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].

Core Viewpoint - The FDA has identified deficiencies in cGMP compliance at a third-party manufacturing vendor for Unicycive Therapeutics' New Drug Application (NDA) for oxylanthanum carbonate (OLC), with a final decision expected by June 28, 2025 [1][2]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead investigational treatment being oxylanthanum carbonate (OLC) [6]. - OLC is an oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology to enhance phosphate binding potency [3][4]. Product Details - OLC aims to reduce the pill burden for patients, potentially improving adherence compared to existing treatments [3]. - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio protecting the product until at least 2031, with potential extensions until 2035 [4]. Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [5]. - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [5].

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney diseases [2] - The company's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2] - 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 [2] Upcoming Events - Shalabh Gupta, M.D., CEO of Unicycive, will present at the Lytham Partners Spring 2025 Investor Conference on May 29, 2025, at 12:30 p.m. ET [1] - The company will also participate in the Noble Capital Markets 2025 Emerging Growth Virtual Equity Conference on June 4, 2025, at 1 p.m. ET [1] - Live and archived webcasts of these presentations will be available on the Unicycive website under the Investors section [1]

Company Overview - Unicycive Therapeutics, Inc. is a clinical stage biotechnology company focused on developing therapies for kidney diseases [2] - The company's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2] - 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 [2] Recent Developments - The company announced a change in the timing of its 2025 Annual Meeting of Stockholders, which will now be held at 7:00 a.m. Pacific Daylight Time on June 9, 2025 [1] - The location of the meeting remains unchanged at 4300 El Camino Real, Suite 210, Los Altos, CA 94022 [1] - Stockholders of record as of April 30, 2025, can find additional participation details on the company's dedicated webpage [1]

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 ...

Financial Performance - The company reported a net loss of $36.7 million for the year ended December 31, 2024, an increase of 20% from a net loss of $30.5 million in 2023[383]. - The company has an accumulated deficit of $101.3 million as of December 31, 2024[383]. - The company incurred a net loss of $36.7 million for the year ended December 31, 2024, with an accumulated deficit of $101.3 million as of the same date[409]. - The company expects to continue incurring losses and will require additional capital for clinical trials and product development[410]. - Cash used in operating activities for the year ended December 31, 2023, was $18.3 million, with a net loss of $30.5 million[417]. Expenses - Research and development expenses rose by approximately $7.1 million, or 55%, from $12.9 million in 2023 to $20.0 million in 2024, primarily due to increased drug development costs[399]. - General and administrative expenses increased by approximately $3.5 million, or 42%, from $8.5 million in 2023 to $12.1 million in 2024, driven by higher consulting and professional services costs[400]. - Net cash used in operating activities was $28.6 million for the year ended December 31, 2024, primarily due to development costs and corporate expenditures[416]. Revenue - The company generated approximately $1.6 million in licensing revenue to date, with a significant decrease of $0.7 million, or 100%, in licensing revenues for the year ended December 31, 2024[398][405]. Capital and Financing - The company raised approximately $50 million through a private placement of Series B Convertible Preferred Stock and an additional $50 million through a sales agreement for common stock[408]. - Net cash provided by financing activities was $45.1 million for the year ended December 31, 2024, primarily from the private placement and public offering[419]. - The company anticipates needing to raise substantial additional capital, which may lead to dilution for existing shareholders[411]. Clinical Development - The company completed a Phase I clinical study in healthy volunteers with UNI-494 in 2024, targeting acute kidney injury[379]. - The company expects operating expenses to increase significantly as it advances product candidates through clinical development and seeks regulatory approval[383]. - The company plans to use proceeds from a securities purchase agreement, which may provide up to $130.0 million, to support the NDA submission for Oxylanthanum Carbonate and its commercial launch in the U.S.[406]. - Oxylanthanum Carbonate is being developed as a next-generation phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis[379]. Compliance and Notices - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement, with a compliance period extended until July 7, 2025[387][388]. Investing Activities - Net cash used in investing activities was $72,000 for the year ended December 31, 2024, due to office furniture purchases[418]. - The company received advances of $210,000 from a stockholder in February 2023, which were fully repaid in March 2023[414].