Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, Aug. 14, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Unicycive Therapeutics, Inc. (“Unicycive Therapeutics” or “the Company”) (NASDAQ: UNCY) investors that the firm has initiated an investigation into possible securities fraud and may file a class action on behalf of investors. Unicycive Therapeutics investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq. Inve ...

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 ...

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 ...

LOS ALTOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dialysis in the Clinical Journal of the American Society of Nephrology. The publication, entitled “A Phase 2 Clinical Tr ...

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]

NEW YORK, July 7, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Unicycive and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action]On June 30 ...

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]

ATLANTA, June 30, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) complied with federal securities laws. On June 30, 2025, Unicycive “announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.” Following this news, the price of the Company’s stock dropped.  If you pur ...

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]