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].

Part I [Business](index=9&type=section&id=Item%201.%20Business) Kodiak Sciences Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for retinal diseases using its proprietary Antibody Biopolymer Conjugate (ABC) Platform. The company's pipeline includes three clinical programs: tarcocimab tedromer (KSI-301), an anti-VEGF therapy; KSI-501, a bispecific antibody targeting IL-6 and VEGF; and KSI-101, an unconjugated bispecific protein. Kodiak is also advancing its ABCD Platform for small molecule drug conjugation and a digital health platform, VETi. The company has established commercial-scale manufacturing capabilities with Lonza and retains global rights to its product candidates [Overview](index=9&type=section&id=Item%201.%20Business%23Overview) Kodiak Sciences, founded in 2009, is developing retinal medicines using its Antibody Biopolymer Conjugate (ABC) Platform. Its lead candidate, tarcocimab, has completed three successful Phase 3 studies and is in two ongoing Phase 3 trials (GLOW2 and DAYBREAK), with a single BLA filing planned for 2026 across wet AMD, RVO, and DR. The pipeline also includes KSI-501 (bispecific anti-IL-6/VEGF) in a Phase 3 study and KSI-101 (unconjugated bispecific) in a Phase 1b study. The company is expanding its technology with the ABCD Platform for small molecule drugs and has established manufacturing capabilities. As of December 31, 2024, Kodiak had $168.1 million in cash and cash equivalents and retains all global rights to its product candidates - Kodiak's lead product, tarcocimab, has completed three successful Phase 3 pivotal studies. Two additional Phase 3 studies, GLOW2 and DAYBREAK, are ongoing with topline data expected in 1Q 2026 and 2Q 2026, respectively. A single Biologics License Application (BLA) is planned for 2026 covering wet AMD, RVO, and DR[20](index=20&type=chunk) - The company is developing two other clinical programs: KSI-501, a bispecific antibody conjugate targeting IL-6 and VEGF, currently in the Phase 3 DAYBREAK study; and KSI-101, an unconjugated bispecific protein targeting IL-6 and VEGF, currently in the Phase 1b APEX study[21](index=21&type=chunk)[22](index=22&type=chunk) - Kodiak is advancing its platform to include small molecule drugs through its Antibody Biopolymer Conjugate Drug (ABCD) Platform, with initial programs targeting glaucoma and geographic atrophy[23](index=23&type=chunk) Financial Position | Metric | Value | | :--- | :--- | | Cash and Cash Equivalents (as of Dec 31, 2024) | $168.1 million | [Clinical Programs and Manufacturing](index=10&type=section&id=Item%201.%20Business%23Clinical%20Programs) Kodiak's clinical development is centered on three main candidates. Tarcocimab (KSI-301) has a mixed record, with three successful pivotal trials (GLOW1, BEACON, DAYLIGHT) but also three failed trials (GLEAM, GLIMMER, DAZZLE). Two ongoing Phase 3 trials, GLOW2 and DAYBREAK, are using an enhanced formulation to improve performance, with data expected in 2026. KSI-501, a bispecific conjugate, has advanced to the Phase 3 DAYBREAK study for wet AMD. KSI-101, a bispecific protein, is in a Phase 1b study (APEX) for inflammatory retinal conditions, with plans for pivotal studies in 2025. The company has also established commercial-scale manufacturing for tarcocimab at its dedicated 'Ursus' facility with Lonza and is progressing manufacturing for KSI-501 and KSI-101 Tarcocimab Ongoing Phase 3 Trials | Study | Indication | Status | Expected Topline Data | | :--- | :--- | :--- | :--- | | GLOW2 | Diabetic Retinopathy (DR) | Enrollment Complete | 1Q 2026 | | DAYBREAK | Wet AMD | Actively Enrolling | 2Q 2026 | - Tarcocimab has a mixed history in pivotal trials. It successfully met primary endpoints in GLOW1 (DR), BEACON (RVO), and DAYLIGHT (wet AMD). However, it failed to meet primary endpoints in GLEAM/GLIMMER (DME) and DAZZLE (wet AMD)[28](index=28&type=chunk)[36](index=36&type=chunk)[38](index=38&type=chunk)[41](index=41&type=chunk)[43](index=43&type=chunk)[46](index=46&type=chunk) - KSI-501, a bispecific (anti-IL-6, VEGF-trap) conjugate, has advanced to the Phase 3 DAYBREAK study in wet AMD to evaluate its efficacy potential beyond anti-VEGF monotherapy[50](index=50&type=chunk)[52](index=52&type=chunk) - KSI-101, a novel bispecific protein (anti-IL-6, VEGF), is being developed for retinal inflammation. Early data from the Phase 1b APEX study showed a strong treatment response, with plans to initiate pivotal studies in Q2 2025[22](index=22&type=chunk)[53](index=53&type=chunk) - The company has established commercial-scale manufacturing through a partnership with Lonza. The custom-built 'Ursus' facility was commissioned in January 2023, and the first commercial-scale cGMP batch of tarcocimab was released in July 2023[49](index=49&type=chunk) [Competition](index=16&type=section&id=Item%201.%20Business%23Competition) Kodiak faces significant competition from established anti-VEGF therapies like Avastin, Lucentis, and Eylea. Newer, formidable competitors include Roche's Vabysmo (faricimab), a bispecific antibody approved for wet AMD, DME, and RVO, which has gained significant market adoption, and Regeneron's Eylea HD (high dose aflibercept), approved for wet AMD, DME, and DR. The retinal disease market is becoming increasingly competitive with other companies developing novel treatments, gene therapies, and biosimilars - The standard of care includes well-established anti-VEGF therapies: Avastin, Lucentis, and Eylea[60](index=60&type=chunk) - Significant new competition comes from Roche's Vabysmo (faricimab), a bispecific antibody approved for wet AMD, DME, and RVO, which has seen strong market uptake[61](index=61&type=chunk) - Regeneron's Eylea HD (high dose aflibercept) was approved in August 2023 for wet AMD, DME, and DR, and is expected to be an important therapy due to Regeneron's established market presence[62](index=62&type=chunk) - The therapeutic landscape is expected to become more competitive with the development of other molecular targets, gene therapies, medical devices, and biosimilars[63](index=63&type=chunk) [Government Regulation](index=16&type=section&id=Item%201.%20Business%23Government%20Regulation) The company's operations are subject to extensive regulation by the FDA in the U.S. and comparable authorities abroad, covering research, development, manufacturing, and marketing. The approval process for a new biologic requires a Biologics License Application (BLA), supported by extensive preclinical and clinical data (Phase 1, 2, and 3 trials) demonstrating safety and efficacy. The FDA offers expedited programs like Fast Track and Priority Review. Post-approval, the company must adhere to ongoing requirements, including cGMP, adverse event reporting, and marketing restrictions. The business is also impacted by healthcare laws like the Anti-Kickback Statute, HIPAA, and pricing reforms such as the Inflation Reduction Act (IRA), which introduces Medicare drug price negotiations - Drug and biologic development in the U.S. is regulated by the FDA and requires a New Drug Application (NDA) or Biologics License Application (BLA) before marketing. The process involves extensive preclinical studies and three phases of clinical trials (Phase 1, 2, 3) to establish safety and efficacy[65](index=65&type=chunk)[66](index=66&type=chunk)[77](index=77&type=chunk) - The FDA has expedited programs such as Fast Track, Priority Review, and Accelerated Approval to facilitate the development and review of drugs for serious conditions with unmet medical needs[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk) - Post-approval, the company is subject to continuous FDA regulation, including cGMP for manufacturing, adverse event reporting, and strict rules on promotion and advertising, which prohibit off-label marketing[91](index=91&type=chunk)[94](index=94&type=chunk) - The business must comply with federal and state fraud and abuse laws, such as the Anti-Kickback Statute and the Physician Payments Sunshine Act, as well as data privacy laws like HIPAA and the EU GDPR[97](index=97&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - Healthcare reform, particularly the Inflation Reduction Act (IRA) of 2022, will impact pricing and reimbursement. The IRA directs HHS to negotiate prices for certain high-expenditure Medicare drugs and imposes rebates for price increases that outpace inflation[111](index=111&type=chunk)[223](index=223&type=chunk) [Intellectual Property](index=30&type=section&id=Item%201.%20Business%23Intellectual%20Property) Kodiak protects its technology through patents, trade secrets, and trademarks. As of December 31, 2024, the company holds approximately 14 issued U.S. patents and has 18 pending U.S. applications, along with 49 issued and 63 pending patents internationally. The patent portfolio covers therapeutic conjugates, specific therapeutics like tarcocimab and KSI-501, and components of the ABC Platform. U.S. patents have expiration dates ranging from 2027 to 2040, with pending applications potentially extending to 2044. The company also has 33 pending and issued trademark registrations globally - As of December 31, 2024, Kodiak's patent portfolio includes approximately **14** issued U.S. patents, **18** pending U.S. applications, **49** issued foreign patents, and **63** pending foreign applications[129](index=129&type=chunk) Key U.S. Patent Expiration Dates | Patent Subject | Representative Patent/Application | Anticipated U.S. Expiration | | :--- | :--- | :--- | | Conjugates | US 8,846,021 | 2/28/2027 | | Copolymers (ABC Platform) | US 8,765,432 | 5/10/2030 | | Polymers | US 10,702,608 | 12/21/2034 | | Antibody Conjugate (tarcocimab) | US 11,066,465 | 12/29/2036 | | Fusion Proteins (KSI-501/101) | US Patent No. 12,071,476 | 3/1/2039 | - Issued U.S. patents are projected to expire between **2027** and **2040**. Patents resulting from pending applications could expire between **2030** and **2044**[134](index=134&type=chunk) - The company has **33** pending and issued trademark registrations, including for "Kodiak" and "Kodiak Sciences", to build brand recognition[135](index=135&type=chunk) [Human Capital Management](index=32&type=section&id=Item%201.%20Business%23Human%20Capital%20Management) As of December 31, 2024, Kodiak employed 109 people worldwide, with 10 based outside the U.S. The workforce is heavily focused on research and development, with 74 employees in these roles, 29 of whom hold Ph.D. or M.D. degrees. The company emphasizes competitive compensation, including salary, bonuses, and equity, to attract and retain talent. None of the employees are covered by a collective bargaining agreement - As of December 31, 2024, the company had **109** employees worldwide[136](index=136&type=chunk) - **74** employees are engaged in research, development, and clinical activities, with **29** holding Ph.D. or M.D. degrees[136](index=136&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks inherent in its clinical-stage status, including a history of significant net losses, no approved products, and reliance on the success of its lead candidates tarcocimab, KSI-501, and KSI-101. Key risks include the potential for clinical trial failures, regulatory hurdles, intense competition from established and new therapies, and manufacturing complexities. The company also highlights its dependence on third parties for manufacturing and clinical trials, challenges in protecting its intellectual property, and the need for additional financing to continue operations, which raises substantial doubt about its ability to continue as a going concern - The company is a clinical-stage entity with a limited operating history, no approved products, and has incurred significant net losses since inception, raising substantial doubt about its ability to continue as a going concern[17](index=17&type=chunk)[334](index=334&type=chunk) - The company's prospects are heavily dependent on its lead candidates tarcocimab, KSI-501, and KSI-101. Previous clinical trial failures for tarcocimab (DAZZLE, GLEAM, GLIMMER) highlight the high risk of drug development[144](index=144&type=chunk)[146](index=146&type=chunk) - Kodiak faces significant competition from established players like Roche (Vabysmo) and Regeneron (Eylea HD), which may impede market adoption of its products if approved[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk) - The company relies on third parties, such as Lonza, for manufacturing, which introduces risks related to supply, quality, and cost. It also relies on third parties for conducting clinical trials[246](index=246&type=chunk)[250](index=250&type=chunk) - Failure to obtain additional financing would jeopardize the completion of development and commercialization of its product candidates[339](index=339&type=chunk) [Unresolved Staff Comments](index=89&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[371](index=371&type=chunk) [Cybersecurity](index=89&type=section&id=Item%201C.%20Cybersecurity) Kodiak has implemented an information security program to manage cybersecurity risks, overseen by the Nominating and Corporate Governance Committee of the Board. The program, managed by a digital transformation team under the CFO and CEO, includes technical measures, employee training, vulnerability assessments, and a vendor management process. The company has not identified any cybersecurity threats or incidents that have materially affected or are likely to materially affect its business, operations, or financial condition - The Nominating and Corporate Governance Committee of the Board of Directors is responsible for overseeing cybersecurity risk management[379](index=379&type=chunk) - The company's cybersecurity risk management is implemented by a digital transformation team supervised by the CFO and CEO, utilizing measures like firewalls, multi-factor authentication, employee training, and vulnerability assessments[373](index=373&type=chunk)[375](index=375&type=chunk)[376](index=376&type=chunk)[380](index=380&type=chunk) - The company has not identified any cybersecurity risks or incidents that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[378](index=378&type=chunk) [Properties](index=90&type=section&id=Item%202.%20Properties) Kodiak's principal corporate offices are located in Palo Alto, California, where it leases approximately 155,000 square feet of office, R&D, and lab space across two buildings with lease terms extending to 2027 and 2033, respectively. In March 2025, the company subleased one of these buildings. Additionally, Kodiak leases about 1,000 square meters of office and lab space in Visp, Switzerland, under a 5-year initial term lease - The company leases approximately **155,000 square feet** for its corporate offices in Palo Alto, California[382](index=382&type=chunk) - In March 2025, the company entered into a sublease agreement for its office space at 1200 Page Mill Road, effective until February 2027[383](index=383&type=chunk) - The company leases approximately **1,000 square meters** of office and laboratory space in Visp, Switzerland[384](index=384&type=chunk) [Legal Proceedings](index=90&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings. While it may be subject to various claims in the ordinary course of business, it does not expect any current litigation to have a material adverse effect on its business - As of the report date, the company is not a party to any material legal proceedings[385](index=385&type=chunk) [Mine Safety Disclosures](index=90&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable. The company has no mine safety disclosures - None[386](index=386&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholders Matters and Issuer Purchases of Equity Securities](index=91&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholders%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is traded on the Nasdaq Global Market under the symbol "KOD". As of February 28, 2025, there were approximately 21 holders of record. The company has never paid cash dividends and does not anticipate doing so in the foreseeable future. There were no recent sales of unregistered securities or issuer purchases of equity securities - Common stock trades on the Nasdaq Global Market under the symbol "KOD"[389](index=389&type=chunk) - As of February 28, 2025, there were approximately **21** holders of record of common stock[390](index=390&type=chunk) - The company has never declared or paid cash dividends and does not plan to in the foreseeable future[391](index=391&type=chunk) [Reserved](index=91&type=section&id=Item%206.%20Reserved) Not applicable [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=92&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Kodiak reported a net loss of $176.2 million for 2024, a decrease from the $260.5 million loss in 2023. The reduction was primarily due to an $80.2 million decrease in R&D expenses, driven by reduced manufacturing and clinical activities for tarcocimab. G&A expenses also decreased by $10.3 million. The company ended 2024 with $168.1 million in cash and cash equivalents. Management has stated there is substantial doubt about the company's ability to continue as a going concern and that it will need to raise additional capital to fund operations into 2026 and beyond [Results of Operations](index=98&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%23Results%20of%20Operations) For the year ended December 31, 2024, Kodiak's loss from operations decreased to $186.8 million from $277.3 million in 2023. This was driven by a 39% reduction in R&D expenses to $126.1 million, primarily from lower tarcocimab program costs, and a 14% decrease in G&A expenses to $60.8 million. Interest income fell to $11.1 million due to lower cash balances. The overall net loss for 2024 was $176.2 million, compared to a net loss of $260.5 million in 2023 Results of Operations (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $126,095 | $206,298 | $(80,203) | (39%) | | General and administrative | $60,754 | $71,023 | $(10,269) | (14%) | | **Loss from operations** | **$(186,849)** | **$(277,321)** | **$90,472** | **(33%)** | | Interest income | $11,148 | $16,733 | $(5,585) | (33%) | | **Net loss** | **$(176,207)** | **$(260,491)** | **$84,284** | **(32%)** | - R&D expenses decreased by **$80.2 million (39%)** in 2024, mainly due to a **$51.0 million** reduction in tarcocimab program expenses from reduced manufacturing and clinical activities for completed trials, and a **$19.9 million** decrease in payroll and personnel expenses[442](index=442&type=chunk)[444](index=444&type=chunk) - General and administrative expenses decreased by **$10.3 million (14%)** in 2024, primarily due to lower stock-based compensation expense as previously issued higher-value awards became fully vested[446](index=446&type=chunk) [Liquidity and Capital Resources](index=99&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%23Liquidity%20and%20Capital%20Resources) As of December 31, 2024, Kodiak had $168.1 million in cash and cash equivalents. The company has a history of net losses and negative cash flows, with an accumulated deficit of $1.33 billion. Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as current cash is not sufficient to fund operations for the next 12 months. The company plans to raise additional capital through equity or debt financing or collaborations to continue its R&D activities, but there is no assurance of success. Material cash requirements include operating lease obligations of $88.6 million and manufacturing commitments of $19.4 million, plus potential obligations of 105.3 million Swiss Francs for the Ursus facility - The company had **$168.1 million** in cash and cash equivalents as of December 31, 2024[450](index=450&type=chunk) - Due to recurring net losses and negative cash flows, management has expressed substantial doubt about the company's ability to continue as a going concern, as existing cash may not be sufficient to fund operations for the next 12 months[451](index=451&type=chunk)[505](index=505&type=chunk) - The company plans to raise additional capital to maintain operations. Failure to do so may require pausing, scaling back, or discontinuing development programs[452](index=452&type=chunk) Material Cash Requirements | Commitment | Future Obligation | Due in Next 12 Months | | :--- | :--- | :--- | | Operating Leases | $88.6 million | $14.9 million | | Manufacturing Agreements | $19.4 million | $15.0 million | | Ursus Facility (Potential) | ~105.3 million CHF | N/A | [Quantitative and Qualitative Disclosures About Market Risk](index=103&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risk from changes in interest rates on its cash and cash equivalents, which totaled $168.1 million as of December 31, 2024, and were primarily held in money market funds. Management believes this risk did not have a material impact on the financial statements. Other market risks, such as foreign currency exchange rate risk, are also not considered to have had a significant impact - The company's primary market risk is related to interest rate changes affecting its **$168.1 million** in cash and cash equivalents, which are mainly in money market funds[474](index=474&type=chunk) - Management does not believe that interest rate risk or foreign currency exchange rate risk had a material impact on the consolidated financial statements for the periods presented[474](index=474&type=chunk)[475](index=475&type=chunk) [Financial Statements and Supplementary Data](index=103&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for Kodiak Sciences Inc. as of and for the year ended December 31, 2024, have been audited by PricewaterhouseCoopers LLP. The auditor's report includes an opinion that the financial statements are fairly presented but also highlights substantial doubt about the company's ability to continue as a going concern due to recurring net losses and negative cash flows. The financial statements show a net loss of $176.2 million for 2024 and total assets of $335.6 million as of year-end [Report of Independent Registered Public Accounting Firm](index=104&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data%23Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) PricewaterhouseCoopers LLP issued an audit opinion stating that Kodiak's consolidated financial statements are fairly presented in conformity with U.S. GAAP. However, the report explicitly raises substantial doubt about the company's ability to continue as a going concern, citing its history of net losses and negative cash flows from operations. The audit identified 'Certain Research and Development Costs' as a critical audit matter due to the high degree of auditor effort required - The auditor's report expresses substantial doubt about the Company's ability to continue as a going concern due to its history of net losses and negative cash flows[482](index=482&type=chunk) - The audit identified 'Certain Research and Development Costs' as a critical audit matter, requiring a high degree of auditor effort to test and evaluate[488](index=488&type=chunk)[489](index=489&type=chunk) [Consolidated Financial Statements](index=106&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data%23Consolidated%20Financial%20Statements) The consolidated financial statements detail Kodiak's financial position and performance. The Balance Sheet shows total assets of $335.6 million and total liabilities of $185.3 million as of Dec 31, 2024. The Statement of Operations reports a net loss of $176.2 million for 2024, an improvement from the $260.5 million loss in 2023. The Statement of Cash Flows indicates net cash used in operating activities was $117.3 million in 2024, leading to a year-end cash and cash equivalents balance of $168.1 million Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $168,074 | $285,507 | | Total current assets | $171,936 | $289,309 | | Total assets | $335,578 | $479,372 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $25,573 | $41,729 | | Total liabilities | $185,290 | $213,591 | | Total stockholders' equity | $150,288 | $265,781 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | :--- | | Research and development | $126,095 | $206,298 | $267,591 | | General and administrative | $60,754 | $71,023 | $73,788 | | **Loss from operations** | **$(186,849)** | **$(277,321)** | **$(341,379)** | | **Net loss** | **$(176,207)** | **$(260,491)** | **$(333,823)** | | Net loss per share | $(3.35) | $(4.97) | $(6.39) | Consolidated Statement of Cash Flows Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(117,319) | $(154,183) | | Net cash provided by (used in) investing activities | $(755) | $249,226 | | Net cash provided by financing activities | $501 | $31 | | **Net (decrease) increase in cash** | **$(117,573)** | **$95,074** | [Notes to Consolidated Financial Statements](index=110&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data%23Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed explanations of the company's accounting policies and financial figures. Key disclosures include the 'Liquidity' section (Note 1), which reiterates the substantial doubt about the company's ability to continue as a going concern. 'Commitments and Contingencies' (Note 8) details significant lease and manufacturing obligations. 'Stock-Based Compensation' (Note 12) outlines the various equity plans, including the 2021 LTPIP, and reports a total stock-based compensation expense of $60.2 million for 2024. 'Liability related to Sale of Future Royalties' (Note 16) describes the $100 million liability from the 2019 funding agreement with BBA, for which royalty payments are not yet probable or estimable - Note 1 (Liquidity) states that existing cash may not be sufficient to meet operating requirements for the next 12 months, resulting in substantial doubt about the company's ability to continue as a going concern[505](index=505&type=chunk) - Note 8 (Commitments) discloses future undiscounted operating lease payments of **$88.6 million** and manufacturing agreement obligations of **$19.4 million** as of Dec 31, 2024[564](index=564&type=chunk)[568](index=568&type=chunk) - Note 12 (Stock-Based Compensation) reports total stock-based compensation expense of **$60.2 million** in 2024, down from **$88.6 million** in 2023. As of Dec 31, 2024, there was **$115.7 million** of unrecognized compensation expense related to unvested awards[611](index=611&type=chunk) - Note 16 (Liability related to Sale of Future Royalties) confirms the **$100 million** liability from the funding agreement with BBA. As of Dec 31, 2024, royalty payments are not yet considered probable and estimable, so no interest expense has been accreted[622](index=622&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosures](index=128&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosures) The company reports no changes in or disagreements with its accountants on accounting and financial disclosures - None[625](index=625&type=chunk) [Controls and Procedures](index=128&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of December 31, 2024. Management also assessed the internal control over financial reporting based on the COSO framework and concluded it was effective. There were no material changes to internal controls during the fourth quarter of 2024. As a non-accelerated filer, an auditor attestation on internal controls is not required - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024[627](index=627&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[628](index=628&type=chunk) - No material changes were made to the internal control over financial reporting during the quarter ended December 31, 2024[629](index=629&type=chunk) [Other Information](index=128&type=section&id=Item%209B.%20Other%20Information) The company reports no other information - None[631](index=631&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=128&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) Not applicable Part III [Directors, Executive Officers and Corporate Governance](index=129&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders, which will be filed within 120 days of the fiscal year-end. The company has adopted a Code of Business Conduct and Ethics, which is available on its website - This section incorporates information by reference from the company's forthcoming Proxy Statement[635](index=635&type=chunk) [Executive Compensation](index=129&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive and director compensation is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[638](index=638&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholders Matters](index=129&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholders%20Matters) Information regarding security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[639](index=639&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=129&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[640](index=640&type=chunk) [Principal Accountant Fees and Services](index=129&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[641](index=641&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=130&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Form 10-K. The consolidated financial statements are filed under Item 8, and all financial statement schedules are omitted as inapplicable. The exhibit index lists various corporate documents, agreements, and certifications, including the company's certificate of incorporation, bylaws, equity plans, material contracts such as the funding agreement with Baker Bros. and leases, and required certifications by the CEO and CFO - The consolidated financial statements are filed under Item 8 of this report[644](index=644&type=chunk) - All financial statement schedules have been omitted as they are not applicable or the required information is included in the financial statements[645](index=645&type=chunk) [Form 10-K Summary](index=133&type=section&id=Item%2016.%20Form%2010-K%20Summary) No Form 10-K summary is provided - None[649](index=649&type=chunk)