10q10k10q10k.net

What changed in Surrozen, Inc./DE's 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of Surrozen, Inc./DE's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+383 added−375 removedSource: 10-K (2026-03-23) vs 10-K (2025-03-31)

Top changes in Surrozen, Inc./DE's 2025 10-K

383 paragraphs added · 375 removed · 287 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

104 edited+25 added−25 removed205 unchanged
Biggest changeWe plan to address multiple serious diseases of the eye (retinopathies) with a novel approach to restoring tissues that may complement or replace existing treatments: • Neovascular or “Wet” Age-Related Macular Degeneration (Wet AMD) 12 • Dry Age-Related Macular Degeneration (Dry AMD) or Geographic Atrophy (GA) • Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME) • Uveitic Macular Edema (UME) AMD is the progressive degradation of the part of the eye responsible for visual acuity, causing a loss of central vision.
Biggest changeOur current product candidates, SZN-8141 and SZN-8143, are for the treatment of retinal vascular associated diseases. 12 Retinopathies Disease Background We plan to address multiple serious diseases of the eye (retinopathies) with a novel approach to restoring tissues that may complement or replace existing treatments: • Neovascular or “Wet” Age-Related Macular Degeneration (Wet AMD) • Diabetic Macular Edema (DME) • Uveitic Macular Edema (UME) Diabetic retinopathy, or DR, is a microvascular complication of diabetes and is a major cause of vision loss and disability in the middle-aged population.
In October 2022, we executed a Collaboration and License Agreement, or CLA, with Boehringer Ingelheim International GmbH, or BI, to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. In September 2024, BI decided to move forward with the development of SZN-413, which triggered a $10.0 million milestone payment to us.
In October 2022, we executed a Collaboration and License Agreement, or CLA, with Boehringer Ingelheim International GmbH, or Boehringer Ingelheim, to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. In September 2024, Boehringer Ingelheim decided to move forward with the development of SZN-413, which triggered a $10.0 million milestone payment to us.
Our core capabilities are described below: Wnt Biology Expertise: We have established a deep understanding of the Wnt pathway and its role in disease biology and have invested significantly in our people and technologies that enable us to selectively modulate Wnt signaling. Our research and 5 development organization is led by world-class scientists.
Our core capabilities are described below: 5 Wnt Biology Expertise: We have established a deep understanding of the Wnt pathway and its role in disease biology and have invested significantly in our people and technologies that enable us to selectively modulate Wnt signaling. Our research and development organization is led by world-class scientists.
Our Platform Our proprietary platform, SWAPs, enables us to potently and selectively modulate Wnt signaling through the generation of Wnt mimetics. Using this technology, we design and develop antibodies that modulate Wnt signaling. Product candidates generated by these technologies have demonstrated the ability to repair tissue damage in multiple preclinical models.
Our Technology Our proprietary platform, SWAPs, enables us to potently and selectively modulate Wnt signaling through the generation of Wnt mimetics. Using this technology, we design and develop antibodies that modulate Wnt signaling. Product candidates generated by these technologies have demonstrated the ability to repair tissue damage in multiple preclinical models.
We consider ourselves to be pioneers in the selective modulation of the Wnt signaling pathway and intend to utilize our proprietary insights into Wnt biology and our proprietary technologies to further advance our research and exploration of its therapeutic potential. • Developing novel product candidates and expanding our platform technologies focused in ophthalmology to further our leading position in developing the Wnt signaling pathway modulators .
We consider ourselves to be pioneers in the selective modulation of the Wnt signaling pathway and intend to utilize our proprietary insights into Wnt biology and our proprietary technologies to further advance our research and exploration of its therapeutic potential. • Developing novel product candidates and expanding our platform technologies focused in ophthalmology to further our leading position in developing Wnt signaling pathway modulators .
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; • Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; • The federal transparency requirements under the Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physician assistants and nurse practitioners), and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members; • Federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; • State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers, and state laws that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and 24 • State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; • Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; • The federal transparency requirements under the Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physician assistants and nurse practitioners), and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members; • Federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; • State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers, and state laws that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and • State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates and covered subcontractors that perform services for them that involve individually identifiable health information.
Similar to the 23 federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates and covered subcontractors that perform services for them that involve individually identifiable health information.
Stanford License Agreements In March 2016, we entered into a license agreement with Stanford University, or the Stanford Agreement, which was amended in July 2016, October 2016 and January 2021, pursuant to which we obtained a worldwide, exclusive, sublicensable license under certain patents, rights, or licensed patents and technology related to our engineered Wnt surrogate molecules to make, use, import, offer to sell and sell products that are claimed by the licensed patents or that use or incorporate such technology, or licensed products, for the treatment, diagnosis and prevention of human and veterinary diseases.
Stanford License Agreement In March 2016, we entered into a license agreement with Stanford University, or the Stanford Agreement, which was amended in July 2016, October 2016 and January 2021, pursuant to which we obtained a worldwide, exclusive, sublicensable license under certain patents, rights, or licensed patents and technology related to our engineered Wnt surrogate molecules to make, use, import, offer to sell and sell products that are claimed by the licensed patents or that use or incorporate such technology, or licensed products, for the treatment, diagnosis and prevention of human and veterinary diseases.
We face potential competition from many different sources, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities and other academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for the research, development, manufacturing, and commercialization of therapies aimed at treating autoimmune, inflammatory, metabolic, and other diseases.
We face potential competition from many different sources, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities and other academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for the research, development, manufacturing, and commercialization of therapies aimed at treating ophthalmic, autoimmune, inflammatory, metabolic, and other diseases.
We expect every employee, officer and director to read and understand our Code of Business Conduct and Ethics and its application to the performance of his or her business responsibilities. 27 Corporate Information Our principal executive offices are located at 171 Oyster Point Blvd., Suite 400, South San Francisco, California 94080 and our telephone number is (650) 489-9000.
We expect every employee, officer and director to read and understand our Code of Business Conduct and Ethics and its application to the performance of his or her business responsibilities. Corporate Information Our principal executive offices are located at 171 Oyster Point Blvd., Suite 400, South San Francisco, California 94080 and our telephone number is (650) 489-9000.
We strive to foster an environment for our employees where: • we bravely explore and innovate together, with passion for the work and honesty towards each other; • flexibility in skills, resilience, and adaptability to change are valued; • we recognize that everyone makes a difference; • the workplace is fun, supportive and rewarding; and • patients are at the heart of what we do.
We strive to foster an environment for our employees where: • we bravely explore and innovate together, with passion for the work and honesty towards each other; • flexibility in skills, resilience, and adaptability to change are valued; • we recognize that everyone makes a difference; 26 • the workplace is fun, supportive and rewarding; and • patients are at the heart of what we do.
Moreover, any significant spending reductions affecting Medicare, Medicaid or other publicly 25 funded or subsidized health programs that may be implemented, or any significant taxes or fees that may be imposed on us, as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, could have an adverse impact on our anticipated product revenues.
Moreover, any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented, or any significant taxes or fees that may be imposed on us, as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, could have an adverse impact on our anticipated product revenues.
Seeking to limit or eliminate the potential oncogenic risk from Wnt pathway activation through our selective activation in the target disease tissue, we focus on severe disease, limited treatment exposure, and mimicking a physiologic repair process that is self-limiting. In preclinical studies, we have observed that the predominant response to Wnt signaling is in diseased tissue.
Seeking to limit or eliminate the potential oncogenic risk from Wnt pathway activation through our selective activation in the target ocular disease tissue, we focus on severe disease, limited treatment exposure, and mimicking a physiologic repair process that is self-limiting. In preclinical studies, we have observed that the predominant response to Wnt signaling is in diseased tissue.
Preclinical model studies have shown that Wnt signaling is instrumental for liver regeneration, intestine epithelium turnover and injury repair, and plays 9 a role in maintaining residential stem cells in many more adult tissues including lung, kidney, cochlea, skin and the central nervous system. • Common activation mechanism across Wnt proteins.
Preclinical model studies have shown that Wnt signaling is instrumental for liver regeneration, intestine epithelium turnover and injury repair, and plays a role in maintaining residential stem cells in many more adult tissues including lung, kidney, cochlea, skin and the central nervous system. • Common activation mechanism across Wnt proteins.
A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that 20 the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.
A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.
Prioritizing disease opportunities where there is significant evidence based on our proprietary model systems and tool compounds that Wnt activation could play a role in tissue repair in severe disease. Focusing efforts and investments in diseases where the strength of our capabilities can potentially address key limitations of existing therapeutic approaches.
Prioritizing disease opportunities where there is significant evidence based on our proprietary model systems and tool compounds that Wnt activation could play a role in tissue repair in severe ophthalmic disease. Focusing efforts and investments in ophthalmic diseases where the strength of our capabilities can potentially address key limitations of existing therapeutic approaches.
The accelerated approval pathway is contingent on a sponsor’s agreement to conduct additional post-approval confirmatory studies to verify and describe the product’s clinical benefit. These confirmatory trials must be completed with due diligence and, in some cases, the FDA may require that the trial be designed, initiated and/or fully enrolled prior to approval.
The accelerated approval pathway is contingent on a sponsor’s agreement to conduct additional post-approval 20 confirmatory studies to verify and describe the product’s clinical benefit. These confirmatory trials must be completed with due diligence and, in some cases, the FDA may require that the trial be designed, initiated and/or fully enrolled prior to approval.
In some cases, such as in certain rare bone diseases, mutations in the Wnt signaling pathway are the cause of the disease. Mutations in Wnt signal pathway components are also associated with retina vessel disorders such as Norrie disease and familial exudative vitreoretinopathy, or FEVR, tooth development disorders, and metabolic diseases including diabetes.
In some cases, such as in certain rare bone diseases, mutations in the Wnt signaling pathway are the cause of the disease. Mutations in Wnt signal pathway components are also associated with retina vessel disorders such as Norrie disease 9 and familial exudative vitreoretinopathy, or FEVR, tooth development disorders, and metabolic diseases including diabetes.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and 23 require strict compliance in order to offer protection.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection.
In October 2022, we executed the CLA with BI to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. Wnt Signaling Pathway—A Central Regulator of Tissue Regeneration As gatekeepers for the maintenance of stem cells and functions, prior attempts at modulating Wnt signaling were hampered by an absence of drug-like properties.
In October 2022, we executed the CLA with Boehringer Ingelheim to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. Wnt Signaling Pathway—A Central Regulator of Tissue Regeneration As gatekeepers for the maintenance of stem cells and functions, prior attempts at modulating Wnt signaling were hampered by an absence of drug-like properties.
Like endogenous Wnt (left side), our SWAP technology activates Wnt signaling by binding specific Fzd and Lrp receptors (right side) Our Product Candidates and Research Programs We believe that our platform has the potential to generate a portfolio of product candidates that can harness the tissue repair activity of the Wnt pathway for a broad spectrum of severe eye diseases. 7 The chart below represents a summary of our product candidates: Figure 3.
Like endogenous Wnt (left side), our SWAP technology activates Wnt signaling by binding specific Fzd and Lrp receptors (right side) Our Product Candidates and Research Programs We believe that our platform has the potential to generate a portfolio of product candidates that can harness the tissue repair activity of the Wnt pathway for a broad spectrum of severe eye diseases. 7 The chart below represents a summary of our product candidates: Figure 2.
In Figure 5 below, in an assay measuring protein concentration (x-axis) against Wnt pathway activation (as measured by relative light units, or RLU, y-axis), we have demonstrated that a simple bivalent antibody containing a single Fzd binding domain (F1) (the blue 11 line) and a single Lrp binding domain (L2) (the red line) did not significantly induce the Wnt signaling pathway.
In Figure 4 below, in an assay measuring protein concentration (x-axis) against Wnt pathway activation (as measured by relative light units, or RLU, y-axis), we have demonstrated that a simple bivalent antibody containing a single Fzd binding domain (F1) (the blue 11 line) and a single Lrp binding domain (L2) (the red line) did not significantly induce the Wnt signaling pathway.
However, multivalent antibodies that contained multiple binding domains, either two Fzd-binding domains with one Lrp binding domain (the blue line in Figure 6 below) or two of each binding domain (the light green line), led to activation of the Wnt signaling pathway at concentrations that were 100 times or lower than required for activation by Wnt3a (the dark green line), as can be observed in Figure 6.
However, multivalent antibodies that contained multiple binding domains, either two Fzd-binding domains with one Lrp binding domain (the blue line in Figure 5 below) or two of each binding domain (the light green line), led to activation of the Wnt signaling pathway at concentrations that were 100 times or lower than required for activation by Wnt3a (the dark green line), as can be observed in Figure 5.
Collaboration and Licensing Arrangements Collaboration and License Agreement with Boehringer Ingelheim International GmbH In October 2022, we executed the CLA with BI to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. We and BI conducted partnership research focused on SZN-413 during a 1.5-year period.
Collaboration and License Arrangements Collaboration and License Agreement with Boehringer Ingelheim International GmbH In October 2022, we executed the CLA with Boehringer Ingelheim to research, develop and commercialize Fzd4 bi-specific antibodies designed using our SWAP technology, including SZN-413. Boehringer Ingelheim and us conducted partnership research focused on SZN-413 during a 1.5-year period.
We found that certain recombinant proteins containing these two antibody-binding domains were able to simultaneously bind both Fzd and Lrp, however, inducing the simple bimolecular interaction of one Fzd and one Lrp was, in most cases, insufficient to induce Wnt signaling, as can be observed in Figure 5.
We found that certain recombinant proteins containing these two antibody-binding domains were able to simultaneously bind both Fzd and Lrp, however, inducing the simple bimolecular interaction of one Fzd and one Lrp was, in most cases, insufficient to induce Wnt signaling, as can be observed in Figure 4.
These patent families are directed to compositions of matter and/or methods of use, and relate to Wnt mimetics that bind to both a FZD receptor and an LRP receptor, and binding domains and uses thereof. Any patents that issue from these patent families are predicted to expire between 2035 and 2044 absent any patent term adjustment or extension.
These patent families are directed to compositions of matter and/or methods of use, and relate to Wnt mimetics that bind to both a Fzd receptor and an LRP receptor, and binding domains and uses thereof. Any patents that issue from these patent families are predicted to expire between 2035 and 2046 absent any patent term adjustment or extension.
Fzd is an integral membrane protein that binds to Wnt protein, in part, through the fatty acid posttranslational modification on the Wnt protein. The second receptor, 10 Lrp 5/6, contains an intracellular domain that is chemically modified by Wnt-protein-induced receptor dimerization to initiate the Wnt signaling pathway cascade in cells. Figure 4.
Fzd is an integral membrane protein that binds to Wnt protein, in part, through the fatty acid posttranslational modification on the Wnt protein. The second receptor, Lrp 5/6, contains an intracellular domain that is chemically modified by Wnt-protein-induced receptor dimerization to initiate the Wnt signaling pathway cascade in cells. 10 Figure 3.
For comparison, an antibody with a single Fzd binding domain (the red line) did not demonstrate significant activity. Figure 6. Multivalent antibodies with two Fzd binding domains (F3) and at least one Lrp binding domain (L2) led to more potent activation of the Wnt signaling pathway.
For comparison, an antibody with a single Fzd binding domain (the red line) did not demonstrate significant activity. Figure 5. Multivalent antibodies with two Fzd binding domains (F3) and at least one Lrp binding domain (L2) led to more potent activation of the Wnt signaling pathway.
For five years after the effective date of the CLA, we are prohibited from preclinically and clinically developing or commercializing Fzd4 bi-specific antibodies that have certain properties for any diseases of the eye, and BI is prohibited from clinically developing or commercializing licensed products for any purpose other than diseases of the eye.
For five years after the effective date of the CLA, we are prohibited from preclinically and clinically developing or commercializing Fzd4 bi-specific antibodies that have certain properties for any diseases of the eye, and Boehringer Ingelheim is prohibited from clinically developing or commercializing licensed products for any purpose other than diseases of the eye.
At similar concentrations, naturally-occurring Wnt (Wnt3a) (the green line) demonstrated pathway activation. Figure 5. A simple bivalent antibody containing a single Fzd binding domain (F1) and a single Lrp binding domain (L2) did not significantly induce the Wnt signaling pathway. At similar concentrations, naturally-occurring Wnt (Wnt3a) demonstrated pathway activation.
At similar concentrations, naturally-occurring Wnt (Wnt3a) (the green line) demonstrated pathway activation. Figure 4. A simple bivalent antibody containing a single Fzd binding domain (F1) and a single Lrp binding domain (L2) did not significantly induce the Wnt signaling pathway. At similar concentrations, naturally-occurring Wnt (Wnt3a) demonstrated pathway activation.
Lead programs Ophthalmology Portfolio Wnt signaling is implicated in multiple diseases and tissues in the eye. We believe our technologies have the potential to generate a portfolio of product candidates that can harness the tissue regenerative activity of the Wnt pathway and potentially bring therapeutic benefit to patients suffering from a broad spectrum of diseases.
Pipeline Ophthalmology Portfolio Wnt signaling is implicated in multiple diseases and tissues in the eye. We believe our technologies have the potential to generate a portfolio of product candidates that can harness the tissue regenerative activity of the Wnt pathway and potentially bring therapeutic benefit to patients suffering from a broad spectrum of diseases.
Beyond our work with BI on SZN-413, we also have multiple novel ophthalmology product candidates targeting Fzd4 which have demonstrated proof-of-concept in preclinical studies. These product candidates do not fall within the scope of the CLA with BI and are wholly owned by us.
Beyond our work with Boehringer Ingelheim on SZN-413, we also have multiple novel ophthalmology product candidates targeting Fzd4 which have demonstrated proof-of-concept in preclinical studies. These product candidates do not fall within the scope of the CLA with Boehringer Ingelheim and are wholly owned by us.
DME is a complication of DR, characterized by fluid buildup in the macula resulting in vision loss if untreated. DME occurs in approximately 15% of patients with DR, or almost 1.4 million people in the US. There remains a significant opportunity to improve on current treatment approaches.
DME is a complication of DR, characterized by fluid buildup in the macula resulting in vision loss if untreated. DME occurs in approximately 15% of patients with DR, or almost 1.4 million people in the U.S. There remains a significant opportunity to improve on current treatment approaches.
We believe that several characteristics of the Wnt signaling pathway make this pathway attractive for drug development: • Broad potential for therapeutic intervention . Signaling through the Wnt pathway is critical in cell fate determination in tissues throughout the body. Aberrant Wnt signaling underlies a broad range of pathologies in humans.
We believe that several characteristics of the Wnt signaling pathway make this pathway attractive for drug development: • Broad potential for therapeutic intervention, including ophthalmic indications . Signaling through the Wnt pathway is critical in cell fate determination in tissues throughout the body. Aberrant Wnt signaling underlies a broad range of pathologies in humans.
Our corporate website address is www.surrozen.com. The contents of our website is not incorporated by reference into this Annual Report or in any other report or document we file with the SEC, and any references to our website is intended to be inactive textual references only. 28
Our corporate website address is www.surrozen.com. The contents of our website are not incorporated by reference into this Annual Report or in any other report or document we file with the SEC, and any references to our website are intended to be inactive textual references only. 27
Merck’s Restoret (gained through its acquisition of EyeBio), an investigational tri-specific Wnt agonist antibody, is in a Phase 2/3 clinical trial in patients with treatment-naïve diabetic macular edema and treatment-naïve neovascular age-related macular degeneration.
Merck’s MK-3000 (gained through its acquisition of EyeBio), is an investigational tri-specific Wnt agonist antibody, in a Phase 2/3 clinical trial in patients with treatment-naïve diabetic macular edema and treatment-naïve neovascular age-related macular degeneration.
Recently acquired by Roche, AntlerA Therapeutics was a preclinical stage company developing Wnt antibody-like molecules (ANTs) that activate specific Fzd receptor complexes and are designed to control tissue stem cells and promote tissue repair and rejuvenation. To our knowledge, neither Merck nor Roche has announced any development stage Wnt agonist compounds in retinal diseases.
Acquired by Roche in 2024, AntlerA Therapeutics was a preclinical stage company developing Wnt antibody-like molecules (ANTs) that activate Fzd receptor complexes and are designed to control tissue stem cells and promote tissue repair and rejuvenation. To our knowledge, neither Merck nor Roche has announced any additional development stage Wnt agonist compounds in retinal diseases.
Under the terms of the CLA, BI agreed to pay a non-refundable upfront payment of $12.5 million less applicable withholding tax, success-based milestone payments up to a total of $587.0 million and mid-single digit to low-double digit royalties on net sales of the licensed products should any reach 14 commercialization.
Under the terms of the CLA, Boehringer Ingelheim agreed to pay a non-refundable upfront payment of $12.5 million less applicable withholding tax, success-based milestone payments up to a total of $587.0 million and mid-single digit to low-double digit royalties on net sales of the licensed products should any reach commercialization.
Our Wnt Therapeutics Platform Our Scientific Capabilities We believe that our breakthrough discoveries and technologies will enable us to overcome the challenges facing drug developers targeting the Wnt pathway. We believe we are potentially the first developer to manufacture synthetic, soluble Wnt mimetics.
Our Antibody Engineering Platform Our Scientific Capabilities We believe that our breakthrough discoveries and technologies will enable us to overcome the challenges facing drug developers targeting the Wnt pathway. We believe we are potentially the first developer to manufacture synthetic, soluble Wnt mimetics.
These patent applications are directed to, for example, the SWAP platform, the out-licensed SZN-413, as well as methods of treating disorders of the liver, intestine, retina, cornea, lacrimal gland, lung and kidney. SWAP Platform Technology As of December 31, 2024, we solely own or exclusively license 15 patent families related to our SWAP platform.
These patent applications are directed to, for example, the SWAP platform, the out-licensed SZN-413, as well as methods of treating disorders of the liver, intestine, retina, cornea, lacrimal gland, lung and kidney. SWAP Platform Technology As of December 31, 2025, we solely own or exclusively license 21 patent families related to our SWAP platform.
These programs include: • SZN-8141: Fzd4-antiVEGF product candidate combining Fzd4 agonism and vascular endothelial growth factor, or VEGF, antagonism which may have benefits over treatment with single agents for diabetic macular edema, or DME, and neovascular age related macular degeneration, or wet AMD • SZN-8143: Fzd4-antiVEGF-antiIL6 product candidate combining Fzd4 agonism, VEGF antagonism, and interleukin-6, or IL-6, antagonism which may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema, or UME 8 The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies.
These programs include: • SZN-8141: Fzd4-antiVEGF product candidate combining Fzd4 agonism and vascular endothelial growth factor, or VEGF, antagonism which may have benefits over treatment with single agents for diabetic macular edema, or DME, and neovascular age related macular degeneration, or wet AMD • SZN-8143: Fzd4-antiVEGF-antiIL6 product candidate combining Fzd4 agonism, VEGF antagonism, and interleukin-6, or IL-6, antagonism which may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema, or UME 8 The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF therapies, including monotherapies and dual-pathway agents targeting VEGF and Ang-2.
Unless terminated earlier, the CLA will remain effective, on a country-by-country and product-by-product basis, until the expiration of BI's royalty obligations. BI has the right to terminate the CLA for any reason after a specified notice period. Each party has the right to terminate the CLA on account of the other party’s bankruptcy or material, uncured breach.
Unless terminated earlier, the CLA will remain effective, on a country-by-country and product-by-product basis, until the expiration of Boehringer Ingelheim’s royalty obligations. Boehringer Ingelheim has the right to terminate the CLA for any reason after a specified notice period. Each party has the right to terminate the CLA on account of the other party’s bankruptcy or material, uncured breach.
In the US, the prevalence of DR is almost 10 million people. The pathogenesis of DR leads to vascular leakage, which causes diabetic macular edema, and capillary occlusion causing retinal ischemia. The longer a person has Type-1 or Type-2 diabetes, the more likely they are to develop DME.
In the U.S., the prevalence of DR is almost 10 million people. The pathogenesis of DR leads to vascular leakage, which causes diabetic macular edema, and capillary occlusion leading to retinal ischemia. The longer a person has Type-1 or Type-2 diabetes, the more likely they are to develop DME.
Companies are developing and/or commercializing therapeutics in the retinal disease area include large companies with significant financial resources, such as Roche, Novartis, Bayer and Regeneron, AbbVie, Boehringer Ingelheim, Amgen, and Samsung Bioepis.
Companies are developing and/or commercializing therapeutics in the retinal disease area include large companies with significant financial resources, such as Roche, Novartis, Bayer, Regeneron, AbbVie, Boehringer Ingelheim, Amgen, Merck, Sanofi, Eli Lilly, and Samsung Bioepis.
In addition, Fzd4 monotherapy has demonstrated proof-of-concept in clinical trials. We believe SZN-8143 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.
In addition, MK-3000, a Fzd4 monotherapy, has demonstrated proof of concept in DME in clinical trials. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.
Certain of our competitors have commercially approved products for the treatment of retinal diseases that we are pursuing or may pursue in the future, including Roche, Regeneron and Novartis for the treatment of wet AMD, DME, DR and retinal vein occlusion. For Dry AMD/ Geographic Atrophy, Apellis and Astellas have commercially approved products.
Certain of our competitors have commercially approved products for the treatment of retinal diseases that we are pursuing or may pursue in the future, including Roche, Regeneron and Novartis for the treatment of wet AMD, DME, DR and retinal vein occlusion.
Our product candidate, SZN-413, utilizes our SWAP technology and is designed to activate the Wnt pathway in injured tissue where certain Fzd receptors are expressed and the natural Wnt ligand is disturbed. 6 Key characteristics of our SWAP technology include: Potency: Our Wnt mimetics are multivalent, designed to bind one or more Fzd receptors and one or more Lrp receptors.
Our product candidates utilize our SWAP technology and are designed to activate the Wnt pathway in injured tissue where certain Fzd receptors are expressed and the natural Wnt ligand is disturbed. 6 Key characteristics of our SWAP technology include: Potency: Our Wnt mimetics are multivalent, designed to bind one or more Fzd receptors and one or more Lrp receptors.
Our Wnt Therapeutics Platform We have discovered proprietary technologies of modulators of Wnt signaling: SWAPs. We have designed and continue to design antibodies that modulate the Wnt signaling pathway by acting as mimetics of the Wnt protein. Product candidates generated by our technologies have demonstrated the ability to repair tissue damage in multiple preclinical retinal disease models.
We have designed and continue to design antibodies that modulate the Wnt signaling pathway by acting as mimetics of the Wnt protein. Product candidates generated by our technologies have demonstrated the ability to repair tissue damage in multiple preclinical retinal disease models.
In preclinical models of FECD, SZN-113 enhanced proliferation of primary human corneal endothelial cells in vitro , demonstrated evidence of wound healing in acute corneal endothelial injury models, and rapidly reduced central corneal thickness along with demonstrating improved corneal clarity in a cryoinjury model in mouse and rabbit.
In preclinical models of corneal endothelial disease, these programs enhanced proliferation of primary human corneal endothelial cells in vitro , demonstrated evidence of wound healing in acute corneal endothelial injury models, and rapidly reduced central corneal thickness along with demonstrating improved corneal clarity in a cryoinjury model in mouse and rabbit.
In preclinical models of FECD, SZN-113 enhanced proliferation of primary human corneal endothelial cells in vitro , demonstrated evidence of wound healing in acute corneal endothelial injury models, and rapidly reduced central corneal thickness along with demonstrating improved corneal clarity in a cryoinjury model in mouse and rabbit.
In preclinical models of corneal endothelial disease, these programs enhanced proliferation of primary human corneal endothelial cells in vitro , demonstrated evidence of wound healing in acute corneal endothelial injury models, and rapidly reduced central corneal thickness along with demonstrating improved corneal clarity in a cryoinjury model in mouse and rabbit.
Our approach includes: Identifying and characterizing areas where Wnt biology is critical to tissue structure and function. To date, we have investigated the importance of Wnt signaling in over 20 different tissue types and have prioritized multiple tissue types for further exploration, with a plan to continue to expand our efforts.
Our approach includes: Identifying and characterizing areas where Wnt biology is critical to tissue structure and function. To date, we have investigated the importance of Wnt signaling in over 20 different tissue types and have prioritized multiple ocular tissue types for further exploration.
We granted BI an exclusive, royalty-bearing, worldwide, sublicensable license, under our applicable patents and know-how, to develop, manufacture and commercialize, for all uses, one lead and two back-up Fzd4 bi-specific antibodies selected by BI.
Under the CLA, Boehringer Ingelheim has an exclusive, royalty-bearing, worldwide, sublicensable license, under our applicable patents and know-how, to develop, manufacture and commercialize, for all uses, one lead and two 14 back-up Fzd4 bi-specific antibodies selected by Boehringer Ingelheim.
Employees and Human Capital Resources Our Employees As of March 3, 2025, we had 40 full-time and 1 part-time employees, with 26 in research and development and 15 in general and administrative functions. None of our employees are represented by a labor union or covered by collective bargaining agreements, and we have not experienced any work stoppages.
Employees and Human Capital Resources Our Employees As of March 1, 2026, we had 44 full-time employees, with 27 in research and development and 17 in general and administrative functions. None of our employees are represented by a labor union or covered by collective bargaining agreements, and we have not experienced any work stoppages.
Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments.
Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.
TCGFB was founded and is controlled by entities affiliated with The Column Group. The agreement constitutes a related party transaction because entities affiliated with The Column Group hold more than 5% of our common stock and Dr.
TCGFB was founded and is controlled by entities affiliated with The Column Group. The agreement constitutes a related party transaction because entities affiliated with The Column Group hold more than 5% of our common stock and Dr. Kutzkey, a member of our board of directors, serves as Managing Partner of The Column Group.
In preclinical models of GA, Fzd127 molecules stimulated retinal pigment epithelium cell proliferation and differentiation in culture and provided neuroprotection in acute injury and progressive degeneration models of photoreceptor degeneration. Our Strategy Our strategy is to develop a portfolio of product candidates that can repair tissue damage and regenerate functional tissues for a variety of diseases.
In retinal research models, these programs stimulated retinal pigment epithelium cell proliferation and differentiation in culture and provided neuroprotection in acute injury and progressive degeneration models of photoreceptor degeneration. Our Strategy Our strategy is to develop a portfolio of product candidates that can repair tissue damage and regenerate functional tissues.
Harold Varmus discovered the first Wnt gene in 1982. Wnt signaling has now been shown to be critical to many essential normal functions. Dr. Nusse is a founder of our company and a member of our Scientific Advisory Board.
Wnt signaling has now been shown to be critical to many essential normal functions. Dr. Nusse is a founder of our company and a member of our Scientific Advisory Board.
Our goal in each of these programs is to activate the natural ability of tissues in the body to heal themselves by increasing the Wnt signaling pathway. We are currently focused on leveraging our expertise in Wnt signaling to develop potential therapeutics for ocular diseases such as retinopathies and Fuchs’ endothelial dystrophy.
Our goal in each of these programs is to activate the natural ability of tissues in the body to heal themselves by increasing the Wnt signaling pathway. We are currently focused on leveraging our expertise in Wnt signaling to develop potential therapeutics for ocular diseases such as diabetic macular edema, wet age-related macular degeneration and uveitic macular edema.
The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards. 26 Strategic Talent and Culture Vision We are committed to being a great place to work for enterprising pioneers.
Our human capital objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards. Strategic Talent and Culture Vision We are committed to being a great place to work for enterprising pioneers.
After an initial period of joint research, BI shall be responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of licensed products at its expense.
After the initial period of joint research, Boehringer Ingelheim is responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of licensed products at its expense.
In preclinical models of GA, Fzd127 molecules stimulated retinal pigment epithelium cell proliferation and differentiation in culture and provided neuroprotection in acute injury and progressive degeneration models of photoreceptor degeneration.
In preclinical retinal research models, 4 these programs stimulated retinal pigment epithelium cell proliferation and differentiation in culture and provided neuroprotection in acute injury and progressive degeneration models of photoreceptor degeneration.
AMD is the leading cause of blindness in individuals who are over 65 years old. As the chances of experiencing any form of AMD increase with age, treatment of this disease is becoming even more important as life expectancy continues to rise in most regions of the world.
As the chances of experiencing any form of AMD increase with age, treatment of this disease is becoming even more important as life expectancy continues to rise in most regions of the world.
The FDA reviews a submitted BLA to determine if it is substantially complete before the FDA accepts it for filing and may request additional information from the sponsor.
The applicant under an approved BLA is also subject to an annual program fee. The FDA reviews a submitted BLA to determine if it is substantially complete before the FDA accepts it for filing and may request additional information from the sponsor.
UME is a serious complication of uveitis, an inflammatory condition affecting the uvea (the middle layer of the eye). In the U.S., estimates range widely from 80,000 to 168,000 cases of uveitis each year. It is estimated that up to 30% of all uveitis patients may develop macular edema, or UME.
UME is a serious complication of uveitis, an inflammatory condition affecting the uvea (the middle layer of the eye). In the U.S., estimates range widely from 80,000 to 168,000 cases of uveitis each year.
The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products. 22 Biosimilars and Reference Product Exclusivity The Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.
Biosimilars and Reference Product Exclusivity The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.
Fzd4 mediated Wnt signaling is known to play a critical role in retinal vascular integrity and function. Data generated in preclinical models of retinopathy demonstrated SZN-413 stimulated Wnt signaling and the ability to induce normal retinal vessel regrowth while suppressing pathological vessel growth.
Data generated in preclinical models of retinopathy demonstrated SZN-413 stimulated Wnt signaling and the ability to induce normal retinal vessel regrowth while suppressing pathological vessel growth.
Consistent throughout our strategy is our goal to activate Wnt signaling only within targeted diseased tissue, focusing on severe diseases, and mimicking the self-limiting physiologic repair process. We plan to achieve this goal by: • Continuing to build on our pioneering research, insights and intellectual property in Wnt pathway modulation.
Consistent throughout our strategy is our goal to activate Wnt signaling only within targeted diseased tissue, focusing on ophthalmology where Wnt biology is strongly validated. We plan to achieve this goal by: • Continuing to build on our pioneering research, insights and intellectual property in Wnt pathway modulation.
Surrozen is developing SZN-113 which targets Fzd127 for FECD and GA. In preclinical models of FECD, SZN-113 enhanced proliferation of primary human corneal endothelial cells in vitro, demonstrated evidence of wound healing in acute corneal endothelial injury models, and rapidly reduced central corneal thickness along with demonstrating improved corneal clarity in a cryoinjury model in mouse and rabbit.
In preclinical models of corneal endothelial disease, our programs enhanced proliferation of primary human corneal endothelial cells in vitro, demonstrated evidence of wound healing in acute corneal endothelial injury models, and rapidly reduced central corneal thickness along with demonstrating improved corneal clarity in a cryoinjury model in mouse and rabbit.
Building upon the seminal work of our founders and scientific advisors who discovered the Wnt gene and key regulators of the Wnt pathway, we have made breakthrough discoveries that we believe will overcome previous limitations in harnessing the potential of Wnt biology. These breakthroughs enable us to rapidly and flexibly design tissue-targeted therapeutics that modulate Wnt signaling.
Building upon the seminal work of our founders and scientific advisors who discovered the Wnt gene and key regulators of the Wnt pathway, we have made breakthrough discoveries that we believe will overcome previous limitations in harnessing the potential of Wnt biology in a tissue-selective manner.
These capabilities enable discovery of novel structures and sequences and optimization for pharmacokinetics, potency, selectivity, manufacturability and other drug-like properties. Our Scientific Approach By combining our Wnt biology expertise with our proprietary technologies and capabilities, we have been able to establish a broad array of therapeutic opportunities.
These capabilities enable discovery of novel structures and sequences and optimization for pharmacokinetics, potency, selectivity, manufacturability and other drug-like properties. Our Scientific Approach By combining our Wnt biology expertise with our proprietary technologies and capabilities, we are focusing on therapeutic opportunities in ophthalmology with high unmet need.
Over the past 30 years our founders and advisors have helped establish the fundamental importance of the Wnt pathway in tissue regeneration. Each has been on the forefront of the Wnt signaling pathway research, and their discoveries are the foundation of our approach to therapeutic development. Wnt proteins exert a wide variety of effects on target cells during development.
Over the past 30 years our founders and advisors have helped establish the fundamental importance of the Wnt pathway in tissue regeneration. Each has been on the forefront of the Wnt signaling pathway research, and their discoveries are the foundation of our approach to therapeutic development. Dr. Roel Nusse and Dr. Harold Varmus discovered the first Wnt gene in 1982.
Our Solution Surrozen is developing SZN-8141 that combines Fzd4 agonism and VEGF antagonism which has the potential to provide benefits over treatment with single agents for DME and wet AMD. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies.
SZN-8141 combines Frizzled 4, or Fzd4, agonism and vascular endothelial growth factor, or VEGF, antagonism and has the potential to provide benefits over treatment with single agents. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF therapies, including monotherapies and dual-pathway agents targeting VEGF and angiopoietin-2, or Ang-2.
Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP. Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with cGMPs.
Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP.
We are developing a series of product candidates based on the SWAP technology, which combines binding domains for specific Fzd receptors and binding domains for specific Lrp receptors. Our current SWAP product candidate, SZN-413, is for the treatment of retinal vascular associated diseases. In addition, we are developing other product candidates for the potential treatment of ocular diseases.
SZN-8141 and SZN-8143 – Our Product Candidates for the Treatment of Retinopathies We are developing a series of product candidates based on the SWAP technology, which combines binding domains for specific Fzd receptors and binding domains for specific Lrp receptors.
In addition, Fzd4 monotherapy has demonstrated proof of concept in clinical trials. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth and reduce vascular leakage.
We believe SZN-8143 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth. Surrozen is also evaluating additional ophthalmology research programs targeting components of the Wnt signaling pathway.
This leads to the thickening of the retina and the misalignment of photoreceptors, causing blurred or distorted vision. An increase in disease prevalence will contribute to market growth.
These newly formed vessels are highly permeable and leak blood and fluid as they penetrate through the layers of the retina. This leads to the thickening of the retina and the misalignment of photoreceptors, causing blurred or distorted vision. An increase in disease prevalence will contribute to market growth.
Kutzkey, a member of our board of directors, serves as Managing Partner of The Column Group. 15 Patents and Other Proprietary Rights As of December 31, 2024, our patent portfolio consisted of over 20 pending patent application families, including 18 families that have entered national phase in the United States and/or other countries, three families with pending Patent Cooperation Treaty, or PCT, applications, and three families with pending U.S. provisional applications.
The Research Collaboration Agreement was terminated effective November 13, 2025. 15 Patents and Other Proprietary Rights As of December 31, 2025, our patent portfolio consisted of over 25 pending patent application families, including 22 families that have entered national phase in the United States and/or other countries, three families with pending Patent Cooperation Treaty, or PCT, applications, and one family with a pending U.S. provisional application.
Item 1. Business. Overview We are a biotechnology company committed to discovering and developing drug candidates to selectively modulate the Wnt pathway, a critical mediator of tissue repair with a current focus in ophthalmology. We are located in South San Francisco, California. Our mission is to transform the treatment of serious disease by fully exploiting the Wnt pathway.
Item 1. Business. Overview We are a biotechnology company committed to discovering and developing product candidates to selectively modulate the Wnt pathway, a critical mediator of tissue repair. Our current strategic focus is ophthalmology, where Wnt signaling plays a central role in retinal vascular integrity, barrier function, and tissue maintenance. We are located in South San Francisco, California.
As a result of our discoveries, we are pioneering the selective activation of Wnt signaling, designing and engineering Wnt pathway mimetics, and advancing tissue-selective Wnt candidates. Our lead product candidates are multi-specific, antibody-based therapeutics that mimic the roles of naturally occurring Wnt proteins, which are involved in activation and enhancement of the Wnt pathway, respectively.
Our lead product candidates are multi-specific, antibody-based therapeutics that mimic the roles of naturally occurring Wnt proteins, which are involved in activation and enhancement of the Wnt pathway. Wnt signaling is essential in tissue maintenance and regeneration throughout the body.
During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product.
During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. 22 International Regulation To market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of other countries governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our products.

… 74 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

117 edited+36 added−22 removed590 unchanged
Biggest changeHowever, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business. • A few stockholders, including one of our former directors, control the voting rights with respect to a large number of shares of our common stock and could exercise their voting power in a manner that adversely affects us or our stockholders. 30 Risks Related to Our Business We are a biopharmaceutical company with a history of losses.
Biggest changeCompliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers. • Clinical development includes a lengthy and expensive process with an uncertain outcome, we may have negative results and results of earlier studies and trials may not be predictive of future trial results. • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that it will be successful in obtaining regulatory approval of our product candidates in other jurisdictions. • A few stockholders, including one of our directors, control the voting rights with respect to a large number of shares of our common stock and could exercise their voting power in a manner that adversely affects us or our stockholders. 29 Risks Related to Our Business We are a biopharmaceutical company with a history of losses.
We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability, which could result in a decline in the market value of our common stock. • We will need substantial additional funds to advance development of product candidates of our Wnt therapeutics platform, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or potential future product candidates. • None of our product candidates have received regulatory approval; our ability to achieve and sustain profitability depends on obtaining regulatory approval and successfully commercializing product candidates, either alone or with collaborators. • If any current or future product candidate, after it begins clinical trials or receives marketing approval, demonstrates undesirable safety or tolerability side effects or safety concerns, our ability to market and derive revenue from the product candidate could be compromised. • We have incurred significant operating losses since inception and anticipate that we will incur continued losses for the foreseeable future. • Any future equity or debt issuances or other financing transactions may have dilutive or adverse effects on our existing stockholders. • We rely on third parties to conduct our preclinical studies and our clinical trials, and those third parties may not perform satisfactorily. • Our clinical development activities could be delayed or otherwise adversely affected for various reasons. • We cannot predict how difficult it will be to enroll and retain patients for our future clinical trials and we may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. • The manufacturing of our product candidates is complex.
We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability, which could result in a decline in the market value of our common stock. • We will need substantial additional funds to advance development of product candidates of our Wnt therapeutics platform, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or potential future product candidates. • None of our product candidates have received regulatory approval; our ability to achieve and sustain profitability depends on obtaining regulatory approval and successfully commercializing product candidates, either alone or with collaborators. • If any current or future product candidate, after it begins clinical trials or receives marketing approval, demonstrates undesirable safety or tolerability side effects or safety concerns, our ability to market and derive revenue from the product candidate could be compromised. • We have incurred significant operating losses since inception and anticipate that we will incur continued losses for the foreseeable future. • Any future equity or debt issuances or other financing transactions may have dilutive or adverse effects on our existing stockholders. • We rely on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily. • Our clinical development activities could be delayed or otherwise adversely affected for various reasons. • We cannot predict how difficult it will be to enroll and retain patients for our future clinical trials and we may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. • The manufacturing of our product candidates is complex.
Doing business internationally involves a number of risks, including but not limited to: • multiple, conflicting and changing laws and regulations such as those relating to privacy, data protection and cybersecurity, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; • failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; • rejection or qualification of foreign clinical trial data by the competent authorities of other countries; • additional potentially relevant third-party patent rights; • complexities and difficulties in obtaining, maintaining, protecting and enforcing our intellectual property; • difficulties in staffing and managing foreign operations; • complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; • limits in our ability to penetrate international markets; • financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for products and exposure to foreign currency exchange rate fluctuations; • natural disasters, political and economic instability, wars, terrorism, political unrest, outbreak of disease, boycotts, trade wars and other significant events; • certain expenses including, among others, expenses for travel, translation and insurance; and • regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.
Doing business internationally involves a number of risks, including but not limited to: • multiple, conflicting and changing laws and regulations such as those relating to privacy, data protection and cybersecurity, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; • failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; • rejection or qualification of foreign clinical trial data by the competent authorities of other countries; • additional potentially relevant third-party patent rights; • complexities and difficulties in obtaining, maintaining, protecting and enforcing our intellectual property; • difficulties in staffing and managing foreign operations; • complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; • limits in our ability to penetrate international markets; • financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for products and exposure to foreign currency exchange rate fluctuations; • natural disasters, political and economic instability, wars, terrorism, political unrest, outbreak of disease, boycotts, trade wars, tariffs and other significant events; • certain expenses including, among others, expenses for travel, translation and insurance; and • regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.
Even if we identify investigational medicines 33 that initially show promise, we may fail to successfully develop and commercialize such products for many reasons, including the following: • the research methodology used may not be successful in identifying potential investigational medicines; • competitors may develop alternatives that render its investigational medicines obsolete; • investigational medicines it develops may nevertheless be covered by third parties’ patents or other exclusive rights; • an investigational medicine may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria; • it may take greater human and financial resources than we will possess to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, thereby limiting our ability to develop, diversify and expand our product portfolio; • an investigational medicine may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and • an approved product may not be accepted as safe and effective by trial patients, the medical community or third-party payors.
Even if we identify investigational medicines that initially show promise, we may fail to successfully develop and commercialize such products for many reasons, including the following: • the research methodology used may not be successful in identifying potential investigational medicines; • competitors may develop alternatives that render its investigational medicines obsolete; • investigational medicines it develops may nevertheless be covered by third parties’ patents or other exclusive rights; • an investigational medicine may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria; • it may take greater human and financial resources than we will possess to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, thereby limiting our ability to develop, diversify and expand our product portfolio; • an investigational medicine may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and • an approved product may not be accepted as safe and effective by trial patients, the medical community or third-party payors.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates and covered subcontractors that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information; • the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; • the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act” under the Affordable Care Act, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Centers for Medicare & Medicaid Services, or CMS, information related to transfers of value made to physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests of such physicians and their immediate family members; and • analogous local, state and foreign laws and regulations, such as state anti-kickback and false claims laws that may apply to healthcare items or services reimbursed by third party payors, including private insurers; local, state and foreign transparency laws that require manufacturers to report information related to payments and transfers of value to other 64 healthcare providers and healthcare entities, marketing expenditures, or drug pricing; state laws that require pharmaceutical companies to register certain employees engaged in marketing activities in the location and comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates and covered subcontractors that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information; • the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; 65 • the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act” under the Affordable Care Act, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Centers for Medicare & Medicaid Services, or CMS, information related to transfers of value made to physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests of such physicians and their immediate family members; and • analogous local, state and foreign laws and regulations, such as state anti-kickback and false claims laws that may apply to healthcare items or services reimbursed by third party payors, including private insurers; local, state and foreign transparency laws that require manufacturers to report information related to payments and transfers of value to other healthcare providers and healthcare entities, marketing expenditures, or drug pricing; state laws that require pharmaceutical companies to register certain employees engaged in marketing activities in the location and comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America, will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: • any derivative claim or cause of action brought on our behalf; • any claim or cause of action for breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; • any claim or cause of action against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, or DGCL, our certificate of incorporation or our bylaws; • claim or cause of action seeking to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; • any action or proceeding as to which the DGCL confers jurisdiction to the Court of Chancery of the State of Delaware; and • any claim or cause of action against us or any of our current or former directors, officers or other employees that is governed by the internal-affairs doctrine, in all cases to the fullest extent permitted by law and subject to the court having personal jurisdiction over the indispensable parties named as defendants.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America, will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: • any derivative claim or cause of action brought on our behalf; • any claim or cause of action for breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; • any claim or cause of action against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, or DGCL, our certificate of incorporation or our bylaws; • claim or cause of action seeking to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; 70 • any action or proceeding as to which the DGCL confers jurisdiction to the Court of Chancery of the State of Delaware; and • any claim or cause of action against us or any of our current or former directors, officers or other employees that is governed by the internal-affairs doctrine, in all cases to the fullest extent permitted by law and subject to the court having personal jurisdiction over the indispensable parties named as defendants.
The enrollment of patients depends on many factors, including: • the severity of the disease under investigation; • the patient eligibility criteria defined in the clinical trial protocol; • the size of the patient population required for analysis of the trial’s primary endpoints; • the proximity and availability of clinical trial sites for prospective patients; • willingness of physicians to refer their patients to our clinical trials; • our ability to recruit clinical trial investigators with the appropriate competencies and experience; • clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; • our ability to obtain and maintain patient consents; • the risk that patients enrolled in clinical trials will drop out of the trials before completion; and • factors we cannot control that may limit patients, principal investigators or staff or clinical site availability.
The enrollment of patients depends on many factors, including: • the severity of the disease under investigation; • the patient eligibility criteria defined in the clinical trial protocol; • the size of the patient population required for analysis of the trial’s primary endpoints; • the proximity and availability of clinical trial sites for prospective patients; • willingness of physicians to refer their patients to our clinical trials; • our ability to recruit clinical trial investigators with the appropriate competencies and experience; • clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; 37 • our ability to obtain and maintain patient consents; • the risk that patients enrolled in clinical trials will drop out of the trials before completion; and • factors we cannot control that may limit patients, principal investigators or staff or clinical site availability.
These transactions would entail numerous operational and financial risks, including: • exposure to unknown liabilities; • disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates or technologies; • incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs; • higher-than-expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses; • difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business; 36 • impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership; and • the inability to retain key employees of any acquired business.
These transactions would entail numerous operational and financial risks, including: • exposure to unknown liabilities; • disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates or technologies; • incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs; • higher-than-expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses; • difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business; • impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership; and • the inability to retain key employees of any acquired business.
The following examples are illustrative: 59 • others may be able to make antibodies or portions of antibodies or formulations that are similar to our product candidates, but that are not covered by the claims of any patents that we own, license or control; • we or any strategic collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own license or control; • we or our licensors might not have been the first to file patent applications covering certain of our owned and in-licensed inventions; • others may independently develop the same, similar, or alternative technologies without infringing, misappropriating or violating our owned or in-licensed intellectual property rights; • it is possible that our owned or in-licensed pending patent applications will not lead to issued patents; • issued patents that we own, in-licenses, or controls may not provide us with any competitive advantages, or may be narrowed or held invalid or unenforceable, including as a result of legal challenges; • our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such trade secrets or know-how; and • the patents of others may have an adverse effect on our business.
The following examples are illustrative: • others may be able to make antibodies or portions of antibodies or formulations that are similar to our product candidates, but that are not covered by the claims of any patents that we own, license or control; • we or any strategic collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own license or control; • we or our licensors might not have been the first to file patent applications covering certain of our owned and in-licensed inventions; • others may independently develop the same, similar, or alternative technologies without infringing, misappropriating or violating our owned or in-licensed intellectual property rights; • it is possible that our owned or in-licensed pending patent applications will not lead to issued patents; • issued patents that we own, in-licenses, or controls may not provide us with any competitive advantages, or may be narrowed or held invalid or unenforceable, including as a result of legal challenges; • our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where 60 we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such trade secrets or know-how; and • the patents of others may have an adverse effect on our business.
This may be exacerbated if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, a product candidate, such as: • negative or inconclusive results from our preclinical or clinical trials (including as described above) or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical studies or clinical trials or abandon any or all of our programs; • product-related side effects experienced by participants in our clinical trials (such as the asymptomatic transaminase elevations discussed above) or by individuals using drugs or therapeutic antibodies similar to ours, including immunogenicity; • delays in submitting IND applications or comparable foreign applications, or delays or failures to obtain the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced; • conditions imposed by the FDA or other regulatory authorities regarding the scope or design of our clinical trials; • delays in enrolling research subjects in clinical trials; 32 • high drop-out rates of research subjects; • inadequate supply or quality of product candidate components or materials or other supplies necessary for the conduct of our clinical trials; • chemistry, manufacturing and control, or CMC, challenges associated with manufacturing and scaling up manufacturing of biologic product candidates to ensure consistent quality, stability, purity and potency among different batches used in clinical trials; • greater-than-anticipated clinical trial costs; • poor potency or effectiveness of our product candidates during clinical trials; • unfavorable FDA or other regulatory authority inspection and review of a clinical trial or manufacturing site; • failure of us or Boehringer Ingelheim International GmbH to adequately perform under the Collaboration and License Agreement; • failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all; • delays and changes in regulatory requirements, policies and guidelines; or • the FDA or other regulatory authorities interpreting our data differently than it does.
This may be exacerbated if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, a product candidate, such as: • negative or inconclusive results from our preclinical or clinical trials (including as described above) or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical studies or clinical trials or abandon any or all of our programs; • product-related side effects experienced by participants in our clinical trials (such as the asymptomatic transaminase elevations) or by individuals using drugs or therapeutic antibodies similar to ours, including immunogenicity; • delays in submitting IND applications or comparable foreign applications, or delays or failures to obtain the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced; • conditions imposed by the FDA or other regulatory authorities regarding the scope or design of our clinical trials; 31 • delays in enrolling research subjects in clinical trials; • high drop-out rates of research subjects; • inadequate supply or quality of product candidate components or materials or other supplies necessary for the conduct of our clinical trials; • chemistry, manufacturing and control, or CMC, challenges associated with manufacturing and scaling up manufacturing of biologic product candidates to ensure consistent quality, stability, purity and potency among different batches used in clinical trials; • greater-than-anticipated clinical trial costs; • poor potency or effectiveness of our product candidates during clinical trials; • unfavorable FDA or other regulatory authority inspection and review of a clinical trial or manufacturing site; • failure of us or Boehringer Ingelheim International GmbH to adequately perform under the Collaboration and License Agreement; • failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all; • delays and changes in regulatory requirements, policies and guidelines; or • the FDA or other regulatory authorities interpreting our data differently than it does.
If we breach any material obligations, including diligence obligations with respect to development and commercialization of product candidates covered by the intellectual property licensed to us, or uses the licensed intellectual property in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate 51 the license, which could result in us being unable to develop, manufacture, and sell products that are covered by the licensed intellectual property or enable a competitor to gain access to the licensed intellectual property.
If we breach any material obligations, including diligence obligations with respect to development and commercialization of product candidates covered by the intellectual property licensed to us, or uses the licensed intellectual property in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture, and sell products that are covered by the licensed intellectual property or enable a competitor to gain access to the licensed intellectual property.
Privacy Shield and the SCCs, any transfers by us or our vendors of personal data from Europe may not 46 comply with European data protection law, which may increase Our exposure to the GDPR’s heightened sanctions for violations of its cross-border data transfer restrictions and may prohibit the transfer of EU personal data outside of the EU (including clinical trial data), and may adversely impact Our operations, product development, and ability to provide our products.
Privacy Shield and the SCCs, any transfers by us or our vendors of personal data from Europe may not comply with European data protection law, which may increase Our exposure to the GDPR’s heightened sanctions for violations of its cross-border data transfer restrictions and may prohibit the transfer of EU personal data outside of the EU (including clinical trial data), and may adversely impact Our operations, product development, and ability to provide our products.
In addition, some courts in the United States and certain foreign jurisdictions disfavor or are unwilling to protect trade secrets. Further, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent that competitor from using the technology or information to compete with it.
In addition, some courts in the United States and certain foreign jurisdictions disfavor or are unwilling to protect trade secrets. Further, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no 58 right to prevent that competitor from using the technology or information to compete with it.
At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from 63 other countries and bulk purchasing.
At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
If our manufacturing 41 collaborators are unable to successfully scale the manufacture of any current or potential future product candidate in sufficient quality and quantity, the development, testing, clinical trials and commercialization of that product candidate may be delayed or infeasible and regulatory approval or commercial launch of any potential resulting product may be delayed or not obtained, which could significantly harm our business.
If our manufacturing collaborators are unable to successfully scale the manufacture of any current or potential future product candidate in sufficient quality and quantity, the development, testing, clinical trials and commercialization of that product candidate may be delayed or infeasible and regulatory approval or commercial launch of any potential resulting product may be delayed or not obtained, which could significantly harm our business.
The regulation imposes numerous requirements for the collection, use and disclosure of personal information, including stringent requirements relating to consent and the information that must be shared with data subjects about how their personal information is used, the obligation to notify regulators and affected individuals of personal data breaches, extensive internal privacy governance obligations and obligations to honor expanded rights of individuals in relation to their personal information.
The regulation imposes numerous requirements for the collection, use and disclosure of 46 personal information, including stringent requirements relating to consent and the information that must be shared with data subjects about how their personal information is used, the obligation to notify regulators and affected individuals of personal data breaches, extensive internal privacy governance obligations and obligations to honor expanded rights of individuals in relation to their personal information.
Patients who are prescribed medications for the treatment of their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Coverage and adequate reimbursement from government healthcare programs, such as Medicare and Medicaid, and private health insurers are critical to new product acceptance.
Patients who are prescribed medications for the treatment of their conditions generally rely on 66 third-party payors to reimburse all or part of the costs associated with their prescription drugs. Coverage and adequate reimbursement from government healthcare programs, such as Medicare and Medicaid, and private health insurers are critical to new product acceptance.
The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on Our business, financial condition, results of operations, and prospects.
The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, 53 or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on Our business, financial condition, results of operations, and prospects.
Although a substantial amount of our efforts will focus on the planned clinical trials and potential approval of our existing product candidates and other potential product candidates we are evaluating, a key element of our strategy is to discover, develop and potentially commercialize additional products beyond our current product candidates to treat various conditions and in a variety of therapeutic areas.
Although a substantial amount of our efforts will focus on the planned clinical trials and potential approval of our existing product candidates and other potential product candidates we are evaluating, a key element of our strategy is to discover, develop and potentially commercialize additional products beyond our current product candidates to treat various conditions and in a variety of therapeutic 32 areas.
As a result, we or any current or future collaborators may be unable to obtain sufficient insurance at a reasonable cost to 45 protect us against losses caused by product liability claims that could have a material and adverse effect on our business, financial condition, results of operations and prospects.
As a result, we or any current or future collaborators may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have a material and adverse effect on our business, financial condition, results of operations and prospects.
Actual or perceived failure to comply with any laws and regulations relating to privacy, data protection or cybersecurity in the U.S. or foreign jurisdictions could result in government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect Our operating results and business.
Actual or perceived failure to comply with any laws and regulations 47 relating to privacy, data protection or cybersecurity in the U.S. or foreign jurisdictions could result in government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect Our operating results and business.
In addition, such redemption may occur at a time when the public warrants are “out-of-the-money,” in which case, holders of public warrants would lose any potential embedded value from a subsequent increase in the value of our common stock had the public warrants remained outstanding. Item 1B. Unresolved Staff Comments. None.
In addition, such redemption may occur at a time when the public warrants are “out-of-the-money,” in which case, holders of public warrants would lose any potential embedded value from a subsequent increase in the value of our common stock had the public warrants remained outstanding. 72 Item 1B. Unresolved Staff Comments. None.
If we or any of our CROs fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, European Medicines Agency, or EMA, or other regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
If we or any of our CROs fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, European Medicines Agency, or EMA, or other regulatory authorities may require us to perform additional clinical trials before 36 approving our marketing applications.
We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. We believe our procedures for storing, handling and disposing of these materials in its facilities comply with the relevant guidelines of the state of California and the Occupational Safety and Health Administration of the U.S.
We 48 are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. We believe our procedures for storing, handling and disposing of these materials in its facilities comply with the relevant guidelines of the state of California and the Occupational Safety and Health Administration of the U.S.
We may be unable to prevent competitors from entering the market with a product that is similar or identical to SZN-413, SZN-8141, SZN-8143, SZN-113 or any future product candidates. The filing of a patent application or the issuance of a patent is not conclusive as to its ownership, inventorship, scope, patentability, validity or enforceability.
We may be unable to prevent competitors from entering the market with a product that is similar or identical to SZN-413, SZN-8141, SZN-8143 or any future product candidates. The filing of a patent application or the issuance of a patent is not conclusive as to its ownership, inventorship, scope, patentability, validity or enforceability.
Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan. Our success largely depends on the continued service of key executive management, advisors and other specialized personnel, including Craig Parker, our President and Chief Executive Officer, and Charles Williams, our Chief Financial Officer and Chief Operating Officer.
Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan. Our success largely depends on the continued service of key executive management, advisors and other specialized personnel, including Craig Parker, our President and Chief Executive Officer and Charles Williams, our Chief Operating Officer.
If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited 57 from commercializing any of our current or future technologies or product candidates that are held to be infringing, misappropriating or otherwise violating third-party intellectual property rights.
If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing any of our current or future technologies or product candidates that are held to be infringing, misappropriating or otherwise violating third-party intellectual property rights.
Furthermore, if we or 44 any current or future collaborator succeed in developing any products, we anticipate marketing them in the European Union, or EU, and other jurisdictions in addition to the United States. If approved, we or any future collaborator may hire sales representatives and conduct physician and patient association outreach activities outside of the United States.
Furthermore, if we or any current or future collaborator succeed in developing any products, we anticipate marketing them in the European Union, or EU, and other jurisdictions in addition to the United States. If approved, we or any future collaborator may hire sales representatives and conduct physician and patient association outreach activities outside of the United States.
There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs or other unforeseen reasons, our existing NOLs could expire 43 or otherwise be unavailable to reduce future income tax liabilities, including for state tax purposes.
There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs or other unforeseen reasons, our existing NOLs could expire or otherwise be unavailable to reduce future income tax liabilities, including for state tax purposes.
In the United States, patent term extension cannot extend the remaining term of a patent beyond 14 years from the date of product approval; only one patent may be extended; and extension is available for only those claims 53 covering the approved drug, a method for using it, or a method for manufacturing it.
In the United States, patent term extension cannot extend the remaining term of a patent beyond 14 years from the date of product approval; only one patent may be extended; and extension is available for only those claims covering the approved drug, a method for using it, or a method for manufacturing it.
Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.
Approval procedures vary among jurisdictions and can involve 62 requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.
As a result, we may forgo or delay pursuit of other opportunities, including with potential future product candidates that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial 35 product candidates or profitable market opportunities.
As a result, we may forgo or delay pursuit of other opportunities, including with potential future product candidates that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial product candidates or profitable market opportunities.
The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned or in-licensed patent applications and the enforcement or defense of our issued, owned or in-licensed patents, all of which could have a material adverse impact on our business prospects and financial condition.
The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned or in-licensed patent 54 applications and the enforcement or defense of our issued, owned or in-licensed patents, all of which could have a material adverse impact on our business prospects and financial condition.
In addition, any delays in completing our clinical trials will increase our costs, slow our product development and approval process and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may materially and adversely affect our business, financial condition, results of operations and prospects.
In addition, 61 any delays in completing our clinical trials will increase our costs, slow our product development and approval process and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may materially and adversely affect our business, financial condition, results of operations and prospects.
Any exercise by the U.S. government of such rights could harm our competitive position, business, financial condition, results of operations and prospects. The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
Any exercise by the U.S. government of such rights could harm our competitive position, business, financial condition, results of operations and prospects. 51 The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we could lose at least part, and perhaps all, of the patent protection for one or more of our product candidates or certain aspects of our platform technology.
If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we could lose at least part, and perhaps all, of the patent protection for one or more of our product candidates or certain aspects of our platform 55 technology.
If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or to continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in marketing our product 56 candidates.
If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or to continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in marketing our product candidates.
Collaborations involving our product candidates, including our collaboration with BI, pose many risks to us, including that: • Collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; • Collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities; • Collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • Collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates or products if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; • A collaborator with marketing and distribution rights to one or more product candidates or products may not commit sufficient resources to the marketing and distribution of such drugs; • Collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; • Collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and • Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all.
Collaborations involving our product candidates, including our collaboration with Boehringer Ingelheim, pose many risks to us, including that: • Collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; • Collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities; • Collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • Collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates or products if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; 49 • A collaborator with marketing and distribution rights to one or more product candidates or products may not commit sufficient resources to the marketing and distribution of such drugs; • Collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; • Collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and • Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all.
In such an event, our trials could be suspended or 34 terminated and the FDA or other regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications.
In such an event, our trials could be suspended or terminated and the FDA or other regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications.
In such an event, potential competitors might be able to enter the market with similar or identical product candidates or platforms, which could have a material adverse effect on our business prospects and financial condition.
In such an event, potential competitors might be able to enter the 59 market with similar or identical product candidates or platforms, which could have a material adverse effect on our business prospects and financial condition.
Moreover, under current law, NOLs generated in taxable years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such NOLs generally will be limited in taxable years beginning after December 31, 2020 to 80% of current year taxable income.
Moreover, under current law, NOLs generated in taxable years beginning after December 42 31, 2017 may be carried forward indefinitely, but the deductibility of such NOLs generally will be limited in taxable years beginning after December 31, 2020 to 80% of current year taxable income.
The license agreements with Stanford impose, and any future license agreements we enter into are likely to impose, various development, commercialization, funding, 52 milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement or other obligations on us.
The license agreements with Stanford impose, and any future license agreements we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement or other obligations on us.
Because the length of time and activities associated with successful research and development of product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities.
Because the length of time and activities associated with successful research and development of product candidates is highly 30 uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities.
We cannot 65 be sure that coverage and adequate reimbursement will be available for any product that it commercializes and, if reimbursement is available, that the level of reimbursement will be adequate. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.
We cannot be sure that coverage and adequate reimbursement will be available for any product that it commercializes and, if reimbursement is available, that the level of reimbursement will be adequate. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.
In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
In addition, government funding of the 67 SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies may pursue strategies to license or acquire third-party intellectual property rights that 58 We may consider attractive or necessary.
The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies may pursue strategies to license or acquire third-party intellectual property rights that We may consider attractive or necessary.
Our development programs may be delayed for a variety of reasons, including delays related to: • unfavorable findings or observations that cause us to pause or modify our clinical trial; • the FDA or other regulatory authorities requiring additional data or imposing other requirements before permitting initiation of a clinical trial; • obtaining regulatory approval to commence a clinical trial; • reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; • obtaining IRB or ethics committee, or EC, approval at each clinical trial site; • recruiting suitable patients to participate in a clinical trial; • having patients complete a clinical trial or return for post-treatment follow-up; • clinical trial sites deviating from trial protocol or dropping out of a trial; • adding new clinical trial sites; or • manufacturing sufficient quantities of our product candidates for use in clinical trials. 60 • Furthermore, we expect to rely on CROs, collaborators such as BI and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we expect to enter into agreements governing their committed activities, we may have limited influence over their actual performance.
Our development programs may be delayed for a variety of reasons, including delays related to: • unfavorable findings or observations that cause us to pause or modify our clinical trial; • the FDA or other regulatory authorities requiring additional data or imposing other requirements before permitting initiation of a clinical trial; • obtaining regulatory approval to commence a clinical trial; • reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; • obtaining IRB or ethics committee, or EC, approval at each clinical trial site; • recruiting suitable patients to participate in a clinical trial; • having patients complete a clinical trial or return for post-treatment follow-up; • clinical trial sites deviating from trial protocol or dropping out of a trial; • adding new clinical trial sites; or • manufacturing sufficient quantities of our product candidates for use in clinical trials. • Furthermore, we expect to rely on CROs, collaborators such as Boehringer Ingelheim and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we expect to enter into agreements governing their committed activities, we may have limited influence over their actual performance.
We thus cannot know with certainty whether we or our licensors were the first to make the inventions claimed in our owned or in-licensed patents or patent applications, or that we or our licensors were the first to file for patent protection of such inventions.
We thus cannot know with certainty whether we or our licensors were 50 the first to make the inventions claimed in our owned or in-licensed patents or patent applications, or that we or our licensors were the first to file for patent protection of such inventions.
We face potential competition from many different sources, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities and other academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for the research, development, manufacturing, and commercialization of therapies aimed at treating 42 autoimmune, inflammatory, metabolic, and other diseases, including indications that we are pursuing or may pursue in the future.
We face potential competition from many different sources, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities and other academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for the research, development, manufacturing, and commercialization of therapies aimed at treating ophthalmic, autoimmune, inflammatory, metabolic, and other diseases, including indications that we are pursuing or may pursue in the future.
If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise additional 34 capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, 55 the patent owner may have limited remedies, which could materially diminish the value of its patents.
In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of its patents.
In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board 68 of directors.
In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors.
The actual cost to manufacture our product candidates could be greater than we expect because we are early in our development efforts. 40 Because we may rely on third parties for manufacturing and supply of our product candidates, some of which may be sole source vendors, for preclinical and clinical development materials and commercial supplies, our supply may become limited or interrupted or may not be of satisfactory quantity or quality.
The actual cost to manufacture our product candidates could be greater than we expect because we are early in our development efforts. 39 Because we may rely on third parties for manufacturing and supply of our product candidates, some of which may be sole source vendors, for preclinical and clinical development materials and commercial supplies, our supply may become limited or interrupted or may not be of satisfactory quantity or quality.
We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held by non-affiliates exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual 70 revenues exceeded $100 million during such completed fiscal year and the market value of our common stock held by non-affiliates equals or exceeds $700 million as of the end of that year’s second fiscal quarter.
We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held by non-affiliates exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common stock held by non-affiliates equals or exceeds $700 71 million as of the end of that year’s second fiscal quarter.
We expect our net losses to increase substantially as our product candidates advance into clinical development. However, the amount of our future losses is uncertain.
We expect our net operating losses to increase substantially as our product candidates advance into clinical development. However, the amount of our future losses is uncertain.
In addition, because of the limited number of drug candidates that target the Wnt pathway, the FDA or other regulatory authorities may require us to perform additional testing before commencing or resuming clinical trials and be hesitant to allow us to enroll patients impacted with its targeted disease indications in Phase 1 trials.
In addition, because of the limited number of product candidates that target the Wnt pathway, the FDA or other regulatory authorities may require us to perform additional testing before commencing or resuming clinical trials and be hesitant to allow us to enroll patients impacted with its targeted disease indications in Phase 1 trials.
Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.
Such 57 announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.
For example, although our lead product candidates exhibited encouraging results in animal studies, they may not demonstrate the same properties in humans and may interact with human physiology in unforeseen, ineffective or harmful ways, as shown by the observations of asymptomatic transaminase elevations discussed above.
For example, although our lead product candidates exhibited encouraging results in animal studies, they may not demonstrate the same properties in humans and may interact with human physiology in unforeseen, ineffective or harmful ways, as shown by the observations of asymptomatic transaminase elevations.
The commencement or completion of our clinical trials could be substantially delayed or prevented by many factors, including: • further discussions with the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, including the endpoint measures required for regulatory approval and our statistical plan; • the limited number of, and competition for, suitable study sites and investigators to conduct our clinical trials, many of which may already be engaged in other clinical trial programs with similar patients, including some that may be for the same indication as our product candidates; • any delay or failure to obtain timely approval or agreement to commence a clinical trial in any of the countries where enrollment is planned; • inability to obtain sufficient funds required for a clinical trial; • clinical holds on, or other regulatory objections to, a new or ongoing clinical trial; • delay or failure to manufacture sufficient quantities or inability to produce quantities of consistent quality, purity and potency of the product candidate for our clinical trials; • delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs; • delay or failure to obtain institutional review board, or IRB, approval to conduct a clinical trial at a prospective site; • the FDA or other comparable foreign regulatory authorities may require us to submit additional data or impose other requirements before permitting us to initiate a clinical trial; • slower than expected rates of patient recruitment and enrollment; • failure of patients to complete the clinical trial; • the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects; • unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths; • lack of efficacy or failure to measure a statistically significant clinical benefit within the dose range with an acceptable safety margin during clinical trials; • termination of our clinical trials by one or more clinical trial sites; • inability or unwillingness of patients or clinical investigators to follow our clinical trial protocols; • inability to monitor patients adequately during or after treatment by us or our CROs; • our CROs or clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; • inability to address any noncompliance with regulatory requirements or safety concerns that arise during the course of a clinical trial; • the impact of, and delays related to, health epidemics; • the need to suspend, repeat or terminate clinical trials as a result of non-compliance with regulatory requirements, inconclusive or negative results or unforeseen complications in testing; and • the suspension or termination of our clinical trials upon a breach or pursuant to the terms of any agreement with, or for any other reason by, any future strategic collaborator that have responsibility for the clinical development of any of our product candidates. 39 Changes in regulatory requirements, policies and guidelines may also occur and we may need to significantly modify our clinical development plans to reflect these changes with appropriate regulatory authorities.
The commencement or completion of our clinical trials could be substantially delayed or prevented by many factors, including: • further discussions with the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, including the endpoint measures required for regulatory approval and our statistical plan; • the limited number of, and competition for, suitable study sites and investigators to conduct our clinical trials, many of which may already be engaged in other clinical trial programs with similar patients, including some that may be for the same indication as our product candidates; • any delay or failure to obtain timely approval or agreement to commence a clinical trial in any of the countries where enrollment is planned; • inability to obtain sufficient funds required for a clinical trial; • clinical holds on, or other regulatory objections to, a new or ongoing clinical trial; • delay or failure to manufacture sufficient quantities or inability to produce quantities of consistent quality, purity and potency of the product candidate for our clinical trials; • delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs; • delay or failure to obtain institutional review board, or IRB, approval to conduct a clinical trial at a prospective site; • the FDA or other comparable foreign regulatory authorities may require us to submit additional data or impose other requirements before permitting us to initiate a clinical trial; • slower than expected rates of patient recruitment and enrollment; • failure of patients to complete the clinical trial; • the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects; • unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths; • lack of efficacy or failure to measure a statistically significant clinical benefit within the dose range with an acceptable safety margin during clinical trials; • termination of our clinical trials by one or more clinical trial sites; • inability or unwillingness of patients or clinical investigators to follow our clinical trial protocols; 38 • inability to monitor patients adequately during or after treatment by us or our CROs; • our CROs or clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; • inability to address any noncompliance with regulatory requirements or safety concerns that arise during the course of a clinical trial; • the impact of, and delays related to, health epidemics; • the need to suspend, repeat or terminate clinical trials as a result of non-compliance with regulatory requirements, inconclusive or negative results or unforeseen complications in testing; and • the suspension or termination of our clinical trials upon a breach or pursuant to the terms of any agreement with, or for any other reason by, any future strategic collaborator that have responsibility for the clinical development of any of our product candidates.
The timing and amount of our operating expenditures will depend largely on: 31 • the timing and progress of preclinical and clinical development of SZN-413, SZN-8141, SZN-8143, SZN-113 and other potential future product candidates; • the timing and progress of the development of our Wnt therapeutics platform; • the price and pricing structure that we are able to obtain from our third-party contract manufacturers to manufacture our preclinical study and clinical trial materials and supplies; • the extent to which prices for supplies and materials increase due to inflationary pressures and labor market constraints; • the number and scope of preclinical and clinical programs we decide to pursue; • our ability to maintain our current licenses, research and development programs and to establish new collaborations; • the progress of the development efforts of parties with whom we may in the future enter into collaboration and research and development agreements; • the costs involved in obtaining, maintaining, enforcing and defending patents and other intellectual property rights; • the impact of the health epidemics on our business; • the cost and timing of regulatory approvals; and • our efforts to enhance operational systems and hire additional personnel, including personnel to support development of our product candidates and satisfy our obligations as a public company.
The timing and amount of our operating expenditures will depend largely on: • the timing and progress of preclinical and clinical development of current and potential future product candidates; • the timing and progress of the development of our Wnt therapeutics platform; • the price and pricing structure that we are able to obtain from our third-party contract manufacturers to manufacture our preclinical study and clinical trial materials and supplies; • the extent to which prices for supplies and materials increase due to inflationary pressures, tariffs and labor market constraints; • the number and scope of preclinical and clinical programs we decide to pursue; • our ability to maintain our current licenses, research and development programs and to establish new collaborations; • the progress of the development efforts of parties with whom we may in the future enter into collaboration and research and development agreements; • the costs involved in obtaining, maintaining, enforcing and defending patents and other intellectual property rights; • the impact of the health epidemics on our business; • the cost and timing of regulatory approvals; and • our efforts to enhance operational systems and hire additional personnel, including personnel to support development of our product candidates and satisfy our obligations as a public company.
From time to time, we consider strategic transactions, such as collaborations, acquisitions of companies, asset purchases, joint ventures and out- or in-licensing of product candidates or technologies. For example, in October 2022, we executed a strategic partnership with BI for the research and development of SZN-413 for the treatment of retinal diseases.
From time to time, we consider strategic transactions, such as collaborations, acquisitions of companies, asset purchases, joint ventures and out- or in-licensing of product candidates or technologies. For example, in October 2022, we executed a strategic partnership with Boehringer Ingelheim for the research and development of SZN-413 for the treatment of retinal diseases.
Risks Related to Our Intellectual Property If we are unable to obtain or protect intellectual property rights related to our technology and current or future product candidates, or if our intellectual property rights are inadequate, we may not be able to compete effectively.
Risks Related to Our Intellectual Prop erty If we are unable to obtain or protect intellectual property rights related to our technology and current or future product candidates, or if our intellectual property rights are inadequate, we may not be able to compete effectively.
Our ability to achieve or sustain profitability, if ever, will depend on, among other things, successfully developing product candidates, continuing development for our lead product candidates, successful development and testing of SZN-413 through our partnership with Boehringer Ingelheim International GmbH, or BI, obtaining regulatory approvals to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, entering into potential future alliances, establishing a sales and marketing organization or suitable third-party alternatives for any approved product and raising sufficient funds to finance business activities.
Our ability to achieve or sustain profitability, if ever, will depend on, among other things, successfully developing product candidates, continuing development for our lead product candidates, successful development and testing of SZN-413 by Boehringer Ingelheim International GmbH, or Boehringer Ingelheim, obtaining regulatory approvals to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, entering into potential future alliances, establishing a sales and marketing organization or suitable third-party alternatives for any approved product and raising sufficient funds to finance business activities.
We may also use a portion of our cash to in-license, acquire or invest in complementary businesses, technologies, products or assets. However, other than our CLA with BI, we have no current commitments or obligations to do so. Therefore, our management will have flexibility in allocating our cash.
We may also use a portion of our cash to in-license, acquire or invest in complementary businesses, technologies, products or assets. However, other than our CLA with Boehringer Ingelheim, we have no current commitments or obligations to do so. Therefore, our management will have flexibility in allocating our cash.
If we or any collaborators fail to achieve one or more of these milestones or other key events as planned, including the milestones in our agreement with BI, our business could be materially adversely affected and the price of common stock could decline.
If we or any collaborators fail to achieve one or more of these milestones or other key events as planned, including the milestones in our agreement with Boehringer Ingelheim, our business could be materially adversely affected and the price of common stock could decline.
To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible. We may amend the terms of the public warrants in a manner that may be adverse to holders with the approval by the holders of at least 50% of the then-outstanding public warrants.
We expect to take advantage of such reduced disclosure obligations which may also make comparison of our financial statements with other public companies difficult or impossible. We may amend the terms of the public warrants in a manner that may be adverse to holders with the approval by the holders of at least 50% of the then-outstanding public warrants.
The market price for our common stock may be influenced by many factors, including the other risks described in this section of the Report titled “ Risk Factors ” and the following: • our ability, or the ability of our business partners, to advance our product candidates into the clinic; • results of preclinical and clinical studies for our product candidates, or those of our competitors or current and potential future collaborators; • the impact of health epidemic on our business; • regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our future products; • the success of competitive products or technologies; • introductions and announcements of new products by us, our future commercialization collaborators, or our competitors, and the timing of these introductions or announcements; • actions taken by regulatory authorities with respect to our future products, clinical trials, manufacturing process or sales and marketing terms; • actual or anticipated variations in our financial results or those of companies that are perceived to be similar to us; • the success of our efforts to acquire or in-license additional technologies, products or product candidates; • developments concerning any future collaborations, including, but not limited to, those with our sources of manufacturing supply and our commercialization collaborators; • market conditions in the pharmaceutical and biotechnology sectors; • announcements by us or our competitors of significant acquisitions, strategic alliances, joint ventures or capital commitments; • developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products; • our ability or inability to raise additional capital and the terms on which we raise it; • the recruitment or departure of key personnel; • changes in the structure of healthcare payment systems; • actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally; • our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • announcement and expectation of additional financing efforts; • speculation in the press or investment community; • trading volume of our common stock; • sales of our common stock by us or our stockholders; • the concentrated ownership of our common stock; • changes in accounting principles; • terrorist acts, acts of war or periods of widespread civil unrest; • natural disasters, public health crises and other calamities; and • general economic, industry and market conditions. 67 In addition, the stock markets in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that has been often unrelated to the operating performance of the issuer.
The market price for our common stock may be influenced by many factors, including the other risks described in this section of the Report titled “ Risk Factors ” and the following: • our ability, or the ability of our business partners, to advance our product candidates into the clinic; • results of preclinical and clinical studies for our product candidates, or those of our competitors or current and potential future collaborators; • the impact of health epidemic on our business; • regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our future products; • the success of competitive products or technologies; • introductions and announcements of new products by us, our future commercialization collaborators, or our competitors, and the timing of these introductions or announcements; • actions taken by regulatory authorities with respect to our future products, clinical trials, manufacturing process or sales and marketing terms; • actual or anticipated variations in our financial results or those of companies that are perceived to be similar to us; • the success of our efforts to acquire or in-license additional technologies, products or product candidates; • developments concerning any future collaborations, including, but not limited to, those with our sources of manufacturing supply and our commercialization collaborators; • market conditions in the pharmaceutical and biotechnology sectors; • announcements by us or our competitors of significant acquisitions, strategic alliances, joint ventures or capital commitments; • developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products; • our ability or inability to raise additional capital and the terms on which we raise it; • the recruitment or departure of key personnel; • changes in the structure of healthcare payment systems; • actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally; • our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • announcement and expectation of additional financing efforts; 68 • speculation in the press or investment community; • trading volume of our common stock; • sales of our common stock by us or our stockholders; • the concentrated ownership of our common stock; • changes in accounting principles; • terrorist acts, acts of war or periods of widespread civil unrest; • natural disasters, public health crises and other calamities; and • general economic, industry and market conditions.
If these companies develop therapeutics or product candidates more rapidly than we do, or if their therapeutics or product candidates are more effective or have fewer side effects, our ability to develop and successfully commercialize product candidates may be adversely affected. • If we are unable to maintain proper and effective internal controls over financial reporting, the accuracy and timeliness of our financial reporting and the market price of our common stock may be adversely affected. • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties. 29 • Our business, operations and clinical development plans and timelines could be adversely affected by the effects of health epidemics, natural disasters and other events on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom it conducts business, including contract manufacturers, contract research organizations, or CROs, shippers and others. • To the extent we enter into any other collaborations, we may depend on such collaborations for the development and commercialization of our product candidates.
If these companies develop therapeutics or product candidates more rapidly than we do, or if their therapeutics or product candidates are more effective or have fewer side effects, our ability to develop and successfully commercialize product candidates may be adversely affected. • If we are unable to maintain proper and effective internal controls over financial reporting, the accuracy and timeliness of our financial reporting and the market price of our common stock may be adversely affected. • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties. 28 • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects. • Our business, operations and clinical development plans and timelines could be adversely affected by the effects of health epidemics, natural disasters and other events on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom it conducts business, including contract manufacturers, contract research organizations, or CROs, shippers and others. • To the extent we enter into any other collaborations, we may depend on such collaborations for the development and commercialization of our product candidates.
SZN-413, SZN-8141, SZN-8143, SZN-113 and any potential future product candidates are subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing and distribution of therapeutic biologics.
Current and any potential future product candidates are subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing and distribution of therapeutic biologics.
Any claims of patent infringement asserted by third parties would be time consuming and could: • result in costly litigation that may cause negative publicity; • divert the time and attention of our technical personnel and management; • cause development delays; • prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law; • require us to develop non-infringing technology, which may not be possible on a cost-effective basis; • subject us to significant liability to third parties; or • require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in its competitors gaining access to the same technology.
Any claims of patent infringement asserted by third parties would be time consuming and could: • result in costly litigation that may cause negative publicity; • divert the time and attention of our technical personnel and management; • cause development delays; • prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law; • require us to develop non-infringing technology, which may not be possible on a cost-effective basis; • subject us to significant liability to third parties; or • require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in its competitors gaining access to the same technology. 56 Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates.
Issued patents and patent applications may be challenged in the courts and in the patent office in the United States and abroad. For example, our patent applications or patent applications filed by our licensors, or any patents that grant therefrom, may be challenged through third-party submissions, opposition or derivation proceedings.
Issued patents and patent applications may be challenged in the courts and in the patent office in the United States and abroad. For example, our patent applications or patent applications filed by our licensors, or any patents that grant therefrom, may be challenged through third-party submissions, opposition or derivation proceedings, which can be complex, time-consuming and costly.
Although our research and development efforts to date have resulted in the discovery and development of SZN-413, SZN-8141, SZN-8143, SZN-113 and other potential product candidates, our current product candidates may not be safe or effective therapeutics and we may not be able to develop any successful product candidates.
Although our research and development efforts to date have resulted in the discovery and development of current and potential product candidates, our current product candidates may not be safe or effective therapeutics and we may not be able to develop any successful product candidates.
As a result of the annual limitations caused by the ownership changes, it was estimated that approximately $2.6 million of federal tax credit, $8.8 million of federal NOL and $76.5 million of California NOL will expire unutilized for income tax purposes, and such amounts are excluded from the carryforward balances of December 31, 2024.
As a result of the annual limitations caused by the ownership changes, it was estimated that approximately $3.9 million of federal tax credit, $9.0 million of federal NOL and $76.2 million of California NOL will expire unutilized for income tax purposes, and such amounts are excluded from the carryforward balances of December 31, 2025.
Failure to comply with any of these, or if any of these policies or any of our representations, certifications, publications or frameworks are, in whole or part, found or perceived to be inaccurate, incomplete, deceptive, unfair, or misrepresentative of its actual practices, could result in reputational harm; result in litigation; cause a material adverse impact to business operations or financial results; and otherwise result in other material harm to our business. 47 We depend on sophisticated information technology systems and data processing to operate our business.
Failure to comply with any of these, or if any of these policies or any of our representations, certifications, publications or frameworks are, in whole or part, found or perceived to be inaccurate, incomplete, deceptive, unfair, or misrepresentative of its actual practices, could result in reputational harm; result in litigation; cause a material adverse impact to business operations or financial results; and otherwise result in other material harm to our business.
If the market opportunities for our current and potential future product candidates, including SZN-413, SZN-8141, SZN-8143 and SZN-113, are smaller than we believe they are, our future product revenues may be adversely affected and our business may suffer.
If the market opportunities for our current and potential future product candidates are smaller than we believe they are, our future product revenues may be adversely affected and our business may suffer.
The foreign regulatory approval process varies among countries and may include all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions.
The foreign regulatory approval process varies among countries and may include all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval.
If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, we may face costs, significant liabilities, harm to our brand and business disruption.
We depend on sophisticated information technology systems and data processing to operate our business. If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, we may face costs, significant liabilities, harm to our brand and business disruption.
As of December 31, 2024, and after taking into account our March 2025 private placement, entities affiliated with The Column Group (of which a member of our board of directors, Tim Kutzkey, Ph.D., is a Managing Partner) beneficially owned approximately 21.7% of our common stock and can significantly influence any matter requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combinations.
As of December 31, 2025, entities affiliated with The Column Group (of which a member of our board of directors, Tim Kutzkey, Ph.D., is a Managing Partner) beneficially owned approximately 22.5% of our common stock and can significantly influence any matter requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combinations.
We may be unable to obtain U.S. or foreign regulatory approval and, as a result, be unable to commercialize SZN-413, SZN-8141, SZN-8143, SZN-113 or potential future product candidates.
We may be unable to obtain U.S. or foreign regulatory approval and, as a result, be unable to commercialize current or potential future product candidates.
As of December 31, 2024, we had NOLs of approximately $160.5 million and $5.0 million available to reduce future taxable income, if any, for federal and California state income tax purposes, respectively. NOLs generated after 2018 for federal tax reporting purposes of $156.8 million have an indefinite carryforward period. The remaining federal and all state NOLs begin expiring in 2036.
As of December 31, 2025, we had NOLs of approximately $185.1 million and $31.3 million available to reduce future taxable income, if any, for federal and California state income tax purposes, respectively. NOLs generated after 2018 for federal tax reporting purposes of $181.6 million have an indefinite carryforward period. The remaining federal and all state NOLs begin expiring in 2036.

… 95 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

3 edited+0 added−0 removed12 unchanged
Biggest changeMembers of our audit committee receive updates on a quarterly basis from senior management, including leaders from our Information Technology team regarding matters of cybersecurity. This includes existing and new cybersecurity risks, status on how management is addressing and/or mitigating those risks, cybersecurity and data privacy incidents (if any) and status on key information security initiatives.
Biggest changeMembers of our audit committee receive updates at least annually from senior management, including leaders from our Information Technology team regarding matters of cybersecurity. This includes existing and new cybersecurity risks, status on how management is addressing and/or mitigating those risks, cybersecurity and data privacy incidents (if any) and status on key information security initiatives.
Depending on the environment, we implement and maintain various processes, standards, and/or policies designed to manage and mitigate material risks from 71 cybersecurity threats to our information system and data, including risk assessments, incident detection and response, vulnerability management, disaster recovery and business continuity plans, internal controls within our accounting and financial reporting functions, encryption of data, network security controls, access controls, physical security, asset management, systems monitoring, vendor risk management program, employee training, and penetration testing.
Depending on the environment, we implement and maintain various processes, standards, and/or policies designed to manage and mitigate material risks from cybersecurity threats to our information system and data, including risk assessments, incident detection and response, vulnerability management, disaster recovery and business continuity plans, internal controls within our accounting and financial reporting functions, encryption of data, network security controls, access controls, physical security, asset management, systems monitoring, vendor risk management program, employee training, and penetration testing.
The audit committee holds quarterly meetings and receives periodic reports from management, concerning our significant cybersecurity threats and risk and the processes we have implemented to address them.
The audit committee holds quarterly meetings and receives periodic reports from management, concerning our significant cybersecurity threats and risk and the processes we have implemented to address them. 73

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+0 added−0 removed1 unchanged
Biggest changeRegardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. Item 4. Mine Safety Disclosures. Not applicable. 72 PART II
Biggest changeRegardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. Item 4. Mine Safety Disclosures. Not applicable. 74 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−0 removed5 unchanged
Biggest changeHolders As of March 20, 2025, there were 56 holders of record of our shares of common stock and 11 holders of record of our public warrants. These amounts do not include stockholders for whom shares are held in street name by banks, brokers and other nominees.
Biggest changeHolders As of March 1, 2026, there were 45 holders of record of our shares of common stock and 7 holders of record of our public warrants. These amounts do not include stockholders for whom shares are held in street name by banks, brokers and other nominees.
Recent Sales of Unregistered Equity Securities There were no sales of unregistered securities during the period covered by this Annual Report other than those previously reported in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K. Issuer Purchases of Equity Securities Not applicable. Item 6. [Reserved] 73
Recent Sales of Unregistered Equity Securities There were no sales of unregistered securities during the period covered by this Annual Report other than those previously reported in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K. Issuer Purchases of Equity Securities Not applicable. Item 6. [Reserved] 75

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

59 edited+35 added−41 removed29 unchanged
Biggest changeLoss on Issuance of Common Stock, Pre-Funded Warrants and Warrants Loss on issuance of common stock, pre-funded warrants and warrants represents the excess of the initial fair value of common stock, pre-funded warrants and warrants over the aggregate gross proceeds in the private placement consummated in April 2024. 77 Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes results of operations for the periods presented (dollars in thousands): Year Ended December 31, $ % 2024 2023 Change Change Collaboration and license revenue $ 10,000 $ — $ 10,000 * Research service revenue - related party 655 — 655 * Total revenue 10,655 — 10,655 * Operating expenses: Research and development 21,132 27,230 (6,098 ) -22 % General and administrative 15,062 15,798 (736 ) -5 % Restructuring — 2,752 (2,752 ) -100 % Total operating expenses 36,194 45,780 (9,586 ) -21 % Loss from operations (25,539 ) (45,780 ) 20,241 -44 % Interest income 1,693 2,340 (647 ) -28 % Other (expense) income, net (19,321 ) 398 (19,719 ) * Loss on issuance of common stock, pre-funded warrants and warrants (20,397 ) — (20,397 ) * Net loss $ (63,564 ) $ (43,042 ) $ (125 ) 0 % * Percentage is not meaningful Collaboration and License Revenue The increase of $10.0 million in collaboration and license revenue for 2024, compared to 2023 is due to the recognition of a milestone achieved under the CLA with BI in September 2024.
Biggest changeOther Expense, Net Other expense, net primarily consists of the non-cash change in fair value of warrant liabilities, financing transaction costs and the non-cash impairment charge on warrant asset. 80 Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes results of operations for the periods presented (dollars in thousands): Year Ended December 31, $ % 2025 2024 Change Change Collaboration and license revenue $ — $ 10,000 $ (10,000 ) -100 % Research service revenue - related party 3,477 655 2,822 * Total revenue 3,477 10,655 (7,178 ) -67 % Operating expenses: Research and development 29,365 21,132 8,233 39 % General and administrative 16,204 15,062 1,142 8 % Total operating expenses 45,569 36,194 9,375 26 % Loss from operations (42,092 ) (25,539 ) (16,553 ) 65 % Interest income 3,020 1,693 1,327 78 % Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE — (20,397 ) 20,397 -100 % Loss on amendment and cancelation of warrants (2,073 ) — (2,073 ) * Loss on execution of the 2025 PIPE (71,084 ) — (71,084 ) * Loss on change in fair value of tranche liability (104,847 ) — (104,847 ) * Gain on settlement of tranche liability 1,362 — 1,362 * Other expense, net (26,312 ) (19,321 ) (6,991 ) 36 % Net loss and comprehensive loss $ (242,026 ) $ (63,564 ) $ (178,462 ) * * Percentage is not meaningful Collaboration and License Revenue The decrease of $10.0 million in collaboration and license revenue for 2025, compared to 2024 is due to the recognition of a milestone achieved under the CLA with Boehringer Ingelheim in September 2024.
This is due to the numerous risks and uncertainties associated with the development of product candidates, many of which are outside of our control, including those associated with: • our ability, and the ability of our primary business partners, to hire and retain key personnel; • the timing and progress of preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we decide to pursue; • our ability to maintain our current research and development programs and to establish new ones; • establishing an appropriate safety profile with IND-enabling studies; • the number of sites and patients included in the clinical trials; • the countries in which the clinical trials are conducted; • per patient trial costs; • successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates, the availability of alternate treatments and the limited pool of eligible patients in certain disease areas; • the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; • the number of trials required for regulatory approval; • the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities; 76 • our ability to establish new licensing or collaboration arrangements; • the performance of our current and future business partners, if any; • establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; • significant and changing government regulation and regulatory guidance; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; • the impact of inflation on our expenses; • launching commercial sales of our drug candidates, if approved, whether alone or in collaboration with others; • the effect of products that may compete with our product candidates or other market developments; and • maintaining a continued acceptable safety profile of the drug candidates following approval.
This is due to the numerous risks and uncertainties associated with the development of product candidates, many of which are outside of our control, including those associated with: • our ability, and the ability of our primary business partners, to hire and retain key personnel; • the timing and progress of preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we decide to pursue; • our ability to maintain our current research and development programs and to establish new ones; • establishing an appropriate safety profile with IND-enabling studies; • the number of sites and patients included in the clinical trials; • the countries in which the clinical trials are conducted; • per patient trial costs; • successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates, the availability of alternate treatments and the limited pool of eligible patients in certain disease areas; • the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; • the number of trials required for regulatory approval; • the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities; • our ability to establish new licensing or collaboration arrangements; • the performance of our current and future business partners, if any; • establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; • significant and changing government regulation and regulatory guidance; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; • the impact of inflation on our expenses; • launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; • the effect of products that may compete with our product candidates or other market developments; and • maintaining a continued acceptable safety profile of the product candidates following approval.
Since our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, developing and optimizing our Wnt therapeutics platform, identifying potential product candidates, undertaking research and development activities, engaging in strategic transactions, establishing and enhancing our 74 intellectual property portfolio, and providing general and administrative support for these operations.
Since our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, developing and optimizing our Wnt therapeutics platform, identifying potential product candidates, undertaking research and development activities, engaging in strategic transactions, establishing and enhancing our intellectual property portfolio, and providing general and administrative support for these operations.
In exchange for our research services, TCGFB agreed to pay us a fixed monthly fee up to $6.0 million in the aggregate, plus any third-party costs, and issued us a warrant exercisable for up to 3.4 million shares of TCGFB common stock at an exercise price of $0.0001 per share based on certain vesting conditions.
In exchange for our research services, TCGFB agreed to pay us a fixed monthly fee up to $6.0 million in the aggregate, plus any third-party costs, and issued us a warrant exercisable 77 for up to 3.4 million shares of TCGFB common stock at an exercise price of $0.0001 per share based on certain vesting conditions.
Licensing Arrangements In October 2022, we executed a Collaboration and Licensing Agreement, or the CLA, with Boehringer Ingelheim International GmbH, or BI, to research, develop and commercialize Frizzled 4, or Fzd4, bi-specific antibodies designed using our SWAP technology, including SZN-413. We and BI conducted partnership research focused on SZN-413 during a 1.5-year period.
Licensing Arrangements In October 2022, we executed a Collaboration and Licensing Agreement, or the CLA, with Boehringer Ingelheim International GmbH, or Boehringer Ingelheim, to research, develop and commercialize Frizzled 4, or Fzd4, bi-specific antibodies designed using our SWAP technology, including SZN-413. Boehringer Ingelheim and us conducted partnership research focused on SZN-413 during a 1.5-year period.
Our future funding requirements will depend on many factors, including, but not limited to: • the scope, rate of progress, results and costs of researching and developing our lead product candidates or any future product candidates, conducting preclinical and clinical studies; • the outcome, costs, and timing involved in obtaining regulatory approvals for our product candidates; • the achievement of milestones that trigger payments to us and the timing, receipt and amount of royalties under the CLA and any collaboration and license agreement we may enter in the future; • the number and scope of clinical programs we decide to pursue; • the cost of acquiring, licensing, or investing in product candidates and technologies; • the costs associated with securing and establishing commercialization; 80 • our ability to maintain, expand, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense, and enforcement of any patents or other intellectual property rights; • our need and ability to retain key management and hire scientific, technical, business, and medical personnel; • the effect of competing products and product candidates and other market developments; • the timing, receipt, and amount of sales from our lead product candidates, if approved; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing of, and success of any collaboration, licensing, or other arrangements which we may enter in the future; and • the effects of the disruptions to and volatility in the credit and financial markets in the U.S. and worldwide.
Our future funding requirements will depend on many factors, including, but not limited to: • the scope, rate of progress, results and costs of researching and developing our lead product candidates or any future product candidates, conducting preclinical and clinical studies; • the outcome, costs, and timing involved in obtaining regulatory approvals for our product candidates; • the achievement of milestones that trigger payments to us and the timing, receipt and amount of royalties and any collaboration and license agreement we may enter in the future; • the number and scope of clinical programs we decide to pursue; • the cost of acquiring, licensing, or investing in product candidates and technologies; • the costs associated with securing and establishing commercialization; • our ability to maintain, expand, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense, and enforcement of any patents or other intellectual property rights; • our need and ability to retain key management and hire scientific, technical, business, and medical personnel; • the effect of competing products and product candidates and other market developments; • the timing, receipt, and amount of sales from our lead product candidates, if approved; • our need to implement additional internal systems and infrastructure, including financial and reporting systems; • the economic and other terms, timing of, and success of any collaboration, licensing, or other arrangements which we may enter in the future; and • the effects of the disruptions to and volatility in the credit and financial markets in the U.S. and worldwide.
For five years after the effective date of the CLA, we are prohibited from preclinically and clinically developing or commercializing Fzd4 bi-specific antibodies that have certain properties for any diseases of the eye, and BI is prohibited from clinically developing or commercializing licensed products for any purpose other than diseases of the eye.
For five years after the effective date of the CLA, we are prohibited from preclinically and clinically developing or commercializing Fzd4 bi-specific antibodies that have certain properties for any diseases of the eye, and Boehringer Ingelheim is prohibited from clinically developing or commercializing licensed products for any purpose other than diseases of the eye.
Under the terms of the CLA, BI paid us a non-refundable upfront payment of $12.5 million less applicable withholding tax and agreed to pay success-based milestone payments up to $587.0 million and mid-single digit to low-double digit royalties on net sales of the licensed products should any reach commercialization.
Under the terms of the CLA, Boehringer Ingelheim paid us a non-refundable upfront payment of $12.5 million less applicable withholding tax and agreed to pay success-based milestone payments up to $587.0 million and mid-single digit to low-double digit royalties on net sales of the licensed products should any reach commercialization.
In September 2024, a milestone was achieved as BI decided to move forward with the development of SZN-413, and we received a $10.0 million non-refundable and non-creditable payment from BI pursuant to the terms of the CLA. The milestone payment of $10.0 million was recognized as collaboration and license revenue for the year ended December 31, 2024.
In September 2024, a milestone was achieved upon decision by Boehringer Ingelheim to move forward with the development of SZN-413, and we received a $10.0 million non-refundable and non-creditable payment from Boehringer Ingelheim pursuant to the terms of the CLA. The milestone payment of $10.0 million was recognized as collaboration and license revenue for the year ended December 31, 2024.
General and administrative expenses also include legal, audit, tax and other consulting fees, investor relations services, insurance costs, and facility costs not otherwise included in research and development expenses, and costs associated with compliance with the rules and regulations of the SEC and Nasdaq. Restructuring Expenses Restructuring expenses include costs in connection with the workforce reductions implemented in 2023.
General and administrative expenses also include legal, audit, tax and other consulting fees, investor relations services, insurance costs, and facility costs not otherwise included in research and development expenses, and costs associated with compliance with the rules and regulations of the SEC and Nasdaq.
We granted BI an exclusive, royalty-bearing, worldwide, sublicensable license, under our applicable patents and know-how, to develop, manufacture and commercialize, for all uses, one lead and two back-up Fzd4 bi-specific antibodies selected by BI.
Under the CLA, Boehringer Ingelheim has an exclusive, royalty-bearing, worldwide, sublicensable license, under our applicable patents and know-how, to develop, manufacture and commercialize, for all uses, one lead and two back-up Fzd4 bi-specific antibodies selected by Boehringer Ingelheim.
Warrant Liabilities We account for all outstanding warrants as liabilities and record at fair value. Transaction costs associated with the warrant liabilities are recognized as other expenses when incurred. At the end of each reporting period, changes in fair value during the period are recognized in other (expense) income, net within the consolidated statements of operations and comprehensive loss.
Transaction costs associated with the warrant liabilities are recognized as other expenses when incurred. At the end of each reporting period, changes in fair value during the period are recognized in other expense, net within the consolidated statements of operations and comprehensive loss.
We will continue to adjust the warrant liabilities for changes in the fair value until the earlier of (a) the exercise or expiration of the warrants or (b) the redemption of the warrants, at which time such warrants will be reclassified to additional paid-in capital.
We will continue to adjust the warrant liabilities for changes in the fair value until the earlier of (a) the exercise or expiration of the warrants or (b) the redemption of the warrants, at which time such warrants will be reclassified to additional paid-in capital. We issued and sold warrants to purchase common stock in private placements.
While we do not believe that inflation has had a material effect on our financial condition and results of operations during the periods presented, it may result in increased costs in the foreseeable future and adversely affect our business and financial condition.
Inflation generally affects us by increasing our labor costs, research and clinical trial costs. While we do not believe that inflation has had a material effect on our financial condition and results of operations during the periods presented, it may result in increased costs in the foreseeable future and adversely affect our business and financial condition.
We have incurred net losses since inception. For the years ended December 31, 2024 and 2023, we incurred net losses of $63.6 million and $43.0 million, respectively. As of December 31, 2024, we had an accumulated deficit of $285.3 million and cash and cash equivalents of $34.6 million.
We have incurred net losses since inception. For the years ended December 31, 2025 and 2024, we incurred net losses of $242.0 million and $63.6 million, respectively. As of December 31, 2025, we had an accumulated deficit of $527.3 million and cash and cash equivalents of $89.2 million.
At the closing of the first tranche of this private placement on March 26, 2025, (i) 5,213,415 shares of common stock, (ii) pre-funded warrants to purchase up to 1,373,000 shares of common stock, and (iii) Series E common stock warrants to purchase up to 3,293,207 shares of common stock were issued and sold for aggregate gross proceeds of approximately $76.4 million, before deducting placement agent fees and other expenses.
At the closing of the first tranche of the 2025 PIPE, (i) 5,213,415 shares of common stock, (ii) pre-funded warrants to purchase up to 1,373,000 shares of common stock, and (iii) Series E common stock warrants to purchase up to 3,293,207 shares of common stock were issued and sold for aggregate net proceeds of $71.2 million, after deducting placement agent fees and other expenses.
Cash used in operating activities of $40.4 million for 2023 was primarily due to the use of funds in our operations and the resulting net loss of $43.0 million and a net change of $3.9 million in our net operating assets and liabilities, partially offset by $6.6 million in non-cash charges.
Cash used in operating activities of $17.6 million for 2024 was primarily due to the use of funds in our operations, and the resulting net loss of $63.6 million and a net change of $0.8 million in our net operating assets and liabilities, partially offset by $46.8 million in non-cash charges.
After an initial period of joint research, BI shall be responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of licensed products at its expense.
After the initial period of joint research, Boehringer Ingelheim is responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of licensed products at its expense.
External expenses include: • costs incurred under agreements with third parties, including CROs and other third parties conducting research and development activities on our behalf; • costs of outside consultants, including their fees, stock-based compensation and related travel expenses; • costs of laboratory supplies and acquiring, developing and manufacturing drug candidate materials; and • license and sublicense costs under our license agreements made for intellectual property used in research and development activities.
External expenses include: • costs incurred under agreements with third parties, including CROs and other third parties conducting research and development activities on our behalf; • costs of outside consultants, including their fees, stock-based compensation and related travel expenses; • costs of laboratory supplies and acquiring, developing and manufacturing product candidate materials; and • license and sublicense costs under our license agreements made for intellectual property used in research and development activities. 78 Internal expenses include: • personnel-related costs, including salaries, bonuses, benefits and stock-based compensation for individuals involved in our research and product development activities; and • facilities, depreciation, and other allocated costs, which include rent and insurance.
In April 2024, we entered into a securities purchase agreement with certain institutional investors and management and issued and sold in a private placement: (i) 1,091,981 shares of common stock, (ii) pre-funded warrants to purchase up to 40,000 shares of common stock, and (iii) warrants to purchase up to 11,136,106 shares of common stock.
In February 2026, Series E common stock warrants were exercised for 34,000 shares of common stock, resulting in gross proceeds of $0.4 million. 2024 Private Placement In April 2024, we entered into a securities purchase agreement with certain institutional investors and management and issued and sold in a private placement: (i) 1,091,981 shares of common stock, (ii) pre-funded warrants to purchase up to 40,000 shares of common stock, and (iii) warrants to purchase up to 11,136,106 shares of common stock.
Private Placements In March 2025, we entered into a securities purchase agreement with certain institutional and accredited investors to issue and sell an aggregate of 15,086,236 units in a two-tranche private placement at a purchase price of $11.60 per share and $11.5999 per pre-funded warrant, for gross proceeds of approximately $175.0 million to fund multiple ophthalmology programs through initial Phase 1 safety, tolerability and efficacy studies.
The compensation payable to TD Cowen is up to 3.0% of the gross sales price of any shares sold pursuant to this new sales agreement. 82 2025 Private Placement In March 2025, we entered into a securities purchase agreement with certain investors to issue and sell an aggregate of 15,086,236 units in a two-tranche private placement (the 2025 PIPE) at a purchase price of $11.60 per share and $11.5999 per pre-funded warrant, for gross proceeds of $175.0 million to fund multiple ophthalmology programs through initial Phase 1 safety, tolerability and efficacy studies.
Liquidity and Capital Resources Since inception, we have only generated revenue and income under the CLA with BI and TCGFB Collaboration. We incurred significant net operating losses and negative cash flows from operations. Historically, we have financed our operations primarily through the sales of our equity securities and the payment received under our collaboration and license agreement.
Liquidity and Capital Resources Since inception, we have only generated revenue from licensing and research collaborations. We incurred significant operating losses and negative cash flows from operations. Historically, we have financed our operations primarily through the sales of our equity securities and the payments received under our collaboration and license agreements.
We allocate internal expenses to our clinical development candidates on a program-specific basis. The internal expenses for early-stage research and discovery programs are not allocated as our internal resources, employees and infrastructure are typically deployed across multiple programs. As such, we do not provide financial information regarding the costs incurred for early-stage research and discovery programs on a program-specific basis.
We track external expenses that are directly attributable to our clinical development candidates. We allocate internal expenses to our clinical development candidates on a program-specific basis. The internal expenses for early-stage research and discovery programs are not allocated as our internal resources, employees and infrastructure are typically deployed across multiple programs.
We anticipate that we will continue to incur net losses for the foreseeable future because of additional costs and expenses related to our research and development activities, including increased expenses from pipeline advancement and advancement of our product candidates into and through clinical developments and associated regulatory submissions, as well as increased general and administrative expenses as we scale our organization as a public company.
We anticipate that we will continue to incur net operating losses for the foreseeable future because of additional costs and expenses related to our research and development activities, including increased expenses from pipeline advancement and advancement of our product candidates into and through clinical developments and associated regulatory submissions, as well as increased general and administrative expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with the rules and regulations of the SEC and Nasdaq.
Unless otherwise indicated, the terms “Surrozen,” “we,” “us,” or “our” refer to Surrozen, Inc., a Delaware corporation. Overview We are discovering and developing biologic drug candidates to selectively modulate the Wnt pathway, a critical mediator of tissue repair, in a broad range of organs and tissues, for human diseases.
Unless otherwise indicated, the terms “Surrozen,” “we,” “us,” or “our” refer to Surrozen, Inc., a Delaware corporation. Overview We are a biotechnology company committed to discovering and developing product candidates to selectively modulate the Wnt pathway, a critical mediator of tissue repair.
Research and Development Expenses Since our inception, we have focused significant resources on our research and development activities. Our research and development expenses consist of external and internal expenses incurred in connection with our research activities and development programs.
Operating Expenses We classify operating expenses into two main categories: (i) research and development expenses and (ii) general and administrative expenses. Research and Development Expenses Since our inception, we have focused significant resources on our research and development activities. Our research and development expenses consist of external and internal expenses incurred in connection with our research activities and development programs.
Building upon the seminal work of our founders and scientific advisors who discovered the Wnt gene and key regulators of the Wnt pathway, we have made breakthrough discoveries that we believe will overcome previous limitations in harnessing the potential of Wnt biology. These breakthroughs enable us to rapidly and flexibly design tissue-targeted therapeutics that modulate Wnt signaling.
Building upon the seminal work of our founders and scientific advisors who discovered the Wnt gene and key regulators of the Wnt pathway, we have made breakthrough discoveries that we believe will overcome previous limitations in harnessing the potential of Wnt biology in a tissue-selective manner.
We also have entered into patent and research license arrangements with third-parties. The license agreements require milestone payments upon the achievement of certain regulatory and developmental stages. In addition, we will be required to pay royalties on sales of certain licensed products. As of December 31, 2024, we have incurred nominal fees and milestone payments under our license agreements.
The Research Collaboration Agreement was terminated effective November 13, 2025. We also have entered into patent and research license arrangements with third-parties. The license agreements require milestone payments upon the achievement of certain regulatory and developmental stages. In addition, we will be required to pay royalties on sales of certain licensed products.
Research Service Revenue – Related Party The increase of $0.7 million in research service revenue – related party for 2024, compared to 2023, is attributable to the research service performed in 2024 in accordance with TCGFB Collaboration.
Research Service Revenue – Related Party The increase of $2.8 million in research service revenue – related party for 2025, compared to 2024, is attributable to the research service performed in accordance with TCGFB Collaboration. The TCGFB Collaboration was terminated effective in November 2025.
Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact our results of operations in future periods. 83 Emerging Growth Company Status We are an emerging growth company, or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.
Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact our results of operations in future periods.
We believe, based on our current operating plan, that our existing cash, cash equivalents and the gross proceeds of approximately $76.4 million received from the private placement in March 2025 will be sufficient to fund our operations for at least the next 12 months from the date of this Annual Report.
We believe, based on our current operating plan, that our existing cash and cash equivalents, plus the net proceeds of $26.9 million received in January 2026 from the sale of common stock under the 2025 ATM and gross proceeds of $3.3 million from warrant exercises in February and March 2026, will be sufficient to fund our operations for at least the next 12 months from the date of the filing of this Annual Report.
General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and stock-based compensation expense for personnel in executive, finance, human resources, business and corporate development, legal, information technology and other administrative functions.
Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates. 79 General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and stock-based compensation expense for personnel in executive, finance, human resources, business and corporate development, legal, information technology and other administrative functions.
Please see Note 17 to the consolidated financial statements for further information regarding this private placement.
Please see Note 8 to the consolidated financial statements for further information regarding the 2025 PIPE.
Critical Accounting Policies, Significant Judgments and Use of Estimates Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or U.S. GAAP.
As of December 31, 2025, we had not accrued for any termination or cancellation charges as these were not considered probable. 85 Critical Accounting Policies, Significant Judgments and Use of Estimates Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or U.S. GAAP.
As a result of our discoveries, we are pioneering the selective activation of Wnt signaling, designing and engineering Wnt pathway mimetics, and advancing tissue-selective Wnt candidates. Our lead product candidates are multi-specific, antibody-based therapeutics that mimic the roles of naturally occurring Wnt proteins, which are involved in activation and enhancement of the Wnt pathway, respectively.
Our lead product candidates are multi-specific, antibody-based therapeutics that mimic the roles of naturally occurring Wnt proteins, which are involved in activation and enhancement of the Wnt pathway. Wnt signaling is essential in tissue maintenance and regeneration throughout the body.
Other (Expense) Income, Net The increase of $19.7 million, or 50%, in other expense, net, for 2024, compared to 2023, is primarily attributable to a $18.0 million increase in non-cash change in fair value of warrant liabilities, and $1.5 million related to the transaction costs allocated to the warrants issued in the April 2024 private placement.
Other Expense, Net The increase of $7.0 million, or 36%, in other expense, net, for 2025, compared to 2024, is primarily attributable to a $5.0 million increase in non-cash change in fair value of warrant liabilities, a $1.3 million increase in the financing transaction costs and a $0.9 million increase in non-cash impairment charge on warrant asset.
The net change in our operating assets and liabilities was primarily due to a net decrease in accounts payable and accrued and other liabilities.
The net change in our operating assets and liabilities was primarily due to a net decrease in accounts payable, accrued and other liabilities and operating lease liabilities. Cash Used In Investing Activities Cash used in investing activities for 2025 and 2024 consisted of the purchases of lab equipment.
As of December 31, 2024, we had cash and cash equivalents of $34.6 million and accumulated deficit of $285.3 million.
As of December 31, 2025, we had cash and cash equivalents of $89.2 million and an accumulated deficit of $527.3 million.
We are party to license or subscription agreements pursuant to which we have in-licensed various intellectual property rights. The license agreements obligate us to make certain milestone payments related to achievement of specified events, as well as royalties in the low single-digit percentages based on sales of licensed products.
The license agreements obligate us to make certain milestone payments related to achievement of specified events, as well as royalties in the low single-digit percentages based on sales of licensed products. The payment obligations under the license agreements are contingent upon future events, such as our achievement of specified milestones or generating product sales.
Components of Results of Operations Revenue Collaboration and License Revenue We had not generated any revenue prior to the execution of the CLA in October 2022.
Please see “ Part I, Item I – Business – Intellectual Property - Collaboration and License Arrangements ” for a further discussion of our collaboration and license arrangements. Components of Results of Operations Revenue Collaboration and License Revenue We had not generated any revenue prior to the execution of the CLA in October 2022.
Summary of Cash Flows The following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for the periods presented below (in thousands): Year Ended December 31, 2024 2023 Net cash used in operating activities $ (17,628 ) $ (40,363 ) Net cash (used in) provided by investing activities (26 ) 51,723 Net cash provided by financing activities 16,176 276 Net (decrease) increase in cash, cash equivalents and restricted cash $ (1,478 ) $ 11,636 Cash Used in Operating Activities Cash used in operating activities of $17.6 million for 2024 was primarily due to the use of funds in our operations and the resulting net loss of $63.6 million and a net change of $0.8 million in our net operating assets and liabilities, partially offset by $46.8 million in non-cash charges.
We may also be required to sell or license to others our rights to any of our current or future product candidates or discovery programs in certain territories or indications that we would prefer to develop and commercialize ourselves. 84 Summary of Cash Flows The following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for the periods presented below (in thousands): Year Ended December 31, 2025 2024 Net cash used in operating activities $ (30,244 ) $ (17,628 ) Net cash used in investing activities (128 ) (26 ) Net cash provided by financing activities 85,052 16,176 Net increase (decrease) in cash, cash equivalents and restricted cash $ 54,680 $ (1,478 ) Cash Used In Operating Activities Cash used in operating activities of $30.2 million for 2025 was primarily due to the use of funds in our operations, and the resulting net loss of $242.0 million, partially offset by a net change of $3.2 million in our net operating assets and liabilities, and $208.6 million in non-cash charges.
We expect that our research and development expenses will increase for the foreseeable future as we identify and develop product candidates. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the development of our lead product candidates.
At this time, we cannot reasonably estimate the nature, timing or costs required to complete the development of our lead product candidates.
Significant unobservable inputs used in the fair value measurement of such warrants include the timing and probability of achieving the milestones and the expected volatility. The fair value of the 2024 PIPE Warrants may change significantly as additional data is obtained, impacting our assumptions to estimate the fair value of the liabilities.
Significant unobservable inputs include the probability of achieving the funding milestone. The fair value of the tranche liability may change significantly as additional data is obtained, impacting our assumptions to estimate the fair value of the liabilities. In evaluating this information, considerable judgment is required to interpret the data used to develop the assumptions and estimates.
In evaluating this information, considerable judgment is required to interpret the data used to develop the assumptions and estimates.
The fair value of the warrants may change significantly as additional data is obtained, impacting our assumptions to estimate the fair value of the liabilities. In evaluating this information, considerable judgment is required to interpret the data used to develop the assumptions and estimates.
We enter into contracts in the normal course of business with third-party vendors for preclinical research studies, clinical trials, research supplies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination on notice, and may or may not include cancellation fees.
As of December 31, 2025, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. We enter into contracts in the normal course of business with third-party vendors for preclinical research studies, clinical trials, research supplies, manufacturing and other services and products for operating purposes.
Given that the amount and timing related to such payments are uncertain, they are not considered to be contractual obligations. As of December 31, 2024, we had not accrued for any termination or cancellation charges as these were not considered probable.
These contracts generally provide for termination on notice, and may or may not include cancellation fees. Given that the amount and timing related to such payments are uncertain, they are not considered to be contractual obligations.
Cash Provided by Financing Activities Cash provided by financing activities of $16.2 million for 2024 consisted primarily of net proceeds from the issuance and sale of common stock, pre-funded warrants and warrants to investors and certain members of management in a private placement. 81 Cash provided by financing activities of $0.3 million for 2023 consisted primarily of proceeds from the issuance of common stock under the employee stock purchase plan.
Cash provided by financing activities of $16.2 million for 2024 consisted primarily of net proceeds from the issuance and sale of common stock, pre-funded warrants and warrants to investors and certain members of management in the 2024 PIPE. Contractual Obligations and Commitments As of December 31, 2025, we have lease obligations primarily consisting of one operating lease for our facility.
In each of these areas, we believe our approach has the potential to change the treatment paradigm for the disease and substantially impact patient outcomes. Our strategy is to exploit the full potential of Wnt signaling by identifying disease states responsive to Wnt modulation, design tissue-selective therapeutics, and advance candidates into clinical development in targeted indications with high unmet need.
Our strategy is to exploit the full potential of Wnt signaling by identifying disease states responsive to Wnt modulation, designing tissue-selective therapeutics, evaluating mechanisms complementary to Wnt signaling, and advancing candidates into clinical development in targeted ophthalmic indications with high unmet need. Our unique approach and platform technologies have led to the discovery and advancement of multiple product candidates.
Loss on Issuance of Common Stock, Pre-Funded Warrants and Warrants The increase of $20.4 million in loss on issuance of common stock, pre-funded warrants and warrants for 2024, compared to 2023, as the fair value of warrants issued was greater than the proceeds received in a private placement closed in April 2024.
Interest Income The increase of $1.3 million, or 78%, in interest income for 2025, compared to 2024, is due to an increase in cash and cash equivalents. 81 Loss on Issuance of Common Stock, Pre-Funded Warrants and Warrants in the 2024 PIPE Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE for 2024 is a result of the fair value of warrants issued being greater than the proceeds received in the 2024 PIPE.
Upon the achievement of further regulatory and developmental milestones and the sale of licensed products, we may incur significant fees and royalties under these licenses. Please see “ Part I, Item I – Business – Intellectual Property - Collaboration and Licensing Arrangements ” for a further discussion of our collaboration and licensing arrangements.
As of December 31, 2025, we have incurred nominal fees and milestone payments under our license agreements. Upon the achievement of further regulatory and developmental milestones and the sale of licensed products, we may incur significant fees and royalties under these licenses.
Contractual Obligations and Commitments As of December 31, 2024, we have lease obligations primarily consisting of one operating lease for our facility. The lease expires in April 2029. Under the terms of our operating leases, we had lease obligations of $10.1 million in payments through 2029 as of December 31, 2024.
The lease expires in April 2029. Under the terms of our operating leases, we had lease obligations of $7.7 million in payments through 2029 as of December 31, 2025. We are party to license or subscription agreements pursuant to which we have in-licensed various intellectual property rights.
At the closing of the private placement, we received aggregate net proceeds of approximately $16.0 million, after deducting placement agent fees and other expenses. If the warrants are exercised in 79 full we will receive additional gross proceeds of approximately $175.5 million.
At the closing of the private placement, we received aggregate net proceeds of approximately $16.0 million, after deducting placement agent fees and other expenses. In March 2025, warrants to purchase up to 8,772,848 shares of common stock were cancelled. As of December 31, 2025, pre-funded warrants for 40,000 shares of common stock had been exercised.
We do not expect to generate any revenue from the sale of our products unless and until we obtain regulatory clearance or approval. 75 Operating Expenses We classify operating expenses into three main categories: (i) research and development expenses, (ii) general and administrative expenses and (iii) restructuring expenses.
Research Service Revenue – Related Party Research service revenue – related party relates to the amounts recognized for the research service performed in connection with TCGFB Collaboration. The research collaboration was terminated in November 2025. We do not expect to generate any revenue from the sale of our products unless and until we obtain regulatory clearance or approval.
General and Administrative Expenses The decrease of $0.7 million, or 5%, in general and administrative expenses for 2024, compared to 2023, is primarily attributable to reductions in employee-related expenses as a result of the workforce reductions in 2023, as well as lower consulting and professional fees as a result of the restructuring plans we implemented in 2023. 78 Restructuring The decrease of $2.8 million, or 100%, in restructuring charges for 2024, compared to 2023, is attributable to workforce reductions implemented in 2023.
General and Administrative Expenses The increase of $1.1 million, or 8%, in general and administrative expenses for 2025, compared to 2024, is primarily attributable to an increase in professional service fees.
In April 2024, we issued and sold warrants to purchase common stock in a private placement, or the 2024 PIPE Warrants. The 2024 PIPE Warrants are classified as liabilities, and the fair value is measured using the Black-Scholes option-pricing model.
The warrants are classified as liabilities, and the fair value is measured using the Black-Scholes option-pricing model. Significant unobservable inputs used in the fair value measurement of such warrants include the probability of achieving the milestones and the expected volatility.
Food and Drug Administration on or prior to October 31, 2026 of our Investigation New Drug Application for SZN-8141, or the second closing milestone, we expect to issue a (i) 6,043,321 shares of common stock, (ii) pre-funded warrants to purchase up to 2,456,500 shares of common stock, and (iii) Series E common stock warrants to purchase up to 4,249,910 shares of common stock; provided that the second tranche may not occur prior to September 27, 2026.
Assuming achievement of the Second Closing Milestone, we will issue (i) 5,741,605 shares of common stock, (ii) pre-funded warrants to purchase up to 2,456,500 shares of common stock, and (iii) Series E common stock warrants to purchase up to 4,099,052 shares of common stock for aggregate gross proceeds of approximately $95.1 million in the second tranche.
These costs consist of employee severance and other termination benefits. Interest Income Interest income consists of interest earned on our cash and cash equivalents. Other (Expense) Income, Net Other (expense) income, net primarily consists of the gain on the change in fair value of warrant liabilities.
Other Income and Expenses Interest Income Interest income consists of interest earned on our cash and cash equivalents.
The decrease of $1.2 million, or 12%, in discovery and preclinical stage program expenses for 2024, compared to 2023, is primarily due to the workforce reductions implemented in 2023 to focus our resources on our clinical stage programs.
Research and Development Expenses The increase of $8.2 million, or 39%, in research and development expenses for 2025, compared to 2024, is primarily due to a $10.2 million increase in manufacturing costs, lab expenses and consulting fees for our ophthalmology programs and a $1.2 million increase in employee-related expenses, offset by a $2.8 million decrease in clinical expenses as a result of the discontinuation of clinical development of SZN-043.
Our unique approach and platform technologies have led to the discovery and advancement of two lead product candidates. The chart below represents a summary of our product candidates: Please see “ Part I, Item I – Business ” for a further discussion of our product candidates and clinical development programs.
We believe that ophthalmology indications are particularly well-suited for Wnt modulating therapeutics due to the combination of strong genetic and biologic validation and the need for approaches to restore tissue structure and function. 76 The chart below represents a summary of our pipeline: Please see “ Part I, Item I – Business ” for a further discussion of our product candidates.
Removed
Given Wnt signaling is essential in tissue maintenance and regeneration throughout the body, we have the potential to target a wide variety of severe diseases, including certain diseases that afflict the intestine, liver, retina, cornea, lung, kidney, cochlea, skin, pancreas and central nervous system.
Added
Our current strategic focus is ophthalmology, where Wnt signaling plays a central role in retinal vascular integrity, barrier function, and tissue maintenance. We are located in South San Francisco, California. Our mission is to transform the treatment of serious ophthalmic disease by fully exploiting the Wnt pathway.
Removed
Research Service Revenue – Related Party Research service revenue – related party relates to the amounts recognized for the research service performed in 2024 in connection with TCGFB Collaboration.
Added
These breakthroughs enable us to rapidly and flexibly design tissue-targeted therapeutics that modulate Wnt signaling and form the foundation of our ophthalmology portfolio and research programs, which are designed to restore tissue structure and function in serious eye diseases with high unmet medical need.
Removed
Internal expenses include: • personnel-related costs, including salaries, bonuses, benefits and stock-based compensation for individuals involved in our research and product development activities; and • facilities, depreciation, and other allocated costs, which include rent and insurance. We track external expenses that are directly attributable to our clinical development candidates.
Added
Our current development efforts are focused on ophthalmology, where the biology of the Wnt pathway is clinically validated and localized delivery enables controlled therapeutic modulation. We believe our approach has the potential to change the treatment paradigm for ophthalmic disease and substantially impact patient outcomes.
Removed
Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our drug candidates.
Added
In March 2026, Boehringer Ingelheim achieved a research milestone, reflecting a positive outcome of the IND-enabling GLP toxicology study. The achievement of the research milestone entitles us to receive a $5.0 million non-refundable and non-creditable payment from Boehringer Ingelheim.
Removed
Research and Development Expenses The following table summarizes research and development expenses for the periods presented (dollars in thousands): Year Ended December 31, $ % 2024 2023 Change Change SZN-043 $ 10,784 $ 11,240 $ (456 ) -4 % SZN-1326 1,462 5,913 (4,451 ) -75 % Discovery and preclinical stage programs 8,886 10,077 (1,191 ) -12 % Total research and development expenses $ 21,132 $ 27,230 $ (6,098 ) -22 % The decrease of $0.4 million, or 4%, in SZN-043 program expenses for 2024, compared to 2023, is primarily due to the workforce reductions effective in 2023.
Added
As such, we do not provide financial information regarding the costs incurred for early-stage research and discovery programs on a program-specific basis. We expect that our research and development expenses will increase for the foreseeable future as we identify and develop product candidates. The successful development of our product candidates is highly uncertain.
Removed
The decrease of $4.5 million, or 75%, in SZN-1326 program expenses for 2024, compared to 2023, is primarily due to the workforce reductions we implemented in 2023, as well as the discontinuation of the clinical development of SZN-1326 in January 2024.
Added
Loss on Issuance of Common Stock, Pre-Funded Warrants and Warrants in the 2024 PIPE Loss on issuance of common stock, pre-funded warrants and warrants represents the excess of the initial fair value of common stock, pre-funded warrants and warrants over the aggregate gross proceeds in the private placement consummated in April 2024, or the 2024 PIPE.
Removed
Interest Income The decrease of $0.6 million, or 28%, in interest income for 2024, compared to 2023, is due to a decrease in cash and cash equivalents.
Added
Loss on Amendment and Cancellation of Warrants Loss on amendment and cancellation of warrants represents the non-cash change in fair value of warrant liabilities as a result of the amendment and cancellation of warrants in March 2025.
Removed
None of the warrants issued in the private placement have been exercised as of the filing of this Annual Report. In the second tranche of the private placement, which is contingent upon the public announcement of the receipt of clearance from the U.S.
Added
Loss on Execution of the 2025 PIPE Loss on execution of the 2025 PIPE represents the non-cash loss recognized upon the initial execution of the private placement consummated in March 2025, or the 2025 PIPE, as the committed proceeds from the 2025 PIPE were less than the fair value of the tranche liability recognized at contract execution date.
Removed
None of the warrants issued in the private placement have been exercised as of the filing of this Annual Report. Please see Notes 9, 10 and 11 to the consolidated financial statements for further information regarding this private placement.
Added
The 2025 PIPE contains a right provided to the investors to purchase securities in two tranches. Each tranche was accounted for as tranche liability at contract execution date. See Note 8 to the consolidated financial statements for further information regarding the 2025 PIPE.
Removed
Sublease In April 2024, we entered into a related party transaction with Nura Bio, Inc., or Nura Bio, to sublease approximately 6,102 square feet of our office and laboratory space in South San Francisco, California. The sublease term is on a month-to-month basis and the monthly base rent is approximately $35,000, escalating at 3% per annum.
Added
Loss on Change in Fair Value of Tranche Liability The tranche liability was initially recognized at fair value and subsequently remeasured at each reporting date until settlement.
Removed
Nura Bio is also responsible for its share of real estate taxes, utilities and other operating expenses applicable to the subleased space. Please see Note 10 to the consolidated financial statements for further information regarding the sublease. Lease Extension In October 2024, we amended our existing lease agreement to extend the lease term from April 2025 to April 2029.

… 55 more changes not shown on this page.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+0 added−0 removed0 unchanged
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information otherwise required under this item. 84
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information otherwise required under this item. 87

Other SRZNW 10-K year-over-year comparisons