Financial Performance - The company reported a net loss of $36.7 million for the year ended December 31, 2024, an increase of 20% from a net loss of $30.5 million in 2023[383]. - The company has an accumulated deficit of $101.3 million as of December 31, 2024[383]. - The company incurred a net loss of $36.7 million for the year ended December 31, 2024, with an accumulated deficit of $101.3 million as of the same date[409]. - The company expects to continue incurring losses and will require additional capital for clinical trials and product development[410]. - Cash used in operating activities for the year ended December 31, 2023, was $18.3 million, with a net loss of $30.5 million[417]. Expenses - Research and development expenses rose by approximately $7.1 million, or 55%, from $12.9 million in 2023 to $20.0 million in 2024, primarily due to increased drug development costs[399]. - General and administrative expenses increased by approximately $3.5 million, or 42%, from $8.5 million in 2023 to $12.1 million in 2024, driven by higher consulting and professional services costs[400]. - Net cash used in operating activities was $28.6 million for the year ended December 31, 2024, primarily due to development costs and corporate expenditures[416]. Revenue - The company generated approximately $1.6 million in licensing revenue to date, with a significant decrease of $0.7 million, or 100%, in licensing revenues for the year ended December 31, 2024[398][405]. Capital and Financing - The company raised approximately $50 million through a private placement of Series B Convertible Preferred Stock and an additional $50 million through a sales agreement for common stock[408]. - Net cash provided by financing activities was $45.1 million for the year ended December 31, 2024, primarily from the private placement and public offering[419]. - The company anticipates needing to raise substantial additional capital, which may lead to dilution for existing shareholders[411]. Clinical Development - The company completed a Phase I clinical study in healthy volunteers with UNI-494 in 2024, targeting acute kidney injury[379]. - The company expects operating expenses to increase significantly as it advances product candidates through clinical development and seeks regulatory approval[383]. - The company plans to use proceeds from a securities purchase agreement, which may provide up to $130.0 million, to support the NDA submission for Oxylanthanum Carbonate and its commercial launch in the U.S.[406]. - Oxylanthanum Carbonate is being developed as a next-generation phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis[379]. Compliance and Notices - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement, with a compliance period extended until July 7, 2025[387][388]. Investing Activities - Net cash used in investing activities was $72,000 for the year ended December 31, 2024, due to office furniture purchases[418]. - The company received advances of $210,000 from a stockholder in February 2023, which were fully repaid in March 2023[414].

"2025 is positioned to be a transformational year for Unicycive, with the near-term potential for FDA approval and commercial launch of oxylanthanum carbonate (OLC)," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "For approximately 75% of people in the U.S. with chronic kidney disease (CKD) on dialysis, hyperphosphatemia remains uncontrolled because of challenges with currently available phosphate binders, potentially increasing their risk of hospitalization and mortality. If approved, we ...

Core Insights - Unicycive Therapeutics is presenting patient-reported outcomes data from its pivotal UNI-OLC-201 clinical study on oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [1][2] - The New Drug Application (NDA) for OLC has been accepted by the FDA, with a target action date set for June 28, 2025 [2][9] - Hyperphosphatemia remains uncontrolled in 75% of U.S. dialysis patients, highlighting a significant unmet need for more effective treatments [3][7] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC as its lead drug candidate [9] - OLC utilizes proprietary nanoparticle technology to reduce pill burden, potentially improving patient adherence [2][5] - The company has a strong global patent portfolio for OLC, with exclusivity until 2031 and potential extension until 2035 [7][9] Market Opportunity - The market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [7] - Despite existing phosphate binders, 75% of dialysis patients do not achieve target phosphorus levels, indicating a substantial market gap [7][8] Clinical Study Insights - OLC has shown the potential to reduce pill burden by half, which is a key factor in improving adherence among dialysis patients [6][8] - The upcoming medical meetings will feature abstracts related to the pivotal clinical study, emphasizing the importance of addressing pill burden in treatment [4][6]

Core Insights - Unicycive Therapeutics announced preclinical data showing that the combination of oxylanthanum carbonate (OLC) and tenapanor significantly reduces urinary phosphate excretion compared to either drug alone [1][2][6] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead candidate being oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients [10] - The company is seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a New Drug Application (NDA) under review and a target action date set for June 28, 2025 [10][7] Product Details - OLC is a next-generation phosphate binder utilizing proprietary nanoparticle technology, designed to improve patient adherence due to a lower pill burden compared to existing treatments [5] - The global market for hyperphosphatemia treatment is projected to exceed $2.28 billion, with North America accounting for over $1 billion [5] Clinical Findings - The combination therapy of OLC and tenapanor resulted in a 41.3% reduction in urinary phosphate excretion, while OLC alone showed a 17.7% reduction and tenapanor alone led to a 12.5% reduction [6] - The study indicates that OLC could be particularly beneficial for patients who are unresponsive or intolerant to current phosphate binders [3] Market Need - Approximately 75% of patients on maintenance dialysis do not meet serum phosphate targets, highlighting the need for new treatment approaches [3] - The greatest unmet need identified by nephrologists is a lower pill burden and improved patient compliance in the treatment of hyperphosphatemia [5]

Core Insights - Unicycive Therapeutics, Inc. has published a review on phosphate management from patient perspectives, highlighting the challenges and limitations of current therapies [2][3] - The review emphasizes the need for patient-centered approaches to improve clinical outcomes and satisfaction in managing phosphorus levels [2] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead candidate being Oxylanthanum Carbonate (OLC) [10] - OLC is a next-generation phosphate binding agent designed to treat hyperphosphatemia in chronic kidney disease patients on dialysis, characterized by a lower pill burden and better patient compliance [6][10] Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [6] - Despite existing FDA-cleared medications, 75% of U.S. dialysis patients do not achieve target phosphorus levels, indicating a significant unmet need in the market [6] Clinical Development - Unicycive is seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a New Drug Application (NDA) submission based on data from three clinical studies and multiple preclinical studies [6][10] - OLC is protected by a strong global patent portfolio, with exclusivity until 2031 and potential extension until 2035 [6][10] Patient Adherence Challenges - Nonadherence to phosphate binders is a significant issue, with rates ranging from 22% to 74%, averaging 51% [8] - Factors contributing to nonadherence include large pill sizes, high pill burdens, and gastrointestinal side effects, underscoring the need for innovative solutions [8]

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead drug candidate being oxylanthanum carbonate (OLC) [1][10] - OLC is a next-generation phosphate binding agent aimed at treating hyperphosphatemia in patients with chronic kidney disease (CKD) [5][10] Clinical Study Findings - Data from a Phase 1 dose escalation study of OLC in healthy volunteers was published, demonstrating that OLC was well tolerated and effectively reduced phosphate absorption [2][3] - The study involved 32 participants and evaluated escalating doses of OLC (500 mg to 2000 mg) administered three times a day, with results showing dose-dependent decreases in urinary phosphorus excretion [3][5] Regulatory Status - Unicycive is currently seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a New Drug Application (NDA) under review and a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025 [3][6][10] Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [5] - Despite existing treatments, 75% of U.S. dialysis patients do not achieve recommended phosphorus levels, indicating a significant unmet need in the market [5][10] Patent Protection - OLC is supported by a strong global patent portfolio, including exclusivity on composition of matter until 2031, with potential extensions until 2035 [6][10]

Core Viewpoint - Unicycive Therapeutics has published positive data from its oxylanthanum carbonate (OLC) bioequivalence study, demonstrating its pharmacodynamic equivalence to lanthanum carbonate (LC), which is crucial for the company's New Drug Application (NDA) currently under FDA review [1][2][3]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead candidate OLC aimed at treating hyperphosphatemia in chronic kidney disease patients [1][8]. - The company is preparing for the commercial launch of OLC in 2025, following the NDA review by the FDA [3][8]. Study Details - The bioequivalence study involved 80 healthy participants, with 75 completing the trial. OLC was administered as 1000 mg swallowable tablets three times a day, while LC was given as 1000 mg chewable tablets in a two-way crossover design [3]. - The primary pharmacodynamic variable measured was the least squares mean (LSM) change in urinary phosphate excretion, showing similar results for both OLC (–320.4 mg/day) and LC (–324.0 mg/day) [3]. Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [5]. - Despite existing FDA-cleared medications, 75% of U.S. dialysis patients do not meet target phosphorus levels, indicating a significant unmet need in the market [5]. Product Advantages - OLC utilizes proprietary nanoparticle technology and has a lower pill burden compared to existing treatments, which may enhance patient adherence [5]. - The product is protected by a strong global patent portfolio, with exclusivity until 2031 and potential extension until 2035 [5][8].

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [1][3] - The lead drug candidate, oxylanthanum carbonate (OLC), is aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis [3] - OLC has shown positive pivotal trial results reported in June 2024, and a New Drug Application (NDA) is currently under review by the U.S. FDA with a target action date of June 28, 2025 [3] Intellectual Property - OLC is protected by a strong global patent portfolio, including an issued patent on composition of matter with exclusivity until 2031, and potential patent term extension until 2035 after approval [3] - The second asset, UNI-494, is a new chemical entity in clinical development for acute kidney injury, which has successfully completed a Phase 1 trial [3] Upcoming Events - CEO Shalabh Gupta will participate in two investment conferences in December 2024: - Noble Capital Markets 20th Annual Emerging Growth Equity Conference on December 3, 2024, at 3:00 p.m. ET in Boca Raton, FL [2] - Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, at 12:30 p.m. ET in New York, NY [2] - Live and archived webcasts will be available on the Unicycive website under the Investors section [2]

Drug Development and Regulatory Approvals - The New Drug Application (NDA) for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a PDUFA Target Action Date set for June 28, 2025[3] - UNI-494 successfully completed its Phase 1 clinical trial, with plans to request a meeting with the FDA by the end of 2024 to advance to Phase 2[5] - A patent for UNI-494 to treat acute kidney injury (AKI) has been granted, valid until 2040, securing protection for its method of use[6] Clinical Trial Outcomes - In a patient-reported outcome survey during the pivotal clinical trial for OLC, 79% of patients preferred OLC over their prior therapy, and 98% found OLC easy to take[4] - OLC demonstrated the ability to achieve serum phosphate control in over 90% of patients with chronic kidney disease on dialysis during the pivotal clinical trial[7] Financial Performance - Research and Development (R&D) expenses for Q3 2024 were $3.0 million, a decrease from $3.4 million in Q3 2023, primarily due to reduced drug development costs[10] - General and Administrative (G&A) expenses increased to $3.2 million in Q3 2024 from $2.6 million in Q3 2023, mainly due to higher non-cash stock compensation expenses[11] - The net loss attributable to common stockholders for Q3 2024 was $4.1 million, an improvement from a net loss of $4.4 million in Q3 2023[12] - As of September 30, 2024, cash and cash equivalents totaled $32.3 million, providing sufficient resources to fund operations into 2026[13] Market Position and Index Inclusion - Unicycive was added to the Russell Microcap Index effective July 1, 2024, which includes automatic inclusion in relevant growth and value style indexes[9]

Core Insights - Unicycive Therapeutics has received FDA acceptance for its New Drug Application (NDA) for oxylanthanum carbonate (OLC), targeting a potential approval date of June 28, 2025, aimed at treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [1][3] - The company is preparing for the commercial launch of OLC in the second half of 2025, emphasizing its high potency and low pill burden as a best-in-class option for patients [2][3] - Unicycive has successfully completed the Phase 1 trial for its second asset, UNI-494, which targets acute kidney injury (AKI), and plans to advance to Phase 2 clinical development [2][3] Drug Development Progress - The NDA for OLC has been accepted by the FDA, with a PDUFA target action date set for June 28, 2025 [1][3] - Patient-reported outcomes from the pivotal clinical trial indicate that 79% of patients preferred OLC over previous therapies, with 98% finding it easy to take [3] - The Phase 1 trial for UNI-494 was completed successfully, showing good tolerability and rapid metabolism, which will inform the dosing for potential Phase 2 trials [3][4] Financial Performance - Research and Development (R&D) expenses for Q3 2024 were $3.0 million, down from $3.4 million in Q3 2023, primarily due to reduced drug development costs [5] - General and Administrative (G&A) expenses increased to $3.2 million in Q3 2024 from $2.6 million in Q3 2023, mainly due to higher non-cash stock compensation [6] - The net loss attributable to common stockholders for Q3 2024 was $4.1 million, a slight decrease from $4.4 million in Q3 2023 [7] Cash Position - As of September 30, 2024, the company reported cash and cash equivalents of $32.3 million, which is expected to fund operations into 2026 [8][13] Market Position - Unicycive Therapeutics has been added to the Russell Microcap® Index effective July 1, 2024, which enhances its visibility and market presence [4]