| --- | --- | |---------------------------------------------------------------------------------------------------------|-------| | | | | | | | KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for Retinal Vein Occlusion: | | | Primary 24-Week Efficacy and Safety Outcomes of the BEACON Phase 3 Pivotal Study | | | Arshad M. Khanani, M.D., M.A., FASRS Director of Clinical Research, Sierra Eye Associates, Reno, NV USA | | | on behalf of the BEACON Study Group | | 2 September 2022 Disclosures | --- | --- | |----- ...

NASDAQ: KOD KODIAK.COM | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------------------------------------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | KO | | | | | | | | | | | THE OPHTHALMOLOGY MEDICINES COMPANY | | | | | | | | | | Corporate Presentation | | | | | | | | | | August 2022 | | | | | | | | --- ...

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, 2022 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 ...

Financial Position - Kodiak Sciences has $671.7 million in cash and cash equivalents as of March 31, 2022[67]. - As of March 31, 2022, the company had cash and cash equivalents of $671.7 million, which is expected to be sufficient for at least the next 12 months[97][98]. - The company has an accumulated deficit of $653.9 million as of March 31, 2022, indicating ongoing financial challenges[98]. - Net cash used in operating activities was $43.2 million for the three months ended March 31, 2022, compared to $34.6 million in the same period of 2021[106]. - The company incurred net cash used in investing activities of $18.3 million for the three months ended March 31, 2022, mainly for property and equipment purchases[107]. - The company has not generated any product revenue to date and does not expect to do so until regulatory approval and commercialization of its product candidates[100]. Clinical Trials and Research - KSI-301 is being investigated in five registrational clinical trials targeting high-prevalence retinal diseases[65]. - The BEACON study for KSI-301 has enrolled over 550 patients and expects to announce top-line data in August 2022[71]. - GLEAM and GLIMMER studies have enrolled approximately 450 patients each and expect to announce top-line data in mid-2023[72]. - The DAYLIGHT study has completed enrollment of approximately 550 patients and expects to announce top-line data in mid-2023[73]. - KSI-501 is targeting a group estimated to be 30% of treated patients who are suboptimal anti-VEGF responders[66]. - Kodiak plans to submit an IND for KSI-501 in the second half of 2022[78]. - The overall rate of missed study visits across ongoing studies remains less than 5%[80]. Expenses and Losses - For the three months ended March 31, 2022, the company reported a net loss of $95.7 million, compared to a net loss of $50.4 million for the same period in 2021, representing an increase in losses of $45.3 million[90]. - Research and development expenses totaled $76.2 million for the three months ended March 31, 2022, up from $40.3 million in 2021, marking a 88.8% increase[91]. - KSI-301 program expenses increased by $17.2 million to $40.7 million in Q1 2022, primarily due to clinical trial costs and manufacturing progress[92]. - Payroll and personnel expenses rose by $11.6 million to $21.2 million in Q1 2022, largely driven by increased stock-based compensation[94]. - General and administrative expenses are expected to increase due to higher personnel costs and compliance-related expenses[87]. - General and administrative expenses increased by $9.4 million to $19.6 million in Q1 2022, primarily due to stock-based compensation[96].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) Delaware 27-0476525 (State or other jurisdiction of 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, 2021 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.COM NASDAQ: KOD THE OPHTHALMOLOGY MEDICINES COMPANY January 2022 1 S P E C I A L N O T E R E G A R D I N G | --- ...

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 | --- ...