Core Insights - Unicycive Therapeutics is advancing its lead investigational treatment, oxylanthanum carbonate (OLC), for patients with hyperphosphatemia and plans to resubmit the New Drug Application (NDA) by the end of 2025 following positive discussions with the FDA [2][8] - The company reported a net loss of $6.0 million for the quarter ended September 30, 2025, an increase from a net loss of $4.1 million in the same period of 2024, primarily due to increased labor and professional services costs [6][9] - Unicycive ended Q3 2025 with $42.7 million in cash, providing a runway into 2027, which positions the company well for regulatory approval and potential product launch [7][9] Financial Results - Research and Development (R&D) expenses for Q3 2025 were $3.0 million, a slight decrease from approximately $3.1 million in Q3 2024, attributed to reduced professional services and drug development costs [4] - General and Administrative (G&A) expenses increased to $4.4 million in Q3 2025 from $3.2 million in Q3 2024, mainly due to higher labor and consulting costs [5] - Other income decreased to $1.3 million in Q3 2025 from $2.2 million in Q3 2024, primarily due to changes in the fair value of warrant liability [6] Upcoming Milestones - The company is on track to resubmit the NDA for OLC by year-end 2025, with a potential new Prescription Drug User Fee Act (PDUFA) date in the first half of 2026 [8] - New data presented at the ASN Kidney Week 2025 indicates that OLC significantly reduces pill burden, with a 7-fold decrease in pill volume and a 2-fold reduction in pill count compared to existing phosphate binders [2][8]

Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $11.9 million, compared to a net loss of $15.2 million for the same period in 2024, indicating a reduction in losses [175]. - As of September 30, 2025, the company had an accumulated deficit of $113.2 million [175]. - Net loss for the nine months ended September 30, 2025, was $11.9 million, a decrease of $3.3 million, or 22%, compared to a net loss of $15.2 million in the same period of 2024 [200]. - The company expects to incur substantial additional losses in future periods and will require additional capital to complete clinical trials and product development initiatives [201]. Expenses - Research and development expenses decreased by approximately $81,000, or 3%, from $3.1 million in Q3 2024 to $3.0 million in Q3 2025 [188]. - General and administrative expenses increased by $1.2 million, or 37%, from approximately $3.2 million in Q3 2024 to approximately $4.4 million in Q3 2025 [189]. - Total operating expenses rose by $1.1 million, or 17%, from $6.3 million in Q3 2024 to $7.3 million in Q3 2025 [187]. - Research and development expenses decreased by approximately $7.9 million, or 53%, from $14.7 million in the nine months ended September 30, 2024, to $6.9 million in the same period of 2025 [192]. - General and administrative expenses increased by $7.3 million, or 90%, from $8.1 million in the nine months ended September 30, 2024, to $15.4 million in the same period of 2025 [193]. Cash Flow - Net cash used in operating activities was $23.3 million for the nine months ended September 30, 2025, compared to $22.0 million for the same period in 2024 [206][207]. - Net cash provided by financing activities was $39.9 million during the nine months ended September 30, 2025, compared to $44.7 million in the same period of 2024 [209]. Stock and Financing - The company sold 8,046,736 shares of common stock at an average price of $4.94 per share, resulting in net proceeds of approximately $38.6 million [179]. - The company sold 8,046,736 shares of common stock at an average price of $4.94 per share, resulting in net proceeds of approximately $38.6 million during the nine months ended September 30, 2025 [199]. - Future revenue streams may consist of collaboration or licensing revenue as well as product sales, with potential gross proceeds of up to $130.0 million from a securities purchase agreement [197]. Product Development - The company plans to resubmit the New Drug Application (NDA) for Oxylanthanum Carbonate by year-end 2025 following a Type A meeting with the FDA [180]. - The company is focused on developing Oxylanthanum Carbonate for hyperphosphatemia in chronic kidney disease patients and UNI-494 for acute kidney injury, addressing significant unmet medical needs [171][173]. - The healthcare costs associated with acute kidney injury exceed $9 billion annually in the U.S., highlighting the market potential for UNI-494 if approved [173]. - The company expects significant increases in operating expenses as it advances its product candidates through clinical development and regulatory approval [175]. Compliance and Reporting - The company is utilizing extended transition periods under the JOBS Act for compliance with new accounting standards, which may affect comparability with other public companies [217]. - As an "emerging growth company," the company plans to rely on certain exemptions, including not providing an auditor's attestation report on internal controls until certain revenue thresholds are met, specifically $1.235 billion [218]. - The company has no off-balance sheet arrangements during the reported periods [221]. - As a smaller reporting company, the company is not required to disclose quantitative and qualitative information about market risk [222]. Other Income - Other income increased by $2.8 million, or 36%, from a $7.7 million expense in the nine months ended September 30, 2024, to a $10.4 million income in the same period of 2025 [194].

Core Insights - Unicycive Therapeutics, Inc. is participating in the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025, where CEO Shalabh Gupta will engage in a fireside chat [1] - The company is focused on developing therapies for kidney diseases, with its lead investigational treatment, oxylanthanum carbonate, currently under FDA review for hyperphosphatemia in chronic kidney disease patients on dialysis [3] - Unicycive's second investigational treatment, UNI-494, is aimed at treating conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [3] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company specializing in novel treatments for kidney diseases [3] - The company is developing oxylanthanum carbonate as a phosphate binding agent and has completed a Phase 1 safety study for UNI-494 [3] - More information about the company can be found on its website and social media platforms [3]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Unicycive Therapeutics, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during the specified class period [2]. Group 1: Legal Investigation - The investigation is focused on long-term stockholders of Unicycive between March 29, 2024, and June 27, 2025, following a class action complaint filed on August 15, 2025 [2][4]. - Investors are encouraged to contact the law firm for discussions regarding their legal rights and options [1][4]. Group 2: Company Performance and Regulatory Issues - The complaint alleges that Unicycive misrepresented its readiness to meet FDA manufacturing compliance requirements for its New Drug Application (NDA) for oxylanthanum carbonate (OLC) [8]. - On June 10, 2025, Unicycive disclosed that the FDA identified deficiencies in current good manufacturing practice (cGMP) compliance at a third-party vendor, leading to a significant stock price drop of over 40% [8]. - Following the issuance of a Complete Response Letter from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock fell nearly 30%, closing at $4.77 per share [8].

Core Insights - Unicycive Therapeutics is presenting new data on oxylanthanum carbonate (OLC) at the ASN Kidney Week 2025, highlighting significant reductions in pill burden for patients with chronic kidney disease (CKD) [1][2] Group 1: Study Findings - The open-label trial showed a 7-fold reduction in pill volume and a 2-fold reduction in pill count compared to pre-trial phosphate binder therapy [1][2] - The mean daily pill volume decreased from 9.3 cm to 1.4 cm, and the average number of pills taken daily dropped from 8.3 to 3.9 [6] - At the end of the OLC titration period, 91% of patients had serum phosphate levels ≤5.5 mg/dL, up from 59% at screening [6] Group 2: Product Information - OLC is an investigational oral phosphate binder utilizing proprietary nanoparticle technology, aimed at improving patient adherence by reducing the number and size of pills [8] - The company is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, supported by data from three clinical studies and a strong patent portfolio [9] Group 3: Industry 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 for phosphate control annually [10] - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [10]

Financial Position - As of September 30, 2025, Unicycive Therapeutics expects to report approximately $42 million in cash and cash equivalents[6] Regulatory Updates - The company received a Complete Response Letter from the U.S. FDA on June 30, 2025, regarding its New Drug Application for Oxylanthanum Carbonate[8] - An update on the timing of the resubmission of the New Drug Application was announced on October 28, 2025[8]

Core Insights - Unicycive Therapeutics plans to resubmit its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) by year-end 2025 after receiving constructive feedback from the FDA regarding a previously identified deficiency [1][2] - The company has over $42 million in cash as of September 30, 2025, providing a financial runway into 2027 to support regulatory processes and potential commercialization of OLC [2] - OLC is an investigational oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, leveraging proprietary nanoparticle technology for improved patient adherence [3][4] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC as its lead investigational treatment for hyperphosphatemia [6] - The company is also developing UNI-494, aimed at treating conditions related to acute kidney injury, which has received orphan drug designation from the FDA [6] Product Details - OLC utilizes proprietary nanoparticle technology to enhance phosphate binding potency, potentially reducing the pill burden for patients 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 its composition until at least 2031, with potential extensions until 2035 [3] 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 [4]

Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. on behalf of shareholders who purchased securities during the specified class period from March 29, 2024, to June 27, 2025 [1] Company Summary - Unicycive Therapeutics, Inc. is identified as a clinical-stage biotechnology company [1] - The lawsuit is being investigated by Rosen Law Firm, a global investor rights law firm [1]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Unicycive Therapeutics, Inc. securities during the class period from March 29, 2024, to June 27, 2025, about the lead plaintiff deadline of October 14, 2025, for a class action lawsuit [1][2]. Group 1: Class Action Details - Investors may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by the specified deadline [2]. - The lawsuit alleges that Unicycive made false and misleading statements regarding its compliance with FDA manufacturing requirements and the regulatory prospects of its New Drug Application [4]. Group 2: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest settlement against a Chinese company at the time and being ranked No. 1 for securities class action settlements in 2017 [3]. - The firm has recovered hundreds of millions of dollars for investors, securing over $438 million in 2019 alone [3]. - Founding partner Laurence Rosen was recognized as a Titan of Plaintiffs' Bar by Law360 in 2020, highlighting the firm's expertise and recognition in the field [3].

Core Viewpoint - The Gross Law Firm is notifying shareholders of Unicycive Therapeutics, Inc. about a class action lawsuit due to alleged misleading statements regarding the company's compliance with FDA manufacturing requirements and the regulatory prospects of its new drug application [1][3]. Group 1: Class Action Details - The class period for the lawsuit is from March 29, 2024, to June 27, 2025 [3]. - Allegations include that Unicycive overstated its readiness to meet FDA manufacturing compliance and the regulatory prospects of its oxylanthanum carbonate new drug application [3]. - The deadline for shareholders to register for the class action is October 14, 2025 [4]. Group 2: Next Steps for Shareholders - Shareholders who register will be enrolled in a portfolio monitoring software for status updates throughout the case [4]. - There is no cost or obligation for shareholders to participate in the case [4]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm focused on protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [5].