Kodiak Sciences Inc. (KOD) reported first-quarter 2024 loss per share of 82 cents, narrower than the Zacks Consensus Estimate of a loss of $1.09. The company had incurred a loss of $1.35 per share in the year-ago quarter. Currently, KOD does not have any approved products in its portfolio. As a result, it is yet to generate revenues. Quarter in Detail Research and development expenses were $29.9 million in the reported quarter, down 47% year over year. The decrease was mainly due to the reduction in expense ...

Financial Performance - Kodiak Sciences reported a net loss of $43.0 million for the three months ended March 31, 2024, a decrease of $27.7 million compared to a net loss of $70.8 million in the same period of 2023[83]. - Net cash used in operating activities was $39.6 million for the three months ended March 31, 2024, compared to $47.2 million for the same period in 2023[97]. - The company experienced a net decrease in cash, cash equivalents, and restricted cash of $39.7 million for the three months ended March 31, 2024, following a net increase of $126.2 million in the same period of the previous year[96]. - The company has an accumulated deficit of $1,195.6 million as of March 31, 2024[90]. Research and Development - Research and development expenses totaled $29.9 million for the three months ended March 31, 2024, down $26.6 million from $56.5 million in the same period of 2023[84]. - Tarcocimab program expenses decreased by $20.2 million to $5.9 million in Q1 2024, primarily due to reduced clinical activities[84]. - KSI-501 program expenses increased by $1.4 million to $2.2 million in Q1 2024, attributed to increased manufacturing activities[85]. - Kodiak intends to conduct two additional Phase 3 clinical studies with tarcocimab, with the first patients treated in the GLOW2 study[71][73]. - The Phase 3 DAYBREAK study for KSI-501 is scheduled to begin patient screening in mid-2024, evaluating its efficacy and durability in wet AMD[67][76]. - KSI-101 is being developed for retinal inflammatory diseases, with plans to initiate a Phase 1b APEX study in June 2024[78]. - Kodiak has not generated any product revenue to date and does not expect to until regulatory approval is obtained for its product candidates[92]. Operational Challenges - The company continues to face significant uncertainties due to public health crises, geopolitical conflicts, inflation, and supply chain disruptions, which may adversely affect operations and capital resources[94]. - Adequate additional funding may not be available on acceptable terms, potentially impacting the company's financial condition and business strategies[95]. - The company may need to delay, reduce, or terminate some or all of its development programs and clinical trials if unable to raise additional funds when needed[95]. - Future debt financing may impose additional covenants that could restrict operations, including limitations on incurring additional debt and engaging in certain transactions[95]. Financial Reporting and Compliance - The company has not experienced material changes in its contractual obligations and commitments since December 31, 2023[98]. - There were no material changes to critical accounting policies during the three months ended March 31, 2024, as reported in the Annual Report for the year ended December 31, 2023[100]. - The company continues to monitor the impact of external events on the development and commercialization of its product candidates[94].

Exhibit 99.1 Kodiak Sciences Announces Recent Business Highlights and First Quarter 2024 Financial Results Palo Alto, CA — May 15, 2024 – Kodiak Sciences Inc. (Nasdaq: KOD), today reported business highlights and financial results for the quarter ended March 31, 2024. "We continue to make excellent operational progress with our three clinical programs of tarcocimab, KSI-501 and KSI-101, as well as on our duet and triplet research programs," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Scien ...

PALO ALTO, Calif., May 13, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases, announced today that the first patients with diabetic retinopathy (DR) have been treated in the randomized double masked Phase 3 GLOW2 study of tarcocimab tedromer. GLOW2 is the second Phase 3 study of tarcocimab in diabetic retinopathy in which all patients on invest ...

Kodiak Sciences Inc. (NASDAQ:KOD) Q4 2023 Results Conference Call March 28, 2024 4:30 PM ET Company Participants John Borgeson - CFO Victor Perlroth - Chairman and CEO Pablo Velasquez Martin - SVP of Clinical Research and Development Conference Call Participants Michael DiFiore - Evercore ISI Malcolm Kuno - J.P. Morgan Andrea Tan - Goldman Sachs Gena Wang - Barclays Samantha Meadows - UBS Daniil Gataulin - Chardan Operator Good day, and thank you for standing by. Welcome to the Kodiak Sciences Business Upda ...

Drug Development and Clinical Trials - The company is in the clinical stage of drug development with no products approved for commercial sale and has not generated any revenue since its inception in June 2009[140]. - Development of the product candidate tarcocimab was paused in July 2023 after pivotal Phase 3 trials did not meet primary efficacy endpoints, but development has since resumed following positive results from other ongoing trials[147][148]. - The company has conducted clinical trials for tarcocimab in patients with wet AMD, DME, NPDR, and RVO, but certain trials did not meet their primary efficacy endpoints[144]. - The company has not yet obtained marketing approval for any product candidates, including tarcocimab and KSI-501, which targets both IL-6 and VEGF[141]. - The company’s future success is heavily dependent on the outcomes of planned or pending clinical studies for tarcocimab and KSI-501[142]. - The company may face significant delays in clinical trials due to various factors, including regulatory requirements and patient recruitment challenges[156][158]. - The company has never submitted an application seeking regulatory approval to market any product candidate in any jurisdiction, which poses a risk to its viability[153]. - Investment in biopharmaceutical product development involves significant risks, including the potential failure to demonstrate adequate efficacy or safety profiles[155]. - The company may need to conduct additional studies if manufacturing or formulation changes are made to its product candidates, which could lead to further delays[157]. - The company’s most advanced product candidate, tarcocimab, is an anti-VEGF biologic studied in multiple retinal diseases including wet AMD and DME[163]. - Tarcocimab and KSI-501 are first-in-class bispecific antibody conjugates designed to inhibit interleukin-6 and VEGF, with potential side effects including intraocular hemorrhage and retinal detachment[163]. - In completed clinical trials, an unexpected increase in cataracts was observed in the tarcocimab arms, contributing to the failure to meet primary efficacy endpoints[162]. - Regulatory authorities may suspend or terminate clinical trials due to various factors, including safety issues and failure to comply with protocols[160]. - Delays in clinical trials could increase costs and jeopardize the ability to commence product sales and generate revenue[160]. - The company may encounter difficulties in patient enrollment for clinical trials, which could lead to significant delays or abandonment of trials[169]. - The development and commercialization of new drug products is highly competitive, with risks of competitors achieving regulatory approval before the company[176]. Competition and Market Dynamics - The company faces significant competition from established therapies such as Lucentis and Eylea, with competitors like Roche and Regeneron having commercially approved products[177]. - Two Lucentis biosimilars were approved in the U.S. in 2022, which may negatively impact market dynamics for the company’s product candidates[178]. - The company faces significant competition from larger firms with greater financial resources and expertise in R&D, manufacturing, and regulatory approvals, which could impact its market opportunities[179]. - The company’s ABC Platform may not produce viable product candidates, and competitors may develop technologies that render it less attractive[175]. Manufacturing and Supply Chain Risks - Manufacturing biologics is complex and costly, with production costs generally higher than traditional small molecule compounds, and the company may face supply chain challenges that could disrupt commercialization[181]. - The company relies on third-party suppliers for raw materials, which are sourced from single suppliers in multiple countries, increasing the risk of shortages and contamination[185]. - The company has limited experience in commercial-scale manufacturing, and any difficulties in production could delay clinical trials and regulatory approvals, adversely affecting business operations[186]. - Changes in manufacturing methods during product development may lead to additional costs or delays, potentially impacting clinical trial results and regulatory approvals[189]. - The company relies exclusively on a third-party manufacturer, Lonza AG, for the production of materials for preclinical studies and clinical trials, which poses risks related to supply availability and compliance with regulations[250]. - The company faces risks related to reliance on third-party suppliers for key raw materials, which could harm its ability to manufacture product candidates if supply is interrupted[256]. Regulatory and Compliance Challenges - Compliance with extensive regulatory requirements is mandatory, and failure to do so could adversely affect commercialization efforts[215]. - The company has invested in clinical trials outside the U.S., but acceptance of this data by the FDA is uncertain[212]. - The company may need to conduct costly post-marketing studies to verify safety and efficacy, which could affect product approval status[217]. - Regulatory approval processes are lengthy and unpredictable, potentially delaying product revenue generation[208]. - The company may face significant costs and delays in obtaining foreign regulatory approvals, impacting market potential[214]. - The FDA and other regulatory authorities may impose restrictions on products if unknown problems are discovered post-approval[218]. Financial and Economic Risks - The company has incurred net losses of $260.5 million, $333.8 million, and $267.0 million for the years ended December 31, 2023, 2022, and 2021, respectively, with an accumulated deficit of $1,152.5 million as of December 31, 2023[338]. - Unfavorable U.S. and global economic conditions, including increasing inflation rates and geopolitical conflicts, could adversely affect the company's business and financial performance[332]. - The company faces risks from potential changes in tax laws, including the impact of the Tax Act and subsequent legislation, which could materially affect its financial condition and results of operations[331]. - A severe or prolonged global economic downturn could increase operating costs and limit access to credit, particularly affecting the company's liquidity[334]. - The ongoing conflict between Ukraine and Russia may adversely affect the company's operations and financial results due to economic sanctions and market volatility[336]. - Economic uncertainty in Europe and other key markets could lead to adverse effects on the company's business and financial condition[337]. Intellectual Property and Legal Risks - Patent protection is critical for the company's success; failure to obtain or maintain patents could allow competitors to commercialize similar products[261]. - The patent prosecution process is complex and costly, and the company may not be able to secure necessary patent protections in a timely manner[264]. - The scope of patent protection may be narrowed during prosecution, potentially allowing competitors to develop similar technologies[266]. - The company may face challenges in enforcing its patent rights, which could lead to reduced exclusivity and increased competition[267]. - There is a risk that patents may expire before product commercialization, potentially allowing competitors to enter the market with similar products[268]. - The company may be compelled to grant licenses to third parties under compulsory licensing laws in certain countries, which could impair its competitive position[271]. - The company faces claims challenging the inventorship of its patents, which could result in loss of valuable intellectual property rights[280]. - There is a risk of third-party claims of intellectual property infringement that could delay the development and commercialization of product candidates[285]. - The company relies on trade secrets and confidentiality agreements to protect proprietary information, but breaches could harm its competitive position[281]. - The intellectual property landscape in the biotechnology and pharmaceutical industries is highly competitive and dynamic, leading to potential litigation[286]. Workforce and Management Risks - As of December 31, 2023, the company had 111 employees and plans to significantly increase its workforce to support future growth[302]. - The company is highly dependent on key personnel, and the loss of any executive or key employee could delay product development[299]. - The company faces intense competition for skilled personnel in the biotechnology sector, which may hinder its ability to attract and retain talent[300]. Healthcare and Reimbursement Challenges - Reimbursement from government and private payors is uncertain, and changes in pricing regulations could negatively impact the commercial viability of the company's products[198]. - The company must navigate complex reimbursement processes, which can vary significantly among payors, potentially impacting the demand and pricing of its products[200]. - The commercial success of the company's products will depend on their perceived advantages over alternative treatments and the ability to offer competitive pricing[197]. - The company anticipates that future healthcare reforms may result in lower reimbursement rates and more rigorous coverage criteria, affecting product pricing and revenue generation[227]. - Legislative measures aimed at reducing healthcare costs may adversely affect the company's ability to sell products profitably, particularly due to the ACA's introduction of lower-cost biosimilars and increased Medicaid rebates[220]. Data Privacy and Security Risks - The company is subject to stringent data privacy and security obligations, which include U.S. and foreign laws, regulations, and industry standards, potentially leading to regulatory investigations and significant fines[236]. - Numerous U.S. states have enacted comprehensive privacy laws, such as the California Consumer Privacy Act (CCPA), which imposes civil penalties of up to $7,500 per violation, increasing compliance costs and potential liabilities[237]. - The EU GDPR and UK GDPR impose strict requirements for processing personal data, with fines of up to €20 million or 4% of annual global revenue for violations, significantly impacting operational costs[238]. - The evolving nature of data privacy laws requires significant resources for compliance, potentially necessitating changes to the company's business model and practices[241]. - Failure to comply with data privacy and security obligations could lead to severe consequences, including regulatory fines, litigation, and damage to the company's reputation and financial condition[242]. - The company relies on third-party service providers for critical business systems, which may expose it to additional security risks[310]. - Cybersecurity threats, including ransomware attacks, pose significant risks to the company's operations and reputation[311].

Dr. Perlroth summarized, "We are one successful clinical trial away from filing for registration, and the trial (GLOW2) will be conducted in a patient population (diabetic retinopathy) where tarcocimab already showed a clear win (GLOW1)." Exhibit 99.1 Kodiak Sciences Announces Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results Palo Alto, CA — March 28, 2024 – Kodiak Sciences Inc. (Nasdaq: KOD), today reported business highlights and financial results for the quarter and year ...

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, 2023 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. Indicate by check mark whether the registrant is a large accelerated filer, a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 WASHINGTON, DC 20549 FORM 10-Q For the quarterly period ended June 30, 2023 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q KODIAK SCIENCES INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) 1200 Page Mill Road (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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _ ...