Surrozen(SRZN) - 2025 Q1 - Quarterly Results

Company Overview and Business Update Surrozen shifted its strategic focus to ophthalmology, advancing lead candidates SZN-8141 and SZN-8143, and secured significant financing to support clinical development First Quarter 2025 Highlights Surrozen announced Q1 2025 financial results and business updates, emphasizing its strategic shift to ophthalmology, leveraging Wnt pathway modulation for severe eye diseases - Surrozen, Inc. (Nasdaq: SRZN) released Q1 2025 financial results and business updates, focusing on tissue repair and regeneration via Wnt pathway modulation, with a current emphasis on severe eye diseases[1] - The company has redirected its R&D focus to ophthalmology, utilizing Wnt biology expertise and antibody technology to develop novel therapies for severe eye diseases like Age-related Macular Degeneration (AMD) and Diabetic Retinopathy[2][4] - Development of SZN-043 for severe alcohol-associated hepatitis was discontinued in Q1 2025 due to insufficient clinical benefit in a Phase 1b trial[2] Strategic Focus and Pipeline Development The company is actively advancing its lead ophthalmic candidates, SZN-8141 and SZN-8143, into clinical studies, with an IND filing for SZN-8141 planned for 2026 - The company has reallocated resources to advance its lead ophthalmic candidates, SZN-8141 and SZN-8143, into clinical studies[3] - SZN-8141 combines Frizzled 4 (Fzd4) agonism with VEGF antagonism, while SZN-8143 adds IL-6 antagonism, potentially differentiating them from existing therapies[3] - Surrozen anticipates filing an IND for SZN-8141 and initiating clinical studies in 2026[3][4] Funding and Collaborations The company enhanced its cash position with a $175 million private placement, with the first tranche of $76.4 million completed in March 2025, and continues collaboration with Boehringer Ingelheim on SZN-413 - The company significantly strengthened its cash position by closing the first tranche of a $175 million private placement in March 2025, generating $76.4 million in gross proceeds[3][5] - The second tranche of $98.6 million in private placement funds will be triggered upon FDA clearance of the SZN-8141 IND application, expected to fund efficacy, safety, and tolerability studies for SZN-8141 and SZN-8143[3] - The company continues its collaboration with Boehringer Ingelheim on SZN-413 for retinal vascular diseases[3] First Quarter 2025 Financial Performance Surrozen's Q1 2025 saw a significant increase in cash due to private placement, but also expanded net loss driven by non-cash charges related to warrant revisions and PIPE execution Financial Highlights Summary Surrozen's Q1 2025 cash and cash equivalents significantly increased to $101.6 million due to private placement, while R&D expenses rose, leading to an expanded net loss of $27.0 million First Quarter 2025 Key Financial Highlights (vs. Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change | Source | | :----------------------------------- | :------------- | :------------- | :----- | :----- | | Cash and Cash Equivalents (End of Period) | $101.6M | $34.6M (Dec 31, 2024) | +$67.0M | [5] | | Related Party Research Service Revenue | $1.0M | $0 | +$1.0M | [6] | | Research and Development Expenses | $6.6M | $5.2M | +$1.4M | [8] | | Selling, General and Administrative Expenses | $4.0M | $3.9M | +$0.1M | [8] | | Interest Income | $0.3M | $0.4M | -$0.1M | [8] | | Loss on Warrant Amendment and Cancellation | $2.1M | $0 | +$2.1M | [8] | | Loss on 2025 PIPE Execution | $71.1M | $0 | +$71.1M | [8] | | Gain from Fair Value Change of Tranche Liability | $16.3M | $0 | +$16.3M | [8] | | Gain from Settlement of Tranche Liability | $1.1M | $0 | +$1.1M | [8] | | Other Income (Expense), Net | $38.0M | -$0.1M | +$38.1M | [8],[9] | | Net Loss | $27.0M | $8.8M | +$18.2M | [9] | | Net Loss Per Share (Basic and Diluted) | ($7.43) | ($4.24) | -($3.19) | [9] | Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, Surrozen reported $0.983 million in related party research service revenue and an expanded net loss of $26.97 million, or $7.43 per share, primarily due to non-cash losses Unaudited Condensed Consolidated Statements of Operations (Three Months Ended March 31, in thousands of USD) | Metric | 2025 | 2024 | | :------------------------------------------ | :----- | :----- | | Related party research service revenue | $983 | $— | | Operating expenses: | | | | Research and development | 6,558 | 5,247 | | Selling, general and administrative | 3,976 | 3,883 | | Total operating expenses | 10,534 | 9,130 | | Operating loss | (9,551) | (9,130) | | Interest income | 296 | 385 | | Loss on warrant amendment and cancellation | (2,073) | — | | Loss on 2025 PIPE execution | (71,084) | — | | Gain from fair value change of tranche liability | 16,340 | — | | Gain from settlement of tranche liability | 1,117 | — | | Other income (expense), net | 37,985 | (85) | | Net loss | $(26,970) | $(8,830) | | Net loss per share (basic and diluted) | $(7.43) | $(4.24) | | Weighted-average shares used in computing net loss per share (basic and diluted) | 3,628 | 2,083 | Condensed Consolidated Balance Sheets As of March 31, 2025, Surrozen's total assets increased significantly to $114.8 million, driven by higher cash, while total liabilities also rose to $109.2 million, with shareholder equity turning positive Condensed Consolidated Balance Sheets (As of March 31, in thousands of USD) | Metric | March 31, 2025 | December 31, 2024 | | :------------------------------------------ | :------------- | :---------------- | | Assets: | | | | Cash and cash equivalents | $101,645 | $34,565 | | Total current assets | 106,011 | 38,932 | | Total assets | $114,829 | $48,467 | | Liabilities: | | | | Total current liabilities | 10,582 | 7,315 | | Tranche liability | 42,423 | — | | Warrant liability | 49,372 | 55,892 | | Total liabilities | 109,155 | 69,847 | | Stockholders' equity (deficit): | | | | Total stockholders' equity (deficit) | 5,674 | (21,380) | | Total liabilities and stockholders' equity (deficit) | $114,829 | $48,467 | Surrozen Ophthalmology Portfolio Surrozen's ophthalmology portfolio includes SZN-8141, SZN-8143, and SZN-413, all designed to modulate Wnt signaling for retinal disease treatment SZN-8141 for Retinal Diseases SZN-8141, combining Fzd4 agonism and VEGF antagonism, aims to offer superior benefits for DME and wet AMD by stimulating Wnt signaling and promoting normal retinal vascular regeneration - SZN-8141 combines Frizzled 4 (Fzd4) agonism and Vascular Endothelial Growth Factor (VEGF) antagonism, potentially offering superior benefits over monotherapies for Diabetic Macular Edema (DME) and neovascular Age-related Macular Degeneration (wet AMD)[10] - Preclinical data in retinal disease models show SZN-8141 stimulated Wnt signaling, induced normal retinal vascular regeneration, and inhibited pathological vessel growth[10] SZN-8143 for Retinal Diseases SZN-8143, building on SZN-8141 with added IL-6 antagonism, offers a triple mechanism of action for DME, wet AMD, and UME, showing similar preclinical benefits in Wnt signaling and vascular growth - SZN-8143 combines Fzd4 agonism, VEGF antagonism, and Interleukin-6 (IL-6) antagonism, potentially offering superior benefits over monotherapies for DME, wet AMD, and Uveitic Macular Edema (UME)[11] - Preclinical data in retinal disease models show SZN-8143 stimulated Wnt signaling, induced normal retinal vascular regeneration, and inhibited pathological vessel growth[11] SZN-413 for Retinal Diseases SZN-413, a bispecific antibody designed using Surrozen's SWAP™ technology, targets Fzd4-mediated Wnt signaling for retinal vascular diseases, showing preclinical efficacy in regenerating healthy eye tissue - SZN-413 is a bispecific antibody designed using Surrozen's SWAP™ technology, targeting Fzd4-mediated Wnt signaling, currently being developed for retinal vascular diseases[12] - Preclinical data show SZN-413 effectively stimulated ocular Wnt signaling, induced normal retinal vascular regeneration, inhibited pathological vessel growth, and reduced vascular leakage[12] - This novel approach may allow for healthy eye tissue regeneration, potentially not only halting retinal disease progression but also achieving complete disease reversal for patients[12] About Surrozen Surrozen is a biotechnology company focused on developing tissue-specific antibodies to selectively modulate the Wnt pathway, with a current emphasis on ophthalmology Company Mission and Focus Surrozen is a biotechnology company dedicated to developing tissue-specific antibodies for selective Wnt pathway modulation, currently focused on ophthalmology to treat severe diseases - Surrozen is a biotechnology company developing tissue-specific antibodies to selectively modulate the Wnt pathway[13] - The company is currently focused on ophthalmology, aiming to leverage the body's biological repair mechanisms to treat severe diseases[13] Forward-Looking Statements This section outlines the forward-looking nature of statements regarding Surrozen's development activities, clinical plans, and financial expectations, subject to various risks Disclaimer and Risks This press release contains forward-looking statements about Surrozen's R&D, clinical plans, and financing, based on current expectations and subject to significant risks detailed in SEC filings - This press release contains forward-looking statements regarding Surrozen's discovery, research, and development activities, particularly its product candidate development plans, including anticipated clinical development plans and timelines, data availability, potential benefits of product candidates for treating human diseases or addressing unmet needs in severe eye diseases, and potential differentiation from existing therapies[14] - These statements are based on various assumptions and current expectations of Surrozen's management, are illustrative only, and should not be considered guarantees; actual events and circumstances are difficult to predict and will differ from assumptions[14] - Forward-looking statements are subject to various risks and uncertainties, including the initiation, cost, timing, progress, and results of R&D activities, and all other factors discussed in the company's SEC filings, such as 10-K and 10-Q; Surrozen undertakes no obligation to update these statements unless required by law[14][15] Investor/Media Contact This section provides the dedicated contact information for investor and media inquiries Contact Information This section provides the dedicated email address for investor and media contact - Investor/Media Contact Email: Investorinfo@surrozen.com[16]