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]

Financial Performance and Losses - Net losses for the nine months ended September 30, 2023, and September 30, 2024, were $22.7 million and $15.2 million, respectively, with an accumulated deficit of $79.7 million as of September 30, 2024[188] - The company reported a net loss of $15.2 million for the nine months ended September 30, 2024, and expects to incur substantial additional losses in future periods, with an accumulated deficit of $79.7 million as of September 30, 2024[215] - Net cash used in operating activities was $22.0 million for the nine months ended September 30, 2024, primarily due to development costs for drug candidates, labor costs, and consulting services[223] Research and Development Expenses - Research and development expenses decreased by $0.4 million (10%) from $3.4 million in Q3 2023 to $3.0 million in Q3 2024, primarily due to a $0.4 million decrease in drug development costs[205] - Research and development expenses increased by $6.0 million, or 70%, from $8.7 million in the nine months ended September 30, 2023, to $14.7 million in the same period in 2024, driven by a $5.4 million increase in drug development costs[209] - Research and development expenses include fees paid to third parties, consulting costs, laboratory supplies, product acquisition and license costs, payroll and personnel-related expenses, and allocated overheads[233] General and Administrative Expenses - General and administrative expenses increased by $640,000 (25%) from $2.6 million in Q3 2023 to $3.2 million in Q3 2024, driven by a $715,000 increase in travel, rent, and other costs[206] - General and administrative expenses increased by $1.7 million, or 26%, from $6.5 million in the nine months ended September 30, 2023, to $8.1 million in the same period in 2024, due to higher non-cash stock compensation and labor costs[210] Regulatory and Drug Development - The company submitted a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) to the FDA on September 3, 2024, with a PDUFA target action date of June 28, 2025[192] - The company expects operating expenses to increase significantly as it advances product candidates through clinical development and seeks regulatory approval[188] - The company entered into a securities purchase agreement in March 2023, which may provide up to $130.0 million in gross proceeds, with an initial upfront funding of $30.0 million, to support FDA submissions and the commercial launch of oxylanthanum carbonate[214] Financing Activities - The company raised $50 million through a private placement of Series B-1 Convertible Preferred Stock on March 13, 2024, with each share convertible into common stock at $1.00 per share[193] - The company issued 42,118,000 shares of common stock and 7,882 shares of Series B-2 preferred stock on July 5, 2024, following the automatic conversion of Series B-1 Convertible Preferred Stock[194] - Net cash provided by financing activities was $44.7 million during the nine months ended September 30, 2024, primarily due to a private placement financing agreement signed on March 13, 2024[227] - The company received $22.3 million in net proceeds from its IPO in July 2021, which were used for pre-clinical and clinical studies, regulatory filings, and general corporate purposes[212] Licensing and Revenue - Licensing revenues were $0 for both Q3 2023 and Q3 2024, with potential future revenue dependent on business development arrangements[204] - Licensing revenues decreased by $0.7 million, or 100%, in the nine months ended September 30, 2024, compared to the same period in 2023, due to an upfront payment from a licensing agreement in February 2023[208] Other Income and Expenses - Other income (expenses) increased by $0.5 million, or 34%, from $1.6 million in Q3 2023 to $2.2 million in Q3 2024, primarily due to a change in the fair value of the company's warrant liability[207] - Other income (expenses) increased by $15.5 million, or 178%, from an $8.7 million expense in the nine months ended September 30, 2023, to a $6.8 million income in the same period in 2024, primarily due to the change in fair value of the company's warrant liability[211] Market and Patient Statistics - The number of patients with end-stage renal disease (ESRD) in the U.S. is projected to reach between 971,000 and 1,259,000 by 2030, with approximately 450,000 patients (~80%) currently taking phosphate binders[184] - Acute kidney injury (AKI) affects over 2 million U.S. patients annually, costing the healthcare system more than $9 billion per year[185] Accounting and Reporting - Stock-based compensation is accounted for using the Black-Scholes option-pricing model, which requires subjective assumptions such as expected stock volatility, dividend yield, term, and risk-free interest rate[234] - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of certain accounting standards until they apply to private companies[235] - The company intends to rely on exemptions under the JOBS Act, including not providing an auditor's attestation report on internal controls over financial reporting and not complying with PCAOB's critical audit matters requirement[237] - The company will remain an "emerging growth company" until it reaches $1.235 billion in total annual gross revenues, completes five years post-IPO, issues over $1 billion in nonconvertible debt, or becomes a large accelerated filer[237] - The company has no off-balance sheet arrangements as defined under SEC rules[239] - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[241]

– FDA sets PDUFA Action Date of June 28, 2025 – Company Preparing for 2025 Commercial Launch – LOS ALTOS, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) ...