Core Insights - Surrozen, Inc. is making significant progress in its clinical trials, particularly with SZN-043 for severe alcohol-associated hepatitis, with proof-of-concept data expected in the first half of 2025 [1][3][17] - The company has also expanded its research pipeline with new preclinical ophthalmology product candidates and received a $10 million milestone payment from Boehringer Ingelheim for the development of SZN-413 [1][9][10] Research and Development Pipeline Highlights - SZN-043 is currently in a Phase 1b trial for severe alcohol-associated hepatitis, with enrollment ongoing across nine sites in five countries [3][17] - Initial results from the first cohort of the Phase 1b trial showed no serious adverse events and potential clinical benefits, including reductions in bilirubin and MELD scores [4][5][17] - Surrozen has nominated a portfolio of novel ophthalmology candidates targeting Fzd4, leveraging its expertise in antibody engineering [5][9] Financial Performance - As of September 30, 2024, Surrozen reported cash and cash equivalents of $31.0 million, down from $37.8 million as of June 30, 2024 [11] - Collaboration and license revenue for Q3 2024 was $10 million, a significant increase from zero in the same period of 2023, attributed to the milestone payment from Boehringer Ingelheim [12] - Research and development expenses decreased to $5.2 million in Q3 2024 from $6.1 million in Q3 2023, reflecting a restructuring to focus on clinical programs [13] Corporate Updates - Surrozen entered a strategic partnership with Boehringer Ingelheim in Q4 2022 for the development of SZN-413, which has now progressed to further development and clinical testing [9][19] - A new research collaboration with TCGFB was announced to discover antibody therapeutics targeting TGF-β, with potential payments to Surrozen of up to $6 million [10]

Core Viewpoint - Surrozen, Inc. has announced a strategic research collaboration with TCGFB, Inc. to develop antibody therapeutics targeting TGF-β for the treatment of idiopathic pulmonary fibrosis (IPF) [1][4]. Group 1: Collaboration Details - Surrozen will provide antibody discovery services for up to two years, with TCGFB owning all related intellectual property [2]. - TCGFB will compensate Surrozen with up to $6 million and issue warrants for up to 3,380,000 shares of TCGFB common stock at an exercise price of $0.0001 per share, contingent on certain vesting conditions [2]. Group 2: Company Background - Surrozen is a clinical-stage biotechnology company focused on discovering and developing drug candidates that selectively modulate the Wnt pathway, with a current emphasis on severe liver and eye diseases [3]. - TCGFB is a biotechnology company founded by The Column Group, concentrating on novel antibodies targeting TGF-β for IPF treatment [4]. Group 3: Leadership Statement - Craig Parker, President and CEO of Surrozen, expressed enthusiasm for the collaboration, highlighting the potential of targeting TGF-β as a novel therapeutic approach for IPF [3].

Core Insights - Boehringer Ingelheim is advancing the development of SZN-413, a bi-specific antibody targeting Frizzled Class Receptor 4 (Fzd4) for potential clinical testing [1][3] - SZN-413 aims to restore retinal function in patients with retinal vascular diseases, which affect nearly 150 million people globally [2][4] - The partnership between Surrozen and Boehringer Ingelheim includes a $10 million payment to Surrozen as part of the agreement [1][4] Company Overview - Surrozen is a clinical-stage biotechnology company focused on discovering and developing drug candidates that selectively modulate the Wnt pathway, particularly for severe liver and eye diseases [6] - The company utilizes its proprietary SWAP™ technology to create targeted therapeutics aimed at tissue repair and regeneration [1][5] Partnership Details - The strategic partnership with Boehringer Ingelheim was established in Q4 2022, granting Boehringer an exclusive worldwide license to develop SZN-413 and other related molecules [4] - The agreement includes an upfront payment of $12.5 million and potential success-based milestone payments totaling up to $586.5 million, along with royalties on sales [4] Scientific Background - Wnt signaling is crucial for the development and regeneration of various organs, including the retina, and has potential therapeutic applications for degenerative diseases [5] - Preclinical data suggest that SZN-413 may stimulate Wnt signaling in the eye, promoting normal retinal vessel regrowth and reducing pathological vessel growth [2][5]

Core Insights - Surrozen is advancing targeted protein degradation (TPD) technologies to enhance Wnt-signal activation for treating liver diseases, specifically through the development of ASGR-targeted bispecific antibodies [1][7][10] - The company has initiated a Phase 1b clinical trial for SZN-043, focusing on severe alcohol-associated hepatitis, with proof-of-concept data expected in the first half of 2025 [3][9] Group 1: TPD Technologies and Research - The publication highlights the development of two new ASGR-targeted SWEETS bispecific antibodies that activate Wnt signaling through a unique TPD platform, enhancing liver function in mouse models [1][8] - A review article published in iScience summarizes the progress in Wnt activating platforms, emphasizing the potential of Wnt agonists in treating tissue degenerative diseases [2] Group 2: Clinical Development - SZN-043 is the first candidate utilizing Surrozen's SWEETS technology, having completed a Phase 1a clinical trial demonstrating safety and target engagement [3][9] - The Phase 1b clinical trial for SZN-043 began enrollment in Q2 2024, with expectations for proof-of-concept data in early 2025 [9] Group 3: Company Overview - Surrozen is a clinical-stage biotechnology company focused on discovering and developing drug candidates that selectively modulate the Wnt pathway, targeting severe liver and eye diseases [5][10] - The company's proprietary technologies aim to overcome limitations in pursuing the Wnt pathway as a therapeutic strategy, with a focus on tissue-specific antibodies [10]

Core Insights - Surrozen, Inc. is advancing its clinical development of SZN-043, a novel biotherapeutic aimed at enhancing Wnt signaling for liver regeneration, particularly in severe alcohol-associated hepatitis [6][11] - The Phase 1a trial of SZN-043 demonstrated safety and tolerability in both healthy volunteers and patients with liver cirrhosis, with evidence of target engagement and pharmacodynamic effects [5][7][11] - Enrollment for the Phase 1b trial in severe alcohol-associated hepatitis began in Q2 2024, with proof-of-concept data expected in early 2025 [6][13] Company Overview - Surrozen is a clinical-stage biotechnology company focused on developing targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration [16] - The company is also developing SZN-413, a bi-specific antibody for retinal diseases, in partnership with Boehringer Ingelheim, which includes an upfront payment of $12.5 million and potential milestone payments totaling up to $587 million [8][16] Clinical Trial Results - The Phase 1a trial involved 40 healthy volunteers and 8 patients with liver cirrhosis, with intravenous doses ranging from 0.5 mg/kg to 3 mg/kg [6][11] - Results indicated transient increases in alkaline phosphatase (ALP) and activation of Wnt signaling, as evidenced by improved liver function metrics [2][5][12] Future Developments - Surrozen is focused on optimizing its platform technologies to enhance Wnt pathway modulation, which is seen as a promising mechanism for liver regeneration [7][15] - The company aims to leverage its proprietary SWEETS™ technology for the development of SZN-043 and other therapeutics targeting severe liver diseases [7][11]

About Surrozen Treatment with SZN-043 in the Phase 1a trial was safe and well tolerated in healthy volunteers and patients with a history of liver cirrhosis Enrollment is ongoing in Phase 1b study in severe alcohol-associated hepatitis Study Overview Pharmacodynamic Biomarkers The study provided evidence of Wnt-mediated pharmacodynamic activity in the liver after treatment with SZN043. "We were pleased to present the first clinical data from this innovative bispecific antibody-based approach to modulating t ...

SOUTH SAN FRANSCISO, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. ("Surrozen" or the "Company") (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today announced that the first patient has been dosed in its Phase 1b clinical trial for SZN-043 in patients with severe alcohol-associated hepatitis. In the fourth quarter of 2022, Surrozen entered into a strategic partnership with Boehringer Ingelheim for the resea ...

SZN-043 is a novel hepatocyte-specific R-spondin mimetic bispecific fusion protein targeting ASGR1 Anticipate potential proof-of-concept data available in the first half of 2025 SOUTH SAN FRANSCISO, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. ("Surrozen" or the "Company") (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today announced that the first patient has been dosed in its Phase 1b clinical trial for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39635 Surrozen, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 30-1374889 | | --- | --- | | ( State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | | 171 Oyster Point Blvd, Suite 400, Sout ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39635 Surrozen, Inc. (Exact name of registrant as specified in its charter) | Delaware 30-1374889 | | --- | | (State or other jurisd ...