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Final APEX Phase 1b Clinical Results for Kodiak's KSI-101 in Macular Edema Secondary to Inflammation to be Presented at Angiogenesis 2026

Key Takeaway: Kodiak Sciences announced the presentation of final results from the Phase 1b APEX study for KSI-101 at the Angiogenesis 2026 meeting. The data indicate significant visual and anatomical improvements in patients with macular edema secondary to inflammation. These findings bolster confidence in KSI-101's potential as a leading therapy for MESI, with ongoing Phase 3 studies actively enrolling participants.
Price reaction · baseline $24.03 (2026-02-03 close) · hit pre-market · clean, no other KOD news in the window
day 0 close
-6.9%
day 1 · peak
-12.6%
day 3
+1.1%

Market Sentiment Analysis

POSITIVE FACTORS

  • KSI-101 shows robust anatomic and visual improvements in MESI patients.
  • Final results support KSI-101's clinical efficacy and safety profile.
  • Potential to become a first-line therapy for all causes of MESI.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+116%
120-day peak, hindsight
Typical move
8.7%
average across 8 past catalysts
Cash runway
~8 mo
Medium dilution risk
Lead asset
Tarcocimab tedromer
Phase 3 · Wet Age-related Macular Degeneration

Full Press Release Details

PALO ALTO, Calif.,Feb. 4, 2026/PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq:KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, announced today participation at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting on February 7, 2026.
Dr. Sumit Sharma, retina and uveitis specialist at the Cole Eye Institute, will present first-time end-of-study clinical results, including Week 24 data, from the Phase 1b APEX study in patients with macular edema secondary to inflammation (MESI).
The presentation will be posted at the start of the event on the "Events and Presentations" section of Kodiak's website athttp://ir.kodiak.com/.
"This year's Angiogenesis meeting marks the first presentation of end-of-study results from the APEX study for KSI-101. These final data continue to demonstrate robust anatomic and visual improvements in patients with MESI, regardless of the underlying etiology or location of inflammation, further supporting the clinical efficacy and safety profile of KSI-101 observed to date. With PEAK and PINNACLE Phase 3 studies actively enrolling, these final results strengthen our confidence in KSI-101's potential to become a safe, first-line unifying therapy for all causes of MESI," said Victor Perlroth, M.D., Chairman and CEO of Kodiak Sciences.

About KSI-101

KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation (MESI). MESI is a heterogenous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology–inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization).
Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. We believe that MESI represents a new market segment separate from the established anti-VEGF market.
We have completed enrollment in our dose-finding Phase 1b study APEX. The APEX study evaluates KSI-101 in two cohorts, Cohort 1 in patients with diabetic macular edema (DME) and Cohort 2 in patients with macular edema secondary to inflammation (MESI). APEX demonstrated that KSI-101 provides meaningful visual and anatomical gains in both DME and MESI and that KSI-101 is well tolerated. Meaningful treatment responses were seen in the MESI population, irrespective of the location of inflammation and specific MESI etiology, opening up the potential for KSI-101 to become a unifying treatment for this patient population.
Based on APEX, the top two dose levels tested were selected to advance into the Phase 3 program. The PEAK and PINNACLE Phase 3 studies are actively enrolling MESI subjects at the 5 mg and 10 mg dose levels versus sham.

About Kodiak Sciences Inc.

Kodiak Sciences (Nasdaq:KOD) is a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Tarcocimab and KSI-501 are being explored in two BLA-facing Phase 3 studies in the retinal vascular diseases, targeting the $15 billion anti-VEGF marketplace, with topline data readouts expected in 1Q 2026 and 3Q 2026. KSI-101 is a bispecific protein being explored in two BLA-facing Phase 3 studies in Macular Edema Secondary to Inflammation (MESI), with topline data readouts expected in 4Q 2026 (PEAK) and 2Q 2027 (PINNACLE).
Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Kodiak's plans, commitments, aspirations and goals related to Kodiak's drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled "Risk Factors" in Kodiak's most recent periodic report filed with the U.S. Securities and Exchange Commission ("SEC") as well as discussions of potential risks, uncertainties, and other important factors in Kodiak's subsequent filings with the SEC. All information in this press release is as of the date presented, and Kodiak undertakes no duty to update such information unless required by law.

Frequently Asked Questions

What are the key findings from the APEX study?

The APEX study showed significant visual and anatomical improvements in patients with MESI.

When will the results from KSI-101 be presented?

The results will be presented at the Angiogenesis meeting on February 7, 2026.

What is KSI-101 developed for?

KSI-101 is developed for treating macular edema secondary to inflammation.

What are the next steps for KSI-101?

KSI-101 will advance into Phase 3 studies with ongoing patient enrollment.

Last updated: Feb 4, 2026