million**) and may pay up to **$587.0 million** in success-based milestones and mid-single to low-double digit royalties on net sales[52](index=52&type=chunk) - Revenue from future milestones is fully constrained due to the inherent uncertainty of success, and sales-based royalties will be recognized when related sales occur[53](index=53&type=chunk) [Note 6. License Agreements](index=18&type=section&id=Note%206.%20License%20Agreements) This note describes the exclusive license agreement with Stanford University for engineered Wnt surrogate molecules, including potential milestone and royalty payments - The company holds an exclusive, sublicensable license from Stanford University for engineered Wnt surrogate molecules, covering patents and technology for treating human and veterinary diseases[54](index=54&type=chunk) - The Stanford Agreement includes potential payments of up to **$0.9 million** for development/regulatory milestones and up to **$5.0 million** for sales milestones, plus very low single-digit royalties on net sales[54](index=54&type=chunk)[55](index=55&type=chunk) - As of June 30, 2025, de minimis R&D expenses were incurred, and no milestones have been achieved under the Stanford Agreement[56](index=56&type=chunk) [Note 7. Commitments and Contingencies](index=20&type=section&id=Note%207.%20Commitments%20and%20Contingencies) This note details the company's operating lease for its office and laboratory space, including lease terms, extension options, and future rental payments - The company has an operating lease for its office and laboratory space in South San Francisco, California, with a term ending in April 2029[57](index=57&type=chunk) - The lease includes an option to extend for four years and a one-time early termination option effective April 30, 2026, with a **$0.4 million** termination fee[57](index=57&type=chunk) Aggregate Future Minimum Rental Payments (in thousands) | Period | Amount | | :------------------------------------ | :----- | | Remaining six months ending Dec 31, 2025 | $1,162 | | Year ending Dec 31, 2026 | $1,797 | | Year ending Dec 31, 2027 | $2,461 | | Year ending Dec 31, 2028 | $2,547 | | Year ending Dec 31, 2029 | $857 | | **Total lease payments** | **$8,824** | | Less: Imputed interest | $(1,310) | | **Operating lease liabilities** | **$7,514** | [Note 8. Stockholders' Equity](index=20&type=section&id=Note%208.%20Stockholders'%20Equity) This note outlines the company's equity transactions, including the 2025 and 2024 Private Placements (PIPEs) and their financial impact - The 2025 PIPE, executed March 24, 2025, aims to raise approximately **$175.0 million** to fund ophthalmology programs. The first tranche closed on March 26, 2025, generating approximately **$71.2 million** in net proceeds[60](index=60&type=chunk)[61](index=61&type=chunk) - The second tranche of the 2025 PIPE, expected to raise **$98.6 million**, is contingent upon FDA clearance of the IND application for SZN-8141 by October 31, 2026[61](index=61&type=chunk)[62](index=62&type=chunk) - The 2024 PIPE, closed in April 2024, generated approximately **$17.5 million** in gross proceeds but resulted in a **$20.4 million loss** on issuance because the fair value of warrants issued exceeded the proceeds received[65](index=65&type=chunk) [Note 9. Related Party Transactions](index=22&type=section&id=Note%209.%20Related%20Party%20Transactions) This note details transactions with related parties, including a research collaboration and a sublease agreement, due to shared affiliations - The company has a strategic research collaboration with TCGFB, Inc. for TGF-β antibody discovery, which is a related party transaction due to shared affiliations with The Column Group[66](index=66&type=chunk)[68](index=68&type=chunk) Research Service Revenue – Related Party (in thousands) | Period | Amount | | :------------------------------- | :----- | | Three Months Ended June 30, 2025 | $1,000 | | Six Months Ended June 30, 2025 | $2,000 | - A sublease agreement with Nura Bio, Inc., also a related party, generated **$0.2 million** and **$0.3 million** in sublease income for the three and six months ended June 30, 2025, respectively, recognized as reductions to operating expenses[72](index=72&type=chunk) [Note 10. Common Stock Warrants](index=25&type=section&id=Note%2010.%20Common%20Stock%20Warrants) This note summarizes the company's outstanding common stock warrants, their terms, and the impact of recent amendments and cancellations Common Stock Warrants Outstanding (in thousands) | Type | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | 2021 Public Warrants | 5,117 | 5,117 | | 2021 PIPE Warrants | 791 | 790 | | 2024 Pre-Funded Warrants | 40 | 40 | | 2025 Pre-Funded Warrants | 1,305 | — | | 2024 PIPE Warrants – Series A | 1,132 | 1,132 | | 2024 PIPE Warrants – Series B | 1,231 | 1,231 | | 2024 PIPE Warrants – Series C | — | 4,386 | | 2024 PIPE Warrants – Series D | — | 4,386 | | 2025 PIPE Warrants – Series E | 3,293 | — | | **Total** | **12,909** | **17,082** | - The 2025 Pre-Funded Warrants have a nominal exercise price (**$0.0001**) and are immediately exercisable, while Series E common stock warrants have an exercise price of **$11.54** and expire in five years[75](index=75&type=chunk) - Series C and D 2024 PIPE Warrants were cancelled in March 2025 due to the discontinuation of SZN-043 development, and exercise prices for Series A and B 2024 PIPE Warrants were reduced[77](index=77&type=chunk) - All outstanding warrants are classified as liabilities and measured at fair value, with changes recognized in other income, net[82](index=82&type=chunk) [Note 11. Stock-Based Compensation Plans](index=26&type=section&id=Note%2011.%20Stock-Based%20Compensation%20Plans) This note details the company's stock-based compensation plans, including option and RSU activity, and total compensation expense - As of June 30, 2025, **0.1 million shares** were available under the 2021 Equity Incentive Plan and approximately **0.1 million shares** under the 2021 Employee Stock Purchase Plan (ESPP)[83](index=83&type=chunk) Stock Option Activity (in thousands, except price) | Metric | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :-------------- | | Options Outstanding (Number) | 536 | 1,220 | | Weighted Average Exercise Price | $19.45 | $14.80 | | Weighted Average Grant-Date Fair Value (6 months) | $7.45 (2024) | $8.97 (2025) | | Aggregate Intrinsic Value (Outstanding) | — | $36 | | Aggregate Intrinsic Value (Exercisable) | — | $13 | Total Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $340 | $350 | $606 | $649 | | General and administrative | $654 | $795 | $1,222 | $1,526 | | **Total** | **$994** | **$1,145** | **$1,828** | **$2,175** | - As of June 30, 2025, approximately **$9.0 million** of stock-based compensation expense remains to be recognized over a weighted-average period of **2.97 years**[87](index=87&type=chunk) [Note 12. Segment Reporting](index=28&type=section&id=Note%2012.%20Segment%20Reporting) This note clarifies that the company operates as a single reportable segment focused on Wnt pathway drug candidate research and development - The company operates in one reportable segment: research and development of drug candidates to modulate the Wnt pathway for tissue repair and regeneration[88](index=88&type=chunk) Segment Profit or Loss Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue | $983 | $— | $1,966 | $— | | Compensation (excl. stock-based) | $(3,283) | $(3,144) | $(6,613) | $(6,520) | | Development and manufacturing costs | $(1,509) | $(1,305) | $(3,619) | $(2,592) | | Stock-based compensation | $(994) | $(1,145) | $(1,828) | $(2,175) | | Other income (expense), including loss on execution of 2025 PIPE | $48,763 | $(16,214) | $31,344 | $(15,914) | | **Segment and consolidated net income (loss)** | **$39,746** | **$(25,261)** | **$12,776** | **$(34,091)** | - All research service revenue (**$1.0 million** for Q2 2025, **$2.0 million** for H1 2025) and long-lived assets are located in the United States[91](index=91&type=chunk) [Note 13. Subsequent Event](index=30&type=section&id=Note%2013.%20Subsequent%20Event) This note discloses the adoption of the 2025 Equity Inducement Plan by the board of directors for new employee equity awards - On August 7, 2025, the board adopted the 2025 Equity Inducement Plan, reserving **250,000 shares** for new employee equity awards[92](index=92&type=chunk) - No awards have been granted under the Inducement Plan as of the filing date of this Quarterly Report[92](index=92&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of the company's financial condition and operational results, covering its biotechnology focus, performance, liquidity, capital resources, and regulatory status [Overview](index=31&type=section&id=Overview) This overview introduces Surrozen, Inc.'s biotechnology focus on Wnt pathway modulation, its key product candidates, and recent financial highlights - Surrozen is a biotechnology company focused on discovering and developing drug candidates to selectively modulate the Wnt pathway for tissue repair, with a current focus in ophthalmology[97](index=97&type=chunk)[98](index=98&type=chunk) - Key product candidates include SZN-8141 (Fzd4 agonism + VEGF antagonism for retinal diseases, IND expected in 2026), SZN-8143 (Fzd4 agonism + VEGF antagonism + IL-6 antagonism for retinal diseases), and SZN-113 (Fzd127 target for Fuchs' Endothelial Corneal Dystrophy and Geographic Atrophy)[101](index=101&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - SZN-413, a Fzd4 bi-specific antibody, is being developed under a collaboration with Boehringer Ingelheim, which triggered a **$10.0 million** milestone payment in September 2024[105](index=105&type=chunk) - Development of SZN-043 for severe alcohol associated hepatitis was discontinued in Q1 2025 due to insufficient early clinical benefit[106](index=106&type=chunk) Financial Summary (as of June 30, 2025, in millions) | Metric | Amount | | :-------------------- | :----- | | Accumulated deficit | $272.5 | | Cash and cash equivalents | $90.4 | Net Income (Loss) (in millions) | Period | Net Income (Loss) | | :------------------------------- | :---------------- | | Three Months Ended June 30, 2025 | $39.7 | | Six Months Ended June 30, 2025 | $12.8 | | Three Months Ended June 30, 2024 | $(25.3) | | Six Months Ended June 30, 2024 | $(34.1) | *Note: 2025 net income includes noncash gains of **$47.6 million** (Q2) and **$104.6 million** (H1) on changes in fair value of tranche and warrant liabilities* [Results of Operations](index=35&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in revenue, operating expenses, and net income or loss for the reported periods Key Financial Changes (Three Months Ended June 30, 2025 vs. 2024, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :---------------------------------------------------------------- | :----- | :----- | :--------- | :--------- | | Research service revenue – related party | $983 | $— | $983 | * | | Research and development expenses | $6,042 | $5,335 | $707 | 13% | | General and administrative expenses | $3,958 | $3,714 | $244 | 7% | | Interest income | $1,025 | $490 | $535 | 109% | | Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE | $— | $(20,397) | $20,397 | -100% | | Gain on change in fair value of tranche liability | $31,520 | $— | $31,520 | * | | Other income, net | $16,218 | $3,695 | $12,523 | * | | Net income (loss) | $39,746 | $(25,261) | $65,007 | * | *Percentage is not meaningful Key Financial Changes (Six Months Ended June 30, 2025 vs. 2024, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :---------------------------------------------------------------- | :----- | :----- | :--------- | :--------- | | Research service revenue – related party | $1,966 | $— | $1,966 | * | | Research and development expenses | $12,600 | $10,582 | $2,018 | 19% | | General and administrative expenses | $7,934 | $7,597 | $337 | 4% | | Interest income | $1,321 | $875 | $446 | 51% | | Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE | $— | $(20,397) | $20,397 | -100% | | Loss on amendment and cancellation of warrants | $(2,073) | $— | $(2,073) | * | | Loss on execution of the 2025 PIPE | $(71,084) | $— | $(71,084) | * | | Gain on change in fair value of tranche liability | $47,860 | $— | $47,860 | * | | Gain on settlement of tranche liability | $1,117 | $— | $1,117 | * | | Other income, net | $54,203 | $3,610 | $50,593 | * | | Net income (loss) | $12,776 | $(34,091) | $46,867 | * | *Percentage is not meaningful - Research and development expenses increased by **$0.7 million** (13%) for Q2 2025 and **$2.0 million** (19%) for H1 2025, primarily due to increased manufacturing costs, lab expenses, and consulting fees for ophthalmology programs, partially offset by decreased clinical expenses from the discontinuation of SZN-043[115](index=115&type=chunk)[123](index=123&type=chunk) - Net income for Q2 and H1 2025 was significantly impacted by noncash gains on changes in fair value of tranche liability (**$31.5 million** for Q2, **$47.9 million** for H1) and warrant liabilities (**$11.0 million** for Q2, **$51.7 million** for H1)[119](index=119&type=chunk)[120](index=120&type=chunk)[129](index=129&type=chunk)[131](index=131&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's historical funding, current cash position, future capital needs, and potential financing strategies - The company has incurred significant operating losses and negative cash flows from operations since inception, primarily financing activities through equity sales and collaboration payments[132](index=132&type=chunk) - The first tranche of the 2025 PIPE, closed in March 2025, generated approximately **$71.2 million** in net proceeds[133](index=133&type=chunk) - A second tranche of the 2025 PIPE, expected to provide **$98.6 million**, is contingent upon FDA clearance of the SZN-8141 IND application by October 31, 2026[133](index=133&type=chunk) - As of June 30, 2025, cash and cash equivalents were **$90.4 million**, and management believes this is sufficient to fund operations for at least the next 12 months[136](index=136&type=chunk) - The company will require substantial additional capital for future product candidate development, clinical trials, regulatory approvals, and commercialization, likely through equity offerings, debt financings, or collaborations, which could lead to stockholder dilution[135](index=135&type=chunk)[136](index=136&type=chunk)[138](index=138&type=chunk) Summary of Cash Flows (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(15,392) | $(14,357) | | Net cash used in investing activities | $(45) | $(7) | | Net cash provided by financing activities | $71,262 | $16,086 | | Net increase in cash, cash equivalents and restricted cash | $55,825 | $1,722 | [Emerging Growth Company Status](index=42&type=section&id=Emerging%20Growth%20Company%20Status) This section explains the company's status as an Emerging Growth Company and Smaller Reporting Company, outlining associated regulatory exemptions - The company is an Emerging Growth Company (EGC) and a Smaller Reporting Company (SRC), allowing it to use exemptions from certain disclosure requirements and an extended transition period for new accounting standards[144](index=144&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk)[124](index=124&type=chunk)[184](index=184&type=chunk)[384](index=384&type=chunk)[385](index=385&type=chunk)[386](index=386&type=chunk) - The EGC status will be maintained until the earliest of December 31, 2025, or reaching specific revenue or market capitalization thresholds[147](index=147&type=chunk)[384](index=384&type=chunk) [Impact of Inflation](index=44&type=section&id=Impact%20of%20Inflation) This section addresses the impact of inflation on the company's labor, research, and clinical trial costs, and its overall financial condition - Inflation has increased labor costs, research and clinical trial costs, and is expected to continue to do so, potentially adversely affecting the company's financial condition and results of operations[149](index=149&type=chunk) [Impact of Tariffs](index=44&type=section&id=Impact%20of%20Tariffs) This section discusses the company's evaluation of potential tariff impacts, particularly concerning its UK-based contract manufacturing organization - The company is evaluating the potential impact of tariffs on its business, particularly as its contract manufacturing organization is located in the United Kingdom[150](index=150&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Surrozen, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[152](index=152&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended June 30, 2025[153](index=153&type=chunk) - The company acknowledges that disclosure controls and procedures provide reasonable, not absolute, assurance and may not prevent all errors or instances of fraud[154](index=154&type=chunk)[155](index=155&type=chunk) [PART II. OTHER INFORMATION](index=47&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other material information, including legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business[157](index=157&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) Investing in Surrozen, Inc. involves significant risks, including a history of losses, substantial funding needs, and uncertainties in product development and commercialization [Summary of Risk Factors](index=47&type=section&id=Summary%20of%20Risk%20Factors) This section provides a concise overview of the material risks associated with investing in Surrozen, Inc., covering financial, operational, and regulatory challenges - The company has a history of losses and expects to incur significant losses for the foreseeable future, with no guarantee of achieving profitability[159](index=159&type=chunk)[161](index=161&type=chunk) - Substantial additional funds are required to advance product candidates, and there is no guarantee of sufficient future funding, which could lead to dilution for existing stockholders[159](index=159&type=chunk)[163](index=163&type=chunk)[187](index=187&type=chunk) - None of the company's product candidates have received regulatory approval, and successful commercialization depends on obtaining such approvals, which is a lengthy, expensive, and uncertain process[159](index=159&type=chunk)[169](index=169&type=chunk)[334](index=334&type=chunk) - The company relies on third parties for preclinical studies, clinical trials, and manufacturing, and their unsatisfactory performance could cause delays or failures[159](index=159&type=chunk)[197](index=197&type=chunk)[217](index=217&type=chunk) - Competition from other pharmaceutical and biotechnology companies, including those with greater resources, poses a significant risk to the company's ability to develop and commercialize product candidates[159](index=159&type=chunk)[225](index=225&type=chunk)[227](index=227&type=chunk) - The company faces risks related to obtaining and protecting intellectual property rights, including challenges to patent validity, enforceability, and scope, as well as potential infringement claims from third parties[159](index=159&type=chunk)[271](index=271&type=chunk)[310](index=310&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=126&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) No unregistered sales of equity securities, use of proceeds, or issuer purchases occurred during the reporting period - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities occurred during the reporting period[393](index=393&type=chunk) [Item 3. Defaults Upon Senior Securities](index=126&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period covered by this report - No defaults upon senior securities occurred during the reporting period[393](index=393&type=chunk) [Item 4. Mine Safety Disclosures](index=126&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[393](index=393&type=chunk) [Item 5. Other Information](index=126&type=section&id=Item%205.%20Other%20Information) No other information is reported under this item - No other information is reported under this item[393](index=393&type=chunk) [Item 6. Exhibits](index=127&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents and certifications - The exhibits include corporate governance documents (Certificate of Incorporation, Bylaws), the Warrant Agreement, and certifications required by the Sarbanes-Oxley Act[395](index=395&type=chunk)
Surrozen(SRZN) - 2025 Q2 - Quarterly Results
2025-08-08 20:12
[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) [Company Profile and Strategic Focus](index=1&type=section&id=Company%20Profile%20and%20Strategic%20Focus) Surrozen is a biotechnology company focused on tissue repair and regeneration through selective Wnt pathway modulation, currently concentrating on severe ophthalmic diseases and leveraging its Wnt biology expertise and antibody technology to develop novel therapies - Surrozen is a biotechnology company dedicated to tissue repair and regeneration by selectively modulating the Wnt pathway, primarily focusing on severe ophthalmic diseases[1](index=1&type=chunk)[16](index=16&type=chunk) - The company leverages its Wnt biology expertise and antibody technology to develop novel therapies for severe ophthalmic diseases[2](index=2&type=chunk) [Second Quarter 2025 Business Highlights](index=1&type=section&id=Second%20Quarter%202025%20Business%20Highlights) Surrozen achieved significant business progress in Q2 2025, including advancing its ophthalmic pipeline (SZN-8141 and SZN-8143), securing a key patent for SWAP™ technology, and strengthening its leadership team and expert guidance through a VP appointment and clinical advisory board formation - Ophthalmic pipeline progress: SZN-8141 and SZN-8143 continue to advance, with the IND application for SZN-8141 expected in **2026**[3](index=3&type=chunk) - Patent approval: In May 2025, the company was granted U.S. Patent No. 12,297,278, covering its SWAP™ technology for creating multi-specific Wnt mimetic molecules, enhancing intellectual property support for SZN-8141 and SZN-8143[3](index=3&type=chunk) - Key leadership appointment: In July 2025, Dr. Daniel Chao was appointed Vice President and Head of Clinical Development, bringing over **15 years** of ophthalmic research and drug development experience to the company[3](index=3&type=chunk) - Clinical Advisory Board formed: Composed of leading ophthalmologists and retina specialists, aiming to guide the clinical development of the ophthalmic pipeline[8](index=8&type=chunk) - Scientific presentations: Preclinical data for SZN-8141 and SZN-8143 were presented at the 2025 ARVO Annual Meeting and Clinical Trials at the Summit, highlighting their ability to stimulate Wnt signaling to promote normal retinal vascular regeneration and inhibit pathological angiogenesis[8](index=8&type=chunk) [Second Quarter 2025 Financial Highlights](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Surrozen achieved **$39.7 million** in net income in Q2 2025, a significant improvement from a net loss in Q2 2024, primarily due to gains from fair value changes in tranche liability and increased other income, with cash and cash equivalents at **$90.4 million** as of June 30, 2025 Key Financial Highlights for Q2 2025 | Metric | Q2 2025 | Q1 2025 (Cash) | Q2 2024 | YoY Change (Q2) | | :-------------------------------- | :---------- | :--------------- | :---------- | :---------------- | | Cash and Cash Equivalents | $90.4 million | $101.6 million | N/A | QoQ decrease of **$11.2 million** | | Related Party Research Services Revenue | $1.0 million | N/A | $0 | YoY increase of **$1.0 million** | | Net Income (Loss) | $39.7 million | N/A | ($25.3 million) | YoY increase of **$65.0 million** | | Net Income (Loss) Per Share | $2.55 | N/A | ($7.99) | YoY increase of **$10.54** | [Ophthalmology Pipeline and Strategic Developments](index=1&type=section&id=Ophthalmology%20Pipeline%20and%20Strategic%20Developments) [Ophthalmology Portfolio Overview](index=3&type=section&id=Ophthalmology%20Portfolio%20Overview) Surrozen's ophthalmic portfolio includes SZN-8141, SZN-8143, and SZN-413, all designed to modulate the Wnt pathway for retinal diseases, aiming to offer differentiated benefits over existing anti-VEGF monotherapies by promoting normal vascular regeneration and inhibiting pathological angiogenesis - The product portfolio includes SZN-8141, SZN-8143, and SZN-413, all targeting retinal diseases by modulating the Wnt pathway[11](index=11&type=chunk)[14](index=14&type=chunk)[15](index=15&type=chunk) - Aims to provide differentiated benefits over existing anti-VEGF monotherapies by promoting normal vascular regeneration and inhibiting pathological angiogenesis[11](index=11&type=chunk)[14](index=14&type=chunk) [About SZN-8141 for Retinal Diseases](index=3&type=section&id=About%20SZN-8141%20for%20Retinal%20Diseases) SZN-8141 is a dual-action candidate combining Frizzled 4 (Fzd4) agonism and vascular endothelial growth factor (VEGF) antagonism, designed to treat diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD), with preclinical data showing it stimulates Wnt signaling, induces normal retinal vascular regeneration, and inhibits pathological angiogenesis - SZN-8141 combines Fzd4 agonism and VEGF antagonism, potentially offering benefits superior to monotherapy for DME and wet AMD[11](index=11&type=chunk) - Preclinical data indicate SZN-8141 stimulates Wnt signaling, induces normal retinal vascular regeneration, and inhibits pathological angiogenesis[13](index=13&type=chunk) [About SZN-8143 for Retinal Diseases](index=4&type=section&id=About%20SZN-8143%20for%20Retinal%20Diseases) SZN-8143 is a triple-action candidate combining Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism, potentially beneficial for DME, wet AMD, and uveitic macular edema (UME), with preclinical studies showing it stimulates Wnt signaling, promotes normal retinal vascular regeneration, and inhibits pathological angiogenesis - SZN-8143 combines Fzd4 agonism, VEGF antagonism, and IL-6 antagonism, potentially benefiting the treatment of DME, wet AMD, and UME[14](index=14&type=chunk) - Preclinical data indicate SZN-8143 stimulates Wnt signaling, induces normal retinal vascular regeneration, and inhibits pathological angiogenesis[14](index=14&type=chunk) [About SZN-413 for Retinal Diseases](index=4&type=section&id=About%20SZN-413%20for%20Retinal%20Diseases) SZN-413 is a bispecific antibody designed using Surrozen's SWAP™ technology, targeting Fzd4-mediated Wnt signaling for retinal vascular diseases, with preclinical data showing it effectively stimulates ocular Wnt signaling, induces normal retinal vascular regeneration, inhibits pathological angiogenesis, and reduces vascular leakage, potentially leading to healthy ocular tissue regeneration and disease reversal - SZN-413 is a bispecific antibody designed using SWAP™ technology, targeting Fzd4-mediated Wnt signaling for retinal vascular diseases[15](index=15&type=chunk) - Preclinical data show SZN-413 effectively stimulates Wnt signaling, induces normal retinal vascular regeneration, inhibits pathological angiogenesis, and reduces vascular leakage[15](index=15&type=chunk) - This novel approach may enable healthy ocular tissue regeneration, not only halting retinal pathology but potentially fully reversing patients' diseases[15](index=15&type=chunk) [Strategic Business Developments](index=1&type=section&id=Strategic%20Business%20Developments) Surrozen solidified its strategic position by securing key patents, appointing crucial leadership, forming a clinical advisory board, and presenting preclinical data at major scientific conferences, accelerating the clinical development of its ophthalmic pipeline [Patent Issuance](index=1&type=section&id=Patent%20Issuance) In May 2025, Surrozen was granted U.S. Patent No. 12,297,278, covering its SWAP™ technology for creating multi-specific Wnt mimetic molecules, thereby strengthening intellectual property support for SZN-8141 and SZN-8143 - In May 2025, the company was granted U.S. Patent No. 12,297,278, covering its SWAP™ technology[3](index=3&type=chunk) - This patent is for creating multi-specific Wnt mimetic molecules and strengthens intellectual property support for SZN-8141 and SZN-8143[3](index=3&type=chunk) [Key Leadership Appointment](index=1&type=section&id=Key%20Leadership%20Appointment) In July 2025, Dr. Daniel Chao was appointed Vice President and Head of Clinical Development; he is an experienced retina specialist and physician-scientist with over **15 years** of ophthalmic research and drug development experience, having previously served at ADARx Pharmaceuticals and Johnson and Johnson - Dr. Daniel Chao was appointed Vice President and Head of Clinical Development in **July 2025**[3](index=3&type=chunk) - He is an experienced retina specialist and physician-scientist with over **15 years** of ophthalmic research and drug development experience[3](index=3&type=chunk) - Previously held leadership roles at ADARx Pharmaceuticals and Johnson and Johnson[3](index=3&type=chunk) [Clinical Advisory Board Formation](index=2&type=section&id=Clinical%20Advisory%20Board%20Formation) Surrozen established a Clinical Advisory Board comprising leading ophthalmologists and retina specialists, including Dr. Jeffrey Heier, Dr. Arshad Khanani, Dr. Carl Regillo, and Dr. Charles Wykoff, to provide expert guidance for the clinical development of the company's ophthalmic pipeline - The company formed a Clinical Advisory Board consisting of leading ophthalmologists and retina specialists[8](index=8&type=chunk) - Board members include Dr. Jeffrey Heier, Dr. Arshad Khanani, Dr. Carl Regillo, and Dr. Charles Wykoff[8](index=8&type=chunk) - The board's expertise is expected to accelerate the progression of Surrozen's drug candidates into clinical trials[8](index=8&type=chunk) [Scientific Presentations](index=2&type=section&id=Scientific%20Presentations) Surrozen presented preclinical data for SZN-8141 and SZN-8143 at the 2025 ARVO Annual Meeting and Clinical Trials at the Summit, highlighting these candidates' ability to promote normal retinal vascular regeneration and inhibit pathological angiogenesis through Wnt signaling stimulation - Preclinical data for SZN-8141 and SZN-8143 were presented at the **2025 ARVO Annual Meeting** and Clinical Trials at the Summit[8](index=8&type=chunk) - The presentations highlighted the candidates' ability to promote normal retinal vascular regeneration and inhibit pathological angiogenesis through Wnt signaling stimulation[8](index=8&type=chunk) [Detailed Financial Performance](index=6&type=section&id=Detailed%20Financial%20Performance) [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2025, Surrozen achieved **$39.7 million** in net income, a significant improvement from a **$25.3 million** net loss in Q2 2024, primarily driven by a **$31.5 million** gain from fair value changes in tranche liability and increased other income; R&D and G&A expenses both grew, while related party research services revenue increased from zero to **$0.983 million** Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric (thousand USD) | Q2 2025 | Q2 2024 | Year-over-Year Change | | :------------------------------------------------ | :------ | :------ | :--------- | | Related Party Research Services Revenue | $983 | $0 | +$983 | | Research and Development Expenses | $6,042 | $5,335 | +$707 | | General and Administrative Expenses | $3,958 | $3,714 | +$244 | | Total Operating Expenses | $10,000 | $9,049 | +$951 | | Operating Loss | ($9,017) | ($9,049) | +$32 | | Interest Income | $1,025 | $490 | +$535 | | Loss on Issuance of 2024 PIPE Common Stock, Prepaid Warrants and Warrants | $0 | ($20,397) | +$20,397 | | Gain from Fair Value Change of Tranche Liability | $31,520 | $0 | +$31,520 | | Other Income, Net | $16,218 | $3,695 | +$12,523 | | Net Income (Loss) | $39,746 | ($25,261) | +$65,007 | | Net Income (Loss) Per Share | $2.55 | ($7.99) | +$10.54 | | Weighted Average Shares Outstanding | 8,541 | 3,162 | +5,379 | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Metric (thousand USD) | H1 2025 | H1 2024 | Year-over-Year Change | | :------------------------------------------------ | :------ | :------ | :--------- | | Related Party Research Services Revenue | $1,966 | $0 | +$1,966 | | Research and Development Expenses | $12,600 | $10,582 | +$2,018 | | General and Administrative Expenses | $7,934 | $7,597 | +$337 | | Total Operating Expenses | $20,534 | $18,179 | +$2,355 | | Operating Loss | ($18,568) | ($18,179) | -$389 | | Interest Income | $1,321 | $875 | +$446 | | Loss on Issuance of 2024 PIPE Common Stock, Prepaid Warrants and Warrants | $0 | ($20,397) | +$20,397 | | Loss on 2025 PIPE Execution | ($71,084) | $0 | -$71,084 | | Gain from Fair Value Change of Tranche Liability | $47,860 | $0 | +$47,860 | | Other Income, Net | $54,203 | $3,610 | +$50,593 | | Net Income (Loss) | $12,776 | ($34,091) | +$46,867 | | Net Income (Loss) Per Share | $0.85 | ($13.00) | +$13.85 | | Weighted Average Shares Outstanding | 6,098 | 2,622 | +3,476 | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Surrozen's total assets significantly increased to **$102.7 million** from **$48.5 million** on December 31, 2024, primarily due to cash and cash equivalents rising to **$90.4 million**; total liabilities decreased to **$55.6 million**, while stockholders' equity shifted from a **$21.4 million** deficit to a positive **$47.1 million** Condensed Consolidated Balance Sheets (As of June 30, 2025 vs. December 31, 2024) | Metric (thousand USD) | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :------- | | Cash and Cash Equivalents | $90,390 | $34,565 | +$55,825 | | Total Current Assets | $94,235 | $38,932 | +$55,303 | | Total Assets | $102,696 | $48,467 | +$54,229 | | Total Current Liabilities | $5,743 | $7,315 | -$1,572 | | Tranche Liability | $10,903 | $0 | +$10,903 | | Warrant Liability | $32,620 | $55,892 | -$23,272 | | Total Liabilities | $55,582 | $69,847 | -$14,265 | | Total Stockholders' Equity (Deficit) | $47,114 | ($21,380) | +$68,494 | [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines the uncertainties and risks inherent in Surrozen's forward-looking statements, which cover product candidate plans, clinical development timelines, and potential market benefits; actual results may differ significantly due to factors like R&D costs, financing capabilities, regulatory conditions, and risks detailed in SEC filings, and Surrozen undertakes no obligation to update these statements unless legally required - Forward-looking statements cover Surrozen's discovery and R&D activities, particularly its product candidate development plans, including anticipated clinical development plans and timelines, data availability, the potential of such product candidates to treat human diseases or address unmet needs in severe ophthalmic conditions, and their potential benefits and differentiation from existing therapies[17](index=17&type=chunk) - These statements are based on various assumptions and management's current expectations, are not predictions of actual performance, and should not be considered guarantees or definitive statements of fact[18](index=18&type=chunk) - Forward-looking statements are subject to various risks and uncertainties, including the initiation, cost, timing, progress, and results of R&D activities, and the company's ability to fund clinical trials and development efforts[18](index=18&type=chunk) - Unless required by law, Surrozen expressly disclaims any obligation to update these forward-looking statements in the future[18](index=18&type=chunk) [Investor/Media Contact](index=5&type=section&id=Investor%2FMedia%20Contact) This section provides contact information for investor and media inquiries, directing to the company's dedicated email address - Investor/Media Contact Email: **Investorinfo@surrozen.com**[19](index=19&type=chunk)
Surrozen Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-08 20:05
Core Viewpoint - Surrozen, Inc. is advancing its ophthalmology pipeline with a focus on developing novel treatments for severe eye diseases, supported by key leadership appointments and patent issuances [1][4][5]. Business Highlights - The company is leveraging its expertise in Wnt biology and antibody technologies to develop treatments for retinal diseases [2]. - Surrozen's lead candidates, SZN-8141 and SZN-8143, are progressing towards clinical development, with an IND application for SZN-8141 expected in 2026 [5]. Key Events in Second Quarter 2025 - The appointment of Dr. Daniel Chao as Vice President of Clinical Development is expected to enhance the company's clinical capabilities [4]. - The formation of a Clinical Advisory Board consisting of leading retinal specialists aims to guide the clinical development of the ophthalmology pipeline [5]. - Surrozen presented preclinical data for SZN-8141 and SZN-8143 at major conferences, showcasing their potential in promoting retinal vessel regrowth [5]. Financial Highlights - As of June 30, 2025, Surrozen reported cash and cash equivalents of $90.4 million, down from $101.6 million as of March 31, 2025 [6]. - The company achieved a net income of $39.7 million, or $2.55 per share, for the quarter, a significant improvement from a net loss of $25.3 million, or ($7.99) per share, for the same period in 2024 [8]. - Research and development expenses increased to $6.0 million from $5.3 million year-over-year, reflecting higher manufacturing and lab costs [11]. Ophthalmology Pipeline - SZN-8141 is designed to treat diabetic macular edema (DME) and wet age-related macular degeneration (AMD) by combining Frizzled 4 (Fzd4) agonism and VEGF antagonism [9]. - SZN-8143 targets DME, wet AMD, and uveitic macular edema (UME) through a combination of Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism [10]. - SZN-413, another candidate, is being developed for retinal vascular-associated diseases and has shown promise in preclinical models [12].
Surrozen to Present at Upcoming Healthcare Investor Conference
GlobeNewswire News Room· 2025-08-06 20:30
Company Overview - Surrozen, Inc. is a biotechnology company focused on developing targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, particularly in severe eye diseases [1][3] - The company utilizes proprietary technologies to harness the body's biological repair mechanisms to treat severe diseases [3] Upcoming Events - Surrozen management will present at the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025, starting at 7:00 AM Eastern Time [2] - The presentation will be accessible via an audio webcast on the Surrozen website, with a replay available afterward [2]
Down -29.72% in 4 Weeks, Here's Why Surrozen (SRZN) Looks Ripe for a Turnaround
ZACKS· 2025-05-16 14:35
Core Viewpoint - Surrozen, Inc. (SRZN) has experienced significant selling pressure, resulting in a 29.7% decline over the past four weeks, but analysts anticipate better earnings than previously expected, indicating potential for recovery [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is utilized to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - SRZN's current RSI reading is 27.4, suggesting that the heavy selling may be exhausting, which could lead to a price rebound [5] Group 2: Fundamental Indicators - There has been a strong consensus among sell-side analysts to raise earnings estimates for SRZN, resulting in a 69.2% increase in the consensus EPS estimate over the last 30 days, which often correlates with price appreciation [6] - SRZN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7]