Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [3] - The company's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3] - 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 [3] Upcoming Events - Shalabh Gupta, M.D., CEO of Unicycive, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on July 14, 2025, at 11 a.m. ET [1] - A link to the webcast of the event will be available on the Unicycive website under the Investors section [2]

Core Points - Unicycive Therapeutics, Inc. announced that the U.S. FDA issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for OLC, intended to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis [1] - Following the FDA's announcement, Unicycive's stock price experienced a decline [1] Company Overview - Holzer & Holzer, LLC is investigating whether Unicycive complied with federal securities laws in light of the recent FDA decision [1] - The law firm specializes in representing shareholders and investors in litigation, including shareholder class action and derivative litigation [3] - Holzer & Holzer has a history of recovering hundreds of millions of dollars for shareholders affected by corporate misconduct since its founding in 2000 [3]

Financial Performance - Net income attributable to common stockholders for Q1 2025 was $0.5 million, a significant improvement from a net loss of $21.2 million in Q1 2024[9] - Total operating expenses for Q1 2025 were $7.99 million, down from $9.20 million in Q1 2024[18] - The change in fair value of the warrant liability contributed to other income of $8.6 million for Q1 2025, compared to an expense of $11.8 million in Q1 2024[8] Research and Development - Research and Development (R&D) expenses decreased to $2.2 million for Q1 2025 from $6.8 million in Q1 2024, primarily due to reduced drug development costs[4] General and Administrative Expenses - General and Administrative (G&A) expenses increased to $5.8 million for Q1 2025 from $2.4 million in Q1 2024, mainly due to higher consulting and professional services for commercial launch preparation[5] Cash and Assets - Cash and cash equivalents as of March 31, 2025, totaled $19.8 million, down from $26.1 million as of December 31, 2024[10] - Prepaid expenses and other current assets increased from $4.8 million as of December 31, 2024, to $7.6 million as of March 31, 2025, reflecting ongoing commercial supply manufacturing efforts[8] Regulatory and Market Preparation - The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for the New Drug Application (NDA) of oxylanthanum carbonate (OLC)[7] - The company is preparing for the anticipated commercial launch of OLC in late 2025, supported by ongoing commercial planning and engagement with prescribers[6] Market Insights - New patient survey data indicated that 200 dialysis patients identified excessive pill numbers and sizes as primary barriers to adherence, highlighting the market potential for OLC[7]

Core Points - The FDA issued a Complete Response Letter (CRL) for Unicycive's New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, citing deficiencies at a third-party manufacturing vendor unrelated to OLC [1][2] - Unicycive has identified a second manufacturing vendor that has already produced OLC drug product, which may help resolve the Clinical Manufacturing and Controls (CMC) issues noted in the CRL [1][3] - The company plans to request a Type A meeting with the FDA to discuss the next steps for addressing the CRL [2] - Unicycive currently has an unaudited cash balance of approximately $20.7 million, with a cash runway expected into the second half of 2026 [1] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead investigational treatment being OLC [8] - OLC is an investigational oral phosphate binder that utilizes proprietary nanoparticle technology to effectively reduce phosphate levels, potentially improving patient adherence due to a lower pill burden compared to existing treatments [4][5] - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio providing exclusivity until 2031, with potential extensions until 2035 [5] Industry Context - Hyperphosphatemia is a serious condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication to manage phosphate levels annually [6] - Treatment strategies for hyperphosphatemia include dietary phosphorus restriction and the use of oral phosphate binding drugs to facilitate the elimination of dietary phosphate [6][7]

Core Viewpoint - Unicycive Therapeutics, Inc. is implementing a 1-for-10 reverse stock split to comply with Nasdaq's minimum bid price requirement, effective June 18, 2025, with trading on a split-adjusted basis starting June 20, 2025 [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will combine every ten shares into one, reducing the number of issued shares from approximately 126,409,281 to about 12,640,929 [4]. - Stockholders will not receive fractional shares; instead, fractional interests will be rounded up to the next whole share [3]. - The reverse stock split will not affect stockholders' percentage ownership or voting power, except for minor changes due to fractional shares [3]. Group 2: Compliance and Adjustments - The reverse stock split aims to increase the bid price of the common stock to meet the $1.00 minimum bid price requirement for continued listing on Nasdaq [2]. - Proportionate adjustments will be made to the exercise prices and number of shares underlying stock options, warrants, and preferred stock as a result of the reverse stock split [5]. Group 3: Company Overview - Unicycive Therapeutics is focused on developing therapies for kidney diseases, with its lead investigational treatment, oxylanthanum carbonate, under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [8]. - The second investigational treatment, UNI-494, is aimed at conditions related to acute kidney injury and has received orphan drug designation from the FDA [9].

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 ...