Summary of Kodiak Sciences Conference Call Company Overview - **Company**: Kodiak Sciences (NasdaqGM: KOD) - **Focus**: Pre-commercial retina-focused biotech company - **Key Asset**: KSI-101, developed for macular edema secondary to inflammation (MESI) [2][3] Industry Context - **Market Size**: The anti-VEGF market exceeds $15 billion [3] - **Competition**: Current agents like Eylea and Lucentis are considered Gen 1 agents, with newer agents like Eylea HD and Vabysmo termed Gen 1.5, showing only incremental improvements [8][9] Core Points and Arguments 1. **Pipeline Development**: - Kodiak has three phase three programs: KSI-101, tarcocimab, and KSI-501 [3][6] - KSI-101 is a bispecific protein targeting both IL-6 and VEGF, aimed at treating MESI [16][21] - Tarcocimab and KSI-501 are conjugates targeting retinal vascular diseases, with positive phase three data expected [5][11] 2. **Clinical Trials**: - Tarcocimab has three completed phase three studies (Beacon, GLO1, Daylight) with positive results, and GLO2 is ongoing [4][5] - KSI-501 is also expected to provide top-line data in the Daybreak study by mid-September [5][12] - KSI-101 is currently enrolling in the Peak and Pinnacle phase three studies, with expectations for top-line data in late 2026 [5][25] 3. **Scientific Innovation**: - Kodiak aims to develop biologics that provide high immediacy and durability, addressing unmet needs in the retinal disease market [10][15] - The company has shown that tarcocimab has a mean ocular half-life of 20 days, significantly longer than competitors [11] 4. **Market Opportunity**: - There is a strong unmet need for effective treatments in the retinal disease market, particularly for conditions like diabetic retinopathy and macular edema [10][14] - KSI-101 is positioned to potentially be a disease-modifying therapy for MESI, with a focus on dual inhibition of IL-6 and VEGF [18][21] 5. **Regulatory Pathway**: - Kodiak plans to file a Biologics License Application (BLA) for tarcocimab in mid-2027 based on positive data from ongoing studies [6][12] Additional Important Insights - **Patient Population**: Kodiak's studies include a broader range of patients compared to competitors, allowing for more inclusive treatment options [28][29] - **Safety Profile**: KSI-101 is designed to have a strong safety profile, differentiating it from steroid treatments [21] - **Future Directions**: Kodiak is considering expanding its research to include diabetic macular edema (DME) with either KSI-101 or KSI-501, depending on upcoming data [32][34] Conclusion Kodiak Sciences is positioned as a leading player in the retina-focused biotech space, with a robust pipeline and innovative approaches to treating retinal diseases. The upcoming clinical data and regulatory filings will be critical in determining the company's future success and market position.

Core Insights - Kodiak Sciences reported a loss of $1.16 per share in Q3 2025, which is wider than the Zacks Consensus Estimate of a loss of $1.07 and compared to a loss of 84 cents per share in the same quarter last year [2][5] - The company currently has no approved products and has not generated any revenue [2] - Kodiak's cash, cash equivalents, and marketable securities totaled $72 million as of September 30, 2025, down from $104.2 million as of June 30, 2025 [4] Financial Performance - Research and development expenses increased to $50.5 million in Q3 2025, reflecting a 58% year-over-year rise due to heightened clinical and manufacturing activities [3][5] - General and administrative expenses decreased to $11.9 million, down 20% year-over-year, primarily due to lower non-cash stock-based compensation expenses [3] Pipeline Developments - Kodiak is advancing its candidates tarcocimab and KSI-501 in phase III studies for diabetic retinopathy (DR) and wet age-related macular degeneration (wet AMD), with data expected in 2026 [5][6] - The company is conducting the phase III GLOW2 study for tarcocimab in treatment-naïve patients with DR, with top-line data anticipated in Q1 2026 [6] - KSI-501 is being evaluated as a dual inhibitor targeting inflammation and abnormal angiogenesis in retinal vascular diseases [6] Future Plans - Kodiak plans to submit a single regulatory filing for tarcocimab to seek approval for three indications: DR, wet AMD, and retinal vein occlusion, based on the success of ongoing pivotal studies [8] - The company has initiated two pivotal phase III studies (PEAK and PINNACLE) for KSI-101, targeting macular edema, with top-line results expected in late 2026 and early 2027 [9] Market Performance - Kodiak's shares have surged 89.1% year-to-date, significantly outperforming the industry growth of 15.4% [4]

Core Insights - Kodiak Sciences Inc. is experiencing strong momentum driven by positive clinical data and execution across its late-stage programs [2][3] - The company anticipates continued momentum into 2026 with multiple Phase 3 data readouts and a planned BLA filing [3] Recent Business Highlights - Follow-up data from the Phase 1b APEX study of KSI-101 showed significant vision improvements, with over 50% of patients achieving a 15-letter gain by week 20 [7] - The Phase 3 PEAK and PINNACLE studies of KSI-101 are enrolling patients faster than expected [7] - KSI-101's mechanism of action received validation at the American Academy of Ophthalmology meetings, highlighting its potential in treating macular edema [7] - Enrollment in the Phase 3 DAYBREAK study for tarcocimab and KSI-501 has been completed, with approximately 690 subjects enrolled [7] Upcoming Catalysts - Topline data for the Phase 3 GLOW2 diabetic retinopathy study is expected in Q1 2026 [7] - Topline data for the Phase 3 DAYBREAK study is anticipated in Q3 2026 [7] - KSI-101's Phase 3 PEAK study topline data is expected in Q4 2026, and PINNACLE study data in Q1 2027 [7] Financial Results - Kodiak ended Q3 2025 with $72.0 million in cash and cash equivalents [8] - The net loss for Q3 2025 was $61.5 million, or $1.16 per share, compared to a net loss of $43.9 million, or $0.84 per share, in Q3 2024 [9] - Research and development expenses increased to $50.5 million in Q3 2025 from $31.9 million in Q3 2024, driven by clinical activities [10] - General and administrative expenses decreased to $11.9 million in Q3 2025 from $14.8 million in Q3 2024 [11] Company Overview - Kodiak Sciences is focused on developing transformative therapeutics for retinal diseases, utilizing its proprietary Antibody Biopolymer Conjugate (ABC) platform [30][31] - The company is advancing three late-stage clinical programs targeting the $15 billion anti-VEGF market [31]

Core Insights - Kodiak Sciences reported a loss of $1.03 per share in Q2 2025, which is wider than the Zacks Consensus Estimate of a loss of $1.01 and a loss of $0.86 per share in the same quarter last year [1][4] - The company currently has no approved products and has not generated any revenue [1] Financial Performance - Research and development expenses increased by 32% year over year to $42.8 million, primarily due to heightened clinical activities [2] - General and administrative expenses decreased by 18% year over year to $12.8 million, mainly due to lower non-cash stock-based compensation [2] - As of June 30, 2025, Kodiak had cash and marketable securities totaling $104.2 million, down from $138.9 million as of March 31, 2025, which the company believes is sufficient to support operations into 2026 [3] Pipeline Developments - Kodiak is conducting a phase III study (GLOW2) to evaluate tarcocimab for treatment-naïve patients with diabetic retinopathy, with top-line data expected in Q1 2026 [5] - The company is also studying tarcocimab in the DAYBREAK study for wet age-related macular degeneration, with results anticipated in Q3 2026 [6] - KSI-101, a candidate for macular edema, has completed an early-stage study, and two pivotal phase III studies (PEAK and PINNACLE) are currently enrolling patients, with results expected in late 2026 or early 2027 [7] Market Performance - Kodiak's shares have declined by 13.4% year to date, contrasting with the industry's growth of 0.6% [3]

Core Insights - Kodiak Sciences Inc. reported significant advancements in its late-stage clinical assets, particularly focusing on the transformative potential of tarcocimab, KSI-501, and KSI-101 in treating retinal diseases [2][3]. Recent Business Highlights and Upcoming Catalysts - The company held an Investor R&D Day on July 16, 2025, showcasing new data and a commercial vision for its clinical assets [2]. - KSI-101 demonstrated rapid anatomical gains and visual acuity improvements in patients with macular edema secondary to inflammation (MESI) during the Phase 1b APEX study [5]. - Upcoming topline data for tarcocimab and KSI-501 is expected in 1Q 2026 and 3Q 2026, respectively, with KSI-101 data anticipated in 4Q 2026 to 1Q 2027 [5]. Financial Results - Kodiak ended Q2 2025 with $104.2 million in cash and cash equivalents, sufficient to support operations into 2026 [4]. - The net loss for Q2 2025 was $54.3 million, or $1.03 per share, compared to a net loss of $45.1 million, or $0.86 per share, in Q2 2024 [6]. - Research and development expenses rose to $42.8 million in Q2 2025 from $32.5 million in Q2 2024, driven by increased clinical activities [7]. Pipeline Programs - Tarcocimab is an investigational anti-VEGF therapy designed for extended durability in ocular tissues, with ongoing Phase 3 studies in diabetic retinopathy and wet AMD [9][10]. - KSI-501 is a bispecific therapy targeting IL-6 and VEGF, currently in the Phase 3 DAYBREAK study for wet AMD [17][19]. - KSI-101 is being developed for MESI, with ongoing Phase 3 studies (PEAK and PINNACLE) actively enrolling patients [22][26]. Digital Health Initiatives - The VETi program has made significant advancements in AI and machine learning, aimed at enhancing the company's commercial retina franchise [5]. Company Overview - Kodiak Sciences is focused on developing transformative therapeutics for retinal diseases, utilizing its proprietary ABC Platform to create next-generation retinal medicines [29].

Core Insights - Kodiak Sciences Inc. is hosting an investor R&D Day webcast on July 16, 2025, from 4:00 pm ET to 5:30 pm ET, focusing on its late-phase clinical assets [1][2]. Company Overview - Kodiak Sciences is a precommercial biotechnology company focused on retinal diseases, aiming to develop transformative therapeutics to prevent and treat blindness globally [4]. - The company utilizes its ABC Platform®, which integrates protein-based and chemistry-based therapies, as the foundation of its discovery engine [4]. - Kodiak's pipeline includes three late-phase clinical assets, all targeting Phase 3 topline data expected in 2026 [4]. Event Details - The webcast will feature presentations from Kodiak's senior leadership and industry experts, providing a comprehensive overview of its three late-phase clinical assets: tarcocimab, KSI-501, and KSI-101 [2]. - Registration for the event is available online, and a recording will be accessible 24 hours post-event [3].

Core Viewpoint - Kodiak Sciences reported a wider loss per share of $1.09 in Q1 2025 compared to the Zacks Consensus Estimate of a loss of 89 cents, and a loss of 82 cents per share in the same quarter last year [1] Financial Performance - Research and development expenses increased to $43.6 million, reflecting a 45.8% year-over-year rise due to heightened clinical activities and manufacturing efforts [1] - General and administrative expenses decreased to $15.4 million, down 4.3% year-over-year, mainly due to lower non-cash stock-based compensation [2] - As of March 31, 2025, Kodiak had cash and marketable securities totaling $138.9 million, down from $168.1 million as of December 31, 2024, which the company believes is sufficient to support operations into 2026 [2] Stock Performance - Kodiak's shares have declined by 60.4% year-to-date, contrasting with an 8.4% decline in the industry [3] Pipeline Developments - Kodiak is conducting the phase III GLOW2 study to evaluate tarcocimab for treatment-naïve patients with diabetic retinopathy, with patient enrollment completed [4] - The company is also studying tarcocimab in the DAYBREAK study for wet age-related macular degeneration, with KSI-501 as the first investigational arm [5] - Kodiak plans to host an investor conference in July to discuss timelines for top-line data from ongoing studies and updates on enrollment for the DAYBREAK study [7] - Kodiak is enrolling patients in the phase Ib APEX study for KSI-101, targeting diabetic macular edema and inflammation-related macular edema, with updates expected in July 2025 [8][9] Regulatory Plans - Based on the outcomes of the GLOW2 and DAYBREAK studies, Kodiak intends to submit a single regulatory filing for tarcocimab to seek approval for three indications: diabetic retinopathy, wet AMD, and retinal vein occlusion [7]