Surrozen and Lonza Announce Partnership for the Development and Manufacture of Surrozen’s Novel Wnt Activating Antibodies

–Surrozen is developing first-in-class bi-specific antibodies that selectively stimulate tissue regeneration–
–Lonza to provide cell line development, drug substance and drug product process development and cGMP manufacturing, and regulatory support for IND filing–
–Lonza’s Light Path™ cell line development program will be tailored enabling Surrozen to prepare for their IND filing–

South San Francisco (CA), USA and Basel, Switzerland, May 29, 2020 – Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, and Lonza today announced that the companies have signed a collaboration agreement. Lonza will provide contract development and cGMP manufacturing services for Surrozen’s first two, and potentially additional, development candidates.

Surrozen will leverage Lonza’s process development and manufacturing capabilities and expertise in cell line development, early-stage formulation development and drug product manufacture. Process development and drug substance manufacturing will take place in Lonza’s cGMP facility for mammalian biopharmaceuticals in Slough, UK. The early-stage formulation and DP manufacture will be carried out in the Drug Product Services facility in Basel and Lonza’s recently acquired fill and finish facility in Stein, Switzerland.

The agreement includes Lonza’s Light Path™ cell line development program that will provide Surrozen with material to enter a phase I clinical study. This offering that includes gene to cGMP drug substance and drug product production services will help Surrozen to meet their clinical product supply needs as well as provide a CMC regulatory package for their IND filing. The scope of the package was tailored for the molecule to ensure the program met their requirements.

The two initial development candidates represent potent multivalent bi-specific antibodies that directly activate the Wnt signaling pathway, which regulates multiple biological processes and plays a key role in tissue homeostasis and injury repair. These candidates are both in the preclinical phase with potential INDs in 2021 and 2022. Surrozen’s targeted approach to tissue specific regenerative medicine aims to impact many areas, including neurodegenerative, lung, and inflammatory diseases.

Quote from Karen Fallen, President, Head of MMDM, Lonza:
“Lonza’s subject matter experts enjoyed working with the Surrozen’s technical team to identify specific molecule needs to design a tailored Light PathTM cell line development work package suitable to achieve their goals. This produced two critical outcomes; an end to end program beginning with their gene, ending with drug product and a CMC IND readiness package that will support Surrozen on their first IND filing. An enhanced, strong and collaborative working relationship between the parties drastically improves the chance of project success. ”

Quote from Craig Parker, President and Chief Executive Office at Surrozen:
“We are excited to be working with Lonza, which has industry leading capabilities and expertise with complex biologics including antibodies and bi-specific molecules. Lonza’s extensive biologics development, manufacturing and CMC regulatory experience makes them an ideal partner for novel molecules like our SWAP and SWEETS bi-specific antibodies. Based on our molecules and some unique program needs, Lonza took a flexible and adaptable approach to designing a program that was tailored to meet our specific needs.”

About Lonza
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.

We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.

Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.com and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.

About Surrozen’s Proprietary Antibody Platforms
Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wnt-mimetics, also referred to as SWAPs (Surrozen Wnt Signal Activating Proteins), are bi specific full-length human (IgG) antibodies that directly activate the canonical Wnt signaling pathway in target tissue. Surrozen Rspondin-mimetics, also referred to as SWEETS (Surrozen Wnt Signal Enhancer Engineered for Tissue Specificity), are uniquely engineered antibodies that  stabilize Wnt receptors.

About Surrozen
Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. Surrozen is designing tissuespecific antibodies that engage the body’s own biological repair mechanisms resulting in a broad pipeline of disease-specific therapies to help patients across multiple disease areas. For more information, please visit surrozen.com.

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Lonza Contact Details

Dr. Kristin Koehler
Investor Relations
Lonza Group Ltd
Tel +41 61 316 8782
kristin.koehler@lonza.com

Dr. Sanna Fowler
Head of External Communications
Lonza Group Ltd
Tel +41 61 316 8929
sanna.fowler@lonza.com

Surrozen Contact Details

Reza Afkhami
VP, Corporate Development and Strategy
Surrozen, Inc.
reza@surrozen.com

Surrozen Raises $50 Million in Series C Financing to Advance Candidates to Human Clinical Trials

IND Candidates Nominated for the Treatment of Liver Disease and Inflammatory Bowel Disease

SOUTH SAN FRANCISCO, Calif., June 19th, 2020 — Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, today announced the successful completion of a $50 million Series C financing. Investors from the Series B financing participated in the Series C round, including The Column Group, Hartford Healthcare Trust, and Horizons Ventures. Four new investors also participated in this recent financing round, including Euclidean Capital. Surrozen is focused on engaging the body’s own biological repair mechanisms through tissue-specific modulation of the Wnt pathway to discover and develop a broad pipeline of first-in-class, targeted regenerative antibodies.

Proceeds from the financing will be used to advance the Company’s two IND candidates to the clinic, one for the for the treatment of liver disease and a second novel antibody for inflammatory bowel disease. The company will also continue its discovery efforts to expand its pipeline to include novel Wnt-modulating regenerative antibodies for additional tissues and disease areas.

“The nomination of our first two candidates marks the culmination of preclinical proof-of-concept work achieved in multiple disease models demonstrating cell proliferation, tissue regeneration, and functional improvement — which suggests an ability to repair damaged tissue and restore function,” said Craig Parker, president and chief executive officer of Surrozen. “Our goal is to file IND applications in 2021 and 2022 for novel antibodies targeting severe liver disease and moderate to severe inflammatory bowel disease, respectively. We believe that these two candidate molecules have the potential to play a critical role in tissue regeneration in these diseases.”

“While it has long been known that the Wnt signaling pathway plays a crucial role in the maintenance and self-renewal of stem cells in a variety of tissues, scientists had been unable to overcome the technical challenges inherent in developing a therapeutic based on Wnt signaling,” said Roeland Nusse, Ph.D., Virginia and Daniel K. Ludwig Professor of Cancer Research and Professor of Developmental Biology at Stanford University School of Medicine. “I am hopeful that Surrozen’s approach to modulating the Wnt pathway, with the flexibility to address insufficient endogenous Wnt or insufficient receptors, may someday lead to therapeutics that have the potential to repair damaged tissue.”

SZN-043: Liver-Specific R-spondin-mimetic
SZN-043 is the first development candidate designed using Surrozen’s SWEETS (Surrozen Wnt signal enhancers engineered for tissue specificity) platform. SWEETS stabilize Frizzled receptors to enhance the body’s response to endogenous Wnt proteins. In preclinical animal models of liver injury and fibrosis, SZN-043 has been shown to selectively activate Wnt signaling in the liver, stimulate hepatocyte proliferation, improve synthetic function, and reduce fibrosis. The Company’s goal is to clinically evaluate the candidate in settings of drastic hepatocyte loss, such as severe acute alcoholic hepatitis (AAH), where SZN-043 may have a rapid impact on hepatocyte regeneration, as well as settings of advanced chronic disease conditions of cirrhosis. Liver cirrhosis is characterized by a decline in liver synthetic function and an increase in liver fibrosis, culminating in various complications such as portal hypertension, ascites, varices, and hepatic encephalopathy.

Severe liver diseases, including severe acute alcoholic hepatitis, and advanced liver cirrhosis from NASH, hepatitis, alcohol, and other etiologies, represent a significant area of high unmet need for patients and medical providers. There are no effective drug treatments available for these patients, who often require, and frequently do not get, a liver transplant. Furthermore, there are no effective treatments to reverse the course of the disease in patients with advanced cirrhosis who are at risk of decompensation and end-stage liver failure. In the United States, annual hospitalizations attributable to severe alcoholic hepatitis and decompensated liver disease are estimated to reach nearly 100,000 and 200,000 per year, respectively, and the number of patients with advanced cirrhosis and at risk of decompensation is estimated to reach over 750,000.

SZN-1326: Intestine-Specific Wnt-mimetic
SZN-1326 is the first development candidate designed using Surrozen’s SWAP (Surrozen Wnt signal activating proteins) platform. Designed to mimic the activity of Wnt proteins, SWAP directly activate Wnt-signaling pathways by binding to Frizzled receptors and co-receptors. SZN-1326 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 intestine, stimulate intestinal epithelial regeneration, and reduce disease activity. Anti-inflammatory effects were also observed.

Inflammatory Bowel Disease (IBD), including Crohn’s disease and ulcerative colitis, remains a significant unmet medical need. In the United States alone, it is estimated that there are approximately 800,000 adults diagnosed with moderate-to-severe IBD. Immune suppressants and anti-inflammatory biologics can be effective treatment options for people with IBD, however many do not achieve adequate long-lasting disease control nor mucosal healing.

About Wnt Signaling
Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. There are 19 Wnt ligands (Wnts) in mammals, and they signal through Frizzled receptors 1-10 and co-receptors LRP5 or 6, two families of receptors. Endogenous Wnts bind to multiple Frizzled receptors and are heavily modified post-translationally, making them difficult to manufacture consistently. R-spondin stabilizes Frizzled receptors, enhancing the body’s response to endogenous Wnts.

About Surrozen’s Proprietary Antibody Platforms and Harnessing Wnt Signaling
Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wnt-mimetics, also referred to as SWAP (Surrozen Wnt signal activating proteins), are bi-specific full-length human (IgG) antibodies that directly activate the canonical Wnt signaling pathway in target tissue. Surrozen R-spondin-mimetics, also referred to as SWEETS (Surrozen Wnt signal enhancers engineered for tissue specificity), are antibody-based molecules that enhance Wnt signaling by stabilizing Frizzled receptors on targeted cells.

About Surrozen
Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. Surrozen is designing tissue-specific antibodies that engage the body’s own biological repair mechanisms resulting in a broad pipeline of disease-specific therapies to help patients across multiple disease areas, including severe liver diseases, inflammatory bowel disease, retinopathies, hearing loss, lung and airway diseases, and certain neurological disorders. For more information, please visit surrozen.com.

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Investors/Partners/Media:
Reza Afkhami
VP, Corporate Development and Strategy
Surrozen, Inc.
reza@surrozen.com

Surrozen Announces Publication of Two Abstracts Providing Evidence for Liver-Targeted Tissue Regeneration

Abstracts originally accepted for 2020 Digestive Disease Week Conference – to be published online  —

SOUTH SAN FRANCISCO, Calif., May 4, 2020 — Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, announced today that two abstracts were published on the 2020 Digestive Disease Week (DDW) site. These abstracts were originally accepted for presentation during the 2020 DDW Conference which was to be held May 2-5 in Chicago, IL.

Both abstracts describe pre-clinical results with a liver-targeted proprietary molecule that enhances Wnt signaling and stimulates tissue regeneration. SWEETS (Surrozen Wnt signal Enhancers Engineered for Tissue Specificity) are antibody-based molecules that enhance Wnt signaling. SWEETS-1, a hepatocyte-targeted SWEETS, is the first proprietary SWEETS molecule to show preclinical proof of concept. The abstracts highlight that SWEETS-1 demonstrated hepatocyte-specific activation of Wnt target genes such as Axin2, stimulated hepatocyte regeneration, and restored liver function as measured by clotting time in a thioacetamide-induced mouse liver injury model.

The first abstract, titled “HEPATOCYTE-TARGETED R-SPONDIN MIMETIC FOR LIVER REGENERATION (Abstract #3346398)” showed that SWEETS-1 enhanced Wnt signaling in a hepatic cell line to a level similar to that induced by R-spondin. SWEETS-1 induced the expression of the Wnt target gene Axin2 in liver only, while R-spondin also induced Wnt signaling in kidney, salivary gland, intestine, heart, and pancreas. Immunofluorescence analysis revealed that SWEETS-1 induced Ki67 positive nuclei specifically in matures hepatocytes.

The second abstract, titled “HEPATOCYTE-TARGETED R-SPONDIN MIMETIC STIMULATES REGENERATION AND RESTORES COAGULATION IN A THIOACETAMIDE-INDUCED LIVER INJURY MODEL (Abstract #3346773)” demonstrated that Wnt family members were elevated in TAA-injured livers, suggesting that SWEETS-1 could be efficacious in liver injury. Indeed, SWEETS-1 induced liver expression of Axin2 to a level similar to that induced by R-spondin in a thioacetamide-induced mouse liver injury model. In addition, SWEETS-1 induced Ki67 positive nuclei in mature hepatocytes. Furthermore, SWEETS-1 treatment restored TAA-impaired clotting time to baseline levels.

“These results suggest that a cell-specific R-spondin-mimetic can selectively stimulate hepatocyte regeneration, differentiation, and function.” said Wen-Chen Yeh, MD, PhD, Chief Scientific Officer at Surrozen.  “We are excited to be able to confirm the relevance of our proprietary SWEETS platform technology and to advance this novel approach to treating liver disease.”

About Wnt Signaling

Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. There are 19 Wnt ligands (Wnts) in mammals, and they signal through Frizzled receptors 1-10 and co-receptors LRP5 or 6, two families of receptors. Endogenous Wnts bind to multiple Frizzled receptors and are heavily modified post-translationally, making them difficult to manufacture consistently. R-spondin stabilizes Frizzled receptors, enhancing the body’s response to endogenous Wnts.

About Surrozen’s Proprietary Antibody Platforms and Harnessing Wnt Signaling
Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wnt-mimetics, also referred to as SWAP (Surrozen Wnt signal Activating Proteins), are bi-specific full-length human (IgG) antibodies that directly activate the canonical Wnt signaling pathway in target tissue. Surrozen R-spondin-mimetics, also referred to as SWEETS (Surrozen Wnt signal Enhancers Engineered for Tissue Specificity), are antibody-based molecules that enhance Wnt signaling by stabilizing Frizzled receptors on targeted cells.

About Surrozen
Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. Surrozen is designing tissuespecific antibodies that engage the body’s own biological repair mechanisms resulting in a broad pipeline of disease-specific therapies to help patients across multiple disease areas. For more information, please visit surrozen.com.

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Investors/Partners:
Reza Afkhami
VP, Corporate Development and Strategy
Surrozen, Inc.
reza@surrozen.com

Surrozen Scientific Founder Roel Nusse, PhD Receives Prestigious Canada Gairdner International Award for Biomedical Research

Award recognizes Dr. Nusse’s seminal contributions to elucidating the mechanism and role of Wnt signaling

SOUTH SAN FRANCISCO, Calif., April 6, 2020 — Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, today announced that one of its scientific founders, Dr. Roel Nusse, received the 2020 Canada Gairdner International Award for Biomedical Research for pioneering work on the Wnt signaling pathway and its importance in development, cancer and stem cells. The Canada Gairdner Foundation annually designates five outstanding biomedical scientists who have made original contributions to medicine resulting in an increased understanding of human biology and disease. Since 1957, 395 awards have been bestowed on laureates from 35 countries and of those awardees, 92 have gone on to receive Nobel Prizes.

Roel Nusse co-founded Surrozen, along with other leaders in Wnt biology, in 2016. Dr. Nusse is The Virginia and Daniel K. Ludwig Professor of Cancer Research, Professor & Chair, Department of Developmental Biology and Member, Institute for Stem Cell Biology and Regenerative Medicine, at the Stanford University School of Medicine. He is a Howard Hughes Medical Institute Investigator, a member of the US National Academy of Sciences, the American Academy of Arts & Sciences, the Royal Dutch Academy of Sciences and is a recipient of the Breakthrough Prize in Life Sciences (2017).

The Canada Gairdner Foundation cited a number of scientific contributions in announcing the award, such as the original discovery of Wnt made by Dr. Nusse together with Harold Varmus, a member of Surrozen’s Board of Directors and Scientific Advisory Board. The Foundation further noted:

Afterwards Dr. Nusse identified the Drosophila Wnt homolog as a key developmental gene, Wingless. Using Drosophila genetics, he established the function of betacatenin as a mediator of Wnt signaling and the Frizzleds as Wnt receptors (with Jeremy Nathans), thereby establishing core elements of what is now called the Wnt pathway. A major later accomplishment of his group was the first successful purification of active Wnt proteins, showing that they are lipid-modified and act as stem cell growth factors.

“All of us at Surrozen are proud of the fundamental contributions our scientific founders have made to the field of Wnt biology,” said Craig Parker, chief executive officer of Surrozen. “The Gairdner Award recognizes Dr. Nusse’s unique role at the epicenter of our understanding of Wnt biology. The discoveries that Dr. Nusse pioneered in understanding the mechanism and role of Wnt signaling serve as a foundation for the approach we are taking to harnessing the pathway for discovery of regenerative therapeutics.”

About Wnt Signaling
Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including bone, liver, skin, intestine, lung, kidney, central nervous system, cochlea and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. There are 19 Wnt ligands (Wnts) in mammals, and they signal through Frizzled receptors (Fzds) 1-10 and LRP5 or 6, two families of receptors. Endogenous Wnts bind to multiple Fzds and are heavily modified post-translationally, making them difficult to manufacture consistently.

About Surrozen’s Proprietary Antibody Platforms and Harnessing Wnt Signaling
Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wntmimetics, also referred to as SWAPs (Surrozen Wnt Signal Activating Proteins), are bi-specific fulllength human (IgG) antibodies that directly activate the canonical Wnt signaling pathway in target tissue. Surrozen R-spondin-mimetics, also referred to as SWEETS (Surrozen Wnt Signal Enhancer Engineered for Tissue Specificity), are uniquely engineered antibodies that stabilize Wnt receptors.

About Surrozen
Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. Surrozen is designing tissuespecific antibodies that engage the body’s own biological repair mechanisms resulting in a broad pipeline of disease-specific therapies to help patients across multiple disease areas. For more information, please visit surrozen.com.

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Investors/Partners:
Reza Afkhami
VP, Corporate Development and Strategy
Surrozen, Inc.
reza@surrozen.com

Media:
Denise Powell
Red House Consulting
denise@redhousecomms.com

Surrozen to Present at Cowen and Company 40th Annual Health Care Conference

SOUTH SAN FRANCISCO, Calif., March 2, 2020 – Surrozen, Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues, today announced that President & Chief Executive Officer, Craig Parker, will present at the Cowen and Company 40th Annual Health Care Conference in Boston, Massachusetts. The presentation will begin at 10:30 a.m. Eastern Standard Time on Wednesday, March 4, 2020.

Combining an understanding of Wnt pathway biology in specific disease settings with advanced antibody engineering techniques, Surrozen designs and develops tissue specific antibodies that have the potential to regenerate tissue in grave diseases including cirrhotic liver disease, inflammatory bowel disease, lung and airway diseases like IPF and COPD, neurodegenerative diseases and retinopathies.

About Surrozen’s Proprietary Antibody Platforms and Harnessing Wnt Signaling
The Wnt signaling pathway plays a critical role in stem cell maintenance, tissue regeneration and other important developmental processes. Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wnt Signal Activators, also referred to as SWAPs (Surrozen Wnt Signal Activating Proteins), are bi-specific full-length human (IGg) antibodies that directly modulate the canonical Wnt signaling pathway in target tissue. Surrozen Wnt Protein Enhancers, also referred to as SWEETS (Surrozen Wnt Signal Enhancer Engineered for Tissue Specificity), are uniquely engineered antibodies that mimic the activity of endogenous R-spondin.

About Surrozen
Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. By designing tissue-specific antibodies that engage the body’s own biological tissue repair mechanisms, Surrozen is developing a broad pipeline of disease-specific therapies to help gravely ill patients across multiple disease areas. For more information, please visit surrozen.com.

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Investors/Partners:
Reza Afkhami
VP, Corporate Development and Strategy
Surrozen, Inc.
reza@surrozen.com

Media:
Denise Powell
Red House Consulting
denise@redhousecomms.com

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