NovaBridge (Nasdaq: NBP) unveils strong VIS-101 Phase 2a wet AMD results
Rhea-AI Filing Summary
NovaBridge Biosciences reported positive Phase 2a results for VIS-101, a dual VEGF-A and ANG-2 inhibitor being developed for wet age-related macular degeneration and other retinal vascular diseases. In 38 patients treated with 3 mg or 6 mg doses, VIS-101 delivered rapid, robust and durable responses.
Patients showed mean best corrected visual acuity gains of more than 10 ETDRS letters and median central subfield thickness reductions of 100–150 µm after three loading injections. Around two thirds of patients were retreatment-free at four months and about half remained retreatment-free at six months, with a favorable safety profile and no dose-limiting toxicity.
The company plans to start a dose-determining Phase 2b study in the second half of 2026 and a global Phase 3 program in 2027. NovaBridge also highlighted a cash balance of $228 million, which it expects will fund operations through 2028 to reach key clinical milestones for VIS-101 and other pipeline assets.
Positive
- VIS-101 delivers strong Phase 2a wet AMD signal: Mean BCVA gains of >10 ETDRS letters, median CST reductions of 100–150 µm, and roughly half of patients retreatment-free at six months after three loading doses support a potentially best-in-class durability profile.
- Solid balance sheet supports late-stage development: NovaBridge reports $228 million in cash, which it expects will provide operational runway through 2028 and fund key milestones, including a Phase 2b VIS-101 study in H2 2026 and a planned global Phase 3 program in 2027.
Negative
- None.
Insights
Positive Phase 2a VIS-101 data strengthen NovaBridge’s retinal franchise and pipeline visibility.
NovaBridge and subsidiary Visara reported that VIS-101 produced mean BCVA improvements of more than 10 ETDRS letters and median CST reductions of 100–150 µm after three loading doses in 38 wet AMD patients. Approximately two thirds were retreatment-free at four months and about half at six months, suggesting notable durability.
Safety appears supportive, with treatment-related treatment-emergent adverse events reported in 0% of patients in the 3 mg arm and 8% (two patients, four events) in the 6 mg arm, and no dose-limiting toxicity. Management and key opinion leaders describe the profile as potentially best-in-class among dual VEGF-A/ANG-2 agents, framed by cross-trial comparisons to faricimab.
The company plans a Phase 2b dose-determining study in
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2026
Commission File Number: 001-39173
NovaBridge Biosciences
2440 Research Boulevard, Suite 400
Rockville, MD 20850
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
On March 9, 2026, NovaBridge Biosciences issued a press release, and a VIS-101 presentation, copies of which are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively.
EXHIBIT INDEX
Exhibit No. |
Description |
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99.1 |
Press Release - NovaBridge and Visara Announce Positive Results from VIS-101 Phase 2a Wet AMD Study |
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99.2 |
VIS-101 Phase 2 Update Presentation - March 9, 2026 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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NovaBridge Biosciences |
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By |
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/s/ Xi-Yong Fu |
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Name |
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Xi-Yong (Sean) Fu |
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Title |
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Chief Executive Officer |
Date: March 9, 2026
Exhibit 99.1
NovaBridge and Visara Announce Positive Results from VIS-101 Phase 2a Wet AMD Study
ROCKVILLE, MD, March 9, 2026 – NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, and its subsidiary, Visara, Inc. (Visara), today announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Topline results show that VIS-101 produced rapid, robust and durable treatment responses in wet AMD, with potential best-in-class durability and a favorable safety profile. Wet AMD affects more than 20 million people globally1.
Topline Data:
VIS-101 produced rapid and robust efficacy, and durable treatment responses with both 3 mg and 6 mg dose cohorts:
“I am encouraged by the positive Phase 2a safety and efficacy data as it provides important proof-of-concept for VIS-101 as a potential treatment for wet AMD. The data validates VIS-101’s purpose-engineered design and gives us added confidence in its potential to deliver best-in-class durability while maximizing visual gains in the treatment of wet AMD,” said Emmett T. Cunningham, Jr., MD, PhD, MPH, Founder and Executive Chairman of Visara and Vice-Chairman of the NovaBridge Board of Directors. “The data clearly show that VIS-101 produced rapid, robust and durable treatment responses, with favorable tolerability, after three loading doses. Importantly, VIS-101 also demonstrated potential best-in-class durability, with nearly half of treatment naïve patients remaining retreatment free for more than six months following induction. Such strong clinical results provide a meaningful foundation to advance our development program, including plans to initiate a dose-determining Phase 2b study in the second half of this year, followed by a global Phase 3 program in 2027.”
“This study is an important milestone for VIS-101. As a retina specialist and drug developer, I am truly encouraged by VIS-101’s emerging product profile. The combination of robust visual and anatomic improvements, with potentially best-in-class durability and a favorable safety profile shown to date by VIS-101, has the potential to offer tangible benefits to people living with wet AMD and other retinal vascular diseases where the high treatment burden required by current
therapies impacts their visual outcomes. I am energized to continue to partner with the Visara team and the retina and patient community worldwide as we work to bring this innovative potential therapy to patients in need,” said Carlos Quezada-Ruiz, MD, FASRS, Chairman of the Scientific Advisory Board of Visara.
Nikolas JS London, MD, FACS, Managing Partner and President, Retina Consultants San Diego added, “It’s an exciting time in our field. The widespread adoption of faricimab has firmly established dual VEGF-A/ANG-2 inhibition as the pathway forward for retinal vascular disease. Durability remains the greatest unmet need, and the Phase 2a data for VIS-101 — with nearly half of treatment-naïve patients retreatment-free at six months after just three loading doses — is among the most encouraging I’ve seen at this stage. If Phase 3 data bear out, I would expect widespread adoption and meaningful benefit for the millions of patients living with these conditions.”
“The positive data reported today for VIS-101 is an important inflection point for Visara, NovaBridge, and our investors. It further de-risks the development of VIS-101 and provides greater visibility to the value-creation potential of NovaBridge’s global biotech platform and our unique “hub-and-spoke” business strategy of partnering with world-class industry leaders to identify and accelerate the development of highly differentiated innovative programs,” said Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge. “These results provide a helpful blueprint and offer an encouraging sign that we are well placed for success as we continue to build our portfolio.”
About the Randomized Phase 2a Study of VIS-101 in Wet AMD
Patient Characteristics:
The study enrolled 38 patients in China, aged 50-80 years of age with wet AMD (both treatment naïve and pre-treated). Patients were randomized 2:1 between 6mg dose (n=25) and 3 mg (n=13). Baseline characteristics were similar between both dose groups (noting a slightly higher proportion of pre-treated patients in the 6 mg dosing group).
Baseline Patient Demographics: Similar between dosing groups
Topline Phase 2a Data Based on patients in the 6mg and 3mg dosing groups |
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Dose level |
6 mg (n=25) |
3 mg (n=13) |
Total (n=38) |
Patients |
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Age (years of age) |
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• Average |
69.5 |
71.5 |
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Gender (%) |
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• Male/Female |
68%/32% |
61.5%/38.5% |
65.8%/34.2% |
Mean Baseline BCVA (Letters) |
54.7 |
52.3 |
53.9 |
Median Baseline CST (mm) |
417.2 |
407.6 |
413.9 |
Prior Anti-VEGF Therapy (%) |
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• Yes/No |
52%/48% |
30.8%/69.2% |
44.7%/55.3% |
Safety: VIS-101 Demonstrated a Favorable Safety Profile With No Dose-Limiting Toxicity
Conference Call and Webcast
NovaBridge will host an Investor Update call today, March 09, 2026, at 9:00 AM ET
A replay of the webcast will be available on the News & Events page of the Investors section of the NovaBridge website for 90 days at: https://www.novabridge.com/investors/news-events/event-calendar.
About the Randomized Phase 2a Study of VIS-101 in Wet AMD
The Phase 2a randomized study (NCT05456828) evaluated the safety and efficacy of VIS-101 (aka AM712 or ASKG712) in patients with wet AMD, including patients who were naïve to treatment or VEGF-experienced. The study enrolled a total of 38 wet AMD patients in China.
Patients were randomized 2:1 to 6mg VIS-101 (n=25) or 3 mg VIS-101 (n=13). The primary endpoint was safety and pharmacokinetics and the secondary endpoint was efficacy, measured by best corrected visual acuity (BCVA) change from baseline (assessed by early treatment diabetic retinopathy scale (ETDRS Letters), change in central subfield thickness (CST, measured in mm), and retreatment rate. Subjects were given three loading doses at weeks 0, 4 and 8, with monthly follow-up to week 36 or retreatment (based on protocol-defined Disease Activity Criteria based on BCVA, CST and wet AMD activity). Safety and efficacy endpoints were assessed at each visit including 24 weeks (6 months) after the last loading dose.
About VIS-101
VIS-101 (also known as ASKG712 or AM712), purpose-designed to be best-in-class, is a dual VEGF-A X ANG-2 inhibitor in development for the treatment of retinal vascular diseases, such as wet AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO), which affect more than 57 million people globally1. VIS-101’s bispecific, tetravalent design format provides more binding sites and increased VEGF-A and ANG-2 affinity, for rapid, robust and class-leading durable responses. VIS-101 has completed initial safety and dose-escalation studies in both the US and China and a randomized, dose-ranging 2a study in China (NCT05456828). VIS-101 is expected to advance to a dose-determining Phase 2b study in 2026, with initiation of the global Phase 3 program in 2027.
Source information:
About Visara, Inc.
Visara is a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics. The Company is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH, a physician, innovator, entrepreneur, and investor and internationally recognized specialist in infectious and inflammatory eye disease, and Chief Medical Officer Cadmus Rich, MD, MBA, a serial entrepreneur and seasoned ophthalmic drug developer. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.
About NovaBridge
NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need.
The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, Claudin 18.2 X 4-1BB bispecific antibody, and VIS-101, purpose-designed to be a best-in-class dual VEGF-A X ANG-2 inhibitor.
Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The product candidate is being evaluated in a global, randomized Phase 2 study, following the recent announcement of positive topline results from a Phase 1b, multi-center, open label study in first line gastric cancer. The
Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer.
VIS-101 targets VEGF-A and ANG-2 to provide more rapid, robust and durable treatment responses for patients with retinal vascular diseases including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. VIS-101 has completed a randomized, dose-ranging Phase 2a study for wet AMD and expects to initiate a Phase 2b study in H2 2026. NovaBridge is the majority shareholder of Visara, Inc., and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.
For more information, please visit www.novabridge.com and follow us on LinkedIn.
Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the strategy, clinical development, plans, results, safety and efficacy givastomig, VIS-101 and its other drug candidates; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, ragistomig, uliledlimab, and VIS-101; the impact of independent evaluations of our clinical trial results; anticipated clinical milestones and results, and related timing. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.
NovaBridge Investor & Media Contacts
PJ Kelleher
LifeSci Advisors
+1-617-430-7579
pkelleher@lifesciadvisors.com
NovaBridge Biosciences
+1-240-745-6330
IR@novabridge.com
VIS-101 Phase 2a Update Clinical Results and Next Steps March 9, 2026
Disclaimer This presentation has been prepared by NovaBridge Biosciences (the “Company”) solely for informational purposes. Certain of the information included herein was obtained from various sources, including certain third parties, and has not been independently verified by the Company. 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Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee, and the accuracy or completeness of such information has not been independently verified. Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions. We own or have rights to trademarks or trade names that we use in conjunction with the operation of our business and that appear in this presentation. This presentation also contains references to trademarks and trade names belonging to other entities. All rights to the trademarks, copyrights, logos and other intellectual property listed herein belong to their respective owners and our use or display thereof does not imply an affiliation with, or endorsement by, any other entities. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. This presentation contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “future”, “promising”, “may”, “plans”, “potential”, “will”, “could position”, “promise”, “advance”, “target”, “design”, “strategy”, “pipeline”, and “project”, and similar terms or the negative thereof. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. The forward-looking statements in this presentation include, without limitation, statements regarding the following: the Company’s pipeline and capital strategy; the design and potential benefits, advantages, promise, attributes, and target usage of givastomig, ragistomig, uliledlimab and VIS-101; the impact of independent evaluations of our clinical trials results; the reliability and reproducibility of comparative clinical data; the projected development and advancement of the Company’s portfolio and anticipated clinical milestones, results and related timing; the Company’s expectation regarding the potential market opportunity of gastric cancer, pancreatic ductal adenocarcinoma, cholangiocarcinoma, neovascular age-related macular degeneration and diabetic macular edema; the market opportunity and the Company’s potential next steps (including the potential expansion, differentiation, or commercialization) for givastomig, ragistomig, uliledlimab and VIS-101; the Company’s expectations regarding the impact of data from past, ongoing and future studies and trials; the benefits of the Company’s collaboration with development partners; the timing and progress of studies (including with respect to patient enrollment and dosing); the availability of data and information from ongoing studies; and the Company’s expectations regarding its anticipated cash runway and future use of its cash position. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or new drug application/biologics license application approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and discussions of potential risks, uncertainties, and other important factors in the Company’s most recent annual report on Form 20-F and the Company’s subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”). The Company may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.
NovaBridge Biosciences and Visara, the 1st Spoke VIS-101 Phase 2a Update VIS-101 KOL Perspective VIS-101 Next Steps Q&A Today’s Agenda 2
Today’s Speakers Emmett T. Cunningham, Jr., MD, PhD, MPH Executive Chairman, Co-Founder, Visara Vice Chairman of the Board, NovaBridge Carlos Quezada-Ruiz, MD, FASRS Chairman, Scientific Advisory Board, Visara Cadmus Rich, MD, MBA Chief Medical Officer, Visara Nikolas JS London, MD, FACS Managing Partner, President, Retina Consultants San Diego Sean Fu, PhD, MBA Chief Executive Officer, NovaBridge
NovaBridge Biosciences Accelerating Access to Innovation 4
NovaBridge: Accelerating Access to Innovation Global biotech platform with a portfolio of first- and best-in-class programs Two lead assets with compelling clinical proof-of-concept supporting differentiated positioning VIS-101: Differentiated VEGF-A/ANG-2 bispecific with favorable safety profile and rapid, durable responses supporting potential best-in-class durability Givastomig: CLDN18.2 × 4-1BB bispecific demonstrating robust and durable responses with broad activity across expression levels and best-in-class potential in 1L gastric cancer $228M in cash providing operational runway through 2028 to support key clinical milestones Multiple near-term catalysts across oncology and ophthalmology programs
Well-positioned to Deliver Innovation from Emerging Biopharma Ecosystems to Patients Globally We are a Hub-and-Spoke Gateway Connecting Global Markets Discovery Pre-clinical development Clinical PoC Late phase development Registration Commerciali- zation 5-10X value creation Acquire early-stage assets with well-defined PoC pathway Leverage deep translation expertise to unleash asset competitiveness Drive assets efficiently to clinical POC 2-3X value creation Selectively engage in late-stage development, leveraging NovaBridge’s world-class clinical execution capabilities and scale / efficiency of China’s clinical infrastructure Maintain flexibility for strategic collaborations Asset value Therapeutic area-agnostic 4 clinical-stage assets Global business development strategy Fast-to-PoC (Proof of Concept) strategy Global Biotechnology Platform Our Business Model Our Positioning Our Competitive Edge BD-in Executive leadership capability with deep expertise across deal sourcing, BD and capital formation Unparalleled healthcare ecosystem access and resources enhanced by CBC Group Clinical Development Unique strategies for accelerated asset development Cross-functional drug development expertise and experience Highly efficient operational execution BD-out Long standing presence in US with strong capability to provide bespoke solutions for biotech/MNCs Local innovation access in Asia backed by CBC Group Healthy cash runway with strong fund-raising capabilities Abundant know-how of platform Co targeting different TA Distinctive PoC approach with deep expertise Strong exit track record Our extended value creation step Our core value creation step We are the FIRST and ONLY listed hub-and-spoke platform specializing in bridging Asian innovations to the global markets
Transaction Structure Visara, Inc. NovaBridge AffaMed ESOP 65% 30% 5% NovaBridge invested cash for 65% equity interest in Visara AffaMed contributed its rights and interests in VIS-101 for 30% of the equity interest in Visara The remaining 5% equity interest in Visara reserved for an ESOP VIS-101-related ownership interests shown schematically Emmett T. Cunningham, Jr., MD, PhD, MPH Co-Founder and Executive Chairman, Visara; Vice-Chairman, NovaBridge World-renowned ophthalmologist; Former Senior Managing Director, Blackstone Group 25+ years of experience as an entrepreneur and investor Co-founder of 5+ companies, with a track record of serial entrepreneurial successes (IPO or acquired by MNCs) Internationally recognized specialist in infectious and inflammatory eye disease with over 450 publications Led the development of Macugen®: a first-in-class VEGF-A inhibitor for AMD and DME Cadmus Rich, MD, MBA Chief Medical Officer (CMO) Carlos Quezada-Ruiz MD, FASRS Chairman, Scientific Advisory Board, Visara 18+ years experience as an Executive level R&D professional with deep ophthalmology experience at multiple pharmaceutical and biotechnology companies including Lassen Therapeutics, Aura Biosciences and Alcon Strong experience working with FDA, EMA and MHRA on multiple, varied research and development projects NewCo Leadership Visara is Led by an Exceptional and Experienced Leadership Team 15+ years experience in ophthalmology holding various roles as a vitreoretinal surgeon, translational science & drug development executive, clinical R&D & TA head CMO, Alkeus Pharmaceuticals. Most recently the medical lead for VABYSMO® at Roche, and played a pivotal role in the global development and approvals of VABYSMO® and SUSVIMO ®, leading design, execution, readouts, fillings and launch
Visara, Inc. NovaBridge’s 1st Spoke 8
VIS-101 – Purpose-Designed to be Best-in-Class for Retinal Vascular Diseases Anti-Ang-2 Anti-VEGF-A Modified Fc Phase 2a wet AMD Update Safe and well-tolerated Rapid, robust, and durable treatment responses Mean BCVA >10 ETDRS letters Median CST 100-150 µm Potentially best in class durability: ~Two-thirds retreatment free at 4 months, ~Half retreatment free at 6 months 9
A leading vitreoretinal surgeon and clinical scientist who directs a prominent, nationally recognized retinal practice and has served as the Principal Investigator for dozens of clinical trials evaluating the next generation of surgical and medical therapies An internationally recognized retina specialist and clinical scientist who has played a pivotal role in the development of novel therapies for retinal disease including the global regulatory filings and approvals of VABYSMO for wet AMD Carlos Quezada-Ruiz, MD, FASRS Chairman, Scientific Advisory Board, Visara Nikolas JS London, MD, FACS Managing Partner, President, Retina Consultants San Diego Today’s Speakers 10
VIS-101 Overview 11
$15B Total Branded Anti-VEGF-A Market1 DME Wet AMD RVO 20M+ 21M+ 16M+ More than 57M people affected globally2 Data source: 1. Ophthalmic Anti-VEGF Therapeutics Market Size & Share 2025 – 2034, published December 2025, 2. Invest Ophthalmol Vis Sci. 2021 Nov 24; 62 (14): 26. doi: 10.1167/iovs.62.14.26, wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) 12
Global revenue projected to grow to >$20B by 2030 Increased revenue correlates with improved durability Lucentis® Q4W Eylea® Q8W Revenue 2y from Launch $1.8B $2.8B Vabysmo® Q8-16W Eylea HD® Q8-16W $4.4B $1.5B VIS-101 $1B+* Early Data Support VIS-101’s Potential for Best-in-Class Durability Q8-24W+ Anti-VEGF Ophthalmology Market Growth Driven by Efficacy and Durability Improvements Data source: Global data & Evaluate Pharma; sales revenue forecasts for Lucentis, Eylea, Vabysmo and Eylea HD, *Estimated VIS-101 revenue, Visara estimate 13
Bispecific, Tetravalent design: increased binding sites and increased VEGF-A and ANG-2 affinity Optimized Fc region for shortened plasma half-life Humanized anti-VEGF-A mAb ~2X inhibitory activity Anti-Ang-2 inhibitory peptides (18mers) ~17X inhibitory activity, for class leading durability ~Half of VIS-101 Patients in Phase 1 and Phase 2a Remain Retreatment-Free at 6 months* ~ 154 kDa biologic VIS-101: Purpose-Designed to be Best-in-Class Dual VEGF-A X ANG-2 Inhibitor *Based on treatment naïve groups from evaluated patients in two clinical studies; The Phase 1 study was conducted in the U.S, the Phase 2a study was conducted in China 14
Anti-VEGF-A Anti-Ang-2 Modified Fc 4 doses Up to 16 weeks Purpose-Bioengineered for Rapid, Robust, Durable Response Name/Company: Status Vabysmo®/Faricimab Roche: Approved VIS-101 Visara: Phase 2 Structure Antibody format Molecular Weight Dose (mg/nM) IC50: VEGF/ANG-21 Bispecific ~150 kDa 6 mg 292 pM/3181 pM Tetravalent Bispecific ~154 kDa 6 mg* 125 pM/191 pM Loading Dose 4 doses 3 doses Durability of Response (post loading) 16 weeks 24 weeks + VIS-101: Best-in-Class Intravitreal Half-Life and Dual Target Inhibition Note: 1. Visara in vitro report *Dose of 6mg based on clinical trial results, picomolar = pM 15
Predicted dynamics of intraocular VEGF-A and ANG-2 suppression through week 32 post dose1,2 Longer VEGF-A and ANG-2 inhibition may predict increased VIS-101 durability Predictive Modeling Suggests Best-in-Class Potential for VIS-101 1. Diack et al,2024, TVST: https://doi.org/10.1167/tvst.13.11.14, https://doi.org/10.1167/tvst.13.11.13, 2. VIS-101 data are estimated using the model 16
VIS-101 Phase 2a Update Dr. Carlos Quezada-Ruiz 17
4 doses Up to 16 weeks Study Assessed Safety and Tolerability of VIS-101, Time to Retreatment After Loading Doses 6 mg (n=25) 3 mg (n=13) Monthly follow-up to Week 36 or retreatment Patient criteria: Aged 50-80 years with wet AMD (both treatment naïve and pre-treated) BCVA ETDRS letter score 78-19 CST ≥250 µm on OCT Endpoints: BCVA (ETDRS letters) CST Safety VIS-101: Phase 2a Study Overview *Specific Disease Activity Criteria defined in the clinical protocol N=38, randomized 2:1 Retreatment rate Study designed to evaluate time to retreatment after 3 loading doses Retreatment based on defined Disease Activity Criteria based on BCVA or CST and wet AMD disease activity Loading Doses 18
Baseline characteristics were similar between the 6mg and 3mg cohorts Patient Characteristics 6mg (N=25) 3mg (N=13) Total (N=38) Age (average), years 69.5 71.5 Sex, (n, %) Male 17 (68.0) 8 (61.5) 25 (65.8) Female 8 (32.0) 5 (38.5) 13 (34.2) Baseline BCVA (Letters) 54.7 52.3 53.9 Baseline CST (μm) 417.2 407.6 413.9 Previously received anti-VEGF therapy, n (%) Yes 13 (52.0) 4 (30.8) 15 (44.7) No 12 (48.0) 9 (69.2) 21 (55.3) Phase 2a Study Demographics Represent Wet AMD Patients Source: ASKG712-CT-I-1_Phase 1/2a Top Line Table 14.1.3 19
VIS-101 (3 loading doses) Source: nAMD China Phase 2a final raw dataset (tab BCVA001_1) – not final analysis Notes: *One patient in the 6mg naïve patient cohort dropped out after week 8 follow-up. **One patient in the 6mg pre-treated cohort dropped out after week 4 visit for reasons unrelated to study drug. #One patient did not have reading on W32. 3mg – Retreatment free Patients 6mg – Retreatment free Patients VIS-101 (3 loading doses) * ** # Treatment Naïve Pre-Treated A high-proportion of 6mg participants (nearly half) are re-treatment free at 36 weeks Rapid, Robust and Sustained Vision Improvement After Three Loading Doses (4 mos) (6 mos) (4 mos) (6 mos) 20
Q12W VIS-101 (3 intravitreal injections) Treatment Interval: 12-16 weeks Treatment Free: up to 28 weeks VIS-101 6mg – Retreatment free Patients Faricimab 6mg (All Treatment Naïve) Treatment free Less loading doses Faricimab (4 intravitreal injections) Faricimab, Q16W (n=31) Ranibizumab, 0.5mg, Q4W (n=16) Faricimab, Q12W (n=24) Q16W * Cross trial comparison, Faricimab data source: Khanani et al., The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. Treatment Naïve (n=12* randomized) Pre-Treated (n=13* randomized) Treatment Naïve and Pre-Treated VIS-101 patients compare favorably to faricimab Phase 2 STAIRWAY trial Fixed Treatment Regimen of 12 and 16 weeks VIS-101 – Robust Efficacy, Best-in-Class Potential 21
% Participants Remaining Treatment Free (16 vs. 24 weeks post loading doses) VIS-101 (3 loading doses) Treatment-Naïve - Retreatment free Patients (7/9) (7/11) (3/9) (5/11) * # * 3mg (n=9 randomized) 6mg (n=12* randomized) Source: nAMD China Phase 2a final raw dataset (tab BCVA001_1) – not final analysis Notes: *One patient in the 6mg naïve patient cohort dropped out after week 8 follow-up. #One patient did not have reading on W32. VIS-101 – Robust Durability, Best-in-Class Potential (4 mos) (6 mos) Mean BCVA >10 ETDRS letters ~Two-thirds retreatment free at 4 months ~Half retreatment free at 6 months 22
3mg – Retreatment free Patients 6mg – Retreatment free Patients * ** VIS-101 (3 loading doses) VIS-101 (3 loading doses) Treatment Naïve Pre-Treated Source: nAMD China Phase 2a final raw dataset (tab BCVA001_1) – not final analysis Notes: *One patient in the 6mg naïve patient cohort dropped out after week 8 follow-up. **One patient in the 6mg pre-treated cohort dropped out after week 4 visit for reasons unrelated to study drug. #One patient in the 6 mg naïve patient cohort did not have reading on W32. VIS-101 – Rapid and Robust CST Improvement (4 mos) (6 mos) (4 mos) (6 mos) 23 #
Mean CST Changes (Treatment-Naïve) (7/9) (7/11) (3/9) (5/11) * * 3mg (n=9 randomized) 6mg (n=12* randomized) VIS-101 (3 loading doses) % Participants Remaining Treatment Free (16 vs. 24 weeks post loading doses) (7/9) (7/11) (3/9) (5/11) * Source: nAMD China Phase 2a final raw dataset (tab BCVA001_1) – not final analysis Notes: *One patient in the 6mg naïve patient cohort dropped out after week 8 follow-up. #One patient did not have reading on W32. ~Half of patients are retreatment free through 36 weeks VIS-101 - Sustained CST Improvement Median CST ~100-150 µm (after 3 loading doses) ~Two-thirds retreatment free at 4 months ~Half retreatment free at 6 months (4 mos) (6 mos) 24 #
Source: nAMD China Phase 2a final raw dataset (tab TREAT001_1) Faricimab Phase 3 data; 16 weeks after loading. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet 2022; 399: 729–40. Retreatment Criteria based on Disease Activity Criteria in the Phase 2a clinical protocol ASKG 712-CT-I-1 Faricimab comparison is not based on a head-to-head study. VIS-101 is an investigational agent that has not been approved in any geography. Neovascular age-related macular degeneration (nAMD), optical coherence tomography (OCT), best corrected visual acuity (BCVA) VIS-101 Retreatment free Rates by Visit (Treatment Naïve) Faricimab ~45%1 ~Half of patients are retreatment free through 36 weeks VIS-101 - Best-in-Class Durability Potential (4 mos) (6 mos) 25 Retreatment Criteria2 Change in CST ≥75 μm compared previous lowest CST BCVA decreases of ≥5 letters compared to the mean BCVA of the last two visits OR decreases by ≥10 letters compared to the previous highest BCVA New or recurrent retinal/subretinal fluid on OCT Presence of new macular hemorrhage related to nAMD
Source: ASKG712-CT-I-1_Phase 1/2a Top Line Table 14.3.2.5, *2 events one with a grade change, System Organ Class/Preferred Term (SOC/PT) SOC/PT 3mg (N=13) n(%) E 6mg (N=25) n(%) E Total Treatment Related TEAE 0 2 ( 8 ) 4 Eye Disorder 0 2 ( 8 ) 4 Uveitis 0 1 ( 4 ) 3* Vitreous opacities 0 1 ( 4 ) 1 *Uveitis was asymptomatic and did not include change in vision or vasculitis Favorable safety profile with only 2 patients with related AEs VIS-101 was Safe and Well-Tolerated with Only 2 Related Events and No Safety Signals Identified in Treatment Emergent Adverse Events VIS-101 - Favorable Safety Profile with No Dose-Limiting Toxicity 26
KOL Perspective: Dr. Nikolas London 27
Anti-VEGF-A Anti-Ang-2 Modified Fc 4 doses Up to 16 weeks Purpose-Bioengineered for Rapid, Robust, Durable Response Name/Company: Status Vabysmo®/Faricimab Roche: Approved VIS-101 Visara: Phase 2 Structure Antibody format Molecular Weight Dose (mg/nM) IC50: VEGF/ANG-21 Bispecific ~150 kDa 6 mg 292 pM/3181 pM Tetravalent Bispecific ~154 kDa 6 mg* 125 pM/191 pM Loading Dose 4 doses 3 doses Durability of Response (post loading) 16 weeks 24 weeks + VIS-101: Best-in-Class Intravitreal Half-Life and Dual Target Inhibition Note: 1. Visara in vitro report *Dose of 6mg based on clinical trial results, picomolar = pM 28
VIS-101: Next Steps 29
VIS-101 – Purpose-Designed to be Best-in-Class for Retinal Vascular Diseases Anti-Ang-2 Anti-VEGF-A Modified Fc Phase 2a wet AMD Update Safe and well-tolerated Rapid, robust, and durable treatment responses Potentially best in class durability Next Steps: Phase 2b study expected to be initiated H2 2026 Global Phase 3 program expected to begin in 2027 30
VIS-101: Q&A 31
Thank you www.novabridge.com IR@novabridge.com
33 Affamed, Principal Investigator Allergan/Abbvie, Consultant Amgen, Principal Investigator Apellis Pharmaceuticals Inc, Consultant, Speaker Astellas Pharmaceuticals, Speaker Eyepoint, Consultant and Principal Investigator Boehringer Ingelheim, Principal Investigator Genentech/Roche, Consultant and Principal Investigator Iveric Bio, Consultant Janssen Pharmaceuticals, Principal Investigator Regeneron, Principal Investigator Chief Medical Officer, Alkeus Pharmaceuticals Chairman of the Scientific Advisory Board, Visara, Inc. Scientific Advisor, Sanro Health Scientific Advisor, VeonGen Therapeutics Carlos Quezada-Ruiz, MD, FASRS Chairman, Scientific Advisory Board, Visara Nikolas JS London, MD, FACS Managing Partner, President, Retina Consultants San Diego Summary of Disclosures
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