DAYBREAK (Phase 3, tarcocimab and KSI-501 in wet AMD) completed enrollment during the period; topline data for the one-year primary endpoint are expected in September 2026. The Phase 3 ALTO study of KSI-501 in diabetic macular edema (~910 patients, three arms) was initiated in August 2026 and is now enrolling. For KSI-101 in macular edema secondary to inflammation, the first 300-patient cohort in the Phase 3 PEAK trial (Pivotal Analysis 1) completed enrollment with topline results expected in December 2026; the second pivotal cohort of 600 subjects across PEAK and PINNACLE is expected to complete enrollment in 4Q 2026 with topline data in 2Q 2027.
The company plans to submit a Biologics License Application for Zenkuda (tarcocimab) in 2026 covering diabetic retinopathy, retinal vein occlusion, and wet AMD, supported by the completed GLOW1, GLOW2, BEACON, and DAYLIGHT Phase 3 studies, and intends to work with the FDA on timing to include the ongoing DAYBREAK study in the filing if successful.
Q2 2026 research and development expenses rose to $56.1 million from $42.8 million a year earlier, driven by a $8.9 million increase in KSI-501 program costs (manufacturing ramp-up and DAYBREAK trial) and a $10.8 million increase in KSI-101 program costs (PEAK/PINNACLE trial and manufacturing). Beginning in 2026, KSI-501 and KSI-101 are reported as separate R&D line items in lieu of a combined presentation, reflecting increased clinical activity in both programs. Tarcocimab program expenses decreased $2.5 million year-over-year due to reduced manufacturing, partially offset by DAYBREAK costs.
In July 2026 (post-quarter), the company terminated the remaining eight months of its lease for 1200 Page Mill Road in Palo Alto and the associated sublease, receiving in exchange an option exercisable through March 1, 2027 to lease a separate building on the same campus with certain lease incentives.
Pipeline programs KSI-102 (anti-TNFα/IL-6) and KSI-103 (anti-IL-1/IL-6) continued through pre-IND activities targeting ocular inflammation, and the new ABCD Platform (conjugating small-molecule drugs into the biopolymer backbone) advanced with two 'retina duet' programs—glaucoma (NLRP3 inhibitor plus IOP-lowering agent) and geographic atrophy (complement-inhibiting macrocyclic peptide plus NLRP3 inhibitor)—progressing toward IND. The VETi AI-enabled wearable headset program reported continued advancement in hardware, software, and machine-learning algorithms.
As of June 30, 2026, cash and cash equivalents stood at $125.9 million (down from $209.9 million at year-end 2025), and the company disclosed substantial doubt about its ability to continue as a going concern, stating that existing cash may not be sufficient to meet anticipated operating and capital expenditure requirements for the 12 months following the filing date. Net loss for the quarter was $65.6 million; the company has no approved products and has not generated product revenue.
(Filed on May 7, 2026)
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$169.5M
DAYBREAK Phase 3 enrollment completed for both Zenkuda (tarcocimab) and KSI-501 arms in wet AMD; topline data for the one-year primary endpoint are expected in 3Q 2026. The study is non-inferiority versus active comparator aflibercept, using an AI-driven treat-to-dryness approach to individualize Zenkuda dosing (every 1 to 6 months) and fixed 8-week dosing for KSI-501.
Kodiak plans to file a BLA for Zenkuda in 2026 covering DR, RVO, and wet AMD, supported by completed GLOW1/GLOW2 (DR), BEACON (RVO), and DAYLIGHT (wet AMD) studies. The company intends to work with the FDA on submission timing to potentially include the ongoing DAYBREAK wet AMD study in the BLA, if successful. GLOW2 completed during Q1 2026.
KSI-101 Phase 3 superiority trials PEAK (moderate-to-severe MESI) and PINNACLE (milder MESI) are actively enrolling at 5 mg and 10 mg dose levels versus sham; topline data readouts are expected in 4Q 2026 (PEAK) and 2Q 2027 (PINNACLE). R&D spending for KSI-101 rose $6.1 million year-over-year to $7.0 million, reflecting the trial ramp-up.
Quarterly R&D expenses shifted materially across programs: tarcocimab program costs fell $4.3 million to $9.9 million (reduced manufacturing and lower GLOW2 costs after its Q1 2026 completion), while KSI-501 costs rose $6.6 million to $9.9 million (DAYBREAK trial and manufacturing ramp-up) and KSI-101 costs rose $6.1 million to $7.0 million (PEAK/PINNACLE). Beginning in 2026, KSI-501 and KSI-101 are reported as separate line items given increased clinical activity in both programs.
Pipeline advancement: KSI-102 (anti-TNFa/IL-6) and KSI-103 (anti-IL-1/IL-6) continue pre-IND activities targeting ocular inflammation; ABCD-platform duet programs in glaucoma and geographic atrophy continue progressing toward IND; VETi digital health platform reported progress in hardware, software, and machine learning for an AI-powered wearable headset.
Liquidity remains a material constraint: cash and cash equivalents were $169.5 million at March 31, 2026, with net cash used in operations of $40.0 million for the quarter and a net loss of $58.2 million. The company has issued a going-concern qualification but states existing cash is expected to support operations into 2027; it plans to raise additional capital through equity, debt, collaborations, or combinations thereof.
(Filed on March 31, 2026)
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$209.9M
Phase 3 DAYBREAK (wet AMD; parallel arms of tarcocimab and KSI-501 vs. aflibercept, using each drug's enhanced 50 mg/mL formulation) has completed enrollment; topline one-year primary endpoint data are expected in 3Q 2026. The Zenkuda arm uses AI-driven, treat-to-dryness individualized dosing every 4–24 weeks after four monthly loading doses; the KSI-501 arm uses fixed q8-week dosing plus individualized as-needed dosing after four monthly loading doses.
Phase 3 PEAK (moderate-to-severe MESI) and PINNACLE (milder MESI) superiority trials for KSI-101 (100 mg/mL anti-IL-6/VEGF bispecific) are actively enrolling at 5 mg and 10 mg doses versus sham; primary endpoints at Week 24, with topline data expected 4Q 2026 (PEAK) and 2Q 2027 (PINNACLE). Completed Phase 1b APEX dose-finding study showed >50% of patients achieved ≥15-letter BCVA gains, >90% IRF/SRF resolution by Week 8, and 20/25 Snellen by Week 20 in top-dose groups.
Q4 completed event: In December 2025, Kodiak closed a public equity offering of 8 million common shares at $23.00 per share, raising $173.0 million in net proceeds after underwriting discount. The company disclosed a going-concern explanatory paragraph from its auditor and stated that existing cash ($209.9 million at 12/31/2025) may not be sufficient for the 12 months following the filing date, while separately indicating current cash is expected to support operations into 2027.
Regulatory plan (outlook, not a completed filing): Kodiak intends to submit a BLA for tarcocimab in 2026 covering diabetic retinopathy (supported by GLOW1/GLOW2), retinal vein occlusion (BEACON), and wet AMD (DAYLIGHT), and will work with the FDA on timing to potentially incorporate the ongoing DAYBREAK wet AMD study into the application. Sector note: Regeneron's Eylea HD received FDA approval for RVO in November 2025, adding a high-dose aflibercept option in a key tarcocimab indication.
Annual context (FY 2025, not quarter-only): R&D expense rose 45% to $182.4 million, driven by the DAYBREAK trial (activated mid-2024), PEAK/PINNACLE and APEX activities, and increased biopolymer manufacturing at the Ursus facility. G&A declined 14% to $52.0 million, partly reflecting a $4.6 million sublease income offset after the March 2025 sublease of the 1200 Page Mill Road building (with a $1.9 million non-cash lease impairment). Full-year net loss was $230.0 million; net operating cash outflow was $136.0 million.
Pipeline and platform progression (ongoing, not completed): KSI-102 (anti-TNFa/IL-6) and KSI-103 (anti-IL-1/IL-6) are advancing through pre-IND activities for ocular inflammation. Two ABCD-platform 'duet' programs are progressing toward IND—one for glaucoma (NLRP3 small-molecule inhibitor plus IOP-lowering agent embedded in the biopolymer backbone) and one for geographic atrophy (macrocyclic complement-pathway inhibitor plus NLRP3 inhibitor), both targeting quarterly-dosing intravitreal delivery. The VETi AI-enabled wearable headset continued to advance in hardware, software, and machine-learning algorithm development.
(Filed on November 13, 2025)
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$72M
Tarcocimab Phase 3 programs advanced: GLOW2 (diabetic retinopathy) completed enrollment with >250 patients randomized (announced March 2025), and DAYBREAK (wet AMD, evaluating both tarcocimab and KSI-501 against aflibercept) completed enrollment. Kodiak plans to file a single BLA in 2026 covering wet AMD, DR, and RVO, contingent on DAYBREAK topline data expected 3Q 2026; GLOW2 topline data is expected 1Q 2026. Increased tarcocimab manufacturing activities with Lonza are underway in preparation for the BLA filing.
KSI-101 (bispecific anti-IL-6/VEGF for macular edema secondary to inflammation) Phase 3 studies PEAK (moderate-severe disease) and PINNACLE (milder disease) are actively enrolling at 5 mg and 10 mg dose levels versus sham; topline data are expected in 4Q 2026 and 1Q 2027, respectively. The prior Phase 1b APEX study (completed) demonstrated vision gains as early as week 4, >50% of patients achieving ≥15-letter BCVA improvement through week 20, and ≥90% retinal dryness at the top two dose levels.
R&D expenses rose to $50.5M in Q3 2025 (vs. $31.9M in Q3 2024), driven by the ongoing DAYBREAK pivotal trial, tarcocimab BLA-preparation manufacturing, expanding KSI-501/KSI-101 clinical activities (DAYBREAK, PEAK/PINNACLE), and increased biopolymer manufacturing for the ABC Platform. Tarcocimab program costs were $15.6M in the quarter; KSI-501/KSI-101 costs were $9.0M; ABC Platform and other program costs were $7.5M.
The company reported cash and cash equivalents of $72.0M as of September 30, 2025 (down from $168.1M at year-end 2024) and raised a substantial doubt about its ability to continue as a going concern, stating existing cash may not cover the 12 months following the filing date. Q3 2025 net loss was $61.5M; nine-month 2025 net loss was $173.2M. Kodiak plans to raise additional capital through equity or debt financings, collaborations, or a combination, and indicated it may need to pause or scale back development programs if funding is insufficient.
In March 2025, Kodiak subleased its 1200 Page Mill Road, Palo Alto building (term March 2025–February 2027), triggering a $1.9M non-cash lease impairment in Q1 2025. The company recognized $1.8M of sublease income in Q3 2025 and $4.2M in the nine months ended September 30, 2025, reducing rent expense within G&A and R&D allocations.
Pipeline and platform progress: dual cytokine-targeting bispecific programs KSI-102 (anti-TNFα/IL-6) and KSI-103 (anti-IL-1/IL-6) continue pre-IND activities for ocular inflammation. ABCD Platform 'retina duet' programs for glaucoma (NLRP3 inhibitor + IOP-lowering agent) and geographic atrophy (macrocyclic complement inhibitor + NLRP3 inhibitor) continue progressing toward IND, targeting quarterly-dose intravitreal therapies. The VETi wearable headset program reported significant hardware, software, and algorithm advancements, with functioning prototype devices developed for broader identity-security and cognitive-science applications.
