Core Viewpoint - The FDA has identified deficiencies in cGMP compliance at a third-party manufacturing vendor for Unicycive Therapeutics' New Drug Application (NDA) for oxylanthanum carbonate (OLC), with a final decision expected by June 28, 2025 [1][2]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead investigational treatment being oxylanthanum carbonate (OLC) [6]. - OLC is an oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology to enhance phosphate binding potency [3][4]. Product Details - OLC aims to reduce the pill burden for patients, potentially improving adherence compared to existing treatments [3]. - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio protecting the product until at least 2031, with potential extensions until 2035 [4]. Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [5]. - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [5].

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney diseases [2] - The company's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2] - Unicycive's second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [2] Upcoming Events - Shalabh Gupta, M.D., CEO of Unicycive, will present at the Lytham Partners Spring 2025 Investor Conference on May 29, 2025, at 12:30 p.m. ET [1] - The company will also participate in the Noble Capital Markets 2025 Emerging Growth Virtual Equity Conference on June 4, 2025, at 1 p.m. ET [1] - Live and archived webcasts of these presentations will be available on the Unicycive website under the Investors section [1]

Company Overview - Unicycive Therapeutics, Inc. is a clinical stage biotechnology company focused on developing therapies for kidney diseases [2] - The company's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2] - Unicycive's second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [2] Recent Developments - The company announced a change in the timing of its 2025 Annual Meeting of Stockholders, which will now be held at 7:00 a.m. Pacific Daylight Time on June 9, 2025 [1] - The location of the meeting remains unchanged at 4300 El Camino Real, Suite 210, Los Altos, CA 94022 [1] - Stockholders of record as of April 30, 2025, can find additional participation details on the company's dedicated webpage [1]

Core Insights - Unicycive Therapeutics is preparing for the potential FDA approval of oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis, with a PDUFA target action date set for June 28, 2025 [1][8] - New patient survey data indicates significant adherence challenges for dialysis patients with hyperphosphatemia, highlighting the market potential for OLC [1][2] Financial Performance - Research and Development (R&D) expenses decreased to $2.2 million for the three months ended March 31, 2025, down from $6.8 million for the same period in 2024, primarily due to reduced drug development costs [4] - General and Administrative (G&A) expenses increased to $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the same period in 2024, mainly due to higher consulting and professional services related to commercial launch preparations [5] - Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, a significant improvement from a net loss of $21.2 million for the same period in 2024, primarily due to a decrease in the fair value of the warrant liability [7] Market Preparation and Patient Insights - The company is actively preparing for the potential launch of OLC by enhancing its commercial infrastructure and engaging with prescribers and stakeholders [8] - Findings from a patient survey involving 200 dialysis patients revealed that excessive pill numbers, large pill sizes, and forgetfulness are major barriers to adherence, with patients expressing a strong preference for regimens with fewer and smaller pills [8] - New patient-reported outcomes data from a pivotal Phase 2 study of OLC showed that patients preferred OLC over their previous phosphate binder medications, significantly enhancing patient satisfaction [8] Cash Position - As of March 31, 2025, the company reported cash and cash equivalents totaling $19.8 million [9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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: 001-40582 UNICYCIVE THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of (Prima ...

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 ...