SOUTH SAN FRANCISCO - Surrozen Inc. (NASDAQ: SRZN), a biotechnology firm engaged in developing therapies for tissue repair and regeneration, has reported favorable outcomes from its Phase 1a clinical trial of SZN-043, a novel biotherapeutic for liver diseases. The study, which involved healthy volunteers and patients with a history of liver cirrhosis, was presented on June 8, 2024, at the European Association for the Study of the Liver in Milan.
The Phase 1a trial, a randomized, placebo-controlled study, established safe and well-tolerated doses of SZN-043 in 40 healthy volunteers and 8 patients. Administered in single or multiple intravenous doses ranging from 0.5 mg/kg to 3 mg/kg, the treatment led to mild-to-moderate, transient serum transaminase elevations that resolved independently. Importantly, these elevations were not linked to signs of liver disease or bile duct damage.
Pharmacodynamic biomarkers indicated that SZN-043 engaged its target in the liver, as evidenced by transient increases in alkaline phosphatase (ALP) levels and improved methacetin clearance from a breath test, suggesting activation of the Wnt target gene CYP1A2 in hepatocytes. Additionally, HepQuant test results showed increased portal hepatic filtration rates, consistent with Wnt-mediated enhancement of liver function.
Craig Parker, President and CEO of Surrozen, stated that the preliminary data supports the therapeutic potential of SZN-043 in liver regeneration. The company is actively enrolling participants in a Phase 1b study for severe alcohol-associated hepatitis, with the aim to evaluate further safety, pharmacokinetics, and efficacy endpoints. Results from this ongoing study are expected in the first half of 2025.
Surrozen is also advancing SZN-043 for severe alcohol-associated hepatitis, leveraging its proprietary SWEETS™ technology. The company has high hopes for SZN-043's mechanism of action, which involves modulating the Wnt pathway, a critical component in tissue regeneration.
In addition to SZN-043, Surrozen is developing SZN-413, a bi-specific antibody for retinal diseases using their SWAP™ technology. The company has entered into a strategic partnership with Boehringer Ingelheim for the development of SZN-413, with potential milestone payments and royalties on future sales.
This news is based on a press release statement from Surrozen, Inc. and has not been independently verified. Investors are advised to follow the progress of Surrozen's clinical trials for a comprehensive understanding of the drug's potential and risks.
In other recent news, Surrozen Inc. has been making significant strides in the biotechnology sector. The company unveiled promising preclinical data for its antibody-based Wnt mimetic technologies, suggesting potential new treatments for corneal endothelial damage and Dry Eye Disease.
Surrozen's research shows its Wnt mimetic can stimulate endothelial cell proliferation in the cornea, potentially halting vision loss in conditions such as Fuchs’ Endothelial Cell Dystrophy. Furthermore, the Wnt mimetic showed promise in increasing tear production in models of Dry Eye Disease.
In addition to these advancements, Surrozen reported the successful completion of a Phase 1a clinical trial for its drug candidate SZN-043, which has shown effects on liver function. Encouraged by these findings, Surrozen is moving forward with a Phase 1b proof-of-concept trial for severe alcohol-associated hepatitis. The company anticipates that data from this Phase 1b trial may be available in the first half of 2025.
Further, Surrozen has secured a private placement agreement that will provide an initial $17.5 million in funding, with the potential for up to $175 million more upon warrant exercises. This capital is intended to extend the company's financial runway and expand the Phase 1b clinical trial for its severe alcohol-associated hepatitis treatment. The company's financial assets, along with this new funding, are projected to support operations and capital expenditures through the first half of 2025.
InvestingPro Insights
As Surrozen Inc. (NASDAQ: SRZN) continues to make strides in the biotechnology sector with its promising clinical trials, investors are closely monitoring the company's financial health and market performance. The latest data from InvestingPro reveals critical insights into Surrozen's financial position and stock activity that could impact investor decisions.
InvestingPro Data indicates a challenging financial landscape for Surrozen, with a market capitalization of $35.47 million and a negative P/E ratio of -0.62, reflecting investor concerns about profitability. The company's gross profit over the last twelve months as of Q1 2024 stands at -$27.18 million, and its operating income is adjusted to -$38.77 million, signaling that the firm is facing significant losses.
Despite these challenges, Surrozen has demonstrated a large price uptick over the last six months, with a 42.18% return, suggesting investor optimism may be growing in light of recent clinical advancements. Moreover, an InvestingPro Tip highlights that Surrozen holds more cash than debt on its balance sheet, which could provide the company with a buffer to navigate its cash burn issues and invest in its pipeline of therapies.
InvestingPro also notes that Surrozen does not pay a dividend to shareholders, which is common for growth-stage biotech companies that prioritize reinvestment in research and development over immediate returns to investors. The InvestingPro Fair Value estimate stands at $14.45, a significant divergence from the analyst target of $33, indicating varying perspectives on the company's valuation.
For investors seeking to delve deeper into Surrozen's financial metrics and future outlook, InvestingPro offers additional tips, including an analysis of the company's liquidity and profitability prospects. There are 6 more InvestingPro Tips available, which can be explored further at https://www.investing.com/pro/SRZN. Interested readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing access to a wealth of investment analysis and data.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.