Core Insights - Unicycive Therapeutics announced new patient-reported outcomes data from its pivotal Phase 2 study of oxylanthanum carbonate (OLC), an investigational treatment for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, which will be presented at the NKF Spring Clinical Meetings [1][4] - OLC utilizes proprietary nanoparticle technology to reduce the number and size of pills, addressing adherence issues in dialysis patients [2][8] Patient-Reported Outcomes - The Phase 2 trial demonstrated high patient satisfaction with OLC compared to prior phosphate binders, with 98% of patients finding OLC easy to take and 89% satisfied with the treatment [6][7] - OLC reduced the pill burden by 50%, with patients taking a median of three tablets per day compared to six tablets of previous phosphate binders [7] Adherence and Preferences - 70% of patients reported consistent adherence with OLC, an increase from 58% adherence to their previous phosphate binders [7] - 79% of patients preferred OLC over their prior medications, highlighting the impact of pill burden on treatment adherence [7][13] Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [8] - Despite existing treatments, 75% of U.S. dialysis patients do not achieve target phosphorus levels, indicating a significant unmet need in the market [8] Regulatory Status - Unicycive is seeking FDA approval for OLC with a PDUFA Target Action Date set for June 28, 2025, through the 505(b)(2) regulatory pathway [2][9]

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [3] - The company's lead drug candidate, oxylanthanum carbonate (OLC), is designed to treat 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 - Shalabh Gupta, M.D., CEO of Unicycive, will present at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, at 2:15 p.m. ET [1] - A live and archived webcast of the presentation will be available on the Unicycive website under the Investors section [2]

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) Unicycive Therapeutics announced 2024 financial results, highlighting 2025 as transformational with anticipated FDA approval and launch of OLC for hyperphosphatemia [Company Overview and Strategic Outlook](index=1&type=section&id=Company%20Overview%20and%20Strategic%20Outlook) Unicycive Therapeutics announced 2024 financial results, highlighting 2025 as transformational with anticipated FDA approval and launch of OLC for hyperphosphatemia - Unicycive Therapeutics is a clinical-stage biotechnology company developing therapies for patients with kidney disease[1](index=1&type=chunk) - Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in CKD patients on dialysis is under review by the FDA[1](index=1&type=chunk) - The PDUFA target action date for OLC is **June 28, 2025**, with commercial launch anticipated in late 2025[1](index=1&type=chunk) - CEO Shalabh Gupta, M.D., stated that OLC is positioned to be an important new option for patients with uncontrolled hyperphosphatemia due to its **high potency and low pill burden**[2](index=2&type=chunk) [Key Highlights & Upcoming Milestones](index=1&type=section&id=Key%20Highlights%20%26%20Upcoming%20Milestones) The company achieved significant regulatory and clinical milestones for OLC and UNI-494, while actively developing commercial infrastructure and expanding OLC awareness [Oxylanthanum Carbonate (OLC) Development & Regulatory Status](index=1&type=section&id=Oxylanthanum%20Carbonate%20(OLC)%20Development%20%26%20Regulatory%20Status) The FDA accepted OLC's NDA for hyperphosphatemia with a PDUFA date of June 28, 2025, while a Korean NDA was also submitted by a partner - The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis[3](index=3&type=chunk) - The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of **June 28, 2025**[3](index=3&type=chunk) - Unicycive's partner, Lotus Pharmaceutical, submitted an NDA for OLC in the Republic of Korea, with an application decision anticipated in **June 2026**[3](index=3&type=chunk) - Unicycive has the potential to receive up to **$3.7 million** in milestone payments and tiered royalties from Lotus Pharmaceutical based on regulatory and commercial achievements[3](index=3&type=chunk) [UNI-494 Development](index=2&type=section&id=UNI-494%20Development) UNI-494 successfully completed its Phase 1 study, demonstrating favorable tolerability and rapid absorption, with data presented at ASN 2024 - Successfully completed Phase 1 study of UNI-494 in healthy volunteers, demonstrating **favorable tolerability, fast absorption, and rapid metabolization**[9](index=9&type=chunk) - Data from the Phase 1 study and supportive preclinical data were presented at ASN 2024 and published in EC Pharmacology and Toxicology[9](index=9&type=chunk) [Commercialization and Awareness Efforts](index=2&type=section&id=Commercialization%20and%20Awareness%20Efforts) The company is establishing commercial infrastructure and expanding OLC awareness through publications and presentations highlighting its safety and efficacy - Continued efforts to establish an efficient commercial infrastructure, including building key functions, engaging with prescribers and stakeholders, and preparing for market access[9](index=9&type=chunk) - Expanded awareness of OLC through publication of clinical, preclinical, and patient survey data in peer-reviewed journals (Clinical Therapeutics, Clinical and Translational Science, Journal of Nephrological Science) and a late-breaker presentation at ASN Kidney Week 2024[9](index=9&type=chunk) - Published data highlighted OLC's **favorable safety and tolerability profile, efficacy in controlling serum phosphate levels, bioequivalence to approved lanthanum carbonate chewable tablets, and potential benefits of combination treatment with tenapanor**[9](index=9&type=chunk) [Financial Performance for Full Year 2024](index=2&type=section&id=Financial%20Performance%20for%20Full%20Year%202024) Unicycive Therapeutics reported a net loss of $37.8 million for 2024, an increase from 2023, driven by higher R&D and G&A expenses, but ended the year with $26.1 million in cash [Summary of Financial Results](index=2&type=section&id=Summary%20of%20Financial%20Results) Unicycive Therapeutics reported a **$37.8 million** net loss for 2024, an increase driven by higher drug development costs, ending the year with **$26.1 million** in cash Key Financials (Year Ended December 31, in thousands) | Metric | 2023 | 2024 | Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | | Licensing revenues | $675 | $0 | -$675 (100% decrease) | | R&D expenses | $12,902 | $20,014 | +$7,112 (55.1% increase) | | G&A expenses | $8,547 | $12,103 | +$3,556 (41.6% increase) | | Other Income (Expenses) | $(9,770) | $(4,612) | +$5,158 (52.8% improvement) | | Net loss attributable to common stockholders | $(31,411) | $(37,824) | -$6,413 (20.4% increase in loss) | | Net loss per share (basic and diluted) | $(1.28) | $(0.56) | +$0.72 (improved loss per share) | | Cash and cash equivalents (as of Dec 31) | $9,701 | $26,142 | +$16,441 (169.5% increase) | - The increase in research and development expenses was primarily due to an increase in drug development and labor costs[5](index=5&type=chunk) - The increase in general and administrative expenses was primarily due to an increase in labor, consulting, and professional services costs[6](index=6&type=chunk) - The increased net loss for the year ended December 31, 2024, was attributable primarily to an increase in drug development costs[7](index=7&type=chunk) - As of December 31, 2024, cash and cash equivalents totaled **$26.1 million**, and the Company believes it has sufficient resources to fund planned operations into **2026**[8](index=8&type=chunk) [Detailed Financial Statements](index=4&type=section&id=Detailed%20Financial%20Statements) This section presents detailed Balance Sheets and Statements of Operations for 2023 and 2024, providing a breakdown of the company's financial position and performance [Balance Sheets](index=4&type=section&id=Balance%20Sheets) The balance sheet shows a significant increase in cash and total assets, with a shift from stockholders' deficit to positive equity in 2024 Balance Sheet Highlights (as of December 31, in thousands) | Metric | 2023 | 2024 | Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | | Cash | $9,701 | $26,142 | +$16,441 | | Total current assets | $13,399 | $30,948 | +$17,549 | | Total assets | $14,191 | $31,668 | +$17,477 | | Warrant liability | $13,134 | $18,936 | +$5,802 | | Total current liabilities | $17,534 | $24,120 | +$6,586 | | Total liabilities | $18,000 | $24,237 | +$6,237 | | Total stockholders' (deficit) equity | $(3,809) | $7,431 | +$11,240 | | Common stock shares outstanding | 34,756,049 | 113,842,364 | +79,086,315 | - Total assets increased from **$14.191 million** in 2023 to **$31.668 million** in 2024[14](index=14&type=chunk) - Total stockholders' equity shifted from a deficit of **$(3.809) million** in 2023 to a positive **$7.431 million** in 2024[14](index=14&type=chunk) [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) The statements of operations reveal a decrease in licensing revenues, a substantial increase in operating expenses, and an improved net loss per share despite a higher net loss Statements of Operations (Year Ended December 31, in thousands) | Metric | 2023 | 2024 | Change (YoY) | | :-------------------------------------------------- | :----- | :----- | :----------- | | Licensing revenues | $675 | $0 | -$675 | | Research and development | $12,902 | $20,014 | +$7,112 | | General and administrative | $8,547 | $12,103 | +$3,556 | | Total operating expenses | $21,449 | $32,117 | +$10,668 | | Loss from operations | $(20,774) | $(32,117) | -$11,343 | | Change in fair value of warrant liability | $(10,303) | $(5,802) | +$4,501 | | Net loss | $(30,544) | $(36,729) | -$6,185 | | Net loss attributable to common stockholders | $(31,411) | $(37,824) | -$6,413 | | Net loss per share, basic and diluted | $(1.28) | $(0.56) | +$0.72 | | Weighted-average shares outstanding | 24,539,309 | 66,985,129 | +42,445,820 | - Licensing revenues decreased to **zero** in 2024 from **$675 thousand** in 2023[16](index=16&type=chunk) - Operating expenses increased by **49.7%** from **$21.449 million** in 2023 to **$32.117 million** in 2024[16](index=16&type=chunk) - Net loss per share improved from **$(1.28)** in 2023 to **$(0.56)** in 2024, despite an increased net loss, due to a significant increase in weighted-average shares outstanding[16](index=16&type=chunk) [About Unicycive Therapeutics](index=3&type=section&id=About%20Unicycive%20Therapeutics) Unicycive Therapeutics is a biotechnology company focused on developing novel kidney disease treatments, with lead candidate OLC under FDA review and UNI-494 in clinical development [Company Profile and Product Pipeline](index=3&type=section&id=Company%20Profile%20and%20Product%20Pipeline) Unicycive Therapeutics develops novel kidney disease treatments, with lead candidate OLC under FDA review and UNI-494 having completed a Phase 1 trial - Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases[10](index=10&type=chunk) - OLC is the lead drug candidate, an investigational phosphate binding agent for hyperphosphatemia in chronic kidney disease patients on dialysis[10](index=10&type=chunk) - OLC has positive pivotal trial results (June 2024) and its NDA is under FDA review with a PDUFA Target Action Date of **June 28, 2025**[10](index=10&type=chunk) - OLC is protected by a strong global patent portfolio, including an issued patent on composition of matter with exclusivity until **2031**, and potential extension until **2035**[10](index=10&type=chunk) - UNI-494 is a patent-protected new chemical entity in clinical development for acute kidney injury, having successfully completed a Phase 1 trial[10](index=10&type=chunk) [Forward-Looking Statements & Disclaimers](index=3&type=section&id=Forward-Looking%20Statements%20%26%20Disclaimers) This section details Unicycive's forward-looking statements, emphasizing that actual results may differ due to various risks, and the company disclaims any obligation to update them [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines Unicycive's forward-looking statements, emphasizing that actual results may differ due to various risks, and the company disclaims any obligation to update them - Statements in the press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995[11](index=11&type=chunk) - Actual results could differ materially due to factors such as lengthy and expensive clinical trials with uncertain outcomes, potential suspension or discontinuation of trials, dependence on third parties for manufacturing, substantial competition, uncertainties of patent protection and litigation, and risks related to FDA clearances or approvals[11](index=11&type=chunk) - Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise[11](index=11&type=chunk)

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].