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 June 30, 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) Delaware 2834 81-3638692 (I.R.S. Employ ...

Core Insights - Unicycive Therapeutics has published pivotal trial data on oxylanthanum carbonate (OLC) for chronic kidney disease (CKD) patients on dialysis, demonstrating its safety and tolerability [1][2] - The Phase 2 clinical trial showed that OLC effectively controlled serum phosphate levels in over 90% of patients with a low pill burden [2][8] - The company is seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a strong patent portfolio supporting its market position [7][11] Company Overview - Unicycive Therapeutics is focused on developing innovative treatments for kidney diseases, with OLC as its lead investigational product aimed at treating hyperphosphatemia in CKD patients on dialysis [11] - The company is also developing UNI-494 for acute kidney injury, which has received Orphan Drug designation from the FDA [11] Clinical Trial Findings - The Phase 2 trial involved 86 patients, with only 59% achieving target serum phosphate levels at screening [2] - OLC was well tolerated, with the most common treatment-related adverse events being gastrointestinal issues, affecting 9% of patients with diarrhea and 6% with vomiting [8] - Two-thirds of patients required three or fewer OLC tablets per day to achieve effective phosphate control [8] Market Need - There is a significant unmet need in managing hyperphosphatemia among CKD patients on dialysis, with over 450,000 individuals in the U.S. requiring medication for phosphate control annually [8][9] - OLC's unique profile may transform the standard of care for these patients by reducing pill burden and improving treatment adherence [5][6]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Unicycive Therapeutics and its officers or directors following a significant stock price drop after the FDA issued a Complete Response Letter for its New Drug Application [1][3]. 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 for its New Drug Application for OLC, intended to treat hyperphosphatemia in patients with chronic kidney disease on dialysis [3]. Group 2: Regulatory Issues - The FDA's Complete Response Letter was issued due to deficiencies found at a third-party manufacturing vendor associated with Unicycive's contract development and manufacturing organization [3]. - Following the announcement of the FDA's decision, Unicycive's stock price fell by $2.03 per share, representing a decline of 29.85%, closing at $4.77 per share on June 30, 2025 [3]. Group 3: Legal Actions - Pomerantz LLP is actively seeking claims from investors of Unicycive regarding potential securities fraud or other unlawful practices [1]. - Investors are encouraged to contact Pomerantz LLP for participation in the investigation [1].

Core Points - Unicycive Therapeutics has regained compliance with Nasdaq's minimum share price requirement following a reverse stock split [1][2] - The company's common stock maintained an average closing share price of at least $1.00 as of July 3, 2025, after the 1:10 reverse stock split effective June 20, 2025 [2] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases [3] - The lead investigational treatment is oxylanthanum carbonate, currently under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3] - The 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]

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].