Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025LOS ALTOS, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will implement a 1-for-10 reverse split of the issued shares of its common stock, effective at 4:01 p.m. Eastern Time on June 18, 2025. The Company's common stock is expected to begin trading on a split-adjusted basis when ...

- The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor - FDA to provide final decision by PDUFA action date of June 28, 2025 LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in pa ...

LOS ALTOS, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer will present at two upcoming virtual investment conferences. Event: Lytham Partners Spring 2025 Investor Conference Type: Fireside ChatDate/Time: Thursday, May 29, 2025, at 12:30 p.m. ET Event: Noble Capital Markets 2025 Emerging Growth Virtual Equity Con ...

Investor Contacts: LOS ALTOS, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) ("Unicycive" or the "Company"), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced a change in the time of the 2025 Annual Meeting of Stockholders (the "Annual Meeting"). The previously announced date of the meeting (June 9, 2025) and location of the meeting (4300 El Camino Real, Suite 210, Los Altos, CA 94022) will not change, but the ...

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 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]

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 March 31, 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) (State or other jurisdiction of (Prima ...

– Patient-reported outcomes from Phase 2 trial of oxylanthanum carbonate (OLC) demonstrate high patient satisfaction with OLC compared to their prior phosphate lowering therapy – – Findings from a patient survey conducted in partnership with the National Kidney Foundation (NKF) showed excessive number and large size of phosphate binder pills to be top barriers to consistent medication use – – Results to be presented in poster sessions at the NKF Spring Clinical Meetings – LOS ALTOS, Calif., April 10, 2025 ( ...

Investor Contact: Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com Media Contact: Rachel Visi Real Chemistry redery@realchemistry.com SOURCE: Unicycive Therapeutics, Inc. LOS ALTOS, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer will present at the 24 Annual Needham Virtual Healthcare Conference on ...

Exhibit 99.1 Unicycive Therapeutics Announces Full Year 2024 Financial Results and Provides Business Update - Oxylanthanum carbonate (OLC) New Drug Application for hyperphosphatemia in chronic kidney disease patients on dialysis under review by the FDA with a PDUFA target action date of June 28, 2025 - Commercial Planning in Preparation for anticipated commercial launch of OLC in late 2025 LOS ALTOS, California, March 31, 2025 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology co ...