PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents the unaudited condensed consolidated financial statements, including balance sheets, operations, equity, and cash flows, with key notes on accounting policies and commitments [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Compares assets, liabilities, and equity between September 30, 2021, and December 31, 2020, showing a decrease in cash and an increase in the accumulated deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $799,247 | $944,396 | | Total current assets | $805,506 | $972,005 | | Total assets | $958,206 | $1,067,347 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $54,396 | $31,422 | | Total liabilities | $231,886 | $206,596 | | Accumulated deficit | $(465,052) | $(291,227) | | Total stockholders' equity | $726,320 | $860,751 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details operating expenses and net loss for Q3 and the first nine months of 2021, highlighting increased R&D and G&A expenses leading to a larger net loss Operating Results Comparison (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $56,002 | $29,306 | $141,743 | $70,033 | | General and administrative | $11,533 | $7,357 | $32,259 | $19,132 | | **Loss from operations** | **$(67,535)** | **$(36,663)** | **$(174,002)** | **$(89,165)** | | **Net loss** | **$(67,526)** | **$(36,122)** | **$(173,825)** | **$(86,513)** | | Net loss per share | $(1.30) | $(0.80) | $(3.36) | $(1.92) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Tracks changes in stockholders' equity, showing a decrease from $860.8 million to $726.3 million driven by the period's net loss - The accumulated deficit grew from **$291.2 million** at the end of 2020 to **$465.1 million** by September 30, 2021, due to continued net losses[23](index=23&type=chunk) - Total stockholders' equity decreased from **$860.8 million to $726.3 million** during the first nine months of 2021[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash flows for the first nine months of 2021, highlighting significant cash use in operating and investing activities Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(123,235) | $(56,409) | | Net cash (used in) provided by investing activities | $(27,939) | $45,976 | | Net cash provided by financing activities | $6,025 | $101,096 | | **Net (decrease) increase in cash** | **$(145,149)** | **$90,663** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides details on liquidity, manufacturing commitments with Lonza, stock-based compensation, and the new Long-Term Performance Incentive Plan (LTPIP) - As of September 30, 2021, the company had **$799.2 million in cash and cash equivalents** and believes this is sufficient to fund operations for at least the next 12 months[28](index=28&type=chunk) - The company amended its manufacturing agreement with Lonza, committing to a revised capital contribution of approximately **75.0 million Swiss Francs** for a custom-built facility for KSI-301[46](index=46&type=chunk) - On October 13, 2021, stockholders approved the 2021 Long-Term Performance Incentive Plan (LTPIP), reserving **5,502,334 shares** for issuance under the plan[66](index=66&type=chunk) - Total unrecognized stock-based compensation cost was **$122.4 million** as of September 30, 2021, expected to be recognized over a weighted-average period of 2.8 years[64](index=64&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical development of KSI-301, financial results, liquidity, and commercialization strategy, noting rising R&D expenses drive net losses [Overview & Recent Updates](index=18&type=section&id=Overview%20%26%20Recent%20Updates) Details progress on pivotal trials for lead candidate KSI-301, manufacturing investments, and key regulatory milestones including IND approval in China - The company is developing its lead therapy, KSI-301, in **six registrational clinical trials** for high-prevalence retinal diseases, aiming for a broad product label[74](index=74&type=chunk) - As of September 30, 2021, the company was well-capitalized with over **$799.2 million in cash**[76](index=76&type=chunk) - Key data readouts are expected to begin in early 2022, with **DAZZLE in Q1 2022**, **BEACON in mid-2022**, and **DAYLIGHT/GLEAM/GLIMMER in early 2023**[82](index=82&type=chunk) - Investigational New Drug (IND) applications for KSI-301 in RVO and DME were **approved by China's NMPA**, allowing enrollment of Chinese patients into global studies[88](index=88&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Analyzes the significant increase in operating expenses, driven primarily by rising R&D costs for the KSI-301 program's Phase 3 trials R&D Expense Breakdown (in thousands) | Expense Category | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | Change | | :--- | :--- | :--- | :--- | | KSI-301 program expenses | $89,557 | $37,587 | +$51,970 | | Payroll and personnel expenses | $30,483 | $20,850 | +$9,633 | | **Total R&D expenses** | **$141,743** | **$70,033** | **+$71,710** | - The increase in KSI-301 program expenses was primarily due to clinical trial costs for ongoing pivotal studies (GLEAM, GLIMMER, BEACON) and the initiation of a new Phase 3 study (DAYLIGHT)[103](index=103&type=chunk) - General and administrative expenses increased by **$13.1 million** for the nine months ended September 30, 2021, compared to 2020, driven by higher headcount, stock-based compensation, and professional services[106](index=106&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's financial position, highlighting sufficient capital from equity sales despite significant net losses and cash used in operations - The company has funded its operations primarily through the sale of equity securities and had cash and cash equivalents of **$799.2 million** as of September 30, 2021[107](index=107&type=chunk) - For the nine months ended September 30, 2021, the company had a **net loss of $173.8 million** and an **accumulated deficit of $465.1 million**[108](index=108&type=chunk) - Net cash used in operating activities increased to **$123.2 million** for the nine months ended Sep 30, 2021, from $56.4 million in the prior-year period, driven by increased R&D costs[114](index=114&type=chunk)[115](index=115&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Confirms no material changes to market risk disclosures since the last Annual Report on Form 10-K - No material changes to market risk disclosures were reported since the Annual Report on Form 10-K for the year ended December 31, 2020[124](index=124&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concludes that disclosure controls and procedures were effective and notes no material changes to internal controls over financial reporting - Management concluded that the company's **disclosure controls and procedures were effective** as of September 30, 2021[126](index=126&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[127](index=127&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) Reports no pending legal actions that could materially and adversely affect the company's financial condition - As of the report date, there are **no pending legal proceedings** that could materially harm the company[129](index=129&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) Outlines key risks including dependence on a single product, clinical trial uncertainties, significant competition, and complex manufacturing dependencies - The company's prospects are **heavily dependent on its single clinical-stage product candidate, KSI-301**; a failure in its clinical development could require the company to discontinue other product candidates based on its ABC Platform[131](index=131&type=chunk)[135](index=135&type=chunk) - The company faces **significant competition** from major pharmaceutical companies like Roche, Regeneron, and Novartis, which have established products and greater resources; Roche's product candidate, faricimab, is identified as an important future competitor[164](index=164&type=chunk)[165](index=165&type=chunk) - Manufacturing biologics like KSI-301 is **highly complex and reliant on third-party manufacturers** such as Lonza; the company has no commercial-scale manufacturing experience and faces risks of production difficulties and supply chain disruptions[168](index=168&type=chunk)[172](index=172&type=chunk)[231](index=231&type=chunk) - The **COVID-19 pandemic continues to pose risks** to clinical trial enrollment, manufacturing, and supply chains, with the ultimate impact remaining uncertain[302](index=302&type=chunk)[303](index=303&type=chunk)[306](index=306&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=71&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales of equity securities during the reporting period - None reported[340](index=340&type=chunk) [Defaults Upon Senior Securities](index=71&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Reports no defaults upon senior securities during the period - None reported[341](index=341&type=chunk) [Mine Safety Disclosures](index=71&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[342](index=342&type=chunk) [Other Information](index=71&type=section&id=Item%205.%20Other%20Information) Reports no other material information for disclosure in this item - None reported[343](index=343&type=chunk) [Exhibits](index=72&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the report, including Sarbanes-Oxley certifications and the 2021 Long-Term Performance Incentive Plan - Key exhibits filed include **CEO and CFO certifications** (Exhibits 31.1, 31.2, 32.1, 32.2) and the **2021 Long-Term Performance Incentive Plan** (Exhibit 10.1)[345](index=345&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Address of principal executive offices) (Zip Code) For the transition period from __________ to _________ Registrant's telephone number, including area code: (650) 281-0850 Commission File Nu ...

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For the quarter ended March 31, 2021, Kodiak Sciences reported a net loss of $50.4 million, an increase from a $24.4 million loss in the same period of 2020, driven by a significant rise in R&D expenses [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2021, the company's total assets were $1.03 billion, a slight decrease from $1.07 billion at the end of 2020 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $920,461 | $944,396 | | Total current assets | $931,897 | $972,005 | | Total assets | $1,032,734 | $1,067,347 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $35,058 | $31,422 | | Total liabilities | $211,057 | $206,596 | | Total stockholders' equity | $821,677 | $860,751 | | Total liabilities and stockholders' equity | $1,032,734 | $1,067,347 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2021, the company reported a net loss of $50.4 million, or ($0.98) per share, compared to a net loss of $24.4 million, or ($0.54) per share, for the same period in 2020 Condensed Consolidated Statements of Operations (in thousands, except per share data) | Account | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $40,337 | $20,170 | | General and administrative | $10,221 | $5,553 | | **Total operating expenses** | **$50,558** | **$25,723** | | Loss from operations | ($50,558) | ($25,723) | | **Net loss** | **($50,447)** | **($24,392)** | | Net loss per common share, basic and diluted | ($0.98) | ($0.54) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first three months of 2021, net cash used in operating activities was $34.6 million, a significant increase from $17.9 million in the prior-year period, reflecting higher R&D and personnel costs Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($34,625) | ($17,932) | | Net cash provided by (used in) investing activities | $9,218 | ($67,197) | | Net cash provided by financing activities | $1,472 | $99,788 | | **Net decrease in cash, cash equivalents and restricted cash** | **($23,935)** | **$14,659** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes to the financial statements highlight the company's liquidity, commitments, and subsequent events, including sufficient cash for the next 12 months and amended manufacturing agreements - As of March 31, 2021, the company had **$929.0 million** in cash, cash equivalents, and marketable securities, which it believes is sufficient to meet anticipated operating and capital expenditure requirements for the next 12 months[27](index=27&type=chunk) - The company has a manufacturing agreement with Lonza for the supply of KSI-301, involving a capital contribution and annual suite fees. The initial agreement required a capital contribution of **40 million Swiss Francs** and annual fees starting at **12 million Swiss Francs**[46](index=46&type=chunk) - In April 2021, the company amended its agreement with Lonza, increasing the maximum capital contribution to **74.5 million Swiss Francs**. The manufacturing suite fee is now **14.5 million Swiss Francs** for 2022 and **20.0 million Swiss Francs** annually thereafter through 2029[64](index=64&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $5,399 | $3,448 | | General and administrative | $4,526 | $2,634 | | **Total** | **$9,925** | **$6,082** | [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 the significant progress and expansion of the KSI-301 pivotal program, including the addition of the DAYLIGHT study to support a broader label, while maintaining a strong liquidity position [Overview](index=17&type=section&id=Overview) Kodiak is a biopharmaceutical company focused on developing next-generation therapeutics for high-prevalence retinal diseases using its proprietary ABC Platform™ - The company's core technology is its **ABC Platform™**, which uses molecular engineering to merge antibody-based and chemistry-based therapies[67](index=67&type=chunk) - The most advanced product candidate is **KSI-301**, a novel anti-VEGF therapy designed for extended intraocular effectiveness to treat major retinal diseases like wet AMD, DME, RVO, and DR[68](index=68&type=chunk) [Recent Updates](index=17&type=section&id=Recent%20Updates) The company expanded its KSI-301 pivotal program with the DAYLIGHT study, adjusted the BLA submission timeline to early 2023 due to enrollment and manufacturing delays, and expanded its manufacturing agreement with Lonza - A new pivotal study, **DAYLIGHT**, is being added to evaluate monthly dosing of KSI-301 in wet AMD patients. This is intended to broaden the potential product label to include more frequent dosing for high-need patients and eliminate potential reimbursement barriers[76](index=76&type=chunk)[77](index=77&type=chunk) - The timeline for the Biologics License Application (BLA) has been adjusted to **early 2023**. This is due to slightly slower enrollment in DME trials (GLEAM/GLIMMER), the addition of the DAYLIGHT study, and manufacturing headwinds from competition with COVID-19 vaccine production[85](index=85&type=chunk) - The bioconjugation agreement with Lonza has been expanded, increasing the estimated capital contribution to **74.5 million Swiss Francs** and boosting annual manufacturing capacity by **70%**. Construction of the facility is now targeted for completion in **early 2022**, delayed from late 2021 due to COVID-19 related resource limitations[83](index=83&type=chunk)[84](index=84&type=chunk) - In January 2021, the company submitted Investigational New Drug (IND) applications for KSI-301 in RVO and DME to China's NMPA, which could allow for enrollment of patients from China in global studies[87](index=87&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Operating expenses for Q1 2021 more than doubled to $50.6 million from $25.7 million in Q1 2020, primarily driven by a significant increase in research and development expenses for ongoing pivotal trials Comparison of Operating Results (in thousands) | Expense Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $40,337 | $20,170 | $20,167 | | General and administrative | $10,221 | $5,553 | $4,668 | | **Loss from operations** | **($50,558)** | **($25,723)** | **($24,835)** | Research and Development Expenses Breakdown (in thousands) | Program | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :--- | :--- | :--- | :--- | | KSI-301 program expenses | $23,486 | $12,285 | $11,201 | | KSI-501 program expenses | $1,665 | $75 | $1,590 | | Payroll and personnel expenses | $9,613 | $5,888 | $3,725 | | **Total R&D expenses** | **$40,337** | **$20,170** | **$20,167** | [Liquidity and Capital Resources; Plan of Operations](index=22&type=section&id=Liquidity%20and%20Capital%20Resources%3B%20Plan%20of%20Operations) The company maintains a strong liquidity position with $929.0 million in cash and marketable securities, sufficient to fund operations for at least the next 12 months, despite ongoing significant losses from clinical program advancements - As of March 31, 2021, the company had cash, cash equivalents and marketable securities of **$929.0 million**[105](index=105&type=chunk) - The company incurred a net loss of **$50.4 million** for the three months ended March 31, 2021, and had an accumulated deficit of **$341.7 million**[106](index=106&type=chunk) - The company has not generated any product revenue and expects to incur significant losses for the foreseeable future as it continues development and seeks regulatory approvals[108](index=108&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reported no material changes to its market risk disclosures during the three months ended March 31, 2021, as compared to the disclosures in its Annual Report on Form 10-K for the year ended December 31, 2020 - There were no material changes to the company's market risk disclosures during the first quarter of 2021[121](index=121&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes in internal control over financial reporting during the quarter - The company's principal executive officer and principal financial officer concluded that the design and operation of disclosure controls and procedures were effective as of March 31, 2021[123](index=123&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2021, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[124](index=124&type=chunk) [PART II. OTHER INFORMATION](index=26&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) As of the report date, the company states that there are no pending claims or actions against it that would be expected to have a material adverse effect on its financial condition or results of operations - The company is not currently involved in any legal proceedings that could have a material adverse effect on its business[127](index=127&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company outlines extensive risks, with a heavy emphasis on its dependence on the single clinical-stage product, KSI-301, and the impact of the COVID-19 pandemic on manufacturing timelines - The company's prospects are heavily dependent on its single clinical product candidate, **KSI-301**, and a failure in its clinical development could require discontinuation of other candidates based on the same ABC Platform[129](index=129&type=chunk)[133](index=133&type=chunk) - The COVID-19 pandemic continues to impact the business, particularly by creating competition for scarce manufacturing resources (materials, personnel, production slots) with vaccine and therapeutic programs, which has already caused delays to commercial manufacturing timelines[290](index=290&type=chunk)[291](index=291&type=chunk) - The company is aware of a pending patent application from a third party that, if issued, could have a patent term beyond the intended launch date of KSI-301, potentially requiring Kodiak to challenge the patent, obtain a license, modify its product, or delay launch[258](index=258&type=chunk) - The company has no experience manufacturing at a commercial scale and relies on third-party manufacturers. Difficulties in production or failure to meet regulatory standards could delay or stop the supply of its product candidates[167](index=167&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[327](index=327&type=chunk) [Defaults Upon Senior Securities](index=67&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[328](index=328&type=chunk) [Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[329](index=329&type=chunk) [Other Information](index=67&type=section&id=Item%205.%20Other%20Information) The company disclosed its intention to file a Form S-3 registration statement to allow the Baker Entities to sell shares of common stock, with CEO Victor Perlroth electing not to include his shares in this filing - The company will file a Form S-3 registration statement to allow the Baker Entities (affiliated with director Felix Baker) to sell shares of common stock. CEO Victor Perlroth has elected not to include his shares in this filing[330](index=330&type=chunk) [Exhibits](index=68&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002, and Inline XBRL documents

NASDAQ: KOD KODIAK.COM | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|---------------------------------------------------------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | THE OPHTHALMOLOGY MEDICINES COMPANY | | | | | | | | | | Barclays Global Healthcare Conference M arch 10, 2 02 1 | | | | | | | 2 | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _________ Commission File Number: 001-38682 KODIAK SCIENCES INC. (Exact Name of Registrant as Specified in its Charter) Delaware 27-0476525 (State or o ...

Clinical Development - KSI-301 has been administered over 1,500 times to more than 400 patients, representing over 250 patient-years of clinical experience[83]. - The ongoing Phase 1b study continues to show promising safety, efficacy, and clinical durability data for KSI-301 in retinal diseases[84]. - The company has initiated two Phase 3 studies in DME (GLEAM and GLIMMER) and one Phase 3 study in RVO (BEACON) in the third quarter of 2020[91]. - The pivotal study for wet AMD (DAZZLE) completed U.S. patient enrollment in the third quarter of 2020, with EU recruitment expected to complete in Q4 2020[85]. - The company has expanded its clinical pivotal program for KSI-301 based on encouraging data from the Phase 1b study[85]. - The ongoing Phase 1b study has provided over 140 patient-years of clinical experience, with data supporting KSI-301's differentiated profile in terms of safety and efficacy[110]. - Improvements in vision and retinal anatomy have been observed through 44 weeks of follow-up in the Phase 1b study, with stability in OCT and BCVA over time[113]. - The average gain in BCVA for wet AMD patients from baseline to week 12 was 6.7 letters, with an improvement in OCT CST of 93 microns[117]. - 92% of wet AMD patients achieved a time to first retreatment of three months or longer, with 72% achieving a six-month treatment interval at least once during follow-up[122]. - In the diabetic macular edema (DME) cohort, 97% of patients went three months or longer before their first retreatment, with 79% achieving a six-month or longer treatment-free interval at least once[128]. - KSI-301 demonstrated a mean change in BCVA of 6.6 letters and a mean change in OCT CST of -132 microns in DME patients at week 44[131]. - In the retinal vein occlusion (RVO) cohort, patients experienced a mean improvement of 22.4 letters in BCVA and a decrease of 370 microns in OCT CST after three loading doses[133]. - 94% of RVO patients went two months or longer before their first retreatment, with 66% achieving a first interval of three months or longer[135]. - The ongoing DAZZLE study for wet AMD aims for a non-inferiority comparison to Eylea, with a primary endpoint at one year[145]. - The pivotal studies for KSI-301 have been optimized based on Phase 1b data, with enrollment expected to complete by the end of 2020[143]. - The company is conducting two Phase 3 studies, GLEAM and GLIMMER, with 450 treatment-naïve DME patients each, comparing KSI-301 and Eylea, with a primary endpoint of BCVA change at one year[150]. - In the BEACON study, 550 treatment-naïve RVO patients will be randomized to KSI-301 every 8 weeks or monthly Eylea, with a primary endpoint at six months and a non-inferiority margin of 4.5 letters[159]. Financial Position - As of September 30, 2020, the company has $380.5 million in cash, cash equivalents, and marketable securities, ensuring a strong financial position[90]. - The company remains well-capitalized and supported by long-term investors, allowing for flexibility in R&D and commercial decision-making[104]. - As of September 30, 2020, the company reported a net loss of $86.5 million for the nine months ended, with an accumulated deficit of $244.6 million[169]. - Research and development expenses for the three months ended September 30, 2020, were $29.3 million, compared to $10.1 million for the same period in 2019, reflecting an increase of 189%[178]. - General and administrative expenses for the nine months ended September 30, 2020, were $19.1 million, compared to $10.8 million for the same period in 2019[178]. - The company expects operating losses to increase significantly as it advances KSI-301 through clinical development and seeks regulatory approval[170]. - Operating activities used $56.4 million in cash for the nine months ended September 30, 2020, an increase of $28.6 million compared to 2019[195]. - Cash provided by financing activities increased by $100.7 million for the nine months ended September 30, 2020, due to proceeds from the sale of future royalties and stock option exercises[197]. - The company has not generated any product revenue since inception and relies on equity securities for funding operations[168]. - The company has not generated any product revenue and does not expect to until regulatory approval is obtained for its product candidates[189]. Manufacturing and Operations - A long-term manufacturing agreement with Lonza has been established, allowing for the production of millions of doses per year, with the facility expected to be completed in 2021[98]. - The company plans to continue using third-party CROs for clinical development and has invested in commercial manufacturing capacity[167]. - The ongoing COVID-19 pandemic may negatively impact the company's operations and capital resources, although it continues to advance its operations[192]. - The company aims to submit a single Biologics License Application (BLA) for KSI-301 in wet AMD, DME, and RVO in calendar year 2022[85]. - Kodiak aims to submit a single BLA for KSI-301 in wet AMD, DME, and RVO in 2022, with a supplemental BLA for diabetic retinopathy (GLOW) planned for 2023[105]. - The company has initiated two Phase 3 studies in DME (GLEAM and GLIMMER) and one Phase 3 study in RVO (BEACON), with high statistical power for non-inferiority (>90%) in these studies[98]. - The BEACON study design incorporates tighter disease activity assessment criteria compared to Phase 1b, aiming for high statistical power for non-inferiority (>90%)[162]. Corporate Developments - Kodiak's new U.S. headquarters spans approximately 82,662 square feet in Palo Alto, California, along with additional space in Switzerland for manufacturing support[98]. - The ABC Platform is being utilized to develop additional product candidates, including KSI-501, targeting high-prevalence ophthalmic diseases[88].

NASDAQ: KOD KODIAK.COM | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------------------------------------|--------------------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | THE OPHTHALMOLOGY MEDICINES COMPANY | | | | | | | | | | | | | | | | | | | | | Corporate Presentation S ep t ember 2 02 0 | | | | | | 2 | --- ...

(Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _________ Commission File Number: 001-38682 KODIAK SCIENCES INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdictio ...

Extended Durability in Exudative Retinal Diseases Using the Novel Intravitreal Anti-VEGF Antibody Biopolymer Conjugate KSI-301 1 Update from Phase 1b Study in Patients with wAMD, DME and RVO Mark R. Barakat, MD Retinal Consultants of Arizona Phoenix, AZ American Society of Retina Specialists 2020 July 10, 2020 Disclosures 2 ▪ Financial: AlconC Kodiak SciencesC AllegroC GenentechBC AllerganC NovartisBC AlimeraC NeuBaseS Bausch and LombC Ocular TherapeutixC Clearside BiomedicalC OxurionS EyePoint Pharmaceutic ...

Financial Data and Key Metrics Changes - As of the end of Q1 2020, the company reported over $430 million in cash, cash equivalents, and marketable securities, with a net loss of $24.4 million, including non-cash expenses of approximately $6 million [8][15][9] - The monthly burn rate for the quarter was $6 million, indicating a strong financial position to support operations into 2022 [15][9] Business Line Data and Key Metrics Changes - The company plans to conduct two Phase 3 studies in Diabetic Macular Edema (DME) and one study in wet Age-related Macular Degeneration (AMD), along with one study in Retinal Vein Occlusion (RVO) and one in non-proliferative Diabetic Retinopathy (NPDR) [19][47] - The DAZZLE study has enrolled 245 patients as of May 8, 2020, with a robust recruitment rate prior to the pandemic [32][33] Market Data and Key Metrics Changes - The company is observing a shift in patient enrollment dynamics due to COVID-19, with a noted decline in overall ophthalmology outpatient visits but an increase in visits for anti-VEGF therapy [29][30] - The company expects to begin patient recruitment activities at certain sites in Europe in Q2 2020, contingent on local COVID-19 conditions [36] Company Strategy and Development Direction - The company aims for a single Biologics License Application (BLA) covering key retinal indications by 2022, with a focus on optimizing pivotal study designs and engaging with regulators [10][18] - The strategic shift to focus on DME studies is driven by the higher prevalence and unmet need in this area compared to RVO [22][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing operations despite COVID-19, noting minimal disruption and continued patient enrollment in clinical trials [13][14] - The company remains committed to its 2022 Vision and is utilizing the additional time to enhance pivotal study plans [18][39] Other Important Information - The company has made significant additions to its Board of Directors, enhancing its expertise in pharmaceutical development and financial management [41] - The company received full registration of its trademarks with the U.S. Patent and Trademark Office, reinforcing its brand recognition in retinal disease treatment [42] Q&A Session Summary Question: How does the company view competition from additional biosimilars in the retinal market? - Management believes that KSI-301's differentiated profile will allow it to capture market share, even in the presence of biosimilars, by offering a better treatment option for patients [78][81] Question: What is the confidence level regarding the completion of enrollment for the AMD study? - Management noted that enrollment rates were robust prior to the pandemic and expect an increase as conditions improve, with a focus on maintaining a balanced approach to U.S. and ex-U.S. patient recruitment [92][94] Question: How sustainable is the current monthly burn rate? - The company indicated that the $6 million monthly burn rate is sustainable in the short term, but it will increase as new pivotal studies are initiated [114]