Surrozen, Inc. is a clinical-stage biopharmaceutical company at the forefront of developing targeted therapeutics that selectively modulate the Wnt pathway, a critical mediator of tissue repair and regeneration. With a focus on addressing severe diseases across various therapeutic areas, Surrozen's innovative approach holds the promise of transforming patient outcomes.
Rooted in Groundbreaking Research and Discovery
Surrozen was founded in 2015, built upon the seminal work of its scientific founders and advisors who were instrumental in the discovery of the Wnt gene and key regulators of the Wnt pathway. Drawing on this deep well of expertise, the company has made breakthrough discoveries that are poised to overcome previous limitations in harnessing the potential of Wnt biology.
Surrozen's proprietary technology platforms, including its SWEETS (Surrozen Wnt signal Enhancer Engineered for Tissue Specificity) and SWAP (Surrozen Wnt Activating Proteins) technologies, enable the rapid and flexible design of tissue-targeted therapeutics that modulate Wnt signaling. This novel approach allows the company to pioneer the selective activation of Wnt signaling, a crucial step in addressing a wide variety of severe diseases.
In 2016, Surrozen solidified its technological foundation by entering into key licensing agreements with Stanford University and the University of California, San Francisco, securing intellectual property related to its Wnt therapeutics platform. The company also entered into an antibody library subscription agreement with Distributed Bio, Inc. that same year, enhancing its ability to identify antibodies directed to its proprietary targets.
Over the subsequent years, Surrozen faced and navigated the challenges typical of a clinical-stage biotechnology company. The company dedicated significant resources to conducting preclinical studies and manufacturing its product candidates in preparation for human clinical trials. These efforts culminated in 2022 when Surrozen initiated its first-in-human clinical trial for its lead product candidate, SZN-043, in healthy volunteers and patients with a history of liver cirrhosis.
Advancing a Diverse Pipeline of Product Candidates
Surrozen's lead product candidate, SZN-043, is a hepatocyte-specific R-spondin mimetic bispecific fusion protein targeting ASGR1. In preclinical studies, SZN-043 has demonstrated the ability to selectively activate Wnt signaling in the liver, stimulate transient hepatocyte proliferation, improve liver function, and reduce fibrosis - making it a promising therapeutic for the treatment of severe alcohol-associated hepatitis (sAH).
The company initiated a Phase 1b clinical trial for SZN-043 in patients with sAH in June 2024 and expects to report proof-of-concept data in the first half of 2025. This milestone would represent a significant step forward in Surrozen's mission to address this debilitating liver disease with high unmet medical need.
Beyond SZN-043, Surrozen's pipeline includes SZN-413, a Frizzled4-targeted bi-specific antibody being developed for the treatment of retinal vascular-associated diseases. In October 2022, Surrozen entered into a collaboration and licensing agreement with Boehringer Ingelheim to research, develop, and commercialize Frizzled4 bi-specific antibodies, including SZN-413. This partnership provided Surrozen with a $12.5 million upfront payment as well as the potential for additional milestone payments and royalties.
Surrozen has also advanced multiple novel ophthalmology product candidates targeting Frizzled4 and Frizzled127, which have demonstrated promising results in preclinical studies for the treatment of retinopathies and Fuchs endothelial corneal dystrophy. These programs, not covered under the Boehringer Ingelheim collaboration, are wholly owned by Surrozen.
Navigating Challenges and Delivering on Milestones
Despite the inherent risks and uncertainties associated with biopharmaceutical development, Surrozen has demonstrated its ability to navigate challenges and deliver on key milestones. In the third quarter of 2024, the company reported substantial enrollment progress in the Phase 1b trial of SZN-043 for sAH, with proof-of-concept data expected in the first half of 2025.
Furthermore, Surrozen has been successful in expanding its pipeline, nominating a novel portfolio of preclinical ophthalmology product candidates and receiving a $10 million milestone payment from its collaboration with Boehringer Ingelheim related to the advancement of SZN-413.
Financials
In April 2024, Surrozen announced a $192.5 million private placement of securities, providing the company with $17.5 million in upfront proceeds and the potential for an additional $175 million upon the exercise of accompanying warrants. This strategic financing not only funds the expansion of the Phase 1b trial for SZN-043 but also extends Surrozen's cash runway, positioning the company to continue advancing its pipeline and achieve key milestones.
Surrozen's financial position is further bolstered by its collaboration agreements, which provide non-dilutive funding and the potential for future milestone payments and royalties. As of September 30, 2024, the company reported cash and cash equivalents of $31.0 million, which, combined with the recent private placement and potential future payments, is expected to sustain operations for at least the next 12 months.
For the most recent fiscal year (2023), Surrozen reported a net loss of $43.0 million. In the most recent quarter (Q3 2024), the company reported revenue of $10 million, primarily due to the recognition of a milestone payment from Boehringer Ingelheim under the Collaboration and License Agreement. This represents a significant increase from the same quarter in the previous year when no revenue was reported. The net loss for Q3 2024 was $1.4 million, a substantial improvement from previous quarters.
Research and development expenses for the three and nine months ended September 30, 2024, were $5.2 million and $15.8 million, respectively, with the majority of these expenses related to the SZN-043 and SZN-413 programs. General and administrative expenses for the same periods were $3.6 million and $11.2 million, respectively.
Liquidity
The company's recent private placement and collaboration agreements have significantly improved its liquidity position. With $31.0 million in cash and cash equivalents as of September 30, 2024, and the potential for additional funding through warrant exercises and milestone payments, Surrozen appears well-positioned to fund its ongoing operations and clinical development programs in the near term.
Surrozen's liquidity metrics as of the most recent quarter include a debt-to-equity ratio of 0.02, indicating a low level of debt relative to equity. The company's current ratio and quick ratio are both 7.40, suggesting a strong ability to meet short-term obligations. These ratios, combined with the recent financing activities and milestone payments, indicate a solid liquidity position for Surrozen.
Addressing Unmet Needs and Driving Innovation
Surrozen's focus on selectively modulating the Wnt pathway to address severe diseases aligns with the growing demand for innovative, targeted therapies. By leveraging its proprietary platforms and advancing a diverse pipeline, the company is positioning itself to address unmet medical needs across a range of therapeutic areas, including liver, ophthalmology, and potentially others.
The company's progress in clinical development, strategic collaborations, and securing additional financing underscores its commitment to delivering on its mission and creating value for shareholders. As Surrozen continues to execute on its strategy, investors will closely monitor the company's ability to navigate the challenges of biopharmaceutical development and capitalize on the significant opportunities presented by its pioneering approach.
Surrozen's pipeline includes several promising candidates beyond SZN-043 and SZN-413. The company has developed multiple novel ophthalmology product candidates targeting Frizzled4, including SZN-8141 (Fzd4-antiVEGF) and SZN-8143 (Fzd4-antiVEGF-antiIL6), which have shown potential benefits over single-agent treatments for conditions such as diabetic macular edema, neovascular age-related macular degeneration, and uveitic macular edema. Additionally, Surrozen is developing SZN-113, targeting Frizzled127, for potential treatment of Fuchs endothelial corneal dystrophy and geographic atrophy.
The company's accumulated deficit stands at $257.2 million as of September 30, 2024, reflecting the substantial investments made in research and development over the years. Despite this, management believes that the current cash position, along with the recent $10 million milestone payment received in October 2024, will be sufficient to fund operations for at least the next 12 months.
Surrozen's ability to secure strategic partnerships, such as the collaboration with Boehringer Ingelheim, not only provides immediate financial benefits but also validates the potential of the company's technology platforms and approach to drug development. As Surrozen progresses its clinical programs and continues to expand its pipeline, the company is well-positioned to capitalize on the growing interest in targeted therapies that modulate critical biological pathways like Wnt signaling.