Kodiak Sciences Inc. reported business highlights and financial results for the quarter ended June 30, 2023.
"We experienced a significant setback with the recently announced topline data for our Phase 3 GLEAM and GLIMMER studies in diabetic macular edema patients," said Victor Perlroth, MD, CEO of Kodiak Sciences. "Tarcocimab demonstrated what we see as industry-leading durability together with solid potency, but an unexpected increased rate of cataracts appears to have been the main driver to missing the primary efficacy endpoint in both studies. In our concurrent DAYLIGHT study in age-related macular degeneration where we dosed patients on a high-exposure regimen of 12 monthly doses of tarcocimab, fewer tarcocimab treated patients had a finding of cataract than did aflibercept treated patients. Notwithstanding the negative primary results in GLEAM and GLIMMER, we have two positive Phase 3 studies with tarcocimab: the BEACON study in patients with retinal vein occlusion and the DAYLIGHT study in patients with wet AMD. Following the recent presentation of the GLEAM and GLIMMER data at the American Society of Retina Specialists (ASRS) annual meeting, we have heard encouraging feedback from the retina community that tarcocimab's 6-month durability profile might be compelling and important for many patients, especially in pseudophakic patients who have already had cataract surgery and make up as many as 40% of anti-VEGF treated patients. While Kodiak has made the business decision to wind down ongoing studies of tarcocimab as previously communicated, we are still evaluating a variety of future options for the tarcocimab program.
"We have also communicated that Kodiak will be advancing the KSI-501 clinical program," continued Dr. Perlroth. "We are fortunate to have the active KSI-501 clinical program in our pipeline. KSI-501 is a first-in-class anti-IL-6 and anti-VEGF bispecific molecule, and we have completed enrollment of the multiple dose escalation Phase 1 study. The obvious question is why are we confident in advancing KSI-501 if it is based on the same platform as tarcocimab, and the answer is multiple. First, KSI-501 has the potential for both better anti-VEGF potency as it is a VEGF-trap as well as enhanced efficacy due to its dual mechanism of action, as compared to tarcocimab. Second, we believe we can deliver a tailored clinical development plan based on the learnings from the tarcocimab clinical program and the ABC platform itself. Third, we may explore an accelerated development pathway through orphan and/or breakthrough therapy designation applications with KSI-501. And fourth, we are planning to explore development of KSI-501 in its two therapeutic forms, both as its unconjugated protein which is itself a novel bispecific protein and as its bioconjugate form. We believe that exploring both therapeutic forms may result in a higher probability of success of the program and also provide us with a better understanding of the ABC platform."
Recent Business Highlights
- Tarcocimab pivotal program: We recently announced that our Phase 3 GLEAM and GLIMMER studies of tarcocimab in diabetic macular edema (DME) did not meet their primary efficacy endpoints of non-inferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after 3 monthly loading doses compared to aflibercept given every 8 weeks after 5 monthly loading doses. Tarcocimab demonstrated strong durability with half of tarcocimab treated patients achieving every 24-week dosing at the primary endpoint. An unexpected increase in cataract adverse events was reported over time in the tarcocimab arms of both GLEAM and GLIMMER and contributed meaningfully to the failure of each study. We also announced that the Phase 3 DAYLIGHT study of tarcocimab in wet age-related macular degeneration (wet AMD) did meet the primary efficacy endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to aflibercept dosed every 8 weeks following 3 monthly loading doses. No imbalance in cataracts was observed between the tarcocimab arm and the aflibercept arm in this study. In light of these clinical trial outcomes, we have made the business decision to wind down on-going clinical studies of tarcocimab.
- KSI-501 clinical program: Our Phase 1 study of KSI-501 has completed enrollment of patients across all dose levels. KSI-501 is our first-in-class bispecific investigational medicine designed to inhibit both IL-6-mediated immune inflammation and VEGF-mediated angiogenesis and vascular permeability. The Phase 1 study is an open-label, multiple ascending dose study to evaluate ocular and systemic safety, to establish a maximum tolerated dose and to explore bioactivity of KSI-501, initially in patients with DME. We are planning to explore development of KSI-501 both as (i) its unconjugated protein which is itself a novel bispecific anti-IL-6 antibody / anti-VEGF trap fusion protein and (ii) its bioconjugate form.
Second Quarter 2023 Financial Results
Cash Position
Kodiak ended the second quarter of 2023 with $378.7 million of cash and cash equivalents.
Net Loss
The net loss for the second quarter of 2023 was $80.2 million, or $1.53 per share on both a basic and diluted basis, as compared to a net loss of $90.6 million, or $1.74 per share on both a basic and diluted basis, for the second quarter of 2022. The net loss for the quarter ended June 30, 2023 included non-cash stock-based compensation of $25.8 million, as compared to $26.0 million for the quarter ended June 30, 2022.
R&D Expenses
Research and development (R&D) expenses were $67.0 million for the second quarter of 2023, as compared to $73.7 million for the second quarter of 2022. The R&D expenses for the second quarter of 2023 included non-cash stock-based compensation of $14.7 million, as compared to $14.1 million for the second quarter of 2022. The decrease in R&D expenses for the second quarter of 2023 was primarily driven by the maturation of the tarcocimab clinical program and the timing of manufacturing activities.
G&A Expenses
General and administrative (G&A) expenses were $17.9 million for the second quarter of 2023, as compared to $18.3 million for the second quarter of 2022. The G&A expenses for the second quarter of 2023 included non-cash stock-based compensation of $11.1 million, as compared to $11.9 million for the second quarter of 2022.