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 ...

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Core Insights - Unicycive Therapeutics announced positive results from the pivotal clinical trial of Oxylanthanum Carbonate (OLC), demonstrating favorable tolerability and safety for patients with chronic kidney disease (CKD) [1][2][6] - The company anticipates submitting a New Drug Application (NDA) for OLC in Q3 2024, utilizing the 505(b)(2) regulatory pathway [1][6][24] Summary by Categories Clinical Trial Results - The UNI-OLC-201 trial showed a low discontinuation rate due to adverse events (AEs), with only 6% (5 out of 86 patients) discontinuing, which is significantly lower than the 14% rate for Fosrenol® [2][3] - In the Evaluable Population (n=71), only 1 patient discontinued due to a treatment-related AE, resulting in a rate of 1.4% [3][13] - The full Safety Population (n=86) had a total of 3 treatment-related discontinuations, yielding a rate of 3.5% [3][13] Safety and Tolerability - Most treatment-related AEs were mild to moderate, with no serious adverse events reported [4][13] - The most common AEs were diarrhea (9%) and vomiting (6%), which are comparable to other phosphate binders [4][13] Efficacy Insights - Although the study was not designed to evaluate efficacy, 90% of patients achieved phosphate levels ≤5.5 mg/dL after titration with OLC [5][15] - At baseline, 59% of patients had phosphate levels ≤5.5 mg/dL, and after washout from prior phosphate binders, 90% achieved the target level [5][15] Market Potential - The global market for treating hyperphosphatemia is projected to exceed $2.5 billion in 2023, with the U.S. accounting for over $1 billion [17] - Approximately 40% of dialysis patients struggle to achieve adequate serum phosphate control, highlighting a significant unmet need in the market [6][17] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC being a next-generation phosphate binding agent utilizing proprietary nanoparticle technology [1][20][17] - The company has over forty issued and granted patents globally for OLC, which aims to improve patient adherence by reducing the pill burden compared to existing treatments [17][20]

– Results from Preclinical Model of Hyperphosphatemia Demonstrate the Relative Potency of OLC Compared to Tenapanor – – Oral UNI-494 Shows Promise in a Preclinical Model as a Potential Candidate for Prevention of Delayed Graft Function Related to Acute Kidney Injury – LOS ALTOS, Calif., May 28, 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 ...

– Results from Preclinical Model of Hyperphosphatemia Demonstrate the Relative Potency of OLC Compared to Tenapanor – – Oral UNI-494 Shows Promise in a Preclinical Model as a Potential Candidate for Prevention of Delayed Graft Function Related to Acute Kidney Injury – LOS ALTOS, Calif., May 28, 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 ...

[Business Update and Strategic Outlook](index=1&type=section&id=Business%20Update%20and%20Strategic%20Outlook) Unicycive is advancing its lead drug candidates, OLC and UNI-494, with significant clinical milestones expected in 2024, including topline data for OLC in Q2 and completion of UNI-494 Phase 1 in H2. The company is also focused on increasing program awareness within the medical community and recently completed a private placement to bolster its financial position - Unicycive is progressing its pivotal clinical trial for oxylanthanum carbonate (OLC), with topline data expected in **Q2 2024**. OLC aims to reduce pill burden for CKD patients with hyperphosphatemia[2](index=2&type=chunk)[5](index=5&type=chunk) - The company is developing UNI-494 for prevention of delayed graft function (DGF) after kidney transplantation, with the Phase 1 study's multiple ascending dose (MAD) portion advancing and full results expected in **H2 2024**[2](index=2&type=chunk) - Unicycive plans to expand awareness of its programs through presentations at prominent nephrology meetings, including NKF Spring Clinical Meeting and ERA Congress[2](index=2&type=chunk)[5](index=5&type=chunk) [CEO's Commentary](index=1&type=section&id=CEO%27s%20Commentary) CEO highlights OLC's pivotal trial progress and UNI-494's advancement, aiming to reduce pill burden and boost program awareness - CEO, Dr. Shalabh Gupta, stated that the pivotal clinical trial for OLC is on track, with topline data expected in **Q2 2024**, potentially offering a **4-fold reduction** in pill burden for CKD patients with hyperphosphatemia[2](index=2&type=chunk) - UNI-494, for DGF prevention, is advancing through its Phase 1 MAD portion, with full trial results anticipated in the **second half of 2024**[2](index=2&type=chunk) - A key priority for **2024** is expanding awareness of Unicycive's programs within the medical and scientific communities through presentations at major nephrology meetings[2](index=2&type=chunk) [Key Program Highlights](index=1&type=section&id=Key%20Program%20Highlights) This section details OLC's pivotal trial progress and UNI-494's Orphan Drug Designation and Phase 1 advancement - Topline data from the pivotal clinical trial of OLC in CKD patients with hyperphosphatemia is expected in **Q2 2024**[5](index=5&type=chunk) - Multiple presentations related to OLC and UNI-494 will be presented at the National Kidney Foundation (NKF) Spring Clinical Meeting and the 61st European Renal Association (ERA) Congress[5](index=5&type=chunk) - Enrollment was completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with OLC[12](index=12&type=chunk) [Oxylanthanum Carbonate (OLC) Program](index=1&type=section&id=Oxylanthanum%20Carbonate%20%28OLC%29%20Program) The OLC program completed pivotal trial enrollment, with topline data expected in **Q2 2024** for hyperphosphatemia in CKD patients - Topline data from the pivotal clinical trial of OLC is expected in the **second quarter of 2024**[5](index=5&type=chunk) - Enrollment was completed in the pivotal clinical trial with OLC, a next-generation lanthanum-based phosphate binding agent for hyperphosphatemia in CKD patients on dialysis[12](index=12&type=chunk) [UNI-494 Program](index=1&type=section&id=UNI-494%20Program) The UNI-494 program received Orphan Drug Designation for DGF prevention and is advancing through its Phase 1 MAD portion - UNI-494 was granted **Orphan Drug Designation (ODD)** by the FDA for the prevention of DGF in kidney transplant patients, potentially providing tax credits, user fee exemption, and market exclusivity[12](index=12&type=chunk) - The single ascending dose (SAD) portion of the Phase 1 clinical trial for UNI-494 was successfully completed, and the multiple ascending dose (MAD) portion is now administering **80 mg twice-a-day**[12](index=12&type=chunk) - New data demonstrating statistically significant results for UNI-494 in a preclinical model of DGF were presented at the AKI and CRRT 2024 conference[12](index=12&type=chunk) [Corporate Milestones](index=2&type=section&id=Corporate%20Milestones) Unicycive completed a private placement, generating **$50 million** and securing funding into **2026** - Unicycive completed a private placement with new and existing healthcare institutional investors, generating **$50 million** in gross proceeds[12](index=12&type=chunk) - As of **March 31, 2024**, cash and cash equivalents totaled **$48.9 million**, with the Company believing it has sufficient resources to fund planned operations into **2026**[11](index=11&type=chunk) [Financial Performance for Q1 2024](index=2&type=section&id=Financial%20Performance%20for%20Q1%202024) Unicycive reported a net loss of **$21.2 million** for Q1 2024, an increase from **$14.8 million** in Q1 2023, primarily driven by higher R&D expenses related to the OLC clinical trial and a significant change in the fair value of warrant liability. The company's cash position improved significantly to **$48.9 million** due to a recent private placement Key Financial Highlights (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :----------- | | Licensing Revenues | $0 | $675 | -$675 | | R&D Expenses | $6,813 | $3,030 | +$3,783 | | G&A Expenses | $2,391 | $1,847 | +$544 | | Total Operating Expenses | $9,204 | $4,877 | +$4,327 | | Loss from Operations | $(9,204) | $(4,202) | $(5,002) | | Change in fair value of warrant liability | $(11,808) | $(10,375) | $(1,433) | | Net Loss attributable to common stockholders | $(21,171) | $(14,767) | $(6,404) | | Net Loss per share (basic and diluted) | $(0.61) | $(0.97) | +$0.36 | - The increase in net loss was primarily attributable to increased drug development costs for the OLC clinical trial and a larger change in the fair value of the warrant liability[7](index=7&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) [Statements of Operations Analysis](index=2&type=section&id=Statements%20of%20Operations%20Analysis) Q1 2024 net loss increased to **$21.2 million**, primarily due to higher R&D expenses and a significant change in warrant liability fair value Q1 2024 vs. Q1 2023 Statements of Operations (in thousands) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :-------------------------------- | :------ | :------ | :----------- | | Licensing Revenues | $0 | $675 | -$675 | | Research and development | $6,813 | $3,030 | +$3,783 | | General and administrative | $2,391 | $1,847 | +$544 | | Total operating expenses | $9,204 | $4,877 | +$4,327 | | Loss from operations | $(9,204) | $(4,202) | $(5,002) | | Change in fair value of warrant liability | $(11,808) | $(10,375) | $(1,433) | | Net loss attributable to common stockholders | $(21,171) | $(14,767) | $(6,404) | | Net loss per share, basic and diluted | $(0.61) | $(0.97) | +$0.36 | - The increase in R&D expenses was primarily due to one-time costs related to the OLC clinical trial[7](index=7&type=chunk) - The increase in G&A expenses was primarily due to an increase in non-cash stock compensation costs[8](index=8&type=chunk) [Balance Sheet Analysis](index=4&type=section&id=Balance%20Sheet%20Analysis) As of **March 31, 2024**, cash and total assets significantly increased, while warrant liability also rose to **$24.9 million** Balance Sheet Highlights (as of March 31, 2024 vs. December 31, 2023, in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change | | :-------------------------------- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $48,930 | $9,701 | +$39,229 | | Total current assets | $51,676 | $13,399 | +$38,277 | | Total assets | $52,385 | $14,191 | +$38,194 | | Warrant liability | $24,941 | $13,134 | +$11,807 | | Total current liabilities | $30,282 | $17,534 | +$12,748 | | Total liabilities | $30,654 | $18,000 | +$12,654 | | Total stockholders' deficit | $(24,456) | $(3,809) | $(20,647) | - The significant increase in cash and cash equivalents was a primary driver for the increase in total assets[18](index=18&type=chunk) - The warrant liability increased from **$13.1 million** to **$24.9 million**, contributing to the rise in total liabilities[18](index=18&type=chunk) [Cash Position and Liquidity](index=2&type=section&id=Cash%20Position%20and%20Liquidity) Unicycive's cash and cash equivalents significantly increased to **$48.9 million**, securing funding into **2026** Cash and Cash Equivalents (in thousands) | Metric | As of March 31, 2024 | As of December 31, 2023 | Change | | :------------------------ | :------------------- | :---------------------- | :----- | | Cash and cash equivalents | $48,930 | $9,701 | +$39,229 | - The Company believes that it has sufficient resources to fund planned operations into **2026**[11](index=11&type=chunk) - A private placement generated **$50 million** in gross proceeds, significantly bolstering the cash position[12](index=12&type=chunk) [About Unicycive Therapeutics](index=3&type=section&id=About%20Unicycive%20Therapeutics) Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing novel treatments for kidney diseases. Its lead drug candidates are oxylanthanum carbonate (OLC) for hyperphosphatemia in CKD patients on dialysis, and UNI-494 for conditions related to acute kidney injury, including delayed graft function - Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases[13](index=13&type=chunk) - OLC is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis[13](index=13&type=chunk) - UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements subject to various risks and uncertainties, including the lengthy and uncertain nature of clinical trials, potential for unexpected side effects, business interruptions, dependence on key personnel, competition, patent protection issues, reliance on third parties, and regulatory approvals. Actual results may differ materially from these statements - Forward-looking statements are subject to risks including uncertain clinical trial outcomes, potential for unexpected side effects, business interruptions, and dependence on key personnel[14](index=14&type=chunk) - Other factors that could cause actual events to differ include substantial competition, uncertainties of patent protection and litigation, dependence upon third parties, and risks related to FDA clearances or approvals and noncompliance with FDA regulations[14](index=14&type=chunk) - Unicycive specifically disclaims any obligation to update any forward-looking statement[14](index=14&type=chunk)

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, 2024 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 ...