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 | --- ...

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 September 30, 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 SCIENCES INC. (Exact Name of Registrant as Specified in its Charter) Delaware 27-0476525 (S ...

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 ...

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 March 31, 2021 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 other jurisdiction of incorporation or organization) 1200 Page Mill Road Palo Alto, CA 943 ...

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 ...

NASDAQ: KOD KODIAK.COM | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|--------------------------------------------------------------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | THE OPHTHALMOLOGY MEDICINES COMPANY | | | | | | | | | | | | | | | | | | | | J.P. Morgan Annual Healthcare Conference Jan uary 11, 2 02 1 | | | | | | | 2 | --- ...

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].