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 Insights - Kodiak Sciences Inc. is presenting KSI-101, a bispecific investigational biologic targeting macular edema secondary to inflammation, at the 2025 Congress of the International Ocular Inflammation Society in Rio de Janeiro [1][6] - The company aims to address the significant unmet need in treating macular edema caused by inflammation, which can lead to vision loss [3][4] Company Overview - Kodiak Sciences is a precommercial biotechnology company focused on developing therapeutics for retinal diseases, utilizing its ABC Platform for innovative drug design [8][9] - The company is advancing its pipeline, which includes three late-phase clinical assets expected to deliver Phase 3 topline data in 2026 [9] Product Details - KSI-101 is a high-strength (100 mg/mL) bispecific protein designed to target both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), addressing the dual mechanisms of macular edema [6][5] - The ongoing Phase 1b study, APEX, is evaluating the safety and tolerability of KSI-101, with plans to progress into dual Phase 2b/3 studies [7]

Core Viewpoint - Kodiak Sciences Inc. has seen a 10.5% increase in share price over the past month, outperforming the S&P 500, but estimates have trended downward, indicating potential challenges ahead [1][2]. Group 1: Earnings and Estimates - The consensus estimate for Kodiak Sciences has shifted downward by 10.35% over the past month [2]. - The stock has a Zacks Rank of 3 (Hold), suggesting an expectation of in-line returns in the coming months [4]. Group 2: VGM Scores - Kodiak Sciences has a subpar Growth Score of D and a Momentum Score of F, with an overall aggregate VGM Score of F, placing it in the lowest quintile for investment strategies [3]. Group 3: Industry Performance - Kodiak Sciences is part of the Zacks Medical - Biomedical and Genetics industry, where Apellis Pharmaceuticals has gained 17.7% over the past month [5]. - Apellis Pharmaceuticals reported revenues of $166.8 million, reflecting a year-over-year decline of 3.2%, and is expected to post a loss of $0.44 per share for the current quarter, indicating a 57.1% change from the previous year [6].

Summary of Kodiak Sciences (KOD) 2025 Conference Call Company Overview - **Company**: Kodiak Sciences - **Date**: June 05, 2025 - **Focus**: Development of biologic therapies for retinal diseases, particularly wet AMD, diabetic retinopathy, and retinal vein occlusion Key Points Industry and Product Pipeline - Kodiak is actively engaged in multiple clinical studies, with a focus on its lead product, **tarcosumab**, an antibody conjugate targeting retinal diseases [2][4] - The **GLOW 2 study** for tarcosumab has been fully enrolled, with top-line data expected in February 2026 [4][5] - The **DAYBREAK study** is also underway, combining tarcosumab with KSI 501, a bispecific conjugate, targeting wet AMD [4][11] Clinical Trial Insights - Tarcosumab has shown the **world's best durability** as a biologic in retinal treatments, with a mean half-life of **20 days** compared to other biologics that average **6-8 days** [8][10] - The new formulations aim to improve both **efficacy** and **immediacy** of action, addressing previous concerns about the size of the conjugates affecting performance [7][8] - The **Doctor study** is anticipated to have a high probability of success, with results expected in Q1 2026 [14][15] Safety and Efficacy - Concerns regarding intraocular inflammation (IOI) have been addressed, with Kodiak reporting that their rates of inflammation are comparable or better than competitors [30][31] - The new formulation of tarcosumab has shown **fewer cataract adverse events** compared to Eylea, which is significant for patient safety [33][34] Market Position and Competitive Landscape - Kodiak aims to differentiate its products from existing treatments like **Eylea** and **Vobizmo** by offering superior durability, efficacy, and safety [20][21] - The company is preparing to file for FDA approval for multiple indications, including AMD, diabetic retinopathy, and retinal vein occlusion [19][20] Financial Position - Kodiak has over **$100 million** in cash, with a quarterly burn rate of approximately **$30 million** [87][88] - The company is exploring various financing options to support its ongoing clinical programs and operational needs [88] Future Outlook - Kodiak is optimistic about the upcoming data readouts from its phase three studies, which are expected to provide critical insights into the efficacy and safety of its therapies [76][78] - The company is also preparing to present more data on its **KSI 501 program** at the upcoming analyst day, highlighting its potential in treating macular edema secondary to inflammation [71][72] Additional Insights - The discussion highlighted the potential for **macular edema secondary to inflammation (MESI)** as a significant market opportunity, with Kodiak's bispecific approach expected to outperform competitors [53][68] - The company is committed to leveraging insights from ongoing studies to refine its approach and enhance the likelihood of successful outcomes in its clinical trials [85][86]

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]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%2E%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q1 2025 reveal a net loss of $57.5 million and reduced cash, raising substantial doubt about the company's going concern ability [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2025, shows a decline in total assets and stockholders' equity, primarily due to reduced cash and cash equivalents | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $138,851 | $168,074 | | Total current assets | $142,685 | $171,936 | | Total assets | $297,909 | $335,578 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $30,876 | $25,573 | | Total liabilities | $189,067 | $185,290 | | Total stockholders' equity | $108,842 | $150,288 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statement of operations for Q1 2025 reports an increased net loss of $57.5 million, primarily driven by higher research and development expenses | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | 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) | | **Net loss** | **($57,461)** | **($43,039)** | | Net loss per common share | ($1.09) | ($0.82) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity significantly declined to $108.8 million by March 31, 2025, primarily due to the quarterly net loss - Stockholders' equity fell by **$41.4 million** during Q1 2025, from **$150.3 million** to **$108.8 million**, mainly due to the quarterly net loss[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for Q1 2025 was $29.1 million, contributing to a significant decrease in total cash and equivalents | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($29,077) | ($39,600) | | Net cash used in investing activities | ($270) | ($166) | | Net cash provided by financing activities | $124 | $38 | | **Net decrease in cash** | **($29,223)** | **($39,728)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail liquidity concerns, a $1.9 million lease impairment, and increased R&D expenses, raising substantial doubt about the company's going concern - The company's existing cash and cash equivalents may not be sufficient to meet anticipated operating and capital expenditure requirements for the next 12 months, raising **substantial doubt** about its ability to continue as a going concern[35](index=35&type=chunk) - In March 2025, the company subleased its building at 1200 Page Mill Road, which triggered a review and resulted in a non-cash lease impairment expense of **$1.9 million**[42](index=42&type=chunk)[60](index=60&type=chunk) R&D Expense Category | R&D Expense Category | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Tarcocimab program | $14,276 | $5,969 | | KSI-501 and KSI-101 programs | $4,217 | $2,221 | | ABC Platform and other | $5,645 | $2,586 | | Payroll and personnel | $14,270 | $14,359 | | Facilities and other | $5,236 | $4,796 | | **Total R&D Expenses** | **$43,644** | **$29,931** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical program progress, a **$13.7 million** increase in R&D expenses, and reiterates substantial doubt about the company's ability to continue as a going concern - The company is focused on three clinical programs: tarcocimab (anti-VEGF), KSI-501 (anti-IL-6, VEGF-trap bispecific conjugate), and KSI-101 (anti-IL-6, VEGF-trap bispecific protein) for retinal diseases[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk) - Key clinical milestones include completing enrollment for the Phase 3 GLOW2 study (tarcocimab), with topline data expected in Q1 2026, and actively enrolling the Phase 3 DAYBREAK study (tarcocimab and KSI-501), with data expected in Q2 2026[89](index=89&type=chunk)[93](index=93&type=chunk)[95](index=95&type=chunk) Expense Category | Expense Category | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $43,644 | $29,931 | $13,713 | | General and administrative | $15,429 | $16,124 | ($695) | | **Net loss** | **($57,461)** | **($43,039)** | **($14,422)** | - The company has **substantial doubt** about its ability to continue as a going concern, with current cash and cash equivalents of **$138.9 million** expected to fund operations only into 2026[117](index=117&type=chunk)[118](index=118&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to the company's market risk disclosures were reported for the three months ended March 31, 2025 - There were no material changes to the company's market risk disclosures during the three months ended March 31, 2025[132](index=132&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[134](index=134&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending legal claims or actions expected to have a material adverse effect on its financial condition or operations - As of the date of the report, the company is not involved in any legal proceedings that could have a material adverse effect on its business[137](index=137&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including its going concern status, dependence on clinical trial success, intense competition, and complex regulatory and manufacturing challenges - The company's financial condition raises **substantial doubt** about its ability to continue as a going concern due to a history of significant net losses and the need for additional financing to complete development and commercialization[349](index=349&type=chunk)[350](index=350&type=chunk) - The company's prospects are heavily dependent on the clinical success of its tarcocimab, KSI-501, and KSI-101 product candidates, and past positive results are not predictive of future outcomes[141](index=141&type=chunk)[142](index=142&type=chunk) - Kodiak faces significant competition from large pharmaceutical companies like Roche and Regeneron, whose products Vabysmo and Eylea HD are already approved and have gained significant market share for treating retinal diseases[177](index=177&type=chunk)[178](index=178&type=chunk) - The company relies on third-party manufacturers for its product candidates, which creates risks related to supply chain disruptions, regulatory compliance (cGMP), and manufacturing scale-up[186](index=186&type=chunk)[255](index=255&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=68&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - None[386](index=386&type=chunk) [Item 3. Defaults Upon Senior Securities](index=68&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon its senior securities - None[387](index=387&type=chunk) [Item 4. Mine Safety Disclosures](index=68&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business operations - None[388](index=388&type=chunk) [Item 5. Other Information](index=68&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans during Q1 2025 - During Q1 2025, no directors or officers adopted or terminated any Rule 10b5-1 trading plans or similar arrangements[389](index=389&type=chunk) [Item 6. Exhibits](index=69&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the 10-Q report, including corporate governance documents and Sarbanes-Oxley Act certifications - The report includes required exhibits such as corporate governance documents and officer certifications under the Sarbanes-Oxley Act (SOX 302 and 906)[391](index=391&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) [Recent Business Highlights and Outlook](index=1&type=section&id=Recent%20Business%20Highlights%20and%20Outlook) 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](index=2&type=chunk) - Topline data for Phase 3 assets is on track for **2026**[2](index=2&type=chunk) - An Investor R&D Update is scheduled for **July 16, 2025**, to feature scientific, clinical, and commercial perspectives across the Kodiak pipeline[3](index=3&type=chunk) - 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](index=7&type=chunk) [Financial Performance (Q1 2025)](index=1&type=section&id=Financial%20Performance%20%28Q1%202025%29) [Cash Position](index=1&type=section&id=Cash%20Position) 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](index=3&type=chunk) [Net Loss](index=1&type=section&id=Net%20Loss) 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](index=4&type=chunk) [Operating Expenses](index=1&type=section&id=Operating%20Expenses) 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](index=1&type=section&id=Research%20and%20Development%20%28R%26D%29%20Expenses) | 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](index=5&type=chunk) - Non-cash stock-based compensation in R&D decreased to **$7.9 million** in Q1 2025 from **$8.7 million** in Q1 2024[5](index=5&type=chunk) [General and Administrative (G&A) Expenses](index=1&type=section&id=General%20and%20Administrative%20%28G%26A%29%20Expenses) | 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](index=6&type=chunk) [Product Pipeline and Clinical Development](index=2&type=section&id=Product%20Pipeline%20and%20Clinical%20Development) [Tarcocimab (Investigational Anti-VEGF Therapy)](index=2&type=section&id=Tarcocimab%20%28Investigational%20Anti-VEGF%20Therapy%29) 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](index=8&type=chunk) - 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](index=8&type=chunk) - Uses an enhanced **50 mg/mL** formulation containing both conjugated and unconjugated antibody, intended to balance immediacy and durability[11](index=11&type=chunk) [Completed Phase 3 Studies](index=2&type=section&id=Completed%20Phase%203%20Studies) - Tarcocimab has completed three successful **Phase 3** pivotal clinical studies: GLOW1 (diabetic retinopathy), BEACON (retinal vein occlusion), and DAYLIGHT (wet AMD)[9](index=9&type=chunk) - 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](index=12&type=chunk) - 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](index=12&type=chunk) [Ongoing Phase 3 Studies](index=2&type=section&id=Ongoing%20Phase%203%20Studies) - 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](index=10&type=chunk) - 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](index=10&type=chunk)[13](index=13&type=chunk) - 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](index=14&type=chunk) [KSI-501 (Investigational Anti-IL-6, VEGF-trap Bispecific Therapy)](index=3&type=section&id=KSI-501%20%28Investigational%20Anti-IL-6%2C%20VEGF-trap%20Bispecific%20Therapy%29) 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](index=15&type=chunk) - 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](index=15&type=chunk) - 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](index=16&type=chunk) [Clinical Development](index=3&type=section&id=Clinical%20Development) - 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](index=17&type=chunk) - 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](index=17&type=chunk)[18](index=18&type=chunk) - 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](index=18&type=chunk) [KSI-101 (Novel IL-6 and VEGF Bispecific Protein)](index=3&type=section&id=KSI-101%20%28Novel%20IL-6%20and%20VEGF%20Bispecific%20Protein%29) 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](index=19&type=chunk) - 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](index=19&type=chunk) - KSI-101 is **platform-independent** and is considered an important part of Kodiak's portfolio[19](index=19&type=chunk)[21](index=21&type=chunk) [Clinical Development](index=3&type=section&id=Clinical%20Development) - 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](index=20&type=chunk) - 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](index=20&type=chunk) [Company Overview](index=3&type=section&id=Company%20Overview) [About Kodiak Sciences Inc.](index=3&type=section&id=About%20Kodiak%20Sciences%20Inc.) 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](index=21&type=chunk) - 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](index=21&type=chunk) - 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](index=21&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) 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](index=23&type=chunk) - 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](index=23&type=chunk) - Readers are cautioned not to place undue reliance on such forward-looking statements, and Kodiak undertakes no obligation to update them[23](index=23&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) 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](index=5&type=section&id=Company%20Contact) [Kodiak Contact](index=5&type=section&id=Kodiak%20Contact) Contact information for investor relations is provided - Contact: John Borgeson, Chief Financial Officer[26](index=26&type=chunk) - Email: ir@kodiak.com[26](index=26&type=chunk) - Phone: (650) 281-0850[26](index=26&type=chunk)

Core Insights - Kodiak Sciences Inc. reported a net loss of $57.5 million for Q1 2025, compared to a net loss of $43.0 million in Q1 2024, reflecting an increase in operational expenses and R&D investments [4][28]. - The company ended Q1 2025 with $138.9 million in cash and cash equivalents, which is expected to support operations into 2026 [3][29]. - Kodiak is focused on advancing its pipeline, particularly three Phase 3 assets, with topline data anticipated in 2026 [2][3]. Financial Results - The net loss for Q1 2025 was $57.5 million, or $1.09 per share, compared to a net loss of $43.0 million, or $0.82 per share, in Q1 2024 [4][28]. - R&D expenses increased to $43.6 million in Q1 2025 from $29.9 million in Q1 2024, driven by heightened clinical activities [5][28]. - General and administrative expenses decreased slightly to $15.4 million in Q1 2025 from $16.1 million in Q1 2024 [8][28]. Pipeline and Upcoming Events - Kodiak plans to host an Investor R&D Update on July 16, 2025, to discuss scientific, clinical, and commercial perspectives across its pipeline [3]. - The company is advancing its investigational therapies, including Tarcocimab, KSI-501, and KSI-101, with ongoing Phase 3 studies and new clinical trial data expected [7][19][21]. Product Development - Tarcocimab is being studied in two Phase 3 trials: GLOW2 for diabetic retinopathy and DAYBREAK for wet AMD, with both studies utilizing an enhanced formulation [11][19]. - KSI-501 is designed to target both IL-6 and VEGF, with a focus on treating wet AMD and is currently in the DAYBREAK study [17][20]. - KSI-101 is being evaluated in a Phase 1b study for diabetic macular edema and macular edema secondary to inflammation, with plans for dual Phase 3 studies [21][22].

Core Viewpoint - Kodiak Sciences Inc. (KOD) has experienced significant selling pressure, resulting in a 28.1% decline over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Technical Analysis - The Relative Strength Index (RSI) is a key indicator for identifying oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - KOD's current RSI reading is 27.59, suggesting that the heavy selling may be exhausting itself, indicating a potential bounce back [5] Group 2: Fundamental Analysis - There is a strong consensus among sell-side analysts to raise earnings estimates for KOD, with a 3.3% increase in the consensus EPS estimate over the last 30 days [7] - An upward trend in earnings estimate revisions is generally associated with price appreciation in the near term [7] Group 3: Analyst Ratings - KOD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [8]

Core Viewpoint - Kodiak Sciences reported a narrower loss per share in Q4 2024 compared to the previous year, but the company has yet to generate any revenues and continues to face significant challenges in its operations [1][2][5]. Financial Performance - In Q4 2024, Kodiak Sciences reported a loss of $0.84 per share, which is an improvement from a loss of $1.13 per share in the same quarter of the previous year [1]. - For the full year 2024, the company recorded a loss per share of $3.35, which is better than the Zacks Consensus Estimate of a loss of $3.49 per share, compared to a loss of $4.97 per share in 2023 [5]. - Research and development expenses for Q4 2024 were $31.8 million, down 32% year over year, primarily due to reduced manufacturing activities and forfeitures of equity awards [3]. - General and administrative expenses were $14.4 million, down 14% year over year, mainly due to lower non-cash stock-based compensation expenses [3]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $168.1 million, down from $197.9 million as of September 30, 2024, which is expected to support operations into 2026 [4]. Pipeline Developments - Kodiak is currently evaluating the efficacy and safety of tarcocimab in treatment-naïve patients with diabetic retinopathy in the phase III GLOW2 study, with top-line data expected in Q1 2026 [6]. - The company is also studying KSI-501, a dual inhibitor designed to target inflammation and abnormal angiogenesis in retinal vascular diseases, with top-line data from the phase III DAYBREAK study anticipated in Q2 2026 [7][9]. - Kodiak is enrolling patients in the phase Ib APEX study for its third investigational candidate, KSI-101, with updates expected in June 2025 [10][11]. Market Performance - Kodiak's shares have declined by 69.2% year-to-date, contrasting with the industry growth of 3.3% [4].