Kodiak(KOD)
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Kodiak(KOD) - 2024 Q3 - Quarterly Results
2024-11-14 21:05
Financial Performance - Kodiak Sciences reported a net loss of $43.9 million, or $0.84 per share, for Q3 2024, an improvement from a net loss of $50.0 million, or $0.95 per share, in Q3 2023[6]. - Total operating expenses for the three months ended September 30, 2024, were $46.6 million, a decrease from $54.5 million in the same period in 2023[14]. - The net loss for the three months ended September 30, 2024, was $43.9 million, compared to a net loss of $50.0 million in the same period in 2023[14]. - Cash and cash equivalents decreased to $197,864,000 from $285,507,000, a decline of approximately 30.6%[15]. - Working capital decreased to $178,433,000 from $247,580,000, representing a decrease of about 28%[15]. - Total assets decreased to $372,669,000 from $479,372,000, a reduction of approximately 22.2%[15]. - Accumulated deficit increased to $(1,284,633,000) from $(1,152,531,000), reflecting a worsening of about 11.5%[15]. - Total stockholders' equity decreased to $185,370,000 from $265,781,000, a decline of approximately 30.2%[15]. Research and Development - Research and development expenses decreased to $31.9 million in Q3 2024 from $36.2 million in Q3 2023, primarily due to reduced manufacturing and completed clinical activities[7]. - General and administrative expenses were $14.8 million in Q3 2024, down from $18.3 million in Q3 2023[8]. - The phase 3 GLOW2 study for tarcocimab in diabetic retinopathy is enrolling patients, aiming for a topline data readout in 48 weeks[1]. - The phase 3 DAYBREAK study for wet AMD is also enrolling patients, with a focus on assessing the 6-month durability of tarcocimab[3]. - Tarcocimab demonstrated an ocular half-life of 20 days, which is 3 times longer than faricimab and 2-3 times longer than aflibercept[1]. - The KSI-101 clinical program is currently in the APEX study, targeting macular edema secondary to inflammation, with early data showing meaningful clinical responses[1]. - Kodiak is advancing two preclinical programs from its ABCD Platform, targeting glaucoma and dry AMD, with the goal of creating therapies with dual mechanisms of action[4]. - The company aims to file a single Biologics License Application for three diseases based on data from five successful phase 3 studies if GLOW2 and DAYBREAK are successful[1]. - Tarcocimab has completed three successful Phase 3 pivotal clinical studies, achieving 100% treatment success in the GLOW1 study for diabetic retinopathy with extended 6-month dosing[9]. - In the BEACON study, nearly 50% of patients treated with tarcocimab did not require any treatment in the second 6 months while achieving similar vision outcomes as the aflibercept group[9]. - Kodiak is currently conducting two Phase 3 clinical trials for tarcocimab: GLOW2 for diabetic retinopathy and DAYBREAK for wet AMD, both actively enrolling patients[9]. - KSI-501, a bispecific antibody, is in a Phase 3 study (DAYBREAK) evaluating its efficacy against aflibercept, with a primary endpoint of non-inferiority in visual acuity[10]. - KSI-101 is in a Phase 1b study (APEX) targeting retinal inflammatory diseases, with plans to progress into dual Phase 2b/3 studies[11]. Strategic Initiatives - Kodiak plans to file a single Biologics License Application (BLA) for three diseases based on data from five successful Phase 3 studies with tarcocimab[13]. - Kodiak's ABCD Platform aims to enhance drug delivery by embedding small molecules into its biopolymer backbone, expanding therapeutic applications[12]. - Kodiak's weighted-average shares outstanding for computing net loss per common share were 52,616,183 for the three months ended September 30, 2024[14].
Kodiak Sciences Announces Recent Business Highlights and Third Quarter 2024 Financial Results
Prnewswire· 2024-11-14 21:01
Core Insights - Kodiak Sciences Inc. reported significant advancements in its clinical programs and financial results for Q3 2024, highlighting the ongoing development of its investigational therapies, particularly tarcocimab, KSI-501, and KSI-101 [1][17]. Clinical Developments - The company hosted an Investor R&D Day, presenting new clinical data showing that tarcocimab has an ocular half-life of 20 days, which is three times longer than faricimab and two to three times longer than aflibercept [2][4]. - The Phase 3 GLOW2 study for diabetic retinopathy is currently enrolling patients, aiming to replicate the success of the previous GLOW1 study with all patients on a 6-month dosing schedule [2][5][7]. - The DAYBREAK study is also enrolling patients for wet age-related macular degeneration (AMD), focusing on longer durability and better efficacy with KSI-501 [2][8][11]. - KSI-101 is being evaluated in the APEX study for macular edema secondary to inflammation, with early data showing promising clinical responses [3][13]. Financial Performance - Kodiak ended Q3 2024 with $197.9 million in cash and cash equivalents, which is expected to support operations into 2026 [17]. - The net loss for Q3 2024 was $43.9 million, or $0.84 per share, an improvement from a net loss of $50.0 million, or $0.95 per share, in Q3 2023 [18][37]. - Research and development expenses decreased to $31.9 million in Q3 2024 from $36.2 million in Q3 2023, primarily due to reduced manufacturing and clinical activities for completed trials [18][37]. Market Context - The retinal vascular diseases anti-VEGF market presents significant opportunities for therapies with high efficacy and durability, which Kodiak aims to address with its enhanced formulations of tarcocimab and KSI-501 [2][4]. - The company is also targeting the unmet needs in the macular edema and inflammation market, where over 100,000 patients in the U.S. currently lack approved therapies beyond steroids [2][3]. Pipeline Expansion - Kodiak is advancing its ABCD Platform to develop new therapies for glaucoma and dry AMD, aiming to create intravitreal injections with dual mechanisms of action for better efficacy and extended durability [14][15][16]. - The company is actively enrolling patients in its clinical studies for KSI-501 and KSI-101, with plans to progress into pivotal studies based on the outcomes of the ongoing trials [27][32].
Kodiak Sciences to Participate in Upcoming Investor Conferences
Prnewswire· 2024-11-11 11:15
Core Insights - Kodiak Sciences Inc. is focused on developing transformative therapeutics for retinal diseases and will present at upcoming investor conferences [1][2][3] Company Overview - Kodiak Sciences Inc. is a biopharmaceutical company dedicated to researching, developing, and commercializing therapeutics for retinal diseases, utilizing its proprietary ABCD Platform™ for drug development [3][7] - The company is advancing a portfolio of three clinical programs, with two in late-stage development and one expected to progress rapidly into pivotal studies [3] Investigational Medicines - Tarcocimab, Kodiak's lead investigational medicine, is an anti-VEGF antibody biopolymer conjugate being studied in two Phase 3 trials for diabetic retinopathy and wet AMD [4] - KSI-501 is a first-in-class bispecific antibody biopolymer conjugate targeting IL-6 and VEGF, currently in a Phase 3 study for wet AMD [5] - KSI-101 is a novel bispecific protein for retinal inflammatory diseases, with a Phase 1b study ongoing and plans for further Phase 2b/3 studies [6] Technology Platform - The ABCD Platform enables the development of high drug-antibody-ratio medicines by embedding small molecules into a proprietary biopolymer backbone, allowing for targeted and tailored therapeutic applications [7]
Kodiak Counts on Tarcocimab Eye Disease Program Despite Setbacks
ZACKS· 2024-10-10 15:06
Kodiak Sciences (KOD) is a clinical-stage biopharmaceutical company engaged in developing novel therapeutics to treat chronic and high-prevalence retinal diseases, which are the major causes of blindness. The company's proprietary antibody biopolymer conjugate platform is designed to maintain potent and effective drug levels in ocular tissues for longer periods than the currently marketed biologic medicines for treating retinal diseases. The company currently has no marketed drug in its portfolio. Kodiak is ...
Why Is Kodiak Sciences (KOD) Down 8.1% Since Last Earnings Report?
ZACKS· 2024-09-13 16:31
Core Viewpoint - Kodiak Sciences Inc. has experienced an 8.1% decline in share price since its last earnings report, underperforming the S&P 500, raising questions about its future performance leading up to the next earnings release [1] Financial Performance - In Q2 2024, Kodiak reported a loss of $0.86 per share, which was narrower than the Zacks Consensus Estimate of a loss of $0.87, and a significant improvement from a loss of $1.53 per share in the same quarter last year [2] - The company has no approved products and has not generated any revenue to date [2] Expense Management - Research and development expenses were $32.5 million, down 51.5% year-over-year, primarily due to reduced manufacturing costs and lower clinical study expenses for its lead candidate, tarcocimab [3] - General and administrative expenses decreased to $15.5 million, a 13.4% reduction year-over-year, mainly due to lower non-cash stock-based compensation [3] Cash Position - As of June 30, 2024, Kodiak had cash, cash equivalents, and marketable securities totaling $219.2 million, down from $245.9 million as of March 31, 2024, with the current balance expected to support operations into 2026 [4] Market Sentiment - Recent estimates for Kodiak have shown a downward trend, indicating a negative sentiment among investors [5] - The stock has a VGM Score of B, with strong growth and momentum scores (A) but a low value score (D), placing it in the bottom 40% for value investment strategy [6] Industry Context - Kodiak Sciences operates within the Zacks Medical - Biomedical and Genetics industry, where competitor Exact Sciences has seen a 15.3% increase in stock price over the past month, reporting revenues of $699.26 million, a year-over-year increase of 12.4% [8]
Kodiak (KOD) Q2 Loss Narrower Than Expected, Pipeline in Focus
ZACKS· 2024-08-16 15:45
Kodiak Sciences Inc. (KOD) incurred a loss of 86 cents per share in the second quarter of 2024, which was narrower than the Zacks Consensus Estimate of a loss of 87 cents. The company had incurred a loss of $1.53 per share in the year-ago quarter. The company currently 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 $32.5 million in the reported quarter, down 51.5% year over year. The decrease was mai ...
Kodiak Sciences Announces Recent Business Highlights and Second Quarter 2024 Financial Results
Prnewswire· 2024-08-14 20:01
PALO ALTO, Calif., Aug. 14, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported business highlights and financial results for the quarter ended June 30, 2024. "Our three clinical programs of tarcocimab, KSI-501 and KSI-101 are making strong operational progress," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "The Phase 3 GLOW2 study of tarcocimab in diabetic retinopathy continues to enroll. The Phase 3 DAYBREAK study of tarcocimab and KSI-501 is now actively enr ...
All You Need to Know About Kodiak Sciences (KOD) Rating Upgrade to Buy
ZACKS· 2024-07-10 17:00
Kodiak Sciences Inc. (KOD) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. Since a chan ...
Should You Hold Kodiak Sciences (KOD) Stock in Your Portfolio?
ZACKS· 2024-06-20 13:25
Core Viewpoint - Kodiak Sciences is revitalizing its lead candidate, tarcocimab, following positive results from the phase III GLOW study for treating non-proliferative diabetic retinopathy, indicating potential for success in retinal disease therapeutics [1][6]. Group 1: Development Programs - Kodiak Sciences has initiated the pivotal phase III GLOW2 study for tarcocimab, with patient enrollment actively ongoing and expected completion by the end of 2024 [2]. - The company plans to advance KSI-501 into a phase III study, DAYBREAK, to evaluate its efficacy in wet AMD, with tarcocimab also being studied in this trial [18]. - The company is also preparing to begin enrollment in the APEX study for KSI-101, targeting retinal inflammation, with pivotal studies expected to start later in 2024 [10][19]. Group 2: Financial Position - As of March-end, Kodiak Sciences reported cash, cash equivalents, and marketable securities totaling $245.9 million, sufficient to support operations into 2026 [20]. Group 3: Market Potential - The success of the GLOW2 study could lead to a biologics license application for tarcocimab, potentially marking the company's first product in its commercial portfolio [16][21]. - KSI-101 represents a new market opportunity, targeting inflammatory conditions of the retina, which is currently underserved by existing therapies [9]. Group 4: Stock Performance - Year to date, shares of Kodiak Sciences have declined by 14.1%, compared to a 7.9% decline in the industry [3].
Why Is Kodiak Sciences (KOD) Down 26.2% Since Last Earnings Report?
ZACKS· 2024-06-14 16:30
Core Viewpoint - Kodiak Sciences Inc. has experienced a significant decline in share price, losing approximately 26.2% over the past month, underperforming the S&P 500 [1] Financial Performance - For Q1 2024, Kodiak reported a loss per share of 82 cents, which was narrower than the Zacks Consensus Estimate of a loss of $1.09, and an improvement from a loss of $1.35 per share in the same quarter last year [10] - Research and development expenses were reported at $29.9 million, reflecting a 47% decrease year over year, primarily due to the conclusion of some clinical studies on its lead pipeline candidate, tarcocimab [3] - General and administrative expenses amounted to $16.1 million, down 11% year over year, mainly due to lower non-cash stock-based compensation expenses [11] Cash Position - As of March 31, 2024, Kodiak had cash, cash equivalents, and marketable securities totaling $245.9 million, a decrease from $285.5 million as of December 31, 2023. The company believes this cash balance is sufficient to support its operations into 2026 [4] Market Outlook - Estimates for Kodiak Sciences have trended upward over the past month, with a consensus estimate shift of 15.48% [5][12] - The company holds a Zacks Rank 3 (Hold), indicating an expectation of an in-line return in the coming months [17] Industry Comparison - Kodiak Sciences operates within the Zacks Medical - Biomedical and Genetics industry, where another player, Halozyme Therapeutics, has seen a 9.3% gain over the past month [7] - Halozyme Therapeutics reported revenues of $195.88 million for the last quarter, representing a year-over-year increase of 20.8% [18]