Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Unicycive Therapeutics, Inc. following a significant stock price drop after the FDA issued a Complete Response Letter for its New Drug Application [1][2]. Group 1: Company Overview - Unicycive Therapeutics, Inc. is a company listed on NASDAQ under the ticker UNCY [1]. - The company recently faced regulatory challenges when the FDA issued a Complete Response Letter regarding its New Drug Application for OLC, intended to treat hyperphosphatemia in patients with chronic kidney disease on dialysis [2]. Group 2: Stock Performance - Following the FDA's announcement, Unicycive's stock price decreased by $2.03 per share, representing a decline of 29.85%, closing at $4.77 per share on June 30, 2025 [2]. Group 3: Legal Context - Pomerantz LLP, a prominent law firm specializing in corporate and securities class litigation, is leading the investigation into Unicycive's practices, emphasizing its long history of fighting for victims of securities fraud and corporate misconduct [3].

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]