Surrozen, Inc./DE Annual Report: How They Did This Year

Thinking about Surrozen, Inc./DE, or just curious how they're doing? You're in the right place. This helps you understand the company, its performance in fiscal year 2025 (ending December 31st, 2025), and what it means for investors.

This summary will cover what they do, their financial performance, key wins or challenges, and their future outlook. Let's dive in!

What Surrozen Does (and How They Fund It)

Surrozen is a biotechnology company in South San Francisco, California. Their mission is exciting: they discover and develop new treatments. They work with the Wnt pathway. Think of this pathway as a crucial communication system in our bodies. It helps with tissue repair and regeneration, essentially how our bodies heal.

Their main focus is ophthalmology. They use Wnt pathway science to treat serious eye diseases. Specifically, they target diabetic macular edema (DME), neovascular age-related macular degeneration (wet AMD), and uveitic macular edema (UME). Their founders and scientific advisors discovered the Wnt gene. This gives them a strong scientific background. They develop special antibody treatments. These mimic natural Wnt proteins. They aim to restore tissue structure and function in the eye.

Why These Eye Diseases Matter (and Offer a Big Market):

• Diabetic Macular Edema (DME): This diabetes complication causes fluid buildup in the macula. The macula is the central part of your vision. It affects about 1.4 million people in the U.S. Untreated, it can cause significant vision loss.
• Wet Age-Related Macular Degeneration (Wet AMD): This is a top cause of blindness for people over 65. Abnormal blood vessels grow and leak in the eye. This causes blurred or distorted vision. It affects an estimated 1.3 million people in the U.S. This number should grow as the population ages.
• Uveitic Macular Edema (UME): This is fluid buildup in the macula. It results from inflammation (uveitis). Uveitis affects 80,000 to 168,000 people in the U.S. yearly. Up to 30% of these patients may develop UME.

Challenges with Current Treatments: Standard treatments for Wet AMD and DME use "anti-VEGF" drug injections. Vabysmo alone made over $5 billion globally in 2025. Other anti-VEGF therapies brought in over $13 billion globally in 2025. These drugs are effective but often need frequent injections. They also don't fully treat all disease aspects. For UME, steroids are used, but they have serious side effects. Anti-VEGFs offer only modest help. This shows a huge unmet need for better, longer-lasting, and safer treatments. Surrozen aims to fill this gap.

Their Key Drug Candidates:

• SZN-8141: This drug treats diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD). These serious eye conditions can cause vision loss. SZN-8141 does two things at once. It activates the Wnt pathway (via Frizzled 4, or Fzd4). This helps regrow healthy blood vessels. It also blocks the VEGF pathway. VEGF causes abnormal, leaky blood vessels. Surrozen hopes to submit an IND (Investigational New Drug application) for SZN-8141. This application, for human trials, is planned for the second half of 2026. Surrozen wholly owns this candidate.
  • What makes it special: Lab and animal tests (preclinical studies) showed SZN-8141 did more than just activate Wnt or block VEGF. It had a synergistic effect. This means it worked better than combining the two approaches separately. It greatly reduced damaged, vessel-free areas and abnormal vessel growth.
• SZN-8143: This candidate is like SZN-8141. It also targets DME and wet AMD. But it adds a third action: blocking interleukin-6 (IL-6). IL-6 is involved in inflammation. This triple approach may offer more benefits for DME, wet AMD, and UME. IL-6 levels are often high in these inflammatory eye diseases. Both SZN-8141 and SZN-8143 show promise in preclinical models (lab and animal tests). They stimulate healthy vessel regrowth and suppress harmful vessel growth. Surrozen also wholly owns this candidate.
  • Why these are different: Current standard treatments for these eye conditions often only block VEGF. Surrozen believes their multi-pronged approach is better. SZN-8141 and SZN-8143 activate the Wnt pathway for healing. SZN-8143 also tackles inflammation. This could offer better results than existing therapies.
• SZN-413 (with Boehringer Ingelheim): This Fzd4-targeted antibody treats retinal diseases. It uses Surrozen's proprietary SWAP technology. This is important because Surrozen has a "Collaboration and License Agreement" with Boehringer Ingelheim (BI). BI is a major pharmaceutical company.
  • Big Win! In September 2024, BI decided to develop SZN-413. This triggered a $10.0 million milestone payment to Surrozen.
  • Another Win! In March 2026, BI reached another research milestone. A key toxicology study (safety testing before human trials) had a positive outcome. This earned Surrozen an additional $5.0 million payment from BI. These payments are direct cash for Surrozen!
• Other Eye Research Programs: Surrozen explores other Wnt-targeting treatments. These target various retinal and corneal diseases. Early lab and animal tests show exciting potential. They help corneal cells grow and heal eye wounds. They also improve eye clarity and protect retinal cells from damage. Specifically, they saw more human corneal cell growth. They observed wound healing in corneal injury models and better corneal clarity. In retinal models, they saw stimulated RPE cell growth. They also noted protection of photoreceptor cells from damage.
• SZN-043 (Discontinued):): Not all research succeeds. Surrozen made a tough decision. In the first quarter of 2025, they stopped developing SZN-043. This drug targeted severe alcohol-associated hepatitis (a liver disease). It was safe in early human trials. It showed some positive liver test changes. But it lacked enough clear benefit to justify continued huge investment. This was especially true given patient sickness and the long development path. This shows they cut losses when a drug doesn't meet expectations.

The Long Road to a New Drug: Understanding Clinical Trials

Developing a new drug is a marathon, not a sprint. Investors must understand this process, especially for early-stage biotechs like Surrozen. Here's a simplified look:

1. Preclinical Studies (Lab & Animal Tests):

   • Drugs undergo extensive lab and animal studies. This happens before human testing. These tests check if the drug works. Crucially, they check if it's safe for people. These studies follow strict rules, like "Good Laboratory Practices" (GLP). This is especially true for safety tests.
   • Surrozen's SZN-8141 and SZN-8143 are in this stage. SZN-8141 aims for the next step in late 2026.

2. IND Application (Permission to Test in Humans):

   • If preclinical studies are good, the company submits an IND (Investigational New Drug) application. This goes to the FDA (U.S. Food and Drug Administration). This asks for permission to start human trials.
   • The FDA reviews this application for 30 days. Concerns can lead to a "clinical hold." This stops the trial until issues are fixed.
   • Surrozen plans to submit an IND for SZN-8141 in the second half of 2026. This is a big milestone. It means they hope to move from animal to human testing.

3. Clinical Trials (Human Testing - Three Phases):

   • After IND approval, the drug enters human clinical trials. These usually have three phases:
     • Phase 1: This is the drug's first human use. It involves a small number of healthy volunteers or patients. The main goal is safety. Researchers check for serious side effects. They see how the body handles the drug and find a safe dosage.
     • Phase 2: If Phase 1 succeeds, the drug moves to Phase 2. This involves more patients with the target disease. The focus is on preliminary effectiveness (does it seem to work?). Researchers also monitor safety and find the best dose. Many drugs fail here if they lack enough benefit.
     • Phase 3: This is the largest and most expensive phase. It involves hundreds or thousands of patients across many locations. The goal is to prove the drug is effective and safe for its intended use. This often means comparing it to existing treatments or a placebo. The FDA usually needs two successful Phase 3 trials for approval.
   • Independent expert groups oversee these trials. They protect patients and ensure ethical conduct. Examples include an "Institutional Review Board" or "Data Safety Monitoring Board."
   • Important for Investors: Clinical trials are very expensive. They can take many years and have a high failure rate. A drug can stop at any phase if it's unsafe, ineffective, or not worth continued investment. Surrozen did this with SZN-043.

4. BLA Submission (Asking for Approval):

   • If all three clinical trial phases succeed, the company gathers all data. This includes good, bad, and everything in between. They compile it into a "Biologics License Application" (BLA) and submit it to the FDA. This massive application covers everything. It details how the drug is made and all trial results.
   • Submitting a BLA costs a substantial fee. The FDA adjusts this fee annually.
   • The FDA then reviews the BLA. They decide whether to approve the drug for sale. This review process can take a long time.

   Speeding Up Approval: Accelerated Programs Sometimes, the FDA can speed up approval. This happens for drugs treating serious conditions with unmet medical needs. This is called accelerated approval.

   • How it works: The FDA might approve a drug based on a "surrogate endpoint." This is an early sign or measurement. It must very likely predict a real clinical benefit. This avoids waiting for direct, long-term benefits like longer life. For example, if a drug significantly lowers a disease-causing biomarker, that might be enough.
   • The Catch: The company must still conduct more studies after approval. These confirm the drug provides the expected clinical benefit. If these follow-up studies fail, or the company doesn't complete them diligently, the FDA can quickly withdraw the drug.
   • Important to remember: Even with accelerated approval or other fast-track programs, FDA standards for safety and effectiveness remain high. These programs only aim to speed up development or review.

   Extra Rules for Biologics (Like Surrozen's Antibody Drugs): Surrozen develops "biologics." These are drugs made from living organisms, like their special antibodies. This means even stricter rules apply.

   • The FDA heavily emphasizes manufacturing controls. This ensures complex drugs are consistent and safe.
   • They may even require Surrozen to submit samples of each batch. These need official testing and release before distribution.
   • In a public health danger, the FDA can immediately suspend a product's license. These extra controls ensure the highest safety for advanced medicines.

   Staying Out of Trouble: Legal Aspects of Selling Drugs Even after approval, biotech companies like Surrozen face ongoing legal and regulatory challenges. This is especially true with government healthcare programs like Medicare or Medicaid. A major risk is the False Claims Act.

   • What it is: This law prohibits false or fraudulent claims to the U.S. government for money or property. Drug companies cannot mislead the government about their products.
   • How it applies to drug companies: Surrozen could be held responsible even if they don't directly bill the government. This happens if their actions cause false claims. For example:
     • "Off-label" promotion: Promoting a drug for uses not officially approved by the FDA.
     • Hiding price concessions: Not accurately reporting pricing to the government. This could affect government program payments.
     • Giving away free products: Providing free drugs. The expectation is customers will then bill federal healthcare programs.
   • Why it matters: Violating the False Claims Act can bring severe penalties. These include huge fines and other legal consequences. This is a significant risk for any pharmaceutical company. Surrozen would need strong compliance programs once their drugs are on the market.

What This Means for Surrozen: Surrozen's wholly-owned candidates (SZN-8141, SZN-8143) are early stage. They are in preclinical stages or preparing for IND submission. This means they are at the very start of a long, risky, and expensive journey. Their partnership with Boehringer Ingelheim for SZN-413 is important. BI takes on much of the cost and risk for that drug. This is a big advantage for Surrozen.

Key Partnerships and Licenses:

• Boehringer Ingelheim (BI) Partnership: This is a major partnership! BI holds an exclusive, worldwide license for SZN-413. They will develop, manufacture, and sell this drug. After initial joint research, BI handles all further development, trials, and commercialization costs. In return, Surrozen could get up to $587.0 million in milestone payments. These payments occur as the drug hits development goals. Surrozen will also receive mid-single digit to low-double digit royalties on net sales if the drug reaches the market. This is a significant potential revenue stream for Surrozen. They avoid bearing all development costs themselves. There are also restrictions: Surrozen cannot develop similar Fzd4 eye disease drugs for 5 years. BI can only use the licensed products for eye diseases.
• Stanford License Agreements: Surrozen holds a foundational license agreement with Stanford University. This agreement, from 2016 and amended several times, grants them exclusive, worldwide rights. They can use certain patents and technology related to their engineered Wnt molecules. These patents should expire in 2035 and 2037. Under this agreement, Surrozen committed to "commercially reasonable efforts." This means developing and selling products using the licensed technology. Initial payments to Stanford were small. However, Surrozen agreed to pay up to $0.9 million for development and regulatory milestones. They also agreed to up to $5.0 million for sales milestones. Plus, a very low single-digit percentage of net sales goes to royalties. These royalties continue in each country until the last relevant patent expires. If Surrozen grants sublicenses (lets another company use the tech), they owe Stanford a small percentage of that income. If Surrozen is acquired, a one-time fee in the low six figures goes to Stanford. This agreement is crucial; it supports their core technology. Stanford and the Howard Hughes Medical Institute keep rights to use this technology for non-profit research.

A Brief Partnership: TCGFB, Inc. In October 2024, Surrozen briefly partnered with TCGFB, Inc. This private company engaged in a research collaboration. Their goal was to find antibody treatments for idiopathic pulmonary fibrosis, a serious lung disease. Surrozen provided antibody discovery services for up to two years. In return, TCGFB was to pay Surrozen up to $6.0 million (plus other costs). TCGFB also gave Surrozen a warrant to buy up to 3.4 million shares of its stock. This was a 'related party' deal. Some investors with a large stake in Surrozen also control TCGFB. However, this partnership ended quickly, effective November 13, 2025. It aimed to generate revenue and future value, but it did not last long.

Their Unique Technology: SWAP

Surrozen's secret is their SWAP (Surrozen Wnt signal Activating Protein) technology. This technology creates their Wnt-mimicking antibodies.

Here's how it works:

• The Wnt Pathway: The Wnt pathway is vital for our bodies to heal and regenerate tissues. But natural Wnt proteins are hard to use as drugs. They don't dissolve well (not very soluble). They are also hard to deliver to specific body parts.
• How Wnt Works: The Wnt pathway "turns on" in a cell. For this, natural Wnt proteins must bind to two specific cell surface receptors at once. These are Frizzled (Fzd) and Lrp 5/6. If only one receptor binds, nothing happens. It's like needing two keys to open a lock.
• Surrozen's Innovation: Their founders found a way to activate this pathway. They used non-Wnt proteins that bind to both Fzd and Lrp. This was a huge breakthrough. These non-Wnt proteins were soluble and easier to use.
• SWAP Technology: Surrozen developed special multivalent bispecific antibodies. They use their SWAP technology for this. These are not simple antibodies. They have multiple "arms" designed to bind both Fzd and Lrp receptors at once. This mimics natural Wnt proteins.
  • Why "Multivalent" Matters: Surrozen found one Fzd-binding arm and one Lrp-binding arm (a "bivalent" antibody) was not enough. It couldn't significantly activate the Wnt pathway. It's like having two keys but no leverage to turn the lock. However, they designed antibodies with multiple binding domains. For example, two Fzd-binding arms and at least one Lrp-binding arm, or two of each. This achieved much more potent Wnt activation. It was sometimes 100 times stronger than natural Wnt proteins. This happened at much lower concentrations. This shows their technology is truly advanced and effective.
  • They also learned to make these antibodies target specific Fzd receptor types. This means they can activate the Wnt pathway in very specific tissues or cells. This potentially reduces unwanted side effects.
• The Benefits: This technology aims for:
  • Potency: Strong Wnt pathway activation.
  • Selectivity: Targeting specific tissues or cells. This helps avoid unwanted side effects.
  • Manufacturability: Producing these complex drugs on a larger scale. This overcomes natural Wnt protein issues.

Protecting Their Innovations (Patents & IP): As of December 31, 2025, Surrozen holds a strong patent portfolio. It includes over 25 pending patent application families. These cover their core SWAP platform, their partnered drug SZN-413, and treatment methods. These methods target disorders in the liver, intestine, retina, cornea, and lung. For their SWAP platform, they either solely own or exclusively license 21 patent families. Patents from these should protect their technology between 2035 and 2046. The two key Stanford-licensed patent families should expire in 2035 and 2037. Patents are crucial, but Surrozen also uses trade secrets and confidentiality agreements. These protect their know-how. Remember, the pharmaceutical world has many patents. There is always a risk of disputes or needing to license technology from others.

Surrozen's Game Plan (Their Strategy)

Surrozen has a clear strategy:

1. Keep Innovating: They will continue building on their groundbreaking research and intellectual property. This includes their patents and discoveries in Wnt pathway modulation. They see themselves as pioneers in this field.
2. Focus and Expand in Ophthalmology: They commit to developing new drug candidates. They also expand their technology platform specifically for eye diseases. This focus helps them lead in using Wnt signaling for eye health.
3. Seek Strong Partnerships: They know the Wnt pathway has vast potential. So, they aim to form strategic alliances. The Boehringer Ingelheim partnership is an example. This speeds up drug development and maximizes treatment success.

Surrozen funds this cutting-edge research and development as a publicly traded company. Their Common Stock (SRZN) and Redeemable Warrants (SRZNW) trade on The Nasdaq Capital Market. As of June 30, 2025, their voting stock held by regular investors (non-affiliates) was worth about $59.7 million. Roughly 11.5 million shares were outstanding as of March 2026. This shows their size. They are a "Smaller reporting company." This means they are smaller and have different reporting rules than giant corporations.

They also raise money by issuing various warrants. Warrants are like options. They give investors the right to buy shares later at a set price. They issued "Public Warrants," "PIPE Warrants" (from private investments), and "Pre-Funded Warrants." They also use an "At-the-Market (ATM) Program." This lets them sell shares directly into the stock market over time to raise cash.

Who Are They Up Against? (Competition)

Biotechnology and pharmaceuticals are highly competitive. New technologies emerge constantly. Surrozen faces tough rivals. These include huge multinational pharmaceutical companies, established biotech firms, and academic institutions. All vie to develop similar disease treatments.

Current Standard Treatments: Surrozen targets eye diseases like wet AMD and DME. Well-established treatments already exist. These are mainly "anti-VEGF" drugs from giants like Roche, Regeneron, and Novartis. Doctors and patients widely use and accept these drugs. Surrozen must convince people their new treatments are significantly better to encourage a switch.

Big Players with Deep Pockets: Many large companies develop or sell retinal disease treatments. These include:

• Roche
• Novartis
• Bayer
• Regeneron
• AbbVie
• Boehringer Ingelheim (their partner, but also a competitor)
• Amgen
• Merck
• Sanofi
• Eli Lilly
• Samsung Bioepis

These companies have massive financial resources. They have extensive research and development capabilities. They also have established sales and marketing teams. This makes them formidable competitors.

Direct Wnt-Targeting Competitors: Surrozen is not alone in exploring the Wnt pathway for eye diseases:

• Merck's MK-3000: This is a tri-specific Wnt agonist antibody. It activates the Wnt pathway in three ways. Merck acquired it through EyeBio. It is already in Phase 2/3 clinical trials. It targets treatment-naïve DME and wet AMD. This is a significant direct competitor, further along in development.
• Roche's AntlerA Therapeutics Acquisition: In 2024, Roche bought AntlerA Therapeutics. AntlerA developed Wnt antibody-like molecules (ANTs) for tissue repair. AntlerA was preclinical. Roche's acquisition shows big pharma's interest in the Wnt space.

This information offers a great look into Surrozen's core business. It covers funding strategies, key partnerships, and competition. As a clinical-stage biotech, Surrozen's revenue mainly comes from collaboration payments. The $10.0 million milestone from Boehringer Ingelheim for SZN-413 was in September 2024 (FY2024). The $5.0 million milestone came in March 2026 (FY2026). This means no specific BI partnership milestone revenue is attributed to fiscal year 2025. The brief TCGFB, Inc. research collaboration, expected to generate up to $6.0 million, ended in November 2025. So, any recognized revenue from it for FY2025 would be minimal. Like most early-stage biotechs without product sales, Surrozen likely had substantial research and development (R&D) and general and administrative (G&A) expenses. This led to a significant net loss (meaning they spent more than they earned) for fiscal year 2025. Keeping a strong cash position is vital. Investors closely watch the company's cash and cash equivalents. They also monitor its "cash burn rate" (how fast it uses cash). This helps assess how long current funds will last (its "cash runway"). The company actively manages its capital. It uses various financing methods. These include issuing warrants and its "At-the-Market (ATM) Program." This program lets them sell shares directly into the stock market to fund operations. The BI partnership provides crucial non-dilutive capital (money that doesn't reduce your ownership percentage). This comes through milestone payments and potential future royalties. It also shifts much of the development cost and risk for SZN-413 to BI. However, Surrozen bears full development costs for its wholly-owned programs like SZN-8141 and SZN-8143. This requires ongoing capital raises. This financial picture is typical for a company focused on long-term drug development, not immediate profit.