Core Viewpoint - Unicycive Therapeutics, Inc. is set to present three poster presentations at the American Society of Nephrology Kidney Week 2024, showcasing their product candidates aimed at treating kidney disease [1][2]. Group 1: Product Candidates - The three presentations will cover the following topics: - **Intravenous UNI-494**: This candidate is reported to slow the progression or halt/reverse acute kidney injury when administered after ischemia/reperfusion in rats [3]. - **Combination of Oxylanthanum Carbonate and Tenapanor**: This combination is shown to lower urinary phosphate excretion in rats [3]. - **UNI-494 Phase I Study**: This study focuses on the safety, tolerability, and pharmacokinetics of UNI-494 [3]. Group 2: Oxylanthanum Carbonate (OLC) - OLC is a next-generation phosphate binding agent designed for treating hyperphosphatemia in chronic kidney disease patients, utilizing proprietary nanoparticle technology [4]. - The global market opportunity for treating hyperphosphatemia is projected to exceed $2.5 billion in 2023, with the U.S. accounting for over $1 billion [4]. - Despite existing FDA-cleared medications, 75% of U.S. dialysis patients do not achieve recommended phosphorus levels [4]. Group 3: Clinical Development - Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, having conducted two clinical studies involving over 100 healthy volunteers [5]. - A pivotal clinical trial in chronic kidney disease patients on hemodialysis demonstrated favorable tolerability of OLC at clinically effective doses [5]. Group 4: UNI-494 - UNI-494 is a novel nicotinamide ester derivative that acts as a selective ATP-sensitive mitochondrial potassium channel activator, potentially beneficial for treating acute kidney injury and chronic kidney disease [9]. - The Phase 1 dose-ranging safety study for UNI-494 has completed enrollment, with results expected in Q3 2024 [9]. Group 5: Acute Kidney Injury (AKI) - AKI is characterized by a sudden loss of kidney function, with primary causes including sepsis, ischemia, and drug-induced nephrotoxicity [10]. - It is estimated that 2 million people die from AKI globally each year, with survivors at increased risk for chronic kidney disease [10].

Core Viewpoint - Unicycive Therapeutics is progressing towards submitting a New Drug Application (NDA) for its lead drug candidate, oxylanthanum carbonate (OLC), by the end of August 2024, following positive results from its pivotal trial [1][2]. Group 1: Clinical Development and Milestones - The pivotal trial for OLC demonstrated significant tolerability and safety, with a low discontinuation rate of 1.4% due to treatment-related adverse events [3]. - OLC achieved phosphate control in 90% of patients at the end of titration, indicating its effectiveness in managing hyperphosphatemia in chronic kidney disease patients on dialysis [2][3]. - A new patent for UNI-494 was granted, targeting acute kidney injury (AKI), with enrollment in the Phase 1 dose-ranging study completed [2][3]. - Initial results from a patient-reported outcome survey indicated that 79% of patients preferred OLC over their previous therapy, highlighting its user-friendliness and patient satisfaction [3]. Group 2: Financial Performance - Research and Development (R&D) expenses increased to $4.9 million for the quarter ended June 30, 2024, compared to $2.3 million for the same period in 2023, primarily due to higher drug development costs [5]. - General and Administrative (G&A) expenses rose to $2.5 million from $2.1 million year-over-year, attributed to increased non-cash stock compensation costs [6]. - The company reported a net income of $3.0 million for the quarter, a significant improvement from a net loss of $4.4 million in the same quarter of the previous year [7]. Group 3: Cash Position and Future Outlook - As of June 30, 2024, the company had cash and cash equivalents totaling $41.8 million, which is expected to fund operations into 2026 [8]. - Unicycive's inclusion in the Russell Microcap® Index effective July 1, 2024, enhances its visibility and access to capital markets [3].

"We are pleased to receive this patent from the USPTO, which ensures intellectual property protection for many years to come," said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. "This Method of Use patent for UNI-494 is an important component of our strategy to become a leader in the development of drugs that target kidney disease. UNI-494 is currently in an ongoing Phase 1 clinical trial and recently received Orphan Drug Designation in Delayed Graft Function, a form of acute kidney injury. This ...

Patent and Intellectual Property - Unicycive Therapeutics received U S Patent No 12 036 211 for UNI-494, a compound targeting acute kidney injury and contrast-induced nephropathy, with protection valid until 2040 [1][2] - The patent covers a method of treating kidney-related conditions using UNI-494, without limitations on salt, dose, or administration type [2] - UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator, addressing mitochondrial dysfunction in kidney diseases [2][4] Clinical Development and Strategy - UNI-494 is currently in a Phase 1 clinical trial in the UK, expected to complete in the second half of 2024 [4] - The compound has received Orphan Drug Designation from the FDA for Delayed Graft Function, a type of acute kidney injury [3][4] - The patent strengthens the company's strategy to lead in kidney disease drug development and expands its intellectual property portfolio [3] Market and Disease Context - Acute kidney injury (AKI) affects 20-200 per million population in the community, 7-18% of hospitalized patients, and approximately 50% of ICU patients [5] - AKI is associated with high morbidity and mortality, with an estimated 2 million deaths annually worldwide [5] - Delayed Graft Function, a form of AKI, occurs in the first week after kidney transplantation and is a key focus for UNI-494 [5] Company Overview - Unicycive Therapeutics is a biotechnology company focused on developing novel treatments for kidney diseases [6] - The company's lead drug candidate, oxylanthanum carbonate (OLC), targets hyperphosphatemia in chronic kidney disease patients on dialysis [6] - UNI-494 is a patent-protected new chemical entity in clinical development for acute kidney injury-related conditions [6]

LOS ALTOS, Calif., July 11, 2024 (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 that Shalabh Gupta, M.D., Chief Executive Officer will participate in a Fireside Chat at the H.C. Wainwright 3rd Annual Kidney Virtual Conference on Monday, July 15, 2024 at 2:00 p.m. ET. About Unicycive Therapeutics Investor Contact: SOURCE: Unicycive Therapeutics, Inc. A ...

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follo ...

– Patients preferred OLC more than 4 to 1 over their prior phosphate binder therapy – LOS ALTOS, Calif., July 10, 2024 (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 initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) t ...

LOS ALTOS, Calif., July 10, 2024 (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 initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) trial in patients with hyperphosphatemia who have chronic kidney disease on dialysis we ...

The annual Russell US Indexes reconstitution captures the 4,000 largest US stocks as of Tuesday, April 30th, ranking them by total market capitalization. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes. "Inclusion in the Russell Microcap Index represents the latest mi ...

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Russell's US indexes serve as the benchmark for about $10.5 trillion in assets as of the close of December 2023. Russell indexes are part of FTSE Russell, a leading global index provider. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. For over 30 years, leading asset owners, asset managers, ETF p ...