Aankondiging • Apr 02

Surrozen Provides Update on the Phase 1A Clinical Trial of SZN-043 in Healthy Volunteers and Patients with Cirrhosis

Surrozen, Inc. provided an update on the Phase 1a clinical trial of SZN-043 in healthy volunteers and patients with cirrhosis. The Phase 1a study was completed in February 2024. SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function. The observed safety and pharmacodynamic activity were the basis for the Company’s previous announcement that it planned to initiate enrollment in the Phase 1b study in alcohol-associated hepatitis. The randomized, placebo-controlled Phase 1a trial enrolled a total of 48 subjects, including 40 healthy volunteers and 8 patients with cirrhosis and a history of liver disease. Single or multiple IV doses were administered in doses ranging from 0.5mg/kg to 3 mg/kg. There were no serious adverse events nor infusion reactions observed. In the planned Phase 1b trial dose range (0.5mg/kg to 1.5 mg/kg), adverse events assessed to be drug related were mild to moderate and all resolved during the study. In healthy volunteers a few asymptomatic and transient transaminase elevations (ranging from mild to moderate) were observed which resolved without intervention, and with no clinical sequelae. There were no drug related adverse events reported in patients with cirrhosis at any dose. The pharmacokinetics of SZN-043 were consistent with expectations and supportive of the planned doses, schedule and route of administration for alcohol-associated hepatitis. In cirrhotic patients with a history of liver disease, the Phase 1a study also demonstrated dose dependent pharmacodynamic (PD) activity through activation of Wnt signaling as assessed by the methacetin breath test. This test measures activation of the Wnt pathway via the metabolism of a Wnt target gene (CYP1A2) substrate. Target engagement was confirmed via transient increases in alkaline phosphatase (ALP). Increases in ALP are indicative of SZN-043 binding to its targeting receptor ASGR1 and reduction in its capacity to clear ALP, consistent with observations in other ASGR1 binding agents. Cirrhotic patients also showed evidence of liver function effects after treatment with SZN-043 as measured by HepQuant which is a test that measures cholate clearance, a liver specific function that quantifies liver function. The Company is in the process of initiating the multi-center Phase 1b clinical trial in multiple countries and expects that proof-of-concept data from this trial may be available in the first half of 2025. The study will enroll patients with severe alcohol-associated hepatitis in an open-label trial. The Company plans to evaluate safety, pharmacokinetics, immunogenicity and a number of efficacy endpoints including MELD score, Lille score and survival. The MELD and Lille scores have been shown to correlate with clinical improvement and 90-day survival. SZN-043 is the first development candidate using Surrozen’s SWEETS™ technology. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on alcohol-associated hepatitis. The Company has completed a Phase 1a clinical trial in patients with chronic liver disease and healthy volunteers. SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function. The Company is initiating the Phase 1b clinical trial in patients with severe alcohol-associated hepatitis and expects that proof-of-concept data from this trial may be available in the first half of 2025. SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen’s SWAP™ technology. It is currently being developed for the treatment of retinal vascular-associated diseases. Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient’s disease. In the fourth quarter of 2022, Surrozen entered into a strategic partnership with Boehringer Ingelheim for the research and development of SZN-413 for the treatment of retinal diseases. Under the terms of the agreement, Boehringer Ingelheim received an exclusive, worldwide license to develop SZN-413 and other Fzd4-specific Wnt-modulating molecules for all purposes, including as a treatment for retinal diseases, in exchange for an upfront payment to Surrozen of $12.5 million. Surrozen will also be eligible to receive up to $587.0 million in success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. After an initial period of joint research, Boehringer Ingelheim will assume all development and commercial responsibilities. Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, retina, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. Surrozen’s platform and proprietary technologies have the potential to overcome the limitations in pursuing the Wnt pathway as a therapeutic strategy.

Aankondiging • May 26

Surrozen, Inc. Presents Data on Lead Therapeutic Candidates at Digestive Disease Week (DDW)

Surrozen, Inc. announced the presentation of data supporting the continued development of its lead therapeutic programs at Digestive Disease Week (DDW) 2022 in San Diego. In an oral presentation entitled, “SZN-1326 promotes colonic mucosal healing in an acute injury model of IBD by first accelerating epithelial regeneration and secondarily reducing inflammation,” Surrozen presented data elucidating the mechanism of action of its proprietary Wnt mimetic, SZN-1326, a FZD5 and LRP6-specific, full-length, effectorless, bi-specific tetravalent IgG1 molecule. The data demonstrate that in an acute dextran sodium sulfate (DSS) epithelial damage model, SZN-1326 promoted mucosal healing by transiently inducing epithelial progenitor cell expansion and accelerating epithelial repair. The data further show that SZN-1326 also reduced stromal and immune cytokine signaling and immune cell infiltration. In a poster entitled, “Modulation of Wnt signaling via a Wnt mimetic improved epithelial healing without causing hyperplasia in a mouse colitis model,” Surrozen presented data from an acute DSS mouse model for ulcerative colitis (UC). UC is characterized by epithelial lesions, and there is a need for therapies that promote mucosal healing. Wnt signaling plays critical roles in regulating intestinal stem cell maintenance and differentiation, and modulation of Wnt signaling could allow for epithelial restoration and histological remission. In this study, Surrozen’s Wnt mimetic repaired the damaged epithelium without causing hyperproliferation of epithelial cells in the intestine and improved body weight loss, demonstrating its therapeutic potential in IBD. In a poster entitled, “SZN-043 induced quick and robust hepatocyte proliferation in a 14-day daily dosing Edu-labeling study in SCID mice,” Surrozen evaluated the kinetics and the overall effects of daily dosing of SZN-043 on hepatocyte proliferation in mice. Wnt/ß-catenin signaling plays a key role in hepatocyte regeneration in homeostasis and after liver injury, and SZN-043, a hepatocyte specific R-spondin-mimetic, amplifies the signal of Wnt ligands by stabilizing and increasing the amount of Wnt receptors on the hepatocyte cell surface. Results showed hepatocytes responded quickly to SZN-043 treatment and underwent a limited number of proliferation cycles, despite the continued exposure to SZN-043 and ß-catenin signaling induction for up to 14 days. SZN-1326 is the first development candidate designed using Surrozen’s SWAP™ technology and targets the Wnt-signaling pathway in the intestinal epithelium. In preclinical animal models of acute and chronic colitis, SZN-1326 has been shown to activate Wnt signaling in the diseased intestine, stimulate intestinal epithelial regeneration, reduce inflammation and reduce disease activity with no treatment related adverse effects observed in 13-week toxicology evaluations in rats and non-human primates (NHPs). Surrozen is initially developing SZN-1326 for moderate to severe ulcerative colitis. The Phase 1 clinical study is posted to the Australian New Zealand Clinical Trial Registry. SZN-043 is the first development candidate designed using Surrozen’s SWEETS™ technology. In multiple preclinical animal models of liver injury and fibrosis, SZN-043 has been shown to selectively activate Wnt signaling in the liver, stimulate transient hepatocyte proliferation, improve liver function and reduce fibrosis with no treatment-related adverse effects observed in 4-week GLP toxicology evaluations in mice and NHPs. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on severe alcoholic hepatitis. Surrozen expects to initiate a Phase 1 clinical trial of SZN-043 in the third quarter if 2022. The Phase 1 clinical study is posted to the Australian New Zealand Clinical Trial Registry.

Rente dekkingsratio	n/a
Contant	US$106.91m
Aandelen	-US$278.15m
Totaal verplichtingen	US$398.86m
Totaal activa	US$120.71m

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/06/12 17:02
Aandelenkoers aan het einde van de dag	2026/06/12 00:00
Inkomsten	2026/03/31
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Tazeen Ahmad	BofA Global Research
Steven Seedhouse	Cantor Fitzgerald & Co.
Yatin Suneja	Guggenheim Securities, LLC

Surrozen Balans Gezondheid

Financiële gezondheid criteriumcontroles 3/6

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