Core Points - Holzer & Holzer, LLC has initiated a shareholder class action lawsuit against Unicycive Therapeutics, alleging that the company made materially false and misleading statements regarding its FDA manufacturing compliance and the regulatory prospects of its OLC NDA [1] - The lawsuit claims that Unicycive overstated its readiness to meet FDA requirements and the likelihood of regulatory approval for its product [1] - Shareholders who purchased Unicycive shares between March 29, 2024, and June 27, 2025, are encouraged to contact the law firm for more information regarding their legal rights [2] Legal Context - The deadline for shareholders to request to be appointed as lead plaintiff in the case is October 14, 2025 [3] - Holzer & Holzer, LLC is recognized as a top-rated securities litigation law firm and has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

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]

Financial Performance - Unicycive ended Q2 2025 with $22.3 million in cash, providing a runway into the second half of 2026[5] - 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, largely due to changes in the fair value of warrant liability[10] - Other income for Q2 2025 was $0.5 million, a significant decrease from $17.3 million in Q2 2024, primarily due to changes in fair value of warrant liability[9] - Total operating expenses for Q2 2025 were $6.96 million, down from $7.40 million in Q2 2024[19] Research and Development - Research and Development (R&D) expenses decreased to $1.8 million in Q2 2025 from $4.9 million in Q2 2024, primarily due to reduced drug development costs[7] - Unicycive's second investigational treatment, UNI-494, has received orphan drug designation for preventing Delayed Graft Function in kidney transplant patients[12] Administrative Expenses - 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[8] Regulatory and Clinical Updates - Unicycive has requested a Type A meeting with the FDA to resolve the Complete Response Letter (CRL) for OLC, typically granted within 30 days[6] - The company plans to provide an investor update in Q3 2025 following FDA feedback[6] - OLC pivotal study data published in CJASN showed over 90% of patients achieved effective phosphate control with a low pill burden[5]

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]

Financial Performance - For the six months ended June 30, 2025, the company reported a net loss of $5.9 million, compared to a net loss of $11.1 million for the same period in 2024, indicating a reduction in losses by approximately 47%[171]. - Net loss for the six months ended June 30, 2025, was $5.9 million, a decrease of $5.2 million, or 47%, compared to a net loss of $11.1 million for the same period in 2024[199]. - The company had an accumulated deficit of $107.1 million as of June 30, 2025[171]. - As of June 30, 2025, the company had an accumulated deficit of $107.1 million[199]. - The company expects to incur substantial additional losses in future periods and will require additional capital to complete clinical trials and product development initiatives[200]. Expenses - Research and development expenses decreased by approximately $3.1 million, or 64%, from approximately $4.9 million for the three months ended June 30, 2024, to approximately $1.8 million for the same period in 2025[187]. - General and administrative expenses increased by $2.7 million, or 106%, from approximately $2.5 million for the three months ended June 30, 2024, to approximately $5.2 million for the same period in 2025, primarily due to increased marketing and consulting expenses[188]. - The total operating expenses for the three months ended June 30, 2025, were approximately $6.96 million, a decrease of $438,000 or 6% compared to the same period in 2024[186]. - Research and development expenses decreased by approximately $7.7 million, or 66%, from $11.7 million for the six months ended June 30, 2024, to $3.9 million for the six months ended June 30, 2025[191]. - General and administrative expenses increased by $6.1 million, or 124%, from $4.9 million for the six months ended June 30, 2024, to $11.0 million for the six months ended June 30, 2025[192]. Income and Financing - Other income increased by $3.6 million, or 65%, from a $5.5 million expense in the six months ended June 30, 2024, to $9.0 million income for the six months ended June 30, 2025[193]. - Net cash used in operating activities was $17.3 million for the six months ended June 30, 2025, compared to $12.8 million for the same period in 2024[205][206]. - Net cash provided by financing activities was $13.5 million during the six months ended June 30, 2025, down from $44.9 million during the same period in 2024[208]. - The company sold 2,009,616 shares of common stock at an average price of $6.07 per share during the six months ended June 30, 2025, resulting in net proceeds of approximately $12.2 million[177]. - The company sold 2,009,616 shares of common stock at an average price of $6.07 per share, resulting in net proceeds of approximately $12.2 million during the six months ended June 30, 2025[198]. Future Outlook - The company expects significant increases in operating expenses as it advances its product candidates through clinical development and seeks regulatory approval[171]. - 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[196]. - The company plans to continue using third-party service providers for pre-clinical and clinical development, as well as for manufacturing and supplying materials for product candidates[175]. Regulatory and Compliance - The company is taking advantage of the extended transition periods under the JOBS Act for complying with new accounting standards, which may affect comparability with other public companies[216]. - The company will remain an "emerging growth company" until it reaches total annual gross revenues of $1.235 billion or more, among other conditions[217]. - There are currently no off-balance sheet arrangements as defined under SEC rules[220].

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]