Kodiak(KOD) - 2025 Q1 - Quarterly Results

Executive Summary Recent Business Highlights and Outlook Kodiak Sciences reported its Q1 2025 financial results and emphasized its strategic focus on advancing three promising Phase 3 assets, with topline data anticipated in 2026. The company plans to host an Investor R&D Update on July 16, 2025, to provide comprehensive updates on its pipeline - Kodiak 2.0 vision: precommercial stage retina-focused biotech company with a maturing portfolio of three promising Phase 3 assets[2] - Topline data for Phase 3 assets is on track for 2026[2] - An Investor R&D Update is scheduled for July 16, 2025, to feature scientific, clinical, and commercial perspectives across the Kodiak pipeline[3] - The Investor R&D Update agenda includes updates on Tarcocimab (GLOW2, DAYBREAK, BLA activities), KSI-501 (DAYBREAK, next clinical steps), and KSI-101 (APEX data, clinical/regulatory plan, commercial opportunity)[7] Financial Performance (Q1 2025) Cash Position Kodiak Sciences concluded the first quarter of 2025 with $138.9 million in cash and cash equivalents, a decrease from the previous quarter, but believes this cash balance is sufficient to fund operations into 2026 | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $138,851 | $168,074 | - Current cash and cash equivalents are believed to support current and planned operations into 2026[3] Net Loss The net loss for the first quarter of 2025 increased to $57.5 million, or $1.09 per share, compared to $43.0 million, or $0.82 per share, in the first quarter of 2024, primarily due to increased operating expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | Net loss | $(57,461) | $(43,039) | $(14,422) | | Net loss per common share, basic and diluted | $(1.09) | $(0.82) | $(0.27) | - Non-cash stock-based compensation included in net loss decreased to $15.9 million in Q1 2025 from $18.4 million in Q1 2024[4] Operating Expenses Total operating expenses rose to $59.1 million in Q1 2025 from $46.1 million in Q1 2024, primarily driven by a significant increase in research and development activities | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | Total operating expenses | $59,073 | $46,055 | $13,018 | Research and Development (R&D) Expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | R&D expenses | $43,644 | $29,931 | $13,713 | - The increase in R&D expenses was primarily driven by increased clinical activities related to the active GLOW2, DAYBREAK, and APEX studies, as well as increased manufacturing activities[5] - Non-cash stock-based compensation in R&D decreased to $7.9 million in Q1 2025 from $8.7 million in Q1 2024[5] General and Administrative (G&A) Expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | G&A expenses | $15,429 | $16,124 | $(695) | - Non-cash stock-based compensation in G&A decreased to $8.0 million in Q1 2025 from $9.7 million in Q1 2024[6] Product Pipeline and Clinical Development Tarcocimab (Investigational Anti-VEGF Therapy) Tarcocimab is an investigational anti-VEGF therapy leveraging Kodiak's proprietary ABC Platform, designed to provide potent and durable drug levels in ocular tissues. It aims to offer a flexible 1-month through 6-month dosing label for all patients with retinal vascular disease - Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate ("ABC") Platform[8] - Designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents, with the ultimate objective of providing a flexible 1-month through 6-month label for all patients with retinal vascular disease[8] - Uses an enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody, intended to balance immediacy and durability[11] Completed Phase 3 Studies - Tarcocimab has completed three successful Phase 3 pivotal clinical studies: GLOW1 (diabetic retinopathy), BEACON (retinal vein occlusion), and DAYLIGHT (wet AMD)[9] - In the GLOW1 study, tarcocimab met its primary endpoint with 41.1% of treated patients demonstrating at least a 2-step improvement on the DRSS score vs. 1.4% in the sham group (p<0.0001) with extended 6-month dosing[12] - GLOW1 also met all key secondary endpoints, showing an 89% decreased risk of sight-threatening complications and a 95% risk reduction in the development of DME vs. sham[12] Ongoing Phase 3 Studies - Tarcocimab is currently being studied in two Phase 3 clinical trials: GLOW2 for diabetic retinopathy (enrollment completed) and DAYBREAK for wet AMD (actively enrolling)[10] - The GLOW2 study design mirrors GLOW1, with the advantage of a third monthly loading dose to provide dosing flexibility, and all patients receive extended 6-month dosing[10][13] - The DAYBREAK study is a non-inferiority study evaluating tarcocimab against aflibercept, designed to maximize the probability of meeting the primary endpoint of non-inferiority in visual acuity gains, using individualized dosing every 4 to 24 weeks after four monthly loading doses[14] KSI-501 (Investigational Anti-IL-6, VEGF-trap Bispecific Therapy) KSI-501 is an investigational anti-IL-6, VEGF-trap bispecific therapy built on the ABC platform, developed to provide extended durability and differentiated efficacy by targeting disease biology beyond VEGF for high prevalence retinal vascular diseases - KSI-501 is an investigational anti-IL-6, VEGF-trap bispecific therapy built on the ABC platform[15] - It is being developed for high prevalence retinal vascular diseases to address the leading unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy[15] - Preclinical models showed KSI-501 to be a potent inhibitor of VEGF and IL-6, and to normalize the blood retinal barrier, suggesting potential as a disease-modifying therapy[16] Clinical Development - A completed Phase 1 multiple ascending dose study demonstrated that repeated monthly dosing of KSI-501 was well tolerated and achieved clinically meaningful and sustained improvement in visual acuity and fluid reduction in patients with diabetic macular edema[17] - Kodiak has advanced KSI-501 into a Phase 3 DAYBREAK study to evaluate its efficacy and safety in wet AMD, which is actively enrolling patients[17][18] - In DAYBREAK, patients randomized to KSI-501 will receive fixed every 8-week dosing with additional individualized dosing (up to monthly) on an as needed basis after 4 monthly loading doses, against aflibercept[18] KSI-101 (Novel IL-6 and VEGF Bispecific Protein) KSI-101 is a novel, high-strength (100 mg/mL) 'traditional' (unconjugated) bispecific protein targeting IL-6 and VEGF. It is being developed for patients with retinal fluid and inflammation, addressing a new market segment distinct from the established anti-VEGF market - KSI-101 is a novel, potent, and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF, which is a 'traditional' (unconjugated) intravitreal biologic[19] - It is being developed for patients who have retinal fluid and inflammation, addressing a new market segment separate from the established anti-VEGF market, as there are currently no available intravitreal biologic therapies for inflammatory retinal conditions[19] - KSI-101 is platform-independent and is considered an important part of Kodiak's portfolio[19][21] Clinical Development - The dose-finding Phase 1b APEX study for KSI-101 is ongoing, evaluating safety and tolerability in two cohorts: patients with diabetic macular edema (DME) and patients with macular edema secondary to inflammation (MESI)[20] - The goal of the APEX study is to identify two dose levels to progress into dual Phase 3 studies (PEAK and PINNACLE) in MESI[20] Company Overview About Kodiak Sciences Inc. Kodiak Sciences is a biopharmaceutical company dedicated to researching, developing, and commercializing transformative therapeutics for a wide range of retinal diseases. The company leverages its proprietary ABC Platform and has a portfolio of three clinical programs, two of which are late-stage and platform-derived, and one is platform-independent - Kodiak Sciences is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases[21] - The company's ABC Platform is at the core of its discovery engine, using molecular engineering to merge protein-based and chemistry-based therapies[21] - Kodiak is developing a portfolio of three clinical programs: two late-stage derived from its ABC Platform, and one platform-independent (KSI-101) that is expected to progress rapidly into pivotal studies[21] Forward-Looking Statements Forward-Looking Statements This section contains forward-looking statements based on management's current expectations, which are subject to various risks and uncertainties that could cause actual results to differ materially. Readers are cautioned against undue reliance on these statements, and the company undertakes no obligation to update them - Statements are forward-looking, based on management's current expectations of future events or conditions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially[23] - Risks include cessation or delay of clinical studies, results not providing anticipated benefits, safety/efficacy data not persisting, BLA not being sufficient or approved, and manufacturing issues[23] - Readers are cautioned not to place undue reliance on such forward-looking statements, and Kodiak undertakes no obligation to update them[23] Financial Statements Condensed Consolidated Statements of Operations This table provides a summary of Kodiak Sciences' operating expenses, interest income, and net loss for the three months ended March 31, 2025, compared to the same period in 2024 | Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $43,644 | $29,931 | | General and administrative | $15,429 | $16,124 | | Total operating expenses | $59,073 | $46,055 | | Loss from operations | $(59,073) | $(46,055) | | Interest income | $1,602 | $3,353 | | Other income (expense), net | $10 | $(337) | | Net loss and comprehensive loss | $(57,461) | $(43,039) | | Net loss per common share, basic and diluted | $(1.09) | $(0.82) | | Weighted-average shares outstanding | 52,746,318 | 52,510,460 | Condensed Consolidated Balance Sheet Data This table presents a snapshot of Kodiak Sciences' financial position, including cash and cash equivalents, working capital, total assets, accumulated deficit, and total stockholders' equity, as of March 31, 2025, and December 31, 2024 | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $138,851 | $168,074 | | Working capital | $111,809 | $146,363 | | Total assets | $297,909 | $335,578 | | Accumulated deficit | $(1,386,199) | $(1,328,738) | | Total stockholders' equity | $108,842 | $150,288 | Company Contact Kodiak Contact Contact information for investor relations is provided - Contact: John Borgeson, Chief Financial Officer[26] - Email: ir@kodiak.com[26] - Phone: (650) 281-0850[26]