Surrozen Announces FDA Clearance of IND Application for SZN-8141 for the Treatment of Diabetic Macular Edema

Expected proceeds would support development of SZN-8141 and SZN-8143, alongside broader operating activities.

Rhea-AI Summary

Surrozen (SRZN) received FDA clearance of its investigational new drug application for SZN-8141, enabling clinical development for diabetic macular edema.

The company expects to dose the first patient in DUET, a Phase 1b/2a study in patients with diabetic macular edema, in the fourth quarter of 2026. The clearance also satisfies the milestone for the second closing of its March 2025 two-tranche private placement.

Surrozen expects that closing on or about October 20, 2026, subject to applicable closing conditions, to provide approximately $95.1 million in gross proceeds before placement agent fees and other expenses. The securities include common shares, pre-funded warrants and Series E common stock warrants.

4 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointFDA clearance of the SZN-8141 application enables clinical development for diabetic macular edema.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Approximately $95.1 million in gross proceeds expected from the private placement’s second closing. 27% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.DUET first-patient dosing expected in the fourth quarter of 2026 for the Phase 1b/2a study.
• Minor point. Forward-looking: it has not happened yet and may not happen.Expected proceeds would support SZN-8141 and SZN-8143 development and broader operating activities.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.Common shares, pre-funded warrants and Series E common stock warrants in the second closing create dilution.
• Minor pointSecond closing expected on or about October 20, 2026 remains subject to applicable closing conditions.
• Minor point. Forward-looking: it has not happened yet and may not happen.Placement agent fees and other expenses will be deducted from the expected gross proceeds.

News Explained

If the second closing occurs, Surrozen is required under its registration-rights agreement to file a Form S-3 within 30 calendar days afterward, registering resale of the common shares and shares issuable upon exercise of the pre-funded and Series E warrants.

Key Figures

Gross proceeds: Approximately $95.1 million Study phase: Phase 1b/2a First-patient dosing: Fourth quarter of 2026 +2 more

Gross proceeds

Approximately $95.1 million

Expected from the second closing of the March 2025 private placement, before fees and expenses

Study phase

Phase 1b/2a

DUET study of SZN-8141 in patients with diabetic macular edema

First-patient dosing

Fourth quarter of 2026

Expected timing for the DUET study

Expected second closing

On or about October 20, 2026

Subject to applicable closing conditions

Registration statement filing deadline

No later than 30 calendar days following the second closing date

Required under the registration rights agreement

Historical Context

1 past event · Latest: Sep 08

1 event

1. Sep 08

   IND submission

   24h Move

   -9.2%

   Surrozen submitted the IND for the same SZN-8141 DME program, preceding FDA effectiveness.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug (ind), vascular endothelial growth factor (vegf), intravitreal injection, pre-funded warrants, +1 more

5 terms

investigational new drug (ind) regulatory

"its Investigational New Drug (IND) application for SZN-8141 has become effective"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

vascular endothelial growth factor (vegf) medical

"vascular endothelial growth factor (VEGF) antagonist antibody"

Vascular endothelial growth factor (VEGF) is a naturally occurring protein that tells the body to grow new blood vessels and can make them more leaky, like a construction foreman directing where new roads and drains should be built. It matters to investors because drugs that block or mimic VEGF are key treatments for certain cancers and eye diseases, so clinical trial results, safety concerns or approvals involving VEGF-targeting therapies can quickly affect a company’s prospects and revenue forecasts.

intravitreal injection medical

"being developed as an intravitreal injection"

An intravitreal injection is a medical procedure that delivers medicine directly into the gel-like center of the eye to reach the retina at the back of the eye, much like putting a targeted dose into a small reservoir. It matters to investors because this delivery method affects how often patients need treatment, the complexity and cost of care, reimbursement decisions, and the commercial prospects and safety profile of eye drugs being developed or sold.

pre-funded warrants financial

"shares issuable upon exercise of the pre-funded warrants"

Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

form s-3 regulatory

"file a new registration statement on Form S-3"

Form S-3 is a legal document companies use to register their stock sales with the government, making it easier and faster for them to raise money by selling shares to investors. It’s like having a pre-approved shopping list that lets a company quickly sell new shares when they need funds, without going through a lengthy approval process each time.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

First patient expected to be dosed in the DUET study in the fourth quarter of 2026

Milestone triggers second closing of March 2025 private placement expected to provide approximately $95.1M in gross proceeds

SOUTH SAN FRANCISCO, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Surrozen or the Company) (Nasdaq: SRZN), a biotechnology company pioneering targeted therapeutics to harness the power of Wnt signaling to address the underlying drivers of disease in sight-threatening ophthalmic conditions, today announced its Investigational New Drug (IND) application for SZN-8141 has become effective, enabling the Company to advance the program into clinical development. SZN-8141 is a bifunctional Wnt agonist and vascular endothelial growth factor (VEGF) antagonist antibody being developed as an intravitreal injection for the treatment of diabetic macular edema (DME).

The Company expects to dose the first patient in DUET, a Phase 1b/2a clinical study evaluating SZN-8141 in patients with DME, in the fourth quarter of 2026.

“FDA clearance of the SZN-8141 IND marks an important milestone for Surrozen as we advance our Wnt-based ophthalmology pipeline into clinical development," said Craig Parker, Chief Executive Officer of Surrozen. "We look forward to initiating the DUET study and evaluating SZN-8141 in patients with diabetic macular edema. Importantly, this milestone also satisfies the condition for the second closing of our March 2025 private placement, which is expected to provide approximately $95.1 million in gross proceeds to support the advancement of SZN-8141 and SZN-8143."

Second Closing of March 2025 Private Placement

The FDA clearance of the SZN-8141 IND satisfies the second closing milestone under Surrozen's March 2025 two-tranche private placement.

Subject to the terms and conditions of the securities purchase agreement, the second closing is expected to provide approximately $95.1 million in gross proceeds to Surrozen, before deducting placement agent fees and other expenses. The second closing is expected to occur on or about October 20, 2026, subject to satisfaction of the applicable closing conditions.

Following the second closing, Surrozen expects to file a new registration statement on Form S-3 with the U.S. Securities and Exchange Commission to register the resale of the shares of common stock and shares issuable upon exercise of the pre-funded warrants and Series E common stock warrants issued in the second closing. Pursuant to a registration rights agreement with the investors, Surrozen is required to file the registration statement no later than 30 calendar days following the second closing date.

The proceeds from the second closing are expected to support the development of SZN-8141 and SZN-8143 and the Company's broader operating activities.

About SZN-8141 for Retinal Diseases 
Surrozen is developing SZN-8141 as an intravitreal injection for the treatment of DME and neovascular age-related macular degeneration (wet AMD). SZN-8141 combines Frizzled 4 (FZD4)-mediated Wnt agonism and VEGF antagonism and has the potential to provide benefits over treatment with single mechanism agents against these targets. 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. In addition, Merck’s MK-3000, a FZD4-mediated Wnt agonist monotherapy, achieved its primary endpoint in a Phase 2b/3 clinical trial in DME, supporting the therapeutic potential of Wnt pathway activation in retinal vascular disease. 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.

About DUET
The Phase 1b/2a DUET study is designed to assess the safety, tolerability, and early signs of biological and clinical activity of SZN-8141. The trial consists of an open-label Phase 1b single-ascending-dose portion enrolling both treatment-naïve and previously treated patients with DME (Part 1), followed by a randomized, double-masked Phase 2a dose-expansion portion in treatment-naïve patients with DME (Part 2). In Part 1, patients will receive a single intravitreal injection of SZN-8141 and be followed for approximately three months to evaluate safety and tolerability, as well as pharmacokinetics, immunogenicity, and exploratory measures of retinal function and anatomy including best-corrected visual acuity (BCVA), optical coherence tomography (OCT), OCT angiography (OCT-A), and ultra-widefield fluorescein angiography. Part 2 is expected to evaluate two dose levels of SZN-8141 compared with Vabysmo^® (faricimab-svoa) in approximately 60 treatment-naïve patients with DME. Patients are planned to receive three monthly doses followed by an additional four-month follow-up period to assess durability of effect. Key outcome measures include the same functional and anatomic measurements as in Part 1. First patient dosing is expected in the fourth quarter of 2026, with initial data expected in the second half of 2027. The Company is also planning to develop SZN-8141 in neovascular age-related macular degeneration and is evaluating development in other retinal vascular diseases.

About SZN-8143 for Retinal Diseases 
Surrozen is developing SZN-8143 for the treatment of DME, wet AMD, and uveitic macular edema (UME). SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism and may have benefits over single mechanism agents against these targets. 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. In addition, Merck’s MK-3000, a Fzd4 monotherapy, achieved its primary endpoint in a Phase 2b/3 clinical trial in DME, supporting the therapeutic potential of Wnt pathway activation in retinal vascular disease. The Company believes 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.

About Surrozen
Surrozen is a biotechnology company, pioneering a new class of Wnt-based therapeutics designed to harness the power of Wnt signaling to treat sight-threatening ophthalmic conditions. Built on deep scientific expertise and a proprietary antibody-engineering platform, Surrozen develops multifunctional biologics that selectively activate Wnt signaling in combination with other key disease pathways. Our approach aims to deliver best-in-class, durable therapies that have the potential to transform patient outcomes in some of the most pressing unmet medical needs in ocular diseases.  For more information, visit www.surrozen.com. 

Forward-Looking Statements 
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates (including anticipated clinical development plans and timelines, such as the Company’s plan to dose the first patient in the DUET Phase 1b/2a study in DME patients in the fourth quarter of 2026, the availability of data, such as initial data from the DUET study being anticipated in the second half of 2027, Surrozen’s plan to develop SZN-8141 in neovascular age-related macular degeneration, the potential for such product candidates to be used to treat human disease or address unmet needs in serious eye diseases, as well as the potential benefits and potential differentiation from existing therapies of such product candidates, and the anticipated use of proceeds from the second closing of the private placement). These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to its product candidates and potential future drug candidates; the Company’s ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for its product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen’s Annual Report on Form 10-K for the year ended December 31, 2025, and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Investor/Media Contact:
Email: Investorinfo@surrozen.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Surrozen expect to start dosing patients in the SZN-8141 DUET study?

Surrozen expects to dose the first patient in the fourth quarter of 2026. DUET is a Phase 1b/2a clinical study evaluating SZN-8141 in patients with diabetic macular edema, enabled by FDA clearance of the investigational new drug application.

How much funding does Surrozen expect from the private placement’s second closing?

Surrozen expects approximately $95.1 million in gross proceeds, before placement agent fees and other expenses. The second closing is expected on or about October 20, 2026, subject to applicable closing conditions; FDA clearance of the SZN-8141 application satisfies its milestone requirement.