Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney diseases [5] - The company's lead investigational treatment is oxylanthanum carbonate, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis [5] - The second investigational drug, UNI-494, is intended for 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 [5] Intellectual Property - The U.S. Patent and Trademark Office has issued U.S. Patent 12,377,082 for UNI-494, ensuring intellectual property protection until 2040 [1] - This patent complements an earlier method of use patent for UNI-494 in treating Acute Kidney Injury [1] - The patent portfolio for UNI-494 supports potential partnership opportunities and future development efforts [2] Product Development - UNI-494 is a novel nicotinamide ester derivative that acts as a selective ATP-sensitive mitochondrial potassium channel activator, addressing mitochondrial dysfunction in kidney diseases [3] - The drug has completed a Phase 1 dose-ranging safety study in healthy volunteers [3] - The company is currently focused on seeking FDA approval for its lead product, oxylanthanum carbonate [2] Acute Kidney Injury Context - Acute kidney injury (AKI) is characterized by a sudden loss of kidney function, with primary causes including sepsis, ischemia, and drug-induced nephrotoxicity [4] - AKI affects 20-200 per million in the community, 7-18% of hospitalized patients, and approximately 50% of ICU patients [4] - An estimated 2 million people die from AKI globally each year, with survivors at increased risk for chronic kidney disease and end-stage renal disease [4]

Core Viewpoint - A class action has been filed against Unicycive Therapeutics, Inc. for allegedly misleading investors regarding the readiness of its drug application and compliance with FDA manufacturing requirements [1][2]. Group 1: Allegations and Legal Action - Robbins LLP is investigating allegations that Unicycive Therapeutics misled investors about the prospects of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) [2]. - The complaint claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements [2]. - Shareholders are encouraged to participate in the class action and can contact Robbins LLP before the October 14, 2025 deadline to serve as lead plaintiff [4]. Group 2: Stock Performance and FDA Actions - On June 10, 2025, Unicycive announced that the FDA identified deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a stock price drop of over 40% [3]. - Following the FDA's issuance of a Complete Response Letter for the OLC NDA on June 30, 2025, Unicycive's stock fell nearly 30%, closing at $4.77 per share [3].

Core Viewpoint - Unicycive Therapeutics is under investigation for possible securities fraud following a significant stock price decline after the FDA issued a Complete Response Letter for its New Drug Application [1][3][4] Company Summary - Unicycive Therapeutics, Inc. (NASDAQ: UNCY) has faced legal scrutiny as the Portnoy Law Firm has initiated an investigation into potential securities fraud and may file a class action on behalf of investors [1] - The company received a Complete Response Letter from the FDA regarding its New Drug Application for OLC, which is intended to treat hyperphosphatemia in patients with chronic kidney disease on dialysis [3] - The FDA's response was triggered by deficiencies found in a third-party manufacturing vendor during a cGMP inspection [3] Stock Performance - Following the FDA announcement, Unicycive's stock price fell by $2.03 per share, representing a decline of approximately 29.85%, closing at $4.77 per share on June 30, 2025 [4]

Exhibit 99.1 Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update LOS ALTOS, California, August 14, 2025 -- Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2025, and provided a business update. "Our team has made great progress in the second quarter and we have request ...

Core Insights - Unicycive Therapeutics has requested a Type A meeting with the FDA to address the Complete Response Letter (CRL) regarding oxylanthanum carbonate (OLC) [1][9] - Recent pivotal study data published in the Clinical Journal of the American Society of Nephrology indicates that OLC was well tolerated and achieved serum phosphate control in over 90% of patients with a low pill burden [1][9] - The company ended Q2 2025 with $22.3 million in cash, providing a financial runway into the second half of 2026 [1][8] Business Update - The CEO of Unicycive highlighted progress in addressing deficiencies noted by the FDA related to a third-party manufacturing vendor, which was not linked to OLC [2] - The company remains committed to improving treatment options for managing hyperphosphatemia in dialysis patients, given the high rates of non-compliance with existing therapies [2] Financial Results - Research and Development (R&D) expenses for Q2 2025 were $1.8 million, a decrease from $4.9 million in Q2 2024, primarily due to reduced drug development costs [4] - General and Administrative (G&A) expenses increased to $5.2 million in Q2 2025 from $2.5 million in Q2 2024, mainly due to higher consulting and professional services for commercial launch preparation [5] - Other income for Q2 2025 was $0.5 million, a significant decrease from $17.3 million in Q2 2024, attributed to changes in the fair value of warrant liability [6] - The net loss attributable to common stockholders for Q2 2025 was $6.4 million, compared to a net income of $3.0 million in Q2 2024, primarily due to changes in warrant liability [7] Cash Position - As of June 30, 2025, Unicycive had cash and cash equivalents totaling $22.3 million, which is expected to fund operations into the second half of 2026 [8]

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].